EPA 730-F-98-033
United States
Environmental Protection
Agency
Office of Prevention,
Pesticides
and Toxic Substances
(7501C)
pesticide
' SEZ/ FACT sheet
%
PPO^
Name of Chemical(s): Potassium dihydrogen phosphate
Reason for Issuance: New Active Ingredient
Date Issued:	October 1998
EPA Publication Number:
1. DESCRIPTION OF THE CHEMICAL(S)
Generic Name(s) of the
Active Ingredient(s):
OPP Chemical Code:
Year of Initial Registration:
Trade name of end-use product:
Type of Pesticide:
Basic Producers:
Potassium dihydrogen phosphate; also known as potassium
monophosphate
076413
1998
eKsPunge
Fungicide
Lidochem, Inc.
20 Village Court
Hazlet, NJ 07730
2. USE SITES. APPLICATION TIMING & TARGET PESTS
Formulation Types: Soluble crystalline powder.
Target Pests:	Powdery mildew.
Registered Uses: Apples, grapes, cucumbers, melons, summer and winter squash,
watermelons, mangoes, peaches, nectarines, plums, cherries, peppers,
tomatoes, and roses.

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Application Timing: As needed. Applications should be repeated at 7-14 day interval,
depending upon the intensity of infestation.
3.	FOOD CLEARANCES I TOLERANCES
The Agency, on its own initiative, proposed to establish an exemption from the requirement of a
tolerance for residues of potassium dihydrogen phosphate in or on all food commodities when
used as a fungicide to control powdery mildew in fruits and vegetables. This proposed rule was
published on March 3. 1998 with a 60-day comment period (63FR10352). The final rule was
published on	 Safety factors from the Food Quality Protection Act of 1996 (FQPA) were
considered.
4.	SCIENCE FINDINGS
A.	CHEMICAL DESCRIPTION
The active ingredient, Potassium dihydrogen phosphate (also referred to as monopotassium
phosphate) is a synthesized active ingredient (a.i.). The end-use product is a crystalline powder
containing 100% active ingredient. The chemical abstract service (CAS) number for
monopotassium phosphate (KH2P04) is 7778-77-0.
B.	BIOCHEMICAL CLASSIFICATION
Potassium dihydrogen phosphate is naturally occurring, has had widespread use with no adverse
effects, but has a toxic mode of action on fungi. OPP's Biochemical Classification Committee
has determined that potassium dihydrogen phosphate is not a biochemical, but is eligible for
reduced data requirements akin to those established for biochemical pesticides because of the
simple inorganic structure and natural occurrence of this compound.
C.	TOXICOLOGY:
The required acute mammalian toxicology studies have been submitted except for those which the
Agency has waived. The submitted data indicates that the product has an acute oral LDS0 >5000
mg/kg in male rats, >500 mg/kg in female rats and a combined LD50 >500 mg/kg in male and
female rats (Toxicity Category III), and an acute dermal LD30 >2000 mg/kg in rabbits (Toxicity
Category III). Additionally, primary skin irritation studies reveal that the product is a non-irritant
(Toxicity Category IV), and primary eye irritation studies reveal that it is a mild eye irritant
(Toxicity Category III).
BPPD waived the acute inhalation study, dermal sensitization study (guinea pig), mutagenicity,
cellular immune response, and developmental toxicity data based on low acute mammalian
toxicity of the active ingredient and the fact that potassium dihydrogen phosphate has been
exempt from requirement of a tolerance when used in accordance with good agricultural practice
as an inert ingredient in pesticide formulations as a buffering agent.
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D. FOOD QUALITY PROTECTION ACT REQUIREMENTS
Safety factors from FQPA were evaluated. BPPD has considered, among other factors,
available information concerning the aggregate exposure levels of consumers (and major
identifiable subgroups of consumers) to the pesticide chemical residue and to other related
substances. Given the low toxicity of potassium dihydrogen phosphate as indicated by toxicity
data, and a history of safe use as a fertilizer and pesticide inert ingredient, a determination of
reasonable certainty of no harm for the general population, as well as subgroups including
infants and children, was made.
E. HUMAN HEALTH EFFECTS
1.	Acute and Chronic Dietary Risks for Sensitive Subpopulations. Particularly Infants
and Children
Dietary risk from potassium dihydrogen phosphate is difficult to estimate due to its being
ubiquitous in nature, and its use as a pesticide inert ingredient and fertilizer. In the
absence of any toxicological endpoints, risk from the consumption of residues is not
expected for both the general population and infants and children from all uses of
potassium dihydrogen phosphate. Furthermore, results from mammalian toxicity studies
as discussed in unit III B, Human Health Assessment, indicate a lack of toxicity, adding
further weight to the lack of risk from exposure. EPA has concluded that there is a
reasonable certainty that no harm will result from use of potassium dihydrogen phosphate,
and due to the lack of mammalian toxicity, the ten-fold exposure (safety) factor docs not
need to be considered.
