GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
DICOFOL
AS THE ACTIVE INGREDIENT
ENVITONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
DECEMBER 30, 1983
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TABLE OF CONTENTS
Introduction i
I. Regulatory Position and Rationale 1
II. Requirement for Submission of Generic Data 20
III. Requirement for Submission of Product Specific
Data 23
IV- Submision of Revised Labeling and Packaging
Information 42
A. Label Contents
1. Product Name
2. Company Name and Address
3. Net Contents
4. Product Registration Number
5. Producing Establishment
Registration Number
6A Ingredient Statement
6B Pounds Per Gallon Statement
7. Front Panel Precautionary Statement
7A Child Hazard Warning Statements
7B Signal Word
7C Skull and Crossbones and Word Poison
7D Statement of Practical Treatment
7E Referral Statement
8. Side/Back Panel Precautionary Labeling
8A Hazard to Humans and Domestic Animals
8B Environmental Hazard
8C Physical or Chemical Hazard
9. Misuse Statement
IDA Storage and Disposal Block
v 10B Directions For Use
B. Collateral Information
V. Instructions for Submission 47
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APPENDICES
I Bibliography
II FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8580-1
III Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6
IV Product Specific Data Report (End-Use Products)
EPA Form 8580-4
V-l 40 CFR §162.10 Labeling Requirements
V-2 Table of Labeling Requirements and Sample Labels
V-3 Physical/Chemical Hazards Labeling Statement
V-4 Storage and Disposal Statements
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 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 fulfill this Congressional mandate, we have established
the Registration Standards program which will review all pesti-
cide 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. The regulatory position 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 herein
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 end-use (formulated) products that contain the active
ingredient. If we find serious concerns, we will bring
end-use products under the provisions of the Registration
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,,it is the Agency's policy
under §3(c)(2)(B) that these data are not required to be
submitted by those registrants who 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
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the active ingredient). 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 registrant's firm, or a firm which has
ownership in common with the registrant's firm. These end-use
producers 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 regist-
rant'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 discontinue the
registration of any of your products subject to the reregistra-
tion 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 time-
frames 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. \
This Guidance Document will be supplemented by EPA with
additional information about compliance with data support
requirements. In Monsanto v. Acting Administrator, EPA was
enjoined from implementing S3(c)(l)(D) of FIFRA. EPA has
decided that as long as this injunction is in effect, it will
proceed with the requirements in this Guidance Document which
do not require compliance with the provisions of §3(c)(l)(D).
In other words, EPA will not at this time require current
registrants to apply to amend their product registrations to
make changes in the labeling, packaging, or composition.
The Agency will supplement the Document with additional
guidance when this litigation concludes. Failure to comply
with the provisions of the subsequent guidance will also
result in issuance by EPA of an intent to cancel the affected
product registration(s).
Registrants are reminded that §6(a)(2) of FIFRA 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.
ii
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be 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 labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End-use products of registrants who also 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 required for products in "11"
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 B 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.
ill
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I. REGULATORY POSITION AND RATIONALE
A. Introduction
B. Chemical Description and Use Sunmary
C. Regulatory Position
D. Regulatory Rationale
E. Criteria for Registration and Reregistration under this Document
F. Acceptable Ranges and Limits
G. Required Labeling
H. Tolerance Reassessment
I. Special Studies
A. INTRODUCTION
.Tjiis Guidance Document describes the Agency's regulatory position on
manufacturing-use products containing dicofol. The Agency's position
• -^
addresses a number of regulatory requirements — labeling requirements,
tolerances, and the data requirements — that must be met to register or
reregister products covered by this Guidance Document.
As part of developing its regulatory position on a pesticide, the
Agency makes a determination whether any of the criteria in 40 CFR 162.11
have been met and whether a Special Reviewl/ should be initiated. This
document serves to notify the registrants that a Special Review will be
initiated. The Special Review process will be explained briefly below,
as well as the Agency's concerns and rationale for initiating the Special
Review.
In addition to the basic regulatory decision and rationale, this Document
includes the following: criteria for the registration or reregistration of
I/ Special Review is the new name for the Rebuttable Presumption Against
Registration (RPAR) process. This name will be proposed in regulations
in the near future.
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dicofol products under the Guidance Document; acceptable ranges and limits
for product composition, acute toxicity and use patterns; required labeling;
and a tolerance reassessment.
B. CHEMICAL DESCRIPTION AND USE SUMMARY
The chemical name for dicofol is l,l-bis(chlorophenyl)-2,2,2-trichloro-
ethanol;,for convenience in writing this Guidance Document, the name
f — "
V^dicofol will be used instead of the chemical nameD Use of the name
dicofol implies no endorsement of any product containing the active
ingredient. TThere is no common name for thfr chemical accepted by the
Y — 1 \ "">
rican /Na£ionaKjJtandardsJhstitute. I
\-/ — ^
The Chemical Abstracts Registry (CAS) number for dicofol is 115-32-2.
The EPA Shaughnessey number is 010501. The chemical formula is C^HgClsO,
and the molecular weight is 370.51.
Trade names and other names for dicofol include: Acarin®, Carbax®,
CAS 115-32-2, CPCA, Decofol®, Dichlorokelthane , DTMC, ENT-23648, FW-293,
Kelthane®, Kelthane A®, p,p'-Kelthane, Kelthanethanol, Mibol®, Mitigan®,
and NCI-000486. Other chemical names for dicofol are:
1. Benzenemethanol, 4-chloro-alpha-(4-chlorophenyl)-alpha-
( tr ichloromethyl ) -
2. Benzhydrol, 4,4I-dichloro-alpha-(trichlorcmethyl)-
3 . 1 , 1-Bis ( 4-chlorophenyl ) -2 , 2 , 2-tr ichloroethanol
4 . 4,4' -Dichloro-alpha-( trichlorcmethyl )benzhydrol
5. Di-(p-chlorophenyl ) trichloromethylcarbinol
6 . 2,2, 2-Tr ichloro-1 , 1-di ( 4-chlorophenyl )ethanol
#•
Manufacturing-use dicofol is a non-flowable liquid (or waxy solid)
at roan temperature. It ranges from dark to yellow-brown in color. It
is stable under cool and dry conditions, and is practically insoluble in
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water, but readily soluble in most organic solvents. Its melting point
ranges from 58°C to 78°C.
Dicofol was first registered as a pesticide in 1957. ^Manufacturing-use
dicofol products are not produced domestically77 Rather,jail dicofol used
~~J c
in domestically registered pesticides is imported. Dicofol is used in
acaricides to control mites on agricultural crops arid ornamentals and
in or around agricultural and \Jomestic buildings. End-use products containing
dicofol are made in a variety of formulations, and marketed as emulsifiable
concentrates, wettable powders, dusts, ready-to-use liquids, and aerosol
sprays. The products act on the surfaces of the sites of application to
control mites.-
There are currently six registered manufacturing-use products
consisting of the technical grade of dicofol (80 - 85%) and four formulation
intermediates, one of which is a multiple active ingredient product.
There are seven registered manufacturers of these manufacturing-use
products: Rohm and Haas Company, Makhteshim Beer-Shiva, Aceto Chemical Company,
Agan Chemical Manufacturers, Drexel Chemical Company, Tricon Chems Inter-
national, and Ida, Inc.
End-use products containing dicofol as their sole active ingredient
include 66 section 3 Federal registrations and 37 Intrastate products.
End-use products containing dicofol plus other active ingredients include
130 section 3 Federal registrations and 49 Intrastate products.
ICertain unintentional impurities have been identified in manufacturing-
use dicofol products""which are the result of the manufacturing process.
(The identified contaminants of concern include the p,p' and o,p' isomers
^-~—- ,
of DOT, DDE, ODD (TDE), and a compound known as "extra-chlorine DOT"
(Cl-DOT). I The chemical names for these contaminants are as follow:
1. l,l-bis-(p-chlorophenyl)-2,2,2-trichloroethane [p,p* DOT]
2. l-(p-chlorophenyl)-l-(o-chlorophenyl-2,2,2-trichloroethane [o,p' DOT]
3. l,l-bis-(p-chlorophenyl)-2,2-dichloroethylene- [p,p' DDE]
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4. l-(p-chlorcphenyl)-l-(o-chlorophenyl)-2,2-dichloroethylene [ofp' DDE]
5. l,l-bis-(p-chlorophenyl)-2,2-di<±LLoroethane [p,p* ODD]
6. l-(p-chlorcphenyl)-l-(o-chlorcpherYl)-2,2-dichloroethane [o,p' ODD]
7. l,l-bis-(p-chlorophenyl)-l,2,2,2-tetrachloroethane [p,p' Cl-DDT]
8. l-(p-chlorophenyl)-l-(o-chlorophenyl)-l,2r2r2-tetradiloroethane [o,p' Cl-DDT]
9. l-( 2,4-dichlorophenyl) -2- (4-chlorophenyl) -1,2,2,2-tetrachloroethane
10. l-(2,4-dichlorophenyl)-2-(4-chlorophenyl)-l,,2,2-tetrachloroethane
In this Document, the term DDTr will be used to denote any or all of
these DDT analogs. Though an environmental effects and fate data base
for Cl-DDT is unavailable, the Agency assumes that this chemical is
potentially a DDE precursor.
C. REGULATORY POSITION
Based upon a review and evaluation of all available data and other
relevant information on dicofol, the Agency has made the following
determinations:
1. The Agency has determined that the risk criterion in 40 CFR 162.11
regarding an adverse wildlife effect has been met by certain outdoor
uses of dicofol products. These products appear to contain a sufficient
quantity of DDT contaminants to cause significant adverse ecological
effects. The Agency focused on the potential to cause eggshell thinning
in documenting the basis for Special Review but recognizes, and is gathering
evidence about, a wide range of other effects associated with DDT and related
compounds. A Special Review of all outdoor dicofol end-use products
containing detectable amounts of DDTr will be initiated.
#-
2. No new registrations for dicofol products intended for outdoor
use will be issued which would further increase the amount of DDTr in
the environment.
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3. Registrants and applicants for registration of manufacturing-use
dicofol products must provide or agree to develop the additional data
specified in Tables A and B of this Document in order to maintain existing
registrations. Tables A and B include special studies, explained in Section I
below, which are needed to address the concerns above. The health effects
data required must be conducted and submitted in accordance with the FIFRA
Good Laboratory Practice Regulations (48 FR 53946). Manufacturing-use
products containing dicofol as the sole active ingredient may be registered
or reregistered subject to the terms and conditions specified in this
Guidance Document.
4. Registrants and applicants for registration must submit data
regarding the composition of their product and in particular the concen-
tration of DDTr contaminants in their manufacturing products. The Agency
is concerned about the presence of these contaminants at levels substantially
below one percent of the technical dicofol product because a no-effect-
level has not been determined for reproductive effects in certain species
of birds and because environmental modeling indicates that current usage
may produce residues in fish that exceed the known effect for these
reproductive effects (Balcomb, 1983b).
5. Because available residue data are inadequate and no definitive
toxicity data are available, a tolerance reassessment cannot be performed
at this time. A complete reassessment will be performed when the data
specified in Tables A and B are supplied. There are also insufficient
data to determine how much DDTr is contributed to the human diet when
dicofol products are used. Special studies must be conducted to measure
whether DDTr residues are present in or on food and feed crops and whether
tolerances for DDTr are needed.
D. REGULATORY RATIONALE
The following section provides the Agency's rationale to support the
regulatory position described above.
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1. Initiation of the Special Review
The Agency has concluded in its review of data during the reregistration
process that dicofol, when used for certain outdoor applications, meet the
risk criterion for unreasonable adverse effects (40 CFR 162.11(a)(3)(ii)(C))
because dicofol is contaminated with DDTr at levels which have unreason-
able adverse effects on the environment. The risks of concern and the
economic importance of pests controlled by dicofol products are summarized
in the sections that follow. A Special Review will be initiated to
examine the risks and benefits of these and other uses and to reach final
regulatory conclusions.
Even though a Special Review will be initiated for dicofol, all
current or prospective registrants of dicofol manufacturing-use products
are still required to satisfy the requirements established by this Guidance
Document. In particular, current registrants are responsible for generating
and providing additional data required by the Guidance Document. Once
the data being required by the Guidance Document have been submitted and
reviewed, the Agency will determine whether those data warrant any changes
in the Agency's current regulatory position.
2. Rationale and Procedures for Lowering DDTr Concentration
The risks of DDTr to the environment are well documented (see
Section 4 A). The intention of the Special Review will be to reduce or
eliminate these risks. One way to alleviate these risks is to reduce or
eliminate the DDTr in the dicofol products. However, current manufacturing
methods apparently preclude the production of dicofol without DDTr contamin-
ation. The Agency does not have adequate information to judge the level to
which the registrants can feasibly reduce DDTr. Therefore, €he Agency is
requiring data on manufacturing methods, the levels of DDTr contamination
in products, and updated Confidential Statements of Formula. It is the
Agency's opinion that it would be prudent for registrants to modify their
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manufacturing processes to reduce the DDTr contamination to non-detectable
levels in the technical product.
In order to develop a complete risk/benefit assessment evaluating
dicofol use, the Agency will need data on the cost of altering the dicofol
manufacturing process to reduce DDTr contamination. If registrants
provide estimates of both capital costs and changes in operating costs
necessitated to reduce DOTr in the manufacturing-^use products, the Agency
will consider this information in its final regulatory decision.
