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Ammonium Sulfamate
Pesticide Registration Standard

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4. Title and Subtitle
Pesticide Registration Standard
Anr.cniur: Sulfanate
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and Registration Division (RD)
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Droducts containing Amr.cniun Sulfanate, including hew tc register under a
registration standard, regulatory position and rationale, and suTmaries of_
data requirements and data gaps. Also, included is a bibliography containing
citations of all studies reviewed by EPA in arriving at the positions and
conclusions contained ir. the standard.
3 7. Dcr.v'rr.ont Analyse r.. Descriptors
Registration Standard
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AMMONIUM SULFAMATE
PESTICIDE REGISTRATION STANDARD
Lois Rossi	Project Manager (SPRD)
Anne Barton	Science Policy Staff (HED)
William Boodee	Residue Chemist (HED)
Wayne Faatz	Wildlife Biologist (HED)
Ralph Freund	Economist (BFSD)
Randy Norris	Editor (SPRD)
Pat Ott	Environmental Chemist (HED)
Donna Peacher	Typist (SPRD)
Bruce Sidwell	Plant Scientist (BFSD)
Ellen Sullivan	Toxicologist (HED)
Dorothy Vaughn	Typist (SPRD)
Vickie Walters	Product Manager (RD)
APRIL, 1981
Office of Pesticides and Toxic Substances
Environmental Protection Agency
Am 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.	Ceneric 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
Find Use .Ammonium Sulfamate	4-5
V.	F.nvironnental 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
in

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Required Labeling	6-2
Topical Discussions	*-2
Crystalline Amoniun Sulfamate	6-8
Toxicology Profile	6-8
Data Requirements	6-8
Topical Discussions	6-8
Soluble Concentrate Annonlun	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 Sultanate	7-1
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	3-1
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
*1

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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)(1)(D)
6.	Obtaining Data to Fill " Data Gaps"; FIFRA 3fc)(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 Arf^iinistrator [of EPA]." To approve the registration of a
pesticide, the Administrator must find, pursuant to Section 3(c)(3) that:
"(A) its composition is such as to warrant the proposed claims for it;
(E) 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 cane 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 (AO CFR
162) and proposed new guidelines for hazard testing in 1978 (43 FR 29686, July
10, 1978 and A3 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 net 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
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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 rereglstration. 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 falls to
comply with the procedures'for rereglstration 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
Fatet Toxicology, Residue Chemistry, and Ecological Effects. These
determinations are based primarily on the data Guidelines proposed in 43 FR
29696, July ]0, 1978; 43 FR 373.16, 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.	Ceneric 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's, unique 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
x-3

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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. (Where it has heen found practicable to group
sinilar 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 lngred ient 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 AO CFR 163.81-1(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 funder FIFRA Section 3(c)(1)(D)]
or data generation [under Section 3(c)(2)(B)! 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)(1)(D)
Under FIFRA Section 3(c)(1)(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 sone 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)(1)(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 test6 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)(1)(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 Co 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 1970, 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 falls 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 he 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" daca 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 atterapt 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 Cuidance 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 chenistry 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
1-6

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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 ingredlent(s), 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
che 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.
1-7

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II
Regulatory Position
1.	Introduction
This chapter describes in detail the Agency's regulatory position on
products which contain ammonium sulfonate 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 sulfatnate 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: "Animate" and "Ikurin". The Chemical Abstracts
Registry (CAS) number for ammonium sulfamate is 7773-06-0, and the EFA
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, 1981, the
Agency finds that none of the risk criteria found in Section 162.11(a) of Title
AO of the U.S. Code of Federal Regulations were met or exceeded for ammonium
sulfamate.
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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 sulfonate
products currently registered nay be reregistered subject to the conditions
imposed for data requirements. New products nay be registered under this
Standard, and are subject to the same requirements.
4. Regulatory Rationale
Ammonium sulfamate was developed and introduced as an herbicide in the early
I940'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. 'V 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.

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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 (FR 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 Reg!stration 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 laheling.
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 1(c)(1)(D) and 3(c)(2)(D) of the Federal
Insecticide, Fungicide, and Rodenticide Act [FTFRAl, as amended, 7 U.S.C. 136
(c)(1)(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:
I	II III IV
Acute Oral Toxicity
yes
yes
yes
yes
Acute Dermal Toxicity
yes
yes
yes
yes
Acute Inhalation Toxicity
yes
yes
yes
yes
Primary Eye Irritation
yes
yes
yes
yes
Primary Dermal Irritation
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
AO 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:
I	II III TV
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
5_'t

-------
To be registered for nondonestic 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
requi renents.
3. Use Patterns and Application Methods
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.
fi. 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 Eivj-Use Herbicide Products
Intended Only for Domestic, (Non Domestic), Food (Non Food),
Terrestrial, Outdoor Use."
2-?

