oEPA
United StatM
Environmental Protection
Agency
Off ice of
Pesticides and Toxic Substanc
Washington DC 20460
Pesticides
April 1987
Guidance for the
Reregistration of
Pesticide Products
Containing EPN
as the Active Ingredient
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GUIDANCE FOR THE
RE REG I STRATI ON OF PESTICIDE PRODUCTS
CONTAINING
EPN
AS THE ACTIVE INGREDIENT
CAS REGISTRY NO. 2104-64-5
OPP SHAUGHNESSY NO. 041801
EPA CASE NUMBER 147
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by This Standard 3
A. Description of Chemical 3
B. Regulatory History 3
1. Cancellation of Uses in The Absence of a
Finite Tolerance 3
2. Classification of Certain Use Patterns as
Non-food Uses 4
3. Classified as Highly Toxic to Bees 4
4. Specific Reentry Period Designated 4
5. Certain Uses Classified for Restricted Use. . . 4
6. Retuttable Presumption Against Registration . . 5
7. Data Call In 10
C. Use Profile 11
III. Agency Findings 13
A. Summary 13
1. Summary of Agency Conclusions 13
2. Summary of New Agency Position Based on
Information and Assumptions Used in
the Current Assessment of Risk 16
3. Summary of Agency Position on Other Effects. . 17
B. Health Risk Assessment 18
1. Acute Toxicity 19
2. Subchronic Toxicity 19
3. Chronic Toxicity 21
4. Oncogenicity 21
5. Teratogenicity 22
6. Reproduction. 22
7. Mitagenicity *.... 22
8. Metabolism 23
9. Neurotoxicity Recovery Study in Hens 25
10. Toxicological Issues Associated With
Delayed Neurotoxicity 26
11. Risk Assessment for Delayed Neurotoxicity ... 29
Dietary Risk Assessment 29
Non-dietary Risk Assessment (applicators and
reentry) 33
C. Environmental Profile 35
1. Ecological Effects 35
2. Endangered Species 42
3. Environmental Fate 42
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TABLE OF CONTENTS (continued)
D. Tolerance Reassessment 43
1. Residue Data 44
2. Pesticide Monitoring Data 74
3. Toxicological Data and Acceptable
Daily Intake 74
4. Tolerance Reassessment Summary and
Current Tolerances. 76
IV. Regulatory Position and Rationale 79
A. Regulatory Positions ., 79
B. Criteria for Registration 84
C. Acceptable Ranges and Limits 84
D. Reguired Labeling 85
V. Products Subject to This Standard 91
VI. Reguirement for Submission of Generic Data 93
A. What are generic data? 93
B. Who must submit generic data? 93
C. What generic data must be submitted? ....... 94
D. How to comply with DCI reguirements 94
E. Testing protocols, standards for donducting
acceptable tests, guidance on evaluating
and reporting data 97
F. Procedures for reguesting a change in protocol . . 97
G. Procedures for reguesting extensions of time ... 97
H. PR Notice 86-5 and any other reguirements
referenced or included within this notice. ... 98
I. Existing stocks provisions upon suspension or
cancellation 98
VII. Reguirement for Submission of Product-Specific Data . . 99
VIII. Requirement for Submission of Revised Labeling 100
11
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TABLE OF CONTENTS (continued)
IX. Instructions for Submission 100
A. Manufacturing use products (sole active) 100
B. Manufacturing use products (multiple active) . . .101
C. End use products 102
D. Intrastate products 103
E. Addresses 103
iii
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APPENDICE
I. DATA APPENDICES
Guide to Tables 104
Table A 106
Table B 138
II. LABELING APPENDICES
Summary of Label Requirements and table 142
40 CFR 162.10 Labeling Requirements 152
Physical/Chemical Hazards Labeling Statements .... 161
Storage Instructions 162
Pesticide Disposal Instructions ... 163
Container Disposal Instructions 164
III. USE INDEX APPENDIX 165
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography 194
Bibliography 196
V. FORMS APPENDICES
FIFRA §3(c)(2)(B) Summary Sheet (EPA Form 8580-1)
Certification of Attempt to Enter into an Agreement with Other
Registrants for Development of Data (EPA Form 8580-6)
Product Specific Data Report (End-Use Products)
Formula tor's Exemption Statement
IV
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the sane active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program 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" criteria of FIFRA. In its review EPA identifies
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request^, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
EPA's reassessment results in the development of a
regulato.ry position, contained in this Registration Standard,
•'•The scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to nan or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer cur questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify
the Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as the products are registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
EPN is the accepted abbreviation for the chemical O-ethyl
O-p-nitrophenyl phenylphosphonothioate. There is no official
common name. The basic manufacturer of EPN is Nissan Chemical
Works, Ltd. of Japan. There are currently no technical EPN
products registered in the United States.^
Some identifying codes and characteristics are:
Chemical Class: non-halogenated, aromatic, phosphonothioate
organ ophosphorus compound.
Empirical Formula:
Molecular Weight: 323.3
CAS Registry No.: 2104-64-5
OPP Shaughnessy No.: 041801
The pure compound occurs as a light-yellow crystalline
powder with an aromatic odor and the technical grade is a
red dish- ye How oily liquid. EPN is only slightly soluble
in water and is miscible with benzene, toluene, xylene, acetone,
isopropyl alcohol, and methanol. EPN has a melting point of
34.5°C, vapor pressure of 0.03 mmHg at 100°C and specific
gravity of 1.27 at 20°C.
B . Regulatory History
EPN was first introduced in 19.49 by E. I. du Pont de Nemours
and Company, Inc. In 1950 E. I. du Pont de Nemours and Company,
Inc. obtained a patent for EPN (Patent Number 2503390) and the
first registration and tolerances were issued for the chemical
in the same year. During the ensuing years EPN has been
subjected to the following regulatory actions.
1 . Cancellation of Uses in The Absence of a Finite Tolerance
PR Notice 68-6 published on February 1, 1968, proposed the
cancellation of use of EPN on onions in the absence of a finite
tolerance or exemption.
Active registrations for, technical EPN were formerly held by
E. I. du Pont de Nemours, Laroche Industries, Inc., Marubeni
America, J. R. Simplot Company, and Velsicol Chemical Company.
However, these registrants have requested voluntary cancellation
of their registrations for technical EPN in lieu of developing
the data required to support the continued registration of their
products.
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2. Classification of Certain Use Patterns as Non-food Uses
PR Notice 68-8 published on April 24, 1968, classified
certain chemical use patterns as non-food uses, allowing
registration of products for these uses to continue in the
absence of finite tolerances. Use of EPN as a special mosquito
larvicide was classified as a non-food use.
3. Classified as Highly Toxic to Bees
PR Notice 68-19 published on November 29, 1968, classified
EPN and certain other pesticides as highly toxic to bees and
required the label statement, "This product is highly toxic to
bees exposed to direct treatment or residues on crops. Protective
information .may be obtained from your Cooperative Agricultural
Extension Service."
4. Specific Reentry Period Designated
On May 10, 1974, the Agency published in the Federal
Register (39 FR 16890) a list of 9 pesticides designated for
a specific reentry period in 40 CFR 170.3 (b). EPN was one of
those 9 pesticides. Pesticide products containing EPN have a
reentry time of at least 24 hours, prior to which workers must
wear protective clothing in order to be permitted to enter a
field treated with EPN.
5. Certain Uses Classified for Restricted Use
On August 1, 1979, the Agency published a proposed rule
in the Federal Register which would amend 40 CFR 162.31 by
adding uses of active ingredients to be classified for
restricted use under 40 CFR 162.30. Under the proposed rule,
all EPN liquid and dry formulations greater than 4% and all
EPN granular formulations 2% and greater would be classified
for restricted use (44 FR 45218). This proposed rule was
based on the risk criteria for determining a pesticide's use
classification, as provided in 40 CFR 162.11 (c)(2) through 5,
which require that determinations concerning the use classifi-
cation of a pesticide must take into account the pesticide's
existing toxicity category, the level of risk posed to humans
and the environment, the adequacy of present labeling, and
other hazard information.
The Agency published the final rule in the Federal
Register on January 19, 1981, adding certain uses of eight
active ingredients (including EPN) to the list of uses which
the Agency has classified for restricted use (46 FR 5696).
The final rule regarding EPN classification became effective
on June 10, 1981 (46 FR 29708), whereupon all uses of EPN
liquid and dry (granular and wettable powder) formulations
greater than 4% were classified for restricted use. !
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6. Rebuttable Presumption Against Registration (RPAR)
On September 19, 1979, the Agency issued a Notice of
Rebuttable Presumption Against Registration3 of Pesticide
Products Containing EPN (44 FR 54384). The Agency based the
presumption against registration upon studies showing that
EPN caused delayed neurotoxic effects in test animals, and
was acutely toxic to aquatic organisms. The Agency also
identified five other possible adverse effects of EPN for
which insufficient information existed to issue a rebuttable
presumption. Those effects were: (1) teratogenic effects;
(2) cholinergic effects; (3) disorders of the eye; (4)
possible mutagenic effects; and, (5) reductions in populations
of nontarget organisms (honeybees). The existence of a data
gap for oncogenic effects was also noted. In addition, the
Agency noted that, when used in combination with malathion,
dimethoate, or Systox, EPN had been observed to potentiate
the acute toxicity of these chemicals, i.e., causes the total
effect of the two chemicals to be greater than the sum of the
two effects taken independently.
The EPN laboratory animal (chicken) neurotoxicity studies
which formed the basis for the Agency's Special Review (RPAR)
demonstrated that EPN caused many effects characteristic of
organophosphate-type delayed neurotoxicity. Some of these
characteristics are: a delay of from 10 to 14 days between a
single effective dose and the appearance of clinical and
histopathological signs; the appearance of the delayed effect
well after the recovery from the acute toxicity of the compound;
the appearance of abnormalities in gait which may proceed to
complete paralysis and are generally irreversible; and, the
destruction of nerve axons in the spinal cord and the subsequent
disappearance of the myelin sheath which surrounded the lost
axons. However, due to inconsistencies in those studies the
Agency at that time concluded it could not use those studies to
establish a NOEL for EPN delayed neurotoxic effects. Rather,
the Agency used a human study, in which a NOEL of 0.1 milligrams
per kilogram (mg/kg) per day was established for EPN-induced
3The Agency created the Rebuttable Presumption Against
Registration (RPAR) process to facilitate the identification
of pesticide products (or uses thereof) which may not satisfy
the statutory standard for registration, and to provide an
informal procedure through which to gather and evaluate
information about the risks and benefits of these products
and uses. Subsequently, on November 27, 1985, the Agency
published revised, final regulations (40 CFR Part 154) in which
the term RPAR was changed to Special Review. A Special Review
arises if a pesticide meets or exceeds any of the risk criteria
set forth in the regulations.
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depression of plasma and red blood cell (RBC) cholinesterase
levels as the most sensitive indicator for human toxicity. On
that basis the Agency calculated dietary and applicator risks
posed by the continued uses of EPN. (However, as explained
below in Section III. A. 2., III. B. 2., and III. B. 9.,
data on histopathological changes in the spinal cord are
more appropriate for setting a NOEL for human risk assessment
purposes.)
The maximum dietary burden if EPN were used on all crops
for which it was registered was calculated to be 0.016 mg/kg
of body weight (bw) per day for a 60 kg person. The maximum
dietary burden assumed that EPN residues existed on each
commodity at the full tolerance level.
Based on tolerances for cotton, corn, and soybeans, three
crops comprising the bulk of EPN useage, the sum of the dietary
burdens for these crops was calculated to be 0.00036 mg/kg/day
for a 60 kg individual. This calculation factored in the
percent of the crop treated. Based on this exposure estimate
and the oral NOEL of 0.1 mg/kg/day for blood cholinesterase
inhibition in humans, an acceptable Margin of Safety (MOS)
of 277 existed. The Agency's Position Document 4 stated that
an acceptable MOS for cholinesterase inhibition was 10 and
for delayed neurotoxicity was 100.
The Agency also calculated MOSs for all applicator
groups, based on a human NOEL of 0.1 mg/kg per day for EPN
cholinesterase inhibition, using a worst case and a more
realistic case approach.
1. If protective clothing and a respirator are worn,
applicator exposure should be limited to the dermal
route. Using the worst case of 100% dermal absorption,
and based on a NOEL of 0.1 mg/kg per day, MOSs
were calculated as follows:
pilots - 38 loaders - 4
flaggers - 1 ground applicators - 9
In using the worst case approach, MDSs for most
applicator groups were considered unacceptable.
2. Another approach was used to reflect a more realistic
risk to applicators from the use of EPN. In this
approach the Agency, using acute toxicity data,
estimated a dermal absorption rate for EPN to be
approximately 31%. Using the 31% dermal absorption
value, the following margins of safety ware calculated:
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pilots - 125 loaders - 13
flaggers - 3 ground applicators - 30
Using the 31% absorption value, adequate MOSs were
considered to exist for all applicator groups except
flaggers with regard to cholinesterase inhibition,
but MOSs for the delayed neurotoxic effect were
below the accepted level except as to pilots.
The Agency received a number of comments from registrants
and others regarding the risks and benefits of EPN in response
to the September 19, 1979 RPAR Notice. In evaluating those
comments the Agency reevaluated EPN's chemistry, environmental
activity and movement, toxicity, effects upon wildlife popula-
tions, and the exposure of humans and animals to EPN. The
Agency also evaluated the benefits of EPN use and the effects
of cancellation upon the agricultural economy.
The Agency's reevaluation confirmed that EPN produces
delayed neurotoxicity in chickens but indicated that, although
subtle histological effects were observed in a well-conducted
test at 0.1 mg/kg per day, the toxicological significance of
these effects could not be determined without additional
study- The Agency's reevaluation also confirmed that EPN is
acutely toxic to honeybees, causing reductions in local and
regional populations of these nontarget organisms; and is
acutely toxic to aquatic organisms (from the mosquito larvicide
use only). The Agency's examination of use patterns in effect
at that time and the potential for exposure indicated that an
ample MOS existed for human dietary exposure and for applicators,
with the exception of human flaggers. With regard to honeybees,
the Agency determined that sufficient residues remain two to
three days after application to present an acute hazard to
bees. However, the Agency determined that this acute toxicity
could be sufficiently mitigated with the use of appropriate
labeling. Following this reevaluation of the risks and
benefits of EPN, the Agency concluded the RPAR for EPN with
the issuance of a Decision Document in June 1983 and the
publication of its final notice of determination concluding
the RPAR for EPN in the Federal Register on August 31, 1983
(48 FR 39494). The Agency's final regulatory decision on EPN
at the conclusion of the Special Review (RPAR) is summarized
in Table 1 below.
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Table 1 - Sumnary of EPA's Final Regulatory Decision Concluding the RIftR for EPN
Use site
Final decision
Mosquito Larvicide use
All other uses
Cancel.
Cancel, unless the following nodif ications are made
to the terms and conditions of registration:
Human flaggsrs prohibited unless in totally enclosed
vehicles.
Standardize label requirements for protective clothing,
goggles, and respirators, the phrase "protective
clothing required" to appear preminently in bold type
as follows:
PROTECTIVE CLOTHING REQUIRED; Wear clean
protective clothing, goggles, and respirators
approved by NIOSH or the American National
Standards Institute when applying or handling,
or when reentering fields within [at least 24]
hours of treatment. The following protective
clothing nust be worn: lightweight unlined
natural rubber gloves at least mid-forearm in
length; a wide brimmed waterproof hat or water-
proof hood; a protective suit or coveralls of a
non-permeable, non-cloth material covering the
body from arkles to wrists; lightweight unlined
natural rubber boots at least mid-calf in length;
full-face respirators are reconrte nded; half-face
respirators and goggles are required.
The following statement must appear in the "Use
Directions" section cf the label:
"Do not apply this product when weather conditions
favor drift from treated area."
The following statement must appear in the
"Environmental Hazards" section of the label for
Vfettable Powder (WP) and Emulsifiable Concentrate (EC)
formulations:
"This product is highly toxic to bees exposed to
direct treatment or residues on blooming crops or
weeds. Do not apply this product or allow it to
drift to blooming crops or weeds if bees are
visiting the treatment area."
(Table 1 continued on next page)
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Table 1 - Summary of EPA's Final Regulatory Decision Concluding the RB^R for EPN
(continued)
Use site
Final decision
WP and EC formulations
for use on Cotton
WP and EC formulations
for use on Field Corn
and/or Sweet Corn
WP and EC formulations
for use on Stone Fruitsf
Pome Fruits, and Citrus
All Food Uses
Areas for Further
Consideration
In addition to the requirements for "All Uses", the
following statement must appear in the "Use Directions"
section of the label:
"Do not apply to blooming cotton if bees are
visiting the treatment area."
In addition to the requirements for "All Uses", the
following statement must appear in the "Use Directions"
section of the label:
"Do not apply to corn daring the pollen-shed
period if bees are visiting the treatment areas."
In addition to the requirements for "All Uses", the
following statement must appear in the "Use Directions"
section of the label:
"Do not apply vhen trees or a substantial number
of veeds in the orchard/grove are in bloon."
Reassess tolerances. Data necessary to reassess EPN
tolerances will be required in the Agency's Registra-
tion Standard Review Process.
The Agency identified the following areas in which
data vrere required:
Teratogenic effects. Teratogenic studies in rats and
rabbits are needed.
Oncogenic effects.
Delayed neurotoxic effects.
Studies on the oncogenic potential
of EPN in rats and nice are needed.
A study to explore the
nechanisoi of "recovery"
from a mild case of
EPN-induced delayed
neurotoxicity in an
experimental species
will be required.
Reentry time reassessment. Data necessary to reassess
the 24-hour reentry time
for EPN were required.
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7. Data Call In (PCI)
The Agency issued a Data Call In (DCI) Notice on
May 31, 1985 requiring teratogenicity , reentry protection,
and delayed neurotoxicity data. These data have been received
and reviewed by the Agency and are discussed below in the
Preliminary Health Risk Assessment section III. B.
The Agency issued another DCI Notice on December 19, 1986
to all EPN registrants, including the basic registrant of
technical EPN, Marubeni America, Inc., for all of the data
gaps identified in this registration standard. The Agency
chose to proceed with the issuance of the data requirements
in December 1986 without this document because the Agency
had not completed its assessment of critical toxicology
data which was to be incorporated into this document. This
Registration Standard provides a review of these and other
data and a reassessment of the RPAR regulatory decisions.
On March 26, 1987 Marubeni America presented to the Agency
its decision that it would not generate and submit these required
data and that it requested a voluntary cancellation of its EPN
product registration. As a result of Marubeni's action, the
Agency reissued the December 1986 DCI Notice on March 26, 1987
to all other remaining EPN registrants (i.e. formulators)
informing them that the Agency could not exempt them from
producing the required data to support continued registration
of their EPN products since all the registrants of technical
EPN had chosen to voluntarily cancel or suspend their EPN
registrations.
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C. Use Profile
EPN is a broad spectrum non-systemic, slightly persistent,
contact and orally active organcphosphate insecticide and
acaricide that has been marketed in the United States for
over 35 years. There are currently no active registrations
for Technical EPN in the United States.
There are currently 5 single active ingredient products4
and 27 multiple active ingredient products5 registered.
Single active ingredient formulations currently registered
consist of:
Product Type Percent Active Ingredient
Granular (2% and 4%)
Wettable Powder (25%)
Single active ingredient formulations formerly registered
included:
Technical (93%)
Formulation Intermediate (80%)
Emulsifiable Concentrate (2 Ib/gal, 4 Ib/gal,
and 5 Ib/gal)
(All liquid formulations and any formulation greater than
4% active ingredient are classified as restricted use
pesticides).
EPN is registered for use on a variety of terrestrial
food crop and terrestrial nonfood sites and can be foliarly
broadcast using aerial or ground equipment. Applicators are
required to be certified or under the direct supervision of
applicators certified to apply EPN. Major use sites include
cotton, soybeans, field corn, and pecans. Other registered
uses include almonds, apples, apricots, beans (green beans,
-lima beans, navy beans, red kidney beans, snap beans),
black-eyed peas, cherries (sweet and sour), citrus (citron,
grapefruit, lemons, limes, oranges, tangelos, tangerines),
corn (sweet), cowpeas, grapes, kumquats, nectarines, olives,
peaches, pears, pecans, plums, prunes, sugar beets, tomatoes,
walnuts, and earthworm farms.
EPN is used to control insects such as the peach twig borer,
spider mites, codling moth, plum curculio, fruittree leafroller,
4 Single active ingredient products registered include
5 under FIFRA Section 3.
5 Multiple active ingredient products registered include
23 under FIFRA Section 3, 3 under FIFRA Section
24(c), and 1 Intrastate.
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pear psylla, cottony peach scale, Lecanium scales, olive scales,
oriental fruit moth, lesser peachtree borer, peachtree borer,
army worm complex, beet webworm, thrips, tomato fruitworm,
European corn borer, Mexican bean beetle, twospotted spider mite,
aphids, flea beetles, leafhoppers, Lygus bugs, climbing cutworms,
darkling beetles, stink bugs, citrus red mites, citrus thrips,
orange tortrix, orangeworms, corn rootworms, southwestern corn
borer, cabbage looper, cotton leaf perforator, tomato russet
mite, grasshoppers, boll weevil, bollworm, pink bollworm,
tobacco budworm, grape berry moth, grape leafhopper, walnut
caterpillar, hickory shuckworm, pecan weevil, may beetles,
pecan leaf casebearer, pecan nut casebearer, spittlebugs,
blister beetles, and corn earworm. (Refer to Appendix III,
"EPA Index to Pesticide Chemicals", for usage rates, calculations
of amount of active ingredient used, and complete listing of use
sites and pests.)
EPN was first registered for use in 1950 but was not
heavily utilized until the mid to late 1970s following the
cancellation of DDT. From annual usage levels in excess of
four million pounds of active ingredient (A.I.), a declining
trend began by 1980 as the newly developed synthetic pyrethroids
started to replace organophosphates in the cotton market.
The current aggregate annual usage estimate of 975,000
pounds of A.I. is considerably less than the 1.7 to 3.2 million
pounds of A.I. presented in the Agency's 1983 Preliminary
Quantitative Usage Analysis. The continued future use of
EPN on cotton is expected for early season applications and
for years of heavy target pest infestations; future usage
could increase if pest resistance develops for the pyrethroids.
Approximately 99% of the total amount of EPN use in the
United States in 1985 was attributed to use on major cotton,
soybeans, field corn, and pecan pests. These four use sites
comprise about 91%, 3%, 5%, and <1% respectively, of the
annual EPN usage. Recommended application rates range from
0.125 to 5.0 Ib. active ingredient per acre (a.i./A). The
percent of the four use sites treated with EPN are 3%, <1%,
7%, and <1%, respectively.
California and Federal reentry intervals of 14 days and
24 hours, respectively, have been established for EPN.
(However, the Agency new has adeguate data to establish interim
reentry levels for all crops as detailed below in Section III. B.
of this Registration Standard.)
Tolerances are established for use of EPN on certain fruit, nut,
field and vegetable crops.
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III. AGENCY FINDINGS
A. SUMMARY
1. Summary of Agency Conclusions
The Agency has reviewed all data currently supporting the
registration of EPN. Based on the review of these data, the
Agency has reached the conclusions listed below. These conclu-
sions are presented in more detail in subsections III B, III C,
and III D below.
a. EPN has been demonstrated to cause delayed neuro-
toxicity in the domestic hen. The effects have been
expressed as ataxia and damage to the sciatic nerve
and spinal nerve cord.
b. There are inadeguate margins of safety (MOSs) for
delayed neurotoxicity from dietary exposure to crops
treated with EPN and from worker exposure associated
with applying EPN and reentering treated fields.
c. EPN is acutely toxic to honeybees. Sufficient residues
remain on treated crops for two to three days after
application to present an acute hazard to honeybees.
As a result of this assessment under the Registration
Standard process, the Agency has determined that the delayed
neurotoxicity characteristics for EPN meet or exceed the delayed
toxic effect risk criterion (40 CFR 154.7(a)(2)) for Special
Review. Also, the Agency has determined that certain additional
or revised label restrictions are necessary to reduce worker
and environmental exposure during the period necessary to
complete the Special Review. These include:
Restricted Use Classification with Corresponding
Statement of Reason
Protective Clothing
Reentry Intervals
The Agency has also identified missing data necessary to
more fully evaluate the human and environmental risks associated
with the use of EPN. These data must be developed in order to
maintain registrations of existing products or register any
new products containing EPN. All data submitted to the Agency
must comply with PR Notice 86-5. A summary of the data gaps
for EPN is given in Table 2. Note that this is only a summary
and that complete details can be obtained by referring to the
tables in Appendix I.
The Regulatory Position and Rationale section of this
Registration Standard discusses the Agency's position on each
of the regulatory issues concerning EPN, and the Required
Labeling section contains the specific wording changes for
each of the labeling provisions necessary in order for EPN
products to remain in compliance with the requirements of FIFRA.
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-14-
Table 2. Summary of Data Gaps for EPN.
(Refer to the tables in Appendix 1 for detailed information
regarding these requirements. Also note that all data submitted
to the Agency must comply wi th PR Notice 86-5.)
Toxicology
Acute delayed neurotoxicity - single dose NOEL
Dermal sensitization
Chronic toxicity (two species - rodent and non-rodent)
Oncogenicity study (two species - rat and mouse preferred)
Reproductive study
Metabolism
Environmental Fate
Hydrolys i s
Photodegradation, water
Photodegradation, soil
Aerobic metabolism
Anaerobic metabolism
Leaching and adsorption/desorption
Soil dissipation
Long-term soil dissipation
Rotational crop (confined)
Rotational crop (field)
Fish accumulation
Droplet size spectrum
Spray drift field evaluation
Ecological Effects
Avian reproduction study
Fish early life-stage study
Aquatic invertebrate life-cycle study
Aquatic monitoring or mesocosm study
[continued on page 15]
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-15-
Table 2. Summary of Data Gaps for EPN. (continued)
Residue Chemistry
Storage stability study
Plant metabolism study
Animal metabolism study
Residue data for almonds, apples, apricots, beans (snap and lima),
cherries, citrus, grapes, lettuce, nectarines, olives, peaches,
pears, pecans, plums, soybeans, sugar beets (without tops), and
walnuts.
Residue data and usage proposal for beets and beet greens,
blackberries, boysenberries, dewberries, loganberries,
pineapples, quinces, raspberries, rutabagas, spinach,
strawberries, turnips and turnip greens, and youngberries.
(tolerances for these items will be revoked if residue data
and usage proposals are not submitted)
Processing data for residues of EPN in sugar beets, soybeans,
tomatoes, citrus, prunes, grapes, apples, cottonseed, corn,
and olives.
Residue data and tolerance proposals for bean vines and hay,
sugar beet tops.
Special Processing Studies to provide:
0 Residue data for cooked (microwaveing and boiling) sweet corn.
0 Residue data on fresh unwashed tomatoes
0 A washing study to provide residue data on lettuce
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-16-
2. Summary of New Agency Positions Based on Information and
Assumptions Used in the Current Assessment of Risk
a. NOEL Used
In the EPN RPAR published in 1983 (48 FR 39494) the
Agency relied primarily on the NOEL of 0.1 mg/kg/day for
EPN-induced depression of plasma and RBC chplinesterase
levels in humans as the NOEL for delayed neurotoxicity.
On that basis, the Agency calculated dietary and applicator
risks posed by continued uses of EPN. The Agency concluded
that adeguate MOSs existed for human dietary exposure and
for applicators with the exception of flaggers. The Agency
used the cholinesterase-inhibition data to establish the
NOEL because they we re the best data available at the time.
Information received since that time on various
cholinesterase-inhibiting compounds indicates an effect
on blood cholinesterase is not necessarily the most
sensitive indicator of toxicity for organophosphates.
This means that using the effect of EPN on human blood
cholinesterase may not be appropriate for determining
human sensitivity to this compound, particularly for
its delayed neurotoxic effect.
New information on recovery after a single large
dose of EPN in hens (Huntingdon Research Centre Ltd.,
Report No. NSA 19(b)/86335, June 20, 1986) indicates
that the spinal histopathological changes are irreversible.
This finding has led the Agency to conclude that the most
appropriate NOEL to use for risk assessment purposes and
the most sensitive indicator of potential human toxicity
for this histopathological effect is 0.01 mg/kg/day from
the 90-day subchronic feeding study in hens.
Using this NOEL to calculate risk from dietary
exposure to EPN, the Agency believes that the MOSs are
not adequate for applicators and mixer/loaders exposed
to EPN. The Agency also believes that the MOSs are not
adequate for human adults and children who eat more than
average amounts of corn and tomatoes during the fresh
market season. Therefore, the Agency has determined that
a Special Review of the chemical for the potential delayed
neurotoxic effect is necessary.
b. Reentry
In the 1983 RPAR document, the Agency did not
calculate potential risk to workers reentering fields
treated with EPN because there were no dislodge able
residue data available on which to calculate exposure.
Data received since that time have enabled the Agency to
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-17-
conduct an exposure and risk assessment for five crops.
The resulting MOSs are apparently inadequate. Therefore,
the reentry intervals must be revised as discussed below
in Section IV. A. 5. (Regulatory Position and Rationale).
c. Margin of Safety Limits
In the 1983 RPAR document, the Agency considered
that a MOS of 10 relative to the blood cholinesterase
NOEL in the human study was adequate; any number below
10 was deemed inadequate in view of the benefits derived
from the use of EPN. However, because the new recovery
study shows that the spinal histopathological changes in
the hen are irreversible, a MOS of at least 100 is
considered necessary. The spinal histopathological
changes have been shown to be the most sensitive
indicator for potential human toxicity.
3. Summary of Agency Position on Other Effects
In the 1979 RPAR, the Agency identified 5 other possible
adverse effects of EPN for which insufficient information
existed to issue a rebuttable presumption. The following
paragraphs summarize the Agency's current position on these
effects.
a. Teratogenicity
Two acceptable studies in the rat and rabbit do not
demonstrate teratogenic effects. These studies are
described in detail in Section III. B. 5. below. The
Agency has determined that EPN has not been shown to
be teratogenic. No further teratology data are required
by the Agency at this time.
b. Cholinergic Effects
EPN produces clinical signs of toxicity secondary to
its inhibition of cholinesterase. These signs are a result
of accumulation of acetylcholine in the organism and are
cholinergic responses. The delayed response shortly after
dosing is indicative of a secondary cholinergic response.
The Agency concludes that there is no evidence that EPN
has a direct effect on cholinergic receptors. However,
because EPN has been shown to be acutely toxic due to
inhibition of cholinesterase, the Agency is requiring a
Restricted Use Classification.
c.. Disorders of the Eye
The 1979 Position Document stated that one study in
Japan indicated that eye disorders such as reduced vision,
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-18-
narrowing of the visual field, abnormal refraction and
other abnormalities were observed. However, the subjects
were exposed to several pesticides, not just EPN, and the
amount of EPN exposure was not determined. Since that time
the Agency has been unable to find evidence that EPN causes
disorders of the eye, thus reaffirming its position in the
original 1979 RPAR that a risk criterion for this effect
has not been met or exceeded.
d. Mutagenicity
Information on mutagenic effects is detailed below in
Section III. B. 7. The Agency concludes, based on all
mutagenicity studies submitted and reviewed, that EPN
is not mutagenic.
e. Reductions in Honeybee Populations
The Agency has reviewed data which show that EPN
is highly toxic to honeybees (Atkins et al. , 1975).
The Agency concluded that labels of end-use products
intended for foliar application must contain a bee
precaution statement. Section IV. D. of this
Registration Standard continues this requirement.
f. Potentiation
In the 1979 RPAR position document the Agency stated
that animal studies indicated that EPN was observed to
potentiate (enhance) the acute toxicity of malathion,
dimethoate, and systox. The Agency requested information
regarding use practices in the United States to determine
whether these pesticides were actually used in combination
with each other. E.I. Du Pont de Nemours responded to the
RPAR and pointed out that there are no registered products
which contain EPN in combination with these other pesticides
and that tank mixes are not used either. Because it does
not appear that these products are used in combination the
Agency concludes that the risk of potentiation is not now
of concern.
B. HEALTH RISK ASSESSMENT
The Agency has reviewed EPN data in the areas of acute
toxicity, chronic toxicity, oncogenicity, reproductive effects,
mutagenicity, environmental fate and exposure, and ecological
effects. Numerous data gaps exist. The following assessment
is based on available data and is subject to change when the
results of the required studies are available for Agency review.
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1. Acute Toxicity
Adequate data are available to fully assess the acute
oral, dermal, and inhalation toxicity of technical EPN. These
data indicate a high acute oral toxicity to mammals with LDso
values of approximately 52.8 and 13.2 mg/kg/body weight in male
and female rats, respectively (E.I. du Pont de Nemours & Co.,
Inc., 1949); acute dermal LDso values of 354 and 500 mg/kg/body
weight in male and female rabbits, respectively (International
Research and Development Corp., Study No. 163-495, Nov. 8,
1977); and acute inhalation LD$Q values of 0.076 and 0.024
mg/liter (1) in male and female rats, respectively (Haskell
Laboratory Report No, 32-71, Feb. 5, 1971). These values
place EPN in Toxicity Category I on the basis of acute oral
toxicity; Toxicity Category II on the basis of acute dermal
toxicity; and Toxicity Category I on the basis of acute
inhalation toxicity.
Sufficient data are also available for the Agency to
conclude that technical EPN does not produce eye irritation
or dermal irritation (International Research and Development
Corp., Dec. 29, 1975 revised Mar. 16, 1976). Technical EPN is
in Toxicity Category IV on the basis of dermal irritation.
There are no dermal sensitization studies available on
technical EPN; therefore, this effect cannot be assessed.
The Agency is requiring a dermal sensit ization study.
The Agency has sufficient data to determine that technical
EPN produces organophosphate type delayed neurotoxicity in the
hen (Huntingdon Research Centre Ltd., NSA 19(a)/8646, May 9,
1986). The acute oral LDso of EPN in adult hens was determined
to be 171 mg/kg. A single oral dose of 175 mg/kg EPN produced
organ ophosphate type delayed neurotoxicity. Eight of the
surviving birds showed signs of delayed neurotoxicity. Neuro-
pathological abnormalities in excess of those observed in control
animals were observed in 10 of 11 EPN dosed birds.
The Agency does not have a study on which to base a NOEL
for spinal histopathological changes for a single toxic dose;
therefore, an acute delayed neurotoxicity study must be submitted
by the registrants.
2. Subchronic Toxicity
Adequate data are available to satisfy the data requirements
for subchronic oral toxicity studies in a rodent and a nonrodent
species. In a subchronic rat study (Hazleton Laboratories
America/ Project No. 2096-111, Feb. 24, 1986), 10 animals of
each sex at each dose level were dosed with EPN orally for
13-weeks at doses of 1, 5, 25 and 125 parts per million (ppm)
in the diet. Ten extra animals included in the high dose
group were maintained for a 4-week post-dose recovery period.
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-20-
EPN-related effects were depression of cholinesterase activity
(plasma NOEL 25 ppm, red blood cell (RBC) NOEL 5 ppm and brain
NOEL 25 ppm); decreased growth in the females at 125 ppm;
decreased erythrocyte parameters in both sexes at 125 ppm;
and increased splenic pigmentation (hemosiderin) in the
females at all doses.
In a subchronic dog study (Hazleton Laboratories America,
Project No. 2096-121, Feb. 24, 1986), 4 animals of each sex
at each dose level were dosed orally by capsule for 13-weeks
at doses of 0.3, 1.0, and 3.0 mg/kg/day. During ophthalmoscopic
examinations at week 13, seven of the eight animals at the
3.0 mg/kg/day dose showed EPN-induced miosis (constriction of
the pupil of the eye). An EPN-related decrease in red blood
cell parameters, indicative of increased destruction and/or
early breakdown of red blood cells, was observed in the high
dose males at treatment weeks 4, 7 and 13. The same values
were depressed in females at the high dose, but there was
some indication of recovery at week 13. Plasma cholinesterase
activity was reduced in the 3.0 mg/kg/day group in both sexes
at 4, 7 and 13 weeks and in the 1 mg/kg/day males at 4, 7 and
13 weeks (p £ 0.05). RBC cholinesterase activity was decreased
in the 3 mg/kg/day group in both sexes at 4, 7 and 13 weeks
(p _< 0.05). Brain cholinesterase activity was significantly
decreased at 3.0 mg/kg/day in both sexes (p £ 0.05). The
authors of the study stated "The most remarkable histopatho-
logical finding in the treated animals was pancreatic acinar
cell atrophy present in two Group 4 males."
Sufficient data are available to the Agency to satisfy the
requirement for a 21-day dermal study in rats (Hazleton Labora-
tories Ame rica, Project No. 209-6120, Oct. 29, 1985). In this
study rats were randomly assigned to the following groups.
EPN Technical
No. of Animals Dosage Levels (mg/kg/day)a
Group
1
2
3
4
5
Males
5
5
5
5
5
Females
5
5
5
5
5
Males
0
2.5
7.5
25.0
75.0
Females
0
0.5
1.5
5.0
15.0
All applications were given in a dosage volume of 1.0 ml/kg
in acetone solvent.
EPN applied dermally for 21-days produced signs typical of
organophosphate toxicity at the highest doses (75 mg/kg/day
for the males and 15 mg/kg/day for the females). A NOEL for
the most sensitive effect, cholinesterase inhibition in plasma
and RBC, was demonstrated at 0.5 mg/kg/day.
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-21-
No data are available to the Agency on the 90-day dermal
toxicity of EPN. However, based on the expected exposure, the
Agency is not requiring a 90-day dermal toxicity study.
The Agency has adequate data to characterize the 13-week
inhalation toxicity of EPN in rats (Hazleton Laboratories Europe
Ltd., Report No. 5160-306/13, July 1986). In this study ten
rats per sex per dose were tested at 0.093, 0.731 and 7.859
micrograms per liter (ug/1) for male rats and 0.0094, 0.093 and
0.731 ug/L for female rats. The only effect observed was
depressed RBC cholinesterase activity in the high dose males.
Sufficient data are available to the Agency to show that
EPN produces organophosphate type delayed neurotoxicity in two
90-day oral studies in the chicken.
In the first study by Abu-Donia and Graham (Toxicology
and Applied Pharmacology 45:685-700; 1978) hens (6 per dose)
were dosed at 0.01, 0.1, 0.5, 1.0, 2.5 and 5.0 mg/kg/day by
capsule. Signs of neurotoxicity were observed at doses of 0.1
to 5.0 mg/kg/day with a NOEL of 0.01 mg/kg/day. Histopathological
evidence of neurotoxicity (neuronal degeneration) were detected
in the spinal cord at doses of 1.0 mg/kg/day and higher. A dose
of 0.5 mg/kg/day was a NOEL for this effect.