2.	Common Mode of Action
Potassium dihydrogen phosphate does not share any common mechanisms of toxicity with
other pesticide active ingredients. Potassium dihydrogen phosphate is used as an
agricultural fertilizer and a buffering agent in pesticide formulations. There arc no
reported adverse effects from these uses and toxicology studies submitted indicated low
mammalian toxicity. Therefore, no impact on the potential for toxic effects from the
pesticidal use is expected when added to the other uses of potassium dihydrogen
phosphate.
3.	Risks Posed by Potential Residential. School or Day Care Exposure
No indoor residential, school or day care uses currently appear on the label. Therefore,
an assumption of no risk due to lack of exposure is made.
4.	Drinking Water Exposure and Risk Characterization
There is no expected human exposure to potassium dihydrogen phosphate in drinking
water. When the end-use product is applied to plants, most of it is absorbed. The
potential exists for a minimal amount of potassium dihydrogen phosphate to enter ground
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water or other drinking water sources if, after application, weather patterns are such that
significant rainfall and surface water runoff occur. But residues arc not expected to be
significantly above background levels due to the naturally occurring and ubiquitous
nature of the compound. Health risk to humans is considered negligible based on the
evaluations of the submitted toxicity information, and low application rate of the active
ingredient.
5. Aggregate Exposure
The Agency has considered the various routes of exposure (dietary, drinking water, and
exposure from non-occupational sources), and potential risks of the subject compound
and determined that the proposed use of the active ingredient docs not pose significant
risk over a lifetime to populations including infants and children even when the extra
ten-fold safety factor is considered. This is demonstrated by low acute mammalian
toxicity, and a history of safe use of the compound as a fertilizer and a pesticide inert
ingredient without reported adverse effects.
F.	OCCUPATIONAL AND RESIDENTIAL EXPOSURE AND RISK
CHARACTERIZATION:
Because of low mammalian acute toxicity, low application rates, and a history of safe use as a
fertilizer and pesticide inert ingredient without reported adverse effects, occupational exposure
data are not required at this time. Risks from occupational exposure will be mitigated through
appropriate precautionary labeling.
G.	ENVIRONMENTAL ASSESSMENT
The ecological database for eKsPunge is adequate and will support registration. All guideline
requirements for potassium dihydrogen phosphate have been satisfied.
H.	ECOLOGICAL EFFECTS:
Data waivers for ecological effects studies were requested and supported based on the current use
as a pesticide inert ingredient and fertilizer, and low acute mammalian toxicity. In addition,
monopotassium phosphate is ubiquitous in nature, and no adverse effects have been reported on
nontarget species with current uses. Risk to nontargct species is minimal due to the use pattern,
application methods, and mitigation of nontarget aquatic organism toxicity with appropriate
precautionary label statements under "Environmental Hazards."
I.	ENVIRONMENTAL FATE AND GROUND WATER DATA
The environmental fate data requirements were not triggered because no human health or
ecological effects issues were manifested in the acute toxicity (Tier I) studies.
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J. ECOLOGICAL RISK ASSESSMENT
A potential for exposure exists to nontarget insects, fish, and other wildlife with foliar spray
applications.. However, test results indicate that the compound is practically nontoxic to birds
and freshwater fish, and, at most, slightly toxic to aquatic invertebrates. Low toxicity, the
proposed rate of application, and mitigating label language present minimal to nonexistent risk
to wildlife.
REQUIRED ENVIRONMENTAL HAZARDS STATEMENT
ON THE END-USE PRODUCT LABEL
"Do not contaminate water when disposing of rinsate or equipment
washwaters. Do not apply directly to water, or to areas where surface
water is present or to intertidal areas below the mean high water
mark."
5.	SUMMARY OF REQUIRED DATA : All hypersensitivity incidents mast be reported to the
Agency when/if they occur.
6.	REGULATORY ACTIONS Unacceptable adverse effects from the use of eKsPunge are not
expected. Unconditional registration was issued.
7.	CONTACT PERSON AT EPA
Rita Kumar
Regulatory Action Leader
Biochemical Pesticides Branch
Biopesticides and Pollution
Prevention Division (7511C)
Office of Pesticide Programs
Environmental Protection Agei
401 M Street, SW
Washington, D.C. 20460
e-mail: kumar.rita@epa.gov
DISCLAIMER: The information in this Pesticide Fact Sheet is a summary only and is not to be used
to satisfy data requirements for pesticide registration and/or reregistration. Contact the Product
Manager listed above for further information.
Office location/telephone number
902W5, Crystal Mall II
1921 Jefferson Davis Highway
Arlington, VA 22202
(703) 308-8291
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F. ECOLOGICAL EFFECTS
Guideline
No.
154-16
154-19
154-20
154-22
154-23
154-24
Study
Avian oral toxicity/
pathogenicity
Fresh water fish
toxicity/
pathogenicity
Fresh water
invertebrate
toxicity/pathogenicity
Nontarget plant
toxicity/pathogenicity
Nnntarget insect
toxicity/pathogenicity
Honeybee
toxicity/pathogenicity
Status, Classification &
Comments
SUPPLEMENTAL. MPCA was practically
nontoxic to northern bobwhite. No reports
of avian toxicity/ pathogenicity or incidents.