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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 100.88). Rased on these established
tolerances fpr 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
resultB 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
nay 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-f

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Ill
Data Requirements and Data Gaps
Manufacturing-Use Ammonium Sulfamate
Table 1, entitled Anraonium 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 sulfainate. 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 anraonium sulfamate products must acknowledge reliance on existing data
which fill indicated data requirements under FIFRA 3(c)(1)(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)(1)(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

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Table 3, entitled Ammonium Sulfanate 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 I
Ammonium Sulfonate Product-Chemistry (See Chapter IV)
Generic Data Requirements
Hunt Additional Data be
Submitted under FIHW
Does EPA Have	3(c)(2)(B)? If so, months
Data to Partially	allowed for submission
Guidelines	Name of	Are Data	or totally Satisfy Bibliographic from published dnte of
Citation
Test
Required
CooDoaitlon
this Requirement
Citation
standard
163.61-8(1)
Color
Yes
Technical
Grade
All
Cain. 1972
MOID# 05006521
No
163.61-8(2)
(Mor
Yes
Technical Grade
No
—
Yes/October, 1981
163.61-8(3)
Melting Point
Yes
Technical
Grade
A11
ftui, 1971,
MUD# 05016316
No
163.61-8(4)
Solubility
Yes
Technical Grade
No
—
Yes/October, 1981
163.61-8(5)
Stability
Yes
Technical Grade
No
—
Yes/October, 1981
163.61-6(6)
Octanol/vater Yes
partition coefflcent
Technical Orade
No
—
Yeo/October, 1981
163.61-6(7)
H\yslcal State
Yes
Technical
Grade
All
Cain. 1972,
mm 05008521
No
These data requirements are current as of April, 1981. Refer to
0ildance package for update requirements.
3-3

-------
Table 1 (Cont'd)
Ammonlun Sulfonate Peoduct Chemistry (See Chapter IV)
Generic Data Requirements
Must Additional Data be
Submitted under F1FI
-------
Table 1 (Cont'd)
Ammonlun Sulfonate ftiviroranental Rste (See Chapter V)
Generic Data Requirements
Quldellnes
Citation
Nnme of
Test
Are Data
Required
Composition
Does EPA Have
Data to Partially
or totally Satisfy
thie Requirement
Bibliographic
Citation
Hoot Additional Data be
Submitted under FIFTCA
3(c)(2)(B)? If go, months
allowed for sutvnlaslon
fran pibllnhed date of
standard
l63.62-7(b)
Hydrolysis
Yes
See Footnote 3
No
—
Yes/October, 1981
l63.62-7(c)
Riotodegradatlon
Yes
See Fbotnote 3
Ho
—
Yes/October, 1981
l63-62-8(b)
Aerobic soil
metabolism
No 2/




16J.62-8(c)
Anaerobic soil
metabolism
No




163.62-8(d)
Anaerobic
aquatic
metabolism
No2/




163.62-8(e)
Aerobic
aquatic
metabollai
No2/




!63.62-8(f)
Microbial
metabolism
(2)	effects of
microbes on
pesticides
(3)	effects of
pesticides on
microbes
No1/
No1/




1/ The requirement for the Rubralsalon of these data la currently being reserved pending the review and modification of the tenting 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 photodegradatlon
data, ftie results of the hydrolysla and photolysis data will determine If any additional testing Is required.
3/ Technical or radio-labeled analytical grade.
These data requirements are current an of April, 1981. Refer to guidance
mckase fQf_ updated reoulrements.
?-5

-------
Table I (Cont'd)
Anmonium 3ulfarante Bivlrormentai Fate (See Chapter V)
Generic Data Requirements






Must Additional Data be






Submitted under PlflRA




Does EPA Have

3(c)(2)(B)? If so, months




Data to Partially

allowed for submission
Guidelines
Name of
Are Data

or totally Satisfy
Bibliographic
from published date of
Citation
Tost
Required
Composition
this Requirement
Citation
standard
163.62-8(g)
163.62-9(b)
163.62—9(o)
163.62-9(d)
l63-6?-9(e)
163.62-)0(b)
Activated
sludge
metabolism
Leaching
Volatility
Adsorption/
deeorptlon
Water dispersal
Terrestrial field
dissipation
(1)	Field ft
vegetable crop
(2)	Tree Fruit
& nut crop uses
(3)	Pasture land
usee
(4)	Domestic out-
door parks,
ornamentals and
turf uses
No1/
No2/
No
No2/
No'
?/
No
No
No
No'
?'
?!
.2/
1/ The requirement for the submission of 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.
2/ The requirement for the submission of data is currently being reserved pending the receipt and evalintlon of hydrolysis and photodegradatlon
data. The results of the hydrolysis and photolysis data will determine If ony additional testing Is required.
These data requirements are current so of April, 19H1-
pscknge for updated requirements.
Refer to guidance
3-6

-------
Table 1 (Cont'd)
Anvnonlum Sulfonate Environmental Ftate (See Chapter V)
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 Additiona) Data be
Submitted under PJTOA
5(c)(2)(B)? If so, months
allowed for submission
from published dnte of
standard
(5) Rights of
my, shelterbelts
end related uoeo
No
2/
163.62-IO(c)
163.62-10(d)
Aquatic field
dlonlpitlon
(1)	Aquatic food	No
crop uses
(2)	Aquatic noncrop No'
uses
(3)	Specialized	No
aquatic uses
Terrestrial/	No'
aquatic (forest)
field dissipation
.2/
?!
163.62-10(e) Aquatic ljojnct	No
uses
(1)	Direct
discharge
(2)	Indirect
discharge
(?) Wastewater
treatment
2/ The requirement for the submission of data is currently being reserved pending the receipt and evaluntion of hydrolysis and photodcgradation
data. The results of the hydrolysis and photolysis data will determine if any additional.tenting Is required.
These data requirements are current as of April, 1981. Refer to guidance
inckage for updated requirements.