In the second study (Huntingdon Research Centre, DAS 2181637,
Mar. 3, 1982) hens (20 per dose) were dosed at 0.01, 0.1, 0.5,
1.0, 2.5 and 5.0 mg/kg/day by capsule. Signs of neurotoxicity
were observed at doses of 2.5 and 5.0 mg/kg/day with a NOEL of
1.0 mg/kg/day. Histopathological evidence of neurotoxicity
(neuronal degeneration) was detected in the spinal cord at
doses of 0.1 mg/kg/day and higher. A dose of 0.01 was a NOEL
for this effect. This study is discussed in detail below in
Section III. B. 10.
After reviewing all of the subchronic toxicity studies,
the Agency has determined that a dose of 0.01 mg/kg/day for
histopathological effects is the most sensitive NOEL on which
to base a human risk assessment.
3. Chronic Toxicity
No data are available to the Agency on the chronic oral
toxicity of technical EPN in rodent and nonrodent sepcies. The
Agency is requiring a two-year feeding study in the rat and a
one-year feeding study in the dog.
4. Oncoqenicity
No data are available for the Agency to evaluate the
oncogenic potential of technical EPN. The Agency is requiring
life-time feeding studies in the rat and the mouse.
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5. Teratogenicity
Sufficient data are available in the rat and the rabbit to
satisfy the requirements for teratology studies of EPN.
In a teratology study in the rat (Hazleton Laboratories
America, Report No. 2096-115, Sept. 4, 1986), 25 females per
dose were dosed at 0.3, 0.6, 1.2 and 2.4 mg/kg/day during
days 6 - 15 of gestation. Clinical signs of EPN toxicity were
observed in the high dose females and consisted of tremors,
prostration, urine stains, hunched appearance, bloody crust
on the eye lids and nose, rhinorrhea and lacrimation. No fetal
toxicity was observed at the highest dose tested.
In a teratology study in the rabbit (Hazleton Laboratories
America, Report No. 2096-116, Sept. 4, 1986), 15 females per
dose were dosed at 1, 3, 6 and 9 mg/kg/day during days 7-19
of gestation. Twelve females died or were sacrificed due to
morbidity at 9 mg/kg/day. Signs of toxicity including languidness,
prostration and salivation were observed in the does sacrificed
and in the survivors. Two 6 mg/kg/day females were found dead.
No signs of toxicity were observed in these females. The only
possible compound-related effect on the fetuses was significantly
lower mean fetal body weights in the females at 6 and 9 mg/kg/day.
The Agency has determined, based on these two studies, that
EPN has not been shown to be teratogenic.
6. Reproduction
No data are available for the Agency to evaluate the
effects of EPN on reproduction. The Agency is requiring a
reproduction study in the rat.
7. Mutagenicity
The Agency has sufficient data to evaluate the mutagenic
potential of EPN. EPN technical was weakly mutagenic in a
single replicate of one of the tests utilized. Based on all
mutagenicity tests submitted, it is concluded that EPN is not
mutagenic.
Two gene mutations studies were available. The first study
(Microtest Research Ltd., Study No. NCJ1/S/AF4/SA3, Oct. 22, 1985)
was performed to determine the ability of technical EPN to induce
mutation in four histidine-requiring strains of Salmonella
typhimurium. EPN was not mutagenic in Salmonella typhimurium
strains TA98, TA100, TA1535 or TA1537 at doses up to 2500 ug/plate
either with or without metabolic activation.
The second study (Microtest Research Ltd., Study No.
NCJ1/MLK/KF20/ML3, Apr. 7, 1986) was performed to determine the
ability of technical EPN to induce mutation to 6-thioguanine
resistance in mouse lymphoma L5178Y cells. EPN was weakly
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-23-
tnutagenic in one of two replicates, in mouse lymphoma L5178Y
cells in vitro in the presence of liver S-9 fraction. Mutagenic
activity was approximately 1/1000 to 1/500 of the positive
control. Because of the ambiguity and weakness of the results
obtained, the study cannot be considered definitive in and of
itself.
Two chromosomal aberration studies were available. The
first study (Microtest Research Ltd., Study No. NCJ1/CHO/KF17/CH3,
Oct. 22, 1985) was performed to evaluate the chromosome damaging
potential of EPN technical by its effects on cultured Chinese
hamster ovary (CHO) cells using an in vitro cytogenetic assay.
EPN technical, at doses up to 5000 micrograms per milliliter
(ug/ml), did not cause an increase in chromosomal aberrations
when tested on cultured Chinese hamster ovary cells either with
or without metabolic activation with rat liver S-9 fraction.
The second study (Microtest Research Ltd., Study No.
NCJ1/MNT/KF19/MN1, Oct. 22, 1985) was performed to evaluate the
potential of technical EPN to induce micronuclei in the bone
marrow of treated mice. EPN did not induce micronuclei in the
bone marrow of mice treated with a single oral dose of 30 mg/kg.
One unscheduled DNA synthesis study (Microtest Research Ltd.,
Study No. NCJl/He/KFl6/HE2, Oct. 23, 1985) was performed to
determine the ability of technical EPN to induce unscheduled
DNA synthesis in HeLa Cells. EPN, at doses up to 500 ug/ml,
does not induce unscheduled DNA synthesis in HeLa cells either
with or without metabolic activation.
8. Metabolism
The Agency has data to partially satisfy the requirement
for a metabolism study of EPN in rats.
In these studies (Hazleton Laboratories Europe, Report No.
4958-306/14, April 1986) EPN was administered orally, by gavage,
as a solution in corn oil to the dose groups. Noted below are
the findings of the excretion study and pharmacokinetic study:
Excretion study:
Group
B
Sex
Males
Females
Males
Females
Males
Fema1e s
Number
5
5
5
5
5
5
Dose EPN
Unlabeled EPN
mg/kg/day
0.8 (14 days)
0.3 (14 days)
Labeled iliC
mg/kg/day
0.8
0.3
0.8
0.3
30.0
15.0
EPN1
*Labeled EPN
in order to
organisms.
is EPN that has a radioactive isotope added
trace its course and behavior in living
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-24-
In both sexes labeled 14C EPN was excreted by urine and feces
over a period of 5 to 6 days for the low dose and 7 days for
the high dose. Excretion appears to be biphasic, with the
majority of the labeled EPN excreted in 48 hours for both low
and high doses. Pretreatment with unlabled EPN for 14 days
increased the relative portion of labeled EPN excreted in the
urine and during the first 12 hours in both sexes. This also
reduced the total excretion time to four days, indicating
induction of metabolizing enzymes. Because different doses
were used for each sex in each dose regimen, it was impossible
to compare the relative excretion by sex. As there is approxi-
mately a seven fold difference in acute toxicity by sex (it is
more toxic in females), this is a critical deficiency in the
study- The male portion of the study must be repeated using
the doses that were used for the females.
The effect of the pretreatment dose regimen on the portion
of the labeled EPN excreted in the urine in both males and females
also indicates that biliary excretion may be responsible for
all or part of the fecal excretion observed. An experimental
evaluation of this possibility is needed.
Analysis of urine and feces showed the existence of several
possible metabolites. However, these were not identified.
Further work must be performed to identify the metabolites.
Tissue analysis showed relatively higher concentrations of
radioactivity in kidney, lung and liver. There appear to be
some dose-related differences in this residue. Due to the use
of different doses for each sex, it is impossible to determine
if there are sex-related differences. The quantities remaining
in these organs do not appear to be toxicologically significant.
Pharmacokinetic study:
Group Sex Number Dose EPN*
Labeled 14C EPN
rag/kg/day
A Males 5 0.8
Females 5 0.3
C Males 5 30.0
Females 5 15.0
*Labeled EPN is EPN that has a radioactive isotope added
in order to trace its course and behavior in living
organisms. Only labeled EPN was used in this kinetics study-
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-25-
This kinetics study showed peak blood concentrations 12 hours
after dosing for both doses and sexes. The clearance curve
appears to be biphasic. Again/ the use of different doses in
each sex makes sex-related comparisons impossible. This is a
scientific deficiency, but since this study is not required it
is not considered a regulatory deficiency.
9. Neurotoxicity Recovery Study in Hens
In order to satisfy an Agency requirement, a study was
performed to determine the ability of hens to recover from a
single oral dose of EPN (Huntingdon Research Centre Ltd.,
Report No. NSA 19(b)/86335, June 20, 1986). A dose of 175 mg/kg
in atropine-protected hens was selected as capable of producing
signs of organophosphate delayed neurotoxicity (ataxiaj in
approximately half of the treated hens without producing
excessive lethality.
A total of 80 hens were protected with atropine against
acute toxicity and given a single oral dose of 175 mg/kg EPN.
All treated hens and 10 untreated controls were observed and
graded for ataxia. Groups of five treated hens were sacrificed
for histopathology of selected parts of the central nervous
system (CNS) and sciatic nerve at intervals for up to 90 days
post dose. Five controls were sacrificed at 45 days and 5 at
90 days.
A total of 20 hens showed delayed ataxia during the study.
Some of the birds which showed ataxia, and were retained for
sufficient time, showed improvement and recovery. Five hens,
with mild class 1 or 2 ataxia recovered fully and 7 hens with
more severe ataxia showed some measure of improvement in gait.
Histopathology showed mild damage to the sciatic nerve in all
20 hens and complete nerve recovery with time. After the 40-day
sacrifice all samples were normal. However, relatively severe
damage (grade III and IV) was observed in the spinal cord and
recovery was relatively minor. There was no correlation between
the severity of the histopathology of the spinal cord and the
oceurance of signs of toxicity. All 48 hens sacrificed at
40 days, and later, showed grade III and/or IV histopathological
damage in the cord, yet only 12 of these hens showed signs of
neurotoxicity (ataxia). By this time the sciatic nerves and
branches were normal. There was nothing in the spinal cord
histopathology to distinguish any single hen showing signs of
neurotoxicity from the hens which did not show neurotoxicity.
A reexamination of the histology slides from the 20 hens
could not distinguish between the hens hens which showed ataxia
and those -which did not.
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10. Toxicological Issues Associated with Delayed Neurotoxicity
Organophosphate delayed neurotoxicity was first observed
in man during the prohibition era in the United States. A
drink called Jamaica Ginger was contaminated with tri-o-cresyl
phosphate (TOCP) , a component of the organic solvent used to
prepare ginger extract. Humans exposed to the contaminated
ginger extract developed a paralysis of the legs and arms.
The severity of the paralysis varied with the victim's exposure
to the contaminant. Animal studies identified TOCP as the
toxic agent and characterized this paralysis syndrome which is
now called Organophosphate Type Delayed Neurotoxicity. Subsequently,
this syndrome was observed following accidental human exposure
to the pesticide leptophos and the experimental compound mipafox,
both of which are Organophosphate inhibitors of cholinesterase.
Organophosphate type delayed neurotoxicity is characterized
as follows: 1) A delay in the order of 10 - 14 days between a
single effective dose and the appearance of clinical and histo-
pathological signs; 2) The appearance of the delayed effect well
after recovery from the acute toxicity of the compound; 3) No
apparent relationship between the compound's ability to inhibit
blood cholinesterase and its ability to produce the delayed
effect; 4) The appearance of abnormalities of gait which may
proceed to complete paralysis and are generally irreversible;
5) The destruction of nerve axons in the sciatic nerve and the
spinal cord and the subsequent disappearance of the myelin sheath
which surrounded the lost axons; and 6) The delayed toxic effect
can also be produced by daily administration of doses which
individually will not produce the acute toxic response, i.e. , the
delayed toxicity is cumulative.
Animal studies with TOCP showed that the toxic syndrome
could not be produced in rats and mice and was produced only
with inconsistent or atypical results in dogs and cats. The
syndrome has been demonstrated in bovine and primate species.
The chicken has been shown to consistently demonstrate the
syndrome with the three compounds that are active in man and/
for practical purposes, has become the species of choice for
detecting this toxic effect.
Several studies with EPN in the chicken have demonstrated
the Organophosphate delayed neurotoxic syndrome. The studies
reviewed in this standard verify the previous reports. They
characterize more precisely the dose and time relationship of
the neurotoxic effect and provide information on the ability
of the experimental animal to recover from the effect.
In the acute oral study (Huntingdon Research Centre Ltd. ,
NSA 19(a)/8646, May 9, 1986), a nominal LDso of 175 mg/kg EPN
produced signs of delayed neurotoxicity in 8 of 14 hens which
survived the acute lethality. Histopathology characteristics
of the syndrome were observed in the spinal cord and sciatic
nerve.
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Two 90-day oral dosing studies summarized above in Section
III. B. 2., were performed in hens and used the same doses.
These studies provided contradictory evidence as to a NOEL.
The doses used were 0.01, 0.1, 0.5, 1.0, 2.5 and 5.0 mg/kg/day
by capsule.
In the first study Abou-Donia (Toxicology and Applied
Pharmacology 45:685-700; 1978) reported the NOEL for neurotoxic
signs (ataxia) as 0.01 mg/kg/day. The histopathologically
determined NOEL was reported as 0.5 mg/kg/day.
In the second study Huntingdon Research Centre (EAS 2181637,
Mar. 3, 1982) reported the NOEL for clinical neurotoxic signs
(ataxia) as 1.0 mg/kg/day. The histopathologically determined
NOEL was reported as 0.5 mg/kg/day. However, an evaluation
of the report of this study by the Agency concluded that
histopathological changes of the spinal cord were observed at
doses as low as 0.1 mg/kg/day and that a dose of 0.01 mg/kg/day
was a NOEL. This conclusion was based on a shift in the relative
number of grade I and II slides reported in the hens dosed at
0.1 and 0.5 mg/kg/day compared with the untreated controls.
Although both grades are considered within the range of
normality, the dosed hens showed relatively more grade II
slides than the controls. Grade I has been described as
showing no abnormalities and grade II as, "Disruption or
fragmentation of occasional axons. Myelin abnormalities were
rare. In general on any slide prepared from the spinal cord
(two longitudinal and one transverse sections), between one
and four degenerate/ altered axons were detected. On a slide
of peripheral nerve one or two degenerate axons were included
in this grade." The ratings of these histopathological changes
in the spinal cord of hens treated for 90 days with EPN at
various doses is shown in Table 3.
The most sensitive NOEL of 0.0.1 mg/kg/day for histopatho-
logical changes in the spinal cord was used as a basis for the
risk assessments discussed below in Section 11.
The recovery study discussed above in Section III. B. 9.
(Huntingdon Research Centre Ltd., Report No. NSA 19(b)/86335,
Jun. 20, 1986) has provided new information on the long-term
effects of a single dose of EPN on gait and on histopathology
of the nervous system. Humans and experimental animals
poisoned by compounds producing delayed neurotoxicity have
displayed a measure of 'recovery1 in locomotor activity with
time. It is not known if this recovery is due to reversal of
nerve damage, to compensation such as occurs following stroke
or to some .combination of both. The recovery study was designed
to provide experimental information on this 'recovery1: was it
real, and if so what was the possible mechanism.
Of the hens which showed delayed ataxia during the study,
five hens with a mild class 1 or 2 ataxia recovered fully and
-------
-28-
seven hens with more severe ataxia showed some measure of
improvement in gait. Histopathology showed mild damage to the
sciatic nerve and complete nerve recovery with time; after
40-day sacrifice all samples were normal. In the spinal cord
recovery was relatively minor from a generally more severe
damage. The Agency considers that this cellular destruction
in the spinal cord is serious because these cells are never
replaced? the damage is permanent.
An additional critical and unexpected observation was the
lack of correlation between the severity of the histopathology
and the occurrence of clinical signs of toxicity (ataxia). All
48 hens sacrificed at 40 daysf and laterf showed grade III and/or
IV damage in the cord yet only 12 of these hens showed ataxia.
By the time of sacrifice the sciatic nerves and branches were
normal. There was nothing in the histopathology to distinguish
any single hen showing signs of ataxia from the hens which
did not show ataxia.
Table 3 - Ratings of Histopathological Changes in the Spinal
Cord of Hens Treated For 90 Days With EPN
DOSE
O.OO
0.00
0.01
0.10
0.50
1.00
2.5
5.0
10.0
GRADE 1
I II III IV V
t
30
28
39
23
29
13
26
11
11
%
75
70
89
58
66
41
54
25
17
#
10
11
5
17
15
14
13
10
4
%
25
28
11
43
34
44
30
25
6
#
0
1
0
0
0
5
3
12
16
%
0
3
0
0
0
16
7
27
25
#
0
0
0
0
0
0
2
9
22
%
0
0
0
0
0
0
5
20
34
f
0
0
0
0
0
0
0
2
11
%
0
0
0
0
0
0
0
5
17
1 The gradings of histopathological changes represent an
increase in severity from Grade I to Grade V.
-------
-29-
This situation has never been reported previously/ most
likely because this type of study, with periodic serial
sacrifices occurring after 40 and through 90 days following
a single dose of a delayed neurotoxin, had never previously
been performed. Acute studies containing a recovery phase
usually go only 30 days post dose and have no interim sacrifices.
The 90-day oral dosing study by Huntingdon Laboratories
(DAS 2181637, Mar. 3, 1982) included a 90-day recovery period.
The study also used three doses of TOCP as a positive control.
Histopathological signs of nerve damage were clearly seen in
the spinal cord for both compounds but, while present, were
minimal in the peripheral nerve (sciatic and branches). In
the spinal cord, effective doses of TOCP showed possible
deterioration and no evidence of recovery. Effective doses
of EPN were equivocal in relation to recovery; there is some
indication of a dose-related recovery in the groups given
0.1 through 0.5 mg/kg/day , but there is also an indication
of deterioration at 0.01 mg/kg/day. In the peripheral
nerve, recovery from both compounds could be considered
complete at 90 days post dose since the treated hens could
not be distinguished from the controls.
11. Risk Assessments for Delayed Neurotoxicity
To assess the risks to the public who consume EPN treated
food commodities and to workers involved with application of EPN,
the Agency estimated dietary and worker exposures and compared
these to the NOEL for histopathological effects of delayed neuro-
toxicity. These comparisons are expressed as margins of safety
(MOSs) and the assessments are presented below. The Agency used
the NOEL of 0.01 mg/kg/day for histopathological effects in the
spinal cord, derived from the Huntingdon Laboratories subchronic
feeding study in hens (DAS 2181637, Mar. 3, 1982). Even if the
Agency used the reported, histopathologically determined NOEL of
0.5 mg/kg/day, the risk concerns expressed below would remain
unchanged.
Dietary Risk Assessment
Dietary exposure occurs from consumption of food crops
treated with EPN. The Agency assessed dietary exposure and
risk under three scenarios: (1) EPN residues on food ccmmo-
dities at the established tolerance levels and assuming 100%
of the crop acreage is treated, (2) for five crops for which
the Agency has actual crop residue data; EPN residues are at
levels suggested by these data, and (3) scenario 2, except
assuming the appropriate percent of crop treated for each crop.
In calculating the Maximum Permissible Intake (MPI) (for
comparison to dietary exposure), the following assumptions
were used: the NOEL of 0.01 mg/kg/day, an average body
weight of 60 kg, a daily diet of 1.5 kg, and a safety factor
of 1,000. This level of safety factor (or uncertainty factor)
is considered appropriate for subchronic studies. The Acceptable
-------
-30-
Daily Intake (ADI) was obtained by multiplying the NOEL of
0.01 mg/kg/day by the safety factor of 1000 to yield 0.00001
mg/kg/day- Assuming a person weighs 60 kg, the MPI was
calculated to be 0.0006 mg/day (0.00001 X 60).
Table 4 (Scenario 1) shows the percentages of the MPI for
EPN as a function of consumed residues based on an individual
consuming commodities containing EPN at tolerance levels, at
the given food factor levels, and consuming 1.5 kg of food
per day. (The food factors represent the percent of the
commodity eaten by a person in his/her diet each day). The
total percentage of the MPI from all crops is 164,000%. A
total percentage of the MPI of up to 100% is generally a
regulatory standard of acceptability.
The Agency believes that the resultant figure of 164,000%
MPI is not a-realistic estimate because of the worst case
assumptions used in the calculation, such as that 100% of the
crop acreage is treated with EPN and that all commodities are
at tolerance level. However, even considering these exaggerated
assumptions the Agency is still concerned about the dietary
exposure.
The Agency has only a limited amount of data at this time
for more realistic estimates of EPN residue levels on the
commodities and the percentages of the crops' acreages that
are treated with EPN. However, for five crops (soybeans, dry
beans, tomatoes, corn, and cotton) the Agency has these data.
Dietary exposure to EPN residues from these five crops and
the percentage of the MPI were assessed. These assessments,
based on maximum observed residues based on field studies and
percentage of crop treated, were compared to assessments
based on these five crops at the tolerance levels and 100% of
the crop acreages treated. These assessments are presented
in Table 5. Based on using tolerance levels and 100% of the
acreage treated, the dietary exposure from these five crops
results in 56,000% of the MPI. However, when the
assessment is corrected for estimates of highest expected
residue levels and percent acreage treated, the percentage of
the MPI for these five crops falls to 120%.
In another dietary assessment of EPN residues, the Agency
chose three commodities (cooked corn, corn on the cob, and
fresh whole tomatoes) to demonstrate the chronic dietary
exposure and the MOSs for the spinal histopathological effect
as calculated using the Tolerance Assessment System (TAS).
(The TAS is a computer-based tool which estimates dietary
exposure to a pesticide and then compares that estimate to a
previously determined acceptable daily intake. The TAS data
files are composed of food comsumption estimates (based on
dietary intake records for 30,770 individuals), toxicology
data on the chemical, and residue concentrations.) These MOSs
-------
-31-
Table 4 - Dietary Exposure and Its Percent of the Maximum Permissible
Intake
Crop
Almonds
Apples
Apr icots
Beans
Beets
Beet greens
Blackberries
Boysenberries
Cherries
Citrus fruits
Corn, all types
Cotton seed (oil)
Dewberries
Grapes/ incl raisins
Lettuce
Loganberries
Nectarines
Olives
Peaches
Pears
Pecans
Pinneapple
Plums, incl prunes
Quinces
Raspberries
Rutabagas
Soybeans
Spinach
Strawberries
Sugar, cane & beet
Toma toes
Turnips
Turnip greens
Walnuts
Youngberries
ToleranceFood Factor1mg/day2Percent MPI
(ppm) (%) (1.5 kg diet)
0
3
3
3,
3
3,
3
3,
3
3,
3,
0,
3,
3,
3,
3,
3,
3.
3.
3.
0,
3.
3.
3.
3,
3.
0,
3.
3,
3.
3.
3.
3.
0.
.500
,000
.000
,000
,000
,000
,000
.000
,000
,000
,000
500
,000
000
,000
000
000
000
000
000
500
000
000
000
000
000
050
000
000
000
000
000
000
500
3.000
0
2
0
2,
0
0,
0
0,
0,
3,
2,
0.
0,
0,
1,
0.
0.
0.
0.
0.
0.
0.
0,
0.
0.
0.
0.
0.
0.
3.
2.
0.
0.
0.
.03
.53
.11
.04
.17
,03
,03
,03
.10
,81
,51
15
,03
49
,31
03
,03
06
90
26
03
30
13
03
03
03
92
05
18
64
87
05
03
03
0.03
0
0
0
0
0
0
0
0,
0
0,
0
0,
0,
0.
0,
0,
0,
0.
0.
0.
0.
0.
0,
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
.00023
.11385
.00506
.09180
.00782
.00135
.00135
,00135
.00460
,17154
.11295
,00112
,00135
,02207
,05887
,00135
,00135
00276
,04047
01150
,00023
01334
,00598
00135
00135
00135
00069
00230
00828
16372
12937
00230
00135
00023
0.00135
38
18,975
843
15,300
1,303
225
225
225
767
28,590
18,825
186
225
3,678
9,811
225
225
460
6,745
1,917
38
2,223
997
225
225
225
115
383
1,380
27,286
21,562
383
225
38
225
Total = 164,317
Theoretical Maximum Residue Contribution
for a 60 kg person.
(TMRC) is 0.9856 mg/kg/day
In the calculation of daily dietary exposure, the Agency used
appropriate fo.od factors, i.e., the percent of that commodity
eaten by the .general population in one day. For example, almonds
represent 0.03% of a person's daily dietary intake.
The dietary intake was calculated assuming that 100% of each crop
was treated with EPN; however, useage date indicate that about 7%
of corn is treated, 3% of cotton is treated and less than 1% of
each of the remaining crops are treated
-------
-32-
Table 5 - Dietary Exposure From Five Crops Based on Tolerance
Levels and 100% Crop Treated
Crop
Soybean Oil
Dry Beans
Tomatoes
Sweet Corn
Cottonseed Oil
TOTALS
Tolerance
(ppm)
0.05
3.0
3.0
3.0
0.5
Food
Factor( %)
0.92
2.04
2.87
2.51
0.15
Dietary Expo.
(mg/day ,
1.5 kq diet)
0.00069
0.09180
0.12937
0.11295
0.00112
0.33593
% of
MPI
115
15,300
21,562
18,825
186
55,988 %
Dietary Exposure From Five Crops Based on Actual Residues
and Percent Crop Treated
Highest
Expect. Res.
Crop (ppm)
Soybean Oil
Dry Beans
Tomatoes
Sweet Corn
Cottonseed Oil
TOTALS
0.3
0.06
0.30
0.13
3.5
Food
Factor( %)
0.92
2.04
2.87
2.51
0.15
Dietary Expo.
% Crop (mg/day ,
Treated 1.5 kq diet)
<1 0.0000414
<1 0.0000183
<1 0.0001291
6 0.0002935
3 0.0002362
0.0006915
% of MPI
6.9
3.0
21.5
48.9
39.4
119.7
-------
-33-
are based on actual residues in these commodities and different
amounts of consumption (average, 95th, and 99th percentile) of
each commodity on a daily basis. Table 6 presents the exposure
and MOS values for the U.S. population and for children. The
MOSs are low for EPN exposure for adults and children who eat
more than average amounts of corn and tomatoes during the fresh
market season.
Specifically, for fresh cooked corn the MOSs for the
general population range from 50 to 500 and for children from
25 to 200 depending upon the amount of daily consumption and
the children's ages. However, for these population groups
the MOSs associated with mean consumption values are between
200 and 500. The MOSs for consumption of 1 or 2 ears of corn
on the cob are lower, varying from 39 to 77 for the general
population and 13 to 26 for children. Finally, for fresh
whole tomatoes, the MOSs for the general population range
from 25 to 125, for adult males from 25 to 143, for adult
females from 25 to 111, and for children from 25 to 143,
depending upon the daily consumption of tomatoes. For these
population groups, the MOSs based on mean consumption levels
are between 111 and 143. The MOSs for these populations would
decrease proportionally if corn and tomatoes were eaten in
large amounts on the same day.
Non-dietary Risk Assessments (application and reentry)
Applicators and mixer/loaders are exposed to EPN during
their work activities. Field workers are also exposed when
entering areas treated with EPN. Typical activities of field
workers include weeding and scouting.
The NOEL used was 0.01 mg/kg/day for spinal histopathological
effects seen in the Huntingdon Laboratories 90-day oral feeding
study in hens (DAS 2181637, Mar. 3, 1982) which assessed the
effects from subchronic exposure to EPN. However, applicators,
mixer/loaders, and reentry workers are primarily acutely exposed;
they are not subjected to subchronic exposures over 90 days.
The Agency used this study to calculate a NOEL because the
study represented the best data available for human risk
assessment purposes. The Agency is requesting an acute
delayed neurotoxicity study to determine a NOEL for spinal
histopathological effects from a single acute exposure to
EPN. When this study is received and evaluated by the Agency,
a new NOEL will be determined and a new risk assessment for
acute exposure to humans will be calculated.
Based on average exposure values from surrogate pesticide
studies, in which mixer/loaders wore gloves and typical work
clothing, and applicators only wore typical work clothing,
MOSs were'calculated for work activities for cotton, soybeans,
and field corn. MOSs for mixers/loaders for cotton, soybeans,
-------
-34-
Table 6 - Tolerance Assessment System Analyses for Dietary Exposure
and Margins of Safety Calculations
1. Fresh Cooked Corn, including fresh, corn on the cob, canned
and frozen, containing 0.1 ppm EPN with no reduction of residues
from cooking.
Fresh Cooked Corn Consumption
Mean 95th percentile 99th percentile
U.S. Population 0.00002
(MOS) (500)
Children l-6yr 0.00005
(MOS) (200)
Children 7-12yr 0.00004
(MOS) . (250)
mg EPN/kg bw/d
0.0001
(100)
0.0002
(50)
0.0002
(50)
0
,0002
(50)
,0004
(25)
,0003
(33)
Corn on the Cob only, containing 77 gm/ear, 0.1 ppm EPN,
and no reduction of residues from cooking. TAS does not single
out corn on the cob but includes it with fresh corn. It is
unique because (1) it is frequently consumed at relatively
large quantities and/or for many consecutive days during the
fresh market season, (2) it does not undergo the processing of
canned or frozen corn, and (3) therefore the TAS analysis may
be an underestimation of exposure.
Corn on the Cob Consumption
1 Ear 2 Ears
mg EPN/kg bw/d
U.S. Population
(MOS)
Children
(MOS)
0.00013
(77)
0.00039
(26)
0.00026
(39)
0.00078
(13)
Fresh Whole Tomatoes containing 0.3 ppm EPN. During the fresh
market season an individual may eat relatively large quantities
and/or for many consecutive days.
Tomato Consumption
Mean 95th percentile
mg EPN/kg bw/d
U.S. Population
(MOS)
Males 20+
(MOS)
Females 20+
(MOS)
Children 1-12 yr
(MOS)
,00008
(125)
,00007
(143)
,00009
(111)
,00007
(143)
0.0003-0.0004
(33-25)
0.0003-0.0004
(33-25)
0.0004
(25)
0.0003-0.0004
(33-25)
-------
-35-
and field corn ranged from 0.003 for cotton to 0.5 for field
corn. The daily MOS for applicators for these crops ranged
from 0.05 for cotton to 1.4 for field corn (Table 7). In the
absence of a dermal absorption study dermal absorption was
assumed to be 31% based on a comparison of oral and dermal
LD5Q values, the best data on the subject currently available.
The MOS is calculated on a daily basis because it is an acute
exposure scenario.
The MOSs for field workers not wearing protective clothing
were calculated for five crops (soybeans, cotton, corn, pecans,
and citrus) based on dislodgeable residue dissipation data for
EPN (Table 8). MOSs for one hour exposure were under 100 for
all crops even several days after application. For example,
for cotton the MOS is 30 for 7 days after application and did
not exceed 100 until 8-14 days after application. For soybeans,
corn, and pecans the MOSs are 30 after 2 days, and did not
exceed 100 until 2-5 days after application. For citrus the
MOS is 30 even at 35 days after application. Currently the
Federally established reentry interval is 24 hours (40 CFR 170.3
C. ENVIRONMENTAL PROFILE
1. Ecological Effects.
Existing data are adequate to show that EPN is highly
toxic to honey bees (Atkins et al. , 1975). The LCso was
0.245 micrograms (ug) per bee (highly toxic). As such, labels
of end-use EPN products intended for foliar application must
contain a bee precaution statement.
Existing data are adequate to show that technical EPN is
very highly toxic to freshwater fish species, freshwater
invertebrates, and estuarine/marine organisms. Short term
fish bioassays with technical EPN show 96-hour LCso values
for rainbow and bluegill to be 80 and 190 ug/1, respectively
(Union Carbide, 1976). Short term freshwater invertebrate
acute studies with technical EPN show 48-hour LCso values for
Daphnia magna to be 0.32 ug/1 (Union Carbide, 1976) and
36.0 ug/1 for Gammarus lacustris (Sanders, 1969). Short term
marine invertebrate studies of EPN show 96-hour LCso values
ranging from 4.6 ug/1 for Penaeus Stylirostris to 13 ug/1 for
Mysidopsis bahia (U.S. EPA, 1981). The 96-hour iJCso values
ranged from 37 ug/1 for spot to 140 ug/1 for sheepshead in a
short term marine fish study of EPN (U.S. EPA, 1981). Eastern
oyster larvae with a 48-hour ECso value of 2200 ug/1 were much
less sensitive than either the fish or invertebrate species
tested (U.S. EPA, 1981).
Two EPN formulated products, Budmor 42 (containing
20.94% EPN, 41.86% methyl parathion and 26.67% xylene) and a
-------
-36-
Table 7 - Average Applicator Exposure and MOS to EPN1
Crop
Cotton
Expos lire
Type2
Aerial
Loading closed
open
Application
Total
Expos xore
mg/kg/day
0.3
12
0.04
Days
Exposed
2
2
2
MOS3
(daily)
0.1
0.003
0.7
Soybeans
Field
Corn
Gr ound
Loading
Application
Combined
Aerial
Loading closed
open
Application
Gr ound
Loading
Application
Combined
Aerial
Loading closed
open
Application
1.5
0.6
2.1
0.1
4.1
0.03
1.0
0.3
1.3
0.07
2.9
0.02
7
7
7
2
2
2
2
2
2
1
1
1
0.02
0.05
0.01
0.3
0.007
1.00
0.03
0.10
0.02
0.5
0.01
1.4
Adapted from R. Zendzian. Internal memorandum entitled "EPN, Risk
Assessment for Organophosphate Delayed Neurotoxicity, Applicator,
Reentry and Dietary" Dated February 6, 1987.
Based on average exposure values from surrogate pesticide studies,
mixers/ loaders wearing gloves and normal work clothes, and
applicators wearing only normal work clothes. Total exposure
estimates amount of EPN reaching the skin, not absorbed dose.
MOS calculation includes an assumed dermal absorption rate of 31%.
-------
-37-
Table 8 - Theoretical Risk to Scouts and Field Wbrkers Fran Exposure to
Dislodaeable Residues after Treatment of Crops with EPN1
Exposed
Crop Population
(DTTON Scouts
SOYBEANS Sccuts
CORN Field
Wbrkers
PECANS Scouts
CITRUS5 Field
Workers
Days after
Application
0
1
2
5
7
14
0
1
2
5
7
0
1
2
5
7
14
0
1
2
5
7
14
21
0
1
2
5
7
14
21
28
35
Exposure^
(itiq/kq/hr )
0.065
0.029
0.015
0.006
0.003
0.0003
0.004
0.003
0.001
0.0001
0.00005
0.01
0.006
0.003
0.0003
0.0002
0.0001
0.01
0.002
0.001
0.0003
0.0002
0.0001
0.0001
0.179
0.097
0.079
0.064
0.041
0.023
0.012
0.010
0.001
MDS/hr
Exposure 6 4
0.55
1.00
1.98
5.00
30.00
300.00
7.50
10.50
30.00
300.00
600.00
3.00
5.00
10.00
100.00
150.00
300.00
3.00
15.00
30.00
100.00
150.00
300.00
300.00
0.20
0.30
0.40
0.50
0.70
1.30
2.50
3.00
30.00
Adapted from R. Zendzian. Internal memorandum entitled "EPN, Risk Assessornt
for Organcphosphate Delayed Neurotoxicity, Applicator, Reentry and Dietary"
Dated February 6, 1987.
2 Assumes 60 kg body weicjit
3 Assures 31 percent dermal absorption based on a comparison of LE^QS of EPN by
the oral and dental route.
4 The NOEL is 0.01 mg/kg/day based on the 90 day feeding study in hens showing
histcpathological effects in the spinal cord. The Agency will recalculate this
NOEL upon receipt and evaluation of the required acute delayed neurotoxicity study,
5 Data on use of EPN on citrus gathered by the Agency indicate that EPN is not used
on citrus in the United States. The exposures and MOSs are presented here to show
what the theoretical risks would be if EPN ware used on citrus, since it remains
a currently registered use.
-------
-38-
wettable powder (containing 25% EPN) were tested in warmwater
fish and found to be hiqhly toxic. The 96-hour LCso for bluegill
exposed to Budmor 42 is 650 ug/1 (001000091). The 96-hour LCso
for fathead exposed to 25% wettable powder is 200 uq/1 (Henderson
et al., 1959).
Since mosquito larvicide uses of EPN have been cancelled as
a result of the RPAR, contamination of water from the remaining
uses of EPN is most likely to occur from runoff. Projected
residues of EPN in water resulting from runoff cannot be
estimated by modeling, since chemical parameters necessary
for modeling are not available. However, predicting residues
in water from runoff without modeling, based on use rates
ranging from 0.25 to 1.0 Ib ai/A, results in concentrations
of approximately 2.0 to 9.0 ug/1. Predicting residues in
water from runoff after application to corn at application
rates of 0.25. to 0 5 Ib ai/A results in concentrations of
approximately 6.0 to 12 ug/1.
The LCso for fish is 80 ug/1 and for aquatic invertebrates
is 0.32 ug/1. Comparison of these fish and aquatic invertebrate
LC5QS to the above estimated residue levels of 2.0 to 12.0 ug/1
suggests that non-target aquatic invertebrates indigenous to
small ponds could be exposed to acutely toxic concentrations of
EPN. The Agency is requesting actual and simulated field
testing to assess more specifically potential adverse effects
to non-target aquatic species.
Based on the mysid shrimp and sheepshead minnows Maximum
Acceptable Toxicant Concentration (MATC) of 0.44 to 3.4 and
0.88 to 2.2 ug/1 respectively, chronic effects may be expected
at the concentrations estimated above 2.0 to 12.0 ug/1.
However, the chronic tests with mysid shrimp and sheepshead
minnows demonstrated' that effects occurred during the later
stages of exposure; thus chronic effects may be unlikely if
EPN occurs intermittently. Although EPN is mildly biocon-
centrated, it is also rapidly depurated (eliminated from the
animal's body). Significant accumulation is unlikely unless
EPN is present continuously. Acute toxicity of EPN is possibly
the greatest hazard. The Agency is requiring an aquatic
residue monitoring study or a mesocosm study in order to
better estimate environmental contamination and to complete
the assessment of the persistence of EPN relative to its
chronic toxicity or bioaccumulation potential.
In addition to the above aquatic study, the Agency has
identified the following areas as data gaps for EPN:
0 A fish early life-stage study. This study is
required to support registration of an end-use
product that is expected to be transported to
water from the intended use site, when certain
conditions apply:
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- Any EC5Q or LCso value in acute tests is
less than 1 mg/1 . (The blueqill LCso with
an 80% EPN formulation was 0.08 mg/1).
- The estimated environmental concentration
(EEC) in water is equal to or greater than
0.01 of any ECso or ££50 from acute testing.
(The EEC from runoff is 2.0 to 12.0 ug/1 ,
which is approximately 2 to 15 times higher
than 0.01 of the bluegill LCso of 80 ug/1).
- The EEC is less than 0.01 of the ECso or
LCso values but the pesticide is persistent
in water. (The persistence of EPN in water
has not been adequately defined).
The Agency expects that aquatic environments will be
exposed from use on cotton therefore a fish early
life-stage study is required.
An aquatic invertebrate life-cycle study. This
study is required to support the registration of
any end-use product that is expected to be trans-
ported to water from the intended use site, when
certain conditions apply:
- Any ECso or LCso value in acute tests is less
than 1 mg/1. (The daphnid LCso with a 99% EPN
formulation was 0.32 mg/1).