The in vitrn growth temperatures of the
intended MPCA are too low to allow
growth and development of PFR-97 Apopka
strain in birds. No further avian testing
required for this use, nor for outdoor
terrestrial use patterns.
Data requirement waived for the limited use
pattern.
Data requirement waived for the limited use
pattern.
Toxicity/infectivity endpoints unknown.
Limited reports in the public literature of
pathogenicity to outdoor terrestrial plants to
date. Data are not required for this limited use
pattern.
The MPCA is a well-documented insect
padiogen; however toxicity/pathogenicity
endpoints are unknown for most insect species.
Risk mitigation label language required for all
labels.
Toxicity/infectivity endpoints unknown.
Studies are not required for this limited use in
greenhouses.
G. ENVIRONMENTAL FATE AND GROUNDWATER DATA
The pesticide is not to be directly applied to water and the proposed uses limit exposure
to the environment. Environmental fate data are required when toxicity/pathogenicity
testing shows adverse effects. Such data will be required if adverse effects are
observed from Tier I tests and if more extensive use patterns are sought.
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LABELING REQUIREMENTS
It is the Agency's position that the labeling for products containing
Paecilottryc.es fumosoroseus Apopka Strain 97 must comply with the current pesticide
labeling requirements.
1.	Manufacturing Use Product Labeling:
Precautionary Statements must include the requirement for workers, when
handling this product, to wear a dust-mist filtering respirator with
NIOSH/MSHA approval number prefix TC-21C or equivalent dust-mist filtering
respirator, meeting NTOSH standards, with prefix N-95, R-95 or P-95.
Directions for Use statements must include the following:
"This product is for manufacturing use only in the formulation of insecticides"
for greenhouses and interiorscapes".
Environmental Hazard Statement:
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the requirements of a
National Pollutant Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
2.	End-use Product Environmental Hazards Labeling
Provided the following statements are placed in the environmental
hazards statement, the risk of exposure to Paecilomyc.es fumosoroseus Apopka
Strain 97 is minimal to nonexistent to nontarget organisms including
endangered species.
The following statements are required as Environmental Hazards labeling
for the end-use product:
"Do not apply directly to water, or to areas where surface water is present or to
intertidal areas below the mean high water mark. Do not contaminate water
when disposing of rinsate or equipment washwaters."
"The potential effects of this product on non-target beneficial insects that may be
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used in greenhouse Integrated Pest Management Programs arc not known".
VI. SUMMARY OF DATA GAPS
1.	The registrant must provide appropriate final printed labels to comply with Agency
requirements prior to release and shipment of products containing this active ingredient.
2.	If the registrant wishes to expand uses to food commodities, further ecological effects and
environmental fate and effects data regarding aquatic and terrestrial non-target organisms,
including honeybee and non-target insects, are required.
VII. CONTACT PERSON AT EPA
Shanaz Bacchus
Regulatory Action Leader
Biopesticides and Pollution
Prevention Division (7511C)
Office of Pesticide Programs
Environmental Protection Agency
410 M Street, S.W.
Washington, D.C. 20460
Office location/telephone number
9th Floor, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
(703) 308-8097
email: bacchus.shanaz@epa.gov
DISCLAIMER: The information in this Pesticide Fact Sheet is a summary only and is not to
be used to satisfy data requirements for pesticide registration and reregistration. Contact the
Product Manager listed above for further information.
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[ 2. REPORT DATE
3. REPORT TYPE AND DATES COVERED
j OCTOBER 1998
PESTICIDE FACT SHEET
4. TITLE AND SUETITlE
EPA Pesticide Fact Sheet - Potassium dihydrogen
Phosphate
5. FUNDING NUMBERS
6. AUTHOR(S)
U.S. Environmental Protection Agency
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division
7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES)
U.S. Environmental Protection Agency
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division
401 M Street, S.W.
Washington, D.C. 20460
8. PERFORMING ORGANIZATION
REPORT NUMBER
EPA 730-F-98-033
9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES)
Same as #7
10. SPONSORING /MONITORING
AGENCY REPORT NUMBER
11. SUPPLEMENTARY NOTES
12a. DISTRIBUTION/AVAILABILITY STATEMENT j 12b. DISTRIBUTION CODE
Publicly Available
i
13. AESTKACT (Maximum 200 words)
This document contains up-to-date chemical information, including a summary
of the Agency's regulatory position and rationale, on a specific pesticide or
group of pesticides. A Fact Sheet is issued after one of the following actions
has occurred.
1.	Issuance or reissuance of a registration standard,
2.	Issuance of each special review document,
3.	Registration of a significantly changed use pattern,
4.	Registration of a new chemical, or
5.	An immediate need for information to resolve controversial issues
relating to a specific chemical or use pattern.
14. SUBJECT TEAMS
Pesticides, Regulations, Chemical Information Fact Sheet,
Use Patterns, Science Findings
15.	NUMBER OF PAGES
5
16.	PRICE CODE
17. SECURITY CLASSIFICATION j IE. SECU~.ITV CLASSIFICATION
OF REPORT j Or THIS °age
Unclassified j Unclassified
19. SECURITY CLASSIFICATION
OF abstract.
Unclassifled
20. LIMITATION OF ABSTRACT
%
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