vvEPA
United StctM
Environmental Protection
Agency
Office of
Pwticidw and Toxic Subetanc
Washington DC 20460
PaftickiM
FEBRUARY 1988
Guidance for the
Reregistration of
Pesticide Products
Containing
Malathion
as the Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
MALATHION
AS THE ACTIVE INGREDIENT
CASE NUMBER 248
CAS Registry Number 121-75-5
EPA Pesticide Chemical Code (Shaughnessy)
Number 057701
FEBRUARY, 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction
II. Chemical Covered by this Standard 4
A. Description of Chemical
B. Data Call-in Notices Issued
C. Use Profile
III. Agency Findings 9
A. Summary
B. Preliminary Health Risk Assessment
C. Environmental Profile
D. Pesticide Incident Reports
E. Tolerance Reassessment
IV. Regulatory Positions and Rationales 33
A. Regulatory Positions and Rationales
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Labeling
V. Products Subject to this Standard 41
VI. Reguirement for Submission of Generic Data 43
A. What are Generic Data?
B. Who Must Submit Generic Data?
C. What Generic Data Must be Submitted?
D. How to Comply with DCI Requirements
E. Procedures for Requesting a Change in Protocol
F. Procedures for Requesting Extensions of Time
G. Existing Stocks Provisions upon Suspension or
Cancellation
VII. Requirement for Submission of Product-Specific Data . . 49
VIII. Requirement for Submission of Revised Labeling 50
IX. Instructions for Submission 50
A. Manufacturing Use Products (sole active)
B. Manufacturing Use Products (multiple active)
C. End Use Products
D. Intrastate Products
E. Addresses
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APPENDICES
Pae
I. DATA APPENDICES ...................
Guide to Tables ................... 55
Table A ....................... 57
Table B ....................... 129
133
II. LABELING APPENDICES .................
134
Summary of label requirements and table .......
40 CFR 162.10 Labeling Requirements
149
Physical/Chemical Hazards Labeling Statements ....
Storage Instructions
Container Disposal Instructions
152
Pesticide Disposal Instructions
III. USE INDEX APPENDIX
JQf.
IV. BIBLIOGRAPHY APPENDICES *°
297
Guide to Bibliography
299
Bibliography
V. FORMS APPENDICES 309
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet .... 310
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data 311
EPA Form 8580-4 Product Specific Data Report 312
314
EPA Form 8570-27 Generic Data Exemption Statement ....
EPA Form Certification With Respect to Citation
of Data 315
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Summary of Tables
Page
Table 1. Summary of Data Gaps 11
Table 2. Summary of Tolerances for Malathion 25
111
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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 same 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.
1The 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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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
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 man 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 our 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
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-3-
the Agency of any information, including interim or preliminary
results of studies, if that information suggest possible
adverse effects on man or the environment. This requirement
is independent of the specific time requirements imposed by
EPA for submission of completed studies called in by the
Agency and continues as long as a product is registered
under FIFRA.
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II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
The following chemical is covered by this Registration
Standard:
Common Name: Malathion
Chemical Name: O,O-dimethyl phosphorodithioate of diethyl
mercaptosuccinate
Other Chemical
Nomenclature: S-l,2-bis(ethoxycarbonyl)ethyl O,0-dimethyl
phosphorodithioate; diethyl(dimethoxy-
phosphinothioyl)thiobutanedioate;
diethyl mercaptosuccinate S-ester with 0,0-
dimethyl phosphorodithioate; O,O-dimethyl
dithiophosphate of diethyl mercaptosuccinate
[S-(l,2-dicarbethoxyethyl) O,O-dimethyl
phosphorodithioate; diethyl mercaptosuccinic
acid, S-ester with 0,O-dimethyl phosphoro-
dithioate
Trade Names: American Cyanamid Co. (USP 2578 652) Code
No. EI4049; Calmathion; Celethion; Cythion
(deodorized grade); Chemathion; Malaspray;
Detmol MA 96% (Albert & Co., Germany);
Emmatos; Emmatos Extra; For-Mal (Forshaw
Chemicals); Fyfanon; Hilthion; Karbofos;
Kop-Thion; Kypfos; Malamar; Malaphele;
Malathion ULV Concentrate; Malatol; Maltox
(All India Medical); Prentox Malathion 95%
Spray; Sumitox; Vegfru Malatox; Zithiol;
Maimed.
CAS Registry Number: 121-75-5
EPA Pesticide Chemical Code (Shaughnessy Number): 057701
Empirical Formula: CioH19°6ps2
Molecular Weight: 330.36
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Chemical/Physical
Characteristics
(technical grade): Color: colorless, yellow, amber, or brown
Physical state: liquid
Odor: mercaptan-like
Specific gravity: 1.2315 at 25°C
Boiling point: 156-157°C at 0.7 mm Hg
Solubility: 145 ppm in water at
25°C; completely soluble
in most alcohols, esters,
high aromatic solvents, and
ketones; poor solubility
in aliphatic hydrocarbons.
Vapor pressure: 0.00004 mm Hg at 30°C
Miscibility: miscible with most
organic solvents
Stability: may gel in contact with iron,
terreplate, or tinplate
B. DATA CALL-IN NOTICES ISSUED
The Agency has issued the following 3(c)(2)(B) Data
Call-In (DCI) Notices:
Date Issued
February 29, 1984
Data Required
chronic feeding study in
a nonrodent species
teratogenicity study in a
species other than the rat
Status
see Section III-B
see Section III-B
May 27. 1986
reentry data (including waiver requests
foliar dissipation, soil granted
dissipation, dermal exposure,
and inhalation exposure
C. USE PROFILE
Type of Pesticide: Insecticide and miticide
Year of Initial Registration: 1956
Pests Controlled:
Number of diverse insect pests attacking
field crops, vegetables, fruits, ornamentals,
livestock (and their premises), and stored
grain. Used in mosquito control programs
and medfly eradication programs.
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AQUATIC FOOD CROP: cranberry and rice.
AQUATIC NON-FOOD: intermittently flooded areas, irrigation
systems, and sewage systems.
FORESTRY: forest trees (including douglas-fir, eastern
pine, hemlock, larch, pines, red pine, spruce, and true
fir.
INDOOR: stored commodity treatment for almonds, barley,
field corn, field or garden seeds, grapes (raisins),
oats, peanuts, rice, rye, sorghum, sunflower, wheat,
bagged citrus pulp, and cattle feed concentrate blocks
(non-medicated); pet and domestic animal uses for beef
cattle, cats, chickens, dairy cattle (lactating and
non-lactating), dogs, ducks, geese, goats, hogs, horses
(including ponies), pigeons, sheep, and turkeys;
animal premise uses for dairy and livestock barns,
stables and pens, feed rooms, poultry houses, manure
piles, garbage cans, garbage dumps, kennels, rabbits on
wire, beef cattle feed lots and holding pens, cat
sleeping quarters, dog sleeping quarters, poultry houses;
agricultural premise uses for cull fruit and vegetable
dumps; household uses for indoor domestic dwellings,
human clothing (woolens and other fabrics), mattresses;
and commercial and industrial uses for bagged flour,
cereal processing plants, edible and inedible commercial
establishments, dry milk processing plants, edible and
inedible eating establishments, edible and inedible food
processing plants, packaged cereals, pet foods and feed
stuff.
Methods of Application: sprays, aerosols and fogging equipment,
ground and aerial equipment (including
ULV), baits, paints, pet collars, dips,
soil, bark and foliar application,
dormant and delayed dormant application,
animal dust bags and oilers, and cattle
feed concentrate blocks.
Annual Usage: 15 to 20 million pounds active ingredient (1985
and 1986 data)
Predominant Usage: Industrial, commercial, and government
applications constitute 40 percent of the
annual U.S. usage. This category includes
malathion use by institutions such as
hospitals, schools, warehouses, commercial
eating establishments, and food-processing
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and packaging plants, and use in government
pest control in programs (such as for
mosquito control). Approximately one third
of all malathion is used in and around the
home for insect control. Agricultural crop
use accounts for approximately 12 percent
of the total annual usage and agricutural
noncrop use (e.g., in and around farm
buildings, livestock, ornamentals, and
stored grain) accounts for 15 percent of
the total annual usage.
Mode of Activity: Cholinesterase inhibition
Formulations: Wettable powders, dusts, granules, emulsifiable
concentrates, liquids, solids, impregnated
materials, and pressurized sprays
Basic Producers: The basic producers of malathion in the United
States are: American Cyanamid Company, A/S
Cheminova, McLaughlin Gormley King Company,
Prentiss Drug and Chemical Co. Inc., Carmel
Chemical Corp., Amvac Chemical Corp., Prochimie
International Inc., Gowan Co., Wesley Industries
Inc., Trans Chemic Industries Inc., Southern
Mill Creek Products Co. Inc., Octagon Process
Inc., FMC Corp., and Aceto Chemical Co. Inc.
End-use Registrants: 342
Number of Registrations: The Agency has issued 1218 registrations
as of November 27, 1987. Of this
total, 28 products are formulation
intermediates and 10 products are
technical products. There are 123
"special local need" registrations
issued under FIFRA section 24(c) and
120 intrastate products.
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III. AGENCY FINDINGS
A. SUMMARY
The Agency has reviewed all data supporting the registration
of malathion as of May, 1987- Based on the available data, EPA
has reached the following conclusions. The points summarized
below are presented in further detail, in the context of EPA's
science findings and additional data requirements, in Sections
B through D.
1. Based on a review of the oncogenicity data for the
chemical malathion, the Agency concludes that malathion is
not carcinogenic to Osborne-Mendel rats or F344 rats, and
malathion's metabolite malaoxon is not carcinogenic to
B6C3F1 mice. Because of questionable findings in the B6C3F1
mice study using malathion and F344 rat study using malaoxon,
the Agency is requiring new oncogenicity studies in these
species. Upon receipt and evaluation of these studies, the
Agency will reevaluate malathion's oncogenic potential.
2. Laboratory data show that technical malathion is
potentially highly toxic to aquatic invertebrates, nontarget
terrestrial invertebrates including bees; aquatic life stages
of amphibians and bees; moderately toxic to birds; and slightly
toxic to fish. Studies with end-use formulations indicate that
the products tested were moderately toxic and very highly toxic
to estuarine invertebrates and freshwater fish, respectively.
Based on theoretical calculations, both terrestrial and aquatic
uses of malathion may pose significant risk to aquatic fauna.
In addition, reported fish kills and results of several field
studies suggest that adverse effects to both aquatic and terrestrial
fauna may result from normal use of malathion. However, these
field studies and fish kill reports are not adequately documented
to enable EPA to propose restrictions on the use of malathion.
EPA will reassess the impacts of malathion use to nontarget
organisms after the required ecological effects and environmental
fate data are received and reviewed.
3. Technical malathion is a mildly acutely toxic pesticide,
which is placed in Toxicity Category III based on the oral,
dermal and inhalation routes of exposure. Technical malathion
is nonsensitizing and only mildly irritating to the eyes and
skin (Toxicity Category III and IV, respectively). Additional
data are required to assess the neurotoxic potential of malathion.
4. Malathion is a cholinesterase inhibitor, reducing
plasma and red blood cell cholinesterase.
5. A tolerance reassessment of malathion is not possible
at this time, since most of the tolerances are not adequately
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supported, and because there are gaps in the chronic
toxicology data base (chronic feeding studies, teratology
studies, a reproduction study, mutagenicity studies, and a
metabolism study). The Theoretical Maximum Residue Contribution
(TMRC) for the U.S. population average is 0.1014 mg/kg/day and
the Provisional Acceptable Daily Intake (PADI) is 0.02 mg/kg/day
based on cholinesterase inhibition in humans and a 10 fold
uncertainty factor. The TMRC occupies 507% of the PADI.
6. The Agency is unable to assess the potential for
malathion to contaminate qroundwater because the environmental
fate of malathion is largely uncharacterized. Preliminary
data indicate that malathion is very mobile in loamy sand
and loam soils. Additional data are needed in order for the
Agency to assess the fate of malathion in the environment and
its potential for contaminating groundwater.
As a result of this Registration Standard review, the Agency
has determined that certain additional or revised label restric-
tions are necessary in order to remain in compliance with
FIFRA. The Agency has also identified missing data reguired
to fully evaluate the human and environmental risks associated
with the use of malathion as an insecticide and miticide. These
data must be developed in order to maintain registrations of
existing products or register any new products containing
malathion. A summary of these data gaps is given in table 1.
Please note this is only a summary and 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 malathion, and the Reguired
Labeling section contains the specific wording reguired for each
of the labeling provisions.
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TABLE 1. SUMMARY OF DATA GAPS
(Please refer to the tables in Appendix 1 for detailed
information regarding these requirements)
Toxicology
Acute delayed neurotoxicity
21 day dermal toxicity—rat
90 day inhalation—rat
Chronic toxicity (rodent and nonrodent)—using malathion
Chronic toxicity (rodent)—using malaoxon
Oncogenicity (mouse)—using malathion
Oncogenicity (rat)—using malaoxon
Teratogenicity—rat
Reproduction
Mutagenicity testing (gene mutation, structural chromosomal
aberration and other genotoxic effects)
Metabolism
Domestic Animal Safety Testing
Environmental Fate/Exposure
Hydrolysis
Aerobic and anaerobic soil metabolism
Anaerobic and aerobic aguatic metabolism
Terrestrial field dissipation
Leaching and adsorption/desorption
Soil dissipation
Aquatic (sediment) dissipation
Forestry dissipation
Photodegradation in air, soil, and water
Volatility (lab)
Rotational crops (confined)
Accumulation: fish
Accumulation: irrigated crops
Accumulation: in aquatic non-target organisms
Spray drift data
Fish and Wildlife
Acute toxicity to freshwater invertebrates—TEPj-/
Acute toxicity to estuarine and marine organism"!—TGAI and TEPl/
Fish early life stage and aquatic invertebrate life cycle
Avian reproduction
Residual toxicity to bees
I/ TEP = Typical end-use product
TGAI = Technical grade active ingredient
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Residue Chemistry
Storage stability data
Plant metabolism data
Animal metabolism data (including direct animal treatment)
Residue data (except for flax seed, hops, and non-medicated
cattle feed concentrate blocks)
Processing studies
Residue data on stored, unfinished tobacco
Residue data to support use in food areas of food-handling
establishments
Residue data in water
Product Chemistry
All product chemistry studies
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B. PRELIMINARY HEALTH RISK ASSESSMENT
Numerous data gaps exist for malathion and few definitive
conclusions can he made pending receipt of additional data.
The following assessment is based upon the data available.
1. Acute Toxicity
With the exception of a reguirement for an acute
delayed neurotoxicity study, there are adeguate acute toxicity
studies. Technical malathion is mildly toxic on an acute oral,
dermal, and inhalation basis. It falls in Toxicity Category
III for oral exposure based on acute oral toxicity values
ranging from 1522 to 1650 mg/kg in male rats, and ranging from
1546 to 1945 mg/kg in female rats. It is in Toxicity Category
III for dermal exposure based on acute dermal toxicity values
of >2000 mg/kg in male and female rats and rabbits. It is also
in Toxicity Category III for inhalation exposure based on acute
inhalation toxicity values ranging from 1.7 to >4.0 mg/m3 in
rats. Technical malathion is only mildly irritating to the eye
{Toxicity Category III) , based on findings of mild conjunctival
reactions in male rabbits' eyes at 72 hours postapplication.
Slight dermal irritation was reported in rabbits exposed for 4
hours, semioccluded, to doses of 0.5 ml, placing technical
malathion in Toxicity Category IV for this route of exposure.
Results of acceptable dermal sensitization studies show that
technical malathion is nonsensitizing by dermal application.
No data are available on the acute delayed neurotoxicity of
malathion in the hen and, since malathion is an organophosphate,
a study is reguired.
2. Subchronic Toxicity
No data are available on the subchronic oral toxicity
of malathion in rodent and non-rodent species. The Agency
is not reguiring these studies, however, since the results from
the rodent and non-rodent chronic feeding studies can be translated
to these subchronic feeding studies. A 21-day dermal study is
reguired since many use patterns of malathion involve repeat
applications in a manner that would result in skin exposure.
A subchronic neurotoxicity study may be reguired if the the
results of the reguired acute delayed neurotoxicity study show
effects. A subchronic inhalation study is required since
inhalation exposure may occur from indoor use of malathion.
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3. Chronic Toxicity
The Agency reviewed a dog chronic feeding study submitted
in response to the 1984 Data Call-in for chronic toxicology.
This study is considered unacceptable because an NOEL was not
identified for the following parameters: increased liver and
kidney weights; elevated platelet count; decreased creatinine
in both sexes; decreased blood urea nitrogen (BUN) in males;
inhibition of serum glutamate pyruvate transaminase (SGPT) in
males; and inhibition of erythrocyte and plasma cholinesterases
in both sexes. A new dog chronic feeding study is required.
A two year Sprague-Dawley rat study was reviewed by
the Agency in 1983 and determined to be acceptable (NOEL = 100
ppm and not oncogenic). A re-examination of this study has
revealed certain deficiencies, and the Agency no longer believes
that the study permits valid conclusions concerning the chronic
toxicity of malathion for the reasons noted below:
0 The summary tables do not distinguish between animals
sacrificed at term and animals found dead, sacrificed moribund or
accidental deaths. The summary tables combine all animals
under one category.
0 Pathology slides were not read blind. Each pathologist
had prior knowledge of the dose level administered to each animal.
0 There is no indication that a numerical rating for the
degree or severity of change observed by each pathologist was used.
0 There were several pathologists involved in reading the
slides raising substantial concern for consistency and uniformity.
0 Animals which died, sacrificed moribund or accidental
deaths were not examined in a manner to preclude autolysis of
tissue.
0 Animals in all groups, including controls, suffered
from a substantial degree of lung disease, kidney degenerative
changes, generalized calcification, lymphadenitis, and inflammation
of the reticuloendotheliac (RE) system, significant incidence
of pituitary chromophobe adenoma (particularly females), and an
increase in medial otitis of the ear. The chronic nature and
advanced stages of these diseases illustrate that changes due
to aging were prevalent in all groups. The significant degree
of bronchopneumonia and acute/chronic lung disease could have
been caused by pathogens as much as by age, yet there was no
apparent attempt to identify such pathogens. Many of the
early deaths in this study were attributed to lung disease.
The substantial amount of geriatric change in all groups makes
it extremely difficult to separate or identify normal aging
processes from compound-related effects.
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0 Kidney, pituitary, adrenal, and thyroid weights were
selectively screened and eliminated from the organ weight and
organ-to-body weight comparisons if they were above or below
preselected values.
0 Hematology and urinalysis measurements were performed at
3, 6, 12, and 24 months, often in different animals. Clinical
chemistry parameters were examined at 24 months only. Brain
cholinesterase activity was not examined. Therefore, sufficient
information for examining biochemical and clinical effects in a
chronic bioassay were not obtained.
A new chronic feeding study is reguired in the F344 rat.
A chronic toxicity study is also reguired in the rodent using
malaoxon. This study should be performed as a combined
chronic/oncogenic bioassay using the F344 rat. Refer to the
following discussion.
4. Oncogenicity - Malathion
Acceptable oncogenicity studies have been performed
using malathion in the Osborne-Mendel rat and Fischer 344
rat. A two-year Sprague-Dawley rat study and a mouse study
have also been reviewed and was determined to be unacceptable
for use as an oncogenicity study. These studies are discussed
below:
a. NCI/NTP Malathion Oncogenicity Study in the Osborne
Mendel Rat
In this study, malathion (purity >95%) was administered
via the diet at time-weighted average dosage levels of 4700 and
8150 ppm for 80 weeks and then animals were removed from test
diets and observed for 29 to 33 weeks. Low-dose animals received
8000 ppm malathion in the diet for an initial 14 weeks, which was
then adjusted to 4000 ppm for an additional 66 weeks. High-dose
animals received 12,000 ppm for 3 weeks followed by 8000 ppm for
77 weeks.
Based on the results of this study, the Agency concludes
that malathion is not carcinogenic in Osborne-Mendel rats.
According to the original NCI/NTP review, there was a statistically
significant (p = 0.026) dose-related trend for follicular cell
carcinomas/adenomas/ hyperplasia of the thyroid in female rats.
However, results of the Fischer Exact Test for direct comparison
between groups was not significant (p = 0.05). NCI/NTP noted that
more dosed males than dosed females had either tumors or hyperplasia
of the follicular cells of the thyroid, but a higher incidence
among male controls rendered the results not significant in males.
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NCI/NTP did not consider the thyroid tumors to he related to
malathion administration. In a reexamination of the same data by
the NCI/NTP in 1985, it was aqain concluded that malathion showed
no evidence of carcinogenicity in male and female Osborne-Mendel
rats.2/ The Agency agrees with the NCI/NTP that malathion is not
carcinogenic in Osborne-Mendel rats.
b. NCI/NTP Malathion Oncogenicity Study in the F344 Rat
In this study, malathion (purity 95%) was administered
to F344 rats via the diet at dosage levels of either 2000 or
4000 ppm for 103 weeks and then rats were observed for an
additional 2 or 3 weeks. Based on the results of this study,
the Agency concludes that malathion is not carcinogenic in
F344 rats.
In the original evaluation of this bioassay, NCI/NTP
concluded that under the conditions of the test, malathion was
not carcinogenic in F344 rats of either sex. In a histopathology
reexamination of this study by the NCI/NTP, it was again concluded
that there was no evidence of carcinogenicity in male or female
F344 rats.l The NCI/NTP reexamination noted, however, that
malathion may have increased the incidences of pheochromocytoma of
the adrenal glands and leukemia in male F344 rats, primarily in
the low-dose group (the incidences for the tumors in males were:
pheochromocytoma, control 5/49, low dose 10/48, high dose 6/46;
leukemia, control 13/50, low dose 20/50, and high dose 8/49).
NCI/NTP noted that these slight increases were not statistically
significant by incidental tumor tests or by Fischer's Exact test
NCI/NTP did not regard them as being related to the administration
of malathion.
The Agency agrees with the conclusions of the NCI/NTP, but
notes that the dose levels employed in this study were approximately
one-half of those employed in the NCI Osborne-Mendel rat study,
and that therefore it is unlikely the maximum tolerated dose
was reached in females.
c. Food and Drug Research Laboratories Study in Sprague-
Dawley Rat
This study was determined by the Agency to be unacceptable
for use as either a chronic rat toxicity study or as a rat
oncogenicity study. An independent reevaluation of the microscopic
slides from this study is reguired in order to determine the
Huff, J.E., R. Bates, S.L. Eustis, J.K. Haseman, E.E. Connell.
(1985) Malathion and Malaoxon: Histopathology Reexamination of
the National Cancer Institute's Carcinogenesis Studies.
Environmental Research 37:154-173.
16
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acceptability of this study. These must include all doses and
both sexes for the following tissues: liver, lung, kidney,
pituitary, spleen, lymph nodes, mammary gland, reproductive
organs, adrenal gland, skin/ear, pancreas, thyroid, and heart.
The reevealuation must include a grading of the severity of
identified changes. The slides must be reread blind, without
prior knowledge of dose level.
d. NCI/NTP Malathion Oncogenicity Study in the B6C3F1 Mouse
In this study, malathion (purity 95%) was administered
to B6C3F1 mice via the diet at one of two doses, either 8000 or
16,000 ppm; for 80 weeks. It was then removed from test diets
and the mice were observed for 14 to 15 weeks.
In evaluating this bioassay, NCI/NTP concluded that under
the conditions of the study, there was "no clear evidence" of
an association between malathion administration and tumor
incidence. The report noted a possible increased incidence of
hepatocellular carcinoma in male mice. This tumor was observed
at the following incidences: matched controls 2/10, pooled
controls 5/49, low dose 7/48, and high dose 11/49. Neoplastic
nodules occurred in 3/49 pooled controls, and 6/49 high-dose
animals yielding overall incidences of 8/49 in pooled controls
and 17/49 in the high dose group. When combined, using pooled
control data, there was a dose-related trend (P = 0.019). For
the direct comparison of the high-dose and pooled control
groups (p = 0.031 Fisher's Exact Test), NCI/NTP employed as its
criterion of significance p = 0.025, based on Bonferroni adjustments,
and hence did not consider this a positive finding. A similar
conclusion was reached by NCI/NTP with respect to data derived
by time-adjusted analyses: matched controls, 2/9; pooled
control, 8/48; low dose, 7/47; high dose, 17/49. NCI/NTP
noted that historical control incidence data for hepatocellular
carcinoma in this strain of mouse often is higher than that
observed in the high-dose group seen in this particular study.
This study was not reexamined by the NCI/NTP.
Because of study design flaws and the guestionable liver
findings (i.e. dose-related trend (p = 0.019) and increased
incidence at hepatocellular carcinomas at the high dose (p =
0.031), another study in mice is reguired.
5. Oncogenicity (Metabolite)
The NCI/NTP has performed Oncogenicity studies on the
cholinesterase-inhibiting malathion metabolite malaoxon, in
the F344 rat and the B6C3F1 mouse. These studies are discussed
below.
17
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a. NCI/NTP Malaoxon Study in the F344 Rat
In this study, malaoxon (purity > 95%) was administered
to F344 rats via the diet at dosage levels of either 500 or 1000
pprn for 103 weeks and were then observed for up to an additional
2 weeks.
