United States
Environmental Protection
Agency
Office of
Pesticides and Toxic Substencw
Washington DC 20460
Pesticide*
Ammonium Sulfamate
Pesticide Registration Standard

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           AMMONIUM SULFAMATE

     PESTICIDE REGISTRATION STANDARD
Lois Rossi
Anne Barton
William Boodee
Wayne Faatz
Ralph Freund
Randy Norris
Pat Ott
Donna Peacher
Bruce Sid well
Ellen Sullivan
Dorothy Vaughn
Vickie Walters
                          Project Manager (SPRD)
                          Science Policy Staff (HED)
                          Residue Chemist (HED)
                          Wildlife Biologist (HED)
                          Economist (BFSD)
                          Editor (SPRD)
                          Environmental Chemist (HED)
                          Typist (SPRD)
                          Plant Scientist (BFSD)
                          Toxicologist (HED)
                          Typist (SPRD)
                          Product Manager (RD)
               APRIL, 1981
Office of Pesticides and Toxic Substances
     Environmental Protection Agency
            401 M Street, SW
         Washington, D.C. 20460

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                          TABLE  OF  CONTENTS


 Chapter                                                         Page

I.    How to Register  Under a Registration Standard              1-1

II.   Agency Position  on  Ammonium  Sulfamate                     2-1
      1.  Introduction                                          2-1
      2.  Description  of  Chemical                                2-1
      3.  Regulatory Position for  Products Containing           2-1
          Ammonium  Sulfamate
      4.  Regulatory Rationale                                   2-2
      5.  Criteria  for Registration  Under  the  Standard           2-3
          Acceptable Ranges and  Limits                           2-3
            Manufacturing-Use Ammonium  Sulfamate
               Product  Composition  Standards                     2-3
               Acute Toxicity Limits                              2-4
               Use Patterns                                       2-4
           End Use  Ammonium Sulfamate                            2-4
             Product Composition Standards                      2-4
             Acute  Toxicity Limits                              2-4
             Use Patterns and Application  Methods                2-5
      6.  Required  Labeling                                      2-5
      7.  Tolerance Reassessment                                2-6

III.  Data Requirements and' Data Gaps                            3-1
      Manufacturing-Use Ammonium Sulfamate
      End Use  Ammonium Sulfamate
      Tables
         1.  Generic Data  Requirements                            3-3
         2.  Product-Specific Data  Requirements  for               3-14
            Manufacturing-Use Products
         3.  Product-Specific Data  Requirements  for               3-17
            End Use Products

IV.   Product  Chemistry                                          4-1
      Introduction                                               4-1
      Manufacturing-Use Ammonium Sulfamate                      4-1
        Product Chemistry Profile                                4-1
        Data Requirements                                        4-2
        Topical Discussions                                      4-2
        End Use Ammonium  Sulfamate                              4-5

V.    Environmental Fate                                         5-1
      Use Profile                                                5-1
      Manufacturing-Use Ammonium Sulfamate                      5-2
        Environmental  Fate Profile                              5-2
        Data Requirements                                        5-2
        Topical Discussions                                      5-2
      Formulations of  Ammonium  Sulfamate                         5-8

VI.   Toxicology                                                 6-1
      Manufacturing-Use Ammonium Sulfamate                      6-1
        Toxicology Profile                                       6-1
        Data Requirements                                        6-2

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        Required Labeling                                        6-2
        Topical Discussions                                      6-2
      Crystalline Ammonium Sulfaroate                             6-8
        Toxicology Profile                                       6-8
        Data Requirements                                        6-8
        Topical Discussions                                      6-8
      Soluble Concentrate Ammonium  Sulfamate                     6-9
        Toxicology Profile                                       6-9
        Data Requirements                                        6-10
        Topical Discussions                                      6-10
      Ready-to-Use and Pressurized  Liquid                        6-12
       Ammonium Sulfamate
        Toxicology Profile                                       6-12
        Data Requirements                                        6-12

VII.  Residue Chemistry                                          7-1
      Manufacturing-Use Ammonium Sulfamate                       7—i
        Residue Chemistry Profile                                7-1
        Data Requirements                                        7-1
        Topical Discussions                                      7-1

VIII. Ecological Effects                                         8-1
      Manufacturing-Use Ammonium Sulfamate                       8-1
        Ecological Effects Profile                               8-1
        Data Requirements                                        8-1
        Topical Discussions                                      8—1
      Crystalline Ammonium Sulfamate                             8-3
        Ecological Effects Profile                               8-3
        Topical Discussions                                      8-3
      Soluble Concentrate Ammonium  Sulfamate                     8-4
        Ecological Effects Profile                               8-4
        Topical Discussions                                      8-4
      Ready-to-Use and Pressurized  Liquid                        8-4
       Ammonium Sulfamate
        Ecological Effects Profile                               8-4
        Topical Discussions                                      8-4

IX.   Bibliography                                               9-1
      Guide to Use of Bibliography                               9-1
      Case Bibliography                                          9-4

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          CHAPTER  I:  HOW TO REGISTER UNDER  A  REGISTRATION STANDARD

   1. Organization of the Standard
   2. Purpose of the Standard
   3. Requirement  to Re-register Under  the Standard
   4. "Product  Specific" Data  and "Generic"  Data
   5. Data Compensation Requirements under FIFRA  3(c)(l)(D)
   6. Obtaining Data to Fill " Data Gaps"; FIFRA  3(c)(2)(B)
   7. Amendments to the Standard

 1. Organization of the Standard

 This  first chapter explains the purpose of a Registration  Standard  and
 summarizes the  legal principles involved  in  registering  or re-registering under
 a  Standard.  The second chapter sets forth the requirements  that  must  be met to
 obtain or retain registration  for products covered by  this particular
 Registration Standard.  In the remaining chapters, the Agency  reviews  the
 available data  by  scientific discipline,  discusses the Agency's concerns with
 the identified  potential hazards, and logically develops the conditions  and
 requirements that would reduce those hazards to acceptable levels.

 2. Purpose of the  Standard

 Section  3 of the Federal Insecticide, Fungicide,  and' Rodenticide  Act (FIFRA)
 provides that "no person in any State may distribute,  sell,  offer for  sale,
 hold  for sale,  ship, deliver for shipment, or  receive  (and having so received)
 deliver or offer to deliver, to any person any pesticide which is not
 registered with the Administrator [of EPA]."   To  approve the  registration of a
 pesticide, the  Administrator must find,  pursuant  to  Section  3(c)(5) that:

   "(A)  its composition is such as to  warrant the proposed  claims  for it;

    (B)  its labeling and other material  required to be  submitted comply
         with the  requirements of this  Act;

    (C)  it will perform its intended function without unreasonable adverse
         effects on the environment; and

    (D)  when used in accordance with widespread  and commonly  recognized
         practice it will not  generally cause  unreasonable adverse  effects
         on the environment."

 In making these findings, the  Agency reviews a wide  range  of data which
 registrants are required to submit, and  assesses  the risks and benefits
 associated with the use of the proposed  pesticide.   But  the  established
 approach to making these findings has been found  to  be defective  on two  counts:

 First, EPA and  its predecessor agency,  the United States Department of
 Agriculture (USDA), routinely  reviewed  registration  applications  on a  "product
by product" basis, evaluating  each product-specific  application somewhat
 independently.   In the review  of products containing similar components, there
was little opportunity for a retrospective review of the full,  range of
pertinent data available in Agency files  and in the  public literature. Thus  the
"product by product" approach  was often inefficient  and  sometimes resulted in
inconsistent or incomplete regulatory judgments.
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 Second,  over  the years,  as a  result  of  inevitable  and  continuing  advances in
 scientific  knowledge, methodology,  and  policy,  the data  base  for  many
 pesticides  came to be considered  inadequate by  current scientific and
 regulatory  standards.  Given  the  long history of pesticide  regulation in
 several  agencies, it is  even  likely  that materials may have been  lost from the
 data  files.   When EPA issued  new  requirements for  registration  in 1975 (40 CFR
 162)  and  proposed new guidelines  for hazard testing in 1978 (43 FR 29686, July
 10,  1978 and  43 FR 37336, August  2,  1978), many products that had already been
 registered  for years were being sold and used without  the same  assurances of
 human and environmental  safety as was being required for new  products.  Because
 of  this  inconsistency, Congress directed EPA to re-register all previously
 registered  products, so  as to bring  their registrations  and their data bases
 into  compliance with current  requirements,  [See FIFRA  Section 3(g)].

 Facing the  enormous  job  of re-reviewing and calling-in new data for the
 approximately 35,000 current  registrations, and realizing the inefficiencies of
 the  "product  by product" approach,  the  Agency decided  that a new,  more
 effective method of  review was needed.

 A new review  procedure has been developed.  Under  it,  EPA publishes documents
 called Registration  Standards, each  of which discusses a particular pesticide
 active ingredient.   Each Registration Standard  summarizes all the data
 available to  the Agency  on a  particular active  ingredient and its current uses,
 and  sets  forth the Agency's comprehensive position on  the conditions  and
 requirements  for registration of  all existing and  future products which contain
 that  active ingredient.  These conditions and requirements, all of which must
 be met to obtain or  retain full registration or reregistration  under  Section
 3(c)(5)  of  FIFRA, include the submission of needed scientific data which the
 Agency does not now have, compliance with standards of toxicity.  composition,
 labeling, and  packaging, and  satisfaction of the data  compensation provisions
 of FIFRA  Section 3(c)(l)(D).

 The Standard  will also serve  as a tool  for product classification.   As part of
 the registration of a pesticide product, EPA may classify each  product for
 "general  use" or "restricted  use" [FIFRA Section 3(d)1-   A  pesticide  is
 classified for "restricted use" when some special  regulatory  restriction is
 needed to ensure against unreasonable adverse effects  to man  or the
 environment.  Many such risks of  unreasonable adverse  effects can be'lessened
 if expressly-designed label precautions are strictly followed.  Thus the special
 regulatory restriction for a  "restricted use" pesticide  is  usually a
 requirement that it he applied only  by, or under the supervision  of,  an
 applicator who has been certified by the State  or  Federal government  as being
 competent to  use pesticide safely, responsibly, and in accordance with label
directions.   A restricted-use pesticide can have other regulatory restrictions
 [40 CFR  162.11(cK5)l instead of, or in addition to, the certified applicator
 requirement.  These other regulatory restrictions  may  include such actions as
 seasonal  or regional  limitations  on  use, or a requirement for the monitoring of
 residue levels after use. A pesticide classified for "general use," or not
classified at all, is available for  use by any  individual who is  in compliance
with  State or local  regulations.  The Registration Standard review compares
 information about potential adverse  effects of  specific  uses  of the pesticide
with  risk criteria listed in  40 CFR  162.11(c),  and thereby determines whether a
product needs to be classified for "restricted  use."  If the  Standard does
classify a pesticide for "restricted use," this determination is  stated in the
second chapter.


                                   1-2

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3. Requirement to Reregister Under the Standard

FIFRA Section 3(g), as amended in 1978, directs EPA  to  reregister  all  currently
registered products as expeditiously as possible.  Congress  also agreed  that
reregistration should be accomplished by the use of  Registration Standards.

Each registrant of a currently registered  product  to which this Standard
applies, and who wishes to continue to sell or distribute his  product  in
commerce, must apply for reregistration.   His application must contain proposed
labeling that complies with this Standard.

EPA will issue a notice of intent to cancel the registration of any  currently
registered product to which this Standard  applies  if the registrant  fails  to
comply with the procedures'for reregistration set  forth in the Guidance Package
which accompanies this Standard.

4. "Product Specific" Data and "Generic" Data

In the course of developing this Standard, EPA has'determined  the  types of data
needed for evaluation of the properties and effects  of  products to which  the
Standard applies, in the disciplinary areas of Product  Chemistry,  Environmental
Fate, Toxicology, Residue Chemistry, and Ecological  Effects.   These
determinations are based primarily on the  data Guidelines proposed in  43  FR
29696, July 10, 1978; 4*3 FR 37336, August  22, 1978;  and 45 FR  72948, November
3, 1980, as applied to the use patterns of the products to which this  Standard
applies.  Where it appeared that data from a normally applicable Guidelines
requirement was actually unnecessary to evaluate these  products, the Standard
indicates that the requirement has been waived.  On  the other  hand,  in some
cases studies not required by the Guidelines may be  needed because of  the
particular composition or use pattern of products  the Standard covers; if  so,
the Standard explains the Agency's reasoning.  Data  guidelines have  not yet
been proposed for the Residue Chemistry discipline,  but the  requirements  for
such data have been in effect for some time and are, the Agency believes,
relatively familiar to registrants.  Data  which we have found  are  needed  to
evaluate the registrability of some products covered by the  Standard may  not be
needed for the evaluation of other products, depending  upon  the composition,
formulation type, and intended uses of the product in question.  The Standard
states which data requirements apply to which produc : categories.  (See the
third chapter.)  The various kinds of data normally  required for registration
of a pesticide product can be divided into two basic groups:

   A. Data that are product specific , i.e. data that relates  only to  the
      the properties or effects of a product with a  particular
      composition (or a group of products  with closely  similar
      composition); and

   B. Generic data that pertains to the properties or effects  of a
      particular ingredient, and thus is relevant  to an evaluation of
      the risks and benefits of all products containing that ingredient
      (or all  such products having a certain use pattern), regardless  of
      any such product'SNunique composition.

The Agency requires certain "product specific" data  for each product to
characterize the product's particular composition  and physical/chemical
properties (Product Chemistry), and to characterize  the product's  acute
toxicity (which is a function of its total composition).  The  applicant  for


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registration or reregistration of any product, whether  it  is  a  manufacturing-
use or end-use product, and without regard  to its  intended  use  pattern,  must
submit or cite enough of this kind of data  to allow EPA to  evaluate  the
product.  For such purposes, "product specific" data on any product  other than
the applicant's is irrelevant, unless the other product  is  closely similar in
composition to the applicant's.  (VJhere  it  has been found  practicable  to group
similar products for purposes of evaluating, with  a single  set  of tests,  all
products in the group, the Standard so indicates.)  "Product  specific" data on
the efficacy of particular end-use products is also required  where the exact
formulation may affect efficacy and where failure  of efficacy could  cause
public health problems.

All other data needed to evaluate pesticide products concerns the properties or
effects of a particular ingredient of products (normally a  pesticidally  active
ingredient, but in some cases a pesticidally inactive,  or "inert",
ingredient).  Some data in this "generic" category are  required  to evaluate the
properties and effects of all products containing  that  ingredient [e.g.,  the
acute LD-50 of the active ingredient in  its technical or purer  grade;  see
proposed 40 CFR 163.81-l(a), 43 FR 373551.

Other "generic" data are required to evaluate all  products  which both  contain a
particular ingredient and are intended for  certain uses  (see, e.g.,  proposed 40
CFR 163.82-1, 43 FR 37363, which requires subchronic oral testing of the  active
ingredient with respect to certain use patterns only).  Where a  particular data
requirement is use-pattern dependent, it will apply to  each end-use  product
which is to be labeled for that use pattern (except where such  end-use product
is formulated from a registered manufacturing-use  product permitting such
formulations) and to each manufacturing-use product with labeling that allows
it to be used to make end-use products with that use pattern.   Thus, for
example, a subchronic oral dosing study  is  needed  to evaluate the safety  of any
manufacturing-use product that legally could be used to make  an  end-use,  food-
crop pesticide.  But if an end-use product's label specified  it  was  for  use
only in ways that involved no food/feed  exposure and no  repeated human
exposure, the subchronic oral dosing study  would not be  required to  evaluate
the product's safety; and if a manufacturing-use product's  label states  that
the product is for use only in making end-use products  not  involving food/feed
use or repeated human exposure, that subchronic oral study  would not be
relevant to the evaluation of the manufacturing-use product either.

If a registrant of a currently registered manufacturing-use or  end-use product
wishes to avoid the costs of data compensation [under FIFRA Section  3(c)(l)(D)]
or data generation [under Section 3(c)(2)(B)l for  "generic" data that  is
required only with respect to some use patterns, he may elect to delete  those
use patterns from his labeling at the time  he reregisters   his  product.   An
applicant for registration of a new product under  this  Standard  may  similarly
request approval for only certain use patterns.

5. Data Compensation Requirements under  FIFRA 3(c)(l)(D)

Under FIFRA Section 3(c)(l)(D), an applicant for registration,  reregistration,
or amended registration must offer to pay compensation  for  certain existing
data the Agency has used in developing the  Registration Standard.  The data for
which compensation must be offered is all data which are described by  all the
following criteria:

   A. The data were first submitted to EPA  (or to  its predecessor

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      agencies,  USDA  or  FDA),  on  or  after  January 1,  1970;

   B. The data were submitted  to  EPA (or USDA or  FDA)  by some other
      applicant  or registant in support of an application for an
      experimental use permit, an amendment adding a  new use to a
      registration, or for  registration, or to support  or maintain in
      effect  an  existing registration;

   C. They are the kind  of  data which are  relevant to  the Agency's
      decision to register  or  reregister the applicant's product
      under the  Registration Standard, taking into account  the
      applicant's product's composition and intended  use pattern(s);

   D. The Agency has  found  the data  to be  valid and usable  in reaching
      regulatory conclusions;  and

   E. They are not data  for which  the applicant has been exempted  by
      FIFRA Section 3(c)(2)(D) from  the duty to offer  to pay
      compensation.   (This  exemption applies to the "generic" data
      concerning the  safety of an  active ingredient of  the  applicant's
      product, not to "product specific" data.  The exemption is
      available  only  to  applicants whose product  is labeled  for end-
      uses for which  the active ingredient in question  is present  in
      the applicant's product  because of his use  of another  registered
      product containing that  active ingredient which  he purchases from
      another producer.)

An applicant  for reregistration of an already registered product under this
Standard, or  for registration  of a new product under  this Standard, accordingly
must determine which  of  the data  used by EPA in developing  the Standard must  be
the subject of an offer  to  pay compensation,  and  must  submit with  his
application the  appropriate statements evidencing his  compliance with FIFRA
Section  3(c)(l)(D).

An applicant  would never be required  to offer to  pay  for "product  specific"
data submitted by another firm.   In  many,  if not  in most cases,  data  which is
specific to another firm's  product will not suffice to  allow EPA to evaluate
the applicant's  product,  that  is, will not  be useful  to  the  Agency in
determining whether the  applicant's  product is registrable.   There may be
cases, however,  where because of close similarities between  the composition of
two or more products, another  firm's data  may suffice  to allow EPA to evaluate
some or all of the "product specific" aspects of  the applicant's product.  In
such a case,  the applicant  may choose to cite that data  instead  of submitting
data from tests  on his own  product,  and if  he chooses  that option, he would
have to comply with the  offer-to-pay requirements of  Section 3(C)(1)(D) for
that data.

Each applicant for registration or reregistration of a manufacturing-use
product, and each applicant for registration  or reregistration of  an  end-use
product, who  is not exempted by FIFRA Section 3(c)(2)(D), must comply with the
Section 3(c)(l)(D)  requirements with respect  to each item of "generic" data
that relates  to his product's  intended uses.

A detailed description of the procedures an applicant must  follow  in  applying
for reregistration (or new  registration) under this Standard is found in the
Guidance Package for  this Standard.

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 6.  Obtaining Data  to Fill  "Data  Gaps";  FIFRA 3(c)(2)(B)

 Some  of  the  kinds  of data  EPA needs  for its  evaluation of the properties and
 effects  of products  to  which  this  Standard  applies have never been submitted to
 the Agency (or,  if submitted,  have been found  to  have deficiencies rendering
 them  inadequate  for  making registrability decisions)  and have not been located
 in  the published literature search that EPA  conducted as part of preparing this
 Standard.  Such  instances  of  missing but required data are referred to in the
 Standard as  "data  gaps".

 FIFRA Section 3(c)(2)(B),  added  to FIFRA by  the Congress in 1978, authorizes
 EPA to require registrants  to  whom a data requirement applies to generate (or
 otherwise produce) data to fill  such "gaps"  and submit those data to EPA.  EPA
 must  allow a  reasonably sufficient period for  this to be accomplished.  If a
 registrant fails to  take appropriate and timely steps to fill the data gaps
 identified by a  section 3(c)(2)(B) order, his  product's registration may be
 suspended until  the  data is submitted.   A mechanism is provided whereby two or
 more  registrants may agree  to  share  in  the costs  of producing data for which
 they  are both responsible:

 The Standard  lists,  in  the  third chapter, the  "generic" data gaps and notes the
 classes of products  to  which  these data gaps pertain.  The Standard also points
 out that to  be registrable  under the Standard, a  product must be supported by
 certain required "product  specific"  data.  In  some cases,  the Agency may
 possess sufficient "product specific" data on  one currently registered product,
 but may lack  such  data  on  another.   Only those Standards which apply to a very
 small number  of  currently  registered  products  will  attempt to state
 definitively  the " product  specific"  data gaps on a "product by product"
 basis.  (Although  the Standard will  in  some  cases note which data that EPA does
 possess would  suffice to satisfy certain "product specific" data requirements
 for a category of  products  with  closely similar composition characteristics.)