-------
Table 1 (Cont'd)
Aanoni.ua Sulfamate Environmental Rite (See Chapter V)
Generic Data Requirements
HiBt Additional Data be
Submitted under FlfRA
3(c)(2)(B)? If eo, months
allowed fpr autmlsslon
from published date of
standard	
Guidelines
Citation
Name of
Test
Are Data
Required
Composition
Does EPA Have
Iteta to Partially
or totally Satisfy
this Requirement
Bibliographic
Citation
I63.62-10(f)
163.62-I0(g)
163.62-11(b)
163-62-11(c)
163.62-11(4)
163-62-11(e)
163.62-13
Combination
and tank nix
field dissipation
Long term field
dissipation
study
Accumulation
in rotational
crops
Accimulation In
irrigated crops
Fish accumulation
Special studies
accwulatlon in
aquatic noncrop
uees
Disposal and
storage
Bo
No
Ho
Ho
No
Ho
Ho
These data requirements are current as of April, 1981. Refer to guidance
package for updated requirements.

-------
Table 1 (Cont'd)
Ammonium Sulfamate Toxicology (See Chapter VI)
Generic Data Requlronents
Ouidellnea
Citation
Name of
Teet
Are Data
Required
Cooposition
Docs EPA Have
Data to Partially
or totally Satisfy
this Requirement
Bibliographic
Citation
Munt Additional Data be
Submitted under FIFDA
3(c)(2)(B)? If 00, months
allowed for submission
from published date of
standard
163-81-1
Acute Oral
Toxicity
Yea
Technical Grade
No
—
Yes/October, 1981
163.01-?
Acute Dermal
To*iclty
Yen
Technical Grade
No
—
Yes/October, 1981
163.81-7
Acute
Neurotoxicity
Ho




163.82-1
Subchronlc
Oral Toxicity
Yea
Technical Orade
No
—
Tea/April, 1982
163.82-2
~ubchronlc
21-day Dermal
Toxicity
Yen
Technical Grade
No
—
Yes/April, 1982
163.82-3
Sibchronic
90-day Dermal
Toxlclty
Ho




163.83-4
flibctironlc
Inhalation
Toxicity
No




These data requlreraente are current as of April, 1981. Refer to guidance
pncknge for updated requirements.
3-
9

-------
Table 1 (Cont'd)
Ammonium Sulfonate Toxicology (Bee Chapter VI)
Generic Data Requirements
ffcist Additional Data be
Submitted under PIFHA
Does EPA Have	3(c)(2)(B)? If so, months
Data to Partially	allowed for ouboisslon
Ouldellnes
Citation
Name of
Teet
Are Data
Required
Composition
or totally Satisfy
this Requlreoent
Bibliographic
Citation
from published date of
standard
163.83-1
Chronic Feeding
No1/




tS3.8V2
Oncogenicity
No1/




163-83-3
Teratogenicity

Technical Orade
Bo
—
Yen/April, 1983
163.83-4
Reproduction
No'/
—
fertlal
Sierman et al.
1964, mine
00004224
No
163.84-2
through 4
Ritagenlclty
Tee2/
Technical Grade
No
—
Yes/April, 1982
163.85-1
Netabolloo
No1/




1/ The requirement for the submission of data Is currently being reserved pending the receipt of requested residue data and
environmental fate data.
2/ These data are required because anroonlum sulfamate is registered for domestic use and significant 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 requirenent for any further submission of data Is currently
being reserved pending the receipt of requested residue data and enviromental fate data.
These data requirements are current as of April, 1981. Refer to guidance
package for updated requirements.
10

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Table t (Cont'd)
Anraonlixn 8ulfamate Bcologlcal Bffecta (See Chapter VIII)
Generic Data Requirements
Must Additional Data be
Submitted under PIF11A
Does EPA Have	3(c)(2)(B)? If bo, months
Data to Partially	allowed for submission
Guidelines	Name of	Are Data	or totally Satisfy	Bibliographic frura published date of
Citation	Teat	Required	Ccmcaltlon	this Requirement	Citation	standard
163.72-1
Pish Acute I/C^q
Yes
Technical Grade No —
Yes/January, 1902
163-72-2
Acute Toxicity to
Aquatic invertebcates
Tes
Technical Grade Bo —
Yeo/January, 1982
163.72-3
Acute Toxicity to
fh taurine and
ferine Organlons
No1/


163-72-4
Babryolarvae and
Life-cycle Studies
of Pish and Aquatic
Invertebrates
No1/


163.72-5
Aquatic Organlai
Toxicity and Residue
Studies
Ho1/


163-72-6
Simulated or Actual
Pleld Testing for
Aquatic Organisms
No1/


1/ The requirement for submission of these data Is currently reserved pending the results of the following tests: Pish Acute 1£cq>
Acute Toxicity to Aquatic Invertebrates.
TTiese data requirements are current as of April, 1901. Refer to guidance
package for updated requirements.
3- 11

-------
Table 1 (Cont'd)
Aumonlum Sulfonate Ecological Effects (See Chapter VIII)
Generic Data Requirements
Ouldellnes
Citation
Name of
Test
Are Data
Required
Composition
Does EPA Have
Data to Partially
or totally Satisfy
this Requirement
Bibliographic
Citation
Hust Additional Data be
Submitted under FIFRA
3(c)(2)(B)? If oo, months
allowed for submission
from published date of
standard
163.71-1
Avian Single-Done
Oral U)^q
Yes
Technical Orade
No
—
Yes/January, 1982
163.71-2
Avian Dietary
^50
Hwmnallan Acute
Toxicity
Yen
Technical Orade
No
—
Yes/January, 19B2
163-71-3
Ho




