REQUIREMENTS FOR INTERIM REGISTRATION
OF PESTICIDE PRODUCTS
CONTAINING ALDICARB
AS THE ACTIVE INGREDIENT
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
MARCH 1984
EPA-540/RS-84-001
-------
TABLE OF CONTENTS
Introduction 1
I. Regulatory Position 4
II. Requirement for Submission of Generic Data 23
III. Requirement for Submission of Product-Specific
Data 32
IV- Submission of Revised Labeling and Packaging
Information 35
A. Label Contents 35
1. Product Name
2. Company Name and Address
3. Net Contents
4. Product Registration Number
5. Producing Establishment
Registration Number
6A Ingredient Statement
6B Pounds Per Gallon Statement
7. Front Panel Precautionary Statements .
7A Child Hazard Warning Statements. . . .
7B Signal Word
7C Skull and Crossbones and Word Poison .
7D Statement of Practical Treatment . . .
7E Referral Statement
8. Side/Back Panel Precautionary Labeling
8A Hazard to Humans and Domestic Animals.
8B Environmental Hazard .........
8C Physical or Chemical Hazard
9 Misuse Statement
10A Storage and Disposal Block
10B Directions for Use
B. Collateral Information 39
V. Instructions for Submission 40
-------
APPENDICES
II-l Bibliography
II-2 FIFRA S3(c)(2)(B) Summary Sheet - EPA Form 8580-1
II-3 Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6
III-l Product Specific Data Report (End-Use Products)
EPA Form 8580-4
IV-1 40 CFR §162.10 Labeling Requirements
IV-2 Table of Labeling Requirements and Sample Labels
IV-3 Physical/Chemical Hazards Labeling Statement
IV-5 Storage and Disposal Statements
Note: Appendices IV-4 and IV-6 are not germane to this
document and are not included.
11
-------
INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 3(g), as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible. Each
registrant of a manufacturing use product of the active
ingredient who wishes to continue to sell or distribute that
product must apply for reregistration.
To fulfill this Congressional mandate, we have established
the Registration Standards program which will review all pesti-
cide active ingredients first registered before January 1,
1977. These pesticides will be reviewed in use clusters
which are prioritized on the basis of a ranking scheme giving
preference to pesticides used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. The regulatory position may
require the registrant to modify product labels to provide
additional precautionary statements, restrict the use of the
pesticide to certified applicators, provide reentry intervals,
modify uses or formulation types, specify certain packaging
limitations, or other requirements designed to assure that
proper use of the pesticide poses no potential adverse effects
to human health or the environment.
The scientific review, which is not contained herein
but is available upon request, concentrates.on the technical
grade of the active ingredient and identifies missing generic
data. However, during the review of these data we are also
looking for potential hazards that may be associated with
the formulated (end-use) products that contain the active
ingredient. If we find serious concerns, .we will bring
formulated products under the provisions of the Registration
Standards program to the extent necessary to protect the
public.
EPA has the authority under FIFRA §3(c)(2)(B) to require
that certain registrants submit generic data that will answer
our questions regarding the hazard that may result from the
intended use of the pesticide under review. Further, §3(c)
(2)(B) provides that these data are to be submitted by
those registrants who do not qualify for the formulator's
exemption [FIFRA §3(c)(2)(D)]. Normally, this means that
the registrants who are responsible for filling the data
gaps are the manufacturing-use product producers (basic
-------
suppliers of the active ingredient). However, end-use producers
will not qualify for the formulator's exemption if the source
of their active ingredient: (1) is not registered with EPA,.
and/or (2) is produced by the registrant's firm, or a firm
which has ownership in common with the registrant's firm.
These end-use producers can qualify for the formulator's
exemption if they change their source of supply to a registered
source, provided the source does not share ownership in
common with the registrant's firm. If the end-use product
registrant decides to switch sources, a new Confidential
Statement of Formula, EPA Form 8570-4, must be submitted to
the appropriate Product Manager within 90 days of receipt of
this Guidance Document. The chart on the following page
shows what is generally required of those who do and do not
qualify for the formulator's exemption in the Registration
Standards program.
If you decide to request the Agency to discontinue the
registration of any of your products subject to the require-
ments of 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 registra-
tion(s). If you decide to maintain your product registration(s),
you must provide the information described in the following
pages within the timeframes outlined. EPA will issue a notice
of intent to cancel or suspend the registration of any currently
registered product if you fail to comply with the requirements
set forth in this document.
Registrants are reminded that §6(a)(2) of FIFRA requires
you at any time to submit factual information raising concerns
of possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in
progress if those results show possible unreasonable adverse
effects.
-------
PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
To continue registration,
labeling, packaging and data
requirements must be satisfied
in accordance with this
document.
B. Multiple Active Ingredient
Products
Generic data required to con-
tinue the registration of the
active ingredient under review,
as described in this document
will be required and some
labeling precautions may also
be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the requirements of this
document. Affected products will
be dealt with in a variety of
ways, including but not limited
to the Label Improvement Program
and special intent to cancel
notices.
* End-use products of registrants who also produce a manufacturing-
use product must registrant fulfill the requirements specified in t
document for manufacturing-use product(s). Such end-use products
subject to the labeling changes required for products in
will be
above.
this
II'
NOTE: If all registrants in "I" above
I-A and B above, then the
fail to meet the requirements in
• • » *** *~* •** V -V «» r -^ff t\*Tt-r >•> *_ %» * « «-» *. N* ^£ ^* J. *. 'W ALl^r * *
registrants in "II" lose their right to
I-A and B above, then the registrants in "II" lose their
qualify for the formulator's exemption and become subject
requirements in I-A and B.
to the
-------
I. REGULATORY POSITION
A. Introduction
This guidance document describes the Agency's current regulatory
position regarding continued registration of manufacturing use
products (MPs) and end-use products (EPs) containing the insecti-
cide, acaricide and nematicide aldicarb. The Agency's position is
based on an evaluation of all registered uses and registered pro-
ducts with aldicarb as the sole active ingredient. This document
considers known chemical and toxicological properties of this
chemical, as well as established tolerances for residues in food
and feed commodities. From these considerations the Agency sets
forth the data and labeling requirements that must be met by regis-
trants and applicants of aldicarb products in order for the products
to be registered. These are interim requirements pending the outcome
of the Special Review process for this chemical, which is being
initiated by the Agency and will be conducted pursuant to 40 CFR
162.11. To be registrable under this document, MPs and EPs must list
aldicarb as the sole active ingredient. However, products containing
aldicarb will not be reregistered until the problem of ground water
contamination, as discussed below, has been resolved. The tables
accompanying this document list the data gaps which must be satisfied
through submission of additional information.
B. Description of Chemical and Use Profile
Aldicarb - C7H14N202S; mol. wt. 190.3
C.A.S. f 116-06-3, Shaughnessy # 098301
Aldicarb is the accepted common name for 2-methyl-2-(methylthio)
-------
propionaldehyde 0-(methylcarbamoyl)oxime. Other names include
the trade name Temik* and UC-21149.
Technical aldicarb is a white crystalline solid. It has a melting
point of 98-100° C (pure material). Under normal conditions,
aldicarb is a heat-sensitive, inherently unstable chemical and must
be stabilized to obtain a practical shelf-life.
f
Aldicarb is a carbamate pesticide which causes cholinesterase in-
hibition at very low dosage levels. Its chief metabolites aldicarb
sulfoxide and aldicarb sulfone are also potent cholinesterase
inhibitors.
This insecticide, acaricide and nematicide is manufactured and re-
gistered in the United States solely by Union Carbide Corporation.
There are no federally registered MPs containing aldicarb. However,
there are three federally registered EPs which contain aldicarb
as the sole active ingredient. There is also one federally regis-
tered EP containing aldicarb in a mixture with the fungicides penta-
chloronitrobenzene and 5-ethoxy-3-(trichloromethyl) 1)2,4-thiadia-
zole. Aldicarb is a soil incorporated pesticide commercially formu-
lated into a 5 percent(%) granular formulation, 10% granular formula-
tions and a 15% granular formulation. Registered uses include beans
(dried), cotton, grapefruit, lemons, limes, oranges, peanuts, pecans,
potatoes, sorghum, soybeans, sugar beets, sugarcane, sweet potatoes,
and ornamental plants. In addition to the federal registrations,
there are twelve (12) intra-state registrations and sixty six (66)
Special Local Need registrations for aldicarb.
-------
C. Regulatory Position
Based on the review and evaluation of all available data and other
relevant information on aldicarb, the Agency has made the fol-
lowing determinations:
1. Aldicarb is highly toxic by the oral, dermal and inhala-
tion routes of exposure. Neither aldicarb or its metabo-
lites have been demonstrated to be neurotoxic, oncogenic,
teratogenic or mutagenic in valid data reviewed to date.
2. Union Carbide has voluntarily restricted the use of
aldicarb products to certified applicators or people under
their direct supervision in part to reduce to potential for
further ground water contamination. Also, based on its high
acute toxicity via the oral, dermal and inhalation routes of
exposure, the Agency has determined that all aldicarb pro-
ducts must bear the "Restricted Use Pesticide" statement on
the product label.
3. Aldicarb leaches through soil and has been found in ground
i
water. The wide natural variability in soil types, weather
patterns and aquifer characteristics make it impossible to
specify a precise set of circumstances under which aldicarb
will not reach ground water. In an effort to reduce further
ground water contamination stringent label/use restrictions
are being imposed by this guidance document. Also, an
expedited Special Review of the aldicarb ground water con-
tamination problem is being initiated under Section 162.11
-------
(a)(6)(i) of Title 40 Code of Federal Regulations to
determine whether aldicarb products could be labeled in
any way that would both permit continued use and pre-
clude ground water contamination at unacceptable levels
and determine what such levels might be.
4. Although the Agency is unable to complete a full toler-
ance reassessment because of certain residue chemistry
data gaps, the Agency concludes that changes in the pre-
sent tolerances for aldicarb are not warranted at this
time. The additional residue data being required under
this document may necessitate a revision of specific
tolerances in the future.
5. In the absence of adequate soil dissipation data and
dermal exposure data, the Agency is imposing an interim
24-hour reentry interval for aldicarb.
6. MPs and EPs containing aldicarb as .the sole active in-
gredient may be registered for sale, distribution, and use
%
under the conditions set forth in the document pending the
outcome of the Special Review Process.
7. Registrants must provide or agree to develop additional
data, as specified in the tables in this guidance do-
cument, to maintain existing registrations or to obtain
new registrations of substantially similar products. .
D. Regulatory Rationale
The Agency has reviewed the available data concerning toxicology,
-------
environmental, residue and product chemistry, and ecological
effects. Sufficient data are available to show that aldicarb has
a high acute toxicity via the oral, inhalation and dermal routes
of exposure and has been assigned to Toxicity Category I. The
toxicology data base for aldicarb is nearly complete; however, ad-
ditional mutagenicity tests are being required by this guidance
document. Neither aldicarb nor its metabolites have been shown
to be neurotoxic, oncogenic, teratogenic, or mutagenic in studies
that have been reviewed to date.
Several data gaps have been identified in the areas of product
chemistry and residue chemistry. These data gaps require the
submission of additional information on the manufacturing process,
chemical analysis, certification of upper limits of impurities, as
well as large animal metabolism data and residue analyses of
various food and feed commodities.
In 1979, aldicarb residues were found in drinking water wells
located near aldicarb treated potato fields in Suffolk County, Long
Island, New York at levels <200 parts per billion (ppb). The
Agency's Office of Drinking Water subsequently established a Health
Advisory Level (HAL) of 10 ppb for residues of aldicarb iin drinking
water. Aldicarb residues have since been found in drinking water
wells at levels above 10 ppb in other states including Wisconsin,
Florida, Maine, Connecticut, Delaware, Maryland, New Jersey, Rhode
Island, Virginia and California.
As a result of the ground water contamination, Union Carbide Corpora'
tion voluntarily imposed use restrictions on their aldicarb products
8
-------
intended to reduce further ground water contamination. First,
aldicarb has been restricted from use in Suffolk County, Long Island,
New York. Secondly, the use on potatoes has been limited to one
application every other year and only after plant emergence in the
counties of of Hartford in Connecticut, Kent and New Castle in
Delaware, Franklin and Hampshire in Massachusetts, Worchester in
Maryland, Atlantic, Burlington, Cumberland, Monmouth and Salem in New
Jersey, Newport and Washington in Rhode Island and Accomack and
Northampton in Virginia. Third, users are advised to apply aldicarb
selectively and to avoid use in well drained soils, particularly in
areas having shallow and unconfined aquifers. Fourth, the sale and
use of all aldicarb products have been voluntarily restricted to
certified applicators or people under their direct supervision.
While the Agency has voluminous ground water monitoring data and
some descriptive environmental fate data on aldicarb, this informa-
tion is not sufficient to fully assess the environmental fate of
aldicarb. However, from these data and other information it has
been determined that aldicarb and its sulfoxide and sulfone meta-
«
bolites may leach in areas of fine to coarse textured soils, in-
cluding those soils with a high organic matter content. Additional
data on soil metabolism, soil and aquatic dissipation, leaching and
volatility are being required to fully assess the environmental fate
and transport of aldicarb and its metabolites.
Based on the current and the additional use restrictions imposed by
this guidance document, the Agency believes that the potential for
further ground water contamination will be reduced. However,
-------
because of the ground water contamination problem an expedited
Special Review is being initiated by the Agency to determine whether
aldicarb products could be practically labeled to permit the con-
tinued use of the products, preclude further ground water contami-
nation at unacceptable levels and determine what such levels might
be.
The available data indicate that aldicarb is highly toxic to mam-
mals, birds, estuarine/marine organisms and freshwater organisms.
However, limited exposure is expected to mammals from a dietary
standpoint. Data from field studies and the use history of
aldicarb provide sufficient information to suggest that applica-
tion of this pesticide may result in some mortality, if not local
population reductions, in certain avian species. Whether these
effects are excessive, long lasting, or likely to diminish wild-
life resources cannot be stated with any degree of certainty.
Therefore, additional field studies are needed which further
quantify the impact on avian and small mammal populations.
i
)
The Pesticide Incident Monitoring System (PIMS) reports on
aldicarb from 1966 through 1982, contained 165 incidents asso-
ciated with human injury, 6 incidents involving animals, 6 inci-
dences involving environmental contamination and 6 incidences
involving non-target plants and crops. Most of the human inci-
dents alleged that aldicarb was the cause of the poisoning, but
there was insufficient evidence to support that conclusion.
Those incidents involving confirmed aldicarb poisonings resulted
from failure to use label recommended safety equipment while
10
-------
applying aldicarb.
Other incidents resulted from accidental spillage, ingestion of
aldicarb, or the consumption of food commodities improperly treated
with aldicarb.
In summary, the Agency has concluded that it can continue the reg-
istration, but not reregister this chemical at this time for the
following reasons:
1. Adequate data are available to assess the acute oral, in-
halation and dermal toxicological effects of this chemical
on humans.
2. The review of the available data and other information
on ground water contamination raises concerns of possible
unreasonable adverse effects to man. The Special Review
will investigate the practicality of labeling/use restric-
tions that would permit aldicarb's continued use while pre-
venting ground water contamination at unacceptable levels
of either aldicarb or its metabolites. Among other things,
the Special Review will attempt to determine what such levels
might be.
3. In accordance with the FIFRA, the Agency's policy is not
to cancel or to withhold registration merely for the lack
of certain data (See sections 3(c)(2)(B) and 3(c)(7) of
FIFRA). Rather, publication of this document provides a
mechanism for identifying data needs, and registration under
this document allows for upgrading of labels during the
11
-------
period in which the required data are being gene'rated.
When these data are received, they will be reviewed by the
Agency. The Agency will then determine whether these data
will affect the registration of this chemical.
E. Criteria for Products Subject to the Document
This guidance document covers all manufacturing use and end use
products that contain aldicarb-as the sole active ingredient.
Registrants and applicants for registration of such products must
comply with all terms and conditions described herein. This in-
cludes making a commitment to fill data gaps on a schedule specified
by the Agency. Also, registrants and applicants for registration
must follow the instructions contained in the document and complete
and submit the appropriate forms within the specified timeframe.
F. Acceptable Ranges and Limits
1. Product Composition Standards
To be fully covered under this document, MPs and EPs must
contain aldicarb as the sole active "ingredient. Each product
formulation proposed for registration must be«fully described
with appropriate certification of limits.
2. Acute Toxicity Limits
The Agency will consider for registration any MPs and EPs
provided the product is supported by acute toxicity data
and the labeling for the product bears appropriate pre-
cautionary statements.
12
-------
3. Use Patterns
To be registered under this document, end-use products
containing aldicarb must be labeled for use on the fol-
lowing agricultural and ornamental commodities. MPs must
be labeled to allow for formulation into EPs which are
intended for use on EPA accepted uses. The attached index
entry lists all registered uses, as well as approved maximum
application rates and frequencies.
Terrestrial Food Use
beans (dried), cotton, grapefruit, lemons, limes, oranges,
peanuts, pecans, potatoes, sorghum, soybeans, sugar beets,
sugarcane and sweet potatoes
Terrestrial Non-Food Use
birch, dahlias, holly, lilies (bulbs), roses and turf
Corrunericial Greenhouses
carnation, chrysanthemum, easter lilies, gerbera, orchids,
poinsettia, roses and snapdragons
«
G. Required Labeling
All MPs and EPs containing aldicarb must bear appropriate labeling
as specified in 40 CFR 162.10, in addition to the following specific
labeling requirements.
1. Labeling Requirements for All Aldicarb Products
The following precautions must be included in the Hazards
to Humans section the the product label:
13
-------
"Poisonous if swallowed. May be 'fatal or harmful by skin
or eye contact or by breathing dust. Causes cholinesterase
inhibition. Warning symptoms of poisoning include weakness,
headache, sweating, nausea, vomiting, diarrhea, tightness in
che^st, blurred vision, pinpoint eye pupils, abnormal flow of
saliva, abdominal cramps, and unconsciousness. Atropine
sulfate is antidotal.
In case of skin contact, wash skin immediately with soap
and water. Remove contaminated clothing and wash before
reuse. In case of swallowing, drink 1 or 2 glasses of
water and induce vomiting by touching back of throat with
finger or blunt object. Do not induce vomiting or give
anything by mouth to an unconscious person."
2. Label Requirements for Manufacturing-Use Products
Use Pattern Statement
For formulation into end-use products intended only for
vises accepted by the United States Environmental Protection
Agency.
Environmental Hazard Statements
This product is toxic to fish and wildlife. Do not discharge
into lakes, streams, ponds or public water except in accord-
ance with a NPDES permit. For guidance contact the nearest
EPA Regional Office.
14
-------
3. Labeling Requirements for End-Use Products
a. The following "Restricted Use Statement" must appear on
the product label.
RESTRICTED USE PESTICIDE
For retail sale to and use only by certified applicators or
persons under their direct supervision and only for those
uses covered by the certified applicator's certification.
b. The product label must state the following:
"Do not apply in Suffolk County, Long Island, New York,
and Del Norte County, California at any time."
"Do not plant any crop other than those with registered
aldicarb uses in aldicarb treated soil."
"This product is usually decomposed into harmless resi-
dues. However, a combination of sandy and acidic soil
•.
conditions, moderate to heavy irrigation and/or rain-
fall, use of 3 or more pounds active ingredient per
acre, and soil temperature below 50°F at the time of
application, tend to reduce degradation and promote
movement of residues to ground water. If this describes
your local use conditions and ground water in your area
is used for drinking, do not use this product without
first contacting (company name)."
15
-------
"Do not apply more than 5 Ibs. active ingredient per acre
in the state of Florida."
"Application to citrus fruits in the state of Florida may
be made between January 1 and April 30 only."
c. Under the potato use directions:
"Do not apply to any field in the state of Maine or
Wisconsin or the counties of Hartford, CT, Kent and New
Castle, DE, Franklin and New Hampshire, MA, Worchester,
MD, Atlantic, Burlington, Cumberland, Monmouth and Salem,
NJ, Newport and Washington, RI and Accomack and
Northampton, VA more than once every two years and only
after plant emergence."
d. Required Clothing
Wear long-sleeved clothing and protective gloves when
handling. Wash hands and face before eating or smoking.
Bathe at the end of the work day. Change clothing daily
and wash before reuse.
e. Environmental Hazard Statements
Do not plant any crop other than those with registered
aldicarb uses in aldicarb treated soil.
This product has been found in ground water. This product
is toxic to fish, birds and other wildlife. Birds feeding
on treated areas may be killed. Cover or incorporate
granules in spill areas. Runoff from treated areas may be
16
-------
hazardous to fish in neighboring areas. Do not apply
directly to water or wetlands. Do not contaminate water
by cleaning of equipment or disposal of waste.
NOTICE: Under the Endangered Species Act, it is a Federal
Offense to use any pesticide in a manner that results in
the death of a member of an endangered species. This act
protects Attwater's Greater Prairie Chicken in the Texas
counties of Aransas, Austin, Brazoria, Colorado, Galveston,
Goliad, Harris, Refugio and Victoria. Prior to making ap-
plications in these counties, the user must determine that
this species is not located in or immediately adjacent to
the area to be treated. If the user is in doubt whether
or not the above named endangered species may be affected,
he should contact either the regional U.S. Fish and
Wildlife Service Office (Endangered Species Specialist)
or personnel of the State, Fish and Game Office.
H. Tolerance Reassessment
Tolerances have been established for aldicarb and its'sulfoxide
and sulfone metabolites on a number of different food and feed
crops. A wide array of toxicology studies have been used in
support of these tolerances. These data include a 2-year rat
feeding/oncogenicity study with a no-observed effect level (NOEL)
(other than cholinesterase inhibition) of 0.3 milligrams (mg)/
kilogram (kg) of body weight (bw)/day and was negative for once—
genie effects at the level tested (0.3 mg/kg bw/day); a 2-year
rat oncogenicity study which was negative for oncogenic effects
17
-------
at the levels tested (0.1 and 0.3 mg/kg bw/day); a 100-day dog
feeding study and a 2-year dog feeding study with NOELs (other
than cholinesterase inhibition) of 0.7 and 0.1 mg/kg bw/day,
respectively (highest levels tested (HLT)); an 18-month mouse
feeding/oncogenicity study with a NOEL of 0.7 mg/kg bw/day (HLT)
and was negative for oncogenic effects at the levels tested (0.1,
0.3 and 0.7 mg/kg bw/day); a 2-year'mouse oncogenicity study
which was negative for oncogenic effects at the levels tested
(0.3 and 0.9 mg/kg bw/day); a 6-month rat feeding study using
aldicarb sulfoxide with a NOEL for cholinesterase inhibition of
0.125 mg/kg bw/day; a 3-generation rat reproduction study with
a 0.7 mg/kg bw/day NOEL; a rat teratology study which was nega-
tive for teratogenic effects at 1.0 mg/kg bw/day (HLT); a
rabbit teratology study which was negative for teratogenic
effects at 0.5 mg/kg bw/day (HLT); and a hen neurotoxicity study
which was negative at up to 4.5 mg/kg bw/day.