 As  part of the process  of  reregistering currently registered products, EPA will
 issue Section  3(c)(2)(B) directives  requiring  the registrants to take
 appropriate  steps  to  fill  all  identified data  gaps — whether the data in
 question are  "product specific" or "generic" — in accordance with a_ schedule.

 Persons who wish to  obtain registrations for new  products  under this Standard
 will  be required to  submit  (or cite)  sufficient "product specific" data before
 their applications are  approved.  Upon  registration,  they  will  be required
 under Section  3(c)(2)(B) to take appropriate steps to submit data needed to
 fill  "generic." data  gaps.  (We expect they will respond  to this requirement by
 entering into cost-sharing agreements with other  registrants who previously
 have been told they must furnish the  data.)  The  Guidance  Package for this
 Standard details the  steps that must  be  taken  by  registrants to comply with
 Section 3(c)(2)(B).

 7-  Amendments to the Standard

 Applications for registration which  propose uses  or formulations that are not
 presently covered by the Standard, or which present product compositions,
 product chemistry data,  hazard data,  toxicity levels, or labeling that do not
meet the requirements of the Standard,  will automatically  be considered by the
 Agency to be requests for amendments  to  the Standard.  In  response to such
applications, the  Agency may request  additional data  to  support the proposed


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amendment to the Standard, or may deny the application for registration  on the
grounds that the proposed product would cause unreasonable adverse  effects to
the environment.  In the former case, when additional data have been
satisfactorily supplied, and providing that the data do not  indicate  the
potential for unreasonable adverse effects, the Agency will  then amend the
Standard to cover the new registration.

Each Registration Standard is based upon all data and information available to
the Agency's reviewers on a particular date prior to the publication  date.
This "cut-off" date is stated at the beginning of the second chapter.  Any
subsequent data submissions and any approved amendments will be incorporated
into the Registration Standard by means of addenda, which are available  for
inspection at EPA in Washington, D.C., or copies of which may be requested  from
the Agency.  When all the present "data gaps" have been filled and  the
submitted data have been reviewed, the Agency will revise the Registration
Standard.  Thereafter, when the Agency determines that the internally
maintained addenda have significantly altered the conditions for registration
under the Standard, the document will be updated and re-issued.

While the Registration Standard discusses only the uses and hazards of products
containing the designated active ingredientfs), the Agency is also  concerned
with the potential hazards of some inert ingredients and impurities.
Independent of the development of any one Standard, the Agency has  initiated
the evaluation of some inert pesticide ingredients.  Where the Agency has
identified inert ingredients of concern in a specific product to which the
Standard applies, these ingredients will be pointed out in the Guidance  Package.

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                                       II

                               Regulatory  Position


 1.  Introduction

 This  chapter  describes  in  detail  the  Agency's  regulatory position on
 products which contain  ammonium  sulfamate  as the sole  active  ingredient.   The
 regulatory  position  adopted  by the  Agency  incorporates a number of
 considerations.   Foremost  among  these  considerations is  an  analysis  of  the
 registrability of products containing  ammonium sulfamate based  on the risk
 criteria found in Section  162.11(a) of  Title 40 of  the U.S. Code  of  Federal
 Regulations.  The Agency's determination  is presented  below,  and  the rationale
 for this decision follows  the  position.

 In  addition to the basic regulatory decision and rationale, this
 chapter includes  the  following:   criteria  for  the registration  of ammonium
 sulfamate products under the Standard;  acceptable ranges and  limits  for product
 composition,  acute toxicity,  and  use  pattern/application method;  required
 labeling; tolerance  reassessment.

 The scientific basis  for a decision presented  in this  chapter can be found by
 reading the various disciplinary  chapters  (Chapters IV-VIII)  which provide
 summaries of  available  scientific data  on  ammonium  sulfamate.   The data
 requirements  and  data gaps are presented in Chapter III,  Tables  1-3.  Also,  the
 reason for  establishing a  data requirement can be found  in  the  footnotes of  the
 tables in Chapter III and  also in the  topical  discussion portion  of  Chapters IV-
 VIII.  References to  Agency  guidelines  for testing  are provided when
 appropriate.  In  instances where  the data  requirements differ from the
 guideline requirements, the  rationale  is presented  in  the footnotes  of  the
 tables.

 2. Description of Chemical

 Ammonium sulfamate is an inorganic  salt used as a herbicide on  a  variety of
 sites.  It  is a non-volatile, crystalline  solid.  Ammonium  sulfamate  also  has
 the following non-pesticidal uses:  flameproofing of textiles and paper
 products, for electroplating solutions, for generation of nitrous oxide gas.
 Only  the herbicidal use of this chemical will  be addressed  in this standard.

 Ammonium sulfamate is the accepted name for the chemical.   The Weed  Science
 Society of  America (WSSA) has adopted  the  common name  of  "AMS".   Trade  names
 for this chemical  include:    "Ammate" and "Ikurin".  The  Chemical  Abstracts
Registry (CAS) number for ammonium  sulfamate is 7773-06-0,  and  the EPA
 Shaughnessy number is 005501.

 3. Regulatory Position  for Products Containing Ammonium  Sulfamate

Ammonium sulfamate as described in  this Standard may be  registered
for sale,  distribution, reformulation, and use in the  United  States.
Considering information available to the Agency as of  March 10,  1081, the
Agency finds that  none of the risk  criteria found in Section  162.11(a)  of  Title
40 of  the U.S. Code of Federal Regulations were met or exceeded for  ammonium
sulfamate.
                                   2-1

-------
The information available to the Agency at the  time of  the  development  of this
Standard was very limited.  The Agency does not have  reason to  believe  that
the use of  this herbicide will cause unreasonable adverse effects  when  used in
compliance  with proper label directions and precautions.  Ammonium sulfamate
products currently registered may be reregistered subject to  the conditions
imposed for data requirements.  New products may be registered  under this
Standard, and are subject to the same requirements.

A. Regulatory Rationale

Ammonium sulfamate was developed and introduced as an herbicide in the  early
1940's for  the control of woody plants.  The chemical has had appreciable use
as a  herbicide since  then, with annual production figures ranging  from  3 to 10
million pounds.

Ammonium sulfamate products are registered for both domestic  and
nondomestic, terrestrial outdoor use.  Also, since the  chemical  is used to
control poison ivy in apple and pear orchards, it is  considered to have a food
use.

Acute toxicity data are available only for a soluble  concentrate formulation of
ammonium sulfamate.  These data indicate a low toxicity potential.   Mr  adequate
chronic studies are available.  Insufficient data on  a  19-month feeding study
in rats and summary data for a rat reproduction study were  submitted.   No
consistent  toxic effects were observed on growth, reproductive  performance,
viability,  or lactation, and no abnormal histopathological  findings were
reported by the authors.

Some data are available on the physical/chemical properties of  ammonium
sulfamate,  but major gaps exist in the product chemistry data base.  There are
no acceptable studies for the ecological effects or environmental  fate
of ammonium sulfamate and, also, there is not adequate  data on  residues on
apples, pears and their by-products.  Therefore, the  hazards  and potential
risks to humans and the environment as a result of exposure to  ammonium
sulfamate cannot be adequately assessed at this time.

The human accident data reported on this chemical included  four incidents
involving ammonium sulfamate alone and one incident involving ammonium
sulfamate in combination with other chemicals.  All of  the  persons involved in
these incidents received emergency and precautionary  medical  attention. Three
of the reported incidents consisted of accidental splashing of  ammonium
sulfamate in the eye and face.  After the affected areas were washed throughly
with water, no symptoms or injury persisted. One incident involved an
agricultural worker who developed a respiratory illness after spraying  ammonium
sulfamate.  However, the attending physician stated that the  case  was not one
of pesticide poisoning.  The case involving the ingestion of  ammonium sulfamate
in combination with other chemicals was an attempted  suicide, but  the subject
remained asymptomatic.

Although some accidents have been reported for  this chemical, the  reported
incidents were not of a serious nature and were treated effectively. The lack
of substantive accident data is significant since this  chemical has been used
for approximately forty years.

-------
In addition, the parent compound of ammonium  sulfamate,  sulfamic  acid,  was
assigned the generally recognized as  safe  status  (GRAS)  as  an  indirect  human
food ingredient by the Food and Drug  Administration  (PR  Notice Vol.44,  No.31 -
February 13, 1979, p.9402).  The review  conducted  by FDA considered  the health
aspects of sulfamic acid as an ingredient  of  food  packaging materials.   An
extensive search of the literature was conducted.  No chronic  studies relating
to possible carcinogenicity, mutagenicity, or teratogenicity of sulfamic acid
were available.  The decision to classify  sulfamic acid  in  the generally
recognized as safe status  (GRAS) as an indirect human food  ingredient was done
on the basis that there was no evidence  in the available information on
sulfamic acid that demonstrates, or suggests  reasonable  grounds to  suspect,  a
hazard to the public when  it is used  in  food-packaging materials  as  currently
practiced or as it might be expected  to  be used for  such purpose  in  the future.


5. Criteria for Registration Under the Standard

To be subject to this Standard, ammonium sulfamate products must  meet the
following conditions:

         1.  contain ammonium sulfamate  as the sole  active  ingredient;
         2.  be within acceptable standards of product composition;
         3.  be within acceptable acute  toxicity limits;
         4.  be labeled for acceptable end-uses; and
         5.  bear required labeling.

Manufacturing-use ammonium sulfamate  products must bear  label  directions
for formulations into acceptable end-uses.

The applicant for registration or reregistration of  ammonium sulfamate
products subject to the Standard must comply  with  all  terms and conditions
described in this Standard, including commitment to  fill  data  gaps  on a time
schedule specified by the Agency and, when applicable, offer to pay
compensation to the extent required by 3(c)(l)(D)  and  3(c)(2)(D)  of  the Federal
Insecticide, Fungicide, and Rodenticide  Act [FIFRAl,  as  amended,  7 U.S.C.  136
(c.)(l)(D) and 136 (c)(2)(D).

The only registrant that has submitted data in support of ammonium  sulfamate
registrations, and has not waived rights to compensation for data,  is
E.I. DuPont de Nemours and Company.

Acceptable Ranges and Limits

A. Manufacturing-use Ammonium Sulfamate

1.  Product Composition Standards

To be covered under this Standard, manufacturing-use  ammonium  sulfamate
products must contain ammonium sulfamate as the sole  active ingredient.
Manufacturing-use ammonium sulfamate products with any percentage of active
ingredient with appropriate certification  of  limits  are  acceptable under this
Standard.

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2.  Acute Toxicity Limits
The Agency will  consider  registration  of manufacturing-use ammonium sulfamate
products in the  following  toxicity categories:
                                                    II
               III
         IV
          Acute Oral Toxicity
          Acute Dermal Toxicity
          Acute Inhalation Toxicity
          Primary Eye Irritation
          Primary Dermal  Irritation
yes     yes
yes     yes
yes     yes
yes     yes
yes     yes
 yes     yes
 yes     yes
 yes     yes
 yes     yes
 yes     yes
 3.  Use Patterns
To be covered under this  Standard, manufacturing-use  ammonium  sulfamate
products must be labeled  for formulation into end-use pesticides  which are
intended for outdoor, domestic and/or nondomestic,  terrestrial, and  orchard
applications.

B. End Use Ammonium Sulfamate - Crystalline, Soluble  Concentrate,  Ready-to-Use,
    Pressurized Liquid

1.  Product Composition Standards

End use ammonium sulfamate products with any percentage of  active
ingredient are acceptable under this Standard with  appropriate
certification  of limits.

Inert ingredients in food-use formulations must be  cleared  for  such  use under
40 CFR 180.1001.  Currently, there are two inert ingredients used  in ammonium
sulfamate end use products that are not cleared.  These two ingredients are
listed in the Confidential Appendix to this Standard.  Registrants of end  use
products with inert ingredients that have not been  cleared  in  40  CFR 180.1001
must either remove the ingredient from the product  or obtain clearance.

2.  Acute Toxicity Limits

The Agency will consider  registration of any end use  ammonium  sulfamate
products for domestic use with the following categories:
          Acute Oral Toxicity            no
          Acute Dermal Toxicity          no
          Acute Inhalation Toxicity      no
          Primary Eye Irritation         no
          Primary Dermal Irritation      no
       II

       yes
       yes
       yes
       yes
       yes
III

yes
yes
yes
yes
yes
IV

yes
yes
yes
yes
yes

-------
To be registered for nondomestic use under  this  Standard,  any  end  use  ammonium
sulfamate products must have established  acute  toxicity  category II-IV ratings
according to the following table:
                                          I     II     III     IV

          Acute Oral Toxicity             no     yes    yes     yes
          Acute Dermal Toxicity           no     yes    yes     yes
          Acute Inhalation Toxicity       no     yes    yes     yes
          Primary Eye Irritation          no     yes    yes     yes
          Primary Dermal Irritation       no     yes    yes     yes

End use products that have estabished acute toxicity  category  II rating
and are registered for domestic use must  meet child resistant  packaging
requirements.

3.  Use Patterns and Application Me'thods

To be registered under this Standard, end use products of  ammonium sulfamate
must be labeled as herbicides  for one or  more of the  following uses:

               food uses                      non-food uses

               Apples                         Non-agricultural  sites
               Pears                          Rangelands and pastures

The Agency finds that it must  limit application  rates not  to exceed current
levels because of a lack of adequate data needed  to complete a hazard
assessment.  This is an interim measure which may need to  be reassessed
following the receipt of required data.

6. Required Label ing

All manufacturing-use and end-use ammonium  sulfamate  products  must bear
appropriate labeling as specified in 40 CFR 162.10.   The guidance  package  for
this Standard contains specific information regarding label requirements.

A. Manufacturing-use Products

1.  Use Pattern Statements

All manufacturing-use ammonium sulfamate  products -must list on the label the
intended end-uses of formulated products produced from the manufacturing-use
product.  In accordance with data to be submitted or  cited, all  ammonium
sulfamate labels must bear the following  statement:

        "For Formulation into End-Use Herbicide  Products
        Intended Only for Domestic, (Non Domestic), Food (Non  Food),
        Terrestrial, Outdoor Use."
                                     2-5

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2.  Precautionary Statements

There are no unique precautionary statements which must  appear  on the ammonium
sulfamate label.  The guidance package provides an updated list  of  all
precautionary statements which must appear for this  type of  product.   The
Agency may, after review of data to be submitted under this  Standard,
impose additional label requirements.

B.  End Use Ammonium Sulfamate Products

There are no unique precautionary statements which must  appear  on the ammonium
sulfamate label.  The guidance package provides an updated list  of
all precautionary statements which must appear for this  type  of  product.

The Agency may, after review of data to be submitted under this
Standard.impose additional label requirements.

7. Tolerance Reassessment

A tolerance of 5 ppm in or on apples and pears has been  established for
residues of ammonium sulfamate (40 CFR 180.88).  Based on these  established
tolerances for residues of ammonium sulfamate and on the  assumption that  each
commodity contains residues which meet the established tolerance  level, the
theoretical human exposure to residues of ammonium sulfamate  is  calculated  to
be 0.2089 mg/day/1.5kg diet.

The established tolerances of 5 ppm for apples and pears  are  not  supported  by
the available data.  Residue data for apples and pears and validation of  the
residue methodology are required.  No data are available  concerning residues
in apple pomace.  Residue data for apple pomace are currently being reserved
pending the results and evaluation of residue data on apples.  The  tolerances
will be reassessed when residue data are submitted.

Since ammonium sulfamate is registered for use in rangelands  and  pastures,
consideration must be given to potential residues in meat and milk and the
establishment of tolerances for these commodities.  Tolerances have not been
established for ammonium sulfamate residues in meat and milk  nor  has  an
exemption for these tolerances been granted.  No data are available on residues
in meat and milk.  Residue data are currently being reserved  pending  the
results and evaluation of residue data on apples at a detectable  level to
determine if residues are present in dairy animal and cattle  feedstuff and  the
receipt and evaluation of environmental fate data.  Milk  and  meat residue data
may be required if the fate data indicate that use of ammonium sulfamate  in
fruit orchards, pastures, and rangelands could result in  exposure to  grazing
animals and residues in meat and milk.
                                    2-6

-------
                                      Ill

                        Data Requirements and Data Gaps


Manufacturing-Use Ammonium Sulfamate

Table 1, entitled  Ammonium Sulfamate Generic Data Requirements, includes
those data that pertain to the properties or effects of ammonium Sulfamate as
an active ingredient.  Thus, these data  are relevant to an evaluation of the
risks and benefits of all products containing ammonium Sulfamate.  Providing
data to fill indicated gaps is the primary responsibility of the manufacturing-
use product registrant(s).  Registrants of end-use products which are not
exempted by FIFRA Section 3(c)(2)(D) are also responsible for  the submission of
these data.  Applicants for the registration or reregistration of manufacturing-
use ammonium sulfamate products must acknowledge reliance on existing data
which fill indicated data requirements under FIFRA 3(c)(l)(D).  These data are
listed under the column entitled Bibliographic Citation in this table.

Table 2, entitled  Ammonium Sulfamate Product-Specific Data Requirements
for Manufacturing-Use Products , includes those data that relate only to the
properties or effects of a product with a specific composition.  Thus, these
data are required of each product to characterize the product's particular
composition and physical/chemical properties, and acute toxicity.  Providing
data to fulfill these data requirements for a particular product is  the
responsibility of each applicant for the registration or reregistration of a
manufacturing-use ammonium sulfamate product.  If the Agency has in  its
possession product-specific data which fulfill a data requirement for a
particular product, this is indicated in the guidance package  accompanying this
Standard.

Applicants for the registration of new manufacturing-use ammonium sulfamate
products must submit all required product specific data or establish that the
proposed product is substantially similar to another product for which the
Agency has received acceptable product specific data.

If the Agency has determined that one or more existing manufacturing-use
ammonium sulfamate products are substantially similar, then this, too, is
indicated.  Product specific data need not be acknowledged under FIFRA
3(c)(l)(D) unless the Agency or a registrant has established that a  product is
substantially similar to another product for which the Agency  has received
acceptable product specific data.  If this should occur, the registrant(s)
of the former product(s) is required to acknowledge reliance on these data.

End Use Products of Ammonium Sulfamate

Registrants of end-use ammonium sulfamate products not exempted by FIFRA
Section 3(c)(2)(D) are responsible for the submission of "generic" data
described in Tables 1 and 2 of this Chapter, in addition to the product
specific data listed in Table 3.

Registrants of all end-use ammonium sulfamate products are advised that if data
are not generated to fill generic data requirements for the manufacturing-use
product(s), these registrations will be suspended.  If continued availability
of the manufacturing-use product is desired, this data must be supplied.


                                     3-1

-------
Table 3, entitled  Ammonium Sulfamate Product-Specific Data Requirements
for End-Use Products ,  includes those data that relate only to the
properties or effects of an end-use product with a specific composition.

-------
                     Table 1

Ammonium Sulfamate Produot-Chemiatry (See Chapter IV)
         Generic Data Requirements
Guidelines
Citation
163.61-8(1)
163.61-8(2)
163.61-8(3)
163-61-8(4)
163-61-6(5)
163-61-8(6)
163-61-8(7)
Name of Are Data
Test Required
Color
CHor
Melting Point
Solubility
Stability
Octanol/water
partition coefficent
Physical State
Yes
Yea
Yes
Yes
Yes
Yes ,
Yes
Must Additional Data be
Submitted under P1PRA
Does KPA Have 3(c)(2)(B)? If so, months
Data to Partially allowed for submission
or totally Satisfy Bibliographic from published date of
Composition this Requirement Citation standard
Technical All
Grade
Technical Grade No
Technical All
Grade
Technical Grade No
Technical Grade No
Technical Grade No
Technical All
Grade
Cain. 1972
MRID# 05008521
—
Fan, 1971,
MRID# 05016316
—
—
—
Cain. 1972,
MRID# 05008521
No
Yes/October,
No
Yea/October,
Yes/October,
Yes/October,
No

1981

1981
1981
1981

                        These data requirements are current as of April, 1981.  Refer to
                        guidance package for update requirements.
                          3-3

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                                                                Table 1  (Cont'd)

                                           Ammonium Sulfamate Peoduct Chemistry  (See Chapter -IV)
                                                     Generic Data Requirements
Guidelines
Citation
Name of
Test
Are Data
Required Composition
Does EPA Have
Data to Partially
or totally Satisfy
this Requirement
Bibliographic
Citation
Must Additional Data be
Submitted under FIFHA
3(c)(2)(B)? If so, months
allowed for submission
from published date of
standard
163.61-8(8)
163-61-8(9)
163-61-8(10)
163-61-8(11)

Density or
Specific Gravity
Boiling Point
Vapor Pressure
pH
Dissociation
Constant
Yes
Ho
Yes
Yes
Yes
Technical Grade

Technical
Grade
Technical
Grade
Technical
Grade
No

No
All
No
— Yes/October,

— Yes/October,
Ran, 1971, No
MRID# 05016316
— Yes/October,
1981

1981

1981
'   The dissociation constant of a chemical can be used  in assessing the aquatic, terrestrial, and metabolic  fate  of  the  chemical.   For water
   soluble compounds such as ammonium sulfamate, water  will usually be ttie reaction 'medium of concern.  Since dissociation  data will tell the
   Agency the active species in water (the intact molecule or only the sulfamate  anion), this piece of information  is required to determine the
   behavior of ammonium sulfaraate in the environment.
                                                                   These data requirements are current as of April, 1981.  Refer to guidance
                                                                   package for updated requirements.