163.71-4
Avfan Reproduction
No




163.71-5
Simulated and Actual
Field Testing for
Manuals and Birds
No




Theoe data requirements are current as of April, 1901. Refer to guidance
pnctage for updated requirements.
3-12

-------
Table 1 (Cont'd)
Aoonlixi Sulfornate Residue Chanletry (See Chapter VII)
Generic Data Requiraaents
Guidelines
Citation
None of
Test
Are Date
Required
Composition
Does EPA Have
Date to Partially
or totally Satisfy
this Requirement
Bibliographic
Citation
Rust Additional Data be
Submitted under FIFKA
3(c)(2)(B)? If so, oonths
allowed for submission
froo published date of
standard
—
Netabolloi in
in Plants
Yea1/
Technical Orade
Ho
—
Yes/April, 1982
—
Netabolloi In
Animals
Yes2^
Technical Orade
No
—
Yes/April, 19®
—
Analytical Methods
Yes"
Technical Orade
Ho
—
les/April, 1982
—
Residue Date:
Crops- Apples;
Pears
Tee4/
Technical Orade
Ho
—
Iss/April, 1982
—
Residue Date:
Processed Crops-
Apple pomace

Technical Orede



—
Residue Date:
Milk and Neat
no6'
Technical Orade



—
Storage Stability
Tea
Technical Orade
No
—
Yes/April, 1982
data are not necessary, Including a discussion of
possible metabolites, nnt be submitted.
2/ Anlml setabolln date or an acceptable justification as to why such data are not necessary, Including a discussion of possible
¦etebolites oust be submitted.
3/ Analytical method for detecting residues of hbotiIub sulfaaate Is required.
4/ Data on the nature end amount of residues on apples and pears are required to support eetabllrtied tolerance levels. The
results of these data will be ussd to nnsnnn possible dietary exposure to aronlua sulfmats; If residues can be expected In apple
¦Ilk and meat; and determine If chronic toxicology testing will be required.
5/ Data are currently being reserved pending the results and evaluation of residue date on apples.
6/ Date are currently being reserved pending the results and evaluation of residue data on apples to determine if eanonlta sulfonate
residues are present on anlsal feedstuff; and environmental fate data to determine if tannlia sulfsaate residues persist in the
environment (pastures, rsnflelanda) and result in exposure to grazing anteals.
These date requirements are current as of April, 1981.
Barfcaaw for undated requlments.
Refer to 0ildance
3-13

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Table 2
Product Chemistry (See Chapter IV)
Ammonium Sulfonate Product-Specific Data Requirements for Manufacturing-Use Products
Nuot Additional Data be
Sutroltted under F1FRA
Doee EPA Have	3(c)(2)(B)? If go, months
Data to Partially	allowed for submission
Guidelines
Citation
Name of
Teat
Are Data
Required
Con position
or totally Satisfy
this Requirement
Bibliographic
Citation
frcra published date of
standard
163.61-3
Product Identity
and Disclosure of
Ingredients
Yes
HUP
No
—
Yes/October, 1901
163.61-4
Description of
Manufacturing
Process
Yes
MUP
No
—
Yes/October, 1901
16J.61-5
Discussion of
Fbrmatlon of Unlnt.
Ingredients
Yes
MUP
No
—
Yes/October, 1981
163.61-6
Declaration and
Certification of
Ingredient Limits
Yes
MUP
No

Yes/October, 1981
163.61-7
Product Analytical
Methods and Data
Yes
MUP
No
—
Yes/October, 1981
163.61-0(7)
Riyslcal State
Yes
MUP
No
—
Yes/October, 1981
163.61-6(8)
Density or Specific
Gravity
Yes
MUP
No
—
Yes/October, 1981
163.61-0(9)
Boiling Point
No




163-61-8(11)
I«
Yes
HUP
No
—
Yen,'October, 1981
163.61-8(12)
Storage Stability
Yes
HJP
No
—
Yes/October, 1901
Ihese data requirements are current as of April, 1991. Refer to guidance
pontage for updated requirements.

-------
Table 2 (Cont'd)
Product Chemistry (See Chapter IV)
Anmonlum 3ulfamate Product-Specific Data Requirements for Hanufncturlng-Use Products
Must Additional Dnta be
Submitted under FIFTCA
Does EPA Have	3(c)(2)(b)? If oo, months
Data to Partially	allowed for submission
Guidelines
Citation
Name of
Test
Are Data
Required
Ceoposition
or totally 9atlsfy
this Requirement
Bibliographic
Citation
from published date of
standard
163.61-6(13)
Fi amiability
Yesl/
HUP
No
—
Yen/October, 1981
163.61-8(14)
Oxidizing or
Reducing Action
Yes
HUP
No
—
Yes/October, 1981
163.61-8(15)
Bcplosiveness
Yes 2/
HUP
No
—
Yes/October, 1981
163.61-0(16)
Wsciblllty
Yes 3/
HUP
No
—
Yes/October, 1981
163.61-8(17)
Viscosity
Yes
HUP
No
—
Yes/October, 1981
163.61-8(18)
Corrosion
Characteristics
Yes
HUP
No
—
Yes/October, 1981
t/ Required for products containing a volatile, flnmable Ingredient.
Jj Required for products containing a potentially explosive ingredient.
Required for products which may be diluted with petroleun solvents.
These data requirements are current an of April, 1981. Refer to guidance
package for updated requirements.
3-15