NCI/NTP concluded that under the conditions of the
bioassay, malaoxon was not carcinogenic in F344 rats. In their
review, NCI/NTP noted an increased incidence of gastric ulcers
in dosed rats of both sexes, and a possible increase in thyroid
C-cell adenomas or carcinomas in female rats at the high dose
(P = 0.024 by Fisher Exact Test). A positive finding for
C-cell tumors, however, was considered by NCI/NTP to be
precluded by historical control data for this tumor. In a
reexamination of this study, NCI/NTP concluded there was equivocal
evidence for carcinogenicity of malaoxon in males and females
in terms of the incidence of C-cell neoplasms of the thyroid
gland.JV For the thyroid C-cell adenomas/carcinomas, the respective
combined incidences for control, low-dose, and high-dose groups
were: males, 3/49, 3/45, and 12/49; and females, 4/48, 7/48,
and ll(12)/48). NTP/NCI noted that the increases observed at
the high dose were significant for both sexes (males, p < 0.05;
females, p = 0.05) and there was evidence of dose-related
trends. An additional finding in rereview was an increase (p <
0.05) in benign mammary gland tumors in low dose females. This
increase was not considered associated with malaoxon administration
since an increase was not seen in the high-dose group and the
incidence among concurrent controls was unusually low.
The percent survival at week 90 of the study for males and
females, respectively, was 80% and 82% for control, 82% and 90%
for low dose, and 64% and 80% for the high dose group. The
NCI/NTP indicated in their reexamination that sufficient numbers
of rats of each sex were at risk for the development of late
appearing tumors. The Agency is uncertain whether the NCI/NTP
evaluated or corrected for the higher mortality in the male
high-dose group in a like manner with the approach taken by the
Agency (survival analysis). However, in the NCI/NTP rereview
of the data, statistical comparisions were made by survival-adjusted
methods and by the Fisher exact test and the Cochran-Armitage
The NCI/NTP uses five levels of interpretative evaluations in
animal carcinogenesis studies; in decreasing order of strength
(not potency or mechanism) of the experimental evidence, these
are: (i) clear evidence of carcinogenicity, (ii) some evidence
of carcinogenicity, (iii) equivocal evidence of carcinogenicity ,
(iv) no evidence of carcinogenicity and (v) inadequate study
of carcinogenicity.
18
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trend test.
The Agency is requiring an additional F344 rat study
using malaoxon to clarify the findings in this study. The
study may be performed according to the Pesticide Guidelines
for a combined chronic/oncogenicity bioassay. The purpose of
this study is to clarify the oncogen'ic potential and provide
additional needed data on the effects of malaoxon on
cholinesterase inhibition.
b. NCI/NTP Malaoxon Study in the B6C3F1 Mouse
In this study, malaoxon (purity > 95%) was administered
to B6C3F1 mice via the diet at dosage levels of either 500 or
1000 ppm for 103^weeks and were then observed for up to an
additional 2 weeks. Based on a review of this study, the
Agency concludes that malaoxon is not carcinogenic in B6C3F1
mice. NCI/NTP has concluded also that under the conditions
of the bioassay malaoxon was not carcinogenic in B6C3F1 mice.
6. Mutagenicity
No data are available on the mutagenic potential of
malathion. Studies are required in all of the following
mutagenicity test areas: gene mutation, structural chromosomal
aberration, and other genotoxic effects.
7. Developmental Effects (Teratogenicity)
A rat teratology study is required to support registration
of products containing malathion. There is an acceptable
rabbit teratology study. ~ In this study, New Zealand rabbit
bred does, 20 per group, were administered, via gastric intubation,
single daily doses of the vehicle (corn oil) or malathion
dissolved in corn oil on days 6 to 18 of gestation. Doses
employed were 25, 50, and 100 mg/kg body weight. The animals
were observed between days 0 to 20 of gestation. No evidence
of developmental effects was seen. Body weight gain was decreased
in dams at 50 nvg/kg/day and increases in mean percent of resorptions
were observed at 50 and 100 mg/kg/day. In accordance with the
Agency's Guidelines for the Health Assessment of Suspect
Developmental Toxicants (FR 5^: September 2.4, 1986, p. 34031),
the increases in these parameters at the mid and high doses are
to be viewed as evidence of developmental toxicity. Hence, the
developmental No Observable Effect Level NOEL is 25 mg/kg/day.
The Maternal NOEL = 25 mq/kg/day.
The Agency reviewed a rat teratology study, in which
no evidence of maternal or fetal toxicity at doses up to and
19
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including 300 mq/kq/day (the highest dose tested) was noted.
This study is considered to be inadequate to assess developmental
toxicity, since maternal toxicity was not achieved. Additional
deficiencies of the study include a lack of information as to
description of test substance, batch and/or lot number, percent
purity, contaminants, age of rats employed, description of animal
housing, feeding, and watering conditions, chow used and its
composition, daily observations of animals, method of animal
sacrifice, and sex of pups.
8. Reproduction
A reproduction study in the rat is required to support
registration of products containing malathion. The Agency
reviewed a 3-generation rat study, in which rats were
exposed via the dietary route of exposure to dose levels of 0,
100, 500, and 2500 ppm, and determined that the study was
unacceptable due to use of an insufficient number of
animals per dose, and lack'of individual autopsy data, microscopic
and skeletal examinations, histopathology, and other detailed
individual animal data. A new reproduction study is required.
9. Domestic Animal Safety Testing
A study is required to determine the effect of malathion
fed to chickens. The Agency has reviewed data which indicates
that malathion may cause adverse effects to chickens, as evidenced
by enhanced embryo toxicity and reduced egg hatchability, when
ingested at relatively low dietary concentrations (1 to 10
ppm)4/. A study is required to confirm or refute this findinq.
V Sauter, E.A. and E.E. Steele (1971). The Effect of Low
Level Pesticide Feeding on the Fertility and Hatchability
of Chicken Eggs. Poultry Science (51)(1): 71-76.
20
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C. ENVIRONMENTAL PROFILE
1. Ecological Effects
Avian Species
Based on acceptable laboratory data, technical malathion
is characterized as moderately toxic to upland game birds and
slightly toxic to waterfowl on an acute oral basis. The single
oral dose toxicity (LDso) values to ring-necked pheasant (an
upland game bird) and mallard (a waterfowl species) are 167 ppm
and 1485 ppm, respectively. Based on acceptable subacute
dietary studies (LCso) in birds, technical malathion is
characterized as slightly toxic to both upland game birds and
waterfowl, with a subacute toxicity value of 3497 ppm for
bobwhite guail and >5000 ppm for mallards. Based on these
data, it is unlikely that malathion use poses any significant
acute risks to avian species.
Birds can be exposed to malathion via both the terrestrial
and aquatic uses of the pesticide. In addition, most uses
allow for multiple applications and may result in repeated
exposure to birds during the breeding season. There are no
chronic toxicity data upon which to estimate the hazards that
repeated use of malathion poses to birds. Therefore, an
avian reproduction study is required. The Agency will reevaluate
malathion risk to birds after receipt and evaluation of the
reproduction study and other data.
Aquatic Species
Based on acceptable laboratory data, technical malathion
is characterized as slightly toxic to fish and highly
toxic to freshwater invertebrates on an acute basis. The
96-hour acute toxicity (LCso) value for rainbow trout, a coldwater
species, is 200 ppm, and the 96-hour LCso value for
blueqill, a warmwater species, ranges from 20 to 103 ppm.
Studies conducted with a 55% active ingredient emulsifiable
concentrate formulation indicate that the formulation is very
highly toxic to the bluegill (LCso=0.01 ppm) and rainbow trout
(LCso =0.03 ppm). The representative 96-hour LCso value for
freshwater invertebrates is 1 ppm for Daphnia magna.
Pish early life stage and aquatic invertebrate life cycle
studies are not available for this chemical. These studies are
required because some of the uses (e.g., rice, mosquito larva-
cide, and cranberry) involve direct application to water, and
many of the terrestrial uses are likely to result in runoff
that may be transported to a water body. The requirement for a
fish life cycle study is reserved pending submission and review
of the fish early life stage study. Tests of acute toxicity to
freshwater invertebrates for a typical end-use product are
required, since malathion may be applied directly to water.
21
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There are limited data describing the effects of malathion
to marine and estuarine organisms. While data indicate that
malathion is practically nontoxic to oysters (EC50 > 1000),
studies with a formulated product indicate that malathion is
moderately toxic to mysid shrimp (EC5Q ranges from 2.6 to 3.1 ppm).
Marine and estuarine testing is required since malathion
may reach the marine and estuarine environment through both
direct and indirect applications. Testing requirements are
for a 96-hour LC5Q study on a marine or estuarine shrimp species
and a 96-hour LC5Q study on a marine or estuarine fish species.
Based on theoretical calculations, application of malathion
to land can result in estimated environmental concentrations
(EECs) in aquatic environments of 0.3 ppm due to surface runoff
and aerial drift. The highest EEC resulting from direct application
of malathion to water (11 ppm) is much greater than the lowest
LC50 (0.01 ppm) for a freshwater fish species (bluegill). There-
fore, fish may be at risk from exposure to malathion via both
aquatic and terrestrial uses. The Agency has reviewed published
articles and other reports regarding fish kills attributed to
the use of malathion. These reports support laboratory toxicity
data findings. However, the Agency cannot use these reports in
its assessment of the chemical due to report deficiencies ((e.g.
lack of replication, no controls, inadequate monitoring and lack
of information on dose used). Acute studies, chronic studies,
residue chemistry data and environmental fate data are needed
to enable the Agency to assess the impact to fish species.
Malathion is potentially highly toxic to aquatic life
stages of amphibians. This is based on acute toxicity values
of 0.20 ppm to the Western chorus frog and 0.42 ppm to the
Fowler's toad. Based on these data, precautionary labeling
concerning the effects of malathion to aquatic life is necessary-
2. Honey Bees
There is sufficient information to characterize malathion
as highly toxic to honey bees (acute toxicity value = 0.27 ug/bee)
when bees are exposed to direct treatment. Because data indicate
a high toxicity to bees, additional data are required to fully
assess the toxicity to honey bees from the outdoor use patterns.
Precautionary labeling is necessary for all malathion products
intended for outdoor applications.
3. Endangered Species
There is sufficient information to indicate that current
registered uses of malathion may adversely affect endangered
species. Threshhold levels for concern for aquatic endangered
species (EEC > 1/20 I>C$Q) are exceeded both by direct aquatic
applications and terrestrial applications (due to runoff
22
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and aerial drift). The EECs based on terrestrial applications
exceed criteria for concern for some terrestrial species (EEC >
1/10 LCso) for many of malathion's uses.
Malathion has been identified by the Office of Endangered
Species (OES), U.S. Fish and Wildlife Service, as being likely
to jeopardize the continued existence of certain endangered
species when used on range and pastureland, grain crops,
soybeans, sorghum and cotton. Based on this determination,
OES specified reasonable and prudent alternatives to avoid
jeopardizing the continued existence of the identified species.
EPA is working with the Fish and Wildlife Service and other
Federal and State agencies to implement the alternatives in a
technically sound manner.
4. Environmental Fate
The Agency is unable to fully assess the environmental
fate of malathion because acceptable data are lacking. Data
are required as set forth in Table A of this document. Prelim-
inary data indicate that malathion is very mobile in loamy
sand and loam soils. Kd values reported were 0.73 to 0.95.
23
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D. PESTICIDE INCIDENT REPORTS
Data on occupational illness due to malathion exposure have
been received from California, which requires that all such
physician-treated illnesses be reported to the State. Between
1981 and 1985, malathion was the third most common cause of
pesticide illness, but was only the eleventh most common cause
of hospitalized pesticide illness. Applicators accounted for
approximately half of all the illnesses reported from 1982 to
1986. Less than 3 percent of these illnesses involved field
reentry, while 28 percent were due to exposure to other residues
or fumes after application, especially indoor application. An
analysis of indoor poisoninqs in California (1975 to 1981)
revealed that inhalation of malathion from spills or contaminated
air was the principal source of exposure. Another 14 percent
of the illnesses were due primarily to spray drift or other
coincidental exposure.
The California data represent a complete count or census of
all occupationally related cases. These data indicate that
malathion can cause serious poisoninq problems. From the
California census, there was an average of 1.3 incidents of
occupational illness per million pounds of pesticide sold from
1981 to 1985 data. For malathion, there were 6.5 illnesses per
million pounds sold, or about 5 times as many occupational
illnesses than the average pesticide.
24
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E. TOLERANCES
1. Tolerances Issued
Tolerances have been established for residues of
malathion in raw agricultural commodities (RACs), in meat, fat,
and meat byproducts (refer to 40 CFR 180.111), and in processed
food (21 CFR 193.260) and animal feeds (21 CFR 561.270) as
listed below:
TABLE 2
SUMMARY OF TOLERANCES FOR MALATHION
(ppm)
Commodity U.S.
Canadian
Mexican
Root and Tuber Vegetables
Beets
Carrots
Horseradish
Parsnips
Potatoes
Radishes
Rutabagas
Salsify
Sugar beet roots
Sweet potatoes
Turnips
Leaves of Root and Tuber
Beet greens
Salsify tops
Sugar beet tops
Turnip tops
Bulb Vegetables Group
Garlic
Leeks
Onions (green and bulb)
Group
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
1.0
1.0
8.0
Vegetables
8.0
8.0
8.0
8.0
8.0
8.0
8.0
0.5
0.5
0.5
0.5
0.5
0.5
0.5
3.0
-
-
0.5
Group
«•
3.0
-
0.5
0.5
3.0
0.5 (d
Shallots 8.0
Leafy Vegetables Group
Celery 8.0
Dandelions 8.0
Endive (escarole) 8.0
Lettuce 8.0
Parsley 8.0
Spinach 8.0
Swiss Chard 8.0
3.0 (green)
3.0
1.0
6.0
6.0
6.0
6.0
6.0
8.0
8.0
8.0
1.0
8.0
8.0
8.0
8.0
8.0
0.5
International
Codex MRL
0,
0,
0,
0,
0,
0
5
5
5
5
5
5
0.5
0
0
0
5
5
5
0.5
1.0
8.0
8.0
8.0
0.5
25
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SUMMARY OF TOLERANCES FOR MALATHION (cont'd) (ppm)
Commodity U.S.
Canadian
Brassica Leafy Vegetables
Broccoli
Brussels sprouts
Cabbage
Cauliflower
Collards
Kale
Kohlrabi
Mustard greens
Legume Vegetables Group
Beans (succulent
and dried)
Lentils
Lupine seed
Peas
Soybeans
Group
5.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
3.0
8.0
Foliage of the Legume Vegetables Group
Cowpea forage and hay
Pea vines and hay
Soybean forage, hay,
and straw
135.0
8.0
135.0
Fruiting Vegetables (except cucurbits)
Eggplant
Peppers
Tomatoes
Cucurbit Vegetables Group
Cucumbers
Melons
Pumpkins
Sguash
Citrus Fruits Group
Grapefruit
Kumguats
Lemons
Limes
Oranges
Tangerines
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
0.5
fi.O
6.0
0.5
0.5
6.0
0.5
—
2.0
3.0
-
0.5
—
0.1(N)V
0.1 (N)V
0.1(N)V
Group
0.5
0.5
3.0
3.0
8.0
3.0
3.0
_
-
-
-
-
Mexican
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
8.0
50.0
50.0
50.0
50.0
50.0
50.0
International
Codex MRL
5.0
8.0
0
0
3.0
0.5
8.0 (dried)
2.0 (green)
8.0
0.5
0.5
0.5
3.0
4.0
4.0
4.0
4.0
4.0
4.0
"57(N) negligible residue
26
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2. Residue Data The residue data reviewed in support of
the malathion tolerances may be summarized as follows:
a. The available data pertaining to metabolism of
malathion in plants are inadequate. The data consists solely
of information on fortified wheat grain. Additional data are
required on the uptake, distribution, and metabolism of malathion
in alfalfa, cotton, soybeans, and either wheat or rice following
foliar applications at a rate sufficiently high to permit
residue identification.
The data pertaining to metabolism of malathion in animals
are inadequate. Additional metabolism studies are required
that utilize ruminants and poultry. Should the metabolism of
malathion in ruminants and/or poultry following oral dosing
differ significantly from that in rats, swine metabolism data
may also be required. Metabolism studies using cattle, poultry,
and swine reflecting direct animal treatment are also required.
b. Analytical methodology for determining the levels
of residues of malathion in plants and animals is adequate.
Malathion is detected by the FDA-USDA multiresidue protocols.
Additional methods may be required if the metabolism studies
indicate that additional metabolites constitute residues of
toxicological concern.
c. Storage stability data demonstrate that residues of
malathion in or on frozen plant commodities are stable up to 185
days after application and in milk stored at -10°C for 98 days
after application. No data are presently available for animal
tissues and are required. Additional storage stability data
are also required in order to evaluate the adequacy of the
malathion tolerances.
d. Insufficient data are available on the magnitude and
levels of and residues of malathion in all the listed crops
except flax seed, hops, wild rice, and non-medicated cattle feed
concentrate blocks.
e. Processing studies are required for potatoes, sugar
beets, soybeans, tomatoes, oranges, apples, plums, grapes,
corn, rice, sorghum, wheat, cottonseed, mint, figs, flax,
peanuts, pineapples, safflower seed, sunflower, almonds,
citrus pulp, and raisins.
f. Tolerances must be proposed and appropriate supporting
residue data submitted for the following feed items: bean vines
and hay; lentil forage and hay; cowpea seed; soybean straw;
30
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barley forage, hay, and straw; corn forage and fodder; oat
forage, hay, and straw; rice straw; rye forage and straw; straw
of wild rice; sorghum fodder; lespedeza forage; lupine forage;
cotton forage; mint hay; peanut hulls, hay, and vines; and
pineapple forage.
g. Feed additive tolerances are reguired for residues
of malathion in or on dried hops and spent hops.
h. A tolerance for residues of malathion in or on
anise must be proposed and submitted along with with appropriate
supporting residue data.
i. Data are needed to support the use of malathion
in food handling establishments.
j. Data reflecting the use of malathion on stored,
unfinished tobacco are reguired.
k. A tolerance must be proposed and appropriate
supporting residue data submitted for grain dust from
corn, wheat, rice, soybeans and sorghum.
1. The FDA Revised Total Diet studies as well as the
Surveillance and Compliance program for domestic and imported
commodities employ methodology which is known to determine
malathion. No tolerance exceeding residues of malathion were
observed in the Total Diet studies (4/82 to 4/86) although
residues were observed in the following commodities for which
no tolerances exist: cooked fish (0.0005 ppm), fried breaded
shrimp (0.004 ppm), fish sticks (0.008 ppm) and pudding (0.005
ppm). Positive findings of malathion were observed in various
commodities of malathion in the Surveillance and Compliance
program (FY 78 through 6/8/87). The USDA monitoring program
for meat utilized methodology known to be capable of determining
malathion. Residues within the tolerance of malathion were
observed in one sample of steer liver analyzed in 1973. No
other findings were reported in samples analyzed from 1972 to
1985.
m. The following changes to 40 CFR 180.111 will be
proposed by the Agency:
Current 40 CFR entry Appropriate commodity definitions
Beets (including tops) Beet roots
Beet greens
Salsify (including tops) Salsify
Salsify tops
Turnips (including tops) Turnips
31
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Onions (including onion greens)
Plums
Prunes
Almonds, shells
Alfalfa
Clover
Lespedeza seed
Lespedeza straw
Lupine straw
Vetch seed
Vetch straw
Turnip tops
Onions (green and bulb)
Plums (fresh prunes)
None a
None a
Alfalfa forage
Clover forage
None a
None a
None a
None a
None a
£ Deletion from the 40 CFR recommended; not a raw agricultural
commodity.
3. Toxicology
Based on a study in man in which red blood cell and
plasma cholinesterase activity was inhibited at a dose of 0.34
mg/kg (the lowest effect level or LRL), a provisional acceptable
daily intake (PADI) of 0.02 mg/kg/day has been calculated using
a 10-fold uncertainty factor (UF). A No Observable Effect Level
(NOEL) was calculated to be 16 mg/day. The PADI is provisional
because the existing data base on malathion is lacking chronic
toxicity studies, a teratology study, a reproduction study,
mutagenicity studies, and a metabolism study.
The Theoretical Maximum Residue Contribution (TMRC)
for the U.S. population average is 0.1014 mg/kg/day, occupying
507% of the PADI. For children 1 to 6 years of age, the TMRC
occupies 1133% of the PADI. The TMRC is based upon current
tolerance levels and an assumption that 100% of the sites are
treated. Actual dietary exposure may be much lower. The Agency
is not a'ble to calculate an Anticipated Residue Contribution
(ARC), which is a much more realistic estimate of dietary exposure,
since no processing or anticipated residue data were available.
When the reguired data are submitted, the Agency will conduct a
full tolerance reassessment.
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IV. REGULATORY POSITIONS AND RATIONALES
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data and
other relevant information on malathion the Agency has made
the following determinations:
1. Malathion is not being placed into Special Review
at this time.
Rationale; Since available data are limited, the Agency is
not yet able to make a determination as to whether any of
the criteria specified in 40 CFR 154.7 have been met or
exceeded.
2. The Agency will not approve tolerances for significant
new uses until the Agency has received data sufficient to
perform a tolerance reassessment.
Rationale; Data gaps exist for plant and animal
metabolism, storage stability and residues in most of the
raw agricultural commodities (RAC's). Data gaps exist in the
area of toxicology testing (chronic feeding, oncogenicity,
teratology, reproduction, mutagenicity, and metabolism). This
lack of data precludes the Agency from conducting a full tolerance
assessment. In addition, the TMRC occupies 507% of the PADI.
For these reasons, significant new uses£/ will not be granted
until these data gaps have been filled.
3. The Agency is concerned about the potential hazards
to aguatic organisms, but is not taking any regulatory
action at this time for fish and wildlife concerns.
Rationale; Based on theoretical calculations, both
terrestrial and aguatic uses of malathion may pose significant
risk to aguatic fauna. Reported fish kills and results of
several field studies suggest that adverse effects to both
terrestrial and aguatic fauna may result from normal use of
malathion. However, these reports are not adeguately documented
to cause EPA to impose restricted use status for malathion.
EPA will reassess the impacts of malathion use to nontarget
organisms after the reguired ecological effects and environmental
fate data reguired by this Standard have been received and
reviewed. The Agency will then determine whether any regulatory
action is necessary.
Significant new use" is defined in 44 FR 27934, May 1, 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%.
33
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4. The Agency is not restricting the use of malathion
products at this time.
Rationale; Section 3(d)(l)(C) of FIFRA provides that
some or all uses of a pesticide will be classified for restricted
use if the Administrator determines that without such restriction
the pesticide "may generally cause unreasonable 'adverse effects
in man or the environment." The Agency has determined that
malathion does not meet any of the risk criteria of 40 CFR 162.11,
and therefore products containing malathion do not warrant
restricted use classification.
5. The Office of Endanagered Species (OES) in the U.S.
Fish and Wildlife Service has determined that certain uses of
malathion, including uses on range and pastureland, on grain
crops, soybeans, sorghum and cotton, may jeopardize the continued
existence of endangered species. EPA is developing a program
to reduce or eliminate exposure to these species to a point
where use does not result in jeopardy, and will issue notice of
any necessary labeling revisions when the program is developed.
No additional labeling is required at this time. Labeling
requirements issued in PR Notices 87-4 and 87-5 have been
withdrawn pending reissuance.
In addition, the Agency is seeking OES evaluation of
additional uses of malathion, including mosquito larvicide,
forestry, stone fruits, citrus, apples, pears, blueberries,
cucumber, peanuts, pineapple, potatoes, tomatoes and celery.
Rationale; Technical malathion is potentially highly
toxic to aquatic invertebrates, aquatic life stages of amphibians
and terrestrial non-target insects including bees.
In May 1987, EPA issued PR Notices 87-4 and 87-5 in response
to OES findings that certain pesticides, including malathion,
jeopardized the continued existence of endangered species.
Those PR Notices directed registrants to add labeling to their
products which referred users to additional information that,
in turn, explained limitations on use of malathion within the
range of jeopardized endangered species.
Subsequent to issuance of these PR Notice, EPA identified
a number of significant technical errors and inconsistencies in
the information to which users would have been referred. There-
fore, on January 26, 1988, the Agency issued PR Notice 88-1,
which withdrew PR Notices 87-4 and 87-5 pending development
of a more focused program to protect endangered species. EPA
is working to correct these errors prior to requiring labeling
to protect endangered species. When that program is fully
developed, notice of any labeling necessary to protect endangered
species will be issued.
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6. In order to meet the statutory standard for continued
registration, the Agency has determined that malathion products
must bear revised and updated fish and wildlife toxicity warnings.
Specific wording is given in Section IV.D.
Rationale; Available data indicate that malathion is
potentially highly toxic to to aquatic invertebrates, aquatic
life stages of amphibians and bees, moderately toxic to birds,
and slightly toxic to fish.
7. The Agency is deferring decisions concerning malathion's
potential for contaminating groundwater until information
on its environmental characteristics and fate have been submitted
and reviewed.
Rationale; The Agency is unable to assess the potential
for malathion to contaminate groundwater because the environmental
fate of this chemical is largely uncharacterized. Preliminary data
indicate that malathion is very mobile in loamy sand and loam
soils. Additional data are needed in order for the Agency to
assess its potential for contaminating groundwater. When these
data have been received and evaluated. The Agency will assess
malathion's potential for groundwater contamination and will
determine whether any regulatory action is necessary.