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                                                                 Table 1  (Cont'd)

                                          Ammonium Sulfamate Qwironmemal  Pate  (See Chapter V)
                                                      Generic Data .Requirements
Guidelines
Citation
163.62-7(b)
163.62-7(c)
163.62-8(b)

163.62-8(c)

163.62-8(d)


163.62-8(e)


163.62-8(f)







Name of
Teat
Hydrolysis
Photodegradation
Aerobic soil
metabolism
Anaerobic soil
metabolism
Anaerobic
aquatic
metabolism
Aerobic
aquatic
metabolism
Microbial
metabolism
(2) effects of
microbes on
pesticides
(3) effects of
pesticides on
microbes
Are Data
Required
Yes
Yes
No2/

No

No2/


No2/



T /
No1/

i/
No1'


Must Additional Data be
Submitted under FIFRA
Does EPA Have 3(c)(2)(B)? If so, months
Data to Partially allowed for submission
or totally Satisfy Bibliographic from published date of
Composition this Requirement Citation standard
See Footnote 3 No — Yes/October,
See Footnote 3 No — Yes/October,


















1981
1981


















I/ The requirement for the submission of these data is currently being reservea  pending the  review and modification of the testing protocols.
   Consequently, the absence of acceptable data does not constitute a data gap.
2/ The requirement for the submission of data is currently being reserved  pending the  receipt  and evaluation of hydrolysis and photodegradation
   data.  The results of the hydrolysis and photolysis data will determine if any additional testing  is required.
3/ Technical or radio-labeled analytical grade.
                                                                   These data requirements  are  current as of April, 1981.
                                                                   cackaee foj-_ updated  reauirements.
Refer to guidance
                                                                 3-5

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                      Table 1 (Cont'd)

Ammonium Sulfamate Environmental Fete (See Chapter V)
            Generic Data Requirements
Guidelines
Citation
163.62-10(f)
163.62-10(g)
16?. 62-1 1(b)
163. 62-1 1(c)
163. 62-1 1(d)
163. 62-1 1(e)
163.62-13
Name of
Test
Combination
and tank mix
field dissipation
long term field
dissipation
study
Accumulation
in rotational
crops
Accumulation in
irrigated crops
Pish accumulation
Special studies
accumulation in
aquatic noncrop
uses
Disposal and
storage
Are Data
Required Composition
Ho
No
No
No
No
No
No
Must Additional Data be
Submitted under FIFRA
Does EPA Have 3(c)(2)(B)? if so, months
Data to Partially allowed for submission
or totally Satisfy Bibliographic from published date of
this Requirement Citation standard







                         These data requirements are current as of April,  1981.
                         package for updated requirements.
Refer to guidance
                      3-8

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                   Table 1  (Cont'd)

Ammonium Sulfamate'Toxicology (See Chapter VI)
             Generic Data Requirements
Guidelines
Citation
163.81-1
163.81-2
163.81-7
163.82-1
163.82-2
163.82-3
163.83-4
Name of
Test
Acute Oral
Toxicity
Acute Dermal
Toxicity
Acute
Heurotoxicity
Subchronic
Oral Toxicity
Subchronic
21-day Dermal
Toxicity
Subchronic
90-day Dermal
Toxicity
Subchronic
Inhalation
Toxicity
Must Additional Data be
Submitted under FIFRA
Does EPA Have 3(c)(2)(B)? If so, months
Data to Partially allowed for submission
Are Data or totally Satisfy Bibliographic from published date of
Required Composition this Requirement Citation standard
Yes Technical Grade No — Yes/October, 1981
Yes Technical Grade No — Yes/October, 1981
Ho
Yes Technical Grade Ho — Yes/April, 1982
Yes Technical Grade No — Yes/ April, 1982
No
Ho
                     These data requirements are current as of April, 1981.
                     package for updated requirements.
Refer to guidance
                   3-0

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                                                                 Table 1  (Cont'd)

                                               Ammonium Sulfamate Toxicology (See Chapter VI)
                                                           Generic Data Requirements


Guidelines
Citation
163.85-1
1-63.83-2
163.83-3
163.83-4


Name of
Test
Chronic Feeding
Oncogenicity
Teratogenicity
Reproduction


Are Data
Required Composition
No1/
No1/
2/
Yes ' Technical Grade
No5/
Does EPA Have
Data to Partially
or totally Satisfy
this Requirement


No
Partial
Must Additional Data be
Submitted under FIFRA
3(c)(2)(B)? If so, months
allowed for submission
Bibliographic
Citation


—
Sherman et al.
from published
standard


Yes/April
No
date of



, 1983

163.84-2
through 4

163-85-1
                                                                                              1964, HRID#
                                                                                              00004224
Mutagenicity


Metabolism
Yesc/


No1/
                               Technical Grade
                                                       No
Yes/April, 1982
T/The requirement for tne submission of data Is currently oeing reserved pending the receipt of requested residue data and
   environmental fate data.
2/ These data are required because ammonium sulfamate is registered for domestic use and aignifleant exposure could result.
3/ A rat reproduction study (Sherman et al. 1964) containing summary data was submitted.  Individual test animal data are
   required for this study to be considered adequate.  -However, the requirement for any further submission of data is currently
   being reserved pending the receipt of requested residue data and environmental fate data.
                                                                   These data requirements are current as of April, 1981.
                                                                   package for updated requirements.
                                                                                                          Refer to guidance
                                                                       •-  10

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                                                                 Table 1  (Cont'd)

                                          Ammonium Sulfamate Ecological Effects (See Chapter VIII)
                                                      Generic Data Requirements
Guidelines
Citation
163.72-1
163.72-2
163.72-3
Name of
Test
Are Data
Required
Pish Acute LC^Q Yes
Acute Toxicity to Yes
Aquatic Invertebrates
Acute Toxicity to No1/
Estaurine and
Marine Organisms
Does EPA Have
Data to Partially
or totally Satisfy
Composition this Requirement
Technical Grade No
Technical Grade No
Must Additional Data be
Submitted under PIFRA
3(c)(2)(B)? If so, months
allowed for submission
Bibliographic from published date of
. Citation standard
— Yes/January, 1982
— Yes/January, 1982
163-72-4         Bnbryolarvae and      No
                 Life-cycle Studies
                 of Pish and Aquatic
                 Invertebrates

163.72-5         Aquatic Organism      No1
                 Toxicity and Residue
                 Studies

163-72-6         Simulated or Actual   No1
                 Field Testing for
                 Aquatic Organisms
                                         I/
I/ The requirement for submission of these data is currently reserved pending the  results of  the following tests:  Pish Acute IC™
   Acute Toxicity to Aquatic-Invertebrates.

                                                                   These data requirements are current as of April, 1981.  Refer to guidance
                                                                   package for updated  requirements.
                                                                   3-  11

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                      Table 1  (Cont'd)

Ammonium Sulfamate Ecological Effects  (See Chapter VIII)
           Generic Data Requirements
Guidelines
Citation
163-71-1
163-71-2
163-71-3
163-71-4
163-71-5
Name of
Teat
Avian Single-Dose
Oral ID^Q
Avian Dietary
Mammalian Acute
Toxiclty
Avfan Reproduction
Simulated and Actual
Field Testing for
Mammals and Birds
Are Data
Required
Yes
Yes
No
No
No
Does EPA Have
Data to Partially
or totally Satisfy
Composition this Requirement
Technical Grade No
Technical Grade No



Must Additional Data be
Submitted under FIFRA
3(c)(2)(B)? If so, months
allowed for submission
Bibliographic from published date of
Citation standard
— Yes/January, 1982
— Yes/January, 1982



                        These data requirements  are current as of April, 1981.
                        package for updated  requirements.
Refer to guidance
                           3-12

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                                                                 Table 1  (Cont'd)

                                           Ammonium Sulfamate Residue Chemistry (See Chapter VII)
                                                     Generic Data Requirements
Guidelines Name of
Citation Test
— Metabolism in
In Plants
— Metabolism In
Animals
— Analytical Methods
— Residue Data:
Crops- Apples;
Pears
— Residue Data:
Processed Crops-
Apple pomace
— Residue Data:
Milk and Meat
•• - • - • - - - - - - ft,st Additional Data be
Submitted under PIPRA
Does EPA Have 5(c)(2)(B)? If so, months
Data to Partially allowed for submission.
Are Data or totally Satisfy Bibliographic from published date of
Required Composition this Requirement Citation standard
Yes1/ Technical Grade Ho —

2/
Yes ' Technical Grade Ho —

Yes5/ Technical Grade No —
Yes4/ Technical Grade No —


NoV Technical Grade


Ho6/ Technical Grade

Yes/April, 1982

Yes/April, 1982

Yes/April, 1982
Yes/April, 1982







Storage Stability   Yes
                                                Technical Grade
                                                                         No
Yes/April, 1982
I/ Plant metabolism data or an acceptable justification as to why plant metabolism data are not necessary, Including a discussion of
   possible metabolites, must be submitted.
2/ Animal metabolism data or an acceptable justification as to why such data are not necessary, including a discussion of possible
   metabolites must be submitted.
5/ Analytical method for detecting residues of ammonium sulfamate is required.
4/ Data on the nature and amount of residues on apples and pears are required to support established tolerance levels.  The
   results of these data will be used to assess possible dietary exposure to ammonium sulfamate; if residues can be expected in apple pomace,
   milk and meat; and determine if chronic toxicology testing will be required.
5/ Data are currently being reserved pending the results and evaluation of residue data on apples.
6/ Data are currently being reserved pending the results and evaluation of residue data on apples to determine If aomoniun suLfanate
   residues are present on animal feedstuff; and environmental fate data  to determine if ammonium sulfamate residues persist in the
   environment (pastures, rangelands) and result in exposure to grazing animals.
                                                                   These" data requirements are current as of April, 1981.
                                                                   Dackase for updated  requirements.
     Refer to guidance
                                                                  3-13

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                                                                     Table 2

                                                       Product Chemistry (See Chapter IV)
                            Ammonium Sulfamate Product-Specific Data Requirements for Manufacturing-Use Products
Guidelines
Citation
163.61-3
163.61-4
163.61-5
163.61-6
Does EPA Have
Data to Partially
Name of Are Data or totally Satisfy Bibliographic
Teat Required Composition this Requirement Citation
Product Identity Yes HUP No —
and Disclosure of
Ingredients
Description of Yes HUP No —
Manufacturing
Process
Discussion of Yea HUP No —
Ptormation of Unint.
Ingredients
Declaration and Yes HUP No —
Certification of
Ingredient Limits
Must Additional Data be
Submitted under PIFTIA
3(c)(2)(B)? If so, months
allowed for submission
from published date of
standard
Yes/October, 1981
Yes/October, 1981
Yes/October, 1981
Yes/October, 1981
163.61-7
Product Analytical
Hethods and Data
                      Yes
                                                        MUP
                                                                            No
Yes/October, 1981
163.61-8(7)
163.61-8(8)
163.61-8(9)
163.61-8(11)
163.61-8(12)
Physical State
Density or Specific
Gravity
Boiling Point
Ifl
Storage Stability
Yes
Yes
No
Yes
Yes
HUP
HUP

MUP
MUP
No —
No —

No —
No —
Yes/October, 1981
Yes/October, 1981

Yes/October, 1981
Yes/October, 1981
                                                                   These data requirements are current as of April, 1981.  Refer to guidance
                                                                   package for updated requirements.

-------
                                    Table 2 (Cont'd)

                          Product Chemistry (See Chapter IV)
Ammonium Sulfamate  Product-Specific Data Requirements  for Hanufacturing-Use Products
Guidelines
Citation
163.61-6(13)
163.61-8(14)
163.61-8(15)
163-61-8(16)
163.61-8(17)
163.61-8(18)
i/
~'/ Required
yi Required
•'' Required
Name of Are Data
Test Required
Flammability
Oxidizing or
Reducing Action
Explosiveness
Miscibility
Viscosity
Corrosion
Characteristics
for products containing a
for products containing a
for products which may be
Yes I/
Yes
Yea?/
Yes3/
Yes
Yes
Does EPA Have
Data to Partially
or totally Satisfy Bibliographic
Composition this Requirement Citation
HUP
MUP
HUP
HUP
HUP
HUP
No —
No —
No —
No —
No —
No —
Must Additional Data be
Submitted under FIBHA
3(c)(2)(B)? If so, months
allowed for submission
from published date of
standard
Yes/October, 1981
Yes/Octgber, 1981
Yes/October, 1981
Yes/October, 1981
Yes/October, 1981
Yes/October, 1981
volatile, flammable ingredient.
potentially explosive ingredient.
diluted with petroleum solvents.
                                      These data requirements are current as of April, 1981.   Refer to guidance
                                      package for updated  requirements.
                                    3-15

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                                                                Table 2 (Cont'd)

                                              Ammonium Sulfamate Toxicology (See Chapter VI)
                                     Product-Specific Data Requirements for Manufacturing-Use  Products
Guidelines
Citation
163.81-1
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
Does EPA Have
Data to Partially
Name of Are Data or totally Satisfy Bibliographic
Test Required Composition this Requirement Citation
Acute Oral Yes* HUP No —
Toxicity
Acute Dermal Yes» MUP No —
Toxicity
Acute Inhalation Yes HUP No —
Toxicity
Primary Eye Yes MUP No —
Irritation
Primary Dermal Yes MUP No —
Irritation
Dermal Yes MUP No —
Sensitization
Must Additional Data be
Submitted under PIFRA
3(c)(2)(B)? If so, months
allowed for submission
from published date of
standard
Yes/October,
Yea/October ,
Yes/October ,
Yes/October,
Yes/October,
Yes/October ,
1981
1981
1981
1981
1981
1981
* Technical ammonium sulfamate and the manufacturing-use product have been determined to be the same.   These requirements
  may be filled by data required in Table  1  entitled:  "Ammonium Sulfamate Toxicology Generic Data Requirements for Hanufacturing-
  Use Products."

                                                                  These data requirements are current as of April, 1981.  Refer  to guidance
                                                                  package for updated requirements.
                                                               3-16

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                                    Table 3

                           Product Chemistry (See Chapter IV)
Ammonium Sulfamate Product-Specific Data Requirements for End-Use Products
Guidelines
Citation
163.61-3
163.61-4
163.61-5
163.61-6
163.61-7
163.61-8(1)
163.61-8(2)
163.61-8(7)
163.61-6(8)
163.61-8(9)
Name of Are Data
Test Required
Product Identity
and Disclosure of
Ingredients
Description of
Manufacturing Process
Discussion of
Ibrmation of
Unint. Ingredients
Declaration and
Certification of
Ingredient Limits
Product Analytical
Color
Odor
Physical State
Density of Specific
Gravity
Boiling Point
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Composition
Each product
Bach product
Each product
Bach product
Each product
Each product
Each product
Each product
Each product

Does EPA Have
Data to Partially
or totally Satisfy Bibliographic
this Requirement Citation
No —
No —
No —
No —
No —
No —
No —
No —
No —

Must Additianal Data be
Submitted under FIPRA
3(c)(2)(B)? If so, months
allowed for submission
from published date of
"" standard
Yes/October,
Yes/October,
Yes/October,
Yes/October,
Yes/October,
Yes/October,
Yes/October,
Yes/October,
Yes/October,

1981
1981
1981
1981
1981
1981
J981
1981
1981

                                      These data requirements are current as of April, 1981.  Refer to guidance
                                      package for updated requirements.
                                    '-  1?

-------
                                    Table 3 (Cont'd)

                          Product Chemistry (See Chapter IV)
Ammonium Sulfamate Product-Specific Data Requirements for Bid-Use Products
Guidelines
Citation
163.61-8(11)
163.61-8(12)
163.61-8(13)
163.61-8(14)
163.61-8(15)
163.61-8(16)
163.61-8(17)
163.61-8(18)
2/ Required
J, Required
y' Required
Name of
Test
JH
Storage Stability
Plamniability
Oxidizing or
Reducing Action
Enplosiveness
Miscibility
Viscosity
Corrosion
Charac teristics
Are Data
Required
Yes
Yes
Yes I/
Yes
Yes2/
Yes3/
Yes
Yes
Composition
Bach product
Bach product
Bach product
Bach product
Bach product
Each product
Bach product
Bach product
Does EPA Have
Data to Partially
or totally Satisfy
this Requirement
No
No
No
No
No
No
No
No
Must Additional Data be
Submitted under FIfflA
3(c)(2)(B)7 If so, months
allowed for submission
Bibliographic from published date of
Citation standard
— Yes/October, 1981
— Yes/October, 1981
— Yes/October, 1981
— Yes/October, 1981
— Yes/October, 1981
— Yes/October, 1981
— Yea/October, 1981
— Yes/October, 1981
for products containing a volatile, flammable Ingredient.
for products containing a potentially explosive ingredient.
for products which nay be diluted with petroleum solvents.
                                      These data requlreoents- are current as of April, 1981.  Refer to guidance
                                      package for updated  requirements.
                                        3-13

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                                                                 Table 3 (Cont'd)

                                              Ammonium Sulfamate Toxicology (See Chapter VI)
                                     Product-Specific Data Requirements for Bid-Use Products
Guidelines
Citation
Name of
Test
Are Data
Required
Must Additional Data be
Submitted under FIFHA
Does EPA Have 3(c)(2)(B)? If so, months
Data to Partially allowed for submission
or totally Satisfy Bibliographic from published date of
Composition this Requirement Citation standard
Crystalline Formulations
163.81-1
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
Acute Oral
Toxicity
Acute Dermal
Toxicity
Acute Inhalation
Toxicity
Primary tye2/
Irritation
21
Primary Dermal '
Irritation
Dermal1/
Sensitization
Yes1/
Yes1/
Yes1/
Yes2/
Yes2/
Yes1/
Ifech product Ho — Ho
Bach product Ho — Ho
Bach product Ho — Ho
See footnote 2 Ho — Yes/October, 1981
See footnote 2 Ho — Yes/October, 1981
Bach product Ho — Ho
I/ The testing of the manufacturing-use product will fill these data requirements for crystalline formulations.   These requirements will be
   filled by data required in Table 2 entitled:  "Ammonium Sulfamate Toxicology Product - Specific Data Requirements for Manufacturing-Use
   Products".
2/ This test is required on any one of the products with the following registration numbers:   2169-262,  829-OBO,  10107-21,  352-206, 8127-22,
   1348-202, 829-220, 8590-219, 2125-47, 5481-56, 4887-134.

                                                                   These data requirements are current as of April,  1981.  Refer to guidance
                                                                   package for updated requirements.