3. 1972 DOT Cancellation Order (37 PR 13369)
In 1972, the uses of nearly all pesticide products containing DOT
and TDE were cancelled. However, products containing dicofol were not
specifically mentioned under this Order. The Agency will evaluate the
risks and benefits associated with each outdoor use of dicofol in the
Special Review to determine whether revisions must be made to the terms
and conditions of registration.
4. Preliminary Risk Assessment for DDTr Contaminants
a. Ecological Hazards Associated with DOT (Balcomb, 1983a)
Dicofol products contain DOT, ODD and DDE. It also contains a
structurally similar chemical (Cl-DDT) of unknown toxicity that reportedly
degrade to DDE. The Agency's assessment of the use of dicofol has considered
risks that may result from the introduction of DOT, ODD, DDE and related
compounds into the environment.
Historically, the use of DOT has adversely affected many terrestrial
and aquatic organisms. DDE is of special concern because its long-term
persistence and tendency to bioaccumulate in terrestrial and aquatic organ-
isms allows for widespread exposure of wildlife. The use of DOT prior to
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1972 resulted in mortality of certain species of birds, bats, fish and
nontarget invertebrates. It has also had profound chronic effects in
many animal species. Severe population reductions in birds and fish have
been related to DDT's effects on reproduction.
Though dicofol outdoor uses are concentrated in certain regions of
the United States, the resulting environmental contamination by DDTr may
reach other areas. Because DDTr bioaccumulates in individual organisms
and biomagnifies through some food chains (particularly those involving
aquatic organisms), it is reasonable to assume that higher trophic level
aquatic organisms and birds may be particularly impacted. Contamination,
however, will not likely be confined only to use areas. One of the major
reasons that virtually all uses of DDT were cancelled in 1972 is that its
widespread use in the U.S. contributed to the nationwide DDTr burden.
Elevated and possibly harmful DDE residues have recently been detected in
wildlife in major dicofol use areas.
There is evidence that the level of DDT-related contamination, on a
nationwide basis, is declining. Nonetheless, residues remain ubiquitous
and may be high enough in seme areas to affect bird and fish reproduction.
Risk assessment for dicofol is therefore complicated in that its use in
some areas may result in residues high enough to cause adverse effects,
regardless of ambient concentrations, while other uses in other locations
may incrementally increase ambient levels such that effects occur. It is
not clear at this time that such distinctions can be made scientifically.
Because of the Agency's concerns that fish-eating birds may be
exposed to residues of DDTr exceeding dietary levels known to impair
reproduction, the Agency developed a model to estimate the level of
DDTr residues in water (Hitch and Reinert, 1983). The simulation relies
upon the Exposure Analysis Modeling System (EXAMS). The Arroyo Colorado
waterway of southern Texas was chosen because of the high level of dicofol
used on citrus and the important aquatic bird habitats in the drainage
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area. Under the conditions of steady-state chemical loading this model
predicts the equilibrium concentration in a water body. The chemical
input to the river system was estimated based on the following assumptions:
1) The amount of dicofol used each year in this drainage basin is
100,000 pounds. This is based on the estimate of 25,000 acres of citrus
with drainage into the Arroyo Colorado, and the estimate that up to four
pounds of dicofol active ingredient are used on citrus. Using this
estimate, the highest label rate for a single application compensated for
the legal use of multiple applications at less than the maximum rate.
2) For purposes of this simulation, the water in the river basin is
assumed to be free of DDTr prior to the introduction of contaminated
dicofol, which yields the EXAMS steady state concentration. Even though
it is documented that background levels of DDTr occur ubiquitously
throughout all matrices of the environment, this assumption is necessary
to calculate the DDTr burden in fish that results solely from the use of
dicofol.
3) The amount of DDTr added to the environment was arbitrarily factored
in at 10% of the dicofol active ingredient applied. The model's residue
predictions are a direct linear function of the loading so that aquatic
residues for any level of product contamination can be estimated by
proportionality.
4) The physical characteristics of DDT and DDE vary slightly and the
modeling capabilities required the choice of one set of chemical parameters.
From a calculation standpoint, counterbalancing factors mitigated the
importance of choosing the physical properties of DDT or DDE for the
purpose of aquatic fate modeling to predict the eventual concentration of
DDE precursors in fish. For the EXAMS model, the physical parameters for
p,p'-DDT, the most extensively studied analog, were used throughout the
simulation and the environmental exposure assessment.
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5) The Agency assumed that most of the DDTr reaching the Arrcyo Colorado
was transported by surface water running off the immediate drainage area
in which dicofol had been used. A recent review of the available literature
on pesticide runoff concluded that DDT consistently shows losses of 2 to 3%
of the amount applied. Therefore, 2% of the DDT applied was assumed to
reach the Arroyo Colorado as a consequence of surface water runoff.
Using the assumptions noted above, EXAMS predicted a steady state
water column concentration of 9 parts per trillion (ppt) DDTr2/. whole
fish concentrations of 9 ppm DDTr were estimated to occur via bioaccum-
ulation and biomagnificationV. Levels of DDTr contamination reported
in the registrant's Confidential Stantement of Formula were then compared
with the model's predictions. It was concluded that levels of reported DDTr
contamination, if contained in dicofol products used in accordance with
the model's assumptions, would generate DDTr residue levels in fish that
would exceed dietary levels shown experimentally to reduce eggshell thickness.
Effects on avian reproduction have been documented experimentally at
dietary levels as low as 0.6 ppm DDE (wet weight). Monitoring studies of
brown pelicans have indicated reproductive effects at lower dietary
concentrations. Because all of the constituants of DDTr are known or
2/ Significant uncertainty is necessarily associated with the type of quanti-
tative exposure assessment presented. This uncertainty results from the
difficulties in describing the geophysical environment, from incomplete
physical-chemical parameters of the chemicals, and from an inability to
completely describe with the EXAMS model the environmental processes that
affect the transport and fate of the DDTr in this simulation. However,
in the absence of monitoring data from a habitat receiving known loadings
of DDTr, the use of a simulation model was considered to be the best
available means of quantitatively estimating exposure to aquatic birds.
3/ Bioaccumulations of 1,000,000 have been determined in field studies.
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expected to degrade to DEE, the Agency concludes that the residue levels
of DDTr in fish pose a significant risk.
Caution must be used in extrapolating the values calculated for the
Arroyo Colorado to other water basins due to the many location specific
factors which can affect the magnitude of aquatic DDTr levels and the
observed trends in the changes in environmental levels.
b. Oncogenicity of Dicofol and DOT
The potential oncogenicity of dicofol per se is unknown due to the
unavailablity of adequate studies. The data available do suggest possible
oncogenicity in male mice. However, the study is unacceptable due to the
reported decomposition of the test material during the study. Additional
testing is required before a conclusion can be reached.
Laboratory tests have indicated that both DDT and DDE can cause tumors
in mice. As indicated in the 1972 DDT cancellation decision, DDT should
be considered a potential human carcinogen. However, adequate dietary
exposure data are not available to estimate the potential risks to humans
through dietary exposure to DDT contaminants in dicofol products. These
data are being required from registrants, and when they are submitted, an
assessment of the carcinogenic risk to humans will be made.
5. Groundwater Contamination
Dicofol residues are relatively immobile in soil. It does not leach
below a depth of two inches in sandy loam soil, and in a soil runoff
study, dicofol was found to be essentially immobile when incorporated
into the top inch of a silt loam soil. Therefore, there is no expectation
of groundwater contamination.
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6. Current Benefits Review for Dicofol4/
An estimated 2 million pounds of dicofol active ingredient are used
annually as an acaracide in the United States (Devine, 1983; Luttner, 1981;
Scheid, 1980). The major dicofol use sites are citrus and cotton5/. These
sites accounted for an estimated two-thirds of the dicofol usage during
the 1980-1981 period.
The farm level value of U.S. orange, grapefruit, and lemon production
was approximately $1.8 billion for the 1980-1981 citrus season. Dicofol
is used throughout the citrus growing regions for control of spider mites.
Spider mite nymphs and adults damage citrus foliage, limiting the trees'
vigor and, therefore, ability to produce maximum yields of good marketable
fruit. Other species of mites damage twigs and young limbs of citrus
trees as well as damaging fruit and causing early fruit drop.
Uncontrolled mite populations reduce yield and quality of citrus and
increase the average cost of citrus production. Although alternative
acaricides to dicofol are available, dicofol's widespread use suggests
that alternatives are less cost effective and/or preferable than dicofol
for control of mite populations under specific circumstances.
The farm level value of U.S. cotton production is approximately $4
billion annually. Dicofol is used for spider mite control on cotton
primarily in the state of California which produces approximately $1
billion of cotton annually. In general, the nymph and adult spider mites
4/ More detailed information on dicofol use, usage, and economic benefits
can be found in two Agency documents prepared under the registration
standards process. Sutherland and Gross, 1983, dicusses th«| biological
aspects of dicofol use. Vlier, 1983, presents a preliminary review of
the economic benefits of dicofol use on cotton and citrus.
5/ Most dicofol use on cotton occurs in the San Joaquin Valley.
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damage cotton foliage, stems, and fruit. Sustained, uncontrolled spider
mite populations may build up and cause defoliation, bract desiccation,
and shedding of cotton squares and bolls. Heavy feeding can cause reduced
lint quality and yield, as well as, lowered cotton seed production and
viability.
Uncontrolled mite populations would therefore increase the average
unit cost of cotton. As in the case of citrus, although alternative
acaricides to dicofol are available, dicofol's use, particularly in the
the San Joaquin Valley, suggests that alternatives are less cost effective
and/or less preferable than dicofol for control of mite populations under
specific circumstances.
E. CRITERIA FOR PRODUCTS SUBJECT TO THIS GUIDANCE DOCUMENT
To be covered by this Guidance Document, products must contain
dicofol as the sole active ingredient, bear required labeling, and conform
to the product composition, acute toxicity limits, and use pattern require-
ments listed in Section F of this Document.
The applicant for registration or reregistration of products subject to
this Document must comply with all terms and conditions described herein.
These include making a commitment to fill data gaps on a schedule specified
by the Agency. Also, applicants for registration under this Document
must contact the Agency for specific instructions, including updated
information on data requirements and companies whose data satisfy the
Agency's data requirements. Applicants for registration or reregistration
must follow the instructions contained in this Guidance Document and
complete and submit the appropriate forms within the time specified.
- 13 -
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F. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be fully covered under this Guidance Document, manufacturing-
use products must contain dicofol as the sole active ingredient. Each
manufacturing-use product formulation proposed for registration or re-
registration must be fully described and an appropriate certification of
limits must be included. The label must also state the nominal concentration
for the active ingredient. However, because the Agency is concerned
about DDT and related compounds as impurities in the manufacturing-use
product, quantification of these impurities must be at a level of detection
below 0.1% of the manufacturing-use product using the best suitable
analytical methods (preferably gas liquid chromatography or high pressure
liquid chrcmotography). The registrant must identify the analytical methods
use.
2. Acute Toxicity Limits
The Agency will consider for registration any manufacturing-use
product whose any acute toxicity category is supported by adequate acute
toxicology data and labeling, including appropriate precautionary statements.
3. Use Patterns
To be covered under this Guidance Document, manufacturing-use products
must be labeled for formulation into end-use products which are registered
by the U.S. Environmental Protection Agency.
LABELING
All dicofol products must bear appropriate labeling as specified in
40 CFR 162.10. Because of the absence of data required to assess the
- 14 -
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environmental and health hazards of dicofol, the Agency is not able to
evaluate the adequacy of all precautionary and required statements on
manufacturing-use product labels. This Guidance Document does not require
changes in the current precautionary statements and environmental hazard
labeling. The Agency may, after review of data to be submitted in response
to this Document, require additional revisions to current labels, and may
impose additional label requirements.
All manufacturing-use product labels must bear the following statement:
"For Formulation into End-Use Products Intended Only for Uses Accepted
by the U.S. Environmental Protection Agency."
H. TOLERANCE REASSESSMENT
U.S. tolerances are established for residues of dicofol in or on raw
agricultural products as follows (40 CFR 180.163):
30 ppm in or on hops;
25 ppm in or on peppermint hay and spearmint hay;
10 ppm in or on apricots, grapefruit, kumquats, lemons, limes, nectarines,
oranges, peaches, tangerines;
5 ppm in or on apples, beans (dry), snap beans (succulent), lima
beans (succulent), blackberries, boysenberries, bushnuts, butternuts,
cantaloupes, cherries, chestnuts, crabapples, cucumbers, dewberries,
eggplant, figs, filberts, grapes, hazelnuts, hickory nuts, loganberries,
melons, muskmelons, pears, pecans, peppers, pimentos, plums (fresh plums),
pumpkins, quince, raspberries, summer squash, strawberries, tomatoes,
walnuts, watermelons, winter squash;
- 15 -
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0.1 ppm in or on cottonseed.
Tolerances for dicofol ccnmodities may be expressed as residues of
dicofol and its metabolites. Some of the metabolites have yet to be
identified. Therefore, following their identification, all existing
tolerances for dicofol must be reassessed. If the requested additional
residue data indicate the presence of residues of DDTr in or on raw
agricultural commodities resulting from the the registered uses of dicofol
on these raw agricultural commodities, then residue tolerances for DDTr
for these commodities may be required.
Current labels allow for maximum application rates greater than those
established with the above tolerances. Thus, current tolerances do not
reflect the current use rates, with the exception of mint and strawberries.