-------
Table 2 (Cont'd)
Ammonium Sulfonate Toxicology (See Chapter VI)
Product-Speciflo Data Requirements for Manufacturing-Use Products
Guidelines
Citation
Name of
Test
Are Data
Required
Comroeitlon
Does EPA Have
Data to Partially
or totally Satisfy
this Reaulrenent
Bibliographic
Citation
Kist Additional Data be
Submitted under FIFRA
3(c)(2)(B)? If so, months
allowed for submission
from published date of
standard
163.81-1
Acute Oral
Toxicity
Tea*
HUP
No
—
Yes/October, 1981
163.81-2
Acute Dermal
Toxicity
Yes*
NIP
No
—
Yes/October, 1981
163-81-3
Acute Inhalation
Toxicity
Tes
HUP
lb
—
Yes/October, 1981
163-81-4
Primary Ifye
Irritation
Yes
HUP
No
—
Yea/October, 1981
163.81-5
Primary Dermal
Irritation
Yee
HUP
No
—
Yes/October, 1981
163.81-6
Dermal
Sensitization
Yes
HUP
No
r.
—
Yes/October, 1981
* Technical annonlum eulfamate and the manufacturing-use product have been determined to be the seme. These requirements
may be filled by data required in Table 1 entitled: "tasoniui Sulfonate Toxicology Generic Data Requirements for Manufacturing-
Use Products."
ftiese data requirements are current as of April, 1981. Refer to guidance
package for updated requirements.
3-16

-------
Table 3
Product Chemistry (See Chapter IV)
Ammonium Sulfamate Product-Specific Data Requirements for Bid-Uoe ProductB
Hust Additlenal Data be
Submitted under PIFHA
Does EPA Have	3(c)(2)(B)? If so, months
Data to Partially	allowed for sutisisslon
Guidelines
Citation
Name of
Teat
Are Data
Required
Cooposition
or totally Satisfy
this Requirement
Bibliographic
Citation
frail published date of
standard
163.61-3
Product identity
and Disclosure of
Ingredients
Tea
fhch product
No
—
Yes/October, 1981
163.61-4
Description of Yes
(bnufacturlng Process
Ehch product
No
—
Yes/October, 1981
163.61-5
Discussion of
formation of
Unint. Ingredients
Yes
Rich product
No
—
Yes/October, 1981
163.61-6
Declaration and
Certification of
Ingredient Limits
Yes
fhch product
No
—
Yes/October, 1981
163.61-7
Product Analytical
Ten
tech product
Ho
—
Yes/October, 1981
163.61-8(1)
Color
Yes
ftich product
No
—
Yes/October, 1981
163.61-8(2)
Odor
Yes
fitch product
No
—
Yes/October, 1981
163.61-8(7)
HiyBlcal State
Yes
fitch product
No
—
Yes/October, 1981
163.61-8(8)
Density of Specific
Gravity
Yes
fitch product
No
—
Yes/October, 1981
163.61-8(9)
Boiling Point
No




These data requlranentB are current to of April, 1981. Refer to guidance
pnckngs for updated requirements.
17

-------
Table 3 (Cont'd)
Product Chemistry (See Chapter IV)
Asnonlim Sulfamate Product-Specific Data Requirements for EM-Use Products
Guidelines
Citation
Name of
Test
Are Data
Reaulred
Ccaposltlon
Does EPA Have
Data to Partially
or totally Satisfy
this Requirement
Bibliographic
Citation
Hist Additional Data be
Submitted under FIftiA
3(c)(2)(B)? If so, months
allowed for submission
from published date of
standard
163-61-0(11)
1*
Tea
bch product
Ho
—
Tee/October, 1981
163.61-8(12)
Storage Stability
Yes
lhch product
No
—
Yes/October, 1981
163.61-8(13)
Flamablllty
Tee 1/
ftch product
No
—
Yes/October, 1981
163.61-0(14)
Oxidizing or
Reducing Action
Tea
bch product
Ho
—
Yee/October, 1981
163.61-8(15)
Kxploslveness
Tes2/
Ihch product
Ho
—
Tee/October, 1961
163.61-8(16)
Hlsciblllty
Ies3/
Ehch product
Ho
—
Yes/October, 1961
163.61-8(17)
Viscosity
Tes
lfeeh iroduct
Ho
—
Yes/October, 1981
163.61-8(18)
•U	
Oorroslon
Characteristics
Tea
ftch product
Ho
—
Yes/October, 1961
ty Required for products containing a volatile, finable Ingredient.
J. Required for products containing a potentially explosive ingredient.
Required for products which maj be diluted with petrolew solvents.
Dnse data requirements are current as of April, 1961. Refer to gildance
package for updated requlf ants.
3-lS

-------
Table 3 (Cont'd)
Annonltn Sulfonate Toxicology (See Chapter VI)
Product-Specific Data Requlrenente for bid-Use Products
Must Additional Data be
Submitted under FlfRA
5(c)(2)(B)? If eo, months
allowed for submission
from published date of
standard
Guidelines
Citation
Name of
Test
Are Data
Required
Composition
Does EPA Have
Data to Partially
or totalljr Satisfy
this Requirement
Bibliographic
Citation
Crysfr»nine 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
Tea
1/
Tee
.1/
Tea
,1/
Primary
Irritation
2/
Tea
2/
Primary Dermal'
Irritation
Dermal^
Sensitization
2/
Tes
?/
Tes
,1/
Efeeh product
Ihch product
Buh iroduct
See footnote 2
See footnote 2
fech product
Ho
Ho
Ho
Ho
lb
Ho
Ho
No
Ho
Tes/October, 1981
Tes/October, 1981
No
1/ The testing of the manufacturing-use product vill fill these data requirements for crystalline formulations. These requirements will be
filled by data required in Table 2 entitled: "Ammonium Sulfonate Toxicology Product - Specific Data Requirements for Manufacturing-Use
Products".
2/ This test Ijb required on any one of the products with the following registration numbers: 2169-262, &29-1B0, 101(77-21, 352-206 , 8127-22,
1348-202, 829-220, 8590-219, 2125-47, 5481-56, 48B7-134.
These data requirements are current an of April, 1981. Refer to guidance
package for updated requirements.