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                                                                 Table 3 (Cont'a)

                                              Ammonium Sulfamate Toxicology (See Chapter VI)
                                     Product-Specific Data Requirements for Bid-Use Products
Guidelines
Citation
Must Additional Data be
Submitted under PiFRA
Does EPA Have 3(c)(2)(B)? If so, months
Data to Partially allowed for submission
Name of Are Data or totally Satisfy Bibliographic from published date of
Test Required Composition thia Requirement Citation standard
2. Soluble Concentrate
163.81-1
163.81-2
163.81-3
163.81H
163.81-5
163.81-6
Acute Oral Yes fech product Yea
Tpxicity
Acute Dermal Yes Each product Yes
Toxic ity
Acute Inhalation Yes ' &ch product No
Toxiclty
Primary EJye Yes Each product Yea
Irritation
Primary Dermal Yes fech product Yes
Irritation
Dermal Yes ' Ibch product Ho
Senaitization
Bullock and
Narcisse 1974a,
HRID# 00004214
Bullock and
Narcisse 1974b,
HRID# 00004215
—
Bullock and
Narcisse 1974d,
HRID# 00004216
Bullock and
Narcisse 1974e,
MRID# 00004217
—
No
Ho
No
No
No
No
37 The testing on the manufacturing-use product(s) will fill these data requirements for the soluble concentrate formulations.
   These requirements will be filled by data required in Table 2 entitled!  "Ammonium Sulfamate Toxicology Product - Specific
   Data Requirements for Hanufacturing-Uae Products".
                                                                   These data requirements are current as of April, 1981.
                                                                   package for updated requirements.
Refer to guidance

-------
                                                                 Table 3  (Cont'd)

                                              Ammonium Sulfamate Toxicology  (See Chapter VI)
                                     Product-Specific Data Requirements for  Bid-Use Products
Guidelines
Citation
Must Additional Data be
Submitted under FIFRA
Does EPA Have 3(c)(2){B)? If so, months
Data to Partially allowed for submission
Name of Are Data or totally Satisfy Bibliographic from published date of
Test Required Composition this Requirement Citation standard
3. Ready-to-Use
163.81-1
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
Acute Oral Yes Each product Yes
Toxicity
Acute Dermal Yes Bach product Yes
Toxicity
Acute Inhalation Yes ' Bach product Bo
Toxicity
Primary Eye Yes Bach product Yes
Irritation
Primary Dermal Yes Bach product Yes
Irritation
Dermal Yes ' Bach product No
Sensitization
Bullock and
Harcisse 1974a,
MRID# 00004214
Bullock and
Narcisse 1974b,
MRID# 00004215
—
Bullock and
Narcisse 1974d,
MRID# 00004216
Bullock and
Narcisse 1974e,
MRID# 00004217
—
No
No
No
No
No
No
4/  The testing on the manufacturing-use product(s)  will fill these data requirements for the ready-to-use formulations.
    These requirements will be filled by data required in Table 2 entitled:  "Ammonium Sulfamate Toxicology Product-Specific
    Data Requirements for Manufacturing-Use Products."

                                                                  These data  requirements are current as of April, 1981.  Refer to guidance
                                                                  package for updated requirements.
                                                               3- 21

-------
                                                                Table 3 (Cont'd)

                                              Ammonium Sulfamate Toxicology (See Chapter VI)
                                     Product-Specific  Data Requirements for End-Use Products
Guidelines
Citation
4. Pressurized
163.81-1
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
Must Additional Data be
Submitted under FIFRA
Does EPA Have 3(c)(2)(B)7 If so, months
Data to Partially allowed for submission
Name of Are Data or totally Satisfy Bibliographic from published date of
Test Required Composition thla Requirement Citation standard
Liquid
Acute Oral Tea Each product Yes
Toxlcity
Acute Dermal Tea Each product Tea
Toxlcity
Acute Inhalation Tea Each product No
Toxlcity
Primary Eye Yes Each product No
Irritation
Primary Dermal Tea Each product Tea
Irritation
Dermal Tes Each product No
Sens Itlzat ion
Bullock and No
Narclsse 1974a,
HRIDf 00004214
Bullock and No
Narclaae 1974b,
MRIDf 00004215
No
— Tes/October, 1981
Bullock and No
Narclsse 1974e,
MRIDf 00004217
— No
5/ The testing on the manufacturing-use product(s) will  fill  these data requirements for the pressurized liquid formulations.
    These requirements will be filled by data  required in Table 2 entitled:  "Ammonium Sulfamate Toxicology Product-Specific
    Data ftequlreraents for Manufacturing-Use Products."
                                                                  These data requirements are current as of April, 1981.   Refer to guidance
                                                                  package for updated requirements.
                                                                   3-22-

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                                      IV
                                           fl

                                Product Chemistry
Introduction
FIFRA  3(c)(2)(A) requires  the  Agency  to  establish  guidelines  for  registering
pesticides in the United States.  The  Agency  requires  registrants  to  provide
quantitative data on all added  ingredients, active  and  inert,  which are  equal
to or  greater than 0.1% of  the  product by weight.

To establish the composition of products proposed  for  registration, the
Agency requires data and information not only on the manufacturing and
formulation processes but  also  a discussion on  the  formation  of manufacturing
impurities and other product ingredients, intentional  and unintentional.
Furthermore, to assure that the composition of  the  product  as  marketed will not
vary from the composition  evaluated at the time of  registration, applicants are
required to submit a statement  certifying upper and lower composition limits
for the added ingredients,  or  upper limits only for some unintentional
ingredients.  Subpart D of  the  Proposed  Guidelines  (43  FR 29696, July 10,  1978)
suggests specific precision limits for ingredients  based on the percentage of
ingredient and the standard deviation  of the  analytical method.

In addition to the data on  product composition, the Agency  guidelines
also require data to establish  the physical and chemical properties of both the
pesticide active ingredient and  its formulations.   For  example, data  are needed
concerning the identity and physical  state of the  active ingredient such as
melting and boiling point data,  ambient vapor pressure  and  solubility.   Data
are also required on the properties of the formulated  product  to establish
labeling cautions e.g., flammability,  corrosiveness or  pesticide storage
stability.  The Agency uses these data to characterize  each pesticide and  to
determine its environmental and  health hazards.

Product Chemistry - Manufacturing-Use  Ammonium  Sulfamate

Product Chemistry Profile

Ammonium sulfamate is a herbicide with the chemical formula:
N H SO .  The technical product  is at least 97% pure,  forms colorless
plates, and is a non-volatile hygroscopic crystalline  solid.

Ammonium sulfamate is very  soluble in water and liquid  NH».   It is moderately
soluble in glycerol, glycols, and formamide.  The melting point of ammonium
sulfamate is 131-132 C and  it decomposes at 160 C  to non-flammable gas.

Technical ammonium sulfamate is  a "manufacturing-use product"  and  is  used
in formulations as a single active ingredient.  There  are two  formulated'
products with multiple active ingredients.

The manufacturing impurities which are present  in  ammonium  sulfamate  were
not reported.   The confidential  statements of ingredients for  about 60
formulated products indicate that, with the exception of two  compounds,  the
inert   ingredients are cleared under 40 CFR 180.1001.  These two inert


                                    4-1

-------
ingredients are listed in the Confidential Appendix  to  this  Standard.
Registrants of end use products with  inert ingredients  that  have  not  been
cleared in 40 CFR 180.1001 must either remove  the  ingredient from the  product
or obtain clearance.

No physical/chemical properties for any of the  formulations  were  reported.

Data Requirements

The data requirements needed to evaluate the continued  registration of
ammonium sulfamate products to which  this Standard applies are  listed  in
Chapter III, Tables 1-3.

Topical Discussions

Corresponding to each of the Topical  Discussions listed  below is  the
number of the section in the 'Proposed Guidelines  for Registering of  Pesticides
in the United States' (A3 FR 29696, July 10, 1978) which explains the  minimum
data that the Agency requires in order to adequately assess  Product Chemistry
of manufacturing-use ammonium sulfamate products.  Also,  under  each of the
following topics is a reference to the appropriate section in the 'Proposed
Guidelines'.

    Chemical Identity	163.61-3
    Manufacturing Processes	163.61-4
    Formation of Unintentional Ingredients	163.61-5
    Active Ingredient Limits in Pesticide Products	163.61-6
    Product Analytical Methods and Data	163.61-7
    Physical/Chemical Properties	163.61-8

Chemical Identity

The Proposed Guidelines (40 CFR 163.61-3(c)) require identifying
information including chemical names, product names, and  numerical  codes of  all
substances known or assumed to be present in pesticide products.

Ammonium sulfamate is the accepted name for the chemical.  The  Weed
Science Society of America (WSSA) has adopted the  common  name 'AMS'.   Ammonium
sulfamate is also known by the Trade names "Ammate" and  "Ikurin".  Other names
for the chemical listed in the  Farm  Chemicals Handbook  1980 include:  Ancide
and Sulfamate.  The Chemical Abstracts Registry (CAS) number for  ammonium
sulfamate is 7773-06-0, and the EPA Shaughnessy number is 005501.

The chemical  name ammonium sulfamate will be routinely used  in  this
registration standard in lieu of trade or other names.

The molecular configuration of ammonium sulfamate  is:

                                  0
                                  II
                         H2 N   - S - 0 - NH^
                                  II
                                  0

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Manufacturing Processes

Because  the  route  by which a pesticide is  synthesized  determines the
nature and amount  of potentially toxic impurities,  a detailed  description of
the manufacturing  process  is required  (40  CFR 163.61-4).

The open literature  describes a  number of  processes by which ammonium
sulfamate may be synthesized:

          (A)   By neutralization  with  ammonia of sulfamic  acid  obtained  by
               careful  heating of urea  with oleum:

                (NH_)CO+SO. + H  SO, -  2 HSO-NH +CO
               The  yield  of  ammonium sulfamate  by this  reaction  is  said  to be
               not  less than 90% with a  purity  of not less  than  90%.   (U.S.
               Patents  2,102,350,  and 2,487,480)  (MRID# 00160001, 00160002.)

          (B)   Directly,  by  reaction of  ammonia and  sulfuric  anhydride at  an
               elevated temperature.  The  purification  is  complicated, but the
               process  is inexpensive.  (Sitting,  Noyes  Data Corp.,  Park  Ridge,
               New  Jersey,  1977).

          (C)   By the action of  non-gaseous  sulfur trioxide on liquid  ammonia.
               (US  Patent 2,426,240) (MRID#  00160003).

          (D)   By heating ammonium nitrilosulfonate  under  high pressure,  (MRID#
               05011074).

          (E)   By heating imidosulfonate in  the presence of ammonia under  high
               pressure (MRID# 05004655).

          (F)   By a laboratory procedure involving the  reaction  of  ammonia and
               sulfur dioxide to produce sulfur,  ammonium  sulfate,  and ammonium
               sulfamate  (MRID#  05010475).

The Farm  Chemicals Handbook 1980   lists the E.I. du Pont  de  Nemours and
Co.,  Inc. as the only basic producer of ammonium sulfamate in the  United
States, which  it markets under  the Trade  name  "Amraate".  No  description of  the
manufacturing  process actually  bein£ used by Du  Pont has  been submitted.   This
constitutes a  data gap.

Ammonium  sulfamate is also  manufactured abroad.   This  material  is  imported
by Aceto  Chemical  Co., but  there  is no  description  of  this manufacturing
process.  This constitutes  a data  gap.

Formation £f_ Unintentional  Ingredients

Section 163.61-5 of the  Proposed  Guidelines required registrants of
manufacturing-use  and of formulated products to  submit a  theoretical  discussion
of the formation of unintended  subtances  in the  product.

No data on the nature of the impurities which  may be present in ammonium
sulfamate were available.   This constitutes a  data  gap.

-------
Active Ingredient Limits i_n Pesticides Products

The Guidelines require that upper and lower limits be established for each
active ingredient and each intentionally added inert in a pesticide product  (40
CFR 163.61-6).

A statement submitted by Du Pont states that its technical grade Ammate
contains at least 97% ammonium sulfamate.  The remaining 3% consists of
manufacturing impurities whose identities have not been reported to the Agency.

Product Analytical Methods and Data

The Proposed Guidelines (40 CFR 163.61-7) require submission of, or
reference to, analytical methods for measuring each active ingredient in a
pesticide product.

The manufacturer of ammonium sulfamate did not report a method for the
identification and quantification of the active ingredient and possible
manufacturing impurities in the technical product nor in the end use
formulations.  This constitutes a data gap.

The EPA Manual of Chemical Methods for Pesticides and Devices reports a method
for the determination of ammonium sulfamate by sodium nitrate titration;
however, the sensitivity of the method, accuracy and reproducibility are not
reported.

Physical and Chemical Properties

For every pesticide product, the Proposed Guidelines (163.61-8) require
data on certain physical and chemical properties useful for identification
purposes or for evaluation of hazard potential.

Available data from the open literature and registrant submissions on the
physical and chemical properties of technical ammonium sulfamate are as follows:

         Color:  colorless (Technical chemical) (MRID# 05008521)
         Odor:   There are no available data.
         Melting Point:  131°C (Technical chemical) (MRID# 05016316)
         Solubility:   Very soluble in water (232 gm/100 cc at 30°C),
                         soluble in glycerol, glycols, and formamide.
                         (MRID# 00160004)     *
         Stability;    There are no data available.
         Octanol/Water Partition Coefficient;   There are no data available.
         Physical State;  Solid crystals (MRID# 05008521)
         Density or Specific Gravity:  There are no data available.
         Vapor Pressure;  There are no data available.
         pH:   For a 5% solution, the pH equals 5.2.  (MRID# 05016316)

-------
The following physical/chemical properties were not reported for manufacturing-
use ammonium sulfamate:

         Physical State
         Density or Specific Gravity
         PH
         Storage Stability
         Flammability
         Oxidizing or reducing action
         Explosiveness
         Miscibility
         Viscosity
         Corrosion Characteristics
         Dissociation Constant

Product Chemistry - Ammonium Sulfamate End Use Products

No data are available on ammonium sulfamate end-use products.  The required
data are presented in Chapter III, Table  3.
                                   4-5

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                          ENVIRONMENTAL FATE

Use Profile

Ammonium  sulfamate  is  an  inorganic  salt used  as  a nonselective  herbicide  on a
variety of sites.   Registered  use sites include:

    Apple and  pear  orchards
    Pastures
    Rangeland
    Right-of-ways
    Industrial  sites (such as  farms  and railroad  switchyards)
    Roadsides
    Landscaped  areas (such as  lawn  borders, walkways  and  patios)
    Paved areas  (such  as  parking lots  and  tennis  courts)
    Borders of  drainage ditches and  reservoirs
    Other noncrop areas

Ammonium  sulfamate  in  effective is  killing most wood  plants  including hardwood
and coniferous  species.   It  is considered  useful  for  control of poison  ivy.
Ammonium  sulfamate  also controls herbaceous perennials  such  as leafy spurge,
bitter dock, goldenrod, perennial ragweed, milkweed,  and  blueweed, as well  as
most annual broadleaf  weeds  and grasses.

About 88% of ammonium  sulfamate domestic annual production is used by
industry, commercial,  or  government  personnel on  the  noncrop uses mentioned
above.  Sites of particular  importance  in  this group  are  roadsides, and brushy
areas along drainage ditches and reservoirs.  About 7%  of ammonium sulfamate
production is applied  to  agricultural  sites,  primarily  in apple and pear
orchards  for control of poison ivy.    Very little is  used on
pastures and rangeland.   An  additional  5%  is  used  by  homeowners, mostly for
control of weeds in landscaped areas and for  control  of poison  ivy.

Three types of  formulation are available:   crystals containing 95 to 99%
A.I.; soluble liquid concentrates containing  19 to 55%  A.I.; and ready-to-use
solutions containing from 8  to 12% A.I.

Ammonium sulfamate  solutions are applied to target weeds  by  airblast sprayers,
tractor-pulled ground  rig, hand-directed sprayers, or backpack and hose-end
sprayers.  Along waterways,  solutions  may  be  applied  by boat-mounted spray
equipment.  Typical right-of-way application  is by a  boom-type sprayer.
Ammonium sulfamate  is  also applied as  dry  crystals to notches in undesired
trees and to tree stumps  to  prevent  sprouting.

Use rates are 57-120 Ibs  A.I.  in 100 gallons  of water per acre  for all  sprayers
except airblast equipment.   The recommended rate  for  airblast equipment is  100-
400 Ibs A.I. per acre  in  100 gallons of water.  Ammonium  sulfamate is not
normally applied with  other pesticides  nor  is it  applied  aerially.  Diesel
oil is often used with ammonium sulfamate  in  dormant  stem treatments of weed
trees since the oil aids  penetration of bark  and  promotes herbicide entry.
Surfactants are also frequently added  at the  time of  application to water-
based solutions.

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Environmental Fate-Manufacturing-Use Ammonium Sulfamate

Environmental Fate Profile

The  submitted data are  insufficient to  predict the  fate  of ammonium sulfamate
(AMS) in the environment.  Preliminary  data  indicate  that  AMS may,  under
certain circumstances,  increase or decrease  microbial  populations  in soil.   The
treatment of starch amended soil with AMS led  to an increase  and decrease in
the  number of fungi and bacteria (including  actinomycetes),- respectively.  AMS
had  no effect-on microbial counts obtained from non-amended  soil.   Fungal
colonization of AMS-treated hardwood stumps  was enhanced over a 2.5-year period
relative to nontreated  stumps, indicating that fungal  cellulose degradation
processes are probably  not inhibited by AMS.   Limited  data on the  leaching  of
AMS  indicate that it is very mobile in  soil  and moves  by mass flow.  AMS at 50-
200  kg/ha will leach about 14 and 15 cm in soil eluted with 2-4 and 50 cm of
water, respectively.


Data Requirements

The  data requirements needed to evaluate the  continued registration of
ammonium sulfamate products to which this Standard  applies are listed in
Chapter III, Table 1.

Topical Discussions

Corresponding to each of  the Topical Discussions listed  below is the number
of the section in the "Proposed Guidelines for Registering Pesticides in the
United States" (43 FR 29696, July 10, 1978)  which explains the minimum data
that the Agency requires  in order to adequately assess the environmental fate
of a pesticide.

              Type of_ Data                       Guideline Section

              Physico-Chemical Transformation         163.62-7
              Metabolism  (Soil, Aquatic and           163.63-8
                           Microbiological)
              Mobility                                163.62-9
              Field Dissipation                       163.62-10
              Accumulation                            163.62-11

PHYSIO-CHEMICAL TRANSFORMATION

Hydrolysis

Hydrolysis data are required to support the  registration of  each manufac-
turing-use product and of each formulated end-use product  intended  for
terrestrial, forestry, aquatic, and aquatic  impact  use patterns.

No data are available on  the hydrolysis of ammonium sulfamate.

All studies specified in  Section 163.62-7(b) are needed  to assess  the
hydrolysis properties.


                                     5-2

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Photolysis

A photodegradation  study  in  water  is  required  to  support  the  registration
of each formulated  end-use product  intended  for terrestrial  (except
greenhouse and domestic outdoor),  aquatic,  and  forestry use  and  for  any aquatic
impact use which results  in  direct  discharges  into  the  aquatic environment.
Such a study  is also  required  to support  the registration of  each manufacturing-
use product which legally could be  used to  make such  an end-use  product.

Photodegradation studies  on  soil surfaces are  required  to support the
registration  of all formulated AMS  products  intended  for  crop and forestry uses.

No data on the photodegradation of  AMS are  available.
                          t
Data specified in Section 163.62-7(c) are needed  to determine the effect  of
ligh  on AMS.  Vapor  phase studies  are not  required since AMS does not  have  a
greenhouse use and  re-entry  is not  a  consideration  at this time.

METABOLISM

Data on metabolism  are required to  determine the  nature and  availability  of
pesticide residues  to rotational crops and  to help  in the assessment of
potential disposal  and reentry hazards.

Soil Metabolism

An aerobic soil metabolism study .is required to support the  registration  of
each end-use  product  intended  for  terrestrial or  forestry use, and also to
support the registration  of  each manufacturing-use  product which legally  could
be used to make such  an end-use product.

An anaerobic  soil metabolism study  is required  to support the registration
of each end-use product intended for  field  or vegetable crop  use, and also
that of each manufacturing-use product which legally  could be used to make such
an end-use product.   Aerobic  soil metabolism data are not required because
ammonium sulfamate  is not used for  field  and vegetable  crops.

Two studies (Abumiya  1966, 05013104)  (Konnai 1974,  05016686)  on  the  soil
metabolism of AMS were reviewed and judged  to be  invalid.

The requirement for the submission  of the above data  is currently being
reserved, pending the receipt and evaluation of hydrolysis and photodegradation
data.  The results of these  tests will determine  what chemical species  remain
in the environment  from ammonium sulfamate  use  and  whether the metabolism study
is needed to predict  the  fate of these species.

Aquatic

An aerobic aquatic metabolism  study is required to  support the registration  of
each formulated end-use product intended  for aquatic  use  or  for  any  aquatic
impact use which results  in  direct  discharges  into  the  aquatic environment.
Such a study  is also  required to support  the registration of  each manufacturing-
use product which legally could be  used to make such  an end-use  product.
                                   5-3

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An anaerobic aquatic metabolism study is required to  support  the  registration
of each formulated end-use product intended  for aquatic  or  forestry  use which
results in direct discharges into the aquatic environment.  Such  a study is
also required to support the registration of each manufacturing-use  product
which legally could be used to make such an end-use product.   The anaerobic
soil metabolism study in Section 63.62-8(c) may not be substituted for this
study.

The requirement for the submission of the above data  is  currently being
reserved, pending the receipt and evaluation of hydrolysis  and  photodegradation
data.  The results of the hydrolysis and photodegradation data  will  determine
if additional testing is required.

Microbiological Metabolism

Data on the effects of microbes on pesticide degradation and  the  effects of
pesticides on microbes are required to support the registration of each
formulated end-use product intended for terrestrial (except greenhouse and
domestic outdoor), aquatic, and forestry use and for  any aquatic  impact use
which results in direct discharges into the aquatic environment.  These data
are also required to support the registration of each manufacturing-use product
which legally could be used to make such a formulated product.