Further, there are no established tolerances for dicofol residues on
currants, gooseberries, peanuts, field corn and sugar beets (roots and
tops). All of the dicofol products used on these commodities are intrastate
products, that is they were registered State labels. In addition, the
following commodities, which appear on labels of federally registered dicofol
products, have no tolerance: almonds, caneberries, olallieberries,
potatoes, prunes, and tangelos. Residue data described in Table A of
this Document must be generated for these commodities, and petitions for
tolerances must be submitted.
Processing studies will be required to show the amount of residues
in the following processed commodities: apple pomace, tomato pomace,
tomato waste, citrus pulp, citrus oil, grape pomace, raisin waste,
cottonseed by-products (i.e. cottonseed meal and hulls, cottonseed oil).
If the processing causes residues to concentrate at levels that would
exceed the tolerance established for the raw agricultural ccnmodity/ a
food additive tolerance for the by-product will be required.
- 16 -
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Animal feeding studies with large ruminants and poultry are required
to establish the extent of transfer of residues to meat, milk, poultry,
and eggs.
TWo uses, for alfalfa and clover seed crops, are designated as food
uses of dicofol and require tolerances under the Federal Food Drug and
Cosmetic Act.
The Theoretical Maximum Residue Contribution (TMRC) is 1.607 mg/day as
dicofol, assuming a 1.5 kg diet, based on the tolerances and food factors
for all commodities for which U.S. tolerances are established. A report
by the Food and Drug Administration's Regulatory Enforcement Program
shows that residues of dicofol found on many agricultural crops during FY
1976, 1977, 1978, 1979, and 1980 did not exceed the residue tolerances
for these crops.
No Acceptable Daily Intake (ADI) or Maximum Permissible Intake (MPI)
figures have been established, due to the absence of acceptable toxicological
data for dicofol. The ADI will be established when appropriate testing data
are available. Until all required data have been submitted and reviewed,
the current U.S. tolerances for dicofol will remain in effect.
I. SPECIAL STUDIES
The following special studies are required to resolve the questions
regarding the environmental fate, effects, and product chemistry of DDTr
compounds.
1. Environmental Fate
Environmental fate studies utilizing Cl-DDT as the test substance
will be required to support the registration of all manufacturing-use
products containing this compound. These environmental fate studies shall
- 17 -
-------
include all tests cited in Table A (Generic Data Requirements for Dicofol),
except for the crop rotation tests. (Note: The tendency of Cl-DDT to
accumulate in rotational crops will be evaluated in the appropriate
studies with dicofol technical). Additionally, it is noted that the
aerobic and anaerobic aquatic metabolism and aquatic field dissipation
studies listed in §158.130 are needed because of a significant potential
for transport to water has been demonstrated.
Protocols for these studies must be submitted to the Agency within
three months of the receipt of this Guidance Document by registrants.
These studies must be designed so as to clearly indicate the chemical
fate of Cl-DDT in the environment. The Agency recognizes that certain
impurities must necessarily occur in any sample of Cl-DDT which the
registrant might select as a test substance. The protocols utilized by
the registrant must, therefore, clearly indicate how the degradation
products of Cl-DDT can, be distinguished from the impurities and their
derivatives.
2. Ecological Effects
No effects data are available for Cl-DDT, therefore chronic toxicity
studies with birds, fish, and aquatic invertebrates are required (Data
Requirements Table A).
Estimated environmental residues of DDTr (front the EXAMS model) are
within the range of concentration showns to cause effects in monitoring
and experimental studies with DDTr. If registrants are able to substantially
reduce the DDTr in dicofol to levels that would indicate environmental
exposures below that for which the Agency can predict effects with the
existing data base (no-effect levels are not yet known), expensive ecological
effects testing would be required to overturn the Agency's presumption
that such low levels may be harmful.
- 18 -
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Field monitoring which would disprove a possible linkage between
dicofol use and environmental effects of DDTr such as, for example, egg-
shell thinning or impairment of fish reproduction, may be impossible or too
impractical to conduct. Factors such as ambient DDTr contamination,
differential species sensitivity, latency of effects, chemical persistance
and mobility, and the varied biological and physical make-up of potential
use sites, which all must be taken into consideration in a general proof
may confound such studies or require that they be unreasonably complex.
3. Product Chemistry
Registrants certifying the presence of Cl-DET in their manufacturing-
use products are required to submit measurements of the octanol-water
partition coefficient (KOW), water solubility, and vapor pressure for this
chemical.
- 19 -
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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 Section 3(c)(2)(B)
and describes, in table format, the data required
for maintaining the registrability of each product.
Additionally, a bibliography (Appendix I) 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 Section 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 I/ Must Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this chapter. That table shows all the
generic data needed to evaluate the continued registrability
of all products, and the dates by which the data must be
submitted. The required data must be submitted2/. Any
necessary studies must be conducted in accordance with
acceptable protocols, examples of which are contained
in EPA's Pesticide Assessment Guidelines3/, and, for the
most part, in 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 registration or reregistration of certain
uses appearing in your labeling, you may delete those
uses at the time you submit your revised labeling.
I/ 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)
2/ U.S. EPA, 1982. Pesticide Registration; Proposed Data
Requirements - Part 158. FEDERAL REGISTER of November 24, 1982
(47 FR 53192).
3/ U.S. EPA, 1983. Pesticide Assessment Guidelines, National
Technical Information Service, Springfield, VA.
-20-
-------
Also for certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and 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 formulations" but not others. Note; The "typical
formulation" 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 IV 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] 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 Registration 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.
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing) the
data. If you elect this option, you must notify EPA
which registrant(s) are parties to the agreement.
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 III)*/
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.)
V FIFRA Section 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides-a mechanism by
which parties can obtain an arbitrator's decision if they agree
(Footnote continued at bottom of next page)
- 21 -
-------
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed.
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
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 registration guidelines or protocols
contained in the 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.
(Footnote continued from previous page)
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 not 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 secpnd 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. While the first firm is
not required to agree to jointly develop data, EPA is not required
to force the second firm to engage in economically inefficient
duplicative testing in order to maintain its registration.
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III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This chapter applies only to manufacturing-use products,
not end-use products.
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 IV) to
fill "gaps" identified by EPA concerning your product. Under the
authority of FIFRA Section 3(c)(2)(B), EPA has determined that
you must submit these data to EPA in order to register or 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 determine which
product-specific data you must submit. This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B)."
-------
GENERIC DATA REQUIREMENTS FOR DICOPOL
Does EPA Have .Data
To Satisfy This
Requirement? (Yes,
Bibliographic
2/
Must Additional
Data Be Submitted
Under PIFRA Section
Data Requirement
5158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification pf Limits
Composition
TGAI
TGAJ
TGAI
TGAI
TGAI
No or Partially)
No
No
Partially
No
Partially
Citation 3(c)(2)(B)?
I/
Yes
3/
Yes
4/
Confidential State- Yes
ment of Formula
5/
Yes
6/
Confidential State- Yes
62-3 - Analytical Methods for
Enforcement of Limits
- Active Ingredient
HP
- Impurities
Physical and Chemical Characteristics
63-2 "• Color
63-3 - Physical State
63-4 " Odor
63-$ - Melting Point
63-6 - Boiling point
MP
TGAI
TGAI
TGAI
TGAI
TQAI
Yes
Yes
Yes
Yes
No
Yes
No
ment of Formula
05005142, 00004348
05014643, 05017499
00004340, 05004951
05005964, 05006333
05005167, 00004336V
05015278, 05020221
05005274, 05004878
05005279, 05015625
05017892
05004176
c/ d/
000043587 00004339
£/ d/
00004358, 00004339
£/
Q0004339
No
No
No~
No
Yes
i/
No
Yes
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICOFOL
Data Requirement
Composition"
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
I/
Must Additional
Data Be Submitted
Under FIFRA Section
3/
~
6_/
2.X
~"
8/
Compositions TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; Choice » Choice of
several test substances determined on a case-by-case basis.
Data must be submitted no later than April, 1984.
Updated information must be supplied by all companies on identity and quantity of impurities and inert ingredients.
Special attention must be given to identifying and quantifying the DDT impurities. The name and address of the
producer of the starting materials, the manufacturing process, and the reaction conditions are needed.
Special testing is required on the impurity known as Cl-DDT. These tests are the octanol-water partition coefficient
water solubility, and vapor pressure.
Five or more representative samples should be analyzed for the amount of active ingredient and each impurity
present in the technical material for which a certified limit is required.
Upper and lower limits must be provided and certified for the dicofol concentrations and each impurity
> 0,1 percent, s y
Ace to Chemical did not submit vany physical/chemical properties, Rohm $ Hasg and Makh^oshiro Beer-Shiva did report
some of these properties for their technical products.
Solubility should be expressed in grams/100 ml solvent or ppm at 20"C,
Not soluble in water.
a/ Data submitted by Intrachem, S.A. These data may be corapensable.
E/ Data submitted by Aceto Chemical Company, These data may be compensable.
cV Data submitted by Rohm and. Haas Company* These data may be compensable,
pa^a submitted by Makh.tash.im. Bser-Sheva Chemical Works, Limited. Thege d.ata may be compensable.,
-------
GENERIC DATA REQUIREMENTS FOR DICOFOL.
Data Requirements
Composition
Does EPA Have Data
TO Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIFRA Section
3(c)(2)(B)7
5158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical Method
- Plant residues
- Animal residues
PAIRA
PAIRA and plant
metabolites
'Partially
NO
TGAI and metabolites Partially
TGAI and metabolites No
05000993, 05006528
00004275, 00004321
05004877, 05006219
05005274,
05005165,
05005167,
05004951,
05006330,
00004426,
05005537,
05012262,
00004420
00004341a/
05004945
05005141
00004371
0501794.2
05006312
05019781
3/
Yes
Yes
Yes
I/
Yes
171-4 - Storage Stability Data
171-4 - Magnitude of the Residue-
Residue Studies for Bach
Pood Use
Peppermint Hay
Mint Oil
Spearmint Hay
Strawberries
Hops
Apricots, nectarines, peaches
Grapefruit, kumquats, lemons.,
PAI
No
Yes
TEP
TSP
TEP
TEP
Yes
Yes
Yes
Yes
Partially
Partially
Partia,lly
00004324, 00004323
00021700, 00021701
00004272, 00004322
00004321, 00021701
00004324, 00021700
00004272
00004305
00004305
00004305
00004305
No
No
No
No
Yes"
c
Yes"
i
Yes"
5/
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TABLE: A
GENERIC DATA REQUIREMENTS FOR DICOFOL
Data Requirements
Composition"
Doos 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)7
S158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue studies for each
food use
Apples, crabapples, pears,
quinces
Blackberries, boysenberries,
dewberries, loganberries, raspberries
Cherries, plums, prunes
Beans (dry)
Snap beans, lima beans (succulent form)
Cantaloupes, melons, muskmelons,
pumpkins, watermelons, winter squash
Cucumbers and summer squash
Bushnuts, butternuts, chestnuts
hazolnuts, hickorynuts, pecans,
walnuts, filberts
Tomatoes, eggplants, peppers, pimentos
Grapes, figs
Cottonseed
Field corn
Alfalfa and clover
Potable water TEP
Fish TEP
Irrigated crops TEP
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Partially
No
No
No
00004504
00004305
00004305
00004305
00004305, 00019894
00004305
00004305
00004305
00004305
00004305
00004305
Yes
i
Yes"
i
Yes"
i
Yes"
i
Yes"
•
Yes"
i
Yes"
i
Yes"
i
Yes"
i
Yes"
i
Yes"
Yes
Yes
Yes
No
No
No
5/
5/
y
\
y
\
y
-------
1>C.NC.KI(J DA1A Kt.UUlKe.Mt.NloTVTn lJJ.<_ur
-------
TABLE: A
GENERIC DATA REQUIREMENTS FOR DICOFOL
Data Requirement
I/ Use 2/
Composition"" Pattern"
Does EPA Have Data
To Satisfy This
Requirement? (Yes*
No or Partially)
Bibliographic
Citation
V
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? _
SI58.130 Environmental Fate
DEGRADATION STUDIES-LABt
161-1 - Hydrolysis
Photodegradation
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB;
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES!
163-1 - Leaching and
Adsorption/DesorpMon
163-2 - Volatility (Lap)
163-3 - Volatility (Field)
DISSIPATION STUDIES-FIELD;
' ' \
164-1 - Soil
164-2 - Aquatic (sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
TGAI or PAIRA A,B,EfF,H
TGAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A,B,E,F,H
TGAI or PAIRA A
TGAI or PAIRA A,B,E,F,H
TEP
TEP
TEP
\
A,B,F-
A,E,F
A,B,H
Partially
No
No
No
Partially
No
Yes
Yes
No
Partially
GS021003
y
y y
QS02JQ01, GS021004
a/ a/
GS021002, GS0210Q7
05011076
y y
GS021008, GS021Q04
Yes
I/
Yes
Yes
Yes
y
y
Yes
Yes
y
No
y
No
No
No
Yes
Yes
y
No
I/
No
10/
No
-------
Data Requirement"
SIS8jJ30'Environmental Fate
(continued)
ACCUMULATION STUDIES}
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Nontarget
Organisms
PAIRA
TEP
A
A
TGAI or PAIRA 'A,B
TGAI or PAIRA A,B
Partially
No
Partially
No
05012142, GS021013
GS021013
a/
ii/
Yes
Yes
il/
No
Yes
Yes
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA =» Pure active ingredient, radiolabelledj
~ TEP = Typical end-use product.
2_/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
~ D=Aqautic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Data must be submitted no later than December, 1986.