The Acceptable Daily Intake (ADI) for aldicarb and its cholines-
terase inhibiting metabolites has undergone extensive critical
«
review within the last few years. In 1982, the World Health
Organization (WHO) re-evaluated the ADI for aldicarb and recom-
mended a value in the range of 0 - 0.005 mg/kg/day. A report
issued by the Institute for Comparative and Environmental Toxico-
logy at Cornell University in 1983, suggested "a reasonable range
for the ADI to be 0.003 to 0.01 mg/kg, the Office of Pesticide
Programs (OPP's) currently accepted value of 0.003 mg/kg being the
most conservative and the upper value of 0.01 mg/kg being a dose
that causes a depression of whole blood cholinesterase approxi-
18
-------
mating the range of normal intra-individual variation".
In 1983, the Assistant Administrator for EPA formed an Aldicarb
Review Committee to evaluate the available toxicity data for
aldicarb and determine the appropriate ADI. A formal report is
not available at this time; however, one of the suggestions of
the committee was the use of an "intermediate uncertainty factor".
Such safety factors were previously discussed by the EPA in the
Consent Decree Water Criteria Documents (U.S. EPA 1980, FR 45 No.
231, November 28, 1980, pg. 79347). The use of the suggested
32-fold "intermediate uncertainty factor" would result in an ADI
approximating 0.0038 mg/kg/day, if adopted. Further, the
National Academy of Sciences is re-evaluating aldicarb this year
(1984) in conjunction with their developmemnt of Drinking Water
and Health Criteria documents.
Considerable effort has been expended by EPA, along with national
and international committees, to evaluate the toxicity of aldicarb
and its relationship to an Acceptable Daily Intake. The collec-
tive recommendations are supportive of the (OPP's) present ADI for
aldicarb. Therefore, OPP considers it prudent, at this time, not
to alter its established ADI of 0.003 mg/kg/day.
Based on the established tolerances for aldicarb and it cholines-
terase inhibiting metabolites in 40 CFR 180.269, the current theo-
retical maximum residue contribution (TMRC) for aldicarb and its
metabolites is 0.1120 mg/day for a 1.5 kg diet, which utilizes
62.14 percent of the ADI.
19
-------
Further, the Agency's Office of Drinking Water has established a
Health Advisory Level (HAL) of 10 parts per billion (ppb) for
residues of aldicarb in drinking water. However, since the HAL
is derived from the ADI and the ADI may undergo changes in the
future, the HAL may be revised. Such a change would likely be an
increase in the HAL.
U.S. Tolerances
Crop Maximum Residue
Limit (PPM)
Bananas 0.3
Beans (dried) 0.1
Beets, sugar 0.05
Beets, sugar, tops 1.0
Cattle, fat 0.01
Cattle, meat by-products (mbyp) 0.01
Cattle, meat 0.01
Coffee beans 0.1
Cottonseed 0.1
Goats, fat 0.01
Goats, mbyp 0.01
Goats, meat 0.01
Grapefruits 0.3
Hogs, fat 0.01
Hogs, mbyp 0.01
Hogs, meat 0.01
Horses, fat 0.01
Horses, mbyp 0.01
Horses, meat 0.01
Lemons 0.3
Limes 0.3
Milk 0.002
Oranges 0.3
Peanuts 0.05
Peanut, hulls 0.5
Pecans 0.5
Potatoes 1.0
Sheep, fat 0.01
Sheep, mbyp 0.01
Sheep, meat 0.01
Sorghum, fodder 0.5
Sorghum, grain 0.2
Soybeans 0.02
20
-------
U.S. Tolerances (cont.)
Crop Maximum Residue
Limit (PPM)
Sugarcane 0.02
Sugarcane, fodder 0.1
Sugarcane, forage 0.1
Sweet potatoes 0.1
International Tolerances
The following tolerances for residues of aldicarb and its cholines-
terase inhibiting metabolites have been established:
Canada: 1.0 ppm potatoes
0.1 ppm sugarbeets
Mexico*: 0.02 ppm soybeans, sugarcane and sweet potatoes
0.05 ppm peanuts and sorghum
0.1 ppm dried beans, coffee and cottonseed
0.5 ppm pecans and sorghum fodder
0.6 ppm citrus fruits
The latest Codex Alimentarius entry and tolerances for aldicarb
^T *.
and its cholinesterase inhibiting metabolites are:
Crop Maximum
Residue Limit
(Mg/Kg)
Bananas 0.5
Beans, dried 0.1
*Mexico tolerances are established for residues of aldicarb
per se.
21
-------
Codex Alimentarius Entry and Tolerances (cont.)
Crop Maximum
Residue Limit
(Mg/Kg)
Citrus fruits
Coffee
Cottonseed
Cottonseed, hulls
Meat
Peanuts
Peanut, hulls
Pecans
Potatoes
Soybeans
Sugar beets
Sugar beet, tops
Sweet potatoes
0.2
0.1
0.1
0.3
0.01
0.05
0.5
0.5
0.1
0.02
0.05
1.0
-0.1
22
-------
II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the 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 II-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
document. As required by FIFRA Section 3(c)(2)(B),
you are required to take appropriate steps to comply
with this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA
how you will satisfy the requirements of this Notice.
Any such suspension will remain in effect until you have
complied with the terms of this Notice.
B. What Generic Data I/ Must Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this chapter. That table shows all the
generic data needed to evaluate the continued registrability
of all products, and the dates by which the data must be
submitted. The required data must be submitted and any
necessary studies must be conducted in accordance with
EPA-approved protocols, the Pesticide Registration
Guidelines j2/, 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 registration 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
\J Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient (or all such
products having a certain use pattern), regardless of any such
product's unique composition or use. Product-specific data relate
only to the properties or effects of a product with a particular
composition (or a group of products with closely similar composition)
V The Pesticide Registration Guidelines were reproposed on
November 24, 1982 in 47 Federal Register 53192.
23
-------
type for each major formulation category (e.g., emulsifiable
concentrates, wettable powders, granulars, etc.) These
are classified as generic data and when needed are
specified in Table A. EPA may possess data on certain
"typical formulations" but not others. Note: The "typical
formulation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Chapter IV of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II-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 II-3)V
4. Request that EPA amend your registration by deleting the
uses for which the data are needed. (This option is not
available to applicants for new products.)
V FIFRA Section 3(c)(2)(B) authorizes joint development of
data Fy 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)
24
-------
5. Request voluntary cancellation of the registrations)
of your products for which the data are needed. (This
option is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required
data or how quickly the data must be submitted. If the
test procedures you plan to use deviate from (or are not
specified in) the registration guidelines or protocols
contained in the reports of the Expert Groups to the
Chemical Groups, Organization for Economic Cooperation
and Development (OECD) Chemicals Testing Programme, you
must submit the protocol for Agency review prior to the
initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product
Manager. The extension request should state the reasons
why you conclude that an extension is appropriate. While
EPA considers your request, you must strive to meet the
deadline for submitting the required data.
(Footnote continued from previous page)
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3(c)(2)(B)(iii ) ] ; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not -
suspend the second firm's registration. 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.
25
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR ALDICARB
V
Data Requirement Corposition
§158.120 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
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Yes
Partially
No
No
No
Yes
Yes
Yes
Yes
N/A
Yes
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?2/
GS0140090*
GS0140090*
_
-
-
GS0140085*
GS0140090*
GS0140090*
GS01 40090*
GS0140090*
-
GS0140090*
No
Yes3/
Yes
Yes
Yes
No
No
No
No
No
No
No
Specific Gravity
26(a)
-------
TABLE A i
GENERIC EftTA REQUIREMENTS FOR ALDICARB
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
S158.120 Product Chemistry
63- 8
63- 9
63-10
63-11
63-12
63-13
Other
64- 1
(continued)
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
coefficient
- PH
- Stability
Requirements:
- Submit tal of samples
TGAI OR PAI
PAI
PAI
PAI
TGAI
TGAI
Choice
Partially
Yes
No
No
No
Yes
N/A
GS0140090* Yes4/
GS0140090* No
Yes
Yes
Yes
GS0140088*, GS0140091* No
No
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; Choice = Choice of
several test substances determined on a case-by-case basis.
2/ Data must be submitted no later than QP.T 1QR4 •
3/ The manufacturing process is needed, including the purity of the starting materials, intermediates and a des-
cription of the reaction conditions, any purification steps and quality control measures.
4/ Solubility data expressed in terms of g/100 ml of solvent at 20° C (68° F) or in terms such as ppm (mgAg)
needed.
* Data submitted by Union Carbide. These data may be compensable.
26(b)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL ALDICARB
Must Additional
Data Be Submitted
Under FIFRA Section]
3(c)(2)(B)?2/
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
5158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants
PAIRA
Yes
- Livestock
171-4 - Residue Analytical Method
- Plant residues
- Animal residues
PAIRA and plant
metabolites
Partially
TGAI and metabolites
TGAI and metabolites
Yes
Yes
GS0140001*,
GS0140003*,
GS0140005,
GS0140007,
GS0140009,
GS0140011,
GS0140013*,
GS0140015*
GS0140002*
GS0140004
GS0140006
GS0140008
GS0140010
GS0140012
GS0140014*
00053373*, 00010933
00053371, GS0140019
00102023, 00101967*
GS0140022,
GS0140024,
GS0140026*,
GS0140028*,
GS0140030*,
GS0140032*,
GS0140034*,
GS0140036*,
GS0140038*,
GS0140040
GS0140023
GS0140025*
GS0140027*
GS0140029*
GS0140031*
GS0140033*
GS0140035*
GS0140037*
GS0140039
No
Yes3/
No
27(a)
-------
GENERIC DATA REQUIREMENTS FDR ALDICARB
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Sectic^
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Storage Stability Data PAI
Partially GS0140041,
GS0140043,
GS0140045*,
GS0140047*,
GS0140049*,
GS0140051*,
GS0140053*,
GS0140055*,
GS0140057*,
GS0140059*
GS0140042
GS0140044
GS0140046*
GS0140048*
GS0140050*
GS0140052*
GS0140054*
GS0140056*
GS0140058*
Yes4/
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Root and Tuber-Vegetable Group
o Potatoes
— Crop field trials TEP
— Processed Food/Feed
potato chips EP
potato, dried EP
potato granules EP
Yes
Yes
No
No
GS0140060, GS0140061
GS0140081*
GS0140060, GS0140061
GS0140081*
No
No
Yes5/
Yes5/
27(b)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALDICARB
Data Requirement
ConpositionV
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
174-4 - Magnitude of the Residue -
Residue Studies (continued)
0 Sugar beets
—Crop field trials TEP
0 Sweet potatoes
—Field trials TEP
- Leaves of Root and Tuber
Vegetables Group
0 Sugar beet tops
—Field trials TEP
- Legume Vegetables (Succulent
or Dried)
0 Dried Beans
—Field trials TEP
0 Soybean
—Field trials TEP
Yes
Yes
Yes
Yes
Yes
GS0140063*
GS0140064*
GS01400631
GS0140066*
GS0140066*
No
No
No
No
No
27(c)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALDICARB
Data Requirement
Composition^/
Does EPA Have Data
To Satisfy This
Requ irement? (Yes,
No or Partially)
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section)
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
— Processed Food/Feed
Soybean meal
Soybean hulls
Soybean oil
Soybean soapstock
- Citrus Fruits Group
0 Grapefruit
— Field trials
0 Lemons
— Field trials
0 Lines
— Field trials
EP
Partially
GS0140066*
Yes6/
TEP
TEP
TEP
Yes
Yes
Yes
GS0140067*, GS0140068*
GS0140069*
GS0140070*
No
No
No
27(d)
-------
GENERIC DATA REQUIREMENTS TOR ALDICARB
Data Requirement
Composition!/
Dees EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Sectior
3(c)(2)(B)?2/
§158,125 Residue Chemistry
(continued)
174-4 - Magnitude of the Residue -
Residue Studies (continued)
0 Oranges
— Field trials
— Processed Food/Feed
Citrus juice
Citrus molasses
Citrus oil
Citrus pulp
- Tree Nut Group
0 Pecans
— Crop field trials
- Cereal Grains Group
0 Sorghum grain
— Crop field trials
TEP
EP
Yes
Yes
GS0140077*, GS0140072*
GS0140077*, GS0140072*
No
No
TEP
Yes
GS0140074*
No
TEP
Yes
GS0140075*
No
27(e)
-------
GENERIC tWTA REQUIREMENTS TOR ALU1CAKB
Data Requirement
Composition^/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
174-4 - Magnitude of the Residue -
Residue Studies (continued).
— Processed Food/Feed
Sorghum bran
Sorghum flour
Sorghum shorts
- Forage, Fodder and Straw
Cereal Grains Group
0 Sorghum fodder
— Crop field trials
- Miscellaneous Crops
0 Bananas
— Crop field trials
0 Coffee
— Crop field trials
EP
Yes
TEP
Yes
TEP
TEP
Yes
Partially
GS0140075*
GS0140076*
GS0140077*
GS0140078*
No
No
No
Yes7/
27(f)
-------
GENREIC DATA REQUIREMENTS FOR ALDICARB
Data Requirement
Composition!/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Secti<
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
174-4 - Magnitude of the Residue -
Residue Studies (continued)
- Miscellaneous Crops (continued)
0 Cottonseed
— Field trials
— Processed Food/Feed
Cottonseed hulls
Cottonseed oil
0 Peanuts
— Field trials
— Processed Food/Feed
Peanut meal
Peanut crude oil
TEP
EP
Partially
Yes
00101977*, GS0140080
00101977*, GS0140080
Yes8/
No
TEP
EP
Yes
Yes
GS0140081*
GS0140081*
No
No
27(g)
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR ALDICARB
Data Requirement
Coiposi t i on V
Does EPA Have Data
To Satisfy This
Requ i rement ? (Yes
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Sectio
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
174-4 - Magnitude of the Residue -
Residue Studies (continued)
- Miscellaneous Crops (continued)
0 Sugarcane
— Field trials TEP
— Processed Food/Feed EP
Sugarcane, juice
Sugarcane, molasses
Sugarcane, raw sugar
0 Sugarcane, fodder
— Field trials TEP
0 Sugarcane, forage
— Field trials TEP
Yes
Yes
Yes
Yes
GS0140082*
GS0140082*
GS0140082*
GS0140082*
No
No
No
No
27(h)
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR ALDICARB
Data Requirement
Composition^/
Does EPA Have Data
To Satisfy This
Requi rement? (Yes
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Sectic
3(c)(2)(B)?2/
S158.125 Residue Chemistry
(continued)
174-4 - Magnitude of the Residue -
Residue Studies (continued)
- Miscellaneous Crops (continued)
0 Tobacco
— Field trials
TEP
Yes
00102179*, 00102180*
No
Meat
Milk
TEP
TEP
Partially
Yes
GS0140081*, 00101967* Reserved9/
00053372*
GS0140083*, 00053372*
No
27(i)
-------
GENERIC DATA REgUlKEMENTS tTJK
§158.125 Residue Chemistry
(continued)
I/ Composition: 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 APR 1986 '
3/ A radio-labelled metabolism study in ruminants^identifying and quantifying residues in tissue is required. If the
the metabolism in the ruminant is found to differ significantly found that in the rat, a swine metabolism study
will be needed.
4/ Stability data are needed for aldicarb residues in animal tissues a milk stored at freezing temperatures for a
tine period approximating the normal storage period.
5/ A processing study determining residues in potato granules and dried potatoes is needed. If residues are found to
concentrate in these commodities, food additive tolerances will be required.
6/ A fractionation study is needed in which field treated soybeans containing weathered residues of 0.02 ppm are
processed into meal, hulls, oil, and soapstock. If residues are found to concentrate in these commodities,
food/feed additives tolerances will be needed.
7/ Residue analyses are needed for instant coffee.
8/ Residue determinations are needed on cotton foliage 90 days after sidedress treatments at 3 Ibs. active ingredient/acre
preceded by at-plant treatments of 1 Ib. active ingredient/acre. If residues are detected, a cotton forage
tolerance will be needed. Alternatively, label restrictions against feeding or grazing of cotton forage may
be proposed.
9/ Depending upon the results of the 14-C radiolabeled ruminant metabolism study, a ruminant feeding study with the
cholinesterase inhibiting metabolites aldicarb sulfoxide, aldicarb sulfone and any other metabolites of
concern at levels of 0.8, 2.4 and 8.0 ppm for 28 consecutive days and subsequent residue analysis on ruminant
tissues (muscle, liver, kidney, and fat) from animals sacrificed within 24 hours of the final feeding may be
required. (The parent compound need not be fed since aldicarb per se is a minor residue in feed items.]
* Data submitted by Union Carbide. These data may be compensable.
27(j)
-------
GENERIC DATA REQUIREMENTS FOR ALDICARB
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Patterns No or Partially) Citation 3(c)(2)(B)?3/
§158.135 Toxicology
ACUTE TESTING:
81-1 - Oral LD5Q - Rat TGAI A,B,F Yes 00060194*,
00100382,
00053342,
00030423,
00049330,
00100389*,
00035376*,
00053343*,
00100391,
00079566,
00080698,
00054442*,
00102070*,
00055536*,
00100393*,
00028645*,
00028647*,
00057332,
00080708
81-2 - Dermal LDcn TGAI A,B,F Yes 00030424*,
00055535*,
00102143*,
00080811,
00035378* ,
00035370,
00510121
00069745* No
00069922
00057333
00035372
00100386*
00054410*
00100390*
00035375*
00101917*
00053341
00061087
00100392*
00044739*
00029295
00080710
00028646*
00100384
00091241
00030425* No
00060195*
00069919
00101914*
00055537
00035371
28(a)
-------
GENERIC DATA REQUIREMENTS FOR ALDICARB
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Conposition Patterns No or Partially)
Bibliographic
Citation
§158.135 Toxicology
(continued)
Acute Testing; (oont.)
81-3 - Inhalation IC$Q - Rat
81-7 - Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
A,B,F
A,B,F
Yes
Yes
00073345*, 00101943
00080699, 00100387
No
No
SUBCHRONIC TESTING;
82-1 - 90-Day Feeding -
Rodent, Non-rodent
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation -
Rat
82-5 - 90-Day Neurotoxicity-
Hen/Mamnal
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,F
A,B,F
A,B,F
A,B,F
Yes
Yes
N/A
N/A
N/A
00057337, 00100381
00069917, 00044737*
0510121, 0058632
00080701, 0080825
No
No
No
No
No
28(b)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALDICARB
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.135 Toxicology
(continued)
CHRONIC TESTING:
83-1 - Chronic Toxicity -
2 species:
Rodent
Non-rodent
83-2 - Oncogenicity Study
2 species:
Rat
Mouse
83-3 - Teratogenicity
2 species
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,F
A,B,F
ArB,F
A,B,F
A,B,F
Yes
Yes
Yes
Yes
Yes
00057340*, 00053350*
00029943*, 00060196*
GS0140201
GS0140202
GS0140203, 00029943*
GS0140203, 00081413
00044732*, 00044733*
00044734*, 00100388*
GS0140200*, GS0140204*
00069918, 00044736*
No
No
No
No
No
83-4 - Reproduction,
2-generation
TGAI
A,B,F
Yes
GS0140204*, 00044736*
00069918
No
28(c)
-------
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.135 Toxicology
(continued)
MUTAGENICITY TESTING;
84-2 - Gene Mutation
TGAI
84-2 - Chromosomal Aberration TGAI
84-2 - Other Mechanisms of TGAI
Mutagenicity
SPECIAL TESTING:
85-1 - General Metabolism
85-2 - Domestic Animal Safety Choice
A,B,F
A,B,F
A,B,F
PAI or PAIRA A,B,F
A,B
Yes
No
Partially
Yes
Yes
00042482*, 00079923*
00073207
00044736*
00102023, 00080709
00035372, 00081414
00034380, 00075794
00101921, 00035377
00080814, 00060554
No
Yes
Yes
No
No
I/ Composition: TGAI = Technical grade of the active ingredient.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor;
I=Indoor. ADD
3/ Data must be submitted no later than Ol
* Data submitted by Union Carbide. These data may be compensable.
28(d)
-------
GENERIC DATA REQUIREMENTS FOR ALDICARB
Data Requirement
Composition
V
Use 2/
Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)7
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradat ion
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB t
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
TGAI pr PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA A,BfF
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
Yes
No
No
No
00102065*, 00102066*
No
NoV
NoV
Yes
Partially
No
No
00102051*,
00035365,
00102054*,
0093642,
00093640 ,
00053370*,
-
w
00101934
00102071
00053370*
00080820
00053366
00102054*
No
Yes5/
Yes6/
Yes6/
29(a)
-------
UKl'A KtyjUiKJUTCJNAO rut*.
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Data Requirement Composition Pattern No or Partially)
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
§158.130 Environmental Fate
(continued)
MOBILITY STUDIES:
163-1
163-2
163-3
- Leaching and TGAI or PAIRA
Adsorption/Desorption A,B,F
- Volatility (Lab) TEP A,B,F
- Volatility (Field) TEP A,B,F
No
No
No
YeslV
YeslV
Reserved^/
DISSIPATION STUDIES-FIELD:
164-1
164-2
164-3
164-4
- Soil TEP A,B
- Aquatic (Sediment) TEP
- Forestry TEP
- Combination and
No
No
No
No
Yes8/
NoV
NoV
NoW
Tank Mixes
164-5 - Soil, Long-term
TEP
A,B
No
Yes3/
29(b)
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR ALDICARB
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Composition Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
SI 58. 130 Environmental Fate
(continued)
ACCUMULATION STUDIES :
165-1 -
165-2 -
165-3 -
165-4 -
165-5 -
§158.140
132-1 -
132-1 -
133-3 -
133-4 -
Rotational Crops
(Confined)
Rotational Crops
(Field)
Irrigated Crops
In Fish
In Aquatic Non-Target
Organisms
Reentry Protection
Foliar Dissipation
Soil Dissipation
Dermal Exposure
Inhalation Exposure
PAIRA A
TEP A
TEP
TGAI or PAIRA A,B
TEP
TEP A,B
TEP A,B
TEP A,B
TEP A,B
No
No
No
No
No
No
No
No
No
Yes
Reserved^ V
NoV
NoW
NoV
No*3/
Yes3/
Yes3/
No*3/
29(c)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALDICARB
§158,130 Environmental Fate
(continued)
I/ 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=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic CXitdoor; I=Indoor.
