540/RS-92-184
United States Office of September 1991
Environmental Protection Pesticide Programs
Agency
&EPA Reregistration
Eligibility Document
(RED)
Inorganic
Nitrate/Nitrite
(Sodium and
Potassium Nitrates)
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INORGANIC NITRATE/NITRITE REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Steve Jarboe Biological Analysis Branch
Phyllis Johnson Biological Analysis Branch
Dave Thomas Biological Analysis Branch
Environmental Fate and Effects Division
Henry Craven Ecological Effects Branch
Dan Balluff Ecological Effects Branch
Jean Holmes Science Analysis and Coordination Staff
Health Effects Division
Linda Kutney Science Analysis and Coordination Branch
Pat McLaughlin Toxicology Branch II
Laura Morris Occupational and Reentry Exposure Branch
Program Manaoeroant and Support Division
Evelyn Alston Information Services Branch
PiVlSiL?!)
Amelia Acierto
Rob Forrest
Bipin Gandhi
Radames Lozada
Olga Odiott
Dan Peacock
Van Seabaugh
Registration Support Branchsd
Insecticide-Rodentide Branch
Registration Support Branch
Registration Support Branch
Registration Support branch
Insecticide-Rodenticide Branch
Registration Support Branch
Special Review and Reregistration Division
Bruce Sidwell Accelerated Reregistration Branch
Mark Wilhite Accelerated Reregistration Branch
Jean Frane
Eran Gasko
Policy and Special Projects Staff
Office of General Counsel
Beverly Updike
Office of Compliance Monitoring
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TABLE OF CONTENTS
PAGE
GLOSSARY OF TERMS AND ABBREVIATIONS i
EXECUTIVE SUMMARY ii
I. INTRODUCTION 1
II. ACTIVE INGREDIENTS COVERED BY THE REREGISTRATION DECISION 2
DOCUMENT,
A. IDENTIFICATION OF ACTIVE INGREDIENT 2
B. USE PROFILE 2
C. REGULATORY HISTORY 4
III. AGENCY ASSESSMENT OF ACTIVE 4
INGREDIENT
A. DESCRIPTION OF ACTIVE INGREDIENTS 4
B. HUMAN HEALTH ASSESSMENT 5
1. TOXICOLOGY DATA 5
2. DIETARY EXPOSURE 6
3. OCCUPATIONAL EXPOSURE 7
4. RISK ASSESSMENT 7
C. ENVIRONMENTAL ASSESSMENT 8
1. ECOLOGICAL EFFECTS ASSESSMENT 8
2. ENVIRONMENTAL FATE ASSESSMENT 10
IV. REREGISTRATION DECISION FOR SODIUM AND POTASSIUM
NITRATES
A. DETERMINATION OF ELIGIBILITY 10
B. ADDITIONAL GENERIC DATA REQUIREMENTS 11
C. LABELING REQUIREMENTS 11
V. PRODUCT REREGISTRATION 11
A. DETERMINATION OF ELIGIBILITY 11
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B. PRODUCT-SPECIFIC DATA REQUIREMENTS 12
C. LABELING REQUIREMENTS 12
VI. APPENDICES
A. APPENDIX A_- USE PATTERNS SUBJECT TO REREGISTRATION 13
B. APPENDIX B - GENERIC DATA REQUIREMENTS FOR
REREGISTRATION OF SODIUM AND POTASSIUM NITRATES
SUPPORTING REREGISTRATION
1. GUIDE TO APPENDIX B 17
2. PRODUCT IDENTIFICATION (SODIUM NITRATE) 18
3. ECOLOGICAL EFFECTS (SODIUM NITRATE) 19
4. TOXICOLOGY (SODIUM NITRATE) 19
5. ENVIRONMENTAL FATE (SODIUM NITRATE) 2 0
6. PRODUCT IDENTIFICATION (POTASSIUM NITRATE) 21
7. ECOLOGICAL EFFECTS (POTASSIUM NITRATE) 22
8. TOXICOLOGY (POTASSIUM NITRATE) 22
9. ENVIRONMENTAL FATE (POTASSIUM NITRATE) 22
B. APPENDIX C - BIBLIOGRAPHY
1. GUIDE TO APPENDIX C 24
2. BIBLIOGRAPHIC CITATIONS 26
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
CAS Chemical Abstracts Service
EP End-Use Product
Agency U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
LD50 Median lethal dose - a statistically derived single
dose that can be expected to cause death in 50% of the
test animals, when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g.,
mg/kg.
MP Manufacturing Use Product
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
i
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Executive Summary
The first registered pesticide product containing sodium or
potassium nitrate dates.from 1948. Currently, there are a total
of six registered products for these two active ingredients. All
currently registered products are pyrotechnic fumigants designed
to be ignited and placed in burrows thereby delivering lethal
doses of toxic gases for the control of various rodents, coyotes
and ground wasps, as well as skunks.
Based on the results of its reregistration review, the U.S.
Environmental Protection Agency (E.P.A.) has determined that the
data bases for these two active ingredients are substantially
complete and sufficient to allow E.P.A. to conduct a reasonable
risk assessment. There are some outstanding requirements for
potassium nitrate concerning product chemistry. These are,
however, seen as confirmatory and not essential for the Agency's
risk assessment.
Accordingly, E.P.A. has determined that the registered uses
of sodium and potassium nitrates are eligible for reregistration.
