GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
' s
CONTAINING
CARBOFURAN
(090601)
CAS 1563-66-2
AS THE ACTIVE INGREDIENT
Case No. 101
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
July 18, 1984
-------
TEAM MEMBERS
BUD - EAB W. Schutte
BUD/Index D. Brassard
D. Hansen
BUD/QUA E. Pelletier
D. Sutherland
E. D. Thomas
HED -EAB H. Boyd
HED - EEB R. Balcomb
E. Fite
"' L. Touart
HED - RGB W. Boodee
HED - SIS E. Saito
HED - TOX W. Dykstra
RD - IRB T. Gardner
J. Ellenbeger
-------
TABLE OF CONTENTS
Introduction ...... 1
I. Regulatory Position 4
II. Requirement for Submission of Generic Data 51
III. Requirement for Submission of Product-Specific
Data 54
IV. Submission of Revised Labeling and Packaging
Information 91
A. Label .Contents 91
1. Product Name 91
2. Company Name and Address 91
3. Net Contents 91
4. Product Registration Number 92
5. Producing Establishment
Registration Number 92
6 Ingredient Statement 92
6A Pounds Per Gallon Statement 92
7. Front Panel Precautionary Statements 92
7A Child Hazard Warning Statements 93
7B Signal Word 93
7C Skull and Crossbones and Word Poison 93
7D Statement of Practical Treatment 93
7E Referral Statement 93
8. Side/Back Panel Precautionary Labeling .... 93
8A Hazard to Humans and Domestic Animals 94
8B Environmental Hazard . 94
8C Physical or Chemical Hazard 94
9. Product Classification 95
10. Misuse Statement 98
11A Storage and Disposal Block 98
11B Directions for Use 98
B. Collateral Information 98
V. Instructions for Submission 99
-------
APPENDICES
Bibliography II-l
FIFRA §3(c)(2)(B) Summary Sheet -
EPA Form 8580-1 II-2
Certification of Attempt to Enter Into an
Agreement With Other Registrants for Development
of Data EPA Form 8580-6 II-3
Product Specific Data Report (End-Use Products)... III-l
Sample Label Formats IV-1
• /•
Table of Labeling Requirements IV-2
Physical/Chemical Hazards Labeling Statement IV-3
Storage and Disposal Instructions IV-5
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 ex'peditiously 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.
• s
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. The regulatory position may
require the registrant to modify product labels to provide
additional precautionary statements, restrict the use of the
pesticide to certified applicators, provide reentry intervals,
modify uses or formulation types, specify certain packaging
limitations, or other requirements to assure that proper use
of the pesticide poses no potential adverse effects to human
health or the environment.
The scientific review, which is not contained herein
but is available upon request, concentrates on the technical
grade of the active ingredient and identifies missing generic
data. However, during the review of these data we are also
looking for potential hazards that may be associated with
the 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)
intended use or tne pesticide under review. rurtner,
(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 reregistra-
tion requirements of this Guidance Document, please notify
the Product Manager named in the cover letter, within 90
days from the receipt of this document, that you wish to
voluntarily cancel the registration(s). If you decide to
maintain your product registration(s), you must provide the
information described in the following pages within the time-
frames outlined. EPA will issue a notice of intent to cancel
or suspend the registration of any currently registered
product if you fail to comply with the requirements set
forth in this Guidance Document.
This Guidance Document will be supplemented by EPA with
additional information about compliance with data support
requirements. In Monsanto v. Administrator, EPA was recently
enjoined from implementing in any way the "mandatory data
licensing" aspects of §3(c)(l)(D) of FIFRA. EPA is assessing
the implications of the injunction for the reregistration
process. Because this situation is currently unresolved, EPA
has decided to proceed with the requirements in this Guidance
Document which do not relate to compliance with the §3(c)(l)(D)
provisions and to supplement the Document with additional
guidance when circumstances permit. Failure to comply with
the provisions of the subsequent guidance will also result
in issuance by EPA of an intent to cancel the affected product
registration(s).
Registrants are reminded that §6(a)(2) of FIFRA requires
you at any time to submit factual information raising concerns
of possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in
progress if those results show possible 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*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Aqtive Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End-use products of registrants who also produce a manufacturing-
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing-use product(s). Such end-use products
will be subject to the labeling changes required for products in "II"
above. If there are no manufacturing-use products registered by any
company end-use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B.
-------
I. REGULATORY POSITION AND RATIONALE
A. Introduction
This guidance document describes the Agency's
regulatory position on registered manufacturing-use products
(MPs) containing the insecticide, and nematicide carbofuran.
The Agency's position is based on an evaluation of all
accepted uses and registered products under sections 3 and
24(c) of the FIFRA, with carbofuran as the sole active
pesticide 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 registrants and applicants of carbofuran products in
order for the products to be registered or reregistered
under this document. The tables accompanying this document
list the data requirements which must be satisfied through
submission of additional information.
-------
B. Description of Chemical and Use Profile
Carbofuran - C^H^NC^; mol. wt. 221.3
C.A.S. #1563-66-2, Shaughnessy #090601
Carbofuran is the accepted common name for 2,3-dihydro-
2,2-dimethyl-7-benzofuranyl methylcarbamate. Other names
include the trade names Furadan, Curaterr, and Yaltox, and the
code numbers Bay 78537, D 1221, ENT 27164, FMC 10242, and NIA
' /•
10242. Technical Carbofuran is a white crystalline solid.
It has a melting point of 153-154°C (pure material). Carbofuran
is stable under neutral or acidic conditions and is unstable
under alkaline conditions.
Carbofuran is a carbamate pesticide which causes
cholinesterase inhibition at very low dosage levels. Its
chief metabolites are 3-keto-carbofuran, the free or glycosidic
conjugate of 3-hydroxy-carbofuran, Carbofuran phenol, 3-keto-
carbofuran phenol and 3-hydroxycarbofuran phenol. This
insecticide, and nematicide is manufactured by FMC Corporation.
The only registered manufacturing-use products of
Carbofuran are a 75% product (EPA Registration No. 279-2862)
and a 85% product (EPA Registration No. 279-3038). These
products are referred to by the registrant (FMC Corporation)
-------
as the 75% and 85% base and are used to formulate end-use
products. These products are manufactured from a true
technical product which is not federally registered and
should thus be denoted as a formulation intermediate (FI)
produced essentially by an integrated formulation process.
Carbofuran is commercially formulated into 2%, 3%, 5%,
9.8%, 10% and 15% granules for soil application, and is
' /•
formulated as 75% wettable powder and 4 pound/gallon flowable
concentrate for use in sprays. Registered uses include
application to alfalfa, bananas, barley, clover, coffee, corn
(field, pop and sweet), cotton, cranberries, cucumbers,
forest trees (cottonwood and pine plantations, southern pine
seed orchards) grapes, melons, oats, ornamental trees
(cottonwood nursey stock and Siberian elm), peanuts, peppers,
plantain, potatoes, pumpkins, rice, sorghum (grain and forage),
soybeans, squash, strawberries, sugar beets, sugarcane,
sunflowers, tobacco and wheat. In addition there are Special
Local Need registrations for use of carbofuran on Bermudagrass
(seed crop), clover (ladino), commercially grown ornamentals,
garlic, nonbearing fruit trees (apple, apricot, cherry,
nectarine, peach and plum), sunflower (seed crop), and white
pine seed orchards.
-------
C. Regulatory Position
Based on the review and evaluation of all available
data and other relevant information on carbofuran, the Agency
has made the following determinations:
1. All concentrate, suspensions (flowable concentrates),
and wettable powders 40% and greater have been
classified for restricted use (CFR 40 162.31).
Based on high acute toxicity via the oral, dermal
and inhalation routes of exposure, the Agency has
determined that all other carbofuran products must
also bear the "Restricted Use Pesticide" statement
on the product label. The "Restricted Use Pesticide"
statement must be on the labels of all carbofuran
products released for shipment after September 1,
1985, and on all labels of carbofuran products still
in channels of trade after September 1, 1986.
2. The Agency is unable to complete a full tolerance
reassessment because of certain residue chemistry
data gaps. Review of the additional residue data
being required under this document may result in
a revision of specific tolerances.
-------
3. In the absence of adequate dissipation data, dermal
toxicity and exposure data, and inhalation toxicity
data, the Agency is imposing an interim 24-hour
reentry interval for carbofuran for all uses where
longer reentry intervals have not previously been
established. A previously established reentry
interval prohibits reentry into fields within 14
days of application without wearing proper protective
clothing if prolonged intimate contact with corn
foliage would result.
4. New and/or amended environmental hazard label
statements are being imposed to reflect data and
use history of carbofuran's effects to nontarget
species.
5. An advisory statement and a geographical use
restriction are being imposed for end-use product
labeling in an effort to minimize further groundwater
contamination.
6. Because of insufficient crop rotation data the Agency
is imposing a crop rotation label restriction on
end-use product labels.
-------
7. Registrants must provide or agree to develop
additional data, as specified in the tables in this
guidance document, to maintain existing registration
or to obtain new registrations of substantially
similar products.
D. Regulatory Rationale
The Agency has reviewed the available data concerning
' s
toxicology, environmental, product and residue chemistry, and
ecological effects.
Sufficient data are available to show that carbofuran
has a high acute toxicity via the oral, inhalation and dermal
routes of exposure and has been assigned to Toxicity Category
I. While carbofuran is highly toxic by the oral, dermal and
inhalation routes of exposure, neither carbofuran nor its
metabolites have been demonstrated to be oncogenic, teratogenic,
fetotoxic, or mutagenic in valid data reviewed to date.