3/ Data roust be submitted no later than APR
Data must be submitted no
Data must be submitted no
4/ This requirement is waived because aldicarb is soil incorporated.
5/ A study is needed to establish a quantitative decline curve and half-life for aldicarb and the pattern of
formation and decline of degradates. Data must be submitted no later-than APR IflRfi
6/ Required based on the results of ground water monitoring and leaching studies.
later than APR 1986 •
7/ Reserved pending results of a laboratory volatility study.
8/ Sampling should be done to a depth sufficient to define the extent of leaching.
later than APR 1086 .
9/ Not required since aldicarb has no forestry or aquatic uses.
10/ This document deals only with single active ingredients.
ll/ Reserved pending the results from confined rotational crop studies.
12/ Not required since aldicarb has an octanol/water coefficient of 5 and is not expected to bioaccumulate.
13/ Not required since aldicarb is soil incorporated.
14/ Data are needed on soil dissipation in the iton l«(
-------
GENERIC DATA
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LD^g TGAI
a. waterfowl
b. upland
71-2 - Avian Dietary DC5o TGAI
a. waterfowl
b. upland
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish I£$Q
a. warmwater TGAI
b. coldwater TGAI
72-2 - Acute l£5o Freshwater TGAI
Invertebrates
A,B,F
A,B,F
A,B,F
A,B,F
A,B,F
Yes
Yes
TGAI
TGAI
TEP
—
A
A
N/A
N/A
Partially
Yes
Yes
Yes
GS0140100*, GS0140103
GS0140101
00022923, 00102132*,
GS0140102
00101961, 00101962
00101960, 00101959
GS0140104*, GS0140105
00003503
GS0140104*, 00003503
GS0140106*
No
No
No
No
Yes4/
No
No
No
30(a)
-------
GENERIC DATA REQUIREMENTS FDR ALDICARB
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Composition Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.145 Wildlife and
Aquatic Organisms
(continued)
72-3 - Acute LC5Q Estuarine
and Marine Organisms
a. shrimp
b. fish
c. mollusk
TGAI
A,B
Yes
00066341
No
72-4 - Fish Early Life
Stage and Aquatic
Invertebrate Life-Cycle
a. Freshwater fish
b. shrimp
72-5 - Fish - Life-Cycle
TGAI
A,B
72i-6 - Aquatic Organism
Accumulation
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
TGAI
TGAI
TGAI
:, PAI OR
A,B
A,B
A,B
—
Partially
Yes
Yes
N/A
GS0140105
00066341
00066341
—
ReservedV
No
No
No
Degradation
Product
TEP
A,B
No
Reserved^/
30(b)
-------
S158.145 Wildlife and
Aquatic Organ!SITS (cont.)
GENERIC OVTA REQUIREMENTS FOR ALDICARB
I/ Composition: TGAI - Technical grade of the active ingredient; PAI = pure active ingredient;
TEP = Typical end-use product;
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; C=Aguatic, Food Cropj
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; gjCreejalKXise, Non-Food; G=Forestry; H=Doroestic Cutdoor; I=Indoor.
3/ Data must be submitted no later than ArK IjOD .
4/ Data are needed which quantify the impact on avian and small mammal populations. Such data should determine whether
the effects are excessive, longlasting or likely to diminish wildlife resources in treated areas.
5/ This requirement is reserved pending registrant satisfying certain environmental fate data requirements (photo-
degradation in water, aquatic metabolism, leaching and adsorption/desorption, and laboratory and field volatility)
and information concerning aldicarb transport to water via runoff.
* Data submitted by Union Carbide. These data may be compensable.
30(c)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALDICARB
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Conposition Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact 11)50 TGAI
141-2 - Honey bee - toxicity TEP
of residues on
foliage
141-3 - Wild bees important in TEP
alfalfa pollination -
toxicity of residues
on foliage
A,B
A,B
A,B
Yes
No
No
00036935
No
No3/
No3/
141-4 - Honey bee subacute
feeding study
(Reserved)4/
141-5 - Field testing for TEP
pollinators
A,B
No
31(a)
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR ALOICARB
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c)(2)(B)?
§158*155 Nontarget Insect
(continued)
NONTARGET INSECT TESTING -
AQUATIC INSECTS:
142-1 - Acute toxicity to (Reserved)V
aquatic insects
142-2 - Aquatic insect (Reserved)V
life-cycle study
142-3 - Simulated or actual (Reserved)5/
field testing for
aquatic insects
143-1 - NONTARGET INSECT (Reserved)V
TESTING - PREDATORS
thru AND PARASITES
143-3
I/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop:
D=Aqautic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic CXJtdcor; I=Indoor.
3/ As aldicarb is registered only as a granular formulation, there is no potential for bee exposure. Thus, testing
beyond the first tier is not required.
4/ Reserved pending development of test methodology.
5/ Reserved pending Agency decision as to whether the data requirement should be established.
31 (b)
-------
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: 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 III-l)
to fill "gaps" identified by EPA concerning your product. Under
the authority of FIFRA Section 3(c)(2)(B), EPA has determined
that you must submit these data to EPA in order to register or
reregister your product(s). All of these data must be submitted
not later than six months after you receive this guidance document,
"Product-Specific Data Requirements for Manufacturing-Use
Products" appearing in Table B permit you to determine which
product-specific data you must submit. This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B)."
V Product specific data pertains to data that support the
formulation which is marketed; it usually includes product chemistry
data and acute toxicology data.
-------
X/VB1JS C»
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALDICARB
§158.120 - PRODUCT CHEMISTRY
Guideline Citation and Test Guidelines
Name of Test SubstanceV Status
Product
61-1 -
61-2 -
Sl-3 -
Identity:
Identity of Ingredients MP R
Statement of Composition MP R
Discussion of FormaUofl o£ M£» P.
Are Data Footnote
Required^/ Number
Yes No
[~] [X]
[XI U
m f) . .._ ,
ingredients
Anaiys i§ Jjad jLte£t i f teat ic&M JlSS&iiJI.
§1-1 - Preliminary Analysis Mf
62-3 - Analytical Methods for Mf
Ehfdtcement el kimlt§
Physical and Chemical Characteristics
63-2 - Color MP
MP
ft
R
R
R
R
R
B O
® n
U ffi
[xi U
© n
ixi n
33(a)
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING ALDICARB
§158.120 - PRODUCT CHEMISTRY (Con't)
Guideline Citation and
Name of Test
Test Guidelines
SubstanceV Status
Are Data Footnote
Required2/ Number
Yes No
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
Ojj.fi isxidizing or Neoucing
Action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
£1— 1Q Wi o«-»~*» i 4-w
Oj 10 viscosity
63-19 - Miscibility
DJ ZU — 1-QrTOSlOn VJlaLaCtcLlStlCo
Other Requirements:
64- 1 - Submittal of samples
I/ Composition: PAI = Pure active
2/ Data must be submitted no later
MP
MP
MP
MP
MP
MP
MP
MP
MP
PAI
ingredient;
than
R
R
CR
CR
R
R
CR
CR
R
CR
MP = Manufacturing
nor 1P84
[X]
[X]
[X]
[X]
[X]
[X]
[X]
[X]
n
n
use product
•
[ ]
n
i"]
n
n
n
n
n
[X]
[X]
*
33(b)
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALDICARB
Must Additional
Data Be Submitted
Under FIFRA Sectiofl
3(c)(2)(B)?
Data Requirement
Composition
V
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
§158.135 Toxicology
ACUTE TESTING
81-1 - Oral 11)50 -Rat
MP
Yes
81-2 - Dermal LD50
MP
Yes
00060194*,
00100382,
00053342,
00030423,
00049330,
00100389*,
00035376*,
00053343*,
00100391,
00079566,
00080698,
00054442*,
00102070*,
00055536*,
00100393*,
00028645*,
00028647*,
00057332,
00080708
00030424*,
00055535*,
00102143*,
00080811,
00035378*,
00035370,
0510121
00069745*
00069922
00057333
00035372
00100386*
00054410*
00100390*
00035375*
00101917*
00053341
00061087
00100392*
00044739*
00029295
00080710
00028646*
00100384
00091241
00030425*
00060195*
00069919
00101914*
00055537
00035371
No
No
34(a)
-------
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALDICARB
Must Additional
Data Be Submitted
Under FIFRA Sectio
3(c)(2)(B)? ,
Data Requirenent
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
§158.135 Toxicology
(continued)
ACUTE TESTING
(continued)
81-3 - Inhalation 1X59 - Rat
81-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation
81-6 - Dermal Sensitization
MP
MP
MP
MP
Yes
Yes
Yes
Yes
00073345*, 00101943
00102070*
00080810, 00069916
00054410*, 00100389*
00035376*
00058632, 00080810
00069916
GS0140201*
No
No
No
No
I/ Composition: MP = Manufacturing-use product.
* Data submitted by Union Carbide. These data may be compensable.
34(b)
-------
IV. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This section applies to end-use products only to the
the extent described under Section II of this document.
Otherwise, the following information pertains exclusively to
manufacturing-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 S162.11(c)], pack-
aging [40 CFR §162.16], and labeling [40 CFR §162.10, Appendix
IV-1 an IV-2], as indicated by the following paragraphs of this
chapter of the guidance document.
If owners of currently registered products fail to submit
revised labeling and packaging information complying with this
Section and/or Section II, EPA may issue a notice of intent to
cancel the registration under FIFRA §6(b)(l).
A. Label Contents
40 CFR §162.10 (Appendix IV-1) requires that certain spe-
cific labeling statements must appear at certain locations
on the label. This is referred to as format labeling.
Specific label items listed below are keyed to Tables D, E,
and F (Appendix IV-2).
Item 1. PRODUCT NAME - The name, brand, or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading. See Appendix
IV-1. [40 CFR Sl62.10(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 IV-1. [40 CFR §162.10(c)]
Item 3. NET CONTENTS - A net content statement is required
on all labels. The preferred location is the bottom of the
front panel immediately above the company name and address,
or at the end of the label text. The net contents must be
stated in terms of weight, expressed as avoirdupois pounds
35
-------
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 IV-1. [40 CFR
S162.10(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 IV-1.
[40 CFR §162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment registration number on
the immediate container cannot be clearly read through such
wrapper or container. See Appendix IV-1. 140 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and must contain the name and
percentage by weight of each active ingredient and the total
percentage by weight of all inert ingredients. The preferred
location is immediately below the product name. The ingredient
statement must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the
body of other text. See Appendix IV-1, [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.
36
-------
Size of Label Signal Word as Re- "Keep Out of Reach
on Front Panel quired Minimum Type of Children"
in Square Inches Size All Capitals as Required
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - All labels are
required to have the statement "Keep Out of Reach of Children"
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
See Appendix IV-1. [40 CFR §162. 10(h) (1 ) ( ii ) ]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[40 CFR §162.10 (h)(l)(i)]
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 IV-1. [40 CFR
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV-1. [40 CFR §162.10 (h ) (1 )( iii )]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix IV-1. [40 CFR §162. 10(h ) (1 ) ( iii ) ]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix IV-1. [40 CFR §162.10
37
-------
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions taken to avoid
accident, injury or damage. See Appendix IV-1. [40 CFR §162.10
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix IV-1. [40 CFR
.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 IV-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-f lammability . The
following criteria will be used to determine if a
product is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of
gases) that will not ignite when a lighted match
is placed against the open cylinder valve.
b. A "non-flammable liquid" is one havfng a flash-
point greater than 350°F (177°C) as determined
by the method specified in 40 CFR §163. 61-8(c ) ( 13 )
(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the
method specified in 40 CFR §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 350°F (177°C),
determined by the method specified in 40 CFR
§163.61-8(c)(13)(i).
38
-------
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 capability, or mixing with
other substances to produce toxic fumes.
Item 9. MISUSE STATEMENT - The following statement is
required on your label: "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling."
See Appendix IV-1. [40 CFR §162.10(1)(2)(ii)]
Item 10A. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. Make certain that the statement you use
pertains specifically to your product. These instructions
must be grouped and appear under the heading "Storage and
Disposal" in the directions for use. This heading must be
set in the same type sizes as required for the child hazard
warning. Refer to Appendix IV-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 IV-1. [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
39
-------
Vl INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Product Manager-12 (Jay S. Ellenberger)
Phone No. (703) 557-2386
Registration Division(TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
For each product for which continued registration is desired:
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA
Form 8580-1. Refer to Appendix II-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
III-l).
c. Two copies of any required product-specific data.
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms
to the requirements of this guidance document and the
results of the short-term data, the registrant may
submit such labeling. (End-use product labeling
needs to comply specifically with the instruction in
Section II of this guidance document.) The labeling
should be either typewritten text on 8-1/^2 x 11 inch
paper or a mockup of the labeling suitable for
stortage in 8-1/2 x 11 inch files. The draft label
must indicate the intended colors of the final label,
clear indication of the front panel label, and the
intended type sizes of the text.
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.
After the Supreme Court has ruled on the Monsanto Decision,
you will be informed as to when you must submit your Application
for Amended Pesticide Registration (EPA Form 8570-1) and the
associated data support information.
40
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0140001 Andrawes, N.R., W.p. Bagley, and R.A. Herrett. 1971.
Metabolism of 2-methyl-2-(methylthio)propionaldehyde
0-(methylcarbamoyl)oxime (Temik aldicarb pesticide)
in Potato Plants. J. Agric. Food Chem. 19(4) :731-
737. Submitted by Union Carbide Corp. under PP#3F1414
(Ace.#118303).
GS0140002 ' Andrawes, N.R., R.R. Bomine, and W.P. Bagley. 1973.
Metabolism and Residues of Temik Aldicarb Pesticide
in Cotton Foliage and Seed Under Field Conditions.
J. Agric. Food Chem. 21(3):379-386. Submitted by
Union Carbide Corp. under PP#7F1995 (Ace.#096302).
GS0140003 Bartley, W.J., N.R. Andrawes, E.L. Chancey, W.P.
Bagley, and H.W. Spurr. 1970. The Metabolism of
Temik Aldicarb Pesticide [2-methyl-2-(methylthio)
propionaldehyde 0-(methylcarbamoyl)oxime] in the
Cotton Plant. J. Agric. Food Chem. 18(3):446-523.
Submitted by Union Carbide Corp. under PP#7F1995
(Ace.#096302).
GS0140004 Coppedge, J.R., D.A. Lindquist, D.L. Bull, and
H.W. Dorough. 1967. Fate of 2-methyl-2-(methylthio)
propionaldehyde 0-(methylcarbamoyl)oxime (Temik) in
Cotton Plants and Soil. J. Agric. Food Chem. 15(5):
902-910. Submitted by Union Carbide Corp. under PP#
9F0798 (Ace.#115902).
GS0140005 Metcalf, R.L., T.R. Fukerto, Crystal Collins, Kathleen
Borck, Janet Burk, H.T. Reynolds, and M.F. Osman.
1966. Metabolism of 2-methyl-2-(methylthio)propional
dehyde O-(methylcarbamoyl)oxime in Plant and Insect.
J. Agric. Food Chem. 14(6):579-584. Submitted by
Union Carbide Corp. under PP#8F0637 (Ace.#115920)
GS0140006 Rouchaud, J., C. Moons, and J.A. Meyer. 1980a.
Metabolism of Temik 14C-aldicarb in the sugar beet.
Med. Fac. Landbouww Rijksuniv. Gent. 45(4):895-903.
GS0140007 Rouchaud, J., C. Moons, and J.A. Meyer. 1980b.
Distribution of the radioactivity in sugar beet plants
treated with [14C]aldicarb. Pestic. Sci. 11:83-89.
GS0140008 Rouchaud, J., C. Moons, and J.A. Meyer. 1980c. The
metabolism of [!4C]aldicarb in the leaves of suga:
beet plants. Pestic. Sci. 11:483-492.
41
-------
Appendix II
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0140009 Rouchaud, J., C. Moons, and J.A. Meyer. 1981. The
metabolism of [14C]aldicarb in the root of sugar beet
plants. Pestic. Sci. 12:548-556.
GS0140010 Union Carbide Corp. 1966. Insecticide Temik:
Metabolism and distribution in potato. Submitted by
Union Carbide Corp. under PP#7F0573. (Ace.#114930).
GS0140011 Union Carbide Corp. 1968. Project No. 111B19, File
No. 10492: Metabolism of C14-Temik in Cotton Plants
Under Field Conditions. Submitted by Union Carbide
Corp. under PP#7F1953 (Ace.#096131).
GS0140012 Union Carbide Corp. 1968. Project No. 111B19, File
No. 10495: Degradation of 2-methyl-2-(methylthio)
propionaldehyde 0-(methylcarbamoyl)oxime (Temik) in
Potato Foliage. Submitted by Union Carbide Corp.
under PP#9F0798 (Ace.#115902).
GS0140013 Union Carbide Corp. 1970. Project No. 111B19, File
~ No. 12694: Metabolism and Associated Residues of
Temik (2-methyl-2-(methylthio)propionaldehyde 0-
(methylcarbamoyl)oxime) in Sugar Beet Plants.
Submitted by Union Carbide Corp. under PP#7F1995
(Ace.#096302).
GS0140014 Union Carbide Corp. 1972. Project No. 111A12, File
No. 17613: The Metabolism and Terminal Residues of
Temik Aldicarb Pesticide in Peanut Plants under Field
Conditions. Submitted by Union Carbide Corp. under
PP#7F1995 (Ace.#096302).
GS0140015 Union Carbide Corp. 1977- Project No. 111B19, File
No. 10496. Metabolism and Associated Residues of
Temik in Spearmint and Lettuce. Submitted by Union
Carbide Corp. under PP#7F1995 (Ace.#096302).
GS0140019 Andrawes, N.R. , e_t a_l. 1967. Degradation and
Elimination of Temik in Rats. J. Econ. Ento. 60:979-
987. Submitted by Union Carbide Corp. under PP#7F1953
(Ace.#096131).
GS0140022 Union Carbide Corp. 1968. UC-21149-lll-COTS and UC-
21149-111-COTO. In section D of PP#9F0798
(Ace.#115905).
42
-------
Appendix II
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0140023
GS0140024
GS0140025
GS0140026
GS0140027
GS0140028
GS0140029
GS0140030
GS0140031
GS0140032
GS0140033
GS0140034
GS0140035
GS0140036
Union Carbide Corp. 1969. UC-21149-lll-COTMH. In
section D of PP#9F0798 (Ace.1115905).
Union Carbide Corp. 1969. UC-21149-lll-SBR, UC-
21149-111-SBT, UC-21149-lll-SBF, UC-21149-lll-MILK,
UC-21149-lll-LIVER. In section D of PPIOF1008
(Ace.1116788).
Union Carbide Corp. 1973. ALDICARB-FPD-PNUT. In
section D of PP#3F1414(118302) (Ace.1118302).
Union Carbide Corp. 1973. ALDICARB-FPD-POT and
ALDICARB-FPD-POTROD. In section D of PP#3F1414
(Ace.#118306).
Union Carbide Corp. 1975. ALDICARB-FPD-GENERAL. In
section D of PP#6G1689 (Ace.#645108).
Union Carbide Corp. 1976. ALDICARB-FPD-GENERAL. In
section D of PP#6F1849.
Union Carbide Corp. 1976. ALDICARB-FPD-BANANA. In
section D of PP#6E1792.
Union Carbide Corp. 1976. Residues of aldicarb on
pecan kernels. USDA memorandum dated April 13, 1976,
Submitted in section D of PP#6G1780.
Union Carbide Corp. 1976. ALDICARB-FPD-GENERAL. In
section D of PP#6F1829.
Union Carbide Corp. 1977. ALDICARB-FPD-GENERAL. In
section D of PP#8F2107 (Ace.#097271).
Union Carbide Corp. 1977. ALDICARB-FPD-TREE NUTS.
In section D of PP#7E1996.
Union Carbide Corp. 1977. ALDICARB-FPD-COFFEE. In
section D of PP#7E1953 (Ace.#096131).
Union Carbide Corp. 1977. ALDICARB-FPD-TOMATOES.
In section D of PP#8F2096(097162) (Ace.#097162);
Union Carbide Corp. 1971. ALDICARB-FPD-SPOT, ALDICARB-
FPD-SCF, and ALDICARB-FPD-LIVER. In section D of
PP#2F1188(117454) (Ace.#117454).
43
-------
Appendix II
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0140037 Union Carbide Corp. 1978. ALDICARB-FPD-GENERAL. In
section D of PP#9F2201.
GS0140038 Union Carbide Corp. 1978. ALDICARB-FPD-GENERAL. In
section D of PP#OG2318 (Ace.#099219).
GS0140039 Krause, R.T. 1980. Multiresidue method for determining
N-methylcarbamate insecticides in crops using high
performance liquid chromatography. JAOAC 63(5):1114-
1124.
GS0140040 Cochrane, W.P., M. Lanouette. 1981. High pressure
liquid chromatography determination of aldicarb,
aldicarb sulfoxide, and aldicarb sulfone in potatoes.
JAOAC 64(3)-.724-728.
GS0140041 Union Carbide Corp. 1966. Potato storage stability
studies. In section D of PP#6G0473 (Ace.#114544).
GS0140042 Union Carbide Corp. 1967. Potato stability studies.
In section D of PP#7F0573 (Ace.#114931).
GS0140043 Union Carbide Corp. 1969. Evidence of stability of
aldicarb residues in sugar beet roots and tops stored
at -15C. In section D of PP#OF1008(116789)
(Ace.#116789)
GS0140044 Union Carbide Corp. 1969. Evidence of stability of
Temik residues in whole cottonseed stored 62-237
days at 20 F. In section D of PP#9F07^8 (Ace.#115901)
GS0140045 Union Carbide Corp. 1973. Potato storage stability
studies. In section D of PP#3F1414 (Ace.#118302).