The decision to reregister specific products will be made after
appropriate labeling and product specific data are submitted
and/or cited. After reviewing these data and labels the E.P.A.
will determine whether or not the conditions of FIFRA 3(c)(5)
have been met, that is, whether product labeling and composition
are acceptable and their uses will not cause unreasonable adverse
effects to humans or the environment. If these conditions are
met, E.P.A. will reregister the products. Those products which
contain other active ingredients will be eligible for
reregistration only when the other active ingredients are
determined to be eligible for reregistration.
ii
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'j
Z. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) was amended to accelerate the
reregistration of products with active ingredients
registered prior to November 1, 1984. The amended Act
provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the
reregistration process. The first four phases of the
process focus on identification of data requirements to
support the reregistration of an active ingredient and the
generati-on and submission of data to fulfill the
requirements. The fifth phase is a review by the U.S.
Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregistration.
Section 4(g)(2)(A) of FIFRA states that in Phase 5 "the
Administrator shall determine whether pesticides containing
such active ingredient are eligible for reregistration"
before calling in data on products, section 4(g)(2)(B), and
either reregistering products or taking "other appropriate
regulatory action," under section 4(g)(2)(C) and (D). Thus,
reregistration involves a thorough review of the scientific
data base underlying a pesticide*s registration. The
purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of the
pesticide; to determine the need for additional data on
health and environmental effects; and to determine whether
the pesticide meets the "no unreasonable adverse effects"
criterion of FIFRA, section 3(c)(5).
•Th-i-s' document presents the Agency's decision regarding
the reregistration case inorganic nitrate/nitrite, which
covers products containing the active ingredients sodium and
potassium nitrates'. No registered pesticide products now
contain nitrites. The document consists of five sections.
Section I is this introduction. Section II describes sodium
and potassium nitrates, their uses and regulatory history.
Section III discusses the human health and environmental
assessments based on the data available to the Agency.
Section IV discusses the reregistration decision for sodium
and potassium nitrates and Section V discusses product
reregistration .^Additional details concerning the Agency's
review of available data are available on request.1
EPA's reviews of specific reports and information on the
set of registered uses considered for EPA's analyses may
be obtained from: EPA, Freedom of Information, 401 M
St. S.W.f Washington, D.C. 20460.
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II. ACTIVE INGREDIENTS COVERED BY THIS REREGISTRATION
ELIGIBILITY DECISION DOCUMENT
A. IDENTIFICATION OF ACTIVE INGREDIENTS
1. Chemical Name: Sodium Nitrate
CAS Number: 7631-99-4
Office of Pesticide Programs Chemical Code Number:
076103
m
Empirical Formula: NaN03
2. Chemical Name: Potassium Nitrate
CAS Number: 7757-79-1
Office of Pesticide Programs Chemical Code Number:
076104
Empirical Formula: KNOs
B. USE PROFILE
Type of Pesticide: Rodenticide, predacide, insecticide
Pests Controlled: Moles, ground squirrels, prairie
dogs, ground-nesting wasps,
voodchucks, gophers, pocket
gophers and skunks.
Registered Use Groups: (See Appendix A for detailed
specific use sites).
For Sodium Nitrate:
Terrestrial Food/Feed
Terrestrial Feed
Terrestrial Non-food
Forestry
Residential Outdoor
For Potassium Nitrate:
Terrestrial Feed
Terrestrial Non-Food
Residential Outdoor
2
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Formulation Types Registered:
Z3X. Sodium Njfrra^; Ready-to-use cartridge
formulated with sulfur and carbon; designed to be
ignited and placed in pest burrow.
Sodium nitrate is used with other components as an
active ingredient to control mammals such as
woodchucks, ground squirrels/ and coyotes in open
fields, non-crop areas, rangelands, lawns and golf
courses. The three end-use products, two
containing 65% a.i. sodium nitrate and one with
46.2%'sodium nitrate, are all used as fumigant gas
cartridges designed to be placed in burrows. The
sodium nitrate supports the combustion of charcoal
in the formulation of each product. The label
instructions for application state that the
applicator should obtain enough material to plug
the entrance of the burrow and then use a nail
with at least a 1/8" diameter to puncture the cap
at the end of the cartridge, where marked; insert
the fuse, with a minimum of 3" exposed, in one of
the center holes. The applicator then should
ignite the fuse (holding cartridge away from face
and body), and place it into the burrow and
immediately close the burrow entrance. The
minimum burn time for the fuse is 5 seconds.
For Potassium Nitrate; Ready-to-use cartridge
formulated with sulfur and carbon; designed to be
ignited and placed in pest burrow.
Potassium nitrate, an active ingredient in two
registered end-use products (4 5% potassium nitrate
and 46.2% potassium nitrate), is employed in the
same manner as sodium nitrate with the following
exceptions: the 45% formulation lists gardens as
a site and the 46.2% formulation is used on ground
wasps.
The smaller cartridges, containing either sodium
or potassium nitrate, are approximately four
inches in length and one inch in diameter and
weigh 1-3 ounces. The larger cartridge, formulated
with sodium nitrate, weighs 8.5 ounces and is
approximately 12.5 inches long and 1.5 inches in
diameter. They are designed to produce, upon
combustion, large amounts various gases which act
as toxicants to the pest inhabiting the burrow.
3
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C. REGULATORY HISTORY
The first pyrotechnic cartridge products
containing the active ingredients sodium and potassium
nitrates were registered in 1948.
In the last thirty years, the Agency has received
nine reports of injuries to applicators for registered
gas cartridge products, including one fatality
attributed to gross misuse. In 1982, in response to
concern over the safety of these products, the Agency
issued a Notice of Intent to Cancel (NOIC) all products
unless registrants submitted upgraded labeling and data
on fuse and cartridge burn tines. Subsequent to
compliance with the NOIC and labeling improvement
program, there have been four reports of injuries, all
involving misfiring of ignited cartridges. The Agency
has contacted the two registrants of these particular
products regarding these incidents to determine the
cause of these accidents, and is including new data
requirements which are intended to address the issue of
quality control and product safety. These are contained
in Appendix D.