4/ The study partially satisfies the data requirement•for hydrolysis by providing information on the rate of hydrolysis
of dicofol in buffered solutions at one concentration, one temperature, and three pHs (acidic, neutral, and basic), j
A material balance and identification of all degradation products greater than 10% of the initial dicofol concentrat
could not be determined. One additional study at a different concentration and temperature at acidic, neutral, and,
basic pHs is required. The study should include a material balance and the identification of all degradation produc
greater than 10% of the initial dicofol concentration.
J>/ The photolysis study was conducted on silica gel-coated thin layer plates, which is no longer a data requirement. F
~ the use patterns identified for dicofol, photodegradatior. studies are required to be conducted in distilled or1 de-
ionized water, on soil, and in air.
6/ Sufficient data on dicofol aerobic soil metabolism in silt loam are available, which is one of the three soil types
required. Two additional soil types must be tested, one should be a sandy loam and the other should be appropriate
to the intended uso areas.
7/ There are no registered aquatic uses for dicofol.
8/ Field dissipation studies are required to be conducted under actual use conditions, using the representative formul
~ product. However,'the submitted studies were conducted using l^C-dicofol formulated into an emulsifiable concentra
Since the results of the studies provided data on the material balance, in addition to data on persistence, mobilit
and identification of degradation products, the Agency will accept the studies as satisfying the data requirement f
silt loam, which is one of the four soil types required. Three additional field dissipation studies are required
using soil types appropriate to the intended use areas. One of the three types of soil should be sandy loam.
9/ There are no registered forestry uses for\3icofol.
I?/ This Guidance Document deals only with single active ingredients.
IT/ Long term field dissipation studies are required to be conducted under actual use conditions, using the representat
formulated product. However, the submitted studies were conducted using *4C-dicofol formulated into an emulsifiab!
concentrate. Since the results of the studies provided data on the material balance, in addition to data on persit
ence, mobility, and identification of degradation products, the Agency will accept the studies as satisfying the d,
t fv»r»r not1 «B ftnnt < r,iifH\ of)
-------
requiremen for silt loam., which is one of the four soil types required. Three additional field dissipation studies
are required using soil types appropriate to the intended use areas. One of the three types of soil should be sandy
loam.
' Results of the submitted rotational crop study indicated that there is a potential for dicofol and its residues to
accumulate in rotational crops. However, the sampling intervals in the confined rotational crop studies were in-
appropriate to assess the potential uptake of dicofol and its residues at 30 days, four months, and one year after
the last dicofol application. Therefore, an additional confined rotational crop study with the appropriate sampling
interals is required. This study should be conducted using the manufacturing-use product as the test substance.
The analytical method utilized in the study must be capable of separating and measuring dicofol, its residues,
and its impurities (DDTr) in the confined rotational crops. Alternatives to conducting the confined rotational
crop study are: 1) rotational crop studies conducted under actual use conditions, 2) a label restriction that pro-
hibits crop rotation with crops other than those specified on the label, or 3) a tolerance for the nontarget crop.
' Dicofol is not registered for intentional application to irrigation water.
' The protocol for the submitted ecosystem study is inappropriate to assess the potential accumulation of- dicofol and its
residues in fish, because the exposure period was not long enough, nor was there a depuration period included in the
protocol to assess elimination of dicofol and its residues from fish. A flowthrough system fish accumulation study is
required. This study should be conducted using the manufacturing-use product as the test substance. The identity.of
the test substance should be specified (qualitative and quantitative description of the chemical composition). The
analytical method utilized in the study must be capable of separating and measuring the DDT* impurities in the test
substance.
f Data submitted by flohra and Haas Company. These data may be compensable.
-------
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? {Yes,
Composition Patterns No or Partially)
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICOFOL
37—
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
ta Requirement
I/ Use 2/
Composition Pattern"
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
Ho or Partially)?
Bibliographic
Citation
58.135 Toxicology
(continued)
TAGENICITY TESTING
-2 - Gene Mutation
-2 - Chromosomal Aberration
-2 - Other Mechanisms of
Mutagenicity
ECIAL TESTING
TGAI
TGAI
TGAI
-1 - General Metabolism PAI or PAIRA
-2 - Domestic Animal Safety Choice
A,B,E,F,H,I No
A,B,E,F,H,I No
A,B,E,F,H,I No
A,B,E,F,H,I No
05002571
Yes
i
Yes'
<
Yes"
Yes"
No
I/
»
9/
9/
/ Composition; TGAI = Technical grade of the active ingredient. PAIRA = Pure active ingredient, radiolabelled;
Choice = Choice of several test substances determined on a case-by-case basis. Due to the uncertainties of the dicofol
impurities (DDTr), and their contribution, if any to. a possible risk potential, all TGAI dicofol must be similar in
compos ition % Any variation of the levels of impurities may result in additional toxicology data testing and requirement
The Agency shall make data testing decisions on a case-by-case basis for each submitted statement of formula.
/ The use patterns are coded as follows; A=Terrestrial, Food Crop; B=Terrestrial, Non-Food) C=Aqautic, Food Crop;
D=Aquatic, Non-Food; E-Greennouso, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
/ Data must be submitted no later than December, 1986.
/ This test is not required because dicofol does not depress cholinesterase acivity, and it is not structurally
related to a compound that induces neuropathy or delayed neurotoxicity.
/ The rat study submitted was adequate, testing in a second species, preferably the dog, is required,
6/ This test is not required because dicofol in not intentionally applied to the skin and its use will not result
human exposure similar to that caused by swimming pool additives or pesticide-impregnated fabrics.
T/ 90-day inhalation toxicity testing requirement is reserved pending results from the acute inhalation test.
B/ The data available on oncogenicity do suggest possible oncogenicity in male mice. However, the study is unacceptable
due to the reported decomposition of the testymaterial during the study.
9/ The minimum standard for mutageijicity testingN,si 1) Two different tests that are sensitive for point mutations, one
for a mammalian system (in vivo or in vitro), 2) Two tests for chromosomal damage, and 3) one auxiliary test for DNA
damage on a tost appropriate for other mechanisms of toxicity, i.e. DNA repair, induct test,
.JO/ A metabolism study comparing DDT and dicofol in the rat was started but not completed (various tissues removed for
examination were not identified and assays were not reported, identification of purity and/or contaminants in the
test substance were not reported). A request for a final report was made, however the registrant replied that the
study was never completed, .
-------
Does EPA Have Data Must Additional
To Satisfy This * Daca Be Submitted
I/ 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c) ( 2) (B)?
Sl58.140 Reentry Protectibn
I/
132-1 - Foliar Dissipation TEP - . Reserved
I/
132-1 - Soil Dissipation TEP - - Reserved
I/
133-3 - Dermal Exposure TEP - - Reserved
i/
133-4 - Inhalation Exposure TEP - - Reserved
I/ Composition:TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Pood Crop; B^Terrestrial, Non-Pood; C=Aquatic, Pood Crop;
~ D=Aquatic, Non-Food; E=Greenhouse, Pood Crop;. F=Greenhouse, Non-Pood; G»Porestry; H=Domestic Outdoor; Ialndoor.
3_/ Data must be submitted no later than December, 1986.
4/ These tests are reserved pending the receipt 6f additional data (inhalation, chronic feeding, oncogenicity, and
teratogenicity).
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICOFOL
37~~
Must Additional
Data Be Submitted
Under PIFRA Section
3(c>(2HB)7
Data Requirement
17 Use 2/
Composition" Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
S158.145 Wildlife and
Aquatic Organisms
AVIAN
71-1
71-2
AND MAMMALIAN TESTING
- Avian Oral LD$Q
- Avian Dietary LCso
TGAI A,B,H
TGAI A,B,H
Yes
Yes
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
TGAI
TEP
A,B,H
A,B,H
Accumulation
Degradation
Product
Partially
No
72-1 -
72-2 -
72-3 -
72-4 -
72-5 -
72-6 -
Freshwater Fish LC§o
Acute LCso Freshwater
Invertebrates
Acute LCso Estuarine
and Marine Organisms
Fish Early Life
Stage and Aquatic
Invertebrate Life-Cycle
Fish Life-Cycle
\
Aquatic Organism
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI, PAI or
A,B,H
A,B/H
A,B,H
A,B,H
v A,B,H
\
Partially
Partially
Partially
Yes
No
00004315, 00004314
GS021052
GS021014
GS021048, GS021049
GS021063 GS021046
GS021047
GS021060
05005326
GS021062
No
No
NO
I/
5/
Yes
No
i/
6/
Yes
7/
Yes
8/
A,B,H
NO
Yes
No
Yes
Yes
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
TEP
No
No
-------
JT/ Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient;
~ TEP = Typical end-use product;
2/ The use patterns are coded as follows: A=Terrestrial, Pood 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 must be submitted no later than December, 1986.
?/ This test is required only on a case-by-case basis when hazards to nontarget vertebrates are likely. Lowered tiered
~ testing does not indicate a potential hazard to nontarget vertebrates.
£/ The avian reproduction requirement involves testing with two species (mallard and bobwhite), Testing with mallards
~ has been received but it does not fulfill the requirements; mallard and bqbwhite testing are required.
6/ Testing is required on a coldwater fish species.
7/ There are insufficient data available in the submitted study to permit a statistical validation.
8/ Dose mortality data are not provided in the original citation.
9/ This test is required on a case-by-case basis when hazards to nontarget aquatic organising are likely.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICOPOL
iata Requirements
Composition
I/
Does EPA Have Data
To Satisfy This
Use 2/ Requirement? (Yes,
Pattern" No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B>?
158.150 Plant Protection
21-1 - TARGET AREA
PHYTOTOXICITV
QNTARGET AREA PHYTOTOXICITY
TIER I
22-1 - Seed Germination/
Seedling Emergence.
22-1 - Vegetative Vigor
22-2 - Aquatic Plant Growth
TIER II
23-1 - Seed Germination/
Seedling Emergence
23-1 - Vegetative Vigor
23-2 - Aquatic Plant Growth
TIER III
24-1 - Terrestrial Field
24-2 - Aquatic Field
EP
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
I/
4/
No
No
No
I/
No
4/
No
I/
>
4/
No
No
No
4/
Compositions TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
EP * End-use product.
The use patterns are coded 4s follows: A=Ter\estrial, Food Crop; B=Terrestrial, Non-Food Crop; C-Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhoitse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
Data must be submitted no later than December, 1986.
This study is not required because dicofol has npt been shown to cause phytotoxicity problems.
-------
Data Requirement
I/ 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>?
S15B.1S5 Nuntarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact 1*050
141-2 - Honey bee - toxicity
of residues on foliage
141-3 - Wild bees important in
alafala pollination -
toxicity of residues
on foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pol 1 inators
NONTARGET INSECT TESTING -
AQUATIC INSECTS |
142-1 •» Acute toxicity to
aquatic insects
142-2 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects v
TGAI
A,B,H
Yes
05001991, 05008989
05008900, 05009244
No
No
I/
I/
NO
i
Reserved'
i/
No
Reserved
Reserved
143-1
t h ru
143-3
•<• NONTARGET INSECT TESTING-
PREDATORS AND PARAS ITKH
Reserved
Reserved
5/
I/ Composition!TGAI = Technical grade of the active ingredient} TEP = Typical end-use product,
~2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=>Terrestrial, Non-Food} C=Aquatic, Food Crops
""" D^Aqautic, Non-Foodi B=Groenhouse, Food Cropi F=Greenhouse, Non-Food| .Gsporestryi H^Domestic Outdoor} I = Indoor.
jy Data must be submitted no later than December, 1986.
4/ Although dicofol is registered for use on Alfalfa grown for seed, dicofol has been shown to be relatively nontoxic to
bees. This study is not required.
g* t r» . - .
-------
PRODUCT SPECIFIC DATA REQUIREMENTS
TABLE B
FOR MANUFACTURING-USE PRODUCTS CONTAINING DICOFOL
L I/
>ata Requirement Composition
[158.120 Product Chemistry
Jroduct Identity
il-1 - Identity of Ingredients MP
il-2 - Statement of Composition MP
il-3 - Discussion of Formation
of Impurities MP
Analysis and Certification
>f Product Ingredients:
•
»2-l - Preliminary Analysis MP
>2-2 - Certification of Limits MP
52-3 - Analytical Methods for
Enforcement of Limits
- Active ingredient MP
- impurities MP
Physical and Chemical
Characteristics
63-2 - Color MP
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
No
No
No Confidential State-
ment of Formula
No
Partially Confidential State-
ment of Formula
a/
Yes 05005142, 00004348
05014643, 05017499
00004340, 05004951
05005964, 05006333
05005167, 00004336b/
05015278, 05020221
05005274, 05004878
05005279, 05015625
05017892
Yes 05004176
c/ d/
Partially 00004358, 00004339
c/ d/
2/
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)7
3/
Yes~
3/
Yes
V
Yes
5/
Yes
6/
Yes
No
No
7/
Yes
63-3 - Physical State
63-4 *• Odor
63-7 - Density, bulk density, or
MP
MP
Partially
No
Partially
00004358, 00004339*
00004358, 00004339
No
Yes
Yes"
7/
-------
PRODUCT SPECIFIC DATAREQUIREMENTSFOR MANUFACTURING-USE PRODUCTS
Data Requirement
Composition
I/
Does SPA have Data
To Satisfy This '
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
y
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
63-14 - Oxidizing or reducing
potential
63-15 - Flammability
63-16 - ExplodabUUy
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
Other Requirements
64- 1 - Submittal of Samples
MP
MP
MP
MP
MP
Choice
No
Yes
No
Yes
No
c/ d/
00004358, OOQ04339
00004359° OOQ04339"
Yes
y
Yes
Yes
y
Yes
I/
No
Yes
I/ Composition! MP ¥ Manufacturing-use product; Choice =• Choice of several test substances determined on a case-by-
"~ case basis.