However, toxicology data requirements for technical
carbofuran are not complete. Because of possible farm worker
exposure, when handling products containing carbofuran and
working with crops that have been treated, a 21-day dermal
study and a 21-day inhalation study must be done. These
studies would replace a 21-day inhalation study (IBT# N5183)
in the guinea pig and a 20-day percutaneous study (IBT#
B3891) in the rabbit. Both of these studies were conducted
-------
by Industrial Bio-Test Laboratories and have been invalidated
by the Agency. Additionally, a dermal absorption study must
be done to characterize the potential for dermal absorption.
Without these data the Agency must assume 100% dermal
absorption. And lastly, to determine potential inhalation
exposure an assessment of the fine respirable particles in
shipped granular carbofuran must be performed. A determination
of the amount of^particulate matter and the percent of active
ingredient which is respirable must be done under conditions
which simulate the opening and transfer operations of packages
containing granular material.
In the absence of adequate dermal toxicity and exposure
data the Agency is retaining the previously established 14-day
reentry period for corn and sorghum treated with carbofuran
because these are the crops where farm workers are likely to
experience prolonged high dermal exposure from such treatment.
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, and residue analyses of various
food and feed commodities.
In 1979 to 1981 carbofuran residues were found in drinking
water wells located near carbofuran-treated potato fields in
10
-------
Suffolk County, Long Island, New York at levels near 50 parts
per billion (ppb). Carbofuran residues have since been found
in drinking water wells in other states including Florida,
Maryland and Wisconsin. The Agency's Office of Drinking
Water has established a Health Advisory of 5 ppb for residues
of carbofuran in drinking water. The Office of Drinking
Water is reviewing the data base on carbofuran in order to
determine whether a National Primary Drinking Water Regulation
should be developed.
While the Agency has some descriptive environmental fate
data and ground water monitoring data on carbofuran, this
information is not sufficient to fully assess the environmental
fate of carbofuran. However, from these data and other
information, it has been determined that carbofuran and its
metabolites leach in areas of fine to coarse textured soils,
including those soils with a high organic matter content.
Additional data are required on soil metabolism, soil and
aquatic dissipation, leaching and volatility and monitoring
of ground water to fully assess the environmental fate and
transport of carbofuran and its metabolites.
Based on new labeling and additional use restrictions
imposed by this guidance document (e.g., prohibition against
use on Long Island, N. Y. and imposition of a groundwater
advisory statement), the Agency believes that the potential
11
-------
for further ground water contamination will be reduced.
Additional special labeling may be required when additional
data that are necessary to complete the assessment of
groundwater potential are received and the Agency reassesses
its current regulatory position.
Because of the restricted use classification of carbofuran
products, certified applicator training will be required
' s
before this pesticide can be used.
The available data indicate that carbofuran is highly
toxic to wildlife, especially to birds. Data from field
studies and the use history of carbofuran provide sufficient
information which strongly suggest that application of this
pesticide results in mortality, and possibly local population
reductions, in certain avian species. Existing data cannot
determine whether these effects are excessive, long lasting,
or likely to diminish wildlife resources. Additional field
studies are required to further quantify the impact on avian
populations.
A special review was considered by the Agency because of
a potential problem with secondary poisoning of raptors.
However, it was determined that the Agency had insufficient
data in this area to justify sending the chemical into special
review and that more data was needed in order to assess the
12
-------
impact of this potential problem on avian populations.
Therefore, in order to obtain the necessary data to assess
the problem, this document requires carbofuran registrants
to do extensive multi-year monitoring of avian populations,
with special emphasis on raptorial birds in areas of heavy
use (i.e., the corn belt) and in areas of early planting
where high densities of wintering birds utilize treated
fields. The decision on whether to proceed with a special
review has been withheld pending review of data to be
developed in the next two years to quantify actual avian
losses.
The Agency is imposing a crop rotation restriction for
end-use product labeling because there is insufficient crop
rotation data on carbofuran. The Agency reviewed confined
accumulation studies, soil accumulation studies, and fish
accumulation studies. However/ these studies all had
inappropriate methodologies. Therefore, until appropriate
rotational crop data are submitted and evaluated, the new
label restriction must be included on end-use product labeling.
In addition to the above label restrictions, the Agency
is also requiring registrants to place extensive environmental
hazard statements on carbofuran labels for various formulations
and use areas. One of the use areas for which such environmental
hazard statements are being required is the use of granular
13
-------
carbofuran products on rice. For this use area registrants
are required to include "Fish may be killed at recommended
rates" in the environmental hazard statement. Although it
is not common practice to grow fish in rice paddies,
nevertheless, there are occassions where fish are inadvertenly
introduced into the paddies at the time of flooding. When
this occurs there is the possibility that treatment of the
rice paddy with garbofuran at recommended rates will result
in fish being killed. However, because of the rapid breakdown
of carbofuran, the Agency feels that there is little likelihood
of a fish kill resulting in natural streams from the discharge
of water from paddies treated with carbofuran.
The Pesticide Incident Monitoring System (PIMS) reports
on carbofuran from 1966 through 1979 (the 1979 report is the
latest one available), contained 73 incidents associated
with human injury. There was one fatality, which was a
verified suicide in the home. Most of the more serious
incidents were caused by accidental exposure to carbofuran.
The manifestations of the cholinergic poisoning symptoms
included nausea, vomiting, cramps, excessive sweating,
salivation and blurred vision.
Cattle deaths were also accidental and involved
inadvertent mixing with feed, improper disposal of containers
and contamination of field water runoff pools. Most reported
incidents in man or livestock were not severe and were
14
-------
reversible in hours. All subjects hospitalized responded
favorably to atropine sulfate (antidote) and exhibited no
recurrent symptoms on subsequent observation.
Most workers in the reported incidents were apparently
exposed by dermal exposure except for the mixer/loaders where
inhalation may have also contributed to the exposure.
In accordance with the FIFRA, the Agency's policy is not
to cancel or to withhold registration for the lack of certain
data as provided under FIFRA sections 3(c)(2)(B) and 3(c)(7).
Rather, publication of this document provides a mechanism for
identifying data needs, and registration under this document
allows for upgrading of labels during the period in which the
required data are being generated. When the Agency receives
these data it will determine whether they affect the carbofuran
registration.
E. Criteria for Products Subject to the Document
This guidance document covers all manufacturing-use and
end-use products that contain carbofuran as the sole active
pesticide ingredient. Registrants and applicants for
registration of such products must comply with all terms and
conditions described herein. This includes 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.
15
-------
F. Acceptable Ranges and Limits
1. Product Composition Standards
To be registered under this document, MPs and EPs
must contain carbofuran as the sole active ingredient.
Each product formulation proposed for reregistration
or registration must be fully described with
appropriate certification of limits.
• x-
2. Acute Toxicity Limits
The Agency will consider for reregistration or
registration any MPs and EPs provided the product
is supported by appropriate acute toxicity data and
the labeling for the product bears appropriate
precautionary statements.
G. Required Labeling
All MPs and EPs containing carbofuran must bear appropriate
labeling as specified in 40 CFR 162.10, in addition to the
following specific labeling requirements.
1. Labeling Requirements for All MPs
a. Ingredient Statement
The ingredient statement for MPs must list the active
ingredient as: carbofuran.
16
-------
b. Use Pattern Statement
All manufacturing use products labels must state
that the product is only intended for formulation
into end-use products for one or more of the use
patterns listed in this document. A limiting factor
will be the data that support each use pattern.
No use may be included on the label if the registrant
fails to agree to comply with the data requirements
in either TABLE A or TABLE B for that use pattern.
The attached "EPA Index to Registered Pesticides"
entry summarizes all currently acceptable uses for
all single active ingredient products containing
carbofuran, including sites of application, target
pests, dosage rates, restrictions and limitations,
and the method and frequency of application.
Terrestrial Food Uses
Alfalfa, bananas, barley, Bermudagrass (seed crop),
clover (ladino), coffee, corn (field, pop, and sweet),
cotton, cranberries, cucumber, garlic, grapes, melons,
nonbearing fruit trees (apples, apricots, cherries,
peaches, plums and nectarines), oats, peanuts, peppers,
plantain, potatoes, pumpkins, sorghum (grain and forage),
soybeans, squash, strawberries, sugar beets, sugarcane,
sunflower, and wheat.
17
-------
Terrestrial Non-Food
Cottonwood (nursery stock), ornamentals (commercially
grown), Siberian elm, and tobacco.
Aquatic Food Crops
Rice
Forestry
Cottonwood plantations, pine plantations, Southern
pine seed nurseries, and white pine seed nurseries.
c. Human Precautionary Statements
The following precautions must be included in the
"Hazards to Humans" section of the product label:
"Poisonous if swallowed. May be fatal or
harmful as a result of skin or eye contact or by
breathing dust. Causes cholinesterase inhibition,
Warning symptoms of poisoning include weakness,
headache, sweating, nausea, vomiting, diarrhea,
tightness in chest, blurred vision, pinpoint
eye pupils, abnormal flow of saliva, abdominal
cramps, and unconsciousness. Atropine sulfate
is antidotal."
18
-------
"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. Do not induce vomiting or give anything
by mouth to an unconscious person."
• /•
d. Environmental Hazard Statements
The following precautions must be included in the
"Environmental Hazards" section of the label.
"This pesticide is toxic to fish, birds
and other wildlife. Do not discharge
effluent containing this product directly
into lakes, streams, ponds, estuaries,
oceans or public water unless this product
is specifically identified and addressed
in an NPDES permit. Do not discharge
effluent containing this product to sewer
systems without previously notifying the
sewage treatment plant authority. For
guidance, contact your State Water Board
or Regional Office of the Environmental
Protection Agency.
19
-------
2. Labeling Requirements for All 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. Ingredient Statement
The ingredient statement for EPs must list the active
ingredient as: carbofuran.
c. Use Directions
In the "Directions for Use" section include the
following statements:
Geographical Use Restrictions;
"Do not use this product on Long Island, N. Y."