8. The Agency is not establishing a longer reentry interval
for agricultural uses of malathion beyond the minimum reentry
interval (sprays have dried, dusts have settled and vapors have
dispersed).
Rationale; Malathion has a relatively low acute
toxicity (Toxicity Category III by the oral, dermal and inhalation
routes of exposure). There have been no scientifically validated
toxicological evidence showing that malathion causes adverse
effects to persons entering treated areas. For these reasons,
the Agency has determined that a longer reentry interval beyond
the minimum established reentry (sprays have dried, dusts have
settled and vapors have dispersed) is not neccessary for this
chemical. Upon receipt and evaluation of the toxicology data
requested in this Standard, the Agency will reevaluate its
position regarding the need for reentry data/reentry intervals.
9. Pesticide spray drift data requirements are imposed
for the outdoor uses of malathion. Data required are droplet
size spectrum and field evaluation studies.
Rationale; The Agency is concerned about the potential
hazards to nontarget organisms (fish and wildlife, domestic
animals and humans) caused by the drift from aerial and ground
applications of malathion. These data requirements are imposed
because of malathion's volatility and its ability to persist
in air, and because pesticide incident data show that spray
drift is a principal source of poisoning risk for humans
from this chemical.
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10. In order to remain in compliance with FIFRA, all
malathion products intended for use indoors must bear precautions
to use with adequate ventilation and to ventilate thoroughly
before occupying enclosed spaces.
Rationale; The Agency has determined that a labeling
precaution to use with adequate ventilation and to ventilate
thoroughly before occupying enclosed spaces is necessary.
This is due to a relatively high number of pesticide incidents
reported for this chemical. Malathion. was the third most
common cause of pesticide illness in California between 1981
and 1985. Twenty-eight percent of the illnesses reported
were attributed to exposure to fumes, especially from indoor
application (1982-1986 data).
11. The Agency will revise the commodity definitions
for certain raw agricultural commodities listed in 40 CFR
180.111 when tolerances for malathion are next revised.
Rationale; Certain listings in 40 CFR 180.111 are not
appropriate and will be corrected by the Agency when tolerances
for malathion are next revised (e.g. the tolerance listing
for beets (including tops) will be revised to enumerate
beet roots and beet greens separately.
12. The Agency has identified certain data that will
receive priority review when submitted to the Agency.
Rationale; Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may trigger
the need for further studies which should be initiated as
soon as possible. The following studies have been identified
to receive priority review as soon as they are received by
the Agency:
§158.135 Toxicology
81-7 Delayed Neurotoxicity
82-2 21-Day Dermal Toxicity
82-4 90-Day Inhalation
§158.125 Environmental Fate
161-1 Hydrolysis
161-2 Photodegradation in Water
161-3 Photodegradation in Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
163-1 Leaching and Adsorption/Desorption
164-1 Terrestrial Field Dissipation
201-1 Droplet Size Spectrum and Drift Field Evaluation
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§158.145 Wildlife and Aquatic Organisms
72-2 Acute Toxicity to Freshwater Invertebrates (TEP)
72-3 Acute Toxicity to Estuarine and Marine Organisms
(TGAI and TEP)
72-4 Fish Early Life Stage and Aquatic Invertebrate
Life Cycle
§158.125 Residue Chemistry
171-4 Plant and Animal Metabolism Data
171-4 Storage Stability Data
171-4 Residue Data
13. While data gaps are being filled, currently registered
manufacturing-use products (MPs) and end-use products (EPs)
containing malathion may be sold, distributed, formulated, and
used, subject to the terms and conditions specified in this
Standard. However, significant new uses will not be registered.
Registrants must provide or agree to develop additional data,
as specified in the Data Appendices, in order to maintain
existing registrations.
Rationale; Even when authorized under FIFRA sections
3(c)(2)(B) and 3(c)(7) the Agency may elect not to cancel or
withhold registration even though data are missing or are
inadequate. Issuance of this Standard provides a mechanism
for identifying data needs. These data will be reviewed and
evaluated, after which the Agency will determine if additional
regulatory actions are necessary. The Agency has elected
not to consider registration of any significant new uses while
data gaps are being filled and data evaluated.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, MPs
must contain malathion as the sole active ingredient. Registrants
must comply with all terms and conditions described in this
section, including submission of an up-to-date Confidential
Statement of Formula, submission of revised labeling, commitment
to fill data gaps on the schedule specified by the Agency and,
when applicable, offer to pay compensation as required by
FIFRA sections 3(c)(l)(D) and 3(c)(2)(D).
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
Each MP proposed for registration or reregistration must
be fully described with an appropriate certification of limits,
stating maximum and minimum amounts of the active and inten-
tionally added inert ingredients which are present in the product,
as well as impurities found at greater than 0.1 percent.
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2. Acute Toxicity Limits
The Agency will consider registration of MPs containing
malathion in any Toxicity Category provided the product labeling
bears appropriate precautionary statements for the acute toxicity
category in which each product is placed.
3. Use Patterns
All MPs must be labeled for formulation into other
MP products or into end use products bearing federally regis-
tered uses. Labeling must specify sites, which are listed in
Use Patterns, Appendix III. However, no use may be included
on the label where the registrant fails to agree to comply
with the data requirement in Table A for that use pattern.
D. REQUIRED LABELING
All MPs and EPs must bear appropriate labeling as specified
in 40 CFR 162.10, PR Notices 83-2 and 83-3, precautions and
warnings listed in the Malathion Use index (Appendix III),
and as indicated in this Registration Standard (as appropriate).
In order to remain in compliance with FIFRA, no EP or MP
containing malathion may be released for shipment by a regis-
trant or producer of that product after March 31, 1989,
unless the product complies with these requirements.
In order to remain in compliance with FIFRA, no EP or MP
containing malathion 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 March 31, 1990, unless the product bears
a label which complies with the requirements listed above.
1. Labeling for MPs
a. The ingredient statement for MPs must declare the
active ingredient as:
Malathion: O,O-diethyl phosphorodithioate of
diethyl mercaptosuccinate
b. Labels for MPs must bear the following identifying
phrase directly beneath the product name:
"An insecticide and miticide for formulating use only."
c. In the directions for use, the following statement
must appear:
"Formulators using this product are responsible for
obtaining EPA registration of their formulated products."
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d. In the directions for use, the following statement
regarding acceptable use patterns must appear:
"For formulation into end-use insecticide products
intended only for (list acceptable sites)."
NOTE: No use may be included on the label where
the registrant fails to agree to comply with the data require-
ments for that use pattern.
e. If detailed instructions for formulating are not
provided on the label, the following statement must appear:
"Refer to attached Technical Bulletin for formulating
and other information."
NOTE: The technical bulletin must be submitted
with the product label for Agency review.
f. The following fish and wildlife statements are
required to appear under the "Environmental Hazards" heading:
This pesticide is toxic to aquatic invertebrates and aquatic
life stages of amphibians. 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 a National Pollution Discharge Elimination
System (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 the Regional Office of EPA.
2. Labeling for EPs
a. The ingredient statement for EPs must declare the
active ingredient as:
Malathion: 0,0-dimethyl phosphorodithioate of
diethyl mercaptosuccinate
b. All products allowing for outdoor use on nonaquatic
sites must bear the following environmental hazards statement:
"This pesticide is toxic to fish, aquatic
invertebrates, and aquatic life stages of amphibians. Do not
apply directly to water or wetlands (i.e., swamps, bogs, marshes,
and potholes). Drift and runoff may be hazardous to aquatic
organisms in areas near the application site. Do not contaminate
water when disposing of equipment washwaters."
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This product is highly toxic to bees exposed
to direct treatment 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.
c. All products allowing for use on aquatic sites must
bear the following environmental hazards statement under the
"Environmental Hazards" heading:
"This pesticide is toxic to fish, aquatic
invertebrates, and aquatic life stages of amphibians. Do not
apply directly to water except as specified on this label.
Do not contaminate water when disposing of equipment washwaters."
This product is highly toxic to bees exposed
to direct treatment on blooming crops or weeds. Do not apply
this product or allow it tOv drift to blooming crops or weeds
if bees are visiting the treatment area.
d. All products allowing for indoor use must bear the
following ventilation statement:
Use only with adequate ventilation. After using
this product indoors, ventilate thoroughly before occupying
enclosed spaces. Do not allow contact with treated surface until
sprays have dried.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.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 B2
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.
2 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:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
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 formulator's exemption3, 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:
1. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
3 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.
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2. If eligible for the formula tor's exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
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.4
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
4 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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that both they and you are not in compliance and will normally
cnac oocn tney and you are not in compliance and will nor
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to
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.
submit
In
If you are not now eligible for a formulator's exemption,
you may quaJify 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 far 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 iises 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 registration 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
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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.
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
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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:
[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 bhan 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-SPECIFIC 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. Generic Data 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. Refer to Certification With Respect to
Citation of Data Form.
5 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.)
50
-------
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
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Generic Data Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months of receipt of this document, you must
submit to the Product Manager:
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.
51
-------
3. Within the time frames 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.
C. End Use Products 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:
a. 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. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
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 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).
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
Within 9 months from the receipt of this document, you
must submit to the Product Manager:
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
52
-------
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).
E. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
KM
in
active ingredients.
Applications for full Federal registration of intrastate
products are required to be submitted no later than July 31,
1988.
F. Addresses
The required information must be submitted to the following
address:
William H. Miller (PM-16)
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
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
53
-------
I. DATA APPENDICES
54
-------
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
N/A = There are no registered use patterns for which the
the data requirement applies.
55
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely 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
t;he 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.
56
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALATHION
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data?1/ Citation1/
Must Additional Tiraeframe
Data be for
Submitted? Submission2/
§158.120 Product Chemistry
Product Identity!
61-1 - Product Identity
and Disclosure of
Ingredients
61-2 - Description of Beginning
Materials and Manufac-
turing Process
61-3 - Discussion of Formation
of Impurities
Analysis and Certification of
Product Ingredients;
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods
to Verify Certified
Limits
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Physical and Chemical Characteristics;
63-2 - Color
63-3 - Physical State
TGAI
TGAI
All
All
All
Yes
Yes
Yes
All
All
All
Yes
Yes
Yes
All
All
Yes
Yes
9 Months
9 Months
9 Months
12 Months
12 Months
12 Months
9 Months
9 Months
57
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR MALATHION
Data Requirement
§158.120 Product Chemistry (conf
Must Additional Time frame
Test Use Does EPA Bibliographic Data be for
Substance Pattens Have Data?1/ Citation1/ Submitted? Submission2/
d)
Physical and Chemical Characteristics:
(cont1
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Other
d)
- Odor
- Melting Point
- Boiling Point
- Density, Bulk Density,
or Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation Constant
- Ocbanol/Water Partition
Coefficient
- pH
- Stability
Requirements:
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
All
All
All
All
All
All
All
All
All
All
Yes
Yes2/
YesV
Yes
Yes
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
64-1 - Submittal of Samples
TGAI, PAI
All
Reserved5/
58
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALATHION
Must Additional Timeframe
Test Use Does EPA Bibliographic Data be for
Data Requirement Substance Patterns Have Data?V Citationy Submitted? Submission^/
§158.120 Product Chemistry (cont'd)
V Although prrxluct 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/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
V Required if the technical is a solid at room temperature.
V Required if the technical is a liquid at room temperature.
5/ These data are not required. When submittal of samples becomes necessary, the Agency will request
m from the registrant.
59
-------
GENERIC DATA REQUIREMENTS FOR MALATHION.
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Addi-
tional Data
Be Submitted?
Time Frame
for Sub-
mission' /
158.125 Residue Chemistry
171-4. Nature of the residue
(Metabolism)
- Plants
- Livestock
171-4. Residue analytical
methods
- Plant residues
- Animal residues
PAIRA Partially 00153985, Yes2/
40397103,
40397102
PAIRA Partially 00108942, Yes4/
00120105
TAI & Partially 00033810,00034342, Reserved^/
Metabolites 00035014,00035318,
00035330,00035870,
00058823,00080769,
00089256,00089521 ,
00096676,00098775,
00102376,00104631,
00108941,00113099,
00113100,00113116,
00113135,00113137,
00113141 ,00113142,
00113143,00113147,
00113149,00113150,
00113171,00113173,
18 months^/
18 months^./
(Continued).
60
-------
GENERIC DATA REQUIREMENTS FOR MALATHION.
Data Requirement
171-4.
171-4.
Residue analytical
methods (Cont'd.)
- Plant residues
- Animal residues
Storage stability
data
Must Addi-
Test Does EPA Bibliographic tional Data
Substance Have Data? Citation Be Submitted?
00113186,00113188,
00113203,00113205,
00113212,00113223,
00113229,00113230,
00120105,00122714,
40397104,40397105,
40397101
TEP & Partially 00048370, Yes^/
Metabolites 00113206,
00089256,
00089521,
00113137
Time Frame
for Sub-
missionl/
18 months3/
(90 Days -
Protocol)
171-4. Magnitude of the Residue
in Plants
- Root and Tuber
Vegetables Group7/
o Beets
o Carrots
o Horseradish
o Parsnips
o Potatoes
(processed)
o Radishes
o Rutabagas
o Salsify
o Sugar beet roots
(processed )
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
No
NO
No
NO
NO
NO
No
No
NO
No
No
Yes8/
Yes?/
YesTO/
YesTT/
YesT2/
YesTJ/
Yes1*/
YesrJ/
YesTT/
YesTS/
18 months3/
18 months3/
18 months3"/
18 months^/
18 months^/
24 months^/
18 months^/
18 months^/
18 months'3/
18 months^/
24 months3"/
(Continued).
61
-------
GENERIC DATA REQUIREMENTS FOR MALATHION.
Test
Data Requirement Substance
171-4. Magnitude of the Residue
in Plants (Continued).
o Sweet potatoes TEP
o Turnips TEP
- Leaves of Root and
Tuber Vegetables Group21 /
o Beet greens TEP
o Salsify tops TEP
o Sugar beet tops TEP
o Turnip tops TEP
- Bulb Vegetables Group26/
o Garlic TEP
o Leeks TEP
o Onions TEP
o Shallots TEP
- Leafy Vegetables Group 31 /
o Celery TEP
o Dandelions TEP
o Endive (escarole) TEP
o Lettuce TEP
o Parsley TEP
Does EPA
Have Data?
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Must Addi-
Bibliographic tional Data
Citation Be Submitted?
YesW
Yes7^/
Yes22/
Yes77/
Yes73"/
Yes7!/
Yes27/
Yes7*/
Yes77/
YesJ^/
Yes77/
Yes7*/
Yes7*/
Yes7*/
Time Frame
for Sub-
mission1 /
18 months3/
18 months7/
18 months3/
18 months7/
18 months7/
18 months7/
1 8 months3/
18 months7/
18 months7/
1 8 month s7/
18 months3/
18 months7/
18 months7/
18 months7/
18 months7/
(Continued).
62
-------
GENERIC DATA REQUIREMENTS FOR MALATHION.
Data Requirement
Must Addi- Time Frame
Test Does EPA Bibliographic tional Data for Sub-
Substance Have Data? Citation Be Submitted? mission1/
171-4. Magnitude of the Residue
in Plants (Continued).
o Spinach
o Swiss chard
Brassica Leafy39/
Vegetables Group
TEP
TEP
Partially 00057674,00089260, Yes3^/
00113143
No
Yes38/
18 months^/
18 months3/
o Broccoli
o Brussels sprouts
o Cabbage
o Cauliflower
o Collards
o Kale
o Kohlrabi
o Mustard greens
- Legume Vegetables
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Groupj^/
o Beans (succulent and TEP
dried)
o Lentils
o Lupine seed
o Peas
o Soybeans
(processed)
TEP
TEP
TEP
TEP
TEP
No
No
Partially
No
No
No
No
No
Partially
No
No
No
No
No
Yes^O/
Yes''1"/
00089260,00113143 Yes77/
Yes77/
Yes*7/
Yes*5"/
Yes**/
Yes^J/
00089245,00100020, Yes49/
00113166,00113143
YesSO/
Yes"51"/
Yes**/
Yes*7/
Yes5*/
18 months3/
18 months7/
18 months7/
18 months7/
18 months7/
18 months7/
18 months7/
18 months7/
18 months^/
18 months3/
18 months7/
18 months7/
18 months7/
24 months7/
(Continued).
63
-------
GENERIC DATA REQUIREMENTS FOR MALATHION.
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Addi-
tional Data
Be Submitted?
Time Frame
for Sub-
mission^ /
171-4.
Magnitude of the Residue
in Plants (Continued).
- Foliage of the
Legume Vegetables
TEP
o Cowpea forage and hay
o Pea vines and hay
o Soybean forage.
hay, and straw
- Fruiting Vegetables
Group^/
o Eggplant
o Peppers
o Tomatoes
(processed)
- Cucurbit Vegetables
Group64/
o Cucumbers
o Melons
o Pumpkins
o Squash
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
No
No
No
NO
No
No
No
No
No
No
No
Yes*6/
Yes57/
YesW
Yes60/
YesW
Yes*7/
Yes**/
Yes6*/
Yes"55/
Yes57"/
YesW
18 months3/
1 8 months3"/
18 months^/
18 months3/
18 months3/
18 months3"/
24 months^/
18 months3/
18 months3"/
18 months3"/
18 months3^/
(Continued).
64
-------
GENERIC DATA REQUIREMENTS FOR MALATHION.
Data Requirement
171-4. Magnitude of the Residue
in Plants (Continued).
- Citrus Fruits Group69/
o Grapefruit
o Kumquats
o Lemons
o Limes
o Oranges
(processed)
o Tangerines
- Pome Fruits Group77/
o Apples
(processed)
o Pears
o Quinces
- Stone Fruits Group82/
o Apricots
o Cherries
o Nectarines
o Peaches
o Plums (fresh prunes)
(processed)
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data?
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Must Addi-
Bibliographic tional Data
Citation Be Submitted?
Yes70/
yes7T/
Yes7*/
Yes"77/
Yes75"/
Yes75/
Yes7£/
Yes78/
Yes7*/
YesW
Yes^/
Yes83/
Yes"5*/
Yes55"/
YesW
Yes*7/
Yes*£/
Time Frame
for Sub-
mission1 /
18 months3/
18 months7/
18 months7/
18 months7/
18 months7/
24 months7/
18 months7/
1 8 months3/
24 months7/
18 months7/
18 months7/
18 months3/
18 months7/
18 months7/
18 months7/
18 months7/
24 months7/
(Continued).
65
-------
GENERIC DATA REQUIREMENTS FOR MALATHION.
Data Requirement
171-4. Magnitude of the Residue
in Plants (Continued).
- Small Fruits and
Berries Group****/
o Blackberries
o Blueberries
o Boysenberries
o Cranberries
o Currants
o Dewberries
o Gooseberries
o Grapes
(processed)
o Loganberries
o Raspberries
o Strawberries
- Tree Nuts Group102/
o Almonds
o Chestnuts
o Filberts
o Macadamia Nuts
o Pecans
o Walnuts
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data?
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Must Addi-
Bibliographic tional Data
Citation Be Submitted?
Yes9°/
Yes51"/
Yes57/
Yes57/
Yes5*/
Yes5*/
Yes55"/
Yes57"/
Yes5*/
Yes55"/
Yes™0/
Yes^/
Yes103/
Yes"™*/
Yes"111*/
Yes™*/
Yes™7/
Yes™*/
Time Frame
for Sub-
mission1 /
18 months3/
18 months7/
18 months7/
18 months7/
18 months7/
18 months7/
18 months7^
18 months7/
24 months7^
18 months7^/
18 months7/
18 months7/
18 months3/
18 months7/
18 months7^/
18 months7/
18 months7/
18 months7/
(Continued).
66
-------
GENERIC DATA REQUIREMENTS FOR MALATHION.
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Addi-
tional Data
Be Submitted?
Time Frame
for Sub-
mission^ /
171-4. Magnitude of the Residue
in Plants (Continued).
- Cereal Grains
o Barley TEP
o Corn (grain and sweet)TEP
o Oats TEP
o Rice TEP
o Rye TEP
o Sorghum TEP
o Wild rice TEP
o Wheat TEP
Forage, Fodder, and Straw
of Cereal Grains Group^ "* **/
o Sorghum Forage and TEP
Sorghum Hay
Grass Forage, Fodder and
Hay Group
o Grass Forage and TEP
Grass Hay
No
No
No
No
No
No
No
No
Yes"™"7"/
Partially 00035013,00153987 Yes119/
No
18 months^/
18 months"3"/
18 months^/
18 months^/
18 months-^/
18 months3"/
18 months^/
18 months3"/
18 months3/
18 months3/
(Continued).
67
-------
GENERIC DATA REQUIREMENTS FOR MALATHION.
Data Requirement
171-4. Magnitude of the Residue
in Plants (Continued).
- Non-Grass Animal Feeds
Group
o Alfalfa Forage and
Hay
o Birdsfoot trefoil
Forage and Hay
o Clover Forage and
Hay
o Lespedeza Forage and
Hay
o Lupine Forage and
Hay
o Vetch Forage and Hay
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
Must Addi-
Does EPA Bibliographic tional Data
Have Data? Citation Be Submitted?
No Yesl21/
No Yes122/
No yes*23/
No Yes124/
No Yes*25/
No yes126/
Time Frame
for Sub-
missionV
18 months3/
6 months
18 monthsV
18 months3/
18 months3/
18 monthsV
- Miscellaneous Commodities
o Asparagus
o Avocados
TEP
TEP
No Yes127/
No YesTW
18 months3/
18 months?/
(Continued)
68
-------
GENERIC DATA REQUIREMENTS FOR MALATHION.
Data Requirement
171-4. Magnitude of the Residue
in Plants (Continued).
o Cottonseed
(processed)
o Dates
o Figs
(processed)
o Flax - (processed)
o Guavas
o Hops
o Mangoes
o Mint
(processed)
o Mushrooms
o Okra
o Papayas
o Passion Fruit
o Peanuts
o Pineapples
(processed)
o Safflower Seed
(processed)
o Watercress
o Tobacco
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
PAIRA
Does EPA
Have Data?
No
No
No
No
No
Partially
No
No
No
Partially
No
No
No
No
No
No
No
Must Addi-
Bibliographic tional Data
Citation Be Submitted?
Yes129/
Yes"770"/
Yes171"/
Yes172"/
Yes173"/
Yes175"/
YesTTEr/
00113118 Yes176"/
Yes177/
Yes175"/
Yes179"/
YesT5D-/
00100020,00108941 Yes1"51"/
Yes1^2"/
Yes1^57/
YesT*3"/
Yesr?5y
Yes1^"/
YesT*7/
Yes1"3*/
Yes1^*/
Yes130"/
Time Frame
for Sub-
mission1 /
18 months3/
24 months7/
18 months7/
18 months7/
24 months7/
24 months7/
18 months7/
18 months7/
18 months7/
18 months7/
24 months7/
^f 1
18 months J/
18 months7/
18 months7/
18 months7/
18 months7/
18 months7/
^T /
24 months-1/
18 months7/
24 months7/
18 months7/
18 months7/
(Continued).
69
-------
GENERIC DATA REQUIREMENTS FOR MALATHION.
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Addi-
tional Data
Be Submitted?
Time Frame
for Sub-
mission1 /
171-4.
171-4.
171-4.
171-4.
Magnitude of the Residue
in Stored Raw Agricultural
and Processed Commodities
- Almonds TEP
- Barley TEP
- Citrus pulp TEP
- Corn TEP
- Oats TEP
- Peanuts TEP
- Raisins TEP
- Rice TEP
- Rye TEP
- Sorghum TEP
- Sunflower TEP
- Wheat TEP
- Cattle feed
concentrate blocks TEP
Magnitude of the Residue PAIRA,EP
Resulting from Treatment
of Food Handling Estab-
lishments
Magnitude of the Residue TEP
in Drinking and Irrigation
Water
Magnitude of the Residue
in Fish and Shellfish
TEP
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
Yes1 51 /
Yes"152"/
Yes133"/
Yes13*/
YesT5F/
40397201
YesT507
Yes^1"/
YesT57/
No
Yes163/
Yes164/
Reserved165/
24 monthsV
24 months3/
24 months^/
24 months3/
24 months^/
24 months^/
24 months3/
24 months^/
24 months-^/
12 months
15 months3/
(Continued).
70
-------
GENERIC DATA
FOR MALATHION.
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Addi-
tional Data
Be Submitted?
Time Frame
for Sub-
mission1/
171-4. Magnitude of the Residue
in Meat/Milk/Poultry/Eggs
- Fat, meat, and meat
by-products of cattle,
goats, hogs, horses,
and sheep
- Milk
- Poultry and Eggs
Partially 00082336,00113120, Reservedl66/
00113191,00120105
Partially 00005309,05006630, Reservedl67/
00034461,00088051,
00089255,00089562,
00113101,00113175,
00120105
Partially 00108941,00113234, Reservedl68/
00113236
(footnotes follow.)
71
-------
S158.125 Residue Chanistry (cont'd)
j/ Due dates refer to number of "tooths following receipt of this Registration Standard or as otherwise
indicated.