III. AGENCY ASSESSMENT OF ACTIVE INGREDIENT
The Agency has conducted a review of the scientific data
base for sodium and potassium nitrates, primarily relying on the
studies and information from published literature submitted by
registrants. These are cited in Appendices B and C, respectively.
The findings are summarized below:
A • Qf jnqpepTENT?
Sodium nitrate, known also as cubic niter, Chile
niter or soda niter, is a naturally occurring compound
with a molecular weight of 85.00. It is a colorless,
odorless solid forming transparent crystals, and is
incorporated into the cartridges as a white powder. It
has a melting point of 306°C and explodes when heated
to 1000°F, producing toxic fumes of NO and Na20.
Potassium Nitrate, known also as saltpeter or
niter, has similar properties when heated and is also a
colorless, odorless compound incorporated as an
oxidizer into the cartridge products. It has a
molecular weight of 101.11 and a melting point of
3 34°C.
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i
Both active ingredients have other industrial
uses. Sodium nitrate is used in the production of other
chemicals, glass, fertilizer and fireworks. Potassium
nitrate also is used in the production of fireworks,
blasting powders and gunpowder.
B. HUMAN HEALTH ASSESSMENT
The Agency has determined that only a minimal data set is
necessary to assess the potential health hazards, exposures
and risk for sodium and potassium nitrates and their
registered uses. Both are common chemical compounds with
very limited uses as pesticides.
Toxicology Data Base
The toxicological data base on the active ingredients
potassium and sodium nitrate is adequate and will support
reregistration eligibility.
A. Acute Toxicity
Test
Result (mg/kg)
Toxicity Category
Acute Oral LD50-Rat
3.700
III
Acute Dermal LD50-
<2 r000
Rabbit
Primary Eye
Corneal ODacity
11
Irritation
reversible within
7 davs:
irritation
Primary Dermal
Irritation
Mild or sliaht
irritation at 72
hours
IY
ACUTE TOXICITY VALUES POR POTASS!
[UM NITRATE:
Acute Oral LD50-Rat
3.750
ill
(References 1, 2, 3, EPA 417860-01, EPA 417860-03)
Published data (4) estimate the minimum lethal dose of sodium
nitrate in cattle to be 650-750 mg/kg and for potassium nitrate
in sheep and cattle a lethal dose was 1,000 mg/kg.
5
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Other published studies indicate values of 5,000 and >3,000
mg/kg for acute oral LD50 in rats and 2,680 mg/kg in rabbits for
sodium nitrate. For potassium nitrate, other available studies
indicate an acute oral toxicity in rats to be 4,300 ng/kg and
1,901 ng/kg for the acute oral LD50 in rabbits.
B. Subchronic Toxicity
No applicable studies are available.
C. fletqbpUsm
It is believed that nitrate is converted in food or in
the digestive system into nitrite. In large doses, nitrite
converts the hemoglobin in the blood to methemoglobin, which
cannot carry oxygen (4).
D. Chronic Toxicity
A 14-month study with male rats given 4000 ppm sodium
nitrate in their drinking water indicated possible lower
plasma vitamin E levels and higher red cell reduced
glutathione than the control group (5).
Available information on the carcinogenic potential of
nitrates is equivocal. The results of some studies suggest
nitrates may cause tumors in laboratory animals, while
others do not. (2, 8)
E. Mutagenicity
Both sodium nitrate and potassium nitrate are reported
to cause mutagenic effects in various genetic toxicity tests
<2, 6).
F. Other Toxicity Information
An epidemiology study conducted in Chile states that
there is a significant association between the rate of
nitrate fertilizer'used per unit area of land and the
mortality rates from gastric cancer in different provinces.
This report hypothesized that carcinogenic nitrosamine was
synthesized in the stomachs of humans from the nitrates and
nitrites of the fertilizers (7).
1. Dietary Exposure
There are no pesticidal food uses for potassium or
sodium nitrate. However, both are permitted, under 21 CFR,
part 172, as food additives or preservatives. These
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clearances include: curing premixes, with conditions against
nitrosamine formation; potassium nitrate may be used as a
curing agent on cod roe, not to exceed a final level of 200
ppm; sodium nitrate, at a level not to exceed 500 ppm in the
finished product, as a color fixative in smoked, cured
sablefish, salmon, or shad, and as a preservative and color
fixative for home curing of meat and meat products. Also, 21
CFR Part 181 cites prior sanctions issued by the U.S.
Department of Agriculture for the use of sodium and
potassium nitrates in cured red meat products and cured
poultry products.
ft
Some of the products containing sodium and potassium
nitrates are registered for use in rangeland and/or
agricultural areas and are therefore classified by the
Agency as food/feed uses. Due to the nature of their action,
however, there is ho reason to expect any contact with food
or feed crops. Therefore, there is no likelihood of residues
in or on food or fe€d crops and tolerances in or on
agricultural commodities are not required.
3. Occupational Exposure
The Agency believes that any human exposure from the
intended use of these products is limited to applicators.
The Agency further believes that any such exposure is
minimal for several reasons. As described above in section
II.B., these products are cartridges, similar to flares, in
which the ingredients are totally encased. Unlike many
pesticide products, there is little opportunity for
splashing, spillage, inhalation or dermal contact with spray
or dust particles. Once ignited, these devices produce
noxious gases which are directed into the pest burrow,
which is sealed or covered. Inhalation exposure to the
applicator should therefore be negligible. Incidents
reported to the Agency in the past have largely involved
dermal burns. The only fatality associated with these
products has been attributed to gross misuse and
inhalation of a smoke produced by a phosphorus-containing
cartridge. This product is being reformulated and will no
longer contain phosphorous. The Agency has received reports
of dermal burns caused by ignited cartridges. These were
largely due to improper handling of ignited cartridges or
defective cartridges. The 1982 notice was intended to
address these safety concerns. There have been four reports
of injuries to applicators since then, due mainly to
defective cartridges. The Agency is addressing the issue of
defective cartridges in the attached data call in notice.