Rotational Crops;
"Do not plant any crop other than those with
registered carbofuran uses in carbofuran-
treated soil sooner than 18 months after
last application."
20
-------
Reentry;
"If prolonged intimate contact with corn and/or
sorghum foliage will result, do not re-enter
treated fields within 14 days of application
without wearing proper protective clothing.
For all other situations, do not re-enter
fields less than 24 hours following
application."
For granular formulation include;
"Cover or incorporate granules in spill areas"
d. Precautionary Statements
The following precautions must be included in the
"Hazards to Humans and Domestic Animals" section of
the product label:
"Poisonous if swallowed. May be fatal or
harmful as a result of skin or eye contact or by
breathing dust. Causes cholinesterase inhibition
Warning symptoms of poisoning include weakness,
headache, sweating, nausea, vomiting, diarrhea,
tightness in chest, blurred vision, pinpoint
eye pupils, abnormal flow of saliva, abdominal
cramps, and unconsciousness. Atropine sulfate
is antidotal."
21
-------
"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. Do not induce vomiting or give anything
by mouth to an unconscious person."
• /•
"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 Statement
The following statements must appear under the
heading "Environmental Hazards."
i. "Carbofuran is known to leach through soil,
and has been found in groundwater as a
result of agricultural use. Users are
advised not to apply in areas where soils
are permeable, i. e., well drained, and
which overlie shallow aquifers, particularly
those currently being used for drinking
water. Consult with the pesticide state
lead agency for information regarding
soil permeability and aquifer locations
in your area."
22
-------
ii. Granular products except for use on rice:
"This pesticide is toxic to fish, birds
and other wildlife. Birds feeding on
treated areas may be killed. Birds
killed by carbofuran pose a hazard to
hawks and other birds-of-prey; bury or
otherwise dispose of dead birds to
prevent poisoning of other wildlife.
Cover or incorporate granules in spill
areas. Runoff from treated areas may be
hazardous to fish in neighboring areas.
Do not apply directly to water. Do not
contaminate wells, wetlands or any body
of water by cleaning of equipment or
disposal of waste."
iii. Granular products used on rice:
Same as for the granular products except
delete "Do not apply directly to water"
and substitute "Fish may be killed at
recommended rates."
23
-------
iv. Non-granular products:
"This pesticide is toxic to fish, birds
and other wildlife. Birds feeding on
treated areas may be killed. Drift and
runoff from treated areas may be hazardous
to fish in neighboring areas. Do not
apply directly to water. This pesticide
.:'_ is highly toxic to bees exposed to direct
treatment or residues on crops. Do not
apply this product or allow it to drift
to blooming crops or weeds if bees are
visiting the treatment area."
v. Non-granular products used on potatoes and/or
alfalfa:
For waterfowl protection, do not apply
immediately before or during irrigation, or
on fields in proximity of waterfowl nesting
areas, or on fields where waterfowl are
known to repeatedly feed.
\
H. Tolerance Reassessment
Tolerances have been established for carbofuran and its
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) of
24
-------
1.0 milligram (mg)/kilogram (kg) of body weight (bw)/day which
was negative for oncogenic effects at the levels tested
(0.5-5.0 mg/kg bw/day); a 1-year dog feeding study with NOEL
of 0.5 mg/kg bw/day, a 2-year mouse feeding/oncogenicity
study with a NOEL of 3.0 mg/kg bw/day which was negative for
oncogenic effects at the levels tested (up to 500 ppm in
feed); a 3-generation rat reproduction study with a 20 ppm
in feed NOEL; a ^rat teratology study which was negative for
teratogenic effects at the highest level tested (HLT)
(1.2 mg/kg bw/day); and a rabbit teratology study which was
negative for teratogenic effects at 2.0 mg/kg/day (HLT).
Based on the 1-year dog feeding study with a NOEL of 0.5
mg/kg/day for cholinesterase depression and systemic effects
and using a safety factor of 100 fold, the Agency calculates
the Acceptable Daily Intake (ADI) to be 0.005 mg/kg/day. The
maximum permissible intake (MPI) for carbofuran and its
cholinesterase-inhibiting metabolites is 0.3 mg/day.
The theoretical maximum residue contribution (TMRC) from
the established tolerances (published in 40 CFR 180.254) is
0.3415 mg/day for a 1.5 kg food diet for a 60 kg person.
The TMRC is 113.84% of the MPI and exceeds the ADI by 13.84%.
Exceeding the MPI does not necessarily indicate adverse
effects in man from excessive carbofuran dietary exposure
25
-------
because in reality: (1) 100% of each of the crops for which
carbofuran is registered is not treated, and (2) residues
in or on treated crops as consumed rarely exist at tolerance
levels. Therefore, the TMRC could be recalculated to a
smaller and more realistic level considering in the calculation
actual percent crop treated and actual residue levels. No more
substantial tolerances will be granted until a tolerance
reassessment is completed.
The United States tolerances are established for
combined residues of carbofuran and its carbamate and
phenolic metabolites. Internationally, other countries do
not establish tolerances in that manner. Canada's tolerances
are expressed as residues of carbofuran and its carbamate
derivatives and they are only interim; Mexico's tolerances
are expressed as carbofuran per se; and under Codex
Alimentarius the MRLs are carbofuran and its cholinesterase
inhibiting metabolites. For comparison of United States',
Canada's, Mexico's, and Codex Alimentarius' tolerances, see
the pages that follow.
26
-------
U. S. Tolerances
Crop
alfalfa forage
alfalfa hay
bananas
barley, grain
barley, straw
cattle, (fat, meat, and meat
by-products)
coffee beans
corn, field and popcorn-grain
corn, fresh-kernels and cob (husk
removed)
corn fodder and forage, field,
pop-, and sweet
cottonseed
cranberries
cucumbers
goats, (fat, meat, and meat
by-products)
grapes
grapes, dried pomace
hogs (fat, meat, and meat
by-products)
horses, (fat, meat, and
meat by-products)
melons
milk
oats, grain
oats, straw
peanuts
peanut hulls
peanut soapstock
peppers
potatoes
pumpkins
raisins
raisin waste
rice, grain
rice, straw
sheep, (fat, meat, and meat
by-products)
sorghum, (grain)
sorghum, (grain), forage & fodder
Maximum Residue
Limits (PPM)
Carbamate
5.0
20.0
-
0.1
1.0
0.02
-
0.1
0.2
5.0
0.2
0.3
0.2
0.02
0.2
1.5
0.02
0.02
0.2
0.02
0.1
1.0
1.5
8.0
3.0
0.2
1.0
0.6
1.0
3.0
-
0.2
0.02
_
0.5
Total
10.0
40.0
0.1
0.2
5.0
0.05
0.1
0.2
1.0
25.0
1.0
0.5
0.4
0.05
0.4
2.0
0.05
0.05
0.4
0.1
0.2
5.0
4.0
10.0
24.0
1.0
2.0
0.8
2.0
6.0
0.2
1.0
0.05
0.1
3.0
27
-------
U. S. Tolerances (continued)
CroD
soybeans
soybean, forage and hay
soybean, soapstock
squash
strawberries
sugar beets
sugar beet tops
sugarcane
sunflower
sunflower seed hulls and meal
sweet potato ;
tobacco
wheat, grain
wheat, straw
*Proposed
N/A not applicable - nonfood use
Maximum Residue
Limits (PPM)
Carbamate Total
0.2
20.0
1.0
0.6
0.2
1.0
0.4
0.5
0.6*
N/A
0.1
1.0
1.0
35.0
6.0
0.8
0
0
2.0
0.1
0.8
1.0
2.0*
N/A
0.2
5.0
28
-------
International Tolerances Maximum Residue
Canada Limit (PPM)
Tolerance*
alfalfa 0.1
bananas 0.1
barley, grain 0.1
coffee beans 0.1
corn, grain 0.1
cucumbers 0.1
grapes 0.1
melons 0.1
oats, grain 0.1
peanuts 0.1
peppers .:; carbofuran + 3-hydroxycarbofuran 0.5
phenolic metabolites 0.5
potatoes carbofuran + 3-hydroxycarbofuran 0.5
phenolic metabolites 1.0
rice, grain 0.1
squash 0.1
strawberries carbofuran + 3-hydroxycarbofuran 0.4
phenolic metabolites 0.5
sugar beets carbofuran 0.1
wheat, grain 0.1
* Except for peppers, potatoes, strawberries and sugar beets
residues include carbofuran and its carbamate derivatives.
29
-------
International Tolerances
Mexico
alfalfa forage
coffee beans
corn, grain
corn, forage & fodder
cucumbers
grapes
melons
peanut nutmeats
peanut hulls ;
peppers (chilli)
potato
rice, grain
rice, straw
sorghum (grain),
sorghum (grain),
soybean
soybean, forage
squash
strawberries
sugarcane
forage & fodder
Maximum Residue
Limit (PPM)
Tolerance
10.1
0.1
0.2
25.0
0.4
0.5
0.6
**
0,
0,
1,
2,
,2
,2
,0
,0
0.2
1.0
0.1
,0
,0
35.0
0.8
0.5
0.1
**
Mexico's tolerances are established for residue of carbofuran
per se.
30
-------
International Tolerances Maximum Residue
Codex Alimentarius Limit (PPM)
MRL
* * *
alfalfa forage 5.0
alfalfa hay 20.0
bananas 0.1
barley, grain 0.1
cattle (meat, meat by-products 0.05 ###
(or edible offal) and fat)
coffee beans 0.1
cottonseed 0.1
goats (meat, meat by-products 0.05 ###
(or edible offal) and fat)
hogs (meat, meat"by-products 0.05 ###
(or edible offal) and fat)
horses (meat, meat by-products 0.05 ###
(or edible offal) and fat)
maize, grain 0.1
maize, fodder (fresh) 5.0
oats, grain 0.1
peanut kernels 0.1
potatoes 0.5
rice, grain 0.2
sheep (meat, meat by-products 0.05 ###
(or edible offal) and fat)
sorghum, grain 0.1
soybean 0.2
strawberries 0.1
sugar beets 0.1
sugar beet tops 0.1
sugarcane 0.1
sweet corn 0.1
wheat, grain 0.1
*** Maximum residue limit includes carbofuran and its
cholinesterase-inhibiting metabolites.