Microbiological - Effects of Microbes on Pesticides

One study (Frederick 1957, 05011435) on the metabolism of AMS by  microbes was
reviewed and considered invalid.

The requirement for the submission of the above data  is  currently being
reserved pending the review and modification of the testing protocols.
Consequently, the absence of acceptable data does not constitute  a data gap.

Microbiological - Effects of Pesticides on Microbes

Two valid studies on the effects of AMS on microbes were reviewed.   Smith
et al. (MRID 05006452) reported that AMS applied at rates equivalent  to 500 and
1,000 Ib ai/A had no adverse effects over a 3-week period on  fungal,  total
bacterial, and actinomycete populations in Cadorous silt loam  soil.   However,
AMS treatment of starch-amended soil resulted in an increase  in the  fungal
population and a decrease in total bacterial and actinomycete populations.

Rayner (MRID 05005817) found that AMS treatment of oak,  beech,  and birch
stumps stimulated initial fungal colonization and the subsequent  rate of
succession on the stumps over a 2.5-year period.  These  results indicate that
fungal cellulose decomposition processes probably are not inhibited  by AMS.   In
summary, the above studies demonstrate that AMS may decrease, and in  some cases
increase, microbial populations in the environment.

The requirement for the submission of the above data  is  currently being
reserved pending the review and modification of the testing protocols.
Consequently, the absence of acceptable data does not constitute  a data gap.

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Activated^Sludge

A laboratory study of  the effects  of  pesticides  on  the wastewater  treatment
process is required to support  the registration  of  all manufacturing-use
chemicals, and all formulated products  that are  indirectly discharged  into
wastewater systems or  are used  as  treatments  in  wastewater treatment systems.

No data on the activated sludge metabolism of  AMS are available.

The requirement for the submission of the above  data is currently  being
reserved pending the review and modification  of  the testing protocols.
Consequently, the absence of acceptable data does not constitute a data gap.

MOBILITY

Data on mobility are required to determine pesticide residue movement  in
the environment.

Leaching

Leaching data are required to support the registration of each  AMS
formulated end-use product intended for terrestrial noncrop, tree  fruit/nut
crop, aquatic, or forestry use, or for  any aquatic  impact use resulting in
direct discharges into the aquatic environment.  Such data are  also required to
support the registration of each manufacturing-use  product which legally  could
be used to make such an end-use product.

Two leaching studies were reviewed and  one was considered a scientifically
valid study, but does  not meet  the guidelines  requirements because the
leaching study was conducted in only  one unspecified type of soil.  Konnai et
al . (MRID 05016686) demonstrated that AMS was very  mobile in soil  and  exhibited
a distribution parallel to the  mass flow.  AMS (95% powder) at  50  kg/ha leached
14 and 50 cm in an unspecified  soil type eluted  with 2 and 50 cm of water.  AMS
at 200 kg/ha leached 12-14 cm in a cedar forest  soil eluted with only  4 cm of
water.

The requirement for the submission of the above  data is currently  being
reserved pending the receipt and evaluation of hydrolysis and photodegradation
data.  The results of  the hydrolysis  and photodegradation data  will determine
what chemical species  remain in the environment  as  a result of  ammonium
sulfamate use and whether the leaching  study  is  needed to predict  the  fate of
these species.

Volatility

No data are required on the volatility  of AMS because the' use pattern  of
AMS does not include a greenhouse use and reentry is not a consideration  at
this time.
                                     5-5

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Adsorption/Desorption

A laboratory study using radioisotopic or nonradiolsotopic  analytical
techniques is required to support the registration  of  all AMS  formulated
products intended for terrestrial, forestry,  and  aquatic  uses,  and  for any
aquatic impact use which results in direct discharges  into  the  aquatic
environment.  These data are also required to support  the registration of each
manufacturing-use product which legally could  he  used  to make  such  a formulated
product.

No data on adso'rption/desorption of AMS are available.

The requirement for the submission of the above data is currently being
reserved, pending the receipt and evaluation  of hydrolysis  and  photodegradation
data.  The results of the hydrolysis and photodegradation data  will  determine
what chemical species remain in the environment as  a result of  ammonium
sulfamate use and whether the adsorption/desorption study is needed  to predict
the fate of these species.

Water Dispersal

A field study tailored to one or more representative sites  is  required to
support the registration of all formulated products intended for  aquatic uses,
and for any aquatic impact use which results  in direct discharges into the
aquatic environment.  These data are also required  to  support  the registration
of each manufacturing-use product which legally could  be used  to  make  such a
formulated product.

No data on the water dispersal of AMS are available.
                  v
The requirement for the submission of the above data is currently being
reserved pending the receipt and evaluation of hydrolysis and  phtodegradation
data.

FIELD DISSIPATION

A field dissipation study under actual use conditions  is  required to
support the registration of all AMS manufacturing-use  and formulated products
intended for terrestrial (except greenhouses,  aquatic, and  forestry uses).

Terrestrial
A terrestrial field dissipation study  is  required  to  support  the  regis-
tration of each end-use product for terrestrial use (except greenhouses),  and
that of each manufacturing-use product which legally  could  be used  to make
such an end-use prooTuct.

No data on the terrestrial field dissipation of AMS are  available.

The requirement for the submission of  the above data  is  currently being
reserved, pending the receipt and evaluation of hydrolysis  and photodegradation
data.  The results of the hydrolysis and  photodegradation data will  determine
if additional testing is required.


                                     5-6

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An aquatic  field  dissipation study is  required  to support  the registration
of each AMS formulated  end-use  product  intended  for  aquatic  uses,  including
products  intended for application to ditch  banks and shorelines  and  for
unintentional direct aquatic applications,  or for any aquatic impact  use  which
results in  direct aquatic  applications  or aquatic impact use with  direct
discharges  into the aquatic  environment.  This  study is also required  to
support the registration of  each  AMS manufacturing-use product which  legally
could be  used to  make such an end-use  product.

One study on the  aquatic field  dissipation  of AMS was reviewed and judged
inval id'.

The requirement for the submission of  the above  data is currently  being
reserved, pending the receipt and evaluation of  hydrolysis and photodegradation
data.  The  results of the  hydrolysis and photodegradation data will determine
if additional testing is required.

Forestry

A forestry  study  is required to support the registration of  each AMS  formulated
end-use product intended for forest  use, and of  each AMS manufacturing-usfe
product which legally could  be  used  to  make such an  end-use  product.

No data on  the dissipation of AMS in forests are available.

The requirement for the submission of  the above  data is currently  being
reserved, pending the receipt and evaluation of  hydrolysis and
photodegradation  data.  The  results  of  the  hydrolysis and photodegradation data
will determine if additional  testing is required.

Aquatic Impact Uses

No data are required under this topic  for AMS.   Required data have been
noted under other sections in this  chapter.

Combination and Tank Mixes

Data requirements for combination and  tank  mixes containing  AMS  are not
cited here  because this registration standard deals  only with the  single  active
ingredient.

ACCUMULATION

Data on accumulation are required to determine accumulation  in food webs.

Rotational  Crops

No data on  the accumulation  of  AMS  in  rotational  crops are required because
the use pattern is such that  application to field/vegetable  and  aquatic food
crops will  not occur.
                                     5-7

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 Irrigated Crops

 No data are  required on  the accumulation  of  AMS  in  irrigated  crops  because
 the use pattern indicates that crops are  not  irrigated  with AMS-treated  water.
 At this time AMS would not be expected  to contribute  significant  quantities of
 AMS to irrigation water.

 Fish

 A fish accumulation study is required to  support  the  registration of  each
 formulated end-use product intended for outdoor  impact  use (except  domestic
 outdoor), or aquatic impact uses resulting in direct  discharge  into aquatic
 environments, and for each manufacturing-use product  that could be  legally used
 to produce such a product.  These data  are not required  if the  registrant can
 offer evidence acceptable to the Agency showing  that  the applied  pesticide and
 one of its principal degradation product(s):

    1.  will not reach water, or will not  persist in  water (i.e., a nominal
    half-life of four days or less); and

    2.  has  physical properties suggesting a relatively low potential  for
    accumulation (i.e.,  a nominal octanol/water  partition coefficient  less than
    1000); or

    3.  does not accumulate in the organs  and tissues of mammals  or avian
    species.

 The Agency may consider  the particular use pattern  and  the rate and frequency
 of application in making a decision to waive or maintain the data requirement
 (such as in  cases where movement to water  is obviously  negligible or where
 frequent application counteracts a fast dissipation rate).

 The requirement for the  submission of the  above data  is currently being
 reserved, pending the receipt and evaluation of hydrolysis and photodegrada-
 tion data.   The results  of the hydrolysis  and photodegradation data will
 determine if additional  testing is requried.

 Formulations of Ammonium Sulfamate

 Three formulations of ammonium sulfamate  are available:  crystals (95  to  J9 %
 A.I.), soluble liquid concentrates (19 to  54% A.I.)., and'ready-to-
 use preparations (8 to 12% A.I.).  The  formulations are usually applied  as a
 hand-directed spray, although high-volume  and airblast  sprayers are also  used.
 Use rates are usually 57-120 Ibs A.I. in  100 gallons water per acre for  all
 sprayers except airblast equipment, where  the recommended rate is 100-400 Ibs
 A.I. per acre in 100 gallons of water.

 Although ammonium sulfamate is not applied aerially,  the use of airblast
machines (which direct the spray upward)  increases  the  potential  for  exposure
via spray drift to humans, livestock or wildlife outside the application  site.
However, the extent to which air blast machinery  is used for application  of
ammonium sulfamate is not known.  Preliminary data  indicates that ammonium
                                  5-8

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sulfamate may leach; therefore, the potential for groundwater contamination
exists.  The potential for surface water contamination exists through the use
of ammonium sulfamate for control of willow, cottonwood and other brush along
waterways.

As with most pesticides, the greatest human exposure may occur during mixing,
loading and treatment operations.  However, quantitative data necessary to
estimate the degree of such exposure are not available.  The potential for
dermal and eye exposure from splashing of the soluble liquid concentrate
formulation exists, but can be minimized by the use of protective clothing and
gloves during mixing and loading.  Ready-to-use formulations can be especially
important in reducing exposures to small-volume users (i.e., homeowners),
because mixing operations are not required.
                                     5-9

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                                   VI

                               TOXICOLOGY

Toxicology  - Manufacturing-Use Ammonium  Sulfamate

Toxicology  Profile

No data were available  to  assess  the  following  toxicity  of  manufacturing-
use ammonium sulfamate: acute  oral, acute dermal,  acute  inhalation,  primary  eye
irritation, primary  dermal  irritation, and  dermal  sensitization  potential.

Insufficient data were  available  to assess  the  subchronic toxicity of
manufacturing-use ammonium sulfamate.  In a subchronic oral  toxicity study
conducted on rats using a  99%  crystalline formulation of ammonium sulfamate,  an
18% weight  gain depression was noted  in  adult  females at the high dose  (500
mg/kg/day).  Histopathological examination  of  the  animals in this group
revealed  that  one rat  showed  slight fatty degenerative changes in the liver.
Lack of individual animal  data and inadequate  reporting  preclude the use of
this study  to  assess the subchronic oral toxicity  potential  of manufacturing-
use ammonium sulfamate  in  humans.

No adequate subchronic  dermal  toxicity data were available  on manufacturing-
use ammonium sulfamate.

Presently,  subchronic  inhalation  testing is not required for the reregis-
tration of  manufacturing-use ammonium sulfamate.   The Proposed Guidelines state
that subchronic inhalation testing is required  on  manufacturing-use  products
whose pesticidal use may result in repeated  inhalation exposure  at a concen-
tration which  is likely to be  toxic as determined  from results of the acute
inhalation  testing.  There  is  no  reason  to  believe that  the  present  use
patterns  of ammonium sulfamate will result  in  repeated inhalation exposure at
toxic concentrations.   This information  may be  required  pending  the  results
from the  acute inhalation  testing.

Adequate  data were not  available  on the  chronic toxicity of  manufacturing-use
ammonium  sulfamate.  A  19-month study was conducted  in which rats were  fed
0.035% and  0.05% ammonium  sulfamate in the  diet.   No histopathological
alterations could be attributed to the ammonium sulfamate in the diet.
Sufficient  data were not available to evaluate  the effects  of ammonium
sulfamate on any other  parameter;  therefore, this  study  cannot be used  to
assess the  chronic toxicity of ammonium  sulfamate.

Summary data from a  three-generation  reproduction  study  in  which rats were fed
0.035% and  0.05% ammonium  sulfamate in the  diet indicated that no reproductive
toxicity was observed  through  the  F_a generation.   This  study was
inadequately reported because  no  individual  animal  data  were available  and,
therefore, an assessment of the reproductive toxicity potential  of ammonium
sulfamate cannot be  made.

No data were available  to  assess  the  oncogenic  and teratogenic potential of  the
manufacturing-use ammonium sulfamate.

Adequate metabolism  studies were  not  available  for ammonium sulfamate.

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Data on the mutagenic potential of ammonium sulfamate in microbial  systems  were
insufficient.  No other data were available to assess the mutagenic potential
of ammonium sulfamate.

Data Requirements

The data requirements needed to evaluate the continued registration of
ammonium sulfamate products to which this Standard  applies are listed  in
Chapter III, Tables 1- 3.

Required Labeling

Precautionary labeling of each product must correspond to the toxicity
categories determined by f/ive acute toxicity tests.

Topical Discussions

Corresponding to each of the Topical Discussions listed below is the number
of the section(s) in the "Proposed Guidelines" of August 22, 1978 (43 FR, No.
163 37336) which explain(s) the minimum data that the Agency usually requires
in order to adequately assess the toxicity of pesticides.  Where no
section number is listed, a minimum requirement has not been set for such
information.  Also under each of the topics is a reference to the section in
the "Proposed Guidelines".

                                           Guidelines Section(s)

    Acute Oral Toxicity                            163.81-1
    Acute Dermal Toxicity                          163.81-2
    Acute Inhalation Toxicity                      163.81-3
    Primary Eye Irritation                         163.81-4
    Primary Dermal Irritation                      163.81-5
    Skin Sensitization                             163.81-6
    Acute Delayed Neurotoxicity                    163.81-7
    Subchronic Oral Toxicity                       163.82-1
    Subchronic 21-Day Dermal Toxicity              163.82-2
    Subchronic 90-Day Dermal Toxicity              163.82-3
    Subchronic Inhalation Toxicity                 163.82-4
    Subchronic Neurotoxicity                       163.82-5

    Chronic Feeding                                163.83-1
    Oncogenicity                                   163.83-2
    Teratology                                     163.83-3
    Reproduction                                   163.83-4
    Mutagenicity                                   163.83-1 to 4
    Metabolism in Laboratory Animals               163.83-1
    Clinical Trials
    Emergency Treatment

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Acute  Testing

Acute  Oral  Toxicity
The
one
rat.
     minimum data  requirement  for testing acute oral  toxicity (LDcr.) is
     test  on the manufacturing-use  product,  preferably using the laboratory
No  acute  oral  toxicity studies  are  available  on manufacturing-use
ammonimum sulfamate.   Testing is  required.

Acute  Dermal Toxicity

The minimum data  requirement  for  testing  acute  dermal  toxicity is one test,
preferably in  the  albino  rabbit,  on each  manufacturing-use  product.

No  acute  dermal  toxicity  tests  on manufacturing-use ammonium sulfamate are
available. Testing  is required.

Acute  Inhalation  Toxicity

Acute  inhalation  testing  is  required to support the registration of  the
manufacturing-use  and  formulated  products if:   the  product  is  a gas,  the
product produces  a respirable vapor or 20%  or more  of  the aerodynamic
equivalent of  the  product is  composed  or  particles  not  larger  than 10 microns.
Testing in the laboratory rat is  preferred.

The use pattern  indicates that  ammonium sulfamate is used by a route  that  could
permit inhalation  exposure (i.e.  used  as  a  spray for weed control).   Since no
information is available  to assess  the aerodynamic  size of  the particles or
the vapor pressure of  ammonium  sulfamate, acute inhalation  testing is required.

No  acute  inhalation  toxicity  studies are  available  on manufacturing-use
ammonium  sulfamate.  Testing  is required.

Primary Eye Irritation

The minimum data  requirement  for  primary  eye  irritation is  one test  on each
manufacturing-use  product, preferably  using the albino  rabbit.  If the test
substance has  a pH of  1-3 or  12-14,  it will be  judged corrosive,  and
an  eye irritation  test  is not needed.  Also,  if the test substance has been
judged to be dermally  corrosive,  an eye irritation  test is  not needed.

No  primary eye irritation studies are  available on  manufacturing-use
ammonium  sulfamate.  Testing  is required.

Primary Dermal Irritation

The minimum data requirement for  primary  dermal  irritation  is  one test on
each manufacturing-use  product, preferably using the albino rabbit.

No  primary dermal  irritation studies are  available  on manufacturing-use
ammonium  sulfamate.  Testing is required.
                                    6-3

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Dermal Sensitization

The minimum data requirement for dermal sensitization is an  intradermal
test on each manufacturing-use product, preferably using the guinea pig-

No dermal sensitization studies are available on manufacturing-use ammonium
sulfamate.  Testing is required.

Acute Delayed Neurotoxicity

The minimum data requirement for acute delayed neurotoxicity is one test  on
the manufacturing-use product, using the adult hen.

An acute delayed neurotoxicity test is required if the active ingredient,
or any of its metabolites, degradation products, or impurities causes esterase
depression or is structurally related to a substance that induces delayed
neurotoxicity.

There are no indications that ammonium sulfamate causes esterase
depression or is structurally related to known neurotoxins.  Therefore,
testing is not required.

Subchronic Testing

Subchronic Oral Toxicity

The minimum data requirement for Subchronic oral toxicity is one test on
the manufacturing-use product in two mammalian species, preferably using  the
rat and dog.

No adequate Subchronic oral toxicity data are available on manufacturing-
use ammonium sulfamate.  However, a supplementary Subchronic oral toxicity
study is available on ammonium sulfamate in rats.  In this study (Gupta et al.
1979, MRID 05014167), groups of adult female rats and male and female
weanling rats were given ammonium sulfamate (crystalline, 99% purity) at  100,
250 or 500 mg/kg orally in an aqueous solution 6 days a week for 90 days.

At the high dose an 18% weight gain depression was observed  in the adult
female, and histological examination revealed that one animal in this group
showed slight fatty degenerative changes in the liver.  No individual animal
data were included; and therefore, this study is not adequate to evaluate the
subchronic toxicity of the chemical.  Additional Subchronic oral toxicity
testing in rats and dogs is required.

Subchronic 21-Day Dermal Toxicity

The minimum data requirement for subchronic 21-day dermal toxicity is one
study on the manufacturing-use product, preferably using the albino rabbit.   A
subchronic 21-day dermal toxicity test is required if pesticidal use is likely
to result in repeated human skin contact.  Since the use of ammonium sulfamate
is likely to result in repeated human skin contact, testing  is required.
                                   6-4

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One subchronic dermal  toxicity  study was  conducted  on  an  unspecified  formu-
lation of ammonium  sulfamate  (Aoyama  1975,  MRID 05005119).   In  this study,  0.75
ml of 15% , 20%, and 30% concentrations of  ammonium sulfamate were  applied  to
the unshaved skin of rats, and  .75 ml  of  15% and  30% concentrations of  the
chemical were applied  to the  shaved skin  of rabbits daily for 20  days.   No
deaths were observed in rats  or rabbits,  and only slight  redness  of the skin
was noted in rats at the highest dose  at  7  days.   Upon histopathological
examination, slight atrophy of  the epidermis was  observed in rabbits. This
study does not satisfy the data  requirements for  subchronic  dermal  toxicity
testing because too few rabbits  were tested, and  more  than one  route  of
exposure was possible  since the  application sites were not covered.   Additional
21-day dermal toxicity testing  is required.

Subchronic 90-Day Dermal Toxicity

A subchronic 90-day dermal toxicity test  is not  required  because  ammonium
sulfamate is not purposely applied to  skin, and  its use will not  result in
human exposure comparable to  that, for example,  from swimming pool  additives or
pesticide-impregnated  fabrics.

Subchronic Inhalation Toxicity

A subchronic inhalation study is required if pesticidal use  may result  in
repeated Inhalation exposure  at  a concentration  that is likely  to be  toxic,  as
determined from results of acute inhalation testing.   A determination of  the
requirement for a subchronic  inhalation toxicity  study of ammonium  sulfamate
cannot be made at present, because no  adequate  acute inhalation toxicity  data
are available.

Subchronic Neurotoxicity

A subchronic neurotoxicity study is not required  on ammonium sulfamate,
because it is not expected to induce neuropathy or  delayed neurotoxicity, and
because it does not have a molecular structure  closely related  to that  of a
compound that is known to induce neuropathy or delayed neurotoxicity.