7
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i
J
4. Human Risk Assessment
Risks associated with the registered uses of potassium
and sodium nitrates are believed to be negligible. This is
due to the limited exposure potential to humans, as 2
described in the above section "Occupational Exposure."
Applicators of these products are largely protected from
exposure to these chemicals by the product packaging.
Further, the application method of these products precludes
exposure to these chemicals. Once the cartridges are
ignited, they are quickly placed in the burrow and covered,
so that the gas$s are directed into the burrow. Improperly
covered burrows could result in potential inhalation
exposure to the gases, if the applicator remains in close
proximity to the burrow. [To assess the toxicity of these
gases, the Agency is requiring acute toxicity data, through
this document, section V.B and Appendix D. Upon receipt of
these data, the Agency will determine whether these products
should be reregistered.] Registrants are also required,
under section 6(a)(2) of FIFRA, to submit to the Agency any
information regarding injuries to humans associated with the
use of these products.
There are some studies which suggest possible
carcinogenic effects for nitrate compounds. However, the
Agency does not believe that this potential toxicological
effect is relevant here because of the absence of chronic
exposure.
In conclusion, at this time the Agency believes, based
on data and information reviewed, that the pesticide active
ingredients sodium and potassium nitrates, as registered for
use in products covered by this document, do not present any
unreasonable adverse effects to humans. After all of the
product specific data has been reviewed, a final
determination will be made.
C. ENVIRONMENTAL ASSESSMENT
The Agency has not required and does not intend to require
any generic environmental fate or ecological effects data on the
active ingredients sodium and potassium nitrates considering the
registered product formulations and uses. All data requirements
for these disciplines that are specified in 40 CFR Part 158 are
waived. The rationale for this decision is presented below in the
"Ecological Effects Assessment" and the "Environmental Fate
Assessment."
Available data on these two chemicals suggest moderate to low
acute toxicity, as described in the above section Toxicology Data
Base.
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1. Ecological Effects Assessment
The intended purpose of products containing these
active ingredients is to kill certain vertebrates and
wasp pest species inhabiting burrows. Pest species are
not exposed to sodium and potassium nitrates, but
rather to the products of their pyrolysis. Application
is subsurface and precludes exposure to avian
populations and aquatic organisms. The Agency realizes,
however, that any organism in a properly treated burrow
will likely be killed and is concerned about potential
impact to populations of non-target and endangered
species.
The open literature indicates that several types
of non-target organisms, including burrowing owls, may
inhabit the burrows of target pests (9, 10). Due to the
potential risk to non-target organisms, the Agency is
currently developing more extensive labeling regarding
timing of application and observation of signs
indicating the presence or absence of target and non-
target organisms. These instructions will be explicit
concerning actions users must take before applying the
product.
The use of these products may also result in a
potential impact on endangered species which utilize
burrows. Gas cartridges have been the subject of
several formal and informal consultations with the U.S.
Fish and Wildlife Service, and as a result, six
endangered or threatened species that utilize burrows
have been identified as being at risk. Current labeling
detailed in Appendix A includes provisions to protect
these species.
The Agency is currently in consultation with the
U.S. Fish and Wildlife Service to re-evaluate the
existing Biological Opinions, incorporate species newly
identified as threatened or endangered and account for
incidental take provisions . A new Biological Opinion
is expected in March 1992. After this Opinion is
issued, any necessary changes in labeling will be
identified and registrants will be required to revise
their labels.
Registrants are reminded of their responsibility,
under section 6(a)(2) of FIFRA, to submit any data
Indicates the number of individual non-target species that
are permitted to be harmed as a result of, or incidental to, the
Agency's action.
9
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regarding unreasonable adverse effects, including
incidents involving non-target organisms, to the
Agency. As more information becomes available regarding
endangered and non-target species, the Agency may
address this issue further.
2. Environmental Fate Assessment
Sodium and potassium nitrates are naturally
occurring substances whose physical properties are veil
understood. It is the Agency's belief that the
pyrolysis of these products results in simple organic
and.( inorgapic compounds, mostly in the form of gases,
which eventually diffuse through burrow openings or
into the soil. Exposure to the environment can be
characterized as limited and localized rather than
widespread or broadcast. Additionally, the Agency
normally requires many of the environmental fate
studies on pesticides in order to assist with its
assessment of risk to living organisms. Given the
Agency's ecological effects assessment, there is no
need for such data. All environmental fate data
requirements have therefore been waived.
IV. REREGISTRATION DECISION FOR ACTIVE INGREDIENT
A. DETERMINATION OF ELIGIBILITY
Section 4(g)(2)(A) of FIFRA calls for the Agency to
determine, after submission of relevant data concerning an
active ingredient, whether products containing the active
ingredient are eligible for reregistration. The Agency has
previously identified and required or waived the submission
of the generic (i.e., active ingredient specific) data
required to support reregistration of products containing
sodium or potassium nitrate as an active ingredient. The
Agency has completed its review of these generic data and
information from published literature, and has determined
that the data are sufficient to support reregistration of
products containing sodium or potassium nitrate. Appendix B
identifies the generic data that the Agency reviewed as part
of its determination of reregistration eligibility of sodium
and potassium nitrates, and lists the submitted studies that
the Agency found acceptable.