- The estimated environmental concentration
(EEC) in water is equal to or greater than
0.01 of any ECso or ^50 from acute testing.
(The EEC from runoff is 2.0 to 12.0 ug/1,
which is approximately 625 to 3750 times higher
than 0.01 of the daphnid LCso of °-32 ug/1).
- The EEC is less than 0.01 of the ECso or
LCsO values but the pesticide is persistent
in water. (The persistence of EPN in water
has not been adequately defined).
The Agency expects that aquatic environments will be
exposed from use on cotton. Therefore, an aquatic
invertebrate life-cycle study is required.
Existing data are also adequate to show that technical
EPN is very highly toxic to waterfowl, upland game birds and
passerine birds. The 8-day dietary studies conducted with
technical EPN show dietary LCso values for waterfowl (mallard
ducks) and upland game birds (bobwhite quail) to be 168 ppm and
349 ppm, respectively (Hill et al., 1975). Avian acute oral
studies have demonstrated LDgQ values of 7.09 mg/kg (Hudson
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-40-
et al., 1979) and 27 mg/kg (Fink, 1976) for waterfowl (mallard
ducks). Avian oral LDso values for upland garre birds were
shown to be 53.4 mg/kg for ring-necked pheasants and 5.25 mg/kg
for coturnix (Tucker and Haegele, 1971). The 24-hour percutaneous
LC^o for mallard ducks was determined to be 400 mg/kg (Hudson
et al. , 1979) .
Acute oral exposure is perhaps the principal route of
pesticide uptake for outdoor application of granular formula-
tions, principally through the accidental ingestion of granules
adhering to food or left on the soil surface either from
incomplete incorporation or spillage. Dietary exposure is
the principal route for emulsifiable concentrate and wettable
powder formulations. With a 24-hour percutaneous LDso value of
400 mg/kg, EPN does not appear to present a dermal hazard.
The risk posed by consuming EPN granules to seven species
of birds known to utilize cultivated fields is shown in Table 9.
For small birds that forage for food and grit on the soil
surface and that may pick up exposed granules, the number of
granules required to cause death may be an important indicator
of potential hazards. Although many factors may contribute
to actual hazards, the Agency believes that the number of EPN
granules required to cause death is large and demonstrates a
wide margin of safety. In a 1984 study, Balcomb et al.
(Bull. Environ. Contam. Toxicol. 33:302-307; 1984) reported
that an EPN 4% granular formulation caused no mortality at
doses up to 20 granules in house sparrows and 40 granules in
red-winged blackbirds, confirming the Agency's predictions.
Kenaga, in a 1973 study (Environmental Quality and
Safety; Vol. II; 1973; pp 166-181) reported that direct
application of EPN emulsifiable concentrate and wettable
powder formulations to croplands at 0.25 to 1.0 lb. a i/A
would be expected to produce upper limit (maximum) initial
residues over that application range of 1.75 to 7 ppm on
fruits, 14.5 to 58 ppm on forage, 31 to 125 ppm on leaves and
leafy crops, 27 to 110 ppm on long grasses and 60 to 240 ppm
on short ra^qegrass. More typical limit (average) estimates
are 0.37 to 1.5 ppm on fruits, 8.25 to 33 pom on forage, 8.75
to 35 ppm on leaves and leafy crops, 23 to 92 ppm on long
grasses and 31 to 125 ppm on short rangegrass. These typical
residues exceed restricted use criteria (40 CFR 162.11 (c)(l)
(iii)(B) and 40 CFR 162.11 (c)(2)(iii)(B)) (1/5 LC50 for
upland game birds of 349 ppm = 69.8 ppm) on certain avian
food items at the higher rates of 1.0 lb. ai/A. EPN is
already a restricted use pesticide.
In a 1984 study (Toxicol. Appl. Pharmacol. 73:284-294;
1984), Hoffman and Sileo examined the effects of topical
applications of EPN on mallard eggs for potential embryonic,
teratogenic and neurotoxic effects. Mallard eggs were topically
treated at 72 hours of incubation with 56% EPN at concentrations
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Table 9. Hazard to Seven Species of Non-Target Birds from
2% and 4% Granular EPN Formulations
Number of Granules equal
to LD^n1
Species
Mallard
(14-day)
Mallard
(adult)
Robin2
Mourning Dove2
House Sparrow2
Redwing
Blackbird
Grasshopper
Sparrow^2
Attwa ter1 s
Body
we igh t
(q)
200
1200
80
100
20
50
13.9
1000
mg/
animals
(q)
0.20
1.20
0.08
0.10
0.02
0.05
0.01
1.00
2G
Granules
3375
20250
160
200
40
100
20
16875
4G
Granules
1687
10125
80
100
20
50
10
8437
Prairie Chicken-^
(adult)
(14-day)
50
0.05
843
422
1 Weight of one granule = 0.08 mg (Balcomb et al.f 1984).
- mg a. i. 2% granule = 0.08 mg X 2% = 0.0016 mg EPN/granule.
- mg a.i. 4% granule = 0.08 mg X 4% = 0.0032 mg EPN/granule.
-.Mallard LD^Q X Weight (kg) = 27.0 mg/kg X 0.200 kg
= 5.4 mg/animal.
The number of 4% granules
required to equal Mallard
LD5Q
5.4 kg
0.0032 mg a.i./granule
= 1687 granules equivalent
to mallard LD5Q
2 Assuming equal sensitivity as the redwing blackbird; 3.2 mg/kg,
as reported by Schafer in 1972.
3 Assuming equal sensitivity as the mallard; 27 mg/kg as reported
by Fink in 1976.
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of 0.25 Ib/gallon (gal), 0.75 Ib/gal and 1.25 Ib/gal. The study
reported that external treatment of mallard eggs with EPN at the
field level of application (0.25 Ib/gal) was both embryotoxic
(22 to 44% mortality over the dose range) and teratogenic (37
to 42% of the surviving embryos at 18 days were abnormal with
cervical and axial scoliosis as well as severe edema). Brain
development was also impaired as reflected by significantly
(p < 0.05) lower brain weight in hatchlings when compared to
controls. Body weight did not differ significantly. Neurotoxic
effects were observed throughout embryonic development and in
hatchlings as manifested by lower brain acetylcholinesterase
(AChE) and brain neurotoxic esterase activity. Although this
is a scientifically sound study, mallard eggs were treated
with EPN under laboratory conditions and may not reflect
actual field conditions. As noted in Table Af the Agency
will request'actual and simulated field studies in avian
species after receipt and review of environmental fate
studies and an avian reproduction study.
Laboratory data indicate that EPN is very highly acutely
toxic to avian species. Estimated exposure on one of the
vegetative groups listed above (short rangegrasses, potential
food sources that have large surface area to mass ratios) is
of particular concern. Additionally, topical treatment to
mallard eggs resulted in embryotoxicity, neurotoxicity and
teratogenicity, under laboratory conditions. Many factors
can contribute to different results under field conditions.
Therefore, the Agency is requiring an avian reproduction
study especially in light of the fact that there are repeat
applications of EPN to cotton.
2. Endangered Species.
Based on the Agency's analysis, it appears that certain
use patterns of EPN may result in sufficient exposure to pose
a potential hazard to certain endangered/threatened species
of mammals, birds, aquatic organisms, crustaceans, reptiles
and insects. (See Regulatory Position #7 in Section IV below.)
3. Environmental Fate.
The available data are insufficient for the Agency to
fully assess the environmental fate and transport of EPN and
the potential exposure of humans and nontarget organisms to
EPN. However, available preliminary information that does not
meet the Agency's data requirements does indicate general trends
of EPN behavior in the environment. EPN degrades in aerobic
sandy loam soil with a half-life of 4 to 8 weeks. Phenylphos-
phonic acid, O-ethyl phenylphosphonic acid, and O-ethyl phenyl-
phosphonothioic acid are expected to be the main degradates
under aerobic conditions. In the field, EPN dissipates with a
half-life of 2 to 8 weeks from silt loam soils in Delaware and
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-43-
Mississippi. EPN was detected in tailwater pit sediments and
water in Kansas in 1974. EPN accumulates in pinfish tissue
700 fold and sheepshead minnow tissues 10,000 fold. Rapid
depuration was noted in pinfish.
To assess the environmental fate of EPN in conjunction
with its terrestrial food crop and terrestrial nonfood use
patterns, the Agency is requiring the following studies:
Hydrolysis
Photodeqradation on soil
Photodegradation in water
Aerobic soil metabolism
Anaerobic soil metabolism
Leaching and adsorption/desorption
Soil dissipation
Long-term soil dissipation
Rotational crops (confined and field)
Fish accumulation.
In addition, a special Droplet Size Spectrum and Spray
Drift Field Evaluation Testing is being required due to the
toxicity of EPN, its methods of application, and the likely
exposure of off-site people and wildlife to the pesticide.
The droplet spectrum study is to be performed to reflect the
nozzle and other equipment types to be used in the application
of EPN. The spray drift field evaluation is to be performed
to reflect the application equipment, use patterns, and
typical locations of use, which include different weather
factors, in the application of EPN.
D. TOLERANCE REASSESSMENT
Tolerances have been established for residues of EPN in
a variety of raw agricultural commodities (40 CFR 180.119).
Most of the tolerances were established with little or no
data in conjunction with the pesticide "Spray Residue Hearings"
of the late 1960s. EPA has evaluated the available residue
chemistry and toxicology data and has determined that a full
tolerance reassessment for EPN can not be made at this time
because of extensive data gaps. However, the Agency has
conducted an assessment of the tolerances relative to dietary
exposure and the estimated risk of the delayed neurotoxic
effect. Dis-ussion of this is provided in subsection B,
above. Since most of the required toxicology studies are
missing and additional data are required in order to more
precisely estimate dietary exposure and its toxicological
significance, no new tolerances, either group or otherwise,
will be established. The residue and toxicology data with
regard to EPN tolerances are discussed in the following
subsections.
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1. Residue Data.
Nature of Residues in Plants.
The metabolism of EPN in plants is not adequately
understood. Detailed characterization of residues in whole,
10-week old cotton plants has revealed the presence of EPN
and two metabolites, O-ethyl phenylphosphonic acid and
phenylphosphonic acid. The latter compound was found only
in bound form. This study also revealed that 14C-residues
of [I^CJEPN are absorbed into plant tissues following foliar
applications. No studies have been submitted that elucidate
the nature of EPN residues in cottonseed (the raw agricultural
commodity processed for human consumption) or in any other
crops on which registered use of EPN exists. The following
data are required:
0 Plant metabolism studies reflecting the distribution
and metabolis" of benzene ring-labeled [l^ClEPN in:
1) mature cottonseed harvested 3 days
after several foliar applications at
1 Ib ai/A made 4 to 5 days apart;
2) field corn fodder and mature field
corn grain harvested 14 days after
several applications at 0.5 Ib ai/A
made 5 days apart; and
3) mature pecans harvested 21 days
following the last of several foliar
applications at 7-day intervals at
3.5 Ib ai/A.
The rates stated here are based on maximum registered
rates; exaggerated rates may be necessary to obtain
sufficient residues in the harvested plant portion for
characterization. Analyses should include hydrolysis
and reextraction of plant residues and aqueous extracts
to determine conjugated -^C-residues of EPN. If metabolism
results differ significantly among the three crops, then
additional metabolism data must be submitted for a
representative crop in each crop group for which
registered uses of EPN exists.
Tolerances for EPN residues in or on plant comodities are
currently expressed in terms of parent only. If the data
required above indicate additional residues of toxicological
concern, the tolerance definition will be changed accordingly.
(The registrant should conduct the required metabolism studies
and should submit them to the Agency for review prior to
conducting the field studies described below under "Magnitude
of Residues in Plants.")
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Nature of Residues in Animals.
No tolerances presently exist for residues of EPN in
animal products. However/ the submitted data pertaining to
the metabolism of EPN in animals indicate that EPN residues
will transfer to tissues of poultry, but otherwise are
inadequate to show the nature of those residues in poultry
or other animals. The nature of EPN residues in animals is
therefore not adequately understood. The following data
are required:
0 Metabolism studies utilizing ruminants.
In these studies the animals must be dosed for
three days with ring-labeled [14C]EPN at a
concentration in the total diet which will
result in sufficient residue in the tissues
and milk for characterization. Animals must
be sacrificed within 24 hours of the final
dose (milk must be collected twice daily).
14C-Residues must be characterized and
quantified in milk, muscle, fat, kidney, and
liver. If residues of toxicological concern
are found to transfer to the tissues and/or
milk of ruminants, appropriate tolerances
must be proposed.
0 Metabolism studies utilizing poultry.
In these studies the animals must be dosed for
three days with ring-labeled [14C]EPN at a
concentration in the total diet which will
result in sufficient residue in the tissues
and eggs for characterization. Animals must
be sacrificed within 24 hours of the final
dose (eggs must be collected twice daily).
l^c-Residues must be characterized and
quantified in eggs, muscle, fat, kidney, and
liver. If residues of toxicological concern
are found to transfer to the tissues and/or
eggs of poultry, appropriate tolerances must
be proposed.
Furthermore, if the nature of the residue in
poultry differs significantly from that in
ruminants, additional data depicting the nature
of the residue in swine will be required (i.e.
in the absence of rat metabolism data). If
poultry and ruminant metabolism differ from
that in the rat then additional swine data are
required.
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Residue analytical methods.
Adequate methods are available for collection of data
pertaining to residues of EPN in plant commodities. These
methods are based on nitrophenyl detection through colorimetry,
and detection by gas chromatography. These methods have not
been assigned company designations. However, the colorimetric
procedure is usually referred to as "The Parathion Method"
(E.I. du Pont de Nemours & Co./ Inc., 1949) Another colorimetric
method, commonly referred to as the "Total Phosphorus Method"
(E.I. du Pont de Nemours & Co., Inc., 1949) cannot be assessed
due to the absence of any recovery data. However, since no
residue data generated using this method may be used to
support established tolerances, due to inadequacies unrelated
to the analytical method, the Agency does not require validation
data for this method. The Agency recommends that the GC method
(E.I. du Pont de Nemours & Co., Inc., 1977) be used in the
future for data collection.
The colorimetric methods are nonspecific and therefore
not suitable for enforcement work. Also, the GC method
(E.I. du Pont de Nemours & Co., Inc., 1977) may not be used
for enforcement purposes because no confirmatory procedure
has been included in the method discussion. However, two
multiple-residue enforcement methods for EPN determination
are listed in the PAM Volume II, Pesticide Regulation Section
180.119. Both involve organic solvent extraction and GC
detection.
It should be noted that the nature of residues in plants
is not adequately understood. If the metabolism data requested
above reveal additional residues of toxicological concern,
additional methods for tolerance enforcement and data collection
will be required.
Storage Stability.
No data have been submitted regarding the stability of
EPN residues in or on plant samples in frozen storage. The
following data are required:
0 Storage conditions and harvest-to-analysis intervals
studies.
These studies must be submitted for the samples of corn
grain, sweet corn, tomatoes, cottonseed, and soybeans
from which residue data were collected and used to
support established tolerances for residues in or on
corn, tomatoes, beans (dried), and cottonseed. Data
reflecting the storage stability of EPN in plant
samples at the intervals specified must be submitted.
If storage stability is poor, conclusions regarding
the adequacy of tolerances for residues in or on these
commodities may change.
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0 Data on the conditions and intervals of sample storage
including fortification and recovery data.
0 All residue data required in this standard must be
accompanied by information pertaining to the conditions
and intervals of sample storage as well as fortification
and recovery data reflecting the stability of EPN at
such intervals.
It should be noted that the nature of the residue in plants
is not understood. If the requested plant metabolism data
reveal additional metabolites of toxicological concern, data
reflecting the stability of these metabolites in frozen storage
will be required. Also, if residues of concern transfer to
livestock, data depic4-' q the stability of EPN and metabolites
of concern in animal products will be required.
Magnitude of the Residue in Plants
Root and Tuber Vegetables Group
A crop group tolerance is not appropriate at this time
for the following reasons:
0 Data are required to support the established tolerances
for EPN residues in or on sugar beets, a representative
crop.
0 Residue data are required for three additional represen-
tative crops: carrots, radishes, and potatoes. (If the
registrant/petitioner proposes a use and submits residue
data in support of the tolerances for residues in or on
beets and turnips, no data are required for carrots and
radishes.)
Beets, Rutabagas, and Turnips
There are currently no registered uses of EPN on beets,
rutabagas, and turnips. However, a tolerance of 3 ppm has been
established for residues of EPN in or on beets (with or without
tops), rutabagas (with or without tops), and turnips (with or
without tops). Since EPN has no registered use on beets,
rutabagas, and turnips, the Agency will revoke the currently
established tolerance for residues of EPN in or on these crops
unless the registrant proposes a use and submits appropriate
residue date in support of the established tolerances.
There are no Canadian or Mexican tolerance, nor are
there Codex Maximum Residue Levels (MRL) for residues of EPN
in or on beets, rutabagas, arid turnips.
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Sugar beets
The 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations of EPN are registered for an unspecified number
of foliar applications at 1 Ib ai/A using aerial equipment.
A 21-day Post Harvest Interval (PHI) is in effect. Use of
ultra-low volume (ULV) application equipment is permitted.
Although EPN is registered for use on sugar beets, no residue
data have been submitted in support of the established tolerance
for residues of EPN in or on sugar beets (without tops), and no
appropriate translatable data for other crops exists. Therefore,
the following data are required to support the established
tolerance:
0 Residue data from sugar beet roots taken 21 days
following the last of several foliar applications
with a registered emulsifiable concentrate formula-
tion of EPN at 1 Ib ai/A, using ground and aerial
equipment, including ULV equipment in separate tests.
The residue tests should take place in California,
Idaho, Minnesota, and North Dakota, which collectively
account for approximately 67% of the United States
sugar beet production.
0 Data reflecting residues of EPN in dehydrated pulp,
molasses, and refined sugar processed from sugar beets
bearing measurable weathered residues. If residues
concentrate in any of these processed products,
appropriate food/feed additive tolerances must be
proposed.
There is no Canadian or Mexican tolerance, nor is there a
Codex MRL for residues of EPN in or on sugar beets
Leaves of Root and Tuber Vegetables Group
A crop group tolerance is not appropriate at this time
for the following reasons:
0 EPN presently has no registered use on turnips,
a representative crop. Should a use be proposed,
appropriate residue data must be submitted.
0 Residue data and a tolerance proposal are required
for one other representative crop: sugar beet tops.
Beet Tops (greens), Rutabaga Tops, and Turnip
Tops (greens).
There are currently no registered uses of EPN on beets,
rutabagas, and turnips. However, a tolerance of 3 ppm has been
established for residues of EPN in or on beet greens, rutabagas
tops, and turnips greens. Since EPN has no registered use on
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-49-
beets, rutabagas, and turnips, the Agency will revoke the
currently established tolerance for residues of EPN in or on
beets greens, rutabaga tops (tops are not presently considered
to be a raw agricultural commodity of rutabagas), and turnip
greens unless the registrant proposes a use and submits appropriate
residue date in support of the established tolerances.
There are no Canadian or Mexican tolerances, nor are
there Codex Maximum Residue Levels (MRL) for residues of EPN
in or on beet greens, rutabagas tops, and turnips greens.
Sugar Beet Tops
The 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations of EPN are registered for an unspecified number
of foliar applications at 1 Ib ai/A using ground or aerial
equipment. A 21-day Post Harvest Interval (PHI) is in effect.
Use of ultra-low volume (ULV) application equipment is permitted.
Although EPN is registered for use on sugar beets, no tolerance
has been established for residues of EPN in or on sugar beet
tops at the present time.
Since sugar beet tops are a raw agricultural commodity of
of sugar beets, residue data and a tolerance proposal or feeding
and grazing restrictions must be proposed. Therefore, the
following is required:
0 Residue data from sugar beet tops harvested at
regular intervals following the last of several
applications with a registered EPN emulsifiable
concentrate formulation at 1 Ib ai/A, using ground
and aerial equipment, including ULV equipment in
separate tests. The residue tests should take place
in California, Idaho, Minnesota, and North Dakota.
A tolerance and a pregrazing interval must be proposed;
alternatively, feeding and grazing restrictions may be
proposed.
.There is no Canadian or Mexican tolerance, nor is there
a Codex MRL for residues of EPN in or on sugar beets.
Leafy Vegetables (except Brassica Vegetables) Group
A crop group tolerance is not appropriate at this time
for the following reasons:
0 Data are required to support the established
tolerances for residues of EPN in or on spinach
and lettuce. There is presently no registered
use"of EPN on spinach.
0 Data are required on one other representative
crop: celery.
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Lettuce
The 4 Ib/gal emulsifiable concentrate formulations, of EPN
is registered in California (intrastate registration) for an
unspecified number of broadcast applications at 1 Ib ai/A using
ground or aerial equipment. A 21-day PHI is in effect. A
tolerance of 3 ppm has been established for residues of EPN
in or on lettuce.
No residue data have been submitted in support of the
established tolerance for residues of EPN in or on lettuce,
nor are appropriate translatable data available. The following
data are required to support the established tolerance:
0 Residue data from mature leaf and head lettuce,
harvested 21 days after the last of several foliar
treatments of the 4 Ib/gal EPN emulsifiable
concentrate formulation at 1 Ib ai/A; aerial
and ground applications should be represented
in separate tests. The tests must take place
in California, the only state in which EPN is
registered for use on lettuce.
There is no Canadian tolerance nor is there a Codex MRL
for residues of EPN in or on lettuce. A Mexican tolerance
of 3 ppm has been established for the residues of EPN in or
on lettuce.
Spinach
There are currently no registered uses of EPN on spinach.
However, a tolerance of 3 ppm has been established for residues
of EPN in or on spinach. Since EPN has no registered use on
spinach, the Agency will revoke the currently established
tolerance for residues of EPN in or on this crop unless
the registrant proposes a use and submits appropriate residue
data in support of the established tolerance.
There is no Canadian tolerance nor is there a Codex MRL
for residues of EPN in or on spinach. A Mexican tolerance
of 3 ppm has been established for the residues of EPN in or
on spinach.
Legume Vegetables Group
A crop group tolerance is not appropriate at this time
for the followina reasons:
0 Data are required for Pisum varieties (both succulent
and dried).
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0 Additional data are required to support the established
tolerances for residues of EPN in or on beans, including
dried beans.
0 Additional data are required to support the established
tolerance for residues of EPN in or on soybeans.
0 The established tolerance of 3 ppm for residues of EPN
in or on beans is more than five times greater than the
established tolerance of 0.05 ppm for residues of EPN
in or on soybeans. If the data requirements outlined
above for peas and beans are metf it may be possible
to propose a crop group tolerance for legume vegetables,
excluding soybeans.
Beans
The 4 Ib/gal emuls if iable concentrate formulation of EPN
is registered for an unspecified number of foliar applications
at 0.5 lb ai/A. Two to four foliar applications at 5- to 7-day
intervals, may be made at 0.125 to 0.5 lb ai/A with the EPN
25% wet table powder formulation or the 4 Ib/gal and 5 Ib/gal
emulsifiable concentrate formulations. There is also an
intrastate product for use in Alabama, Arkansas, Georgia,
Louisiana, Mississippi, Tennessee, and Texas which permits
use of a 3 Ib/gal multiple active ingredient (EPN and methyl
parathion) emulsifiable concentrate on beans (dry, green,
and lima) at 1.5 lb ai/A. The emulsifiable concentrate
formulations may be applied by aerial equipment. The
emulsifiable concentrate formulations may also be applied
using ULV equipment. A 21-day PHI is in effect. A tolerance
of 3 ppm has been established for residues of EPN in or on
beans.
No residue data have been submitted in support of the
established tolerance for EPN residues in or on beans. The
Agency recommends that separate tolerances be established for
residues of EPN in or on lima beans, snap beans, and dry beans.
The available soybean data provide adequate support for the
3 ppm "bean" tolerance for residues of EPN in or on dry beans.
However, if a crop group tolerance is desired, additional data
must be submitted for dry beans since data translated from
soybeans, a representative commodity of the Lequme Vegetables
Group, cannot be used to satisfy the data requirements for
dried beans, which is also a representative commodity. Data
are required to support the 3 ppm tolerance for EPN residues
in or on snap beans and lima beans. The data requested below
for snap beans will be translated to lima beans. The following
data are required:
0 Residue data from mature snap beans harvested 21 days
following several foliar applications of the 3 Ib/gal
emulsifiable concentrate formulation, at 1.5 lb ai/A.
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-52-
Separate tests must be run for both aerial and ground
applicationsf including separate tests for the use of
ULV equipment. The tests should take place in Georgia,
Tennessee, and Louisiana, representative states in
which use of the high rate (1.5 Ib ai/A) is permitted.
Data may be translated from snap beans to lima beans
to support a tolerance for residues of EPN in or on
lima beans.
0 Residue data from snap bean cannery residue, processed
from snap beans bearing measurable, weathered residues.
Exaggerated rates may be necessary to achieve such
residue levels. If residues are higher in cannery
waste than in snap beans per se an appropriate feed
additive tolerance must be proposed.
There is no Canadian tolerance nor is there a Codex MRL
for residues of EPN in or on beans. A Mexican tolerance of
3 ppm has been established for residues of EPN in or on beans.
Soybeans
The 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations of EPN are registered for all necessary foliar
applications at 1 Ib ai/A. Ground and aerial applications
may be made. The use of ULV equipment is also permitted. A
21-day PHI is in effect. A tolerance of 0.05 ppm (negligible
residues) has been established for residues of EPN in or on
soybeans.
The submitted data do not provide adequate support for
the established tolerance for residues of EPN in or on soybeans
for the following reasons: 1) geographic representation is
poor; and 2) no aerial application data were submitted. The
following additional data are required:
0 Residue data from soybeans, harvested 21 days after
the last of several applications of an emulsifiable
concentrate formulation of EPN at 1 Ib ai/A. The data
should reflect both aerial and ground applications,
including separate tests for the use of ULV equipment.
The tests should be conducted in Illinois, Nebraska,
Ohio, and Tennessee, which represent the major soybean
production and climatic regions of the United States.
0 Residue data from two soybean processed commodities
(hulls and soapstock). These products must be processed
from mature soybeans bearing measurable, weathered
residues of EPN. Exaggerated rates may be necessary
to achieve such initial residue levels. If residues
are found to concentrate in hulls and soapstock, an
appropriate feed additive tolerance must be proposed.
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-53-
The available data are adequate to show that EPN residues
will not concentrate in soybean meal. However, these data do
show that EPN residues will concentrate up to 5.5 times in
soybean oil. Therefore/ the petitioner must propose a tolerance
for residues in soybean oil that is approximately 6 times the
final accepted tolerance for EPN residues in or on soybeans.
There is no Canadian nor is there a Codex MRL for residues
of EPN in or on soybeans. A Mexican tolerance of 0.05 ppm
(negligible residues) has been established for the residues of
EPN in or on soybeans.
Foliage of the Legume Vegetables Group
A crop group tolerance is not appropriate at this time
for the following reason:
0 Data are required for the representative commodities,
bean vines and hay (any Phaseolus sp.), field pea vines
and straw (Pisum sp. ) and soybean forage and straw.
EPN is presently registered for use on soybeans and
beans but no tolerances for residues in or on forage,
vines, hay, or straw have been established.
Bean Vines and Hay
The 4 Ib/gal emulsifiable concentrate formulation of EPN
is registered for an unspecified number of foliar applications
at 0.5 Ib ai/A. Two to four foliar applications at 5- to 7-day
intervals, may be made at 0.125 to 0.5 Ib ai/A with the EPN
25% wettable powder formulation or the 4 Ib/gal and 5 Ib/gal
emulsifiable concentrate formulations. There is also an
intrastate product for use in Alabama, Arkansas, Georgia,
Louisiana, Mississippi, Tennessee, and Texas which permits
use of a 3 Ib/gal multiple active ingredient (EPN and methyl
parathion) emulsifiable concentrate on beans (dry, green,
and Lima) at 1.5 Ib ai/A. The emulsifiable concentrate
formulations may be applied by both aerial and ground equipment.
The emulsifiable concentrate formulations may also be applied
using ULV equipment. A 21-day PHI is in effect. No tolerance
has been established or proposed for residues of EPN in or on
bean vines or hay.
No residue data have been submitted for residues of EPN
in or on bean vines or hay. The registrant must either
propose a feeding and grazing restriction for these commodities,
or submit tolerance proposals for residues of EPN in or on bean
hay and bean vines, a pregrazing interval for vines, and the
following supporting residue data:
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-54-
0 Residue data from bean vines and bean hay harvested
after the last of several applications of the 3 Ib/gal
EPN emuIsifiable concentrate formulation, at 1.5 Ib
ai/A. Tests must include both aerial and ground
applications, including separate tests for the use of
ULV equipment. Vines must be sampled at intervals
following the last treatment and hay must be harvested
21 days after the last treatment. The tests should
take place in Georgia, Tennessee, and Louisiana,
representative states in which use of the high rate
is permitted. Tolerances for residues in or on bean
vines and hay must be proposed and a pregrazing interval
for bean vines must be proposed. Alternatively, feeding
and grazing restrictions may be proposed for bean vines
and hay.
There are no Canadian or Mexican tolerances nor is there a
Codex MRL for residues of EPN in or on bean vines or hay.
Soybeans
The 4 Ib/gal and 5 Ib/gal enauls if iable concentrate
formulations of EPN are registered for all necessary foliar
applications at 1 Ib ai/A. Ground and aerial applications
may be made. The use of ULV equipment is also permitted.
A 21-day prefceding and pregrazing interval is in effect.
A tolerance has neither been established nor proposed for
residues of EPN in or on soybean forage or soybean straw.
No data have been submitted for residues in or on soybean
forage or straw. The registrant must submit tolerance proposals
for residues of EPN in or on soybean forage and soybean straw,
and the following data:
0 Residue data from soybean forage and straw , harvested
21 days after the last of several applications of an
EPN emulsifiable concentrate formulation at 1 Ib ai/A.
The data must reflect both aerial and ground applications,
and must include separate tests for use of ULV equipment.
The tests should be conducted in Illinois, Nebraska,
Ohio, and Tennessee. Tolerances for residues of EPN
in or on soybean forage and straw must be proposed.
There is no Canadian or Mexican tolerance nor is there a
Codex MRL for residues of EPN in or on soybean forage or soybean
straw .
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-55-
Fruiting Vegetables (Except Cucurbits) Group
A crop group tolerance is not appropriate at this time for
the followina reason:
0 Residue data are required for an additional
representative crop: peppers.
Tomatoes
The 25% wettable powder formulation is registered for
all necessary foliar applications at 7- to 10-day intervals
at 0.125 to 0.25 lb ai/A using ground equipment. The 4 Ib/gal
and 5 Ib/gal emulsifiable concentrate formulations are registered
for all necessary foliar applications at 7- to 10-day intervals
at 0.25 to 1 lb ai/A using aerial or ground equipment. A 21
day PHI is in effect for these registrations. In addition,
there is also an intrastate product registered for use in
Alabama, Arkansas, Georgis, Louisianna, Mississippi, Tennessee,
and Texas that permits the use of a 3 Ib/gal emulsifiable
concentrate multiple-active ingredient (EPN and methyl parathion)
at 1 lb ai/A as needed. A 15-day PHI is in effect for this
formulation. The emulsifiable concentrate formulations may
be applied with ULV equipment. A tolerance of 3 ppm has been
established for residues of EPN in or on tomatoes.
The submitted data are adequate to support the established
tolerance for the residues of EPN in or on tomatoes. However,
the following data are required to determine whether food and/or
feed additive tolerances are needed for the processed products
of tomatoes:
0 Residue data from processed tomato products, including
wet pomace, dried pomace, puree, catsup and juice,
processed from tomatoes bearing measurable, weathered
residues of EPN. Exaggerated application rates may
be necessary to achieve such initial residue levels.
Should concentration of residues in processed products
-occur, appropriate food and/or feed additive tolerances
must be proposed.
There is no Canadian tolerance nor is there a Codex MRL
for residues of EPN in or on tomaotes. A Mexican tolerance
of 3 ppm has been established for the residues of EPN in or
on tomatoes.
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-56-
Citrus Fruits Group
Citrus Fruit
The 25% wettable powder formulation is registered for
foliar applications at 0.75 to 3 Ib ai/A or 0.25 to 0.5 Ib
ai/100 gallons using ground equipment. The 4 Ib/gal and
5 Ib/gal emulsifiable concentrate formulations are registered
for foliar applications at 0.5 to 2.25 Ib ai/A using ground
or aerial equipment. ULV applications of the emulsifiable
concentrate formulations are also permitted. A 30-day PHI
is in effect. Treated rinds may not be used for food or
feed. However, the restriction prohibiting the use of the
rind for food or feed in not practical since the disposition
of the citrus rind is not under the control of the grower.
A tolerance of 3 ppm has been established for residues of EPN
in or on citrus fruit.
The submitted data are not adequate to support the
established tolerance for EPN residues in or on citrus for
the following reasons: 1) the residue data submitted were
for pulp or peel instead of whole fruit; 2) no data reflected
aerial applications; 3) no tests reflected use of an emulsifiable
concentrate formulation; 4) geographic representation was poor;
and 5) the representative commodities of the Citrus Fruits Group
(lemons, grapefruit, oranges) were not represented. The following
data are required:
0 Residue data from whole sweet oranges, lemons, and
grapefruit harvested 30 days after the last of several
foliar applications with an emuslifiable concentrate
formulation of EPN at 2.25 Ib ai/A. The data must
reflect both aerial and ground applications, and must
include separate tests for use of ULV equipment.
Tests must also reflect ground applications of the
25% wettable powder formulation at 0.5 Ib ai/100 gal
(>2000 gal/A). The studies involving oranges and
grapefruit should take place in California and Florida;
those involving lemons should take place in California
»nd Arizona. These states represent the major United
ates production areas of the representative citrus
Dps. If the maximum residue values determined for
r two of the three crops differ by more than a factor
five, separate tolerances should be proposed for
:h of three crops, since a crop group tolerance would
be appropriate. The registrant must propose a
.imum Ib ai/A rate to complement the 0.5 Ib ai/100 gal
e for ground applications of the 25% wattable powder
mulation since it is unlikely that >2000 gal/A will
applied. The Agency recommends a maximum rate of
Ib ai/A.
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-57-
0 Residue data from the processed products of oranges,
including dried pulp, oil, molasses, and juice,
processed from oranges bearing measurable, weathered
EPN residues. Exaggerated rates may be reguired to
achieve such residue levels. If EPN is found to
concentrate in any of these products, appropriate
food and/or feed additive tolerances must be proposed.
There is no Canadian tolerance nor is there a Codex MRL
for residues of EPN in or on citrus fruit. A Mexican tolerance
of 3 ppm has been established for residues of EPN in or on
citrus fruit.
Pome Fruits Group
A crop group tolerance is not appropriate at this time
for the following reason:
0 Data are reguired to support the established tolerances
for residues of EPN in or on two representative crops,
apples and pears.
Apples
The 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations and the 25% wettable powder formulation of EPN
are registered for foliar applications at 0.125 to 0.375 Ib
ai/100 gal beginning at petal fall and continuing at 10- to
14-day intervals as needed. The 5 Ib/gal emulsifiable
concentrate formulation is registered for the same type of
application at 1 to 1.5 Ib ai/A. A 21-day PHI is in effect.
Emulsifiable concentrate formulations may be applied using
aerial or ground eguipment. ULV eguipment is also permitted
for emulsifiable concentrate formulations. Applications of
EPN may not be made to Mclntosh or related varieties. A
tolerance of 3 ppm has been established for residues of EPN
in or on apples.
The submitted data are not adequate to support the
established tolerance for residues of EPN in or on apples for
the following reasons: 1) maximum application rates were not
represented; 2) rates in gal/A were not provided; and 3) no
aerial application data were submitted. The following data
are required:
0 Residue data from mature apples harvested 21 days
after the last of several foliar ground applications,
beginning at petal fall and continuing at 10-day
intervals thereafter, of the 25% wettable powder
foHrtulation. In separate tests, residue data from
mature apples harvested 21 days after the last of
several foliar ground applications of an emulsifiable
concentrate formulation at 0.375 Ib ai/100 gallons
(800 gal/A). These tests must also reflect both
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-58-
aerial and ground ULV application of an emulsifiable
concentrate formulation at 3 Ib ai/A (800 gal/A rate
at 0.375 Ib ai/100 gal adjusted to maintain Ib ai/A
rate). The tests should take place in Washington,
New York, Michigan, Virginia, and California, which
collectively account for approximately 70 % of the
United States apple production. The registrant must
also propose a maximum Ib ai/A rate for applications
for the 25% wettable powder and emulsifiable concentrate
formulations to complement the registered 0.375 Ib
ai/100 gal rate since it is unlikely that >800 gal/A
will be applied. The Agency recommends a maximum
rate of 3 Ib ai/A.
0 Residue, data from dried pomace and juice, processed
from apples bearing measurable, weathered EPN residues.
Exaggerated rates may be necessary to achieve such
levels. If concentration of residues occurs upon
processing, appropriate food and/or feed additive
tolerances must be proposed.
There is no Canadian tolerance nor is there a Codex MRL
for residues of EPN in or on apples. A Mexican tolerance of
3 ppm has been established for residues of EPN in or on apples.
Pears
The 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations and the 25% wettable powder formulation of EPN
are registered for foliar applications at 0.125 to 0.375 Ib
ai/100 gal beginning at petal fall and continuing at 10- to
14-day intervals as needed. The 5 Ib/gal emulsifiable
concentrate formulation is registered for the same type of
application at 1 to 1.5 Ib ai/A. A 14-day PHI is in effect.
Emulsifiable concentrate formulations may be applied using
aerial or ground eguipment. ULV eguipment is also permitted
for emulsifiable concentrate formulations. A tolerance of 3
ppm has been established for residues of EPN in or on pears.
The submitted data are not adeguate to support the
established tolerance for residues of EPN in or on pears for
the following reasons: 1) maximum appliation rates were not
represented; 2) rates in gal/A were not provided; and 3) no
aerial application data were submitted for the emulsifiable
concentrate formulations. The following additional data are
required:
0 Residue data from mature pears harvested 14 days
after the last of several foliar ground applications,
beginning at petal fall and continuing at 10-day
intervals thereafter, of the 25% wettable powder
formulation. In separate tests, residue data from
mature pears harvested 14 days after the last of
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-59-
several foliar ground applications of an emuls if iable
concentrate formulation at 0.375 Ib ai/100 gallons (500
gal/A). These tests must also reflect both aerial and
ground ULV application of an emulsifiable concentrate
formulation at 2 Ib ai/A (500 gal/A rate at 0.375 Ib
ai/100 gal adjusted to maintain Ib ai/A rate). The
tests should be conducted in California and Washington/
which collectively produce approximately 73% of the
domestic pears. The registrant must also propose a
maximum Ib ai/A rate for applications fo the 25%
wettable powder and emulsifiable concentrate formula-
tions to complement the registered 0.375 Ib ai/100
gal rate since it is unlikely that >500 gal/A will be
applied. The Agency recommends a maximum rate of 2
Ib ai/A.