Chronic Feeding

A chronic feeding study is required if pesticidal  use  requires  a  tolerance
or exemption from a tolerance,  requires an  issuance of a  food additive
regulation or is likely to result in repeated human exposure over a significant
portion of the life-span.

A tolerance exists for ammonium  sulfamate on apples and pears;  however,
ammonium sulfamate is not applied directly  to the fruits  since  it is  used for
weed control in these orchards.  If the requested residue data  (Chapter III,
Table 1) shows that negligible  residues of  ammonium sulfamate and its
metabolites are present on raw  agriucltural commodities and  the environmental
fate data indicates that repeated human exposure  by other routes  is unlikely,
this data requirement will be waived.

The available data were inadequate to  assess the  chronic  feeding  effects  of
ammonium sulfamate.  In a 19-month feeding  study  with  rats (Sherman et  al.,
1964 MRID #00004224), no histopathological  alterations could be attributed  to


                                     6-5

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the feeding of .035% and .05% ammonium sulfamate in'the diet.   Sufficient  data
were not available to evaluate the effects of ammonium sulfamate  on  any other
parameter, therefore, an adequate assessment of the chronic toxicity of
ammonium sulfamate cannot be made from this data.

Oncogenicity

Oncogenicity tests on the manufacturing-use product are required  in  two
mammalian species, preferably the rat and the mouse, for all food  uses. A
tolerance exists for ammonium sulfamate on apples and pears; however,  ammonium
sulfamate is not applied directly to the fruits since it is used  for weed
control in these orchards.  If requested residue data (Chapter  III,  Table  1)
shows that negligible residues of ammonium sulfamate and its metabolites are
present on raw agricultural commodities and the environmental fate data
indicates that repeated hum^n exposure by other routes is unlikely,  this data
requirement may be waived.


Teratogenicity

The minimum requirement for evaluating a pesticide for teratogenicity is
testing in two mammalian species.  Teratogenicity testing is required  on
ammonium sulfamate because it is registered for domestic use and may be
expected to result in significant exposure to human females.  No data  were
available to evaluate the teratogenicity potential of ammonium  sulfamate.
Testing is required in two mammalian species.

Reproduction

The minimum data requirement for reproduction is testing in one mammalian
species, preferably the laboratory rat, using the manufacturing-use  product and
lasting for two generations.  This is required for all food uses.  No  adequate
studies assessing the effects of ammonium sulfamate on reproduction  are
available at this time.  A rat reproduction study (Sherman et al.  1964, MRID
00004224) containing summary data only, is in the Agency files.   In  this study,
rats were fed 0.035% and 0.05% ammonium sulfamate in the diet through  the  F_a
generation.  No consistent toxic effects were observed on growth,  reproductive
performance, viability, or lactation, and no abnormal histopathological
findings were reported by the authors in summary form.  The requirement for
additional reproduction testing may be waived if adequate residue  data show
that negligible residues of ammonium sulfamate and its metabolites are present
in raw agricultural commodities and adequate environmental fate data
indicates that repeated human exposure by other routes is unlikely,  this data
requirement may be waived.
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Mutagenicity

The following studies represent the minimum data likely  to  be  required  on the
potential heritable effects of ammonium sulfamate:

    1.  A mammalian in vitro point mutation test.
    2.  A sensitive sub-mammalian point mutation test  (Bacteria,
        fungi, insect).
    3.  A primary DNA damage test (i.e., sister chromatid
        exchange or unscheduled DNA synthesis).
    4.  A mammalian in vitro cytogenics test.  If  this suggests
        a positive result, a dominant lethal or heritable
        translocation test may be required.

After results from these test systems and other toxicology  disciplines  have
been considered, additional testing may be required  to further characterize  or
quantify the potential genetic risks.

Although the Agency mutagenic testing requirements are not  final,  the
standards for these tests should be based on the principles  set forth in  FR  43,
No. 163, August 22, 1978.  Protocols and choices of  test systems should be
accompanied by a scientific rationale.  Substitution of  test systems for  those
listed above will be considered after discussion with  the Agency.

A supplementary study is available in which an unspecified  formulation  of
ammonium sulfamate was evaluated for its ability to  produce  point  mutations  in
histidine requiring mutants of Salmonella typhimurium  (Anderson et al.  1972,
MRID 05001460).  Negative results were observed with ammonium sulfamate while
positive responses were produced with three known mutagens.  No numerical data
were available for the positive controls; therefore, the reliability of the
assay cannot be determined.  Thus, the minimum mutagenicity data requirements
for ammonium sulfamate have not been fulfilled and additional testing as
specified above is required.

Metabolism in Laboratory Animals

A general metabolism study is required to support  the  registration of each
manufacturing use product which requires a chronic feeding  study or an
oncogenicity study.

No adequate metabolism study is available on ammonium  sulfamate.   An assessment
of this data requirement cannot be made at the present time, because the  need
for the chronic feeding or oncogenicity data is not  yet  established.

Clinical Trials

No clinical studies in humans have been conducted using  ammonium sulfamate.

Emergency Treatment

No information is available on emergency treatment of  ammonium sulfamate
poisoning.


                                     6-7

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Toxicology - Crystalline Ammonium  Sulfamate

Toxicology Profile

No data were available  to assess the  acute oral,  acute  dermal,and acute
inhalation toxicity of  crystalline  formulations containing 95-99% ammonium
sulfamate.  Testing is  not  required since testing of  the  manufacturing-use
product will be sufficient  to evaluate  the acute  toxicities of  these products.

No data were available  to evaluate  the  primary eye irritation,  primary dermal
irritation and dermal sensitization potentials of ammonium sulfamate.   Dermal
and eye irritation testing  is required  on any one of  the  products listed in
Chapter III, Table 3.   These products contain an  inert  ingredient that may
cause dermal and eye  irritation.

Dermal sensitization  testing is not required since testing of  the manufacturing-
use product will be sufficient to  fulfill this requirement.

Data Requirements

The data  requirements needed to evaluate the continued  registration
of ammonium sulfamate products to which this Standard applies are listed
in Chapter III, Tables  1-3.

Topical Discussions

Acute Testing

Acute Oral Toxicity

The minimum data requirement for testing acute oral toxicity (LD,.,.) is one
test in the laboratory  rat  on each formulated crystalline  product.

No acute  oral toxicity  studies are available on crystalline formulations
of ammonium sulfamate.  Testing on manufacturing-use ammonium sulfamate will
fill this requirement.

Acute Dermal Toxicity

The minimum data requirement for testing acute dermal toxicity  is one  test on
each formulated crystalline product, preferably using the  albino  rabbit.

No acute dermal toxicity studies are available on crystalline formulations
of ammonium sulfamate.  Testing on manufacturing-use ammonium sulfamate will
fill this requirement.

Acute Inhalation Toxicity

The minimum data requirement for testing acute inhalation  toxicity (LC,-n)  is
one test on each formulated crystalline product,  preferably using the
laboratory rat.

No acute inhalation toxicity studies are available on crystalline formulations
of ammonium sulfamate.  Testing on manufacturing-use ammonium sulfamate will
fill this requirement.


                                    6-8

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Primary Eye Irritation

The minimum data requirement for primary eye irritation is one test on  each
formulated crystalline product, preferably using the albino rabbit.  •

No primary eye irritation studies are available on crystalline formulations.
Testing is required on one of the products with the following registration
numbers:  2169-262, 829-180, 10107-21, 352-206, 8127-22,  1348-202, 829-220,
8590-219, 2125-47, 5481-56, 4887-134.

Primary Dermal Irritation

The minimum data requirement for primary dermal irritation is one  test  on
each formulated crystalline product, preferably using the albino rabbit.

No primary dermal irritation studies are available on crystalline  formulations.
Testing is required on one of the products with the following registration
numbers:  2169-262, 829-180, 10107-21, 352-206, 8127-22,  1348-202, 829-220,
8590-219, 2125-47, 5481-56, 4887-134.

Dermal Sensitization

The minimum data requirement for dermal sensitization is  an intradermal test on
each formulated crystalline product, preferably using the guinea pig.

No dermal sensitization studies are available on crystalline formulations of
ammonium sulfamate.  Testing on manufacturing-use ammonium sulfamate will
fill this requirement.

Toxicology - Soluble Concentrate Ammonium Sulfamate

Toxicology Profile

Sufficient data are available to assess the acute oral and dermal  toxicities
of a soluble concentrate formulation containing 43% ammonium sulfamate.  The
high acute oral LD,.^ in rats (male rats, 6.9 g/kg; female rats, 3.9 g/kg)
indicates a potentially low acute oral toxicity in humans.  A high acute dermal
LD ^ in rabbits (greater than 2 g/kg) with this formulation, indicates  a
potentially low acute dermal toxicity in humans.

An acute inhalation toxicity study conducted with rats using a 43% ammonium
sulfamate soluble concentrate formulation is available.   However,  since the
exposure concentration and the particle size distribution were inadequately
described, the study cannot be used to assess the potential acute  inhalation
toxicity of this formulation in humans.

Data are available to assess the primary eye irritation and primary dermal
irritation potentials of a 43% ammonium sulfamate soluble concentrate formu-
lation.  These data indicate that this formulation is not a primary eye
irritant but may cause transient eye irritation in humans, also, the data
indicate a low dermal irritation potential in humans-.  No data were available
to assess the dermal  sensitization potential of the soluble concentrate
formulations.


                                   6-9

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Data Requirements

The data requirements needed  to evaluate  the  continued  registration of ammonium
sulfamate products to which this standard applies  are listed  in  Chapter III.
Tables  1-3.

Topical Discussions

Acute Testing

Acute Oral Toxicity

The minimum data requirement  for testing  acute  oral  toxicity  (LD^^) is one
test on each formulated soluble concentrate product, preferably  using the
laboratory rat.

An adequate acute oral toxicity study  in  rats is available  with  a soluble
concentrate containing 43% ammonium sulfamate (Bullock  and  Narcisse,
1974a, MRID 00004214).  The undiluted material  was administered  by gavage to
four groups of male and female rats.   The LE>    in  males was 6.9
g/kg with a 95% confidence interval of 2.6-18.3 g/kg.   In females the LD
was 3.9 g/kg with a 95% confidence interval of  2.0-7.6  g/kg.   No adverse
clinical signs were observed  in females receiving  the lowest  dose (1.9 g/kg).
Slight depression was observed in males receiving  2.8 g/kg.   Signs of toxicity
in animals receiving the higher dose levels included depression, salivation,
bloody tears, and collapse.   All deaths,  7 males and 8  females,  occurred within
24 hours of dosing.  The- survivors (12 males and 13  females)  showed no
chemical-related gross pathological changes.

These data are sufficient to  fulfill the  acute  oral  toxicity  data requirement
for the existing soluble concentrate formulations  containing  19-55% ammonium
sulfamate and place these products in Toxicity  Category III.

Acute Derm;1 Toxicity

The minimum data requirement  for testing  acute  dermal toxicity (LD..,) is one
test on each formulated soluble concentrate product, preferably  using the
albino rabbit.

An adequate acute dermal toxicity study is available with a soluble concentrate
containing 43% ammonium sulfamate (Bullock and  Narcisse 1974b, MRID 00004215).
In this study the acute dermal LD,.. in male New Zealand albino rabbits was
determined to be greater than 2 g/kg.  No mortality  was observed when six males
were administered 2 g/kg of the undiluted material under an occlusive wrap;
half of the animals had abraded skin, and half  had intact skin.   At 24 hours
slight to severe erythema was observed but there were no other signs  of
toxicity during the 14-day observation period.  Although only males were
tested,  the study is sufficient to fulfill the  acute dermal toxicity  data
requirement for the existing  soluble concentrate formulations containing 19-55%
of ammonium sulfamate.  The data place these products in Toxicity Category
III.

Acute Inhalation Toxicity

Acute inhalation testing is required to support the  registration of formulated
products if:  the product is a gas, the product produces a  respirable vapor  or

                                    6-10

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20% or more of  the aerodynamic  equivalent  of  the  product  is composed of
particles not larger than  10 microns.   Testing  in the  laboratory rat is
preferred.

An acute inhalation toxicity study  (Bullock and Narcisse,  I974c, MRID#
00004218) was conducted with a  43%  soluble concentrate formulation of ammonium
sulfamate in rats.  This study  was  inadequate  to  assess the inhalation toxicity
of this formulation.

Based on information in the Confidential Statement  of  Formulations (CSF's)  for
the soluble concentrates containing 19-55% ammonium sulfamate,  the inert
ingredients used in these  products  are  not anitcipated to  present problems  with
respect to inhalation toxicity.  Therefore, acute inhalation  toxicity testing
on the manufacturing-use product will fill this data requirement for the
soluble concentrate formulations.

Primary Eye Irritation

The minimum data requirement for primary eye  irritation is one  test on each
formulated product, preferably  using the albino rabbit.

An adequate primary eye irritation  study is available  with a  soluble concen-
trate formulation containing 43% ammonium  sulfamate.   (Bullock  and Narcisse
1974d, MRID 00004216).  Instillation of 0.1 ml of the  undiluted test
material into the conjunctival  sac  of one  eye of  each  of six  rabbits (three
males, three females) caused slight to moderate conjunctival  irritation in
all of the treated eyes.   By 72 hours this condition had cleared  in all but one
animal who still had slight irritation.  No corneal  opacity or  iritis was
observed in any of the treated  eyes, and by 7 days  all  the eyes were normal.
The data are sufficient to fulfill  the  primary eye  irritation data require-
ments for the existing soluble  concentrate formulations containing 19-55%
ammonium sulfamate and place these  products in Toxicity Category III,
indicating a low potential for  eye  irritation.


Primary Dermal Irritation

The minimum data requirement for primary dermal irritation is one test on
each formulated product, preferably using  the albino rabbit.

An adequate primary dermal irritation study is available with a soluble
concentrate formulation containing  43% ammonium sulfamte (Bullock and Narcisse
1974e, MRID 00004217).  In this study, the product  was applied  undiluted to
the abraded and intact skin of  six  New Zealand rabbits and  the  primary skin
irritation score was determined to  be 0.6 out of  a  possible 8.0 score. This
study is sufficient to fulfill  the  primary dermal irritation  potential data
requirement for the existing soluble concentrate  formulations containing
19-55% ammonium sulfamate.  These products should not  be considered  primary
skin irritants and should be placed in Toxicity Category IV.

Dermal Sensitization

The minimum data requirement for dermal sensitization  is an intradermal test on
each formulated product, preferably using the guinea pig.


                                     6-11

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No dermal sensitization  studies  are  available  on  soluble  concentrate
formulations of ammonium sulfamate.   Based  on  information in  the  Confidential
Statement of Formulations  (CSF's)  for the  soluble  concentrate formulations
containing  19-55% ammonium sulfamate,  the  inert ingredient  used  in these
products are not expected  to  present  a problem with  respect to dermal
sensitization.  Therefore, dermal  sensitization testing on  the manufacturing-
use product will fill this data  requirement.

Toxicology  Ready-to-Use and Pressurized Liquid Ammonium Sulfamate

Toxicology  Profile

No data were available to assess the  acute  oral, acute dermal, and acute
inhalation  toxicity as well as the primary  eye irritation,  primary dermal
irritation, and the dermal sensitization potential of  the ready-to-use
formulations containing 8-55% ammonium sulfamate and the  pressurized liquid
formulations containing 9.5% ammonium sulfamate.

The Confidential Statements of Formulations (CFS) do not  indicate that the
acute toxicities Coral, dermal,  inhalation), or the  eye irritation,  dermal
irritation  and dermal sensitization potentials of the ready-to-use products
will differ from those observed  with  the soluble concentrates. Therefore,
refer to the Toxicology Profile  and Topical Discussions for soluble  concentrate
formulations, for an assessment  of these toxicity parameters.

Data on the soluble concentrate  formulations will fill the  following
requirements for ready-to-use formulations:  acute oral toxicity,  acute dermal
toxicity, primary eye irritation and  primary dermal  irritation.   Data  on the
manufacturing-use product will fill the toxicity and dermal sensitization  data
requirements.

The Confidential Statements of Formulations (CFS) does not  indicate  that the
acute toxicities or the dermal irritation or the dermal sensitization
potentials  for the pressurized liquid  product will differ from those observed
with the soluble concentrates.

Therefore, data on the soluble concentrate  formulations will  fill  the
following requirements for the pressurized liquid formulation:  acute  oral
toxicity, acute dermal toxicity, and  primary dermal  irritation.   Data  on the
manufacturing-use product will fill the requirement  for acute  inhalation
toxicity and dermal sensitization  for  the pressurized liquid.

The pressurized liquid product may have eye irritation properties  different
from those of the soluble concentrates.  Therefore,  primary eye irritation
testing is required.

Data Requirements

The data requirements needed to  evaluate the continued registration  of ammonium
sulfamate products to which this standard applies are listed  in Chapter III,
Tables 1-3.
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                                       VII

                              Residue  Chemistry


Residue Chemistry - Manufacturing-Use  Ammonium Sulfamate

Residue Chemistry Profile

Ammonium sulfamate is used as a herbicide  for  the  control  of woody plants,
particularly poison ivy.

No data on the metabolism or breakdown patterns of ammonium sulfamate in plants
or animals are currently available.  There  is  some indication in the literature
that ammonium sulfamate can hydrolyze  in the soil  to  form  ammonium sulfate.
Additional data are needed showing the nature  of any  major residues resulting
from the applied use of ammonium  s olfatnate  as  a result  of  application to the
plants at the tree roots.  Similarly,  data  are needed showing the nature of
major residues when ingested by grazing cattle or  dairy cows from cover crops
in apple or pear orchards, pastures and rangelands that have been treated with
ammonium sulfamate, or apple pomace used in feed.

The results from method trials conducted by FDA on the  residue analytical
methods submitted by the manufacturer  were  unsatisfactory.  Two residue
studies were submitted.  The studies showed that residues  of ammonium
sulfamate per se, resulting from  certain applications on ten tests with apples
and one on pears, did not exceed  the established tolerances for apples and
pears.  However, these test summations were submitted without supporting hard
data and were conducted several years  prior to the FDA  analytical method
trials.

There are no records of regulatory incidents or actions with respect to the
registered uses of ammonium sulfamate.

Data Requirements

The data required to support the  registered food use  and tolerances for
ammonium sulfamate are presented  in Chapter III, Table  1.

Topical Discussions

Use Patterns and Restrictions

Ammonium sulfamate is used as a herbicide  primarily for control of woody
plants and herbaceous perennials.  It  is considered especially useful for the
control of poison ivy in apple and pear orchards when applied as a foliage
spray.  The use of ammonium sulfamate  in apple and pear orchards is considered
to be a food use due to the possibility of  residues on  the fruit through
absorption and translocation or from a  contaminative  source.

The formulation type and percent  active ingredient used in apple and pear
orchards are:  95-99% a.i. crystalline  and  19-54%  soluble  concentrate.

The recommended use is 1-3 treatments  per growing  season (every 6 to 8 weeks)
when poison ivy plants are in full leaf.  The  type of application is foliar


                                    7-1

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drench or hand directed by using either a backpack  or  ground  rig  high volume
sprayer.  The application rate  is  57 Ibs. A.I.  in  100  gal.  water.  The spray
volume depends on the density and  size of the poison ivy  plants but  usually 1
gallon will cover 200-250 sq. ft.  of surface.

Present use restrictions include:

    Do not spray fruit tree foliage.
    Do not spray green or immature fruit tree bark.
    Avoid excessive wetting of  fruit tree bark.
    Use coarse spray.

Metabolism in. plants

Ammonium sulfamate is known to  be  non-selective and translocates  readily.   One
study on its translocation'(Carvell 1955, 05005498) showed  that ammonium
sulfamate moves into the leaves of plants more  rapidly that it moves down  into
the root system.

No data are available on the metabolic fate of  ammonium sulfamate in plants or
on residues in plants or trees.

Metabolism in Animals

No studies are available regarding the metabolic fate  of  ammonium sulfamate
residues in large animals.                              '

Analytical Methodology

The accepted method for the determination of ammonium  sulfamate in apples  and
pears is that of H.L. Pease (Pease 1957, 00004228,  05003443,  00004232).  This
method could not be made to work adequately in  government laboratory tests;
adequate validation data and data  in support of the claimed sensitivity  of 0.1
ppm are not presented.  Therefore, an adequate  analytical method  is  required.

Residue Data;  Apples and Pears

The available residue data for  ammonium sulfamate (DuPont  1960, 00004229)  is a
summary report of two tests conducted from 1957 to  1960,  prior to method
trials.

The first test consisted of a series of trials  conducted  in three states using
ammonium sulfamate under apple and pear trees.  Ammonium  sulfamate was used in
doses from 0.3 to 1 Ib. per tree at 28 to 122 day intervals between  treatment
and harvest.  Residues in ten samples of fruit  ranged  from  0.1 ppm to 0.6  ppm.