GS0140046 Union Carbide Corp. 1973. Untitled peanut storage
stability data. In section D of PP#3F1414
(Ace.#118302).
GS0140047 Union Carbide Corp. 1973. Stability of aldicarb
residues in potato tubers during frozen storage at
-10 F. In section D of PP#3F1414(118303)
(Ace.#118303).
GS0140048 Union Carbide Corp. 1975. Storage stability of
residues (oranges). In section D of PP#6G1689/6H5108.
(48)
44
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0140049
GS0140050
GS0140051
GS0140052
GS0140053
GS0140054
GS0140055
GS0140056
GS0140057
GS0140058
GS0140059
GS0140060
GS0140061
Union Carbide Corp. 1976. Untitled banana storage
stability data. In section D of PP#6E1792.
Union Carbide Corp. 1977. Evidence of stability of
aldicarb residues in sugarcane stalk and leaves at -
15 C. In section D of PP|2F1188(117454) (Ace.#117454)
Union Carbide Corp. 1977. Untitled storage stability
data for pecans. In section D of PP#7E1996.
Union Carbide Corp. 1973. Untitled storage stability
data for dry, green coffee. In section D of PP#7F1953
(Ace.#096131).
Union Carbide Corp. 1973. Untitled storage stability
data for sweet potatoes. In section D of PP#7F1995
(Ace.#096302).
Union Carbide Corp. 1977. Untitled storage stability
data for tomatoes. In section D of PP#8F2096
(Ace.#097162)
Union Carbide Corp. 1967. Cottonseed storage stabi-
lity studies. In section D of PP#8F0637 (Ace.#115221)
Union Carbide Corp. 1977. Untitled storage stability
data for potatoes. In section D of PP#8F2096
(Ace.#097162).
Union Carbide Corp. 1977. Untitled storage stability
data for potatoes. In section D of PP#8F2107
(Ace.#097271).
Union Carbide Corp. 1978. Untitled storage stability
data for potatoes. In section D of PP#8F2107(097271)
(Ace.#097271).
Union Carbide Corp. 1978. Untitled storage stability
data for potatoes and citrus. In section D of
PP#9F2201 (Ace.#098223).
Union Carbide Corp. 1966. Section D of PP#6G0473'
(Ace.#114544).
Union Carbide Corp. 1967. Section D of PP#7F0573
(Ace.#114931).
45
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0140063
GS0140064
GS0140066
GS0140067
GS0140068
GS0140072
GS0140073
GS0140074
GS0140075
GS0140076
GS0140077
GS0140080
GS0140081
GS0140082
GS0140085
Union Carbide Corp. 1970. Part B of section D in
PP#OF1008 (Ace.#116789).
Union Carbide Corp. 1977. Part I, B of section D in
PP#7F1995(096302) (Ace.#096302).
Union Carbide Corp. 1976. Section D of PP#6F1849.
Union Carbide Corp. 1978. Section D of
PP#8G2026/FAP#8H5174.
Union Carbide Corp. 1979. Section F of PP#9F2201/
FAP#9H5218 (Ace.#098223).
Union Carbide Corp. 1976. Section D of PP#6F1829.
Union Carbide Corp. 1976. Section D of PP#6G1689
and FAP#6H5108.
Union Carbide Corp. 1977. Reference Nos. 13769-114,
-116 to -119, -121 to -123, and -126. Submitted by
Union Carbide Corp. under PP#7E1996.
Union Carbide Corp. 1978. Section D of PP#8F2107
(Ace.#070212).
Union Carbide Corp. 1978. Section D of PP#8F2107
(Ace.#097271).
Union Carbide Corp. 1976. Section D of PP#6E1792.
Union Carbide Corp. 1969. Section D of PP#9F0798.
[Data generated using GC method UC-21149-III-Cotton-
seed used; data obtained with colorimetric method
UC-21149II-Cottonseed not used.] (Ace.#115901).
Union Carbide Corp. 1973. Section D, part B of
PP#3F1414 (Ace.#118303).
Union Carbide Corp. 1972. Section D of PP#2F1188
(117454) (Ace.#117454).
Union Carbide Corp. 1978. Section A of PP#8F2107.
Five Methods for the Analysis of Aldicarb Products.
(Ace.#097271).
46
-------
Appendix II
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
CITATIONS CONSIDERED to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0140088
GS0140090
GS0140091
GS0140100
Union Carbide Corp. 1965. Stability Reports Agenda
to PP#8F0637 (Ace.#115219).
Union Carbide Corp.
(Ace.#097211)
1978. Section A of PP#8F2107
GS0140101
Union Carbide Corp. 1966. Data from a Data Sheet
for Temik 10G. Submitted under PP#6G0473 (Ace. #114544 )
Hill, E.F. and Camardese, M.B. 1981. Subacute
Toxicity Testing with Young Birds: Response in
Relation to Age and Interest Variability of LC50
Estimates. Avian and Mammalian Wildlife Toxicology:
Second Conference. ASTM STP 757, D.W. Lamb and E.E.
Kenega, Eds., American Society for Testing and
Materials. (BOWOAL01).
Hill, E.F. 1983. Avian Acute Oral LD50 Toxicity
Data. Unpublished Report. U.S. Fish and Wildlife
Service. Patuxent Wildlife Research Center, Laurel,
MD (BOWOAL04)
GS0140102
M.B. Subacute Toxicity
in Relation to
Estimates Avian
Hill, E.F. and Camardese, M.B. Subacut
Testing with Young Birds: Response n Reaton to
Age and Interest Variability of LC5Q Estimates Avian
and Mammalian Wildlife Toxicology: Second Conference.
ASTM STP 757, D.W. Lamb and E.E. Kenaga, Eds., American
Society for Testing and Materials, -
BOWOA101) .
1981, pp. 41-65
GS0140103
GS0140104
GS0140105
Hudson, R.H., R.K. Tucker, and M.A. Haegele. 1972.
Effect of Age on Sensitivity: Acute Oral Toxicity of
14 Pesticides to Mallard Ducks of Several Ages. 6
pp. Toxicol. Appl. Pharmacol. 22:556-561. Submitted
by Union Carbide Corp. (6F1849, 096397) (Ace. #096397)
10/26/77.
Hutchinson, C. 1979. Aldicarb Fish and Wildlife
Studies. Union Carbide Corp. Environ. Ser. Tarrytown
Technical Center. Tarrytown, New York 10591. UCES
Proj. No.: 11504-14-04 (BOWOAL06).
Pickering, Q.H. and Gilliam, W.T. 1982. Toxicity of
Aldicarb and fonofos to the Early-Life state of
fathead minnow, Archives of Experimental Contamination
and Toxicology. Vol. 11, 699-702p. (BOWOAL07).
47
-------
Appendix II
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the DAta Base Supporting
Registrations Under this Guidance Document
GS0140106 Vilkas, Algirdas G. 1977. The acute toxicity of
aldicarb technical to the water flea, Daphnia magna
Atraus. 7 p. Submitted by Union Carbide Corp.
(Ace.1096683).
GS0140200 Union Carbide Corp. 1983. Teratology Study in
Rabbits. Unpublished Report. International Research
and Development Corporation. (Ace.1251510).
GS0140201 Weil, C.S. and Carpenter, C.P. 1965. Two Year
Feeding of compound 21149 in the Diet of Rats.
Unpublished Report. Mellon Institute Special Report
28-123.
GS0140202 Weil, C.S. and Carpenter, C.P. 1966. Two-year
feeding of compound 21149 in the Diet of Dogs.
Unpublished Report. Mellon Institute Special Report
29-5.
GS0140203 National Institutes of Health. 1979. Bioassay of
Aldicarb for Possible Carcinogenicity. U.Sr Department
of Health, Education, and Welfare Publ. No. (NIH) 79-
1391. 103 pp.
GS0140204 Woodside, M.D., Weil C.S. and Cox, E.F. 1977.
Inclusion in the Diet of Rats for Three Generations
(Aldicarb Sulfone), Dominant.Lethal Mutagenesis and
Teratology Studies. Unpublished Report. Mellon
Institute Special Report 40-1.
48
-------
Appendix II
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975)
Lethal Dietary Toxicities of Environmental Pollutants
to Birds: Special Scientific Report—Wildlife No. 191.
(U.S. Dept. of the Interior, Fish and Wildlife Service,
Patuxent Wildlife Research Center; unpublished report)
00028645 Maronpot, R.R. (1980) Effect of a Single Peroral Dose
of Aldicarb on Cholinesterase Inhibition and Recovery
in the Rat: Project Report 43-2. (Unpublished study
received Jan 22, 1980 under 264-330; prepared by
Carnegie-Mellon Univ., Institute of Research, submitted
by Union Carbide Agricultural Products Co., Ambler,
Pa.; CDL:241639-B)
00028646 Maronpot, R.R. (1980) Effect of a Single Peroral Dose
of Aldicarb on Cholinesterase Inhibition and Recovery
in the Rabbit: Project Report 43-3. (Unpublished
study received Jan 22, 1980 under 264-330; prepared
by Carnegie-Mellon Univ., Institute of Research,
submitted by Union Carbide Agricultural Products Co.,
Ambler, Pa; CDL:241639-C)
00028647 Maronpot, R.R. (1980) Effect of a Single Oral Dose of
Aldicarb on Cholinesterase Inhibition and Recovery in
the Dog: Project Report 43-4. (Unpublished study
received Jan 22, 1980 under 264330; prepared by Carnegie
Mellon Univ., Institute of Research, submitted by
Union Carbide Agricultural Products Co., Ambler, Pa.;
CDL:241639-D)
00029295 Union Carbide Corporation (1968) Toxicity of the Formu-
lated Product Temik 10G Aldicarb Pesticide. (Unpublished
study received Feb 6, 1969 under 1016-69; CDL:005587-F)
00030423 Field, W.E.; Mellott, M.J. (1979) Oral LD50 in Rabbits:
Study No. CDC-UC-007-79. (Unpublished study received
Feb 28, 1980 under 264-330; prepared by CDC Research,
Inc., submitted by Union Carbide Agricultural Products
Co., Ambler, Pa.; CDL:242164-A)
00034380 Getzen, L.W. (1960) Efficacy Study Using Tomatoes.
(Unpublished study received Oct 17, 1960 under 279-1242;
prepared by Texas A & M Univ., Agricultural Experiment
Station, submitted by FMC Corp., Philadelphia, Pa.;
CDL:002306-D)
49
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Donsidered to be Part Of the Data Base Supporting
Registrations Under this Guidance Document
00035365 Bull, D.L.; Stokes, R.A.; Coppedge, J.R.; et al. (1970)
Further studies of the fate of Aldicarb in soil.
Journal of Economic Entomology 63(4):1283-1289. (Also
In unpublished submission received Jul 26, 1971 under
1F1008; submitted by Union Carbide Corp., Washington,
D.C.;CDL:091747-C)
00035370 Union Carbide Corporation (1970) Full Reports of Investi-
gations Made with Respect to the Safety of the Pesti-
cide Chemical: Temik. (Unpublished study received
Jul 26, 1971 under 1F1008; CDL:091747-J)
00035371 Weil, C.S.; Condra, N.I.; White, C. (1969) Temik
Sulfoxide and Temik Sulfone Single Rabbit Skin Penetra-
tion Studies: Special Report 32-78. (Unpublished study
received Jul 26, 1971 under 1F1008; prepared by Mellon
Institute, submitted by Union Carbide Corp., Washington,
D.C.; CDL-.091747-K)
00035375 Weil, C.S.; McGee, M.A.; Baughman, J.A. (1970) Temik
and Other Materials—Miscellaneous Single Dose Peroral
and Parenteral LD50 Assays and Some Joint Action
Studies: Special Report 33-7. (Unpublished study
received Jul 26, 1971 under 1F1008; prepared by
Carnegie-Mellon Univ., Mellon Institute, submitted by
Union Carbide Corp., Washington, D.C.; CDL:091747-O)
00035376 Weil, C.S. (1970) Miscellaneous.-Toxicity Studies:
Special Report 33-18. (Unpublished study received
Jul 26, 1971 under 1F1008; prepared by Carnegie-Mellon
Univ., Mellon Institute, submitted by Union Carbide
Corp., Washington, D.C.; CDL:091747-P)
00035377 Woodside, M.D.; Chin, B.H.; Tallant, M.J. (1969) Temik
10GV 2Methyl-2-(methylthio)propionaldehyde O-(methyl
carbamoyDoxime: Peroral Dosing of a Hereford Heifer
with Notes on Cholinesterase Inhibition: Special
Report 32-82. (Unpublished study received Jul 26,
1971 under 1F1008; prepared by Mellon Institute,
submitted by Union Carbide Corp., Washington, D.C.;
CDL:091747-Q)
50
-------
Appendix II
OFFICE OF PESTICIDES PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
00035378 Weil, C.S.; McGee, M.A.; Baughman, J.L. (1970) Compara-
tive Skin Penetration Toxicity of Temik 10GV and 15
Other Pesticide Formulations as Marketed: Special
Report 33-15. (Unpublished study received Jul 26,
1971 under 1F1008; prepared by Carnegie-Mellon Univ.,
Mellon Institute, submitted by Union Carbide Corp.,
Washington, D.C.; CDL:091747-R)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975)
Toxicity of Pesticides and Other Agricultural Chemicals
to Honey Bees: Laboratory Studies. By University of
California, Dept. of Entomology. ?: UC, Cooperative
Extension. (Leaflet 2287; published study.)
00044734 Weil, C.S. (1976) Reanalysis of Tumor Incidence Data of
Aldicarb 18-Month Mouse Feeding Studies: Special Report
39-55. (Unpublished study received May 19, 1976 under
6E1792; prepared by Carnegie-Mellon Univ., Carnegie-
Mellon Institute of Research, submitted by Union
Carbide Corp., Arlington, Va.; CDL:096503-D)
00044736 Weil, C.S.; Woodside, M.D.; Bernard, J.R.; et al. (1974)
Aldicarb: Inclusion in the Diet of Rats for Three
Generations and a Dominant Lethal Mutagenesis Test:
Special Report 37-90. (Unpublished study received
May 19, 1976 under 6E1792; prepared by Carnegie-Mellon
Univ., Carnegie-Mellon Institute of Research, submitted
by Union Carbide Corp., Arlington, Va.; CDL:096503-F)
00044739 Moorefield, H.H.; Myers, R.C.; Weil, C.S. (1975) Temik
10G BC (Coal); 10G and 15G (Gypsum); 15G~(Corn Cob):
Comparative Toxicity Studies via Peroral, Dermal, and
Inhalation Routes: Special Report 38-141. (Unpublished
study received May 19, 1976 under 6E1792; prepared by
Carnegie-Mellon Univ., Carnegie-Mellon Institute of
Research, submitted by Union Carbide Corp., Arlington,
Va.; CDL:096503-I)
00049330 Gaines, T.B. (1969) Acute toxicity of pesticides.
Toxicology and Applied Pharmacology 14:515-534.
(Report no. 25529; also In unpublished submission
received Jul 15, 1976 under 3125-EX-135; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL: 226487-E)
51
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
00053341 Kinkead, E.R.; Chin, B.H.; Weil, C.S.; et al. (1968)
Toxicity Studies on Temik (2-Methyl-2-methylthiopro-
pionaldehyde-N-methylcarbamoyloxime) and Related Car-
bamates: Special Report 31-48. (Unpublished study
received Jan 18, 1977 under 1016-EX-37; prepared by
Mellon Institute, Chemical Hygiene Fellowship, submitted
by Union Carbide Corp'., Arlington, Va.; CDL: 228976-D)
00053342 Striegal, J.A.; Condra, N.I.; Haun, C.C. (1963) Special
Report: Comparison of the Acute Toxicity of Compound
21149 with Several of Its Analogues: Report 26-29.
(Unpublished study received Jan 18, 1977 under
1016-EX-37; prepared by Mellon Institute, submitted by
Union Carbide Corp., Arlington, Va.; CDL:228976-E)
00053343 Weil, C.S.; McGee, M.A.; Baughman, J.A. (1970) Temik and
Other Materials: Miscellaneous Single Dose Peroral and
Parenteral LD50 Assays and Some Joint Action Studies:
Special Report 33-7. (Unpublished study received Jan
18, 1977 under 1016-EX-37; prepared by Carnegie-Mellon
Univ., Mellon Institute, Chemical Hygiene Fellowship,
submitted by Union Carbide Corp., Arlington, Va.;
CDL:228976-F)
00053350 Weil, C.S.; Woodside, M.D.; Bernard, J.R.; et al. (1972)
Aldicarb (A), Aldicarb Sulfoxide (ASO). Aldicarb Sulfone
(ASO 2) and a 1:1 Mixture pf ASO:AS02: Two Year Feeding
in the Diet of Rats: Special Report 35-82. (Unpub-
lished study received Jan 18, 1977 under 1016-EX-37;
prepared by Carnegie-Mellon Univ., Mellon Institute,
Chemical Hygiene Fellowship, submitted by Union Carbide
Corp., Arlington, Va.; CDL:228976-M)
00053358 Bartley, W.J.; Andrawes, N.R.; Chancey, E.L.; et al.
(1970) Metabolism of Temik Aldicarb pesticide 2-Methyl-
2-(methylthio)propionaldehyde 0-(methylcarbamoyl)oxime
in the cotton plant. Journal of Agriculture and Food
Chemicals 18(3):446-453. (Also In unpublished submis-
sion received Jan 18, 1977 under 1016-EX37; submitted
by Union Carbide Corp., Arlington, Va.; CDL: 228975-L)
00053364 Bull, D.L. (1968) Metabolism of UC-21149 (2-Methyl-2-
(methythio)propionaldehydeo-(methylcarbamoyl)oxime) in
cotton plants and soil in the field. Journal of Eco-
nomic Entomology 61(6):15981602. (Also In unpublished
submission received Jan 18, 1977 under 1016-Ex-37;
submitted by Union Carbide Corp., Arlington, Va.; CDL:
228979-D)
52
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00053366 Coppedge, J.R.; Lindquist, D.A.; Bull, D.L.; et al.
(1967) Fate of 2-Methyl-2-(methylthio)propionaldehydeo-
(Methylcarbamoyl) oxime (Temik) in cotton plants and
soil. Journal of Agricultural and Food Chemistry 15(5):
902-910. (Also In unpublished submission received Jan
18, 1977 under 1016-EX-37; submitted by Union Carbide
Corp., Arlington, Va.; CDL:228979-F)
00053368 Metcalf, R.L.; Fukuto, T.R., Collins, C.; et al. (1966)
Metabolism of 2-Methyl-2-(methylthio)-propionaldehydeo-
(Methylcarbamoyl)oxime in plant and insect. Journal of
Agricultural and Food Chemistry 14(6):579-584. (Also
In unpublished submission received Jan 18, 1977 under
1016-EX-37; submitted by Union Carbide Corp., Arlington,
Va.; CDL:228979-H)
00053370 Hirsh, D.H.; Sheets, K.P.; Holsing, G.C. (1976) Sulfocarb:
Fate in Aerobic and Anaerobic Soils. (Unpublished
study received Jan 18, 1977 under 1016-EX-37; submitted
by Union Carbide Corp., Arlington, Va.; CDL:228979-J)
00053371 Dorough, H.W.; Ivie, G.W. (1968) Temik-S metabolism in a
lactating cow. Journal of Agricultural and Food Chemis-
try 16(3):460-464. (Also In unpublished submission
received Jan 18, 1977 under 1016-EX-37; submitted by
Union Carbide Corp., Arlington, Va.; CDL:228979-K)
00053372 Dorough, H.W.; Davis, R.B.; Ivie, G.W. (1970) Fate of
Temik-Carbonl4 in lactating cows during a 14-day feeding
period. Journal of Agricultural and Food Chemistry
18(1):135-142. (Also In unpublished submission received
Jan 18, 1977 under 1016-EX-37: submitted by Union
Carbide Corp., Arlington, Va.; CDL:228979-L)
00053373 Hicks, B.W.; Dorough, H.W.; Mehendale, H.M. (1972) Meta-
bolism of Aldicarb pesticide in laying hens. Journal
of Agricultural and Food Chemistry 20(1):151-156.
(Also In unpublished submission received Jan 18, 1977
under 1016-EX-37; submitted by Union Carbide Corp.,
Arlington, Va.; CDL:228979-M)
00054410 Weil, C.S. (1977) Miscellaneous Toxicity Studies: Temik:
Special Report 33-18. (Unpublished study received Aug
4, 1977 under 1016-79; prepared by Carnegie-Mellon
Univ., Mellon Institute, Chemical Hygiene Fellowship,
submitted by Union Carbide Corp., Arlington, Va.;
CDL:231509-S)
53
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00055535 Wolfe, G.W.; Wentz, K.L. (1980) Final Report: Primary
Dermal Irritation Study in Rabbits: Project No.
400-633. (Unpublished study received Oct 23, 1980
under 264-319; prepared by Hazleton Laboratories
America, Inc., submitted by Union Carbide Agricultural
Products Co., Inc., Ambler, Pa.; CDL:243546-G)
00055537 Dauvin, E.M.; Wolfe, G.W.; Voelker, R.W.; et al. (1980)
Final Report: Acute Dermal Toxicity Study in Rabbits:
Project No. 400632. (Unpublished study received Oct 23,
1980 under 264-319; prepared by Hazleton Laboratories
America, Inc., submitted by Union Carbide Agricultural
Products Co., Inc., Ambler, Pa.; CDL: 243546-1)
00057332 Kinkead, E.R.; Chin, B.H.; Weil, C.S.; et al. (1968)
Toxicity Studies on Temik (2-Methyl-2-methylthiopro-
pionadehyde-M-methylcarbamoyloxime) and Related Car-
bamates: Special Report 31-48. (Unpublished study
received Jan 18, 1977 under 1016-EX-37; prepared by
Carnegie-Mellon Univ., Mellon Institute, Chemical
Hygiene Fellowship, submitted by Union Carbide Corp.,
Arlington, Va.; CDL:228152-D)
00057340 Weil, C.S.; Woodside, M.D.; Bernard, J.R.; et al. (1972)
Aldicarb (A), Aldicarb sulfoxide (ASO), Aldicarb
sulfone (ASO2) and a 1:1 Mixture of ASO:AS02: Two Year
Feeding in the Diet of Rats: Special Report 35-82.
