PB84-210335
Guidance for the Reregistration of
Manufacturing-Use and Certain End-Use
Pesticide Products Containing Terbufos as the'
Active In9redient
(U.S.) Environmental Protection Agency
Washington, DC
Jun S3
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GUIDANCE FOR THE REREGISTRATION OF
MANUFACTURING-USE AND CERTAIN END-USE
PESTICIDE PRODUCTS CONTAINING TERBUFOS AS
AS THE ACTIVE INGREDIENT
June 1983
EPA-540/RS-83-011
Office of Pesticides and Toxic Substances
Environmental Protection Agency
401 M. St. SW
Washington, DC 20460
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4. THmri
idance for Reregistration of
Pesticide\prooucts Containing TERBUFOS
As the Active Ingredient ^
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Washington, DC 20460
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v This document contains information regarding reregistration of
pesticide products containing the subject active ingredient. The
document includes how to register under a registration standard,
regulatory position and rationale, arid summaries of data requirement ;
and data gaps. Also included is a bibliography containing citations
of all studies reviewed by EPA in arriving at the positions and
conclusions contained in the standard.
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Table of Contents
Section Page
I
I. Introduction 1
II. Regulatory Position and Rationale 3
III. Requirement for Submission of Generic Data 20
IV. Requirement for Submission of Product-Specific
Data 49
V. Submission of Revised Labeling and Packaging
Information 50
A. Label Contents 50
1. Product Name 50
2. Company Name and Address 50
3. Net Contents 51
4. Product Registration Number 51
5. Producing Establishment
Registration Number 51
6A Ingredient Statement 51
6B Pounds Per Gallon Statement 51
7. Front Panel Precautionary Statements 51
7A Child Hazard Warning Statements 52
7B Signal Word 52
7C Skull and Crossbones and Word Poison ...... 52
7D Statement of Practical Treatment 52
7E Referral Statement 52
8. Side/Back Panel Precautionary Labeling 52
8A Hazard to Humans and Domestic Animals 53
8B Environmental Hazard 53
8C Physical or Chemical Hazard 53
9 Misuse Statement >.54
10A Storage and Disposal Block 54
10B Directions for Use 54
B. Collateral Information 54
VI. Instructions for Submission 55
i-a.
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APPENDICES
III-l Bibliography 56
III—2 FIFRA 53(C)(2)(B) Summary Sheet 70
III-3 Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data. ... 71
IV-1 Product Specific Data Report (End-Use Products) ... 72
V-2 Table of Labeling Requirements 74
V-3 Physical/Chemical Hazards Labeling Statement 78
V-5 Storage and Disposal Instructions .... 79
Note: Appendices V-l, V-4, and V-6 are not germane to this
document and are not included.
ii
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I. INTRODUCTION
The Federal Insecticidef Fungicide, and Rodenticide Act
(FIFRA) Section 3(g), as amended in 1978, directs the Environ-
mental Protection Agency (EPA) to reregister all currently
registered products as expeditiously as possible. Each regis-
trant of a currently registered product who wishes to continue
to sell or distribute that product in commerce must apply
for reregistration.
This guidance document sets forth certain of the require-
ments for registcation and reregistration of all manufac-
turing-use products (MPs) containing the subject chemical as
the sole active ingredient. These requirements include:
that certain scientific data be submitted and that certain
standards of toxicity, composition, labeling, and packaging
be met. Registrants of MPs are referred to all Sections and
Tables for specific information regarding their responsibili-
ties under this guidance document.
This guidance document also sets forth the data require-
ments for those end-use products which contain the subject
active ingredient and for which the source of that active
ingredient is (1) not registered with EPA or (2) produced by
the registrant's firm, or a firm which has ownership in
common with the registrant's firm, or (3) both (1) and (2).
Registrants of such end-use products can exempt themselves
from these requirements if thoy change their source of supply
to a registered source, provided the source (i.e., registered
active ingredient product) is obtained from a firm that does
not share ownership in common with the registrant's firm.
(If the end-use product registrant decides to switch sources,
a new confidential statement of formula, EPA Form 8570-4,
must be submitted to the appropriate Product Manager within
90 days of receipt of this guidance document.) RegV.strar.ts
of affected end-use products are referred to only Sections
II, III, and VI and Table A '.or specific information regarding
their responsibilities under this guidance document.
It should be noted that end-use products containing the
subject active ingredient will not be reregistered at this
time. Any necessary labeling changes will be implemented
under the Agency's Label Improvement Program at a future
time.
EPA will issue a notice of intent to cancel or suspend
the registration of any currently registered product if the
registrant fails to comply with the requirements set forth
in this guidance document and with the requirements contained
in subsequent information from EPA about compliance with
certain data support requirements.
1
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This guidance document has been prepared to provide regis-
trants with specific information on how they may reregister
their manufacturing-use products or maintain t.heir end-use
products' registration. (Refer to the cover letter's attach-
ment for a listing of your affected products-) If for any
reason you decide to request that the Agency discontinue the
registration of any of your products subject to the registra-
tion requirements in this 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
registrations), you must provide the information described
in the following pages within the timeframes outlined.
Registrants are reminded that Section 6(a)(2) of FIFRA
requires you at any time to submit factual information raising
concerns of possible unreasonable adverse effects of a pesti-
cide. You should notify the Agency of interim results of
studies in progress if those results show possible adverse
effects.
This guidance document, will be supplemented by EPA with
additional information about compliance with data support
requirements. In Monsanto v. Administrator, EPA was recently
enjoined by the District Court for the Eastern District of
Missouri from implementing in any way the "mandatory data
licensing" aspects of §3(c)(l)(D) of FIFRA. EPA is assessing
the implications of the injunction for the reregistration
process. Because this situation is currently unresolved,
EPA has decided to proceed with the requirements in this
guidance package which do not relate to the "data licensing"
issue and to supplement the package with additional guidance
when circumstances permit.
2
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II. REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
This Registration Standard describes the regulatory position
of the Environmental Protection Agency (EPA) on manufacturing
use products (MPs) containing the insecticide-nematicide
terbufos. The Agency's position is based on an evaluation
of all registered uses and registered MPs with terbufos as
the sole active ingredient. There are no products registered
that contain terbufos in a mixture with other active ingredients.
This position is based on a number of considerations. Foremost
among these is an analysis of terbufos data based on the risk
criteria found in Section 162.11(a) of Title 40 of the U.S.
Code of Federal Regulations. The Standard also considers
labeling requirements, tolerances, "Special Local Needs"
registrations authorized by Section 24(c) of the FIFRA as
well as federal registrations granted under Section 3 of the
FIFRA. Finally, the Agency sets forth the data requirements
that must be met to register or reregister products covered
by the Standard.
This Standard only addresses registration requirements for
current or substantially similar future MPs and their inter-
mediaries. Terbufos MPs that differ appreciably from those
described here may require amendments to the Standard.
Additionally, use patterns which differ from those described
here may also require amendments to the Standard.
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B. USE PROFILE
Terbufos is the acceptable common name for S-l[(1,1-dimethyl-
t
ethyl)thio] methyl]0,0-diethyl pho3phorodithioate recognized
by the American National Standards Institute, British Standards
Institution, New Zealand and International Organization for
Standardization. Trade names and other names for terbufos
are: Counter8, CL 92100, AC 92100, ENT 97920, and ST 100.
American Cyanaraid Company, Agricultural Division is currently
the sole manufacturer of the technical produc* a'td foraulator
of granular end-use products in the U.S.A.
Terbufos, an organophosphate chemical, is principally used as
an insecticide for corn rootwoms on corn and is applied as
a soil incorporated product at planting and at post-emergence.
Other uses include use as a nematocide for lesion, spiral,
stunt, sting,- stubby-root and dagger nematodes on corn; and
as an insecticide for greenbugs on grain sorghum, sugarbeet
root maggot on sugarbeets, and seedcorn maggots, symphylans,
wireworms, maize billbug, southern corn billbug and reduction
of white grubs on corn.
There are two federal registrations for products containing
terbufos: one, an MP containing 85.0% terbufos, the other, an
end-use granular product containing 15.0ft. There are several
Special Local Need Registrations which were issued for 15%
granular products.
4
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C. REGULATORY POSITION
Based on a review and evaluation of available data and other
relevant information on the chemical, the Environmental
Protection Agency has made the following determinations
regarding terbufosx
1. Manufacturing - use pesticide products containing
terbufos as a sole active ingredient or mixed with
other active ingredients may be registered for sale#
distribution, and use, subject to the terns and
conditions specified in this Standard.
2. Based on available data, the Agency has determined
that terbufos has not been demonstrated to cause
unreasonable adverse effects in man when used in
accordance with prescribed label directions and pre-
cautions.
However, the safety of this chemical cannot be ade-
quately addressed at the present time due to extensive
data gaps.
3. The review has identified potential environmental
concerns. Results of available laboratory studies
indicate a very high acute toxicity to fish and aquatic
invertebrates. The SWRRB* and EXAMS** models predict
* SWRRB is a hydrology model combined with a pesticide runoff model.
** EXAMS is a hydrologic model to predict "steady-state" and "pulse-
load" behavior of organic toxicants in aquatic ecosystems.
5
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aquatic concentrations of terbufos in excess of the
LC50 for aquatic organisms. In order to determine
whether significant evidence relating to aqustic
organisms would raise prudent concerns of unreasonable
tdversfe risk to the environment, the Agency is re-
quiring further monitoring of water, sediment, and
fish; in ponds adjacent to treated fields. The
Agency will also conduct additional modoling utilizing
various parameters. Once the Agency has evaluated
these additional data, it will determine whether the
Agency should initiate a public interim review process
by placing the chemical in special review. If,
instead, regulation of the chemical through the
normal registration process is found to be appropriate,
the Agency will update its regulatory position and
rationale to reflect this conclusion and the reasoning
behind it.
A May 19, 1983 Biological Opinion from the Office of
Endangered Species (CES), Fish and Wildlife Service,
U.S. Department of Interior, predicted that the
use of terbufos on corn is ..likely to jeopardize
the continued existence ..." of a variety of
federally-listed endangered/threatened species.
These species include three species of birds, two
species of fish, twelve aquatic invertebrate species
end two insect species. Consultation for an opinion
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from OES has recently been initiated for use on
sorghum; and consultation for sugar beets may be
initiated, if. it is deemed necessary. Labeling and/or
other alternatives, as appropriate will be prescribed
by the Agency based on the biological opinions received
from OBS for the use of terbufos on corn, sorghum and
sugar beets.
5* Based on available information, there appears to be c
potential for substantial hazard to terrestrial organisms
from the use of terbufos as described in this Standard.
This is baattd on the availability of granules to wild-
life at and below the soil surface, the high to very high
acute toxicity of terbufos to terrestrial organisms,
and the record of field kills with other granular
products of similar toxicity. Additional avian and
mammalian testing including actual field testing are
needed to fully assess this hazard potential.
6. Registrants must provide or agree to develop additional
data, as specified in Tables A and B located in
Chapter IV of this document, in order to maintain
existing registrations or to permit new terbufos
registrations.
7. Tolerance reassessment is normally a part of the Regis-
tration Standard review process. Because essential
toxicology 'lata are not available, the Agency is unable
7
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to complete its reassessment of terbufos tolerances.
Specifically, due to the extensive data gaps the Agency
is unable to establish a valid "No Observable Effect
Level" (NOEL) or determine an Acceptable Daily Intake
(AOI) for terbufos.
The tolerances listed under 40 CFR 180.352 for terbufos
are currently set for " combined residues of the
insecticide terbufos.....and its cholinesterase-
inhibiting metabolites This wording will be
revised to read " phosphorylated (cholinesterase-
inhibiting) metabolites ¦ as specified in Section H.
8. On August 1, 1979, a notice was published in the Pederal
Register (44 PR 45219) of a proposal to amend 40 CFR
162.31 by assigning the granular formulations of
several pesticide chemicals a restricted use classi-
fication under the optional classification by regulation
procedures pursuant to 40 CFR 162.30. On August 7, 1979
(44 PR 46303) this notice was corrected to include
granular formulations of terbufos, on the basis of
acute oral, and dermal toxicity and residue effects on
avian speciea. A final classification determination
of the end-use formulations containing terbufos will
be made by the Agency pursuant to these optional
classification by regulation procedures.
8
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D. REGULATORY RATIONALE
Terbufos, a cholinesterase-inhibiting chemical has a high
acute toxicity to humans. The available acute studies in-
dicate that the chemical is in Toxicity Category I for both
the oral and dermal routes of exposure. The acute inhalation
toxicity remains to be determined pending receipt and review
of the requested rat LC50 inhalation testing.
Tho Agency has determined that it should continue to allow
registration of terbufos for the following reasons:
1. The stringent label warning statements reflecting the
high acute toxicity to humans which include directions
for use of protective clothing including gloves*
goggle8, and a mask or respirator will minimize the
acute hazards to users of the manufacturing use product
associated with the oral, dermal, inhalation and ocular
routes of exposure. The registered manufacturing use
product described in this Standard, a liquid product,
bears such stringent warning statements.
