&EPA
United States
Environmental Protection
Agency
Office of
Pesticide* and Toxic Subtu
Washington OC 20460
Pesticide*
February 1985
Guidance for the
Reregist ration
of Pesticide Products
Containing
Demeton
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CAS NUMBER 143
GUIDANCE FOR THE
REREGISTRATION OF MANUFACTURING-USE
AND CERTAIN END-USE PESTICIDE PRODUCTS
CONTAINING
DEMETON
(057601)
CAS 8065-48-3
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
February, 1985
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TABLE OF CONTENTS
Introduction • 1
I. Regulatory Position and Rationale 4
II. Requirement for Submission of Generic Data 94
III. Requirement for Submission of Product-Specific
Data 97
IV. Submission of Revised Labeling and Packaging
Information 98
A. Label Contents 98
1. Product Name 98
2. Company Name and Address 98
3. Net Contents 98
4. Product Registration Number 98
5. Producing Establishment
Registration Number 98
6A Ingredient Statement 99
6B Pounds Per Gallon Statement 99
7. Front Panel Precautionary Statements 99
7A Child Hazard Warning Statements 99
7B Signal Word 99
7C Skull and Crossbones and Word Poison 100
7D Statement of Practical Treatment 100
7E Referral Statement 100
8. Side/Back Panel Precautionary Labeling 100
8A Hazard to Humans and Domestic Animals 100
8B Environmental Hazard 100
8C Physical or Chemical Hazard 100
9 Product Classification . 100
10 Misuse Statement 103
10A Storage and Disposal Block 103
10B Directions for Use 103
B. Collateral Information 103
V. Instructions for Submission. 104
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APPENDICES
II-l Guide to Bibliography
II-2 Bibliography
II-3 FIFRA S3(c)(2)(B) Summary Sheet - EPA Form 8580-1
II-4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-2
III-l Product Specific Data Report (End-Use Products)
IV-1 40 CFR 162.10 Labeling Requirements
IV-2 Table of Labeling Requirements
IV-3 Physical/Chemical Hazards Labeling Statement
IV-4 Storage and Disposal Instructions
ii
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. 3(g), as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible. Each
registrant of a manufacturing use product of the active
ingredient who wishes to continue to sell or distribute that
product must apply for reregistration.
To carry out this task, we have established the Regis-
tration Standards program, which will review all pesticide
active ingredients first registered before January 1, 1977.
These pesticides will be reviewed in use clusters which are
prioritized on the basis of a ranking scheme giving preference
to pesticides used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. Based on the regulatory position,
the Agency may require the registrant to modify product labels
to provide additional precautionary statements, restrict the
use of the pesticide to certified applicators, provide
reentry intervals, modify uses or formulation types, specify
certain packaging limitations, or other requirements to
assure that proper use of the pesticide poses no potential
adverse effects to human health or the environment.
The scientific review, which is not contained in this
Guidance Package but is available upon request, concentrates
on the technical grade of the active ingredient and identifies
missing generic data. However, during the review of these
data we are also looking for potential hazards that may be
associated with the formulated (end use) products that contain
the active ingredient. If we find serious concerns, we will
bring formulated products under the provisions of the Regis-
tration Standards program to the extent necessary to protect
the public.
EPA has the authority under FIFRA §3(c)(2)(B) to require
that registrants submit data that will answer our questions
regarding the hazard that may result from the intended use of
the pesticide under review. Further, §3(c)(2)(B) provides
that these data are to be submitted by those registrants who
do not qualify for the formulator's exemption [FIFRA
§3(c)(2)(D)]. Normally, this means that the registrants who
are responsible for filling the data gaps are the manufacturing
use product producers (basic suppliers of the active ingredient)
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However, end-use producers will not qualify for the formulator's
exemption if the source of their active ingredient: (1) is
not registered with EPA, and/or (2) is produced by the regis-
trant's firm, or a firm which has ownership in common with
the registrant's firm. These end use produce is can qualify
for the formulator's exemption if they change their source of
supply to a registered source, provided the source does not
share ownership in common with the registrant's firm. If the
end use product registrant decides to switch sources, a new
Confidential Statement of Formula, EPA Form 8570-4, must be
submitted to the appropriate Product Manager within 90 days
of receipt of this Guidance Document. The chart on the
following page shows what is generally required of those who
do and do not qualify for the formulator's exemption in the
Registration Standards program.
If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the reregistration
requirements of this Guidance Document, please notify the
Product Manager named in the cover letter, within 90 days
from the receipt of this document, that you wish to voluntarily
cancel the registration(s). If you decide to maintain your
product registration(s), you must provide the information
described in the following pages within the timeframes
outlined. EPA will issue a notice of intent to cancel or
suspend the registration of any currently registered product
if you fail to comply with the requirements set forth in
this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you at
any time to submit factual information raising concerns of
possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in
progress if those results show possible adverse effects.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
I. Products That Do Not. Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
ACTIONTST REOUIRED~TO~
MAINTAIN REGISTRATION
These products must he reregis- |
tered. To obtain reregistration,;
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labelTng~precautions may
also be required. There are no
products containing demeton in
this category.
II. Products That Do Qualify For
The Formulator1s Exemption
In the case of this Standard,
labeling statements are required
to protect man and the environ-
ment. These products are subject
to certain provisions of this
Standard as described herein.
*End use products of registrants who aTso produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes reguired for products in "II"
above. If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and R above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B.
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II. REGULATORY POSITION AND RATIONALE
A. Introduction
This chapter contains the Agency's regulatory position and
rationale on products containing the pesticide demeton as a
sole active ingredient. The Agency bases its position and
rationale on a consideration of all uses of demeton appearing
on pesticide products registered under Sections 3 and 24(c)
of the FIFRA as well as on products authorized for distribu-
tion in intrastate commerce under 40 CFR 162.17. The Agency
has reviewed the known chemical, environmental, and toxico-
logical characteristics of this pesticide and its established
tolerances for residues in or on food and feed commodities.
From these considerations the Agency sets forth the data and
labeling requirements that must be met by registrants and
applicants for registration of demeton manufacturing-use (MP)
products in order for their products to be registered or
reregistered under this Standard. Unique labeling requirements
and certain data needs for end-use products (EPs) containing
demeton are also established by this Standard.
Only those data and labeling requirements for current
and future substantially similar MPs and EPs are addressed
here. Applications to register products that differ appreciably
from those described in this Standard may be subject to addition-
al data and/or labeling requirements.
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B * Pescripti°n °f Chemical
Demeton is the British Standards Institute (BSI) and Entomo-
logical Society of America (ESA) approved common name given
to the chemical mixture consisting of 0 ,0-diethyl 0- [ 2- ( ethylthio)
ethyl] phosphorothioate and 0,f)-diethyl S- [ 2-ethylthio) ethyl]
phosphorothioate. Other names include Systox , Demeton-0 +
Demeton-S, mercaptophos and mercaptophos teolevy (USSR), Bay
10756, Bayer 8169, E-1059 , Systemox and Demox . Demeton-S is
also known at Isosystox. Identifying characteristics and
codes are as follows:
Empirical Formula: CpH^gO3PS2
Molecular Weight: 258.32
CAS Registry No.: 8065-48-3
ENT Registry No.: 17295
Shaughnessy No.: 057601
Technical demeton is a light brown liquid. Its odor is char-
acteristic of sulfur compounds. Demeton is soluble in most
organic solvents, and is subject to hydrolysis under alkaline
conditions. Information on the chemical and physical properties
of technical demeton are for the most part lacking and constitute
data gaps.
Mobay Chemical Corporation is the sole producer of demeton in
the United States and markets its products under the trade
name Systox®. There is one 85% technical (MP) product and six
(EP) products registered for use in the United States. These
are all single-active ingredient formulations.
Demeton is a systemic acaricide/insecticide registered for
use on vegetable, field, orchard, and ornamental (including
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greenhouse) sites. It is formulated into a 1.985% granular
(G) formulation, and 2 and 6 Ib/gal emulsifiable concentrate
(EC) formulations. Demeton is applied to agricultural crops
as a foliar spray using ground or aerial equipment. Ornamentals
are treated by applying granules around the base of each
plant, or alternatively when emulsifiable concentrates are
used, as a foliar spray or soil drench. Usage data available
to the Agency indicate that apples, potatoes and wheat are
the high volume use sites, while Brussels sprouts have the
greatest percentage of the crop acreage treated. Demeton is
a restricted-use pesticide and applicators must be certified
or be under the direct supervision of applicators certified to
apply demeton [43 FR 5782, February 9, 1978].
C. Regulatory Position and Rationale
Based on a review and evaluation of all available data and
other relevant information on demeton, the Agency has made
the following determinations:
1. All products containing demeton as a sole active ingredient
may continue to be registered for sale, distribution,
reformulation, and use, subject to the terms and conditions
specified in this Guidance Document. Registrants must
provide, or agree to develop, additional data, as specified
in Tables A, B, and C, in order to maintain existing
registrations or to permit new registrations.
Rationale: Under FIFRA, the Agency normally does not cancel
or withhold registration simply because data are missing
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or inadequate (see Sections 3(c)(2)(B) and 3(c)(7) of
the FIFRA). Rather, issuance of this Standard provides
a mechanism for identifying data needs. These data will
be reviewed and evaluated when they are received and the
Agency will determine at that time whether they will
affect the registration(s) of demeton.
2. The Agency will not allow any signficant new uses* to be
established for demeton until the toxicological and
residue chemistry data deficiencies identified in Table
A have been satisfied.
Rationale: The Agency is unable to complete a tolerance
reassessment of demeton because of extensive residue chem-
istry and toxicology data gaps. The data requested in Table
A are needed for EPA to calculate an acceptable daily intake
(ADI) level of demeton and its metabolites and to reassess
the present tolerances. Refer to Section G. Tolerance
Reassessment Summary for a complete discussion. The
Agency will not allow any significant new uses until the
toxicological and residue data have been received and evaluated
3. The Agency is requiring that a gene mutation assay in
mammalian cells in culture and a chromosome aberration
assay in vivo be performed to assess the mutagenic potential
* The terminology "significant new use" is defined in 44
FR 27934, May 11, 1979. In the case of a new food or
feed use, the Agency will generally consider as signif-
icant an increase in the Theoretical Maximal Residue
Concentration of greater than 1%.
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of demeton. After a review of these studies, the Agency
will determine whether a special review is warrented.
Rationale; Six mutagenicity studies available to the
Agency demonstrate positive results. The mutagenicity
exhibited by demeton is demonstrated in tests for point
mutations and for chromosome aberrations. Of the positive
studies available at this time, however, all have been
performed jln vitro in cells. In order to better characterize
the mutagenic potential of demeton, a gene mutation
assay in mammalian cells in culture and a chromosome
aberration assay in vivo are required. Depending upon
the results of the above studies, the Agency may request
further data.
4. All end-use products containing demeton shall continue to
be classified for restricted use.
Rationale: EPA has very limited data on the acute toxicity
of end-use products containing demeton. Based on the high
acute toxicity of the active ingredient, demeton, the Agency
has determined that demeton products should continue to
be classified for restricted use. Registrants may submit
data specified in Table C if they believe that their particular
product does not warrant the restricted use classification.
Refer to Section IV(a) for classification information.
5. The Agency is requiring that pertinent chemistry and
environmental fate data be submitted on an accelerated basis
in order to characterize demeton's potential for contaminating
ground water.
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Rationale; At present, no data are available to assess
the environmental fate of demeton or to characterize its
potential for contaminating ground water. The Agency
has become increasingly concerned about the presence of
pesticide chemicals in ground waters in the United States
and has identified a number of chemicals, including
demeton, which may have the potential to enter ground
waters based on factors such as chemical structure,
solubility and use patterns. On March 31, 1984, the
Agency issued a Special Data Call-in Notice under FIFRA
§3(c)(2)(B) requesting that pertinent data be submitted
in an expedient manner (most data are due by March, 1985).
6. The Agency will continue to require the reentry interval
of 48 hours established under 40 CFR 170 for all outdoor
uses of demeton in order to minimize exposure to workers
entering treated areas, pending the receipt and evaluation
of reentry data to assess the potential for exposure to
workers handling demeton.
Rationale: The Agency is concerned about the possible
dermal and inhalation exposure to workers handling demeton
because of its high acute toxicity. A Federal reentry
interval of 48 hours is set for all crops under 40 CFR
170. Because of demeton's high acute toxicity, this
reentry interval is being retained. Through this Standard,
studies are being required to further evaluate demeton's
exposure potential. Based on these submitted data, EPA may
impose a different reentry interval.
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7. Pesticide spray drift data requirements are being imposed
by this Standard. Data being required include droplet size
spectrum studies and field evaluation of pesticide drift.
Rationale: The Agency is concerned about the potential
hazards to non-target organisms (fish and wildlife,
domestic animals and humans) caused by drift from aerial
and ground air-blast applications of demeton. The Agency
is imposing these data requirements because demeton is a
highly toxic pesticide and because demeton may be applied
by air or ground air-blast equipment.
8a. A study is required to monitor the residues of demeton in
aquatic sites adjacent to grove/orchards.
Rationale: Demeton is very highly toxic to freshwater
invertebrates. The Agency calculates that if demeton
emulsifiable concentrate is applied at the label rate of
six pounds a.i. per acre to an apple orchard 10 acres in
size draining into a two acre pond, and assuming a 2%
loss from the treated area through drift and runoff, the
resulting concentration in the pond will exceed the
acute toxicity level for an aquatic invertebrate species.
Therefore, EPA is requiring field monitoring data which
will be useful in the evaluation of this exposure calcu-
lation.
8b. A study to monitor the residues of demeton on avian feed
items is required.
Rationale; Acute toxicity studies indicate that demeton
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is very highly toxic to birds. Calculations show that a
direct application of demeton emulsifiable concentrate
at a label rate of five to six pounds a.i. per acre to
an apple orchard may result in a residue level on avian
feed items greater than the acute toxicity level in an
avian species. Therefore, EPA is requiring a monitoring
study which will be useful in the evaluation of this
exposure calculation. Based on the results of this study,
and the outcome of the environmental fate profile, the
Agency may request that an avian field study be performed.
Once the Agency has reviewed these studies, it will
determine whether EPA should initiate a public interim
review process by placing the chemical in Special Review.
If instead, regulation of the chemical through the
normal registration process is found to be appropriate,
the Agency will update its regulatory position and rationale
to reflect this conclusion and reasoning behind it.
9. The Agency will impose interim labeling to protect endangered
species, if the generic (cluster) analysis for endangered
species has not been completed in time to impose appropriate
labeling in time for the 1986 growing season. At this time,
no label statements are being imposed.
Rationale; Appropriate labeling for the protection of
endangered species determined to be in jeopardy is being
developed in conjunction with a generic (cluster) approach,
rather than under this Standard. This generic approach,
which entails the analysis of the effects of all pesticides
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on endangered species on a crop by crop basis, rather
than a chemical by chemical approach, is being developed
in cooperation with Federal and State enforcement agencies,
the Office of Endangered Species (OES) and the U.S.
Department of Agriculture (USDA), using the extension services
and the National Agricultural Chemical Association (NACA)
Thus, the labeling developed under this approach
will encompass all endangered species associated with use
of pesticides on a particular crop.
The Office of Endangered Species, Fish and Wildlife
Service, has issued biological opinions for the cotton,
sorghum, and small grains (wheat, barley, oats) clusters.
The continued existence of the Attwater's greater prairie
chicken, Aleutian Canada goose, Everglades kite, slackwater
darter, woundfin, freshwater mussels, valley elderberry
longhorn beetle, delta green ground beetle and Kern
primrose sphinx moth is jeopardized by the uses of several
pesticides, including demeton, on the above crops.
It may be determined that more species are jeopardized by
demeton when other clusters are completed. It is anticipated
that appropriate labeling will be developed in time for
the 1986 growing season. If not, the Agency will impose
interim labeling to protect endangered species.
10. Registrants of end-use products must submit revised labeling
which incorporates the label precautions found in Section F.
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Rationale; The Agency believes that label statements
prescribed in this Guidance Document should minimize the
acute hazards associated with the oral, dermal, inhalation
and ocular routes of exposure to users of demeton, and
should minimize the hazards to terrestrial and aquatic
organisms.
D. Criteria for Registration Under This Standard
To conform to this Standard, products must contain
demeton as the sole active ingredient, bear required
labeling, and conform to the product composition, acute
toxicity limits, and use pattern requirements listed in
section E of this document.
The application for registration or reregistration of
manufacturing-use products subject to this Standard must
comply with all terms and conditions described in it,
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 3(c)(l)(D) and 3{c)(2)(D) of the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA), as amended, 7
U.S.C. 136(c)(l)(D) and 136(c)(2)(D). Registrants of
end-use products who qualify for the Formulator's Exemption
must submit five (5) copies of draft labeling incorporating
the unique label statements identified in Section F.
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E. Acceptable Ranges and Limits
Product Compos i t ion Standa rd
To conform to this Standard, manufacturing-use products
must contain demeton as the sole active ingredient. Each
MP formulation proposed for registration must be fully
described with an appropriate certification of limits,
stating maximum and minimum amounts of the active and
intentionally added inert ingredients which will be present
in products.
Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing demeton, provided
that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which each
product is placed.
Use Patterns
To conform to this Standard, manufacturinguse products
containing demeton may be labeled for formulation into
end-use products only for the commodities listed below.
The attached index entry lists all registered uses (and
intrastate label uses*) as well as approved maximum application
rates and frequencies.
0 Terrestrial, non-domestic, food uses on:
alfalfa/ almond^ apple,aprTcot, Barley,
beans, broccoli, Brussels sprouts, cabbage,
* Intrastate uses have not been reviewed for acceptability
under sec. 3 of the FIFRA. Therefore, these uses may not
be added to any product registered under sec. 3 until the
supporting data have been submitted, reviewed and found to
be acceptable
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cauliflower, celery, cherry, cotton, eggplant,
filbert, grapefruit, grapes, hops, lemon,
peach, pear, peas, pecan, peppers, potatoes,
plums (fresh prunes), sorghum, strawberry,
sugar beets, tomato, walnut and wheat. State
registration ( intrastate) exist for the following
additional crops: trefoil, leafy vegetables
(including Chinese cabbages, mustard greens),
cucurbits (including oriental squashes, melons,
gourds and pumpkins), yard-long beans, Chinese
peas, and endive.
0 Terrestrial, non-domestic npj}l£°°l H£!ls on :
pTneappT~Tnon-Bea r £ rigT", ~s tTone~Fru i t s Tnon-bearing) ,
ornamental flowering plants (incl. chrysanthemum,
daffodil, delphinium, lilies, pansies and
primrose), ornamental flowering shrubs (incl.
azalea, camellia, roses and viburnum), ornamen-
tal trees (incl. linden and American holly);
post-harvest treatment to blackberry, dewberry,
gooseberry, loganberry and raspberry.
0 Greenhouse non-food uses on: ornamental
FTowerrng~pra77Fs"~rTncTT~chrysanthejnum, daffodils,
lilies and primrose), ornamental shrubs and
ornamental trees.
0 Forestry Uses on: forest tree plantings
flntraslfaTe laBe 1 ) .
F. Required Labeling
All manufacturing-use and end-use demeton products must
bear appropriate labeling as specified in 40 CFR 162.10.
The guidance package for this Standard contains information
on label requirements.
0 Ingredient Statement
The ingredient statement for MPs and EPs must list the
active ingredient as:
demeton: 0,0-diethyl 0- [ 2- ( ethylthio) ethyl] phosphorothioate
and 0,0-diethyl S- [ 2- ( ethylthio) ethyl] phosphorothioate
0 Use Pattern Statement
All manufacturing-use demeton products must state that
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they are intended for formulation into end-use products
for the aforementioned use patterns. Labeling must specify
sites, which are listed in Use Patterns, Section 5.3. A
limiting factor will be data that support these use patterns.
No use may be included on the label where the registrant
fails to agree to comply with the data requirements in
either Table A or Table B for that use pattern. For intrastate
uses, the data requirements must be met first.
° Precautionary Statements
Statements for Manufacturing-Use Products
1. Labels for manufacturing-use demeton products must
bear statements reflecting the compound's acute human
toxicity. Demeton is in Toxicity Category I by the
dermal and ocular routes of exposure; required precautionary
statements associated with this category are specified
in 40 CFR 162.10.
2. The following revised environmental hazard statement
must appear on all MP Labels:
This pesticide is toxic to fish and wildlife. Do not
discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans, or public waters
unless this product is specifically identified and
addressed in an NPDES permit. Do not discharge effluent
containing this product to sewer systems without previously
notifying the sewage treatment plant authority. For
guidance contact your State Water Board or Regional
Office of the EPA.
Statements for End-Use Products
1. All end-use products must bear the restricted-use
statement:
RESTRICTED USE PESTICIDE
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.
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The basis for the restricted-use classification must
appear directly beneath the RESTRICTED USE PESTICIDE
HEADING. The basis for the restricted use classifi-
cation is as follows:
1.985 percent granular Acute oral toxicity
formulation and acute dermal toxicity
All granular formulations, Acute dermal toxicity and
emulsifiable concentrates, residue effects on mammalian
and concentrated solutions and avian species.
2. The worker protection statements below must appear on
all products, if they do not already appear on the
labeling:
Wear rubber gloves, protective clothing, rubber
overshoes and goggles. Wear a respirator jointly
approved by the Mine Safety and Health Admini-
stration (formerly U.S. Bureau of Mines) and the
National Institute of Occupational Safety and Health.
If the product is in Toxicity Category I on the basis of
inhalation toxicity, the registrant must specify an
appropriate respirator for users.
3. The reentry statement below must appear on all demeton
products with directions for outdoor use:
Do not reenter treated fields within 48 hours unless
appropriate protective clothing is worn.
4. In the absence of crop rotation data, the crop rotation
restriction below must be placed on all EP's which
may be used in a situation where rotation with crops
used for food or feed that are not registered with
demeton may occur:
Do not rotate with any food or feed crop for which demeton
is not registered.
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5. One of the Environmental Hazard statements listed below
is required to appear on each EP product:
Granular
This pesticide is toxic to fish and wildlife. Do not
apply directly to water. Runoff from treated area may
be hazardous to aquatic organims in adjacent aquatic
sites. Cover or incorporate granules which are spilled,
Do not contaminate water by cleaning of equipment or
disposal of wastes.
Non Granular
This pesticide is toxic to fish and wildlife. Do not
apply directly to water. Runoff and drift from treated
area may be hazardous to aquatic organisms in adjacent
aquatic sites. Do not contaminate water by cleaning of
equipment or disposal of wastes.
7. Tolerance Reassessment Summary
The established tolerances for demeton are published in
40 CFR 1R0.105 and 21 CFR 561.130. A summary of these
tolerances is presented in Table I.
Sufficient data are available to determine that the
established tolerances for residues of demeton in or on
eggplant, sorghum grain and forage, and cottonseed are
adequate. However, additional data are required to
support the tolerances for residues in or on potatoes,
sugar beet roots and tops, dehydrated sugar beet pulp,
celery, lettuce, broccoli, Brussels sprouts, cabbage,
cauliflower, beans, peas, peppers, tomatoes, muskmelons,
grapefruit, lemons, oranges, apples, pears, apricots,
nectarines, peaches, plums, grapes, strawberries, almonds,
almond hulls, filberts, pecans, walnuts, grain of barley,
oats, and wheat, green fodder and straw of barley, oats,
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and wheat, alfalfa (fresh and hay), clover (fresh and
hay) and hops.