The data identified in Appendix B are sufficient to
allow the Agency to conduct a reasonable risk assessment for
the registered uses of sodium and potassium nitrates. The
data available to the Agency support the belief that the
registered uses of sodium and potassium nitrates will not
result in unreasonable adverse effects to the environment.
10
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particular products is addressed in section V of this
document ("Product Reregistration").
The Agency made its reregistration eligibility
determination based upon the target data base required for
reregistration, the current guidelines for conducting
acceptable studies to generate such data, various articles
available in the public literature which are identified in
Appendix C and the data identified in Appendix B. Although
the Agency has found that products containing sodium and
potassium nitrates are eligible for reregistration, it
should be understood that the Agency may take appropriate
regulatory action, and/or require the submission of
additional data to support reregistration of products
containing sodium or potassium nitrate, if new information
comes to the Agencyfs attention or if the data requirements
for registration (or the guidelines for generating such
data) change.
B. ADDITIONAL GENERIC DATA REQUIREMENTS
The generic data base supporting the reregistration of
products containing sodium nitrate has been reviewed and
determined to be complete. The data base for potassium
nitrate is substantially complete. The following generic
data for potassium nitrate have not been submitted and are
still required:
o A copy of all available technical specifications, data
sheets and other documents by which the manufacturer,
producer or supplier describes the composition
information.
o A description of the recovering and refining process if
any of the material is obtained from natural sources.
o A discussion of the impurities present in technical
potassium nitrate.
C. LABELING REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
CONTAINING SODIUM OR POTASSIUM NITRATE
No manufacturing-use products are registered.
V. PRODUCT REREGISTRATION
A. DETERMINATION OF ELIGIBILITY
Based on the reviews of the generic data for the
active ingredients, sodium and potassium nitrates, the
11
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products containing them are eligible for
reregistration. Section 4(g)(2)(B) of FIFRA calls for
the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of
eligibility has been made. The Agency will review
these data when they have been submitted and/or cited
and determine whether to reregister individual
products.
B. PRODUCT SPECIFIC DATA REQUIREMENTS
The product-specific data requirements are listed
in Attachment D.
4 C. LABELING REQUIREMENTS FOR END-USE PRODUCTS
CONTAINING SODIUM OR POTASSIUM NITRATE
The labels and labeling of all products must
comply with EPA's current regulations and
requirements. Follow the instructions in the
Product Reregistration Handbook with respect to
labels and labeling.
The Agency is currently developing detailed
guidance on labeling for gas cartridge products
which will further address concerns about
applicator safety and potential impact to
endangered and non-target organisms. This guidance
will be sent to registrants prior to submission of
labeling which is required eight months after
issuance of this document. Registrants will be
required to follow this guidance in revising their
labels.
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APPENDIX A
USE PATTERNS SUBJECT TO REREGISTRATION
FOR
INORGANIC NITRATE/NITRITE
(SOblUM AND POTASSIUM NITRATES)
13
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APPENDIX A: USE PATTERNS SUBJECT TO REREGISTRATION FOR CASE 4052: INORGANIC NITRATE/NITRITE
srrt
Appflcatton Type. Application Timing, Application Equipment
Form
Maximum
Application
Rate
(al)
Max. #
Apps.
Max. #
Appa. 9
Max. Rate
Mln. Interval
Between Appm.
9 Max. Rata
(Oaya)
Restricted
Entry
Interval
(Oays)
Geographic
limitations
Use Umffattom
Allowed
Dtaalowed
¦cHveIngredient'POTASSIUM NITRATE
FOOD/FEED USES
RANGELAND (UNSPECIFIED)
Fumigation, When needed. Hand placed cartridge
IMPR
0.0217 b
al/cartridge 1
not
spec
not spec
5
not spec
none
none
•
endangered species restrictlons;use in
burrows only, not Inside buldlngs: use
on woodchucksmay be restricted by
state law
NONFOOD USES
AGRICULTURAL UNCULTIVATED AREAS
Fumigation, When needed. Hand placed cartridge
IMPR
0.0217 b
al/cartridge 1
not
spec
not spec
not spec
not spec
none
•none
use on woodchucksmay be restricted
by state law
GOLF COURSE TURF
Fumigation, When needed. Hand placed cartridge
IMPR
0.0217 b
al/cartridge 1
not
spec
not spec
5
not spec
none
none
endangered species restrictk>ns;use In
burrows only, not inside buRdbtgs; use
on woodchucksmay be restricted by
state law
HOUSEHOLD/DOMESTIC DWELLINGS
OUTDOOR PREMISES
Fumigation, When needed. Hand placed cartridge
IMPR
0.0217 b
al/cartridge 1
not
spec
not spec
5
not spec
none
none
endangered species restrictions; use in
burrows only, not Inside birikfings; use
on woodchucksmay be restricted by
state law
NONAGRICULTURAL UNCULTIVATED AREAS
Fumigation, When needed. Hand placed cartridge
IMPR
0.0217 b
al/cartridge 1
not
spec
not spec
not spec
not spec
none
none
endangered species restrictlons;use In
burrows onfy, not Inside buddings; use
on woodchucksmay be restricted by
state law