The second test examined residues  from applications of ammonium sulfamate  for
three successive years to soil under apple trees applied  at two rates:  1.2
Ibs/tree and 6 Ibs/tree.  Residues ranged from  1.5  to  2.5 ppm and 2.7 to 6.1
ppm from the higher rate.

The limited residue data and the inadequacy of  the  data collection method  do
not permit a conclusion that the registered tolerance  of  5  ppm is adequately
supported.

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Residue Data:  Meat and Milk

Consideration should be given to the possibility of cattle grazing  in  fruit
orchards, pastures and rangelands treated with ammonium sulfamate,  and to  the
agricultural practice of feeding apple pomace to cattle, including  dairy
animals.  No residue studies were reported for the indicated feed uses.  These
data requirements are being reserved pending the receipt and evaluation of
residue data on apples to determine if residues of ammonium sulfamate  are
present in cattle and dairy animal feedstuff at a detectable level.  Also,
residue data on milk and meat are being reserved pending the receipt and
evaluation of environmental fate data.  Milk and meat residue data  may be
required if the fate data indicate that use of ammonium sulfamate in fruit
orchards, pastures, and rangelands could result in exposure to grazing animals
and residues in meat and milk.

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                                       VIII

                            Ecological Effects Chapter

Manufacturing-Use Ammonium Sulfamate

Ecological Effects Profile

No adequate data are available to assess the toxicity of ammonium  sulfamate
to terrestrial and aquatic organisms.

Supplementary data indicate that toxicity to aquatic organisms  is  probably
low.  One study (Matida et al., 1975, 05010743) was conducted by dripping a  70
% a.i. solution of ammonium sulfamate into an artificial stream containing
rainbow trout.  No adverse effects were noted at concentrations up  to  30 ppm.
Another study (Eddleman 1974, 05008669) conducted with a 43% a.i.  formulated
product on Chaoborus punctipennis, the phantom midge, yielded 48-hour  L^CQ
values of 6096 ppm and 3183 ppm at 15C and 20°C respectively.   These
toxicity values indicate this particular product is practically non-toxic to
aquatic invertebrates.

One adequate beneficial insect study was conducted  (Atkins et al.  1969,
00018842) in which honey bees were exposed to a mixture of technical ammonium
sulfamate and pyrolite dust.  The study provided sufficient information  to
characterize ammonium sulfamate as relatively non-toxic to honey bees  (^D,.-
value is greater than 60.43 micrograms/bee).

Available data on the toxicity of ammonium sulfamate to terrestrial and  aquatic
plants indicate that a temporary phytotoxic effect on turf may  occur at
application rates of 2.18 Ibs. a.i./acre, and aquatic plants may suffer  growth
reduction if the concentration in the aquatic environment were  to  reach
approximately 1000 ppm.

Data Requirements

The data requirements needed to evaluate the continued registration of
ammonium sulfamate products to which this Standard applies are  listed  in
Chapter III,,,Table 1.

Topical Discussions

Corresponding to each of the Topical Discussions listed below is the number  of
the section(s) in the Proposed Guidelines of July 10, 1978 (43  FR  No.  132,
29696) which explain(s) the minimum data that the Agency requires  to adequately
assess the effects of ammonium sulfamate to fish and wildlife.

                                                Guidelines Section

        Birds                                   163.71-1,  163.71-2
        Fish                                               163.72-1
        Aquatic Invertebrates                              163.72-2
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Birds

Birds may be exposed to pesticides by feeding on contaminated plants  or
insects, by dermal contact and/or inhalation when close to outdoor  sprays  and
dust.  To assess the impact of a pesticide on birds, the Agency  requires
certain avian toxicity tests to support the registration of pesticides.

A determination of the avian acute single-dose oral LD5  is required  to
support the registration of every manufacturing-use product and  formulated
product for outdoor application.  Information regarding the acute toxicity of
ammonium sulfamate to birds is not available.

A determination of the subacute dietary LC^ (5-day dietary exposure) is  also
required to support the registration of all manufacturing-use products and all
formulated products intended for outdoor application.  Testing shall  be
performed on two avian species, one species of waterfowl (preferably  the
mallard duck) and one species of upland game bird (preferably the bobwhite
quail).

One study on quails (Maki 1973, GS0016-0020) was submitted and reviewed for
this topic.  The study was determined invalid.  The study contained data  from a
secondary source, the study protocol and the determination of the LC_Q was
not reported, and the species of quail was not reported.  Therefore,  no
acceptable data on technical ammonium sulfamate are available on this topic and
a data gap exists.

Fish

Freshwater Fish

The minimum data required for establishing the acute toxicity of manufacturing-
use ammonium sulfamate for fish is a determination of the 96-hour LC,.^ for a
coldwater species (preferably rainbow trout) and a warmwater species
(preferably bluegill sunfish).  No acceptable data on technical  ammonium
sulfamate are available on this topic and, therefore, a data gap exists.

Matida (1975, 05010743) provides supplemental information for coldwater
fish (rainbow trout).  This study does not fulfill the guideline requirements
for toxicity studies for coldwater fish.  In this study, rainbow trout, in an
artificial stream situation, showed no adverse effects to concentrations  up to
30 ppm of ammonium sulfamate.

There is no requirement for an artificial stream test in the guidelines.
Various field studies on an artificial ecosystem study can be requested if the
required data indicate that the pesticide poses an environmental threat.
These additional data requests are decided on a case-by-case basis.

Aquatic Invertebrates

An acute toxicity LC   test with the technical product on an aquatic
invertebrate is required to support registration of all manufacturing-use
products and all formulated products intended for outdoor applications.   No
study on this topic was received and, therefore, the requirement for  the
technical  product has not been satisfied.
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Aquatic Plants

One study was available (Fromm 1949, 05004558) concerning  the effects  of
ammonium sulfamate on aquatic plants.  The study showed that when Spirodela was
grown in a nutrient solution, ammonium sulfamate at  1140 ppm caused a  decrease
in the number of fronds per plant, even though the number  of plants increased
temporarily.  Therefore, some aquatic plants would be expected to suffer
growth reduction if the concentration in the aquatic environment were  to  reach
approximately 1000 ppm.

This type of data is not currently required for registration.

Terrestrial Plants

Acceptable data are available on the toxicity of ammonium  sulfamate to
terrestrial plants.  The information is summarized in the  following table:

    Table 1:  Toxicity of Ammonium Sulfamate To Terrestrial Plants

     Species     Formulation    No Effect Level    Author/Date    MRIDff

    Turfgrass      A.I.           <2.18 Ibs/A      Pridham,1946  05004926
    Eggplant       A.I.           <100 ppm         Dubey,  1977   05004270
    Bean           A.I.            1140 ppm        Fromm,  1949   05004558

Ammonium sulfamate can be expected to have a temporary phytotoxic effect  on
turf at an application rate of 2.18 Ibs a.i./acre.   Since  ammonium sulfamate
is used as a non-selective herbicide on areas where  a complete vegetation kill
is desired, it seems unlikely that this chemical would be  used in areas where
it would significantly damage non-target plants.

This type of data is not currently required for registration.

Beneficial Insects

An acceptable study (Atkins et al. 1969, 00018842) on the  toxicity of  ammonium
sulfamate to beneficial insects is available.  There is sufficient information
to characterize ammonium sulfamate as relatively non-toxic to honey bees, when
bees are exposed to a mixture of technical ammonium  sulfamate and pyrolite dust
(LD50 60.43 micrograms/bee).

This type of data is not currently required for registration.

Crystalline Ammonium Sulfamate

Ecological Effects Profile

The toxicity of crystalline ammonium sulfaraate to wildlife may be estimated
from tests on the technical chemical.

Topical Discussions

See the Manufacturing-use Ammonium Sulfamate section of this chapter  and
Chapter III, Table 1 for the ecological effects data requirements to  support
the registration of ammonium sulfamate formulated products.

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The use patterns and formulations currently under  consideration  do not indicate
the need for acute fish and wildlife  tests using the  formulated  products.  The
toxicity of various formulations and  the subsequent hazard  to  wildlife can be
estimated by using the toxicity data  provided by tests  on  the  technical
chemical.

Soluble Concentrate Ammonium Sulfamate

Ecological Effects Profile

The toxicity of soluble concentrate ammonium sulfamate  formulations to wildlife
may be estimated from tests on the technical chemical.

Topical Discussions

See the Manufacturing-Use Ammonium Sulfamate section  of this chapter
and Chapter III, Table 1 for the ecological effects data required  to
support the registration of ammonium  sulfamate formulated  products.

The use patterns and formulations currently under  consideration  do not indicate
the need for acute fish and wildlife  tests using the  formulated  products.  The
toxicity of various formulations and  the subsequent hazard  to  wildlife can be
estimated by using the toxicity data  provided by tests  on  the  technical
chemical .

Freshwater Fish

A study (Matida et al ., 1975, 05010743) was done by dripping a 70% soluble
concentrate formulation of ammonium sulfamate into an artificial stream
containing rainbow trout.  No adverse effects were noted at concentrations
up to 30 ppm.

Aquatic Invertebrates

One available study (Eddleman 1974, 05008669) was  conducted with a 43% soluble
concentrate ammonium sulfamate formulation on Chaoborus punctipennis
(the phantom midge).  The 48-hour LC   values at 15 C and  20 C were
6096 ppm and 3183 ppm.  These toxicity values indicate  that this formulated
product is practically non-toxic to aquatic invertebrates.

Ready-to-Use and Pressurized Liquid Ammonium Sulfamate

Ecological Effects Profile

The toxicity of ready-to-use and pressurized liquid formulations to wildlife
may be estimated from tests on the manufacturing-use product.

Topical Discussions

See the Manufacturing-Use Ammonium Sulfamate section  of this chapter and
Chapter III, Table 1 for the ecological effects data  required  to support
the registration of ammonium sulfamate formulated  products.
                                     8-4

-------
The use patterns and formulations currently under consideration do not indicate
the need for acute fish and wildlife tests using formulated products.  The
toxicity of various formulations and the subsequent hazard to wildlife can be
estimated by using the toxicity data provided by tests on the manufacturing-
use chemical.
                                     8-5

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GUIDE TO USE OP BIBLIOGRAPHY
          9-1

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                       Guide to Use of This Bibliography

 1.  Content of Bibliography.  This bibliography contains citations  of
    the studies reviewed by EPA in arriving at the positions and conclusions
    stated elsewhere in this standard.  The bibliography is divided  into
    3 sections: (1) citations that contributed information useful to the review
    of the chemical and considered to be part of the data base  supporting
    registrations under the standard, (2) citations examined and judged  to  be
    inappropriate for use in developing the standard, and (3) standard
    reference material.  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, and the published technical
    literature.

 2.  Units of Entry.  The unit'of entry in this bibliography is  called a
    "study".  In the case of published materials, this corresponds closely  to
    an article.  In the case of unpublished materials submitted to  the
    agency, the Agency has sought to identify documents at a level parallel  to
    a 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 attempted also 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
    by author, date of the document, and  title.  Each entry bears, to the left
    of the citation proper, an  eight-digit numeric identifier.  This number  is
    unique to the citations, and should be used at any time specific reference
    is required.  This number is called the "Master Record Identifier",  or
    "MRID".  It is not related  to the six-digit "Accession Number" which  has
    been used to identify volumes of submitted data; see paragraph 4(d)(A)
    below for a further explanation.  In  a few cases, entries added to the
    bibliography late in the review may be preceded by a nine-character
    temporary identifier.   This is also to be used whenever a specific
    reference is needed.

4.  Form of the Entry.  In addition to the Master Record Identifier (MRID),
    each entry consists of a bibliographic citation containing standard
    elements followed, in  the case of materials submitted to EPA, by a
    description of the earliest known submission.  The bibliographic
    conventions used reflect the standards for the American National Standards
    Institute (ANSI),  expanded  to provide for certain special needs.  Some
    explanatory notes  of  specific elements follow:

      a.  Author.    Whenever the Agency could confidently identify one,
         the  Agency has chosen  to show a  personal author.  When no individual
         was  identified,  the Agency has shown an identificable laboratory or
         testing  facility  as author.  As  a last resort, the Agency has shown
         the  first known  submitter as author.

      b.  Document  Date.   When  the date appears as four digits with no
         question  marks,  the Agency took  it directly from the document.  When a
         four-digit  date  is followed by a question mark, the bibliographer


                                     9-2

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

c. Title.  This is the third element in the citation.  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 Parenthesis.  For studies submitted to us in the past, the
   trailing parenthesis "include (in addition to any self-explanatory
   text) the following elements describing the earliest known submission.

        (1)  Submission Date.  Immediately following the word
             'received' appears the date of the earliest known
             submission.

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

        (3)  Submitter.  The third element is the submitter, following
             the phrase 'submitted by'-  When authorship is defaulted to
             the submitter, this element is omitted.

        (4)  Volume Identification.  The final element in the trailing
             parenthesis 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
             'GDI/, standing for "Company Data Library".  This accession
             number is in turn followed by an alphabetic suffix which
             shows the relative position of the study within the volume.
             For example, within accession number 123456, the first
             study would be 123456-A; the second, 123456-B; the 26th,
             123456-Z; and the 27th 123456-AA.
                                  J-3

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   OFFICE OP PESTICIDE PROGRAMS




PESTICIDE DOCUMENT MANGEMENT SYSTEM




         CASE BIBLIOGRAPHY
               9-4

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                         OFFICE OF PESTICIDE PROGRAMS
                      REGISTRATION STANDARD BIBLIOGRAPHY
          Citations Considered to be Part of the Data Base Supporting
                       Registrations Under the Standard
1016-001-02
00004227
MRID          CITATION

05001460      Anderson, K.G., E.G. Leighty and M.T. Takahashi, 1972
              Evaluation of herbicides for possible mutagenic properties.
              J. Agr. Food. Chem. 20:649-656.

05005119      Aoyama, M. 1975.  Effect of anti-flame treating agents on the
              skin.  Nagoya Med. J. 20:11-19.

00018842      Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969)
              Effect of Pesticides on Apiculture:  Project No.
              1499; Research Report CF-7501.  (Unpublished study
              received May 8, 1971 under 1F1174; prepared by Univ. of
              California—Riverside, Dept. of Entomology, submitted by
              Ciba Agrochemical Co., Summit, N.J.; CDL:090973-8).

              Baumgarten, Paul, inventor; E.I. du Pont de Nemours  & Company,
              assignee (1937) Process for manufacturing amino sulphonic acid
              U.S. patent 2,102,350.  Dec 14. 2p.

              Bergen, D.S. and Wiley, F.H., 1938.  The metaboism of sulfamic
              acid and ammonium sulfamate.  (Unpublished study received Nov.
              10, 1954 under pp0376 submitted by E.I. DuPont de Nemours and
              Co., Inc. Wilmington, DEL., CDL:  9048-4.

00004214      Bullock, C.H., and Narcisse, J.K., 1974a. S-662:  The Acute Oral
              Toxicity of Ortho Brush Killer A (CC-5110): Socal 5882/XVIII:81.
              (Unpublished study received April 30, 1976, under 239-2336;
              submitted by Chevron Chemical Co., Richmond, Calif.;
              CDL: 224772-B)

00004215      Bullock, C.H., and Narcisse, J.K., 1974b. S-663:  The Acute
              Dermal Toxicity of Ortho Brush Killer A (CC-5110): Socal
              5883/XV:73A.  (Unpublished study received April 30,  1976,,
              under 239-2336; submitted by Chevron Chemical Co., Richmond,
              Calif.; CDL:224772-C)

00004218      Bullock, C.H., and Narcisse, J.K., 1974c. S-666:  The Acute
              Inhalation Toxicity of Ortho Brush Killer A (CC-5110): Socal
              586/XIII:122.  (Unpublished study received April 30, 1976,
              under 239-2336; submitted by Chevron Chemical Co., Richmond,
              Calif.; CDL:224772-F)

00004216      Bullock, C.H., and Narcisse, J.K., 1974d. S-665:  The Eye
              Irritation Potential of Ortho Brush Killer A (CC-5110): Socal
              584/XX:21.  (Unpublished study received April 30, 1976, under
              239-2336; submitted by Chevron Chemical Co., Richmond,
              Calif.; CDL:224772-D)
                                       9-5

-------
00004117      Bullock, C.H., and Narcisse, J.K., 1974e. S-664:  The
              Skin Irritation Potential of Ortho Brush Killer A (CC-5110):
              Socal 585/XX:21.  (Unpublished study received April 30, 1976,
              under 239-2336; submitted by Chevron Chemical Co., Richmond,
              Calif.; CDL:224772-E)

05008521      Cain, B.E.; Kanda, F.A. (1972)  The crystal structure of ammonium
              sulfamate.  Zeitschrift fuer Kristallographie, Kristallgeometrie ,
              Kristallphysik, Kristallchemie 135(3/4): 253-261

05005498      Carvell, K.L. (1955) Translocation of Ammate.  Forest Science


05004270      Dubey, P.S. (1977) Herbicidal pollution—pollen damage due
              to herbicides.' Environmental Pollution 13(3):169-171.

05008669      Eddlemon, G.K. (1974) The Effects of Three Herbicides on
              Larvae of the Phantom Midge,  Chaoborus punctipennis
              (Say) Master°s Thesis.  Knoxville, Tenn.:  University
              of Tennessee.  (Available from;  NTIS, Springfield, VA:
              PB-269 343).

00004229      E.I. Dupont de Nemours & Company, Incorporated (1960)  Results of
              Tests on Amount of Residue Remaining on Apples and Pears:
              Ammonium Sulfamate.   (Unpublished study received on unknown
              date under PP0376; CDL: 090408-J)
1016-001-01
05016316
05004558
00014379
05014 167
E.I. Dupont de Nemours & Company (1962) Ammonium sulfamate.
(unpublished study received 8/8/62 under pp#376; CDL: 114188).

Fan, Y.T. (1971)  Yp kuan yu lin yong chu chou gee tz yen jo (I):
an qi ya liu shwan an (AMS) si chu chou gee tz shing tz gee (I):
properties and usages of herbicides—series of sulfamate-1
Quarterly Jounal of Chinese Forestry 4(2): 69-85.

Fromtn, F. (1949) The action of herbicides on Lemnaceae.
Pages 85-90, In Proceedings of the Pennsylvania Academy
of Science.  Easton, PA.:  Pennsylvania Academy of
Science.

Gordon, D.L. (1963)  Validation of Pesticide Petition for
Ammonium Sulfamate.  (Unpublished study including letters
dated Dec 10, 1962, Feb 5, 1963, and Apr 30, 1963 from F.J.
McNall, D.L. Gordon, R.T. Ottes and E.M. Hoshall, respectively,
to U.S. Bureau of Field Administration, received on unknown date
under 3F0376; submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, Del.; CDL: 098425-A)

Gupta, B.N., Khanna, R.N., and Datta, K.K., 1*979.  Toxicological
studies of ammonium sulfamate in rats after repeated oral
administration.  Toxicology 13:45-49.

-------
05011255
05004655
05011074
05016686
05010475
05010743
1016-001-08
05018857
00004228
1016-001-07
Hofmeister, H.K.; Heubach, E., inventors; Farbwerke Hoechst,
A.G., assignee (1971) Verfahren zur Gewinnung von Ammonium
sulfamate Process for obtaining ammonium sulfamate.  German
(Fed. Rep.) offenlegungsschrift 1,936,854.  Jan 28. 10 p. Int.
Cl. C Olb 21/10.

Ito, Y. (1957) Studies on the nonaqueous reaction of NHH3 and
SOH3; Part 7; Synthesis of ammonium sulfamate under pressure.
Tokyo Kogyo Shikensho Hokoku.  Reports of the Government Chemical
Indusrial Research Institute, Tokyo,  52(8): 281-284.

Ito, Y.; Kobayashi, E. (1960) Ka-atsuho ni yoru nitorirosuruhon-
san-atnrnonium nitrilosulfonate by the high pressure method.  Kogyo
Kagaku Zasshi.  Journal of Industrial Chemistry.  63(8): 1298-
1300.

Konnai, M.; Takeuchi, Y.; Takematsu, T. (1974) Ringyoyo
josozai no oojochu niokeru zanryu oyobi ido nikansuru kisoteki
kenkyu - Basic studies on the residues and movements of
forestry herbicides in soil-1  Utsunomiya Daigaku Nogakubu
Gakujutsu hokoku.  Bullentin of the College of Agriculture,
Utsunomiya University.  19(1) :95-112.

Mackay, J.S., inventor; American Cyanamid Co., assignee (1956)
Verfahren zur Herstellung von ammoniumsulfamat (Procedure for the
production of ammmonium sulfamate  German (Fed. Rep.)
patenschrift 940,823.  March 29. 2p.