### Combined residues of carbofuran and 3-hydroxycarbofuran
(expressed as carbofuran).
31
-------
Index of Currently Acceptable Uses**
"" EPA Index to Pesticide Chemicals
CARBOFURAN*
TYPE PESTICIDE; Insecticide (also refer to Nematlclde entry)
FORMULATIONS; '
FI(75%, 85%)
G (2%, 3%, 51, 9.8%, 10%, 15%)
WP (75%)
F1C (4 Ib/gal)
GENERAL WARNINGS AND LIMITATIONS; RESTRICTED USE PESTICIDES. Do not use
carbofuran on Long Island, NY. Wear long-sleeved clothing and protective «
gloves when handling.
Bee Caution (Non-granular formulations only):
Carbofuran is highly toxic to bees exposed to direct treatment or residues
on crops. Do not apply carbofuran or allow it to drift to blooming crops
or weeds if bees a^e visiting the treatment area.
Enviornmental Hazards;
Carbofuran is known to leach through soil and has been found in ground-
water as a result of agricultural use. Users are advised not to apply in
areas where soils are permeable, that is, well drained, and which overlie
shallow aquifers, partlcularily those currently being used for drinking
water. Consult with the state lead pesticide agency for information re-
garding soil permeability and aquifer locations in your area.
Carbofuran is toxic to fish, birds and other wildlife. Birds feeding on
treated areas may be killed. Cover or Incorporate granules in spill
areas. Drift and runoff from treated areas may be hazardous to fish in
neighboring areas. Do not apply directly to water or wetlands.
Agricultural Crop Tolerances;
"O..T ppm - coffee beans
0.4 ppm - cucumbers (of which not more than 0.2 ppm is carbamates)
0.4 ppm - melons (of which not more than 0.2 ppm is carbamates)
0.8 ppm - pumpkins (of which not more than 0.6 ppm is carbamates)
0.8 ppm - squash, (of which not more than 0.6 ppm is carbamates)
Livestock and Poultry Tolerances;
0.1 ppm in milk (of which not more than 0.02 ppm is carbamates)
0.05 ppm in the fat, meat, and meat byproducts of cattle, goats, hogs,
sheep (of which not more than 0.02 ppm is carbamates)
Definition of Terms;
Claims for pest control limited to suppression of populations are indi-
cated by parenthesized pest name.
*2,3-dihydro-2,2-dimethyl-7-benzofuranyl methylcarbamate
**covers single active ingredient labeling only.
Issued: 2-01-82 III-090601-1
Provisional Update: 6-29-84
32
r-
-------
EPA Index to Pesticide Chemicals
CARBOFURAN
GENERAL WARNINGS AND LIMITATIONS (continued)
The use of carbofuran may pose a hazard to the following Federally desig-
nated endangered/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
Aleutian Canada Goose - CA counties Including Colusa, Merced, Stanis-
laus, and Sutter
Kern Primrose Sphinx Moth - Walker Basin of Kern County, CA
Carbofuran 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 carbofuran 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.
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
23001AA
AGRICULTURAL CROPS
General Warnings and Limitations; Do not plant any crop other than those
with registered carbofuran uses in carbofuran-treated soil sooner than 18
months after last application. Do not re-enter treated fields within 24
hours following application.
Alfalfa
10 ppm alfalfa (fresh) (of which not
more than 5 ppm are carbamates)
40 ppm alfalfa hay (of which not
more than 20 ppm are carbamates)
7 day preharvest interval through
0.25 pound per acre for foliar ap-
plication.
14 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
28 day preharvest Interval through 1
pound per acre for foliar applica-
tion.
Do not make more than 2 applications
per growing season. Do not ezeed
0.5 pound per acre on second appli-
cation.
Apply to pure stands of alfalfa. Do
not move bees to alfalfa fields
within 7 days of application. Apply
Issued: 2-01-82
III-090601-2
33
-------
Site and Pest
EPA Index to Pesticide Chemicals
CARBOFURAN
Dosages and Tolerance, Use, Limitations
Formulation(s) r
Alfalfa (continued)
IOABANA
INASBWC
INASBWJ
IRAFAJA
IRACFGH
IRACFGJ
INASETC
IRACAIA
INASAAA
IVABAAA
Alfalfa blotch leaf-
miner
Alfalfa weevil
(larvae)
Alfalfa weevil
(adults)
Potato leafhopper
0.5-1 Ib/A
(4 Ib/gal
F1C)
0.25-1 Ib/A
(75Z WP)
(4 Ib/gal
F1C)
0.5-1 Ib/A
(4 Ib/gal
F1C)
wettable powder formulation in a
minimum of 5 gallons of water and
flowable concentrate formulation in
a minimum of 2 gallons of water per
acre by aircraft. Unless otherwise
specified apply in a minimum of 10
gallons of water per acre by ground
equipment. For waterfowl protec-
tion, do not apply on fields in
proximity of waterfowl resting areas
and/or fields where waterfowl are
known to repeatedly feed.
Use limited to Northeastern states.
Foliar application. Apply when pest
first appears.
Foliar application. Apply after
first larval feeding is observed.
Foliar application.
first appears.
Apply when pest
Blue alfalfa aphid 0.25-0.5 Ib/A Use limited to AZ and CA.
(nymphs) • (4 Ib/gal Foliar application. Apply in a min-
Blue alfalfa aphid F1C) imum of 30 gallons of water per acre
(wingless adults) by ground equipment. Apply when
feeding is noticed or when pest ap-
pears.
IQAMARA
Egyptian alfalfa
weevil (larvae)
Pea aphid
Snout beetles
Grasshoppers
Lygus bugs
0.25-1 Ib/A
(4 Ib/gal
F1C)
0.125-0.25
Ib/A
(4 Ib/gal
F1C)
1 Ib/A
(4 Ib/gal
F1C)
Foliar application. Apply when
feeding is noticed or when pest ap-
pears. For snout beetles in NY.
Foliar appliction.
ing is noticed.
Apply when feed-
Foliar application prior to bloom.
Issued: 2-01-82
III-090601-3
34
-------
/06002AA
/06016AA
INASAWA
Site and Pest
Banana
Plantain
EPA Index to Pesticide Chemicals
CARBOFURAN
Dosages and Tolerance, Use, Limitations
Foraulation(s)
0.1 ppm bananas
Soil application through 2.5 grams
per unit of production.
Banana root borer
7240 01AA
INAMCMA
INAVBAA
Cereal leaf beetle
Grasshoppers
1.25-1.5 g/
unit of
production
(5% G)
2 g/unit of
production
(52 G)
2-2.5 g/unit
of produc-
tion
(5% G)
0.25 Ib/A
(4 Ib/gal
F1C)
0.125-0.25
Ib/A
(4 Ib/gal
F1C)
Soil application at planting. Apply
0.8 to 1 gram to the planting hole
and 0.45 to 0.5 gram to the soil
surface after the hole is covered.
Retreat soil surface with 2 grams, 4
months and 8 months after planting.
Soil application to established
plantings. Apply 0.4 to 0.5 gram
around the base of the mother,
daughter, and granddaughter plants.
Apply the remaining 1.6 to 2 grams
over an area of 50 centimeters
around the producing unit (mother,
daughter, and granddaughter plants).
Make 2 applications per year.
0.2 grain (of which not more than
0.1 ppm is carbamates)
5 ppm straw (of which not more than
1 ppm is carbamates)
Foliar application before heads
emerge from boot through 0.25 pound
per acre. Do not make more than 2
applications per season. Do not
feed treated forage to livestock.
For waterfowl protection, do not ap-
ply on fields in proximity of water-
fowl nesting areas and/or on fields
where waterfowl are known to repeat-
edly feed.
Foliar application. Apply in a min-
imum of 2 gallons of water per acre
by aircraft and a minimum of 10 gal-
lons of water per acre by ground
equipment. Apply when pests appear.
Apply before heads emerge from boot.
Issued: 2-01-82
III-090601-4
35
-------
Site and Pest
EPA Index to Pesticide Chemicals
CARBOFURAN
Dosages and Tolerance, Use, Limitations
Formulation(s)
/22017BA
/23003AA
/14007AA
Bermudagrass (seed crop)
Clover (ladino)
Garlic
This use occurs only on Special
Local Need (2A(C)) labeling and has
not been included in this entry.
Refer to appropriate labeling for
use information and limitations.
/28006AA
Clover (ladino)
Corn, Field
See Bermudagrass (seed crop) cluster.
1TBMCCA
ITBMBYA
European corn borer 1 Ib/A
Southwestern corn (10-15% G)
borer (second and
third generation)
0.2 ppm corn grain (of which not
more than 0.1 ppm is carbamates)
25 ppm forage and fodder (of which
not more than 5 ppm is carbamates)
No preharvest interval through 1
pound per acre for foliar applica-
tion.
Banded soil application (at time of
planting) through 1.2 ounces per
1,000 feet of row. Do not make a
foliar application if more than 1.2
ounces per 1,000 feet of row have
been applied at planting. Do not
make more than 2 foliar applications
per season.
If prolonged intimate contact with
corn foliage will result, do not
re-enter treated fields within 14
days without proper protective
clothing.
Foliar application. Apply with air-
craft over the corn plants or with
ground equipment by directing the
granules into the whorl. Apply when
eggs begin to hatch.