(Unpublished study received Jan 18, 1977 under
1016-EX-37; prepared by Carnegie-Mellon Univ., Mellon
Institute, Chemical Hygiene Fellowship, submitted by
Union Carbide Corp., Arlington, Va.; CDL:228152-M)
00058632 Carpenter, C.P-; Condra, N.I.; Humes, C.; et al. (1966)
Temik 10G (10.5% Granular Formulation of Compound
21149) 15-Day Dermal Applications to Rabbits: Report
29-80. (Unpublished study received Oct 8, 1966 under
1016-EX-24; prepared by Mellon Institute, submitted by
Union Carbide Corp., Arlington, Va.; CDL: 126491-B)
00060194 Weil, C.S. (1972) Miscellaneous Toxicity Studies:
Special Report 35-41. (Unpublished study received
Jun 25, 1973 under 3F1414; prepared by Carnegie-Mellon
Univ., Mellon Institute, Chemical Hygiene Fellowship,
submitted by Union Carbide Corp., Washington, D.C.;
CDL:093778-B)
54
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00060195 Weil, C.S.; DeMary, L.J.; Soo, V. (1971) Comparative
Skin Penetration Toxicity of Temik 10GV, Temik 15GV
and 5 Other Pesticide Formulations as Marketed: Special
Report 34-76. (Unpublished study received Jun 25,
1973 under 3F1414; prepared by CarnegieMellon Univ.,
Mellon Institute, Chemical Hygiene Fellowship, sub-
mitted by Union Carbide Corp., Washington, D.C.; CDL:
093778-C)
00060196 Weil, C.S.; Woodside, M.D.; Bernard, J.R.; et al. (1973)
Aldicarb (A), Aldicarb sulfoxide (ASO), Aldicarb
sulfone (AS02) and a 1:1 Mixture of ASO:ASO2 Two Year
Feeding in the Diet of Rats: Special Report 35-82.
(Unpublished study received Jun 25, 1973 under 3F1414;
prepared by Carnegie-Mellon Univ., Mellon Institute,
Chemical Hygiene Fellowship, submitted by Union Carbide
Corp., Washington, D.C.; CDL:093778-D)
00061087 Carpenter, C.P.; Goldberg, M.E.; Johnson, H.E.; et al.
(1966) Special Report: Recapitulation of Acute Toxicity
and Pharmacodynamic Studies on Dessin (Compound 19786):
Report 29-47. (Unpublished steady received Sep 1, 1966
under 1016-EX-18; prepared by -Mellon Institute, Indus-
trial Fellowship, submitted by Union Carbide Corp.,
Arlington, Va.; CDL:126458-D)
00066341 U.S. Environmental Protection Agency, Environmental
Research Laboratory (1981) Acepha-te, Aldicarb, Carbo-
phenothion, DBF/ EPN, Ethoprcfp, Methyl Parathion, and
Phorate: Their Acute and Chronic Toxicity, Bioconcen-
tration Potential, and Persistence as Related to
Marine Environments: EPA-600/4-81-023. *
(Unpublished study)
00069916 Striegel, J.A.; Condra, N.I.; Haun, C.C.; et al. (1962)
Range Finding Tests on Compound 21149: Report 25-53.
(Unpublished study received Sep 8, 1965 under unknown
admin, no.; prepared by Mellon Institute of Industrial
Research, Industrial Fellowship, submitted by Union
Carbide Corp., Arlington, Va.; CDL:131905-C)
00069919 Carpenter, C.P.; Condra, N.; McGee, M.A. (1965) A 4-hour
Test for Evaluation of Comparative Skin Penetration
Hazard: Report 28-34. (Unpublished study received
Sep 8, 1965 under unknown admin. no.; prepared by
Mellon Institute, Industrial Fellowship, submitted by
Union Carbid-e Corp., Arlington, Va.; CDL: 131905-F)
55
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00073207 Ercegovich, C.D.; Rashid, K.A. (1977) Mutagenesis
Induced in Mutant Strains of Salmonella typhimurium by
Pesticides. (Unpublished study, including letter
dated Sep 22, 1977 from C.D. Ercegovich to Tom Evrard,
received Aug 24, 1979 under 1258-812; prepared by
Pennsylvania State Univ., Pesticide Research Labora-
tory, submitted by Olin Corp., Stamford, Conn.; CDL:
240890-C)
00073345 Kimmerle, ? (1971) Letter sent to PF-ATEA Product
Development dated Jan 25, 1971: Di-syston and Temik
granular: Report No. 29378. (Unpublished study re-
ceived Dec 15, 1976 under 3125-58; prepared by Bayer,
W. Germany, submitted by Mobay Chemical Corp., Kansas
City, Mo.; CDL:095640-E)
00079566 Kinkead, E.R.; Chin, B.H., Weil, C.S.; et al. (1968)
Toxicity Studies on Temik ... and Related Carbamates:
Special Report 3148. (Unpublished study received
Jan 18, 1977 under 1016-EX-37; prepared by Mellon
Institute, Chemical Hygiene Fellowship, sub-
mitted by Union Carbide Corp., Arlington, Va.;
CDL:229032-D)
00079923 Rashid, K.A. (1974) Mutagenesis Induced in Two Mutant
Strains of Salmonella typhimurium by Pesticides and
Pesticide Degradation Products. Master's thesis,
Pennsylvania State Univ., Dept. of Entomology.
(Unpublished study received Feb 23, 1978 under 100-551;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
232925-A)
00080701 Carpenter, C.P.; Condra, N.I.; Humes, C.; et al. (1966)
Temik 10G (10.5% Granular Formulation of Compound
21149): 15-day Dermal Applications to Rabbits: Report
298-80. (Unpublished study received Mar 2, 1967 under
7F0573; prepared by Carnegie-Mellon Univ., Mellon
Institute, Industrial Fellowship, submitted by Union
Carbide Corp., Charleston, W.Va. ; CDL-.090072-G)
00080709 Knaak, J.B.; Sullivan, L.J.; Tallant, M.J.; et al. (1965)
Metabolism of UC 21149 in the Rat: Report 28-138.
(Unpublished study received Mar 2, 1967 under 7F0573;
prepared by CarnegieMellon Univ., Mellon Institute,
Industrial Fellowship, submitted by Union Carbide
Corp., Charleston, W.Va.; CDL:090072-T)
56
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00080710 Carpenter, C.P.; Goldberg, M.E.; Johnson, H.E.; et al.
(1965) Recapitulation of Pharmacodynamic and Acute
Toxicity Studies on Temik (Compound 21149): Report
28-78. (Unpublished study received Mar 2, 1967 under
7F0573; prepared by Carnegie-Mellon Univ., Mellon
Institute, Industrial Fellowship, submitted by
Union Carbide Corp., Charleston, W.Va.; CDL:090072-V)
00080810 Striegel, J.A.; Condra, N.I.; Haun, C.C.; et al. (1963)
Range Finding Tests on Compound 21149 (2-Methylthio-2-
methylpropionaldehyde N-Methylcarbamoyloxime): Report
25-53. (Unpublished study received Jan 25, 1966 under
6G0473; prepared by Mellon Institute of Industrial
Research, Industrial Fellowship, submitted by Union
Carbide Corp., New York, N.Y.; CDL:090525-C)
00080811 Carpenter, C.P.; Condra, N.; McGee, M.A. (1965) A 4-hour
Test for Evaluation of Comparative Skin Penetration
Hazard: Report 28-34. (Unpublished study received
Jan 25, 1965 under 6G0473; prepared by Mellon Insti-
tute, Industrial Fellowship, submitted by Union
Carbide Corp., New York, N.Y.; CDL:090525-F)
00080820 Coppedge, J.R.; Lindquist, D.A. (19??) Preliminary
Studies on the Fate of Radiolabeled Union Carbide
21149 in Soil and Cotton Plants. (U.S. Agricultural
Research Service, Entomology Research Div.; unpub-
lished study; CDL:09525-T)
00080825 Carpenter, C.P.; Condra, N.I.; Humes, C.; et al. (1966)
Temik 10G (10.5% Granular Formulation of Compound
21149): 15-day Dermal Applications to Rabbits: Report
29-80. (Unpublished study received Mar 11, 1968 under
6G0473; prepared by Mellon Institute, Industrial
Fellowship, submitted by Union Carbide Corp, New
York, N.Y.; CDL:090527-I)
00081414 Knaak, J.B.; Sullivan, L.J.; Tallant, M.J.; et al.
(1965) Metabolism of UC 21149 in the Rat: Report
28-138. (Unpublished study received Jan 14, 1966 under
1016-EX-24; prepared by Mellon Institute, Industrial
Fellowship, submitted by Union Carbide Corp.,
Arlington, Va.; CDL:126498-B)
57
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00093640 Coppedge, J.R.; Lindquist, D.A. ; Bull, D.L.; et al.
(1966?) A Report on 2-Methyl-2-(methylthio)propionalde-
hyde N-(raethylstudy received Feb 27, 1967 under 7F0573;
prepared by Texas A & M Univ., Agricultural Experiment
Station, Entomology Research Div. , submitted by
Union Carbide Corp., Charleston, W.Va.; CDL:090741-B)
00093642 Coppedge, J.R. (1967) Fate of 2-Methyl-2-(methylthio)
propionaldehyde 0-(methylcarbamoyl)oxime (Temik) in
Plants and Soil. Master's thesis, Texas A & M Univ.
(Unpublished study received Feb 27, 1967 under
7F0573; submitted by Union Carbide Corp., Charleston,
W.Va.; CDL:090741-D)
00100381 Union Carbide Corp. (1968) Feeding in the Diet of Rats
for Three or Six Months: Report 31-142. (Unpublished
study received Jan 25, 1978 under 1016-79; CDL:
096728-A)
00100382 Striegel, J.; Condra, N.; Haun, C. (1963) Acute Toxicity
of Compound (21865): Special Report 26-29. (Unpub-
lished study received Jan 25, 1978 under 1016-79;
prepared by Mellon Institute, Industrial Fellowship,
submitted by Union Carbide Corp., Arlington, VA;
CDL:096728-B)
00100386 Weil, C. (1974) Miscellaneous Toxicity Studies: UC 21865:
Special Report 37-10. (Unpublished study received
Jan 25, 1978 under 1016-79; prepared by Carnegie-Mellon
Univ., Div. of Sponsored Research, Chemical Hygiene
Fellowship, submitted by Union Carbide Corp.,
Arlington, VA; CDL:096728-F)
00100388 Woodside, M.; Weil, C.; Bernard, J.; et al. (1977)
Aldicarb Sulfone: 18-month Feeding in the Diet of
Mice: Project Report 4038. (Unpublished study re-
ceived Jan 25, 1978 under 1016-79; prepared by
Carnegie-Mellon Univ., Institute of Research, Chem-
ical Hygiene Fellowship, submitted by Union Carbide
Corp., Arlington, VA; CDL:096728-0)
00100389 Weil, C. (1970) Miscellaneous Toxicity Studies: Temik
Special Report 33-18. (Unpublished study received
Jan 25, 1978 under 1016-79; prepared by Carnegie-
Mellon Univ., Mellon Institute, Chemical Hygiene
Fellowship, submitted by Union Carbide Corp.,
Arlington, VA; CDL:096728-T)
58
-------
Appendix II
OFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00100391 Weil, C. (1970) Miscellaneous Toxicity Studies: Temik:
Special Report 33-92. (Unpublished study received
Jan 25, 1978 under 1016-79; prepared by Carnegie-Mellon
Univ., Mellon Institute, Chemical Hygiene Fellowship,
submitted by Union Carbide Corp., Arlington, VA;
CDL:096728-V)
00100392 Weil, C.; Condra, N. ; Geary, D.; et al. (1973) UC 21865
Formulation 22RZB-75-B; SOW: Range Finding Toxicity
Studies: Special Report 36-24. (Unpublished study
received Jan 25, 1978 under 1016-79; prepared by
Carnegie-Mellon Univ., Div. of Sponsored Research,
Chemical Hygiene Fellowship, submitted by Union
Carbide Corp., Arlington, VA; CDL:096728-X)
00100393 Weil, C.; Burton, D.; Calisti, L. (1974) UC 21865
Technical, UC 21865—75% WP, Peroral Intubation of
Rats with or without Subsequent Dose(s) of Atropine:
Special Report 37-60. (Unpublished study received Jan
25, 1978 under 1016-79; prepared by CarnegieMellon
Univ., Div. of Sponsored Research, Chemical Hygiene
Fellowship, submitted by Union Carbide Corp.,
Arlington, VA; CDL:096728-AA)
00101929 Andrawes, N.; Bagley, W.; Herrett, R. (1968) Metabolism
of C14Temik in Cotton Plants under Field Conditions:
File No. 10492. (Unpublished study received Apr 18,
1969 under 9F0798; submitted by Union Carbide Corp.,
New York, NY; CDL:091372-D)
00101930 Andrawes, N.; Bagley, W.; Herrett, R. (1968) Degradation
of Temik ... in Potato Foliage: File No^ 10495.
(Unpublished study received Apr 18, 1969 under 9F0798;
submitted by Union Carbide Corp., New York, NY;
CDL:091372-F)
00101931 Andrawes, N. ; Bagley, W. ; Herrett, R. (1968) Metabolism
and Associated Residues of Temik in Spearment and
Lettuce: File No. 10496. (Unpublished study received
Apr 18, 1969 under 9F0798; submitted by Union Carbide
Corp., New York, NY; CDL: 091372-G)
00101933 Dorough, H. (1968) Continuous Feeding of Radiolabeled
Temik to Laying Hens. (Unpublished study received
Apr 18, 1969 under 9F0798; prepared by Texas A and M
Univ., submitted by Union Carbide Corp., New York, NY;
CDL:091372-I)
59
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
.Citations Considered to be' Part of the Data Base Supporting
Registration Under this Guidance Document
00101934 Bull, D.; Coppedge, J. ; Ridgway, R. (19??) Fate of Temik
in Soil with Special Reference to Chemical Changes,
Movement, and Volatilization. (U.S. Agricultural
Research Service, Entomology Research Div., Cotton
Insects Systemic Chemicals Investigations; unpublished
study; CDL:091372-J)
00101943 Pozzani, U. ; Kinkead, E.; Geary, D.; et al. (1968) Temik
10G and Temik 10G-V: Response of Rats to Saturated
Vapors Generated under Simulated Greenhouse Conditions:
Special Report 31-173. (Unpublished study received
Apr 18, 1969 under 9F0798; prepared by Mellon Institute,
Chemical Hygiene Fellowship, submitted by Union Carbide
Corp., New York, NY; CDL:091373-F)
00101959 Lund, R.; Haines, R. (1969) Field Evaluation of Temik 10G
Aldicarb Pesticide: Potential Hazard to White-tail
Deer and Cottontail Rabbits from Simulated Spills.
(Unpublished study received Aug 20, 1970 under OF1008;
prepared in cooperation with New rsey, Fish and Game
Commission, Black River State Game Field Station,
submitted by Union Carbide Corp., Washington, DC;
CDL:091748-B)
00101960 Clarkson, V.; Haines, R. ; Hennsley, W.; et al. (1969)
Report on Additional Field Tests with Temik 10G
Aldicarb Pesticide on the Potential Hazard to Bobwhite
Quail. (Unpublished study received Aug 20, 1970 under
OF1008; submitted by Union Carbide Corp., Washington,
DC; CDL:091748-C)
00101961 Haines, R. <1970) Field Evaluation of Potential Hazard of
Temik 10G Aldicarb Pesticide to Valley Quail and
Ring-necked Pheasants: Trial I. (Unpublished study
received Aug 20, 1970 under OF1008; submitted by Union
Carbide Corp., Washington, DC; CDL:091748-D)
00101962 Haines, R. (1970) Field Evaluations of Potential Hazard of
Temik 10G Aldicarb Pesticide to Valley Quail and
Ring-necked Pheasants: Trial II. (Unpublished study
received Aug 20, 1970 under OF1008; submitted by Union
Carbide Corp., Washington, DC; CDL:091748-E)
60
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00101967 Dorough, H. (1970) Extraction of Radioactive Residues
from Liver of Cow Fed 1.2 ppm Aldicarb-Aldicarb
Sulfone-C14 in the Diet for 14 Days. (Unpublished
study received Aug 20, 1970 under OF1008; prepared by
Univ. of Kentucky, Dept. of Entomology, submitted by
Union Carbide Corp., Washington, DC; CDL:091748-L)
00101977 Andrawes, N.; Romine, R.; Bagley, W. (1973) Metabolism
and residues of Temik aldicarb pesticide in cotton
foliage and seed under field conditions. J. Agr. Food
Chem. 21(3):379-386. (Also In unpublished submission
received Jul 24, 1973 under 9F0798; submitted by Union
Carbide Corp., New York, NY; CDL:093106-A) 00101996
00101996 Andrawes, N.; Bagley, W.; Herrett, R. (1971) Metabolism
of ... (Temik aldicarb pesticide) in potato plants.
J. Agr. Food Chem. 19(4):731-737. (Also In unpublished
submission received Aug 6, 1971 under 2F1188; submitted
by Union Carbide Corp., Washington, DC; CDL:093511-B)
00102009 Andrawes, N.; Moorefield, H. (1972) The Metabolism and
Terminal Residues of Temik Aldicarb Pesticide in
Peanut Plants under Field Conditions: Project No.
111A12; File No. 17613. (Unpublished study received
Jun 25, 1973 under 3F1414; submitted by Union Carbide
Corp., Washington, DC; CDL:093776-D)
00102022 Andrawes, N. ; Dorough, H.; Lindquist, D. (1967) Degrada-
tion and elimination of Teraik in rats. Journal of
Economic Entomology 60(4):979-987. (Also In unpub-
lished submission received May 6, 1977 under 1016-69;
submitted by Union Carbide Co., Arlington, VA; CDL:
096131-0)
00102023 Knaak, J.; Tallant, M.; Sullivan, L. (1966) The metabo-
lism of 2-methyl-2-(methylthio)propionaldehyde 0-
(methyl-carbamoyl)oxime in the rat. J. Agr. Food
Chem. 14(6):573-578. (Also In unpublished submission
received May 6, 1977 under 1016-69; submitted by Union
Carbide Corp., Arlington, VA; CDL:096131-P)
00102132 Fink, R.; Beavers, J.; Brown, R. (1979) Final Report:
Eight-day Dietary LC50—Bobwhite Quail: Technical
Grade Aldicarb: Project No. 142-118. (Unpublished
study received Dec 12, 1979 under 1016-78; prepared by
Wildlife International Ltd., submitted by Union Carbide
Corp., Arlington, VA; CDL:099120-B)
61
-------
Appendix II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Consideredd to be Part of the Data Base Supporting
Registration Under this Guidance Document
00102143 Weil, C.; DeMary, L.; Soo, V. (1971) Comparative Skin
Penetration Toxicity of Temik 10GV, Temik 15GV and 5
Other Pesticide Formulations As Marketed: Special
Report 34-76. (Unpublished study received on unknown
date under unknown admin, no.; prepared by Carnegie-
Mellon Univ., Mellon Institute, Chemical Hygiene
Fellowship, submitted by Union Carbide Corp.,
Arlington, VA; CDL:126446-A)
00102179 Andrawes, N.; Moorefield, H. (1972) Metabolism and
Terminal Residues of Temik Aldicarb Pesticide in Flue
Cured Tobacco: Project No. 111A12, File No. 17805.
(Unpublished study received Sep 21, 1976 under 1016-69;
submitted by Union Carbide Corp., Arlington, VA;
CDL:232221-M)
00102180 Khasawinah, A.; Hirsh, D.; Meeker, R. (1976) Temik
Aldicarb Pesticide: Metabolism of Aldicarb in Green
and Cured Tobacco and Pyrolysis Products in Smoke:
Project No. 111A13, File No. 21978. (Unpublished
study received Sep 21, 1976 under 1016-69; submitted
by Union Carbide Corp., Arlington, VA; CDL:232221-N)
62
-------
MMARY SHEET
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data impend by the FIFRA action 3(C)(2)(B) notici contiinid in tht referenced
Guidance Document, I am responding in tht following manner
D1. I will submit data in a timely manner to satisfy the following requirements. If the ten procedures I will USB deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
D3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
EGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8B8O-1 (1042)
63
-------
(To qutlify, certify ALL
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
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
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all termt could not be reached otherwise. This offer was made
to the following firm(s) on the following data(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid'suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYFED NAME
SIGNATURE
DATE
SPA Form 8S8O-6 (10-62)
64
-------
Appendix III-l
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for
Date
Registration
Guideline No.
§158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
Name of Test
Identity of
ingredients
Statement of
cotposition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting pjDint
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Test not
required
for my
product
listed
above
( check
below)
I am complying with
data requirements by
t
Citing MRID#
Submit-
ting
Data
(At-
tached)
«
(For EPA Use Only)
Accession Numbers
Assigned
65
-------
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Corrosion
character i st ics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
66
-------
Chopter I—Environmental Protection Agency
§ 162./0
at obtained the data from anoth
fir»i (identify); applicant copied da
frori a publication: applicant obtained
a copy of the data from EPA).
(dVThe applicant shall submit j[ith
his application a statement that rfPA.
In itsVvaluation of the properties/effi-
cacy. Vnd safety of the formi/lated
end-usA product, may not consid/r any
data aA supporting the appljpation.
except tne following data:
(1) Th\ data the applicant
mitted to\
this sectic
(2) OthJ
safety of tl
ents, rather
end-use pro
'A under paragral
as sub-
h (b) of
data pertainii* to the
|e product's actae ingredi-
Uhan to the s^ety of the
jet; and
(3) Existing, tolerances, fcod additive
regulations, exemptions/ and other
clearances issfced undey the Federal
Pood, Drug, ann Cosmet/c Act.