The granular composition of the end-use product as de-
scribed in this Standard together with the recommended
stringent label precautions which include the use of
gloves, goggles, and protective clothing, will minimize
the acute hazards to loader/ applicators through the
oral, dermal and ocular routes of exposure. Due to
the size of the granulars and the method of application
9
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(soil incorporation), exposure through inhalation
from use of the end-use product i3 not expected. The
end-use product for terbufos as described in this
• Standard is intended for outdoorf nondomestic use
only, and bears the label restriction, "not for use
or storage in or around the home".
Because the end-use product is of a granular composition,
and because the current registered use patterns require
soil incorporation, there is little potential for
worker re-entry exposure. Consequently, no re-entry
data are required to support current registered uses
described in this Standard and no re-entry interval as
defined in 40 CPR 170.2 of Part 170, Worker Protection
Standards for Agricultural Pesticides would be required
for these current uses.
2. Based on available data, terbufos is not expected to
leach into ground water.
3. Terbufos was first registered in 1974 for use in corn
fields to control com rootworas. The Pesticide
Incident Monitoring System (PIMS) records through
June, 1981, include 31 reports involving terbufos, of
which 19 involved terbufos alone. Of these 19 tncidents,
9 involved humans; 8 involved domestic livestock and 2
involved wildlife. No human fatalities resulted. In
those human exposure incidents which were reported
with some detail, it appears that carelessness or
10
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negligence were important factors. In two of these
incidents, the granular pesticide was reported to
have been handled with bare hands during loading and
application procedures.
In those instances involving livestock, one resulted
in the death of about 600 cattle, another in the
death of 127 cattle. The accidental contamination of
livestock feed was reported as the cause in these
incidents. The two wildlife instances involved fish
kills which were reportedly due to runoff froa treated
fields. Only one included analysis of the water samples.
Though the sampling agency was unable to test for
terbufos, no evidence of organophosphorous compounds
was found in the sampled water.
Carelessneoa and/or negligence appear to have been
important factors in most incidents. Strict adherence
to proper storage and application techniques as pre-
scribed in the label directions and precautions will
minimize the risk of potential adverse effects to
humans and domestic animals.
4. It is not the Agency's policy to cancel or to withhold
registration merely because data are missirg or inade-
quate [see FIFRA Sections 3(c)(2)(B) and 3(c)(7)].
Rather, publication of this Standard provides a mechanism
for identifying data needs, and registration of terbufos
under this standard allows for the upgrading of labels
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during the period in which the required data are being
developed. These data will be reviewed and evaluated
tfhen they are received and the agency will determine,
at that time whether they will affect the registration(s)
of terbufos.
B. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
To be covered by this Standard, products must*
• Contain terbufos as the sole active ingredient or in combination
with other active ingredients in a mixture,
* Bear required labeling, and
° Conform to the acute toxicity limits, product compo-
sition, and use pattern requirements listed in
Section P of this Standard.
The applicant for registration or reregistration of products
subject to this standard must comply with all terms and
conditions described in it. That Includes making a commitment
to fill data gaps on a schedule agreed to by both this agency
and the applicant. Applicants for registration under this
Standard must follow the instructions contained in this
guidance package and complete and submit the appropriate
forms within the time specified.
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F. ACCEPTABLE RANGES AND LIMITS
1. Product Composition
To be covered under this Standard, technical grade
products must contain at least 85 percent terbufos
as the sole active ingredient. Each manufacturing
use product formulation proposed for registration
must be fully described with appropriate certifi-
cation of limits.
2. Acute Toxicity Limits
The Agency will consider registration of technical
grade and manufacturing-use products containing
terbufos for acute Toxicity Category I,II,III, or IV
provided that the labeling of these products bears
appropriate precautionary statements.
3. Use Patterns
To be registered under this Standard manufacturing
use products containing terbufos may De labeled for
formulation only into end-use products for outdoor,
non-domestic use on corn (field, sweet or pop), sugar
beets or grain sorghum.
End-use products formulated from products registered
under this Standard must be granular formulations
for ground incorparated application.- Other formulation
13
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types or other methods of application may require
amendments to this Standard.
G. REQUIRED LABELING:
All technical grade, manufacturing - use, and end-use products
containing terbu£os must bear appropriate labeling as specified
in 40 CFR 162.10. Other portions of the guidance package con-
tain specific information regarding label requirements. Both
the currently registered manufacturing-use and end-use products
are in Toxicity Category I and, as such must bear appropriate
precautionary labeling as designated in 162.10 for this high
toxicity category including the »ord Poison (in red) and
the skull and crossbones. Statements instructing use of
protective clothing, including gloves and goggles, must also
appear on all labeling.
1. Manufacturing-Use
In addition to the labeling as described above, the
labels of all manufacturing-use products must contain
the following statements:*
* "Hear protective clothing, rubber gloves and goggles."
° "Hear a pesticide respirator jointly approved by the
Mining Enforcement and Safety Administration (formerly
the U.S. Bureau of Mines) and by the National Institute
•It should be noted that the labeling for the current registered
MP already contains the required Category I labeling as well as
the protective clothing, rubber gloves, goggles and respirator
statements.
14
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for Occupational Safety and Health under the provision
of. 30 CFR Part 11 for organic phosphate protection.
° "For formulation into end-u«a insecticide products
intended for non-domestic outdoor terrestrial use
on (crops to be specified)".
° "This pesticide is toxic to fish and wildlife. Do
not discharge into lakes, streams, ponds, or public
waters unless in accordance with an NPDES permit.
For guidance contact your Regional Office of the
Environmental Protection Agency".
2. End-Use Products
Though this Standard does not address registration/
reregistration requirements for end-use products, the
following labeling recommendations are being made at
this time based on current use patterr.s and based on
review of available data. Additional labeling state-
ments may be needed upon receipt and evaluation of the
data requested in this Standard.
In addition to the Toxicity Category I labeling as
designated in 40 CFR 162.10, the labels must contain
the statements:*
° "Hear protective clothing, gloves and goggles."
•it should be noted that, with the exception of the recommendation
to wear goggles, these statements, or similar wording already
appear on the current registered labeling along with the required
Toxicity Category I labeling.
15
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• "Not for use or storage in or around the home."
* "This pesticide is toxic to fish and wildlife.
Treated granules exposed on soil surface nay be
hazardous to birds and other wildlife. Do not
apply directly to water or wetlands. Runoff
from treated areas may be hazardous to aquatic
organisms in neighboring areas. Do not con-
taminate water by cleaning of equipment or
disposal of wastes. Cover or incorporate granules
that are spilled."
Appropriate labeling, if necessary will be prescribed by the
Agency based on the biological opinions received from the
Office of Endangered Species, U.S. Fish and Wildlife Service.
16
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H. TOLERANCE REASSESSMENT
Tolerances have been established for corn, sugar beets and
grain sorghum under 40 CFR 180.352. There are currently no
food or feed additive tolerances and it has been determined
that none are required for food and/or feed byproducts of
these commodities. Canada has established tolerances on
sugar beets and corn on a negligible residue basis, i.e.,
at less than 0.1 ppm in human food. There are no Mexican
tolerances or Codex Maximum Residue Limits for these crops.
Refer to the tolerance summary table at the end of this
section.
Based on available data, it has been determined that the
establishment of a crop group tolerance is not appropriate,
at any level, for the crop groupings to which these crops
belong, i.e., root and tuber vegetable group (sugar beets),
and cereal grains group (corn and sorghum).
There are no tolerances for meat, milk, poultry and eggs,
and none are required to support the current established
tolerances on sugar beets, corn and sorghum. There is no
reasonable expectation of finite residues occuring in these
foods from feed use of these raw agricultural commodities
including their processing byproducts. Requests for new
livestock feed crops, however, may require tolerances for
meat, milk, poultry and eggs.
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The established tolerances for terbufos are presently ex-
pressed in terms of terbufos and its cholinesterase-
inhibiting metabolites without specifying the latter as
phosphorylated metabolites. The Agency will proceed towards
revising 40 CPR 180.352 by changing the wording to read
"... ..terbufos.... .and its ph-.^phorylated {cholinesterase-
inhibiting) metabolites:
• Phosphorothioic acid, ^-{t_-butyl-thio) methyl 0,0-
diethyl ester.
• Phosphorothioic acid, S-(t-buty1-suIfiny1) methyl
0,0-diethyl ester.
• Phosphorothioic acid, S-(t-butyl-sulfonyl) methyl
0,0-diethyl ester.
• Phosphorodithioic acid, S-(t-butyl-sulfinyl) methyl
0,0-diethyl ester.
• Phosphorodithioic acid, S-(t-butyl-suifonyl) methyl
0,<>~diethyl ester."
Reassessment of the established terbufos tolerances must await
receipt and evaluation of the pertinent toxicolcgical studies
as requested on the accompanying Tables A and B. Available
chronic toxicity studies are only supplementary data and thus
may not be used as a basis for tolerance assessment. Con~
sequently, a "No Observable Effect Level" (NOEL) cannot be
established at the present time, hence a maximum permissible
intake (HPI) cannot be calculated.
18
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Summary of present tolerances for terbufos.
Canada
Mexico
Codex
o.s
Beets,
sugar, roots
0.1*
-
-
0.05
Beets,
sugar, tops
0.1*
-
-
0.10
Corn,
field, fodder
0.1*
-
-
0.5
Corn,
field, forage
0.1*
-
-
0.5
Corn,
pop, fodder
0.1*
-
-
0.5
Corn,
pop, forage
0.1*
-
-
0.5
Corn,
grain
0.1*
-
0.05
Com,
sweet (K+CWHR)
0.1*
-
-
0.05
Corn,
sweet, forage
0.1*
-
0.5
Corn,
sweet, fodder
0.1*
-
-
0.5
Sorghum, fodder
-
-
-
0.5
Sorghum, forage
-
-
¦ -
in
•
o
Sorghum, grain
-
mm
-
0.05
•Negligible residue basis, i.e., at less than 0.1 ppm in human food.
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III. 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 III-l) 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 1/Must Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this section. 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 submitted and any
necessary studies must be conducted in accordance with
EPA-approved protocols, the Pesticide Registration
Guidelines 2J, or data collected under the approved
protocols of the Organization for Economic Cooperation
and Development (OECD). If you wish not to develop data
which are necessary to support the regiptration or
reregistration of certain uses appearing in your labeling,
you may delete those uses at the time you submit your
revised labeling.
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
1/ Generic data pertain to tha ptoperties 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/ The Pesticide Registration Guidelines were reproposed on
November 24, 3.982 in 47 Federal Register 53192.
Oft
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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
formulaeion" daia should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Section IV of '.his 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 "PIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
111-2} 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 111-3)^/
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.)
*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
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.
(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. (This
option is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
CPA 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 ths 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 nay
submit a request for an extension of time. The extension
request oust be submitted in writing to the Product
Manager. The extension request should state the reasons
why you conclude tnat 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)
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 f'IFRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terrr.3 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.
22
-------
TABLE A
GENERIC DATA RBQUIR&IENTS FOR TERBUPOS
Data Requitranant
Composition
y
Does EPA Have Data
To Satisfy This
Requirement? (Yea,
No or Partially)
Must Additional
Data Be Submitted
Bibliographic 5/ Under FIFRA Section
Citation 3(c)(2HB)?2/
$158.120 Product Chemistry
Product Identltyt
61-2 - Statement of exposition
61-3 - Discussion of Formation of
Ingredients
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
TGAI
TGAI
TGAI
TGAI
TCAI
TGAI
TGAI
TCAI
Partial
Yes
Yes
Yea
Yes
Yes
Yes
Partial
Yes
00085161*
00069499* 4/
00085160* 4/
00087711* J/
00040389*
00040385*
00040385*
00040385*
00040385*
00040385*
00036234*
00040385*
Yes 3/
NO
No
No
No
No
No
Yea 7/
No
* Data submitted by American Cyananid*
These data may be ccmpsnsable.
23
-------
TABLE A
GENERIC DATA REOUIREMOJTS FOR TERB3JTOS
Data Requironont
Does EPA Have Data
To Satisfy This
1/ Requirement? (Yea,
Composition No or Partially)
S158.120 Product Chemistry (continued)
63- 8 - Solubility TGAI OR PAI
63- 9 - Vapor Pressure TGAI OR PAI
63-10 - Dissociation constant TGAI OR PAI
63-11 - Octanol/water partition PAI
coefficient
63-12 - pH TGAI
63-13 - Stability TGAI
Other Requirements:
64- 1 - submittal of sanples Choice
Partial
Partial
Not Applicable
No
No
Yes
Must Additional
Data Be Submitted
Bibliographic 5/ Under FIFRA Section
Citation 3(c)(2)(B)?2/
00040385*
00040385*
00087716*
Yes 6/
Yes 1/
Yes
Yes
No
No 8/
* Data submitted by American Cyanaraid. These data may be condensable.