INAMBLA
INAMBMA
INAMBOA
Northern corn root- 1.2 oz/ Soil application at planting (band).
worm 1,000 ft row Apply a 7 inch band over the row or
Southern corn root- (4 Ib/gal inject on each side of the corn row
worm F1C) by mixing with water or liquid fer-
Western corn root- tilizer.
worm
Refer to Corn, Pop for additional information.
Issued: 2-01-82
III-090601-5
36
-------
EPA Index to Pesticide Chemicals
CARBOFURAN
/15004AA
/28006AA
ITBCCFA
ITBMCCA
INAMBMA
INAMBQA
ITBCBZA
ITBMCCA
IRAFAAA
INASDWA
INAVAAA
ITBMAYA
INAMBLA
INAMBQA
Site and Pest
Corn, Pop
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.2 ppm corn grain including popcorn
(of which not more than 0.1 ppm is
carbamates)
25 ppm forage and fodder (of which
not more than 5 ppm is carbamates)
Banded soil application (at time of
planting) through 3.6 ounces per
1,000 feet of row.
Banded soil application (postemer-
gent) through 1.2 ounces per 1,000
feet of row.
If prolonged intimate contact with
corn foliage will result, do not
re-enter treated fields within 14
days without proper protective
clothing.
Armyworm
(European corn
borer (first
generation))
Flea beetles
Northern corn root-
worm
Southern corn root-
worm
Western corn root-
worm
(Common stalk
borer)
European corn borer
(first generation)
(Leafhoppers)
Southern corn bill-
bug
Wireworms
Southwestern corn
borer (second and
third generation)
1.2 oz/
1,000 ft row
(10-15% G)
2.4-3.6 oz/
1,000 ft row
(10-15% G)
1.8-3.6 oz/
1,000 ft row
(10-15% G)
Soil application at planting (band).
For conventional, minimum, and no
tillage fields. Apply a 7 inch band
ahead of the planter press wheel and
incorporate into the top 1 inch of
soil, or direct the granules into
the planter shoe with the seed, or
place the applicator tube directly
behind the planter shoe so that the
granules drop into the furrow and
mix with the covering soil. Label-
ing claims control of armyworms for
up to 4 to 6 weeks after planting.
For early season suppression of the
common stalk borer. For southwest-
ern corn borer, apply to the seed
furrow. Southern corn billbug for
use in the Southeastern states, ap-
plied to the seed furrow. To sup-
press leafhoppers, and thereby
reduce losses due to maize chloratic
dwarf virus and corn smut, apply to
the seed furrow.
Northern corn root- 1.2 oz/ Postemergent soil application
worm 1,000 ft row (band). Apply by banding over the
Western corn root- (10-15% G) row or by sidedressing both sides of
worm the row and cultivate into the soil.
Issued: 2-01-82
III-090601-6
37
-------
/15005AA
Site and Pest
Corn, Sweet
EPA Index to Pesticide Chemicals
CARBOFURAN
Dosages and Tolerance, Use, Limitations
Fonnulation(s) -^
1 ppm fresh corn, including sweet
corn (kernels plus cob with husk re-
moved) (of which not more than 0.2
ppm is carbamates)
25 ppm forage and fodder (of which
not more than 5 ppm is carbamates)
7 day preharvest and 21 day pregraz-
ing intervals through 0.5 pound per
acre for foliar application.
Do not make more than 4 applica-
tions.
If prolonged intimate contact with
corn foliage will result, do not
re-enter treated fields within 14
days without proper protective
clothing.
ITBMCCA
European corn borer 0.5 Ib/A
(4 Ib/gal
F1C)
/28007AA
Cotton
IMQAAAA
/01010AA
Thrips
Cranberry
Garlic
Use limited to IA, IL, MN, NY, VA,
and WI.
Foliar application to machine har-
vested sweet corn. Apply in a mini-
mum of 10 gallons of water per acre
by ground equipment. Apply just
prior to first silking and repeat at
7 day intervals. For second genera-
tion European corn borer.
1 ppm cottonseed (of which not more
than 0.2 ppm is carbamates)
Banded soil application (at planting
time) through 1.2 ounces per 1,000
feet of row.
Do not graze treated areas or feed
treated forage to livestock.
1.2 oz/ Soil application at planting (band).
1,000 ft row Apply in the seed furrow.
(102 G)
0.5 ppm (of which not more than
0.03 ppm is carbamates)
This is a new use established sub-
sequent to the development of this
entry. Refer to appropriate label-
ing for use information and limita-
tions.
See Bermudagrass (seed crop) cluster.
Issued: 2-01-82
III-090601-7
38
-------
.„• EPA Index to Pesticide Chemicals
CARBOFURAN
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s) ^
/01014AA Grapes N.F.
Postharvest application through 10
pounds per acre.
Do not use on soil of pH 8 or
greater.
IRAVAJA Grape phylloxera 10 Ib/A Use limited to CA.
(10% G) Postharvest soil application.
Broadcast over the soil surface be-
tween the vine rows and Immediately
Incorporate. Apply after harvest
but before February. Remove dense
weed growth prior to treatment. Re-
peat biannually or when buildup of
phylloxera on roots causes a loss in
vine productivity. Dosage for light
to moderate infestations.
Oats See Barley cluster.
/2fi^5AA Peanuts 4 ppm peanuts (of which not more
than 1.5 ppm is carbamates)
10 ppm peanut hulls (of which not
more than 8 ppm is carbamates)
24 ppm fatty acids of peanut soap-
stock (of which not more than 3 ppm
is carbamates, reflecting residues
of 8 ppm phenolic metabolite and 1
ppm in alkaline soapstock)
Banded soil application (preplant)
through 5.6 ounces per 1,000 feet of
row; (at planting through 1.1 ounces
per 1,000 feet of row; (at pegging)
through 2.2 ounces per 1,000 feet of
row.
Do not feed treated peanut forage to
dairy animals or animals being fin-
ished for slaughter.
IRAFAJA Potato leafhopper 0.53-1.1 oz/ Use limited to Southeastern states.
INAMBMA (Southern corn 1,000 ft row Soil application at planting (band).
rootworm) (10-15% G) Apply in furrow.
Issued: 2-01-82 III-090601-8
39
-------
Site and Pest
EPA Index to Pesticide Chemicals
CARBOFDRAN
Dosages and Tolerance, Use, Limitations
Formulation(s)
IRAFAJA
INAMBMA
IMOAAAA
Peanuts (continued)
(Potato leafhopper)
(Southern corn
rootworm)
Thrips
INAMBMA
2.13-4.4 oz/ Use limited to Southeastern states.
1,000 ft row Preplant soil application (band).
[12 in. Apply in a band over the row prior
band] to planting and incorporate 3 inches
or into the soil. Additional control
3.2-5.6 oz/ measures may be needed in late sea-
1,000 ft row son for potato leafhopper.
[18 in.
band]
(10-15Z G)
Southern corn_root- 1.1-2.2 oz/ Soil application at pegging (band).
worm * 1,000 ft row Apply a 14 to 18 inch band over the
(10% G) row when pegs begin to form or up to
30 days after pegging begins (ap-
proximately 60 to 90 days after
planting). Incorporate granules im-
mediately if vine growth permits.
Do not apply at pegging if carbofur-
an was applied at planting.
AA
Peppers
1 ppm (of which not more than 0.2
ppm is carbamates)
21 day prebarvest interval through
3.2 ounces per 1,000 feet of row.
ITBMCCA
European corn borer 2 Ib/A Soil application (band). Make first
or application 2 to 4 weeks after
2.4 oz/ transplanting. Sidedress on either
1,000 ft row one or both sides of the row.
[38 in. row
spacing]
(10-15Z G)
3 Ib/A soil application (band). Make sec-
or ond application 4 to 6 weeks follow-
3.2 oz/ ing the first application. Side-
1,000 ft row dress on either one or both sides of
[38 in. row the row.
spacing]
(10-15% G)
Issued: 2-01-82
III-090601-9
4JQ.
-------
IRACCUA
Site and Pest
Peppers (continued)
Green peach aphid
EPA Index to Pesticide Chemicals
CARBOFURAN
Dosages and Tolerance, Use, Limitations
Formulation(s)
/1A012AA
Plantain
Potato
INAMCFA
ITBMCCA
INAMBSA
IRAFAJA
INAMBWA
INAVAAA
INAMCFA
ITBMCCA
INAMBSA
IRAFAJA
Colorado potato
beetle
European corn borer (10-15% G)
Potato flea beetle
Potato leafhopper
Tuber flea beetle
(Wireworms)
2 Ib/A use limited to Delmarva Peninsula
or and South NJ.
2.A oz/ Soil application (band). Make first
1,000 ft row application 2 to A weeks after
[38 in. row transplanting. Sidedress on either
spacing] one or both sides of the row.
(10-15% G)
3 Ib/A use limited to Delmarva Peninsula
or and South NJ.
3.2 oz/ Soil application (band). Make sec-
1,000 ft row ond application A to 6 weeks follow-
[38 in. row ing the first application. Side-
spacing] dress on either one or both sides of
(10-15% G) the row.
See Banana cluster.
2 ppm (of which not more than 1 ppm
is carbamates)
1A day preharvest interval through 1
pound per acre for foliar applica-
tion.
Do not make more than 8 foliar ap-
plications per season.
Do not apply more than 3 pounds to
foliage that has been treated with
carbofuran at planting.
0.225 lb/ Soil application at planting (band).
1,000 ft row Apply directly into the bottom of
the furrow during the planting oper-
ation.
Colorado potato
beetle
European corn borer
Potato flea beetle
Potato leafhopper
0.5-1 Ib/A
(A Ib/gal
F1C)
Foliar application. Apply in suffi-
cient water for thorough coverage by
ground equipment. Apply when pest
first appears and repeat as needed.