2/ Data are required on the uptake, distribution, and metabolism of [32P], !35S] (thiolo oroup S), or
(14c]malathion( Ithio C-l] labeled) in alfalfa, cotton, soybeans, and either wheat or rice following foliar
applications at a rate sufficiently high to permit residue identification. The identities and quantities of
residues in or on nature nlant parts must be determined in order to elucidate the terminal residues. Residue
information Must be confirmed by a Method such as GC, HPLC, and/or mass spectrometry. Data reflecting solvent
extraction of malathion residues mist also be represented. Representative sables from these tests must also
be analyzed by appropriate enforcement methods to ascertain that these methods are adequate for determining
all metabolites of concern,
V A prooress report is due twelve months after receipt of this Standard.
V Metabolism studies are required utilizing ruminants and poultry. Animals must be dosed orally for a minimum
of 3 days with either [32pj or 1*&S\ (thiolo qroup S) or [ Hcjmalathion ((thio C-l]-labeled) at a level
sufficient to make residue identification and quantification possible. Milk and eggs must be collected twice
daily during the dosing period. Animals must be sacrificed within 24 hours of the final dose. The distributi
and identity of residues must be determined in milk, eggs, liver, kidney, muscle, and fat. Metabolism studies
reflecting direct animal treatment must be conducted using cattle, poultry, and swine. Animals must be
sprayed daily for 28 days using either [32p] or [35SJ (thiolo group S) or [Hcjmalathion ((thio C-1J-
labeled at a rate sufficiently highly to permit complete characterization of He-residues in muscle, fat,
liver, kidney, milk, eggs, and swine skin. Eggs and milk must be collected twice daily throughout the treatme
period and animals nust be sacrificed with 24 hours of the final application. Representative samples from
these tests described must be analyzed using current enforcement methods to determine the usefulness of
these methods for residue analysis of animal commodities. Should the metabolism of malathion in ruminants
and/or poultry following oral dosing differ significantly from that in rats, swine metabolism data may also
be requited,
V Additional methods, validation data, and residue data (for representative commodities) are required via this
Standard if the metabolism studies requested in the sections entitled "Nature of the Residue in Plants" and
•nature of the Residue in Animals' indicate that additional metabolites constitute residues of lexicological
concern in plants or animals.
72
-------
§158.125 Residue Chegistry (cont'd)
— *°fl*Port cr°P residue data, storage stability studies Must be finnA»n«-ari on both weathered ca^pio? and
fortified frozen saMples of one representative crop froM each crop grouping (40 CFR 180.34) on which
registered uses of Malathion exist. Analyses of each crop Must be conducted over a tiMe period that
Includes the time interval that the raw agricultural ccMModity is held on frozen storage prior to the
crop residue analysis. To support residue data on processed coMModities, fortified storage stability
data are required for all processing studies suMritted to the Agency. Analyses Must be conducted over
at tiMe period that includes the frozen storage of the raw agricultural ccMModity prior to processing
and each processed ccMMOdity prior to the residue analysis. Protocols Must be submitted to the Agency ninety
(90) days after receipt of this Botioe.
(a) Storage stability data using weathered sables. Data are required on the parent compound in Which
crop saaples field treated with a typical end-use product are frozen iaaodiatoly upon harvesting, the
integrity of the samples mast be Maintained by freezing, the saaples Must be analyzed for •alathion
the day they arrive at the analytical laboratory, and then stored frozen and analyzed periodically for
•alathion during the tiMe intervals specified in the Agency approved protocols.
(b) Storage stability data using fortified ajMples. Data are required on •alathion and Metabolites of
concern in Which a group of untreated saaples of raw agricultural ccMcdities and process crops
are fortified (spiked) with only •alathion (pure active ingredient) and other groups are fortified
individually with each Metabolite of concern. iMMediately after fortification, the samples
fortified with •alathion Must be analyzed for •alathion and samples fortified with other Metabolites
of concern Must be analyzed for only the Metabolite with which the saMple was fortified. SaMple
integrity Must be Maintained by freezing, and analyses for Malathion and Metabolites Must be conducted
during the tiMe intervals specified in the Agency approved protocols.
Storage stability data for livestock/poultry feeding studies. If cattle and poultry feeding studies are
required, fortified storage stability studies will be required on all aniMal ooMMOdities (i.e., tissues,
•ilk, and eggs) for which residue data are submitted to the Agency. Analyses Must be conducted over a
tiMe period that includes the tiMe interval that each coMModity is held in frozen storage prior to
residue analyses.
If the requested MetabolisM studies indicate the presence of additional residues of toxioological concern in
plant or aniMal ooMMOdities, data depicting the stability of such residues in storage will be required.
73
-------
§158.125 Residue Chemistry (cont'd)
"li A crop group tolerance is not appropriate at this time because adequate residue data are not available for
representative crops of this group (potatoes, carrots, and sugar beets) and the metabolism of malathion in
plants is not adequately understood.
8/ Residue data are required to determine malathion residues of concern in or on beets. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule to
be tested on beets; or b) indicate support of the use of turnips and request that the required data for
that use pattern be used to support the use on beets.
£/ Residue data are required to determine malathion residues of concern in or on carrots. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on carrots; or b) indicate support of the use of turnips and request that the required data for that
use pattern be used to support the use on carrots. Note that the translated data may not be used to support
a crop group tolerance. To support a crop group tolerance, a D, the 25% WP, and an EC formulation must be
applied to carrots (each in a separate test) at 2 Ib ai/A. Samples must be collected 7 days following
multiple foliar applications. The registrant must propose a maximum number of applications per season and
the requested data must reflect this maximum number. Tests must be conducted in CA, FL, and TX.
In addition, data are required to determine malathion residues of concern in or on carrots harvested 7 days
following multiple foliar applications (using ground and aerial equipment in separate tests) of the 25%
WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A.
Ground applications must be made in at least 75 gal/A and aerial applications must be in a minimum of
10 gal/A. The number of applications in the required tests must reflect either the maximum number
proposed by the registrant to appear on the federal labels or a maximum number proposed for this use
in CA. Alternatively, the registrant may elect to cancel these uses permitted under EPA SUJ Nos.
CA810071, CA810052, CA810053, CA810054, and CA810055.
10/ Residue data are required to determine malathion residues of concern in or on horseradish. The registrant
must contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on horseradish; or b) indicate support of the use on turnips and request that the required data
for that use pattern be used to support the use on horseradish.
ll/ Residue data are required to determine malathion residues of concern in or on parsnips. The registrant
must contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: 1) request a determination of the specific formulations, rates, and application schedule
74
-------
§158.125 Residue Chemistry (cont'd)
to be tested on parsnips; or b) indicate support of the use on turnips and request that the required data for
that use pattern be used to support the use on parsnips.
12/ Data are required to determine malathion residues of concern in or on potatoes harvested on the day of the
last multiple foliar applications of a D and EC formulation (each in separate tests) at 3 Ib ai/A, and
the 25% WP formulation at 2.5 Ib ai/A. The registrant must propose a maximum number of applications
per season or maximum seasonal use rate, and the requested data must reflect the proposed maximum rate.
Tests must be conducted in ID and ME. Data are required to determine malathion residues of concern
in or on greenhouse grown potatoes harvested 7 days following the last the multiple foliar application of
the 50% EC formulation at 0.18 oz ai/gal.
Data are also required to determine malathion residues of concern in or on potatoes harvested immediately
following the last multiple foliar application (using ground and aerial equipment in separate tests) of
the 25% WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A.
Ground applications must be made in at least 75 gal/A and aerial applications must be made in a minimum of 10
gal/A. The number of applications in the required tests must reflect either the maximum number proposed by
the registrant to appear on the federal labels or a maximum number proposed for this use in CA. Tests must
be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted under EPA SLK
Nbs. CA810051, CA810052, CA810053, CA810054, and CA810055.
13/ Data are required to determine the potential for concentration of malathion residues in potato chips,
granules flakes, wet peel, and dry peel during the processing of treated potatoes bearing measurable,
weathered residues. If the data indicate a potential for residue concentration in any of these commodities,
the registrant must propose appropriate food/feed additive tolerances.
14/ Data are required to determine malathion residues of concern in or on greenhouse-grown radishes resulting
from multiple foliar applications of the 25% WP and (in a separate test) the 5 Ib/gal EC formulation at 1.25
Ib ai/100 gal, and, in a separate test, the 10% RTU formulation at 16.7 fl oz/product/50,000 cu ft as a fog.
Field residue data are required to determine malathion residues of concern in or on radishes. The registrant
must contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on winter squash; or b) indicate support of the use on turnips and request that the required
data for that use pattern be used to support the use of radishes.
15/ Data are required to determine malathion residues of concern in or on rutabagas. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on rutabagas; or b) indicate support of the use on turnips and request that the required data for
that use pattern be used to support the use on rutabagas.
75
-------
§158.125 Residue Chemistry (cont'd)
_ Data are required to determine malathion residues of concern in or on salsify. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on salsify; or b) indicate support of the use on turnips and request that the required data for
that use pattern be used to support the use on salsify.
_ ' Data are required to determine malathion residues of concern in or on sugar beets harvested 3 days
following each of the following applications (in separate tests): (i) a D formulation at 2 Ib ai/A; (ii)
an E or SC/L formulation at 2.5 Ib ai/A; and (iii) an RTU formulation at 0.61 Ib ai/A using ULV equipment.
Each formulation must be applied using ground and aerial equipment in separate tests. Tests must be in CA,
ID, MN, and ND) The registrant must propose a maximum number of application per season or a maximum
seasonal use rate. The requested data must reflect the proposed maximum rate.
Data are also required to determine malathion residues of concern in or on sugar beets harvested 3 days
following multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP
formulation and (in a separate test) the 5 Ib/gal, or 57% EC formulation at 3 Ib ai/A. Ground applications
must be made in at least 75 gal/A and aerial applications must be made in a minimum of 10 gal/A. The
number of applications in the required tests must reflect either the maximum number proposed by the registrant
to appear on the federal labels or a maximum number proposed for this use in CA. Tests must be conducted
in CA. Alternatively, the registrant may elect to cancel these uses permitted under EPA SLN Nos. CA810051,
CA810052, CA810053, CA810054, and CA810055.
18/ Data are required to determine the concentration of malathion residues in molasses, dehydrated pulp, and
refined sugar processed from sugar beets bearing measurable, weathered residues. If the data indicate a
potential for concentration of residues in any of these processed commodities, appropriate food/ feed additive
tolerances must be proposed.
2£/ Data are required to determine malathion residues of concern in or on sweet potatoes. The registrant
must contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on sweet potatoes; or b) indicate support of the use on turnips and request that the required
data for that use pattern be used to support the use on sweet potatoes.
20 / Data are required to determine malathion residues of concern in or on turnips harvested 3 days following
the last of multiple foliar applications of a D and the 25% WP formulations at 2.5 Ib ai/A and an EC
formulation a 3 Ib ai/A. Each formulation must be applied in a separate test. Tests must be conducted in
CA, GA, PA, and TX. The registrant must propose a maximum number of applications per season or maximum
seasonal use rate. Requested data must reflect the proposed maximum rate. The requested data may also be
used to support the uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
76
-------
§158.125 Residue Chemistry (oont'd)
2V A crop group tolerance is not appropriate at this time because adequate residue data are not available for
representative crops of this group (sugar beet tops and turnip tops) and the metabolism of raalathion in
plants is not adequately understood.
22/ Data are required to determine malathion residues of concern in or on beet greens. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on beet greens; or b) indicate support of the use on turnips tops and request that the required data
for that use pattern be used to support the use on beet greens.
23/ Data are required to determine malathion residues of concern in or on salsify tops. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on salsify tops; or b) indicate support of the use on turnips tops and request that the required
data for that use pattern be used to support the use on salsify tops.
24/ Data are required to determine malathion residues of concern in or on sugar beet tops harvested 7 days
following the last of multiple foliar applications of (in separate tests): (i) a D formulation at 2 Ib ai/A;
(ii) an EC and SC/L formulation at 2.5 Ib ai/A; and (iii) a FTU formulation at 0.61 Ib ai/A using ultra-low-
volume equipment. Each formulation must be applied using ground and aerial equipment in separate tests.
Tests must be conducted in CA, ID, MN, and ND. The registrant must propose a maximum number of applications
per season or maximum seasonal use rate, and requested data must reflect this number.
Data are also required to determined malathion residues of concern in or on sugar beet tops harvested 7
days following multiple foliar applications (using ground and aerial equipment in separate tests) of the
25% WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A.
The number of applications in the required tests must reflect either the maximum number proposed by the
registrant to appear on the federal labels or a maximum number proposed for this use in CA. Alternatively
the registrant may elect to cancel these uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053,
CA810054, and CA810055.
25/ Data are required to determine malathion residues of concern in or on turnip tops harvested 3 days
following multiple foliar applications of a D and the 25% WP formulations at 2.5 Ib ai/A and an EC formulation
at 3 Ib ai/A. Each formulation must be applied in a separate test. Tests must be conducted in CA, GA, PA,
and TX. The registrant must propose a maximum number of applications per season or maximum seasonal use
rate, and the required data must reflect the proposed maximum rate. These data will also support the uses
permitted under EPA SIN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
77
-------
§158.125 Residue Chemistry (cont'd)
—/ A crop group tolerance is not appropriate at this time because adequate residue data are not available for
representative crops of this group (dry bulb onions, green onions, and one other group member) and the
metabolism of malathion in plants is not adequately understood.
' Data are required to determine malathion residues of concern in or on garlic. The registrant must contact
the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and either
a) request a determination of the specific formulations, rates, and application schedule to be tested on
garlic; or b) indicate support of the use on onions and request that the required data for that use
pattern be used to support the use on garlic.
' Residue data are required to determine malathion residues of concern in or on leeks. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicting intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on leeks; or b) indicate support of the use on onions and request that the required data
for that use pattern be used to support the use on leeks.
Data are required to determine of malathion residues of concern in or on onions harvested 3 days following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP formulation
and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulations at 3 Ib ai/A. Ground applications
must be made in at least 75 gal/A and aerial applications must be made in a minimum of 10 gal/A. The
number of applications in the required tests must reflect either the maximum number proposed by the
registrant to appear on the federal labels or a maximum number proposed for this use in CA. Tests must be
conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted under EPA SLN
Nos. CA810051, CA810052, CA810054, and CA810055.
Data are required to determine malathion residues of concern in or on onions (green and bulb) harvested 3
days following multiple foliar applications of a D, the 25% WP, and an EC formulation (each in a separate
test) at 2 Ib ai/A. The registrant must propose a. maximum number of applications per season or a maximum
seasonal use rate, and the requested data must reflect the proposed maximum rate. Tests must be conducted
in CA or OR, CO, NY, and TX.
Data are also required to determine malathion residues of concern in or on greenhouse-grown onions harvested
3 days following foliar application of the 50% EC formulation at 0.18 oz ai/gal. The registrant must
propose a maximum number of applications per season or a maximum seasonal use rate. Requested data must
reflect the proposed maximum rate.
78
-------
§158.125 Residue Chemistry (cont'd)
30/ Data are required to determine raalathion residues of concern in or on shallots. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on shallots; or b) indicate support of the use on onions and request that the required
data for that use pattern be used to support the use on shallots.
31 / A crop group tolerance is not appropriate at this time because adequate residue data are not available
for representative crops of this group (celery, lettuce, and spinach) and the metabolism of malathion
in plants is not adequately understood.
32/ Data are required to determine malathion residues of concern in or on celery collected 7 days following
multiple foliar application of (i) a D, (ii) the 25% WP, and (iii) an EC formulation at 1.5 Ib ai/A in
separate tests. The registrant must propose a maximum seasonal rate or number of applications, and
the requested data must reflect this number or rate. Tests must be conducted in CA and FL.
Data are required to determine malathion residues of concern in or on greenhouse-grown celery harvested
7 days following multiple foliar applications of the 50% EC formulation at 0.18 oz ai/gal.
Data are also required to determine malathion residues of concern in or on celery harvested 7 days
following multiple foliar applications (using ground and aerial equipment in separate tests) of the
25% WP formulation and the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A in separate tests.
Ground applications must be made in at least 75 gal/A and aerial applications must be made in a
minimum of 10 gal/A. The number of applications in the required tests must reflect either the maximum
number proposed by the registrant to appear on the federal labels or a maximum number proposed for
this use in CA. Tests must be conducted in CA. Alternatively, the registrant may elect to cancel
these uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
33/ Data are required to determine malathion residues of concern in or on dandelions. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support
this use, and either: a) request a determination of the specific formulations, rates, and application
schedule to be tested on dandelions; or b) indicate support of the use on spinach and request that
the required data for that use pattern be used to support the use on dandelions.
34/ Data are required to determine malathion residues of concern in or on endive. The registrant
must contact the Agency, within the allowed ninety (90) day period for indicating intention to support
this use, and either: a) request a determination of the specific formulations, rates, and application
schedule to be tested on endive; or b) indicate support of the use on lettuce and request that
the required data for that use pattern be used to support the use on endive.
79
-------
§158.125 Residue Chemistry (cont'd)
J Data are required to determine malathion residues of concern in or on head lettuce and leaf lettuce
harvested 7 and 14 days, respectively, following multiple foliar applications of a D formulation at 4 Ib
ai/A and, in separate tests, the 25% WP formulation at 2 Ib ai/A. The registrant must propose a
maximum number of applications per season or a maximum seasonal application rate. The requested data
must reflect this maximum application rate or number. Tests must be conducted in CA.
Data are also required to determine malathion residues of concern in or on head lettuce and leaf
lettuce harvested 7 days and 14 days, respectively, following multiple foliar applications (using
ground and aerial equipment in separate tests) of the 25% WP formulation and, in a separate test, the
5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A. Ground applications must be made in at least
75 gal/A and aerial applications must be made in a minimum of 10 gal/A. The seasonal rate or number
of applications in the required tests must reflect either that proposed by the registrant on the federal
labels or a maximum seasonal rate or number proposed for this use in CA. Tests must be conducted in
CA. Alternatively, the registrant may elect to cancel these uses permitted under EPA SLN Nos. CA810051,
CA810052, CA810053, CA810054, and CA810055.
36/ Data are required to determine malathion residues of concern in or on parsley. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support
this use, and either: a) request a determination of the specific formulations, rates, and application
schedule to be tested on parsley; or b) indicate support of the use on* spinach and request that the
required data for that use pattern be used to support the use on parsley.
37/ Data are required to determine malathion residues of concern in or on spinach harvested 7 days following
multiple foliar applications of the 25% WP formulation at 2 Ib ai/A. The registrant must amend all
pertinent labels to specify a maximum number of applications per season or a maximum seasonal application
rate. The requested data must reflect this maximum number or rate. We note that the available data
support a maximum of five applications per season at 2 Ib ai/A or a maximum seasonal rate of 10 Ib
ai/A. Tests must be conducted in CA, NJ, and TX, or its neighboring state of OK.
Data are also required to determine malathion residues of concern in or on spinach harvested 7 days
following multiple foliar applications (using ground and aerial equipment in separate tests) of the
25% WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib
ai/A. Ground applications must be made in at least 75 gal/A and aerial applications must be made in
a minimum of 10 gal/A. The seasonal rate or number of applications in the required tests must reflect
that proposed by the registrant on the federal labels or a maximum seasonal rate or number proposed
for this use in CA. Tests must be conducted in CA. Alternatively, the registrant may elect to
cancel these uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
80
-------
§158.125 Residue Chemistry (cont'd)
Data are required to determine malathion residues of concern in or on Swiss chard. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on Swiss chard; or b) indicate support of the use on spinach and request that the required
data for that use pattern be used to support the use on Swiss chard.
39/ A crop group tolerance is not appropriate at this time because adequate residue data are not available for
representative crops of this group (broccoli, cabbage, and mustard greens) and the metabolism of malathion
in plants is not adequately understood.
Data are required to determine malathion residues of concern in or on broccoli harvested 3 days following
multiple foliar applications of the 25% WP formulation at 2.5 Ib ai/A and (in a separate test) an EC
formulation at 3 Ib ai/A. Tests must be conducted in CA. The registrant must propose a maximum number
of applications per season or a maximum seasonal application rate. The requested data must reflect
this maximum rate.
Data are required to determine malathion residues of concern in or on greenhouse-grown broccoli harvested
3 days following foliar application of the 50% EC formulation at 0.18 oz ai/gal.
Data are also required to determine malathion residues of concern in or on broccoli harvested 3 days
following multiple foliar applications (using ground and aerial equipment in separate tests) of the 25%
WP and, in a separate test, an EC formulation at 3 Ib ai/A. Ground applications must be made in at
least 75 gal/A and aerial applications must be made in a minimum of 10 gal/A. The maximum seasonal
rate or number of applications in the required tests must reflect either that proposed by the registrant
on the federal labels or a maximum seasonal rate or number proposed for this use in CA. Tests must be
conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted under EPA SLN
Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
41 / Data are required to determine malathion residues of concern in or on Brussels sprouts. The registrant
must contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: a) request a determination of the specific formultions, rates, and application schedule
to be tested on Brussels sprouts; or b) indicate supprt of the use on broccoli and request that the
required data for that use pattern be used to support the use on Brussels sprouts.
42/ Data are required to determine malathion residues of concern in or on cabbage harvested 7 days following
multiple foliar applications of a D and (in a separate test) the 25% WP formulation at 2.5 Ib ai/A. Tests
must be conducted in CA, FL, NY, TX, and WI^The registrant must propose a maximum number of applications
per season or a maximum seasonal application rate." The requested data must reflect this maximum rate. We
81
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§158.125 Residue Chemistry (cont'd)
note that the available data support a maximum of five applications of an EC formulation or a maximum
seasonal rate of 12.5 Ib ai/A. These data may be used to support applications permitted in CA under
EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
Data are also required to determine malathion residues of concern in or on greenhouse-grown cabbage
harvested 7 days following multiple foliar applications of the 50% EC formulation at 0.18 oz ai/gal.
Data are required to determine malathion residues of concern in or on cabbage harvested 7 days following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP and,
in a separate test, an EC formulation at 3 Ib ai/A. Ground applications must be made in at least 75
gal/A and aerial applications must be made in a minimum of 10 gal/A. The maximum seasonal rate or
number of applications in the required tests must reflect either that proposed by the registrant
on the federal labels or a maximum seasonal rate or number proposed for this use in CA. Tests
must be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted
under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
Data are required to determine malathion residues of concern in or on cauliflower. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determinataion of the specific formulations, rates, and application schedule
to be tested on cauliflower; or b) indicate support of the use on broccoli and request that the
required data for that use pattern be used to support the use on cauliflower.
44 / Data are required to determine malathion residues of concern in or on collards. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determinataion of the specific formulations, rates, and application schedule
to be tested on collards; or b) indicate support of the use on mustard greens and request that the
required data for that use pattern be used to support the use on collards.
45/ Data are required to determine malathion residues of concern in or on kale. The registrant must contact
the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determinataion of the specific formulations, rates, and application schedule to
be tested on kale; or b) indicate support of the use on mustard greens and request that the required
data for that use pattern be used to support the use on kale.
Data are required to determine malathion residues of concern in or on kohlrabi. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determinataion of the specific formulations, rates, and application schedule
to be tested on kohlrabi; or b) indicate support of the use on broccoli and request that the required
data for that use pattern be used to support the use on kohlrabi.
82
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§158.125 Residue Chemistry (cont'd)
_f Data are required to determine malathion residues of concern in or on mustard greens harvested 7 days
following multiple foliar applications of a D and the 25% WP formulation (each in a separate test) at
2.5 Ib ai/A and (in a separate test), an EC formulation at 3 Ib ai/A. Tests must be conducted in
AZ, CA, NCf and TX. The registrant must propose a maximum number of applications per season or a
maximum seasonal application rate.
Data are required to determine malathion residues of concern in or on greenhouse-grown mustard greens
harvested 7 days following multiple foliar applications of the 50% EC formulation at 0.18 oz ai/gal.
Data are also required to determine malathion residues of concern in or on mustard greens harvested 7
days following multiple foliar applications (using ground and aerial equipment in separate tests) of
the 25% WP and, in a separate test, an EC formulation at 3 Ib ai/A. Ground applications must be made
in at least 75 gal/A and aerial applications must be made in a minimum of 10 gal/A. The maximum
seasonal rate or number of applications in the required tests must reflect either that proposed by
the registrant on the federal labels or a maximum seasonal rate or number proposed for this use in
CA. Tests must be conducted in CA. Alternatively, the registrant may elect to cancel these uses
permitted under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
& crop group tolerance is not appropriate at this time because adequate residue data are not
available for representative crops of this group (beans, peas, and soybeans) and the metabolism
of malathion in plants is not adequately understood.
Data are required to determine malathion residues of concern in or on succulent and dried beans harvested
1 day following multiple foliar applications of a D and the 25% WP formulation (in separate tests) at 1.75
Ib ai/A. Tests must be conducted in CA, OR or ID, MI or WI, NE, and NY. The registrant must propose
a maximum number of applications per season or a maximum seasonal use rate. The requested data must
reflect this maximum rate. We note that the available data support five applications of an EC formulation
per season or a total seasonal rate of 10 Ib ai/A.
Data are required to determine malathion residues of concern in or on greenhouse-grown beans harvested
1 day following foliar application of the 50% EC formulation at 0.18 oz ai/gal.
Data are also required to determine residues of concern in or on beans harvested 1 day following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP
formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A.