Additional data are needed to determine whether food/feed
additive tolerances must be proposed for the following
processed products: potato granules, chips and dried
processed potatoes; molasses and refined sugar processed
from sugar beets; bean cannery residue; tomato juice,
puree, catsup and wet and dry pomace; dried pulp, peel,
oil, molasses and juice of citrus; wet and dry pomace
and juice of apples; dried prunes; raisins, juice, raisin
waste, and wet and dry grape pomace; barley germ and
milling products; milled products of oats and wheat;
flour and milled products of sorghum; alfalfa meal;
meal, hulls, soapstock, and crude and refined oil of
cottonseed; and dried and spent hops.
Feeding restrictions or additional data and tolerance
proposals are needed for the following raw agricultural
commodities: bean vines and hay; pea vines and straw;
and sorghum fodder, silage, and hay. Also, residue data
and tolerance proposals are needed for oat hulls, hay of
barley, oats and wheat, and alfalfa seed. The commodity
definitions for "green fodder" of barley, oats, and
wheat will be changed to "forage" and the commodity
definitions for "fresh" alfalfa and clover will be changed
to "forage."
Registrations exist for several commodities for which no
tolerances have been established because these uses have
19
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previously been considered to be "non-food" uses. The 2
and 6 Ib/gal EC formulations are registered for foliar
use on nonbearing cherries, postharvest foliar use on
blackberries, dewberries, gooseberries, loganberries,
and raspberries, and dip treatment to planting stock of
pineapples. Additional data are needed to determine
whether "non-food" classification is justified.
Intrastate registrations exist for the following
raw agricultural commodities: Chinese cabbages, mustard
greens, green onions, endive, oriental squash, melons,
gourds, pumpkins, trefoil grown for seed. Tolerance
proposals and residue data must be submitted if registration
of these uses under sec. 3 of FIFRA is sought.
The metabolism of demeton in plants is adequately understood,
Demeton is readily absorbed and translocated by plants.
Identified metabolites include 0,0-diethyl O-ethyl-2-
sulfinylethyl phosphorothioate (III), 0,0-diethyl 0-ethyl-
2-sulfonylethyl phosphorothioate (IV), 0,0-diethyl
O-ethyl-2-sulfinylethyl phosphate (VI), 0,0-diethyl
S-ethyl-2-sulfinylethyl phosphorothioate (VIII), and
0,0-diethyl S-ethyl-2-sulfonylethyl phosphorothioate
(IX). Although not identified, 0,0-diethyl O-ethyl-2-
mercaptoethyl phosphate (V) and 0,0-diethyl O-ethyl-2-
sulfonylethyl phosphate (VII) are expected to occur
through oxidation of the thiono-isomer of demeton.
Also, 0,0-diethyl phosphorothioate (X), 0,0-diethyl
phosphoric acid (XI), and phosphoric acid (XII) are
20
-------
metabolites expected to occur through hydrolysis from the
oxidative products of both demeton isomers; compounds X,
XI and XII have been identified as hydrolysis products
of the related pesticide, disulfoton. Refer to Table II
for a listing of demeton and its metabolites.
No data are currently available regarding the metabolism
of demeton (0,0-diethyl 0(and S)-2(ethylthio)ethyl pho-
sphorothioates) in livestock. Therefore, the nature of
the residue in animals is not adeguately understood.
This constitutes a data gap.
Tolerances published in 40 CFR 180.105 and 21 CFR 561.30
are currently expressed in terms of residues of demeton
per se. This definition will be changed to include the
sum of the combined residues of the demeton thiono-isomer
(I), the demeton thiol-isomer (II), 0,0-diethyl O-ethyl-2-
mercaptoethyl phosphate (V) and their corresponding
sulfoxides (III, VI and VIII) and sulfones (IV, VII and
IX). Because of their cholinesterase-inhibiting properties,
the demeton thiol-isomer (II) and its sulfoxide (VIII)
and sulfone (IX) and the phosphate (V) and its sulfoxide
(VI) and sulfone (VII) are of toxicological concern.
Although the thiono-isomer (I) and its sulfoxide (III)
and sulfone (IV) are not cholinesterase-inhibiting
metabolites per se, they may be oxidized to form
cholinesterase-inhibiting compounds V through VII.
Therefore, all of these metabolites are of toxicological
concern and must be included in the tolerance definition.
21
-------
40 CFR 180.3(d)(2) states that where tolerances are
established for residues of both disulfoton and demeton
on the same raw agricultural commodity, the total amount
of such pesticides shall not yield more residue than
that permitted by the larger of the two tolerances,
calculated as demeton. The Agency has determined
that tolerances for residues of disulfoton should no
longer be calculated as demeton; that calculation of
residues as disulfoton sulfone is more appropriate. The
reason for this is that disulfoton sulfone has the
highest molecular weight of disulfoton, demeton, and
their metabolites; thus, calculation of residues in
terms of disulfoton sulfone will result in the most
accurate estimation of total residue present. Since
disulfoton and demeton share two common metabolites
[0-analog sulfoxide and sulfone of disulfoton = thiolphosphate
sulfoxide and sulfone of demeton (metabolites VIII and
IX in Table 1)], disulfoton 0-analog is identical to
demeton thiol-isomer (II), and because these pesticides
are registered for use on many of the same raw agricultural
commodities, it is concluded that the tolerance expression
for both should be the same. Therefore, the combined
residues of the demeton thiono-isomer, the demeton
thiol-isomer, O,0-diethyl O-ethyl-2-mercaptoethyl
phosphate and their sulfoxides and sulfones shall be
expressed as disulfoton sulfone in 40 CFR 180.3(d)(2),
40 CFR 180.105 and 40 CFR 561.30.
22
-------
The analytical methods for residues in plants are not
adequate for enforcement because they have not been
shown to be sufficiently specific to distinguish between
residues of demeton and all other organophosphate pesticides
registered for use on plant commodities having tolerances
for residues of demeton. Therefore, a confirmatory method
which can be used for the enforcement of residues of
demeton is required.
Although no tolerances for residues in animal products
presently exist, an analytical method is available for
collection of residue data provided the residues of
concern include only the thiol- and thiono-isomer
and metabolites III-IX. If the requested animal metabolism
data indicate additional residues of concern, then this
method will not be adequate for residue analysis.
Furthermore, if tolerances for residues in animal products
are established in the future, a decision as to the
suitability of this method for enforcement purposes will
be dependent on submission of additional data regarding
its specificity or the availability of an adequate confirmatory
procedure.
The Provisional Acceptable Daily Intake (PADI) of demeton
is 0.005 mg/kg/day. This is based on i study by Barnes
and Denz (1954) with a No Observed Effect Level (NOEL) of 0.05
mg/kg/day for whole blood and brain cholinesterase and a
10-fold Safety Factor (SF).
This study is not considered to be adequate to define a NOEL
23
-------
for purposes of setting an Acceptable Daily Intake (ADI),
since the experimental design of the study was considered to
be inadequate. It is being retained on an interim basis
for calculation of the PADI. The Agency is requiring a
90-day metabolite feeding study to be performed on the
demeton thiolphosphate sulfoxide, which appears to be
the major plant metabolite at the time of harvest and is
also a more potent cholinesterase inhibitor than parent
demeton.
The Provisional Maximum Permissible Intake (PMPI) is
0.30 mg/day based on a 60 kg body weight person. The
Theoretical Maximum Residue Concentration (TMRC), based
on relevant food factors and established tolerances is
0.386 mg/day. Therefore, the TMRC for demeton occupies
129% of the PMPI.
Although the Agency is concerned that the residue con-
centration exceeds the permissible daily intake, no
regulatory action is warranted pending receipt of the
metabolite feeding study and residue chemistry data with
which to evaluate the magnitude of human dietary exposure
to demeton. The Agency believes for the reasons provided
below, that the public will be in no immediate danger while
awaiting receipt and evaluation of the requested data.
The TMRC assumes that 100 percent of the crop for which
a tolerance is established is treated with demeton. Demeton1s
major uses are apples, potatoes and wheat, and the estimated
percentage of demeton1s use on these crops is low. When
24
-------
adjustments are made for the estimated percentage of crops
treated with demeton, the Agency assumes that the ratio
between the residue contribution and the PADI is actually
lower than 129 percent of the PMPI.
The Agency is requesting data pertinent, to the reassessment
on an accelerated basis as indicated in Table A. The
Agency will not allow any significant new uses for
demeton until these data requirements have been satisfied.
25
-------
TABLE I
SUMMARY OF PRESENT TOLERANCES
Tolerances (ppm)
Commodity
alfalfa (fresh)
alfalfa (hay)
almonds
almond hulls
apples
apricots
barley fodder (green)
barley straw
barley grain
beans
broccoli
brussels sprouts
cabbage
cauliflower
celery
cherries
clover (fresh)
clover hay
cottonseed
eggplant
filberts
grapefruit
grapes
hops
lemons
lettuce
muskmelons
nectarines
oranges
oat fodder (green)
oat straw
oats grain
peaches
pears
peas
pecans
peppers
plums
potatoes
strawberry
sugar beets
sugar beet pulp
sugar beet tops
sorghum forage
sorghum grain
tomatoes
walnuts
wheat
wheat fodder (green)
wheat straw
a/per se
T Combined residues of demeton-S, demeton-O, and their sulfoxides and sulfones.
United States3/ Canada3/ Mexico International (Codex)
5
12
0.75
5
0.75
0.75
5
5
0.75
0.3
0.75
0.75
0.75
0.75
0.75
5
12
0.75
0.3
0.75
0.75
1.25
1.25
0.75
0.75
0.75
0.75
0.75
5
5
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.5
5
5
0.2
0.2
0.75
0.75
0.75
5
5
_
- -
0.75
0.75
0.75
-
- -
- -
0.3
0.75
0.75
0.75
0.75
0.75
- -
-
_
-
0.5
0.75
- -
0.5
0.75
0.3
- -
0.5
-
- -
- -
0.75
0.75
0.75
0.75
0.75
0.75
0.2
0.5
- -
-
-
-
0.3
0.75
- -
-
- —
_
—
0.5*
1.0*
-
—
—
—
-
-
-
-
-~
-
—
—
—
0.5*
—
0.5*
—
0.1*
—
0.5*
—
—
—
1.0
—
-
—
0.2*
—
1.0*
—
—
-
—
—
-
—
—
—
26
-------
TABLE II
DEMETON AND ITS METABOLITES
CODE CHEMICAL NAME
I n,0-diethyl r»-2-(ethyltho)ethyl phosphorothioate
II 0,0-diethyl S-2(ethyltho)ethyl phosphorothioate
II 0,0-diethyl O-ethyl-2-sulfonylethyl phosphorothioate
TV 0,0-diethyl O-ethyl-2-sulfonylethyl phosphorothioate
V 0,f>-diethyl O-ethyl-2-mercaptoethyl phosphate
VI 0,0-diethyl O-ethyl-2-sulfinylethyl phosphate
VII 0,0-diethyl O-ethyl-2-sulfonylethyl phosphate
VIII 0,0-diethyl S-ethyl-2-sulfinylethyl phosphorothioate
IX 0,0-diethyl S-ethyl-2-sulfonylethyl phosphorothioate
X 0,0-diethyl phosphorothioate
XI 0,0-diethyl phosphoric acid
XII Phosphoric acid
ABBREVIATION
demeton thiono-isomer
demeton thiol-iscroer
thionophosphate suIfoxide
thionophosphate sulfone
phosphate
phosphate suIfoxide
phosphate sulfone
thiolphosphate sulfoxide
thiolsphosphate sulfone
27
-------
EPA Index to Pesticide Chemicals
DEMETON
Table of Contents
Site
AGRICULTURAL CROPS
General Warnings and Limitations
Alfalfa
Alfalfa (seed crop)
Almond
Apple
Apricot
Barley (including seed crop)
Beans
Beans, Yard-long
Blackberry
Broccoli
Brussels Sprouts
Cabbage
Cauliflower
Celery
Chinese Peas
Clover
Clover (seed crop)
Cotton
Cucurbits (including oriental squashes, melons, gourds, and
pumpkins)
Dewberry
Eggplant
Endive
2
2
2
3
3
4
4
5
5
5
6
6
6
6
6
6
2
2
7
7
5
7
7
Issued: 12-06-82 III-057601-i
Provisional Update: 1-10-85
28
-------
EPA Index to Pesticide Chemicals
DEMETON
Table of Contents
Site
Filbert
Gooseberry
Grapefruit
Grapes
Hops
Leafy Vegetables (including Chinese cabbages and mustard
Lemon
Lettuce
Loganberry
Muskmelons
Nectarine
Oats (including seed crop)
Orange
Peach
Pear
Peas
Pecan
Peppers
Pineapple (nonbearing)
Plum
Potato
Prune
Raspberry
Sorghum
Page
7
5
8
8
8
greens) 8
8
9
5
9
4
4
8
4
9
10
10
10
11
11
11
11
5
12
Issued: 12-06-82 III-057601-ii
Provisional Update: 1-10-85
29
-------
EPA Index to Pesticide Chemicals
DEMETON
Table of Contents
Site
Stone Fruits (nonbearing)
Strawberry
Sugar Beets
Tomato
Trefoil
Walnut
Wheat (including seed crop)
ORNAMENTALS
General Warnings and Limitations
(Ornamental Plants (herbaceous, woody shrubs, trees and vines))
American Holly
Azalea
Camellia
Chrysanthemum
Daffodils
Forest Tree Plantings
Larkspur (Delphinium)
Lilies
Linden
Ornamental Herbaceous Plants
Ornamental and/or Shade Trees
Ornamental Woody Shrubs
Pansies
Primrose
Page
12
12
12
12
13
13
4
13
13
13
13
13
14
14
13
13
13
14
14
14
13
14
Issued: 12-06-82 III-057601-iii
Provisional Update: 1-10-85
30
-------
EPA Index to Pesticide Chemicals
DEMETON
Table of Contents
Site Page
Rose 13
Viburnum 13
(Ornamental and Forest Greenhouse Plants)
Ornamental Herbaceous Plants 14
Ornamental and/or Shade Trees 14
Ornamental Woody Shrubs 14
AERIAL, MOTHPROOFING AND TANK MIX APPLICATIONS
Aerial Application 15
Listing of Registration Numbers by Site 16
Appendix B 17
Issued: 12-06-82 III-057601-iv
Provisional Update: 1-10-85
31
-------
EPA Index to Pesticide Chemicals
c05760'l DEMETON*
TYPE PESTICIDE: Insecticide, Acaricide (also refer to Nematicide entry)
FORMULATIONS:
Tech (85%)
G (1.985%)
EC (2 Ib/gal, 6 Ib/gal)
GENERAL WARNINGS AND LIMITATIONS: RESTRICTED USE PESTICIDE. Workers
must not enter areas treated with demeton until 48 hours after applica-
tion. If area is to be entered before the end of this interval, protec-
tive clothing is required. Wear a mask or respirator effective for pro-
tection against demeton jointly approved by the Mining Enforcement and
Safety Administration (formerly the United States Bureau of Mines) and
the National Institute of Occupational Safety and Health under provisions
of 30 Code of Federal Regulations Part II. Wear protective clothing,
natural rubber gloves, goggles and rubber overshoes.
Demeton is toxic to fish and wildlife. Do not apply directly to water.
Runoff and drift from treated areas may be hazardous to aquatic organisms
in adjacent aquatic sites. Cover or incorporate granules which are
spilled.
Bee Caution:
Demeton is toxic to bees exposed to direct treatment. Do not apply deme-
ton while bees are actively visiting the treatment area.
Definition of Terms:
Claims for pest control limited to suppression of population are indicated
by parenthesized pest name.
*0,0-diethyl 0-[2-(ethylthio)ethyl] phosphorothioate and 0,0-diethyl
S-[2-(ethylthio)ethyl] phosphorothioate
Issued: 12-06-82 III-057601-1
Provisional Update: 1-10-85
32
-------
/23001AA
/23003AA
IRACAAA
ILAAABA
/23001BA
/23003BA
IRACAAA
ILAAABA
Site and Pest
AGRICULTURAL CROPS
EPA Index to Pesticide Chemicals
DEMETON
Dosages and Tolerance, Use, Limitations
Formulation(s)
General Warnings and Limitations: Unless otherwise specified, apply per
acre rates in sufficient water for thorough coverage by ground equipment
and in a minimum of 1 gallon of water per acre by aircraft. For per 100
gallon rates, apply with conventional hydraulic type sprayers. When lower
volumes of spray are applied per acre with concentrate sprayers, increase
the concentration of demeton in the spray mixture in order to apply an
amount of active ingredient per acre equivalent to a full coverage spray.
Where conditions dictate an aerial application, apply the dosage per acre
equivalent to a full coverage spray in not less than 1 gallon of water
per acre. When low volumes of spray are applied, complete coverage is
essential.
Do not plant any crops used for food or feed in demeton treated soils
other than those with registered demeton uses.
Resistance to demeton: Due to spotted alfalfa aphid resistance to organo-
phosphates, in certain areas demeton used alone may not provide satisfac-
tory control. Consult state cooperative extension service for additional
information.
Alfalfa
Clover
Aphids
Mites
Alfalfa (seed crop)
Clover (seed crop)
Aphids
Mites
5 ppm (fresh)
12 ppm (hay)
21 day preharvest/pregrazing inter-
val through 0.25 pound per acre for
foliar application.
Do not make more than 1 application
per cutting.
Observe resistance statement.
0.25 Ib/A Foliar application. Apply in a
(2-6 lb/ minimum of 2 gallons of water per
gal EC) acre by aircraft or in a minimum of
10 gallons of water per acre by
ground equipment.
12 ppm (hay)
Chaff and hulls from treated seed
crop may be used for feed, however,
do not use greenchop for feed or
forage.
15 day preharvest interval through
0.5 pound per acre for foliar appli-
cation to seed crop.
Observe resistance statement.
0.25-0.5 Ib/A Foliar application to seed crop.
(2-6 lb/ Apply in a minimum of 2 gallons of
gal EC) water per acre by aircraft or in a
minimum of 10 gallons of water per
Issued: 12-06-82
III-057601-2
33
-------
Site and Pest
EPA Index to Pesticide Chemicals
DEMETON
Dosages and Tolerance, Use, Limitations
Formulation(s)
Alfalfa (seed crop) cluster (continued)
/03001AA
Almond
IRACAAA
ILAAABA
/04001AA
Aphids
Mites
Apple
IRACAAA
Aphids
ILAAABA
Mites
0.75 Ib/A
(2-6 lb/
gal EC)
acre by ground equipment. Repeat
as needed.
0.75 ppm
5 ppm (hulls)
21 day preharvest interval through
0.75 pound per acre for foliar ap-
plication.
Do not make more than 1 application
during the growing season.
Foliar application.
0.75 ppm
21 day preharvest interval through
6 pounds per acre for foliar appli-
cation.
Do not apply rates through 0.25
pound per hundred gallons (3 pounds
per acre) more than 3 times per
season.
Do not apply rates through 0.5 pound
per hundred gallons (6 pounds per
acre) more than 1 time per season.
0.125-0.5 lb/ Foliar application. For aphids and
100 gal mites, apply the low rate for pre-
[max 1,200 ventative spray programs and the
gal/A] high rate for established popula-
(2-6 lb/ tions.
gal EC)
0.188-0.5 lb/
100 gal
[max 1,200
gal/A]
(2-6 lb/
gal EC)
Issued: 12-06-82
III-057601-3
34
-------
ITAPACA
Site and Pest
Apple (continued)
Unspotted tenti-
form leafminer
IRAFBAA
White apple leaf-
hopper
/05001AA
/05003AA
/05004AA
IRACAAA
ILAAABA
Apricot
Nectarine
Peach
Aphids
Mites
EPA Index to Pesticide Chemicals
DEMETON
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.25 lb/
100 gal
[max 1,200
gal/A]
(2-6 lb/
gal EC)
0.125-0.25
lb/100 gal
[max 1,200
gal/A)
(2-6 lb/
gal EC)
0.75 ppm
30 day preharvest interval through
2 pounds per acre for foliar appli-
cation.
Do not make more than 3 applications
during the growing season.
/24001AA
/24001DA
/24003AA
/24003DA
/24007AA
/24007DA
0.25 lb/
100 gal
[max 800
gal/A]
(2-6 lb/
gal EC)
Barley (including seed crop)
Oats (including seed crop)
Wheat (including seed crop)
Foliar application.
0.75 ppm (grain)
5 ppm (green fodder and straw)
45 day preharvest interval through
0.25 pound per acre for foliar ap-
plication (grain).
21 day preharvest/pregrazing inter-
val through 0.25 pound per acre for
foliar application (forage and fod-
der).
Do not make more than 2 applications
during the growing season.
Allow a minimum of 14 days between
application.
No limitation on number of applica-
tions or preharvest interval for
seed crops. Do not use treated seed
crop for food, feed or forage.
Issued: 12-06-82
III-057601-4
35
-------
EPA Index to Pesticide Chemicals
Site and Pest
DEMETON
Dosages and Tolerance, Use, Limitations
Formulation(s)
(including seed crop) cluster (continued)
IRACAAA
ILAAABA
/15027AA
IRACAAA
ILAAABA
Aphids
Mites
Beans
Aphids
Mites
Beans, Yard-long
/01002AA
/01004AA
/01013AA
/01005AA
/01006AA
IRACAAA
IRAFAAA
ILAAABA
Blackberry
Dewberry
Gooseberry
Loganberry
Raspberry
(Aphids)
(Leafhoppers)
(Mites)
0.125-0.25
Ib/A
(2-6 lb/
gal EC)
0.25 Ib/A
(2-6 lb/
gal EC)
0.375-0.5
Ib/A
(2-6 lb/
gal EC)
0.25-0.5
lb/100 gal
(2-6 lb/
gal EC)
Foliar application.
0.3 ppm
21 day preharvest interval through
0.5 pound per acre for foliar ap-
plication.
Foliar application.
needed.
Repeat as
This use occurs only on Intrastate
labeling and has not been included
in this entry. Refer to appropriate
labeling for use information and
limitation.
N.F.
Do not apply more than 1.5 pounds
per acre.
Postharvest application. Apply up
to 600 gallons of finished spray
per acre, at the low rate and up to
300 gallons of finished spray per
acre at the high rate. Apply in
the late summer or fall months for
reduction of infestations and to
permit further plant growth.
Issued: 12-06-82
III-057601-5
36
-------
/13005AA
/13006AA
/13007AA
/13009AA
IRACAAA
Site and Pest
Broccoli
Brussels Sprouts
Cabbage
Cauliflower
Aphids
EPA Index to Pesticide Chemicals
DEMETON
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.75 ppm
21 day preharvest interval through
0.5 pound per acre for foliar ap-
plication.
Transplant water application through
0.5 pound per 100 gallons of water.
Brussels Sprouts
Cabbage
Cauliflower
/28003AA
IRACAAA
ILAAABA
Aphids
Mites
Chinese Peas
Clover
Clover (seed crop)
0.5 Ib/A
or
0.5 lb/100
gal trans-
plant water
(2-6 lb/
gal EC)
See Broccoli cluster.
See Broccoli cluster.
See Broccoli cluster.
Foliar application. First applica-
tion may be applied in transplant
water.
0.25 lb/
100 gal
[max 200
gal/A]
(2-6 lb/
gal EC)
0.75 ppm
28 day preharvest interval through
0.5 pound per acre for foliar ap-
plication.
Foliar application.
This use occurs only on Intrastate
labeling and has not been included
in this entry. Refer to appropriate
labeling for use information and
limitation.