For waterfowl protection, do not ap-
ply immediately before or during ir-
rigation, or on fields in proximity
of waterfowl nesting areas, or on
fields where waterfowl are known to
repeatedly feed.
Issued: 2-01-82
111-090601-10
41
-------
EPA Index to Pesticide Chemicals
CARBOFURAN
Site and Pest
IRACCUA
Potato (continued)
Green peach aphid
INAMAPA
Potato tuberworm
/28072AA
Rice
IQAMARC
INA5CBA
Dark ricefield
mosquito (larvae)
Rice water weevil
Issued: 2-01-82
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.225 lb/ Use limited to Western and North-
It 000 ft row eastern states including the Delmar-
(10-15% G) va Peninsula.
Soil application at planting (band).
Apply directly into the bottom of
the furrow during the planting oper-»
ation.
0.225 lb/ Use limited to VA.
1,000 ft row Soil application at planting (band).
(10-15% G) Apply directly into the bottom of
the furrow during the planting oper-
ation.
0.5-1 Ib/A Use limited to VA.
(4 Ib/gal Foliar application. Apply in suffi-
F1C) cient water for thorough coverage by
ground equipment. Apply when pest
first appears and repeat as needed.
For waterfowl protection, do not ap-
ply immediately before or during ir-
rigation, or on fields in proximity
of waterfowl nesting areas, or on
fields where waterfowl are known to
repeatedly feed.
0.2 ppm rice (of which not more than
0.1 ppm is carbamates)
1 ppm rice straw (of which not more
than 0.2 ppm is carbamates)
Broadcast soil application (pre-
plant) through 0.5 pound per acre.
Broadcast water application (post
plant) through 0.6 pound per acre.
Do not make more than 1 application
per season.
May be applied by aircraft. Subse-
quent use of propanil may result in
crop injury.
Fish may be killed at listed appli-
cation rates.
0.45-0.6 Ib/A Use limited to AR, LA, MS, and TX.
(3-5% G) Broadcast water application. Apply
1 day or within 21 days after perma-
nent flooding. For dark ricefield
mosquito larvae apply 2 to 4 days
after the field has been flooded.
III-090601-ll
42
-------
Site and Pest
Rice
EPA Index to Pesticide Chemicals
CARBOFURAN
Dosages and Tolerance, Use, Limitations
Formulation(s)
INASCBA
/22004AA
/24006AA
Rice water weevil
Sorghum, Forage
Sorghum, Grain
IQALAEA
IRACDNA
A
NA
/28023AA
INAPAFC
0.5 Ib/A Use limited to CA.
(2-5% G) Preplant broadcast soil application.
Apply prior to flooding.
0.1 ppm grain
3 ppm fodder and forage (of which
not more than 0.5 ppm is carbamates)
75 day preharvest or pregrazing in-
terval (for forage) through 1.2 oun-
ces per 1,000 feet or row for banded
soil application (at planting).
1.2 oz/ soil application at planting (band
1,000 ft row in furrow). Apply directly into
(10-15% G) seed furrow.
0.9-1.2 oz/
1,000 ft row
(10-15% G)
1.2 oz/ Soil application at planting (band).
1,000 ft row Apply a 7 inch band over the row and
(10-15% G) incorporate into the top 1 inch of
soil by press wheel or by dragging a
short length of chain.
1 ppm soybeans (of which not more
than 0.2 ppm is carbamates)
35 ppm forage and hay (of which not
more than 20 ppm is carbamates)
Banded soil application (at time of
planting) through 2.4 ounces per
1,000 feet of row.
Mexican bean beetle 2.4 oz/ Soil application at planting (band).
(larvae) 1,000 ft row Apply in a 10 to 16 inch band and
(10% G) incorporate into the top 3 inches of
soil.
1.3-2.4 oz/ Soil application at planting (band
1,000 ft row in furrow). Direct the granules in-
(10% G) to the planter shoe with the seed or
placing the applicator tube behind
the planter shoe so that the gran-
ules drop into the furrow and mix
with the covering soil.
Chinch bug
Greenbug
Chinch bug
Greenbug
Soybeans
Issued: 2-01-82
111-090601-12
43.
-------
/01016AA
Site and Pest
Strawberry
INASABA
Root weevils
/28020AA
Sugar Beets
IflAXACA
/25003AA
ITBMBAA
Sugarbeet root
maggot
Sugarcane
Sugarcane borer
INAVAAA
Wireworms
EPA Index to Pesticide Chemicals
CARBOFURAN
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.5 ppm (of which not more than 0.2
ppm is carbamates)
Postharvest application through 2.55
ounces per 1,000 feet of row.
Do not make more than 1 application
per season.
Do not apply if berries are present.
1.3-2.55 oz/ Use United to OR and WA.
1,000 ft row Postharvest soil application (band).
(4 Ib/gal Apply 10 to 12 inch band over the
F1C) row after harvest but before October
1.
0.1 ppm sugar beets
2 ppm sugar beet tops (of which not
more than 1 ppm is carbamates)
Banded soil application (at time of
planting) through 1.35 ounces per
1,000 feet of row.
1.35 oz/ Soil application at planting (band).
1,000 ft row Apply 6 to 7 inch band. Incorporate
(10-15Z G) into top 1 inch of soil.
0.1 ppm
17 day preharvest interval through
1.5 pounds per acre for foliar ap-
plication.
1-1.5 Ib/A use limited to areas other than HI.
(5Z G) Foliar application. May be applied
or by aircraft. Apply after visible
0.5-0.75 Ib/A joints form and a minimum of 5 per-
(4 Ib/gal cent of the plants are infested with
F1C) young larvae feeding in or under the
leaf sheath and which have not bored
into the stalks. Repeat when field
checks indicate infestation exceed-
ing 5 percent. Check sugarcane
fields weekly beginning in early
June and continue through August.
0.25-0.5 lb/ use limited to areas other than HI.
1,000 ft row Soil application to plant cane
(10-15Z G) (band). Apply 15 inch band directly
over the planted cane and cover with
soil.
Issued: 2-01-82
111-090601-13
. 4.4 ..
-------
EPA Index to Pesticide Chemicals
CARBOFURAN
Site and Pest
Sugarcane (continued)
Dosages and Tolerance, Use, Limitations
Formulation(s)
/28021AA
Sunflower
0.25-0.5 lb/ Use limited to FL.
1,000 ft row Soil application to stubble cane
(15% G) (band). Apply a 15 inch band over
stubble row. Use anytime after har-
vest until regrowth reaches 18
inches. Cover with 1 to 2 Inches of
soil. Covering with more than 2
inches of soil may reduce stand.
0.08 ppm (sunflower seed)(of which
not more than 0.04 ppm is carbam-
ates)
BA
Sunflower (seed crop)
/26005AA
INAMADA
Tobacco, Air Cured, Burley
Flea beetles
3-4 Ib/A
(10-15% G)
or
4 Ib/A
(4 Ib/gal
F1C)
/26006AA
IZZZADA
ITBRAAA
Tobacco, Flue Cured
(Budworms)
Horn worms
Wireworms
Flea beetles
Horn worms
Issued: 2-01-82
6 Ib/A
(10-151 G)
4 Ib/A
(10-15% G)
This is a new use established sub-
sequent to the development of this
entry. Refer to appropriate label-
Ing for use information and limita-
tions.
0.08 ppm (sunflower seed)(of which
not more than 0.04 ppm is carbam-
ates)
This use occurs only on Special
Local Need (24(O) labeling and has
not been included in this entry.
Refer to appropriate labeling for
use information and limitations.
N.F.
Preplant broadcast soil application.
Apply to soil surface prior to
transplanting and incorporate into
the top 3 inches of soil.
N.F.
Carbofuran may induce flecking of
bottom or lower leaves.
Preplant broadcast soil application.
Apply before forming beds and incor-
porate into 4 to 6 inches of soil.
For hornworms labeling claims lower
dosage will control for approximate-
ly 60 days.
111-090601-14
45
-------
Site and Pest
EPA Index to Pesticide Chemicals
CARBOFURAN
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
Tobacco, Flue .Cured (continued)
IZZZADA
INAVAAA
INAMADA
(Budworms)
Wireworms
Flea beetles
Wheat
6 Ib/A
(4 Ib/gal
F1C)
4 Ib/A
(4 Ib/gal
F1C)
See Barley cluster.
Preplant broadcast soil application.
Apply before forming beds and incor-
porate into 3 inches of soil.
/351330A
1TBQAAA
1NAMAZA
/32000AA
/30135AA
ORNAMENTALS
(Ornamental Plants (herbaceous, woody shrubs, trees and vines))
Cottonwood (nursery stock)
Clearwing borer
Cottonwood leaf
beetle
Cottonwood twig
borer
0.3 lb/ Post plant soil application to nur-
1,000 ft row sery stock (band). Apply during May
(10-15% G) or June to the root zone of the cut-
ting, sidedressing 10 to 12 inches
from the trees in a continuous band
on both sides of the trees.
Ornamentals (Commercially Grown)
White Pine Seed Orchards
This use occurs only on Special
Local Need (24(C)) labeling and has
not been Included in this entry.
Refer to appropriate labeling for
use information and limitations.
Issued: 2-01-82
111-090601-15
46
-------
Site and Pest
/35115AA Siberian Elm
INAMDDA Elm leaf beetle
EPA Index to Pesticide Chemicals
CARBOFURAN
Dosages and Tolerance, Use, Limitations
Formulation(s)
Measure tree circumference 3 to 4
feet above the ground.
0.05 oz/in.
of tree cir-
cumference
(10-15% G)
or
1 unit dose/
in. of tree
circumfer-
ence
(9.8% G)
Use limited to AZ, CO, KS, NE, NM,
UT, and WV.