There is no Canadian tolerance nor is there a Codex MRL
for residues of EPN in or on pears. A Mexican tolerance of
3 ppm has been established for the residues of EPN in or on
pears.
Quinces
There are no registered uses of EPN on quinces. A
tolerance of 3 ppm has been established for residues of EPN
in or on quinces. Since EPN has no registered use on quinces,
the Agency will revoke the currently established tolerance for
residues of EPN in or on this crop unless the registrant proposes
a use and submits appropriate residue data in support of the
established tolerance.
There is no Canadian or Mexican tolerance nor is there
a Codex MRL for residues of EPN in or on quinces.
Stone Fruits Group
A crop group tolerance is not appropriate at this time
for the followirv reason:
0 Data are required to support the established tolerances
for residues of EPN in or on fruit of the representative
crops, cherries, peaches, and plums.
Apricots
The 25% wettable powder formulation is registered for
foliar applications at 0.125 to 0.625 Ib ai/100 gal or 0.25
Ib ai/100 gal plus 1.5% light medium oil. The 4 Ib/gal and
5 Ib/gal emul.s if iable concentrate formulations are registered
for foliar applications at 1 to 1.5 Ib ai/A. Foliar applications
may begin at petal fall and continue at 10- to 14-day intervals
as needed. A delayed dormant application may be made with the
4 Ib/gal and 5 Ib/gal emulsifiable concentrate formulations at
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-60-
5 Ib ai/A (plus 1.5% oil) at bud swell. TWo or three bark
applications, made in summer when borer moths appear, may be
made at 0.313 to 0.75 Ib gal/100 gal with the 25% wettable
powder or the 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations, or at 0.75 to 1.5 Ib ai/A using the 5 Ib/gal
emulsifiable concentrate formulation. A 21-day PHI is in
effect. Both aerialand ground-applied foliar applications of
emulsifiable concentrate formulations may be made. ULV
applications are also permitted. A tolerance of 3 ppm has
been established for residues of EPN in or on apricots.
No residue data were submitted in support of the established
tolerance for residues of EPN in or on apricots. Data requested
for peaches will be translated to assess the established tolerance
for residues of EPN in or on apricots.
There is no Canadian or Mexican tolerance nor is there a
Codex MRL for residues of EPN in or on apricots.
Cherries
The 25% wettable powder formulation is registered for
foliar applications at 0.125 to 0.625 Ib ai/100 gal or 0.25
Ib ai/100 gal plus 1.5% light medium oil. The 4 Ib/gal and
5 Ib/gal emulsifiable concentrate formulations are registered
for foliar applications at 0.125 to 0.375 Ib ai/100 gal. The
5 Ib/gal emulsifiable concentrate formulation is also registered
for foliar applications at 1 to 1.5 Ib ai/A. Foliar applications
may begin at petal fall and continue at 10- to 14-day intervals
as needed. A single delayed dormant application may be made with
the 4 Ib/gal and 5 Ib/gal emulsifiable concentrate formulations
at 5 Ib ai/A (plus 1.5% oil) at bud swell. Two or three bark
applications, made in early to late summer when borers appear,
may be made at 0.313 to 0.75 Ib gal/100 gal with the 25% wettable
powder or the 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations, or at 0.75 to 1.5 Ib ai/A using the 5 Ib/gal
emulsifiable concentrate formulation. A 21-day PHI is in
effect. Both aerial- and ground-applied foliar applications
of emulsifiable concentrate formulations may be made. ULV
applications are also permitted. A tolerance of 3 ppm has been
established for residues of EPN in or on cherries.
The submitted data are not adequate to support the
established tolerance for EPN residues in or on cherries for
following reasons: 1) the data do not represent multiple
foliar applications at the maximum-registered use rates;
2) aerial application data were not submitted; 3) geographic
representation was not adequate; 4) no residue data from
sour cherries were submitted; 5) rates were not given in
Ib ai/A; and 6) no tests reflected the use of 1.5% oil.
The following data are required:
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-61-
0 Residue data from mature sweet and sour cherries,
harvested 21 days following the last treatment
included in the following regimen: 1) one delayed
dormant application using an emulsifiable concentrate
formulation at 5 Ib ai/A plus 1.5% oil; 2) foliar
applications, beginning at petal fall and continuing
at 10-day intervals until 21 days prior to harvest,
using (in separate tests):
a) the 25% wettable powder formulation at 0.625 Ib
ai/100 gal (ground application);
b) the 25% wettable powder formulation at 0.25 Ib
ai/100 gal plus 1.5% light medium oil (ground
application); and
c) ULV applications (ground and aerial, in separate
tests) of an emulsifiable concentrate formulation
at 3.75 Ib ai/A (maximum expected gal/A rate of
1000 at 0.375 Ib ai/100 gal adjusted to maintain
Ib ai/A rate); and
3) two late summer bark applications of the 5 Ib/gal
emulsifiable concentrate formulation at 1.5 Ib ai/A.
In the case of ground-applied high-volume foliar
applications, 1000 gallons of spray mixture should be
applied per acre. The tests should be conducted in
Washington and Michigan, which account for approximately
63% of the United States sweet cherry production and
84% of the United States sour cherry production. The
registrant must also propose a maximum Ib ai/A rate
to complement the Ib ai/100 gal rates for foliar
applications since it is unlikely that >1000 gal/A
will be applied. The Agency recommends maximum rates
of 3.75 Ib ai/A for the emulsifiable concentrate
formulations and 6.25 Ib ai/A for the 25% wettable
powder formulation, unless 1.5% oil is added, in
which case 2.5 Ib ai/A of the 25% wettable powder
would be the maximum rate.
There is no Canadian or Mexican tolerance nor is there a
Codex MRL for residues of EPN in or on cherries.
Nectarines
The 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations are registered for foliar applications at 0.125 to
0.375 Ib ai/100 gal beginning at petal fail and continuing to
10- to 14-day intervals as needed. The foliar applications of
5 Ib/gal emulsifiable concentrate formulations may also be made
at 1 to 1.5 Ib ai/A. The 4 Ib/gal and 5 Ib/gal emulsifiable
concentrate formulations are also registered for one delayed
dormant application at 5 Ib ai/A (mixed with 1.5% oil) at bud
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-62-
swell. The 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations are also registered for 2 to 3 bark applications
at 0.375 to 0.75 Ib ai/100 gal in early to late summer when
borer moths appear. The 5 Ib/gal emulsifiable concentrate
formulation is also registered for bark applications at 0.75 to
1.5 Ib ai/A. A 21-day PHI is in effect. Both ground and
aerial, foliar applications are permitted. ULV applications
are also permitted. A tolerance of 3 ppm has been established
for residues of EPN in or on nectarines.
No data have been submitted in support of the established
tolerance for residues of EPN in or on nectarines. Data requested
for peaches will be translated to assess the established tolerance
for residues of EPN in or on nectarines.
There is no Canadian or Mexican tolerance nor is there a
Codex MRL for residues of EPN in or on nectarines.
Peaches
The 25% wettable powder formulation is registered for
foliar applications at 0.125 to 0.625 Ib ai/100 gal plus
1.5% light medium oil. The 4 Ib/gal and 5 Ib/gal emulsifiable
concentrate formulations are registered for foliar applications
at 0.125 to 0.375 Ib ai/100 gal. The 5 Ib/gal emulsifiable
concentrate formulation is also registered for foliar applications
at 1 to 1.5 Ib ai/A or for ULV ground or aerial applications
at 0.42 to 0.625 Ib ai/A (3 to 10 gal/A). Foliar applications
may begin at petal fall and continue at 10- to 14-day intervals
as needed. A delayed dormant application may be made with the
4 Ib/gal and 5 Ib/gal emulsifiable concentrate formulations at
5 Ib ai/A (plus 1.5% oil) at bud swell. Two or three bark
applications, made in summer when borer moths appear, may be
made at 0.313 to 0.75 Ib ai/100 gal with the 25% wettable
powder formulation or the 4 Ib/gal and 5 Ib/gal emulsifiable
concentrate formulations, or at 0.75 to 1.5 Ib ai/A using the
5 Ib/gal emulsifiable concentrate formulation. a 21-day PHI
is in effect. Foliar treatments with the emulsifiable concentrate
formulations may be applied by both aerial and ground equipment.
ULV applications are also permitted for the emulsifiable
concentrate formulations. A tolerance of 3 ppm has been
established for residues of EPN in or on peaches.
The submitted data are not adequate to support the
established tolerance for the residues of EPN in or on peaches
for the following reasons: 1) the data do not reflect residues
in samples harvested at the 21-day PHI following multiple
applications at maximum permissible rates; 2) rates were not
given in Ib ai/A; 3) geographic representation was poor; 4)
aerial application data were not submitted; and 5) no data
relect use of the 25% wettable powder formulation at 0.25 Ib
ai/100 gal plus 1.5% oil. The following data are required to
support the established tolerance:
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-63-
0 Residue data from nature peaches harvested 21 days
following the last treatment in the following regimen:
1) one delayed dormant application using an
emulsifiable concentrate formulation at 5 Ib
ai/A plus 1.5% oil;
2) foliar applications, beginning at petal fall
and continuing at 10-day intervals until 21
days prior to harvest using (in separate tests):
a) the 25% wettable powder formulation at
0.625 Ib ai/100 gal (ground application);
b) the 25% wettable powder formulation at
0.25 Ib ai/100 gal plus 1.5% light medium
oil (ground application); and
c) ULV applications (ground and aerial, in
separate tests) of an emulsifiable
concentrate formulation at 2 Ib ai/A
(maximum expected gal/A rate of 500
adjusted to maintain Ib ai/A rate);
3) two late-summer bark applications at 1.5 Ib
ai/A using the 5 Ib/gal emulsifiable concentrate
formulation at 1.5 Ib ai/A. In the case of ground-
applied high-volume foliar applications, 500 gallons
of spray mixture should be applied per acre. The
tests should be conducted in California and South
Carolina, which produce approximately 74% of
peaches in the United States. The data required
for peaches will also be used for assessment of
the tolerance for residues of EPN in or on
nectarines and apricots. The registrant must
also propose a maximum Ib ai/A rate to complement
the Ib ai/100 gal rate for foliar applications
since it is unlikely that >500 gal/A will be
applied. The Agency recommends a maximum rate
of 2 Ib ai/A for the emulsifiable concentrate
formulations and 3.1 Ib ai/A for the 25% wettable
powder formulation, unless 1-5% oil is added in
which case 1.25 Ib ai/A-of the 25% wettable powder
formulation would be the maximum rate.
There is no Canadian tolerance or nor is there a Codex MRL
for residues of EPN in or on peaches. A Mexican tolerance for
residues of EPN in or on peaches has been established at 3 ppm.
Plums (fresh prunes)
The 25% wettable powder formulation is registered for
foliar applications at 0.125 to 0.625 Ib ai/100 gal plus 1.5%
light medium oil. The 4 Ib/gal and 5 Ib/gal emulsifiable
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-64-
concentrate formulations are registered for foliar applications
at 0.125 to 0.375 Ib ai/100 gal. The 5 Ib/gal emulsifiable
concentrate formulation is also registered for foliar
applications at 1 to 1.5 Ib ai/A. Foliar applications may
be in »t petal fall and continue at 10- to 14-day intervals as
needed. A delayed single delayed dormant application may be
made with the 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations at 5 Ib ai/A (plus 1.5% oil) at bud swell. Two or
three bark applications, made in summer when borer moths appear/
may be made at 0.313 to 0.75 Ib ai/100 gal with the 25% wettable
powder formulation or the 4 Ib/gal and 5 Ib/gal emulsifiable
concentrate formulations, or at 0.75 to 1.5 Ib ai/A using the
5 Ib/gal emulsifiable concentrate formulation. A 21-day PHI is
in effect. Foliar treatments with the emulsifiable concentrate
formulations may be applied by both aerial and ground equipment.
ULV applications are also permitted for the emulsifiable
concentrate formulations.
The submitted data are not adequate to support the
established tolerance for residues of EPN in or on plums
(fresh prunes) for the following reasons: 1) the data do
not reflect multiple foliar applications at maximum-
registered use rates; 2) rates were not given in Ib ai/A;
no data reflect aerial or ground application of an
, beginning at petal fall
and continuing at 10-day intervals until 21
days prior to harvest using (in separate tests)
a) the 25% wettable powder formulation at
0.625 Ib ai/100 gal (ground application);
b) the 25% wettable powder formulation at
0.25 Ib ai/100 gal plus 1.5% light medium
oil (ground application); and
c) ULV applications (ground and aerial, in
separate tests) of an emulsifiable
concentrate formulation at 2 Ib ai/A
(maximum expected gal/A rate of 500
adjusted to maintain Ib ai/A rate).
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3) two late-summer bark applications at 1.5 Ib
ai/A using the 5 Ib/gal emulsifiable concentrate
formulation at 1.5 Ib ai/A. In the case of ground-
applied high-volume foliar applications, 500 gallons
of spray mixture should be applied per acre. The
tests should be conducted in Oregon and Michigan,
which account for approximately 69% of the United
States plum production The registrant must also
propose a maximum Ib ai/A rate to complement the
Ib ai/100 gal rate for foliar applications since
it is unlikely that >500 gal/A will be applied.
The Agency recommends a maximum rate of 2 Ib ai/A
for the emulsifiable concentrate formulations and
3.1 Ib ai/A for the 25% wettable powder formulation,
unless 1.5% oil is added in which case 1.25 Ib
ai/A of the 25% wettable powder formulation would
be the maximum rate.
0 Residue data from dried prunes, processed from plums
bearing measurable, weathered EPN residues. Exaggerated
rates may be required to achieve such residue levels.
If residues are found to concentrate in the dried fruit,
an appropriate food additive tolerance must be proposed.
There is no Canadian or Mexican tolerance nor is there a
Codex MRL for residues of EPN in or on plums (fresh prunes).
Small Fruits Group
A crop group tolerance is not appropriate at this time
for the following reasons:
0 Residue data and a use proposal are needed for four
representative crops: blueberries, cranberries,
strawberries, and blackberries (or another Rubus
species).
0 Data are required to support the established
tolerance for residues of EPN in or on grapes, a
representative crop.
Blackberries, Boysenberries, Dewberries, Loganberries,
Raspberries, Strawberries, and Youngberries
There are currently no registered uses of EPN on black-
berries, boysenberries, dewberries, loganberries, raspberries,
strawberries, and youngberries. However, tolerances of 3 ppm
have been established for residues of EPN in or on blackberries,
boysenberries, dewberries, loganberries, raspberries, strawberries,
youngberries. Since there are no registered uses of EPN for these
crops the Agency will revoke the established tolerances unless the
registrant proposes uses for these crops and submits appropriate
residue data in support of the established tolerances.
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There are no Canadian or Mexican tolerances nor are there
Codex MRLs for residues of EPN in or on blackberries, boysen-
berries, dewberries, loganberries, raspberries, strawberries,
and youngberries.
Grapes
The 25% wettable powder formulation is registered for an
unspecified number of foliar applications to grapes at 0.125
to 0.25 lb ai/100 gal, and at 0.25 Ib ai/A. The 4 Ib/gal and
5 Ib/gal emulsifiable concentrate formulations are also
registered for foliar applications at 0.125 to 0.25 lb ai/100
gal. A 21-day PHI is in effect. Both aerial and ground
applications of the emulsifiable concentrate formulation are
permitted. Emulsifiable concentrate formulations may also be
applied with ULV equipment. A tolerance of 3 ppm has been
established for residues of EPN in or on grapes.
The submitted data are not adequate to support the
established tolerance for residues of EPN in or on grapes
for the following reasons: 1) no data were submitted for
the emulsifiable concentrate formulations; 2) no data were
submitted for aerial application of the emulsifiable concentrate
formualtions; 3) samples were not collected at the 21-day PHI;
and 4) geographic representation was poor. The following data
are required:
0 Residue data from mature grapes, harvested 21 days
after the last of several foliar applications made,
in separate tests, aerially (including ULV applications)
and with ground equipment (including ULV and high-volume
applications) using an emulsifiable concentrate formula-
tion at 0.25 lb ai/100 gal (250 gal/A) for high-volume
applications and at 0.63 lb ai/A for ULV applications.
High-volume foliar application tests (ground-applied)
with the 25% wettable powder formulation must also be
made at 0.25 lb ai/100 gal (250 gal/A). The ULV rate
was calculated from the lb ai/100 gal rate at a maximum
expected gal/A of 250 to maintain the correct rate of
active ingredient per acre. The applications should be
made at 10-day intervals beginning at bloom. The
registrant must propose a maximum lb ai/A rate for
high-volume applications since the maximum expected
gal/A rate is 250. The Agency recommends that a maximum
rate of 0.63 lb ai/A be proposed.
0 Residue data from raisins, raisin waste, juice, wet
pomace and dried pomace processed from grapes bearing
measurable, weathered EPN residues. Exaggerated rates
may be necessary to achieve such residue levels. If
residues concentrate in any of these processed products,
appropriate food and/or feed additive tolerances must be
proposed.
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There is no Canadian tolerance nor is there a Codex MRL
for the residues of EPN in or on grapes. A Mexican tolerance
of 3 ppm has been established for the residues of EPN in or on
grapes.
Tree Nuts Group
A crop group tolerance is not appropriate at this time for
the following reason:
0 Data must be submitted to support the established
tolerances for residues of EPN in or on the
representative crops: almonds, pecans, and English
walnuts.
Almonds
The 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations are registered for an unspecified number of
foliar applications at 0.125 to 0.25 Ib ai/100 gal using
aerial or ground equipment. Use of ULV applications
equipment is also permitted for the emulsifiable concentrate
formulations. The 25% wettable powder formulation is also
registered for an unspecified number of foliar applications
at 0.125 to 0 188 Ib ai/100 gal (800 gal/A maximum), using
ground equipment. A 21-day PHI is in effect. A tolerance
of 0.5 ppm has been established for residues of EPN in or
on almonds.
No residue data have been submitted in support of the
established tolerance for residues of EPN in or on almonds.
Likewise, no data or tolerance proposal have been submitted
for residues of EPN in or on almond hulls. The following
data are required:
0 Residue data from mature almond nutmeats and
corresponding hulls, harvested 21 days after the
last of several foliar ground applications of an
emulsifiable concentrate formulation at, 0.25 Ib
ai/100 gal (800 gal/A) using high-volume ground
equipment and 2 Ib ai/A using ULV ground equipment,
in separate tests. The data should also reflect
ULV aerial applications of the emulsifiable concentrate
at 2 Ib ai/A. The Ib ai/A rate for ULV applications
was calculated from the maximum expected gal/A rate
(800) at 0.25 Ib ai/100 gal to maintain the correct
rate of active ingredient per acre. The tests should
take place in California, where the majority of almonds
are produced in the United States. In addition, the
registrant must propose a maximum Ib ai/A rate for
foliar applications to complement the maximum registered
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Ib ai/100 gal rate (0.25) since it is unlikely that
>800 gal/A will be applied. The Agency recommends that
a maximum rate of 2 Ib ai/A be proposed.
There is no Canadian tolernce nor is there a Codex MRL for
residues of EPN in or on almonds. A Mexican tolerance of 0.5 ppm
has been established for residues of EPN in or on nuts.
Pecans
The 25% wettable powder formulation and the 2 Ib/gal and
5 Ib/gal emulsifiable concentrate formulations are registered
for multiple foliar treatments as needed at 0.125 to 0.5 Ib
ai/100 gal. The 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations are also registered for use at 1 to 3.5 Ib ai/A.
Emulsifiable concentrate formulations may be applied using
aerial or ground equipment. Use of ULV equipment is also
permitted for applying emulsifiable concentrate formulations.
A 21-day PHI is in effect. A tolerance of 0.5 ppm has been
established for residues of EPN in or on pecans.
No residue data have been submitted in support of the
established tolerance for residues of EPN in or on pecans.
The following data are required:
0 Residue data from pecans harvested 21 days after the
last of several foliar applications with the 25%
wettable powder formulation and, in separate tests,
an emulsifiable concentrate formulation, at 0.5 Ib
ai/100 gal (1000 gal/A). The data should also
reflect, in separate tests, both ground and aerial ULV
applications of an emulsifiable concentrate formulation
at 5 Ib ai/A. The Ib ai/A rate for ULV applications
was calculated from the maximum expected gal/A rate
(1000) at 0.5 Ib ai/100 gal to maintain the correct
rate of active ingredient per acre. The tests should
take place in Georgia and New Mexico, which together
produce approximately 70% of the United States pecan
crop. The registrant must also propose a maximum Ib
ai/A rate for foliar applications to complement the
maximum registered Ib ai/100 gal rate (0.5) since
it is unlikely that >1000 gal/A will be applied.
The Agency recommends that a maximum rate of 5 Ib
ai/A be proposed.
There is no Canadian tolerance nor is there a Codex MRL
for residues of EPN in or on pecans. A Mexican tolerance of
0.5 ppm has been extablished for residues of EPN in or on nuts.
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Walnuts
The 4 Ib/gal emulsifiable concentrate formulation is
registered for multiple foliar applications at 3 to 3.5 Ib
ai/A. The 25% wettable powder formulation and the 4 Ib/gal
and 5 Ib/gal emulsifiable concentrate formulations are also
registered for multiple foliar applications at 0.125 to 0.25
Ib ai/100 gal. Emulsifiable concentrate formulations may be
applied using aerial or ground equipment. Applications of
emulsifiable concentrate formulations is also permitted with
ULV equipment. A 21-day PHI is in effect. A tolerance of
0.5 ppm has been established for residues of EPN in or on
walnuts.
No residue data have been submitted in support of the
established tolerance for residues of EPN in or on walnuts.
The following data are required:
0 Residue data from mature walnuts, harvested 21 days
after the last of several applications of the 4 Ib/gal
emulsifiable concentrate formulation at 3.5 Ib ai/A,
beginning at petal fall and continuing at 10-day
intervals using, in separate tests, aerial and ground
equipment, including tests using ULV equipment. Data
reflecting the 25% wettable powder formulation are not
required since the maximum-expected Ib ai/A rate, based
on 1000 gal/A, for this formulation is much lower than
3.5 Ib ai/A. The tests should take place in California,
where the majority of walnuts are grown. The registrant
must also propose a maximum Ib ai/A rate for high-volume
applications to complement the maximum Ib ai/100 gal
rate.
There is no Canadian tolerance nor is there a Codex MRL for
residues of EPN in or on walnuts. A Mexican tolerance of 0.5 ppm
has been established for residues of EPN in or on nuts.
Cereal Grains Group
A crop group tolerance is not appropriate at this time
for the following reason:
0 Data are required for three additional representative
commodities: rice, sorghum and wheat.
Corn
The 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations, the 25% wettable powder formulation, and the
2% and 4% granular formulations are registered for multiple
foliar applications on field and sweet corn and corn grown
for seed at 0.47 to 0.5 Ib ai/A. The 4 Ib/gal emulsifiable
concentrate formulation may be similarly applied to field
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corn only at 0.75 lb ai/A. A 14-day PHI is in effect for all
corn crops. Emulsifiable concentrate formulations may be
applied both aerially and from the ground. ULV applications
of emulsifiable concentrate formulations are also permitted.
A tolerance of 3 ppm has been established for residues of EPN
in or on corn.
The submitted data support the established tolerance for
residues of EPN in or on corn; however, the Agency recommends
that the registrant or petitioner propose two separate tolerances
for residues of EPN in or on 1) field corn grain and 2) sweet
corn (kernels plus cob with husks removed) at the currently
established level of 3 ppm. Data are required, however, to
determine if residues of EPN concentrate in field corn processed
products. The following data are required:
0 Residue data from corn processed products, including
milled products, crude oil, and refined oil, processed
from corn grain bearing measurable, weathered EPN residues.
Exaggerated rates may be required to achieve such residue
levels. If residues are found to concentrate, appropriate
food and/or feed additive tolerances must be proposed.
There is no Canadian tolerance nor is there a Codex MRL
for residues of EPN in or on corn. A Mexican tolerance of
3 ppm has been established for residues of EPN in or on corn.
Forage, Fodder and Straw of Cereal Grains Group
A crop group tolerance is not appropriate at this time
for the following reasons:
0 Additional data are required for residues in or on
corn forage, fodder and silage. Tolerances must be
proposed for residues in or on these commodities.
0 Data are required for two additional representative
crops: wheat and another cereal grain.
Corn Forage, Silage and Fodder
The 4 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations, the 25% wettable powder formulation, and the 2%
and 4% granular formulations are registered for multiple foliar
applications on field and sweet corn and corn grown for seed at
0.47 to 0.5 lb ai/A. The 4 Ib/gal emulsifiable concentrate
formulation may be similarly applied to field corn only at 0.75
lb ai/A. A 14-day PHI is in effect for all corn crops.
Emulsifiable concentrate formulations may be applied both
aerially and from the ground. ULV applications of emulsifiable
concentrate formulations are also permitted. There are no
tolerances for residues of EPN in or on corn forage, silage or
fodder.
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Since EPN is registered for use on field and sweet corn,
tolerances for residues in or on the following raw agricultural
commodities must be proposed: forage, silage/ and fodder.
The submitted data are not adequate to determine appropriate
tolerances for EPN residues in or on corn forage, fodder and
silage. Therefore, the following data are required:
0 Residue data from sweet corn forage and field corn
forage, fodder and silage harvested after the last
of several foliar applications of an emulsifiable
concentrate formulation and in, separate tests, a
granular formulation and a wettable powder formualtion
at 0.75 Ib ai/A. The tests should include aerial and
ground ULV applications of an emulsifiable concentrate
formulation. Forage must be collected at intervals
following the last application. A pregrazing interval
must be proposed. Fodder and silage must be harvested
14 days after the last treatment. Test should take
place in Iowa, Indiana, Florida, Minnesota, California,
New York, and Tennessee, which collectively represent
all of the major areas of the United States where field
and sweet corn foliage would be used for forage, fodder
or silage.
There are no Canadian or Mexican tolerances nor is there
a Codex MRL for residues of EPN in or on corn forage, silage,
or fodder.
Miscellaneous Commodities
Cottonseed
The 2 Ib/gal and 5 Ib/gal emulsifiable concentrate
formulations are registered for aerial or around multiple
foliar applications at 0.313 to 1 Ib ai/A. The 5 Ib/gal
emulsifiable concentrate formulation may also be used at a
lower rate of 0.188 Ib ai/A. Use of ULV equipment is
permitted. A 3-day PHI is in effect. Treated forage or
gin may not be fed to livestock. A tolerance of 0.5 ppm
has been established for residues of EPN in or on cottonseed.
The submitted data are adequate to support the established
tolerance for residues of EPN in or on the raw agricultural
commodity, cottonseed. The data are also adequate to show
that concentration of residues does not occur upon processing
cottonseed into meal, but does occur, at up to approximately
40 times, upon processing into oil. The registrant must
propose a food additive tolerance for residues of EPN in
cottonseed oil. The Agency recommends that a tolerance of
20 ppm be proposed. In addition, the following data are
required to determine if EPN residues concentrate in two
other processed products, hulls and soapstock:
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0 Residue data from cottonseed hulls and soapstock,
processed from cottonseed bearing measurable,
weathered EPN residues. Exaggerated rates may be
necessary to achieve such initial residue levels.
If residues are found to concentrate in either product,
appropriate feed additive tolerances must be proposed.
There is no Canadian tolerance nor is there a Codex MRL
for residues of EPN in or on cottonseed. A Mexican tolerance
of 0.5 ppm has been established for residues of EPN in or on
cottonseed.
Olives
The 25% wettable powder formulation is registered for an
unspecified number of ground-applied foliar applications at
<4 Ib ai/A (0.313 to 0.625 Ib ai/100 gal) or at 0.25 lb/100
gal when mixed with 1.5% light medium oil. The 4 Ib/gal and
5 Ib/gal emulsifiable concentrate formulations are registered
for ground or aerial foliar applications at 4 to 12 Ib ai/A.
ULV treatments are permitted with the emulsifiable concentrate
formulations. No PHI is in effect, but applications may not
be made after July 15. A tolerance of 3 ppm has been established
for residues of EPN in or on olives.
No data were submitted in support of the established
tolerance for residues of EPN in or on olives. Therefore, the
following data are reguired:
0 Residue data from mature olives harvested from trees
which received several foliar applications of the
4 Ib/gal or 5 Ib/gal emulsifiable concentrate formulation
at 12 Ib ai/A and, in separate tests, of the 25% wettable
powder formulation at 0.25 Ib ai/100 gal plus 1.5%
light medium oil (800 gal of spray/A). The last
application should be made on July 15. Residue data
reflecting both aerial and ground applications, including
the use of ULV equipment, with an emulsifiable concentrate
formulation must be submitted. Only ground application
data are reguired for the 25% wettable powder formulation.
Tests must be conducted in California.
o
Residue data from olive oil, produced from olives bearing
measurable, weathered residues of EPN. Exaggerated rates
may be necessary to achieve such initial residue levels.
If concentration of residues does take place, an appropriate
food additive tolerance must be proposed.
There is no Canadian or Mexican tolerance nor is there a
Codex MRL for residues of EPN in or on olives.
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Pineapples
There are currently no registered uses of EPN on pineapples.
However, a tolerance of 3 ppm has been established for residues
of EPN in or on pineapples. Since there is no registered use
of EPN for this crop the Agency will revoke the established
tolerance unless the registrant proposes a use and submits
appropriate residue data in support of the established tolerance,
There is no Canadian tolerance nor is there a Codex MRL
for residues of EPN in or on pineapples. A Mexican tolerance
of 3 ppm has been established for residues of EPN in or on
pineapples.
Magnitude of the Residue in Meat, Milk/ Poultry and Eggs
Tolerances have not been proposed or established for
residues of EPN in the fat, meat and meat by-products of
cattle, goats, hogs, horses, sheep or poultry, or for the
residues of EPN in milk or eggs.
There are no direct animal treatments for EPN on cattle,
goats, hogs, horses, sheep or poultry. Tolerances have been
established for residues of EPN in or on the following raw
agricultural commodities on which registered uses exist and
which may either be fed directly (unprocessed) or processed
into commodities which may be fed to livestock: sugar beets
(tops, dehydrated pulp, mollasses), beans (seeds, vines, hay,
cannery residue), soybeans (seed, meal, hulls, ensiled hay,
straw, forage, soapstock), citrus (pulp, molasses), apples
(dehydrated pomace), almonds (hulls), corn (grain, forage,
silage, fodder, cannery waste), cotton (seed, seed meal,
hulls, soapstock), tomatoes (pomace) and grapes (pomace and
raisin waste). Since additional data are required to support
tolerances for residues of EPN in or on many of these raw
agricultural commodities and data are needed to determine
whether concentration of residues occurs on processing, the
Agency is unable to estimate the maximum expected intake of
EPN residues by cattle, poultry or swine at this time.
(Refer to the section of this document entitled "Magnitude
of the Residues in Plants" for details of data requirements.)
Also, the nature of the residue in animals has not been
adequately described. Therefore, the Agency will not assess
the adequacy of the available data at the present time.
However, it has been determined that 14C-residues of [14C]EPN
transfer to the tissues of poultry and that EPN per se
constitutes a major percentage of the residues in fat. (Refer
to the section of this document entitled "Nature of the Residue
in Animals" for details. ) Upon receipt of the requested animal
metabolism data, and data pertaining to residues in major feed
items, the adequacy of the available data will be assessed and
specific data requirements regarding residues in animal products
will be determined.
There are no Canadian or Mexican tolerances nor are there
Codex MRLs for residues of EPN in or on animal products.
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2. Pesticide Monitoring Data
No information has been received to date from the United
States Department of Agriculture pertaining to monitoring data,
although the Agency has requested such information. Data are
available, however, from the Food and Drug Administration for
samples of several crops analyzed between fiscal years 1978
and 1984. These data are summarized below.
Residue Range (ppm)
Ap pi e s
Rice hulls
Rice bran
Wheat
Okra
Peppers (1980)
Mustard greens
Lettuce
Spices
Peppers (1983)
Peppers (1984)
1
1
1
1
1
1
1
1
1
4
2
0.06
0.27
0.14
trace
0.10
0.38
trace
0.02
0.02
0.03 - 0.86
0.09 - 0.59
Of the crops represented, only apples and lettuce have EPN
registrations and tolerances for residues of EPN. The values
reported are well below the established tolerances. The measurable
EPN residues in the other corps, which do not have EPN registrations
or tolerances for residues of EPN, may represent illegal use of
EPN in the United States or may represent use of EPN on crops
imported from other countries. Seven samples of peppers, in
three different years, contained an average of 0.35 ppm EPN.
However, the fifteen crop samples reported are apparently the
only samples having measurable EPN residues out of 50,000 samples
tested in fiscal years 1978 thru 1984. The Agency will request
that FDA conduct further monitoring on these crops to determine
how widespread the problem may be. Subsequently, the registrants
may be asked to submit data proposing tolerances for these crops.
3. Toxicology Data and Acceptable Daily Intake (ADI)
The Acceptable Daily Intake (ADI) or Provisional Acceptable
Daily Intake (PADI), if there are inadequate toxicology data to
establish an ADI, and the Maximum Permissible Intake (MPI) are
ways of expressing the amount of substance that the Agency believes,
on the basis of the results of data from animal studies and the
application of "safety" or "uncertainty" factors, may safely be
ingested by humans without risk of adverse health effects. The
ADI and PADI are expressed in terms of milligrams (mq) of the
substance per kilogram (kg) of body weight per day (mg/kg/day).
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The MPIf a related figure based on whole body exposure, is
obtained by assuming a human body weight of 60 kg, and is
expressed in terms of mg of substance per day (mg/day).
Section I I.E. of this document discussed the regulatory
history of EPN relative to the Agency's earlier assessment of
neurotoxicity studies in which it concluded that the subchronic
(90-day hen) delayed neurotoxicity study was inadeguate and
that the Agency would rely on a human cholinesterase inhibition
study to assess toxicological risks to consumers and workers.
However, with the subseguent submission of the new, acceptable
delayed neurotoxicity studies (90-day and recovery), the Agency
now believes that these two studies are more appropriate to use
for risk assessments.
These assessments are provided in subsections B.9. and 10.,
above. In summary, the Agency concludes that the NOEL of 0.01
mg/kg/day from irreversible nerve damage in the spinal cord
is appropriate to use at this time to establish a PADI. Because
the NOEL is from a subchronic study, a 1000-fold safety factor
(or uncertainty factor) is being used, which results in a PADI
value of 0.00001 mg/kg/day. The MPI value is therefore 0.0006
mg/day- The theoretical maximum residue contribution (TMRC),
which is the maximum amount of a pesticide that would be in the
human diet, is 0.9859 mg/kg/day. The TMRC is based on the
assumptions of an average body weight of 60 kg, a 1.5 kg daily
diet, and certain food factors for the commodities with EPN
tolerances (Table 4 on page 31). Based on the PADI value of
0.00001 mg/kg/day, the TMRC is 164,000 percent of the PADI.
For reasons discussed in subsection B, the Agency believes this
percentage is likely to be exaggerated due to unrealistic
residue (tolerance) values and the assumption of 100% of crop
acreage treated. Table 5 on page 32 presents a more likely
assessment for five crops based on actual residue data and
percent of crop treated
At this time, the Agency concludes that the present TMRC,
which is a measure of the upper limit of possible dietary
exposure, is far greater than what is reasonably likely to be
found in practice, but there are several data gaps. When the
additional chronic feeding studies necessary to establish an
ADI are submitted and the extensive residue chemistry and
toxicology data gaps are filled, the Agency will again evaluate
the percentage of the ADI utilized. In the meantime the Agency
will not approve any significant^ new uses for EPN, including
group tolerances. In the Special Review of EPN, the Agency will
consider cancellation of some or all uses of EPN and will
consider revoking tolerances.
6 "Significant new use is defined in 44 FR 27934, May 11, 1979.
In the case of a new food or feed use, the Agency will generally
consider as significant an increase in the Theoretical Maximum
Residue Contribution (TMRC) of greater than 1%.
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4. Tolerance Reassessment Summary and Current Tolerances
It should be noted that data gaps exist for the storage
stability and metabolism of EPN in plants and animals.
Because the requested data and perhaps the continued adequacy
of all established tolerances are dependent upon the results
of the studies in the "Residue Data" section above, it is
imperative that the metabolism data be collected prior to
the requested residue data. Furthermore, the conclusions
stated below are subject to change on receipt of the
requested metabolism data and storage stability data.
Sufficient data are available to ascertain the adequacy
of the established tolerances for residues of EPN in or on
the following raw agricultural commodities (RACs): beans
(dried), cottonseed, tomatoes, and corn. In order to be
consistent with the commodity definitions listed in
40 CFR 180.34 (f), the Agency requires (1) that the
tolerance for residues in or on corn be changed to two
tolerances, each at 3 ppm, for residues in or on field corn
grain and sweet corn (kernels plus cob with husks removed) and
(2) that the tolerance for residues in or on beans be changed to
three tolerances for residues in or on dried beans, at 3 ppm,
and lima and snap beans for which additional data are required.
Additional data are required to support the established
tolerances for residues in or on almonds, apples, apricots,
beans (snap and lima only), cherries, citrus, grapes, lettuce,
nectarines, olives, peaches, pears, pecans, plums, soybeans,
sugar beets (without tops), and walnuts.
Also, residue data and EPN usage proposals are required
to support tolerances for residues in or on beets and beet
greens, blackberries, boysenberries, dewberries, loganberries,
pineapples, quinces, raspberries, rutabagas, spinach,
strawberries, turnips and turnip greens, and youngberries;
alternatively, the Agency will move to revoke these tolerances.
The Agency will also move to revoke the tolerance for residues
in or on rutabaga tops since rutabaga tops are not presently
considered a raw agricultural commodity (RAC) of rutabagas
and no registered use of EPN on rutabagas exists.
In addition to the conclusions given above regarding
established tolerances, the following requirements and
recommendations are made pertaining to residues in RACs and
processed products:
1) data are required to determine whether food and/or
feed additive tolerances are needed for residues in the
following processed products: dehydrated sugar beet pulp,
sugar beet molasses, refined sugar beet sugar, soybean hulls,
soybean soapstock, bean cannery residue, wet and dried tomato
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poroace, tomato puree, tomato catsup, tomato juice, dried
citrus pulp, citrus oil, citrus juice, citrus molasses, dried
prunes, raisins, raisin waste, grape juice, wet and dried
grape pomace, apple juice, wet and dried apple pomace,
cottonseed hulls, cottonseed soapstock, crude and refined
corn oil and corn milling products, and olive oil.
2) data and tolerance proposals for residues of EPN in
or on corn forage, silage and fodder, almond hulls, and
soybean forage and straw are required.