See Alfalfa cluster.
See Alfalfa (seed crop) cluster.
Issued: 12-06-82
III-057601-6
37
-------
EPA Index to Pesticide Chemicals
/28007AA
IRACAAA
ILAAABA
IMOAAAA
Site and Pest
Cotton
Aphids
Mites
Thrips
DEMETON
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.75 ppm (cottonseed)
21 day preharvest interval through
0.375 pound per acre for foliar ap-
plication.
Do not allow livestock or dairy
animals to graze on treated areas.
Do not feed gin waste to livestock.
0.375 Ib/A
(2-6 lb/
gal EC)
0.25 Ib/A
(2-6 lb/
gal EC)
Cucurbits (including oriental
squashes, melons, gourds, and
pumpkins)
Foliar application.
needed.
Repeat as
This use occurs only on Intrastate
labeling and has not been included
in this entry. Refer to appropriate
labeling for use information and
limitation.
/11001AA
Dewberry
Eggplant
See Blackberry cluster.
IRACAAA
Aphids
Endive
0.25-0.375
Ib/A
(2-6 lb/
gal EC)
/03005AA
Filbert
0.3 ppm
7 day preharvest interval through
0.375 pound per acre for foliar ap-
plication.
Do not make more than 2 applications
during the growing season.
Foliar application.
This use occurs only on Intrastate
labeling and has not been included
in this entry. Refer to appropriate
labeling for use information and
limitation.
0.75 ppm
40 day preharvest interval through
2.5 pounds per acre for foliar ap-
plication.
Issued: 12-06-82
III-057601-7
38
-------
EPA Index to Pesticide Chemicals
DEMETON
IRACAAA
Site and Pest
Filbert (continued)
Aphids
/02002AA
/02004AA
/02006AA
IRACAAA
IRACFZA
Gooseberry
Grapefruit
Lemon
Aphids
Citrus red mite
/01014AA
IRAFAAA
ILAAABA
/08020AA
IRACAAA
Leafhoppers
Mites
Dosages and Tolerance, Use, Limitations
Formulation(s)
Foliar application.
needed.
0.25 lb/
100 gal
[max 1,000
gal/A]
(2-6 lb/
gal EC)
See Blackberry cluster.
Repeat as
0.25 lb/
100 gal
[max 1,000
gal/A]
(2-6 lb/
gal EC)
0.375 Ib/A
(2-6 lb/
gal EC)
Aphids 0.25 lb/
100 gal
[max 200
gal/A]
(2-6 lb/
gal EC)
Leafy Vegetables (including Chi-
nese cabbages and mustard greens)
0.75 ppm
21 day preharvest interval through
2.5 pounds per acre for foliar ap-
plication.
Foliar application.
1.25 ppm
21 day preharvest interval through
0.375 pound per acre for foliar ap-
plication.
Foliar application.
1.25 ppm
21 day preharvest interval through
0.5 pound per acre for foliar ap-
plication.
Foliar application.
This use occurs only on Intrastate
labeling and has not been included
in this entry. Refer to appropriate
labeling for use information and
limitation.
Issued: 12-06-82
III-057601-8
39
-------
/13020AA
IRACAAA
Site and Pest
Lemon
Lettuce
Aphid s
/10006AA
IRACAAA
IRAFADA
ILAAABA
Loganberry
Muskmelons
Aphids
Beet leafhopper
Mites
Nectarine
Oats
/04003AA
Pear
IRACAAA
ILAAABA
Aphids
Mites
EPA Index to Pesticide Chemicals
DEMETON
Dosages and Tolerance, Use, Limitations
Formulation(s)
See Grapefruit cluster.
0.75 ppm
21 day preharvest interval through
0.5 pound per acre for foliar ap-
plication.
0.25-0.5 lb/ Foliar application. Apply up to
100 gal 200 gallons of finished spray per
(2-6 lb/ acre at the low rate and up to 100
gal EC) gallons of finished spray per acre
at the high rate.
See Blackberry cluster.
0.75 ppm
21 day preharvest interval through
0.375 pound per acre for foliar ap-
plication.
0.375 Ib/A Foliar application. Repeat as need-
(2-6 lb/ ed. For band applications, reduce
gal EC) the dosage in porportion to the
amount of acreage actually sprayed.
See Apricot cluster.
See Barley cluster.
See Grapefruit cluster.
See Apricot cluster.
0.75 ppm
21 day preharvest interval through
2.25 pounds per acre for foliar ap-
plication.
Do not make more than 3 applications
during the growing season.
0.188 lb/ Foliar application.
100 gal
[max 900
gal/A]
(2-6 lb/
gal EC)
Issued: 12-06-82
III-057601-9
-------
ITAPACA
Site and Pest
Pear (continued)
Unspotted tenti-
forra leafrainer
/15009AA
IRACAAA
Peas
Aphids
/03008AA
IRACAAA
ILAAABA
Pecan
Aphids
Mites
/28017AA
IRACAAA
Peppers
Aphids
EPA Index to Pesticide Chemicals
DEMETON
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.25 lb/
100 gal
[max 900
gal/A]
(2-6 lb/
gal EC)
0.75 ppm
21 day preharvest interval through
0.5 pound per acre for foliar ap-
plication.
0.25 lb/
100 gal
[max 200
gal/A]
(2-6 lb/
gal EC)
0.25 lb/
100 gal
[max 400
gal/A]
(2-6 lb/
gal EC)
0.375 Ib/A
(2-6 lb/
gal EC)
Foliar application.
0.75 ppm
21 day preharvest interval through
1 pound per acre for foliar appli-
cation.
Foliar application.
needed.
Repeat as
0.75 ppm
3 day preharvest interval through
0.375 pound per acre for foliar ap-
plication.
Foliar application.
needed.
Repeat as
Issued: 12-06-82
111-057601-10
41
-------
Site and Pest
EPA Index to Pesticide Chemicals
DEMETON
Dosages and Tolerance, Use, Limitations
Formulation(s)
/06013DA
ILAAABA
Pineapple (nonbearing)
Mites
/05005AA
/05006AA
Plum
Prune
IRACAAA
ILAAABA
Aphids
Mites
/14013AA
IRACAAA
IRAFAAA
Potato
Aphids
Leafhoppers
Prune
Raspberry
0.5 lb/
100 gal
[dipping
emulsion]
(2-6 lb/
gal EC)
0.25-0.375
lb/100 gal
[max 800
gal/A]
(2-6 lb/
gal EC)
0.188-0.5
Ib/A
(2-6 lb/
gal EC)
N.F.
Do not handle stock with bare hands.
Dip treatment to planting stock.
For temporary protection.
0.75 ppm plums (fresh prunes)
30 day preharvest interval through
0.25 pound per hundred gallons (2
pounds per acre) for foliar appli-
cation.
Do not make more than 3 applications
during the growing season.
60 day preharvest interval through
0.375 pound per hundred gallons (3
pounds per acre) for foliar appli-
cation.
Do not make more than 2 applications
during the growing season.
Foliar application.
0.75 ppm
21 day preharvest interval through
0.5 pound per acre for foliar ap-
plication.
Foliar application. Repeat as
needed.
See Plum cluster.
See Blackberry cluster.
Issued: 12-06-82
III-057601-ll
42
-------
/28019AA
IRACAAA
ILAAABA
/05000DA
IRACAAA
ILAAABA
/01016AA
IRACAAA
ILAAABA
/28020AA
IRACAAA
ILAAABA
/11005AA
IRACAAA
ILAAABA
Site and Pest
Sorghum
EPA Index to Pesticide Chemicals
DEMETON
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.2 ppm (grain)
0.2 ppm (forage)
35 day preharvest/pregrazing inter-
val through 0.25 pound per acre.
Do not make more than 1 application
during the growing season.
Aphids
Mites
0.25 Ib/A
(2-6 lb/
gal EC)
Stone Fruits (nonbearing)
Aphids
Mites
Strawberry
Aphids
Mites (excluding
cyclamen mite)
Sugar Beets
Aphids
Mites
Tomato
Aphids
Mites
0.25-0.5 lb/
100 gal
(2-6 lb/
gal EC)
0.375 Ib/A
(2-6 lb/
gal EC)
0.5 Ib/A
(2-6 lb/
gal EC)
0.25-0.375
lb/100 gal
(2-6 lb/
gal EC)
Foliar application.
N.F.
Foliar application.
ed.
Repeat as need-
0.75 ppm
21 day preharvest interval through
0.375 pound per acre for foliar ap-
plication.
Foliar application.
0.5 ppm (sugar beets)
5 ppm (tops)
5 ppm (sugar beet pulp)
30 day preharvest interval through
0.5 pound per acre.
Do not make more than 3 applications
during the growing season.
Foliar application.
0.75 ppm
3 day preharvest interval through
0.375 pound per acre for foliar ap-
plication.
Foliar application. Apply up to
150 gallons of finished spray per
acre at the low rate and up to 100
gallons of finished spray per acre
at the high rate.
Issued: 12-06-82
111-057601-12
43
-------
/03009AA
IRACAAA
ILAAABA
Site and Pest
Trefoil
Walnut
Aphids
Mites
Wheat
EPA Index to Pesticide Chemicals
DEMETON
Dosages and Tolerance, Use, Limitations
Formulation(s)
This use occurs only on Intrastate
labeling and has not been included
in this entry. Refer to appropriate
labeling for use information and
limitation.
0.75 ppm
- 21 day preharvest interval through
0.75 pound per acre for foliar ap-
plication.
Do not apply more than 1 application
during the growing season.
0.75 Ib/A Foliar application. May be applied
(2-6 lb/ in combination with codling moth
gal EC) spray.
See Barley cluster.
ORNAMENTALS
General Warnings and Limitations: Do not apply within 5 days of hand-
picking, pruning, transplanting, or other handling. Phytotoxicity has
occurred on African violets, cibotium ferns, and Croft lilies. Caution
should be exercised when treating these plants.
(Ornamental Plants (herbaceous, woody shrubs, trees and vines))
/35142AA American Holly
/34022AA Azalea
/34036AA Camellia
/31065AA Chrysanthemum
/31129AA Larkspur (Delphinium)
/31131AA Lilies
/35075AA Linden
/31149AA Pansies
/34120AA Rose
/34137AA Viburnum
IRACAAA Aphids (including
greenbug and rose
aphid)
ILAAAIA Bulb mites
IRAKBEA Camelia scale
ILAVASA European red mite
IRAXAAA Lace bugs
IRAKAZA Tea scale
IMOAAAA Thrips
Issued: 12-06-82 111-057601-13
1 oz 1.985% Soil application. Apply around the
G/18-24 in. base of each plant. For larger
high plant plants, use proportionately more.
(1.985% G) Water thoroughly after application.
Repeat at 21 day intervals.
44
-------
ILAVBEA
IRABAAA
Site and Pest
EPA Index to Pesticide Chemicals
DEMETQN
Dosages and Tolerance, Use, Limitations
Formulation(s)
American Holly cluster (continued)
Pest list continued from previous page.
Twospotted spider-
mite
Whiteflies
Daffodils
Refer to Nematicide entry.
Forest Tree Plantings
This use occurs only on Intrastate
labeling and has not been included
in this entry. Refer to appropriate
labeling for use information and
limitation.
Careful observation by a qualified
biologist must be made of wildlife
utilizing areas treated with demeton
during and after application.
Ornamental Herbaceous Plants
Refer to (Ornamental and Forest Greenhouse
Plants), Herbaceous Plants cluster for additional
information.
Ornamental and/or Shade Trees
Refer to (Ornamental and Forest Greenhouse
Plants), Herbaceous Plants cluster for additional
information.
Ornamental Woody Shrubs
Primrose
Refer to (Ornamental and Forest Greenhouse
Plants), Herbaceous Plants cluster for additional
information.
Refer to Nematicide entry.
Issued: 12-06-82
111-057601-14
45
-------
/31000CA
/35000CA
/34004CA
/31000AA
/35000AA
/34004AA
IRACAAA
IRAWAAA
ILAAABA
IRABAAA
ISBEAMA
IOAHASA
IOABALA
IQAXAAA
IRAKBEA
IRAKA1A
IRAHAAA
IRAKAZA
Site and Pest
EPA Index to Pesticide Chemicals
DEMETON
Dosages and Tolerance. Use. Limitations
Formulation(s)
(Ornamental and Forest Greenhouse Plants)
Ornamental Herbaceous Plants
Ornamental and/or Shade Trees
Ornamental Woody Shrubs
Aphids
Mealybugs
Mites
Whiteflies
Birch leafminer
Boxwood leafminer
Holly leafminer
Lace bugs
Camellia scale
Howard scale
Soft scale insects
Tea scale
0.25-0.375 Foliar application. Repeat as
lb/100 gal needed.
(2-6 lb/ OR
gal EC) Soil drench:
One pint finished spray per square
0.375-0.5 foot of bench or bed area. Repeat
lb/100 gal as needed.
(2-6 lb/ OR
gal EC) 0.25 pint finished spray per 6 inch
pot. Repeat as needed.
0.5 lb/ OR
100 gal Apply to the base of each plant.
(2-6 lb/ One to 2 gallons of finished spray
gal EC) per shrub or tree up to 6 feet high.
Apply proportionately more for tal-
ler plants. Repeat as needed.
AERIAL, MOTHPROOFING AND TANK MIX APPLICATIONS
9001500
AAAAAAA
Aerial Application
Refer to
AGRICULTURAL CROPS
Alfalfa, Alfalfa (seed crop), Al-
mond, Apple, Apricot, Barley (in-
cluding seed crop), Beans, Black-
berry, Broccoli, Brussels Sprouts,
Cabbage, Cauliflower, Celery,
Clover, Clover (seed crop), Cotton,
Dewberry, Eggplant, Filbert, Goose-
berry, Grapefruit, Grapes, Hops,
Lemon, Lettuce, Loganberry, Musk-
melons, Nectarine, Oats, Orange,
Peach, Pear, Peas, Pecan, Peppers,
Plum, Potato, Prune, Raspberry,
Sorghum, Stone Fruits (nonbearing),
Strawberry, Sugar Beets, Tomato,
Walnut, Wheat
Issued: 12-06-82
111-057601-15
46
-------
EPA Index to Pesticide Chemicals
DEMETON
Listing of Registered Pesticide Products by Formulation
&085.0001 85% technical chemical
demeton (057601)
003125-00008
&001.9804 1.985% granular
demeton (057601)
000456-00044
&102.0012 2 Ib/gal emulsifiable concentrate
demeton (057601)
002749-00115
demeton (057601) plus aromatic petroleum distillate (006601)
003125-00004
demeton (057601) plus xylene (086802)
002749-00200
&106.0012 6 Ib/gal emulsifiable concentrate
demeton (057601) plus aromatic petroleum distillate (006601)
003125-00221
demeton (057601) plus xylene (086802)
002749-00192
9999999 State Label Registrations
CA Reg. No.
003125-07842 003125-07843 010965-09902
FL Reg. No.
037347-10563
HI Reg. No.
037843-08583
Issued: 12-06-82
111-057601-16
47
-------
EPA Index to Pesticide Chemicals
DEMETON
Appendix B
Listing of Registration Numbers by Site
AGRICULTURAL CROPS
/23001AA Alfalfa
002749-00115 002749-00192 002749-00200
/23001BA Alfalfa (seed crop)
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/03001AA Almond
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/04001AA Apple
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/05001AA Apricot
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/24001AA Barley (including seed crop)
/2400IDA
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/15027AA Beans
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/01002AA Blackberry
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/13005AA Broccoli
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/13006AA Brussels Sprouts
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/13007AA Cabbage
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/13009AA Cauliflower
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
Issued: 12-06-82
111-057601-17
48
-------
EPA Index to Pesticide Chemicals
DEMETON
Appendix 6
Listing of Registration Numbers by Site (continued)
/28003AA Celery
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/23003AA Clover
002749-00115 002749-00192 002749-00200
/23003BA Clover (seed crop)
002749-00192 002749-00200 003125-00004 003125-00221
/28007AA Cotton
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/01004AA Dewberry
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/11001AA Eggplant
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/03005AA Filbert
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/01013AA Gooseberry
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/02002AA Grapefruit
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/01014AA Grapes
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/08020AA Hops
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/02004AA Lemon
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/13020AA Lettuce
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
Issued: 12-06-82
111-057601-18
49
-------
/01005AA
/24003AA
/24003DA
/02006AA
EPA Index to Pesticide Chemicals
DEMETON
Appendix B
Listing of Registration Numbers by Site (continued)
Loganberry
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/10006AA Muskmelons
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/05003AA Nectarine
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
Oats (including seed crop)
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
Orange
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/05004AA Peach
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/04003AA Pear
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/15009AA Peas
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/03008AA Pecan
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/28017AA Peppers
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/06013DA Pineapple (nonbearing)
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/05005AA Plum
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
Issued: 12-06-82
111-057601-19
50
-------
EPA Index to Pesticide Chemicals
DEMETON
Appendix B
Listing of Registration Numbers by Site (continued)
/14013AA Potato
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/05006AA Prune
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/01006AA Raspberry
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/28019AA Sorghum
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/05000DA Stone Fruits (nonbearing)
002749-00192 002749-00200 003125-00004 003125-00221
/01016AA Strawberry
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/28020AA Sugar Beets
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/11005AA Tomato
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/03009AA Walnut
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/24007AA Wheat (including seed crop)
/24007DA
002749-00115 002749-00192 002749-00200 003125-00004
003125-00221
/35142AA
ORNAMENTALS
(Ornamental Plants (herbaceous, woody shrubs, trees and vines))
American Holly
000456-00044
Issued: 12-06-82
111-057601-20
51
-------
/34022AA
/34036AA
/31065AA
/31129AA
/31131AA
/35075AA
/31000AA
/35000AA
/34004AA
/31149AA
/34120AA
/34137AA
/31000CA
/35000CA
EPA Index to Pesticide Chemicals
DEMETON
Appendix 8
Listing of Registration Numbers by Site (continued)
Azalea
000456-00044
Camellia
000456-00044
Chrysanthemum
000456-00044
Larkspur (Delphinium)
000456-00044
Lilies
000456-00044
Linden
000456-00044
Ornamental Herbaceous Plants
002749-00115
003125-00221
002749-00192 002749-00200 003125-00004
Ornamental and/or Shade Trees
002749-00115
003125-00221
002749-00192 002749-00200 003125-00004
Ornamental Woody Shrubs
002749-00115002749-00192 002749-00200
003125-00221
Pansies
000456-00044
Rose
000456-00044
Viburnum
000456-00044
(Ornamental and Forest Greenhouse Plants)
Ornamental Herbaceous Plants
003125-00004
002749-00115
003125-00221
002749-00192 002749-00200 003125-00004
Ornamental and/or Shade Trees
002749-00115
003125-00221
002749-00192 002749-00200 003125-00004
Issued: 12-06-82
111-057601-21
52
-------
EPA Index to Pesticide Chemicals
DEMETON
Appendix B
Listing of Registration Numbers by Site (continued)
/34004CA Ornamental Woody Shrubs
000456-00044 002749-00115 002749-00192 002749-00200
003125-00004 003125-00221
Issued: 12-06-82 111-057601-22
53
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETON
S158.120 - PRODUCT CHEMISTRY
Guideline Citation and
Name of Test
Product Identity:
61-1 - Identity of Ingredients
61-3 - Discussion of Formation of
Ingredients
Analysis of Certification of Product
Ingredients
62-1 - Preliminary Analysis
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Test I/
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Guidelines
Status
R
R
R
R
R
R
R
R
Are Data 2/
Required
Yes No
1*1 f|
I*T 1 T
l*| M
1*1 U
1*1 M
(Xj |X|
1*1 IJ
1*1 M
Footnote
Number
3
Specific Gravity
54
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETON
§158.120 - PRODUCT CHEMISTRY
Guideline Citation and
Name of Test
Test I/
Substance ~
Fnysicai ana cnemical Characteristics
(Continued)
63-8 - Solubility TGAI or PAI
63-9 - Vapor Pressure PAI
63-10 - Dissociation constant PAI
63-11 - Octanol/water partition PAI
coefficient
63-12 - pH TGAI
63-13 - Stability TGAI
Other Requirements;
64-1 - Submittal of Samples Choice
Guidelines
Status
Are Data 2/
Required ~
Yes No
Footnote
Number
R
R
R
R
R
CR
1*1
1*1
I El
1*1
1*1
1*1
I/ Composition: TGAI = Technical grade of the Active Ingredient; PAI= Pure active Ingredient.
2/ Data are due March 1985 for 63-8, 63-9, and 63-11. All other data are due August, 1985.
3/ Not required because the technical is a liquid at room temperature.
55
-------
TABLE A
GENERIC DATA RETIREMENTS POP CHEMICAL nEMETTN
Data Requirements
V
Composition
Hoes EPA Have Data
To Satisfy This
Requ i rement? ( Yes ,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
S158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants
PAIRA
Yes
- Livestock
171-4 - Residue Analytical Method
- Plant residues
PAIRA and plant
metabolites
NO
TGAI and metabolites Partially
00095640*,00100834,
00100836,00100845,
00100872,00100898,
00100926,00100928,
00100930,00100933,
00102264,GS0143007,
GS0143008,GS0143009,
GS0143010,GS014011
GS0143016,GS0143011
00071233/00071242,
00071243,00089855,
00095608,00095618,
00100829,00100838,
00100863,00100864,
00100871,00100877,
00100883,00100902,
00100903,00100904,
00100Q12,00100929,
00100930,00100934,
00100936 ,00100962*,
00100964*,00102224,
00102232,00102239,
00102241,00102260,
00105405,GS0143012
through GSO143017,
No
Yes3/
YesV
- Animal residues
TGAI and metabolites Reserved^/
56
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirements
I/
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Sectic
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Storage Stability Data
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Root and tuber Vegetables GroupV
o Potatoes
— Crop field trials
— Processed Food/Feed
o Sugar Beets
o Sugar Beets (processed)
- Leaves of Root and Tuber
Vegetables Group11-1/
o Sugar beet tops
- Leafy Vegetables Group12/
o Celery
o Lettuce
PAI
TEP
EP
Partially
Partially
No
Partially
No
Partially
No
No
00057268,00100923,
00100831,
Yes6/
00100930
00100921,00100943
Yes8
Yes9/
00100921,00100^43
Yes.ll/
YesW
57
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
Does EPA Have Data
To Satisfy This
_1/ Requirement? (Yes,
Composition No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
- Brassica Leafy Vegetables
Group1S/
o Broccoli
o Brussels sprouts
o Cabbage
o Cauliflower
- Legume Vegetables (Succulent
or Dried) Group2®/
o Beans
o Beans (processed)
o Peas
- Foliage of Legume Vegetable
Group2V
o Bean vines and hay
o Pea vines and straw
- Fruiting Vegetables (Except
Cucurbi ts) Group2**/
o Eggplant
o Peppers
No
No
Partially
No
NO
No
No
No
No
Yes
No
00095572
00102235
No
Yes"/
58
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
o Tomatoes
o Tomatoes (processed)
- Curcurbit Vegetables Group29/
o Muskmelons
- Citrus Fruits Group^1/
o Grapefruit
o Lemons
o Oranges
o Oranges (Processed)
- Pome Fruits Group^-v
o Apples
o Apples (Processed)
o Pears
- Stone Fruit
o Apricots
o Cherries
o Nectarines
No
No
No
No
No
No
Partially
No
Partially
No
Partially
Partially
No
No
Yes28/
00100930
YesW
00100930
00100930
00102237
59
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
_
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially) _
§158.125 Residue Chemistry
(continued)
o Peaches
o Plums (fresh prunes)
o Plums (Processed)
- Small Fruits and Berries Groupj^/
o Grapes
o Grapes (Processed)
o Strawberry
- Tree Nuts Group'* "V
o Almonds
o Filberts
o Pecans
o Walnuts
- Cereal Grains Group£^/
o Barley
o Barley (Processed)
o Oats
o Oats (Processed)
No
No
No
No
No
No
No
No
No
Partially
Partially
No
Partially
No
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
YesW
Yes«/
00100930
00100923
00100923
NC-5V
Ye353/
Yes£3/
Yes*/
60
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
V
Composition
Does EPA Have Data
To Satisfy This
Requi rement? ( Yes ,
No or Partially)
Bibliographic-
Citation
Must Additional
Data Be Submitted
Under FIFRA Sectio
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
o Sorghum
o Sorghum (Processed)
o Wheat
o Wheat (Processed)
- Forage, Fodder, and Straw
of Cereal Grains Group;*?/
o Barley forage, hay and straw
o Oat Forage, hay and straw
o Sorghum forage, fcoder, silage
and hay
o Wheat forage, hay and straw
- Non-Grass Animal Feeds (Forage,
fodder, straw, and Hay) Group*^/
o Alfalfa
o Alfalfa (Processed)
o Clover
Partially
No
Partially
No
Partially
Partially
No
Partially
00100937
00100923
Partially
Partially
Partially
00100923
00100923
00100937
00100923
00100931
00100962*
00100962*
00100931
YeS55/
Yes63/
61
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TABIE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
Composition No or Partially)
Bibl iographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Sectior
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
- Miscellaneous Commodities
o Cottonseed
o Cottonseed (Processed)
o Hops
o Hops (Processed)
- Meat/milk/poultry/eggs
- Intrastate Uses
Yes
No
No
No
00100919
No
Yes65/
TGAI or plant
metabolites
00100963*,00100964*
trefoil, leafy vegetables (including Chinese cabbage, mustard greens^curcubits (including
oriential squashes, melons, gourds and pumpkins), yard-long beans, Chinese peas, and endive
No
Yes
62
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DFMETON
S15B.125 Residue Chemistry
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolahelled; TEP =
~ Typical end-use product; FP = End-use product.