Ground applications must be made in at least 75 gal/A and aerial applications must be made in a
83
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§158.125 Residue Chemistry (oont'd)
minimum of 10 gal/A. The number of applications in the required tests must reflect either the maximum
number proposed by the registrant to appear on the federal labels or a maximum number proposed for
this use in CA. Tests must be conducted in CA. Alternatively, the registrant may elect to cancel
these uses permitted under EPA SLN Nos. GA810051, CA810052, CA810053, CA810054, and CA810055.
Since bean vines and bean hay are raw agricultural commodities, the registrant must propose tolerances
for residues of malathion in or on bean vines and hay and submit appropriate supporting residue
data. Alternatively, the registrant may propose a label amendment that restricts feeding or grazing
treated bean vines and bean vine hay by livestock.
5°/ Data are required to determine malathion residues of concern in or on lentils grown from seed treated
with the 34% F1C formulation at 0.06 Ib ai/100 Ib of seed. The test must be conducted in WA. Alternatively,
the registrant may elect to cancel this use permitted under EPA SLH No. WA780017.
Since lentil forage and hay are raw agricultural commodities, the registrant must propose tolerance for
residues of malathion in or on lentil forage and hay and submit appropriate supporting residue data.
Alternatively the registrant may propose a label restriction prohibiting the feeding or grazing of
lentil forage or hay.
51/ Data are required to determine malathion residues of concern in or on lupine seed harvested on the day
of the last of multiple foliar applications of an EC formulation at 1.25 Ib ai/A. Tests must be
conducted in EL, GA, or SC. Alternatively, the registrant may propose a 1-day preharvest interval
(PHI), and indicate support of the use of beans and request that the required data for that use
pattern be used to support the use on lupine seed. The registrant must contact the Agency within
ninety (90) days to indicate intent.
52/ Data are required to determine malathion residues of concern in or on peas collected 3 days following
multiple foliar applications of (i) a D formulation at 2.5 Ib ai/A; (ii) the 25% WP formulation at 1.75 Ib
ai/A; and (iii) an EC formulation at 2.5 Ib ai/A. Each formulation must be applied in a separate
test. The registrant must propose a maximum number of applications per season or a maximum seasonal
application rate. The requested data must reflect this maximum rate. Tests must be conducted in
MN or WI and WA.
Data are also required to determine malathion residues of concern in or on peas harvested 3 days
following multiple foliar applications (using ground and aerial equipment in separate tests) of the
25% WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib
ai/A. Ground applications must be made in at least 75 gal/A and aerial applications must be made in
a minimum of 10 gal/A. The number of applications in the required tests must reflect either the
84
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§158.125 Residue Chemistry (cont'd)
maximum number proposed by the registrant to appear on the federal labels or a maximum number proposed
for this use in CA. Tests must be conducted in CA. Alternatively, the registrant may elect to cancel
these uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
' Data are required to determine malathion residues of concern in or on soybeans harvested 7 days following
the last of multiple foliar applications of a D, the 25% WP, the 95% SC/L, and an EC formulation (each applied
in a separate test) at 2 Ib ai/Ar and multiple foliar applications of an RTU formulation (9.3-9.7 Ib/gal)
using DLV equipment at 0.6 Ib ai/A. The registrant must propose a maximum number of applications per
season or a maximum seasonal rate for each of these uses. The requested data must reflect these maximum
rates. Tests must be • conducted in IL, IN, IA, MN, or OH.
Data are required to determine the potential for concentration of malathion residues in meal, hulls,
soaps took, crude oil, refined oil, and the resulting grain dust processed from soybeans bearing measurable,
weathered residues. If the data indicate a potential for concentration of residues in any of these
processed commodities, appropriate food/ feed additive tolerances must be proposed.
crop group tolerance is not appropriate at this time because adequate residue data are not available for
representative crops of this group (pea vines and hay and soybean forage and hay) and the metabolism of
malathion in plants is not adequately understood.
56 / Data are required to determine malathion residues of concern in or on cowpea forage and hay harvested on
the day of the last of multiple foliar applications of an EC formulation at 1.25 Ib ai/A. The registrant
must propose a maximum number of applications per season or maximum seasonal application rate. The
requested data must reflect the maximum rate. Tests must be conducted in CA and TX.
Data are also required to determine malathion residues of concern in or on cowpea forage and hay harvested
immediately following multiple foliar applications (using ground and aerial equipment in separate
tests) of the 25% WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation
at 3 Ib ai/A. Ground applications must be made in at least 75 gal/A and aerial applications must be
made in a minimum of 10 gal/A. The number of applications in the required tests must reflect either
the maximum number proposed by the registrant to appear on the federal labels or a maximum number
proposed for this use in CA. Tests must be conducted in CA. Alternatively, the registrant may elect
to cancel these uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
Since cowpea seed is a raw agricultural commodity, the registrant must propose a tolerance and submit
appropriate supporting residue data.
•
85
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S158.125 Residue Chemistry (cont'd)
57/ Data are required to determine malathion residues of concern in or on pea vines and hay harvested 7 days
following the last of multiple foliar applications of a D formulation at 2.5 Ib ai/A, the 25% WP formulation
at 1.75 Ib ai/A, and an EC formulation at 2.5 Ib ai/A, each formulation applied in a separate test; and
data to determine malathion residues in or on peavine hay harvested 14 days following the last of
multiple ULV applications using an RTU formulation (9.3-9.7 Ib/gal) at 0.6 Ib ai/A. The registrant
must propose a maximum number of applications per season or a maximum seasonal application rate for
each use and the requested data must reflect these maximum rates. Tests must be conducted in (1) WA and
(2) MN or WI.
Data are also required to determine malathion residues of concern in or on pea vines and hay harvested
7 days following multiple foliar applications (using ground and aerial equipment in separate tests) of
the 25% WP formulation at 3 Ib ai/A. Ground applications must be made in at least 75 gal/A and aerial
applications must be made in a minimum of 10 gal/A. The number of applications in the required tests
must reflect either the maximum number proposed by the registrant to appear on the federal labels or
a maximum number proposed for this use in CA. Tests must be conducted in CA. Alternatively, the
registrant may elect to cancel these uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053,
CAR 10054, and CA810055.
58/ Data are required to determine malathion residues of concern in or on soybean forage and hay harvested 7
days following the last of multiple foliar applications of a D, the 25% WP, the 95% SC/L, and an EC
(each applied in a separate test) at 2 Ib ai/A, and multiple foliar applications of an PTU formulation
formulation (9.3-9.79 Ib/gal) using ULV equipment at 0.6 Ib ai/A. The registrant must propose a maximum
number of applications per season or a maximum seasonal rate for each of these uses. The requested
data must reflect these maximum rates. Tests must be conducted in IL, IN, IA, MN, or OH.
Data are also required to determine malathion residues of concern in or on soybean forage and hay
harvested 7 days following multiple foliar applications (using ground and aerial equipment in separate
tests) of the 25% WP formulation at 3 Ib ai/A. Ground applications must be made in at least 75 gal/A
and aerial applications must be made in a minimum of 10 gal/A. The number of applications in the
required tests must reflect either the maximum number proposed by the registrant to appear on the
federal labels or a maximum number proposed for this use in CA. Tests must be conducted in CA.
Alternatively, the registrant may elect to cancel these uses permitted under EPA SLN Nos. CA810051,
CA810052, CAS 10053, CA810054, and CA810055.
Since soybean straw is a raw agricultural commodity, the registrant must propose a tolerance and
submit appropriate supporting residue data or propose a feeding restriction.
86
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S158.125 Residue Chemistry (cont'd)
59/ A crap group tolerance is not appropriate at this time because adequate residue data are not available
for representative crops of the group (peppers and tomatoes) and the metabolism of malathion in plants
is not adequately understood.
60/ Data are required to determine malathion residues of concern in or on eggplants. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on eqgplants; or b) indicate support of the use on tomatoes and request that the required
data for that use pattern be used to support the use on eggplants.
61/ Data are required to determine malathion residues of concern in or on peppers. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and applications schedule
to be tested on peppers; or b) indicate support of the use on tomatoes and request that the required
data for that use pattern be used to support the use on peppers. Note that translated data may not
be used to support a crop group tolerance. Data to determine malathion residues of concern in or on
peppers harvested 3 days following multiple foliar applications of D, WP, and EC formulations at 1.5
Ib ai/A are required to support a crop group tolerance. Tests must be conducted in CA, PL, NC, and
TX.
The registrant must propose a maximum number of applications per season or a maximum seasonal application
rate. In addition, data are required to determine malathion residues of concern in or on peppers
harvested 3 days followinq multiple foliar applications (using ground and aerial equipment in a
separate test) of the 25% WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC
formulation at 3 Ib ai/A. Ground applications must be made in at least 75 gal/A and aerial applications
must be made in a minimum of 10 gal/A. Tests must be conducted in CA. The number of applications in
the required tests must reflect either the maximum number proposed by the registrant to appear on the
federal labels or a maximum number proposed for this use in CA. Alternatively, the registrant may
elect to cancel these uses permitted under EPA SIJJ Nos. CA810051, CA810052, CA810053, CA810054, and
CA810055.
62/ Data are required to determine malathion residues of concern in or on tomatoes following multiple foliar
applications of a D, WP, and an EC formulations at 2.0 Ib ai/A (1-day posttreatment interval) and 3.5
Ib ai/A (5-day interval). Tests must be conducted in (1) CA, (2) FL and (3) MI, NJ, or PA. The
registrant must propose a maximum number of applications per season or a maximum seasonal application
rate, and the requested data must reflect the proposed maximum rate or number of treatments.
Data are also required to determine malathion residues of concern in or on greenhouse-grown tomatoes
harvested 1 day following the last of multiple foliar applications of the 25% WP and (in a separate
test) the 5 Ib/gal EC formulation at 1.25 Ib ai/100 gal, and, in a separate test, the 10% RTU formulation
at 16.7 fl oz product/50,000 cu ft as a fog.
87
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J158.125 Residue Chemistry (cont'd)
Data are required to determine malathion residues of concern in or on tomatoes harvested 3 days following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP
formulation at 3 lb ai/A. Ground applications must be made in at least 75 gal/A and aerial applications
must be made in a minimum of 10 gal/A. Tests must be conducted in CA. The number of applications in
the required tests must reflect either the maximum number proposed by the registrant to appear on the
federal labels or a maximum number proposed for this use in CA. Alternatively, the registrant
may elect to cancel these uses permitted under EPA SLN Nos. CA810051, CA810052, and CA810055.
fi, , v j
_' Data are required to determine the potential for concentration of malathion residues in catsup, juice,
puree, and dry pomace processed from tomatoes bearing measurable, weathered residues. If concentration
occurs during processing, the registrant must propose appropriate food/feed additive tolerances.
4' A crop group tolerance is not appropriate at this time because adequate residue data are not available
for representative crops of the group (cucumbers, summer squash, and melons) and the metabolism of
malathion in plants is not adequately understood.
_**/ Data are required to determine malathion residues of concern in or on cucumbers harvested 1 day following
the last of multiple foliar applications at 7-day intervals of a D formulation at 2.25 lb ai/A and the 25%
WP and an EC formulation each at 1.88 lb ai/A (each formulation must be applied in a separate test).
The registrant must propose a maximum number of applications per season or a maximum seasonal application
rate for each use. Required tests must reflect this maximum rate. Tests must be conducted in CA,
MI, NC, OH, TX, and WI.
Data are required to determine malathion residues of concern in or on greenhouse-grown cucumbers
harvested 1 day following the last of multiple foliar applications of the 25% WP and (in a separate
test) the 5 Ib/gal EC formulation at 1.25 lb ai/100 gal, and, in a separate test, the 10% RTU formulation
at 16.7 fl. oz of product/50,000 cu ft as a fog. The registrant must propose a maximum number of
applications per crop for this use.
Data are also required to determine malathion residues of concern in or on cucumbers harvested 1 day
following multiple foliar applications (using ground and aerial equipment in separate tests) of the
25% WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 lb
ai/A. Ground applications must be made in at least 75 gal/A and aerial applications must be made in
a minimum of 10 gal/A. The number of applications in the required tests must reflect either the
maximum number proposed by the registrant to appear on the federal labels or a maximum number proposed
for this use in CA. Tests must be conducted in CA. Alternatively, the registrant may elect to
cancel these uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
88
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§158.125 Residue Chemistry (cont'd)
Data are required to determine of malathion residues of concern in or on cantaloupes harvested 1 day
following multiple foliar applications at 7-day intervals of a D formulation at 2.25 Ib ai/A and the 25% WP
and EC formulation each at 1.88 Ib ai/A (each formulation must be applied in a separate test). The registrant
must propose a maximum number of applications per season or a maximum seasonal application rate. Required
tests must reflect this maximum rate. Tests must be conducted in CA and TX.
Data are required to determine malathion residues of concern in or on greenhouse-grown cantaloupes
harvested 1 day following multiple foliar applications of the 50% EC formulation at 0.18 oz ai/gal.
The registrant must propose a maximum number of applications per crop and the requested data must
reflect this number.
Data are also required to determine malathion residues of concern in or on cantaloupes harvested 1 day
following multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP
formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A. Ground
applications must be made in at least 75 gal/A and aerial applications must be made in a minimum of 10 gal/A.
The number of applications in the required tests must reflect either the maximum number proposed by the
registrant to appear on the federal labels or a maximum number proposed for this use in CA. Tests must be
conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted under EPA SLN Nos.
CA810051, CA810052, CA810053, CA810054, and CA810055.
Data are required to determine malathion residues of concern in or on pumpkins. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on pumpkins; or b) indicate support of the use on melons and request that the required data for that
use pattern be used to support the use on pumpkins.
68/ Data are required to determine malathion residues of concern in or on squash. The registrant must contact
the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on squash; or b) indicate support of the use on cucumbers and request that the required data for that
use pattern be used to support the use on squash.
69/ A crop group tolerance is not appropriate at this time because adequate residue data are not available for
representative crops of this group (grapefruit, lemons, and sweet oranges) and the metabolism of malathion
in plants is not adequately understood.
89
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§158.125 Residue Chemistry (cont'dj
' Data are required to determine malathion residues of concern in or on grapefruit. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use, an
either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on grapefruit; or b) indicate support of the use on oranges and request that the required data for
that use pattern be used to support the use on grapefruit.
' Data are required to determine malathion residues of concern in or on kumquats. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on kumquats; or b) indicate support of the use on oranges and request that the required data for
that use pattern be used to support the use on kumquats.
' Data are required to determine malathion residues of concern in or on lemons. The registrant must contact
the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on lemons; or b) indicate support of the use on oranges and request that the required data for
that use pattern be used to support the use on lemons. Note that the translated data may not be used to
support a crop group tolerance.
Residue data are required to determine malathion residues of concern in or on limes. The registrant
must contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on limes; or b) indicate support of the use on oranges and request that the required data for
that use pattern be used to support the use on limes.
74/ Data are required to determine malathion residues of concern in or on oranges harvested 7 days following
the last of multiple foliar applications of (in separate tests) the 5% D and an EC formulation at 25 Ib
ai/A, and the 25% WP at 2 Ib ai/100 gal. The registrant must amend all pertinent labels specifying a
maximum Ib ai/A/application rate for use of the 25% WP formulation, and the requested data must reflect
this rate. In addition, the registrant must propose a maximum number of applications per season or a
maximum seasonal application rate, and the requested data must reflect this total rate. Tests must be
conducted in CA and FL.
Data are also required to determine malathion residues of concern in or on oranges harvested 7 days
following multiple foliar applications of the 9.33 Ib/gal RTU formulation using ULV equipment. Ground
and aerial applications must be represented in separate tests. The tests must be conducted in CA at 0.656
Ib ai/A. Tests must also be conducted in TX at 0.175 Ib ai/A. Alternatively, the registrant may elect
to cancel these uses permitted under EPA SLN Nos. CA820007, CA820008, TX830039, and TX830041.
90
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§158.125 Residue Chemistry (cont'd)
75/ Data are required to determine the potential for concentration of malathion residues of concern in
dehydrated citrus pulp, citrus oil, molasses, and juice processed from oranges bearing measurable, weathered
residues. If residues concentrate in any commodity, the registrant must propose an appropriate food/feed
additive tolerance.
76 / Data are required to determine malathion residues of concern in or on tangerines. The registrant
must contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on tangerines; or b) indicate support of the use on oranges and request that the required
data for that use pattern be used to support the use on tangerines.
77/ A crop group tolerance is not appropriate at this time because adequate residue data are not available for
representative crops of this group (apples and pears) and the metabolism of malathion in plants is not
adequately understood.
Data are required to determine malathion residues of concern in or on apples harvested 3 days following
multiple foliar application of a D, the 25% WP, and an EC formulation (each in separate tests) at 3 Ib ai/A,
2 ai/A, and 15 Ib ai/A, respectively. Tests must be conducted in CA, NY, NC or VA, and WA. The registrant
must propose a maximum number of application per season or a maximum seasonal rate for each use. The
requested data must reflect the maximum rate.
Data are also required to determine malathion residues of concern in or on apples harvested 3 days following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP formulation
at 3 Ib ai/A. Ground applications must be made in at least 75 gal/A and aerial applications must be made
in a minimum of 10 gal/A. The number of applications in the required tests must reflect either the maximum
number proposed by the registrant to appear on the federal labels or a maximum number proposed for this use
in CA. Tests must be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted
under EPA SLN Nos. CA810051, CA810052, and CA810055.
79/ Data are required to determine malathion residues of concern in dry apple pomace and juice processed from
apples bearing measurable, weathered residues. If residues concentrate in any of these processed commodities
then an appropriate food/feed additive tolerance must be proposed.
80/ Data are required to determine malathion residues of concern in or on pears harvested 1 day following
multiple foliar applications of the 5% D formulation at 3 Ib ai/A, the 25% WP formulation at 2 Ib ai/A, and an
EC formulation at 15 Ib ai/A (each formulation must be applied in a separate test). Tests must be conducted
in CA and either OR or WA The registrant must propose a maximum seasonal rate or number of applications per
season. The requested data must reflect this maximum.
91
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§158.125 Residue Chemistry (oont'd)
Data are also required to determine malathion residues of concern in or on pears harvested 1 day following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP formulation
at 3 Ib ai/A. Ground applications must be made in at least 75 gal/A and aerial applications must be made
in a minimum of 10 gal/A. The number of applications in the required tests must reflect either the maximum
number proposed by the registrant to appear on the federal labels or a maximum number proposed for this use
in CA. Tests must be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted
under EPA SUI Nos. CA810051, CA810052, and GA810055.
§!/ Data are required to determine malathion residues of concern in or on quinces. The registrant must contact
the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and either
a) request a determination of the specific formulations, rates, and application schedule to be tested on
quinces; or b) indicate support of the use on apples and request that the required data for that use
pattern be used to support the use on quinces.
82/ A crop group tolerance is not appropriate at this time because adequate residue data are not available for
representative crops of this group (cherries, peaches, and plums) and the metabolism of malathion in plants
is not adequately understood.
83/ Data are required to determine malathion residues of concern in or on apricots harvested 7 days following
multiple foliar application of: (i) the 5% D formulation at 3 Ib ai/A; (ii) the 25% WP formulation at 1 Ib
ai/100 gal; and (i) an EC formulation at 10 Ib ai/A. In addition, the registrant must amend all pertinent
labels specifying a maximum Ib ai/A application rate for use of the 25% WP formulation, and the requested
data must reflect this rate. Tests must be conducted in CA. The registrant must propose a maximum seasonal
application rate or number of application per season. The required tests must reflect this maximum.
84/ oata are required to determine malathion residues of concern in or on cherries harvested 3 days following
multiple foliar applications of the 5% D and 25% WP formulations (each in separate tests) at 3 Ib ai/A and
an EC formulation at 8 Ib ai/A. Tests must be conducted in MI and CA, OR, or WA. The registrant must
propose a maximum seasonal application rate or number of applications per season. Required tests must
reflect this maximum.
85/ Data are required to determine malathion residues of concern in or on nectarines. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on nectarines; or b) indicate support of the use on apricots and request that the required
data for that use pattern be used to support the use on nectarines.
92
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§158.125 Residue Chemistry (cont'd)
' Data are required to determine malathion residues of concern in or on peaches harvested 7 days following
multiple foliar applications of, in separate tests: (i) a D formulation at 3 Ib ai/A; (ii) the 25% WP
formulation at 3 Ib ai/A and (iii) an EC formulation at 9 Ib ai/A. Tests must be conducted in CA, GA or
SC, and MI or PA. The registrant must propose a maximum seasonal application rate or number of applications
per season. The requested data must reflect the proposed number of applications or maximum seasonal
rate.
87 / Data are required to determine malathion residues of concern in or on plums or fresh prunes harvested 3
days following multiple foliar applications at 7-day intervals in separate tests of: (i) a D formulation
at 3 Ib ai/A; (ii) the 25% WP formulation at 1 Ib ai/100 gal; and (iii) an EC formulation at 10 Ib ai/A.
In addition, the registrant must amend all pertinent labels specifying a maximum Ib ai/A/application rate
for use of the 25% WP formulation, and the requested data must reflect this rate. Tests must be conducted
in ID, MI, and WA. The registrant must propose a maximum seasonal application rate or number of application
per season. The requested data must reflect this maximum.
88/ Data are required to determine malathion residues of concern in dried prunes processed from plums (fresh
prunes) bearing measurable weathered residues. If concentration is found to occur during processing, an
appropriate food additive tolerance must be proposed.
89 / A crop group tolerance is not appropriate at this time because adequate residue data are not available
for representative crops of this group (blueberries, blackberries, cranberries, grapes, and strawberries)
and the metabolism of malathion in plants is not adequately understood.
90 / Data are required to determine malathion residues of concern in or on blackberries harvested 1 day
following multiple foliar application of a D and (in a separate test) an EC formulation at 4 and 4.5 Ib
ai/A, respectively, and the 25% WP formulation at'2 Ib ai/A. Tests must be conducted in OR. The registrant
must propose a maximum number of applications per season or a maximum seasonal use rate. The requested
data must reflect this maximum rate.
Data are also required to determine malathion residues of concern in or on blackberries harvested 1 day
following multiple foliar applications (using ground and aerial equipment in separate tests) of the 25%
WP formulation at 3 Ib ai/A. Ground applications must be made in at least 75 gal/A and aerial applications
must be made in a minimum of 10 gal/A. The number of applications in the required tests must reflect
either the maximum number proposed by the registrant to appear on the federal labels or a maximum number
proposed for this use in CA. Tests must be conducted in CA. Alternatively, the registrant may elect to
cancel these uses permitted under EPA SLN Nos. CA810051, CA810052, and CA810055.
93
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§158.125 Residue Chemistry (cont'd)
' Data are required to determine malathion residues of concern in or on blueberries harvested 1 day following
the last of multiple foliar applications (in separate tests) of: (i) a D formulation at 2.5 Ib ai/A (ii) the
25% WP formulation, mixed with bait, at 2 Ib ai/A; (iii) an EC formulation at 2.5 Ib ai/A, and (iv) the
40% SC/L formulation at 2.5 Ib ai/A. In addition, data are required depicting malathion residues in
blueberries collected on the day of the last of multiple foliar applications (using aerial ULV equipment)
of a RTU formulation (9.3-9.79 Ib a.i./gal) at 0.76 Ib ai/A. The registrant must propose a maximum number of
applications per season or a maximum seasonal application rate for each of these uses and the requested
data must reflect this maximum total rate. Tests must be conducted in MI and NJ.
Data are also required to determine malathion residues of concern in or on blueberries collected 8 hours
following the last of multiple foliar applications of the 5 Ib/gal EC formulation (mixed with bait) at
0.625 Ib ai/A. Tests must be conducted in OR or WA. The requested data must reflect a maximum seasonal
application rate proposed by the registrant.
Data are required to determine malathion residues of concern in or on winter boysenberries. The registrant
must contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on boysenberries; or b) indicate support of the use of blackberries and request that the
required data for that use pattern be used to support the use on boysenberries.
93/ Data are required to determine malathion residues of concern in or on cranberries harvested 3 days
following the last multiple foliar applications of a D and an EC formulation at 2.5 Ib ai/A and the 25% WP
formulation at 0.625 Ib ai/A. (Each formulation type must be represented in a separate test.) The registrant
must propose a maximum number of applications per season or a maximum seasonal use rate. The requested
data must reflect this maximum rate. Tests must be conducted in MA and WI.
Data are required to determine malathion residues of concern in or on cranberries harvested 14 days following
application of an EC formulation to cranberry bog irrigation water in OR or WA at 2.5 Ib ai/A. Alternatively
the registrant may elect to cancel this use permitted under EPA SLN Nos. OR790063, WA780015, WA780053, and
WA780054.
94 / Data are required to determine malathion residues of concern in or on currants. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support
this use, and either: a) request a determination of the specific formulations, rates, and application
schedule to be tested on currants; or b) indicate support of the use on blueberries and request that the
required data for that use pattern be used to support the use on currants.
94
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§158.125 Residue Chemistry (cont'd)
95/ Data are required to determine malathion residues of concern in or on dewberries. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule to
be tested on dewberries; or b) indicate support of the use on blackberries and request that the required
data for that use pattern be used to support the use on dewberries.
96/ Data are required to determine malathion residues of concern in or on gooseberries. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either; a) request a determination of the specific formulations, rates, and application schedule to
be tested on gooseberries; or b) indicate support of the use on blueberries and request that the required
data for that use pattern be used to support the use on gooseberries.