Soil application. Apply before in-
sects appear in the spring. Dig 1
hole per inch of tree girth, 3 to 9
inches deep under the drip line of
the tree. (For 9.8 percent granular
use applicator provided.) Thorough-
ly soak area under the tree. Place
granules required in each hole.
Replace soil plug immediately and
compress soil. Keep treated area
soaked with water for 14 days. The
10 and 15 percent formulas are
intended for commercial applicators.
White Pine Seed Orchards
See Ornamentals (Commercially Grown) (cluster).
/30037DA
ITBQAAA
INAMAZA
1TBGAUA
/30059DA
IN AS BRA
INASCVA
FOREST, CHAPARRAL, NONAGR1CULTURAL, AND WASTELANDS
Cottonwood Plantations
Clearwing borer
Cottonwood leaf
beetle
Cottonwood twig
borer
Pine Plantations
Pales weevil
Pitch^eating weevil slurry
lings]
(4 Ib/gal
F1C)
4.3-8.8 oz/ Post plant soil application to com-
1,000 ft row mercial plantations (subsoil band).
(10-15% G) Apply during June or July. Apply to
the root zone of the cutting with a
granular subsoil applicator as a
sidedress 10 to 12 inches from the
trees in a continuous band on both
sides of the trees.
1% clay
Root dip to pine seedlings prior to
transplanting. Thoroughly cover
[0.8 oz/150- roots or seedlings and keep roots
200 seed- moist until transplanting. Mix 0.8
ounce in 0.5 gallon of water with 2
pounds pulverized kaolin clay (pH
4.5). Adequate ventilation is re-
quired for Indoor treatment.
Issued: 2-01-82
111-090601-16
47
-------
/30075BA
IZZZDIA
ITAAADA
IQAIASA
INBQCKA
Site and Pest
EPA Index to Pesticide Chemicals
CARBOFURAN
Dosages and Tolerance, Use, Limitations
Formulation(s)
Pine Plantations (continued)
1 g/seedling
(10% G)
Southern Pine Seed Orchards
Coneborers
Coneworms
Seedbugs
Pine cone beetles
0.4-0.8 oz/
in. of tree
diameter
(10-15% G)
0.8 oz/in.
of tree
diameter
(10-15% G)
Soil application at transplanting.
Apply within a 6 inch radius around
each seedling. Cover granules with
soil. Do not apply if seedlings
were treated with clay slurry root
dip.
Do not graze or feed orchard plants
or plant parts.
Broadcast soil application to the
drip area. Incorporate Into the
soil. Make 1 application in winter
or early spring.
9001500
AAAAAAA
AERIAL, MOTHPROOFING AND TANK MIX APPLICATIONS
Aerial Application
— Refer to
AGRICULTURAL CROPS
Alfalfa, Rice
Issued: 2-01-82
111-090601-17
48
-------
EPA Index to Pesticide Chemicals
.*.' *
CARBOFURAN
Listing of Registered Pesticide Products by Formulation
75% formulation intermediate
carbofuran (090601)
000279-02862
85Z formulation intermediate
carbofuran (090601)
000279-03038
2% granular
carbofuran (090601)
000279-02791
3% granular
carbofuran (090601)
000279-02792 '
5% granular
carbofuran (090601)
000279-02874 000279-02922
9.8% granular
carbofuran (090601)
015056-00001
10% granular
carbofuran (090601)
000279-02712
15% granular
carbofuran (090601)
000279-03023
75% wettable powder
carbofuran (090601)
000279-02875
A Ib/gal flowable concentrate
carbofuran (090601)
000279-02876
Issued: 2-01-82 111-090601-18
49
-------
9999999
.... EPA Index to Pesticide Chemicals
CARBOFURAN
Listing of Registered Pesticide Products by Formulation (continued)
' ' "V
State Label Registrations
CA Reg. No.
000279-04018
LA Reg. No.
006735-04750
NC Reg. No.
000279-03215
NM Reg. No.
000279-03217
NY Reg. No.
038655-10428
SC Reg. No.
000279-03251
TX Reg. No.
000279-03889
006735-04826
010965-09895
006735-04845
000279-04021
006735-04847
006735-04846
006735-04815
006735-04848
006735-04819
Issued: 2-01-82
111-090601-19
50
-------
II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA Section 3(c)(2)(B)
and describes, in table f-ormat, 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 guidance document.
As required by FIFRA Section 3(c)(2)(B), you are
required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those
products unless, within the specified time, you have
informed EPA how you will satisfy the requirements
of this Notice. Any such suspension will remain in
effect until you have complied with the terms of
this Notice.
B. What Generic Data I/ Must Be Submitted. You may
ascertain which generic data you must submit by
consulting Table A at the end of this chapter. That
table shows all the generic data needed to evaluate
the continued registrability of all products, and
the dates by which the data must be submitted. The
required data must be submitted and any necessary
studies must be conducted in accordance with EPA-
approved protocols, the Pesticide Registration Guide-
lines 2_/', or data collected under the approved proto-
cols of the Organization for Economic Cooperation
and Development (OECD). If you wish not to develop
data which are necessary to support the registration
or reregistration of certain uses appearing in your
labeling, you may delete those uses at the time you
submit your revised labeling.
I/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient (or all such
products having a certain use pattern), regardless of any such
product's unique composition or use. Product-specific data relate
only to the properties or effects of a product with a particular
composition (or a group of products with closely similar composition)
_2/ The Pesticide Registration Guidelines were reproposed on
November 24, 1982 in 47 Federal Register 53192.
51
-------
Also for certain kinds of testing (generally eco-
logical effects), EPA requires the test substance to
be a "typical formulation," and in those cases EPA
needs data of that type for each major formulation
category (e.g., emulsifiable concentrates, wettable
powders, granulars, etc.) These are classified as
generic data and when needed are specified in Table
A. EPA may possess data on certain "typical formu-
lations" but not others. Note; The "typical formu-
lation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further
explained in Chapter 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 agree-
ment with one or more other registrants to
jointly develop (or share in the cost of develop-
ing) the data. If you elect this option, you
must notify EPA which registrant(s) are parties
to the agreement.
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
V FIFRA Section 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
(Footnote continued at bottom of next page)
52
-------
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.)
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed.
(This option is not available to applicants for new
products.)
D. Procedures for Requesting Changes in Testing
Methodology and Extensions of Time
EPA recognizes that you may disagree with our con-
clusions regarding the appropriate ways to develop
the required data or how quickly the data must be
submitted. If the test procedures you plan to use
deviate from (or are not specified in) the regis-
tration guidelines or protocols contained in the
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
(Footnote continued from previous page)
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a 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.
53
-------
submit a request for an extension of time. The ex-
tension request must be submitted in writing to the
Product Manager. The extension request should state
the reasons why you conclude that an extension is
appropriate. While EPA considers your request, you
must strive to meet the deadline for submitting the
required data.
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
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" iden-
tified 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 deter-
mine which product-specific data you must submit.
This can be done by examining the entries in the column
of those tables entitled "Must Data Be Submitted Under
§3(c)(2)(B)."
jV Product specific data pertains to data that support the
formulation which is marketed; it usually includes product chemistry
data and acute toxicology data.
54
-------
TABLE
GENERIC DATA REQUIREM!
ME^K
FOR CARBOFURAN
Guideline Citation and
Name of Test
§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
Test2
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Guidline
Status
R
R
R
CR
R
R
R
R
R
R
R
Are Data Footnote
Required 1, 3 Number
Yes No
[xl
[x]
[X]
[x]
[x]
[x]
[xl
[x]
[x]
[x]
n
[ ]
n
n
n
n
n
n
n
n
n
[x]
55
-------
TABLE
GENERIC DATA REQUIREM!
MOT^D
FDR CARBOFURAN
Guideline Citation and Test2
Name of Test Substance
§158.120 Product Chemistry
(continued)
Physical and Chemical Characteristics
(continued)
63- 7 - Density, Bulk Density, or TGAI
Specific Gravity
63- 8 - Solubility TGAI or PAI
63- 9 - Vapor Pressure PAI
63-10 - Dissociation Constant PAI
63-11 - Octanol/tyater Partition PAI
Coefficient
63-12 - pH TGAI
63-13 - Stability TGAI
63-20 - Corrosion Characteristics TGAI
Other Requirements
64- 1 - Submittal of Samples C
Guidlines Are Data Footnote
Status Required 1, 3 Number
Yes No
R [x]
R [x]
R M
R [x]
R [xl
R [x]
R [x]
R [x]
CR [~]
[ 1
n
[ ]
n
n
n
n
n
[x]
56
-------
SMI^rS I
TABLE
GENERIC DATA REOUIREMEM5 FOR CARBOFURAN
§158.120 Product Chemistry
(continued)
1 - If current information has been submitted to the Agency, the applicant should refer to it or resuhmit the data.
2 - Test Substance: TGAI = Technical grade of active ingredient; ; PAI = Pure Active Ingredient; C = Either substance.
3 - Data must be submitted no later than November, 1984 .
57
-------
TABLE
GENERIC DATA REQUIREMENTS FOR CHEMICAL CARBOFURAN
Data Requirements
Conpositionl
Dees EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants
PAIRA
Yes
- Livestock
PAIRA and plant
metabolites
Yes
171-4 - Residue Analytical Method
- Plant residues
TGAI and metabolites
Yes
- Animal residues
TGAI and metabolites
Yes
GSftlOlOOl,*
GSO101003,
GSO101005,
GS0101007,
GSO101009,*
GS0101011,*
GS0101002
GS0101004
GS0101006
GS0101008
GSO101010*
GS0101012*
GS0101013, GSO101014
GS0101015,* GS0101016
GS0101017, GS0101018*
GS0101019*
GS0101020,
GS0101023,
GS0101025,
GS0101027,
GS0101029,*
GS0101031,
GS0101034,*
GS0101036,*
GS0101038,*
GS0101040,*
GS0101042,*
GS0101044,*
GS0101046,*
GS0101022
GS0101024*
GS0101026
GS010102R*
GS0101030*
GS0101032*
GS0101035*
GS0101037*
GS0101039*
GS0101041*
GS0101043*
GS0101045*
GS0101047*
GS0101020, GS0101022
GS0101023, GS0101033*
No
No
No
No
*Data submitted by FMC Corporation. These data maybe compensable.