(e) If the applicant tfnows that any
item of data heXsubmftted under this
section was genekatedcy (or at the ex-
pense of) anotheAperlon who original-
ly submitted theca/a to EPA (or its
predecessor, USDAyon or after Janu-
ary 1, 1970, to supVort an application
for registration, /Experimental • use
permit, or amendAiint adding a new
use to an existin/ registration, or for
reregistration (uWesS the applicant
and the origina/data\ submitter have
reached writte/ agreement on the
amount and the tennsXpf payment of
any compensa/ion thalXmay be pay-
able unde/ FIFAA section
3(c)(l)(D)(ii)/vith regard to approval
of the application), the applicant shall
submit to fPA a statement that he
has furnished to each sue* identified
original da/a submitter:
(DA n«.ification of the Applicant's
Intent to Ipply for registration, includ-
ing the p/oposed product n
(2) An/offer to pay the per^n com-
pensation, with regard to the approval
of the/application, to the extent re-
quired/by FIFRA sections 3(c\(l)(D)
and 3fc)(2)(D);
(3)/An identification of the it%m(s)
of d/ta to which the offer applies\
An offer to commence negtia-
to ascertain the amount Vnd
of compensation to be paid; and
The applicant's name, addre\
id telephone number.
If the applicant's product «on-
tain any active ingredient other /nan
thosX that are present solely because
of thk incorporation into the psfcduct.
duringXformulation, of one of more
other ^gistered pesticide ijroducts
purchased from another /roducer,
then the Applicant shall a^o comply
with § 162)0-5 as to such a/tive ingre-
dient, and \he applicatio/ shall con-
tain an acknowledgment/hat for pur-
poses of FIFJIA sectiony6(c)(l)(D) the
application relies on (ahd any result-
ing registrationXshouldr be regarded as
if it were based M th/Administrator's
consideration of Ah^ollowing data:
(1) All data subrX/ted or specifically
cited by the appl/^nt in support of
the registration;
(2) Each othe/iteffc of data in the
Agency's files w/ich:
(i) Concerns/he propVties or effects
of any such a^ive ingreaent; and
(ii) Is one Li the typesVpf data that
EPA would/equire to be submitted for
scientific nlview by EPA i\ the appli-
cant sought the initial registration
under HIFRA Section 3(cX5) of a-
producywith composition anok intend-
ed uses/identical to those propped for
the applicant's product, under" the
data/requirements in effect orV the
dater EPA approves the applicant's
present application.
(Slcs. 3, 6, and 25 of FIFRA. u amended
^.S.C. 136 et ieij.)
(44 FR 27953. May 11. 19793
6 162.10 Labeling requirements.
(a) General—(1) Contents of the
label Every pesticide products shall
bear a label'containing the informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this
section;
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
(iii) The net contents as prescribed
in paragraph (d) of this section;
67
-------
Appendix IV-1 (continued)
§ 162.10
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph (f)
of this section:
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this
section;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger .type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(i) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act, "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
Title 40—Protection of Environment
wrapper or outside container through
which the label cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily distributed or sold.
(ii) Tank cars and other bulk con-
tainers—(A) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189, concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car, tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers,
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the immediaTe vicinity of the dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(q)(l)(A) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
§ 162.15. is misbranded if its labeling is
false or misleading in any particular
including both pesticidal and non-pes-
ticidal claims. Examples of statements
or representations in the labeling
which constitute misbranding Include:
(i) A false* or misleading statement
concerning the composition of the
product;
(ii) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(iii) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device;
(iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or indi-
rectly implying that the pesticide or
device Is recommended or endorsed by
68
-------
Chapter I—Environmental Protection Agency
§162.10
any agency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe," "nonpoison-
ous," "noninjurious," "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as'directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling, (i) Except
as provided in paragraph (a)(6)(ii) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(il) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to § 162.6(b)(4).
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • • •." "Distribut-
ed by • * V or "Sold by • • •" to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 68' F (20'C)
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semiso-
lid, viscous or pressurized, or is a mix-
ture of liquid and solid, the net con-
tent statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units, i.e., "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
tent or around an average is permi&ai-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated minimum is not permit-
ted. In no case shall the average con-
tent of the packages in a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label,
preceded by the phrase "EPA Regis-
tration No.." or the phrase "EPA Reg.
No." The registration number shall be
set in type of a size and style similar to
other print on that part of the label
on which it appears and shall run par-
69
-------
§ 162.10
Title 40—Protection of Environment
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(I") Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement.
(i) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(ii) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears,
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement The name used for each in-
gredient shall be the accepted
common name, if there is one, fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(cK6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms'of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages,
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(i) In cases where it is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following
statement in a prominent position on
the label: "Not for sale or use after
[date]."
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
70
-------
Chapter I—Environmental Protection Agency
§ 162.10
inert ingredi'ent(s) to be listed in the
ingredient statement if he determines
that such ingredient(s) may pose a
hazard to man or the environment.
(h) Warninffs and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxicological
hazard including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Hazard indicator*
Oral LO.
Inhalation LC».
Derma) LD....._
Eye etlects
Slun effects
Toiicrty categories
1
Up 10 and including 50
mg/kg
Up to ind including 2
mg/ liter.
Up to and including 200
mg/kg
Corrosive, comeal
opacity not reversible
witrtn 7 days
II
From 50 thru 500 mg/kg..
From .2 thru 2 mg/IH«r
From 200 thru 2000
Comaal opacity
reversible within 7
days, mtabon
persisting lor 7 days.
Severe imubon at 72
hours
HI
From 500 thru 5000 mg/
"9
From 2. tfvj K rfij.'Kef...
From 2.000 thru 20.000....
No comeal opacity.
Titanon reversible.
wrthm 7 days.
Moderate irritation at 72
hours
(V
Greater than 5000 mg/
*fl
Greater than 20 mg/kter.
Greater than 20.000.
No rotation.
MHd or slight rotation at
72 hours.
(i) Human hazard signal word—(.A)
Toxicity Category I. All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral, inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(ii) CTitZd hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonstrated by
the applicant, to be extremely remote,
or if the nature of the pesticide is such
that it is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(iii) Statement of practical treat-
ment—(A) Toxicity Category I. A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing into Toxicity Category I on the
basis of oral, inhalation or dermal tox-
icity. The Agency may, however,
permit reasonable variations in the
71
-------
§ 162.10
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIXiilXA) of
this section. The applicant may, how-
ever. Include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (h)(2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Title 40—Protection of Environment
Pants
Sat of label Ironi panel m square
inches
5 and under
Above 5 to 10
Above 1010 15
Above 15 to 30
Over 30
Requited
signal
word, all
capitals
"Keep out
0< reach ol
Children
10 I
12 |
14 I
18 I
8
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Toiocity
category
Precautionary statements by toncity category
Oral, inhalation, or dermal Unocrty
Skin and eye local effects
III....
rv.._
Fatal (poisonous) if swallowed [inhaled or absorbed
through slun] Do not breathe vapor [dust or spray
mist]. Do nol get m eyas, on slun. or on clothing
[Front panel statement of practical treatment re-
gured.1.
May be lalai if swallowed [inhaled or absorbed
through the slun]. Do not breathe vapors [dust or
spray mat}. Do not get m eyes, on slun. or on
clothing. [Appropriate first aid statements requned.].
Harmful if swallowed [inhaled or absorbed through the
sfcm]. Avoid breathing vapors [dual or spray mail
Avc«d contact witn slun [eyes or dotttng). [Appro-
priate first aid statement required.].
[No precautionary statements requred.]
Corrosive, cause* eye and slun damage [or *un
irritation]. Do not gel *i eyes, on slun. or on
ctothng Wear goggles or face sh*M and rubber
glove* when handing Harmful or fatal rf swallowed.
[AporoonaM first aid statement requred.}
Causes eye [and slun] muton. Do not get n eyes.
on skin, or on ctotnmg. Harmful if swallowed [Ap-
propriate first aid statement requred.]
Avoid contact with Hun, eyes or doming, m case of
contact immediately flush eyes or slun with plenty of
•rater. Get medical attention if rntation perasts.
[No precautionary statements recured]
(il) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
injury or damage. Examples of the
hazard statements and the circum-
72
-------
Chapter I—Environmental Protection Agency
§162.10
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LD» of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for put-
door use contains an active ingredient
with a fish acute LC» of 1 ppm or less,
the statement "This Pesticide is Toxic
to Pish" is required.
(C) If a pesticide intended for put-
door use contains an active ingredient
with an avian acute oral LDH of 100
mg/kg or less, or a subacute dietary
LCM of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(iii) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Fiasfi pewit
Required text
(A) PRESSUWZEO CONTAINERS
Fiasfi point at or bettw 20* F. if (tore « a flashback at Extremely flammable Conlenu under pressure Keep away from
any vilv« opefwig. hr«. (parks, and heated surfaces Do not puncture o> inanerale
container. Exposure to temperatures above 130* f may cause
| bursting
Flash pom! above 20' f and not over SO' F or if the , Flammable Contents under pressure. Keep away from heat.
sparks, and open flame Do not puncture or rionerate container.
Exposure to temperatures above 130* F mey cause bursting.
Contents unoer pressure Do not use or store near Neat Of open
flame Do not puncture or ncmerata container. Exposure to
temperatures above 130' F may cause bursting.
flame extension a more then 16 in long at a data/ice
of 6 in from the name.
AH orne< pressunzed container*
(B) NoNPtttssuAizEC CONTAINERS
At or below 20' F
Above W F and not over 80' F._
Above 80' F and not over 150" F
Extremely flammable Keep away from fire, sparks, and heated
surfaces
Flammable Keep away from heat and open flame.
Do no! use or store near heal or open flame
(i) Directions for Use—(1) General
requirements—(I) Adequacy and clar-
ity of directions. Directions for use
must be stated in terms which can be
easily read and understood by the
average person likely to use or to su-
pervise the use of the pesticide. When
followed, directions must be adequate
to protect the public from fraud ar.d
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(ii) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag;
(B) The label bears a reference to
the directions for use in accompanying
leaflets or circulars, such as "See dl-
. rections in the enclosed circular" and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(iii) Exceptions to requirement for
direction for use—(A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides wliich are intended
73
-------
§162.10
Title 40—Protection of Environment
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
U) The label clearly shows that the
product Is intended for use only in
manufacturing processes and specifies
the type(s) of products involved.
(.2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type Af product involved and its
proper aase m raaawtfactwi^g process-
es;
(J) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
(I) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product Is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(.1) There is information readily
available to the formulators on the
composition, toxicity, methods of use,
applicable restrictions or limitations,
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product is intended for use only in
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(1) The statement of use classifica-
tion as prescribed in 162.10(j) Immedi-
ately under the heading "Directions
for Use."
(ii) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(iii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
-------
Chapter I—Environmental Protection Agency
§162.11
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22, 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (JK1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s), both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of 5 162.10(j)(2).
(1) General Use Classification, Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words "General
Classification" 'mmediately below the
heading "Dim 'ions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of misbranding.
(2) Restricted Use Classification,
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(i) Front panel stateTnent of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as required
for human hazard signal words (see
table in § 162.10(h)(l)(iv)). and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use, the state-
ment "Restricted Use Pesticide" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use is restricted to certified
applicators, the following statement is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If,
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. [Reserved]
.[40 FR 28268, July 3, 1975; 40 FR 32329,
Aug. 1. 197S; 40 FR 36571, Aug. 21, 1975, as
amended at 43 FR 5786. Feb. 9. 1978]
§ H2.ll Criteria for determinations of un-j
reasonable advene effects.
ria for Issuance of Notice,
Intent\to Deny Registration, Ca
Reyistrotton, or to Hold a Heajtnp—
(1) Pres-winption. (i) A rebuttahle pre-
sumption ViaD arise that a notice of
Intent to de\y registration pursuant to
section 3(c)(9i of the Act,/notice of
intent to cancV registration pursuant
to section 6(b\l) of tire Act, or 'a
notice of intent V) hoUT a hearing to
determine wheth\- Ine registration
should be canceDeouor denied, as ap-
propriate, shall beyOsued, upon a de-
termination by th/AdViinistrator that
the pesticide mafls orVcceeds any of
the criteria for^isk set north in para-
graph (a)(3) oXthis sectionV Upon such
determinaticjf. the Administrator
shall issue Xotice by certified mail to
the applicant or registrant, as\£e case
may be,/tating that the applicant or
registrant has the opportunity to
submi)r evidence in rebuttal of Vich
presj/nption in accordance with para-
graph (a)(4) of this section. The appl
ca/u or registrant shall have forty-fiv?
-------
APPENDIX I\
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (REFER TO THE SAMPLE LABELS FOLLOWING)
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Est. No.
EPA Reg. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precaut ionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, in
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition t<
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead c
the label.
Text must run parallel with other tej
on the panel.
All front panel precautionary stateme
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
76
-------
APPENDIX IV-2 (continue
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
77
-------
APPENDIX IV-2 (continud
ITEM
8C
9A
9C
10A
IOC
10D
U.S.
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
All
chol i nes terase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Iimediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS 1
Includes a statement of the terms of
restriction. The words "RESTRICTED U!
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. unit
78
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire^, sparks, and
heated surfaces.
.Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
79
-------
Appendix IV-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 DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under 6 point
Above 10 to 15 8 point
Above 15 to 30 10 point
Over 30 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed,
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
*
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
80
-------
Appendix IV-5
(continued)
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions;
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on, the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
81
-------
Appendix IV-5
(continued)
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
3. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
:ontainer Type Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or. puncture.
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
82
-------
Container Type
Appendix IV-5
(continued)
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^ , dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
' or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording).
^Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix.
83
-------
Appendix IV-5
(continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts);
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
84
-------
Appendix IV-5
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
85
-------
Appendix IV-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-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
6-Dfchlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12 )
3,5-Dichloro-N-(1,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
86
-------
Appendix IV-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11 )
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
87
-------
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
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 1
Vinyl chloride
Xylene
88
-------
_Iiidex of Currently Acceptable Uses
EPA Index to Pesticide Chemicals
ALDICARB*
TYPE PESTICIDE: Insecticide, Acaricide (also refer to Nematicide entry)
FORMULATIONS: G (5%, 10%, 15%)
GENERAL WARNINGS AND LIMITATIONS; RESTRICTED USE PESTICIDE
Do not apply in Suffolk County, Long Island, NY.
Avoid use in well draining soils, particularly in areas having shallow
and unconfined aquifers, and a total precipitation and/or irrigation re-
charge greater than 10 inches per year.
The use of aldicarb may pose a hazard to the Federally designated endan-
gered/threatened species known to be found in certain areas within named
locations.
Attwater's Greater Prairie Chicken - TX counties including Aransas,
Austin, Brazoria, Colorado, Galveston, Goliad, Harris, Refugio, and
Victoria
Aldicarb may not be used in areas where adverse impact on the Federally
designated endangered/threatened species noted above is likely. Prior to
making applications, the user of aldicarb must determine that no such
species are located in or immediately adjacent to the area to be treated.
If the user is in doubt whether or not the above endangeres species may
be affected, he should contact either the regional U.S. Fish and Wildlife
Service Office (Endangered Species Specialist) or personnel of the State
Fish and Game Office.
Agricultural Crop Tolerances:
Bananas - 0.3 ppm
Coffee Beans - 0.1 ppm
Sugarcane - 0.02 ppm
Sugarcane (forage and fodder) - 0.1 ppm
Sweet Potatoes - 0.1 ppm
Livestock Tolerances;
Cattle (fat, meat, meat byproducts) - 0.01 ppm
Goats (fat, meat, meat byproducts) - 0.01 ppm
Hogs (fat, meat, meat byproducts) - 0.01 ppm
Horses (fat, meat, meat byproducts) - 0.01 ppm
Milk - 0.002 ppm
Sheep (fat, meat, meat byproducts) - 0.01 ppm
Definition of Terms;
Claims for pest control limited to suppression of populations are indi-
cated by parenthesized pest name.
*Temik
2-methyl-2-(methylthio)propionaldehyde 0-(methylcarbamoyl)oxime
Issued: 8-19-82 III-098301-1
89
-------
Site and Pest
AGRICULTURAL CROPS
EPA index to Pesticide unemicais
ALDICARB
Dosages and Tolerance, Use, Limitations
Formul at ion ( s )
General Warnings and Limitations; Do not plant any crop other than those
registered aldicarb uses in aldicarb treated soil. Do not allow livestock
to graze treated areas before harvest. Do not store or use in or around
the home or home garden. Aldicarb is not effective if used with alkaline
materials such as lime. Use high rate on heavy organic or clay soils.
Applications in excess of 0.75 pound (actual) per acre of 5 per cent
granular formulation or 1 pound (actual) per acre of 10 to 15 per cent
granular formulations made directly to seed furrow of beans (dried-type),
cotton, soybeans, and sugar beets may delay emergence and reduce plant
stand. Make side-dress applications close enough to plants to allow good
uptake by roots without injury to the plants from root pruning. In ir-
rigated areas, follow application with irrigation within 7 days. If al-
ternate furrows are irrigated after side-dress application, the aldicarb
and water must be on the same side of the plant row. To provide maximum
performance and minimize hazards to birds, incorporate granules into or
cover with soil to a depth of 2 inches or more. Deep disc any spills at
row ends.
'15001AA
Beans, Dried-type
2ACAAA
Aphids
SAFAAA
HAPAFA
1AAABA
Leafhoppers
Mexican bean
Mites
beetle
0.1 ppm
90 day preharvest interval through
2.3 ounces per 1,000 feet of row
for soil application.
Do not make more than 1 application
per crop. Do not harvest green
pods for human consumption. Do not
feed green forage, hay, or straw to
livestock.
0.8-1.1 oz/ Soil application at planting. Drill
1,000 ft row granules 2 to "3 inches below seed
(with 30-48 line or 2 to 3 inches to side of
in. row seed row and 2 to 3 inches* deep.
spacing) Granules may be placed in seed fur-
(10-15% G) row if rate does not exceed 0.75
pound active ingredient per acre.
1.1-2.3 oz/
1,000 ft row
(with 30-48
in. row
spacing)
(10-15% G)
Issued: 8-19-82
III-098301-2
90
-------
EPA Index to Pesticide Chemicals
Site and Pest
AIDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
Beans, Dried-type (continued)
.OACAAA
Seedcorn maggot
28007AA
Cotton
0.5-0.75 Ib/A Use limited to NY.
or Soil application at planting.
0.6-0.8 oz/ Apply granules in seed furrow and
1,000 ft row cover with soil.
(with 36 in.
row spacing)
(15% G)
0.1 ppm (cottonseed)
0.3 ppm (cottonseed hulls)
90 day preharvest interval through
3 pounds per acre (with 40 inch row
spacing) for soil application.
Do not make more than 1 at planting
application and 1 postemergence ap-
plication per crop.
MCAAA
JIOAAAA
Aphids
Thrips
MSAHJ
.QAMBDA
;MAAAGA
1AAABA
LAMBDA
iRAFAAA
UASAAA
IAAABA
QUiAAA
0.3-0.5 Ib/A
or
0.4-0.7 oz/
1,000 ft row
(with 40 in.
row spacing)
(5-15% G)
0.6-1 Ib/A
or
0.8-1.3 oz/
1 ,000 ft row
(with 40 in.
row spacing)
(5-15% G)
1-2 Ib/A
or
1.2-2.6 oz/
1,000 ft row
(with 40 in.
row spacing)
(10-15% G)
Boll weevil 2-3 Ib/A
Mites or
Plant bugs (includ- 2.4-3.7 oz/
ing lygus bugs) 1,000 ft row
(with 40 in.
row spacing)
(10-15% G)
Boll weevil (over-
wintering adults)
Fleahoppers
Leafminers
Mites
Plant bugs (includ-
ing lygus bugs)
Fleahoppers
Leafhoppers
Soil application at planting. Drill
granules just below seed line or
place in seed furrow and cover with
soil. For hill-dropped seed, reduce
dosage by one-half.
May be formulated with pentachloro-
nitrobenzene and 5-ethoxy-3-(tri-
chloromethyl)-l,2,4-thiadiazole.
Soil application at first squaring.
Side-dress granules 8 to 16 inches
to 1 side of the plant row and 2 to
6 inches deep, usually at or below
bottom of water furrow.
Issued: 8-19-82
III-098301-3
91
-------
AYAHA
Site and Pest
Cotton (continued)
Cotton leaf-
perforator
ABAAA
Whiteflies
I2002AA
12004 AA
I2005AA
Grapefruit
Lemon
Lime
(ACAAA
JAVARA
AJBCA
iVAKA
Aphids
Citrus red mite
Citrus rust mite
Texas citrus mite
AIDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
2-2.1 Ib/A Soil application from squaring
or through early bloom. Side-dress
2.4-2.6 oz/ granules 8 to 16 inches to 1 side
1,000 ft row of the plant row and 2 to 6 inches
(with 40 in. deep, usually at or below bottom of
row spacing) water furrow.
(10-15% G)
2-3 Ib/A
or
2.4-3.7 oz/
1,000 ft row
(with 40 in.
row spacing)
(10-15% G)
0.3 ppm
0.6 ppm (citrus pulp, dried)
30 day preharvest interval through
10 pounds per acre for soil appli-
cation for lemon.
Do not make more than 1 application
per year. ~
5-10 Ib/A
(with 18-25
ft row
spacing)
(15% G)
Soil application. Apply just prior
to or during spring flush of foliage
growth. Apply in a band along drip-
line on both sides of tree row by
spreading granules uniformly and
immediately working into soil (pre-
ferred method) or shank 2 to 3 inch-
es deep using 4 to 6 shank€ on 12
inch centers. Band width should
equal one fourth tree row spacing.
Thoroughly irrigate'immediately
after application. May also be ap-
plied in irrigation furrows using 2
shanks per furrow.
Issued: 8-19-82
III-098301-4
92
-------
I06AA
Site and Pest
Orange
;AAA
fARA
JBCA
Aphids
Citrus red mite
Citrus rust mite
'007AA
il)06AA
Peanuts
: to Pesticide Chemicals
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.3 ppm
0.6 ppm (citrus pulp, dried)
Soil application through 10 pounds
per acre.
Do not make more than 1 application
per year.
Soil application. Apply just prior
to or during spring flush of fol-
iage growth. Apply in a band along
dripline on both sides of tree row
by spreading granules uniformly and
immediately working into soil (pre-
ferred method) or shank 2 to 3 inch-
es deep using 4 to 6 shanks on 12
inch centers. Band width should
equal one fourth tree row spacing.
Thoroughly irrigate immediately
after application. May also be ap-
plied in irrigation furrows using 2
shanks per furrow.
0.05 ppm (peanuts)
0.5 ppm (peanut hulls)
90 day preharvest interval through
2.1 pounds per acre (with 36 inch
row spacing) for soil application.