2/ Data are due March, 1987.
?/ Metabolism studies utilizing ruminants are required. Animals must be dosed for 3 days with [32p}ctemeton at a con-
~ centration in the total diet which will result in sufficient residue in the tissues and milk for characterization.
Animals must be sacrificed within 24 hours of the final dose (milk must be collected twice daily). 32p_resiclueg must
be characterized and quantified in milk, muscle, fat, kidney and liver. If residues of toxicological concern are
found to transfer to the tissues and/or milk of ruminants, appropriate tolerances must be proposed, in addition,
metabolism studies utilizing poultry are required. Animals must be dosed for 3 days with [32p]ciemeton at a
concentration in the total diet which will result in sufficient residue in the tissues and eggs for characterization.
Animals must be sacrificed within 24 hours of the final dose (eggs must be collected twice daily). 32p_residues
must be characterized and quantified in eggs, muscle, fat, kidney, and liver. If residues of toxicological concern
are found to transfer to the tissues and/or eggs of poultry, appropriate tolerances must be proposed. Also if
metabolism in poultry differ from that in ruminants additional metabolism of demeton in swine is needed.
4/ A method which can be used for enforcement of residues of demeton is required. This requirement may be satisfied
"~ by the submission of data which verify that the use of alternate column packings (DC-200 vs DFGS) in the GC
procedures will provide adequate specificity. Alternatively, a validated mass spectrometry method may be submitted
for confirmatory purposes.
5/ Although no tolerances for residues in animal products presently exist, GS method 46795 is adequate for collection
"~ of residue data provided the residues of concern include only the thiol- and thiono-isomers and metabolites III-
IX. If the requested animals metabolism data indicate additional residues of concern, then this method will not
be adequate for data collection. Furthermore, if tolerances for residues in animal products are established in
the future, a decision as to the suitability of this method for enforcement purposes will be dependent on submission
of additional data regarding its specificity or the availability of an adequate confirmatory procedure.
6/ Data reflecting the frozen storage stability of demeton and metabolites III-IX in two plant commodities fortified
~ at levels of each ranging from 0.2 to 12 ppm at intervals of 5-10 months are required. The additional data
requested in the various commodity sections should be accompanied by storage interval information and additional
storage stability data if intervals longer than those requested above occur. It should also be noted that the
acceptability of tolerances for residues in or on eggplant, sorghum grain and forage and cottonseed are subject
to change on receipt of the requested storage stability data.
7/ Residue data are required for two additional members of this crop group (carrot and radish); currently, demeton
~ formulations are registered for use only on potatoes and sugar beets. Additional residue data are required for
potatoes and sugar beets.
63
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
§158.125 Residua Chemistry
(continued)
8/ Data are required reflecting residues in or on potatoes as the result of foliar application of the 2 or 6 Ib/gal
EC at 0.5 Ib ai/A beginning when plants emerge and continuing at 10- to 14-day maintenance intervals until 21
days before harvest; both ground and aerial equipment use must be represented. An alternative to submission of
the above data reflecting multiple applications would be the establishment of a label restriction limiting the
number of applications allowed per season and the submission of data reflecting this restricted number. Tests
are to be conducted in CA, ID, ME, ND [or MN or WI], and WA.
Data are required reflecting residues in granules, chips, and dried processed potatoes from potatoes bearing
detectable weathered residues.
9/ Data reflecting residues in or on sugar beet roots as the result of three foliar applications of the 2 or 6 Ib/gal
EC at 0.5 Ib ai/A using ground and aerial equipment are required. Beets must be harvested 30 days after the final
treatment. Tests are to be conducted in CA, ID, Mi, MN, and NE.
Data reflecting residues in dehydrated pulp, molasses, and refined sugar processed from sugar beets bearing
measurable weathered residues are required.
10/ A crop group tolerance is not appropriate at the present time for the following reasons:
(i) Residue data are required for one additional member of this group (turnip leaves); currently, demeton
formulations are registered for use only on sugar beets.
(ii) Additional residue data are required for sugar beets tops.
11/ Data reflecting residues in or on sugar beets tops as the result of three foliar applications of the 2 or 6 Ib/gal
EC at 0.5 Ib ai/A using ground and aerial equipment are required. Samples must be collected 30 days after the
last treatment. Tests are to be conducted in CA, ID, MI, MN, and NE.
12/ Residue data are required for the three representative members of this crop group [celery, lettuce (leaf and head),
and spinach]; currently, tolerances exist for residues in or on celery and lettuce.
13/ Data are required reflecting residues in or on celery (untrimmed) as the result of foliar application of the 2 or
6 Ib/gal EC at 0.5 Ib ai/A beginning when plants emerge (when infestation is likely to occur) and continuing at
10- to 14-day maintenance intervals until 28 days before harvest; treatments must reflect the use of both ground
and aerial equipment. An alternative to the submission of the above data reflecting multiple applications would
be the establishment of a label restriction limiting the number of applications allowed per season and the
submission of data reflecting that restricted number. Tests are to be conducted in CA, FL, and MI. CA tests must
include irrigated regions.
14/ Data are required reflecting residues in or on leafy and head (with and without wrapper leaves) lettuce as the
result of foliar application of the 2 or 6 Ib/gal EC at 0.5 ai/A beginning when plants emerge (when infestation
is likely to occur) and continuing at 10- to 14-day maintenance intervals until 21 days before harvest; treatments
must reflect the use of both ground and aerial equipment. An alternative to the submission of the above data
reflecting multiple applications would be the establishment of a label restriction limiting the number of
applications permitted per season and the submission of data reflecting that restricted number. Tests must be
conducted in AZ, CA, and FL. CA and AZ tests must include irrigated regions.
64
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
§158.125 Residue Chemistry
(continued)
15/ Residue data are required for the three representative members of this crop group (broccoli, cabbage and mustard
greens); currently, tolerances exist for broccoli and cabbage.
16/ Data are required reflecting residues in or on broccoli as the result of foliar application of the 2 or 6 Ib/gal
EC at 0.5 Ib ai/A using ground and aerial equipment are required. The first application is to be made in transplant
water at 0.5 Ib ai/100 gal, and after transplanting, foliar applications are to be made at 10- to 14-day maintenance
intervals until 21 days before harvest. Alternative to the submission of the above data reflecting multiple
applications would be the establishment of a label restriction limiting the number of applications allowed per
season and the submission of data reflecting that restricted number. Tests are to be conducted in CA and TX. CA
tests msut include irrigated regions.
17/ Sufficient data are not available to assess the adequacy of the established tolerance and label directions; the
data submitted were generated with an inadequate cholinesterase-inhibition assay. However, additional data are
not required because the data requested for broccoli will be translated to Brussels sprouts.
18/ Data reflecting residues in or on cabbage (with and without wrapper leaves) as the result of foliar application
of the 2 or 6 Ib/gal EC at 0.5 Ib ai/A using ground and aerial equipment are required. The first application is
to be made in transplant water at 0.5 Ib ai/100 gal, and after transplanting, foliar applications are to be made
at 10- to 14-day maintenance intervals until 21 days before harvest. An alternative to the submission of the
above data reflecting multiple applications would be the establishment of a label restriction limiting the number
of applications allowed per season and the submission of data reflecting that restricted number. Tests are to be
conducted in CA, FL, NY, and WI.
19/ Sufficient data are not available to assess the adequacy of the established tolerance and label directions; the
data submitted were generated with either an inadequate cholinesterase-inhibition, turbidimetric, or biological
method of analysis. However, additional data are not required because the data requested for broccoli will be
translated to cauliflower.
20/ Residue data are required for an additional representative member of this crop group (soybeans); currently,
tolerances have been established for beans and peas only. Additional residue data are required for beans and
succulent peas. The following additional residue data are required for dry peas; data reflecting residues in or
on dry peas as the result of multiple ground and aerial foliar applications of the 2 or 6 Ib/gal EC at 0.5 Ib
ai/A beginning soon after plant emergence and continuing at 10- to 14-day intervals until 21 days prior to
harvest. Tests must be conducted in ID and WA.
21/ Data are required reflecting residues in or on beans (one dry and one succulent variety) as the result of ground
and aerial foliar application of the 2 or 6 Ib/gal EC at 0.5 Ib ai/A beginning soon after plant emergence and
continuing at 10- to 14-day maintenance intervals until 21 days before harvest. An alternative to the submission
of the above data reflecting multiple applications could be the establishment of a label restriction limiting the
number of applications allowed per season and the submission of data reflecting that restricted number. Tests
are to be conducted in OR, NY, and WI for succulent beans and CA, ID, and ND for dry beans.
65
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETCN
$158.125 Residue Chemistry
(continued)
Residues must he determined in or on beans hearing measurable weathered residues and in cannery residue processed
from such beans to determine whether a feed additive tolerance is needed for residues in cannery residue.
Data are required reflecting residues in or on yard-long beans as the result of multiple foliar applications of
the 2 Ib/gal EC at 3 lb ai/A fron tests conducted in HTj only one application is to be made during the first 21
days of growth followed by additional applications at in- to 14-days of growth followed by additional applications
at in- to 14-day intervals until 28 days before harvest.
22/ Sufficient data are not available to assess the adequacy of the established tolerance and use directions because
~~* the data submitted involved an inadequate cholinesterase-inhibition or turbidimetric method of analysis. No
additional data are required for dry peas or Chinese peas because upon fulfillment of the data requirement for
beans, data will be translated to peas. However, additional data will be required for dry peas in the event that
a crop group tolerance is sought. The following additional data are required for succulent peas (seed only):
data reflecting residues in or on succulent peas (seed only) as the result of group and aerial foliar application
of the 2 or 6 Ib/gal EC at 0.5 lb ai/A beginning soon after plant emerence and continuing at in- to 14-day
maintenance intervals until 21 days before harvest. An alternative to the submission of the above data reflecting
multiple applications would be the establishment of a label restriction limiting the number of applicaions allowed
per season and the submission of data reflecting that restricted number. Tests are to be conducted in MM, OR, or
m., WL, and DE or NY.
23/ A crop group tolerance is not appropriate at the present time for the following reasons:
(i) Additional data are required for bean vines and hay.
(ii) The following additional data are required for pea vines and straw: data reflecting residues in or on pea
vines at intervals following the last of several foliar applications of the 2 or 6 Ib/gal KC at n.5 lb ai/A
beginning soon after plant emergence and continuing at in- to 14-day maintenance intervals until 21 days prior
to harvest (of peas). Roth aerial and ground application data must be submitted. Pea straw must be collected
and analyzed for residues 21 days after the last treatment. An alternative to submission of the above data
reflecting an unlimited number of applications would be the establishment of a label restriction limiting
the number of applications allowed per season and the submission of data reflecting that restricted number.
Tests are to he conducted in MN, OR or WA, WI, and DE or NY for green peas and in ID and WA for dry peas, and
data reflecting residues in or on Chinese pea vines immediately after the last of several foliar appli-
cation of the 2 Ib/gal EC at 2 lb ai/A from tests conducted in HI; only one application is to be made during
the first 21 days of growth followed by additional applications at in- to 14-day intervals until 28 days
before harvest (of peas). Pea straw must be collected and analyzed for residues 28 days after the last
treatment.
24/ Data are required reflecting residues in or on bean vines at intervals following the last of several foliar
applications of the 2 or 6 Ib/gal EC at n.5 lb ai/A beginning soon after plant emergence and continuing at. in- to
14-day maintenance intervals until 21 days prior to harvest (of beans). Roth aerial and ground application data
must he submitted. Bean hay must be collected and analyzed for residues 21 days after the last treatment. An
alternative to submission of the above data reflecting an unlimited number of applications would be the establishment
66
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
§158.125 Residue Chemistry
(continued)
of a label restiction limiting the number of applications allowed per season and the submission of data reflecting
that restricted number. Tests are to be conducted in OR, NY, and WI for succulent beans and in CA, ID, MI, NE,
and ND for dry beans. Data are required reflecting residues in or on yard-long bean vines immediately after the
last of several foliar applications of the 2 Ib/gal EC at 3 Ib ai/A from tests conducted in HI; only one applica-
tion is to be made during the first 21 days of growth followed by additional applications at 10- to 14-day inter-
vals until 28 days before harvest (of beans). Bean hay must be collected and analyzed for residues 28 days
after the last treatment. Tolerance for residues in or on bean vines and hay and a pregrazing restiction for
bean vines must be proposed; alternatively, you may propose feeding and grazing restrictions.
25/ Since pea vines and straw are raw agricultural commodities and no feeding or grazing restrictions have been
established, tolerances or feeding and grazing restictions must be proposed. No data are required, however,
because the requested data for bean vines and hay will be translated to peas. Additional data for pea vines and
straw will be required if a crop group tolerance is sought.
26/ A crop group tolerance is not appropriate at the present time for the following reason: residue data are required
for tomatoes.
27/ Sufficient data are not available to assess the adequacy of the established tolerance and label directions. An
inadequate chlolinesterase-inhibition method of analysis was used to generate the data submitted. However, no
additional data are required because the requested data for residues in or on tomatoes will be translated to
peppers.
28 / Data are required reflecting residues in or on tomatoes as the result of ground and aerial foliar application of
the 2 or 6 Ib/gal EC at 0.375 Ib ai/A beginning when plants are first set out and continuing at 10- to 14-day
maintenance intervals until 3 days before harvest. An alternative to submission of the above data involving
multiple applications would be the establishment of a label restriction limiting the number of applications allowed
per season and submission of data reflecting that restricted number. Tests are to be conducted in CA and FL. CA
tests must include irrigated regions.
Data are required reflecting residues in tomato juice, puree, catsup, and wet and dry pomace processed from
whole tomatoes bearing measurable weathered residues. If residues are found to concentrate in any of these
processed products, appropriate food/feed additive tolerances must be proposed.
29/ A crop group tolerance is not appropriate at the present time for the following reasons:
(i) Residue data are required for two additional members of this group (cucumbers and summer squash [of the
members in this group, muskmelons are the only one for which a tolerance has been established]).
(ii) Additional data are required for muskmelons.
30/ Data are required reflecting residues in or on muskmelons after foliar application of the 2 or 6 Ib/gal EC at
0.375 Ib ai/A using both ground and aerial equipment. Treatments should begin soon after plant emergence (when
infestation is likely to occur) and continue at 10- to 14-day maintenance intervals until 21 days before harvest.
An alternative to the submission of the above data reflecting multiple applications would be the establishment of
a label restriction limiting the number of applications allowed per season and the submission of data reflecting
that restricted number. Tests should be conducted in AZ, CA, and TX. CA and AZ test sites must include irrigated
regions.
67
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
§158.125 Residue Chemistry
(continued)
31/ A crop group tolerance is not appropriate at the present time for the following reasons:
(i) Additional residue data are required for sweet oranges.
(ii) The following additional residue data are required for both lemon and grapefruit: data reflecting residues
in or on lemons and grapefruit from foliar application of the 2 or 6 Ib/gal EC at 2.5 Ib ai/A beginning in
early spring (when infestation is likely to occur) and continuing at 10- to 14-day maintenance intervals
until 21 days before harvest; treatments must involve both ground and aerial equipment use. An alternative
to the submission of the above data reflecting multiple applications would be the establishment of a label
restriction limiting the number of applications allowed per season and the submission of data reflecting
that restricted number. Tests are to be conducted in AZ and CA for lemons and in CA, FL, and TX for
grapefruit.
32/ Sufficient data are not available to assess the adequacy of the established tolerance and label directions because
the data submitted were generated with an inadequate cholinesterase-inhibition assay. However, additional data
are not required because upon fulfillment of the data requirements for oranges, data will be transferred to
grapefruit. In the event that a crop group tolerance is sought, additional data for grapefruit will be required.
33/ Sufficient data are not available to assess the adequacy of the established tolerance and label directions because
the data submitted were generated with an inadequate cholinesterase-inhibition assay. However, additional data
are not required because upon fulfillment of the data requirements for oranges, data will be transferred to
lemons. In the event that a crop group tolerance is sought, additional data will be required for lemons.
34/ Data are required reflecting residues in or on oranges (sweet and sour varieties) from foliar application of the
2 or 6 Ib/gal EC at 2.5 Ib ai/A beginning in early spring (when infestation is likely to occur) and continuing at
10- to 14-day maintenance intervals until 21 day before harvest; treatments must involve both ground and aerial
equipment use. An alternative to the submission of the above data reflecting multiple application would be the
establishment of a label restriction limiting the number of applications allowed per season and the submission of
data reflecting that restricted number. Tests are to be conducted in FL and CA.
Data are required reflecting residues in dried pulp, peel, oil, molassess, and juice processed from oranges
bearing measurable weathered residues.
35/ A crop group tolerance is not appropriate at the present time for the following reasons:
(i) Data requirements for apples must be fulfilled.
(ii) Residue data must be submitted for pears harvested 21 days after the last of three foliar applications of
an EC formulation at 0.25 Ib ai/100 gal (2.25 Ib ai/A). The data should reflect ground and aerial applica-
tions. The tests should be conducted in CA, WA and NY.
36/ Residue data from apples harvested 21 days after the last of three foliar applications of an EC formulation at
0.25 Ib ai/100 gal (3 Ib ai/A/application), and in separate tests, 21 days after a single foliar application at
0.5 Ib ai/100 gal (6 Ib ai/A/application) are required. The data should reflect aerial and ground applications.
Tests should be conducted in WA, NY, MI and CA.
Residue data are required from processed apple products (wet pomace, dry pomace and juice) produced from field-
treate bearing detectable, weathered residues. Exaggerated application rates may be necessary to obtain such
residues. If residues concentrate in any of these processed products, appropriate food/feed additive tolerances
must be proposed.
68
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
§158.125 Residue Chemistry
(continued)
37/ The submitted data do not provide adequate support for the established tolerance for demeton residues in or on
pears for the following reasons: (i) the data do not reflect potential residues in pears treated at the maximum
rate; (ii) no registered formulation was tested; (iii) no aerial application data were submitted; and (iv) a
portion of the data were generated with inadequate analytical methods. However, no additional data are required
because we will translate the requested data for apples to pears. If a crop group tolerance is proposed, additional
data for residues in pears must be submitted.
38/ A crop group tolerance is not appropriate at the present time for the following reason: data requirements for
peaches, plums and cherries (the representative crops) must be fulfilled.
39/ The available data do not adequately support the established tolerance for demeton residues in or on apricots.
However, no additional data are required because the data requested for peaches will be used to further evaluate
the tolerance for residues in or on apricots.
40/ The available data are not adequate to support the established non-food-use status of cherries treated in nonbearing
years. The following data are required:
Residue data from cherries harvested from trees treated several times at 0.5 Ib ai/100 gal with an EC formulation
in the season previous to that in which the samples are harvested. If detectable residues are found, a tolerance
must be proposed.
41/ No data were submitted for nectarines. Furthermore, the available, translatable data (for apricots and peaches)
are not adequate to support the established tolerance for demeton residues in or on nectarines. However, no
additional data are required because the data requested for peaches will be used to further evaluate the nectarine
tolerance.
42/ Residue data are required from peaches harvested 30 days after the last of three applications of an EC formulation
at 0.25 Ib ai/100 gal (800 gal/A), made by aerial and ground equipment. The tests should be conducted in CA and SC.
43/ Residue data are required from plums harvested 60 days after the last of two applications of an EC formulation at
0.375 Ib ai/100 gal (800 gal/A), and in separate tests, 30 days after the last of three applications at 0.25 Ib
ai/100 gal (800 gal/A), made using ground or aerial equipment. Tests should be conducted in OR and MI.
Residue data are required from dried plums (prunes) , processed from fieldtreated plums bearing detectable,
weathered residues. The use of exaggerated rates may be required to obtain such residue levels. If residues
concentrate in dried prunes, an appropriate food additive tolerance must be proposed.
44/ A crop group tolerance is not appropriate at the present time for the following reasons:
(i) Residue data are required for additional representative members of this crop group {blackberry, blueberry and
cranberry); currently, tolerances exist only for grapes and strawberries.
(ii) Additional residue data are required for grapes and strawberries.
45/ Data are required reflecting residues in or on grapes as the result of foliar application of the 2 or 6 Ib/gal EC
at 0.375 Ib ai/A beginning in early spring (when infestation is likely to occur) and continuing at 10- to 14-day
maintenance intervals until 21 days before harvest; treatments must involve both ground and aerial equipment use.
An alternative to the submission of the above data reflecting multiple applications would be the establishment of
a label restriction limiting the number of applications allowed per season and the submission of data reflecting
that restricted number. Tests are to be conducted in CA.
69
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
§158.125 Residue Chemistry
(continued)
Data reflecting demeton residues in raisins, juice, wet and dry pomace, and raisin waste processed from grapes
bearing detectable weathered residues are required.
46/ Data are required reflecting residues in or on strawberries as the result of foliar application of the 2 or 6
Ib/gal EC at 0.375 Ib ai/A beginning in spring (when infestation is likely to occur) and continuing at 10- to 14-
day maintenance intervals until 21 days before harvest; treatments must include both ground and aerial equipment
use. An alternative to the submission of the above data reflecting multiple applications would be the establishment
of a label restriction limiting the number of applications allowed per season and the submission of data reflecting
that restricted number. Tests are to be conducted in CA, FL, and OR.