Matida, Y.; Kimura, S.; Kumada, H.; Yokote, M. (1975)
Effects of some herbicides applied in the forest to the
freshwater fishes and other aquatic organisms  II
Effects of sodium chlorate and ammonium sulfamate to the
aquatic organisms in the artificial stream.  Bulletin of
Freshwater Fisheries Research Laboratory 25(l):55-62.

McNall, F.J. (1962) Memorandum sent to U.S.D.A. Bureau of Field
Administration dated December 10, 1962. [Concerning Ernest L.
Brisson°s analysis of Ammonium submitted by Bureau of Field Adm.,
Boston, FDA/HEW CDL:  114188.)

Miki, M.; Katsu, K.; Matsumoto, I.; Matsuda, M.; Arimoto, H.,
inventors; Seitetsu Kagaku Kogyo Ltd., assignee (1971) Surufamin
san anmoniumu no seizohoho.   Manufacturing method of ammonium
sulfamate.  Japanese patejt  specification 71-40531.  Nov 30.  4
p. Int. Cl. C Olc.

Pease, H.L. (1957?) The Determination of Sulfamate Residues.
Undated method.    (Unpublished study received on unknown date
under PP0376; submitted by E.I. Dupont de Nemours & Co., Inc.,
Wilmington, Del.; CDL: 090408-1)

Pease, Harlan L. (1963) The  Determination of Sulfamate Residues.
(Unpublished study received  3/1/63 under PP 376; CDL: 114188)
                                        9-7

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00004232      Pease,  H.L.  (1964)  The  Determination  of  Sulfamate  Residues.
              Method  dated May 8,  1964.   (Unpublished  study received  May 10,
              1965 under 352-311;  submitted  by  E.I.  Dupont  de  Nemours &  Co.,
              Inc., Wilmington, Del.;  CDL:   002944-B)

              Pease,  H.L.  (1964)  Sulfamate Residue  Method.   (Unpublished study
              received on unknown date under 3F0376; submitted by E.I. Dupont
              de Nemours & Co., Inc.,  Wilmington, Del.;  CDL: 092659-A)

              Pease,  H.L.  (1966)   Determination of  sulfamate residues.  Journal
              of Agricultural  and  Food Chemistry 14(2):  140-142.

              Pridham, A.M.S.  (1946)  2,4-Dichlorophenoxyacetic acide
              reduces germination  of  grass seed.  Proceedings  of the
              American Socity  for  Horticultural Science  47:439-445.

              Rayner, A.D.M.  (1977) Fungal colonization  of  hardwood stumps
              from natural sources:   I-  Non-basidiomycetes.
              Transactions of  the  british Mycological  Society  69(2):291-302.

              Rohrmann,  Charles A., iventor;  E.I. du Pont de Nemour & Company,
              assignee (1949)  Process  for producing  ammonium sulfamate U.S.
              patent  2,487,480. Nov.  8.  2p.

              Sherman, H., and Stula,  E.F.,  1964.   Haskell  Laboratory Progress
              Report  No. 142-64,  MR No.  730.  (Unpublished  study received  on
              unknown date,  under  PPO  376; submitted by  E.I. du  Pont  de
              Nemours &  Co.,  Inc., Wilmington,  Del.; CDL:   09048-E)

05011429      Sisler, H.H.;  Audrieth,  L.F. (1946) Triammonium  imidodisulfate  1-
              hydrate.  Pages  179-181, In-inorganic  syntheses  II.  Edited  by
              W.C. Fernelius,  L.F. Audrieth,  J.C. Bailar, Jr., H.S. Booth,
              W.C. Johnson,  R.C.  Kirk, W.C.  Schumb,  J.D.  Scott.   New  York:
              McGraw-Hill.
00004230
05003443
05004926
05005817
1016-001-06
0004224
05006452      Smith,  N.R.;  Dawson,  V.T.;  Wenzel,  M,E.  (1946)  The  Effect  of
              certain herbicides  on soil  microorganisms.   Pages 197-
              201,   In Proceedings  of the Soil  Science Society of
              America.  Vol.  10 Madison,  Wis.:   Soil  Science  Society  of
              America.
GS0016-0033
05011250
1016-001-03
              U.S.  Department of Health,  Education,  and  Welfare (1973).
              Sulfamic Acid:   Affirmation of GRAS  Status as  an Indirect  Human
              Food  Ingredient.  Federal  Register 44(31): Feb.  13,  1979.

              Voigt,  A.;  Brand,  H.,  inventors;  Farbwerke Hoechst A.G.,  assignee
              (1962)   Unkrautbekaetnpfungsmittel.  Herbicidal mixtures.   German
              (Fed. Rep.)  patentschrift  1,112,854.   Mar  8.  2 p. Int.  Cl. A Oln.

              Yip,  George  (1964) Letter  sent to George Beusch  ddated  April 14,,
              1964.   [Modification of procedures used  to determine ammonium
              sulphamate*residues]   (In  upublished submission  rreceived  4-20-64
              under pp. 376;  submitted by Div of Food  Chem.  FDA/HEW;  CDL: 11489)
                                      9-8

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1016-001-04   Yip, George (1964) memoraqndum to Howard Jones dated March 5,
              1964.  [Summary of findings on the method proposed by DuPont for
              determination of sulphamate]  (In unpublished submission reeceived
              3/10/64 under pp#376; submitted by Div of Food, Chem; FDA/HEW;
              CDL: 114189)
                                       9-9

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                          OFFICE OF PESICIDE PROGRAMS
                      REGISTRATION STANDARD BIBLIOGRAPHY
                 Citations Judged to be Inappropriate for Use
                          in Developing this Standard

005013104   Abumiya, H.; Azakami, N.; Hirose, A. (1966) Dojo ni okeru
            surufuamin- san anmonno bunkai narabini ido ni tsuite.  [On the
            decomposition and migration of ammonium sulfamate in the soil.]
            Pages 95-98, Jn Hokkaido Nogyo Striken jo Ihb.  [Research
            Bulletin of the Hokkaido National Agricultural Experiment
            Station.]  No. 90.  Sapporo, Japan:   Hokkaido National
            Agricultural Experiment Station.

005011384   Ahrens, J.F.; Dunbar, D.M. (1975) Are herbicides effective in
            control of pales ajid northern pine weevils in Christmas tree
            plantations   American Christmas Tree Journal 19(2):17-20.

005006317   Ahrens, J.F.; Stoddard, E.M. (1962)  Eradication of Poison Ivy and
            Poison Sumac.  New Haven, Conn.:  Connecticut Agricultural
            Experiment Station. (Connecticut Agricultural Experiment
            Station circular no. 222)

005010750   Akhurst, C.G. (1953) Chemical weed control on rubber estates in
            Malaya.  Plant Protection Overseas Review 4:5-14.

GS0016-0024 Alabaster, J.S. (1969)  Survival of Fish in 164 Herbicides,
           Insecticides, Fungicides,  Wetting Agents and Miscellaneous
           Substances:  International Pest Control March/April 1969.

005007395   Allgaier, B.E. (1944) The chemical control of Klamath weed.  I.
            Application of ecological methods in determining the herbicidal
            fertilizing properties of ammonium sulfamate and commercial
            borax.  Ecology 25(4):424-432 .

000004226   Ambrose, A.M. (1943) Studies on the  physiological effects of sul-
            famic acid and ammonium sulfamate.  Journal of Industrial Hy-
            giene and Toxicology 25(l):26-28.  (Also In unpublished submis-
            sion received Nov 10, 1954 under PP0376; submitted by E.I.
            Dupont de Nemours & Co.,  Inc., Wilmington, Del.; CDL:090408-G)

GS0016-0026 Anon. (?)  Ammonium Sulfamate:  Fish.  (Unpublished study received
            March 10, 1981; submitted by E.I. DuPont de Nemours Co.;
            Wilmington,  Delaware CDL:  224902)

000030208   Anon. (1950) Research Report of the  Seventh Annual North Central
            Weed Control Conference;  Dec 12-14,  1950,  Milwaukee, Wisconsin.
            N.P.  (pp. 34-51,83 only;  also ^n unpublished submission re-
            ceived Jun 4, 1976 under 960-163; submitted by Balcom Chemicals,
            Inc., Greeley, Colo.; CDL:224776-M)

000027252   Anon. (1954) Research Report of the  Eleventh Annual North Central
            Weed Control Conference:  1954; Dec 7-9, 1954, Fargo, North Da-
            Kota.   N.P.  (pp. 28,50,72-73,92-94 only; also _In unpub-
            lished submission received Jun 4, 1976 under 960-163; submitted
            by Balcom Chemicals, Inc., Greeley,  Colo.; CDL:224776-K)
                                      9-10

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005005497   Anon.  (1963) Focus on chemicals: 7.  Sulphatnic acid and
            sulphamates.  Chemical Products and Chemical News 26(10):32-36.

005004172   Anon.  (1973) Common names of pesticides.  Revised list—February
            1973.  PANS  19(2):287-306.

005014617   Anon.  (1973) Degree of hazard when using herbicides.  South
            African Sugar Journal 57(2) :71.

GS0016-0035 Anon.  (1974)  Documentation of the Threshold Limit Values.
            American Conference of Governmental Industrial Hygenists:  2nd
            Printing.

005003247   Anon.  (1976) The possible alternatives.  Nature 263(5578) :539.

005005119   Aoyama, M. (1975) Effect of anti-flame treating agents on the
            skin.  Nagoya Medical Journal 20(1):11-19.

005013706   Arbonnier, P- (1957) La devitalisation des feuillus par le
            sulfamate d  ammonium.  [The devitalization of deciduous trees
            with ammonium sulfamate.]  Revue Forestiere Francaise
            6:458-469.

005006426   Arend, J.L.  (1952) Bark loosening effects with 2,4-D, 2,4,5-T and
            ammate.  Pulp and Paper Magazine of Canada 53(7):159,161,164.

005006183   Armitage, I.P. (1976) Some limitations to the controlled use of
            fire as an alternative to herbicides in forest establishment.
            Pages  301-305, In The Use of Herbicides in Forestry in New
            Zealand, 1975.  Proceedings of the F.R.I. Symposium No. 18.
            Rotorua, New Zealand:  Forest Research Institute.

005014609   Ashton, F.M.; Crafts, A.S. (1973) Mode of Action of Herbicides.
            New York:  Wiley Interscience.

000009181   Atkins, E.L., Jr.; Anderson, L.D.; Gr,eywood, E.A. (1969) Effect of
            Pesticides on Apiculture: Project No. 1499.  (Unpublished study
            received Jul 29, 1976 under 352-342; prepared by Univ. of Cali-
            fornia—Riverside, Dept. of Entomology, submitted by E.I. du
            Pont de Nemours & Co., Wilmington, Del.; CDL:224800-C)

005004927   Bailey, J.S. (1948) Controlling quack grass by spraying with
            Ammate or Atlacide.  Proceedings of the American Society for
            Horticultural Science 51:563-564.

005010067   Baker,  G.; Bitting, L.E.; Lambert, P.A.; McClintock, W.L.;  Hogan,
            W.D. (1975)  Improved application techniques for aquatic
            herbicides.  Hyacinth Control Journal 13:21-24.

005017496   Ball, W.L. (1956) Threshold limits for pesticides.  AMA Archives
            of Industrial Health 14:178-185.

005003486   Beatty, R.H. (1953) Brush control: status of chemical methods.
            Journal of Agricultural and Food Chemistry 1(2):178-181.

005009719   Bel°kov, V.P.; Shutov, I.V- (1960) Sul°famat ammoniya kak sredstvo

                                      9-11

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005010071
bor°by s sornymi i nezhelatel°nymi rasteniyami.  [Ammonium
sulfamate as a means of controlling weeds and undesirable
plants.]  Lesnoe Khozyaistvo.   [Forestry.]  1:7-10.

Bel°kov, V.P.; Shutov, I.V.  (1972) Vliyanie zhivogo napochvennogo
pokrova na rost kultur sosny na osushennora bolote.   [Effect of
ground biocover on the growth  of Scotch pine on drained swamp.]
Lesnoe Khozyaistvo.  [Forestry.]  (6):33-36.
005008954
000027267
Bennett, J.M. (1958)  Chemical control of conifers.
Research News 3:17-20.
Ontario Hydro
005004034
005006428
005007394
Bennett, J.M.  (1959)  Chemical control of conifers.   Down to Earth
(Winter):18-20.   (Also _In unpublished submission received
May 9, 1972 under 264-61; submitted by Union Carbide Agricul-
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Berry, F.H.; Bretz,  T.W.  (1964)  Urea and other  chemicals effective
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Birch, W.R. (1958) The effect of weeds, and their control by MCPA
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Blair, B.O.; Glendening,  G.E. (1953) Intake and movement of
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005003751   Bock, F.G.; Michelson, I.;  Bross, I.D.J.; Priore, R.L. (1974)
            Carcinogenic activity of smoke condensate from cigarettes with
            ammonium sulfamate-treated  paper.  Cancer 33(4):1010-1016.

GS0016-0030 Bodek, Itamar and Smith, Richard H. (1980) Determination of
            Ammonium Sulfamate in Air Using Ion Chromatagraphy.  American
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005012906   Bovey, R.W. (1976) Response of Selected  Woody Plants in the United
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005004828   Boyce, J.S., Jr. (1957) Oak wilt spread  and damage in the Southern
            Appalachians.  Journal of Forestry  55(7):499-505 .

005005798   Boyd, W.I. (1952) Chemical  weed control  around water reservoirs.
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000014380   Brisson, E.L. (1962)  Ammonium sulfamate  Residues.  (Unpublished

                                     9-12

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            study received on unknown date under 3F0376; submitted by
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005000993   British Crop Protection Council (1974) Pesticide Manual: Basic
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005010533   Brown, R.H. (1972) Chemical control of the cereal cyst nematode
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000004792   Buchholtz, K.P.; Holm, L.G. (1952) Herbicide Applications Recom-
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005013240   Buehring, N.; Santelmann, P.W.; Elwell, H.M. (1971) Responses of
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005004629   Cable, D.R. (1957) Chemical control of chaparral shrubs in central
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005004175   Cain, B.E. (1971) Crystal structures of three inorganic compounds:
            (A) Ammonium sulfamate.  (B) Tetraethylammonium tetrabromo-
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005008488   Candeli, A.; Lindsey, A.J.; Persaud, K. (1960) Carta di sigarette
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                                      9-13

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            36(10):452-454.

005003244   Carlson, A.E. (1951) United Gas Pipe Line Co. uses new weapon in
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005004628   Carvell, K.L. (1956) The use of chemicals in controlling forest
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005005098   Castillo, B.S.;  Agati,  J.A. (1951) Using weedicides in eradicating
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005004627   Chaiken, L.E. (1951) Chemical control  of inferior species in the
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000004213   Chevron Chemical Company (19	) Human  Safety: Summary of Toxicology
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GS0016-0021 Clemens, Howard  P. and  Sneed, Kermit E. (1959) Lethal Doses of
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005003248   Committee on Threshold  Limits (1963) Threshold limit values for
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005007904   Consolidated Mining and  Smelting Company, of Canada, assignee
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005004928   Conway, E.; Forrest, J.D.  (1956) Chemical treatment of bracken.
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005010737   Cook, D.B.; Hamilton, L.S. (1953) Chemi-peeling pulpwood in New
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000004791   Cornell University (1952)  Weed control in legumes.  Pages 7,16-
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005005453   Corns, W.G.; Schraa, R.J.  (1965) Mechanical and" chemical control
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005013388   Cowley, G.T.; Lichtenstein, E.P. (1970) Growth inhibition of soil
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                                       9-14

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            Microbiology 62(0:27-34.
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000014478   E.I. du Pont de Nemours  and Company (1962) Hyvar X Weed Killer for
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                                       9-16

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000004219   E.I. Dupont de Nemours & Company, Incorporated (1964) Animate X
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000004231   E.I. Dupont de Nemours & Company, Incorporated (1964) Data Support-
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GS0016-0029 E.I. DuPont de Nemours & Company, Incorporated. (1980)  Sulfamic
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GS0016-0028 E.I. DuPont de Nemours & Company, Incorporated. (1980) Sulfamic
            Acid:  Ammonium Salt:  Method No: A360.00SE (Unpublished study
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GS0016-0027 E.I. DuPont de Nemours & Company, Incorporated. (1980)  Sulfamic
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000037597   Edson, E.F.; Sanderson, D.M.; Noakes, D.N. (1965) Acute toxicity
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005011078   Egler, F.E. (1954) Vegetation management for rights-of-way and
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005021870   Eijsackers, H.; Chardon, W.J. (1979) Nevenwerkingen van
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            Agricultural Experiment Station.

                                       9-17

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000026970   Evans, R.A.; McKell, C.M.; Kay, B.L.; et al. (1972) AAtrex SOW—
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000012150   Foy, C.L.; Witt, H.L. (1971) Fruit: Evaluation of Herbicides for
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005006408   Fromm, F. (1948) El desyerbo de la grama por una mixtura de 2,4-D
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005004829   Fuller, R.M.; Boorman, L.A. (1977) The spread and development
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                                      9-19

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            Control].  (Unpublished study including published data, received
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005014972   Gangstad, E.G.; Novosad,  C.;  Nailon, W.T.; Guerra, L.V.; Maddox,
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005012893   Giban, J. (1972) L°emploi des phytocides en sylviculture
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                                                      4

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005015749   Ginns, J.H., Jr.; Driver, C.H.  (1969) Annosus root-rot  in slash
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005015748   Grane, C.X. (1952) Effectiveness of Animate in controlling
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005008388   Grigsby, B.H. (1952) Recommended practices in brush control.

                                      9-20

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005004825   Hildebrand, E.M.; Palmiter, D.H. (1942) Control of X disease of
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005009176   Hill, G.D.; Klingtnan, G.C.; Woltz, W.G. (1953) Chemical Weed
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005004868   Holmes, G.D. (1956) Experiments on the  chemical control
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005006622   Hurd-Karrer, A.M. (1946) Relation of Soil Reaction to Toxicity and

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            Persistence of Some Herbicides in Greenhouse Plots.
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005017628   Ito, S., inventor; Institute of Industrial Technology, assignee
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005011248   Ito, Y. (1954) Surufamin-san ammoniumu no ka-atsu gosei ni okeru
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005012260   Ito, Y.; Kobayashi, E. .(I960) [The equilibrium of
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005011075   Ito, Y. (1972) Pepa kuromatogurafi ni yoru akuo ammono ryusan no
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005013241   Itoh, M.; Kadota, M. (1972) Sulfaminsan ammonium siuyoeki no
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005004662   Jacobs, H.L. (1952) Chemical brush and weed control along rights
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005005818   Jarvis, J.M. (1957) The effectiveness of ammonium sulphamate for
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                                     9-24

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005010114   King, J.R.; Simanton, W.A.; Kretchraan, D.W. (1958) Chemical
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                           9-29

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                                       9-30

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005010355
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005007652
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005005078


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                                       9-33

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000027614   Schweizer, E.E.; Santelmann, P.W.; Upchurch, R.P.; et al. (1963)
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                           9-34

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                          9-37

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005004929   Wester,  H.V. (1949) Comparative studies of ammonium sulfamate,
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                                       9-3^

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            unpublished submission received Jan 28, 1964 under 352-206;
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                                        9-39

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                            OFFICE PESTICIDE PROGRAMS
                        REGISTRATION STANDARD BIBLIOGRAPHY

                           Standard  Reference Material

Farm Chemical Handbook.  (1979)  Meister  publishing.  Willoughby.  Ohio.

The Federal Insecticide,  Fungicide,  and  Rodenticide Act, as amended  in  1978,
    7th U.S. Code, Chapter  135,  61  Statute  163.78 Statute 190.

Pesticide Process Encyclopedia  ,  1977,  Noyes Data Corp., Park Ridge, New
    Jersey.

Pesticide Index:  Basic  information  on  the  chemicals used as active
    components of pesticides.  ;  Martin,  H.,  and  Worthington, C.R., eds.,  1977.
    5th ed., British Corp.  Protection Council, Worcestershire, England

U.S. Environmental Protection  Agency (1978a);  Proposed Guidelines for
    Registering Pesticides  in  the United  States.   Federal Register,  43  (132)
    29696.

U.S. Environmental Protection Agency (1978b);  Proposed Guidelines for
    Registering Pesticides  in  the United  States; Hazard  Evaluation:  Humans and
    Domestic Animals.   Federal  Register,  43  (163) 37336.

U.S. Environmental Protection Agency (1980);  Regulations for the Enforcement
    of the  Federal Insecticide,>Fungicide,  and Rodenticide Act, Title 40,
    Chapter 1, Part 162.

U.S. Environmental Protection Agency (in  press)  Proposed Guidelines for
    Registering Pesticides  in the United  States.  Subparts G (Product
    Performance) and H  (Label Development).
                                      9-40
                                                      *U S GOVERNMENT PRINTING OFFICE: 1981 341-085/4471

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