Do not make more than 1 application
per crop. Do not feed or allow
livestock to graze on treated hay
or vines.
5-10 Ib/A
(with 18-25
ft row
spacing)
(10-15% G)
5AAAA
Thrips
1-2.1 Ib/A Soil application at planting. Apply
or granules in seed furrow anH cover
1.1-2.3 oz/ with soil. In the Southwest, apply
1,000 ft row high rate only.
(with 36 in.
row spacing)
(10-152 G)
Issued: 8-19-82
III-098301-5
93
-------
AIDICARB
03008AA
Site and Pest
Pecan
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.5 ppm
Soil application through 10 pounds
per acre.
Do not make more than 1 application
per year. Do not harvest foliage
or hay from treated areas.
;RACAAA
ilAAABA
KAVAIA
Aphids
Mites
(Pecan leaf phyllo-
xera)
5-10 Ib/A Use limited to Southeastern United
(10-15% G) States.
Soil application (band). Apply dur-
ing period from bud break to nut set
(approximately April 15 to May 15).
For pecan leaf phylloxera, apply 7
to 14 days before bud break. Apply
as a 4 to 6 foot band along dripline
on both sides of tree row by spread-
ing granules uniformly and immedi-
ately working into soil or by shank-
ing 2 to 3 inches into soil on 12
inch centers.
/03008DA
IRACAAA
ILAAABA
IIBGATA
IRAVAIA
Pecan (nonbearing transplants
1 to 5 years old)
0.5 ppm
Aphids
Mites
Pecan bud moth
(Pecan leaf phyllo-
xera)
0.8-3.2 ozl Use limited to Southeastern United
tree States.
(10-15% G) Soil application. Apply during
period of bud break (approximately
April 15 to May 15). For pecan bud
moth and pecan leaf phylloxera,
apply 7 to 14 .days before bud break.
Apply as a side-dress to individual
trees row by spreading granules uni-
formly around the tree and immedi-
ately working into soil to a depth
of 2 to 3 inches.
Issued: 8-19-82
III-098301-6
94
-------
,013AA
Site and Pest
Potato
ACAAA
Aphids
ACAAA
AMCEA
AFAAA
Aphids
Colorado potato
beetle
Leafhoppers
EPA Index to Pesticide Chemicals
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
1 ppm
90 day preharvest interval through
3 pounds per acre (with 34 inch row
spacing) for soil application at
planting.
50 day preharvest interval through
3 pounds per acre (with 34 inch row
spacing) for postemergence soil
application.
Do not make more than 1 application
per crop.
1 Ib/A Use limited to ME.
or Postemergent soil application. Ap-
1.05 oz/1,000 ply granules in 4 to 6 inch band
ft row over row on the top of hill at
(with 34 in. emergence. Do not apply more than
row spacing) once every 2 years.
(10-15% G)
2-3 Ib/A Use limited to areas other the
or states and counties listed in para-
2.1-3.1 oz/ graph below.
1,000 ft row Soil application at planting. Apply
(with 34 in. granules- with seed pieces in plant-
row spacing) ing furrow and cover with soil of
(10-15% G) drill granules 2 to 4 inches on both
sides of seed row and 3 to 8 inches
deep, usually 1 to 2 inches below
seed pieces.
2-2.1 Ib/A Use limited to" ME and WI and the
or counties of:
2.1-2.2 oz/ Hartford CT
1,000 ft row Kent and New Castle DE '
(with 34 in. Franklin and Hampshire MA
row spacing) Worchester MD
(10-15% G) Atlantic, Burlington, Cumberland,
Monmouth and Salem NJ
Newport and Washington RI
Accomack and Northampton VA.
Postemergent soil application. Ap-
ply granules in 4 to 6 inch band
over row on top of hill at emer-
gence. Cover granules with soil by
cultivators or hilling discs. "Do
not apply more than once every 2
years.
Issued: 8-19-82
III-098301-7
95
-------
EACAAA
NAMCEA
Site and Pest
Potato (continued)
Aphids
Colorado potato
beetle
INAMADA
Flea beetles
[RAXAAA
Psyllids
inaex to Pesticide Chemicals
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
2-3 Ib/A Use limited to areas other than the
or states and counties listed in above
2.1-3.2 oz/ paragraph.
1,000 ft row Postemergent soil application.
(with 34 in. Apply at 75 percent emergence or
row spacing) before plants are 6 inches high up
(10-15% G) to 42 days after emergence. Side-
dress granules 4 to 5 inches on both
sides of plant row and 4 inches
deep. Apply where pest populations
are expected 14 to 21 days after
plant emergence. Do not apply if
an at planting1 application was made.
3 Ib/A
Use limited to areas other than the
or states and counties listed above.
3.1 oz/1,000 Soil application at planting. Apply
ft row granules with seed pieces in plant-
(with 34 in. ing furrow and cover with soil.
row spacing)
(10-15% G)
2-2.1 Ib/A Use limited to AZ.
or Soil application at planting. Apply
2.1-2.2 oz/ granules with seed pieces in plant-
1,000 ft row ing furrow and cover with soil or
(with 34 in. drill granules 2 to 4 inches on both
row spacing) sides of seed row and 3 to 8 inches
(10-15% G) deep, usually .1 to 2 inches below
seed pieces.
Issued: 8-19-82
III-O98301-8
96
-------
Site and Pest
8019AA Sorghum
EPA Index to Pesticide Chemicals
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.5 ppm (fodder, bran)
0.2 ppm (grain)
90 day preharvest interval through
1 pound per acre (with 36 inch row
spacing) for soil application.
The use of aldicarb may pose a haz-
ard to the following Federally des-
ignated endangered/threatened spe-
cies known to be found in certain
areas within named locations. Att-
water's Greater Prairie Chicken -
TX counties including Aransas, Aus-
tin, Brazoria, Colorado, Galveston,
Goliad, Harris, Refugio, and Vic-
toria. Aldicarb may not be used in
areas where adverse impact on the
Federally designated endangered/
threatened species noted above is
likely. Prior to making applica-
tions, the user of aldicarb must
determine that no such species are
located in or immediately adjacent
to the area to be treated. If the
user is in doubt whether or not the
above endangered species may be af-
fected, he should contact either the
regional U.S. Fish and Wildlife Ser-
vice Office (Endangered Species
Specialist) or personnel of the
State Fish and Game Office.
Do not make more than 1 application
per year. Do not feed green forage
to livestock.
JACDNA
(Chinch bug)
(Greenbug)
1 Ib/A
or
1.1 oz/1,000
ft row
(with 36 in.
row spacing)
(10-15% G)
Soil application at planting. Apply
in seed furrow and cover with soil.
Issued: 8-19-82
III-098301-9
97
-------
EPA Index to Pesticide Chemicals
S023AA
Site and Pest
Soybeans
APAPA
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.02 ppm
90 day preharvest Interval through
1.7 oz per 1,000 feet of row for
soil application.
Do not make more than 1 application
per crop. Do not feed green forage,
hay, or straw to livestock.
Mexican bean beetle 0.8-1.65 oz/ Soil application at planting. Drill
1,000 ft row granules 2 to 3 inches below seed
(with 30-48 line or 2 to 3 inches to side of
in. row seed row and 2 to 3 inches deep.
spacing)
(10-15% G)
18020AA
Sugar Beets
SACAAA
Aphids
UFAAA
1AAAGA
Leafhoppers
Leafminers
l-2«li
or
0.65-1.4 oz/
1,000 ft row
(with 22 in.
row spacing)
(10-15% G)
2-3 Ib/A
or
1.3-2 oz/
1,000 ft row
(with 22 in.
row spacing)
(10-15% G)
0.05 ppm (roots)
1 ppm (tops)
90 day preharvest interval through
3 pounds per acre (with 22 inch row
spacing) for soil application.
120 day preharvest interval through
3 pounds per acre for soil
application if tops are to be fed
to livestock.
Do not harvest tops for human con-
sumption. Do not exceed a total of
6 pounds per acre, including an at
planting application. Do not make
more than 1 at planting application
and 2 postemergence applications per
crop. Do not make any postemergence
applications if a preemergence
application of 4 to 5 pounds per
acre for nematode control *is made.
Soil application at planting. Drill
granules 1 to 3 inches below seed
line. Granules can be placed in
seed furrow if rate does not exceed
1 pound per acre.
OR
Postemergence soil application.
Side-dress granules to 4 to 8 inches
to 1 side of plant row and 2 to 6
inches deep. Repeat if needed for
continued protection against virus
vector.
Issued: 8-19-82
111-098301-10
98
-------
xuuex to resLiCiae
Site and Pest
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
Sugar Beets (continued)
XACA
Sugarbeet root
maggot
Soil application at planting (band).
Apply in a 2 to 4 inch band over the
seed row. Immediately incorporate
1,000 ft row into at least the top 2 inches of
(with 22 in. soil after application or cover with
row spacing) soil. Where furrow irrigation is
employed for seed germination, drill
granules 2 inches deep and 2 inches
from seed row on water furrow side.
1.5-2.1 Ib/A
or
1-1.4 oz/
(10-15% G)
1-2.1 Ib/A Postemergent soil application.
or Apply to both sides of plant row and
0.7-1.4 oz/ incorporate into the soil or cover
1,000 ft row with soil immediately.
(with 22 in.
row spacing)
(10-15% G)
Issued: 8-19-82
III-098301-ll
99
-------
j.uuci to resticiae
5028AA
I5028DA
I4070AA
I4070DA
IACAAA
1AAAGA
Site and Pest
ORNAMENTALS
AIDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
General Warnings and Limitations; Use limited to trained personnel in
commercial production of ornamental plants. Do not use plant parts for
food or feed purposes. Do not plant food crops in soil treated with
aldicarb for at least 180 days after last application. Do not market
potted plants within 28 days after last application. Do not mix aldicarb
with potting soil. Do not apply to open blooms as plant injury may occur.
(Ornamental Plants (herbaceous, woody shrubs, trees and vines))
General Warnings and Limitations;
and nursery plantings.
Birch
For use on commercial field grown
Aphids
Leafminers
31084AA
J1084DA
RACAAA
RAFAAA
HAAAGA
UVAAA
Dahlias
Aphids
Leafhoppers
Leafminers
Spider mites
Soil application. Apply after
spring growth begins and prior to
occurance of leafminer activity.
Apply as a side-dress 3 to 4 inches
deep and 10 to 12 inches to 1 or
both sides of row. Cover with a
minimum of 2 inches of soil.
5-10 Ib/A
or
0.5-0.9 Ib/A
1,000 ft row
(with 42 in.
row spacing)
or
0.1-0.2 oz/
1 in. dia-
meter of
trunk at
soil level
(10% G)
5-8 Ib/A Soil application. Apply when pest
or first appears and repeat if needed.
0.4-0.6 lb/ Apply as a side-dress to both sides
1,000 ft row of plant or row. Incorporate into
(with 42 in. at least top 2 to 4 inches of soil.
row spacing)
(10% G)
Issued: 8-19-82
111-098301-12
1 00
-------
EPA Index to Pesticide Chemicals
A1DICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
U20AA
U20DA
iVAAA
11057CA
K120CA
J1184CA
JACAAA
IAVAAA
3K1G5CA
RACAAA
MAAAGA
HOAAAA
LAVAAA
RABAAA
31093CA
RACAAA
Site and Pest
Rose
Spider mites 7-10 Ib/A Soil application. Apply when pest
or first appears and repeat if needed.
0.5-0.8 lb/ Apply as a side-dress to both sides
1,000 ft row of plant or row. Incorporate into
(with 42 in. at least top 2 to 4 inches of soil.
row spacing)
(102 G)
(Ornamental and Forest Greenhouse Plants)
General Warnings and Limitations: For use on potted plants or plant
beds in commercial greenhouses. If beds are covered with leaf or com-
post type mulch, remove mulch or place granules beneath mulch. Work
into soil and water thoroughly. Use the high rate on heavy organic or
clay soils or if pest populations become severe. Apply granules evenly
around base of plants. Wash off granules adhering to foliage.
Carnation
Rose
Snapdragon
Aphids
Spider mites
Chrysanthemum
Aphids
Leafminers
Thrips
Spider mites
Whiteflies
Easter Lily
Aphids
5-7.5 ozl
2,500 sq.ft
(10% G)
7.5-10 ozl
2,500 sq.ft
(10% G)
Soil application to greenhouse grown
plants. Apply after plants are
established and pests appear.
Repeat in 42 to 56 days, if needed.
On old, well-established roses,
apply maximum rate for mite control.
5-7.5 ozl Soil application to greenhouse grown
2,500 sq.ft plants. Apply 21 to 35 days after
(10% G) transplanting cuttings or just after
pinching. Repeat in 42 to 56 days,
if needed.
7.5-10 ozl
2,500 sq.ft
(10% G)
5-7.5 ozl Soil application to greenhouse grown
2,500 sq.ft plants. Apply after plants are
(10% G) established and pests appear.
Repeat in 42 to 56 days, if needed.
Issued: 8-19-82
111-098301-13
101
-------
202CA
CAM
AAGA
,VAAA
iBAAA
L147CA
1VAAA
Site and Pest
Gerbera
Aphids
Leafminers
Spider mites
Whiteflies
Orchids
Spider mites
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
5-7.5 oz/ Soil application to greenhouse grown
2,500 sq.ft plants. Apply after plants are
(102 G) established and pests appear.
Repeat in 42 to 56 days, if needed.
7.5-10 oz/
2,500 sq.ft
(10% G)
7.5-10 oz/ Soil application to greenhouse grown
2,500 sq.ft plants. Apply just prior to emer-
(10% G) gence of flower spikes. Repeat if
needed.
1159CA Poinsettia
AWAAA • Mealybugs
AVAAA Spider mites
AEAAA Whiteflies
7.5-10 oz/ Soil application to greenhouse grown
2,500 sq.ft plants. Apply after plants are
(10% G) established and pests appear.
Repeat in. 42 to 56 days, if needed.
Issued: 8-19-82
111-098301-14
1 02
-------
inaex to festiciae Lnemicals
ALDICARB
Listing of Registered Pesticide Products by Formulation
5% granular
aldicarb (098301), pentachloronitrobenzene (056502) plus 5-ethoxy-3-
(trichloromethyl)-l,2,4-thiadiazole (084701)
000264-00319
10% granular
aldicarb (098301)
000264-00322 000264-000331
15% granular
aldicarb (098301)
000264-00330
J9999 State Label Registrations
AZ Reg. No.
001016-04683 001016-04684
CA Reg. No.
001016-04677 001016-04682 001016-04686 001016-04687
001015-04683
FL Reg. No.
001016-04678
ID Reg. No.
001016-04680
NY Reg. No.
001016-04679
OR Reg. No.
001016-04681
WY Reg. No.
001016-04685
Issued: 8-19-82 111-098301-15
1 03
-------
Index of Currently Acceptable Uses
ALDICARB
Provisional Update Cover Sheet (for Nsnaticide uses)
The purpose of this "Provisional Update Cover Sheet" is to reflect any
additions or modifications to use information and precautionary language
subsequent to the development of the original "Index" entry. This update
sheet also reflects additional uses covered by special local need (24-c)
registrations and multiple active ingredient (MAI) registrations that were
not originally covered in the attached single active ingredient (SAI)
entry. The reader should note that the scope of this update sheet is
limited to changes and additions reflected by the Registration Standard
Guidance Document for aldicarb and is not intended to serve as a comprehensive
update.
Additional Use Information
Type of
Site of Application Registration Comments
Bananas 24-C Hematicide only
Ornamental broadleaf evergreen shrubs 24-C
(nursery stock and greenhouse soil
treatment)
Ornamental bulbs (nursery stock and 24-C
greenhouse soil treatment)
Ornamental conifers 24-C
Ornamental evergreens (broadleaf) 24-C
Ornamental ferns 24-C
Ornamental ferns (containerized) 24-C
Ornamental flowering plants (nursery and 24-C
bedding plants)
Ornamental foliar plants (nursery stock 24-C
and greenhouse soil treatments)
Ornamental herbaceous plants (greenhouse 24-C
soil and containerized soil treatment)
Ornamental trees (deciduous) (nursery stock 24-C
and greenhouse soil treatment)
Ornamental vines 24-C
Ornamental woody plants 24-C
Ornamental woody shrubs (nursery stock and 24-C
greenhouse soil treatments)
Ornamental woody vines (nursery stock and 24-C
greenhouse soil treatment)
Roses 24-C
Strawberries (nursery stock) 24-C
Tobacco (flue cured) (transplant beds) 24-C
Provisional update 3/29/84 II-II-098301-A
104
-------
Index of Currently Acceptable Uses
ALDICARB
Other changes or Modified Precautionary Language
Site
Formulation
heading
General
Warnings &
Limitations
Page
1
Instruction
Add
Add
Livestock
Tolerances:
Add
Will read as follows;
G (5%, 10%/ 15%)
"RESTRICTED USE PESTICIDE"
"Do not apply in Suffock County,
Long, Island, NY."
"Aldicarb is readily decomposed
into harmless residues under most
use conditions. However, a combin-
ation of sandy and acidic soil
conditions moderate to heavy irri-
gation and/or rainfall, use of
3 or more pounds per acre active
ingredient and soil temperatures
below 50°F at application time, tend
to reduce degradation and premote
movement of residues to groundwater.
If this describes your local con-
ditions and groundwater in your
area is used for drinking, do not
use this product without first
contacting the company represent-
ative."
"Do not apply this product in
Del Norte County, California."
"Do not apply more than 5 Ibs.
•active ingredient in the state
of Florida."
"Application to citrus fruits in
the state of Florida may be made
between January 1 and April 30
only."
0.002 ppm in milk.
General
Warnings &
Limitations
(under Agric-
tural Crops
heading)
Add
"Do not plant any crop other than
those with registered aldicarb
uses in aldicarb treated soil."
Provisional update 3/29/84
II-II-098301-B
105
-------
ALDICARB
Other changes or Modified Precautionary Language (continued)
Page
2
Instruction
Add
Potatoes
Potatoes
Change to:
Add
Potatoes
Formulation
page
14
Delete
replace
Will read as follows;
For dosage column:
OR MAI
0.6-0.9 oz/1000 ft of row
(equivalent to 0.5-0.75
Ib/A using 40 in. row
spacing)
(5% G)
For use pattern column:
OR MAI
Formulated with 5-Ethoxy-3-
(trichlorcmethyl) 1,2,4-
th iodiazole
90 day preharvest interval
through 3.0 pounds per acre
at planting application
"Do not apply in Suffock County,
Long, Island, NY. In the follow-
ing areas apply at emergence only.
The states of Maine and Wisconsin,
and counties of: Harford, CT;
Kent and New Castle, DE; Franklin
and Hampshire, MA; Worchester, MD;
Atlantic, Burlington, Cumberland,
Monmouth and Salem, NJ; Newport
and Washington, RI; Accomack and
Northampton, VA."
In all other states, at planting.
Delete the pest "golden nematode"
and all use paragraphs under that
pest.
Use page II-I1-098301-D to replace
original page 14.
Provisional update' 3/29/84
II-II-098301-C
106
-------
EPA Index to Pesticide Chemicals
ALDICARB
Listing of Registered Pesticide Products by Formulation
5% granular
aldicarb (098301), pentachloronitrobenzene (056502) plus 5-ethoxy-3-
(trichlorcmethyl)-l ,2 ,4-thiadiazole (084701)
000264-00319
10% granular
aldicarb (098301)
000264-00322 000264-00331
15% granular
aldicarb (098301)
000264-00330
State label Registrations:
AZ Reg. No.
001016-04683 001016-04684
CA Reg. No.
001016-04677
001016-04688
FL Reg. No.
001016-04678
ID Reg. No.
001016-04680
NY Reg. No.
001016-04679
OR Reg. No.
001016-04681
Wf Reg. No.
001016-04685
001016-04682 001016-04686 001016-04687
Issued: 04-10-79
Provisional update: 03-29-84
II-II-098301-D
107
-------
EPA Index to Pesticide Chemicals
ALDICARB*
TYPE PESTICIDE; Insecticide, Acaricide (also refer to Nematicide entry)
FORMULATIONS; G (5%, 10%, 13%)
GENERAL WARNINGS AND LIMITATIONS; RESTRICTED USE PESTICIDE
Do not apply in Suffolk County, Long Island, NY or in Del Norte County,
CA. Do not apply more than 5 pounds per acre in FL.
Aldicarb is usually decomposed into harmless residues. However, a combi-
nation of sandy and acidic soil condition, moderate to heavy irrigation
and/or rainfall, use of 3 or more pounds per acre, and soil temperature
below 50 F (10.0 C) at the time of application, tend to reduce degradation
and promote movement of residues to groundwater. If this describes your
local use conditions and groundwater in your area is used for drinking,
do not use this product without first contacting the company.
The use of aldicarb may pose a hazard to the Federally designated endan-
gered/threatened species known to be found in certain areas within named
locations.
Attwater's Greater Prairie Chicken - TX counties including Aransas,
Austin, Brazoria, Colorado, Galveston, Goliad, Harris, Refugio; and
Victoria.
Aldicarb may not be used in areas where adverse impact on the Federally
designated endangered/threatened species noted above is likely. Prior to
making applications, the user of aldicarb must determine that no such
species are located in or immediately adjacent to the area to be treated.
If the user is in doubt whether or not the above endangered species may
be affected, he should contact either the regional U.S. Fish and Wildlife
Service Office (Endangered Species Specialist) or personnel of the State
Fish and Game Office.
Agricultural Crop Tolerances;
Bananas - 0.3 ppm
Coffee Beans - 0.1 ppm
Sugarcane - 0.02 ppm
Sugarcane (forage and fodder) - 0.1 ppm
Sweet Potatoes - 0.1 ppm
Livestock Tolerances;
Cattle (fat, meat, meat byproducts) - 0.01 ppm
Goats (fat, meat, meat byproducts) - 0.01 ppm
Hogs (fat, meat, meat byproducts) - 0.01 ppm
Horses (fat, meat, meat byproducts) - 0.01 ppm
Milk - 0.002 ppm
Sheep (fat, meat, meat byproducts) - 0.01 ppm
Definition of Terms;
Claims for pest control limited to suppression of populations are indi-
cated by parenthesized pest name.