ORNAMENTAL LAWNS AND TURF
Fumigation, When needed. Hand placed cartridge
IMPR
0.0217 b
al/cartridge 1
not
spec
not spec
5
not spec
none
none
endangered species restrictions;use In
burrows only, not inside buildings; use
on woodchucksmay be restricted by
state law
14
-------
SfTE
Application Type. Appteetkjo Tlmtno, Applcatton Equipment
Form
Maximum
AppScatlon
Rata
SODIUM NITRATE
FOOO/FEED USES
AGRICULTURAL CROPS
(UNSPECIFIED) (CROPLAND)
Fumigation, When needed. Hand placed cartridge
IMPR
0.3439 b
alfcartridge 1
not
spec
not spec
not spec
not spec
none
none
endangered species restrictfons;use kt
burrows only, not inside buMngs; do
not treat H nontarget species present In
pest burrows
RANGE LAND (UNSPECIFIED)
Fumigation, When needed. Hand placed cartridge
IMPR
0.3439 b
al/cartridge 1
not
spec
not spec
not spec
not spec
none
none
1
endangered species restrictions , use in
borrows only, not Inside buddings; use
on woodchudcsmay be restricted by
state law; do not treat H nontarget
species present In pest burrows
NONFOOD USES
AGRICULTURAL UNCULTIVATED AREAS
Fumigation, When needed, Hand placed cartridge
IMPR
0.3439 b
a I/cartridge 1
not
spec
not spec
not spec
not spec
none
none
endangered species restrictions; use In
burrows only, not Inside buddings; use
on woodchucfcs may be restricted by
state law; do not treat If nontarget
spedes present h pest burrows
FOREST PLANTINGS
(REFORESTATION PROGRAMS)
Fumigation, When needed, Hand placed cartridge
IMPR
.0613 b
al/cartridg* 1
not
spec
not spec
not spec
not spec
none
none
endangered species restrictions;use In
burrows only, not Inside buddings; use
on woodchucfcsmay be restricted by
state law, do not treat It nontarget
species present In pest burrows
GOLF COURSE TURF
Fumigation, When needed. Hand placed cartridge
IMPR
0013 b
aVcartridge 1
not
spec
not spec
not spec
not spec
none
none
endangered species restrictlons;use In
burrows only, not Inside buHdlngs; use
on woodchudcs may be restricted by
state law; do not treat If nontarget
spedes present In pest burrows
15
-------
srn*
Application Type. AppScalton Timing, Applcalton Equipment
NONAGRICULTURAL UNCULTIVATED AREAS
Fumigation, When needed, Hand placed cartridge
Form
Maximum
Appflcatton
Rata
(•0
Max. #
Appa.
Max. *
Appa.®
Max. Rata
Mln. Interval
Batman Appa.
• Max Rata
(Day*)
Raatrtctad
Entry
Intarval
(Day*)
QaograpNc
Limitation*
Uaa Umltatlona
Alio wad
Dtialonwd
IMPR
0.3439 b
al/cartridge 1
not
spec
not spec
not spec
not spec
none
none
endangered spedes restrlctions:use In
burrows only, not inside buildings; use
on woodchudcsmay be restricted by
state law, do not treat If nontarget
species present In pest burrows
ORNAMENTAL LAWNS AND TURF
Fumigation, When needed, Hand placed cartridge
IMPR
.08131b
al/cartridge 1
not
spec
not spec
not spec
not spec
none
none
m
endangered spedes restrictions; use In
burrows only, not Inside buddings; use
on woodchudcsmay be restricted by
state law; do not treat If nontarget
spedes present In pest burrows
Header max. - maximum; mfn. • mlnbrnim; apps. • applications: not spec. - not specified
Form: IMPR • Impregnated material
Rate: al • active Ingredient
Footnotes
1. Number of cartridges used per burrow varies with sire of animal and burrow.
16
-------
APPENDIX B
Generic Data Requirements for Reregistration
of Sodium and Potassium Nitrates and Data Citations
Supporting Reregistration
17
-------
'i
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which
support the reregistration for the pesticide covered by this
Reregistration Eligibility Document.
Appendix B contains generic data requirements that apply to
the pesticide in all products, including data requirements for
vhich a "typical formulation" is the test substance.
The data table are generally organized according to the
following format: .
1. Data Requirements (Column 1). The data requirements
are listed in the order in which they appear in 4 0 CFR Part 158.
The reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Assessment Guidelines, which
are available from the National Technical Information Service,
5285 Port Royal Road, Springfield, VA 22161.
2. Use Pattern (Column 2). This column indicates the use
patterns to which the data requirement applies. The following
letter designations are used for use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
J Forestry
K Residential
Any other designations will be defined in a footnote to the
table.
3. Bibliographic citation (Column 3). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no MRID
number has been assigned. Refer to the Bibliography Appendices
for a complete citation of the study.
18
-------
APPENDIX B
GENERIC DATA REQUIREMENTS FOR REREGI8TRATION OF SODIUM NITRATE
AND DATA CITATIONS SUPPORTING REREGI8TRATION
GUIDELINE
CITATION
TITLE OP
8TUDY
U8E
PATTERNS
BIBLIOGRAPHIC
CITATION
Product Chemistry
61-1 Product Identity ABCJK
61-2(a) Begin. Mat. and Mfg.Process ABCJK
61-2(b) Discussion of Impurities ABCJK
62-1 Preliminary Analysis ABCJK
62-3 Analytical Method ABCJK
63-2 Color ABCJK
63-3 Physical State ABCJK
63-4 Odor ABCJK
63-5 Melting Point ABCJK
63-7 Density ABCJK
63-8 Solubility ABCJK
19
417600-01
417600-02
417600-03
417600-04
417600-06
417931-01
417600-07
417600-08
417600-09
417600-10
417600-11
417600-12
-------
63-10
63-12
63-13
Dissociation Constant
PH
Stability
ABCJK
ABCJK
ABCJK
417600-13
417600-14
417600-15
Ecological Effects;
EPA waived all of these guideline as discussed in section C.l.