24
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 1ERBUP0S
5158.120 Product Chemistry (continued)
1/ composition: TGAI « Technical grade of the active ingredient; PAI = Pure active ingredient; Choice = Choice
several test substances determined on a case-by^-case basis.
2/ Data must be submitted no later than December, 1983 .
3/ Further information is needed on the ccnpoaition oC starting materials.
y Any ono of these citations ara adequate to meet this data requirement.
5/ These data citations pertain to the technical terbufos currently registered under EPA Reg. No. 241-241 and
may not be applicable to technical terbufos material which differs from that described herein.
6/ Solubility in quantitative terms for solvents other than water is needed.
Jj Clarification is needed on the substance tested.
8/ May be requested on a case-by-case basis.
25
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUPOS
Data Requirements
CcTi-osltion
y
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
5158.125 Residue Ctranistry
171-4 - Nature of Residue (Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical Method
- Plant residues
- Animal residues
171-4 - Storage Stability Data
PAIRA
PAIRA and plant
metabolites
Pure Analytical
Standard and
metabolites
Pure Analytical
Standard and
metabolites
PAI
Yes 3/
Yes 3/
Yes 3/
Yes 3/
Yes
00069512*;
00087689* ;
000876B8*;
00087686*;
00087691*;
00036123*;
00038210*;
00087692*;
00079429*;
00062871*
00087695*; 00032636*;
00036241*
00036246*;
00042022*;
00079431*;
00042020*;
00049235*;
00032646*;
00036127*;
00062872*;
00088211*;
00087687*
00036242*; 00036241*;
00087702*; 00087704*;
00042021*
No
No 4/
No
No 4/
No
* Data submitted by American Cyanamid Company. These date may be compensable.
-------
TABLE A
GENERIC DATA REQU1REMENIS FOR TERBUFOS
Data Requirements
Composition
1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
S150.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residua-
Residue Studies for Each
Food Use
0 Sugar beets
- Crop field trials
° Sugar beet roots
and tops
- Processed Food/Feed
0 Sugar beet pulp
° Sugar beet sugar
•Corn
- Crop field trials
° Com grain, forage,
fodder
- Processed food/feed
° Corn meal, corn oil
TEP
EP
EP
EP
EP
Yes
Yes
Yes y
Yes y
No
00036124*
00036129*
00036129*
00036123*
00037722*» 00042017*1
00042019*; 00039018*;
GS0109001*
No
No
No
No
NO 5/
" Data submitted by American Cyanamid Catipany. These data may be compensable.
27
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTOS
Data Rrxwirement
Composition
1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRa Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
° Sorghum
- Crop field trials
0 Sorghum grain, forage,
fodder
- Processed rood/Feed
° Sorghvan flour and
milled products
• Sorghum syrup
- Potable Water
- Fish
- Irrigated Crops
— Field trials
— Processed Food/teed
- Food Handling
- Meat/milk/poultry/eggs
TEP
EP
EP
EP
EP
EP
EP
EP
EP
1GAI or plant
metabolites
Yes
No
No
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Yes 3/
00079431*
No
No 5/
No 6/
00032636*» 00032641*;
00087702*
No 4/
"Data submitted by American Cyanamid. These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUPOS
$158.125 Residue Chemistry (continued)
1/ Canpositiom TGAI ™ Technical grade of the active ingredient; PAIRA ° Pure active ingredient, radiolabelled; TEP *»
Typical end-use product; EP ¦= End-use product.
2/ Data must be submitted no later than June, 1986
3/ All of the data cited are needed to satisfy this data requirenent.
4/ These data f»*-e sufficient to support current established and pending crop tolerances, i.e., corn, sugar beets,
sorghum, soybean, cabbage, broccoli, and cauliflower. Additional studies may be required to support new livestock
feed crop3.
5/ There is no reasonable expectation that detectable residues will be found.
6/ These data are not required to support the current established tolerance on grain sorghun (which does not include
sweet sorghum).
29
-------
TABLE A "
GENERIC DATA REQUIREMENTS TOR TERBUFOS
Data Requirement
y
Composition
Use 2/
Pattern
Does EPA Have Data
Tt> Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB 1
161-1 - Hydrolysis
TGAI or PAIRA
A
Yes
00087694*
No
Photodeqradat ion
161-2 - In water
TGAI or PAIRA
A
Partial
00087694*
Yes 5/
161-3 - On soil
TGAI or PAIRA
-
No
-
No 6/
161-4 - In Air
TGAI or PAIRA
A
No
-
No 14/
METABOLISM STUDIES-IABt
162-1 - Aerobic Soil
TGAI or PAIRA
A
Yes
00087690*
No
162-2 - Anaerobic Soil
TGAI or PAIRA
A
Yes
00087690*
No
162-3 - Anaerobic Aquatic
TGAI or PAIR*
-
No
-
No 7/
162-4 - Aerobic Aquatic
TGAI or PAIRA
-
No
-
No 8/
MOBILITY STUDIES:
163-1 - Leaching and
Adsorpt ion/D9sorption
TGAI or PAIRA
A
Yes
00087693*
No
163-2 - Volatility (Lab)
TEP
A
NO
-
Yes
163-3 - Volatility (Field)
TEP
A
NO
Reserved 4/
* Data submitted by American Cyanamid. These data may be
cooen&able.
30
-------
table; a
GENERIC DATA REQUIREMENTS FOR TERBUPOS
Data Requirement
1/ Use 2/
Conposition Pattern
Does EPA Have Data
To Satisfy Ttiis
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c?(2)(B)?3/
S153.130 Envirormtental Fate
(continu&i)
DISSIPATION STUDIES-FIE LP I
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
.(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Organisms
MONITORING STUDIES
- Soil, and water,
sediment and fish
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TCAI or PAIRA
TEP
TEP
Yes 13/
No
No
No
No
Yes
No
No
Yes
No
No
00087708*; 00087706*
00087692*
00085184*
No
NO 8/
No 9/
No 10/
No 11/
NO
Yes
NO 12/
NO
No 7/
Yes 15/
• Data submitted by American Cyanamid. These data may be compensable!
31
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUFOS
S158.130 Environmental Fate (continued) '
1/ Composition: TGAI = Technical grade of the active ingredient} PAIRA » Pure active ingredient, radiolabelled;
TEP ° typical end-use product.
2/ The use patterns are coded as follows: A^Tferrestrial, Food Crop; B^Terrestrial, Non-FOod; C= Aquatic, Food Crop;
D=Aquatic, Non-Food; B=Greenhouse, Food Crop; F^Greenhouse, Non-Food; G=Forestry; H=Damastic Outdoor; I=Indoor.
3/ Data must be submitted no later than June, 1986 .
4/ Reserved pending result of lab volitility data (163-2).
5/ A study utilizing proper controls is needed.
6/ This study is not required to support the current application method of soil incorporation.
7/ This study is not required to support the current use pattern which does not include aquatic, forestry or aquatic
impact uses.
8/ This study is not required to support the current use pattern which does not include aquatic or aquatic impact uses.
9/ This study is not requrled to support the current use pattern which does not include forestry uses.
10/ There are no current registered combination or tank mixes for terbufos.
11/ This study is not required because less than 50% terbufos residues remain upon subsequent application.
J2/ This study is not required to support the current pattern which does not Include aquatic uses.
13/ Both data citations are needed to satisfy this data requirement.
T4/ This data is not required to support the current uses of terbufos which are outdoor, soil-incorporated uses.
15/ The objective of this monitoring requirement is to measure real world levels of terbufos and metabolites in treated
fields and ponds adjacent to fields where terbufos is used.
The majority of terbufos marketed is used for corn rootworm control and it is most likely that environmental
concerns will arise in the corn growing areas of the U.S. The application sites chosen should possess a known
application history and be adjacent to ponds. Geographic areas for sampling should Include: com belt states,
plains states and lake states.
Soil in treated fields should be monitored before and after application of terbufos. Pond water, sediment and fish
should be monitored before and after fields are treated with terbufos. The scheme of monitoring (where, when, how)
rhould reflect the atterrpt to measure maximum residues. Fish samples should be analyzed for cliolinesterase inhibi-
tion, a9 well as terbufos residues. Baseline cholinesterase levels in fish brains should be established both in the
ponds at the treatm°nt sites and in an area without any history of anticholinesterase pesticide use (e.g., ponds
near pastureland, t.i not where hay is harvested). The pH-stat technique as described by Coppage (1971) should be
u«od. Metabolites as well as parent levels should be monitored (Cook, et. al., 1976). Additional information on
this type of field study can be found in Tagatz, et.al. {1974) and Coppage and Braidech (1976).
Treatment rates should be at highest recommanded rate for that site end crop. Normal agricultural practice should
be followed, including repeated applications if appropriate. If possible, sane sites with i, .ilstory of terbufos
treatment should also be chosen.
The monitoring protocol (including analytical methodology) must be subnitted to the Agency, prior to initiating
the study, with enough lead time for Agency review (two months).
32
-------
TABLE ft
GENERIC DATA REQUIREMENTS FOR TERBUPOS
Data Requirement
Does EPA Have Data
To Satisfy This
1/ Use 2/ Requirement? (Yes,
OOTDosltlon Patterns No or Partially)
Bibliographic
Citation I7/
S158.135 Toxicology
ACUTE TESTING:
81-1 - Oral LD50 - Rat TGAI
81-2 - Dermal LD50 TGAI A
81-3 - Inhalation LC50 - Rat TCAI A
81-7 - Acute Delayed TGAI A
Neurotoxicity - Hen
SUBCHHONIC TESTING:
82-1 - 90-Day Feeding - TCAI A
Rodent, Non-rodent
82-2 - 21-Day Dermal TGAI A
82-3 - 90-Day Denrnl TCAI A
82-4 - 90-Day Inhahatlon - TCAI A
Rat
82-5 - 90-Day Neurotoxicity- TCAI A
Herv/Marwnal
Yes y
Partial
No
Yes y
Yes 10/
Yes
No
No
NO
00037467*
00037471*
00035121**
00029863**
00037467*
00037472*
00045379*
00109446*
00037469*
00085169*
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
No
Yes 4/
Yes
NO
No
NO
No 5/
No 6/
NO 7/
* Data submitted by American Cyanamid. These data may be compensable.
** Data submitted by Ace to Chemical Co. These data may be compensable.
33
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUPOS
Data Requlrentant
Does KPA Have Data
TO Satisfy This
1/ Use 2/ Requirement? (Yes,
Oonposltlon Pattern No or Partially)?
Bibliographic
Citation
S158.135 lexicology
(continued!
CHRONIC TESTING:
83-1 - Chronic Toxicity -
2 species: Rodent
and Non-rodent
- Rat TGAI
- Dog TGAI
83-2 •- Oncogenicity Study -
2 spsciesi Rat and
Mouse preferred
- Rat TGAI
- Mouse THAI
83-3 - Teratogenicity - TGAI
2 species
83-4 - Reproduction, TGAI
2-generation
A
A
A
A
A
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? 3/
Partial
Partial
Partial
Partial
No
Yes 15/
00045378*r 00049236*
00069502*f 00041139*
00049236*; 00045378*
00085170*) 00045380*
00085172*
00037473*
Yes 12/
Yes 13/
Yes 12/
Yes 14/
Yes
No
* Data submitted by American Cyanamid. These data a»ay be compensable.
34
-------
TABLE A
GENERIC EWTA REQUIREMENTS FOR TERBUPOS
Data Requireanent
1/ Uae 2/
Oarposltion Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data bo Submitted
Under FIFRA Section
3(c)(2)(B)?3/
S158.135 Toxicology (continued)
MUTAGENICITY TESTING
84-2 - Gene Mutation TGAI
- In vitro mamnalian cell TGAI
point mutation L5178Y
(TO); or CHO (HGPRT)j or
V79 (HGPRT).
84-2 - Chromosomal Aberration TGAI
- In vitro cytogenetic TGAI
damatjet both chrarTK*3croal
aberration and SCE (in CHO
colls) or human lymphocytes|
or other rodent/hunan cell
liras/strains.
- In vivo cytogenetics TGAI
tost for chromosomal
aberrations using bona
matew preparations of rats.
- Dcriinant lethal test in TGAI
rats or mice.
84-2 - Other Mechanisms of TGAI
Mutagenicity
- In vltro/in vivo prinury
hepatocyte repair for UD8
testing both in vivo *\nd
in vitro exposure of cells
to terbufos.
TGAI
A
A
A
A
Partial
No
No
NO
NO
No
Partial
No
00063209*
Yes 11/
Yes
Yes
Yes
00063209*
Yes
Yes
Yes 11/
Yes
* Data submitted by American Cyanamid. These data may be compensablef"
36
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUP06
Data Requirement
Ccanposltion
Use 2/
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)? 3/
S158.135 Toxicology
(continued)
SPECIAL TESTING
85-1 - General Metabolism
PA2 or
PAIRA
Yes
00087695*
NO
85-2 - Domestic Animal Safety Choice
No
No 16/
"Data submitted by American Cyoneroid. Those data may be compensable.