-------
Table 3 (Cont'd)
Amnonlum Sulfaoate Toxicology (See Chapter VI)
Product-8peclflo Data Requirements for Bid-Use Products
(fast Additional Data be
Submitted under FIFRA
3(c)(2)(B)? If so, months
allowed for submission
fTan published date of
standard 	
Ouldellnee
Citation
Kane of
Teat
Are Data
Required
Composition
Does EPA Have
Data to Partially
or totally Satisfy
this Requirement
Bibliographic
Citation
2. Soluble Concentrate
163.81-1
163.81-2
163.81-3
163.81-4
163.01-5
163-81-6
Acute Oral
Toxicity
Acute Deraal
Toxicity
Acute Inhalation
Toxicity
Prloary fye
Irritation
Primary Dermal
Irritation
Denial
Sensitization
Tee
Tee
Tee
Tea
Yes
Tea
.3/
.3/
&ch product
fhch product
fech product
lbch product
thch product
foch product
Yes
Tee
Ho
Yes
Yes
No
Bullock and
Narcisae 1974a,
HRID# 00004214
Bullock and
Narcisae 1974b,
HUD# 00004215
Bullock and
Narcisae 1974d,
MUD# 00004216
Bullock and
Narclsse 1974e,
WIElC 00004217
No
No
No
No
No
No
3/ The testing on the manufacturing-use product(s) will fill these data requirenente for the soluble concentrate formulations.
These requirements will be filled by data required In Table 2 entitled: "Ansonlun Sulfamate Toxicology Product - Specific
Data Requirements for Manufacturing-Use Products".
These data requirements are current ae of April, 1981.
package for updated requirements.
Refer to guidance
3- PD

-------
Table 3 (Cont'd)
AnsDoniim Sulfamate Toxicology (See Chapter VI)
Product-Specific Data Requirements for Bid-Use Products
Must Additional Data be
Submitted under FIFRA
Does EPA Have 3(c)(2)(B)? If no, months
Data to Partially allowed for submission
Guidelines Name of Are Data or totally Satisfy Bibliographic frun published date of
Citation	Teat	Required	Composition	this Requirement	Citation	standard	
3- Ready-to-Use
163.81-1	Acute Oral	Tee	ffcch product	Tes	Bullock and	No
Toxicity	NarciHse 1974a,
HKID# 00004214
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
Acute Dermal
Toxicity
Acute Inhalation
Toxicity
Primary Jtye
Irritation
Primary Dermal
Irritation
Dermal
Sensitization
Tes
Tes
Tes
Tes
Tes'
V
4/
Bhch product
Ihch product
Ihch product
ft»h product
Ihch product
Tes
No
Tes
Tes
Bo
Bullock and
Narcisse 1974b,
HUD# 00004215
Bullock and
Narcisse 1974d,
WUD# 00004216
Bullock and
Narcisse 1974e,
WID# 00004217
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.
Ihese requirements will be filled by data required in Table 2 entitled: "Anmonlum 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.
?- 21

-------
Table 3 (Cont'd)
Anoolua Sulfuite Toxicology (See Chapter VI)
Product-Specific Data Requirement* for End-Use Product*
Culdellnea
Citation
Naio of
Test
Are Data
Required
Composition
Does BPA Nave
Data to Partially
or totally Satisfy
this Requirement
Bibliographic
Citatloo
Must Additional Data be
Submitted under PIFRA
3(c)(2)(B)? If so, monl
allowed for submission
from published date of
standard
4. Pressurized
Liquid





163.01-1
Acuta Oral
Toxicity
Tea
Bach product
Tea
Bullock and
Narclsse 1974a,
MID# 00004214
No
~
163.81-2
Acute Denial
Toxicity
Tea
Bach product
Tes
Bullock and
Narclase 1974b,
MIDI 0000421)
No
»
163.81-3
Toxicity
Tea5'
Bach product
No
—
No
163.81-4
Primary Bye
Irritation
Tes
Bach product
No
—
Yea/October, 11
163.81*5
Primary Dermal
Irritation
T..5'
Each product
Tes
Bullock aod
Narclase 1974®,
MR ID# 00004217
No
i
163.81-6
Oermal
Sensitization
Tes
Each product
No
—
No
5/ The testing on the manufacturing-use product(a) will fill theee data requirements (or the pressurised liquid formulations.
Theae requirements will be filled by data required in Table 2 entitled: "Aoaoniui Sulfamate Toxicology Product-Specific
Data Requirements for Hanufacturlng-Uae Products*"
Theae data requlresenta ara current as of April* 1981* Refer to guidance
package for updated requirements*
3-??