Toxicoloav
81-1 Acute oral tox - rat
ABCJK
417860-01
81-2
Acute dermal tox - rabbit
ABCJK
417860-02
81-4
Primary eye irritation - rabbit
ABCJK
417860-04
81-5
Primary dermal irritation - rabbit
ABCJK
417860-03
Environmental Fate:
EPA waived all of these guideline requirements as discussed in section C.2.
20
-------
APPENDIX B
GENERIC DATA REQUIREMENTS POR REREQI8TRATION OF POTA88IUM NITRATE
AND DATA CITATIONS SUPPORTING REREGI8TRATION
GUIDELINE
TITLE OP
USE
BIBLIOGRAPHIC
CITATION
STUDY
PATTERNS
CITATION
Product Chemistrv
61-1
Product Identity
ABCK
417667-01
61-2a
Begin. Mat. and Mfg Process
ABCK
DATA GAP
61-2b
Discussion of Impurities
ABCK
DATA GAP
62-1
Preliminary Analysis
ABCK
DATA GAP
62-2
Certification of Limits
ABCK
WAIVED
62-3
Analytical Method
ABCK
WAIVED
63-2
Color
ABCK
417667-01
63-3
Physical State
ABCK
417667-01
63-4
Odor
ABCK
417667-01
63-5
Melting Point
ABCK
417667-01
63-6
Boiling Point
ABCK
WAIVED
63-7
Density
ABCK
417667-01
21
-------
63-8
Solubility
ABCK
417667-01
63-10
Dissociation Constant
ABCK
WAIVED
63-11
Oct/Water Partition Coef.
ABCK
WAIVED
63-12
PH
ABCK
WAIVED
63-13
Stability
ABCK
417667-01
•
Ecoloaical Effects:
EPA
waived all of these guideline requirements as discussed
in section C.l
Toxicoloav
81-1
Acute oral tox - rat
ABCK
WAIVED
81-2
Acute dermal tox - rabbit
ABCK
WAIVED
81-3
Acute Inhalation - rat
ABCK
WAIVED
81-4
Primary eye irritation -
rabbit
ABCK
WAIVED
Environmental Fate:
EPA waived all of these guideline requirements as discussed in section C.2.
22
-------
APPENDIX C
SODIUM AMD POTASSIUM NITRATES BIBLIOGRAPHY
Citations Considered to be Part of the
Data Base Supporting Reregistration
23
-------
GUIDE TO APPENDIX C
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. Primary sources
for studies in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support of
past regulatory decisions. Selections from other sources
including the published literature, in those instances where
they haVe been fconsidered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study". In the case of published materials, this
corresponds closely to an article. In the case of
unpublished materials submitted to the Agency the Agency has
sought to identify documents at a level parallel to the
published article from within the typically larger volumes
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 numerically by Master Record Identifier, or MRID
number. This number is unique to the citation, and should
be used at any time specific reference is required. It is
not related to the six-digit "Accession Number" which has
been used to identify volumes of submitted studies; see
paragraph 4(d)(4) below for further explanation. In a few
cases, entries added to the bibliography late in the review
may be preceded by a nine-character temporary identifier.
These entries are listed after all MRID entries. This
temporary identifier number is also to be used whenever
specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
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 identifiable laboratory or testing facility as
24
-------
author. As a last resort, the Agency has shown the
first 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 deduced the date
from evidence in the document. When the date appears
as (19??), the Agency was unable to determine or
estimate the date of the document.
c. Title. In some cases, it has been necessary for Agency
bibliographers to create or enhance a document title.
Any such editprial insertions are contained between
square brackets.
d. Trailing parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the
following elements describing the earliest known
submission:
(1) Submission date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
25
-------
OFFICE OF PESTICIDE PROGRAMS
REREGISTRATION ELIGIBILITY DOCUMENT
BIBLIOGRAPHY
41760001 Bullard, R. (1991) Sodium nitrate: Product identity and Disclosure
of Ingredients. Unpublished study prepared by Denver Wildlife
Research Center. 4p.
41760002 Bullard, R. (1991) Sodium Nitrate: Description of Beginning
Materials and Manufacturing Process. Unpublished study prepared
by Denver Wildlife Research Center. 9p.
41760003 Bullard, R. (1991) Sodium Nitrate: Discussion of Impurities.
Unpublished study prepared by Denver Wildlife Research Center.
Sp.
41760004 Bullard, R. (1991) Sodium Nitrate: Preliminary Analysis of Product
Samples. Unpublished study prepared by Denver wildlife Research
Center. 17p.
41760005 Bullard, R. (1991) Sodium Nitrate: Certification of Ingredient
Limits. Unpublished study prepared by Denver Wildlife Research
Center. 5p.
41760006 Bullard, R. (1991) Sodium Nitrate: Analytical Method to Verify
Certified Limits. Unpublished study prepared by Denver Wildlife
Research Center. 12p.
41760007 Bullard, R. (1991) Sodium Nitrate: Color. Unpublished
study prepared by Denver Wildlife Research Center. 4p.
41760008 Bullard, R. (1991) Sodium Nitrate: Physical State. Unpublished
study prepared by Denver Wildlife Research Center. 4p.
41760009 Bullard, R. (1991) Sodium Nitrate: Odor. Unpublished study
prepared by Denver Wildlife Research Center. 4p.
41760010 Bullard, R. (1991) Sodium Nitrate: Melting Point. Unpublished study
prepared by Denver Wildlife Research Center. 4p.
41760011 Bullard, R. (1991) Sodium Nitrate: Bulk Density. Unpublished Study
prepared by Denver Wildlife Research Center. 5p.
26
-------
41760012 Builard, R. (1991) Sodium Nitrate: Solubility: Unpublished study
prepared by Denver Wildlife Research Center. 5p.
41760013 Bullard, R. (1991) Sodium Nitrate: Dissociation Constant.
Unpublished study prepared by Denver wildlife Research Center.