36
-------
TABLE A
GENERIC DATA HBOtf HEHOTO COR TERBLTOS
Si58.135 lexicology (continued)
1/ CcmpciglticRit TGAI « Technical grade of the arrive ingredient; PAX = Pure active ingredient; PA1RA " Pure active
ingredient, radioLaballed) Choice c Choice of several test substances dote mined on a case-bycase basis-
2/ Ihe use patterns ate coded as follows* A=Terrestrial, food Crop; B=Terrestrial, Non-Food; OAqautic, Food Crop;
D3Aquatic, Kojj-Pood; EXJreenhouse, Food Crop; P^resnhrjuse, Non-Food; Oforostryf H=Damai;tlc Outdoor; 1= Indoor.
3/ Data must ba Buisni tted no later than June, 1986 .
4/ Th0 acuta dental LD50 was performed on one eext additional data nuat be submitted on the other Bex, or a repeat
study in rata (M + tf) is required.
5/ The 21 day dermal study is adequate to assess the dermal exposure associated with the current peuticidal use
of terbufos.
6/ This study is not required. It Ib unlikely that the current peaticidal use of terbufos Mill involve repeated
inhalation exposure, i.e., as granular formulations applied as a soil incorporated treatment.
7/ This test is not required becausa the results of the acute delayed neurotoxicity test were negative.
8/ Data citations 0003746?, and 00037471 combined, satisfy this data requlrsnant for the technical currently
registered under EPA Reg. Mo. 241-241. Data citation 00035121 satlfies this data requirssaent for the technical
currently pending under file Symbol 2749-UEL. These data citations may not be adequate to satisfy this require-
ment for technicals which differ from thor>e described herein.
9/ Both data citations are reeded to satisfy this data requirement.
10/ Data citation number 00109446 is sufficient to satisfy this data requirement.
11/ Additional testa as specified in T.M3LE A are required.
12/ The submitted 2-year rat atudy lacked microscopic examinations on animals that died or ware sacrificed moribund
during the study! or for the 3-raonth interim sacrifice.
13/ The submitted 6-month dog study was not adequate because the actual ooaagaa could not be determined. A one year
study is now required.
14/ The submitted 18-month mouse study lacks a sufficient ranker of histologically examined animals per sex per
group.
15/ Both data citations ere needed to satisfy this data requirement.
16/ Testing is not required based on current registered uses. However, depending on the extent of future use in
feed iters end whether or not tolerances would be requested in meat and milk, a combined study can be performed
for both residues end dauaslic animal safety determinations.
17/ Except as noted in footnote 8, these data citations pertain to the technical currently registered under EPA
Reg. No, 241-241, and may not be applicable bo technicals which differ frcn that described herein.
37
-------
TABLE A
GENERIC DKTA REQUIREMENTS FUR TCRBUP06
Do63 EPA Have Data Must Additional
To Satisfy This Data Be Submitted
1/ 2/ Raqulrenwnt? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c)(2)(B)?
8158,140 Reentry Protection
132-1 - Foliar Dissipation
TEP
A
No
No 3/
132-1 - Soil Dissipation
TEP
A
No
No 3/
133-3 - Dermal Exposure
TCP
A
No
No 1/
132-4 - Inhalation Exposure
TEP
A
No
No 3/
1/ Composition: TEP «* Typical end-use product.
J/ The use patterns are coded as follows* A=Terrestrial, Food Crop; B^errestrial, Non-Food; OAquatic, Food Crop;
D=Aguatic, Non-Food; E=Greenhouse, Food Crop; F=Gceenhouse, Non-Food; G=Forostry, tWtaiestic Outdoor) InIndoor.
3/ There is little potential for worker exposure based on the cornpouitlon o£ the present registered TEP which is
a granular formulation and since the present registered uses require soil incorporation o£ the granules.
* Data submitted by American Cyanamid.These data may be compensable.
38
-------
TABLE A
GENERIC DATA REQUIREMENTS EUR TERBUFU6
Must Additional
Data Be Submitted
Under ETFRA Section
3(c)(2)(B)?3/
Data Requirement
1/ Use y
Composition Pattern
Does epa Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
S158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LD50 7GAI
71-2 - Avian Dietary LC50 TGAI
71-3 - Wild Mamnal Toxicity TGAI
71-4 - Avian Reproduction TGAI
71-5 - Simulated and Actual TEP
Field Testing -
Mamrals and Birds
A
A
A
A
Yes
Yes 8/
Not Applicable
Partial
Partial
00106551*
00087717**
00035120**
00085177*
00097892*
00085178*
00087726*
00085180*
00085179*
00085183*
NO
NO
Yes 5/
Yes 6/
AQUATIC OFCAN7.SM TESTING
72-1 - Freshwater Fish LC50
TGAI
TEP
Yes 9/
Yes
00037483*
00085176*
00087718**
G30109002
GS0109003
NO
No
* Data submitted by Aneri
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TABLE A
GENERIC DATA REQUIREMENTS TOR TEHEJJF06
Data Requirement
1/ Use 2/
CaEposition Pattern
Does EPA Hava Data
To Satisfy This
Requirement? (Yea,
Mo or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c»2»B)?V
$158.145 Wildlife and Agoatlc Organ lata
(continued)
72-2 - Acute LC50 Freshwater
Invertebrates
-do-
72-3 - Acute LC50 Estuarina
and Marine Organisns
72-4 - Fish Early Life
Stage and Aquatic
Invertebrate Life-Cycle
72-5 - Fish ~ Life-Cycle
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
TGAI
TKP
TGAI
TGAI
TGAI
A
A 4/
TGAI,PAZ or
Degradation
Product
TEP
A
A
Yes 1/
Yes
No
NO
Reserved 10/
Reserved 10/
Reserved 10/
00101495*
00085176*
CS0109004
No
NO
Yes
Yes 11/
" Data submitted by American Cyanarald. These data nay be ccnpensable.
40
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TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUPOS
S158.145 Wildlife and Aquatic Organisms
(continued)
1/ Compositions TGAI = Teclinical grade of the active ingredient; PAI = pure active ingredient;
TCP = Typical end-use product;
y The use patterns are coded as follows: AtfTerrestrlal, Food Crop; B*Itrrestrial, Non-Food Crop; C=>Aquatic, Food Crop;
I>=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Ncn-Food; G=Forestry; H-Dcmeacic Outdoor; I=Indoor.
3/ Data must be submitted no later than June, 19B6 .
4/ ihis data ia necessary to support corn and sorghum uses.
5/ All pen-by-pan data must ba provided to enable full statistical evaluation of results.
6/ Actual field testing should be conducted with the corn use, using the present maximum application rate (2.4 oz
a.i./lOOO feet of row). Census data should be taken before and aft.er treatment, intensive searches for dead or
dying animals should be made within one day of application, and aralyses for cholinesterase inhibition should be
conducted. A protocol for conducting this study should be submitted to the Agency for review, at least six months
prior to initiation of testing.
7/ The data citation 00101495 is sufficient to satisfy this data requirement.
8/ Data citation 00087717 is sufficient to satisfy the data requirement for a Bobwhite quail dietary LC50 study.
Though data citation 00035120 only partially satisfies the guideline requirement for a mallard duck dietary LC50
study, further mallard testing is not deaned warranted because of the food rejection problem.
9/ To satisfy this data requirement, both a coldwater species and a warmwater species study must be cited. Either
data citation 00087718, or 00037183 is sufficient to satisfy the data required for a ooldwater species; and
either 00087718 or (J0037483 is sufficient to satisfy the data requirement for a warmwator species.
10/ The need for these studies is reserved pending evaluation oft 1) the monitoring data (§ 158.130), 2) completion of
additional EECs (discussed in Chapter II), 3) the outstanding aquatic studies (72-3 and 72-4). This information
will then dictate the need for anyone ot the reserved studies.
11/ The applicant should consult with the Agency regarding the appropriate test species and test methodologies.
41
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TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUPOS
Data Requirements
Composition
1/
Does tlPA Have Data
lb Satisfy This
Use 2/ Requirement? (Yes*
Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3'c)(2)(B)?
S158.150 Plant Protection
121-1 - TARGET AREA
PHOTOTOXICITY
NCKTARGET AREA PHOTOTOXICITY
TIER I
122-1 - Seed Genninatiorv'
Seedling Divergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant Growth
TIER II
123-1 - Seed Germination/
Seedling Qnargence
123-1 - Vegetative Vigor
123-2 - Aquatic Plant Growth
TIER III
124-1 - Terrestrial Field
124-2 - Aquatic Field
EP
TGAI
TGAI
TCAI
TCAI
TGAI
TGAI
TEP
TEP
THESE REQUIREMENTS ARE GENERALLY WAIVED UNLESS IT IS
BELIEVED THERE IS A PHYTOTCKICITY PROBLEM
1/ Composition! TCAI •= Technical grade of the active ingredient: TEP = Typical end-use product.
EP = End-use product.
2/ The use patterns are coded as follows: A^^Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop? C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
42
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUFOS
Data Requirement
1/ Use y
Composition Pattern
Does EPA riavo Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
§158.155 Nontarget Insect
NOMTARGBT INSECT TESTING -
POLLINATORS I
141-1 - Honey bee acute
contact LD50
141-2 - Honey bee - toxicity
of residues cm
foliage
141-3 - Wild bees important in
alfalfa pollination -
toxicity of residues
on foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
TCAI
TEP
TEP
(Reserved) A
TEP
res
No
No
00066220*
Reserved 5/
No
No
No 3/
No 4/
No 3/
* Data submitted by Penick Corporation. These data may be compensable.
43
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TABLE A
GENERIC LATA REQUIREMENTS FOR TERBUFOS
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
1/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Ocmposition Pattern No or Partially) Citation 3(c)(2)(B)?
§158.155 Montarqet Insect
(continued)
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
143-1 - NONTARGET INSECT
TESTING-PREDATORS
thru AND PARASITES
143-3
1/ Composition t TCAI ¦ "technical grade of tlte active ingredient) TEP => lypical end-use product!
2/ The use patterns are coded as foJ lows: A=Terrestrial, Food Crop; B=Terrestrial, cfon-Food; C=Aquatic, Food Crept
D=Aqautic, Non-Food; E=Greenhouse, Food Crept F=Greenhcu3e, Non-Food; OForestry; H^Danestic Outdoor; I°Indoor.
3/ Since the current registered uses of terbufos will not result in bee exposure, honey bee testing beyond the first
level (acute contact LD50) is not required.
4/ This data is not required to support the current registered terbufos products which are not intended for use as a
foliar application to seed alfalfa.
5/ Reserved pending development of test methodology. Also refer to footnote 3/.
6/ Reserved pending decision as to whether the data requirement should be established.
44
(Reserved) 6/
(Reserved) 6/
(Reserved) 6/
(Reserved) 6/
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURENO-USE PRODUCTS CONTAINING TERPUPOS
Data Requirement
Conposition
1/
Does EPA Have Data
To Satisfy Thiu
Requirement? (Yes,
No or Partially)
Must Additional
Data Be Submitted
Bibliographic 7/ Under FIFRA Section
Citation 3(c)(2)(B)?2/
S158.120 Product Chemistry
Product Identity
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation
of Ingredients
Analysis and Certification
of Product Ingredients:
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, bulk density, or
specific gravity
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Yes
Partial
Yed
Yes
partial
Partial
Yes
Yes
Yes
Yes
00040385*
00085161*
00069499* y
00085160* 6/
00087711* t/
00040389*
000877)1*
00085160*
00040388*
00087712*
00040390*
00040385*
00040385*
00040385*
00040385*
No
Yes y
No
No
Yes 4/
Yes 5/
No
No
No
No
*Data submitted by American Cyanamid. ' These data may be compensable.
45
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING TERBUPOS
Must Additional
Data Re Submitted
Under PIFRA Section
3(c)(2)(B)?2/
Data Requirement
Canposltion
1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
S158.120 Product Chemistry
(continued)
63-12 - pH
63-14 - Oxidizing or reducing
action
63-15 - Flamnability
63-16 - Explodability
63-17 - Storage Stability
63-10 - Viscosity
63-19 - Miscibility
63-20 - Corrosion
MP
MP
No
No
MP (Combustible No
liquids only)
MP
MP
MP (Liquids
only)
No
No
No
MP (Bmilsifiable No
liquids only)
MP No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Other Reguiraients
64- 1 - Submittal o£ Soqples
Choice
No 8/
4 6
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING TERBUPOS
S158.120 Product Chanistry (continued)
1/ Compositions mp = Manufacturing-use product; Choice » Choice of several test substances determined on a case-by-
case basis.