47/ A crop group tolerance is not appropriate at the present time for the following reason: additional data are
required for almonds, fiberts and pecans. [Since no additional residue data have been requested for the repre-
sentative commodity, English walnuts (data will be translated from almonds), filberts may substitute for English
walnuts as a representative commodity for tree nuts.]
48/ Data are required reflecting residues in or on almonds and almond hulls harvested 21 days after a single foliar
application of the 2 or 6 Ib/gal EC at 0.75 Ib ai/A; both ground and aerial application data must be submitted.
Tests must be conducted in CA.
49/ Data are required reflecting residues in or on filberts as the result of foliar application of the 2 or 6 Ib/gal
EC at 2.5 Ib ai/A beginning in spring (when infestation is likely to occur) and continuing at 10- to 14-day
maintenance intervals until 40 days before harvest; treatments must include both ground and aerial equipment use.
An alternative to the submission of the above data reflecting multiple applications would be the establishment of
a label restriction limiting the number of applications allowed per season and the submission of data reflecting
that restricted number. Tests should be conducted in OR.
50/ Data are required reflecting residues in or on pecans as the result of foliar application of the 2 or 6 Ib/gal EC
at 1 Ib ai/A beginning in spring (when infestation is likely to occur) and continuing at 10- to 14-day maintenance
intervals until 21 days before harvest; treatment must involve ground and aerial equipment. An alternative to
the submission of the above data reflecting multiple applications would be the establishment of a label restriction
limiting the number of applications allowed per season and the submission of data reflecting that restricted
number. Tests should be conducted in AL, GA, and LA.
51/ Additional data are not required, because the requested data for almonds will be translated to walnuts to assess
the adequacy of the established tolerance.
52/ A crop group tolerance is not appropriate at the present time for the following reasons:
(i) Residue data are required for two additional representative members of this group [corn (field and sweet) and
rice.]; currently tolerances exist for residues in or on the grain of barley, oats, sorghum, and wheat.
(ii) Additional residue data are required for the grain of oats.
53/ Data are required reflecting residues in germ processed from barley grain bearing measurable weathered residues.
If residues concentrate in this processed product, an appropriate food additive tolerance must be proposed.
70
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
§158.125 Residue Chemistry
(continued)
54/ Sufficient data are not available to assess the adequacy of the established tolerance because: (i) no data reflect
the registered use on crops grown for seed, and (ii) no data were submitted regarding possible concentration of
residues in milling products. Despite the established label restrictions, crops grown for seed may be diverted
for human or animal consumption. In addition, since hulls are a raw agricultural commodity of oats, residue data
must be submitted and an appropriate tolerance must be proposed. The following data are required:
(i) Data are required reflecting residues in or on oat grain and hulls as the result of foliar ground and aerial
applications of the 2 or 6 Ib/gal EC formulations at 0.25 Ib ai/A beginning in the spring (when infestation is
most likely to occur) and continuing at 10- to 14-day intervals until harvest. Samples must be collected
immediately after the last treatment. Tests must be conducted in IA, MN, NY, SD, and TX.
(ii) Data are required reflecting residues in the milled products processed from oats bearing measurable weathered
residues. If residues are found to concentrate in any of the milled products of oats, an appropriate food
additive tolerance must be proposed.
55/ The available data provide adequate support for the established tolerance covering residues of demeton in or on
the grain of sorghum. However, the following additional data are required to determine whether separate food
additive tolerances are needed for flour and milled products:
Data reflecting residues in flour and milled products from grain bearing measurable weathered residues. It may
be necessary to treat at exaggerated rates to obtain detectable residues in grain. If residues concentrate during
processing, appropriate food additive tolerances must be proposed.
56/ Sufficient data are not available to assess the adequacy of the established tolerance because: (i) no data reflect
the registered use on crops grown for seed, and (ii) no data were submitted regarding possible concentration of
residues in milling products. Despite the established label restrictions, crops grown for seed may be diverted
for human or animal consumption. No additional data for wheat are required, however, because the requested data
for oats will be translated to wheat.
57 / Residue data are required for an additional representative member of this group (corn); currently tolerances
exist for barley, oats, sorghum, and wheat. Additional residue data are required for oats. Additional residue
data and tolerance proposals or feeding restrictions are needed for the fodder, silage and hay of sorghum.
58/ Sufficient data are not available regarding residues of demeton in or on the forage, fodder and straw of small
grains, including barley for the following reasons: (i) geographic representation was inadequate for forage and
hay; (ii) only one hay sample, from a CA test, was submitted; (iii) the means of application (ground or aerial)
was unspecified; and (iv) no data were submitted reflecting the registered use on crops grown for seed. In our
opinion, despite the label restriction, crops grown for seed may be diverted for animal consumption. The necessary
data for tolerance evaluation will be translated from the data which has been requested for oats: thus no additional
data for barley are required. It should be noted that hay is a raw agricultural commodity of small grains;
therefore a tolerance for residues in or on hay must be proposed. Furthermore, the commodity definition of "green
fodder" should be changed to "forage."
71
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TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETCN
3158.125 Residue Chemistry
(continued)
59/ Data are required reflecting residues in or on the straw, forage, and hay of oats treated several times with an
~~~ EC formulation at 0.25 lb ai/A/application. Both aerial and ground application data must he submitted. Treatments
must begin in the spring (when infestation is likely to occur) and continue at 10- to 14-day maintenance intervals
thereafter. Samples must be collected immediately following the last treatment. Tests must be conducted in SD,
IA, MM, ND, and WI. It should be noted that hay is a raw agricultural commodity of small grains; therefore a
tolerance for residues in or on hay must be proposed. Furthermore, the commodity definition of "green fodder"
should be changed for "forage."
60/ The available data provide adequate support for the established tolerance covering residues of demeton in or on
"""" the forage of sorghum, however, since fodder, silage and hay are raw agricultural commodities of sorghum, feeding
restrictions or the following residue data (accompanied by appropriate tolerance proposals) are required:
Data reflecting residues in or on fodder, silage, and hay harvested 35 days after a single foliar application of
an EC formulation at 0.25 lb ai/A. Both ground and aerial application data must be submitted. Tests must he
conducted in KS and TX.
61/ Sufficient data are not available regarding residues of demeton in or on the forage, fodder and straw of small
grains, including wheat for the following reasons: (i) geographic representation was inadequate for forage and
hay; (ii) only one hay sample, from a CA test, was submitted: (iii) the means of application (ground or aerial)
was unspecified; and (iv) no data were submitted reflecting the registered use on crops grown for seed.
Despite the label restriction, crops grown for seed may he diverted for animal consumption. The necessary
data for tolerance evaluation will be translated from the data which has been requested for oats; thus no additional
data for wheat are required. It should be noted that hay is a raw agricultural commodity of small grains; therefore
a tolerance for residues in or on hay must be proposed. Furthermore, the commodity definition of "green fodder"
should be changed to "forage."
62/ A crop group tolerance is not appropriate at the present time for the following reasons:
(i) Additional residue data are required for alfalfa.
(ii) The following additional residue data are required for clover: data reflecting residues in or on clover forage
an hay as the result of several ground and aerial foliar applications, beginning in the spring when infestation
is likely to occur and continuing at in- to 14-day intervals thereafter, of the 2 or 6 Ib/gal EC at 0.5 lb
ai/A from tests conducted in MO, NY, OH, PA, and WI; samples of hay are to be harvested 15 days after treat-
ment. Forage must be collected immediately after the last treatment and at intervals thereafter; alterna-
tively, a 15-day pregrazing interval on crops grown for seed may be proposed and data submitted for foliage
collected 15 days after the last treatment, as above.
63/ Sufficient data are not available to assess the adequacy of the established tolerances for the following reasons:
(i) no data reflect the registered use on crops grown for seed; despite the label restriction, these crops may he
diverted for livestock feed; (ii) several tolerance-exceeding residue values were reported for green forage
harvested >21 days following the registered use on crops grown for feed; (iii) the method of application was
unspecified; and (iv) no information as to the presence or absence of detectable levels of metabolites V-VII was
72
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
§158.125 Residue Chemistry
(continued)
given. In addition, no data were submitted pertaining to potential concentration of residues in alfalfa meal or
to residues in the raw agricultural commodity, seed. A tolerance for residues in or on seed must be proposed.
The following data are required:
(i) Data reflecting residues (demeton plus metabolites III-IX) in or on hay and seed of alfalfa 15 days after
the last of several foliar applications (beginning in the spring when infestation is likely to occur and con-
tinuing at 10- to 14-day maintenance intervals thereafter) of an EC formulation at 0.5 Ib ai/A. Forage must
also be collected immediately after the last treatment and at intervals thereafter; alternatively, a 15-day
pregrazing interval on crops grown for seed may be proposed and data submitted for foliage collected 15 days
after the last treatment, as above. Data reflecting the use of both ground and aerial application equipment
must be submitted. Tests must be conducted in CA, IA, MN, NE, and SD.
(ii) Data reflecting residues in or on meal processed from alfalfa bearing measurable weathered residues. If
residue concentrate during meal production, a feed additive tolerance must be proposed.
(iii) It should be noted that the commodity definition "fresh alfalfa" should be changed to "alfalfa forage."
64/ No data are available to assess the adequacy of the established tolerances and label directions. However, no
data are required because upon fulfillment of the data requirements for alfalfa forage and hay, data will be
transferred to clover. However, in the event that a crop group tolerance is desired, residue data for clover
will be required. The current tolerance expression for "fresh clover" should be changed to "clover forage,"
which more appropriately describes this raw agricultural commodity.
65/ The submitted data support the established tolerance for the residues of demeton in or on cottonseed. The data
do not, however, show if residues will concentrate upon processing cottonseed into processed products. The
following data are required to determine if processed products require feed/food additive toierar.es:
(i) Residue data from meal, hulls, soapstock, crude oil and refined oil produced from field-treated cottonseed
bearing measurable, weathered residues. Exaggerated rates may be required to obtain detectable residue levels.
(ii) If a concentration factor greater than one is determined for any of the processed commodities, an appropriate
food/feed additive tolerance should be proposed.
66/ The available data are not adequate to support the established tolerance for demeton residues in or on hops; all
submitted data were generated with unacceptable cholinesterase-inhibition assay methods. The following data are
required:
(i) Residue data from mature hops harvested 21 days after the last of several foliar applications, beginning in the
spring when infestation is likely to occur and continuing at 10- to 14-day intervals thereafter, with an EC
formulation at 0.5 Ib ai/A. The tests should include aerial and ground applications and should be conducted in
WA.
(ii) Residue data from dried hops and spent hops produced from field-treated hops bearing detectable, weathered
residues. Exaggerated application rates may be required to obtain detectable residues levels. If residues
concentrate in either of these processed products, appropriate food/feed additive tolerances must be proposed.
73
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
§158.125 Residue Chemistry
(continued)
67/ There are no direct animal treatments for demeton on cattle, goats, hogs, horses or sheep. The maximum expected
dietary intake of demeton residues by dairy or beef cattle is 6.8 ppm if the diet included 40% small grains,
10% sugar beet pulp, and 50% alfalfa or clover hay. The maximum expected intake by poultry is 0.775 ppm, based
on a diet of 95% grains (<50% barley, <25% oats, <60% sorghum, <73% wheat) and 5% dried grape pomace. For swine,
a reasonable diet, containing 50% grains (<50% oats, wheat or barley), 10% clover forage, 15% dehydrated sugar
beet pulp, and 25% potatoes, would contain up to 1.81 ppm demeton residues.
A decision as to the adequacy of the available data regarding magnitude of residues in animals cannot be made at
the present time because the nature of the residue in animals has not been elucidated. On receipt of the requested
animal metabolism data, the adequacy of the available data will be determined.
* Data submitted by Mobay Chemical Corp. Data may be compensable.
74
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
I/
Data Requirement Composition
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI or PAIRA
Photodegradat ion
161-2 - In water TGAI or PAIRA
161-3 - On soil TGAI or PAIRA
161-4 - In Air TGAI or PAIRA
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA
162-2 - Anaerobic Soil TGAI or PAIRA
162-3 - Anaerobic Aguatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab) TEP
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Pattern" No or Partially) Citation 3(c)(2) (B)?3/
A,B,F,G No
A,B,G No
A,B,G NO
A,B No
A,B,F,G No
A,B No
G No
Not Applicable
A,B,F,G No
A,B,F NO
Yes
Yes
Yes
Yes
Yes
YesV
Yes
Yes
Yes
163-3 - Volatility (Field)
TEP
A,B,F ReservedV
75
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
I/
Data Requirement Composition
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI or PAIRA
Photodegradat ion
161-2 - In water TGAI or PAIRA
161-3 - On soil TGAI or PAIRA
161-4 - In Air TGAI or PAIRA
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA
162-2 - Anaerobic Soil TGAI or PAIRA
162-3 - Anaerobic Aquatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Pattern" No or Partially) Citation 3(c) (2) (B)?3/
A,B,F,G
A,B,G
A,B,G
A,B
A,B,F,G
A,B
G
Not Applicable
A,B,F,G
A,B,F
A,B,F
No
No
NO
No
No
No
No
No
No
ReservedV
Yes
Yes
Yes
Yes
Yes
YesV
Yes
Yes
Yes
76
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Does EPA Save Data""
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Composition" Pattern" No or Partially)
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
Data Requirement
Bibliographic
Citation
§158.130 Environmental Fate
Tcontinuen)
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)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Organisms
TEP
TEP
A,B No
Not Applicable
No
No
TEP G
TEP A,B Reserved?/
PAIRA A,B No
TEP A,B No
TEP Not Applicable
TGAI or PAIRA A,B,G
TEP G
No
Reserved8/
Yes
Yes
NoV
Yes
Yes
Yes
77
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TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETON
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition" Pattern" No or Partially) Citation 3(c)(2)(B)?3/
S158.130 Environmental Fate
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled,
"" TEP=Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop,
"" D * Aquatic, Non-Food; G = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor;
I = Indoor.
3/ Data are due March, 1985 for 161-1, 161-2, 161-3 and 163-1; August, 1985 for 161-4 and 163-2; June, 1986 for 162-1,
~ 162-3, and 164-1; March, 1987 for 164-3 and 165-1; and March, 1988 for 165-2.
4/ Data from an anaerobic soil metabolism study need not be submitted if data from an anaerobic aquatic metabolism
*" study are submitted.
5/ May be required, depending on results of 163-2 (Lab volatility).
£/ Not required because this standard only deals with single active ingredient products.
7/ May be required depending on results from 164-1 (Terrestrial [Soil] Field Dissipation) and 162-1 (Aerobic
"" Soil metabolism).
8/ May be required depending on results from 165-4 (Fish Accumulation Study).
78
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TABLR A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Data Requirement Composition" Patterns" No or Partially)
5158.135 Toxicology
ACUTE TESTING:
81-1 - Acute Oral Toxicity - Rat TGAI A,B,F,G Yes
81-2 - Acute Dermal Toxicity 1GAI A,R,F,G Yes
- Rabbit
81-3 - Acute Inhalation Toxicity TGAI A,B,F,G No
- Rat
81-6 - Dermal Sensitization - A,R,F,G No
Guinea Pig
81-7 - Delayed TGAI A,B,F,G Partiallyll/
Neurotoxicity - Hen
SUBCHRONIC TESTING
82-1 - 90-Day Feeding -
Rodent, Non- rodent TGAI A,F No
82-2 - 21-Day Dermal - Rabbit TGAI A,B,F,G No
82-3 - 90-Day Dermal - Rabbit TCAI A,B,F,G No
82-4 - 90-Day inhalation - A,B,F,G No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c) (2) (B)?3/
05002272 No
05002272 No
Yes
NoV
00052735 Yes
Yes5/
Yes
No
No
Rat
82-5 - 90-Day Neurotoxicity-
Hen/Mammal
TCAI
A,B,F,G
Partially6/H/
GS0143019
Reserved
79
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETCN
Data Requirement
I/ Use
Composition" Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(C)(2)(B)?2/
S158.135 Toxicology
(continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity -
2 species: Rodent
and Non-rodent
83-2 - Oncogenicity -
2 species: Rat and
Mouse preferred
83-3 - Teratogenicity -
2 species
83-4 - Reproduction - Rat
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Domestic Animal Safety
82-1 - 90-Day feeding - Rat
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,F,
A,B,F,G
A,B,F,G
A,B,F,G
PAI or PAIRA A,B,F,G
Choice A,B,G
Thiol sulfoxide A,B,F,G
(metabolite)
No
No
Partiallyll/
No
A,B,F,G Partially
A,B,F,G Partially
A,B,F,G Yes
Partially
Not Required
No
GS0143018
00028625
YesV
YesV
Yes**/
Yes"7/
Yesl2/
GS0143001, GS0143002
(supplementary)
00028625 No
00100927(mouse study) Yes9/
YesW
80
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TABLE A
TABLE A
GENERIC DATA REQUIREMENTS FOR DEMETON
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
_!/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c)(2) (B)?V
§158.130 Toxicology
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=<3reenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; Indoor
_3/ Data are due March, 1985 for 83-1; data are due August, 1985 for 81-3, 81-7, 82-2 and 84-2; data are due
December, 1987 for 83-2 and 83-4; data are due March, 1986 for 85-1; and data are due December, 1985 for 83-3.
For 82-1, data are due June, 1986 for the 90-day feeding rodent, non-rodent, and January, 1986 for the 90-day
feeding rat- thiol sulfoxide study.
4/ Due to the extreme acute dermal toxicity, a dermal sensitization study is not required on the technical material.
j>/ An additional 90-day rat feeding study (82-1) is required on demeton thiolphosphate sulfoxide.
6/ This study is reserved pending the results of 81-7.
7/ Data for 83-1, 83-2, and 83-4 may be fulfilled by citing data on disulfoton. The Agency is allowing the data to be
bridged on the basis of chemical structural similarities.
8/ A teratogenicity study is required in each of two species.
_9/ An additional general metabolism study in the rat is required.
10/ A 90-day feeding study in the rat with emphasis on determination of ChE inhibition is required to assist
determination of the ADI.
ll/ Studies are considered supplementary.
12/ A gene mutation assay in mammalian cells in culture is required.
13/ A chromosome aberration assay in vivo is required.
81
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition" Pattern" No or Partially) Citation 3(c)(2)(B)?V
SI58.140 Reentry Protection
132-1 - Foliar Dissipation TEP A,B,G No YesVV
132-1 - Soil Dissipation TEP A,B,G No YesVV
133-3 - Dermal Exposure TEP A,B,G No
133-4 - Inhalation Exposure TEP A,B,G No
I/ Conposition: TEP = Typical end-use product.
7/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop;
~ D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor;
I = Indoor.
3/ Data are due March, 1<»88.
37 An interim reentry interval of 48 hours is in effect until data are received and evaluated.
=>/ Further information on these data requirements and a discussion of appropriate methodology are contained in Subdivision
~ K of the Pesticide Assessment Guidelines. That document is available (50 FR 159, January 2, 1985) and can be purchased
through NTIS. Orders for Subdivision K may be placed on telephone (703-487-4650), to the NTIS order desk. The document
number is PB-85-120962, and the prices are SlO.OO for the hardcopy and S4.50 for the microfiche copy.
82
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TABLE A
GBNERIC DATA REQUIREMENTS FOR CHEMICAL DEMETTN
Data Requirement
Does EPA Have Data"
To Satisfy This
V Use 2/ Requirement? (Yes,
Composition" Pattern" No or Partially)
S158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
70-1 - Special test TEP
71-1 - Acute Avian Oral Toxicity TGAI
71-2 - Avian Rubacute Dietary TGAI
Toxicity
71-3 - Wild Mammal Toxicity TGAI
71-4 - Avian Reproduction TGAI
71-5 - Simulated and Actual TEP
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
70-1 - Special test TEP
72-1 - Freshwater Fish Acute
Toxicity
Warm water TGAI
Not Applicable
A,B
Partially
A,B,F 5/.G
No
Yes
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
A
A,B,G
A,B,F5/ fi/fG
NO
Yes
Yes
05000975
00022923
00100956*,00100958*
00100957*,00102259*
Yesf/
No
No
Reserved7/
Reserved7/,
YesV
GS0143006,00013531
00035796,00112132
00060630*
No
83
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
I/
Data Requirement Composition
TEP
Cold water TGAI
TEP
Use 2/
Pattern"
A
A,R,G
A
noes EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Partially
Yes
Partially
Bibliographic
Citation 12/
00090378, GS0143003
Gsni43nofi
nn09031R,GS0143004
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/ 12/
Reserved?/
NO
Reserved 7/
72-2 - Acute Toxicity to
Freshwater Invertebrates TGAI A,B,F5/fG
72-3 - Acute Toxicity to Estuarine
and Marine Organisms
Fiddler crab
Oyster-
Shrimp
Estuarine fish
72-4 - Fish Early Life
Stage and Aquatic
Invertebrate Life-Cycle
72-5 - Fish - Life-Cycle
72-fi - Aquatic Organism
Accumulation
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms TEP A,B
TGAI
TEP
TEP
TEP
TEP
TGAI
TGAI
A
A
A
A
A
A,B
A,B
TGAI , PA1 or
Degradation
Product
Yes
No
GS0143005
GS0143Dr)6
PartiallylI/ 00100960*
No
Reserved?/
Reserved?/
Reserved?/
Reserved"?/
Reserved?/
Reserved?/
Reserved 7/
ReservedI/
84
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data""
To Satisfy This
Requ i rement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient; TEP = Typical end-use
product
2/ Th<3 use patterns are coded as follows: A = Terrestrial, Food Crop; R = Terrestrial, Non-Food Crop; C = Aquatic,
Food Crop; D = Aquatic, Non-Food; E = C-reenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H - Domestic
Outdoor I = Indoor.
3/ Data are due September, 1986.
4/ Monitoring of residues on avian feed items in an apple orchard when treated at 5.o to 6.0 Ib. ai/A is required.
5/ Study is required to support the manufacturing-use product to be reformulated into the end-use product.
6/ Only one species must be tested.
7/ Study may be required pending receipt of environmental fate data.
8/ Studies in apples do not fulfill requirement. Studies in alfalfa are not required.
9/ Monitoring of residues in aquatic sites adjacent to grove orchards when treated at 2.0 to 6.0 Ih. ai/A
are required.
in/ Data are required for such crops as citrus, cotton, sorghum where 300,000 acres are grown in coastal counties.
ll/ Fiddler crab is not a recommended species.
12/ Citations 05000975, 00022923, 00100956, 00100958, GS0143006, GSOJ43003, GS0143006, GS0143004, GS0143005, and
GS0143006 each stand alone to fulfill data requirement. Citations 00100957, 00102259, 00013531, 00035796,
00112132, 00060630, 00090378 and 00090318 must be cited with an additional study to fulfill data requirement.
* Data submitted by Mobay Chemical Corp. Data may be compensable.
85
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirements
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Composition" Pattern" No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIPRA Section
3(c)(2)(B)?3/
S158.150 Plant Protection
121-1 - TARGET AREA
PHYTOTOXICITY
EP
NONTARGET AREA PHYTOTOXICITY
TIER I
122-1 - Seed Germination/
Seedling Emergence
TGAI
No
No
No 4/
No 4/
122-1
122-2
123-1
123-1
123-2
124-1
124-2
- Vegetative vigor
- Aquatic Plant Growth
TIER II
- Seed Germination/
Seedling Emergence
- Vegetative vigor
- Aquatic Plant Growth
TIER III
- Terrestrial Field
- Aquatic Field
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
No
No
No
No
No
No
No
No 4/
No 4/
NO 4/
No 4/
No 4/
No 4/
No 4/
17Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
~ EP = End-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food Crop; C = Aquatic,
~ Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic
Outdoor I = Indoor.