97/ Data are required to determine malathion residues of concern in or on grapes harvested 3 days following the
last of multiple foliar applications of a D and, in a separate test, an EC formulation at 2.75 Ib ai/A, the
25 WP formulation at 1.5 Ib ai/A, and the 40% SC/L formulation at 5 pt of product/A. The registrant must
propose a maximum number of applications per season or a maximum seasonal application rate. The requested
data must reflect the maximum seasonal rate. The tests must be conducted in CA.
In addition, the registrant must submit data depicting total residues of malathion on raisins processed
from grapes harvested 3 days following multiple foliar treatments at 2.75 Ib ai/A and dried on tray
treated with an EC formulation or the 1.8% impregnated formulation at 200 mg ai/sq ft of tray.
Data are also required to determine malathion residues of concern in or on grapes harvested 3 days following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP and (in a
separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A. Ground applications must be
made in at least 75 gal/A and aerial applications must be made in a minimum of 10 gal/A. The number of
applications in the required tests must reflect either the maximum number proposed by the registrant to
appear on the federal labels or a maximum number proposed for this use in CA. The registrant must also
submit data depicting residue on raisins processed from grapes receiving multiple applications at 3 Ib ai/A
and dried on trays treated at 200 mg ai of malathion/sq ft. Alternatively, the registrant may elect to
cancel these uses permitted under EPA SItf Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
98/ Data are required to determine the potential for concentration of malathion residues in dry pomace, raisin
waste, and grape juice processed from raisins bearing measurable weathered residues. If the data indicate
a potential concentration of residues in any of these commodities, an appropriate food/feed additive
tolerance must be proposed.
95
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§158.125 Residue Chemistry (cont'd)
99 /
' Data are required to determine malathion residues of concern in or on loganberry. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on loganberry; or b) indicate support of the use on blackberries and request that the required
data for that use pattern be used to support the use on loganberries.
' Data are required to determine malathion residues of concern in or on raspberries. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use, a
either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on raspberries; or b) indicate support of the use on blackberries and request that the required
data for that use pattern be used to support the use on raspberries.
' Data are required to determine malathion residues of concern in or on strawberries harvested 3 days
following multiple foliar applications of a D formulation at 2.5 Ib ai/A and (in separate tests) the 25% WP
and an EC formulation at 2 lb ai/A, each preceded by a preplant incorporated (to 6-8 inches) soil applica-
tion of a D, WP, or EC formulation at 2 lb ai/A. The registrant must propose a maximum number of foliar
applications per season or a maximum seasonal application rate. The requested data must reflect this
maximum rate. Tests must be conduct in CA and FL.
Data are also required to determine malathion residues of concern in or on strawberries harvested 3 day
following multiple foliar applications (using ground and aerial equipment in separate tests) of the 25%
WP formulation and (in a separated test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 lb ai/A.
Ground applications must be made in at least 75 gal/A and aerial applications must be made in a minimum
of 10 gal/A. The number of applications in the required tests must reflect either the maximum number
proposed by the registrant to appear on the federal labels or a maximum number proposed for this use in
CA. Tests must be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted
under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
102/ A crop group tolerance is not appropriate at this time because adequate residue data are not available
for representative crops of the group (almonds and English walnuts) and the metabolism of malathion in
plants is not adequately understood.
103/ Data are required to determine malathion residues of concern in or on almonds and almond hulls harvested
the day of the last of multiple foliar applications of (in separate tests) the 25% WP formulation at 1 lb
ai/A and an EC formulation at 8 lb ai/A. The registrant must propose a maximum number of applications per
season or a maximum seasonal use rate. Required tests must reflect the proposed maximum rate. Tests must
be conducted in CA.
96
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j158.125 Residue Chemistry (cont'd)
104/ Data are required to determine malathion residues of concern in or on chestnuts harvested following
multiple application the last application made at shuck-split of (in separate tests) the 25% WP formulation
0.5 Ib ai/100 gal and an EC formulation at 5 Ib ai/A. The registrant must propose a maximum number of
applications per season or a maximum seasonal use rate* Required tests must reflect the proposed maximum
rate. Tests must be conducted in the major chestnut growing regions of the U.S.
105/ Data are required to determine malathion residues of concern in or on filberts harvested 3 days after the
last of multiple foliar applications of a D formulation at 3 Ib ai/A. The registrant must propose a maximum
number of applications per season or a maximum seasonal use rate. Required data must reflect the proposed
maximum rate. Tests must be conducted in OR.
106/ Data are required to determine malathion residues of concern in or on Macadamia nuts harvested on the day
the last of multiple foliar applications of (in separate tests) the 25% WP formulation at 1 Ib ai/100 gal and
an EC formulation at 15 Ib ai/A. In addition, the registrant must amend all pertinent labels to include a
maximum Ib ai/A/application rate for use of the 25% WP formulation, and the requested data must reflect this
rate. The registrant must propose a. maximum number of applications per season or a maximum seasonal use rate
Required tests must reflect the proposed maximum rate. Tests must be conducted in HI.
107/ Data are required to determine malathion residues of concern in or on pecans. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this use,
and either: a) request a determination of the specific formulations, rates, and application schedule to
be tested on pecans; or b) indicate support of the use on walnuts and request that the required data for
that use pattern be used to support the use on pecans. The translated data may not be used to support a
crop group tolerance.
108/ Data are required to determine malathion residues of concern in or on walnuts harvested on the day of the
last of multiple foliar applications of (in separate tests) the 25% WP formulation, an EC formulation,
and a D formulation at 2.5, 12.5, and 12.0 Ib ai/A, respectively. The registrant must propose a maximum
number of applications per season or a maximum seasonal use rate. Required tests must reflect the
proposed maximum rate. Tests must be conducted in CA.
109/ A crop group tolerance is not appropriate at this time because adequate residue data are not available
for representative crops of this group (corn, rice, sorghum, and wheat) and the metabolism of malathion
in plants is not adequately understood.
110/ Since barley forage, hay, and straw are raw agricultural commodities, the registrant must either
propose tolerances and provide appropriate supporting residue data or revise labeling to incorporate
a feeding restriction.
97
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§158.125 Residue Chemistry (cont'd)
•*V Vata are required to determine malathion residues of concern in or on corn grain and sweet corn harvested
5 days following multiple foliar applications of a D formulation at 1.5 Ib ai/A, the 25% WP and an EC
formulation at 1.25 Ib ai/A, and the 9.7 or 9.79 Ib/gal PTU formulation at 0.3 Ib ai/A (using ULV equipment);
each formulation must be represented in a separate test. Grain tests must be conducted in IA, IL, and
NE. Sweet corn tests must be conducted in CA, FL, MN, and WI.
Data are also required to determine malathion residues of concern in or on corn grain and sweet corn
harvested 5 days following multiple foliar applications (using ground and aerial equipment in separate
tests) of the 25% WP formulation and (in a separate test) the 5 Ib Al/gal, 8 Ib Al/gal, or 57% EC formulation
at 3 Ib ai/A. Ground applications mus be made in at least 75 gal/A and aerial applications must be made
in at least 10 qal/A. The required tests must reflect either the maximum number proposed by the registrant
to appear on the federal labels or a maximu number proposed for this use in CA. Tests must be conducted
in CA. Alternatively, the registrant may elect to cancel these uses permitted under EPA SLN Nos. CA810051,
CA810052, CA810053, CA810054, and CA810055.
Since corn forage and fodder are raw agricultural commodities, the registrant must propose tolerances
and submit appropriate supporting residue data.
112/ since oat forage, hay, and straw are raw agricultural commodities, the registrant must either propose
tolerance and provide appropriate supporting residue data or revise labeling to incorporate a feeding
restriction.
113/ Data are required to determine malathion residues of concern in or on rice grain collected 7 days
following the last of multiple foliar applications of an EC formulation at 1.75 Ib ai/A (using ground and
aerial equipment in separate tests) and, in a separate test, a RTU formulation (9.3-9.7 Ib a.i./gal) at 0.58
Ib ai/A using aerial ULV equipment. Tests must be conducted in AR, LA or TX, and CA. The registrant
must propose a maximum number of preharvest applications and the requested data must reflect this number.
Data are also required to determine malathion residues of concern in or on rice harvested 7 days following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP formulation
and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A. Ground applications
must be made in at least 75 qal/A and aerial applications must be made in a minimum of 10 gal/A. The
required tests must reflect either the maximum number proposed by the registrant to appear on the federal
labels or a maximum number proposed for this use in CA. Tests must be conducted in CA. Alternatively,
the registration may elect to cancel these uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053,
CA810054, and CA810055.
98
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§158.125 Residue Chemistry (cont'd)
Data are required to determine malathion residues of concern in or on rice grain harvested 7-days following
the last of multiple foliar applications of an EC formulation at 2 Ib ai/A. These tests must be conducted
in CA. The number of applications must reflect the maximum number or total seasonal rate proposed by
the registrant.
Since rice straw is a raw agricultural commodity, the registrant must propose a tolerance and submit
appropriate supporting residue data or revise labeling to incorporate a feeding restriction.
114/ Since rye forage and straw are raw agricultural commodities, the registrant must either propose tolerance
and provide appropriate supporting residue data or revise labeling to incorporate a feeding restriction.
^1 5/ Data are required to determine malathion residues of concern in or on sorghum grain harvested 7 days
following the last of multiple foliar applications of an EC formulation and, in a separate test, ULV
application of a RTU formulation (9.3-9.79 Ib/gal) at 0.94 Ib ai/A. Tests must be conducted in AR
or TX and KS or NE. The registrant must propose a maximum number of applications per season and the
submitted data must reflect this maximum number.
Data are also required to determine malathion residues of concern in or on sorghum grain harvested 7
days following multiple foliar applications (using ground and aerial equipment in separate tests) of the
25% WP formulation and (in a test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A. Ground
applications must be made in at least 75 gal/A and aerial applications must be made in a minimum of 10
gal/A. The number of application in the required tests must reflect either the maximum number proposed
by the registrant to appear on the federal labels or a maximum number proposed for this use in CA.
Tests must be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted
under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
116/ Since the straw of wild rice is a raw agricultural commodity, the registrant must propose a tolerance and
submit appropriate supporting residue data or revise labeling to incorporate a feeding restriction.
117/ Data are required to determine malathion residues of concern in or on wheat grain harvested 7 days
following the last of multiple foliar applications of a D, the 25% WP, an EC and the 40% SC/L formulation
at 1.25 Ib ai/A/application and a RTU formulation (9.3-9.79 Ib/gal) at 0.61 Ib ai/A/application (ULV
application). Each formulation type must be represented in a separate test. ULV applications must be
applied using ground and aerial equipment in separate tests. Tests must be conducted in KS or CO; MN,
ND, or SD; TX or OK; and WA or MT. The registrant must propose a maximum seasonal application rate or a
maximum number of applications per season. The requested data must reflect this maximum total rate.
Also, since wheat forage and hay are raw agricultural commodities, the registrant must propose tolerances
and provide appropriate residue data for these commodities.
99
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§158.125 Residue Chemistry (cont'd)
Data are also required to determine malathion residues of concern in or on wheat harvested 7 days following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP formulation
and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A. Ground applications
must be made in at least 75 gal/A and aerial applications must be made in a least 10 gal/A. The required
tests must reflect either the maximum number proposed by the registrant to appear on the federal labels
or a maximum number proposed for this use in CA. Tests must be conducted in CA. Alternatively, the
registrant may elect to cancel these uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053,
CA810054, and CA810055.
118/ A crop group tolerance is not appropriate at this time because adequate residue data are not available
for representative crops of the group (sorghum forage) and the metabolism of malathion in plants is
not adequately understood.
/ Data are required to determine malathion residues of concern in or on sorghum forage and sorghum hay
harvested 7 days following the last multiple foliar applications of an EC formulation at 0.94 Ib ai/A.
The registrant must propose a maximum seasonal application rate or number of applications, and the
submitted data must reflect this maximum rate. We note that the available data support five applications
of the ULV RTU formulations or a total seasonal rate of 4.7 Ib ai/A. Tests must be conducted in KS or
NE and TX.
Data are also required to determine malathion residues of concern in or on sorghum forage harvested 7
days following multiple applications (using ground and aerial equipment in separate tests) of the 25% WP
formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A. Ground
applications must be made in at least 75 gal/A and aerial applications must be made in a minimum of 10
gal/A. The number of applications in the required tests must reflect either the maximum number proposed
by the registrant to appear on the federal labels or a maximum number proposed for this use in CA.
Tests must be conducted in CA. Alternatively, the registrant may elect to cancel these uses, permitted
under EPA SLN Nos. CA810051, CA810052, CA810053, CA81005 and CA810055.
Since sorghum fodder is a raw agricultural commodity, the registrant must propose a tolerance and submit
appropriate supporting residue data.
120/ Data are required to determine malathion residues of concern in or on Bermuda grass, bluegrass, and
bromegrass or fescue (as fresh grass and hay) harvested 7 days following multiple foliar applications of
a D, the 25% WP, and an EC formulation at 2 Ib ai/A (each formulation must be applied in a separate
test). Both aerial and ground equipment must be represented in separate tests. The registrant must
propose a maximum seasonal use rate or number of treatments per season. The required tests must reflect
this number or maximum rate. Tests must be conducted in AR, KS, KY, MO, NY, OK, PA, TN, TX, and VA.
100
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§158.125 Residue Chemistry (cont'd)
Data are required to determine malathion residues of concern in or on Bermuda grass, bluegrass, and
bromegrass or fescue (as fresh grass and hay) harvested on the day of the last of multiple foliar application
of a RTU formulation using both ground and aerial ULV equipment (9.3-9.79 Ib/gal) at 0.875 Ib ai/A. The
registrant must propose a maximum seasonal use rate or number of treatments per season. The required
tests must reflect this number or maximum rate.
Data are also required to determine malathion residues of concern in or on Bermuda grass, bluegrass, and
bromegrass or fescue (as fresh grass and hay) harvested 7 days following multiple foliar applications
(using ground and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A.
Ground applications must be made in at least 75 gal/A and aerial applications must be made in a minimum
of 10 gal/A. The number of applications in the required tests must reflect either the maximum number
proposed by the registrant to appear on the federal labels or a maximum number proposed for this use in
CA. Tests must be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted
under EPA SLN Nos. CA810051, CA8100525, CA810053, CA810054, and CA810055.
/ Data are required to determine malathion residues of concern in or on alfalfa forage and alfalfa hay
(ca. 10 % moisture content) following the last of multiple foliar applications (using ground and aerial
equipment) of a D, an EC, and the 25% WP formulations at 1.5 Ib ai/A (0 days post treatment) or 2.5 Ib
ai/A (7 days posttreatment). Each formulation must be applied in separate tests. The registrant must
propose a maximum number of applications per season or a maximum seasonal application rate for each
registered use. The required tests must reflect this maximum number or rate. Tests must be
conducted in CA, IA, MI, MN, HE, SD, and WI. The registrant must propose a tolerance for residues of
malathion in or on alfalfa hay.
Data are required to determine malathion residues of concern in or on alfalfa forage and alfalfa hay
(ca. 10% moisture content) harvested on the day of and 5 days after the last of multiple foliar applications
of a RTU formulation at 0.58 Ib ai/A and 1.16 Ib ai/A, respectively; ground and aerial ULV equipment
must be used in separate tests. The registrant must propose a maximum number of applications per season
or a maximum seasonal application rate for each registered use. The required tests must reflect this
maximum number or rate. The registrant must propose a tolerance for residues of malathion in or on
alfalfa hay.
Data are also required to determine malathion residues of concern in or on alfalfa forage and alfalfa
hay (ca. 10% moisture content) harvested 7-days following multiple foliar applications (using ground and
aerial equipment in separate tests) of the 25% WP formulation and (in a separate test) the 5 Ib/gal,
8 Ib/gal, or 57% EC formulation at 3 Ib ai/A. Ground applications must be made in at least 75 gal/A
and aerial applications must be made in a minimum of 10 gal/A. The number of applications in the
101
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§158.125 Residue Chemistry (cont'd)
required tests must reflect either the maximum number proposed by the registrant to appear on the
federal labels or a maximum number proposed for this use in CA. Tests must be conducted in CA. The
registrant must propose a tolerance for residues of malathion in or on alfalfa hay. Alternatively,
the registrant may elect to cancel these uses permitted under EPA SLN Nos. CA810051, CA810052,
CA810053, CA810054, and CA810055.
' Residue data and accompanying use directions are required to determine malathion residues of concern in
or on birdsfoot trefoil forage and hay. The registrant must contact the Agency, within the allowed ninety
(90) day period for indicating intention to support this use, and either: a) request a determination of
the specific formulations, rates, and application schedule to be tested on birdsfoot trefoil; or b)
indicate support of the use on alfalfa and request that the required data for that use pattern be used
to support the use on birdsfoot trefoil.
Data are required to determine malathion in residues of concern or on clover forage and clover hay
resulting from the following treatment schedules: (i) multiple foliar applications of a D, the 25% WP,
and an EC formulation at 2.5 Ib ai/A (the last application must be made 7 days prior to harvest); (ii)
multiple foliar applications of each of the aforementioned formulations at 1.5 Ib ai/A (the last application
made on the day of harvest); and (iii) multiple foliar applications of a RTU formulation (9.3-9.79
Ib/gal) at 0.875 Ib ai/A, the last application made on the day of harvest. Each formulation must be
applied in a separate test, and separate tests using ground and aerial equipment must be conducted
representing each use. The registrant must propose a maximum seasonal use rate or number of treatments
per season or per cutting for each use. The required tests must reflect this number of applications or
maximum rate. Tests must be conducted in ID, MI, MN, MS or GA, NY, OK, and WI. The registrant must
propose a tolerance for residues of malathion in or on clover hay.
Data are required to determine malathion residues of concern in or on clover forage and clover hay
harvested on the day of the last of multiple foliar applications of a RTU formulation using aerial ULV
equipment at 0.95 Ib ai/A. The number of applications must reflect that proposed by the registrant.
Tests must be conducted in OR. The registrant must propose a tolerance for residues of malathion in
or on clover hay. Alternatively, the registrant may elect to cancel this use permitted under EPA
SLN No. OR810070.
Data are also required to determine malathion residues of concern in or on clover forage and clover hay
harvested 7 days following multiple foliar applications (using ground and aerial equipment in separate
tests) of the 25% WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation
at 3 Ib ai/A. Ground applications must be made in at least 75 gal/A and aerial applications must be
made in minimum of 10 gal/A. The number of applications in the required tests must reflect either
102
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S15R.125 Residue Chemistry (cont'd)
the maximum number proposed by the registrant to appear on the federal labels or a maximum number
proposed for this use in CA. Tests must be conducted in CA. The registrant must propose a tolerance
for residues of malathion in or on clover hay. Alternatively, the registrant may elect to cancel
these uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
124/ Since lespedeza forage is a raw agricultural commodity, the registrant must propose a tolerance for
residues of malathion in or on lespedeza forage and submit appropriate supporting residue data.
125/ Data are reguired to determine malathion residues of concern in or on lupine hay and forage harvested on
the day of the last of multiple foliar applications of an EC formulation at 1.25 Ib ai/A. Tests must be
conducted in PL, GA, or SC. Alternatively, the registrant may propose a 7-day PHI and reguest that
data on soybean forage, hay, and straw be translated to lupine hay.
Since lupine forage is a raw agricultural commodity, the registrant must propose a tolerance for residues
of malathion in or on forage and submit appropriate supporting residue data.
126/ Data are required to determine malathion residues of concern in or on vetch forage and hay harvested 7
days following the last of multiple foliar applications of (in separate tests) a D, the 25% WP, and an EC
formulation at 1.25 Ib ai/A. The registrant must propose a maximum number of applications per season or
maximum seasonal application rate. Requested data must reflect this proposal. Tests must be conducted
in CA, OK, OR, and PA. The registrant must propose a tolerance for vetch forage.
127/ Data are reguired to determine malathion residues of concern in or on asparagus harvested 1 day following
the last of multiple foliar applications of a D, the 25% WP, and an EC formulation at 1.25 Ib ai/A, with
each formulation applied in a separate test. The registrant must propose a maximum number of applications
per season or a maximum seasonal application rate for each use and the reguested data must reflect
these maximum rates. Tests must be conducted in (1) MI and (2) CA or WA.
Data are also reguired to determine malathion residues of concern in or on asparagus harvested 1 day
following multiple foliar applications (using ground and aerial equipment in separate tests) of the 25%
WP formulation and (in a separate test) the 5 ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A.
Ground applications must be made in at least 75 gal/A and aerial applications must be made in a minimum
of 10 qal/A. The number of applications in the reguired tests must reflect either the maximum number
proposed by the registrant to appear on the federal labels or a maximum number proposed for this use in
CA. Tests must be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted
under EPA SLN Nos. CA810051, CA810052, CA810052, CA810054, and CA810055.
103
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§158.125 Residue Chemistry (cont'd)
' Data are required to determine malathion residues of concern in or on mature avocados harvested 7 days
following multiple foliar applications of the 25% WP formulation at 1 Ib ai/A and an EC formulation at 9
Ib ai/A (each formulation must be applied in a separate test). Tests must be conducted in CA. The
registrant must propose a maximum seasonal use rate or maximum number of applications per season and the
data must reflect this maximum number or total rate.
Data are also required to determine malathion residues of concern in or -on avocados resulting from
multiple foliar application of the 95% RTU formulation using aerial ULV equipment at 0.6 Ib ai/A. The
number of applications made in the required test must reflect either the maximum number proposed by the
registrant to appear on the federal labels or a maximum number proposed for this use. Tests must be
conducted in CA. Alternatively the registrant may elect to cancel this use permitted under EPA SLN
No. CA770303.
Data are also required to determine malathion residues of concern in or on avocados harvested 7 days
following multiple foliar applications (using ground and aerial equipment in separate tests) of the 25%
WP formulation at 3 Ib ai/A. Ground applications must be made in at least 75 gal/A and aerial applications
must be made in a minimum of reflect either the maximum number proposed by the registrant to appear on
the federal labels or a maximum number proposed for this use in CA. Tests must be conducted in CA.
Alternatively, the registrant may elect to cancel these uses permitted under EPA SLN Nos. CA810051,
CA810052, and CA810055.
T29/ Data are required to determine malathion residues of concern in or on cottonseed collected on the day of
the last of multiple foliar applications of the 25% WP, an EC formulation at 4 Ib ai/A, and a D formulation
at 7.25 Ib ai/A, and a RTU formulation (9.3-9.79 Ib/gal) using ULV equipment at 1.17 Ib ai/A. Each
formulation must applied in a separate test using both ground and aerial equipment. Tests must be
conducted in CA, MS, and TX. The registrant must propose a maximum number of applications per season or
a total seasonal use rate. The requested data must reflect this maximum number or rate.
Since cotton forage is a raw agricultural commodity, the registrant must propose a tolerance for residues
of malathion in or on cotton forage and submit appropriate supporting residue data.
130/ Data are required to determine the potential for concentration of malathion residues in meal, hulls,
soapstock, crude oil, and refined oil processed from cottonseed bearing measurable weathered residues.
If the data indicate a potential for concentration of residues in any processed commodity, an appropriate
food/feed additive tolerance must be proposed.
104
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§158.125 Residue Chemistry (cont'd)
' Data are required to determine malathion residues of concern in or on dates harvested 7 days following
the last of multiple foliar applications of a D and an EC formulation at 2 Ib ai/A, each formulation
applied in a separate test. The registrant must propose a maximum number of applications per season or
a maximum seasonal application rate for each use and the requested data must reflect these maximum
rates. Tests must be conducted in AZ or CA.
Data are required to determine malathion residues of concern in or on dates harvested 21 days following
the last of multiple foliar applications of the 5% D formulation at 4.25 Ib ai/A. The number of appli-
cations in the required tests must reflect either the maximum number proposed by the registrant to
appear on the federal labels or a maximum number proposed for this use in CA. Tests must be conducted
in CA. Alternatively the registrant may elect to cancel these uses permitted under EPA SLN Nos. CA820039,
CA820040, and CA820041.
Data are also required to determine malathion residues of concern in or on dates harvested 21 days
following multiple foliar applications (using ground and aerial equipment in separate tests) of the 25%
WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A.
Ground applications must be made in at least 75 gal/A and aerial applications must be made in a minimum
of 10 gal/A. The number of applications in the required tests must reflect either the maximum number
proposed by the registrant to appear on the federal labels or a maximum number proposed for this use in
CA. Tests must be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted
under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
132/ Data are required to determine malathion residues of concern in or on figs harvested 3 days following the
last of multiple foliar applications of a D and an EC formulation at 2.0 Ib ai/A and 2.5 Ib ai/A,
respectively. Each formulation must applied in a separate test.
Data are also required to determine malathion residues of concern in or on figs harvested 3 days following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP
formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A. Ground
applications must be made in at least 75 gal/A and aerial applications must be made in a minimum of 10
gal/A. The number of applications in the required tests must reflect either the maximum number proposed
by the registrant to appear on the federal labels or a maximum number proposed for this use in CA.
Tests must be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted
under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
105
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§158.125 Residue Chemistry (cont'd)
Data are required to determine the potential for concentration of roalathion residues of concern in dried
figs processed from figs bearing measurable, weathered residues. If concentration occurs during processing,
registrant must propose an appropriate food additive tolerance.
134/ Data are required to determine concentration of malathion during processing of flax meal and hulls
derived from flax seed bearing measurable weathered residues. If concentration occurs during processing,
the registrant must propose food/feed additive tolerances.