2/. Data must be submitted no later than April, 1984.
T/ Updated information must be supplied by all companies on identity and quantity of impurities and inert ingredients.
~* Special attention must be given to identifying and quantifying the DDT impurities. The name and address of the
producer of the starting materials, the manufacturing process, and the reaction conditions needed.
4/ Special testing is required on the impurity known as Cl-DDT. These tests are the octanol-water partitian coefficient,
water solubility, and vapor pressure.
]>/ Five or more representative samples should be analyzed for the amount of active ingredient and each impurity present
~* in the technical material for which a certified limit is required.
6/ Upper and lower limits must be provided and certified for the dicofol concentrations and each impurity > 0.1 percent.
?/ Aceto Chemical did not submit any physical/chemical, properties. Rohm & Haas and Makhteshim Beer-Shiva did report some
~ physical/chemical properties for the technical product.
j}/ Not soluble in water, therefore no pit data are required.
][/ Not applicable because the material is not a liquid.
a/ Data submitted by Intrachemy S.A. These datV may be compensable.
b/ Data submitted by Aceto Chemical Company. These data may be compensable.
c/ Data submitted by Rohm and Haas Company. These data may be compensable.
3/ Data submitted by Makhteghim Beer-Sheva Chemical Works, Limited, These data may be compensable.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DICOFOL
)ata Requirement
Composition
I/
Does EPA Have Data '
To Satisfy This
Requirement? (Yes,
Ko or Partially) .
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2HB)7
U 58.
Toxicology
ICUTE TESTING
-1 - Oral
-2 - Dermal
-3 - Inhalation, LC^ft -
aj- 4 - Pffimarif Eye
Irritation - Rabbit
ftl-5 - Primary Derma.il
Irritation
ai-& - Dermal Sensitization
HP
HP
HP
HP
HP
HP
Yes
Yes
No
No
No
NO
00004373; 0000436$
05002S71? 00004374
00004366
No
No
Yes
i
Yes"
Yes
Yes
I/ Composition: HP = Manufacturing-use product.
2/ Data must be submitted no later than December, 1986.
3/ Based on the primary eye irritation data available on formulation intermediates, manufacturing-use dicofol
~ ia considered a potentially severe eye irritant. If the registrants agree that it is a severe eye irritant,
the formulation intermediate data will suffice, 'otherwise, the study must be conducted with 9 manufacturing-
use product.
-------
IV- SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This chapter applies only to manufacturing-use products,
not -end-use products.
The Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate, complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are suffi-
ciently standardized to avoid user confusion.
As part of your application, you will be required to submit
draft labeling consistent with: applicable product-specific
data; the precautionary statements and use directions; and the
regulations concerning classification [40 CFR §162.11(c)], pack-
aging [40 CFR §162.16], and labeling [40 CFR §162.10, Appendix
V-l an V-2], as indicated by the following paragraphs of this
chapter of the guidance document.
You must submit the revised labeling set forth in this guidance
package within 90 days of receipt of this guidance package.
A. Label Contents
40 CFR §162.10 (Appendix V-l) requires that certain spe-
cific labeling statements must appear at certain, locations
on the label. This is referred to as format labeling.
Specific label items listed below are keyed to Tables D, E,
and F (Appendix V-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. See Appendix
V-2. [40 CFR §162.10(b)]
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.
See Appendix V-2. [40 CFR §162.10(c)]
Item 3. NET CONTENTS - A net content statement is required
on all labels. 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
stated in terms of weight, expressed as avoirdupois pounds
-------
and ounces, and stated in terms of the largest suitable unit,
i.e., "1 pound 10 ounces" rather than "26 ounces." In
addition to the required units specified, net contents may be
expressed in metric units. See Appendix V-2. [40 CFR
§162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix V-2.
[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 registration number on
the immediate container cannot be clearly read through such
wrapper or container. See Appendix V-2. [40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient 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 ingredient
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 V-2. [40 CFR 162.10(g)]
Item 6A. POUNDS PER GALLON STATEMENT - For liquid
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, preferably within a block outline. The
table below shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
-------
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 - All labels are
required to have the statement "Keep Out of Reach of Children"
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
See Appendix V-2. [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 V-2.
[40 CFR §162.10 (h) (l)(i)]
Item 1C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, or dermal 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 V-2. [40 CFR
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 V-2. [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 V-2. [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 V-2. [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 taken to avoid
accident, injury or damage. See Appendix V-2. [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 V-2. [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 V-3. The requirement is based on the results
of the flashpoint determinations and flame extension
tests required to be submitted for all products.
These statements are to be located in the side/back
panel precautionary statements section, preceded by
the heading "Physical/Chemical Hazards." Note that
no signal word is used in conjunction with the flam-
mability statements.
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 flash-
point greater than 350°F (177°C) as determined
by the method specified in 40 CFR §163.61-8(c) (13)
(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the
method specified in 40 CFR S161.61-8(c) (13) (ii) ;
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C),
determined by the method specified in 40 CFR
§163.61-8(c)(13)(i).
-------
3. Declaration of non-flammability. Products which meet
the criteria for non-flammability specified above may
bear the notation "non-flammable" or "nonflammable
(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 submitted in accordance with 40 CFR
§163.61-10(c) 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. 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."
See Appendix V-2. [40 CFR §162.10(1)(2)(ii)]
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. Make certain that the statement you use
pertains specifically to your product. 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 V-4 for the latest specific
storage and disposal product label statements.
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 V-2. [40 CFR §162.10]
B. Collateral Information
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, and 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.
-------
V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Jay Ellenberger (PM 12)
Phone No. (703)-557-2386
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
For each product for which continued registration is desired:
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA
Form 8580-1 and revised labeling. Refer to Appendix
II with appropriate attachments.
2. Within 6 months from receipt of this document registrants
must submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4 (Appendix
III).
c. Two copies of any required product-specific data.
3. Within the time set forth in Table A, all generic data
must be submitted by the affected registrant(s).
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 listed above.
You will be informed at a later date when you must submit your
Application for Amended Pesticide Registration (EPA Form 8570-1).
-------
APPENDIX I
-------
Guide to Use of This Bibliography
1. CONTENT OP 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 themr treating them as a single study;
3. IDENTIFICATION OP 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 explanation. In a few
cases, entries added to the bibliography late in the review
may be preceded by a nine-character temporary identifier.
These entries are listed after all MRID entries. This
temporary identifier number is also to be used whenever
specific reference is needed.
4. FORM OP ENTRY. In addition to the Master Record Identifier.
(MRID), each entry consists of a citation-containing
standard elements followed, in the case of materials
submitted to £?Af by a description of the earliest Jcnown
submission. Bibliographic conventions used reflect the
standards of the American National Standardq institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has shown
an identifiable laboratory or testing facility as
author. As a last resort, the Agency has shown the
first known submitter as author.
-------
b. Document Data. When the date appears as four digits •
with no question narks, 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
(ia addition to any self-explanatory text) the
following elements describing the earliest known
submission:
(1) Submission Date. Immediately following the word
'received* appears the date of the earliest known
submission*
(2) Administrative Number.' The next element,
immediately following the word 'under'., is the
registration number, experimental 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 SPA accession number of the volume
in which the original submission of the study
appears-. The six-digit accession number follows
the symbol 'CDL1, 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 123-456, the
first study would be 123456-A; the second, 123456-
B; the 26th 123456-Z; and the 27th, 123456-AA.
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00004272 Rohm and Haas Company (1961) Report: Analytical Results of Resi-
due on Peppermint Hay. (Unpublished study received Jun 17,
1965 under PP0390; CDL:090422-B)
00004275 Gordon, C.F. (1962) Dichlorobenzhydrol in Mint Oil. Includes
method dated Dec 4, 1962. (Unpublished study received Jun 17,
1965 under PP0390; submitted by Rohm & Haas Co., Philadelphia,
Pa.; CDL:090422-M)
00004305 Rohm and Haas Company (1957) Explanatory Notes on Residue Data.
(Unpublished study received Oct 12, 1957 under PP0154; CDL:
090180-K)
00004312 Brown, J.R. (1965) Toxicologic Studies on the Effects of Kelthane
in the Diet of Albino Rats on Reproduction. (Unpublished study
including first, second, and third interim reports, received
Jan 28, 1966 under 6F0472; prepared by Univ. of Toronto, Dept.
of Physiological Hygiene, submitted by Rohm & Haas Co., Phila-
delphia, Pa.; CDL.-090524-B)
00004314 Harper, K.H.; Palner, A.K. (19??) Toxicity of Kelthane AP to the
Mallard Duck: Report No. 1024/64/39. (Unpublished study re-
ceived Jan 28, 1966 under 6F0472; prepared by Huntingdon Re-
search Centre, Eng., submitted by Rohm & Haas Co., Philadelphia,
Pa.; CDL:090524-D)
00004315 Harper, K.H.; Palmer, A.K. (1965) Toxicity of Kelthane AP to Japan-
ese Quail: Report No. 1162/65/79. (Unpublished study received
Jan 28, 1966 under 6F0472; prepared by Huntingdon Research Cen-
tre, Eng., submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL:090524-E)
00004321 Rohm and Haas Company (1964) Kelthane in Mint Oil. Includes four
undated methods. (Unpublished study received Jan 28, 1966 under
6F0472; CDL:090524-K)
00004322 Lawrence, S.C. (1964) Analytical Results of 4,4'-Dichldrobenzo-
phenone (DCBP) Residue. (Unpublished study received Jan 28,
1966 under 6F0472; submitted by Rohm & Haas Co., Philadelphia,
Pa.; CDL:090524-L)
00004323 Frick, K.E.; Franzkeit, N.H. (1959) Pesticide Residue Analysis.
(Unpublished study received Jan 28, 1966 under 6F0472; prepared
by State College of Washington, Dept. of Entomology and Agricul-
tural Chemistry, Prosser Irrigation Experiment Station, sub-
mitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:090524-M)
-------
00004324 Terriere, ? (1963) Analytical Results of Kelthane Residue. (Unpub-
lished study received Jan 28, 1966 under 6F0472; submitted by
Rohm & Haas Co., Philadelphia, Pa.; CDL:090524-O)
00004336 Gordon, C.F.; Schuckert, R.J. (19??) Kelthane. Pages 263-271, In
By ? N.P. (Also In unpublished submission received Oct 30,
1972 under 2749-286; submitted by Aceto Chemical Co., Inc.,
Flushing, N.Y.; CDL.-006094-A)
00004339 Makhteshim Beer-Sheva Chemical Works, Limited (1972) Acarin: Acari-
cide: Pure Compound (Analytical Grade). (Unpublished study re-
ceived Jun 20, 1972 under 11678-7; CDL:011016-A)
00004340 Makhteshim Beer-Sheva Chemical Works, Limited (1972) Acarin: Ana-
lytical Method. Method dated Jan 1972. (Unpublished study re-
ceived Jun 20, 1972 under 11678-7; CDL:011016-B)
00004341 Makhteshim Beer-Sheva Chemical Works, Limited (1972) Acarin: Resi-
due Analysis. (Unpublished study received Jun 20, 1972 under
11678-7; CDL:011016-C)
00004348 Intrachem SA (1971) Manufacturing Process for Dicofol. Includes
undated method. (Unpublished study received Jul 25, 1972 under
13801-5; submitted by Registration Consulting Assoc., Andover,
Mass.; CDL:224521-A)
00004358 Rohm and Haas Company (19??) Technical Bulletin: Keltane (R)
Technical: Agricultural Acaricide. (Unpublished study received
Jun 26, 1972 under 707-107; CDL:101453-A)
00004365 Haag, H.B.; Larson, P. (19??) Acute Oral Toxicity of FW-293 (Tech-
nical Grade, lot SW-4807), FW-293 (Pure, Lot W-569), o,p-Z-33
(lot N-1818) and p,p-Z-33 (Lot N-1811). (Unpublished study re-
ceived Aug 13, 1956 under PP0108; prepared by Medical College of
Virginia, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
090138-G)
00004366 Haag, H.B.; Larson, P. (19??) The Acute Percutaneous LD50 of Com-
pound F.W. 293 Technical in Rabbits. (Unpublished study re-
ceived Aug 13, 1956 under PP0108; prepared by Medical College of
Virginia, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
090138-H)
00004371 Rohm and Haas Company (19??) The Determination of Kelthane Residues
in Lima Beans by Gas Liquid Chromatography. Undated method.