-------
IV
Produce 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 ,Qglycols, 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
U_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' (43 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 163.6I-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 "Animate" 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
n
H2 N - S - 0 - NH^
tl
0
4-2

-------
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 +C0?
hso3nh2 + nh3 - nhaso3nh2.
The yield of ammonium sulfamate by this reaction is said to be
not less than 901 with a parity of not less than 907,. (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 2,426,2.40) (MRIDf? 00160003).
(D)	By heating ammonium nitrilosulfonate under high pressure, (MRID0
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 (MRlDlJ 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 "Amnate". No description of the
manufacturing process actually being 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.
Format ion of 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 in 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 hy Du Pont states that its technical grade Animate
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) (MRIDl? 05008521)
Odor: There are no available data.
Melting Point: 131°C (Technical chemical) (MRID0 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 (MRIDlf 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)
h _i"

-------
The following physical/chemical properties were not reported for manufacturing-
use ammonium sulfamate:
Physical State
Density or Specific Gravity
pH
Storage Stability
F1 ammability
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.
14-5

-------
V
ENVIRONMENTAL FATE
Use Profile
Ammonium sulfamate is an inorganic salt used as a nonselective herhicide 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 6purge,
bitter dock, goldenrod, perennial ragweed, milkweed, and blueweed, as well as
nost 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 lbs A.I. in 100 gallons of water per acre for all sprayers
except airblast equipment. The recommended rate for airblast equipment is 100-
400 lbs 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.

-------
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
watfer, 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.
Cuidellne Section
163.62-7
163.63-8
163.62-9
163.62-10
163.62-11
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.
Type of Data
Physico-Cheralcal Transformation
Metabolism (Soil, Aquatic and
Microbiological)
Mobility
Field Dissipation
Accumulat ion
PHYSIO-CHEMICAL TRANSFORMATION

-------
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 dti 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 1066, 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.
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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 lb 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 1s required to support the registration of all nanufacturing-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 albo 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 (957„ powder) at 50 kg/ha leached
14 and 50 cm in an unspecified soil type eluted with 2 and 50 cn 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 k 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.

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Adsorpt ion/Desorpt ion
A laboratory study using radioisotopic or nonradioisotopic 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
sulfantote 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 v/htch legally could be used to make such a
formulated product.
No data on the water dispersal 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 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 product.
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.
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Aquatic
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
lnvalid.
The requirement for the submission of the above data is currently being
reserved, pending the receipt and evaluation of hydrolysis and photodegradatlon
data. The results of the hydrolysis and photodegradatlon 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-use
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
photodegradatlon data. The results of the hydrolysis and photodegradatlon 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 fleld/vegetable and aquatic food
crops will not occur.

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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 AMR 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
.1. does not accumulate in the organs and tissues of matnttal s 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 Aimaonlum Sulfamate
Three formulations of ammonium sulfamate are available: crystals (95 to ^9%
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 lbs A.I. in 100 gallons water per acre for all
sprayers except airblast equipment, where the recommended rate is 100-400 lbs
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 nixing operations are not required.

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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 992 crystalline formulation of ammonium sulfamate, an
182 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-nonth 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 0.057 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 anlnal 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 I- 3.
Requi red Labellng
Precautionary labeling of each product must correspond to the toxicity
categories determined by Mve 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
Acute Dermal Toxicity
Acute Inhalation Toxicity
Primary Eye Irritation
Primary Dermal Irritation
Skin Sensitization
Acute Delayed Neurotoxicity
Subchronlc Oral Toxicity
Subchronic 21-Day Dermal Toxicity
Subchronlc 90-Day Dermal Toxicity
Subchronlc Inhalation Toxicity
Subchronic Neurotoxicity
163.81-1
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
163.81-7
163.82-1
163.82-2
163.82-3
163.82-4
163.82-5
Chronic Feeding
Oncogenicity
Teratology
Reproduction
Mutagenicity
Metabolism in Laboratory Animals
Clinical Trials
163.83-1
163.83-2
163.83-3
163.83-4
163.83-1 to 4
163.83-1
Emergency Treatment
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Acute Testing
Acute Oral Toxicity
The minimum data requirement for testing acute oral toxicity (LD,-q) is
one test on the manufacturing-use product, preferably using the laboratory
rat.
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 Irrltation
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.

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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 18Z 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 livar. 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.

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One subehronic dermal toxicity study was conducted on an unspecified formu-
lation of ammonium sulfainate (Aoyama 1975, MRID 05005119). In thi6 study, 0.75
ml of 15% , 20%, and 307. concentrations of ammonium sulfainate 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 redneBs 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. TYiis
study does not satisfy the data requirements for subehronic 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.
Subehronic 90-Day Dermal Toxicity
A subehronic 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.
Subehronic Inhalation Toxicity
A subehronic 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 subehronic inhalation toxicity study of ammonium sulfamate
cannot be made at present, because no adequate acute inhalation toxicity data
are available.
Subchroni c Neurotoxicity
A subehronic 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 L9-month feeding study with rats (Sherman et al.,
1964 MRID #00004224), no histopathological alterations could be attributed to
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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 teBts 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 hunvan exposure by other routes is unlikely, this data
requirement nay 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 he
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 typhlmurium (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.
CIinical 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.
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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 uill 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 inanufacturing-use ammonium sulfamate will
fill this requirement.
Acute Inhalation Toxicity
The minimum data requirement for testing acute inhalation toxicity (LC^q) 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.
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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, 820-180, 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.
Ho primary dermal irritation studies are available on crystalline formulations.
Testing is required on one of the products with the following registration
numbers: 2169-262, 829-130, 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 437' ammonium sulfamate. The
high acute oral	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 437, 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,
1074a, MRID 00004214). The undiluted material was administered by gavage to
four groups of male and female rats. The LD,-., in males was 6.9
g/kg with a 95% confidence interval of 2.6-18.3 g/kg. In females the I^q
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.R 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% amoniun
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 LDc^ 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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20t 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, 1974c, MRID#
00004218) was conducted vith 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 437. 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 minirvum 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 sulfarate (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 i6 an intradermal tesf on
each formulated product, preferably using the guinea pig.
6-11