_135/ Data are required to determine malathion residues of concern in or on guavas harvested 2 days following
the last of multiple foliar applications of the 25% WP formulation at 0.75 Ib ai/A (with bait). The
registrant must propose a maximum number of applications per season or a maximum seasonal application
rate. The requested data must reflect this maximum number or rate.
Data are required to determine malathion residues of concern in or on guavas harvested 2 days following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP formulation
and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib ai/A. Ground applications
must be made in at least 75 gal/A and aerial applications must be made in a minimum of 10 gal/A. The
number of applications in the required tests must reflect either the maximum number proposed by the
registrant to appear on the federal labels or a maximum number proposed for this use in CA. Tests must
be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted under EPA
SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
136/ The registrant must propose a label amendment that specifies a maximum seasonal use rate or maximum
number of applications per season for hops. We note that the available data support a maximum of four
applications per season or a total of 4 Ib ai/A/season.
The registrant must propose a tolerance for residues of malathion in dried hops based on the concentra-
tion factor during drying of about 5x. The available data support a food additive tolerance of 5 ppm.
The registrant must also propose a feed additive tolerance for malathion residues in spent hops at
the same level as that for residues in dried hops.
137/ Data are required to determine malathion residues of concern in or on mangoes harvested following the
last of multiple foliar applications of the 25% WP formulation at 0.75 Ib ai/A mixed with bait material.
The registrant must propose a maximum number of applications per season or a maximum seasonal application
rate. The requested data must reflect this maximum rate. Tests must be conducted in FL.
106
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§•58.125 Residue Chemistry (cont'd)
139-x Data are required to determine malathion residues of concern in or on mint harvested 7 days following the
last of multiple foliar applications of the 5% D and an EC formulation (each in a separate test) at
1 Ib ai/A The registrant must propose a maximum number of applications per season and the requested data
must reflect this maximum number. Tests must be conducted in OR.
Data are also required to determine malathion residues of concern in or on mint harvested 7-days following
multiple foliar applications (using ground and aerial equipment in separate tests) of the 25% WP formulation
and (in a separate test) the 5 Ib/gal, 8 li>/gal, or 57% EC formulation at 3 Ib ai/A. Ground applications
nust be made in at least 75 gal/A and aerial applications must be made in a minimum of 10 gal/A. The
number of applications in the required tests must reflect either the maximum number proposed by the
registrant to appear on the federal labels or a maximum number proposed for this use in CA. Tests must
be conducted in CA. Alternatively, the registrant may elect to cancel these uses permitted under EPA
SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
Since mint hay is a raw agricultural commodity, the registrant must either propose a tolerance and
provide appropriate supporting residue data or revise labeling to incorporate feeding restriction.
139/ Data are required to determine the potential for concentration of malathion residues of concern in mint
oil and spent hay processed from mint bearing measurable, weathered residues. If residues concentrate
in either of these commodities, an appropriate food/feed additive tolerance must be proposed.
43/ Data are required to determine malathion residues of concern in or on mushrooms harvested 1 day following
multiple applications of an EC and the 25% WP formulations (in separate tests) at 1.5 Ib ai/A. Tests
must be conducted in CA, MI, and PA. The registrant must propose a maximum number of applications per
crop and the requested data must reflect this number.
Data are required to determine malathion residues of concern in or on mushrooms harvested on the day of
the last of multiple drench applications of the 25% WP formulation to mushroom compost at 5 oz ai/3
gal/1000 sq ft. Alternatively, the registrant may elect to cancel this use permitted under EPA SLN
JJo. NY810006.
Data are also required to determine malathion residues of concern in or on mushrooms collected 1 day
following the last of multiple drench applications of the 25% WP formulation at (i) 2.5 oz ai/1000 sq
ft; (ii) 5 oz ai/1000 sq ft; and 7.5 oz ai/1000 sq ft. Alternatively, the registrant may elect to
cancel these uses permitted under (i) EPA SLN Nos. CA790174 and CA790190; (ii) EPA SLN Nos. CT780004,
CT790004, PA780017, PA780019, MI790006, and OR790004; and (iii) EPA Reg. No. 279-739 in OR.
107
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§158.125 Residue Chemistry (cont'd)
141/ Data are required to determine malathion residues of concern in or on okra harvested 1 day following
multiple foliar applications of a D formulation at 1.25 Ib ai/A and the 25% WP and an EC formulation
each at 1.5 Ib ai/A. Each formulation must be applied in a separate test. The registrant must
propose a maximum number of applications per season or a maximum seasonal application rate. Required
tests must reflect the maximum number or seasonal rate proposed. Alternatively, the registrant may
propose to limit this use to one application per season, which is supported by the available data.
Tests must be conducted in GA and TX.
Data are also required to determine malathion residues of concern in or on okra harvested 1 day
following multiple foliar applications (using ground and aerial equipment in separate tests) of the
25% WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC formulation at 3 Ib
ai/A. Ground applications must be made in at least 75 gal/A and aerial applications must be made in
a minimum of 10 gal/A. The number of applications in the required tests must reflect either the
maximum number proposed by the registrant to appear on the federal labels or a maximum number proposed
for this use in CA. Tests must be conducted in CA. Alternatively, the registrant may elect to
cancel these uses permitted under EPA SLN Nos. CA810051, CA810052, CA810053, CA810054, and CA810055.
•*^ Data are required to determine malathion residues of concern in or on mature papayas harvested
immediately following the last of multiple foliar applications of the 25% WP (and in a separate
test) an EC formulation at 1.25 Ib ai/100 gal/A. Tests must be conducted in HI. The registrant
must propose a maximum number of applications per season or a maximum seasonal application rate.
The requested data must reflect this maximum number or rate.
*43. Data are required to determine malathion residues of concern in or on passion fruit harvested following
the last of multiple foliar applications of the 25% WP formulation at 0.75 Ib ai/A with bait. The
registrant must propose a maximum number of applications per season or a maximum seasonal application
rate for each use and the requested data must reflect this maximum rate. Tests must be conducted in
HI.
144/ Data are required to determine malathion residues of concern in or on mature peanuts harvested on the
day of the last of multiple foliar applications of a D, an EC, and the 25% WP formulations (in
separate tests) at 1 Ib ai/A. Ground and aerial equipment must be represented in separate tests.
Tests must be conducted in AL, GA, NC, VA, and TX. The registrant must propose a maximum number of
applications per season or a maximum seasonal use rate. Required tests must reflect this maximum
number or rate.
The registrant must propose tolerances for malathion residues in or on the raw agricultural commodities
hulls, hay, and vines of peanuts and provide appropriate supporting residue data.
108
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§158.125 Residue Chemistry (cont'd)
Data are required to determine malathion residues of concern in or on pineapples harvested 7 days
following multiple foliar applications of the 5 Ib/gal EC, 25% WP, and the 5% D formulation each at 5 Ib
ai/A (each formulation must be applied in a separate test). The registrant must propose a maximum
number of applications per season or a maximum seasonal use rate. Required tests must reflect this
maximum total rate. Tests must be conducted in HI.
».
Since pineapple forage is a raw agricultural commodity, the registrant must either propose a tolerance
for pineapple forage and provide the appropriate supporting residue data, or revise labeling to incorporate
feeding or grazing restrictions.
146/ Data are required to determine malathion residues of concern in pineapple juice and pineapple bran
(chopped, dehydrated pineapple tops and shells) processed from pineapple fruit bearing measurable, weathered
residues. If residues concentrate in any of these processed commodities then an appropriate food/feed
additive tolerance must be proposed.
147/ Data are required to determine malathion residues of concern in or on safflower seed harvested 3 days
following multiple foliar applications of an EC formulation at 1.25 Ib ai/A and a RTU formulation (9.3-9.79
Ib/gal or 95%) at 0.6 Ib ai/A using ultra-low-volume equipment. Tests must be conducted in CA. The
registrant must propose a maximum seasonal application rate or a maximum number of applications per
season. Required studies must reflect the proposed total rate or number of applications.
Data are also required to determine malathion residues of concern in or on safflower seed harvested
3 days following the last of multiple foliar applications (using ground and aerial equipment in
separate tests) of the 25% WP formulation and (in a separate test) the 5 Ib/gal, 8 Ib/gal, or 57% EC
formulation at 3 Ib ai/A. Ground applications must be made in at least 75 gal/A and aerial applications
must be made in a minimum of 10 gal/A. The number of applications in the required tests must reflect
either the maximum number proposed by the registrant to appear on the federal labels or maximum
number proposed for this use in CA. Tests must be conducted in CA. Alternatively, the registrant
may elect to cancel these uses permitted under EPA SLN Nos. CA810051, CA800152, CA800153, CA800154,
and CA800155.
148/ Data are required to determine malathion residues of concern in meal and refined safflower oil processed
from seed bearing measurable, weathered residues. If the data indicate a potential for concentration of
residues in safflower meal, the registrant must propose a feed additive tolerance.
109
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§158.125 Residue Chemistry (oont'd)
Data are required to determine malathion residues of concern in or on watercress harvested 7 days
following the last of foliar applications of the 5% D, 25% WP, and an EC formulation at 1.75 Ib ai/A, 1.25 Ib
ai/A, and 2.0 Ib ai/A, respectively (each formulation applied in a separate test). The registrant must
propose a maximum number of applications per season or a maximum seasonal application rate. The requested
data must reflect this maximum rate. Tests must be conducted in HI and FL.
Data are also required to determine malathion residues of concern on greenhouse-grown watercress collected
7 days following the last of multiple foliar applications of the 25% WP and (in a separate test)
the 5 Ib/gal EC formulation at 1.25 Ib ai/100 gal, and, in a separate test, the 10% RTU formulation at
16.7 fl oz product/50,000 cu ft as a fog.
Data are required to determine malathion residues of concern in or on tobacco harvested from the last
of multiple foliar applications of a D, and an EC formulation (each in separate tests) at 1.56 Ib ai/A.
All significant tobacco plant metabolites must be determined using ring-labeled [14C]malathion. Any
significant translocated degradation products from soil and photodegradation products must also be
determined. If total residues found in or on tobacco are >0.1 ppm, then (i) complete analytical methods
must be submitted for detecting and quantifying malathion and all metabolites of concern in or on tobacco
and in tobacco smoke; and (ii) pyrolysis products from malathion must be characterized using ring-labeled
[14C]malathion.
151/ Data are required to determine malathion residues of concern in or on shelled almond nutmeats sampled
immediately following treatment of shelled almonds at 0.156 Ib ai/10,000 Ib of nuts using a D formulation.
152/ Data are required to determine malathion residues of concern in or on stored barley. The registrant must
contact the Agency, within the allowed ninety (90) day period for indicating intention to support this
use, and either: a) request a determination of the specific formulations, rates, and application schedule
to be tested on barley; or b) indicate support of the use on wheat and request that the required
data for that use pattern be used to support the use on barley.
153/ Data are required to determine malathion residues of concern in or on bagged citrus pulp sampled
immediately following treatment schedule that includes initial treatment at 170 mg ai/sq ft and subsequent
monthly treatments at 127 mg ai/sq ft. Treatments using a D, the 25% WP, and an EC formulation must be
represented in separate tests.
110
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§158.125 Residue Chemistry (oont'd)
154/ Data are required to determine malathion residues of concern in or on corn grain sampled immediately
following the following series of applications Which includes: (i) application of a D and an EC formulation a
0.66 Ib ai/1000 bushels prior to storage in facilities which have received residual spray application of
the 3% RTU formulation at 0.6 Ib ai/1000 sq ft; (ii) treatment of the surface of stored seed using a D
and EC formulation at 0.33 Ib ai/1000 sq ft; and (iii) subsequent application of the 4% RTU at 2 fl oz
of 4% spray/1000 cu ft.
Data are also required to determine the potential for concentration of malathion residues during processing
of corn grain bearing measurable, weathered residues. Data are required for the following processed
commodities: starch, crude oil, and refined oil from wet milling and grits, meal, flour, crude oil and
refined oil from dry milling. If the data indicate a potential for concentration of residues in any of
these commodities, the registrant must propose a food/feed additive tolerance.
A tolerance must be proposed and appropriate supporting residue data submitted for grain dust from stored
com which has received the full series of stored-commodity treatments listed in above.
155/ Data are required to determine malathion residues of concern in or on oats. The registrant must contact
the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on oats; or b) indicate support of the use on wheat and request that the required data for that use
pattern be used to support the use on oats.
156/ Data are required to determine malathion residues of concern in or on peanut nutmeats collected
immediately after the last treatment in a series that includes: one pre-storage residual spray application
to the warehouse interior using an EC formulation as a 3.4% finished spray (2 gal/1000 sq ft), then one
treatment to the peanuts while moving onto storage using a D formulation at 1.25 Ib ai/15 tons of peanuts
and (in a separate test) an EC formulation at 1.7 Ib ai/5 gal/15 tons. After the bin is filled in each
test, the surfaces of the stored peanuts must be sprayed using the 25% WP formulation as a 1.65% finished
spray (2 gal/1000 sq ft); a second such treatment must be made 1 month later, immediately prior to sampling.
Data are required to determine malathion residues of concern in meal, crude oil, refined oil, and soapstock
processed from from stored peanuts bearing measurable, weathered residues. If residues concentrate in any
of these processed commodities, then an appropriate food/feed additive tolerance must be proposed.
I57/ Data are required to determine malathion residues of concern in or on raisins collected after 6 months of
storage in trays treated with an EC formulation at 1.4 g ai/144 sq ft of tray paper or in trays manufactured
using the 9% Impr formulation.
Ill
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§158,125 Residue Chemistry (cont'd)
158/ °ata are required to determine malathion residues of concern in or on rice grain sampled immediately
following the following series of applications: (i) application of a D and an EC formulation at 0.66 Ib ai/
1000 bushels prior to storage in facilities which have received residual spray application of the 3% RTU
formulation at 0.6 Ib ai/1000 sq ft; (ii) treatment of the surface of stored seed using a D and EC
formulation at 0.33 Ib ai/1000 sq ft; and (iii) subsequent application of the 4% RTU at 2 fl oz of 4%
spray/1000 cu ft.
The registrant must propose a tolerance for grain dust from rice and submit appropriate supporting
residue data.
Data are also required depicting the potential for concentration of residues during processing rice
grain bearing measurable weathered residues. Data are required for polished rice, hulls, and bran. If
the data indicate a potential for concentration of residues in any of these commodities, the registrant
must propose a food/feed additive tolerance.
Data are required to determine malathion residues of concern in or on rye. The registrant must contact
the Agency, within the allowed ninety (90) day period for indicating intention to support this use, and
either: a) request a determination of the specific formulations, rates, and application schedule to be
tested on rye; or b) indicate support of the use on wheat and request that the required data for that use
pattern be used to support the use on rye.
Data are required to determine malathion residues of concern in or on sorghum grain sampled immediately
following the series of applications which includes: (i) application of a D and an EC formulation at 0.66 Ib
ai/1000 bushels prior to storage in facilities which have received residual spray application of the 3%
RTU formulation at 0.6 Ib ai/1000 sq ft; (ii) treatment of the surface of stored seed using a D and EC
formulation at 0.33 Ib ai/1000 sq ft; and (iii) subsequent application of the 4% RTU at 2 fl oz of 4%
spray/1000 cu ft.
Data are also required to determine malathion residues of concern in flour and starch processed from
sorghum grain bearing measurable, weathered residues. If the data indicate a potential for concentration
of residues in either of these commodities during processing, a food/feed additive tolerance must be
proposed.
The registrant must propose a tolerance for residues of malathion in grain dust from sorghum grain
and submit appropriate supporting residue data.
112
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§158.125 Residue Chemistry (cont'd)
' Data are required to determine malathion residues of concern in or on sunflower seeds sampled immediately
following series of applications which includes: (i) application of a D and an EC formulation at 0.66 Ib
ai/bushels prior to storage in facilities which have received residual spray application of the 3% RTU
formulation at 0.6 Ib ai/1000 sq ft; (ii) treatment of the surface of stored seed using a D and EC
formulation at 0.33 Ib ai/1000 sq ft; and (iii) subsequent application of the 4% RTU at 2 fl oz of 4%
spray/1000 cu. ft.
162/ Data are required to determine malathion residues of concern in or on wheat grain sampled immediately
following the series of applications that includes: (i) application of a D and an EC formulation at
0.66 Ib ai/1000 bushels prior to storage in facilities which have received residual spray application
of the 3% RTU formulation at 0.6 Ib ai/1000 sq ft; (ii) treatment of the surface of stored seed using a
D and EC formulation at 0.33 Ib ai/1000 sq ft; and (iii) subsequent application of the 4% RTU at 2 fl oz
of 4% spray/1000 cu ft.
A tolerance must be proposed and appropriate supporting residue data submitted pertaining to residues of
malathion in the additional processed commodity and feed item, wheat grain dust.
The registrant must propose appropriate tolerances for malathion residues in bran, flour, middlings, and
shorts based on concentration factors of 57x, 8x, 10x, and 46x, respectively.
163/ A petition for a food additive regulation/tolerance must be submitted or the use in food areas of food
handling establishments, restuarants, or other areas where food prepared or processed must be deleted
from the labeling. The following type data must accompany the petition.
Data are required to determine the nature of residue in representative food products from typical food
handing establishments resulting from known contamination by [14C]malathion (labeled in a benzene ring).
Tests must represent the range of normal heating and processing procedures following fortification with
the M^C]malathion at typical stages where contamination resulting from treatment of the establishment
premises might occur. Characterization of residues must be conducted in samples representing the range of
normal shelf life for the food products.
113
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§158.125 Residue Chemistry (cont'd)
Data are also required to determine malathion residues of concern in food products resulting from application
of malathion in a food service establishment and a food manufacturing or food processing establishment.
Tests are required in these establishments utilizing a D, an EC and a RTU formulation as a contact spray,
and a RTU as a fogging treatment. Tests conducted must be representative examples of worst case scenarios
for potential residue contamination of food products which might include, but not be limited to, some of
the following: (i) particulate aerosol contact with packaged products or unwrapped fresh produce present
and/or on display at the itme of malathion treatment; (ii) contact of packaged foods with treated surfaces,
such as flour sacks stacked on treated floor surfaces in storage areas; (iii) accidental treatment of food
work surfaces and subsequent contact of food before surfaces are cleaned; (iv) treatment occurring near
stacks of new or cleaned product containers that are then filled without being cleaned; or (v) tracking of
residues by insects or rodents from treated areas to food or food contact surfaces.
j^/ Data are required to determine the nature and magnitude of the residue in water following treatment of
intermittently flooded areas with multiple applications of the 6% G, an EC, a SC/L, and the 3% RTU
formulation at 0.51 Ib ai/A, the 1.9% EC formulation at 16 gal of product/acre-foot, and registered treatment
of cranberry bogs and rice paddies (refer to the "Cranberry" and "Rice" sections for details of test
requirements). Degradation products in water must be identified and quantified. Should detectable residues
of concern occur in water then tolerance proposals for irrigated crops along with an estimated appropriate
level in water will be required. In lieu of the above, the registrant may modify the use as follows:
Broadcast use only over intermittantly flooded areas. Application may not be made around bodies of water
where fish or shellfish are grown and/or harvested commercially.
165/ The nature and magnitude of residues of malathion in water resulting from aquatic uses have not been
identified. If detectable residues of concern are found in water (refer to the "Nature and Magnitude of
the Residue in Drinking and Irrigation Water" section for details), then data from residue and metabolism
studies using fish will be required. Since the present use sites may include tidal areas, data depicting
residues in shellfish (a mollusc and a crustacean) will be required. If the registrant(s) modifies the
present pertinent labels as discussed in footnote 164, then no additional information will be needed for
fish and shellfish.
166/ This data is not required. On receipt of the data requested in the section entitled
"Nature of the Residue in Animals," the appropriate nature of tolerances for residues in animal products
will be determined and, with consideration for any newly found metabolites of toxicological concern, the
adequacy of the available data regarding the magnitude of residue in cattle and swine will be determined.
Additional data may be required.
114
-------
§158.125 Residue Chemistry (oont'd)
167/ This data is not required. On receipt of the data requested in the section entitled "Nature of the Resid
in Animals," the appropriate nature of tolerances for residues in animal products will be determined and,
with consideration for any newly found metabolites of toxicological concern, the adequacy of the
available data regarding the magnitude of residue in milk will be determined. Additional data may be
required.
168/ This data is not required. On receipt of the data requested in the section entitled "Nature of the
Residue in Animals," the appropriate nature of tolerances for residues in animal products will
be determined and, with consideration for any newly found metabolites of toxicological concern, the adequacy
of the available data regarding the magnitude of residue in fat, meat, and meat by-products and eggs will
be determined. Additional data may be required.
115
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TABLE A
GENERIC DATA REQUIREMENTS FOR MALATHION
Data Requirement
Test Use
Substance Patterns
Does EPA Bibliographic Must Additional Timeframe
Have Data? Citation Data be for
Submitted? Submission1/
TGAI or PAIRA A,B,C,D,G
TGAI or PAIRA A,G
TGAI or PAIRA A
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis TGAI or PAIRA A,B,C,D,E,F,G,H No
Photodegradation
161-2 - In Water
161-3 - On Soil
161-4 - In Air
METABOLISM STUDIES-LAB;
162-1 - Aerobic Soil TGAI or PAIRA A,B,E,F,G,H
162-2 - Anaerobic Soil TGAI or PAIRA A
162-3 - Anaerobic Aquatic TGAI or PAIRA C,D,G
162-4 - Aerobic Aquatic TGAI or PAIRA C,D
No
No
No
No
No
No
No
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 27 Months
(12 Months - Progress
Report)
Yes 27 Months
(12 Months - Progess
Report)
Yes 27 Months
(12 Months - Progress
Report)
Yes 27 Months
(12 Months - Progress
Report)
116
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TABLE A
GENERIC DATA
FOR MAlAffllON
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic Must Additional Timeframe
Citation Data be for
Submitted? Submission1/
§158.130 Environmental Fate (continued)
MOBILITY STUDIES;
163-1 - Leaching and Adsorption/ TGAI A,B,C,D,E,F,G,H No
Desorption ' or PAIRA
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DISSIPATION STUDIES - FIELD;
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES;
165-1 - Rotational Crops
(Confined)
TEP A,E,F
TEP A,E,F
• *
TEP A,B,H
TEP C,D,G
TEP G
TEP
TEP
N/A
A,C
PAIRA A,C
No
No
No
No
No
No
No
No
Yes
Yes
Reserved2/
Yes
Yes
Yes
NoV
Reserved^/
Yes
12 Months
12 Months
27 Months
(12 Months - Progress
Report)
27 Months
(12 Months - Progress
Report)
27 Months
(12 Months - Progress
Report)
To be Determined
39 MonthsS/
(12 Months - Progress
Report)
117
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TABLE A
GENERIC DATA REQUIREMENTS FOR MAIATHION
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data be for
Submitted? Submission1/
§158.130 Environmental Fate (continued)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Nontarget
Organisms
TEP
TEP
A,C
C,D
TGAI A,B,C,D,G
or PAIRA
TEP D,G
No
NO
NO
No
Reserved**/
Yes
Yes
Yes
39 MonthsV
(12 Months - Progress
Report)
12 Months
12 Months
I/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
2/ This study is reserved pending the results of the laboratory volatility study.
3/ The Agency is not imposing tank mix data requirements at this time.
4/ This study is reserved pending the results of the field dissipation studies.
5/ The first progress report is due twelve months after receipt of this Standard. Interim reports are due annually
thereafter.
6/ This study is reserved pending the results of the confined rotational crop study. Once acceptable data are available
~~ appropriate rotational crop intervals (if needed) will be established.
118
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TABLE A
GENERIC DATA REQUIREMENTS FOR MALATHION
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional Timeframe
Data be for
Submitted? Submission1/
§158.140 Reentry Protection
132-1 - Foliar Dissipation
TEP
A,B
No
N2/
132-1 -
133-3 -
133-4 -
Soil Dissipation
Dermal Exposure
Inhalation Exposure
TEP
TEP
TEP
A
A,B
A,B
NO
No
No
Nb2/
Nb2/
Nq2/
§158.142 Spray Drift
201-1 -
201-1 -
Droplet Size Spectrum
Drift Field Evaluation
TEP
TEP
A,B
A,B
No
No
Yes 18 Months
Yes 18 Months
I/ Due dates refer to number of months following receipt of this Registration Standard or as otherwise indicated.
2/ Data requirement has been waived. Although malathion is registered for use on crops whose production and/or harvest
~ would require human tasks characterized by a high likelihood of dermal and inhalation exposure, malathion does not
meet the toxicity requirements of §158.140.