(Unpublished study received Aug 17. 1966 under 707-73; CDL:
101452-D)
00004373 Haag, H.B.; Larson, P. (19??) Acute Oral Toxicity of Technical
Grade FW-293, Lot SW-5508, to the Rat. (Unpublished study re-
ceived Aug 13, 1956 under PP0108; prepared by Medical College of
Virginia, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
090138-N)
-------
00004374 Haag, H.B.; Larson, P. (19??) Acute Oral Toxicity of FW-293 (Tech-
nical Grade, Lot SW-5508) to Rabbits. (Unpublished study re-
ceived Aug 13, 1956 under PP0108; prepared by Medical College of
Virginia, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
090138-0)
00004420 Rohm and Haas Company (1961) Microdetermination of Kelthane in
Plants, Fruits and Vegetables. Method 1634-1 dated Nov 20,
1961. (Unpublished study received Jan 28, 1966 under 6F0472;
CDL:092762-C)
00004424 Brown, J.R. (1967) lexicological Studies on 2,2-Bis-(chlorophenyl-
2,2,2-trichloroethanol) (Kelthane): The Effect of Dietary Kel-
thane on Mouse Reproduction. (Unpublished study received on
unknown date under PP0590; prepared by Brown Biological Labora-
tories, Ltd., Canada, submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:097533-A)
00004426 Rohm and Haas Company (1967) Determination of Kelthane Residues in
Crops and Soils. Method dated Mar 13, 1967. (RAR memorandum
no. 518; unpublished study received Mar 28, 1967 under 7F0590;
CDL:092878-H)
00004429 Haag, H.B.; Larson, P. (1952?) Toxicologic Study on the Effect of
Adding FW-293 to the Diet of Rats for a Period of Three Months.
(Unpublished study received Feb 1, 1956 under PP0060; prepared
by Medical College of Virginia, submitted by Rohm & Haas Co.,
Philadelphia, Pa.; CDL:092340-D)
00004504 Arnold, W.E. (1966) Combination of Bromoxynil with Phenoxy Herbi-
cides for Wild Buckwheat Control, Fargo 1966. (Unpublished
study received Oct 30, 1968 under 264-239; prepared by Amchem
Products, Inc., submitted by Union Carbide Agricultural Products
Co., Ambler, Pa.; CDL:002199-N)
00019894 U.S. Agricultural Research Service (1959) Report of Residue Analy-
sis: Report No. PC-V-59-14. (Unpublished study received Sep 29,
1959 under unknown admin, no.; prepared by Entomology Research
Div., Pesticide Chemicals Research Branch, submitted by ?; CDL:
124252-A)
00021700 Rohm & Haas Company (19??) Summary of Residue Reports Submitted
Previously with Pesticide Petitions No. 6F0472 and 7G0512. (Un-
published study received Jun 19, 1967 under 7F0590; CDL:
090757-E)
00021701 Lawrence, S.C.; Chollet, C.C. (1966) Analytical Results of Kelthane
Residues. (Unpublished study received Jun 19, 1967 under
7F0590; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
090757-F)
-------
05005167 George, D.A.; Fahey, J.E.; Walker, K.C. (1961) A modification of
the Rosenthal method for rapid determination of Kelthane
residues. Journal of Agricultural and Food Chemistry
9(4):264-266.
05005274 Rosenthal, I.; Frisone, G.J.; Gunther, F.A. (1957) Colorimetric
microdetermination of the acaricide
4,4I-dichloro-alpha-(trichloromethyl)benzhydrol (FW-293).
Journal of Agricultural and Food Chemistry 5(7):514-517.
05005279 Sphon, J.A.; Damico, J.N. (1970) The mass spectra of some
chlorinated aromatic pesticidal compounds. Organic Mass
Spectrometry 3(1):51-62.
05005326 Khorram, S.; Knight, A.W. (1977) The toxicity of Kelthane to the
grass shrimp (Crangon franciscorum). Bulletin of
Environmental Contamination and Toxicology 18(6):674-682.
05005537 Moats, W.A. (1966) Analysis of dairy products for chlorinated
insecticide residues by thin layer chromatography. Journal of
the Association of Official Analytical Chemists 49(4):795-800.
05005964 Diemair, W.; Maier, G.; Schloegel, K. (1969) Beitrag zum Nachweis
und zur Bestimmung von Pesticiden in pflanzlichen
Lebensmitteln I Mitteilung: Duennschichtchromatographisches
Verhalten chlorierter Pesticide Contribution to the
detection and determination of pesticides in plant foodstuffs
I Thin-layer chromatographic behavior of chlorinated
pesticides Zeitschrift fuer Lebensmittel-Untersuchung und
Forschung 139(5):294-301.
05006219 Jeppson, L.R.; Gunther, F.A. (1970) Acaricide residues on citrus
foliage and fruits and their biological significance. Pages
101-136, In Residue Reviews. Vol. 33. New York: Springer.
05006312 Osadchuk, M.; Romach, M.; McCully, K.A. (1971) Cleanup and
separation procedures for multipesticide residue analysis in
monitoring and regulatory laboratories. Pages
357-381, In Pesticide Chemistry: Proceedings of the
International IUPAC Congress of Pesticide Chemistry, 2nd; Feb
22-26, 1971, Tel-Aviv, Israel. Vol. 4: Methods in Residue
Analysis. Edited by A.S. Tahori. New York: Gordon and
Breach.
05006330 Morgan, N.L. (1968) Separation of dicofol (Kelthane) and its
dichlorobenzophenene degradation product from a standard
Florisil column. Bulletin of Environmental Contamination and
Toxicology 3(4):254-257.
05006333 Susi, H.; Rector, H.E. (1958) Quantitative infrared analysis of
pesticides in the solid state. Analytical Chemistry
30(12):1933-1935.
-------
05000993
05001991
05002571
05004176
05004708
05004877
05004878
05004945
05004951
05005141
05005142
05005165
British Crop Protection Council (1974) Pesticide Manual: Basic
Information on the Chemicals Used as Active Components of
Pesticides. Edited by H. Martin and C.R. Worthing. 4th ed.
London, England: British Crop Protection Council.
Stevenson, J.H. (1978) The acute toxicity of unformulated
pesticides to worker honey bees (Apis melliferaL). Plant
Pathology 27(1):38-40.
Brown, J.R. ; Hughes, H.; Viriyanondha, S. (1969) Storage,
distribution, and metabolism of l,l-bis(4-chlorophenyl)-
2,2,2-trichloroethanol. Toxicology and Applied Pharmacology
15(l):30-37.
Aryeetey, A.N. (1973) Chemical weed control in rice in Ghana.
Ghana Journal of Agricultural Science 6(3) : 199-204.
Zweig, G.; Pye, E.L. ; Peoples, S.A. (1963) Residues in butterfat
and body fat of dairy cows fed at two levels of Kelthane (1.0
and 2.0 ppm). Journal of Agricultural and Food Chemistry
Kawar, N.S.; De Batista, G.C.; Gunther, F.A. (1973) Pesticide
stability in cold-stored plant parts, soils, and dairy
products, and in cold-stored extractives solutions. Pages
45-77, In Residue Reviews. Vol. 48. Edited by F.A. Gunther.
New York: Springer.
Chen, J.Y.T.; Dority, R.W. (1972) Infrared studies of DDT,
structurally related halogenated pesticides, and some
metabolites. Journal of the Association of Official Analytical
Chemists 55(1):15-31.
Eiduson, H.P. (1961) The determination of Kelthane residues on
fruits and vegetables. Journal of the Association of Official
Agricultural Chemists 44(2) : 183- 188.
Gunther, F.A.; Blinn, R.C. (1957) Ultraviolet spectre-photometric
microdetermination of the acaricide
4,4' -dichloro-alpha- ( trichloromethyl ) benzhydrol ( FW-29 3 ) .
Journal of Agricultural and Food Chemistry 5(7) : 517-519.
Ives, N.F. (1973) Observations on the gas chromatography of
Kelthane (dicofol). Journal of the Association of Official
Analytical Chemists 56 (6): 1335-1338.
Hughes, J.T. (1961) Colorimetric determination of "Kelthane"
residues. Analyst 86(1028):756-757.
Gordon, C.F.; Haines, L.D.; Martin, J.J. (1963) An improved method
for Kelthane residue analysis with applications for
determination of residues in milk. Journal of Agricultural and
Food Chemistry ll(l):84-86.
-------
05006528 Scheel, D.; Sandermann, H., Jr. (1977) Metabolism of DDT and
Kelthane in cell suspension cultures of parsley (Petroselinum
hortense, Hoffm) and soybean (Glycine maxL). Planta
133(3):315-320.
05008989 Johansen, C.; Eves, J. (1967) Toxicity of Insecticides to the
Alkali Bee and the Alfalfa Leafcutting Bee. Pullman, Wash.:
Washington State University Agricultural Research Station.
(Washington Agricultural Research Station circular no. 475)
05008990 Johansen, C.; Jaycox, E.R.; Hutt, R. (1963) The Effect of
Pesticides on the Alfalfa Leafcutting Bee, Megachile
rotundata. Pullman, Wash.: Washington State University
Agricultural Research Station. (Washington Agricultural
Experiment Station circular no. 418)
05009244 Keener, J.A.; Pless, C.D. (1974) Effects of direct application of
selected pesticides on honey bee colonies. Tennessee Farm and
Home Science Progress Report (89):5-8.
05011076 Wagner, R.; Hoyer, J. (1975) Zur Methodik der Ermittlung von
Arbeitsplatzkonzentrationen und zur arbeitshygienischen
Situation waehrend und nach dem Heissvernebeln von PSM im
Gewaechshaus Method of determining workplace concentrations
and occupational hygiene conditions during thermal fogging
atomization of pesticides in the greenhouse Zeitschrift fuer
die Gesamte Hygiene und Ihre Grenzgebiete 21(1):18-20.
05012142 Lloyd-Jones, C.P. (1973) The absorption of chlormequat and SADH
into leaves of fruit plants. Acta Horticulturae 34(l):79-84.
05012262 Katz, D. (1964) Beitrag zum Problem der Sichtbarmachung von
chlorierten Insektiziden am Duennschichtchromatogramm A
contribution to the problem of coloring the spots of
chlorinated insecticides in the thin-layer chromatogram
Journal of Chromatography 15(2):269-272.
05014643 Wang, R.T.; Chou, S.S. (1968) Ch'enfou ju kuasheng wut'ien
semup'i Detection of pesticides by reversed phase paper
Chromatography Chung Kuo Nung Yeh Hua Hsueh Hui Chin.
Journal of the Chinese Agricultural Chemical Society.
6(3/4):63-68.
05015278 Blinn, R.C.; Gunther, F.A. (1962) The promising utility of
infrared assay of pesticides and their residues. SRI Pesticide
Research Bulletin 2(3):1-9.
05015625 Antoine, O.; Kiel, K. van; Mees, G. (1977) Test de routine pour la
determination des insecticides organo-chlores par la
chromatographie en couche mince et la chromatographie gazeuse
Routine method for the determination of organochlorine
insecticides by thin-layer Chromatography and gas
Chromatography Annales de Medecine Veterinaire 121(1):43-54.
-------
05017499 Takahama, K.; Araki, S.; Kataoka, S.; Matunoto, K.; Kakihara, Y.;
Ogata, Y.; Kanda, M. (1971) Ultraviolet spectrophotometry of
organic synthesized pesticides. Nippon Hoigaku Zasshi.
Japanese Journal of Legal Medicine. 25(1):85-90.
05017892 Aly, O.M.; Faust, S.D.; Suffet, I.H. (1971) Ultraviolet
spectrophotometry in residue analysis; spectra-structure
correlations. Pages 95-118, In Pesticides Identification at
the Residue Level. Washington, B.C.: American Chemical
Society Publications. (Advances in chemistry series no. 104)
05017942 Kashiwa, T.; Onda, K.; Ito, F. (1965) Kanshiki ususo
kuromatogurafi niyoru kerutanu seizai no bunseki Dry
thin-layer chromatographic determination of Kelthane
formulations Bunseki Kagaku. Japan Analyst.
14(3) .-207-212.
05019781 Mitchell, L.C. (1958) Separation and identification of chlorinated
organic pesticides by paper chromatography XI A study of
114 pesticide chemicals: technical grades produced in 1957 and
reference standards. Journal of the Association of Official
Agricultural Chemists 41(4):781-816.
05020221 Gore, R.C.; Hannah, R.W.; Pattacini, S.C.; Porro, T.J. (1971)
Infrared and ultraviolet spectra of seventy-six pesticides.
Journal of the Association of Official Analytical Chemists
54(5):1040-1082.
GS021001 Fisher, J.D. (1972) Dissipation study of Kelthane in soil and
its effects on microbial activity. (Unpublished report
prepared by Rohm and Hass Co., Philadelphia, PA. Lab. 11
Metabolism Group Memorandum Report 12).
GS021002 Krzeminski, S.F. (1972) Leaching and metabolism of p,p'-
Kelthane in various soil types. (Unpublished study pre-
pared by Rohm and Hass Co., Philadelphia, PA. Lab. 23
Tech. Report No. 23-72-4).
GS021003 Spillner, C.J. (1978) Hydrolysis of Kelthane. (Unpublished
report prepared by Rohm and Haas Co., Philadelphia, PA.,
Tech. Report No. 3423-76-36).
GS021004 Spillner, C.J. (1976) 14C Kelthane fallow field study. (Unpub-
lished report prepared by Rohm and Haas Co., Philadelphia,
PA., Tech. Report No. 3423-76-37).
GS021005 Spillner, C.J. (1978) The photodegradation of Kelthane on
silica gel. (Unpublished report prepared by Rohm and Haas
Co., Philadelphia, PA., Tech. Report No. 34F-78-5).
GS021007 Fisher, J.D. (1975) Laboratory leaching study with soil-aged
Kelthane. (Unpublished study prepared by Rohm and Haas Co.,
Philadelphia, PA., Tech. Report No. 3423-75-50).
-------
GSO21008 Parker, C.O. (1979) 1*C Kelthane fallow field study. The
effect of alkaline soil pH on Kelthane degradation and
dissipation. (Unpublished study prepared by Rohm and Haas
Co., Philadelphia, PA., Tech. Report No. 34F-79-16).