3/ Data are due (not applicable).
T/ These requirements are generally waived unless it is believed there is a phototoxicity problem.
86
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TABLE A
GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETON
Data Requirement
V Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?V
S158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honeybee acute
contact toxicity
141-2 - Honeybee - toxicity
of residues on
foliage
141-4 - Honeybee subacute
feeding study
141-5 - Field testing for
pollinators
TT,AI
TEP
A,B
A,B
TEP
A,B
Yes
Yes
No
00036935
00060628
No
No
Reserved^/
NoV
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
foes EPA Have Data - Must Additional
To Satisfy This Data Be Submitted
I/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement _ Composition Pattern" No or Partially) _ Citation _ 3(c)(2)(B)? V
S158.155 Nontarget Insect
(continued)
NONTAFGET INSECT TESTING -
INSECTS;
142-1 - Acute toxicity to Reserved*/
aquatic insects ~
142-2 - Aquatic insect Reserved6/
life-cycle study ~
142-3 - Simulated or actual Reserved*/
field testing for ~
aquatic insects
143-1 - NONTARGET INSECT Reserved*/
TESTING - PREDATORS
thru AND
143-3
I/ Composition: TGAT = Technical grade or the active ingredient; TEP = Typical end-use product.
7/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop:
"~ D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor;
I = Indoor.
3/ Data are due (not applicable).
?/ Reserved pending development of test methodology.
5/ Data from lower level tests do not indicate the need for a field study.
£/ Reserved pending Agency decision as to whether the data requirement should he established.
88
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TABLR A
GENERIC DATA REQUIREMENTS FOR DEMETCN
noes EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use Requirement? (Yes, Bibliographic Under FIFRA
Data Requirement CompositionV Pattern2/ No or Partially) Citation S3(c) (2) (B)?3/
201.1 Droplet Size Spectrum TEP A,B,G No - Yes
Testing
202.1 Drift Field TEP A,B,G No - Yes
Evaluation
I/ Composition = TEP- TYpical end-1 use product.
7/ The use patterns are coded as follows: A=Terrestrial, Food Crop,; B=Terrestrial, Non-food Crop; OAquatic, Food Crop;
"" D=Aquatic, Non-food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor;I=Indoor
3/ Data are due February, a987.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURIMS-USE PRODUCTS CONTAINING DEMETON
S158.120 - PRODUCT CHEMISTRY
Guideline Citation and
Name of Test
Test I/
Substance ~
Guidelines
Status
Are Data 2/
Required ~
Yes No
Footnote
Number
Product Identity;
61-1 - Product Identity and Disclosure MP
of ingredients
61-2 - Description of Beginning Materials MP
and Manufacturing Process
61-3 - Discussion of Formation of MP
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
R
R
R
R
R
R
jxj
90
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TABLE R
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DEMETON
15158.120 - PRODUCT CHEMISTRY
Guideline Citation and
Name of Test
Test I/
Substance
Guidelines Are Data
Status Required 2/ Footnote
Yes No ~ Number
Physical and Chemical Characteristics
f Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flantnability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
Other Requirements:
64-1 -
- Suhmittal of samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
PAI
R |Xj | j
R |X| | j
CR jx| |~|
CR |X| j~j
R )Xj j~j
R (X| j j
CR |X| |~|
CR |X| j~j
R (X| |~|
CR |~| jxj
I/ Composition: MP= Manufacturing-Use Product; PAI = Pure Active Ingredient.
2/ Data are due August, 1985.
91
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL DEMETON
Data Requirement
Composition"
Roes EPA Have~D~aEaT~
To Satisfy This
I/ Requirement? (Yes,
No or Partially)
S158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat MP
fil-2 - Acute nermal Toxicity MP
81-3 - Acute Inhalation Toxicity MP
- Rat
81-4 - Primary Eye MP
Irritation - Rabbit
81-5 - Primary Dermal MP
Irritation - Rabbit
81-6 - Dermal Sensitization - MP
Guinea pig
Yes
Yes
No
No
No
No
Bibliographic
Citation
Must Adaltlonal
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
05002272
05002272
No
No
Yes
NoV
NoV
NoV
17Composition:MP = Manufacturing-use product, which is Systox TecTTnicaT 85% a.i.
7/ Data are due August, 1985.
3/ Data are not required due to the extreme acute dermal toxicity of the manufacturing-use product.
92
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TABLE C
PRODUCT RPRCIFIC DATA RETIREMENTS TOR END-USE PRODUCTS CONTAINING CHEMICAL DEMETON
Data Requirement
Composition"
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No or Partially)
S158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity- Rat EP
81-2 - Acute Dermal Toxicity- F,p
Rabbit
81-3 - Acute Inhalation Tox- EP
icity- Rat
Bibliographic
Citation
~Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
No
No
No
YesV
YesV
Yes3/
I/Composition: EP = End-Use Product
7/ Data are due August, 1985.
3/ Registrants have the option of accepting the restricted-use classification, or submitting the data.
93
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II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA sec. 3(c)(2)(B)
and describes, in table format, the data required
for maintaining the registrability of each product.
Additionally, a bibliography (Appendix II-2) is
included that identifies that data considered as
part of the data base supporting this standard.
EPA has determined that additional generic data
described in this Notice must be submitted to EPA
for evaluation in order to maintain in effect the
registration(s) of your product(s) identified as
an attachment to the cover letter accompanying this
guidance document. As required by FIFRA sec.
3(c)(2)(B), you are required to take appropriate
steps to comply with this Notice.
EPA may suspend the registration of each of those
products unless, within the specified time, you have
informed EPA how you will satisfy the requirements
of this Notice. Any such suspension will remain in
effect until you have complied with the terms of
this Notice.
B. What Generic Data^/ Must be Submitted. You may
determine which generic data you must submit by con-
sulting Table A at the end of this chapter. That
table lists the generic data needed to evaluate the
continued registrability of all products, and the
dates by which the data must be submitted. The
required studies must be conducted in accordance
with EPA approved protocols (such as those contained
in the Pesticide Assessment Guidelines _£/ or data
collected under the approved protocols of the
Organization for Economic Cooperation and Development
(OECD). If you wish not to develop data which are
necessary to support the reregistration of certain
_W Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation
of the risks of all products containing that ingredient (or
all such products having a certain use pattern), regardless
of any such product's unique composition or use. Product-
specific data relate only to the properties or effects of a
product with a particular composition (or a group of products
with closely similar composition).
j2/ The Pesticide Assessment Guidelines are available in
hard copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
94
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uses appearing in your labeling, you may delete
those uses at the time you submit your revised label-
ing.
Also for certain kinds of testing (generally eco-
logical effects), EPA requires the test substance
to be a "typical formulation, " arid in those cases
EPA needs data of that type for each major formulation
category (e.g., emulsifiable concentrates, wettable
powders, granulars, etc.) These are classified as
generic data and when needed are specified in Table A.
EPA may possess data on certain -"typical formu-
lations" but not others. Note; The "typical formu-
lation" data should not be confused with product-
-specific data (Table B) which are required on each
formulation. Product-specific data are further
explained in Chapter III of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you
must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet"
[EPA Form 8580-1, Appendix II-3] for each of your
products. On that form you must state which of the
following methods you will use to comply with the
requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe
will satisfy the requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Pesticide Assessment Guidelines or
protocols contained in the Reports of Expert
Groups to the Chemicals Group, Organization
for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you
must enclose the protocols you will use.
OR
2. Notify EPA that you have entered into an agree-
ment with one or more other registrants to
jointly develop (or share in the cost of develop-
ing) the data. If you elect this option, you
must notify EPA which registrant(s) are parties
to the agreement.
95
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3. File with EPA a completed "Certification of
Attempt to Enter Into an Agreement With Other
Registrants for Development of Data" (EPA Form
8580-6, Appendix II-4)V
OR
4. Request that EPA amend your registration by
deleting the uses for which the data are needed,
(This option is not available to applicants for
new products.)
OR
5. Request voluntary cancellation of the regis-
tration^) of your products for which the data
are needed. (This option is not available to
applicants for new products.)
D. Procedures for Requesting Changes in Testing
Methodology and Extensions of Time
EPA recognizes that you may disagree with our con-
clusions regarding the appropriate ways to develop
the required data or how quickly the data must be
submitted. If the test procedures you plan to use
deviate from (or are not specified in) the regis-
tration guidelines or protocols contained in the
V FIFRA sec. 3(c)(2)(B) authorizes joint development of
data by two or more registrants, arid provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion riot to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3(c)(2)(B)(iii)]; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration.
96
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reports of the Expert Groups to the Chemical Groups,
Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit
the protocol for Agency review prior to the initiation
of the test.
If you think that you will need more time to generate
the required data than is allowed by EPA's schedule,
you may submit a request for an extension of time.
The extension request must be submitted in writing
to the Product Manager. The extension request
should state the reasons why you conclude that an
extension is appropriate. While EPA considers your
request, you must strive to meet the deadline for
submitting the required data.
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
A necessary first step in determining which statements
must appear on your product's label is the completion
and submission to EPA of product-specific data* listed
on the form entitled "Product Specific Data Report"
(EPA Form 8580-4, Appendix III-l) to fill "gaps" iden-
tified by EPA concerning your product. Under the
authority of FIFRA sec. 3(c)(2)(B), EPA has determined
that you must submit these data to EPA in. order to
reregister your product(s). All of these data must be
submitted not later than six months after you receive
this guidance document.
"Product-Specific Data Requirements for Manufacturing-
Use Products" appearing in Table B permit you to deter-
mine which product-specific data you must submit.
This can be done by examining the entries in the column
of those tables entitled "Must Data By Submitted Under
§3(c)(2)(B)."
^_/ Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
97
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IV. SUBMISSION OF REVISED LABELING INFORMATION
Note; This section applies to all products containing
demeton.
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CFR 162.10 (see
Appendix IV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix IV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
If you fail to submit revised labeling information
complying with this section and/or Section I, EPA may issue
a notice of intent to cancel the registration under FIFRA
sec. 6(b)(l) .
A. Label Contents
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items
listed below are keyed" €6 Appendix IV-2.
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
require 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. See Appendix IV-1. f40 CFR
162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
98
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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. See Appendix IV-1.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container
See Appendix IV-1. [40 CFR 162.10(f)j
Item 6. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel and 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. See Appendix IV-1. [40 CFR 162.10(g)]
Item 6A. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word as Re- "Keep Out of Reach
on Front Panel quired Minimum Type of Children"
in Square Inches Size All Capitals as Required
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. See Appendix IV-1.
[40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[40 CFR 162.10 (h)(l)(i)]
99
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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. See Appendix IV-1. [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. See Appendix IV-1. [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.
See Appendix IV-1. [40 CFR 162. 10(h) (1) (iii) ]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as 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. See Appendix IV-1. [40 CFR 162.10
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. See Appendix IV-1. [40 CFR 162.10
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. See Appendix IV-1. [40 CFR
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements relating
to flammability of a product are required to appear on the
label if it meets the criteria in Appendix IV-3 . The require-
ment 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.
100
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2. Criteria for declaration of non-flammability. The
following criteria will be used to determine if a product
is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A "non-flammable liquid" is one having a flashpoint
greater than 350°F (177°C).
c. A "non-flammable aerosol" is. one which meets the
following criteria:
i. The flame extension is zero inches;
ii. There is no flashback; and
iii. The flashpoint of the rion-volatile liquid
component is greater than 350°F (177°C).
3. Declaration of non-flammability. Products which
meet the criteria for non-flammability specified
above may bear the notation "non-flammable" or "non-
flammable (gas, liquid, etc.)" on the label. It may
appear as a substatement to the ingredients statement,
or on a back or side panel, but shall not be highlighted
or emphasized (as with an inordinately large type
size) in any way that may detract from precaution.
4. Other physical/chemical hazard statements. When
chemistry data demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
Item 9. PRODUCT CLASSIFICATION - Section 3(d) of FIFRA
requires that all pesticide formulations/uses be classified
for either general or restricted use, and that those uses
classified as restricted be limited to use by certified
applicators or persons under their direct supervision (or
subject to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses to be restricted, based either on a
previous classification determination made through the optional
procedures of 40 CFR 162.30 or based on data already available
to the Agency, or (2) reserved any classification decision until
appropriate data are submitted.
101
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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 wish to propose that your product should not 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
classification 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.
A. Classification Labeling Requirements
1. All Uses Restricted - Pesticide products bearing
directions for use for formulations or uses classified
restricted shall bear statements of restricted use classi-
fication on the front panel as described below:
a. The statement "RESTRICTED USE PESTICIDE,"
must appear at the top of the front panel of the
label, set in type of the same minimum sizes as
required for human haaard signal words (see table in
40 CFR 162.10(h)(l)(iv).
b. Directly below this statement on the front
panel, a summary statement of the terms of restric-
tion shall appear. If use is restricted to certified
applicators, the following statement is required:
"For retail sale to and use only by Certified Applicators
or 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 Regula-
tory Position and Rationale states that some uses are
classified for restricted use and some uses are unclassified,
several courses of action are available:
a. You may label the product for restricted use.
If you do so, you may include those 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 unres-
tricted uses.
102
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c. You may "split" your registration, i.e.,
register two separate products with identical formula-
tions, one containing only unrestricted uses, and
the other restricted uses. To do so, submit two
applications for reregistration, each containing all
forms and necessary labels. Both applications should
be submitted simultaneously. Note that the product
names will be assigned separate registration numbers.
Item 10. MISUSE STATEMENT- The following statement is required
on your label: "It is a violation of Federal law to use this product
in a manner inconsistent with its labeling."
Item 10A. 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
IV-4 to determine the disposal instructions appropriate for
your products.
Item 10B. 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
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV-1. [40 CFR 162.10]
B. Collateral Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other 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.
103
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V. IKSTKUCT1GN^ FOR Sl'hMI SSICA"
All P. i ; Z i c -1 5 or r ; • -; -r<~'~ : •" responr t r> this No*:"-- ct~oul^
b-,_- addressf": ^s follows:
William H. Miller-
Product Manager (16)
Registration Division (TS-767C)
Office- of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
Phone No. (703) 557-2400
For each product for which continued registration is desired:
A. For Manufacturing Products (MP) containing only demeLon
as an active ingredient.
1. Kith in 90 days from receipt of this document, you must
s u bm i t:
a. "FIFRA Section 3(c ) (2 ) (B) Summary Sheet" EPA
Form 8580-1. Refer to Appendix II-3 with appropriate
attachments.
b. Confidential Statement of Formula, EPA form c3~0-4.
2. Within 6 months from receipt of this document yc-j must
submit:
a. Application for Pesticide Registration, EPA Form
8570-1.
b. Product Specific Data Report, EPA Form 8580-4
(Appendix III-]).
c. Two copies of any required product-specific data.
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms
to the requirements of this guidance document and the
results of the product-specific data, you may submit such
labeling. End use product labeling must comply specif-
ically with the instructions in Section II (Regulatory
Position and Rationale) of this guidance document.
The labeling should be either typewritten text on 8-1/2
x 1] inch paper or a mockup of the labeling suitable
for storage in 8-1/2 x 11 inch files. The draft label
must indicate the intended colors of the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to PR Notice 84-4
for latest requirements.
104
-------
3. Within the times set forth in TaMeA, all generic data
must 5e
Note: If for any reason any required test is delayed or
aBorted so that meeting the agreed submission time will be
delayed, notify the Product Manager.
B. For Manufacturing Use Products containing demeton in
combination with other active ingredients.
1. Within 90 days from receipt of this document, you must
submit':
a. "FIFRA Section 3{c)(2)(B) Summary Sheet" EPA
Form 8580-1. Refer to Appendix II-3 with appropriate
attachments .
b. Confidential Statement of Formula, EPA Form 8570-4
2. Within the times_set f ££i!Li!l-T^~£-^ ' a11 generic
cTata mus~C~b~e~"s~ubnn~£Tecr .
Note: If for any reason any required test is delayed or
aborted so that meeting the agreed submission time will be
delayed, notifiy the Product Manager.
C. For End Use products containing demeton alone or in
combination with other active ingredients:
1. Within 90 days from receipt of this document, you must
"sUBmlTTF
a. "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA
Form 8580-1. Refer to Appendix II-3 with appropriate
attachments. If you purchase a£d jj£e_as_the source of the
active ingredTenF"In~you£~ena-u£e^pf o3uct_onTy ^PA-reg3.sTered
proa'ucTs~Fh'e'n~ydu are~exemjpT7From fRe__ge ne r Tc _c[a t a_req u i££l
ments~l!or~(!eitie ton and~"need' not _s ^mT t_ tHe _ s umma ry_ s^eeT L
b. Confidential Statement of Formula, EPA Form 8570-4.
2. Within 6 months from receipt of this document you must
submit":
a. Application for Pesticide Registration, EPA Form
8570-1 .
b. Product Specific Data Report, EPA Form 8580-4
(Appendix III-l ) .
c. Two copies of any required product-specific data.
(Refer to Table C)
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms
105
-------
to the requirements of this guidance document and the
results of the short-term data, you may submit such
labeling. End use product labeling must comply specif-
ically with the instructions in Section II (Regulatory
Position and Rationale) of this guidance document.
The 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 inch files. The draft label
must indicate the intended colors of the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to PR Notice 84-4
for latest requirements.
3. For those end use product registrations that are not
eligible for the formulations exemption [FIFRA sec. 3(c)(2)(D)],
submit all generic data within the time set forth in Table A.
106
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Appendix II-l
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
-------
Appendix II-l (continued)
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element, immedi-
ately following the word "under," is the regis-
tration number, experimental use permit number,
petition number, or other administrative number
associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
-------
Appendix
OFFICE OF PESTICIDE PROGRAMS
REGISTRATIONS STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Demeton Standard
00013531 Henderson, C.; Pickering, Q.H.; Tarzwell, C.M,
(1959) The Toxicity of Organic Phosphorus and
Chlorinated Hydrocarbon Insecticides to Fish:
Report No. 4276. (Unpublished study received
Mar 4, 1966 under unknown admin, no.; prepared
by U.S. Public Health Service, Robert A. Taft
Sanitary Engineering Center, submitted by Mobay
Chemical Corp., Agricultural Div. , Kansas City,
Mo.; CDL-.130685-B)
00022923 Hill, E.F.; Heath, R,G.; Spann, J.W.; et al. (1975)
Lethal Dietary Toxicities of Environmental
Pollutants to Birds: Special Scientific Report-
-Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife
Research Center; unpublished report)
00028625 Simmon, V.F. (1979) In vitro Microbiological
Mutagenicity and Unscheduled DNA Synthesis
Studies of Eighteen Pesticides: Report No. EPA-
600/1-79-041. (Unpublished study including
submitter summary, received Apr 3, 1980 under
279-2712; prepared by SRI International, submitted
by FMC Corp., Philadelphia, Pa.; CDL: 099350-A)
00035796 Pickering, Q.H.; Henderson, C.; Lemke, A.E. (1962)
The toxicity of organic phosphorus insecticides
to different species of warmwater fishes.
Transactions of the American Fisheries Society
91(2):175-184. (Also in unpublished submission
received Mar 4, 1966 under unknown admin, no.;
submitted by Mobay Chemical Corp., Kansas City,
Mo.; CDL:130685-F)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975)
Toxicity of Pesticides and Other Agricultural
Chemicals to Honey Bees: Laboratory Studies. By
University of California, Dept. of Entomology.
?: UC, Cooperative Extension. (Leaflet 2287r
published study.)
00052735 Durham, W.F.; Gaines, T.B.; Hayes, W.J., Jr. (1955)
Paralytic and Related Effects of Certain Organic
Phosphorus Compounds: Report No. 863. (U.S.
Public Health Service, Communicable Disease
Center, unpublished study; CDL:107616-P)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Demeton Standard
00057268 Chemagro Corporation (1962) Stability of Di-Syston
and Systox Residues during Frozen Storage: Report
No. 8857. (Unpublished study received Mar 24,
1965 under 6F0478; submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:090534-F)
00060628 Johansen, C.A.; Eves, J. (1965) Bee Poisoning
Investigations, 1965: Report No. G-1705? Report
No. 17338. (Unpublished study, including letter-
dated Jun 12, 1973 from C.A. Johansen to A.D.
Cohick, received Mar 27, 1974 under 4F1485;
prepared by Washington State Univ., Dept. of
Entomology, submitted by Chemagro Corp., Kansas
City, Mo.; CDL:092011-I)
00060630 Ludemann, D.; Neumann, H. (1971) Tests on the Acute
Toxic Effects of the Latest Contact Insecticides
on One-Summer Carp: Report No. 19938. (Unpublished
study received Mar 27, 1974 under 4F1485;
submitted by Chemagro Corp., Kansas City, Mo.;
CDL: 092011-K)
00071233 Anderson, C.A. (1962) Colorimetric Determination of
Di-syston and Systox Residues in Plant Material:
Report No. 8544. (Unpublished study received
Feb 4, 1962 under PP0331; submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:099937-A)
00071242 Anderson, C.A. (1960) Relative cholinesterase-inhibiting
power of several Systox derivatives:Report No. 5915.
(Unpublished study received Jan 5, 1961 under PP0256;
submitted by Mobay Chemical Corp; CDL:099938-E)
00071243 Anderson, C.A. (I960) Coloriroetric Determination of
Di-syston and Systox Residues in Plant Material:
II. Application to Potatoes, Sugar Beets, Sugar
Beet Tops, Cabbage, Broccoli, Pineapple, and
Alfalfa: Report No. 5511. Method dated Jul 25,
1960. (Unpublished study received Jan 5, 1961
under PP0256; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:099938-F)
00089855 Mobay Chemical Corporation (1962) Synopsis of
Analytical and Residue Information on Di-syston
(Alfalfa, Broccoli, Wheat). Includes methods
dated Jun 2, 1961 and Jul 25, I960. (Compilation;
unpublished study received Apr 1, 1962 under
PP0358; CDL:090388-A)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Demeton Standard
0009318 McCann, J.A. (1970) Systox Insecticide:Rainbow Trout
(Salmo gairdneri) Test No. 235. (U.S. Agricultural
Research Service, Pesticides Regulation Div.
, Animal Biology Laboratory, Fish Toxicity
Laboratory; unpublished study? CDL:130492-A)
00090378 McCann, J.A. (1970) Systox Insecticide: Bluegill
(Leporois macrochirus): Test No. 232. (U.S.
Agricultural Research Service, Pesticides
Regulation Div., Animal Biology Laboratory, Fish
Toxicity Laboratory; unpublished study; CDL:130477-
A)
00095572 Chemagro Corporation (1960) Residue Report: Systox:
Report No. 5857. (Unpublished study received on
unknown date under PP0244; submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:092521-C)
00095608 Olson, T.J. (1969) A Confirmatory Gas Chromatographic
Procedure for (R) Di-syston-(P) systox Residue
Analysis: Report No. 26335. (Unpublished study
received Feb 2, 1970 under OF0945; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:093251-
E)
00095618 Anderson, C.A. (I960) Colorimetric Determination of
Di-syston and Systox Residues in Plant Material:
Report No. 5339. Method dated Jun 1, 1960.
(Unpublished study received on unknown date
under PP0282; submitted by Chemagro Corp., Kansas
City, Mo.; CDL:098758-B)
00095640 Mobay Chemical Corporation (1973) Analyses for
Residues of (R) Di-syston in Cabbage and Broccoli.