119
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TABLE A
GENERIC DATA REQUIREMENTS FOR MALATHION
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data be for
Submitted? Submission^-/
§158.135 Toxicology
ACUTE TESTING;
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dermal Toxicity -
Rabbit
Acute Inhalation Toxicity -
Rat
81-3
81-7 - Delayed Neurotoxicity - Hen
SUBCHRONIC TESTING;
82-1 - 90-Day Feeding - Rodent
and Nonrodent (Dog)
82-2 - 21-Day Dermal - Rabbit
82-3 - 90-Day Dermal - Rat
82-4 - 90-Day Inhalation - Rat
82-5 - 90-Day Neurotoxicity
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
Yes
Yes
Yes
No
No
No
No
No
No
00144490,00158056
00159876,00164730
00144491,00158055,
00159877,00164730
00144492,00158057,
00159878
No
No
No
Yes
Nb2/
Yes
NoV
Yes4/
ReservedS/
9 Months
9 Months
15 Months
120
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TABLE A
GENERIC DATA REQUIREMENTS FOR MAIATHION
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic Must Additional Timeframe
Citation Data be for
Submitted? Submission1/
§158.135 Toxicology (continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity - Rodent
TGAI A,B,C,D,E,
F,G,H,I
Malaoxon A,B,C,D,E,
F,G,H,I
83-1 - Chronic Toxicity - Non-Rodent TGAI A,B,C,D,E,
F,G,H,I
83-2 - Onoogenicity - Rat
83-2 - Onoogenicity - Rat
83-2 - Qncogenicity - Mouse
TGAI A,B,C,D,E,
F,G,H,I
Malaoxon A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
Malaoxon A,B,C,D,E,
F,G,H,I
No
No
No
Yes
No
No
Yes
00043268, 00043269
00110562
Yes6/ 50 Months7/
(12 Months -
Progress Report)
Yesf/ 50 Months?/
(12 Months -
Progress Report)
Yesf/ 50 Months?/
(12 Months -
Progress Report)
YeslO/ 12 Months
50 MonthsV
(12 Months -
Progress Report)
50 Months?/
(12 Months -
Progress Report)
00043270
Yes
No
121
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TABLE A
GENERIC DATA REQUIREMENTS FOR MALATHION
Data Requirement
§158.135 Toxicology (continued)
83-3 - Teratogenicity - Rat
83-3 - Teratogenicity - Rabbit
83-4 - Reproduction - Rat
2-generation
MUTA6ENICITY TESTING;
84-2 - Gene Mutation
Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data? Citation Data be for
Submitted? Submission1/
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
NO
Yes
No
No
00152569
Yes
No
Yes
Yes
15 Months
39 MonthsV
(12 Months- Progress
Report)
9 Months
84-3 - Structural Chromosomal
84-4 - Other Genotoxic Effects
SPECIAL TESTING;
85-1 - General Metabolism
85-2 - Domestic Animal
Safety Testing
TGAI A,B,C,D,E,
F,G,H,I
TGAI A,B,C,D,E,
F,G,H,I
PAI A,B,C,D,E,
or F,G,H,I
PAIRA
TGAI A
NO
No
No
No
Yes 12 Months
Yes 12 Months
Yes 24 MonthsV
(12 Months - Progress
Report)
Yes 15 Monthsl2/
(Protocol - 90 DaysT"
122
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TABLE A
GENERIC DATA REQUIREMENTS FOR MALATHION
Data
Requirement
Test
Substance
Use
Patterns
Does
Have
EPA
Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission*/
S158.135 Toxicology (continued)
I/ Due dates refer to the number of months following receipt of the Registration Standard by the registrant, unless
otherwise indicated.
2/ These studies are not required since requirements for chronic rodent and non-rodent toxicity studies have been
imposed.
3/ The present use patterns and toxicity characteristics of malathion do not trigger the need for this study.
4/ This study is required because inhalation exposure may occur from use of malathion indoors.
"5/ This study is required via this Standard pendinq results of the delayed neurotoxicity study. If the results show
~~ neuropathy or neurotoxicity, the Agency will request that a 90-day neurotoxicity study be
submitted.
6/ A chronic feeding study is required in the F344 rat using malathion. It is suggested that the study be conducted
~~ as a combined chronic/oncogenicity study.
7/ A progress report is due 12 months from receipt of the Standard. Progress reports are due annually thereafter.
8/ A chronic toxicity study is required using malaoxon. This study may be performed as a combined chronic/oncogenicity
~ study. It is suggested that the study be performed in the F344 rat.
9/ This study was originally required under an Agency 1984 Data Call-in. A study was submitted to the Agency and
~ determined to be unacceptable. A new chronic dog feeding study is required.
10/ Acceptable oncogenicity studies have been performed in the Osborne-Mendel rat and Fischer 344 rat. Because of
concerns regarding the preparation of slides, pathology diagnoses and presentation of results in the Sprague-
Dawley rat study, an independent reevaluation of the microscopic slides is required. These must include all doses
and both sexes for the following tissues: liver, lung, kidney, pituitary, spleen, lymph nodes, mammary gland,
skin/ear, pancreas, thyroid, and heart. The reevaluation must include a grading of the severity of identified
changes. The slides must be reread blind, without prior knowledge of dose level. ._.„,_
ll/ An oncogenicity study is required using malaoxon. This study can be performed as a combined chronic/oncogenicity
study. It is suggested that the study be performed in the F344 rat. _
12/ A study is required to determine the effects of malathion on poultry when fed feed comprised of grain
dust (wheat, rice, soybeans and sorghum) containing residues of malathion.
123
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TABLE A
GENERIC DATA REQUIREMENTS FOR MALATHION
Data Requirement Test
Substance
§158.
AVIAN
71-1
71-2
71-3
71-4
71-5
72-1
145 Wildlife and Aquatic Orqanisms
AND MAMMALIAN TESTING:
- Acute Avian Oral Toxicity TGAI
- Avian Subacute Dietary
- Upland Game Bird TGAI
- Waterfowl TGAI
- Wild Mammal Toxicity TGAI
- Avian Reproduction TGAI
Upland Game Bird
- Simulated Field Testing and TEP
Actual Field Testing -
Mammals and Birds
- Freshwater Fish Toxicity
- Coldwater Species TGAI
TEP
Use Does EPA Bibliographic Must Additional Timeframe
Patterns Have Data? Citation Data be for
Submitted? Submission1/
A,B,C,D,E,F, Yes 00022923 No
G,H,I 40094601
A,B,C,D,E, Yes 00022923 No
F,G,H,I
A,B,C,D,E, Yes 00022923 No
F,G,H,I
N/A
A,B,C,D, No Yes2/ 24 Months
G,H (12 Months -
Progress Report)
A,B,C,D, Partially 00113233 ReservedV
G,H
BfD,C,D,E, Yes 40094602 No
F,G,H,I
A,B,CrD, Yes 40378301 No
G,H
124
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALATHION
Data
§158.
Requirement
145 Wildlife and Aquatic
- Warmwater Species
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic Must Additional
Citation Data be
Submitted?
Timeframe
for
Submission
Organisms (continued)
TGAI
TEP
B,DfC,D,E,
F,G,H,I
A,B,C,D,
G,H
Yes
Yes
40094602 No
40378301 No
AQUATIC ORGANISM TESTING:
72-2
72-3
- Acute Toxicity
to Freshwater
Invertebrates
- Acute Toxicity to
TGAI
TEP
A,B,C,D,E,
F,G,H,I
A,B,C,D,
G,H
Yes
No
40094602 No
YesV 9
Months
Estuarine and Marine
Organisms
a. Shrimp
b. Oyster
c. Fish
TGAI
TEP
TGAI
TEP
TGAI
TEP
A,B,C,D,
G,H
A,B,C,D
A,B,C,D,
G,H
A,B,C,D
A,B,C,D,
G,H
A,B,C,D
No
Yes
Yes
No
No
No
Yes 12
40398901 No
40228401 No
YesV 12
Yes 12
YesV 12
Months
Months
Months
Months
125
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TABLE A
GENERIC DATA REQUIREMENTS FOR MALATHION
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.145 Wildlife and Aquatic Organisms (continued)
72-4 - Fish Early Life Stage and
Aquatic Invertebrate Life
Cycle
TGAI
A,B,C,D,G,
H.I5/
No
Yes
15 Months
72-5 - Fish Full Life-Cycle
(Freshwater Species and
Estuarine/Marine Species)
TGAI
A,B,C,D,G
72-6 - Aquatic Organism
Accumulation
TGAI,PAI or A,B,C,D,G
Degradation Product
72-7 - Simulated Field Testing TEP
and Actual Field Testing
-Aquatic Organisms
A,B,C,D,G
No
NO
Partially 00058747,
00092217,
00092220,
00102372,
00105364,
00113198
Reserved^/
Reserved?/
Reserved^/
I/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
2/ This study is required because malathion formulations allow repeat formulations.
3 This study is required pending receipt and evaluation of environmental fate data and the avian reproduction study.
5/ Data must be derived from typical end-use products of the type used (i.e., emulsifiable concentrate with 50-60%
active ingredient).
5/ Required to support registrations of those formulations applied to livestock as the treated
livestock may move into waterways.
6/ This study is required pending receipt and evaluation of lower tier testing.
7/ This study is required pending receipt and evaluation of the environmental fate data.
B/ This study is required pending receipt and evaluation of the lower tier aquatic studies and environmental fate data.
126
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TABLE A
GENERIC DATA REQUIREMENTS FOR MALATHION
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic
Citation
Must Additional Tlmeframe
Data be for
Submitted? Submission
§158.155 Nontarget Insect
NONTARGET INSECT TESTING - POLLINATORS;
141-1 - Honey Bee Acute Contact
LD50
141-2 - Honey Bee - Toxicity of
Residues on Foliage
141-4 - Honey Bee Subacute
Feeding Study
141-5 - Field Testing for
Pollinators
TGAI
TEP
A,B,G,H
A,B,G,H
Reserved^/
TEP A,B,G,H
NONTARGET INSECT TESTING - AQUATIC INSECTS;
142-1 - Acute Toxicity to Reserved^/
Aquatic Insects
142-2 - Aquatic Insect Reserved^/
Life Cycle Study
142-3 - Simulated or Actual Field Reserved^/
Testing for Aquatic
Insects
143-1 - NONTARGET INSECT TESTING- Reserved5/
thru PREDATORS AND PARASITES
143-3
Yes
No
No
00001999,
00162751
No
Yes2/
15 Months
Reserved1*/
127
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MAIATHION
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission I/
§158.155 Nbntarget Insect (continued)
I/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
2/ As data from the acute toxicity study indicate a high toxicity, residual toxicity data are required.
3/ Reserved pending development of test methodology.
4/ Reserved pending results of the residual bee toxicity study.
5/ Reserved pending Agency decision as to Whether data requirement should be established.
128
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING MALATHION
Data Requirement
Test^/
Substance
Use Does EPA Bibliographic Must Additional Timeframe
Patterns Have Data?£/ Citation ^/ Data be for
Submitted? Submission^/
§158.120 Product Chemistry
Product Identity;
61-1 - Product Identity and MP All
Disclosure of
Ingredients
61-2 - Description of Beginning MP All
Materials and
Manufacturing Process
61-3 - Discussion of Formation MP All
of Impurities
Analysis and Certification of Product
Ingredients;
62-1 - Preliminary Analysis MP All
62-2 - Certification of Limits MP All
62-3- Analytical Methods to Verify MP All
Certified Limit
Physical And Chemical Characteristics;
63-2 - Color MP All
63-3 - Physical State MP All
63-4 - Odor MP All
Yes
Yes
Yes
9 Months
9 Months
9 Months
Yes
Yes
Yes
Yes
Yes
Yes
12 Months
12 Months
12 Months
9 Months
9 Months
9 Months
129
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING MALATHION
Data Requirement Test^/ Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have T>ata?V Citation V Data be for
Submitted? Submission^/
§158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
(continued)
63-7 - Density, Bulk Density, or MP All
Specific Gravity
63-12 - pH MP All
63-14 - Oxidizing or Reducing MP All
Action
63-15 - Flammability MP All
63-16 - Explodability MP All
63-17 - Storage Stability MP All
63-18 - Viscosity MP All
63-19 - Miscibility MP All
63-20 - Corrosion Characteristics MP All
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 15 Months
(8 Months - Progress
Report)
Yes 15 Months
(8 Months - Progress
Report)
Yes 9 Months
Yes 15 Months
(8 Months - Progress
Report)
Other Requirements;
64-1 - Submittal oE
Samples
All
137T
Reserved4/
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING MALATHION
Test^/
Substance
Use
Patterns
Does EPA
Have Data??/
Bibliographic
Citation V
Must Additional
Data be
Submitted?
Time frame
for
Submission-3/
Data Requirement
§158.120 Product Chemistry (continued)
I/ Formulation intermediates are also included in the category of manufacturing-use products.
J/ Although product chemistry data may have been submitted in the past/ the Agency has determined that these data
must be resubmitted for each manufacturing-use product. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations foe the old data are not applicable.
3/ Due dates refer to the number of months following receipt of this Registration Standard by the registrHnt,
unless otherwise indicated.
4/ These data are not required. When submittal of samples becomes necessary, the Agency will request them from the
~~ registrant.
131
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING MALATHION
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data?1/ Citation1/
Must Additional Timeframe
Data be for
Submitted? Submission^/
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation Toxicity
- Rat
- Primary Eye Irritation
- Rabbit
- Primary Dermal Irritation
- Rabbit
- Dermal Sensitization
MP3/ A,B,C,D,E,F,
G,H,I
MP A,B,C,D,E,F,
G,H,I
MP A,B,C,D,E,F,
G,H,I
MP A,B,C,D,E,F,
G,H,I
MP A,B,C,D,E,F,
G,H,I
MP A,B,C,D,E,F,
Yes
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
- Guinea Pig
G,H,I
\J Although acute toxicology 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/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
3 Formulation intermediates are also included in the category of manufacturing-use products.
132
-------
II. LABELING APPENDICES
133
-------
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 it-ems 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.lO(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 162.10(e)]
t
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)l
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 name.
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)]
134
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SUMMARY-2
Item 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 ot 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 )1
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))
Item 7C. SKULL & CROSSBONES 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 162.10(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)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - 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.lOftf)(2)].
135
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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 162.10(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)(ii)]
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
"Physical/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.
136
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following l^bel 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.
137
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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. When followed, directions must be adequate to
prdtect 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 connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
138
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PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
It OOMESTC ANMALS)
OANOBI
•NVMONMOfTAt HAZARDS
PNYSCALOHCHSMCAL
HAZARDS
OMOTONS FOR USE
to* to
• » • «MMM tf
In •
NMNTMV tTATIMfNT
STORAGE AND
r DISPOSAL
STORAOI
RESTRICTED USE
PESTICIDE
(reason for clasnifylnpj
KZ TO AMD OBK ONLT »T COffinO) APPUCMDRS OK
raooa wm THEIR omcr wFexvuioH AW ONLY TOR THOSE
uses omoo) tr THE CERTOTCO APPUOOOR'S
PRODUCT
NAME
ACTIVC tKWEOCNT:
Mf NT MOAEOCNT8:
TOTAL:
100.00%
TN0 mODUCT CONTAMa LB8 OF PEHOAUON
KEEP OUT OF REACH OF CHILDREN
DANGER -POISON
fTATEMCMT OF PRACTCAL TREATMENT
FSWA1LOM
FMHALfD:
VONIKM:
VMEYEt:
SCE K)C PANEL KM ADDITIONAL PRECAUTIONARY STATEMENTS
WARRANTY STATEMENT
MFOSY:
TOWN. STATE gj.
ir ABUSMMENT NO.:
EPA REMTRATON NO.
NET CONTENTS:
139
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SUMMARY-6
LABELING REQUIREMENTS Ob1 THE KIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Keg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
ot 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 tront
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not thfe producer, must
be qualified by "Packed tor . . .,"
"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 ot
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.
141
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SUMMARY-7
ITEM
7C
7D
7E
8
8A
«B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement ot
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I. II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, 11, and III
All products
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
ot back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
bA, 8b, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
142
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SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
limned lately
after misuse
statement
Immediately
before
specific
directions
tor use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix 11 guide
PHYS/CHEM
Includes a statement ot the teems of
restriction. The words ' "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation ot Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
tor use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/D1S for further
information and required statements.
May be in metric as well as U.S. units
143
-------
Chester J-— I nvirewnenteri Prel««*<«4i Agency
5 1*2.10
it obtained the data from anothi
(Identify): applicant copied
a publication: applicant ob
ipy of the data from EPA).
(A) The applicant shall submit
his application a statement that
in It* evaluation of the propertl
cacyAand safety of the formi
end-use product, may not consider any
data it supportint the applj
except \he followlnc data:
data the applicant £as sub-
(1)
mitted
, EPA under
safety of
ents.
eneVuM
(3)
regulations.
clearances
Pood. Drug.
A* offer to pay the
with regard to the
>pplli*it1frTii to the
by FXPRA sections
CX2XDK
An identification of the li
to which the offer applies:
An offer to commence
to ascertain the amount
of compensation to be paid:
The applicant's name.
it's
Includ-
com-
EPA would fMulre to be i
scientific reftew by EPA
cant sought the Initial
under PLFRA Section 3
-------
5 uno
(hr) The product registration
number M prescribed hi paragraph (e)
of thto section;
(v> The producing establishment
number M prescribed In paragraph (f)
of thto section:
(vl) An Ingredient statement M pre-
wrlbed hi paragraph <•> of thto sec-
tion;
(Til) Warning or precautionary state-
ments aa prescribed hi paratraph (h)
of thb section;
<»lll) The directions for vac as pre-
acrlbed hi paracraph C I) of this section:
and
(Ix) The uae clasatftcatloirts) a* pre-
aerlbed In paragraph of thto section.
(2) Prominence ant teffibilitf. (I) All
words, statements, graphic representa-
tions, dealgna or other Information re-
quired on the labeling by the Act or
the regulations In Into part muat be
dearly legible to a penon with normal
vision, and must be placed with men
conaplcuousnesa (aa eompared with
other woids. statements, designs, or
graphic matter on the labeling) and
expressed In aueh terma aa to render H
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchaae and uae.
(II) All required label text must
(A) Be net in 6-potnt or larger type;
(B) Appear on a clear contrasting
background: and
(C) Not be obscured or ciowded.
(9) Lanynaoe to be tued. All required
label or labeling text shall appear hi
the English language. However, the
Agency may require or the applicant
may propose additional text In other
languages as to considered necessary to
protect the public. When additional
text In another language to necessary.
all labeling requlrementa will be ap-
plied equally to both the English and
other-language versions of the label-
Ing.
(4) Placement of I*6eJ- Storage- When pesticide pro*
nets are stored hi bulk containers,
whether mobile or stationary, which
remain hi 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.
(B) FalM or mitteading statement!.
Pursuant to section ftqMlMA) of the
Act. a pesticide or a device declared
subject to the Act pursuant to
| U2.1B. to mtobranded If Ita labeling to
lalae or mtoteadlng hi any particular
Including both pestlddal and non-pea-
tlctdal claims. Examples of statements
or representations In the labeling
which constitute mtobrandlng Include:
(I) A fatoe or misleading statement
concerning the composition of the
product:
(ID A fatoe or misleading statement
concerning the effectlveneas of the
product as a pesticide or device;
(III) A false or misleading statement
about the value of the product for
purposes other than an 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 to recommended or endorsed by
any agency of the Federal Govern
(vl) The name of a pesticide which
contains two or more principal active
Ingredients If the name SURRCHU one
or more but -not all such principal
active Ingredients even though the
names of the other Ingredients are
stated elsewhere In the labeling:
(vll) A true statement used In such a
way an to give a false or misleading Im-
pression to the purchaser;
(vlll) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tion*;
(IX) Claims as to the safety of the
pesticide or Its Ingredients. Including
statements such M "safe," "nonpolson-
ous," "nonlnjurlous." "harmless" or
"nontoxte to humans and pels" 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 leant toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labettno. (I) Except
as provided In paragraph
-------
alfaj to It The registration
ami the required Identifying
shall not appear m such a i
> of -the. product by the
lf> Producing ateMtakmenls regis-
tration number. The producing intsli-
nshment registration nussber preced-
ed by the phrase "BPA Sat", ol the
final estaMfahment at which the prod-
uct was produced assy appear m any
austahbj location on the Hfrri or fasme-
dfaie container. It SMS* appear on the
wrapper or outside container of the
package If the EPA estabtfa
tatralmn number on the
container cannot be clearly
(g) rngmfteaf stelrmenf-41) OetMT-
TMe
(H) The text of the
.->eot must run parallel with
text on the panel on whMi It i
and must be clearly
from and must not be pmced bi the
body of other text
(3) Names to se used ta IngrnUenf
statement The name used for each tov
shall be the accepted
If there fa one, fO4-
may be used alone only
shall be used. In no ease
etary name be permitted unless such
•f.'rhelabel of each
must bear a statement which contains
the name and percentage by weight of
each active Ingredient the total per-
m. n_— aaamaWmhA •»•* •»!• •*»*•• aWmn^*M
OCTHm'iyg Ojr wMgm Ol gU| I1WT% vWlCTvQI-
enUc and If the pesticide contains ar-
senic m any form, a statement of the
percentages of total and water-soluble
snenlc 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. Roth terms shall be to the
same type she.' be aligned to the same
margin and be equally prominent The
statement "Inert Ingredients, none" fa
not required for pesticides which con-
tain lot percent active Ingredients.
Unless the Ingredtent statement ta a
complete analysis of the pestMdc. the
term "analysis" shall not be used ss a
heading for the big- ~ •
(1) futlffcm «/ f
(I) The nwredlent statement
graUenf
statement
Is nor-
mally required on the front panel of
the label. If then Is an outsMe con-
tainer or wrapper throuch which the
Ingredient statement cannot be clearly
read, the Increment statement must
also appear on such outside container
or wrapper. If the atse or form of the
package makes It Impracticable to
place the Ingredient statement on the
front panel of the label, permission
may be granted for the OH "
statement to appear else where.
name by the Administrator under the
authority of Section VMeMO.
(«l Statements «/ percentages. The
percentages of Ingredients shall be
stated m terms of wdght-lo-wilght
The sum of piiriiilagis of the active
and the Inert IngredtenU shall be MO.
Percentages shall not be expressed by
a range of values such as "»-»%." If
the uses of the pesticide product are
cBpvCunVJGQ •• wdctili of gmCuvvs tnifredl-
cni per unit are*, a daUmtiii of the
•- »-« -.* -, «•%••- wwamm^Mr' - * **
wfitum 01 fACuvfc mq"*^m
volume of the pesUchi
ahallataa appear ha the
(S) ^ccurucy o/ states! „
The pereentages sjtven shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the vatae stated for
each active tngredvent shall be the
lowest percentage which may be pres-
ent
(•) Deterioration. PesUddes whMi
change to chemical composition sig-
nificantly must meet the following m-
twmlmraav BMfcvuanVMMBwtamftfl*
(I) In cases where R fa determined
that a pestMdc formulation changes
chemical composition significantly.
the product must bear the following
statement m a prominent position on
the label: -Hot for sale or use after
Idatel."
(II) The product must meet all fabd
chums up to the expiration time Indi-
cated on the labd.
(7) Inert tagfcdfents. The Adminis-
trator may require the name of any
J46
Inert IngredlenUs) to be listed In the
mxTcdbait ststenunt If he detenumes
that such mgredtenUs* may pose a
hoard to man or the environment
i**tsi.
l-pr mtme. anil promlnrnrr ivr «Nrn
(l> JCrmrirnf front mmrf ttmtrmrnt*.
WHh the exceptlnn of thr chlW
hasard warning slatrment the Irxl tr
qutoed on the front panel of thr tanrl
fa detei mined by the ToxirUy CnU-Ko
ry of the ptsth-lde. The rstrsnry Is «n-
slgned on the baids of the hbtltrxl
hasard shown by any of the ImMrabtni
m the table betow.
(I) Hmmrnn hmx*rm •fowaf uont—4A)
ToxleUy Osteoory /. All pesticide prod-
ucts meeting the criteria of ToxMty
Category 1 shall bear on the front
panel the signal word "Danger." In ad-
dition If the product was smtgned to
ToxMty Category I on the basb of Its
oral. Inhalation or dermal toxldty (as
dktlnct from skin and eye local ef-
fects) the word "Poison" shall appear
m red on a background of distinctly
contrasting color and the skull and
crombuneii shall appear hi Immediate
proximity to the word "poison."
TaxtcUf Category II. All pest!
dde products meeting the criteria of
ToxMty Category II shall bear on the
front panel the signal word "Warn-
ing."
(O TtafcUy Oslesory III. All pesti-
cide products meeting the criteria of
ToxMly Category III shall bear on
the front panel the signal word "Cau-
tion."
roxJrtty Category IV. All pesti-
cide products meeting the criteria of
ToxMty Category IV shall bear on the
front panel the signal word "Caution."
Vie of tipnml awnf*. Use of any
signal wonMs) amoctated with a higher
ToxMty Category fa not permitted
except when the Agency determmni
that such labeling fa neresmry to r»rr
vent unreasonable adverse effect* on
man or the environment. In no roue
shall more than one human huou-d
signal word appear on the front panrl
of a label.
(II) OklM Jkacanf uwrntao. Rvery pen
Udde product label shall bear on the
front panel the statement "keep out ol
reach of children." Only In our*
where the likelihood of contart with
children during distribution, market
Ing. storage or use fa demonstrated hy
the applicant to be extremely remote.
or If the nature of the pesUcMe h such
that It to approved for use on Infant.*
or small children, may the Admlnfcitrm.
tor waive thb requirement
Statement o/ practical Irraf
ment-4M Ttafctty Gsfepnnr I. A
statement of practical treatment (Unit
aid or other) shall appear on the front
panel of the label of all pesUcMe* fell
Ing mto ToxMty Category I on thr
bsafa of oral. Inhalation or dermal to.
Mty. The Agency may. however.
permit reasonable variations In thr
of the statement of prsrtl
30