3) data and tolerance proposals for residues of EPN in
or on bean vines and hay and sugar beet tops and pregrazing
interval proposals for bean vines and sugar beet tops must be
submitted; alternatively, feeding and grazing restrictions
may be proposed.
4) food additive tolerances must be proposed for residues
of EPN in cottonseed oil and soybean oil; the data indicate
that a tolerance of 20 ppm will be adequate for residues in
cottonseed oil; a food additive tolerance 6 times the acceptable
tolerance for soybeans will be appropriate for residues in
soybean oil.
5) crop group tolerances for EPN are not appropriate at
this time because extensive additional residue are needed.
Also, since most of the required toxicological studies are
missing and data are required in order to estimate dietary
exposure, no new tolerances either group or otherwise, or
new uses, will be established.
The Agency's calculation of the ADI for EPN is discussed
in detail in Section III. D. 3. "Toxicology Data and Acceptable
Daily Intake (ADI)" above.
Tolerances issued
The present United States tolerances (40 CFR 180.119)
and Mexican tolerances are listed on the following page. There
are no Canadian tolerances or Codex MRL's established for EPN.
The regulatory results of the Agency's review are set out
in Section IV.A., Regulatory Positions and Rationales.
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EPN
Summary of Present Tolerances
Commodity
Apples
Apricots
Beans
Beets
Beet greens
Blackberries
Boysenberries
Cherries
Citrus fruits
Corn
Dewberries
Grapes
Lettuce
Loganberries
Nectarines
Olives
Peaches
Pears
Pineapples
Plums (fresh prunes)
Quinces
Raspberries
Rutabagas
Rutabagas tops
Spinach
Strawberries
Sugarbeets (but not sugar
beet tops)
Toma toes
Turnips
Turnip greens
Youngberries
Almo nds
Cottonseed
Pecans
Walnuts
Soybeans
Nuts
Tolerance (ppm)
United States
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
0.5
0.5
0.5
0.5
0.05
Mexico
3.0
3.0
_._ _
3.0
3.0
3.0
3.0
_ —
— _
___
3.0
3.0
3.0
___
—
» __
— — _
M -__
3.0
3.0
3.0
— — —
_ __
— _ _
_ -.—
0.5
— «_
— .— —•
0.05
0.5
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IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Positions and Rationales
Based on review and evaluation of all available data and
other relevant information on EPN, the Agency has made the
following determinations:
1. EPN is being placed in Special Review.
Rationale: The Agency is initiating a Special Review for
all registered uses of EPN based on the results of the
delayed neurotoxicity studies, and risks to workers
involved with EPN application and working in fields
treated with EPN and the risks to the public from con-
sumption of food ccmmodities containing EPN residues.
The delayed neurotoxicity effects and the risks from
continued use of EPN meet or exceed the criteria for
unreasonable adverse effects (40 CFR 154.7(a)(2)). The
Agency is also concerned about the toxicity of EPN to
aquatic and avian species and is requesting actual and
simulated field studies to assess the potential toxic
effects of EPN to these organisms.
The Agency has reviewed the comments received in
response to the Preliminary Notification to Registrants
issued pursuant to 40 CFR 154.21. The comments do not
change the Agency's position regarding the need for
Special Review of EPN.
Therefore, the Agency is placing EPN in the Special
Review Process. The comments received by the Agency will
be addressed in detail in the Federal Register
Notice which the Agency plans to issue.
2. The Agency will continue to restrict all uses of liquid
and dry (granular and wettable powder) formulations
of EPN greater than 4%.
Rationale; The restricted use classification was originally
imposed on EPN liquid and dry formulations greater than 4%
in January 1981 because of its acute dermal toxicity, acute
inhalation toxicity and residue effects on avian species.
Acute toxicity data available to the Agency show that EPN
continues to meet or exceed these criteria for restricted
use. Therefore, the Agency will continue to classify EPN
liquid and dry formulations greater than 4% for restricted
use.
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3. In order to remain in compliance with FIFRA, registrants
must amend their labels to incorporate a label statement
concerning the histopathological changes in the spinal
cord and delayed neurotoxicity to be used in conjunction
with the restricted use statement.
Rationale; The Agency believes that a statement of the
reason for a product's restricted use classification should
be included on the labels of restricted use products. This
statement affords the product user with important information
about the potential product hazard(s) that are associated
with the use of the product and are the foundation for
the restricted use classification.
4. The Agency does not believe that a groundwater advisory
statement on EPN labeling is necessary at this time.
Rationale; Data currently available to the Agency are
insufficient to either assess the environmental fate of EPN
or to characterize its leaching potential for contamination
of ground water. EPN was not included in the Special Ground-
water Data Call-in Notice the Agency issued on March 31,
1984. Data allowing assessment of the leaching potential
and environmental fate of EPN are required.
5. Pending receipt of acute delayed neurotoxicity
data on which to base the risk assessment to determine
the most effective reentry interval for EPN, the Agency
has determined that the following reentry intervals are
necessary in order for these products to remain in
compliance with FIFRA; 7 days for corn and cotton;
35 days for citrus; and 2 days for all other crops.
The reentry intervals were chosen based on MOSs shown
in Table 7.
Rationale; Preliminary evaluation of recently submitted
toxicity and dissipation data indicate that the 24-hour
reentry interval established in 1974 for EPN under
40 CFR 170.3 (b)(2) does not provide adequate protection
for fieldworkers. Therefore, the Agency is establishing
these new and longer reentry intervals. However, upon
receipt and review of the required acute delayed neuro-
toxicity data the Agency may need to revise these reentry
intervals.
6. The Agency has determined that, in order to meet applicable
FIFRA standards, protective clothing must be worn by mixer/
loaders and applicators and that all EPN end-use product
labeling must contain work safety rules, precautionary
statements, and protective clothing statements. (Refer to
Section IV. D. for the required protective clothing labeling)
Rationale; EPN is an organophosphate chemical that can
induce cholinesterase inhibition upon repeated significant
exposure and has been shown to produce delayed neurotoxicity
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and histopathological changes in the spinal cord in labora-
tory animals. To protect workers against the acute toxicity
and potential nerve damage of EPN, protective clothing (a
protective suit of one or two pieces that covers all parts
of the body except the head, hands/ and feet; chemical
resistant gloves and chemical resistant boots, shoes, or
shoe coverings) is necessary to lessen worker exposure
during the mixing, loading and application of EPN. The
required work safety rules and precautionary labeling
statements provide specific guidance for persons handling
EPN products, describe the required protective clothing
and equipment for use, as well as procedures for minimizing
exposure to EPN contaminated materials.
7. Endangered species labeling may be required at a later date
for certain use patterns of EPN.
Rationale; EPN is toxic to certain endangered/threatened
species of mammals, birds, aquatic organisms, crustaceans,
reptiles and insects. The Agency, in an attempt to limit
use of EPN in areas where its use may be detrimental to
endangered/threatened species, will require that endangered
species information be included on labeling of end-use
products which contain certain terrestrial food crop and
terrestrial nonfood use patterns. The required labeling
will be based on Biological Opinions by the Office of
Endangered Species (OES) of the Fish and Wildlife Service,
U. S. Department of Interior. The Agency has developed
labeling to protect endangered species from exposure to
EPN and will impose these labeling requirements through
a Pesticide Registration (PR) Notice which addresses not
only EPN, but other pesticides with similar uses, determined
to cause jeopardy to endangered species.
8. The Agency is requiring an aquatic residue monitoring
study or a mesocosm study.
Rationale; Ecological effects data currently available
to the Agency are insufficient for estimating EPN's
environmental contamination potential. The above
studies are necessary in order for the Agency to estimate
environmental contamination and to complete the assessment
of the persistence of EPN relative to its chronic toxicity
or bioaccumulation potential.
9. The Agency does not believe that a rotational crop
restriction is necessary.
Rationale; The Agency lacks appropriate rotational crop
data at the present tine to determine whether planting
food or feed crops in EPN-treated soils would result in
illegal residues in these crops. If required data
demonstrate that follow-up crops take up EPN residues
from soil, rotational crop restrictions or tolerances
in those crops may be neccesary.
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10. The Agency cannot conduct a full tolerance reassessment
for EPN at this time.
Rationale: Data gaps exist for plant and animal metabolism,
storage stability, magnitude of the residues in several raw
agricultural commodities and processed food and feed items,
in addition to toxicology data gaps in the area of chronic
f eed ing/oncogen icity. Upon receipt of the data required in
Table A, the Agency's conclusions with regard to the adequacy
of established tolerances are subject to change. Since the
data required for individual commodities are dependent on
the metabolism data, the metabolism data will be obtained
and reviewed prior to any required residue data.
11. No significant7 new uses, including group tolerances, will
be granted while EPN is in the Special Review process and
until the Agency has received data sufficient to evaluate
the dietary exposure to EPN.
Rationale; The current tolerance assessment, based on the
subchronic delayed neurotoxic effect, residues at tolerance
levels and 100% crop treated, shows a Theoretical Maximum
Residue Contribution (TMRC) which occupies 164,000% of
the Provisional Acceptable Daily Intake (PADI). While
calculation of the five crops for which there are residue
data, based on percent crop treated, shows roughly
acceptable intake levels, many other tolerances and data
gaps remain. The residue chemistry and toxicology data
bases for EPN are not sufficient to assess the existing
tolerances or to establish crop group tolerances. Plant
and animal metabolism data and residue data on various
commodities are required. The pertinent toxicology data
requirments include: chronic feeding/ oncogenicity, and
reproduction. (Refer to Appendix I, Table A, for a listing
of residue chemistry and toxicology data required). Until
these data are submitted and reviewed, the Agency cannot
perform a full tolerance reassessment for EPN. The Agency
believes that allowing significant dietary exposure to
pesticides for which a full tolerance reassessment is
impossible would not adequately protect the public.
12. The Agency has determined that the tolerances for beets and
beet greens, blackberries, boysenberries, dewberries, logan-
berries, pineapples, quinces, raspberries, rutabagas, spinach,
strawberries, turnips and turnip greens, and youngberries
should be revoked because there are no registered uses of
EPN for these raw agricultural commodities. Alternatively,
7 "Significant new use" is defined in 44 FR 27934, May 11, 1979.
In the case of a new food or feed use, the Agency will generally
consider as significant an increase in the Theoretical Maximum
Residue Contribution (TMRC) of greater than 1%.
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the residue data and usage proposals are required for each
of the above crops. This data roust be submitted by
September 26, 1988 to avoid revocation action by the Agency
Rationale; There are currently no registered uses for
EPN on these crops. The Agency can not evaluate the
adequacy of the tolerance in the absence of directions
for use.
13. The Agency will move to revoke the tolerance for residues
of EPN in or on rutabaga tops.
Rationale: Rutabaga tops are not presently considered a
agricultural commodity of rutabagas. In addition, there i
no registered use of EPN on rutabagas at the present time.
14. The Agency is requiring processing data for the following
raw agricultural commodities: sugar beets, soybeans,
tomatoes, citrus, prunes, grapes, apples, cottonseed,
corn, and olives.
Rationale; The Agency has no data to determine whether
residues of EPN concentrate when these commodities are
processed into food or feed items.
15. The Agency believes that the addition of the telephone
number of the National Pesticide Telecommunications
Network to the labels of all end-use EPN products is
necessary in order for such products to meet applicable
FIFRA standards.
Rationale; The telephone number is included in order
to provide a source of first aid information in the
event of an exposure accident.
16. While data gaps are being filled, currently registered
manufacturing use products (MPs) and end use products
(EPs) containing EPN as the sole active ingredient may
be sold, distributed, formulated and used, subject to
the terras and conditions specified in this Standard.
Registrants must provide or agree to develop additional
data, as specified in the Data Appendices, in order to
maintain existing registrations.
Rationale; Under FIFRA, the Agency may choose not to
cancel or withhold registration if data are
missing or are inadequate (see FIFRA sec. 3(c)(2)(B)
and 3(c) (7) ).
raw
is
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain EPN as the sole active ingredient, bear
required labeling, and conform to the product composition,
acute toxicity limits, and use pattern requirements listed
in this document.
The applicant for registration or reregistration of
manufacturing use products subject to this standard must comply
with all terms and conditions described, including submission of
an up-to-date Confidential Statement of Formula, submission of
revised labeling, commitment to fill data gaps on the schedule
as specified by the Agency and, when applicable, offer to pay
compensation as required by sections 3(c)(l)(D) and 3(c)(2)(D)
of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIRFA), as amended, 7 U.S.C. 136 (c)(2)(D). Registrants of
end-use products who qualify for the Formulator's Exemption**
must submit five (5) copies of draft labeling incorporating
the unique label statements identified in Section D of the
document. Registrants of end-use products who do not qualify
for the Formulator's Exemption must comply with the terms and
conditions set forth above for manufacturing-use registrants.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain EPN as the sole
active ingredient. Each MP formulation proposed for registration
must be fully described with an appropriate certification of
limits, stating maximum and minimum amounts of the active
ingredient and inert ingredients which are present in products,
as well as impurities found at greater than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing EPN provided that
the product labeling bears appropriate precautionary statements
for the acute toxicity category in which each product is
placed.
O
0 As of the date of issue of this registration standard,
there are no registrations for Technical EPN
products or manufacturing-use products in the United
States. Therefore, registrants of end-use products
containing EPN do not qualify for the Formulator's
Exemption at this time.
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3. Use Patterns
To be registered under this Standard, manufacturing-use
products ay be labeled for formulation into end-use products
only for the commodities listed below.
Terrestrial Food Crop
(Agricultural Crops)
Almond
Apple
Apricot
Beans
Black-eyed Peas
Cherry
Citrus Citron
Citrus Fruits
Corn, Field
Corn (seed crop)
Corn, Sweet
Cotton
Cowpeas
Grapefruit
Grapes
Green Beans
Kumquat
Lemon
Lima Beans
Lime
Navy Beans
Nectarine
Olive
Orange
Peach
Pear
Pecan
Plum
Prune
Red Kidney Beans
Snap Beans
Sour Cherries
Soybeans
Sugar Beets
Sweet Cherries
Tangelo
Tangerine
Toma to
Walnut
Terrestrial Non-Food Crop
Earthworm Farms
The "EPA Index to Pesticide Chemicals" lists all
uses of EPN, as well as approved maximum application
frequencies.
registered
rates and
D. REQUIRED LABELING
All manufacturing-use products and end-use products
must bear appropriate labeling as specified in 40 CFR 162.10,
PR Notices 83-2 and 83-3, and as indicated in this Registration
Standard, as appropriate to the use. Appendix II contains
information on labeling requirements.
No end-use or manufacturing-use product containing EPN
may be released frr shipment by a registrant or producer of
that product after April 30, 1988, unless the product bears
an EPA-approved amended label which complies with this
Registration Standard.
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No end-use or manufacturing-use product containing EPN
may be distributed, sold/ offered for sale, held for sale,
shipped, delivered for shipment, or received and (having
been so received) delivered or offered to be delivered by
any person after April 30, 1989, unless the product bears
an EPA-approved amended label which complies with this
Registration Standard.
In addition to the above, the following information must
appear on the labeling:
1. All Products
Pesticide Disposal Statement. The following pesticide
disposal statement must appear on all labels:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a violation
of Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State Pesticide
or Environmental Control Agency, or the Hazardous Waste
representative at the nearest EPA Regional Office for
guidance."
2. Manufacturing-use Products - All manufacturing-use products
must bear the following statements:
Ingredients Statement. The ingredient statement for
Manufacturing-use Products must list the active ingredient
as:
O-ethyl 0-p-nitrophenyl phenylphosphonothioate
Use Pattern Statements. All manufacturing-use products
must state that they are intended for formulation into
end-use products for acceptable use patterns. Labelina
must specify sites, which are listed in Use Patterns,
Section C.3. However, no use may be included on the
label where the registrant fails to agree to comply with
the data reguirements in Table A for that use pattern.
Precautionary Statements. The following statement must
appear in the Environmental Hazards section of the label
for all Manufacturing-use Products:
This pesticide is toxic to fish and wildlife. Do not
discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans or public waters
unless this product is specifically identified and
addressed in an NPDES permit. Do not discharge
effluent containing this product to sewer systems
without previously notifying the sewage treatment
plant authority. For guidance contact your
State Water Board or Regional Office of the EPA.
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3. End-use Products - Labels for end-use products must bear
the statementsin quotes below.
Restricted Use Statement. All liquid formulations and
any formulation greater than 4% EPN are classified as
restricted use pesticides and must bear the following
statement in a prominent position on the front panel of
the label:
"RESTRICTED-USE PESTICIDE
Due to acute toxicity and demonstration of delayed
neurotoxicity and irreversible nerve damage in the
spinal cord in laboratory animals.
For retail sale to and use only by Certified Applicators
or persons under their direct supervision and only for
those uses covered by the Certified Applicator's certifi-
cation. Direct supervision for this product is defined
as the Certified Applicator being physically present
during mixing, loading/ equiplment repair/ and equipment
cleaning. Applicators must ensure that all persons
involved in these activities under direct supervision
are informed of the precautionary statements."
Precautionary Statements. The following statements must
appear in the Hazards to Humans section of the label
for all End-use Products:
"WORK SAFETY RULES
REPEATED EXPOSURES TO CHOLINESTERASE INHIBITORS SUCH
AS ARE CONTAINED IN THIS PRODUCT MAY, WITHOUT WARNING/
CAUSE PROLONGED SUSCEPTIBILITY TO VERY SMALL DOSES OF
ANY CHOLINESTERASE INHIBITOR.
Persons working with this product should have frequent
blood tests of their cholinesterase levels. If the
cholinesterase level falls below a critical point/ no
further exposure should be allowed until it has been
determined by means of blood tests that the cholinesterase
level has returned to normal. Before using this product
consult the National Pesticide Telecommunication Network
for recommendations regarding such blood tests/ poisoning
management/ emergency treatment, and other information
regarding the toxicity of EPN. The toll free number for
the National Pesticide Telecommunication Network is
1-800-858-7378.
CAUSES DELAYED NEUROTOXICITY IN LABORATORY ANIMALS
FOLLOWING A LARGE SINGLE DOSE OR SEVERAL/ SMALLER,
DAILY DOSES. Neurotoxicity may occur after recovery
from acute effects. No antidote for delayed neurotoxicity
exists - symptomatic treatment only.
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If handled indoors provide mechanical exhaust ventilation.
Keep all unprotected persons, children, livestock, and
pets away from treated area.
DO NOT APPLY THIS PRODUCT WHEN WEATHER CONDITIONS FAVOR
DRIFT FROM TREATED AREAS.
Do not rub eyes or mouth with hands. If you feel sick
in any way, STOP work and get help right away. See
First Aid (Practical Treatment) section.
HANDLE THE CONCENTRATE AND LOAD THE GRANULES ONLY WHEN
WEARING THE FOLLOWING PROTECTIVE CLOTHING AND EQUIPMENT:
Wear a protective suit of one or two pieces that covers
all parts of the body except the head, hands, and feet.
Wear chemical resistant gloves, chemical resistant apron,
and chemical resistant shoes, shoe coverings, or boots.
Wear goggles or a face shield. Wear a pesticide respirator
approved by the National Institute for Occupational Safety
and Health under the provisions of 30 CFR part II.
If handling the concentrate with a closed system, a long
sleeved shirt and long legged pants may be substituted
for the protective suit and the respirator requirement
is waived.
WEAR THE FOLLOWING PROTECTIVE CLOTHING AND EQUIPMENT
DURING APPLICATION, EQUIPMENT REPAIR, EQUIPMENT CLEANING,
DISPOSAL OF EXCESS SPRAY SOLUTION, AND DURING REENTRY
TO TREATED AREAS PRIOR TO THE EXPIRATION OF THE REENTRY
INTERVAL:
Wear a protective suit of one or two pieces that covers
all parts of the body except the head, hands, and feet.
Wear chemical resistant gloves and chemical resistant
boots, shoes, or shoe coverings.
Application must be made only from a tractor with a
completely enclosed cab or aerially with an enclosed
cockpit. For these applications a long sleeved shirt
and long legged pants may be worn in place of the above
protective clothing. Chemical resistant gloves must be
available in the cab or cockpit and must be worn while
exiting. This clothing is inadequate to protect you
during equipment repair, cleaning or reentry.
IMPORTANT! Before removing gloves, wash them with soap
and water. Always wash hands, face, and arms with soap
and water before smoking, eating, drinking, or toileting.
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AFTER WORK, take off all clothes and shoes. Shower
using soap and water. Wear only clean clothes. Do not
use contaminated clothing. Wash protective clothing
and protective equipment with soap and water after each
use. Respirators must be cleaned and filters replaced
according to instructions included with the respirators.
Personal clothing worn during use must be laundered
separately from household articles. Clothing and
protective equipment heavily contaminated or drenched
with EPN must be destroyed in accordance with state and local
regulations. HEAVILY CONTAMINATED OR DRENCHED CLOTHING
CANNOT BE ADEQUATELY DECONTAMINATED.
DURING AERIAL APPLICATION, HUMAN FLAGGERS ARE PROHIBITED
UNLESS IN A TOTALLY ENCLOSED VEHICLE."
Precautionary Statements. The following statements must
appear in the Environmental Hazards section of the label
for all end-use emulsifiable concentrate and wettable
powder formulations:
"This pesticide is toxic to fish and wildlife. Do not
apply directly to water or wetlands (swamps, bogs,
marshes and potholes). Runoff and drift from treated
area may be hazardous to aquatic organisms in adjacent
aquatic sites. Do not contaminate water by cleaning of
equipment or disposal of wastes.
This product is highly toxic to bees exposed to direct
treatment or residues on blooming crops and weeds.
Do not apply this product or allow it to drift to
bloomina crops or weeds if bees are visiting the
treatment area."
Re-entry Statements. The following statement must
appear in the re-entry section of the label for all
end-use products:
"Do not reenter fields treated with EPN to perform tasks
requiring contact with EPN treated surfaces within:
7 days for corn or cotton crops; 35 days for citrus; or
48 hours for other crops unless the protective clothing
specified in the "Precautionary Statements -- Hazards to
Humans" section is worn."
Directions for Use Statements. The following statement
must appear in the Directions for Use section of the
label for all end-use emulsifiable concentrate and
wettable powder formulations:
"Do not apply this product when weather conditions favor
drift from treated areas."
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Cotton. The statement listed below must appear on
end-use emulsifiable concentrate and wettable powder
products intended for use on cotton:
"Do not apply to blooming cotton if bees are visiting
the treatment area."
Field or Sweet Corn. The statement listed below must
appear on end-use emulsifiable concentrate and wettable
powder products intended for use on field or sweet corn:
"Do not apply to corn during the pollenshed"period if
bees are visiting the treatment area."
Stone Fruits/ Pome Fruits and Citrus. The statement
listed below must appear on end-use emulsifiable
concentrate and wettable powder products intended for
use on stone fruits, pome fruits and citrus:
"Do not apply when trees or a substantial number of
weeds in the orchard/grove are in blocm."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section 11.A. are subject to certain requirements
for data submission or changes in composition/ labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B9
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
9 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formula tor's exemption-^, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the data requirements listed in Tables A and C.
b. If eligible for the formulator's exemption, the
data requirements listed in Table C.
10 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) if no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements. This has occurred for EPN.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
"be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient. H
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
11 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new regi stration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
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The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
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[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c) (2) (B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
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E. Testing Protocols/ Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA' s Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than 'is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
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extension which is made as an initial response to a section
3(c) (2) (B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
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such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIF1C DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D. , EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.-^
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
12 if on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
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2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments11 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B)'.
c. Three copies of draft labeling, including the
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container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sises of the text.
d. Product Specific Data Report (EPA Form 8580-4).
2. Within the time frames set forth in Table A, you roust
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing the subject pesticide as an
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any product-specific data, if required
by Table C.
c. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
d. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft labeling must
indicate the intended colors of the final label, clear
indication of the front panel of the label, and the
intended type sizes of the text. End use product
labeling must comply specifically with the instructions
in Section IV (Regulatory Position and Rationale).
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D. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
E. Addresses
The required information must be submitted to the following
address:
Dennis Edwards (PM 12)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St. , SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Mon i tor i ng is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St. , SW
Washington, D.C. 20460.
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I. DATA APPENDICES
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 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. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table.
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TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two- required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). 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.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived .or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
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TABLE A
GENERIC DATA REQUIREMENTS FDR Oethyl Op-nitrcphervl phenylphosphonothioate
[EPN]
Data Requirement Composition
§158.120 Product Chemistry
Product Identity
61-2 - Description of Beginning
Materials and Manufacturing
Process
61-3 - Discussion of Fomation of
Inpurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Ingredient
Limits
62-3 - Analytical Methods to Verify
Certified Limits
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TGAI
TGAI
TGAI
IGAI
1GAI
IGAI
IGAI
TGM
IGAI
IGAI
Use
Patterns
All
All
All
All
All
All
All
All
All
All
Does EPA
Have Data?1
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Bibliographic
Citation1
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Mist Additional
Data be
Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No 3/
Yes
Timefrane
For Data
Submission 2
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
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TABLE A
GENERIC DATA REQUIREMENTS FDR Oethyl Op-nitrcphervl pherylphosphonothioate [EPN]
Data Requirement
Use Does EPA Bibliographic Must Additional
Composition Patterns Have Data?* Citation1 Data be
Submitted?
Time Frame
for
Submission 2
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
All
N/A
N/A
Yes
6 Months
63-8
63-9
63-10
63-11
63-12
63-13
Other
64- 1
- Solubility
- Vapor Pressure
- Dissociation constant
- Octane]/ water partition
coef f icient
-pH
- Storage Stability
Requirements:
- Submittal of sanples
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
TGAI, PAI
All
All
All
All
All
All
All
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes
Yes
Reserved 4/
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
TGAI = Technical Grade of the Active Ingredient; EAI = Pure Active Ingredient; R = Required; CR = Conditionally Required
I/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each pesticide. New requirements have been introduced and previously submitted
data must be updated. Therefore bibliographic citations for the old data are not applicable.
2. Data itust be submitted within the indicated tins frame. The beginning date for these tine frames is March 26, 1987,
the date of the Agency's most recent Data Call In Notice calling in these data.
6 Month Due Date is SEPTEMBER 26, 1987 ; 12 Month Due Date is MARCH 26, 1988 .
3/ Not required because EPN is a liquid at room temperature.
4/ T£ samples aire needed the Agency will request than.
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GENERIC DATA REQUIREMENTS FOR CHEMICAL:
TABLE A
O-ethyl-O-p-nitropheryl pherylphosphonothioate ' [EPN]
Data Requirenents
Composition
Dbes EPA Have Data
To Satisfy This
Requi rene nt? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
F1FRA § 3(c)(2)(B)?
Time Frames For Data
Submission^
PAIRA
PAIRA and Plant
Metabolites
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical Method
- Plant residues
- Animal residues
- Storage Stability Data
171-^4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Root and Tuber Vegetables Group
Beets TEP
Rutabagas TEP
Sugar beets TEP
Partial
Partial
TGAI and Metabolites Yes
TGAI and Metabolites No
TGAI and Metabolites No
No
No
No
00109147
Yes3 18 Months
00079794;00079794 Yes4 18 Months
00085429
00068437; 00068905 No
00079807;00100090
00100099; GSO147-0 01
00101107
Reserve d^
Yes6 15 Months
Yes7
Yes7
Yes8 24 Months
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-109-
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
TABLE A
O-ethyl-O-p-nitropheryl pherylphosphonothioate [EPN]
Eat a Requirements
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Mist Additional Data
Be Submitted Under
FIFRA § 3(c) (2) (B)?
Time Frartes For Data
Submission2
§158.125 Residue Chemistry - Continued
Turnips TEP No
- Leaves of Root and Tuber Vegetables Group
Beet tops (greens) TEP No
Ritabaga tops TEP No
Sugar beet tops TEP No
Turnip tops (greens) TEP No
- Leafy Vegetables (Except Brassica Vegetables) Group
Lettuce TEP No
Spinach TEP No
Beans TEP No
Soybeans TEP Partial
- Foliage of the Legume Vegetables Group
Beans vines and hay TEP No
Soybean forage and straw TEP No
- Fruiting Vegetables (Except Cucurbits) Group
Tomatoes TEP Partial
Yes/
Yes7
Yes7
Yes9 24 Months
Yes7
Yes10 18 Months
Yes7
Yes11 18 Months
00068905 Yes12 18 Months
Yes13 18 Months
Yes14 18 Months
00068437;00100090 Yes15 24 Months
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-110-
TABIE A
GENERIC DATA REQUIREMENTS EDR CHEMICAL: Oe thy 1-O-p-ni trap hery 1 pherylphosphonothioate
[RPN]
Data Requirement
Coonposition
Does EPA Have Data
To Satisfy This
Requi rene nt? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
ETFRA § 3(c)(2)(B)?
Time Frames for Data
Submission 2
§158.125 Residue Chemistry - Continued
- Citrus Fruits Group
Citrus Fruits
- Pome Fruits Group
Apples
Pears
Quinces
- Stone Fruits Group
Apricots
Cherries
Nectarines
Peaches
Plums (fresh prunes)
- Small Fruits Group
Blackberries
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Partial
Partial
Partial
No
No
Partial
No
Partial
Partial
No
000683 67; 000684 37 Yes16 24 Months
00100078; 00100099
00068437;00100078
00100099
00068367;00068437
00068367;00068437
00100078;00100099
00100078
Yes17 24 Months
Yes18 18 Months
Yes7
Yes19 18 Months
Yes20 18 Months
Yes21 18 Months
Yes22 24 Months
Yes23 24 Months
Yes7
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-111-
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: O-etlyl-O-p-nitrcpheryl pherylphosphonothioate [EPN]
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requi rone nt? (Yes,
No or Partially)
Bibliographic
Citation
- Cereal Grains Group
Corn
TEP
Partial
- Forage, Fodder and Straw of Cereal Grains Group
Corn forage, silage and fodder TEP
Partial
Must Additional Data
Be Submitted Under
FTFRA § 3(c)(2)(B)?
Time Frames for Data
Submission 2
§158.125 Residue Chemistry - Continued
Boysenberries
Dewberries
Grapes
Loganberries
Raspberries
Strawberries
Youngberries
- Tree Nuts Group
Almonds
Pecans
Walnuts
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
No
No
Partial
No
No
No
No
No
No
No
Yes7
Yes7
0006836 7;00100078 Yes24
Yes7
Yes7
Yes7
Yes7
Yes25
Yes26
Yes27
24 Months
18 Months
30 Months
18 Months
00068437;00068905 Yes28 36 Months
00100088
00068437; 00068905 Yes29 24 Months
00100088
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-112-
TABLE A
GENERIC DATA REQUIREMENTS RDR CHEMICAL: Oetbyl-O-p-nitrcpheivl pherylphosphonothioate
[EPN]
Data Requirenent
Cornposition
Does EPA Have Data
To Satisfy This
Requi rene nt? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(3)?
Time Frames for Data
Submission 2
§158.125 Residue Chemistry - Continued
- Miscellaneous Crops
Cottonseed
Olives
Pineapples
- Meat/Milk/Poultry/Eggs
171-4 - Special Processing Studies:
TEP
TEP
TEP
TGAI or Plant
Metabolites
TEP
- To Provide Residue Data for Cocked
(Microwaveing and Boiling) Sveet Corn
- To Provide Residue Data on Fresh Unwashed Tomatoes
- A Vfeshing Study to Provide Residue Data on Lettuce
171-13 - Submittal of Analytical
Reference Standards
BVIRA
Partial
No
No
No
No
No
No
00068905;00089025 Yes30 36 Months
Yes31 24 Months
Yes7
Yes 24 Months
Yes 24 Months
Yes 24 Months
No
-------
-113-
TABLE A
GENERIC DATA RBDUIREMENTS FOR CHEMICAL: <>ethyl-O-p-nitrcpheryl pherylphosphonothioate [EPN]
§158.125 Residue Chemistry - Continued
1. Composition: TGAI = Technical grade of the active ingredient; EftlRA = Pure active ingredient, radiolabelled; TEP =
Typical end-use product; EP = End-use product.
2. Data must be submitted within the indicated time frame. The beginning date for these time frames is March 26, 1987,
the date of the Agency's most recent Data Call In Notice calling in these data.
6 Month Due Date is _ SEPTEMBER 26, 1987 ; 15 Month Due Date is JUNE 26, 1988 _ ;
18 Month Due Date is _ SEPTEMBER 26, 1988 ; 24 Month Due Date is _ MARCH 26, 1989 _ ;
30 Month Due Date is _ SEPTEMBER 26, 1989 ; 36 Month Due Date is MARCH 26, 1990 .
3. Data nust be submitted reflecting the distribution and metabolism of benzene ring-labeled [cjEPN in (i) nature
cottonseed harvested 3 days after several foliar applications at 1 Ib ai/A made 4-5 days apart; (ii) field corn
fodder and nature field corn grain harvested 14 days after several applications at 0.5 Ib ai/A made 5 days apart;
and (ii) nature pecans harvested 21 days following the last of several foliar applications at 7-day intervals at 3.5
Ib ai/A. The rates stated here are based on maximum use rates; exaggerated rates may be necessary to obtain
sufficient residues in the harvest portion for char acteri ration. Analyses should include hydrolysis and reextraction
of plant residues and aqueous extracts to determine conjugated 14C-residues of EPN. If the metabolism results
differ sicyiif icantly among the three crops, then additional netabolism data must be submitted for a representative
crop in each crcp group for which registered uses of EPN exist. If the required data indicate additional residues of
toxicological concern, the tolerance definition will be changed accordingly. The registrant should conduct the
required netabolism studies and submit them to the Agency for review prior to conducting the required field studies.
4. No tolerances exist for residues of EPN in animal products. The submitted data pertaining to the netabolism
of EPN in animals indicate that EPN residues will transfer to tissues of poultry, but otherwise are inadequate to
show the nature of those residues in poultry or other animals. Therefore, ne tabo Is im studies utilizing ruminants are
required. Animals must be dosed for three days with ring-labeled [14C]EPN at a concentration in the total diet
which will result in sufficient residue in the tissues and milk for characterization. Animals nust be sacrificed
within 24 hours of the final dose (milk must be collected twice daily). 14C-Residues must be characterized and
quantified in milk, nuscle, fat, kidney, and liver. If residues of toxicological concern are found to transfer to
the tissues and/or milk of ruminants, appropriate tolerances must be proposed.
Metabolism studies utilizing poultry are also required. Animals nust be dosed for three days with ring-labeled
[14C]EPN at a concentration in the total diet which will result in sufficient residue in the tissues and eggs for
characterization. Animals must be sacrificed within 24 hours of the final dose (eggs must be collected twice
daily). 14C-Residues nust be characterized and quantified in eggs, nuscle, fat, kidney, and liver. If residues
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TABLE A
GENERIC DATA REQUIREMENTS EDR CHEMICAL: O-ethyl-O-p-nitrqpheryl phenylphosphonothioate [EPN]
§158.125 Residue Chemistry - Continued
of toxicological concern are found to transfer to the tissues and/or eggs of poultry/ appropriate tolerances must
be proposed. Furthermore, if the nature of the residue in poultry differs significantly from that in ruminants,
additional data depicting the nature of the residue in swine will be required (i.e. in the absence of rat metabolism
data). If poultry and ruminant netabolian differ from that in the rat, then additional swine data are required.
5. If residues of toxicological concern are found to transfer to the tissues and/or milk of ruminants or to the tissues
and/or eggs of poultry and appropriate tolerances are proposed, then analytical nethods must be submitted with the
tolerance proposal.
6. No data have been submitted regarding the stability of EPN residues in or on plant samples in frozen storage. There-
fore data are required. Storage conditions and harvest-to-analysis intervals must be submitted for the samples of
corn grain, sweet corn, tomatoes, cottonseed, and soybeans from which residue data were collected and used to support
established tolerances for residues in or on corn, tomatoes, beans (dried), and cottonseed. Data reflecting the
storage stability of EPN in plant samples at the intervals specified must be submitted. If storage stability is
poor, conclusions regarding the adequacy of tolerances for residues in or on these commodities may change.
All residue data required in this standard must be accompanied by information pertaining to the conditions and
intervals of sample storage as well as fortification and recovery data reflecting the stability of EPN at such
intervals.
7. The registrant must submit usage proposals and data to support the established tolerance. Otherwise, the Agency
will move to revoke this tolerance, as there are no registered uses for EPN on this commodity. This data must
be submitted by September 26, 1988 to avoid revocation by the Agency.
8. Residue data from sugar beet roots taken 21 days following the last of several foliar applications with a registered
EC formulation at 1 Ib ai/A, using ground and aerial equipment, including UIV equipment (separate tests) are
required. The tests should take place inCA, ID, MN, and ND which collectively account for approximately 67% of
U.S. sugar beet production.
Data reflecting residues of EPN in dehydrated pulp, molasses, and refined sugar processed from sugar beets bearing
Measurable waathered residues are required. If residues concentrate in any of these processed products, appropriate
food/feed additive tolerances must be proposed at the time these data are submitted to the Agency.
9. Sugar beet tops are a raw agricultural commodity of sugar beets. Therefore, residue data and a tolerance proposal
must be submitted or feeding and grazing restrictions must be proposed. The following data must be submitted if
-------
-115-
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: O-eth/1-Op-nitrcphervl pherylphosphonothioate [EPN]
§158.125 Residue Chemistry - Continued
a tolerance is proposed: residue data from sugar beet tops harvested at regular intervals following the last of
several foliar applications with a registered EC formulation at 1 Ib ai/A, using ground and aerial equipment,
including ULV equipment (separate tests). The tests should take place in CA, ID, MN, and ND which collectively
account for approximately 67% of U.S. sugar beet production.
10. The only product which contains this use at this tine is an intrastate product for use in California only. Vhen this
product is called in for section 3 registration, the following data must be submitted: residue data from nature leaf
and head lettuce, planted 21 days after the last cf several foliar treatments of a 4 Ib/gal EC formulation (only
formulation with use directions for lettuce) at 1 Ib ai/A. Aerial and ground applications should be represented in
separate tests. The tests must take place in CA, the only registered state. If this product is to be used in
other states, then appropriate geographical data must be submitted.
11. No residue data hare been submitted in support of the established tolerance for EPN residues in or on beans.
Separate tolerances must be established for residues of EPN in or on lima beans, snap beans and dry beans. The
soybean data provide adequate support for the 3 ppm "bean" tolerance for residues in or on dry beans. Data are
required to support the 3 ppm tolerances for residues in or on snap beans and lima beans. The data requested
below for snap beans will be translated to lima beans. Residue data from nature snap beans harvested 21 days
following several foliar applications of the 3 Ib/gal EC formulation, at 1.5 Ib ai/A are required. Tests must
include ( in separate tests) both aerial and ground applications, including the use of ULV equipnent. The tests
should take place in GA, TN, and IA, representative states in which use of the high rate (1.5 Ib ai/A) is permitted.
Data may be translated from snap beans to lina beans to support a tolerance for residues in or on lina beans. Note
if a crop group tolerance for beans is desired, additional data must be submitted for dry beans; data translated
from soybeans, a representatire ccmnodity of the Legune Vegetables Group, cannot be used to satisfy the data
requirements for dried beans, which is also a representative commodity.