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No :!ernial sensitization studies are available on soluble concentrate
formulations of arraoninn 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 Sulfonate
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 dernal sensitization potential of the ready-to-use
formulations containing ft-55% ammonium sulfamate and the pressurized liquid
formulations containing 9.5°< ammonium sulfamate.
The Confidential Statements of Formulations (CFR) do not indicate that the
acute toxicities foral, 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 HI,
Tables 1-3.
6-12

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VII
Residue Chemistry
Residue Chemistry - Manufacturing-Use Ammonium Sulfamate
Residue Chemistry Profile
Ammonium sulfamate 16 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 shoving the nature of any major residues resulting
from the applied use of ammonium i llfamate as a result of application to the
plants at the tree roots. Similarly, data are needed shoving 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
t r i al s.
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 Restrict Ions
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.l. 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 lbs. A.l. 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'(Carvel1 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 I960, 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 lb. 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
lbs/tree and 6 lbs/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: Heat 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.
7_ "3

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VIII
Ecological Effects Chapter
Manufacturing-Use Ammonium Sulfamate
Ecologlcal Effects Profile
No adequate data are available to assess the toxicity of ammonium sulfaraate
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 punctlpennls, th^ phantog midge, yielded 48-hour
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
sulfaraate and pyrolite dust. The study provided sufficient information to
characterize ammonium sulfamate as relatively non-toxic to honey bees
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 lbs. 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
Fish
Aquatic Invertebrates
163.71-1, 163.71-2
163.72-1
163.72-2
9-1

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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 LD 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 LCcq (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, CS0016-0020) 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	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	for a
coldwater species (preferably rainbow trout) and a warmwater species
(preferably hluegill 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 ppn 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.
8-2

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Aquatic Plants
One study was available (Fromm 1949, 05004558) concerning the effects of
ammonium sulfamate on aquatic plants. The Btudy 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 Fomulation No Effect Level Author/Date MBIDi?
Ammonium sulfamate can be expected to have a temporary phytotoxic effect on
turf at an application rate of 2.18 lbs 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 sulfamate 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.
Turfgrass
Eggplant
Bean
A.I.
A. I.
• A.I.
<2.18 lbs/A
<100 ppm
1140 ppm
Pridham,1946 05004926
Dubey, 1977 05004270
Fromm, 1949 05004558

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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 Chaobgrus punc^lpennis
(the phantom midge). The 48-hour LC,q 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
Ecologlcal 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.

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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 OF BIBLIOGRAPHY

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Guide to Use of This Bibliography
1.	Content of Bibliography. This bibliography contains citations of all
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 hody 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
"MHID". It is not related to the six-digit "Accession Number" which has
been used to identify volumes of submitted data; see paragraph 4(d)(4)
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

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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.
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.
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 Pate. 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 suhmitter, 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
'CDL', 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,
123456-7.; and the 27th 123456-AA.

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OFFICE OF PESTICIDE PROGRAMS
PESTICIDE DOCUMENT MANGEKENT SYSTEM
CASE BIBLIXRAPHY
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
MRID	CITATION
05001460	Anderson, K.G., E.G. Leighty and H.T. Takahashi, 1972
Evaluation of herbicides for possible mutagenic properties.
J. Agr. Food. Chera. 20:649-656.
05005119	Aoyama, H. 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 Agrocheraical Co., Summit, N.J.; CDL:090973-8).
1016-001-02 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.
00004227	Bergen, D.S. and Wiley, F.H., 1938. The metaboism of sulfamic
acid and ammonium sulfamate. (Unpublished 6tudy 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 :8l.
(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

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00004217
05008521
05005498
05004270
05008669
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)
Cain, B.E.; Kanda, F.A. (1972) The crystal structure of ammonium
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Q_n

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05011255	Hofmeister, H.K.; Heubach, E., inventors; Farbwerke Hoechst,
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9-7

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00004232	Pease, H.L. (1964) The Determination of Sulfamate Residues.
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9-8

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1016-001-04 Yip, George (1964) meraoraqndum Co Howard Jones daced March S,
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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
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9-16

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OFFICE PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBUOCRAPHY
Standard Reference Material
Farm Chemical Handbook. (1979) Meister publishing. Willoughby. Ohio.
The Federal Insecticide, Fungicide, and Rodenticide Act, as amended in 1978,
7tb U.S. Code, Chapter )35, 61 Statute 163.78 Statute 190.
Pestl' de Process Encyclopedia , 1977, Noyes Data Corp., Park Ridge, New
sey.
restic^de Index: Basic Information on the chemicals used as actlve
components of pesticides. ; Martin, H., and Worthington, C.R., eds., 1977.
5th ed., British Corp. Protection Council, Worcestershire, England
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Registering Pesticides in the United States. Federal Register, 43 (132)
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Registering Pesticides in the United States; Hazard Evaluation: Humans and
Domestic Animals. Federal Register, 43 (163) 37336.
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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-^0
*U S 60VSSWEMT PR IHT113 OFFICE: 1981 341-085/4471

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