(Compilation; unpublished study, including report
nos. 37822, 37823, 27824..., received Jun 26,
1974 under 3125-172; CDL:102091-F)
00100829 Hensel, J.; Hewitt, A.; Sheets, U.; et al. (1952?)
Microestimation of Demeton Residues. (Unpublished
study received Mar 21, 1^55 under PP0010; prepared
in cooperation with Pittsburgh Coke and Chemical
Co., submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:092012-B)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Demeton Standard
00100831 Kelly, M.; Hensel, J. (1954) Effect of Crop Cold
Storage on the Cholinesterase Measurement of
Systox Residues. (Unpublished study received
Mar 21, 1955 under PP0010; prepared by Pittsburgh
Coke and Chemical Co., submitted by Mobay Chemical
Corp., Kansas City, MO; CDL-.092012-D)
00100834 Mobay Chemical Corp. (1954) Systox: Residues on
Pears. (Compilation; unpublished study received
Mar 21, 1955 under PP0010; CDL:092012-H)
00100836 Mobay Chemical Corp. (1954) Systox Residue Data—
Walnuts. (Compilation; unpublished study received
Mar 21, 1955 under PP0010; CDL:092012-K)
00100838 Metcalf, R.; Kukuto, T.; March, R.; et al. (1954)
Spray Residue Tests with Systox: Oranges and
Pears: 4452. (Unpublished study received Mar
21, 1955 under PP0010; prepared by Univ. of
California—Riverside, Dept. of Entomology,
Citrus Experiment Station, submitted by Mobay
Chemical Corp., Kansas City, MO; CDL:092012-M)
00100845 Muehlmann, R. (1954) Report on Tests with Radioactive
Systox on Citrus Trees Conducted in Zebediela
(South Africa) from Sep 29, 1953 to Jan 12,
1954: *482. (Translation; unpublished study
received Mar 21, 1955 under PP0010; submitted by
Mobay Chemical Corp., Kansas City, MO; CDL:092014-
F)
00100863 Hensel, J.; Sheets, U. (1953) Estimation of Plant
Residues of Systox in Potatoes by Measurement of
Cholinesterase Inhibition. (Unpublished study
received Apr 6, 1955 under PP0010; prepared in
cooperation with Pittsburgh Coke & Chemical Co.,
submitted by Mobay Chemical Corp., Kansas City,
MO; CDL:092295-B)
00100864 Sheets, U.; Hensel, J. (1953) Estimation of Plant
Residues of Systox in English Walnuts by
Measurement of Cholinesterase Inhibition.
(Unpublished study received Apr 6, 1955 under
PP0010; prepared by Pittsburgh Coke and Chemical
Co., submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:092295-E)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Demeton Standard
00100871 Dahm, P.; Jacobson, N. (1955?) Effects of Feeding
Systox-treated Alfalfa Hay to Dairy Cows:
Submitter #826. (Unpublished study received Jan
20, 1956 under PP0068; prepared by Iowa State
College, submitted by Mobay Chemical Corp.,
Kansas City, MO; CDL:092348-B)
00100872 Fukuto, T.; Wolf, J.; Metcalf, R.; et al. (1956)
Identification of the Sulfoxide and Sulfone
Plant Metabolites of the Thiol Isomer of Systox:
Submitter f1063. (Unpublished study received
Jan 20, 1956 under PP0068; prepared by Univ. of
California—Riverside, Citrus Experiment Station,
submitted by Mobay Chemical Corp., Kansas City,
MO; CDL:092348-C)
00100877 Chemagro Corp. (1959) Microestimation of Systox
Residues by the Cholinesterase Technique: Report
No. 4638. (Unpublished study received on unknown
date under PP0230; submitted by Mobay Chemical
Corp., Kansas City, MO; CDL:092413-B)
00100883 Mobay Chemical Corp. (1957) Systox on Hops.
(Compilation; unpublished study received on
unknown date under PP0121; CDL: 092402-A)
00100898 Metcalf, R.; Reynolds, H.; Fukuto, T.; et al. (1956)
Systox Residues in Alfalfa: Submitter #1202.
(Unpublished study received Nov 30, 1956 under
PP0121; prepared by Univ. of California—Riverside,
Agricultural Experiment Station, Dept. of
Entomology, Citrus Experiment Station, submitted
by Mobay Chemical Corp., Kansas City, MO;
CDL:092402-Q)
00100902 Dahm, P.; Jacobson, N. (1956) Effects of Feeding
Alfalfa Meal Containing Systox Residue Toxins to
Dairy Cows: Project No. 1256; 1254. (Unpublished
study received Nov 30, 1956 under PP0121; prepared
by Iowa State College, Agricultural Experiment
Station, Depts. of Animal Husbandry and Zoology
& Entomology; submitted by Mobay Chemical Corp.,
Kansas City, MO; CDL:092402-X)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Demeton Standard
00100903 Ellis, L. (1956) The Physiological Effects of
Feeding Systox Residues to Cows and Calves:
Submitter 1378. Master's thesis, Utah State
Agricultural College. (Unpublished study received
Nov 30, 1956 under PP0121; submitted by Mobay
Chemical Corp., Kansas City, MO; CDL:092402-Y)
00100904 Balloun, S.; Dahm, P.; Croll, J.; et al. (1957) A
Summary of Poultry Feeding Studies Employing
Rations with Alfalfa Meal Containing Systox
Residue Toxins: Project No. 1256; #1583.
(Unpublished study received on unknown date
under PP0121; prepared by Iowa State College,
Agricultural Experiment Station, Depts. of
Poultry Husbandry and Zoology & Entomology,
submitted by Mobay Chemical Corp., Kansas City,
MO; CDL:092402-Z)
00100912 Williams, G. (1959) Letter sent to W. Cook dated
Apr 30, 1959 Questions concerning Systox.
(Unpublished study received May 4, 1959 under
PP0205; submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:092482-F).
00100919 Mobay Chemical Corp. (1960) Systox: Analytical and
Residue Data: Apricots, Cottonseed, Peppers and
Plums (Fresh Prunes). (Compilation; unpublished
study received Aug 18, 1960 under PP0264;
CDL:092542-D)
00100921 Mobay Chemical Corp. (1960) Systox: Analytical and
Residue Data (Sugar Beets). (Compilation;
unpublished study received Feb 2, 1961 under
PP0293; CDL:092573-B)
00100923 Mobay Chemical Corp. (1961) Systox: Analytical,
Residue, and Taste Data (Barley, Oats, and
Wheat). (Compilation; unpublished study received
Mar 2, 1962 under PP0332; CDL:092614-C)
00100926 Fukuto, T.; Metcalf, R.; March, R.; et al. (1955)
Chemical Behavior of Systox Isomers in Biological
Systems. (Unpublished study received Feb 8,
1955 under PP0230; prepared by Univ. of California-
-Riverside, Agricultural Experiment Station,
Dept.of Entomology, Citrus Experiment Station,
submitted by Chemagro Corp., New York, NY;
CDL:093728-B)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Demeton Standard
00100927 March, R.; Metcalf, R.; Fukuto, T. (1955) Metabolism
of Systox in the White Mouse and American
Cockroach. (Unpublished study received Feb 8,
1955 under PP0230; prepared by Univ. of California-
-Riverside, Citrus Experiment Station, submitted
by Chemagro Corp., New York, NY; CDL:093728-C)
00100928 Metcalf, R.; March, R. ; Fukuto, T.; et al. (1955)
The Nature and Significance of Systox Residues
in Plant Materials. (Unpublished study received
Feb 8, 1955 under PP0230; prepared by Univ. of
California—Riverside, Citrus Experiment Station,
submitted by Chemagro Corp., New York, NY;
CDL:093728-D)
00100929 Laski, R.; Sabatino, F. (1968) Letter sent to Chief
Chemist, Buffalo District and SC-540, Div. of
Food Standards and Additives, Pesticides Branch
dated Apr 29, 1968. Calculations, chromatograms
and method tryout on the Systox pesticide
petition. (U.S. Government; unpublished study;
CDL-.098130-A)
00100930 Mobay Chemical Corp. (1954) Systox Residue Data—
1953. (Compilation; unpublished study received
Jan 29, 1954 under 3125-4; CDL: 101738-A)
00100931 Mobay Chemical Corp. (1969) Systox: Analytical and
Residue Information on Alfalfa and Clover Grown
for Seed. (Compilation; unpublished study
received Jan 12, 1970 under 3125-4; CDL:102094-
A)
00100933 Gortner, W. (1953) Metabolism of Radioactive Systox
in the Pineapple Plant: Joint Project 67. Final
rept. (Unpublished study received Jan 7, 1954
under 3125-4; submitted by Mobay Chemical Corp.,
Kansas City, MO; CDL:102109-B)
00100934 Cleary, T. (1952) Systox Residue Analyses of Refined
Cotton Seed Oil and Meal from Field Treated
Cotton and from Artificially Contaminated Seed
Meats. (Unpublished study received Mar 6, 1952
under 3125-4; submitted by Mobay Chemical Corp.,
Kansas City, MO; CDL:102110-A)
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OFFICE OF PESTICIDE PROGRAMS
REIGSTRATION STANDARD BIBLIOGRAPHY
Citations Considered to he Part of the Data Rase Supporting
Registrations under the Demeton Standard
00100936 Mohay Chemical Corp. (1964) Systox: Analytical
and Residue Data (Eggplant). (Compilation;
unpublished study received Sep 21, 1964 under
.3125-4; CDL:102323-A)
00100937 Mobay Chemical Corp. (1964) Systox: Analytical and
Residue Data (Sorghum). (Compilation; unpublished
study received Apr 16, 1964 under 3125-4; CDL:102324-A)
00100943 Mobay Chemical Corp. (1962) Summary Table: Di-syston
and Systox. (Compilation; unpublished study
received Apr 24, 1962 under unknown admin, no.;
CDL:120172-A)
00100956 Lamb, D. (1971) Toxicity of Repeated Applications
of Systox Spray Concentrate to Juvenile Pheasants
under Simulated Field Conditions: Report No.
31597. (Unpublished study received Dec 30,
1971 under unknown admin, no.; submitted by Mobay
Chemical Corp., Kansas City, MO; CDL:12R223-A)
00100957 Lamb, D.; Nelson, D. (1971) Toxicity of Systox 6
Ib/gal Spray Concentrate to Bobwhite Ouail
under Simulated Apple Orchard Conditions:
Report No. 29470. (Unpublished study received
Mar 3, 1971 under unknown admin, no.; submitted
by Mobay Chemical Corp., Kansas City, MO; CDL:128224-A)
00100958 Lamb, D. (1971) Toxicity of Repeated Applications
of Systox Spray Concentrate to Bobwhite Ouail
under Simulated Apple Orchard Conditions: Report
No. 31657. (Unpublished study received Jan 18,
1972 under 3125-221; submitted by Mobay Chemical
Corp., Kansas City, MO; CDL:221884-A)
00100960 Heitmuller, T. (1975)
Fiddler Crabs (uca
(Unpublished study
3125-111; prepared
submitted by Mobay
MO; CDL:221965-A)
Acute Toxicity of Systox 6 to
pugilator) Submitter 44767.
received Aug 18, 1975 under
by Bionomics—EG & G, Inc.,
Chemical Corp., Kansas City,
00100962 Mobay Chemical Corp. (1977) Synopsis of Systox:
Residue Chemistry on Forage Crops. (Compilation;
unpublished study received Jun 20, 1977 under
WA 77/22; submitted by state of Washington for
Mobay; CDL:236703-A)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Demeton Standard
00100963 Thornton, J.; Horton, J. (1976) Effect of Feeding
Systox Metabolites to Cattle: Report No. 46794.
(Unpublished study received Jun 20, 1977 under
WA 77/22; submitted by state of Washington for
Mobay Chemical Corp., Kansas City, MO;
CDL:236703-B)
00100964 Thornton, 3. (1976) Effect of Feeding Systox
Metabolites to Dairy Cattle: Report No. 47134.
(Unpublished study received Jun 20, 1977 under
WA 77/22; submitted by state of Washington for
Mobay Chemical Corp., Kansas City, MO;
CDL:236703-C)
00102224 Mobay Chemical Corp. (1951) Residues of Systox in
Fruits and Vegetables. (Compilation; unpublished
study received Mar 4, 1952 under 3125-4; CDL:006880-
H)
00102232 Cleary, T.; Wagner, W. (1950?) A Bioassay for Two
New Insecticides. (Unpublished study received
Mar 4, 1952 under 3125-4; prepared by Geary
Chemical Corp., submitted by Mobay Chemical
Corp., Kansas City, MO; CDL:006880-P)
00102235 Mobay Chemical Corp. (1964) Synopsis of Analytical
and Residue Data of Systox: (Eggplant).
(Unpublished study received Sep 18, 1964 under
8F0635; CDL-.091104-A)
00102237 Mobay Chemical Corp. (1963) Systox Residues on
Fruits and Plants. (Compilation; unpublished
study received Sep 18, 1964 under 8F0635;
CDL:091104-C)
00102239 Mobay Chemical Corp. (1967) Synopsis of Analytical
Information for Systox on a Variety of Crops.
(Unpublished study received Jan 18, 1968 under
8F0635: CDL:091106-A)
00102241 Mobay Chemical Corp. (1958) Systox Residues in
Cherries. (Compilation; unpublished study
received Feb 12, 1958 under 3125-4; CDL-.006872-A)
00102259 Lamb, D.; Nelson, D. (1970) Toxicity of Systox 6
Ibs./gal.Spray Concentrate to Juvenile Pheasants
When Applied to Alfalfa: Report No. 28649.
(Unpublished study received Dec 11, 1970 under
3125-4; submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:025708-A)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to he Part of the Data Rase Supporting
Registrations under the Demeton Standard
nr)10226f) Mobay Chemical Corp. (1960) Synopsis of Analytical
and Residue information on Systox—(Potatoes).
(Compilation; unpublished study received Jun 3,
I960 under 3125-4; CDL-.006864-A)
00102264 Chatters, R. (1953) Studies on the Translocation of
Systox in Potato Plants, following Foliage
Applications of Phosphorus Labeled Systox.
(Unpublished study received May 21, 1953 under
3125-4; prepared by Oklahoma A & M College,
Research Foundation, submitted by Mohay Chemical
Corp., Kansas City, MO; CDL: 006866-C)
00105405 Van Middelem, C.; Waites, R. (19??) Residues of
toxaphene, chlordane, parathion, malathion and
demeton on several fresh vegetables. American
Society for Horticultural Science:365-370 .
(Also In unpublished submission received Nov 1,
1970 under unknown admin, no.; submitted by
Hercules, Inc., Agricultural Chemicals, Wilmington,
DE; CDL:005105-AC)
00112132 Pickering, 0.; Henderson, C.; Lemke, A. (19??) The
toxicity of organic phosphorus insecticides to
different species of warmwater fishes. Source
unknown p.175-184. (Submitter 9886; also In
unpublished submission received Jan 19, 1967
under unknown admin, no.; submitted by Mobay
Chemical Corp., Kansas City, MO; CDL:131549-C)
05002272 Gaines, T.B. (1960) The acute toxicity of pesticides
to rats. Toxicology and Applied pharmacology
2:88-99 .
05000975 Tucker, R.K.; Haegele, M.A. (1971) Comparative
acute oral toxicity of pesticides to six species
of birds. Toxicology and Applied Pharmacology
20(1) :57-65.
-------
OFFICR OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Rase Supporting
Registrations under the Demeton Standard
GS0143001 U.S. Environmental Protection Agency (1980). An
evaluation of the effect of the demeton on sister
chromatid exchange frequencies in cultured Chinese
hamster ovary cells, Final Report. June, 1980.,
SRI Project LSU-7558. (Study prepared for U.S.
EPA by SRI International).
GS0143002 U.S. Environmental Protection Agency (1980).
Micronucleus test on demeton. Prepared February
12, 1980; SRI Project SLU 7558-19. (Study
prepared for U.S. EPA by SRI International).
GS0143003 McCann, J.A. (1975) Systox 25% EC: Rluegill
sunfish (Lepomis macrochinus); Test No. 892:
U.S. Environrne~nTaI"~P' rotecETon Agency, Animal
Biology Laboratory, Technical Service Div.
GS0143004 McCann, J.A. (1975) Systox 6: Rainbow Trout (Salrno
gairderni): Test No. 1098; U.S. Environmental
Protect ion Agency, Animal Biology Laboratory,
Technical Service Div.
GSD143005 McCann, J.A. (1977) Systox 6: Brook Trout
(SalvelLinus f°rvtinali_s) ; Test No. 1103; U.S.
EnvTronmenEaT~PToTectTon Agency, Animal Biology
Laboratory, Technical Service Div.
GS0143006 Johnson, W.W. et al. (1980) Handbook of Acute
Toxicity of Chemicals to fish and aquatic
invertebrates; Resource Publication No. 137;
U.S. Fish and Wildlife Service; Washington,
D.C.
GS0143007 Fukuto, T.R., Robert L. Metacalf, Ralph R. March,
and Marion G. Maxon. 1955. Chemical behavior
of Systox isomers in biological systems. J.
Econ. Entomol. 48(4) :347-353 . (Published study;
no MRID assigned).
GS0143008 Metcalf, R.L., March, R., Fukuto, T.R., and M.G.
Maxon. 1954. The behavior of Systox-isomers
in bean and citrus plants. Journal of Economic
Entomology Vol. 47, No. 6, pp. 1045-1055.
(Published study; no MRID assigned).
GS0143009 Metcalf, R.L., Fukuto, T.R., March, R.R. and E.M.
Stafford. 1956. The systemic behavior of Systox
thiol isomer sulfoxide and methosulfate in plants.
Journal of Economic Entomology vol. 49 No. 6,
pp. 738-741. (Published study; no MRID assigned)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Demeton Standard
GS0143010 Reynolds, H.I., Fukuto, R.R., Metcalf, R.L. and
R.B. March. 1957. Seed treatment of field crops
with systemic insecticides. Journal of Economic
Entomology, Vol. 50, No. 5 pp. 527-539. (Submitted
by Chemagro Corp. as report number 1783 under
PP#0244 (113667); no MRID assigned).
GS01430.ll Thomas, W.D.E., Bennett, S.H. and C.P. Lloyd-Jones,
1955. The absorption, breakdown, and systemic
behavior in plants of 32p_ia5eiied demeton-S,
Annals of Applied Biology (London), Vol. 43, No. 4,
pp. 569593. (Published study; no MRID assiged) .
GS0143012 Adams, J.M. 1959. A qualitative method for the
determination of Systox residues in plant material.
Chemagro Report No. 3957. (Unpublished study
submitted by Chemagro Co. under PP t230; no
MRID assigned.)
GS0143013 Adams, J.M., C.A. Anderson, and D. MacDougall.
1963. The detection of residues of Systox and
its toxic metabolites in the presence of other
organophosphorus pesticides. J. Ag. Food Chem.
11:178-180. (Published study; no MRID assigned.)
GS0143014 Cummings, J.G. 1962. Method tryout for Systox on
grain, PP#0332. Memorandum to J.W. Cook, Chief,
Pesticides Branch, dated May 10, 1962. (In
correspondence file for PP#0332; no MRID assigned).
GS0143015 Eidelman, M. 1968. Method tryout for PP#7F0624
(Di-syston) and PP#7F063 (Systox). (Memorandum
dated May 7, 1968 in the correspondence file
for PP#7F0635; no MRID assigned.)
GS0143016 Jones, H.A. 1980. Pesticide Petition No. 230,
Systox, Evaluation of residue method and data.
(Memorandum dated April 11, 1960, in the corre-
spondence file for PP#02301 no MRID assigned.)
GS0143017 Puma, B. 1968. Analtytical methodology for the
determination of residues of the thiono isomer
of Systox. (Memorandum dated June 25, 1968 in
the correspondence file for PP#F0635; no MRID
assigned.)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to he Part of the Data Base Supporting
Registrations under the Demeton Standard
GS0143018 Budreau, C.H. and R.P. Singh. 1973. Teratogenicity
and Embryotoxicity of Demeton and Fenthion in
CF #1 Mouse Embryos. Tox. and Applied Pharmacol.
24:324-332.
GS0143019 Mobay Chemical Corp. (1955) Neurotoxicity of Systox
(Unpublished study received July 25, 1955, under
PP#10; CDL .-092015)
-------
Appendix I1-3
OMB Approval No. 2000-0468 (Expires 12-31-83)
EPAR
FIFKA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANT'S NAME DATE
EGISTRATION NO.
GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FSFRA section 3(C)(2)(B) notice contained in the reference
Guidance Document, 1 am responding in the following manner:
D 1. 1 will submit data in a timely manner to satisfy the following requirements. If the test procedures 1 will
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to
Chemicals Testing Programme, 1 enclose the protocols that 1 will use:
use deviate from (or are not
the Chemicals Group, OECO
D 2. 1 have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
CD 3. 1 enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4. 1 request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
d 5. 1 request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE SIGNATURE
DATE
EPA Form 8580-1 (1042)
-------
Appendix II-A
OMB Approval No. 2000-0468 (Expires: 12-31-83)
(To qualify, certify /\ (. L four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2HB)(iii) if final agreement on all terms couid not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8580-6 (10-82)
-------
Appendix III-l
EPA Registration No.
PRODUCT SPECIFIC DATA REPORT
Guidance Document for
Date
Registration
Guideline No.
§158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID#
Submi t-
ting
Data
(At-
tached )
(For EPA Use Only)
Accession Numbers
Assigned
-------
Appendix III-l (continued)
Regi s tra tion
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
$158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
( check
below)
I am complying with
data requirements by
Citing MRID#
Submi t-
ting
Data
(At-
tached )
(For EPA Use Only)
Accession Numbers
Assigned
-------
APPENDIX IV-1
Chapter I—Environmental Protection Agency
§ 162.10
it obtained the data from anothe
(identify); applicant copied daj/
frbm a publication; applicant obta
a copy of the data from EPA).
(4) The applicant shall submit
his application a statement that
in iu evaluation of the properties/ effi-
cacy A and safety of the formulated
end use product, may not consider any
data Its supporting the appljfcation,
except the following data:
(1) The data the applicant Aas sub-
mitted tv EPA under paragraph (b) of
this section;
(2) Otner data pertainicfe to the
safety of the product's active ingredi-
ents, ratheV than to the
end-use prosuct; and
(3) ExistinV tolerances,
regulations, ^exemptions,
clearances issued unde
Pood. Drug, and Cosme
(e) If the applicant
Jety of the
'ood additive
and other
the Federal
c Act.
iows that any
Item of data he\ submnted under this
section was generatedroy (or at the ex-
pense of) anothe\peqGon who original-
ly submitted the
predecessor, USD
ary 1, 1970, to su
for registration,
permit, or amen
use to an exist!
reregistration (
and the ori
reached writ
to EPA (or its
on or after Janu-
ort an application
xperimental use
nt adding a new
registration, or for
the applicant
dataXsubmitter have
agreement on the
amount and thfe terms \pf payment of
any compensation thatVmay be pay-
able under FTFKA section
3UXD)
and 3/CX2XD);
(3/An identification of the ite*n(s)
of dfcta to which the offer applies;
(«) An offer to commence negotia-
tions to ascertain the amount and
of compensation to be paid; and
/(5) The applicant's name, addre
ad telephone number.