2/ Data roust be submitted no later than December 1983 .
3/ Further information is needed on the corrposition of starting materials.
~A/ A declaration and certification of limits is required.
5/ Validation data for the analytical methods are required.
6/ Any one of these data citations are adequate to meet this data requirement.
2/ These data citations pertain to the MP currently registered under EPA Reg. No. 241-241 and may not ba applicable
to MPs which differ from that described herein.
8/ May be required on a case-by-case basis.
4 7
-------
TABLE D
PRODUCT SPECIFIC DMA REQUIREMOTS FOR MANUFACTURING-USE PRODUCTS CONTAINING TERBUPOS
Data Requirement
Composition
y
Does EPA Have Data
lb Satisfy This
Fequitenant? (Yes,
No or Partially)
Bibliographic
Citation 6/
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)??/
§158.135 Toxicology
ACUTE TESTING
81-1 - Oral LD50 - Rat
81-2 - Decmal LD50
81-3 - Inhalation LC50 - Rat
81-4 - Primacy Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation
81-6 - Dbtmal Sensitization
MP
MP
MP
MP
MP
MP
Yes 5/
Partial
No
Yes
Yes
No
00037467*
00037471*
00035121**
00029863**
00037467*
00044957*
00044957*
No
Yes 4/
Yes
No
No
No 3/
1/ Conpositions MP » Manufacturing-use product.
2/ Data must be submitted no later than December 1983 «
3/ This data requirement is waived because mooiallty would occur before sensitization.
~$/ This data requirement for testing in male rabbits is satisfied. Acute dermal LJD50 data for female rabbits
must be submitted.
5/ Data citations 00037467, and 00037471 combined, satisfy this data requirement for the manufacturing use
product (MP) currently registered under EPA Reg. No. 241-241. Data citation 00035121 satisfies ths data
requirement for the MP currently pending under File Symbol 2749-UEL. These data citations may not be adequate
to satisfy this requirement for MPs which differ fron those described herein.
6/ Except as noted in footnote 5, these data citations pertain to the manufacturing use product (MP) currently
registered under EPA Reg. No. 241-241, and may not be applicable to MPs which differ fron that described herein.
Data submitted by American Cyananid. - These data may be compensable.
** Data submitted by Ace to Chemical Co. Thesa data may be carps ns able.
-------
IV. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Notes This section 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-1)
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
ceregister 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 Tnble B permit you to determine which
product-specific data you must submit. This can be done by
examining the entcies in the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B)."
37* Product specific data pertains to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicology data.
-------
V. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This section 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 and v-2], as indicated by the following paragraphs of this
section of the guidance document.
You will be informed later when you must submit the revised
labelii.g set forth in thx3 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 Dr E,
and F (Appendix VI-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-l. {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-l. [40 CFR §162.10(c)]
Item 3. NET CONTENTS - A net content statement i.3 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
50
-------
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-l. 140 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-l.
140 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 r?ad through such
wrapper or container. See Appendix V-l. [40 CFR 5162.10(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-l. [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.
51
-------
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
above 5 to 10
above 10 to 15
above 15 to 30
over 30
5 and under
6 point
10 point
12 point
14 point
18 point
6 point
6 point
8 point
10 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 w:»ere
contact with children during distribution or use unlikely.
Hee Appendix V-l. [40 CFR S162.10(h)(1)(ii)1
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-l.
140 CFR §162.10 (h)(1)(D)
Item 7C. 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-l. [40 CFR
$162.10(h)(1)(i) ]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix V-l. [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-l. [40 CFR §162.10(h)(1)(iii)1
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 ttu-ee hazard warning statements must be headed by the
appropriate hazard title. See Appendix V-l. [40 CFR §162.10
(h)(2)]
52
-------
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Wher<2 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-l. {40 CFR §162.10
(h)(2)(i) ]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix V-l. [40 CFR
§162.10(h)(2)(ii)]
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 clinder 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 Sl63.61-8(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 §163.61-8(c)(13)(ii);
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 3S0°F (177-C),
determined by the method specified in 40 CFR
§163.61-8(c)(13)(i).
53
-------
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
S163.61-10(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 capaDility, 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-l. [40 CFR §162.10(1)(2)(ii)1
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 ycur 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-5 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-l. [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.
54
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VI. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Mr. William H. Killer, Product Manager
. Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
Phone No. (703) 557-2600
A. For each manufacturing-use 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. Refer to Appendix III-2 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 IV-1).
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.
B. For each affected product for which continued registration
is desired, within 90 days from receipt of this document
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" (F.PA
Form 8580-1, Appendix III-2) with appropriate attachments.
C. You will be informed at a later date "when you must submit
your Application for Amended Pesticide Registration (EPA
Form 8570-1) and tne revised labeling set forth in this
guidance package.
55
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Appendix III-l
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources £or studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required *
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRiD), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
56
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Appendix III-l
(continued)
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parencheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental usi permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
57
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00029863 Consultax Laboratories (1975) Acute Oral and Percutaneous
Toxicity Evaluations. (Unpublished study received Feb 3,
1976 under 2749-425; submitted by Ace to Chemical Co.,
Inc., Flushing, N.Y.; CDL:24i780-A)
00032636 Fischer, J.E. (1979) Toxicity Data Report: Report No. A79-109.
(Unpublished study received Jun 11, 1980 under 241-260;
ouLmitted by American Cyanaanid Co., Princeton, N.J.;
CDL:099451-B)
00032646 Palochak, M.E.; Shapiro, R.L. (1971) Microbiology Laboratory
Report: Report No. 710903M1. (Unpublished study received
Jan 19, 1971 under 52-127; prepared in cooperation with
Hudson Laboratories, Inc., submitted by West Chemical
Products, Inc., Lynbrook, N.Y.; CDL:000053-A)
00035120 Krize, J.W.; Terrel Y. (1978) Repoct: Avian Dietary IC50
(5-Day Dietary Exposure) of Enlist Technical (Terbufas
Technical) EPA File Symbol 2749-UEL to Mallard Duck;
Laboratory No. 8E-3451. (Unpublished study received
Mar 27, 1979 under 2749-425; prepared by Cannon Labora-
tories, Inc., submitted by Ace to Chemical CO., Ire;.,
Flushing, N.Y.; CDL:241730-A)
00035121 Parke, G.S.E.; Terrell, Y. (1976) Acute Oral Toxicity in
Rats: Compound: Enlist Technical Insecticide (Terbufos)
EPA File Symbol 2749-UEL: Laboratory No. 6E-3164.
(Unpublished study received Nov 29, 1976 under 2749-425;
prepared by Cannon Laboratories, Inc., submitted by
Ace to Cherical Co., Inc., Flushing, N.Y.; CT>L:241733-A)
00036123 Caballa, S.H.; Ku, C.; Miller, P.; et al. (1975) Sumaty—
Metabolism of Counter (CL 92,100) in Sugar Beets. (Unpub-
lished study including project no. 2-404 and report
nos. C-698 and W-606, received Jun 10, 1975 under 5F1640;
submitted by America Cyanaraid Co., Princeton, N.J.;
CDL:094445-G)
00036124 Higham, J.W.; Alvarez, C.C.; Burhardt, C.C.; et al. (1975)
General Sisrcnary: Counter"(R) 15G Soil Insecticide Residues
in Sugar Beet Tops and Roots. (Unpublished study received
Jun 10, 1975 urder 5F1640; submitted by American Cyanamid
Co., Princeton, N.J.; CDL:094445-H)
58
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Urder the Standard
00036127 Highara, J.W.; Peterson, R.P. (1974) CL 92,100 and 92,100
Related Compounds: Gas Chranatographic Procedure for the
Deteoninaticn of CL 92,100 in Sugar fleet Tops (Greens)
and Roots. Includes method M-395 dated Kar 1, 1973.
(Unpublisired study including report no. C-532, received
Jun 10, 1975 under SF1640; submitted by American Cyanamid
Co., Princeton, N.J.; CDL:094WK)
Peterson, R.P.; McGinn is, R.A. (1975) Counter (CL 92,100):
Total Counteu-Related Residues in Sugar Beet Dried Pulp
and Juice (Thick and Thin): Report No. C-679. Includes
method no. M-501 dated May 1, 1975. (Unpublished study
received Jun 10, 1975 under 5F1640; prepared in cooperation
with Spreckels Sugar co., sutmitted by American Cyanamid
Go*, Princeton, N.J.; CDL:094445-H.
American Cyanamid Car^any (197?) Name, Chemical Identity
and Composition of AC 92,100. (Unpublished study received
Apr 9, 1973 under 3GLKn; CDL:093581-A)
Manuel, A.J. (1972) Total CL 92,100 end Its Metabolites in
MilJc: Report No. C-336. Includes method !4-353 dated Jul 31,
19'2. (Unpublished study received Apr 9, 1973 under 3G1340;
sutmitted uy American Cyanamid Co., Princeton, M.J;
CBL:093581-J)
Manuel, A.J.; Petersen, K.P.; Potts, C.R.; et al. (1972)
CL 92,100 and Its Metabolites in Cattle Fat, Muscle,
Liver and Kidney: Report No. C-337. Includes method
M-372 dated New 9, 1972. (Unpublished study received
Apr 9, 1973 under 3G1340; submitted by American Cyanamid
Co., Pirinceton, N.J.; CDL:093581-K)
American Cyanamid Company (1972) CL-92100: Determination of
Total CL-92100-Reiated Residues in Corn Forage and Grain.
Method M336 dated Jun 21, 1972. (Unpublished study received
Apr 9, 1973 under 3G1340; CDL:093582-C)
00037467 American Cyanamid Company (1972) Toxicity Data: 0,0-Diethyl-S
(tert-butylthicmethyl) phosphorodithioate Technical, 85.8%
AC 2162-42: Report **-72-95. (Uroublished study received
Apr 9, 1973 under 3G1340; CDL:093584-B)
00037469 Sabol, R.J.; Smith, J.M.; Wilson, N.H.; et al. (1972) A 3
and 24 Month Oral Toxicity and Carcinogenicity Study of
AC 92, 100 in Rats: Three Month Report: Project No.
71R-7L;'.. (Unpublished study received Ape 9, 1973 under
3G1340; prepared by Bio/dynamics, Inc., submitted by
American Cyanamid Co., Princeton, W.J.; CDL:093584-D)
00036129
00036234
00036241
00036242
00036246
59
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00037471 Kretchroar, b. (1972) Report to American Cyanamid: Acute
Oral Toxicity Studies with Two Samples in Female Albino
Rats: IBT No. A1373. (Unpublished study received Apr
9, 11973 under 3G1340; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by American Cyanamid
Co., Princeton, N.J.; CDL:093584-G)
00037472 Smith, J.H.; Rosselet, C.; Cannelongo, B.; et al. (1972) A
Neurotoxicity Study of AC 92,100, an Organic Phosphate
Cholinesterase Inhibitor, in Hens: Project No. 72S-783.
(Unpublished study received Apr 9, 1973 under 3G1340;
prepared by Bio/dynamics, Inc. submitted by Anerican
Cyanamid Co., Princeton, N.J.; CDL: 093584-H)
00037473 Smith, J.M.; Kasner, J. (1972) Status Report Cor American
Cyanamid Company, November 28, 1972: A Three Generation
Reproduction Study of AC 92,100 in Rats: Project No.
71R-727. (Unpublished study received Apr 9, 1973 under
3G1340; prepared by Bio/dynamics, inc., submitted by
American Cyanamid Co., Princeton, N.J.j CDL:093584-I)
00037483 Sleight, B.H., III (1972) The Acute Toxicity of Cycocerw
and Experimental Insecticide AC 92,100 to Bluegill
(Lepcmis maclished study received Apr 9, 1973 under
3G1340; prepared by Bionomics, Inc., submitted by
American Cyanamid Co., Princeton, N.J.; CDL:093584-U)
00039018 American Cyanamid Company (1974) General Summary: Counrwc
Relateu Residues in Immature Corn Corned i ties from In-
Furrow Application of Counter"(R) 15G Soil Insecticide
at Planting. Sunmacy of studies 094895-D through
094895-G. (Unpublished study received 1976 under 6F1657;
CDL:094895-C)
00040385 American Cyanamid Caipany (19??) Name, Chemical Identity
and Composition of Counter"(R) Soil Insecticide.
(Unpublished study received May 1, 1974 under 4F1496;
CDL:093978-A)
00040388 .American Cyanamid Company (1973) Gas Liquid Chromatography
Assay of CL 92,100 Technical Material. Method M-399
dated Mar 7, 1973. (Unpublished study received Hay 1,
1974 under 4F1496; CDL: 093978-D)
00040389 American Cyanamid Company (1973) Gas Liquid Chranatography
Analysis of Minor Components in Technical CL 92,100.