Residue data from snap bean cannery waste, processed from snap beans bearing neasurable, weathered residues
are required. Exaggerated rates may be necessary to achieve sich residue levels. If residues are higher
in cannery waste than in snap beans per se an appropriate feed additive tolerance must be proposed.
12. Residue data are required from soybeans, harvested 21 days after the last of several applications of an EC formulation
at 1 Ib ai/A» Ihe data should reflect both aerial and ground applications, including the use of ULV equipment
(separate tests). Tests should be conducted in IL, NE, OH, and TN which represent the major soybean production and
climatic regions of the U.S.
-------
-116-
TABLE A
GENERIC E&TA REQUIREMENTS FOR CHEMICAL: O-^thyl-O-p-nitrcpheryl pherylphosphonothipate [EPN]
§158.125 Residue Chemistry - Continued
Residue data 'from the two soybean processed commodities, hulls and soapstock are required. These products must be
processed from nature soybeans bearing measurable, weathered residues of EPN. Exaggerated rates may be necessary to
achieve such initial residue levels. If residues are found to concentrate in hulls and soapstock, appropriate feed
additive tolerances trust be proposed.
Data are adequate to show that EPN residues will not concentrate in soybean meal/ but will concentrate up to 5.5x in
soybean oil. A food additive tolerance for EPN residues in soybean oil that is approximately 6 times the tolerance
for EPN residues in or on soybeans must be proposed at the time the required residue data for soybeans are submitted
to the Agency.
13. Residue data from bean vines and bean hay harvested after the last of several applications of the 3 Ib/gal EC
formulation, at 1.5 Ib ai/A are required. Tests must include both aerial and ground applications, including the
use of ULV equipment ( in separate tests). Vines trust be sampled at intervals following the last treatment and
hay must be harvested 21 days after the last treatment. The tests should take place in GA, TN, and IA, repre-
sentative states in which use of the high rate is permitted. Tolerances for residues in or on bean vines and hay
must be proposed; a pregrazing interval for bean vines must be proposed. Alternatively, feeding and grazing
restrictions may be proposed for bean vines and hay.
14. Residue data are required from soybean forage and strav, harvested 21 days after the last of several applications of
an EC formulation at 1 Ib ai/A« The data must reflect aerial and ground applications, including the use
of ULV equipment (in separate tests). Tests should be conducted in IL, NE, OH, and TN, which represent the
major soybean production and climatic regions of the U.S. Tolerances for residues in or on soybean forage and
straw mast be proposed.
15. The submitted data are adequate to support the established tolerance for tomatoes. However, residue data from
processed tomato products, including wet pomace, dried pomace, puree, catsup and juice, processed from tomatoes
bearing measurable, weathered residues are required to deteimine whether food/feed additive tolerances are
needed. Exaggerated application rates may be necessary to achieve such initial residue levels. Should
concentrations of residues in processed products occur, appropriate food/feed additive tolerances must be
proposed at the tine these data are submitted to the Agency.
16. Residue data from whole sweet oranges, lemons, and grapefruit (representative crops of the Citrus Fruits group)
harvested after the last of several foliar applications with an EC formulation (using aerial and ground
application equipment, including UIV equipment, in separate tests) at 2.25 Ib ai/A are required. Tests must also
-------
-117-
TABLE A
GENERIC I&TA REQUIREMENTS FDR CHEMICAL: <>ethyl-O-p-nitropheryl pherylphosphonothioate [EPN]
§158.125 Residue Chemistry - Continued
reflect ground applications of the 25% WP at 0.5 Ib ai/100 gal (>2000 gal/A). The studies involving oranges and
grapefruit should take place in CA and PL; those involving lenons should take place in CA and AZ; these states
represent the major U.S. production areas of the representative citrus crcps. If the maximum residue values
determined for any two of the three crops differ by more than a factor of five, separate tolerances nust be
proposed for each of the three crcpsf since a crop group tolerance would not be appropriate. A maximum Ib ai/A
rate to complement the 0.5 Ib ai/100 gal rate for ground applications of the 25% WP must be proposed. Since it is
unlikely that >2000 gal/A will be applied, wa suggest a maximum rate cf 10 Ib ai/A.
Residue data from the processed products of oranges, including dried pulp, oil, molasses, and juice processed
from oranges bearing neasurable, weathered residues are required. Exaggerated rates may be required to achieve
such residue levels. If EPN is found to concentrate in any of these products, appropriate food/feed additive
tolerances must be proposed at the tine these data are submitted to the Agency.
17. Residue data are required from nature apples harvested 21 days after the last of several foliar ground applications
(beginning at petal fall and continuing at 10-day intervals thereafter) of the 25% WP, and, in separate tests, an EC
formulation at 0.375 Ib ai/100 gal (800 gal/A). Tests must also reflect both aerial and ground ULV application
of an EC formulation at 3 Ib ai/A (800 gal/A rate at 0.3751b ai/lQQ gal adjusted to maintain Ib ai/A rate). The tests
should take place in WA, NY, MI, VA, and CA, which collectively account for approximately 70% of the U.S. apple
production and the major geographic areas of production. A maximum Ib ai/A rate for applications of the 25% WP and EC
formulations must be proposed to complement the registered 0.375 Ib ai/100 gal rate. Since it is unlikely that more
than 800 gal/A will be applied, wa suggest a maximum rate cf 3 Ib ai/A.
Residue data from dried pomace and juice, processed from apples bearing neasurable, weathered residues are required.
Exaggerated rates may be necessary to achieve sxch residue levels. If concentration of residues occurs upon pro-
cessing, appropriate food/feed additive tolerances must be proposed at the time the data are submitted to the Agency.
18. Residue data are required from nature pears harvested 14 days after the last of several foliar ground applications,
beginning at petal fall and continuing at 10-day intervals thereafter, of the 25% WP and in separate tests, an EC
formulation at 0.375 Ib ai/100 gal (500 gal/A) • Tests must also reflect both aerial and ground ULV applications of
an EC formulation at 2 Ib ai/A (500 gal/A rate at 0.375 Ib ai/100 gal adjusted to maintain Ib ai/A rate). Tests
should be conducted in CA and WA, which collectively produce approximately 73% of domestic pears. A maximum Ib ai/A
rate for application of the 25% WP and EC formulations must be proposed to complement the registered 0.375 Ib ai/100
gal rate. Since it is unlikely that more than 500 gal/A will be applied, we suggest a maximum rate of 2 Ib ai/A.
-------
-118-
TABLE A
GENERIC i&TA REQUIREMENTS FDR CHEMICAL: O-ethyl-O-p-nitrcpneryl phenylphosphonothioate [EPN]
§158.125 Residue Chemistry - Continued
19. Residue data from peaches vd.ll support the tolerance for apricots.
20. Residue data are required fron nature sveet and sour cherries, harvested 21 days following the last treatment included
in the following regimen: (1) one delayed dormant application using an EC formulation at 5 Ib ai/A plus 1.5% oil;
(2) foliar applications, beginning at petal fall and continuing at 10-day intervals until 21 days prior to harvest,
using (in separate tests): (a) the 25% WP at 0.625 Ib ai/100 gal (ground application); (b) the 25% WP at 0.25 Ib
ai/100 gal plus 1.5% light medium oil (ground application); and, (c) UIV applications (ground and aerial, in
separate tests) of an EC formulation at 3.75 Ib ai/A (maximum expected gal/A rate of 1000 at 0.375 Ib ai/100 gal
adjusted to maintain Ib ai/A rate) and two late sunner bark applications of the 5 Ib/gal EC at 1.5 Ib ai/A.
In the case of ground-applied high-volune foliar applications, 1000 gallons of spray mixture should be applied per
acre. The tests should be conducted in WA and MI which account for approximately 63% of U.S. sweet cherry production
and approximately 84% of U.S. sour cherry production. A maximum Ib ai/A rate must be proposed to complement the Ib
ai/100 gal rates for (foliar) applications. Since it is unlikely that more than 1000 gal/A will be applied, wa
suggest maximum rates of 3.75 Ib ai/A for the EC formulations and 6.25 Ib ai/A for the 25% WP, unless the 1.5% oil is
added, in which case 2.5 Ib ai/A of the 25% WP would be the maximum rate.
21. Residue data from peaches will support the nectarine tolerance.
22. Residue data are required for mature peaches harvested 21 days following the last treatment in the following regimen:
(i) one delayed dormant application using an EC formulation at 5 Ib ai/A plus 1.5% oil; (ii) foliar applicat
beginning at petal fall and continuing at 10-day intervals until 21 days prior to harvest using (in separate tests):
(a) the 25% WP at 0.625 Ib ai/100 gal (ground application); (b) the 25% WP at 0.25 Ib ai/100 gal plus 1.5% light
medium oil (ground application); and, (c) ULV applications (ground and aerial, in separate tests) of an EC formula-
tion at 2 Ib ai/A (maximum expected gal/A rate of 500 adjusted to naintain Ib ai/A rate); (iii) two late-summer
bark applications at 1.5 Ib ai/A using the 5 Ib/gal EC. In the case of ground-applied high-volume foliar
applications, 500 gallons of spray mixture should be applied per acre. Ihe tests should be conducted in CA and SC
which produce approximately 74% of U.S. peaches. The data required here will also be used for assessment of the
tolerance for residues of EPN in or on nectarines and apricots. A maximum Ib ai/A rate must be proposed to
complement the Ib ai/100 gal rates for (foliar) applications. Since it is unlikely that more than 500 gal/A will
be applied, wa suggest a maximum rate of 2 Ib ai/A for the EC formulations and 3.1 Ib ai/A for the 25% WP,
unless 1.5% oil is added in which case 1.25 Ib ai/A of the 25% WP would be the maximum rate.
23. Residue data are required from nature plums, harvested 21 days following the last treatgtient included in the following
regimen: (i) one delayed dormant application using an EC formulation at 5 Ib ai/A plus 1.5% oil; (ii) foliar
-------
-119-
TABLE A
GENERIC CATA REQUIREMENTS FDR CHEMICAL: 0-ethyl-CHp-nitropheryl pherylphosphonothioate [EPN]
§158.125 Residue Chemistry - Continued
applications, beginning at petal fall and continuing at 10-day intervals until 21 days prior to harvest, using (in
separate tests): (a) the 25% WP at 0.625 Ib ai/100 gal (ground application); (b) the 25% WP at 0.25 Ib ai/100 gal
plus 1.5% light medium oil (ground application); and, (c) ULV applications (ground and aerial, in separate tests) of
an EC fonnulation at 2 Ib ai/A (maximum expected gal/A rate of 500 adjusted to maintain Ib ai/A rate); and, (iii) two
late-summer bark applications of the 5 Ib/gal EC at 1.5 Ib ai/A. In the case.of ground-applied high-volume foliar
applications, 500 gallons of spray mixture should be applied per acre. The tests should be conducted in OR and MI
which account for approximately 69% of U.S. plum production. A maximum Ib ai/A rate must be proposed to complement
the Ib ai/100 gal rates for (foliar) applications. Since it is unlikely that more than 500 gal/A will be applied, ve
suggest maximum rates of 2 Ib ai/A for the EC formulations and 3.1 Ib ai/A for the 25% WP, unless 1.5% oil is added
in which case 1.25 Ib ai/A if the 25% WP
would be the maximum rate.
Residue data from dried prunes, processed from plums bearing neasurable, weathered residues are required.
Exaggerated rates may be required to achieve such residue levels. If residues are found to concentrate in the
dried fruit, an appropriate food additive tolerance must be proposed at the time the data are submitted to the
Agency.
24 Residue data from mature grapes, harvested 21 days after the last cf several foliar applications made, in
separate tests, aerially (including ULV applications) and with ground application equipment (including ULV
and high volume applications) using an EC fomulation at 0.25 Ib ai/100 gal (250 gal/A) for high-volume
applications and at 0.63 Ib ai/A (UIV applications). High-volume foliar application tests (ground-applied)
with the 25% WP must also be made at 0.25 Ib ai/100 gal rate at a maximum expected gal/A of 250 to maintain
the correct rate of active ingredient per acre. The applications should be made at 10-day intervals
beginning at bloom. A maximum expected ai/A rate for high-volume applications must be proposed. Since the
maximum expected gal/A rate is 250, we suggest that a maximum rate cf 0.63 Ib ai/A be proposed.
Residue data from raisins, raisin waste, juice, wat pomace and dried pomace processed fron grapes bearing
measurable, weathered residues are required. Exaggerated rates may be necessary to achieve such residue
levels. If residues concentrate in an/ of these processed products, appropriate food/feed additive
tolerances must be proposed at the tine the data are submitted to the Agency.
25. Residue data from nature almond nutmeats and corresponding hulls, harvested 21 days after the last of several
foliar ground applications of an EC formulation at, in separate tests, 0.25 Ib ai/100 gal (800 gal/A) using
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-120-
TABLE A
GENERIC DATA RETIREMENTS FOR CHEMICAL: Oethyl-O-p-nitrcphenyl phervlphosphDnothioate [EPN]
§158.125 Residue Chemistry - Continued
high-volume ground equipnent and 2 Ib ai/A using UIV ground equipment are required. The data should also
reflect UIV aerial applications of the EC at 2 Ib ai/A. (The Ib ai/A rate for UIV applications was calculated from
the maximum'expected gal/A rate (800) at 0.25 Ib ai/100 gal to maintain the correct rate of active ingredient per
acre.) The tests should take place in CA where the majority of almonds are produced. A maximum Ib ai/A rate for
foliar applications to complement the maximum registered Ib ai/100 gal rate (0.25) should be proposed. Since
it is unlikely that more than 800 gal/A will be applied, vte suggest that a maximum rate of 2 Ib ai/A be
proposed.
26. Residue data from pecans harvested 21 days after the last of several foliar applications with the 25% WP and, in
separate tests, an EC fomiulation, at 0.5 Ib ai/100 gal (1000 gal/A) are required. The data should reflect, in
separate tests, both ground and aerial UIV applications of an EC formulation at 5 Ib ai/A. (The Ib ai/A rate for
UIV applications was calculated from the maximum expected gal/A rate (1000) at 0.5 Ib ai/100 gal to maintain the
correct rate of act ire ingredient per acre.) The tests should take place in GA and tM which together produce
approximately 70% of the U.S. pecan crop. A maximum Ib ai/A rate for foliar applications to complement the
maximum registered Ib ai/100 gal rate (0.5) must be proposed. Since it is unlikely that more than 1000 gal/A
will be applied, wa suggest that a maximum rate of 5 Ib ai/A be proposed.
27. Residue data are required from nature walnuts, harvested 21 days after the last of several applications of the 4
Ib/gal EC at 3.5 Ib ai/A, beginning at petal fall and continuing at 10-day intervals using, in separate tests,
aerial and ground application equipnent, including tests using ULV equipnent. Data reflecting the 25% WP are not
required since the maximum expected Ib ai/A rate, based on 1000 gal/A, for this formulation is much lower than 3.5
Ib ai/A. The tests should take place in CA where the majority of the walnuts are grown. A maximum Ib ai/A rate for
high volume applications must be proposed to complement the maximum Ib ai/100 gal rate.
28. Data are adequate to support the established tolerance for residues of EPN in or on corn. However, data are required
to determine if residues of EPN concentrate in field corn processed products. Therefore, residue data from corn
processed products, including milled products, crude oil and refined oil processed from corn grain bearing neasurable,
weathered residues are required. Exaggerated rates may be required to achieve sich residue levels. If residues are
found to concentrate, appropriate food/feed additive tolerances must be proposed at the time these data are submitted
to the Agency.
29. Residue data from sweet corn forage and field corn forage, foddsr and silage harvested after the last of several
foliar applications of an EC and in, separate tests, a G and a WP at 0.75 Ib ai/A are required. The tests should
include aerial and ground ULV applications of an EC formulation. Forage trust be collected at intervals following the
-------
-121-
TABLE A
GENERIC EATA REQUIREMENTS FDR CHEMICAL: CKsthyl-O-p-nitrophervl pherylphosphonothioate [EPN]
§158.125 Residue Chemistry - Continued
last application; a pregrazing interval rtust be proposed. Fodder and silage must be harvested 14 days after the last
treatment. Tests should take place in IA, INr FL, MN, CA, NY, and TN which collectively represent all of the major
areas of the U.S. where field and sweet corn foliage would be used for forage, fodder or silage.
30. The submitted data are adequate to support the established tolerance for residues of EPN in or on cottonseed. The
data are also adequate to show that concentration of residues does not occur upon processing cottonseed into rteal,
but does occur, up to approximately 40x, upon processing into oil. Therefore, a food additive tolerance for
residues of EPN in cottonseed oil trust be proposed at the time the data on cottonseed hulls and soapstock are
submitted. Wfe suggest that a tolerance of 20 ppm be proposed. In addition, the following data are required to
determine if EPN residues concentrate in two other processed predicts, hulls and soapstock. Residue data from
cottonseed hulls and soapstock, processed fron cottonseed bearing neasutrable, weathered residues are required.
Exaggerated rates may be necessary to achieve such initial residue levels. If residues are found to concentrate in
either product, appropriate feed additive tolerances nust be proposed at the tine these data are submitted to the
Agency.
31. Residue data from nature olives harvested frcm trees which received several foliar applications of the 4 or 5 Ib/gal
EC at 12 lb ai/A and, in separate tests, of the 25% WP at 0.25 Ib ai/100 gal puls 1.5% light medium oil (800 gal of
spray/A). The last application should be made on July 15. Residue data reflecting both aerial and ground applica-
tions, including the use of ULV equipment, with an EC formulation rrust be submitted. Only ground application data
are required for the 25% WP. Tests must be conducted in CA.
Residue data from olive oil produced frcm olives bearing measurable, waathered residues of EPN are required.
Exaggerated rates may be necessary to achieve sich initial residue levels. If concentration of residues does take
place, an appropriate food additive tolerance mast be proposed at the tine these data are submitted to the Agency.
32. There are no direct animal treatments for EPN. However, tolerances are established on raw agricultural commodities
with registered uses which may either be fed directly (unprocessed) or processed into commodities which may be fed
to livestock. Since additional data are required to support tolerances for residues of EPN in or on many of these
raw agricultural ccmitDdities and data are needed to determine whether concentration of residues occurs on processing,
we are unable to estimate the maximum expected intake of EPN residues by cattle, poultry, or swine at this time.
Upon receipt of the requested animal metabolism data, and data pertaining to residues in major feed items, the
adequacy of the available data will be assessed and specific data requirements regarding residues in animal products
will be determined.
-------
-122-
TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL: C>-ethyl-O-p-nitrcphen/l pherylphosphonothioate [EPN]
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Mast Additional Data
Be Submitted Under
FTFRA § 3(c)(2)(B)?
Time Frane for Data
Submission ^
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradation
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB;
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
TGAI or PAIRA A,B,
1GAI or PAIRA A,B,
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A,B,
TGAI or PAIRA A
No
No
No
No
No
No
Yes
9 Months
Yes
Yes
No
Yes
Yes
9 Months
9 Months
27 Months
27 Months
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
TGAI or PAIRA -
TGAI or PAIRA -
163-1 - Leaching and TGAI or PAIRA A,B,
Adso rp t ion/Deso rp t ion
163-2 -Volatility (Lab)
163-3 - Volatility (Field)
TEP
TEP
A
A
No
No
No
No
No
No
No
Yes
No
No
12 Months
-------
-123-
TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL: O-ethyl-O-p-nitropheryl pherylphosphonothioate [EPN]
1 Use 2
Data Requirenent Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Mist Additional Data
Be Submitted Under
Bibliographic FIFRA § 3(c)(2)(B)?
Citation Time Frame for Data
Submission 3
§158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELD:
164-1
164-2
164-3
164-4
- Soil TEP A,B
- Aquatic (Sedinent) TEP
- Forestry TEP
- Combination and
No
No
No
No
Yes 27 Months
No
No
No
Tark Mixes
164-5 - Soil, Long-tern
ACCUMULATION STUDIES;
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Organisms
TEP A
PAIRA A
TEP A
TEP
TGAI or PAIRA A,B
TEP A
No
No
No
No
No
No
Yes4
Yes
Yes5
No
Yes
No
50 Months
39 Months
50 Months
12 Months
-------
-124-
TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL: 0-ethyl-O-p-nitrop hen/1 pherylphosphonothioate [EPN]
§158.130 Environmental Fate - Continued
1. Camposition: TGftI = Technical grade cf the active ingredient; EMRA = Pure active ingredient, radio-labelled;
TEP = Typical end-use product.
2. The use patterns are coded as follows: A^Terrestrial, Pood Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhcuse, Food Crop; F=<3reenhcuse, Non-Food; G=Forestry; H=Doitestic Outdoor; I=Indoor.
3. Data must be submitted within the indicated time frane. The beginning date for these time frames is March 26, 1987,
the date of the Agency's most recent Data Call In Notice calling in these data.
9 Month Due Date is DECEMBER 26, 1987 ; 12 Month Due Date is MARCH 26, 1988 ;
15 Month Due Date is JUNE 26, 1988 ; 27 Month Due Date is JUNE 26, 1989 ;
39 Month Due Date is JUNE 26, 1990 ; 50 Month Due Date is MAY 26, 1991 .
4. Based on the aerobic soil netabolism study or field dissipation studies, if 50% dissipation is reached by the time
of subsequent applications no long-term study is required.
5. This study is required only if significant residues of concern are found in the confined study.
-------
-125-
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: O-ethyl-O-p-nitrcpheryl pherylphosphonothioate [EPN]
1 Use
Data Requirement Composition Pattern
Does EPA Have
Data To Satisfy
2 This Require- Bibliographic
nent? (Yes, No Citation
or Partially)
Mist Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frane for Data
Submission^
§158.135 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral Toxicity - Rat
- Acute Dental Toxicity
- Rabbit
- Acute Inhalation Toxicity
- Rat
- Eye Irritation - Rat
- Dermal Irritation - Rat
- Dermal Sensitization
- , Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
Yes
Yes
Yes
Yes
Yes
No
Yes
00100099
00145678
00057028
00100099
00100099
-
00159372
No
No
No
No
No
Yes 9 Months
No
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-^
- 90-Day Feeding :
- Rodent, and
- Non-rodent (Dog) -,.
' ' A
- 21-Day Dental - Rabbit
- 90-Day Dermal - Rat
- 90-Day Inhalation:
TGAI
TGAI
TGAI
TGAI
A
A
A
A
Yes
Yes
Yes
No
00158874
00158890
00152760
-
No
No
No
No4
- Rat
82-5 - 90-Day Neurotoxicity:
- Hen
TGAI
Yes
Yes
00161799
00003945
No
Mb
-------
-126-
TABLE A
GENERIC D&TA REQUIREMENTS FOR CHEMICAL: C>-ethyl-O-p-nitrcphenyl pherylphosptonothioate [EPN]
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
1 Use 2 This Require- Bibliographic FIFRA § 3(c) (2) (B)?
Data Requirement Composition Pattern nent? (Yes, No Citation Time Frane for Data
or Partially) Submission
§158.135 Toxicoloqy - Continued
CHRONIC TESTING:
83-1 - Chronic Toxicity - 1GAI
2 species:
- Rodent, and A No
- Non-rodent (Doq) A No
83-2 - Oncogen icity - TGAI
2 species:
- Rat (preferred), and A No
- Mouse (preferred) A No
83-3 - Teratogsn icity - TGAI
2 species:
- Rat A No
- Rabbit A No
83-4 - Reproduction - Rat TGAI A No
2-ganeration
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI A Yes
84-2 - Structural Chromosomal TGAI A Yes
Aberration
Yes5
Yes5
Yes6
Yes6
00162934 No
00163019 No
Yes7
00153511 No
00160618
00153510 No
00153509
84-2 - Unscheduled DNA
Synthesis
TGAI
Yes
001535089
No
-------
-127-
GENERIC D\TA REQUIREMENTS FDR CHEMICAL:
TABLE A
O-ethyl-CHp-nitrcphen/l pherylphosphonothioate [EPN]
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
1 Use 2 This Require- Bibliographic FEFRA § 3(c) (2) (B)?
Data Requirenent Composition Pattern nent? (Yes, No Citation Time Frane for Data
or Partially) Submission 3
§158.135
Toxicology - Continued
SPECIAL TESTING
85-1 -
85-3 -
85-X -
General Metabolian EAI or PAIRA A Partial
Dermal Absorption PAIRA A No
Acute Delayed Neuro- TGAI A Yes
00158920 Yes8
Yes9
00160200 No10
24 Months
12 Months
toxicity - Mechanism
Recovery - Hen
85-Y - Neurotoxicity in Hens
Single Dose NOEL
TGAI
No
12 Months
-------
-128-
TABLE A
GENEREC DATA REQUIREMENTS FOR CHEMICAL: O-ethyl-0-p-nitrqphen/l pherylphosphonothioate > [EPN]
§158.135 Toxicology - Continued
1. Composition: EAI = Pure active ingredient; BVIRA = Pure active ingredient, radio-labelled; Choice = Choice of several
test substances determined on a case-by-case basis.
2. The use patterns are coded as follows: A=Terrestrial, Food Crcp; Bterrestrial, Non-Food; C=Agautic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhcase, Non-Food; G=Forestry; H=Donestic Outdoor; I=Indoor.
3. Data must be submitted within the indicated time frame. The beginning date for these time frames is March 26, 1987,
the date of the Agency's most recent Data Call In Notice calling in these data, except where indicated otherwise.
9 Month Due Date is DECEMBER 26, 1987 ; 12 Month Due Date is MARCH 26, 1988 ;
24 Month Due Date is MARCH 26, 1989 .
4. Based on expected exposure patterns this study is not required.
5. The chronic feeding studies are due by May 1, 1989.
6. The onccgenicity studies are die by October 1988.
7. The 2-ganeration reproduction study is due November 1, 1987.
8. Male rats must be treated with the same dose used for females. Metabolites must be identified.
Potential excretion in bile trust be inrestigated.
9. Contact EPA for protocol.
10. The only requirement for this previously submitted study was a revaluation of the spinal cord slides
in groups 7, 8, 9 and 10 in order to determine if the hens showing signs of neurotoxicity can be
distinguished by the pattern cf abnormalities in the cord. This ree/aluation has been completed.
There are no further requirements for this study.
11. A single dose study in hens to determine a NOEL for delayed neurotoxicity by observation and histcpatnology.
20 hens per dose to allow sacrifice of 10 hens per dose at 21 and 40 days post dose.
-------
-129-
TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL O-ethyl 0-p-nitrcphervl phenylphosptonothioate
[EPN]
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
I/ Use y This Require- Bibliographic FIFRA § 3(c) (2) (B)?
Data Requirenent Composition Pattern nent? (Yes, No Citation Time Frane for Data
or Partially) Submission 3/
§158.140
132-1
132-1
133-3
133-4
§158.142
201-1
201-1
Reentry Protection
- Foliar Dissipation TEP A Yes 00162999
00163515
- Soil Dissipation TEP A No
- Demval Exposure TEP A No
- Inhalation Exposure TEP A No
Spray Drift
- Droplet Size Spectrum TEP A No
- Drift Field Evaluation TEP A No
No 27 Months
No
No
No
Yes4 12 Months
Yes4 12 Months
-------
-130-
TABLE A
GENERIC DATA REQUIREMENTS EDR CHEMICAL O-ethyl O-p-nitrcpheivl pherylphosphonothioate [EPN]
Data Requirement
i/
Composition
Use 2/
Pattern
Does EPA Have
Data To Satisfy
This Require-
nent? (Yes, No
or Partially)
Bibliographic
Citation
Mast Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frane for Data
Submission •*/
§158,140 Reentry Protection continued
1. Composition: TEP = Typical end-use product.
2. The use patterns are coded as follows: A=Ter res trial, Food Crop; B=Ter res trial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Q:eenhcuse, Food Crop; F=Greenhouse, Non-Food; OForestry; H=Domestic Cutdoor; I=Indoor.
3. Data must be submitted within the indicated time frame. The beginning date for these time frames is March 26, 1987,
the date of the Agency's most recent Data Call In Notice calling in these data.
12 Month Due Date is MARCH 26, 1988 ; 27 Month Due Date is JUNE 26, 1989 .
4. The spray drift droplet spectrum and field evaluation may be done together in order to evaluate the drop spectrums
that are associated with actual field use patterns.
-------
-131-
TABLE A
GENERIC DATA RBQUIREMENTS FOR CHEMICAL O-etbyl-O-p-nitrcpheryl phen/lphosphonothioate
[EPN]
1 Use
Data Requirement Composition Pattern
§158. 145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral Toxicity TGAI
- Upland Game Bird, and
- Waterfowl
71-3 - Wild Mammal Toxicity TGAI
71-4 - Avian Reproduction TGAI
- Upland Game Bird, and
- Waterfowl
71-5 - Simulated Field Testing TEP
- Mammals, and
- Birds
- Actual Field Testing TEP
- Mammals, and
- Birds
A
A
A
A
A
A
A
A
A
A
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
2 This Require- Bibliographic FIFRA § 3(c) (2) (B)?
nent? (Yes, No Citation Time Frame for Data
or Partially) Submission 3
Yes
Yes
Yes
No
No
No
No
No
No
No
•
00111931 ;05000975 No
00022923 No
00077299
00022923 No
No
Yes4 24 months
Yes4 24 nonths
Reserved^
Reserved^
Reserved^
Reserved ^
-------
-132-
TABLE A
GENERIC D\TA REQUIREMENTS FDR CHEMICAL 0-ethyl-O-p-nitropheryl pherylphosphonothioate [EPN]
Data Requirenent
Composition
Use 2
Pattern
Does EPA Have
Data To Satisfy
This Require-
nent? (Yes, No
or Partially)
Bibliographic
Citation
Mist Additional Data
Be Submitted Under
FTFRA § 3(c)(2)(3)?
Time Frane for Data
Submission ^
§158.145 Wildlife and
Aquatic Organisms - Contirued
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish Toxicity TGAI
- Coldwater Fish Species,
and
- Warmwater Fish Species
72-2 - Acute Toxicity to
Freshwater Invertebrates
TGAI
72-3 - Acute Toxicity to TGAI
Estuarine and Marine
Organ isms
- Fish
- MDllask
- Shrimp
72-4 - Fish Early Life Stage, TGAI
and - Aquatic Invertebrate
Life-Cycle
a. Freshwater fish
b. Shrimp
c. Freshwater invertebrate
Yes
00100093
No
A
A
A
A
A
A
Yes
Yes
Yes
Yes
Yes
No
Yes
No
00100093
00100093 ,-05009242
00002875;00085219
00066341
00066341
00066341
00066341
No
No
No
No
No
Yei
No
Ye:
Yes6 15 months
No
Yes6 15 months
-------
-133-
TABLE A
GENERIC EATA REQUIREMENTS FDR CHEMICAL O-ethyl-O-p-nitrophenyl phenylphosphonothioate
[EPN]
Does EPA Have Mast Additional Data
Data To Satisfy Be Submitted Under
1 Use 2 This Require- Bibliographic FTFRA § 3(c) (2) (B)?
Data Requirement Composition Pattern nent? (Yes, No Citation Time Frane for Data
or Partially) Submission •*
§158.145
Aquatic
72-5
72-6
Wildlife and
Organisms - Continued
-Fish - Life-Cycle TGAI A Yes
- Aquatic Organism TGAI, PAI OR
Accumulation Degradation
Product
- Crustacean A No
- Fish A No
- Insect Nymph A No
- Mollusk A No
00066341 No
7
7
7
7
72-7 - Simulated Field Testing
- Aquatic Organisms
- Actual Field Testing
-Aquatic Organisms
TEP
No
No
Yes8 24 Months
Yes8 48 Months
-------
-134-
TABLE A
GENERIC DATA REDUTREMENTS FOR CHEMICAL: Oeth/l-O-p-nitrcpheryl pherylphosphonothioate [EPN]
§158.145 Wildlife and Aquatic Organisms - Continued
1. Composition: 1GAI = Technical grade of the active ingredient; E&I = pure active ingredient;
TEP = Typical end-use product;
2. The use patterns are coded as follows: A=Terrestrial, Food Crop; B^Terres trial, Non-Food Crop; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=<3reenhcuse, Food Crop; F=<3reenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3. Data roust be submitted within the indicated time frame. The beginning date for these time franes is March 26, 1987,
the date of the Agency's most recent Data Call In Notice calling in these data.
15 Month Due Date is JUNE 26, 1988 ; 24 Month Due Date is MARCH 26, 1989 .
48 Month Due Date is March 26, 1991 .
4. Data are required to support repeated applications to cotton.
5. This data requirement is reserved pending receipt and evaluation of certain environmental fate data requirements and
review of required avian reproduction study.
6. It is expected that aquatic environments will be exposed frcm the use on cotton, corn and soybeans to the extent
that this study is required.
7. See Table A, data requirements for Accumulation Studies under Section 158.130, 165-4 and 165-5.
8. Residue monitoring in aquatic environments adjacent to cotton and corn producing areas are required. In lieu of
monitoring, a mesoccsm study may be submitted. An acceptable protocol nust be submitted prior to initiating these
studies. Acceptable environmental fate data, when submitted, may alter these requirements.
-------
-135-
TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL: O-ethyl-O-p-nitrcpheryl phen/lphosphonothioate [EPN]
1 Use 2
Data Requirement Composition Pattern
§158.150 Plant Protection
121-1 - TARGET AREA
PHYTOTOXICITY EP
NONTARGET AREA PHYTOTOXICITY
Does EPA Have
Data To Satisfy
This Require- Bibliographic
nent? (Yes, No Citation
or Partially)
3
Mist Additional Data
Be Submitted Under
EIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
TIER I
122-1 - Seed Germination/
Seedling Emergence
TGAI
122-1
122-2
123-1
123-2
123-3
124-1
124-2
- Vegetative Vigor
- Aquatic Plant Growth
TIER II
- Seed Genni nation/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
TIER III
- Terrestrial Field
- Aquatic Field
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
3
3
3
3
3
3
3
1. Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product. EP = End-use product.
2. The use patterns are coded as follows: A=Terrestrialr Food Crop; B terrestrial, Non-Food Crop; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhcuse, Food Crop; F=<3i:eenhojse, Non-Food; G=Forestry; H=Domsstic Outdoor; I=Indoor.
3. These data are net required in accordance with §158.150.
-------
GENERIC EATA REQUIREMENTS EDR CHEMICAL:
-136-
TABLE A
O--ethyl-O-p-nitrcphen/l phen/lphosphonothioate
[EPN]
1 Use 2
Data Requirenent Composition Pattern
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honey bee acute TGAI A
contact toxicity
141-2 - Honey bee - toxicity TEP A
of residues on foliage
141-4 - Honey bee subacute (Reserved) ^
feeding study
141-5 - Field testing for TEP A
Does EPA Have
C&ta To Satisfy
This Require- Bibliographic
itent? (Yes, No Citation
or Partially)
Yes 00036935
No
No
Mist Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frane for Data
Submission 3
No
Yes4 15 Months
No6
pollinators
1. Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2. The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhcuse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3. Data most be submitted within the following tine frame. The beginning date for these tine franes is March 26, 1987,
the date of the Agency's most recent Data Call In Notice calling in these data.
15 Month Due Date is JUNE 26, 1988 .
4. Data from the acute contact test indicate high toxicity, therefore, data on residual toxicity are required.
5. Requirenent reserved pending the developnent of test methodology.
6. The data reviewed do not indicate the need for a field study.
-------
-137-
TAELE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL O-ethyl 0-p-nitrcphenyl phenylphosphonothioate [EPN]
Does EGA Have Mast Additional Data
Data To Satisfy Be Submitted Under
1 Use 2 This Require- Bibliographic FIFRA § 3(c) (2) (B)?
Data Requironent Composition Pattern nent? (Yes, No Citation Tirae Frane for Data
or Partially) Submission 3
§158.155 Nontarget Insect - Continued
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to (Reserved)
aquatic insects
142-1 - Aquatic insect (Reserved)
life-cycle study
142-3 - Simulated or actual (Reserved)
field testing for
aquatic insects
143-1 - NONTARGET INSECT (Reserved)
TESTING - PREDATORS
thru AND PARASITES
143-3
1. Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2. The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop:
D=Aqautic, Non-Food; E=Greenhcuse, Food Crop; F=Greenhcuse, Non-Food; G=Forestry; H=Donestic Outdoor; I=Indoor.
-------
-138-
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS EOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL:
O-ethyl O-p-nitrqphenyl phenylphcsphonothioate [EPN]
Data Requirement
Conposition
Does EEA Have
Data To Satisfy
This Require-
nent? (Yes, No
or Partially)1
Bibliographic
Citation1
Mist Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frane for Data
Submission ^
§158.120 Product Chemistry
Product Identity!
61-1 - Product Identity and Disclosure MP
of Ingredients
61-2 - Description of Beginning Materials MP
and Manufacturing Process
61-3 - Discussion of Formation of MP
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
Physical and Chemical Characteristics
63-2 - Color MP
63-3 -Physical State MP
63-4 -Odor MP
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
6 Months
6 Months
6 Months
Yes 12 Months
Yes 12 Months
Yes 12 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
-------
-139-
TABLE B
PRODUCT SPECIFIC EATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL:
Q-ethyl O-p-nitrcphenyl phenylphasphonothioate [EPN]
Data Requirenent Composition
Does EBV Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)1
Mist Additional Data
Be Submitted Under
Bibliographic FIFRA § 3(c)(2)(B)?
Citation 1 Time Frane for Data
Submission 2
§158*120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 -
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
- Density, Balk Density, or
Specific Gravity
-pH
- Oxidizing or Reducing
Action
- Flamnability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
MP
MP
MP
MP
MP
MP
MP
MP
MP
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
Other Requirements:
64- 1 - Submittal of samples
MP
N/A
Yes
6 Months
-------
-140-
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL:
O-ethyl O-p-nitrophenyl pheny]phosphonothioate [EPN]
Data Requirenent
Composition
Does EE& Have
Data To Satisfy
This Require-
nent? (Yes, No
or Partially)1
Bibliographic
Citation *
Wast Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frane for Data
Submission 2
§158.120 Product Chemistry (Continued)
MP = Manufacturing-use Predict; R = Required; CR = Conditionally Required
I/ Not applicable.. Although product chemistry data may hare been submitted in the past, the Agency has determined that
these data nust be resubttitted for each pesticide. New requirements have been introduced and previously submitted
data must be updated. Therefore bibliographic citations for the old data are not applicable.
2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
6 Month Due Date is OCTOBER 30, 1987 ; 12 Month Due Date is APRIL 30, 1988 ;
15 Month Due Date is JULY 30, 1988 .
-------
-141-
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANIFACTURING-USE PRODUCTS CONTAINING CHEMICAL:
O-ethyl O-p-nitrqphenyl phenylphosphonothioate [EPN]
Does EPA Have Mjst Additional Data
Data To Satisfy Be Submitted Under
I/ This Require- Bibliographic ETFRA § 3(c) (2) (B)?