O If the applicant's product coy
any active ingredient other tt
those that are present solely because
of th\e incorporation into the pro/uct,
durink formulation, of one or/more
other Vegistered pesticide pibducts
purchased from another p/oducer,
then the\applicant shall als/ comply
with 5 162^-5 as to such aclflve ingre-
dient, andVhe application/shall con-
tain an acknowledgment that for pur-
poses of FIF1LA section *c)(lXD) the
application reiies on (aiid any result-
ing registratiorkshould/fee regarded as
if it were based \n the/Administrator's
leyfollowing data:
fled or specifically
it in support of
of data in the
Jtted for
the appli-
stration
consideration of) i
(1) All data subc
cited by the appl
the registration; i
(2) Each othes^itei
Agency's files which:
(1) Concerns trie properties or effects
of any such active ingredient; and
(ii) Is oneyftf the types\f data that
EPA would/equire to be st
scientific neview by EPA
cant sou/ht the initial
under SIFRA Section 3(c)
-------
§ T62.10
(Iv) The product registration
number as prescribed In paragraph (e)
of this section;
(v) The producing establishment
number as prescribed In paragraph (f)
of this section:
(vl) An Ingredient statement as pre-
scribed In paragraph of this sec-
tion;
(vll) Warning or precautionary state-
ments as prescribed In paragraph (h)
of this section;
(vlll) The directions for use as pre-
scribed In paragraph (I) of this section:
and
(Ix) The use classlflcatlon(s) as pre-
scribed In paragraph (J) of this section.
(2) Prominence and legibility. (I) AH
words, statements, graphic representa-
tions, designs or other Information re-
quired on the labeling by the Act or
the regulations In this part must be
clearly legible to a person with normal
vision, and must be placed with such
consplcuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed In such terms as to render It
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
(II) All required label text must:
(A) Be set In 6-polnt or larger type:
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be uaed. All required
label or labeling text shall appear In
the English language. However, the
Agency may require or the applicant
may propose additional text In other
languages as Is considered necessary to
protect the public. When additional
text In another language Is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(I) General.
The label shall appear on or be secure-
ly attached to the Immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mls-
brandlng provisions of the Act, "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the Im-
mediate container Is enclosed within a
Ttt|« 40—Protection of Environment Chopter I—Environmental Protection Agency
APFT.'JI'iX IV-l
(cont inued)
§ 167.10
wrapper or outside container through
which the label cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer. If It Is a part of the package as
customarily distributed or sold.
(11) Tank can and other bulk con-
tainers—(At Transportation, While a
pesticide product Is In transit, the ap
propriate provisions of 49 CFR Parts
170-189. concerning the transportation
of ha74»rdous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when r-iy
registered pesticide product Is trans-
ported In a tank car. tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the time
of delivery.
(B) Storage.. When pesticide prod-
ucts are stored In bulk containers.
whether mobile or stationary, which
remain In the custody of the user, a
copy of the label of labeling. Including
all appropriate directions for use, shall
be securely attached to the container
In the Immediate vicinity of the dis-
charge control valve.
(B) False or misleading statements.
Pursuant to section 2(qxi>(A> of the
Act. a pesticide or a device declared
subject to the Act pursuant to
{ 162.18, to mlsbranded If Its labeling Is
false or misleading In any particular
Including both pestlcldal and non-pes-
tlcldal claims. Examples of statements
or representations In the labeling
which constitute mlsbrmndtng Include:
(I) A false or misleading statement
concerning the composition of the
product;
(II) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device:
(III) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device:
(Iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or Indi-
rectly Implying that the pesticide or
device Is recommended or endorsed by
any agency of the Federal Govern-
ment;
(vl) The name of a pesticide which
contains two or more principal active
Ingredients If the name suggests one
or more but not all such principal
active Ingredients even though the
names of the other Ingredients are
stated elsewhere In the labeling;
(vll) A true statement used In such a
way as to give a false or misleading Im-
pression to the purchaser;
(vlll) Isabel disclaimers which negate
or detract from labeling statements re-
qulrpd under the Act and these regula-
tions;
(Ix) Claims as to the safety of the
pesticide or Its Ingredients, Including
statements such as "safe." "nonpolson-
ous." "nonlnjiirlous," "harmless" or
"nontoxlc to humans and pets" with
or without such a qualifying phrase as
"when used as directed": and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product. Including but not limited to:
(A) "Contains all natural Ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling. (I) Except
as provided In paragraph (a)(6HII) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(II) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product Is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(I) Is false or misleading, or
(II) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to S 162.6(b)(4).
(c) Name and address of producer.
registrant, or person for whom pro
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant Is
not the producer, or If the name of the
person for whom the pesticide was
produced appears on the label. It must
he qualified by appropriate wording
such as "Packed for • * V "Distribut-
ed by * * V or "Sold by • • •" to show
that the name Is not Hint of the pro-
ducer.
(d) Nf.t weight or mrnsurr nf rnn
tents. (1) The net weight or measure
of content shall be exclusive of wrap
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide Is a liquid, the
net content statement, shall be In
terms of liquid measure at S8" F (20"C>
and shall be expressed In conventional
American units of fluid ounces, pint*.
quarts, and gallons.
(3) If the pesticide Is solid or Rcmlso-
lld, viscous or pressurized, or Is a mix-
ture of liquid and solid, the net con-
tent statement shall be In terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated In terms of the largest suitable
units. I.e., "1 pound 10 ounces" rather
than "23 ounces."
(5) In addition io the required units
specified, net content may be ex-
pressed In metric units.
(6) Variation above minimum con
tent or around an average Is permissi-
ble only to the extent that It repre-
sents deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum Is not permit
ted. In no case shall the average con-
tent of the packages In a shipment fall
below the stated average content.
(e) Product registration nvmttrr.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label,
preceded by the phrase "EPA Regis-
tration No.," or the phrase "EPA Reg.
No." The registration number shall be
set In type of a size and style similar to
other print on that part of the label
on which It appears and shall run par-
-------
§ 1«2.10
allel to It. The registration number
and the required Identifying phrase
shall not appear In such a manner as
to suggest or Imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishment* regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
package If the EPA establishment reg-
istration number on the Immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(1) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active Ingredient, the total per-
centage by weight of all Inert Ingredi-
ents; and If the pesticide contains ar-
senic In any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active Ingredients must be
designated by the term "active Ingredl-
ent»" and the Inert Ingredients by the
term "Inert Ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be In the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" to
not required for pesticides which con-
tain 100 percent active Ingredients.
Unless the Ingredient statement Is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement.
(2) Position of ingredient statement.
(1) The Ingredient statement Is nor-
mally required on the front panel of
the label. If there Is an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read, the Ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes It Impracticable to
place the Ingredient statement on the
front panel of the label, permission
may be granted for the Ingredient
statement to appear elsewhere.
fill, 40—Protection of Environment
(II) The text of the Ingredient state-
ment must run parallel with other
text on the panel on which It appears,
and must be clearly distinguishable
from and must not be placed In the
body of other text.
(3) Name* to be used in ingredient
statement. The name used for each In-
gredient shall be the accepted
common name. If there Is one, fol-
lowed by the chemical name. The
common name may be used alone only
If It Is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 35(0(8).
(4) Statements of percentage* The
percentages of Ingredients shall be
stated In terms of welght-to-welght.
The sum of percentages of the active
and the Inert Ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-28%.' If
the uses of the pesticide product are
expressed as weight of active Ingredi-
ent per unit area, a statement of the
weight of active Ingredient per unit
volume of the pesticide formulation
shall also appear In the Ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active Ingredient shall be the
lowest percentage which may be pres-
(6) Deterioration. Pesticides which
change In chemical composition sig-
nificantly must meet the following la-
beling requirements:
t/.ip of .t»cnal words. Use of any
signal worrl(s) associated with R higher
Toxlclty Category Is not, permitted
except when the Agency determines
that such labeling Is necessary to pre
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(II) Child hazard warning. Fvery pes
tlclde product label shall bear on the
front panel the statement "keep out of
reach of children." Only In cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use Is demonstrated by
the applicant to be extremely remote.
or If the nature of the pesticide Is such
that It Is approved for use on Infant,-:
or small children, may the Administra-
tor waive this requirement.
(Ill) .Statement of practical treat-
ment—(A) Toxlclty Category I. A
statement of practical treatment (first
aid or other) shall appear on the front.
panel of the label of nil pesticides fall-
Ing Into Toxlclty Category I on the
basis of oral. Inhalation or dermal tox-
lclty. The Agency may. however.
permit reasonable variations In the
placement of the statement of prnctl
-------
§ 162.10
cal treatment Is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the sKull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment Is not
required on the front panel except as
described In paragraph (h)(l)(HI)(A) of
this section. The applicant may, how-
ever. Include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re
quired elsewhere on the label In
accord with paragraph (h)(2) of this
section If they do not appear on the
front panel.
(Iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
ToiMy
Till* 40—Protection of Environment
Siro o» «m Iron ptrwitn mum
5«ndunrJ«r_
Abov« S 10 10.
Abow 1010 IS
Abov» IS 10 30
Ovor 30
e
8
10
1?
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals " "Environmental Hazard" and
"Physical or Chemical Hazard."
(I) Haxard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required Indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident.
Injury or damage. The precautionary
paragraph shall be Immediately pre-
ceded by the appropriate hazard signal
(B) The following table depicts typi-
cal precautionary statement*. These
statement* must be modified o' es
panded to reflect specific hazards.
Or*. InhttaHon. or cfcrrml tontefly
Fit* (pofnnout) I *••*>**> (Inhrtdd or «b«orb»d
through X*). DO not be»«th« «por trjOTl w «pr»r
mW). Do not »«t * •»«. ornkh. a on doTNng
[Front Ptn* trtWn.nl Of pr«*c«l tr»»tm«nl r»-
qulrwf ]
May b* M* II i»«»o»i««l ttnNW o> Btotorbod
through Th» lUn). Oo not tw»»» v«eor» I*m «
nrn n#it). Oo not gx m •»«. on «Wn. or on
dotNng. lApproprtiM »»< ad «t«»m«*« t*t*nt.\.
HvnrM » nn*r**l (InMtod or •btortw) Ihrouoji m»
•Wn) A**» bn>«thlng wwonj tdmt or «pr«Y n*t]
Avoid OOnMCt w"tl Mn («vn or cWhJngl (Appro-
prim Dnt tU mum** raquMd I
tNo |»«-«iHlon«ry ll«l«m»ntt r»o*»d 1
SMn vd •>• tooM •"«<•
Cera**. C.U.M •».
MMonl Oo not jl< In «r«. Or. Hdn. or on
O-
Imd **) WWIon. Oo not «M In «r«.
dW«rf *«r! •»«• Ot **> "H" pUnr, ol
> H « n«ht)«cli HI
imh poM tbrnK JO" F «nd out ovw WT r or K In*
rim™* nvlfrfnlon h morn rhtin ffl In lonq nl H dHtnnc*
of C rn r>nm (t>*» Unm^
-vtMtrrMtfy flftntmivhM Coot4*m
-------
§ 1M.10
(/) The label clearly shows that the
product Is Intended for use only In
manufacturing processes and specifies
the type(s) of products Involved.
(2) Adequate Information such as
technical data sheets or bulletins. Is
available to the trade specifying the
type of product Involved and It*
proper use In manufacturing process-
es;
U> The product will not come Into
the hands of the general public except
after Incorporation Into finished prod-
ucts; and
«) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
There to Information readily
available to the formulators on the
composition, toxlclty. methods of use,
applicable restrictions or limitation/),
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product Is Intended for use only In
manufacturing, formulating, mixing,
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts Involved;
(3) The product as finally mamifac-
tured, formulated, mixed, or repack-
aged Is registered; and
«) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
T1»U 40—Protection ef tnvlr»nm«n»
(3) Contents of Directions for V*e.
The directions for use shall Include
the following, under the headings "Di-
rections for Use":
(I) The statement of use classifica-
tion as prescribed In 182.100) Immedi-
ately under the heading "Directions
for Use." i k
(ID immediately below the state-
ment of us* classification, the state-
ment "It Is a violation of Federal law
to use this product In a manner Incon-
sistent with Its labeling."
(Ill) The sltHs) of application, as for
example the crops, animals, areas, or
objects to be treated.
(Iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vl> The method of application. In-
cluding Instructions for dilution. If re-
quired, and type(s) of application ap-
paratus or equipment required.
(vll) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(vlll) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
fix) Specific direction* concerning
the storage and disposal of the pesti-
cide and Ita container, meeting the re-
quirements of 40 CFR Part 165. These
Instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set In type of the same minimum slees
as required for the child hazard warn-
ing (See Table In I l«.l.)
(x) Any limitations or restrlctlo. j on
use required to prevent unreasonable
adverse effects, such as;
(A) Required Intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
In or adjacent to certain areas.
(D) (Reserved)
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who Is not phys-
ically present at the site of application
Chapter I—Environmental Protection Agency
Ar'M-.NDIX IV-L
(continued)
§ 167.11
but nonetheless available to the
person Applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who Is physically present.
(P) Other pertinent Information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(J) Statement of Vse Classification.
By October 22, 1918, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
In paragraphs (JXl) and (2) of this sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth In this sub-
section, and shall be marketed as sepa-
rate products with different registra-
tion numbers, one bearing directions
only for general use(s) and the other
bearing directions for restricted use(s)
except that. If a product has both re-
stricted use(s) and general use(s). both
of these vises may appear on a product
labeled for restricted use. Such prod-
uct-i shall be subject to the provisions
of 5 162.10(JK2).
(1) General Vie Classification. Pesti-
cide products bearing directions for
wse(s> classified general shall be la-
beled with the exact words "General
Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or Implies that the gen-
eral utility of the pest/clde extends
beyond those purposes and uses con-
tained In the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of mlsbrandlng.
(2) Restricted Use Classification,
Pesticide products bearing direction
for use(g) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below.
(I) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set In type
of the same minimum sizes as required
for human hazard signal words (see
table In ) 162.10(h)(l)dv)), and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make It unlikely to
be overlooked under customary cnndl
tlnns of purchase und use. the state-
ment. "Restricted Use Pestlrlrte" shall
appear.
(B) Directly below (.his statement on
the front panel, n summary statement.
of the terms of restriction Imposed as
a precondition to registration shall
appear. If use Is restricted to certified
applicators, the following statement Is
required: "For retail sale to «nd us*1
only by Certified Applicators or nrr
sons under their dlrrrt supervision and
only for those uses covered by the Or
t If led Applicator's rrrtlf (ration." If.
however, other regulatory rrslrM.lons
are Imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. I Reserved!
(40 FR 28268, July 3. ISIS: 40 FR .12.129.
An*. I, 1BV5; 40 Ftt 3BS7). Au*. 21. 1975. MS
amended at 43 FR R7BB. Frh. 9. 191*1
(1*2.11 Criteria for rirttrmlnHtlnn* of MI,
rmnnnahlr ailTrrw rnxift.
Criteria for Issuance of Noticf of
Inteat to Deny Registration, Cfnc.rl
Registration, or to Hold a lleajnna
(1) Presumption. (I) A rebuttaMe pre-
sumption shall arise that a dotlce of
Intent tcVleny registration pursuant to
section 3(tX6) of the Act./notice of
Intent to cancel reglstratlim pursuant
to section VbKl) of the Art. or a
notice of Intent to holtf a hearing to
determine whether U(e registration
should be cancelled or denied, as ap-
propriate, shall lie bfeued. upon a de-
termination by tWeAdmlnlstrntor that
the pesticide meetX or exceeds any of
the criteria for rJSkVset forth In para-
graph
-------
ll (X)M(SIC *N'l«MSI
c Aur ION
PII»SC»I On CMJMCM
DinfClO'iS ron ust
rcm«Ai
TORAGE AND
DISPOSAL
\ CHOP .
PRODUCT
NAME
AC iivc vinn(oi(Ni
urni
IOIAI
too DO x
i>ns rnonuci COUSINS ins ix rin(i«uo»(
» nn«l in :
f OH 5«n —~rrrr.
» n(»tS :n-~T •_:::.-:-
S*>r p»Hfi 'on *t)nitiOM«i rnt c*uiO'««»»t
M'a 1» - —-=rr. -rrr._--__:rr== /'/TN
iow>/ si»if —--_•—: :—-—zmHV^y
rr»P|r,^in.to.,Wo ~^V
0(1
KEEP OUT OF REACH OF Ct IILDRCN ^ ©
CAUTION
te
cnrx*
cno*1
COOP
CHOP
m
3
O,
-------
*qp
PHECAUTCNABY STATEMENTS
HAJAADS TO HUMANS
II DOMESTC ANIMAlSl
OAMOEfl
ENVfKJNMENTAl.
MA/A'nOS
PWYSCAL OO CMfMCAL
MAJATOS
UK
EN1WY STATEMENT
STORAGE AND
DISPOSAL
RESTRICTED USE
PESTICIDE
for ret»1) illr lo tnrf uif 0"lr t>r C«rtl((t4 »ppllc«tori
Or f<«ri»ni under fitlr tflrttl lupirvltlon «nd only f«r
Ihoif «l(l C0«»r«ij bf th* Ctrliriril *pp!lc«lor« CtrtUI-
Cltlon, .
PRODUCT
NAME
KtRT NOflEDCWTS
TOTA1
10000%
t»«3 PnODUCT CONTAMS LS9 Of PEK GALLON
KEEP OUT OF REACH OF CHILDREN
©» DANGER -POISON
STATEMENT Of PAAC'CAL 1REATVENT
r SWAUOWEO:
r WMALfD==
r ON 8KM
BYf '
. S^ATE
5&ESTABU$MWENTMO
EPA nEt)l3TRATION MO
NET CONTENTS:
SEE SfX PANEL rOA ADOmONAt. PftfCAIITONAAY STATEMENTS
To
CHOP
CHOP
CHOP
CHOP
CHOP
WAMRAMTY STATEMENT
5
0-
-------
APPENDIX IV-2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1 "
"1
3
4
-5~ ~
-M"
'6ft
7
TA
7B '
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Est. No.
•SPAT Reg1. No.
TngfeHierifs
statement
Pounds/gal Ion
statement
Front panel
precautionary
statements
Keep Out of ReacK
of Children
(Child hazard
warning)
Signal word
AFPLIUWILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
ATI products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
HLAUSMEN
REOUIRED
front panel
~Norie
None
tfone
None
Front panel
Front panel"
Front panel
Front panel
Front panel
1 t>N LAbKL
| PREFERRED
j Center front
I panel
1 ~Bo€tbm~fron£
1 panel or end
1 of label text
j feottom front
I panel or end
1 of label text
j Frbnt~paneT~
1 .. .. .
) Front panel,
1 immediately
I before or
| following
| Reg. No.
1 Immediately
j following
I product name
| Directly BeKw
1 the main
j ingredients
1 statement
1
1
j Above signal
1 word
1
1
I Immediately
j below child
j hazard
1 warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units Tri addition to
U.S. units
. -
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with" other text
on the panel .
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
APPENDIX IV-2 (continued)
ITEM
7C
'/tt
"7E
• * & • - -
8A
$B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side1 /back" panel
precautionary
statements
Hazards to
humans and
domestic
animals
tlnvtronmeriEal
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxic ity
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, II, and III
All products
| PLACEMENT-
| REQUIRED ' j
j Front panel [
1 I
1 1
! 1
1 I
~l-~ „ '
1 Category I: j
j Front panel j
1 unless refer- j
I ra.l statement)
j is used. |
I Others : |
I Grouped with |
j side panel j
1 precautionary}
j statements, j
1 Front panel j
1 t
1 1
1
1
!
1
ftbhe j
1
1
I
1 1
j None j
I 1
1 1
1 1
I None j
1 !
ON CABEL
PREFERRED
Both in close
proximity to
signal word
Front panel
for all .
Top or side
of back panel
preceding
directions
for use
Same as above
Same as" above"
COMMENTS
"Must~be~grouped" "und~eTr~tlTe^eadings"in""
8A, 8B, and 8C; preferably blocked.
"Must T5e *preced"edTy~"approprrate s ignal"
word.
"E"nvironmental""Razards include 5ee~
caution where applicable.
-------
APPENDIX IV-2 (continued)
ITEM
8C
9A
9C
"10A '
IOC
lflt>
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
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
All
chol inesterase
inhibitors
All products
All products
PLACEMENT
REQUIRED |
None j
1
1
1
1
Top center j
of front j
panel j
1
Inmediately |
following |
statement of j
classifica- |
tion or |
ahead of |
directions j
for use |
In the j
directions j
for use j
In the j
directions j
for use |
1
1
1
1
1
None j
1
ON LA&EL
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must T>e set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
-------
Appendix IV-3
Criteria
PHYSICAL-CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 1R inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150° F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away fron
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
Appendix lV-5
STORAGE ftND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instruction
about storage and disposal. Storage and disposal instruct ic
must be grouped together in the directions for use portion o
the label under the heading STORAGE AND DISPOSAL. Produces
intended solely for domestic use need not include the headin
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
r in the minimum type size listed he low-
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under 6 point
Above 10 to 15 6 point
Above 15 to 30 10 point
Over 30 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
-------
Appendix IV-5
(continued)
4. instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions;
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
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Appendix IV-5
(centinued)
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation cf
Federal Law. If these wastes cannot be disposed of b.
use according to label instructions, contact your Stat-
ppct-i o •>'^P ^v r-><>ironmental Control Agency, or the Haze -dous
Waste representative at the nearest EPA Regional Offic
for guidance."
Labels for all other products, except those intended f;r
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility. "
use only must bear the
"Securely wrap original
newspaper and discard in
3. Products intended for domestic
following disposal statement:
container in several layers of
trash."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar),
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Metal
containers
( non-aerosol )
Plastic containers
Glass containers
Triple rinse (or
for recycling or
and dispose of in
other procedures
authorities.
Triple rinse (or
for recycling or
and dispose of in
incineration, or,
local authorities
stay out of smoke
Statement
equivalent). Then offer
reconditioning, or puncture
a sanitary landfill, or by
approved by state and local
equivalent). Then offer
reconditioning, or puncture
a sanitary landfill, or
if allowed by state and
, by burning. If burned,
•
Triple rinse (or equivalent). Then dispose
of in allsaanitary landfill or by other
approved state and local procedures.
-------
Container Type
Appendix IV-5
(continued)
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused-^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording).
^Manufacturer
and how fiber
may replace
drum may be
this phrase
reused.
with one indicating whether
2. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix.
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Appendix IV-5
(continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e^ and (t
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" L: t_)_
Active Ingredients, (no inerts):
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomy1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
-------
Appendix IV-5
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmercuric acetate (PMA)
Phcrate
Pot.-.ssium cyanide
Prc^argyl alcohol
So:\;um azide
Sod)urn cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
-------
Appendix IV-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Isobutyl alcohol
Lead acetate
Lindnne
Male.c hydrazide
Merc,ry
Methyl alcohol
Met)- 1 bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
I,I,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11 )
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
-------
Appendix IV-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA
Inert Ingredients:
List
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene.
Chloroform
Cyclohexane
Cyclohexanone e
Dichlorodifluoromethane (Freon 12 )
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (mrihanol)
Methyl ethyl ketoro
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane £
Trichlorofluoromethane (Freon 11 )
Vinyl chloride
Xylene
-------
Appendix IV-5
(cont inued)
"Toxic" Commercial Pesticide Products (RCRA "F1 List)
Active Ingredients:
Acetone
Aerylonitrile
Airii trole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3, 4-metheno-2H-cyclobuta [c ,d]-pent.alen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropyIthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12 )
3, 5-Dichloro-N-( 1, l-dimethyl-2-propyny 1) benzarnide (pronamide , Kerb)
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
*U.S. GOVERNMENT PRINTING OFFICE:
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