Method M-398 dated Mar 7, 1973. (Unpublished study
received May 1, 1974 under 4F1496; CDL:093978-E)
60
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to ba Part of the Data Base Supporting
Registration Under the Standard
00040390 taarican Cyanamid Canpany (1971) CL 92,100: Analysis of
Granular Forralation by Gas Chromatography. Method m-248
dated Oct 12, 1971. (Unpublished study reoeived Kay 1,
1974 under 4F1496; CDL:093978-F)
00041139 Report: Six Month Feeding Study in Dogs on AC-92,100: Lab-
oratory No. 1193. (Unpublished study received Feb 14,
1973 under 3G1340; prepared in cooperation with Food
and Drug Research Laboratories, Inc. and Coma 11 Univ.,
Dept. of Small Aiiroal Medicine & Surgery, subnitted by
American Cyananid Co., Princeton, N.J.; CDL:094923-A)
00042017 American Cyananid Canpany (1973) Sismary—Counter-Related
Residues in Corn. (Unpublished study received May 1,
1974 under 4F1496; CGL:091452-A>
00042019 Highan, J.W.; Manuel, A.J.; Peterson, R.P.; et al. (1974)
Efficacy of Counter and Other Herbicides on Corn:
Report No. C-415. Includes method m-336 dated Jun
21, 1972. (Unpublished study including report nos.
C-416 and C-425, received May 1, 1974 under 4F1496;
prepared in cooperation with Quality Control Laboratories
and others, submitted by Araerican Cyanamid Co., Princeton,
N.J.j CDL:091452-C)
00042020 Higham, J.W.; Manuel, A.J.; Congleton, W.F.jet al. (1974)
Counter" (R) 15G: Total Counter (CL 92,100)-Related
Residues in Soybean Ccraaodities: Immature Plant,
Harvest Plant and Harvest Beans (Kansas and Iowa):
Report No. C-429. Includes method M-480 dated Jan 9,
1974. (Unpublished study received May 1, dus tries and
Icwa State Univ., Dept. of Zoology & Entomology, submitted
by American Cyanaoid Co., Princeton, N.J.; CDL: 091452-D)
00042021 Manuel, A.J.? Elenewski, C.A. (1974) Counter (CL 92,100)
Stability of Residues in Counter-Treated Corn Grain
and Forage Samples When Stored in the Frozen State:
Report No. C-430. Includes method tt-336 dated Jun 21,
1972. (Unpublished study received May 1, 1974 under
4F1496; subnitted by American Cyanamid Co., Princeton,
N.J.; CDL:091452-F)
00042022 Manuel, A.J. (1973) Counter (CL 92,100): Confirmatory Gas-
Liquid Qircxnatography Test for Counter Residues in
Corn Grain and Forage, and in Animal Tissues: Report
No. C-379. Includes method M-460 dated Sep 27, 1S73.
(Unpublished study received Kay 1, 1974 under 4F1490;
subnitted by American Cyanamid Co., Princeton, N.J.;
CDL:091452-G)
61
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OFFICE OF PESTISCID5 PROGRAMS
REGISTRATION STANDARD BIRLI03RAPH?
Citations Considered to be Part of the Data Efli.9 Supporting
Registration Under the Standard
00044957 American Cyai anid Company (1972) Toxicity Data of 0,0-Diethyl
S(tect.-Uit/lthicmethyi; phosphotrodithioate: Report A-72-3.
(Unpublished study received Aug 1, 1974 under 241-241; CDL:
100877-A)
00045378 Smith, J.M.; Kasner, J.A. (1973) Status Report for American
Cyananid—March 9. 1973; A Three and Twenty-Four Konth
Oral Toxicity and Carcinogenicity Study of AC 92,100 Li
Rats—11 Month Status of Eye Observations: Project No.
71R-725. (Unpublished study received Apr 9, 1973 under
3G1340; prepared by Bio/dynamics, Inc., submitted by
American Cyanamid Co., Princeton, N.J.; CDL:093580-A)
00045379 Snith, J.M.; willigan, D.A. (1973) A Neurotoxicity Study of
AC 92,100, an Organic Phosphate Cholinesterase Inhibitor
in Hens: Project No. 72S-788. (Addendum I; unpublished
study received Apr 9, 1973 under 3G1340; prepared by
Bio/dyrvnics. Inc., submitted by American Cyananid Co.,
Princeton, N.J.; CDL:093580-B)
00045380 Snith, J.M.; Kasner, J.A. (1973) Status Report for American
Cyanamid Company—March 14, 1973; An 18-W*ith Carcino-
genicity Study of AC 92,100 in Mice—12 Month Status of
Eye Observations: Project No. 71R-728. (Unpublished study
received Apr 9, 1973 under 3G1340; prepared by Bic/dynanics,
Inc., submitted by American Cyanamid Co., Princeton, N.J.;
CDL:093580-C)
00049235 Snyder, E.H. (1975) Counter"(R) (CL 92,100): The Gas Oranato-
graphic Determination of CL 92, 100 (0,0-Diethyl) SSutyl-
thiomethyl-phosphorodithioate)-Related Residue in Fortified
Barley, Green Beans, Red Beets and Wheat: Report No. C-730.
(Unpublished study received Oct 9, 1975 under 241-238; aol>-
mitted by American Cyananid Co., Princeton, N.J.;
CDL:224U99-C)
00049236 Rapp, W.R.; Wilson, N.H.; Mann ion, M.; et al. (1974) A Three
and TVyenty-Four Month Oral Toxicity and Carcinogenicity
Study of AC 92,100 in Rats: Project No. 71R-725. (Unpub-
lished study received May 29, 1975 under 241-238; prepared
by Biodynamics, Inc., subm'tted by American Cyananid Co.,
Princeton, N.J.; CDL: 224096-A)
00062871 Peterson, R,p. (1976) Oxinter"(R) Insecticide 15-G and Liquid
(CL 92,100): Metabolism of "14C-Labeled CL 92,10C ... in
Cabbage Plants: PD-M 13-1:1-19. (Unpublished study received
Nov 3, 1980 under 241-238; submitted by Aoerican Cyanamid
Co., Princeton, N.J.; CDL:099682-A)
62
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00062872 American Cyanamid Company (1976) Residue Studies in Cabbage,
Broccoli and Cauliflower. (Compilation; unpublished
study received Now 3, 1S80 under 241-238; CDL:099682-B)
00063209 Allen, J.S.; Johnson, E.j Wairwright, C. (1977) Mutagenicity
Testing of Technical Ccunter*(R) Soil Insecticide (Terbufos)
in the Ames Test: AIR 5:419-431. Final rept. (Unpublished
study received Apr 17, 1978 under 241-241; submitted by
American Cyanamid Co., Princeton, N.J.; CEL:234103-B)
00066220 Atkins, B.L., Jr.; Anderson, L.D.; Rellum, D.; et al. (1976)
Protecting Honey Bees frcm Pesticides. ?: Univ. of Cali-
fornia, Div. of Agricultural Sciences. (Leaflet 2883;
also In unpublished submission received Mar 20, 1980
under 432-502; sutmitted by Penick Corp., Lyndhurst,
N.J.; CEL:243536-B)
00069499 American Cyananid Company (19??) Chemical Data on AC 92,100.
(Compilation; unpublished study received on unknown date
under 241-EX-59; CDL:223458-A)
.00069502 Horgareidge, K. (1972) Preliminary Report: Six-month Feeding
Study in Dogs on AC-92,100: Laboratory No. 1193. (Unpub-
lished study received on unknown date under 241-EX-59;
prepared by Food and Drug Research Laboratories, Inc.,
submitted by American Cyanamid Co.Princeton, N.J.;
CDL:223458-F)
00069512 North, F..H.; Barringer, C.F.; Gatterdam, P.E.; et al. (1972)
CL 92,100 Insecticide: Fate of C"14-Labeled CL 92,100 in
Sweet Corn Plants: PDM 9:249-301. (Unpublished study
received on unknown date under 241-EX-59; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:223458-X)
00079429 Chiu, T.Y.; Lucas, L.H. (1981) Counter"" ("IM) Terbufos
(CL 92,100): 18-16:1-43. (Unpuolished study received Jul
13, 1981 under 241-238; sutmitted by American Cyanamid
Co., Princeton, N.J.; CDL:070186-A)
00079431 Peterson, R.P.; Good, T. (1979) Counter"(R) Terbufos
(CL 92,100): Validation of GC Method M-0995 for ths
Determination of Total CL 92,100-Related Residues in
Sorghxm Tissues (Silage, Fodder and Grain): Report No.
C-1592. Includes method M-995 dated Jul 11, 1979.
(Unpublished study received Jul 13, 1981 under 241238;
submitted by American Cyanamid Co., Princeton, N.J.j
CDL: 070186-C)
63
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Past of the Data Base Supporting
Registration Under the Standard
00085160 American Cyanamid Canpany (IV??) Description of Typical
Counter Technical. (Unpublished study received May 1,
1974 under 4F1496; QL:09080G-A)
00085161 American Cyanonid Company (19??) Brief Description of the
Manufacturing Process for Counter Technical. (Unpublished
study received May 1, 1974 under 4F1496; CDL:090803-B)
00085169 Rrugev, R. ? Feiirnan, H.; (1973) 30-day Subacute Dermal
Toxicity in Rabbits of AC-92100: Laboratory No. 1611.
(Unpublished study received May 1, 1974 under 4F1496;
prepared by Food and Drug Research Laboratories, Inc.,
submitted by American Cyanamid Co.# Princeton, N.J.;
CEl.: 090808-0/
00085170 Rapp, W.R.j Tebaldi, A.; Wilson, N.H.; et &1. (1974) An lb
Month Carcinogenicity Study of PC 92,100 in Nice: Project
No. 71R-729 (Unpublished study received ."ay 1, 1974 urtdar
4P149S* prepared by Bio/dynanics, Inc., sutmitted by
American Cyanamid Co., Princeton, N.J.; CDL:090808-K)
00085172 Snith, J.K.; Kasner, J.A.; Wilson, N.H.; et al. (1972) A
Three Generation Reproduction Study of Pesticide
AC 92,100 in Rats: Project No. 715^727. (Unpublished
study received May 1, 1574 under 4F1496; prepared by
Bio/dynanics, Inc., submitted by American Cyananid Co.,
Princeton, N.J.j CDL:090808-M)
00085176 Bentley, R.E. (1973) Acute Toxicity of Gountes'flM) to Blue-
gill (Lepct \s macrochirus), Channel Catfish (Ictalurus
punctatus) and Crayfish (Procfflisbarus clarkii). (Unpub-
lished study received May 1, 1974 under 4F1496; prepared
by Bionomics, Inc.. submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:090808-0)
00085177 Pink, R.s Rene, F.E. (1973) Final Report: One-generation
Reproduction Study—Bobwhite Quail: Project No. 362-145.
(Unpublished study received May 1, 1974 under 4F14?6»
p&eparoc! by Environmental Sciences Corp., submitted by
Ansrican Cyauaaid Co., Princeton, N.J. r CDL:090808-S)
00085178 Labisky, R.F.; Anoorson, W.L. (1973) Effects of Field Appli-
cations of Caunter°(R) Soil Insecticide on Wildlife.