GS021013 Spillner, C.J. (1976) Evaluation of Kelthane in a model eco-
system. (Unpublished report prepared by Rohm and Haas Co.,
Philadelphia, PA., Tech. Report No. 34-19).
GS021014 Heath, R.G.; Spann, J.W. (1973) Effects of Kelthane on mallard
reproduction. Unpublished toxicity data. U.S. Fish and Wild-
life Service. Patuxent Wildlife Research Center.
GS021046 McCann, J. (1971) Toxicity of Kelthane 35 to bluegill sunfish.
Fish toxicity laboratory report. Animal Biology Laboratory
ARS-PR, ARC, Beltsville, MD.
GS021047 Schoettger, R. (1971) The acute toxicity of Kelthane to cutthroat
trout. Unpublished toxicity data. Columbia National Fisheries
Research Laboratory, Columbia, Missouri.
GS021048 Schoettger, R. (1967) The acute toxicity of Kelthane to channel
catfish. Unpublished toxicity data. Columbia National Fisheries
Research Laboratory, Columbia, Missouri.
GS021049 Schoettger, R. (1966) The acute toxicity of Kelthane to bluegill sun-
fish. Unpublished toxicity data. Columbia National Fisheries
Research Laboratory, Columbia, Missouri.
GS021051 National Cancer Institute (1978) Dioassay of dicofol for possible
carcinogenic!ty. NCI Carcinogenicity Technical Report No. 90,
Washington, D.C. DREW (NIH) Publication No. 78-1340.
GS021052 Hill, E.F.; Heath, R.G.; Spann, J.W.; Williams, J.D. (1975)
Lethal dietary toxicities of environmental pollutants
to birds. U.S. Fish and Wildlife Service. Special Scientific
Report — Wildlife No. 191. Washington, D.C.
GS021055 Hill, E.F. (1976) The toxicity of Kelthane to Japanese quail.
Unpublished toxicity studies. Patuxent Wildlife Research
Center. U.S. Fish and Wildlife Service.
GS021060 Schoettger, R. (1966) The acute toxicity of Kelthane to stone-
fly. Unpublished toxicity data. Columbia National Fisheries
Research Laboratory, Columbia, Missouri. *
GS021062 Spehar, R.L.; Tanner, D.K.; Gibson, J.H. (1980) The effect of
Kelthane on early life stages of two species of aquatic
organisms. U.S. EPA. Environmental Research Laboratory,
Duluth, Minnesota.
GS021063 Spehar, R.L. (19??) The toxicity of Kelthane to fathead minnows.
Unpublished toxicity data. U.S. EPA. Environmental Research
Laboratory, Duluth, Minnesota.
-------
Other References
Balcomb, R. (1983a) Fish and Wildlife Hazards Associated with DOT. Unpublished
summary report prepared by U.S. Environmental Protection Agency, Office of
Pesticide Programs, Hazard Evaluation Division, Ecological Effects Branch.
Washington, D.C. October 19.
Balcomb, R. (1983b) Memorandum prepared for James M. Conlon, Deputy Office
Director of the Office of Pesticide Programs, dated Dec. 23, 1983.
[Acceptable DDTr Gomtamination Levels] (Prepared by U.S. Environmental
Protection Agency, Office of Pesticide Programs, Hazard Evaluation
Division, Ecological Effects Branch. Washington, D.C.
Devine, K. (1983) Estimated U.S. Annual Usage of Dicofol, 1980/1981. Un-
published report prepared by U.S. Environmental Protection Agency,
Office of Pesticide Programs, Benefits and Use Division, Economic
Analysis Branch. Washington, D.C. April 22.
Hitch, R.K.; Reinert, J.C. (1983) Exposure Simulation for DDTr in Fish of
the Arroyo Colorado Lower Rio Grande Basin, Texas. Unpublished report
with discussions of ambient levels and attachments concerning effect
levels, terrestrial exposure estimates and usage information. Prepared
by U.S. Environmental Protection Agency, Office of Pesticide Programs,
Hazard Evaluation Division, Exposure Assessment Branch. Washington,
D.C. April 5.
Luttner, M.A. (1981) Usage of Dicofol in California and the United States.
U.S. Environmental Protection Agency, Office of Pesticide Programs,
Benefits and Use Division, Economic Analysis Branch. Washington, D.C.
August 29. Unpublished.
Scheid, A. (1980) Preliminary Quantitative Usage Analysis of Dicofol.
U.S. Environmental Protection Agency, Office of Pesticide Programs,
Benefits and Use Division, Economic Analysis Branch. Washington, D.C.
August 29. Unpublished.
Sutherland, D.W.; Gross, W.L. (1983) Biological Data Base for a Current
Benefits Evaluation of Dicofol. Unpublished report prepared by the
U.S. Environmental Protection Agency, Office of Pesticide Programs,
Benefits and Use Division, Science Support Branch. Washington, D.C.
December.
Vlier, L.K. (1983) Current Benefits Review of Dicofol. Unpublished
report prepared by the U.S. Environmental Protection Agency, Office
of Pesticide Programs, Benefits and Use Division, Economic Analysis
Branch. Washington, D.C. December.
-------
APPENDIX II
-------
QMtf
No.
toansfy me following data
reauiremerra. The taso, and any required protocol*, will be sutminad to c?A by:
NAME OF QTHEFl aEGISTHANT
L_i 1 I andoa a completed "Certification of Attamprto Enter Into an Agreement with Other Registrants for Development of Data" vwtn
nspect to the following dao.requiraments
Q 4. I request that you amend my registration by dilating the. fallowing uses (this option is not available to applicants for new products):
C 5. I request voluntary eanoilation of the regjjtretion of rnis product. (This option is not avaiiaoie to applicann for new producaJ
fEGlSTSANTS AUTHORI2SD BEPHESSNTATIve
SIGNATURE
OATS
i Porai
US80.1 (KM2J
-------
APPENDIX III
-------
eo NAME
StGNATUfle.
OATS
-------
APPENDIX IV
-------
EPA Registration No.
PRODUCT SPECIFIC DATA REPORT
Guidance Document for_
Date
Registration
Guideline Mb.
§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
63-13
63-14
63-15
63-16
63-17
63-18
63-19
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
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID#
-
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
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
-
-------
APPENDIX V-l
-------
I 162.10
-cvcy. aitd safely of Ilio formulated
cucJ HUB product, may uui consider my
lint* as supporting the application.
except the following data:
II) The data (ho applicant IIM auu-
mltted la EPA under paragraph (b) of
fills section;
ia> Other ilulo pertaining to |lio
aafety ul the product's active Ingredi-
ents, rather Iliuu to the safety of the
end use product; unit
(3) Existing lolerancea. food additive
regulations, exemptions, and oilier
clearance* Issued under the Fedora)
Food. Drug, and Coumellu Ac|. ' >
(e) II the applicant know* that any
Item ol data he submitted under this
section was generated by (or ft the ex-
pcnsq of) another person who original-
jy submitted the duU |o EPA for It*
predecessor. II3DA) uii or alter Janu-
ary I. 10*10. to support an application
for registration, experimental use
penult, or amendment Adding ft new
nae to an existing registration, or fur
reregblratlon (unless ilia applicant
•nd the original data submitter |iavo
reached written agreement on the
amount and the forma of payment of
any compensation, that may bo pay-
able under FIFJIA ' seul|on
9<|>)
.•nd 8(cHJ)(l»;
Ok All Ideiillllcallon of the |lemU)
of data to which the offer applied;
44) An offer to commence negotia-
tions lo ascertain the •mount and
term* of compensation to bo paid; and
(ft) The applicant'* name, address,
•nd telephone number.
(f) If the applicant')! product con-
tains any active Ingredient other than
fltoso that are present soluly because
of the Incorporation Into the product.
ihirlng forntiilalioi}, of one Of more
other registered, peallcMe producU
purchased from •nalher producer.
iheii M" applicant s|ial| also comply
|HU 40— ff«|«cflon of
with | loan 6 M to mich active Ingredi-
ent. and the application shall contain
•n acknowledgment that for purpose*
of PIPIIA ueclluii 9(o)(|MO) tiie ai>n||.
cation rclleu tin (and any reuniting reg-
kitratlou ulionld bo regarded a« If ft
were baaed on the Adinlnbliator'a con-
tilde rut Ion of) the following data:
(|) All data •iibmltted or «peclllca||y
cited by tha applicant In aupport o|
(|ie reglutratlon; and
(3) Bach other Item of flata |i| tlio
lAgency'a (lien which;
(I) Concent* the properties or effect*
Af any «uch act)yp Ingredient; and. .
(II) In one of the tyi>e« of data, that
flPA, would require lo bo aubniltled for
•clentlflo review by KPA If the appll-
cunt nought the lnlM*| reglalrnllun
under PffTIA Section l(c)(6) of a
product with composition and Intend-
ed linen Identical to tltone proponed for
the appllcant'a product, under the
data requirement* In effect on the
date KPA approve* the applicant's
preaen|> application. ' '
Jdec*. I, •. anil ]» of Kir|lA. M anundui, 1
II.
labeling require wciilf.
(a) General -< I) Coiifenfi ej f/u
Intel. Every peatlclde produotn »|i*l|
bear • label containing tlio Informa-
tion upeclfled by the Ac| ami the regi«-
lutloim In lhl« Part. The pontenU of a
label iiiuut ahow clearly f»»d prom|-
pcntly the following:
(I) Tha name, brand, or Iredemaik
under which the product hj aold aa prp-
•crlbed In paragraph (b) of thli iec-
tlon;
(II) The name and addreua of lite
piodncur. regliilrant. or peraon for
tvhom produced u preacilMed li| para-
grapli (c) of thli aecllon;
(III) The net contenU M prescribed
In paragraph (d) of thl< aeetlon;
of this flection: '
(vlll) The directions for use as pre-
scribed In paragraph <» of IhU aec(lon;
and
(Ix) The use c|asslflr.at|on(fl) as pre-
scribed |n paragraph (J> of this section.)
(a) fiiimlnenca anil fepfoHtiy. (I) A|l
words, slatemenla. graphlu representa-
tions, designs or other Information re-
quired on the labeling by the Act or
the regulations |n this part must be
clearly legible to a person w|l|i norma)
Vision! and must be placed with *»c|»
conapjciiousuees (as compared will)
0.||ier words. statements, design*, or
gtaphlo matter oil the labeling) and
expressed hi such terms as to render ||
|lke|y lo be read and understood, by
Ihe ordinary Individual under custom-
ary conditions of purchase and. use.
Ill) All required label lexl must: \
(A) Da set |n d point or larger type;
(U) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded-
I)) ^anauage to be \netl. All required
label or labeling |ex(. shall appear hi
the dtgllsh language. However, the
Agency inay require or me applicant
juty propose additional text In other
languages as Is considered necessary |Q
protect Ihe public. When additional
(ext In another language Is necessary,
all labeling requirements will be ap-
plied equally to both Iho klug'ltdt and.
other |angntgo versions of |ho label-
ing.
(4) Placement A/ l.ao«J-(|) 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 flection, and the nils-
brand ;ig provisions ol tha Act. "se-
curely attached" shall mean that a
l»bel can reasonably be expected to
(emaln affixed during the foreseeable
conditions and period of use. If the Im-
mediate container Is enclosed within a.
wrapper or outside container through
which the label cannot be clearly read.
the |«be| must also ba securely at-
tached lo such outside wrapper or con-
tainer; If It hi a part of fhe package as
ciutomailly distributed or sold.
(II) 1'vitlf can and a//i«r bulk eon-
i) jTrtfiiipoi/udoii, While a
product U |u transit. ||ie ap-
propriate provisions of 40 CFIt I'wjls
110-100. concerning the transportation
of hazardous .materials, and apeclllcul-
ly those provisions concerning the .la-
beling, inaiking and placarding of haz-
ardous materials am) the vehicles car-
rying them, define Ihe basic Federal
requirements. In addition, when any
registered 'pesticide product Is liuns-
poiled In • (auk car. tank truck or
Other mobile'or poi table bulk contain-
er, a copy of the accepted label must
be attached to t|te sldpplng pupcia,
and left with the consignee ut Iho time
pf delivery.
(U) Storage, When pesticide prod-
ucts are stored hi bulk conlulnuia.
whether mobile or stationary, which
(email) In the custody of Ihe nuer. a
copy of the label of labeling. Including
•II appropriate directions for use. shall
be securely attached lo the container
In the Immediate vicinity of lliu dis-
charge control valve-
til) >V||jd or wlileatUng ttatcmenl*.
Pursuant to secllcm 2(q)(|NA) of the
Act. a pesticide or a device declared
subject to the Ai;| pursuant to 11*02.16.
|u mlsbranded If Us labeling Is lalse or
misleading In any particular Including
both pesllcldal and non pcstlcldul
claims. Examples of statements or rep
rcscnlallona In the labeling which con
•lllule ntlsbrandlug Include:
(|*i A false or misleading statement
concerning tha composition of Ihe
product;
(II) A false or misleading statement
concerning the effectiveness o| the
product ad a pesticide or device;
(III) A false or misleading fclalement
about the value of t|io product for
purposes other than as a pesticide or
device;
(Iv) A false or misleading comparison
with other pesticides or devices;
(V) Any statement dlieclly 01 hull
reclly Implying thai the pesllcldu or
device b recommended or endorsed by
any agency of the Federal Oovern-
meitl;
(vl) The name of a pcallclda 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
pomes of the other Ingredients are
aluled elsewhere In the labeling;
-------
thoue required on Iho front panel of
Ilia labeling mid thoae which may
appear eluewhcie. Clpeelflu reipilru-
ineiita concerning content, placement,
typo utee. and iiromjncnce are given
below.