*Temik
2-methyl-2-(methylthio)propionaldehyde 0-(methylcarbamoyl)oxime
Issued: 8-19-82 III-Q98301-1
Provisional Update: 3-28-84
1 08
-------
Site and Pest
AGRICULTURAL CROPS
ALDICARB
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
General Warnings and Limitations; Do not plant any crop other than those
registered aldicarb uses in aldicarb treated soil. Do not allow livestock
to graze treated areas before harvest. Do not store or use in or around
the home or home garden. Aldicarb is not effective if used with alkaline
materials such as lime. Use high rate on heavy organic or clay soils.
Applications in excess of 0.75 pound (actual) per acre of 5 per cent
granular formulation or 1 pound (actual) per acre of 10 to 15 per cent
granular formulations made directly to seed furrow of beans (dried-type),
cotton, soybeans, and sugar beets may delay emergence and reduce plant
stand. Make side-dress applications close enough to plants to allow good
uptake by roots without injury to the plants from root pruning. In ir-
rigated areas, follow application with irrigation within 7 days. If al-
ternate furrows are irrigated after side-dress application, the aldicarb
and water must be on the same side of the plant row. To provide maximum
performance and minimize hazards to birds, incorporate granules into or
cover with soil to a depth of 2 inches or more. Deep disc any spills at
row ends.
(liOOlAA
Beans, Dried-type
Aphids
IAFAAA
HAPAFA
UAABA
Leafhoppers
Mexican bean
Mites
beetle
0.8-1.1 oz/
1,000 ft row
(with 30-48
in. row
spacing)
(10-15% G)
1.1-2.3 oz/
1,000 ft row
(with 30-48
in. row
spacing)
(10-15% G)
0.1 ppm
90 day preharvest interval through
2.3 ounces per 1,000 feet of row
for soil application.
Do not make more than 1 application
per crop. Do not harvest green
pods for human consumption. Do not
feed green forage, hay, or straw to
livestock.
Soil application at planting. Drill
granules 2 to 3 inches below seed
line or 2 to 3 inches to side of
seed row and 2 to 3 inches*deep.
Granules may be placed in seed fur-
row if rate does not exceed 0.75
pound active ingredient per acre.
Issued: 8-19-82
III-098301-2
109
-------
EPA Index to Pesticide Chemicals
Site and Pest
IJN07AA
IACAAA
IOAAAA
DASAHJ
IJ4MBDA
IUAGA
LMABA
WAAA
flBDA
fAAA
(NASAAA
BA
PAAA
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
Beans, Dried-type (continued)
Seedcorn maggot
Cotton
0.5-0.75 Ib/A Use limited to NY.
or Soil application at planting.
0.6-0.8 oz/ Apply granules in seed furrow and
1,000 ft row cover with soil.
(with 36 in.
row spacing)
(15% G)
0.1 ppm (cottonseed)
0.3 ppm (cottonseed hulls)
90 day preharvest interval through
3 pounds per acre (with 40 inch row
spacing) for soil application.
Do not make more than 1 at planting
application and 1 postemergence ap-
plication per crop.
Aphids
Thrips
Boll weevil (over-
wintering adults)
Fleahoppers
Leaf miners
Mites
Plant bugs (includ-
ing lygus bugs)
Fleahoppers
Leafhoppers
0.3-0.5 Ib/A
or
0.4-0.7 oz/
1,000 ft row
(with 40 in.
row spacing)
(5-15% G)
0.6-1 Ib/A
or
0.8-1.3 oz/
1,000 ft row
(with 40 in.
row spacing)
(5-15% G)
1-2 Ib/A
or
1.2-2.6 oz/
Soil application at planting. Drill
granules just below seed line or
place in seed furrow and cover with
soil. For hill-dropped seed, reduce
dosage by one-half.
May be formulated with pentachloro-
nitrobenzene and 5-ethoxy-3-(tri-
chloromethyl)-l,2,4-thiadiazole.
Soil application at first squaring.
Side-dress granules 8 to 16 inches
to 1 side of the plant row and 2 to
1,000 ft row 6 inches deep, usually at or below
(with 40 in. bottom of water furrow.
row spacing)
(10-15% G)
Boll weevil 2-3 Ib/A
Mites or
Plant bugs (includ- 2.4-3.7 oz/
ing lygus bugs) 1,000 ft row
(with 40 in.
row spacing)
(10-15% G)
Issued: 8-19-82
III-098301-3
110
-------
1JAHA
Site and Pest
Cotton (continued)
Cotton leaf-
perforator
Whiteflies
2002AA
2004AA
2005AA
Grapefruit
Lemon
Lime
ftCAAA
JVAKA
iJBCA
AVAKA
Aphids
Citrus red mite
Citrus rust mite
Texas citrus mite
n. iuuei to resticiae unemicaxs
AIDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
2-2.1 Ib/A Soil application from squaring
or through early bloom. Side-dress
2.4-2.6 oz/ granules 8 to 16 inches to 1 side
1,000 ft row of the plant row and 2 to 6 inches
(with 40 in. deep, usually at or below bottom of
row spacing) water furrow.
(10-152 G)
2-3 Ib/A -
or
2.4-3.7 oz/
1,000 ft row
(with 40 in.
row spacing)
(10-15% G)
0.3 ppm
0.6 ppm (citrus pulp, dried)
30 day preharvest interval through
10 pounds per acre for soil appli-
cation for lemon.
Do not make more than 1 application
per year.
Applications in FL may be made be-
tween January 1 and April 30 only.
5-10 Ib/A
(with 18-25
ft row
spacing)
(15% G)
Soil application. Apply just prior
to or during spring flush of foliage
growth. Apply.in a band along drip-
line on both sides of tree row by
spreading granules uniformly and
immediately working into sbil (pre-
ferred method) or shank 2 to 3 inch-
es deep using 4 to 6 shanks on 12
inch centers. Band width should
equal one fourth tree row spacing.
Thoroughly irrigate immediately
after application.- May also be ap-
plied in irrigation furrows using 2
shanks per furrow.
Issued: 8-19-82
III-098301-4
111
-------
EPA Index to Pesticide Chemicals
J2006AA
Site and Pest
Orange
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.3 ppm
0.6 ppm (citrus pulp, dried)
Soil application through 10 pounds
per acre.
Do not make more than 1 application
per year.
Applications in FL may be made be-
tween January 1 and April 30 only.
4CAAA
AVARA
AJBCA
Aphids
Citrus red mite
Citrus rust mite
7007AA
Peanuts
Thrips
5-10 Ib/A
(with 18-25
ft row
spacing)
(10-15% G)
Soil application. Apply just prior
to or during spring flush of fol-
iage growth. Apply in a band along
dripllne on both sides of tree row
by spreading granules uniformly and
immediately working into soil (pre-
ferred method) or shank 2 to 3 inch-
es deep using 4 to 6 shanks on 12
inch centers. Band width should
equal one fourth tree row spacing.
Thoroughly irrigate immediately
after application. May also be ap-
plied in irrigation furrows using 2
shanks per furrow.
0.05 ppm (peanuts)
0.5 ppm (peanut hulls)
90 day preharvest interval through
2.1 pounds per acre (with 36 inch
row spacing) for soil application.
Do not make more than 1 application
per crop. Do not feed or allow
livestock to graze on treated hay
or vines.
1-2.1 Ib/A Soil application at planting. Apply
or granules in seed furrow and cover
1.1-2.3 oz/ with soil. In the Southwest, apply
1,000 ft row high rate only.
(with 36 in.
row spacing)
(10-15% G)
Issued: 8-19-82
III-098301-5
11 2
-------
EPA Index to Pesticide Chemicals
08AA
Site and Pest
Pecan
ALDICARB
Dosages and Tolerance, Use. Limitations
Formulation(s)
0.5 ppm
Soil application through 10 pounds
per acre.
Do not make more than 1 application
per year. Do not harvest foliage
or hay from treated areas.
EACAAA
1MABA
HAVAIA
Aphids
Mites
(Pecan leaf phyllo-
xera)
5-10 Ib/A Use limited to Southeastern United
(10-15% G) States.
Soil application (band). Apply dur-
ing period from bud break to nut set
(approximately April 15 to May 15).
For pecan leaf phylloxera, apply 7
to 14 days before bud break. Apply
as a 4 to 6 foot band along dripline
on both sides of tree row by spread-
ing granules uniformly and immedi-
ately working into soil or by shank-
ing 2 to 3 inches into soil on 12
inch centers.
D3008DA
SACAAA
UAAfiA
IBGATA
IAVAIA
Pecan (nonbearing transplants
1 to 5 years old)
Aphids
Mites
Pecan bud moth
(Pecan leaf phyllo-
xera)
0.8-3.2 oz/
tree
(10-15% G)
0.5 ppm
Use limited to Southeastern United
States.
Soil application. Apply during
period of bud break (approximately
April 15 to May 15). For pecan bud
moth and pecan leaf phylloxera,
apply 7 to 14 days before bud break.
Apply as a side-dress to individual
trees row by spreading granules uni-
formly around the tree and.immedi-
ately working into soil to a depth
of 2 to 3 inches.
Issued: 8-19-82
III-098301-6
11 3
-------
[14013AA
Site and Pest
Potato
EPA Index to Pesticide Chemicals
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
1 ppm
90 day preharvest interval through
3 pounds per acre (with 34 inch row
spacing) for soil application at
planting.
50 day preharvest interval through
3 pounds per acre (with 34 inch row
spacing) for postemergence soil
application.
Do not make more than 1 application
per crop.
BCAAA
Aphids
MCAM
HAMCEA
MFAAA
Aphids
Colorado potato
beetle
Leafhoppers
1 Ib/A
Use limited to ME.
or Postemergent soil application. Ap-
1.05 oz/1,000 ply granules in 4 to 6 inch band
ft row over row on the top of hill at
(with 34 in. emergence. Do not apply more than
row spacing) once every 2 years.
(10-15% G)
2-3 Ib/A
or
2.1-3.1 oz/
1,000 ft row
(with 34 in.
row spacing)
(10-15% G)
Use limited to areas other the
states and counties listed in para-
graph below.
Soil application at planting. Apply
granules with seed pieces in plant-
ing furrow and cover with soil of
drill granules 2 to 4 inches on both
sides of seed row and 3 to 8 inches
deep, usually 1 to 2 inches below
seed pieces.
2-2.1 Ib/A Use limited to ME and WI and the
or counties of:
2.1-2.2 oz/ Hartford CT
1,000 ft row Kent and New Castle DE
(with 34 in. Franklin and Hampshire MA
row spacing) Worchester MD
(10-15% G) Atlantic, Burlington, Cumberland,
Monmouth and Salem NJ
Newport and Washington Rl
Accomack and Northampton VA.
Postemergent soil application. Ap-
ply granules in 4 to 6 inch band
over row on top of hill at emer-
gence. Cover granules with soil by
cultivators or hilling discs. Do
not apply more than once every 2
years.
Issued: 8-19-82
III-098301-7
11 4
-------
Site and Pest
Potato (continued)
Aphids
Colorado potato
beetle
Flea beetles
Psyllids
ALDICARB
Dosages and Tolerance, Use. Limitations
Formulation(s)'
2-3 Ib/A Use limited to areas other than the
or states and counties listed in above
2.1-3.2 oz/ paragraph.
1,000 ft row Postemergent soil application.
(with 34 in. Apply at 75 percent emergence or
row spacing) before plants are 6 inches high up
(10-15% G) to 42 days after emergence. Side-
dress granules 4 to 5 inches on both
sides of plant row and 4 inches
deep. Apply where pest populations
are expected 14 to 21 days after
plant emergence. Do not apply if
an at planting application was made.
3 Ib/A
Use limited to areas other than the
or states and counties listed above.
3.1 oz/1,000 Soil application at planting. Apply
ft row granules with seed pieces in plant-
(with 34 in. ing furrow and cover with soil.
row spacing)
(10-15% G)
2-2.1 Ib/A Use limited to AZ.
or Soil application at planting. Apply
2.1-2.2 oz/ granules with seed pieces in plant-
1,000 ft row ing furrow and cover with soil or
(with 34 in. drill granules 2 to 4 inches on both
row spacing) sides of seed row and 3 to 8 inches
(10-15% G) deep, usually 1 to 2 inches below
seed pieces.
Issued: 8-19-82
III-098301-8
115
-------
19AA
Site and Pest
Sorghum
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.5 ppm (fodder, bran)
0.2 ppm (grain)
90 day preharvest interval through
1 pound per acre (with 36 inch row
spacing) for soil application.
The use of aldicarb may pose a haz-
ard to the following Federally des-
ignated endangered/threatened spe-
cies known to be found in certain
areas within named locations. Att-
water's Greater Prairie Chicken -
TX counties including Aransas, Aus-
tin, Brazoria, Colorado, Galveston,
Goliad, Harris, Refugio, and Vic-
toria. Aldicarb may not be used in
areas where adverse impact on the
Federally designated endangered/
threatened species noted above is
likely. Prior to making applica-
tions , the user of aldicarb must
determine that no such species are
located in or immediately adjacent
to the area to be treated. If the
user is in doubt whether or not the
above endangered species may be af-
fected, he should contact either the
regional U.S. Fish and Wildlife Ser-
vice Office (Endangered Species
Specialist) or personnel of the
State Fish and Game Office.
Do not make more than 1 application
per year. Do not feed green forage
to livestock.
KAIAEA
RACDNA
(Chinch bug)
(Greenbug)
1 Ib/A
or
1.1 oz/1,000
ft row
(with 36 in.
row spacing)
(10-15% G)
Soil application at planting. Apply
in seed furrow and cover with soil.
Issued: 8-19-82
III-098301-9
116
-------
EPA Index to Pesticide Chemicals
Site and Pest
Soybeans
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.02 ppm
90 day preharvest interval through
1.7 oz per 1,000 feet of row for
soil application.
Do not make more than 1 application
per crop. Do not feed green forage,
hay, or straw to livestock.
Mexican bean beetle 0.8-1.65 oz/ Soil application at planting. Drill
1,000 ft row granules 2 to 3 inches below seed
(with 30-48 line or 2 to 3 inches to side of
in. row seed row and 2 to 3 inches deep.
spacing)
(10-15% G)
Strawberry (nursery stock)
28020AA
Sugar Beets
Aphids
N.F.
This use only occurs on Special Lo-
cal Need (24-C) labeling and has
not been included in this entry.
Refer to appropriate labeling for
use information and limitations.
0.05 ppm (roots)
1 ppm (tops)
90 day preharvest interval through
3 pounds per acre (with 22 inch row
spacing) for soil application.
120 day preharvest interval through
3 pounds per acre for soil
application if tops are to be fed
to livestock.
Do not harvest tops for human con-
sumption. Do not exceed a total of
6 pounds per acre, including an at
planting application. Do not make
more than 1 at planting application
and 2 postemergence applications per
crop. Do not make any postemergence
applications if a preemergence
application of 4 to 5 pounds per
acre for nematode control is made.
1-2.1 Ib/A Soil application at planting. Drill
or granules 1 to 3 inches below seed
0.65-1.4 oz/ line. Granules can be placed in
1,000 ft row seed furrow if rate does not exceed
(with 22 in. 1 pound per acre.
row spacing) 0^
(10-15% G)
Issued: 8-19-82
111-098301-10
11 7
-------
EPA Index to Pesticide Chemicals
ALDICARB
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
Sugar Beets (continued)
IEHFAM
JiAAAGA
Leafhoppers
Leaf miners
Sugarbeet root
maggot
'060A
2-3 Ib/A Postemergence soil application.
or Side-dress granules to 4 to 8 inches
1.3-2 oz/ to 1 side of plant row and 2 to 6
1,000 ft row inches deep. Repeat if needed for
(with 22 in. continued protection against virus
row spacing) vector.
(10-15% G)
1.5-2.1 Ib/A Soil application at planting (band).
or Apply in a 2 to 4 inch band over the
1-1.4 oz/ seed row. Immediately incorporate
1,000 ft row into at least the top 2 inches of
(with 22 in. soil after application or cover with
row spacing) soil. Where furrow irrigation is
(10-15% G) employed for seed germination, drill
granules 2 inches deep and 2 inches
from seed row on water furrow side.
1-2.1 Ib/A Postemergent soil application.
or Apply to both sides of plant row and
0.7-1.4 oz/ incorporate into the soil or cover
1,000 ft row with soil immediately.
(with 22 in.
row spacing)
(10-15% G)
Tobacco (flue cured)(transplantbed) N.F.
This use only occurs on Special Lo-
cal Need (24-C.) labeling and has
not been included in this entry.
Refer to appropriate labeling for
use information and limitations.
Issued: 8-19-82
III-098301-ll
11 8
-------
Site and Pest
ORNAMENTALS
EPA Index to Pesticide Chemicals
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
General Warnings and Limitations; Use limited to trained personnel in
commercial production of ornamental plants. Do not use plant parts for
food or feed purposes. Do not plant food crops in soil treated with
aldicarb for at least 180 days after last application. Do not market
potted plants within 28 days after last application. Do not mix aldicarb
with potting soil. Do not apply to open blooms as plant injury may occur.
(Ornamental Plants (herbaceous, woody shrubs, trees and vines))
I5028AA
15028DA
14070AA
14070DA
IACAAA
IAAAGA
General Warnings and Limitations;
and nursery plantings.
Birch
For use on commercial field grown
Aphids
Leafminers
11084AA
11084DA
IACAAA
IAFAAA
IAAAGA
Dahlias
Aphids
Leafhoppers
Leafminers
Spider mites
Soil application. Apply after
spring growth begins and prior to
occurance of leafminer activity.
Apply as a side-dress 3 to 4 inches
deep and 10 to 12 inches to 1 or
both sides of row. Cover with a
minimum of 2 inches of soil.
5-10 Ib/A
or
0.5-0.9 Ib/A
1,000 ft row
(with 42 in.
row spacing)
or
0.1-0.2 oz/
1 in. dia-
meter of
trunk at
soil level
(10% G)
5-8 Ib/A Soil application. Apply when pest
or first appears and repeat if needed.
0.4-0.6 lb/ Apply as a side-dress to both sides
1,000 ft row of plant or row. Incorporate into
(with 42 in. at least top 2 to 4 inches of soil.
row spacing)
(10* G)
Issued: 8-19-82
111-098301-12
11 9
-------
(34120AA
(34120DA
IIAVAM
13105 7CA
I34120CA
I31184CA
1KACAAA
1LAVAAA
'31065CA
MCAAA
HAAAGA
HOAAAA
lAVAAA
8ABAAA
'31093CA
8ACAAA
Site and Pest
Rose
Spider mites
EPA Index to Pesticide Chemicals
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
7-10 Ib/A Soil application. Apply when pest
or first appears and repeat if needed.
0.5-0.8 lb/ Apply as a side-dress to both sides
1,000 ft row of plant or row. Incorporate into
(with 42 in. at least top 2 to 4 inches of soil.
row spacing)
(10% G)
(Ornamental and Forest Greenhouse Plants)
General Warnings and Limitations; For use on potted plants or plant
beds in commercial greenhouses. If beds are covered with leaf or com-
post type mulch, remove mulch or place granules beneath mulch. Work
into soil and water thoroughly. Use the high rate on heavy organic or
clay soils or if pest populations become severe. Apply granules evenly
around base of plants. Wash off granules adhering to foliage.
Carnation
Rose
Snapdragon
Aphids
Spider mites
Chrysanthemum
Aphids
Leafminers
Thrips
Spider mites
Whiteflies
Easter Lily
Aphids
5-7.5 oz/
2,500 sq.ft
(10% G)
7.5-10 oz/
2,500 sq.ft
(10% G)
Soil application to greenhouse grown
plants. Apply after plants are
established and pests appear.
Repeat in 42 to 56 days, if needed.
On old, well-established roses,
apply maximum rate for mite control.
i-7.5 oz/ Soil application to greenhouse grown
2,500 sq.ft plants. Apply 21 to 35 days after
•* f\a/ /"» \ ^._ __1A._^J_.A At*^-^4MAA J-.*- •!•**•«+• r«£^A^»
(10% G)
7.5-10 oz/
2,500 sq.ft
(10% G)
plants. Apply 21 to 35 days after
transplanting cuttings or just after
pinching. Repeat in 42 to 56 days,
if needed.
5-7.5 oz/ Soil application to greenhouse grown
2,500 sq.ft plants. Apply after plants are
(10% G) established and pests appear.
Repeat in 42 to 56 days, if needed.
Issued: 8-19-82
111-098301-13
12 0
-------
J1202CA
IACAAA
IAAAGA
llAVAAA
IJABAAA
31147CA
1AVAM
Site and Pest
Gerbera
Aphids
Leafminers
Spider mites
Whiteflies
Orchids
Spider mites
'3115 9CA
IAWAAA
UVAAA
MBAAA
Poinsettia
Mealybugs
Spider mites
Whiteflies
EPA Index to Pesticide Chemicals
ALDICARB
Dosages and Tolerance, Use, Limitations
Formulation(s)
5-7.5 oz/ Soil application to greenhouse grown
2,500 sq.ft plants. Apply after plants are
(10% G) established and pests appear.
Repeat in 42 to 56 days, if needed.
7.5-10 oz/
2,500 sq.ft
(10% G)
7.5-10 oz/
2,500 sq.ft
(10% G)
Soil application to greenhouse grown
plants. Apply just prior to emer-
gence of flower spikes. Repeat if
needed.
7.5-10 oz/ Soil application to greenhouse grown
2,500 sq.ft plants. Apply after plants are
(10% G) established and pests appear.
Repeat in 42 to 56 days, if needed.
Issued: 8-19-82
111-098301-14
1 21
-------
EPA Index to Pesticide Chemicals
ALDICARB
Listing of Registered Pesticide Products by FormiiLatilim
5% granular
• aldicarb (098301), pentachloronitrobenzene (.
(trichloromethyl)-l,2,4-thiadiazole (084M3J
000264-00319
101 granular
aldicarb (098301)
000264-00322 000264-000331
15% granular
aldicarb (098301)
000264-00330
3-ethoxy-3-
001016-04682
W9999 State Label Registrations
AZ Reg. No.
001016-04683
CA Reg. No.
001016-04677
001016-04688
FL Reg: No.
001016-04678
ID Reg. No.
001016-04680
NY Reg. .No.
001016-04679
OR Reg. No.
001016-04681
WY Reg. No.
001016-04685
Issued: 8-19-82
111-098301-13
122
------- |