4p.
41760014 Bullard, R. (1991) Sodium Nitrate: pH. Unpublished study prepared
by Denver wildlife Research Center. 4p.
41760015 Bullard, R. (1991) Sodium Nitrate: Stability, unpublished study
prepared by Denver Wi-ldlife Research Center. 4p.
41766701 HarXins, H. (1991) Potassium Nitrate: Product chemistry.
Unpublished study prepared by Nott Manufacturing. 7p.
41766001 Cerven, D. (1991) Sodium Nitrate: Single Dose Oral toxicity in
Rats/LD50 in Rats. Final Report: Lab Project No. MB/90-B1
A:DWRC/QA-166. Unpublished Study prepared by MB Research
Laboratories, Inc. 67p.
41786002 Cerven, D (1991) Sodium Nitrate: Acute Dermal Toxicity in
Rabbits/LD50 in Rabbits. Final Report: Lab project No. MB90-81
B:DWRC/QA-167. Unpublished study prepared by MB Laboratories,
Inc. 41p.
41786003 Cerven, D. (1991) Sodium Nitrate: Primary dermal Irritation in
Albino Rabbits. Final report; Lab Project No. MB 90-81
C:DWRC/QA-16B. Unpublished study prepared by MB Laboratories,
Inc. 33p.
41786004 Cerven, D. (1991) Sodium Nitrate: Primary Eye Irritation/Corrosion
in Rabbits. Final Report: Lab Project No. MB 90-8 D: DWRC/QA-
169. Unpublished study prepared by MB Research Laboratories Inc.
36p.
41793101 Kimball, B. and F. Mishalanie (1991) Sodium Nitrate: Technical
Assay by Ion Chromatography: Lab project Number 30A. Unpublished
Study
27
-------
The following are the sources of the references cited in this document:
(1) Savarie, P. J., et al. (1980) Vertebrate Pest Conference 9:215-221.
(2) Sax, N. I.# and Lewis, R. J. SR (1989) Dangerous Properties of Industrial
Materials. 7th Edition. Van Nostrand Reinhold, New York.
(3) Nott Mfg. CO. MRID 41766701
(4) Clarke, M. L., Harvey, D. G., and Humphreys, D. J. (1981) 'Nitrates and
nitrites', in Veterinary Toxicology. 2nd Ed. London: Bailliere
Tindall, p. 66.
(5) Chow, C. K., Chen, C. J., and Gairola, C. (1980) Toxicology Letters 6:199-
206.
(6) Ishidate, M. Jr., and Odashima, S. (1977) Mutation Research 48:337-354.
(7) Zaldivar, R. (1977) Experientia 33:264-265.
(8) Maekawa, A., et al. (1982) Food Chem. Toxicol. 20:25.
prepared by Denver Wildlife Research Center. 21p.
(9) Vaughan, .A. (1961) Vertebrates Inhabiting Pocket Gopher Burrows in
Colorado. J. Mamrool. 42(2):171-174.
(10) Schmeltz, L.L. and Whitaker, J.O., Jr. (1977) Use of Woodchuck Burrows by
Woodchuck and Other Mammals. Trans. Kentucky Acad. Sci. 38 (1-
2):79-82
7R
-------
S0372-101
REPORT DOCUMENTATION
PAGE '
I. REPORT NO,
4. Till# end SuStitH
Reregistration Eligibility Document-(R.E.D.)
Inbrcfanic: Nitrate /Nitrite (Rod-hm and Mit-rat-Ag)
7„ Aulhodi)
EPA, Office of Pesticide Programs.•Special Review & ReReg. Div
9, Performing Organizafion Nam* and Arfdr«s«
U.S. Environmental Protection Agency .. ,-¦
Office of Pesticide Programs '
Special Review and Reregistration Division
401 M Street, S.W.
Washington, D.C. 20460
a. FUciofeftft Ae««««iaA Ho.
1 Report Dit«
3/19/92
«. Performing Orfaniiation Rept. He.
54Q/RS- 92-184
10. Project/T«*h/Work Unit No.
11. CortlrectIC) or GunlfG) No.
ta
(G!
12. SooniQrtna Orgon.ntion N*m« end Addreu
same as #9
13L Type ot R«pof» & Period Covarad
]«.
IS. Suppt«meM«ry NUn
IS. AbMraet (limit: 200 wontt)
EPA is directed by the Federal Insecticide, Fungicide, and
Rodenticide Act as amended in 1988 (FIFRA '88) to review all
pesticide products containing active ingredients initially
registered before November 1, 1984, and to reregister those
products that have a substantially complete data base and do not
pose unreasonable adverse effects to people or the enviroiiment
This pesticide reregistration program is to be conpleted by th£
late 1990's.
The Reregistration Eligibility Document (or RED) discusses
the scientific data and other information supporting EPA's
regulatory conclusion that products containing a pesticide do not
pose unreasonable risks when used as directed by Agency-approved
labeling, and are eligible for reregistration.
IT. Document AAalyalt *. Oetcrtctera
Pesticides, standards regulations, manufacturing, chemistry, toxicology,
residues, ecology, path of pollutants.
6. Idtnttfiera/OpenEndetf T»«tn»
e. COSAT1 FleKJ/Groue
11. AvetUbtlrty Statement
Publicly Available
19. Security Cliu (This Beport)
unclassified
20, S*«urfr* Clan (This P»g«>
unclassified
21. No. ef P««*.
22. Prtce
(See ANSt-Z39,l«
5«e Irttnjetlnnm on
OPTION*!. FORM 272 (4-7 7)
(Tormffly NTlS-35)
Department ol conirrtrc*
------- |