Data Requirement Composition nent? (Yes/ No Citation Time Frame for Data
or Partially) Submission 3/
§158.135
Toxicology
ACUTE TESTING
81-1 -
81-2 -
81-3 -
81-4 -
81-5 -
81-6 -
Acute Oral Toxicity - Rat MP No
Acute Dermal Toxicity MP No
- Rabbit
Acute Inhalation Toxicity MP No
- Rat
Primary Eye MP No
Irritation - Rabbit
Primary Dermal MP No
Irritation - Rabbit
Denial Sensitization MP No
Guinea Pig
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 9 Months
I/ Composition: MP = Manufacturing-use product.
2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 9 Month Due Date is JANUARY 30, 1988
-------
II. LABELING APPENDICES
-------
-142-
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.lO(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f )]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product nane.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
-------
-143-
SUMMARY-2
I ton 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)l
Item 7C. SKULL & CROSS BONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.lO(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h) (1) (iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h) (1) (iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY IABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.lO(h)(2)].
-------
-144-
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.lO(h) (2) (i ) ]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h) ( 2) (i i )]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Phys ical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved' any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
-------
-145-
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h) (1) (iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-------
-146-
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. Viien followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connect ion with registration of the product. It
should be made part of the response to this notice and submitted
for review.
-------
-147-
SUMMARf-6
IABELING REQUIREMENTS CF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
•LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gal Ion
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning )
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front •
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
imnediately
before or
following
Reg. No.
Imnediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Imnediately
below child
hazard
warninq
COMMENTS
If registrant is not the producer/ must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
-148-
SUMMARf-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLE: ABE LITY
OF REQUIREMENT
All products
wh ich are Cat-
egory I based
on oral, der-
mal/ or inhala-
tion toxicity
All predicts
in Categories
I, II, and III
All predicts
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All predicts
in Categories
I, II, and III
All predicts
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Sane as above
COMMENTS
Hist be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Mast be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
-149-
SLMMARY-8
ITEM
8C
9A
9B
1QA
10B
IOC
IABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Direct ions
for use
APPLE: ABC LIT*
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150 °F
All restricted
products
All products
PR Notice 83-2
or as deteunined
by the Agency
All products
All predicts
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Itratedi ately
fo Hawing
heading of
directions
for use
In the
di rect ions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Imnedi ately
after misuse
statement
Imnedi ately
before
specific
d'' rect ions
for use or
at the end of
di rect ions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" trust be sane type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Mast be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in ire trie as well as U.S. units
-------
-150-
PRCCAUnONARY STATEMENTS
HAZARDS TO HUMANS
ftDOMESTC ANMALS
. CAUTION
ENVmONMENTAL HAZARDS
PHYSICAL OH CHCMCAL
HAZARDS
I h t tfoMo* tf Ndrt hi* to
M* noduol h • mmr
M-ENTOY STATEMENT
CROP:
PRODUCT
NAME
ACTVC MOREDENT:,
NERT MOREOCNT8:,
TOTAL
100.00%
THIS PRODUCT CONTAW3 LB8 OF PER QAU.ON
KEEP OUT OF REACH OF CHILDREN
CAUTION
STATEMENT OF PRACTICAL TREATMENT
p SWALLOWED:
FMHALEOSSSS
PON8KNSSS
F M EYES =
SEE 8KXE PANEL FOA ADOfTlOMAL PRECAUTIONARY STATEMENTS
MFO BY .
TOWN. STATE 7
ESTABLISHMENT NO. =
EPAREOISTRATlONNa:
NET CONTENTS:
CROP:;
CROP;
CROP:<
STORAGE AND
DISPOSAL
STORAGE •,
DISPOSAL;
WARRANTY STATEMENT
-------
-151-
PRECAUnONARY STATEMENTS
HAZARDS TO HUMAN3
(I OOMESTC ANMAL8)
OANOER
ENVIRONMENTAL HAZARD*
PHYSICAL ON CHEMICAL
HAZARDS
DMEOTONS FOR USE
I * • '.HUM at Mdvri hv |»
x •
RE-ENTRY STATEMENT
P Apple**)
STORAGE AND
DISPOSAL
STOfUOE:
RESTRICTED USE
PESTICIDE ,
(reason for clasnifylnp)
tKZ TO WO US CNLT 8T CBWiriB) AWUCMWS OR!
ONTO 1H8IR DIMCT SOPCRVISION AND Wit FOR THOSE
USD ovtiaa) ir THE CERTIFIED APPUOOOR'S CERTIPICATION
PRODUCT
NAME
ACTIVE NOREDIENT: ,
MERT MQREOIENTS:,
TOTAU
100.00 X
THIS PRODUCT CONTAMS IBS OF PER GALLON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
STATEMENT OF PRACTCAL TREATMENT
SWALLOWED:
r ON SKN
T N EYES
SEE 8OE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
MFQBY—-
TOWN. STATE =====
ESTABLISHMENT NO.:
EPA REGISTRATION NO.;
NET CONTENTS:
CROP:
CROP:
CROP:
CROP:.
CROP:
WARRANTY STATEMENT
-------
§ 162.8
-152-
40 CFR Ch. I (7-1-86 Edition)
(fe) Conditional registration. Any a;
plication for which aflreview of scie#-
tifiddata is needed, otlher than an
plication which the! Agency deter-
mines may be considered for uncondi-
tional), registration under parar ~*~
(d) of this section, will be treated
application for condit
under KIFRA sec. 3(
reviewea and acted
in §§ 162A160 through
(f) Denial of registration.
ministrator shall deify an ap;
reviewed under p
section if any of th
paragraph MX 2) of
not met, or\if the:
data to make\the
tions.
(1) Notification.
making a determina
istration, the \ A
ph
an
nal registration
(7) and vAll be
on as set/forth
62.177.
" e Ad-
lication
of this
requirements of
this sefction are
are Insufficient
uired/determina-
notif y the applk
of the denial of
set forth the ret
for the detei
tions, if any, whic
in order for the
proved.
(2) Opportunity f^
cant (i) The appj
days from the
certified letter
corrective actioi
(ii) The applk
Administrator tp witi
tion. The A<
discretion, dez
drawal and pi
denial in accordant
(f )(3) of this/sectioi
(3) FEDERAL REGIS
the applicant fails
ciency of
the Ad
issue in
of deni
shall set forth the
for the denia
Prorfiptly after
Jon to deny a reg-
ptrator shall
)y Certified letter
Ition and shall
id factual basis
and the condi-
lust be satisfied
ition to be ap-
remedy by appli-
it will have 30
receipt of the
the specified
petition the
LW his applica-
tion may, in his
petition for with-
a notice of
witti\ paragraph
Unistratoi
.e and addr< ss of the applicant.
iuct name,
?e by weight <
basis
the
the
cen
dient in the produ
terns of use. and t!
cation.
|f4) Hearing rigi
fallowing publica
le FEDERAL REGI
»y interested p
ation. If
remedy the defi-
ition application.
shall promptly
e FEDERA! REGISTER^ notice
of registration. Such notice
•easons and factual
and shall cpntain
the name an6n the ebvironme;
that:
(1) Hafe been ob
come to his atten
(2) Insofar as
previously been
Agency.
Such informatio^ shall include, \but
shiul not be limited to, published\or
ipublished laboratory studies and
fdent experience!
L48 FR 34005rJuly-26r49S33
ed by
on; and
e is aware,
submitted
or has
not
the
§ 162.10 Labeling requirements.
(a) General—(1) Contents of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
122
-------
Environmental Protection Agency -153-
$ 162.10
scribed in paragraph (b) of this sec-
tion:
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
ciii) The net contents as prescribed
in paragraph (d) of this section;
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(i) General.
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably bo expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily distributed or sold.
(ii) Tank cars and other bulk con-
tainers—(A) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189, concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car, tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers,
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(q)(l)(A) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
§ 162.15, is misbranded if its labeling is
false or misleading in any particular
including both pesticidal and non-pes-
ticidal claims. Examples of statements
or representations in the labeling
which constitute misbranding include:
(i) A false or misleading statement
concerning the composition of the
product;
(ii) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device.
(iii) A false or misleading statement
about the value of the product for
123
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§ 162.10
-154-
purposes other than as a pesticide or
device;
(iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe." "nonpoison-
ous," "noninjurious," "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling, (i) Except
as provided in paragraph faXGXii) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
label.
40 CFR Ch. I (7-1.86 Edition)
(2) No name, brand, or trademark
may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to § 162.6(b)(4).
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • * *," "Distribut-
ed by • * V or "Sold by * * •" to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 68* F (20*C)
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units, i.e.. "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated minimum, is not permit-
ted. In no case shall the average con-
tent of the packages in a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
124
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Environmental Protection Agency
-155-
§ 162.10
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.." or the phrase "EPA Reg.
No." The registration number shall be
set in type of a size and style similar to
other print on that part of the label
on which it appears and shall run par-
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(1) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement
(i) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the Ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable jto
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(ii) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears.
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement The name used for each in-
gredient shall be the accepted
common name, if there is one, fol-
lowed by the chemical name. The
common name may be used-alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of section 25(c)(6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(i) In cases where it is determined
that a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement in a prominent position on
125
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§ 162.10
-156-
40 CFR Ch. I (7-1-86 Edition)
the label: "Not for sale or use after
[date]."
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredient(s) to be listed in the
ingredient statement if he determines
that such ingredient(s) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxicological
hazard including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type- size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
_
Hazard indicators
Oral LOM ~.
Inhalation LC»
Dermal LDM
Eye effects
Skin effects
1
Up to and Jndudmg SO
mg/kg.
Up to and inckKfing 2.
ing/Her.
Up to and indudtog 200
mg/kg.
Corrosive' corneal
opacity not reversible
within 7 days.
Corrosive
Tmddtv c
II
From 50 thru 500 mg/kg..
From 2 thru 2 mg/fiter —
From 200 thru 2000
Comoal opacity
reversible within 7
J— , - f.-iH a 11 ii ii
oays; •iiiauoii
persisting for 7 days.
Severe irritation at 72
hours.
Ill
From €00 thru 5000 mg/
kg-
From 2. thru 20 mg/iter_
From 2.000 thru 20.000—
No corneal opacity"
Irritation reversible
within 7 days.
Moderate Irritation at 72
hours.
rv
Greater than 5000 mg/
kg.
Greater than 20 mg/ttter.
Greater than 20.000.
No irritation.
MMd or slight irritation at
72 hours.
(i) Human hazard signal word—(A)
Toxicity Category I. All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral, inhalation or dermal toxiclty (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(ii) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonstrated by
the applicant to be extremely remote,
or if the nature of the pesticide is~5iich
that it is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(iii) Statement of practical treat-
ment—(A) Toxicity Category I. A
126
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Environmental Protection Agency
-157-
§ 162.10
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing into Toxicity Category I on the
basis of oral, inhalation or dermal tox-
icity. The Agency may. however.
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (h)QXiiiXA) of
this section. 'The' applicant may, how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (h)(2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Size of label front panel in square
inches
5 and unde»
Above 5 to 10
Above 10 to 15
Above 15 to 30
Over 30
Pa
Required
signal
word, all
capitals
6
10
12
14
18
nts
"Keep out
of reach of
children"
6
6
g
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
routeXs) of exposure and the precau-
tions to be taken to avoid accident.
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Toxicity
category
Precautionary statements by toxicity category
Oral, inhalation, or dermal toxfctty
Skin and eye local effects
III.
IV.
Fatal (poieonoue) if twaiowed [inhaled or absorbed
through akin). Do not breathe vapor [duet or spray
miet]. Do not get in eyes, on akin, or on dothing
(Front panel statement of practical treatment re-
quired.].
May be fatal H swatowed [inhaled or absorbed
through the akin). Do not breathe vapors [duet or
spray mist). Do not get in eyes, on akin, or on
dothing. (Appropriate first aid statements required.).
Harmful if swallowed [inhaled or ebeorbed through the
skin). Avoid breathing vapors (duet or spray miet).
Avoid contact with akin (eyes or dothing]. (Appro-
priate first aid statement required.].
[No precautionary statements required.]
Corrosive, causes eye and akin damage (or skin
irritation]. Do not get in eyes, on skin, or on
dothing. Wear goggles or face shield and rubber
gloves when handing. Harmful or fatal If swafewad.
(Appropriate first aid statement required.]
Causes eye (and akin] irritation. Do not get in eyes.
on skin, or on dothing. Harmful if swallowed. (Ap-
propriate first aid statement required.]
Avoid contact with akin, eyes or dothing. In case of
contact immediately flush eyes or skin with plenty of
water. Get medical .attention if irritation persists.
(No precautionary statements required.]
(ii) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
injury or damage. Examples of the
127
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§ 162.10
-158-
40 CFR Ch. I (7-1-86 Edition)
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LDM of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCM of 1 ppm or less,
the statement "This Pesticide is Toxic
to Pish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LDM of 100
mg/kg or less, or a subacute dietary
LCM of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ill) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flashpoint
Required text
(A) PRESSURIZED CONTAINERS
Rash point at or below 20* F; if them to • flashback at
any valve opening.
Flash point above 20* F and not over 80* F or If the
flame extension is more than 16 in long at a Distance
of 6 in from the flame.
AN other pressurized containers.......
Extremely flammable. Contents under pressure. Keep away from
fire, sparks, and heated surfaces. Do not puncture or incinerate
container. Exposure to temperatures above 130* F may cause
bursting.
Flammable. Contents under pressure. Keep away from heat.
sparks, and open flame. Do not puncture or Incinerate container.
Exposure to temperatures above 130* F may cause bursting.
Contents under pressure. Do not use or ston near heat or open
flame. Do not puncture or incinerate container. Exposure to
temperatures above 130* F may cause bursting.
(B) NoNPRE&suRiZEO CONTAINERS
At or below 20* F.....
Above 20* F and not over 80* F_
Above 80* F and not over 150* F.
Extremely flammable. Keep away from fire, sparks, and heated
surfaces.
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.
(i) Directions for Use—<1) General
requirements—(I) Adequacy and clar-
ity of directions. Directions for use
must be stated in terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(ii) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag;
(B) The label bears a reference to
the directions for use in accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular:" and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(iii) Exceptions to requirement for
direction for use—(A) Detailed direc-
128
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Environmental Protection Agency -159-
§ 162.10
t.ions for use may be omitted from la-
beling of pesticides which are intended
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
(1) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process-
es;
(3) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
(1) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product is also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(1) There is information readily
available to the formulators on the
composition, toxicity, methods of use,
applicable restrictions or limitations,
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product is intended for use only in
manufacturing, formulating, mixing,
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
(3) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use':
(i) The statement of use classifica-
tion as prescribed in 162.100) immedi-
ately under the heading "Directions
for Use."
(ii) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(iii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pestCs) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vl) The method of application, in-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vii) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viil) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing. (See Table in « 162.10
-------
§162.11
-160-
40 CFR Ch. I (7-1-86 Edition)
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(J) Statement of Use Classification.
By October 22,1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (j) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general useXs) and
the other bearing directions for re-
stricted use(s) excep that, if a product
has both restricted use(s) and general
use(s), both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
orovisions of § 162.KXJX2).
(1) General Use Classification. Pesti-
cide products bearing •directions for
use(s) classified general shall be la-
beled with the exact words "General
Classification" immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of misbranding.
(2) Restricted Use Classification.
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(D Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as required
for human hazard signal words (see
table in § 162.10(h)(l)(iv)). and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use, the state-
ment "Restricted Use Pesticide" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use is restricted to certified
applicators, the following statement is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If,
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. [Reserved]
[40 FR 28268. July 3. 1975; 40 FR 32329,
Aug. 1, 1975; 40 FR 36571. Aug. 21. 1975. as
amended at 43 FR 5786. Feb. 9.1978]
§ H2.ll
(a)
Criteria for
mable adrc
>) [Reserved]
cl
for
Except as provided
of this section, a
pesticide product n<
tered shall be
if each of the
forth in paragra]
(ill) of this sectio
the product use0)
for restricted
the labeling
(cX3) of thiXsection
product use may be
era! use/or the
strictecruse of the
the risks of
icide. Each of th|
'set forth below
ic product use(s)
^terminations of
I effect*,
n—(1) ClcuMJica-
reffistfations.
iph (cX4)
of a
preously regis-
edyfor general use
le criteria set
r(c)(l)(i) through
met. Otherwise,
be classified
a review of
,t >to paragraph
that the
for gen-
efits fr\hn~uhre-
icide outweigh
cted use oil the
separate criteria
just be appliedXr
to be classifu
130
-------
-161-
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flane extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None reguired.
-------
-162-
STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
-------
-163-
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact
wording that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or
feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
that are Acute Hazardous Wastes or are assigned to Toxicity
Category I on the basis of oral or dermal toxicity, or
Toxicity Category I or II on the basis of acute inhalation
toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper
disposal of excess pesticide, spray mixture, or rinsate
is a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions, contact
your State Pesticide or Environmental Control Agency, or
the Hazardous Waste representative at the nearest EPA
Regional Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that
are Toxic Hazardous Wastes or meet any of the criteria in
40 CFR 261, Subpart C for a hazardous waste must bear the
following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
e c de, spray mixture, or rinsate is a violation of
Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. Products intended for domestic use only must bear the
following disposal statement:
"Securely wrap original container in several layers
of newspaper and discard in trash."
-------
-164-
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bea:
container disposal statements:
Container Type
one of the following
Statement
Non-aerosol products
(bottlesr cansr jars)
Non-aerosol products
(bags )
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must
based on container type, listed
Container Type
bear container
below:
disposal instructions,
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
s^ay out. 01 siuone.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Glass containers
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner*
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder
similar wording)
for reuse (or
\f Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
-------
III. USE INDEX APPENDIX
-------
-165-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE*
TABLE OF CONTENTS
Site Name page
TERRESTRIAL FOOD CROP 2
(Agricultural Crops) 2
Almond 3
Apple 4
Apricot 5
Beans (including blackeyed peas, cowpeas, lima beans, red
kidney beans, and snap beans) 6
Cherry 5
Citrus Fruits (including grapefruit, kumquat, lemon, lime,
orange, tangelo, and tangerine) 8
Corn (seed crop) 10
Corn, Field 9
Corn, Sweet 11
Cotton 12
Grapes 15
Nectarine 5
Olive 15
Peach 16
Pear 4
Pecan 17
Plum 5
Prune 5
Soybeans 19
Sugar Beets 21
Tomato 21
Walnut 22
TERRESTRIAL NON-FOOD CROP 23
(General Soil Treatment and Composting) 23
Earthworm Farms 23
Issued: 8-15-85 III-041801-1
Provisional Update: 12-03-86
-------
-166-
EPA Compendium of Acceptable Uses
'41801 0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE*
TYPE PESTICIDE; Insecticide, Acarlcide
FORHULATIONS;
Tech~(93%)
FI (80%).
G (0.26%, 1%, 2%, 4%)
WP (5%, 25%)
EC (2 Ib/gal, 3 Ib/gal, 4 Ib/gal, 5 Ib/gal)
GENERAL WARNINGS AND LIMITATIONS; All liquid femulations and any femu-
lation greater than 4 percent are RESTRICTED USE PESTICIDES. Do not use
in combination with bordeaux or zinc sulfate-lime sprays. Do not combine
emulsifiable concentrate formulation with wettable powder formulation un-
less previous use of this mixture has proven physically compatible and
safe to plants. Do not allow entry into treated fields within 24 hours
after treatment, unless full protective clothing is worn.
HANDLE THE CONCENTRATE ONLY WHEN WEARING THE FOLLOWING PROTECTIVE CLOTHING
AND EQUIPMENT: Wear a protective suit of 1 or 2 pieces that covers all
parts of the body except the head, hands, and feet. Wear chemical resis-
tant gloves, chemical resistant apron, and chemical resistant shoes, shoe
coverings, or boots. Wear goggles or a face shield. Wear a pesticide
respirator approved by the National Institute for Occupational Safety and
Heatlh under the provisions of 30 CFR Part II. If handling the concen-
trate with a closed system, a long sleeved shirt and long legged pants may
be substituted for the protective suit and the respirator requirement is
waived.
WEAR THE FOLLOWING PROTECTIVE CLOTHING DURING APPLICATION, EQUIPMENT RE-
PAIR, EQUIPMENT CLEANING, AND DURING EARLY REENTRY TO TREATED AREAS: Wear
a protective suit of 1 or 2 pieces that covers all parts of the body ex-
cept the head, hands, and feet. Wear chemical resistant gloves and chemi-
cal resistant boots, shoes, or shoe coverings. Application must be made
only from a tractor with a completely enclosed cab or aerially with an
enclosed cockpit. For these applications a long sleeved shirt and long
legged pants may be worn in place of the above protective clothing. Chem-
ical resistant gloves must be available in the cab or cockpit and must be
worn while exiting. This clothing is inadequate to protect you during
equipment repair, cleaning or reentry.
Refer to appropriate labeling for ENDANGERED SPECIES RESTRICTION^.
Bee Caution;
EPN is highly toxic to bees exposed to direct treatment or residues on
blooming crops or weeds. Do not apply EPN or allow it to drift to bloom-
ing crops or weeds if bees are visiting the treatment area.
Agricultural Crop Tolerances;
Beets (with or without tops) 3 ppm
Beet greens 3 ppm
Blackberry 3 ppm
Boysenberry 3 ppm
Dewberry 3 ppm
Lettuce 3 ppm
Loganberry 3 ppm
Pineapple 3 ppm
*EPN
Issued: 8-15-85 III-041801-1
Provisional Update: 12-03-86
-------
-167-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
GENERAL WARNINGS AND LIMITATIONS (continued)
Quince 3 ppm
Raspberry 3 ppm
Rutabaga (with or without tops) 3 ppm
Rutabaga (tops) 3 ppm
Spinach 3 ppm
Strawberry 3 ppm
Turnips (with or without tops) 3 ppm
Turnips greens 3 ppm
Youngberry 3 ppm
Slte.and Pest Dosages and Tolerance, Use, Limitations
Formulatlon(s)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations; Do not use In home plantings nor ap-
ply with hand equipment. Do not use In mist blower type or thermal
aerosol type (fog) equipment. Consult your State Cooperative Agricul-
tural Extension Service for proper timing of applications and for in-
structions regarding posting treated areas. When a dosage range is
given, use the lower rate on small young plants or when Infestation is
light. Use the higher rate on large or mature plants or when infesta-
tion is heavy.
For fruits, apply the first cover spray following bloom or with the
first sign of Infestation. Repeat as needed unless otherwise specified.
Granular formulations may be applied by aircraft.
For wettable powder formulations, apply per acre rates in a minimum of
20 gallons of water per acre by high pressure hydraulic equipment.
For emulsifiable concentrate formulations, apply per acre rates in a
minimum of 1 to 10 gallons of water by aircraft or in a minimum of 3 to
10 gallons of water by low volume ground equipment. Labeling^claims
varying minimum gallonages depending on crop growth and size. If low
volume ground equipment is desired, the rate per 100 gallons should be
adjusted in order to maintain the correct rate of active ingredient per
acre. For aerial applications, flagging must be by fully automated
mechanical means or by humans working in totally enclosed vehicles.
Emulsifiable concentrate formulations may be tank mixed with methyl
parathion.
Do not apply when weather conditions favor drift from areas treated.
Issued: 8-15-85 III-041801-2
-------
)3001AA
Site and Pest
Almond
-168-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.5 ppm
21 day preharvest interval through
2 pounds per acre for foliar appli-
cation.
Do not apply when trees or a sub-
stantial number of weeds in the or-
chard/grove are in bloom.
TAMABA
Peach twig borer
LAVAM
Spider mites (in-
cluding European
red mite, Pacific
spider mite and
twospotted spider
mite)
0.25 lb/
100 gal
(4, 5 Ib/gal
EC)
0.125-0.188
lb/100 gal
[max 800
gal/A]
(25% WP)
(4, 5 Ib/gal
EC)
Foliar application.
Issued: 8-15-85
III-041801-3
-------
-169-
Site and Pest
34001AA
)4003AA
TBUCSA
NASAVA
TBUAGA
1RAXALA
CLAVAAA
/OA001AA
ITBUCSA
ITBUAGA
IRAXALA
INASAVA
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulation(s)
3 ppm
21 day preharvest interval (apples)
or 14 day preharvest interval
(pears) through 4.5 pounds per acre
for foliar application.
Do not apply when trees or a sub-
stantial number of weeds in the or-
chard/grove are in bloom. Do not
use on Mclntosh or related varieties
(apples).
Codling moth
Plum curculio
Fruittree leaf-
roller
Pear psylla
Spider mites (in-
cluding European
red mite, Pacific
spider mite,
Schoene spider
mite, twospotted
spider mite and
Willamette spider
mite)
(Apple)
Codling moth
Fruittree leaf-
roller
Pear psylla
Plum curculio
0.25-0.375
lb/100 gal
(25% WP)
(4, 5 Ib/gal
EC)
or
1-1.5 Ib/A
(5 Ib/gal EC)
0.188-0.375
lb/100 gal
(25% WP)
(4, 5 Ib/gal
EC)
0.125-0.375
lb/100 gal
(25% WP)
(4, 5 Ib/gal
EC)
0.125-0.188
lb/100 gal
(25% WP)
(4, 5 Ib/gal
EC)
Foliar application. Apply at petal
fall and repeat at 10 to 14 day in-
tervals as needed.
Foliar application.
0.5 lb/100 Foliar application.
gal May be formulated with methyl para-
[900 gal/A] thion.
(4 Ib/gal EC)
Issued: 8-15-85
III-041801-4
-------
-170-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
uAVAAA
05001AA
05002AA
05003AA
05005AA
05006AA
05004AA
Site and Pest
Apple (continued)
Spider mites (in-
cluding European
red mite, Pacific
spider mite,
Schoene spider
mite, twospotted
spider mite and
Willamette spider
mite)
Apr.lcot
Cherry
Nectarine
.RAHAVJG
:RAHAJG
ITBUAGA
Cottony peach
scale (crawlers)
Lecanium scales
(crawlers)
Fruittree leaf-
roller
LRAKBPG
Olive scale
(crawlers)
Dosages and Tolerance, Use, Limitations
Formulation(s)
[MAI]
4.5 Ib/A
(3 Ib/gal EC)
0.313 lb/
100 gal
(25% WP)
(4, 5 Ib/gal
EC)
0.188 lb/
100 gal
(25% WP)
(4, 5 Ib/gal
EC)
0.625 lb/
100 gal
(25% WP)
or
0.25 lb/
100 gal
[plus 1.5%
light medium
oil]
(25% WP)
3 ppm
21 day preharvest interval through
3 pounds per acre for foliar and
bark applications.
Delayed dormant application through
5 pounds per acre. Do not make more
than 1 application during the delay-
ed dormant period. Do not apply
when trees or a substantial number
of weeds in the orchard/grove are
in bloom.
Foliar application.
Issued: 8-15-85
III-041801-5
-------
Site and Pest
LAVAAA
:RAHAWG
KAHAJG
RAKBPG
:TBUCJA
-171-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulation(s)
Apricot; cluster (continued)
Spider mites (in-
cluding European
red mite, Pacific
spider mite, two-
spotted spider
mite and Willa-
mette spider mite)
Cottony peach
scale (crawlers)
Xecanium scales
(crawlers)
Olive scale
(crawlers)
Oriental fruit
moth
0.125-0.188
lb/100 gal
(25% WP)
(4, 5 Ib/gal
EC)
5 Ib/A Delayed dormant application. Apply
[plus 1.5% once at the time flower buds begin
oil] to swell.
(4, 5 Ib/gal
EC)
1TBQALA
TBQAHA
CTBUCJA
CNASAVA
/28001AA
ITBCDCA
Lesser peachtree
borer
Peachtree borer
Oriental fruit
moth
Plum curculio
0.313-0.75 Bark application. Make application
lb/100 gal during appearance of the moths in
(25% WP) early to late summer. Apply 2 or 3
(4, 5 Ib/gal sprays to trunk from ground to scaf-
EC) fold limbs timed with moth flight.
or
0.75-1.5 Ib/A
(5 Ib/gal EC)
0.25-0.375
lb/100 gal
(25% WP)
(4, 5 Ib/gal
EC)
or
1-1.5 Ib/A
(5 Ib/gal EC)
Beans (including blackeyed peas,
cowpeas, lima beans, red kidney
beans, and snap beansj
ITBMBWA
Armyworm complex
(Including beet
armyworm and yel —
lowstriped army-
worm)
Beet webworm
0.5-1 Ib/A
(2, 3, 4 lb/
gal EC)
Foliar application. Apply at petal
fall and repeat at 10 to 14 day in-
tervals as needed.
3 ppm
21 day preharvest interval through
1.5 pounds per acre for foliar ap-
plication.
Do not feed treated vines to live-
stock.
Foliar application.
May be formulated with methyl para-
thlon.
Issued: 8-15-85
III-041801-6
-------
QAMACA
OABADA
QAMATA
MOAAM
TBCBOA
TBMCCA
KAPAFA
LAVBEA
:RACAAA
TBCDCA
[NAMADA
CRAFAAA
[QAMARA
CLAAABA
CTBCCZA
INBUAAA
IQAQAAA
Site and Pest
-172-
EPA Compendium of Acceptable Uses
6-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulation(s)
'Beans (continued)
Pest list continued from previous page.
Rapid plant bug [MAI]
Serpentine leaf- 0.5-1 Ib/A
miner complex (2, 3 Ib/gal
Tarnished plant bug EC)
Thrips
Tomato fruitworm
European corn borer 0.25 Ib/A
(25% WP)
Mexican bean beetle 0.125-1 Ib/A
Twospotted spider
mite
(25% WP)
(2, 4, 5 lb/
gal EC)
[MAI]
0.125-1 Ib/A
(3 Ib/gal EC)
Foliar application. Make 2 to 4
applications beginning 5 to 7 days
after eggs are laid.
Foliar application. For Mexican
bean beetle, make 2 to 4 applica-
tions starting 5 to 7 days after
eggs are laid.
May be formulated with methyl para-
thion.
Aphids
Armyworm complex
(including beet
armyworm, southern
armyworm, and yel-
lows trlped army-
worm)
Flea beetles
Leafhoppers
Lygus bugs
Mites (including
russet mite)
Climbing cutworms
Darkling beetles
Stink bugs
[MAI] Foliar application.
0.25-1.5 Ib/A Formulated with methyl parathion.
(2, 3 Ib/gal
EC)
[MAI]
0.67 Ib/A
(2 Ib/gal EC)
[MAI]
0.5-0.94 Ib/A
(3 Ib/gal EC)
[MAI]
0.5-1 Ib/A
(2, 3 Ib/gal
EC)
Issued: 8-15-85
III-041801-7
-------
ZOOOAA
AVARA
IOCAOA
tOCAOA
CBUAGA
DBUALA
CAAAFA
IBUAGA
TBUALA
TAAAFA
Site and Pest
(Sherry
-173-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulation(s)
Citrus Fruits (including grape-
fruit, kumquat, lemon, lime,
orange, tangelo, and tangerine)
Citrus red mite
Citrus thrips
Citrus thrips
Fruittree leaf
roller
Orange tortrix
Orangeworms
Fruittree leaf-
roller
Orange tortrix
Orangeworms
0.25-0.375
lb/100 gal
(25% WP)
0.5 lb/100
gal
or
2-3 Ib/A
(251 WP)
or
0.5 Ib/A
(4, 5 Ib/gal
EC)
1.5-2 Ib/A
(25% WP)
(4, 5 Ib/gal
EC)
See Apricot cluster.
3 ppm
30 day preharvest interval through
8 pounds per acre for foliar appli-
cation.
Do not use treated rinds for food
or feed. Do not apply when trees
or a substantial number of weeds in
the orchard/grove are in bloom.
Use limited to FL.
Foliar application.
Foliar application.
Foliar application.
4-8 Ib/A Foliar application.
(4 Ib/gal EC)
0.75-2.25
Ib/A
(25% WP)
(4, 5 Ib/gal
EC)
1.25-1.5 Ib/A
(25% WP)
(4, 5 Ib/gal
EC)
Issued: 8-15-85
III-041801-8
-------
'8006AA
TBCCFA
:TBCCZA
[NAMBHJ
IRACDKA
1QAQAAA
ITMBCCA
Site and Pest
Corn, Field
Armyworm
-174-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulation(s)
3 ppm
14 day preharvest interval through
0.75 pound per acre for foliar ap-
plication.
Do not apply during the pollenshed
period if bees are visiting the
treatment area.
May be tank mixed with methorny1.
0.47-0.5 Ib/A Foliar application.
(4, 5 Ib/gal May be formulated with methyl para-
EC) thion.
[MAI]
0.25-0.5 Ib/A
(2, 3 Ib/gal
EC)
Climbing cutworms
Corn rootworms
(adults)
Corn leaf aphids
Stink .bugs
[MAI]
0.188-0.5
Ib/A
(2, 3 Ib/gal
EC)
Foliar application.
Formulated with methyl parathion.
0.23-0.5 Ib/A Foliar application. Apply when
(4, 5 Ib/gal pests first appear (to protect silk
EC)
[MAI]
0.188-0.25
Ib/A
(3 Ib/gal EC)
[MAI]
0.188-0.25
Ib/A
(3 Ib/gal EC)
from damage).
May be formulated with methyl para-
thion.
Foliar application.
Formulated with methyl parathion.
European corn borer 0.2-0.5 Ib/A Foliar application. Apply 10 days
(1Z, 2%, 4Z after eggs first hatch or when 75
G)
(25Z WP)
(2, 3, 4, 5
Ib/gal EC)
or
0.75 Ib/A
percent of the plants show evidence
of feeding in leaf whorls. Repeat
7 to 10 days later if new evidence
of leaf feeding is present. For
second brood, apply when eggs begin
to hatch.
(4 Ib/gal EC) May be formulated with methyl para-
or thlon.
Issued: 8-15-85
III-041801-9
-------
-175-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
Corn, Field' (continued)
[TBCCOA
Fall armyworm
CTBMAYA
Southwestern corn
borer
ILAVAAA
ITBCCXA
/28005BA
Spider mites (in-
cluding Pacific
spider mite and
twospotted
spider mite)
Surface feeding
cutworms
Corn (seed crop)
INAMBHJ
ITMBCCA
Corn rootworms
(adults)
[MAI]
0.2-0.5 Ib/A
(2, 3 Ib/gal
EC)
[MAI]
0.188-0.5
Ib/A
(3 Ib/gal EC)
Foliar application.
Formulated with methyl parathion.
0.5 Ib/A Foliar application. For second to
(4, 5 Ib/gal third generation borer, apply when
EC) 10 percent of plant population have
eggs masses. Repeat at 5 to 10 day
[MAI] intervals as needed.
0.25-0.5 Ib/A May be formulated with methyl para-
(3 Ib/gal EC) thion.
0.75 Ib/A Foliar application.
(A Ib/gal EC) May be formulated with methyl para-
thion.
[MAI]
0.5 Ib/A
(3 Ib/gal EC)
[MAI]
0.5 Ib/A
(2 Ib/gal EC)
Foliar application.
Formulated with methyl parathion.
3 ppm
14 day preharvest interval through
0.5 pound per acre for foliar appli-
cation (forage and fodder^.
Do not apply during the pollenshed
period if bees are visiting the
treatment area.
0.25-0.5 Ib/A Foliar application to seed crop.
(4 Ib/gal EC) Apply when pests first appear (to
protect silk from damage).
European corn borer 0.2-0.5 Ib/A
(2, 4* G)
(25% WP)
Foliar application to seed crop.
Apply when 25 percent of the plants
show first brood whorl feeding.
(4 Ib/gal EC) Repeat in 7 days if new feeding
damage occurs. For second brood,
apply at pollen shedding and while
plants are in the green silk stage.
Issued: 8-15-85
111-041801-10
-------
L5005AA
TBCCFA
ITBCCZA
:NAMBHJ
ERACDKA
[QAQAAA
ITMBCCA
Site and Pest
CoTn, Sweet
Armyworm
-176-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulation(s)
3 ppm
14 day preharvest interval through
0.75 pound per acre for foliar ap-
plication.
Do not apply during the pollenshed
period if bees are visiting the
treatment area.
May be tank mixed with methorny1.
0.47-0.5 Ib/A Foliar application.
(4, 5 Ib/gal May be formulated with methyl para-
EC) thion.
[MAI]
0.25-0.5 Ib/A
(2, 3 Ib/gal
EC)
Climbing cutworms
Corn rootworms
(adults)
Corn leaf aphids
Stink bugs
[MAI]
0.188-0.5
Ib/A
(2, 3 Ib/gal
EC)
Foliar application.
Formulated with methyl parathion.
0.23-0.5 Ib/A Foliar application. Apply when
(4, 5 Ib/gal pests first appear (to protect silk
EC)
[MAI]
0.188-0.25
Ib/A
(3 Ib/gal EC)
[MAI]
0.188-0.25
Ib/A
(3 Ib/gal EC)
from damage).
May be formulated with methyl para-
thion.
Foliar application.
Formulated with methyl parathion.
European corn borer 0.2-0.5 Ib/A Foliar application. Apply when 25
(1%, 2Zt 4% percent of the plants show evidence
of leaf feeding. Repeat at 5 day
intervals as long as leaf feeding
is evident. One to 3 applications
may be required. For control of
second brood borers, apply when eggs
begin to hatch.
(4 Ib/gal EC) May be formulated with methyl para-
or thion.
G)
(25% WP)
(2, 3, 4, 5
Ib/gal EC)
or
0.75 Ib/A
Issued: 8-15-85
III-0418 01-11
-------
-177-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
Corn, Sweet (continued)
BCOOA
Fall armyworm
BMAYA
Southwestern corn
borer
AVAAA
TBCCXA
28007AA
Spider mites (in-
cluding Pacific
spider mite and
twospotted
spider mite)
Surface feeding
cutworms
Cotton
RACAAA
Aphids (including
cotton 'aphid)
[MAI]
0.2-0.5 Ib/A
(2, 3 lb/gal
EC)
[MAI]
0.188-0.5
Ib/A
(3 lb/gal EC)
Foliar application.
Formulated with methyl parathion.
0.5 Ib/A Foliar application. For second to
(4-5 lb/ third generation borer, apply when
gal EC) 10 percent of plant population have
eggs masses. Repeat at 5 to 10 day
[MAI] intervals as needed.
0.25-0.5 Ib/A May be formulated with methyl para-
(3 lb/gal EC) thion.
0.75 Ib/A Foliar application.
(4 lb/gal EC) May be formulated with methyl para-
thion .
[MAI]
0.5 Ib/A
(3 lb/gal EC)
[MAI]
0.5 Ib/A
(2 lb/gal EC)
Foliar application.
Formulated with methyl parathion.
[MAI]
0.125-0.67
Ib/A
(2, 3 lb/gal
EC)
0.5 ppm (cottonseed)
3 day preharvest or hand picking
interval through 1 pound per acre
for foliar application.