(Unpublished study received May 1, 1974 under 4F1496;
prepared by Illinois Natural History Survey, sutrnitted
by American Cyanamid Co., Princeton, N.J.; CDL:090808-T)
64
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00085179 Labisky, R.F. (1974) Responses of Confined Hen Pheasants
to Simulated field Applications of Counter"(R) Soil
Insecticide. (Unpublished study received May 1, 1974
under 4F1496; prepared by Illinois Natural History
Survey, submitted by American Cyanamid Co., Princeton,
N.J.; CDL:090808-U)
00085180 Manuel, A.J. (1973) Counter"(TM) 15G Soil Insecticide;
CL 92,100 and Its Metabolites in Wildlife Tissues and
Bggs: Report No. C377. {Unpublished study received
Hay 1, 1974 under 4F1496; submitted by American Cyanamid
CO., Princeton, N.J.; OX: 090808-V)
00085183 Manuel, A.J. (1973) Counter"(TM) (a 92,100) Related Residues
in Pheasant Muscle, Liver, Skin, Kidney and Fat: Report
No. C378. (Unpublished study received May 1, 1974
under 4F1496; submitted by American Cyanamid Co., Princeton,
N.J.) CDL; G90808-Y)
00085184 Sleight, B.H., III (1973) Kinetics of Aged "1400ounter"(TM)
in a Synthetic Aquatic Ecosystem. (Unpublished study
received May 1, 1974 under 4F1496; prepared by Bionomics,
Inc., submitted by American Cyanamid Co., Princeton,
N.J. j CDU09C308-Z)
00087686 Higham, J.W.j North, H.H. (1974) Counter"(R) 15G: CL 99875
(Metabolite 13) Residue in Corn Silage and Fodder:
Report No. C-437. (Unpublished study received May 1,
1974 under 4F1496> submitted by American Cyanamid CO.,
Princeton, N.J.f CEL:091409-C)
00087687 Higham, J.W. (1974) CL 99 , 875: The Determination of CL 99,875
in Corn Silage and Fodder. Method M-489 dated Feb 19,
1974. (Unpublished study received May 1, 1974 under
4F1496; submitted by American Cyanamid Co., Princeton,
N.J.t CDL:091409-D)
00087688 North, H.H.; Jenney, K. (1974) Counter"(R) Soil Insecticide:
Residue Levels and Metabolism in Sweet Corn Foliage
and Grain: Report No. 442. (Unpublished study received
May 1, 1974 under 4F1496; submitted by Aserican Cyanamid
Go., Princeton, N.J.; CDL:091409-E)
00037699 Barring^*, D.F.; Gatterdan, P.; Steller, W.A. (1973)
CL 92,100 Counter"(R) Insecticide: The Identification
of ttv Major Metabolites Found in Mature Sweet Corn
Plants and in Soil: PD-M 10: 423-454. Progress rept.,
Jun 27, 1972 through Mar 30, 1973. (Unpublished study
cecaived May 1, 1974 under 4F1496; submitted by American
Cyanamid Co., Princeton, N.J.; CDL:091409-F)
65
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Untie? the Standard
00087690 North, H.H.; Chanpa^ne, D.A. (1973) Counter"(TM) Soil
Insecticide: Metabolism of CL 92,100 in Soils: PD-H
10:484-583. Progress rspt., Mas 16, 1972 through Sep
28, 1973. (Unpublished study received May 1, 1974
under 4F1496; submitted by American Cyansnd Co.,
Princeton, N.J.; CDL: 091409-G)
00087691 Caballa, S.j Ku, C.j Miller, P. (1973) Counter"(R) Insecti-
cide (15-G): Metabolisn of "14C-Labeled CL 92,100 in
Sugar Beats: Report No. C-405. (Unpublished study
received May 1, 1974 under 4F1496; sufcmitted by Anerican
Cyanamid Co., Prinoeton, N.J.; CDL:091409-H)
00087692 Gatterdaa, P.) Jenrtey, K. (1974) Counter"(R) Soil Insecticide:
Residue Levels in Soybeans Grown as a Follow Crop on Soil
Previously Treated with "14C-CL 92,100: Report No. C-422.
(Unpublished study received Nay 1, 1974 under 4F1496;
sutmitted by American Cyanamid Co., Princeton, N.J.;
CDL;091409-1)
00087693 Hui, T. (1973) Counter* (TM) Soil Insecticide: Soil-leaching
Studies of CL 92,100 PD-M 10:455-483. Final rept.
(Unpublished study received May 1, 1974 under 4F1496;
submitted by American Cyansdd Co., Princeton, N.J.;
CDL:091409-J)
00087694 Metabolic studies of "14C-labeled CL 92,100 in Hydrolytic
and Photolytic Environments: PD-M 10:959-1007. Progress
rept., Apr 5, 1973 through Oct 15, 1973. (Unpublished
study received May 1, 1974 under 4F1496; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:091409-K)
00087693 North, K.H. (1973) Counter"(R) Insecticide: Rat Metabolisn
of CL 92, 100 PD-M 10:1008-1080. Progress rept., Mar
1, 1973 througn Sep 23, 1973. (Unpublished study cecieved
May 1, 1974 under 4F1496; subnitted by American Cyanamid
Oo., Princaton, N.J.J CDL:091409-L)
00087702 Manuel, A.J. (1973) CL 92,100 and Its Metabolites in Chicken
Fat, Muscle, Liver, Kidney, Skin, and Eggs: Report No.
C-372. (Unpublished study received May 1, 1974 under
4F1496; sutriitted by American Cyanamid Co., Princeton,
N.J.; CLL:091837-B)
00087704 American Cyananid Oonpany (1973) CL 92,100: Determination
of Total CL 92,100 and Oxidative Metabolites in Chicken
Fat, Muscle, Skin.. Liver, and Kidney by Gas Liquid
Chraoatography. Method M-401 datt>d Mar 15, 1973.
(Unpublished study received May 1, 1974 under 4F1496;
CDL:091837-D)
66
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLICGRAFHY
Citations Considered to ba Part rf the Data Base Supporting
Registration Under the Standard
00087706 Stiller, W.A.; Schopbacn, A.; Ogg, P.J.; et al. (1973) Coun-
ter"(lM) 15G: Total Residues of Counter (CL 92,100) and
Its Toxic Metabolites in Soil: Report No. C-480.
Includes method rt-370 dated Oct 2, 1972. (Unpublished
study eeoeived May 1, 1974 under 4P1496; submitted by
American Cyansmid Co., Princeton, N.J.; CDL:091837-F)
00087708 Steller, W.A.; Ogg, P.J.; Van Scoik, W.S. (1973) Ccunter*(TM)
156: Residues of Counter (CL 92,100) and Its Individual
Tbxic Metabolites in Soil: Report No. C-385. Includes
mathod 14-453 dated Sep 4, 1973. (Unpublished study
received Hay 1, 1974 under 4F1496; submitted by American
Cyanamid Co., Princeton, N.J.; CEL:091837-H)
00087711 Barron, F.R., Jr. (1973) Letter sent to P. Critchlow date)
Apr 6, 1973: Counter 1SG soil insecticide. (Unpublished
study reoeived Apr 9, 1973 under 3G1340; submitted by
¦ American Cyananid Co*, Princeton, N.J.; CDL:092075-A)
00087712 American Cyananid Company (1971) CL 92,100: Analysis of
Granular FoEmulation by Gas Chromatography. Method
H-248 dated Oct 12, 1971. (Unpublished study received
Apr 9, 1973 under 3G1340; CDL:092075-B)
00087713 Anfiirican Cyanamid Company (1973) Gas Liquid Chromatography
Assay of CL 92,100 Technical Material. Method M-399
dated Mar 7, 1973. (Unpublished study received Apr 9, '
1973 under 3G1340; CDL:092075-C)
00087716 Anerican Cyanamid Canpany (1977) AC 92,100 Technical:
Stability. (Unpublished study received Apr 9, 1973
under 3G1340; CDL: 092075-G)
00087717 Roberts, S.; Wineholt, R.L. (1976) 81-day Dietary LC50 Study
of Terbufos in Bobwhite Quail and Mallard Duck: Laboratory
No. 6E3165. (Unpublished study received Nov 24, 1976
under 2749-427; prepared tff Cannon Laboratories, Inc.,
submitted by Ace to Chemical Co., Inc., Flushing, N.Y.;
CDL:226950-A)
00087718 Roberts, S.; Wineholt, R.L. (1976) Static 96-hour Toxicity
Study of Terbufos in Bluegill Sunfish and Brown Trout:
Laboratory No. 6E-3166. (Unpublished study received
Nov 24, 1976 under 2749-427; prepared by Cannon Labora-
tories, inc., submitted by Ace to Chemical Co., Inc.,
Flushing, N.Y.; CDL.-226951-A)
67
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00087722 American Cyananid Canpany (1972) Residue of AC 92,100 in
Corn. Includes method M—336 dated Jun 21, 1972. (Com-
pilation? unpublished study, including report nos.
0-335, 72-43, 82-47, received on unknown date under
241-EX-3; CDL:i23080-B>
00087726 Nang, G.T. (1973) Letter sent to Harold H. Nau dated Jun
21, 1973t Fost-morten examination—wildlife. (Unpublished
study received on unknown date under unknown acsmin.
no.; submitted by American Cyanamid Co., Princeton,
N.J.j CDL:223457-A)
00088210 Chiu, T.; Iucas, L.; Goldenbaun, L. (1981} Counter"(TM)
Terbufos (CL 92,100): Metabolism of Carbon-14 labeled
CL 92,100 in Soybeani Report No. PD-M 18-19:1-65.
(Unpublished study received tec 1, 1981 under 241-238;
sucnitted by American Cyananid Co., Princeton, N.J.;
CDL:070496-A)
00088211 American Cyanamic Company (1981) General Sunnaey: Counter
15-G. (Compilation; unpublished study received Dec 1,
1981 under 241238; CDL:C'70496-B)
00097892 Fink, R.; Reno, F.E. (1973) Final Report: Ore-gemration
Reproduction Study—Mallard Ducks: Project No. 362-146.
(Unpublished study received May 1, 1974 under 4F1496;
prepared by Environmental Sciences Corp.. submitted by
American Cyananid Co., Princeton, N.J.; CDL:090808-R)
00101495 Boudireau, P.; Forbis, A.D.; Franklin, L.; et al. (1982)
Acute Toxicity of Counter3 Terbufos to Oaphnia magna:
Static Acute Bioassay Report 28686. (Unpublished
study received Apr 20, 1982 under 241-238; submitted
by American Cyanamid Co., Princeton, N.J., CEL:247247-C)
00106551 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1982) Final
Report: Acute Oral ID50 — Botohite Quail: Ccunter®
Terbufos Technical: Project No. 130-133. (Unpublished
study received Apr 20, 1982 under 241-238; sufcmitted by
American Cyanamid Co., Princeton, N.J.; CDL:247247-B)
00109446 Daley, I.; Rinehart, W.; Martin, A. (1979) A Three Month
Feeding Study of Counter0 Terbufos Insecticide in Rats:
Project Mo. 78-2343 (Unpublished study received ? ,
1982 submitted by American Cyanamid Co., Princeton, N.J.;
CD'-: 247985-A)
68
-------
OFFICE OF PESTICIDE PROURK^S
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered bo be Part of the Data Base Supporting
Registration Under the Standard
GS0109001 American Cyanamid Cunjx>ny. Residue Studies Cor the Use
of Counter3 15G As a Cultivation Ti/ne Application for
Control of Con. Rootwonns. (Unpublistied study re-
ceived Now 10, 1977 under 241-238; CDL:232258)
GS0109002 U.S. Environmental Protection Agency (1975). Report on
the Ibxicity of Counter9 J.5G to Blusgill Sunfish.
Static Jar, Test No. 894, Nov 7, 1975; (unpublished
study prepared by U.S. EPA Chemical and Biological.
Investigations Branch, Beltsville, MO)
GS0109003 U.S. Environmental Protection Agency (1975). Report cn
the Toxicity of Counter® 15G to Rainbow Trout. Static
Jar, Test No. 909, Dec 12, 1975; (unpublished study
prepared by U.S. EPA Chemical and Biological
Investigations Branch, Beltsville, MO)
GS0109004 U.S. Environmental Protection Agency (1976). Report on
the Toxicity of Counter* 15G to Daphnia magna. Static
Jar, Test No. 922, Feb 2, 1976; (unpublished study pre-
pared by U.S. EPA Chemical and Biological Investigations
Branch, jBelstville, KD)
69
-------
APPEND IX 111 - 2 CMB Approval No. 2000-CS8 (Expires 1231-831
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA wci'on 3(C)(2)(B) notice contained in the referenced
Guidance Document I >m responding in the following manner
~ t. I will submit data in 8 n.Tiely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the RegLtrttion Guidelines or the Protocols contained
-------
APPENDIX II1-3
OMB Approval No. 20000468 {Expires: 12-31-83)
1 CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
\(To qualify, certify ALL four items) FOR DEVELOPMENT OF OATA
j 1. 1 am duly authorized to represent the following firm(s) who are subject to the require-
| ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
j to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to beiow as "my firm".)
2. My firm is willing to develop and submit the data a-, required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the fullowing required
items or data:
3. My firm has offered in writinj to enter into such an agreement. Copies of the offers ere tttsched-That crffer was irrevocable and included en offer to ae
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was nwd*
to the following firm(s) on the following date(s):
| NAME OF FIRM
DATE OF OFFER
I However, none of those firm(i) accepted mv offer.