(II Keaulred /rant panel •laJtuieiil*.
Wllh |he livccpllofi (tf !|io child
IMIa 40—f»o|ett|oo of fnvlianinait)
liutard warning alalemenl. Ihe text re-
quired on Ilia Iron! pane) ol the label
|ii determined by Iho faxlclty Calega-
ry ol lha peullclde. The category la aa-
algned on tha baala ol Ihe hlgheut
hazard ahown hy any of the Indicator*
|n lha Ublu below:
OullO..
iHUbfcMtG....,
OuwwIIO........
flow M Owi W» « I* *A4 lnU«l»a .1
I"***
-I-
(|) Human htuartl «l0nol word—(At
)\uii:nnul lha ntgniil word "Hanger." In ad-
dition If the product wu« Aaalgnud to
ToMlclty Culcgory 1 on the bavin of IU
orul. Inhulatlon or durinal toxldty (an
dlatlncl (runt ttkln and ayu local cf-
fcctttt the word "i'olaon" ahull ai)|»:ar
In rta on a background of dlalinclly
coiktraallng color and flic ukull ant)
tt ultull a|»|>^ar In liumedlale
to lha vuurd "po|uun."
4Ut roxluKy Vateouiv Ij. M\ pesti-
cide itrodiicla niucUug Ilia criteria of
Tovtclty Cutegory II ahall bear on t|k«
front panel the algna) wor4 "Warn-
ing." -»
(C) •fotlf.llv Cuteoorv flf. AU peatl-
clda prtuhicU meeting tba criteria of
Tonlclly Category 1(1 ultall hear oi>
Ihu front panel tha ulgnal word "Cau-
Hon."
(l» Toxtaltv Cuteoorv IV- All peall-
cldo projucla iituutlng tint criteria of
ToKlclly Ctttegory IV ahall bear on tbe
front panel the ulgnal ward "Caution."
I {bit l/je a/ »l|>nul uunlt. Uua of any
Itinal wprdttil aauoclhted w|th a higher
Ruliigory U not pei milled
except when tha Agency determine^
that auch labeling la neceaiiary lo pro-
venl |inr«aaonable adverue edcvU oi|
man or the environment. In no caao
ahall more than one human h*xkrf\clty categoiitt. The
atalempnt of practical treatment hi no!
required on the Iron! panel except aa
described In paragraph (htdHUIMAt of
!hla accllon. The applicant may, how-
ever, (ncludo auch a front pane) alate-
men! at hla option, fitalemenla o(
pracl|caj Irealmunt are. however, re-
quired elaewhere on t|io label In
accor4 wllh paragraph (liHat of |hbi
iec||p|) |f they do not appear on the
front panel.
(Ivl Placement flinf prominence. A\\
Ibo require front panel, wanting «Uta-
lltenlq ahall l>o groupeif together on
Ibe labe). and ahall appear with miffl-
cleiit proinlnenoo relative tp olher
(runt panel |ext and graphic mateilal
lo make then) unlikely lo be over-
|ouke4 un4er cualomary candllloiu) of
purchoae and nue. Tlte following table
ihuwii the mln|i|ium type a.Ue re'iulre-
Iticnta (or the iron! panel warnljig
i|alemenlj( oit varlouu alzea of labeb:
ul i«aut ol
110 tall.....
AlK»*|l k»M
II
M
I*
I*
U
mail, tt HUM e(
ClJklrM*
fltuU
(31 Other requited wanting* uutl vre-
cautionary ttateineutt. Tbe warnlnga
and precMtillonary alutemeuta an re-
quired below ahal| appear together on
the label under (he general heading
"Precautionary filalemenlu" and
under appropriate aiibheadlngii uf
"llaeard to Iliimana and Domestic Anl-
iiiultt." "ti'uvlronnieiilal Hazard" and
''I'hyulcal or Chemical Hazard."
j (I) //a«ard to human* «»<< ttoncillo
\anlmalt. (A> \Vhere f hazard exlsla la
. humana Of damevllc anhuula. precau-
tionary alatemenU are required hull
cutlug !|ie particular hazard. Ihe
rouleiat of exposure and the prccuu-
lluna |o ho taken lo avoid accident.
Injury or (Uunago. The' prccuulloiiury
paragraph ahall bo Immedlulely pri>-
teilcd by Ihe appropriate huzuid ulgual
word.
(Ut The following table deplcla typi-
cal precaiUlanary atalemenU. Thefiu
ataluiuciila nuial be modlfleil or ex-
i>ande<| !i|' sef led upecldc huzurila.
6Un uul «y* local *tna»
•Jil| IV> |U4
•Ui| Do «ul
t»t h »»«•. aa tUn. at M cluk
IHonl »tA<| tUlMMAI «l ptdlctl Icalmwil IW^M! I
Da AM |)4I In •>•». INI »thV Ui* »«jwi» |ik«l angiti*ltH Da nut
8*1 U •)••. wt UK w M tbltu |AJv«6j»l.U Arf *U
M*Uui*M«i*«*»i|)
I II 4»«4>«»4 |b4ul«l M »Ji*uitMk| HHU^I •>• AvaU cwilicl wU> >Ui, •«•> w iJullJna hi KM* al
AkiAl builiid vtpou lAitt m *AIU mtll A»aU cuni»d L.ui^-l..i^ t,,,), «^1( M til* »Wi |4<
-------
ilium t<> avoid potential acclden|..
ln|ury or damage. i!xample« o| the
hazard alttlemenla and (he c|rcum-
alancca under which they are required,
follow:
(4) || a. pcatlcldo Intended fur out-
door uae contain* an active Ingredient
with a mammalian acute ora| MX. at
Ida or lesa. M" alalcment 'T hit Veatl-
Clde la Toulo (u Wildlife" la requ|i-e<|. '
(ft) ll a peatlclde Intended far out-
door use conlalna an active Ingredient.
with a lluh aculo l.t).. o( 1 ppm ur |eaa.
Ihe uluicment "Tlilu )>ciitMda U Toxlo
|o Flali" U required.
If a. pcbtlelda Intended for out-
door uuu contains an active Ingredient
with an avlun acute pral 1JX. of 100
ing/kg or lean, or a aubacute dietary
I.O.. of 600 |i|)iii or |ea». tho atatcmeiil
'Tlilu Featlcldb in Tox|o la WIJclHfe" la
required.
hlli
ID) U either accident history or f|e|d
aludlus demonstrate that uao of tho
peatlcjde (nay result h| fatality to
Itlnla. tla|| or mammals, the statement
"Thla peatlclde U extremely tox|q to
wlldllf a (|lsltV N required.
(E) For l|ae« Involving foliar applica-
tion to agricultural cropa. foreata, or
phade treca. or (or mosquito abate-
ment treatments, pesticide* toxjc to
pollinating Insect* njuat hear approprf-
fkle label cautions.
'(F) For all outdoor uaea other than
aquatic applications the label must
bear the caution "Keep out of lake*.
ponda or streams. |)o not contaminate
Water by cleaning qf equipment or dlu-
poaal of wastes."
(Illl I'/iyiicul or chemical hayaidt.
Warning statement* on tho flaiumabll-
Ity or explosive characteristic Qf the
idutlclde are required 04lollowa:
Null IK*,! tl 4M U*M W fi I) f».
tJltf fc*l** OIHUilflA * H1*1**. •«»•«••••*• •**!•«•• *« ._ i—
M t'uuM** lu kfl^MokaM »Lovf OO' f Hxy •
fUJ. p44 «|HM* W f «i« nut «« l*/u« Du iwt kkwk>« to I
|4 tuiiy»l«k*«l «L<«W« IJO* f IMy A*IM* IHJIIIUiy
........ CulltMlU UkUl |u«l*««« Otl Itol !!«• M >tU(« |WM I»M| M 0|M4
IUIM Uo nui (x»».k«« u kKinK«l» cmililitM. £«yOM« ki U»
• «L •«•» torn *>M| «•! u(>«n (Unit.
o/ dlicclloiia. Olrccllona lor uae
iniut be utated In terms which can be
easily read and understood by the
average person likely |o uue or lo au-
pci vlae the uae of the peatlclde. When
followed, dlrectlona muat be adequate
to protect the public from fraud and
from peraonal ln|ury and lo prevent
unreasonable adverae effects on the
environment.
(lit fiuceitieiif tj t!Jr«c(Joni /or inc.
Directions may appear on any portion
of the label provided that they ai*
conuplcuotia enough to be caally rc«4
by I >e user of the peallclde proJucl
niiectlona for u«e may appear •»»
printed or graphic matter *hloh «
compunlea the lieal|elde provided |lnj-
4A) It rwinlred by the Agency. •»«•
printed or graphic matter ]•••««• »
of th* '««
<"'UllU
altached to each puckaga
clde. or Placed
wrapper or bag; •.
(IlV The label bear. »reler«»c.J
the dlrecllona for uae In accoi»i>» »» '«
leallcta or clrculara. auch M *• ,
recllona In the encloaed, circular. M'
t
10
(O) The Admtulatralor (|ii|ermlue«
that It \H not neceasary fqr «||c|t «1I' Ft«-'
l|ona to ap|)ea|* on \\\o }*\>t\. i
' (|||> Xicef>Ht>n» fa i«uu(r«i''li:it( /or
Dulalled dlrcctlona for uae. may
be oiitllled from the labeling of peat|-
clile produeU for which aale ta limited
to phyalclana. velerlnarlaiu. Pf drug-
llala. provided lhat:
U) The label clearly alatea that the
product la for uae only by phynlclane,
t>( veterlnarlana;
tilalle4 dlrectlona for uae may
be ontllleil from the labcll|tg of pcbtf-
Flile piuducla which are Intended for
UM only by luinttilittoia In preparing
vw'd 11"• ***" lo Ml* mllillc> |>ra"
U Information readily
|a ihu formulatara on the
ii. toxlulty. melitoda of uae
realrlc|lona or llmllatlona.
•put ulfeellvencaa of tliu product for
peatlclde put poacs;
<1) The |abu| cfearly Nlu.tea that the
product la IntcptM for uae only lu
fnanufacliu Ing. formulal|ug. mixing.
or repacking (or uae an a puallr.lde and
apcc|l|ea the type(sl of peallcldu prod
I ticls Involved;
' (ft The proi|i|ct as finally manufuc-
|urtd. forniuli>|ed. mixed, or repack-
aged U regla|erei|; and
(
-------
Environr
nazes
as required for tae cftlld hazard warn-
m* y*fAt^rtm asa>y be
applied intrfay th* ^i ••_• .««|p»^n-'qaii of* caole in i 1.
(2)
P^stldde products' besrln?
for usecsJ rfafatftinl reacrtesad.
besr statements of restxtesed Tiyt
«i-^««*gtqH on. t&e. fzonc r""H a-
xnbed beiowr
(13 front ymel rtatematt of i
CS.J At Uieupc
T?*TI*< of tiie labeLset in '
and ape
to otaer
Ennc1rlf1» maty
tna
onlr t» acpiled under
at a»cextuied an»
C0
bft orcriooKed. md general, usets;. bota
of taes* uses may appear on a. product.
labeled for restricted. USK. Sues prod-
^2X6* QVO^^JStOfl^C
July X 1373: 40 ?S 3S3».
Au«. i. 1373: 40 ?R 3S3T1. in«, 21. U7S, a .
.a* 43 ?a S734. A^ 3,1373]
at { ISSOOf JX23.
(13
for
be*
beied wttn sne ggacs worts- "C*aerai_
-Qtreetions for
- or iaoilfti tiac. cne sen-
etai utllit? of cne- gestltnrie- extends
-------
APPENDIX V-2
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LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (REFER TO THE SAMPLE LABELS FOLLOWING)
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Est. No.
EPA Reg. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning )
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked .
Note type size requirements.
Note type size requirements.
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ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
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ITEM
8C
9A
9C
IDA
IOC
10D
U.S.
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
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
In the
directions
for use
In the
directions
for use
None
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 be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
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PRODUCT
NAME
KEEP QurOF REACH Of OHLCPBI
PRODUCT
NAME
aeatrictad Oge pggtla
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APPENDIX V-3
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PHYSICAL-CHEMICAL HAZARDS
Criteria
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 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
.B. Flashpoint above 20°F
and over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
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APPENDIX V-4
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STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
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 8 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.
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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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"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law- If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility." :vJ£, «.-
3. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap-.original
container in several layers of newspaper and discard in
trash."
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 Type
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
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill^ or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
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Container Type
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 may replace this phrase with one indicating whether
and how fiber drum may be reused.
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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Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
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
Methorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
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"Acutely Hazardous" Commercial,;Pesticides (RCRA "E" List)
Active Ingredients continued:
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium 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).
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"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-ra-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c ,d]-pentalen-2-one
(kepone, chlordecone)
l,2-Dibrorao-3-chloropropane (DBCP) •
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12®)
3,5-Dichloro-N-(1,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyaceticf 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
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"Toxic" Commercial Pesticide Products (RCRA. "F" List)
Active Ingredients:
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl 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
Pentachlbroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1-, 2,4,5-Te trachlorobenzene
1,1,2,2-Tetrachloroethane
-Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene ; .
Trichloromonofluoromethane (Freon 11 )
•2,4,5-Trichlorophenol
2r.4,6-Tri"chlorophenol
2,4,5*Trichlorophenoxyacetic acid (2,4,5-T)
Xyle'ne
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