Do not feed treated forage or gin
trash to livestock. Do not apply
to blooming cotton if bees are
visiting the treatment area.
May be tank mixed with chlordime-
form, chlordimeform hydrochloride
and methorny1.
Foliar application.
Formulated with methyl parathion.
Issued: 8-15-85
111-041801-12
-------
TBCCNA
TABACA
TBCCSA
TAYAHA
TBCCQA
TBCAOA
QAMARA
INBUAAA
SAPAFA
10ABADA
1TBCCLA
:TBMBWA
ILAJAHA
XAVBEA
Site and Pest
-178-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulation(s)
"Corton (continued)
Beet armyworm
Saltmarsh cater-
pillar
Cabbage looper
[MAI]
0.5-1 Ib/A
(2, 3 Ib/gal
EC)
[MAI]
Cotton leafperfer- 0.25-1 Ib/A
(2, 3 Ib/gal
EC)
ator
Yellow striped
armyworm
Cotton leaf worm
Lygus bugs (and
other mirids)
[MAI]
0.167-0.94
Ib/A
(2, 3 Ib/gal
EC)
Darkling beetles [MAI]
Mexican bean beetle 0.94 Ib/A
Serpentine leaf- (3 Ib/gal EC)
miner
Southern armyworm
Sugarbeet webworm
Tomato russet mite
Twospotted spider
mite
ITBCCOA
DLAVAAA
[QAMBDA
ITBMBVA
IVABAAA
IKOAAAA
Fall armyworm
Spider mites
Fleahoppers (in-
cluding cotton
fleahopper)
Garden webworm
Grasshoppers
Thrips
[MAI]
0.125-0.56
Ib/A
(2, 3 Ib/gal
EC)
[MAI]
0.0635-0.94
Ib/A
(2, 3 Ib/gal
EC)
-0.67
Ib/A
(2, 3 Ib/gal
EC)
Issued: 8-15-85
111-041801-13
-------
-179-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
JAMACA
JAMATA
IBCCNA
QAMACA
DABADA
IBCCLA
QAMATA
HAS AHA
:TBCBOA
ITAMADA
:TBCBNA
IRAFCFA
ITBCADA
ILAVAAA
DtOAAAA
ITBCCQA
Site and Pest
Cotton (continued)
Dosages and Tolerance, Use, Limitations
Fortnulation( s)
Rapid plant bug [MAI]
Tarnished plant bug 0.67-0.94
Ib/A
(2, 3 Ib/gal
EC)
Beet armyworm
Rapid plant bug
Serpentine leaf-
miner complex
Southern armyworm
Tarnished plant bug
Boll weevil
1 Ib/A Foliar application.
(4 Ib/gal EC)
Bollworm
Pink bollworm
Tobacco budworm
Cotton fleahoppers
Cotton leafworm
Spider mites
Thrips
Yellowstriped
armyworm
0.5-1 Ib/A
(2, 4, 5 lb/
gal EC)
Foliar application. Apply when
plants are fruiting and 10 to 25
percent of squares are punctured.
Repeat at 5 day intervals as needed.
0.188-0.94 Foliar application. Apply the lower
Ib/A dosage for overwintered adults.
(5 Ib/gal EC) Apply the higher dosage for middle
and late season control.
[MAI] May be formulated with methyl para-
0.1-0.67 Ib/A thion.
(2, 3 Ib/gal
EC)
0.94-1 Ib/A
(2, 4, 5 lb/
gal EC)
[MAI]
0.33-1 Ib/A
(2, 3 Ib/gal
EC)
Foliar application. For bollworm,
apply when eggs and 4 to 5 larvae
per 100 terminals are found or be-
fore larvae have infested bolls.
May be formulated with methyl para-
thion.
0.313-0.625 Foliar application. Apply when
Ib/A pests first appear and repeat at 4
(2, 4, 5 lb/ to 5 day intervals as needed.
gal EC)
Issued: 8-15-85
111-041801-14
-------
-180-
1014AA
:BGBDA
IAFAOA
LAVAAA
28014AA
IRAHAWG
CRAHAJG
Site and Pest
Grapes
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-KITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulation(s)
3 ppm
21 day preharvest interval through
0.75 pound per acre for foliar
application.
Grape berry moth
Foliar application.
Grape leafhopper
0.25 Ib/A
(25% WP)
or
0.25 lb/100
gal
(25% WP)
(4, 5 Ib/gal
EC)
or
0.75 Ib/A
(4 Ib/gal EC)
[MAIJ Foliar application.
0.75 Ib/A Formulated with methyl parathion.
(3 Ib/gal EC)
0.125-0.188
lb/100 gal
(25% WP)
Spider mites (In-
cluding European
red mite, Pacific
spider mite, two- (4, 5 Ib/gal
spotted spider EC)
mite and Willa-
mette spider [MAI]
mite) 0.75 Ib/A
(3 Ib/gal EC)
Nectarine
Olive
Foliar application.
May be formulated with methyl para-
thion.
See Apricot cluster.
3 ppm
Foliar application through^!2
pounds per acre.
Do not apply after July 15.
Cottony peach scale 0.313 lb/ Foliar application.
(crawlers)
Lecanium scales
(crawlers)
100 gal
[max 4 Ib/A]
(25% WP)
or
4-6 Ib/A
(4 Ib/gal EC)
or
8-12 Ib/A
(4, 5 Ib/gal
EC)
Issued: 8-15-85
111-041801-15
-------
-181-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
AKBPG
Site and Pest
Olive (continued)
Olive scale
(crawlers)
Dosages and Tolerance, Use^ Limitations
Formulation(s)
0.625 lb/
100 gal
[max 4 Ib/A]
(25% WP)
or
0.25 lb/
100 gal
[plus 1.5%
light medium
oil]
(25% WP)
or
4-6 Ib/A
(4 Ib/gal EC)
or
8-12 Ib/A
(4, 5 Ib/gal
EC)
)5004AA
Peach
NASAVA
QAMATA
Plum curculio [MAI]
Tarnished plant bug 0.375 lb/100
gal
(5% WP)
RAHAWG
RAHAJC
:TBUCJA
:NASAVA
:QAMATA
Cottony peach
scale (crawlers)
Lecanium scale
(crawlers)
Oriental fruit moth
Plum curculio
Tarnished plant bug-
[MAI]
0.375 lb/100
gal
(5% WP)
3 ppm
21 day preharvest interval through
3 pounds per acre for foliar and
bark applications.
Delayed dormant application through
5 pounds per acre. Do not make more
than 1 application during the delay-
ed dormant period. Do not apply
when trees or a substantial number
of weeds in the orchard/grove are
in bloom.
Delayed dormant and foliar applica-
tion. Apply in the first 2_or 3
early season sprays. For the con-
trol of overwintering generation of
the plum curculio.
Formulated with sulfur.
Foliar application. May be applied
in a complete spray schedule. Early
ripening varieties will not require
the full schedule of application.
Formulated with sulfur.
Pear
Issued: 8-15-85
Also refer to Apricot cluster for additional pest
and use information.
See Apple cluster.
111-041801-16
-------
-182-
03008AA
Site and Pest
Pecan
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulation( s)'
0.5 ppm
21 day preharvest interval through
3.75 pounds per acre for foliar ap-
plication.
Do not graze livestock in treated
groves. Do not use in home plant-
ings.
RACAAA
LAAABA
Aphids
Mites (excluding
spider mites)
[TABAIA
:TBDABA
Fall webworm
Walnut caterpillar
CTBGAXA
[NASBBA
Hickory shuckworm
Pecan weevil
0.3-0.5 lb/ Foliar application. Apply when
100 gal pests first appear or when injury
(25% WP) is first seen. Repeat as needed.
(2, 4, 5 lb/ May be formulated with parathion.
gal EC)
or
1-1.5 Ib/A
(4 Ib/gal EC)
[MAI]
2 Ib/A
(4 Ib/gal EC)
0.375-0.5 lb/ Foliar application. Apply while
100 gal caterpillars are small.
(25% WP) Kay be formulated with parathion.
(2, 4, 5 lb/
gal EC)
[MAI]
2 Ib/A
(4 Ib/gal EC)
0.5 lb/100
gal
(25% WP)
or
0.375-0.5
lb/100 gal
[250-500
gal/A]
or
1.25-2.5 Ib/A
(2, 4, 5 lb/
gal EC)
[MAI]
2 Ib/A
(4 Ib/gal EC)
Foliar application. For hickory
shuckworm, make first application
at time of shell hardening or about
August 10 to 15. Make.,2 additional
applications at 14 day intervals.
This treatment will also control the
pecan weevil. If pecan weevil is
the only pest, make only 2 applica-
tions. Make first application about
August 1 to 10 or when 6 or more
weevils can be jarred from a single
tree. Repeat 10 to 14 days later.
May be formulated with parathion.
Issued: 8-15-85
111-041801-17
-------
fBPAEA
rBMAFA
TBMADA
QAQALA
CLAVAAA
-183-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Site and Pest
"Pecan (continued)
May beetles
Pecan leaf case-
bearer
Pecan nut case-
bearer
Southern green
stink bug
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
0.375-0.5 lb/ Foliar application. Apply when
100 gal beetles appear in the spring.
(25% WP)
(2, 4, 5 lb/
gal EC)
Foliar application. Apply when
pest first appears and repeat as
needed.
May be formulated with parathion.
0.4-0.5 lb/
100 gal
[250-300
gal/A]
(25% WP)
(2, 4, 5 lb/
gal EC)
or
1.25-1.56
Ib/A
(5 Ib/gal EC)
[MAI]
2 Ib/A
(4 Ib/gal EC)
0.3-0.5 lb/ Foliar application. Apply when tips
100 gal of small nuts begin to turn brown.
(25% WP) Repeat at 7 to 10 day intervals as
(2, 4, 5 lb/ needed.
gal EC) May be formulated with parathion.
or
1-3.5 Ib/A
(4, 5 Ib/gal
EC)
[MAI]
2 Ib/A
(4 Ib/gal EC)
0.375-0.5 lb/ Foliar application.
100 gal
(25% WP)
(2, 4, 5 lb/
gal EC)
Spider mites (in- 0.125-0.188 Foliar application.
eluding twospotted lb/100 gal May be formulated with parathion.
(25% WP)
(4, 5 Ib/gal
EC)
spider mite)
or
Issued: 8-15-85
111-041801-18
-------
RAEAAA
NALBCA
'28023AA
CRACAAA
ITBCCFA
INAMARA
INBGAAA
-184-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Site and Pest
"Pecan (continued)
Spittlebugs
Twig girdler
Plum
Prune
Soybeans
Aphids
Armyworm
Bean leaf beetle
Blister beetles
Dosages and Tolerance, Use, Limitations
Formulation(s)
3-3.5 Ib/A
(4 Ib/gal EC)
[MAI]
2 Ib/A
(4 Ib/gal EC)
[MAI] Foliar application. Apply when
2 Ib/A pest appears. If past experience
(4 Ib/gal EC) indicates spittlebugs will be a
problem, apply to the second pre-
pollination spray.
Formulated with parathion.
0.375-0.5 lb/ Foliar application. Make 3 appli-
100 gal cations at 14 day intervals begin-
(25% WP) ning when damage appears.
(2, 4, 5 lb/ May be formulated with methyl para-
gal EC) thion.
[MAI]
2 Ib/A
(4 Ib/gal EC)
See Apricot cluster.
See Apricot cluster.
0.05 ppm (negligible residue)
21 day preharvest, prefeeding and
pregrazing interval through 1 pound
per acre for foliar application.
[MAI]
0.25-0.52
Ib/A
(2, 3 Ib/gal
EC)
[MAI]
0.5 Ib/A
(2 Ib/gal EC)
[MAI]
0.25-0.375
Ib/A
(2, 3 Ib/gal
EC)
Foliar application.
Formulated with methyl parathion.
Issued: 8-15-85
111-041801-19
-------
TBCCSA
TBCCCA
CTBCCZA
CRASADA
LTAAAMA
CTBCCOC
CTABACA
LNAPAFA
IQAQAAA
ILAVBEA
ITBCATA
ITBCBOA
-185-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Site and Pest
Soybeans (continued)
Cabbage looper
Green cloverworm
Climbing cutworms
Threecornered
alfalfa looper
Webworms (includ-
ing garden web-
worm)
Fall armyworm (up
to 3rd instar
larvae)
Saltmarsh cater-
pillar
Dosages and Tolerance, Use, Limitations
Formulation^s)
[MAI]
0.25-0.75
Ib/A
(2, 3 Ib/gal
EC)
[MAI]
0.125-0.52
Ib/A
(2, 3 Ib/gal
EC)
[MAI]
0.5-1 Ib/A
(2, 3 Ib/gal
EC)
Mexican bean beetle [MAI]
0.25-1 Ib/A
(2, 3 Ib/gal
EC)
Stink bugs
Twospotted spider
mite
Velvetbean cater-
pillar
Corn earworm
[MAI]
0.63-1 Ib/A
(2, 3 Ib/gal
EC)
[MAI]
0.2-0.375
Ib/A
(2, 3 Ib/gal
EC)
1 Ib/A Foliar application. Apply when
(A, 5 Ib/gal larval counts show 1 larva per 3
EC) feet of row. Repeat as needed.
May be formulated with methyl para-
[MAI] thion.
0.375-1 Ib/A
(2, 3 Ib/gal
EC)
Issued: 8-15-85
III-OA1801-20
-------
2802OAA
1TBCCNA
[TBMBWA
1QAMACA
[OABADA
[QAMATA
EMOAAAA
ILAVBEA
/11005AA
IRACAAA
ITBCDCA
ITBCCSA
INAMADA
IRAFAAA
IMAAAGA
IRACCHA
IRAXAAA
IQAMACA
IQAMATA
IMOAAAA
HBCBOA
ITBRAJA
ITBMANA
ILAJAHA
ILAVBEA
Site and Pest
Sugar Beets'
-186-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulatlon(s)
3 ppm (roots)
21 day preharvest interval through
1 pound per acre for foliar appli-
cation.
Beet armyworm
Beet webworm
Rapid plant bug
Serpentine leaf-
miner complex
Tarnished plant bug
Thrips
Twospotted spider
mite
Tomato
1 Ib/A
(4, 5 Ib/gal
EC)
Foliar application,
Aphids
Armyworm complex
(including beet
armyworm, southern
armyworm> and
yellowstriped
armyworm)
Cabbage looper
Flea beetle
Leafhoppers
Leafminers (includ-
ing serpentine
leafminer complex)
Potato aphid
Psyllids
Rapid plant bug
Tarnished plant bug
Thrips
Tomato fruitworm
Tomato hornworm
Tomato pinworm
Tomato russet mite
Twospotted spider
mite
0.125-0.25
Ib/A
(25% WP)
or
0.25-1 Ib/A
(2, 3, 4, 5
Ib/gal EC)
[MAI]
0.125-0.25
Ib/A
(2, 3 Ib/gal
EC)
3 ppm
3 day preharvest interval through
0.25 pound per acre for foliar ap-
plication.
21 day preharvest interval from
above 0.25 through 1 pound per acre
for foliar application.
Foliar application. Repeat at 7 to
10 day intervals as needed.
May be formulated with methyl para-
thion.
Issued: 8-15-85
III-041801-21
-------
D3009AA
Site and Pest
"Walnut
-187-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPROSPHONOTHIGATE
Dosages and Tolerance, Use, Limitatlons
Formulation(s)
0.5 ppm
21 day preharvest interval through
2 pounds per acre of wettable powder
formulation or 3.5 pounds per acre
of emulslfiable concentrate formu-
lations for foliar application. Do
not graze livestock in treated
groves.
TBUCSA
RACBHA
Codling moth
Walnut aphid
TBUAGA
Fruittree leaf-
roller
LAVAAA
Spider mites (in-
cluding European
red mite, Pacific
spider mite and
twospotted spider
mite)
0.25 lb/ Foliar application. For codling
100 gal moth, apply at petal fall and repeat
(25% WP) at 10 to 14 day intervals as needed.
(4, 5 Ib/gal
EC)
or
3-3.5 Ib/A
(4 Ib/gal EC)
0.188 lb/100
gal
(25% WP)
(4, 5 Ib/gal
EC)
or
3-3.5 Ib/A
(4 Ib/gal EC)
0.125-0.188
lb/100 gal
(25% WP)
(4, 5 Ib/gal
EC)
or
3-3.5 Ib/A
(4 Ib/gal EC)
Foliar application.
Issued: 8-15-85
111-041801-22
-------
Site and Pest
-188-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Dosages and Tolerance, Use, Limitations
Formulation(s)
TERRESTRIAL NON-FOOD CROP
(General Soil Treatment and Composting)
610170A Earthworm Farms
30 day preharvest interval through
0.0416 ounce per 100 square feet for
earthworm soil treatment.
Do not make more than 2 applications
per year. Wear protective rubber
gloves during treatment and worm
harvest. If earthworm pits are
located indoors such as a utility
building or barn, make sure to va-
cate the area of pets, fish, and
wildlife. After treatment, close
doors and leave closed for a 24
hour period. Thoroughly ventilate
before reentry.
LBHABA Red fishworm mite 0.0416 oz/100 Earthworm soil treatment. Apply to
sq.ft earthworm enclosed soil pits. Dis-
(0.26% G) tribute the granules evenly over the
soil surface and follow with a light
watering to move the granules into
the soil surface. Red fishworm mite
will be controlled for up to 30 to
40 days. Repeat if needed. If the
soil has become heavily infested
after treatments remove the soil and
replace with new soil.
AERIAL, MOTHPROOFING AND TANK MIX APPLICATIONS
>001500
lAAAAAA
Aerial Application
5900300
AAAAAAA
Tank Mix
Refer to
TERRESTRIAL FOOD CROP
(Agricultural dropsy
All sites
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
All sites
Issued: 8-15-85
111-041801-23
-------
-189-
EPA Compendium of Acceptable Uses
O-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Listing of Registered Pesticide Products by Formulation
&293.0001 33Vtechnical chemical
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801)
003442-00681***007001-00348***
***voluntary cancellation
&280.0002 80% formulation intermediate
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801)
000352-00338***
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801) plus xylene
range aromatic solvent (086803)
000876-00235***009566-00002***
***voluntary cancellation
&000.2604 0.26% granular
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801)
047056-00003
&001.0004 1% granular
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801)
019713-00120
&002.0004 2% granular
O-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801)
000876-00408 002393-00219 005905-00171 044215-00013
&004.0004 4% granular
O-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801)
000876-00407 002393-00232 005905-00181 008590-00625
034704-00059 044215-00021
&005.0006 5% wettable powder
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801) plus sulfur or
sulphur (077501)
000769-00382
&025.0006 25% wettable powder
O-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801)
000279-02675** 000769-00276 000876-00438 001842-00267
002169-00186*
*jacket currently unavailable for review
**suspended
&102.0012 2 Ib/gal emulsifiable concentrate
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801) plus aromatic
petroleum derivative solvent (006501)
005905-00101
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (0*1801) plus xylene
(086802)
005905-00134
Issued: 8-15-85
111-041801-24
-------
-190-
EPA Compendium of Acceptable Uses
•0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Listing of Registered Pesticide Products by Formulation (continued)
2 Ib/gal emuls.iflable concentrate (continued)
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801) plus xylene
range aromatic solvent (086803)
005905-00191
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801), aromatic
petroleum derivative solvent (006501) plus 0,0-dimethyl 0-p-nitrophenyl
phosphorothioate (053501)
000769-00431
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801), aromatic
petroleum distillate (006601) plus 0,0-dimethyl 0-p-nitrophenyl phos-
phorothioate (053501)
009779-00131 025030-00009
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801), 0,0-dimethyl
0-p-nitrophenyl phosphorothioate (053501) plus xylene (086802)
001339-00220 001842-00268 005905-00107 013166-00010
044317-00024
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801), 0,0-dimethyl
0-p-nitrophenyl phosphorothioate (053501) plus xylene range aromatic
solvent (086803)
003442-00691 006735-00154
103.0012 3 Ib/gal emulsifiable concentrate
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801) plus
0,0-dimethyl 0-p-nitrophenyl phosphorothioate (053501)
010163-00093
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801), aromatic
petroleum derivative solvent (006501) plus 0,0-dimethyl 0-p-nitrophenyl
phosphorothioate (053501)
000769-00376
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801), aromatic
petroleum distillate (006601) plus 0,0-dimethyl 0-p-nitrophenyl phos-
phorothioate (053501)
007467-00060 009779-00031 019713-00057 025030-00007
045115-00031
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801), 0,0-dimethyl
0-p-nitrophenyl phosphorothioate (053501) plus xylene (086802)
001339-00219 001842-00265 005905-00085 012130-00010
013166-00007 044317-00030
Issued: 8-15-85 111-041801-25
-------
-191-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Listing of Registered Pesticide Products by Formulation (continued)
3 j.b/gal emuls.ifiable concentrate (continued)
0-ethyl, O-(p-nltrophenyl) phenylphosphonothloate (041801), 0,0-dimethyl
0-p-nltrophenyl phosphorothloate (053501) plus xylene range aromatic
solvent (086803)
000352-00406** 000876-00413 000876-00414 000876-00418
000876-00422 000876-00424 000876-00426 000876-00430
000876-00431 001063-00122 001191-00346* 001339-00222
001598-00248 002935-00349 003442-00694 004841-00065
004841-00066* 006735-00238* 007001-00351 008867-00041
032928-00010 033722-00013* 034704-00071 037686-00001
044605-00001
*jacket currently unavailable for review
**suspended
L04.0012 4 Ib/gal emulslflable concentrate
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801) plus aromatic
petroleum distillate (006601)
009779-00032 044215-00008
0-ethyl O-(p-nitrophenyl) phenylphosphonothloate (041801) plus xylene
(086802)
001990-00487* 002737-00017 005905-00174
*jacket currently unavailable for review
0-ethyl O-(p-nltrophenyl) phenylphosphonothioate (041801) plus xylene
range aromatic solvent (086803)
000279-02650 000876-00433 002935-00346 006735-00142
008590-00594 019713-00130 034704-00061
0-ethyl O-(p-nltrophenyl) phenylphosphonothioate (041801), aromatic
petroleum distillate (006601) plus parathion (057501)
009779-00213
105.0012 5 Ib/gal emulslflable concentrate
0-ethyl O-(p-nltrophenyl) phenylphosphonothioate (041801) pius^-aromatic
petroleum derivative solvent (006501)
000769-00359
0-ethyl O-(p-nitrophenyl) phenylphosphonothioate (041801) plus xylene
(086802)
000876-00234 000876-00328* 001842-00264 005905-00123
005905-00349
*jacket currently unavailable for review
Issued: 8-15-85 HI-041801-26
-------
-192-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Listing of Registered Pesticide Products by Formulation (continued)
5 Ib/gal emulsifiable concentrate (continued)
0-ethyl O-(p-nltrophenyl) phenylphosphonothioate (041801) plus xylene
range aromatic solvent (086803)
000352-00405** 000876-00359* 000876-00360 000876-00361
000876-00362 000876-00363 000876-00364 000876-00365
000876-00366 000876-00367 000876-00368 000876-00369
000876-00370 000876-00371 000876-00372 000876-00373
000876-00374 000876-00375 000876-00376 000876-00377
000876-00378 000876-00379 000876-00380 000876-00381
001386-00612 003442-00690 008590-00608 010107-00041
019713-00121 034704-00060
*jacket currently unavailable for review
**suspended
)999999 State Label Registrations
AL Reg. No.
009779-04760 015575-05331
CA Reg. No.
005967-05161 007001-07720
KS Reg. No.
002737-09563
LA Reg. No.
004841-06166
Issued: 8-15-85 111-041801-27
-------
-193-
EPA Compendium of Acceptable Uses
0-ETHYL O-(p-NITROPHENYL) PHENYLPHOSPHONOTHIOATE
Appendix A-l
of the Active Ingredient(s) Found In Combination With the Report Chemical
Chemical Common Name EPA Acceptable
Code (source) Common/Chemical Name
053501 methyl parathlon 0,0-dlmethyl 0-p-nltrophenyl phosphorothioate
(ISO)
057501 — parathlon
077501 sulfur sulfur or sulphur
— Use EPA Acceptable Common/Chemical Name
Issued: 8-15-85 IH-041801-28
-------
IV. BIBLIOGRAPHY APPENDICES
-------
-194-
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
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 Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, 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 unigue to the citation, and
should be used at any time specific reference is reguired.
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 a further explana-
tion. 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.
-------
-195-
BIBGUIDE-2
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 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 editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"rece ived."
(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.
-------
-196-
OFFICE OF ffiSTIQDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the EPN Standard
MRID CITATION
00002875 Frear, D.E.H.; Boyd, J.E. (1967) Use of Daphnia magna for the
microbioassay of pesticides: I. Development of standardized
techniques for rearing Daphnia and preparation of dosage-mor-
tality curves for pesticides. Journal of Economic Entomology.
60(5) :1228-1236. (Also in unpublished submission received
May 11, 1977 under 239-2458; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:230225-A)
00003945 Cuthbert, F.P., Jr.; teid, W.J., Jr. (1962) Laboratory Tests of
Compounds for Toxicity to Larvae of the Banded Cucumber Beetle.
By U.S. Agricultural Research Service, Entomology Research Divi-
sion. Washington, D.C.: U.S. Dept. of Agriculture. (ARS-33-
72; also in unpublished submission received on unknowi date
under unknown admin, no.; submitted by FMC Corp. , Philadelphia,
Pa.; CDL:008870-B)
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00036935 Atkins, E.L.; Greyvood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: X, Cooperative Extension. (Leaflet 2287; published
study.)
00057028 Tayfun, F.O. (1971) One-Hour Inhalation Toxicity: Haskell Laborato-
ry Report No. 32-71. (Unpublished study received Mar 21, 1977
under 352-338; submitted by E.I. du Pont de Nemours & Co., Wil-
mington, Del.; CDL:228727-B)
00066341 U.S. Environnental Protection Agency, Environmental Research Labo-
ratory (1981) Acephate, Aldicarb, Carbcphenothion, DEF, EPN,
Ethoprop, Methyl Parathion, and Phorate: Their Acute and Chronic
Toxicity, Bioconcentration Potential, and Persistence as Related
to Marine Environments: EPA-600/4-81-023. (Unpublished study)
00068367 E.I. du Pont de Nemours & Company (1951) Residues of EPN on Food
Crops. (Unpublished study received on unknown date under 352-
1.46; CDL:231094-B)
-------
-197-
OFFICE OF BEST ICE DE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Eat a Base Supporting
Registrations Under the EPN Standard
MRID CITATION
00068437 E.I. du Pont de Nemours & Company (1961) EPN 300 Insecticide: Ex-
perinental Results. (Reports by various sources; unpublished
study/ including published data, received on unknown date under
352-146; CDL:231099-A)
00068905 E.I. du Pont de Nemours & Company (1978) Residue Analysis (1977 Re-
sults). (Compilation; unpublished study received Jun 15, 1978
under unknown admin, no.; CDL:234119-G)
00077299 Fink, R. (1976) Final Report: Eicht-Day Dietary LC50--Mallard
Duck: Project No. 107-128. (Unpublished study received Aug 31,
1976 under 876-235; prepared by Truslow Farms, Inc., submitted
by Velsicol Chemical Corp. , Chicago, 111.; CDL: 226817-A)
00079794 Fisher, R.L. (1978) Letter sent to J.A. Gardiner dated Aug 30,
1978: Metabolism of 14C-EPN in chickens. (Unpublished study
received on unknovn date under 352-338; submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:236741-J)
00079807 E.I. du Pont de Nemours & Company, Incorporated (1977) Technical
Manual for Insecticide Formulators: EPN Technical. Wilmington,
Del.: DuPont. (Also in unpublished submission received on un-
known date under 352-338; CDL:236741-X)
00085219 Sanders, H.O. (1972) Toxicity of Some Insecticides to Four Species
of Malaccstracan Crustaceans. By U.S. Fish and Wildlife Serv-
ice, Fish-Pesticide Research Laboratory. Washington, D.C.:
USFW3. (Technical papers of the Bureau of Sport Fisheries and
Wildlife 66; published study; CDL:232666-T)
00085429 E.I. du Pont de Nemours & Company (1978?) Summary of Preliminary
Studies on the Hen Metabolism of EPN at a High Dose Level.
Summary of study 236741-L. (Unpublished study received on un-
knowi date under 352-338; CDL:236741-K)
00089025 E.I. du Pont de Nemours & Conpary (1972) Residue Analyses of Taric
Mix Combinations of EPN + lannate Insecticide on Cotton. (Un-
published study received May 29, 1981 under 352-342; CDL:
246524-B)
00100078 E.I. du Pont de Nemours & Co., Inc. (1950) Residue Data for EPN
300 Insecticide on Various Fruit. (Compilation; unpublished
study received Oct 14, 1950 under 352-146; CDL:002747-D)
00100088 Anon. (19??) Residue Data EPN on Sveetcorn. (Unpublished study
received on unknown date under unknown admin, no.; submitted
by ?; CDL:124392-A)
-------
-198-
OFFICE OF EESTICEDE PROGRAMS
REGISTRATION STANDXFD BIBLICX&APHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the EPN Standard
MRID CITATION
00100090 E.I. du Pont de Nemours & Co., Inc. (1959) Data Supporting Revised
Use Claims for EPN 300 Insecticide on Tonatoes. (Unpublished
study received Feb 26, 1959 under unknown admin, no.; CDL:
124557-A)
00100093 Union Carbide Corp. (1976) Acute Toxicity of EPN (80% Active In-
gredient) to Bluegill Sunfish ...f Rainbow Trout ... f and the
Water Flea Daphnia Magna Straus. (Unpublished study received
Apr 26, 1976 under 876-235; submitted by VeJsicol Chemical
Corp., Cnicago, IL; CDU223991-B)
00100099 E.I. du Pont de Nemours & Co. , Inc. (1949) Residues, Analyses,
Essential Data: EPN. (Unpublished study received Feb 10, 1950
under 352-146; CDL:023207-C)
00101107 Averell, P.; Norris, M. (1948) Estimation of stall anounts of O,O-
diethyl 0,p-nitrcphenyl thiophcsphate. Analytical Chemistry 20
(8):753-756. (Also in unpublished submission received Jul 20,
1955 under PP0032; submitted by American Cyanamid Co., New York,
NY; CDL:090977-G)
00109147 Chrzancwski, R. (1977) Metabolism of 14C-EPN on Cotton Plants.
(Unpublished study received Dec 1, 1977 under 352-338; submitted
by E.I. du Pont de Nemours & Co., Inc., Wilmington, DE; CDL:
232389-C)
00111931 Firk, R. (1976) Final Report: Acute Oral LD5 0—Mai lard Duck: Tech-
nical EPN: Project No. 107-129. (Unpublished study received
Apr 26, 1976 under 876-235; prepared by Truslcw Farms, Inc.,
submitted by Velsicol Chemical Corp., Chicago, IL; GDL:223991-A)
00145678 Dean, W. (1977) Acute Denial Toxicity (LD50) Study in Albino Rab-
bits: Study No. 163-495. Unpublished study prepared by Inter-
national Research and Development Corp. 18 p.
00152760 Cox, R.; Dean, R.; Quander, R.; et al. (1985) 21-day Dermal Toxici-
ty Study in Rats: EPN Technical: Final Report: Project No.
2096-120. Unpublished study prepared by Hazleton Laboratories
America, Inc. 145 p.
00153508 Kennel]y, J. (1985) Study To Determine the Ability of EPN Technical
To Induce Unscheduled DNA Synthesis in HeLa Cells: Study No.:
NCJ l/He/KF16/HE2. Unpublished study prepared by Microtest Re-
search Ltd. 16 p.
-------
-199-
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the EPN Standard
MRID CITATION
00153509 Kirkland, D. (1985) Study To Evaluate the Potential of EPN Techni-
cal To Induce Micronuclei in the Bone Marrow of Treated Mice:
Study No.: N2J 1/MMT/KF19/MM1. Unpublished study prepared by
Microtest Research Ltd. 31 p.
00153510 Kirkland, D. (1985) Study To Evaluate the Chromosome Danaging
Potential of EPN Technical by Its Effects on Cultured Chinese
Hamster Ovary (CHO) Cells Using an in Vitro Cytogenetics Assay:
Study No.:'NCJ 1/CHO/KF17/CH3. Unpublished study prepared by
Microtest Research Ltd. 21 p.
00153511 Kennelly, J. (1985) Study To Detemiine the Ability of EPN-Technical
To Induce Mutation in Four Histidine-requiring Strains of
Salmonella typhimurium: Study No.: N2J 1/S/AF4/SA3. Unpublish-
ed study prepared by Microtest Research Ltd. 33 p.
00158890 Osherof f, M. (1986) Subchronic Toxicity Study in Dogs: [Using EPN
Technical]: Final Report: Project No. 2096-121. Unpublished
study prepared by Hazleton Labs. America, Inc. 232 p.
00158920 Cresswell, D.; Hopkins, R. (1986) [Carbon-14]-EPN: A Study of the
Absorption, Distribution, Metabolian and Excretion in the Rat:
Report No. 4958-306/14. Unpublished study prepared by Hazleton
Laboratories Europe Ltd. 561 p.
00159372 Roberts, N.; Phillips, C.; Gcpinath, C.; et al. (1986) Acute De-
layed Neurotoxicity Study with EPN in the Domestic Hen: Report
No. NSA 19(a)/8646. Unpublished study prepared by Huntingdon
Research Centre Ltd. 50 p.
00160200 Roberts, N.; Phillips, C. (1986) Acute Delayed Neurotoxicity Study
with EPN in the Domestic Hen, Providing Additional Information
on Recovery Aspects: NSA 19 (b)/86335. Unpublished study pre-
pared by Huntingdon Research Centre Ltd. 101 p.
00160618 Kennelly, J. (1986) Study To Determine the Ability of EPN Technical
To Induce Mutations to 6-Thioguanine Resistance in Mouse
Lynphcma L5178y Cells Using a Fluctuation Ass^: Study No.
NCJ 1/ML/KF20/ML3. Unpublished study prepared by Microtest
Research Ltd. 26 p.
00161799 Collins, C. (1986) EPN Technical: 13 Week Inhalation Toxicity Study
in the Rat: Report No. 5160-306/13. Unpublished study prepared
by Hazleton Laboratories Europe, Ltd. 206 p.
-------
-200-
OFFICE OF EESTICEDE PROGRAMS
REGISTRATION STANt&HD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the EPN Standard
MRID CITATION
00162934 Morseth, S. (1986) Rat Teratology Study EPN Technical: Final Re-
port: Project No. 2096-115. Unpublished study prepared by Haz-
leton Laboratories America, Inc. 197 p.
00162999 Rahland, J. (1986) Detertrination of Dislodgeable Residues of EPN,
EPN Oxon, and EPN S-ethyl fron Corn, Soybean, Cotton, Pecan,
and Citrus Foliage (Analytical Results): Cotton Repeat: Adden-
dum B to the Final Report: Study No. 6157-124. Unpublished
study prepared by Hazleton Laboratories Anerica, Inc. 89 p.
00163019 Morseth, S. (1986) Rabbit Teratology Study EPN Technical: Final Re-
port: Project No. 2096-116. Unpublished study prepared by
Hazleton Laboratories America, Inc. 149 p.
00163515 Rahland, J. (1986) Determination of the Dislodgeable Residues of
EPN, EPN Oxon, and EPN S-Ethyl from Corn, Soybean, Cotton,
Pecan, and Citrus Foliage (Analytical Results): Stability Study:
Interim Addendum A to the Report: Study No. 6157-124. Unpub-
lished study prepared by Hazleton Laboratories Anerica, Inc.
96 p.
05000975 Tucker, R.K.; Haegele, M.A. (1971) Comparative acute oral toxicity
of pesticides to six species of birds. Toxicology and Applied
Pharmacology 20(l):57-65.
05008363 Hudson, R.H.; Haegele, M.A.; Tucker, R.K. (1979) Acute oral and
percutanecus toxicity of pesticides to mallards: correlations
with mammalian toxicity data. Toxicology and Applied
Phaunacolcgy 47(3) :451-460.
05009242 Sanders, H.O. (1969) Toxicity of Pesticides to the Crustacean
Gammarus lacustris:. Washington, D.C.: U.S. Bureau of
Sport Fisheries and Wildlife. (U.S. Bureau of Sport Fisheries
and Wildlife technical paper 25)
GS0147-001 Horwitz, W. ed. (1980) Officeial Nfethods of Analysis of the
Association of Official Analytical Chemists: 13th ed.
Washington, D.C.: A.O.A.C. (Section 29.039-29.043 only.
-------
V. FORMS APPENDICES
-------
-201-
OMB Approval No. 2OO&0468 (Expires 12-31-83)
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
01. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are nut
specified in) the Registration Guidelines or the Protocols contained hi the Report! of Expert Groups to the Chemicals Group. OECO
Chemicals Testing Programme, I endow the protocols that I will use:
separate page with a list of the data requirements your company
agrees to satisfy.
D 2. I haw entered into M agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, w9l be submitted to EPA by:
NAME OF OTHER REGISTRANT
Attach list of data requirements
D 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D S. I request voluntary cancellation of the leuuuation of this product (This option a not available to applicants for new products)
REGISTRANTS AUTHORIZED REPRESENTATIVE
ETA Form 8680-1 <1fr82t
SIGNATURE
DATE
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-202-
OMB Approval No. 20OOO468 (Expires: 12-31-83)
(To qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Nottca under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is wilting to develop anfl submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with ori^br rrfore other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice, t understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DfcTE
EPA Form 8S8O« (1O-S2)
-------
-203-
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
foimation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical nethods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Oct ano]/wa ter
partition
coefficient
pH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data reguirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached )
(For EPA Use Only)
Accession Numbers
Assigned
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-204-
Regi stration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Fl amenability
Explodability
Storage stability
Viscosity
Miscibility
Corrcs ion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am conplying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached )
(For EPA Use Only)
Accession Numbers
Assigned
-------
-205-
FORMULATOR'S EXEMPTION STATEMENT
(40 CFR 152.85)
EPA File Symbol/Reg. No. Product Name
Applicant's Name and Address
As an authorized representative of the applicant for registration of the
product identified above, I hereby certify that:
(1) This product contains the active ingredient(s):
(2) Each active ingredient listed in paragraph (1) is present solely
as the result of the incorporation into the product (during formulation or
packaging) of another product which contains that active ingredient, which
is registered under FIFRA sec. 3, and which is purchased by us from another
producer.
(3) Indicate by circling (A) or (B) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number and product
name, the source of the active ingredient (s) listed in paragraph (1).
(B) The Confidential Statement of Formula dated _ on file with
the EPA is complete, current and accurate and contains the information
required on the current CSF Form No. 8570-4. The registered source(s)
of the active ingredient(s) listed in paragraph (1) is/are listed below:
Active ingredient Source: Product name and Reg. No.
Signature
Hate Title
EPA Form (April 1985)
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