14. My firm requests (hat EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
j have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. 1 understand CPA will promptly inform
9 me whether my firm must submit data to avoid suspension of its regirtration(s) under FIFRA Section 3(c)(2)(B). (This statement
1 does not apply to applicants for new products.) 1 give EPA permission to c'isclose this statement upon request.
i TYPED NAME
SIGNATURE
DATE
EPA Form 6580-6 (10-82)
-------
Appendix IV-1
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Gjidanc. Document for
Date
1 litest not
1 1 required
1 I for my
1 | product
1 |listed
1 1above
Registration I j(check
Guideline No.j Name of Test (below)
1
I am complying with 1
data requirements byI
I Submit-1
Iting |
iData I (For EFA Use Only)
1(At- |Accession Numbers
Citing MRIDt I tached", j Assigned
1 1
§158.20 | |
PRODUCT | |
CHEMISTRY | j
1 1
1 1
1 1
1 1
I 1
61-1 | Identity of I
1 inqredients I
1 1
I 1
61-2 | Statement of I
1 composition I
1 1
1 1
61-3 1 Discussion of j
I formation of j
1 ingredients j
1 1
1 1
62-1 | Preliminary I
j analysis j
1 1
1 1
62-2 j Certification of j
I limits I
1 1
62-3 | Analytical methods 1
1 for enforcement I
1 limits j
1 1
1 1
63-2 | Color 1
1 1
63-3 1 Physical state I
1 1
63-4 | Odor I
1 1
63-5 I Meltinq point 1
1 1
63-6 | Boiling point I
1 1
63-7 j Density, bulk- I
1 density, or j
1 specific gravity j
1 1
1 1
1 1
63-8 | Solubility j
1 1
63-9 | Vapor pressure j
1 1
63-10 | Dissociation I
1 constant j
1 1
1 1
72
-------
Appendix IV-1
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document foe
Date
1 iTest not
1 Irequired
1 |for my
1 | product
I |listed
1 1above
Registration I I(check
Guideline No. I Name of Test I below)
I am complying with j
data requirements by I
1 Submit-j
Iting |
iData 1 (For EPA Use Only)
1(At- IAccession Numbers
Citinq MRIDSItached)IAssigned
63-12 | pH |
63-13 j Stability 1
1 1
63-14 | Oxidizing/reducing |
1 reaction I
1 1
63-15 1 Flanmability 1
1 1
63-16 I Explodability j
1 1
63-17 | Storaqe stability I
1 1
63-18 1 Viscosity I
1 1
63-19 | Miscibility |
1 1
63-20 | Corrosion j
I characteristics 1
1 i
1 1
63-21 i Dielectric break- I
1 down voltaqe I
1 I
1 1
§158.135 | |
TOXICOLOGY | |
1 1
1 1
1 1
1 1
1 1
81-1 | Acute oral LD-50, I
1 rat |
81-2 I Acute dermal I
I LD-50 |
81-3 | Acute inhalation, j
1 LC-50 rat I
81-4 | Primary eye I
I irritation, rabbit|
81-5 | Primary dermal I
1 irritation 1
81-6 I Dermal sensitiza- |
I tion |
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1 1
73
-------
APPENDIX V-2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (REFER TO TOE SAMPLE LABELS FOLLOWING)
1
ITEM | LABEL ELEMENT
1 | Product name
1
1 APPLICABILITY I PLACEMENT
1 OF REQUIREMENT I REQUIRED
44
117
All products 1 Front panel
1
CN LABEL I
PREFERRED I COMMENTS
Center front 1
panel j
2 i Company name
I and address
1
All products 1 None
1
1
Bottom front: | If registrant is not the producer, must
panel or end j be qualified by "Packed for . . .,"
of label text I "Distributed by. . etc.
3 1 Net contents
1
1
A1J products 1 None
1
1
Bottom front | May be in metric units in addition to
panel or end j U.S. units
of label text j
4 I EPA Est. NO.
1
All products 1 None
1
Front panel I Must be in similar type size and run
1 parallel to other type.
5 | EPA Reg. No.
1
1
1
1
All products 1 None
1
1
1
1
Front panel, 1 May appear on the container instead of
immediately j the label.
before or j
following 1
Req. No. 1
6A | Ingredients
1 statement
1
All products I Front panel
1
1
Immediately I Text must run parallel with other text
following j on tihe panel,
product name 1
6B 1 Pounds/gallon
I statement
1
I
Liquid products I Front panel
where dosage j
given as lbs. I
ai/unit area j
Directly below I
the main I
ingredients !
statement j
7 | Front panel
1 precautionary
j statements
All products | Front panel
1
1
1 All front panel precautionary statements
1 must be grouped together, preferably
I blocked.
7A | Keep Out of Reach
I of Children
I (Child hazard
j warning)
All products I Front panel
1
j
Above signal I Note type size requirements,
word I
1
7B | Signal word
1
1
All products I Front panel
1
1
1
Immediately I Note type size requirements,
below child 1
hazard j
warning j
7 4
-------
APPENDIX V-2 (continued)
1
ITEM | LABEL ELEMENT
APPLICABILITY
OP REQUIREMENT
PLACEMENT
REQUIRED
ON LABEL I
PREFERRED I CCMMENTS
7C 1 Skull & cross-
1 bones and word
1 POISON (in red)
1
1
I
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
Front panel
Both in close i
proximity to j
signal word 1
1
1
1
7D
1 Statement of
practical
treatment
All products
in Categories
I, II, and III
Category Ii
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel I
for all. I
I
1
1
1
1
1
1
1
7E
Referral
statement
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
Front panel
1
1
1
1
1
1
1
8
Side/back panel
precautionjty
statements
All products
None | Tap or side 1 Must be grouped under the headings in
I of back panel I 8A, 8B, and 8C; preferably blocked.
1 preceding j
1 directions j
I for use I
8A
Hazards to I All products
humans and j in Categories
domestic I I, II, and III I
animals j |
None 1 Same a-3 above j Must be preceded by appropriate signal
1 1 word.
I 1
1 1
8B
Environmental 1 All products I None I Same as above I Environmental hazards include bee
hazards 1 I j | caution where applicable.
75
-------
1
| APPLICABILITY
PLACEMENT ON LABEL
ITEM
I FABEL ELEMENT
I OF REQUIREMENT
REQUIRED
PREFERRED
COMMENTS
8C
1 Physical or
j chemical
I hazards
I All pressurized
I products, others
I with flash
I points under
1 150°F
None
Same as above
9A
I Restricted
I block
I All restricted
I products
1
1
Tbp center
of front
panel
Preferably
blocked
Includes «. statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
siqnal word.
9C
I Misuse
1 statement
I All products
1
1
1
1
1
1
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
10A
I Re-entry
I statement
1 All
1 cholinesterase
1 inhibitors
In t±ie
directions
for use
Inmediately
after misuse
statement
IOC
1 Storage and
1 disposal block
1 All products
1
1
1
1
1
1
1
In the
directions
for use
Immediately
before
specific
directions
for use or
at the end of
directions
for use
Must be set apart and clearly distin-
guishable from fron other directions
for use.
10D
T Directions
I All products
None
None
May be in metric as well as U.S. units
U.S.
1 for use
1
76
-------
Appendix V-5
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 DISPOS-\L.n The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
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 devilop 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.
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under .
Above 10 to 15
Above 15 to 30
Over 30. . . .
.6 point
.8 point
10 point
12 point
77
-------
Appendix v-5
(continued)
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions:
The label of all products, except those intended solely for
domestic use, must uear 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 w«ter, 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 th.s 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 11 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."
78
-------
Appendix V-5
(continued)
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-
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Fet^ral 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 pesticiue disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
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 nisposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use nust bear one
ot the following container disposal statements:
Container Type Statement
Non-aerosol products
(bottles, cans,jars)
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Non-aerosol products
(bags)
Do not reuse bag. Discard bag in trash.
Aerosol products
Replace cap and discard containers in
trash. Do not incinerate or puncture.
79
-------
Appendix v-5
{continued)
2. The labels Cor 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.
Container Type
Statement
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and Dottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused*, dispose of in the same manner.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill oc by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording).
^Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
3. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix.
80
-------
Appendix v-5
(continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (£)
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 pento/ide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniiine
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 O-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomy1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
81
-------
Appendix V-5
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued:
Phenylraercuric 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
Tnallium 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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Appendix V-5
(continued)
"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-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-tolu idine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,dJ-pentalen-2-one
(kepone, chlordecone)
1,2-Dibrorao-3-chloropropane (DBCP)
Dibutyl phthalate
5-3,3-(Dichloroallyl diisopropylthiocarbamats (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12®)
315-Dichloro-N-(1,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroetiiar.e (DDT)
Dichlorethyl ether
2»4-Dichlorophenoxyacetic, esters and salts (2r4-D)
l»2-Dicnioropropane
lf3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4r4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
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Appendix V-5
(continued)
"Toxic" Commercial pesticide Products (RCRA "F" List)
Active ingredients:
Isobutyl alcohoi
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2»2'-«ethylenebis (3,4,6-trichlorophenol) {hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Iiethyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphoroaithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Si1vex
1,2 , 4,5-Tetrachloroben2ene
1,1,2, 2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
TrichloromonoEluoromethane (Freon 11 )
2.4.5-Tr ichlorophenol
2.4.6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
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Appendix V-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" Line)
Inert Ingredients:
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane (Freon 12®)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1»2-Trichloroethane
Trichlorofluoromethane (Freon 11®:
Vinyl chloride
Xylene
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^t0ST«*,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PKTICIDO AMD TOXIC SUBSTANCES
CERTIFIED MAIL
SUBJECT: Initiation of Reregistration Process for Pesticide
Products Containing Terbufos as the Single Active
Ingredient
Dear Registrant:
In accordance with the Federal Insecticide, Fungicide,
and Rodenticide Act (PIFRA), as amended, EPA's Office of
pesticide programs has begun the reregistration process for
pesticide products containing the subject ingredient. Signifi-
cant changes to the statute wore made in 1972, 1975, and
1978; thus, current requirements may be substantially different
from those in effect at the time your product(s) were registered.
The first phase of reregistration requires that you (1) make
a commitment to the Agency regarding data development and
(2) subsequently submit revised product labeling and associated
information.
This mailing contains the Guidance Document for prepara-
tion of submissions, as well as a listing of your affected
product(s) (Attachment A), and a separate list of registrants
with products subject to this standard and which contain
this active ingredient (Attachment B). The latter list is
for the purpose of cooperative data development.
The Guidance Document sets out the Agency's evaluation
of all available data pertaining to the subject chemical and
its registered uses, and its rationale for the regulatory
actions being taken At this time. Additionally, the Guidance
Documert contains instructions describing certain of the
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steps you must take to maintain registration for your product(s).
Products not brought into compliance with the Guidance Document
as supplemented by subsequent information from EPA about compliance
with certain data support requirements will be subject to suspension
and/or cancellation.
Specifically, the enclosed Guidance Document does the
following:
1. Introduces the purpose of this document.
2. Explains the Agency's policy regarding data submis-
sion and identifies, in table format, the data
that must be submitted to complete the Agency's
evaluation of each product. In addition, a
bibliography identifying the data which is considered
part of the data base supporting the registration
standard is included.
3. Sets out time-frames for submission of required
data.
4. Explains how to revise labeling for maufacturing use
products. (As the Guidance Document explains,
labeling is not required at this time.)
5. Provides submission instructions.
Because of: the variety and complexity of the requirements,
and the short statutory time-frames available for certain
actions, it is essential that you understand the specific require-
ments and procedures in order that you may respond in a correct
and timely manner. Since a part of these requirements is under
Section 3(c)(2)(B) of FIFRA, your first response may be required
within 90 days from receipt of this letter. Please note that
if you do not respond or do not comply fully with the requirements,
your application may be rejected or your product registration
cancelled or suspended.
If, after reviewing this material, you do not understand
what you must do or how or when you must respond, please contact
the Product Manager listed below who will assist you in every
reasonable way. If you wish to discuss the data requirements
or request that certain data be waived, you must write to the
Agency and indicate those data requirements with which you take
issue and your rationale for doing so. After the Agency has
had a chance to review your submission, the Product Manager will
contact you to set up a meeting for the purpose of resolving all
issues relative to data requirements.
87
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Please note that this guidance document will eventually
be supplemented by EPA with additional information about
compliance with data support requirements. In Monsanto v.
Administrator, EPA was recently enjoined by the District
Court for the Eastern District of Missouri from implementing
in any way the "mandatory data licensing" aspects of §3(c)(l)(D)
of FIFRA. EPA is assessing the implications of the injunction
for the reregistration process. Because of this unresolved
situation, EPA has decided to proceed with the requirements in
this guidance package which do not relate to the "data licensing"
issue and to supplement the package with additional guidance
when circumstances permit.
If you have any questions concerning this Guidance.Document,
you may contact the Product Manager listed below:
Mr. William H. Miller (Product Manager 16)
Registration Division (TS-7C7)
Office of pesticide Programs
Environmental protection Agency
Washington, D.C. 20460
Telephone: 703/557-2600
Sincerely, ..
Douglas D. Campt, Director
Registration Division (TS-767)
Enclosure
88
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ATTACHMENT A
PRODUCTS AFFECTED BY THIS
F.EREGISTRATION PROCESS
Following Is a list of your products affected by this rereg-
istration process. If this list is incomplete or inaccurate
in any way, please notify the Product Manager (PM) identified
in the letter.
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ATTACHMENT B
REGISTRANTS WITH PESTICIDE PRODUCTS CONTAINING
THE ACTIVE INGRED-IENT
The information attached will allow registrants with pesticide
products containing the above ingredient to contact, one
another regarding joint data development or sharing the cost
of data development under section 3(c)(2)(B) of FIFRA. This
information includes the following: EPA Reg. No., company
name, company address, active ingredient, percentage of active,
ingredient and type of formulation, such as Manufacturing-use
Product (MP), Technical Product (TP), Wettable powder (WP),
and Bmulsifiable Concentrate (EC).
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