58
-------
TABLE A'
GENERIC DATA REQUIREM
FOR CARBOFURAN
Data Requirements
Compos itionl
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
Nof or Partially)
Bibliographic
Citation
Must Additional
Data Re Submitted
Under FIFRA Section
3(c)(2)(B)2
§158.125 Residue Chemistry
(continued)
171-4 - Storage Stability Data
PAI
Partially
GS0101047*
Yes-
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
Partially
No
No
No
GS0101048, GSO101049 Yes4
GSO101050,* GS0101051*
GS0101052,* GS0101053*
GS0101054,* GS0101055*
Yes5
Yes5
*Data submitted by FMC Corporation. These data maybe compensable.
59
-------
TABLE
GENERIC DATA REOUIREMENT
CARBOFURAN
Data Requirement
Composition^/
Does EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No, or Partially)
§158.125 Residue Chemistry
174-4 - Magnitude of the Residue -
Residue Studies (continued)
0 Sugar beets
—Crop field trials
- Leaves of Root and Tuber
Vegetables Group 7
0 Sugar beet tops
—Field trials
- Legume Vegetables (Succulent
or Dried)°
0 Soybean
—Field trials
"Soybean soapstock
-Foliage of Legume
Vegetable Group9
"Soybean forage and hay
TEP
Partially
TEP
Yes
TEP
Yes
Yes
Yes
Bibliographic
Citation
GS0101056*
GS010105fiv
GS0101057 *
GS0101057 *
GS0101057
Must Additional"
Data Be Submitted
Under FIFRA Section
3(c)(2)(R)?2/
No
No
No
No
*Data submitted by FMC Corporation. These data maybe compensable.
60
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CARBOFURAN
Data Requirement
Compos itionV
Does EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No or Partially)
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
-Fruiting Vegetables (Except
Cucurbits) Group 10
"Peppers
-Fruiting Vegetables (Cucurbits)
Group
"Cucumbers
"Melons
°Pumpkins
"Squash
-Small Fruits And Berries Group12
"Cranberries
Partially
Yes
Yes
Yes
Yes
Yes
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)
GS0101058*
GS0101059*
GS0101060*
GS0101060*
GS0101060*
GS0101061*
Yes
11
No
No
No
No
No
*Data submitted by FMC Corporation. These data maybe compensable.
61
-------
TABLE A'
GENERIC DATA REQUIREMENTS FDR CARBOFURAN
Data Requirement
Compos itionV
Does EPA Have Data
To Satisfy This
Requirment? (Yes,
No or Partialy)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
"Grapes
Processed comodities
Raisins
Raisin waste
Raisin ponace
Raisin juice
"Stawberries
-Cereal Grains Groupl4
"Barley
"Corn
Partially
Partially
Partially
Partially
No
Yes
Yes
Partially
GS0101062,*
GS0101064,*
GS0101066,*
GS0101068*
GS0101062,*
GS0101065,*
GS0101068*
GS0101062,*
GS0101065,*
GS010106R*
GS0101063* Yes]3
GsnioiOKs*
GS0101067*
GS0101063* Yes13
GS0101067*
GS0101063*
GS0101067*
GS0101064,* GS0101065*
Yes13
GS0101069,* GS0101070* No
GS0101069*
GS0101070,* GS0101071*
GS0101072*
No
*Data submitted by FMC Corporation. These data maybe compensable.
62
-------
TABLE f
GENERIC DATA REQUIREMENTS FOR CARBOFURAN
Data Requirement
Compos i t ionV
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)
- Cereal Grains Group (continued)
°0ats
°Rice
"Sorghum grain
°Wheat
-Forage, Fodder,and Straw of
Cereal Grains Group18
°Barley straw
"Corn forage and fodder
°Oat straw
°Rice straw
"Sorghum (grain) forage and
fodder
"Wheat straw
Yes
Partially
Partially
Yes
Yes
Partially
Yes
Partially
Partially
Yes
GS0101073* No
GS0101074
GS0101075,* GS0101076* Yes17
GS0101073,* GS0101077* No
GS0101073*
No
GS010107R, GS0101079* Yes l
GS0101080,* GS0101081*
GS0101073* No
GS0101082 Yes^O
GSOIOIOR.!,* GSniOin84* Yes21
GS0101073,* GS0101085* No
*Data submitted by FMC Corporation. These data maybe compensable.
63
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CARBOFURAN
Data Requirement
Composition^/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
§158.125 Residue Chemistry
(continued)
174-4 - Magnitude of the Residue -
Residue Studies (continued).
- Non-Grass Animal Feeds (Forage,
Fodder,Straw,and Hay)Group22
°Alfalfa forage and hay
Partially
Bibliographic
Citation
GS0101086
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
Miscellaneous Crops
0 Bananas
— Crop field trials
0 Coffee
— Crop field trials
0 Cottonseed
"Peanuts
"Sugarcane
°Tobacco
TEP
TEP
TEP
TEP
TEP
TEP
Partially
Partially
Yes
Yes
Partially
Partially
GS0101087*
Yes24
GSO101088* Yes25
GS0101089* No
GS0101090, GS0101091* No2*
GS0101092 Yes27
GS0101093*
*Data submitted by FMC Corporation. These data maybe compensable.
64
-------
TABLE
GENERIC DATA REQUIREMENTS FOR CARBOFURAN
Data Requirement
Composition1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
§158.125 Residue Chemistry
(continued)
174-4 - Magnitude of the Residue -
Residue Studies (continued).
-Magnitude of the Residue in
Meat,MiIk,Poultry,and Eggs
"Cattle,goats,hogs,horses,
and sheep
°Milk
"Poultry and eggs
Yes
Yes
Yes
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
GS0101094, GS0101095* No
GS0101096*
GS0101097, GS0101098
GS0101099,* GSOlOllOO*
GS0101101, GS0101102* No
GS0101103*
*Data submitted by FMC Corporation. These data maybe compensable.
65
-------
TABLE
GENERIC DATA REQUIRENi^^ FOR CARBOFURAN
§158.125 Residue Chemistry
(continued)
1. Composition: TGAI = Technical grade of the active ingredient; PAIRA - Pure active ingredient, radiolabelled; TRP =
Typical end-use product; EP = End-use product.
2. Data must be submitted no later than June 30, 1986 .
3. Storage stability data are required for carbofuran and its metabolites of concern in or on corn grain and forage,
alfalfa, animal tissues, and milk following storage at subfreezing temperatures for periods up to one year.
4. A crop-group tolerance is not appropriate for the following reasons: 1) the tolerance for potatoes is more than
five times the tolerance for sugar beets, 2) the use pattern for sugar beets (10% granular soil applications only)
differs substantially from the use pattern for potatoes (10-15% granular soil applications and/or 4 Ib/gal flev/able
concentrate foliar applications), 3) there are gaps in the residue data supporting the currently estabjished
tolerances for potatoes and sugar beets, and 4) residue data would be required for two additional members of this
group (carrots and radishes), however carbofuran formulations are currently registered for use only on potatoes and
sugar beets within this crop group
5. Processing studies are required to determine residues of carbofuran and its metabolites in or on dried potatoes,
and potato granules and chips.
6. A processing study is needed to determine residues of both carbamates and phenolic metabolites in dried sugar
beet pulp, molasses, and refined sugar. This is necessary due to the uncertainty of the nature of the unextractable
and unidentified polar materials encountered in the sugar beet metabolism study. Residues may be released during
processing.
7. A crop-group tolerance is not appropriate for the following reason: Residue data are required for turnips.
8. A crop-group tolerance is not appropriate for the following reason: Residue data are required for several
additional members of this group (dried and succulent beans, lima beans, and dried and succulent peas).
9. A crop-group tolerance is not appropriate for the following reason: Residue data are required for the forage
and hay of two additional members of this group, beans and field peas, for which there are no tolerances.
10. A crop-group tolerance is not appropriate for the following reasons: 1) Residue data are required for one
additional member of this group (tomatoes); carbofuran formulations are currently registered for use on peppers
only. (Note: available residue data for tomatoes are not useful for purposes of establishing a group tolerance
because they reflect different formulations,methods of application and dosage rates than those registered for
peppers),and 2) additional residue data are required to support the currently established tolerance for carbofuran
residues in or on fresh peppers.
11. The available data do not support the established tolerance for peppers because phenolic metabolites were not
determined; carbamate residues in excess of 0.2 ppm were detected in or on peppers harvested later than
the 21-day PHI; and because residue field trials were not conducted in the principal growing region of the crop.
The following additional data are required: Residue data for fresh peppers at intervals up to 21 days after the
last of two soil treatments at 2 and 3 (split applications) Ibs. a.i./A or until residues are below the established
tolerance; residues of carbofuran and its carbamate and phenolic metabolites must be determined. Studies must br>
conducted in CA, FL, and TX.
66
-------
TABL^
GENERIC DATA REQUIREM^^ FDR CARROFURAN
§158.125 Residue Chemistry
(continued)
12. A crop-group tolerance is not appropriate for the following reasons: 1) residue data are required for two
additional members of this group (blueberry and a Rubus spp. such as blackberry) since carbofuran
formulations are currently registered for use only on cranberries, grapes, and strawberries, 2) the
registered use directions and limitations for cranberries, grapes, and strawberries are dissimilar,
and 3) there are gaps in the residue data to currently established tolerances for grapes, dried pomace,
and raison waste.
13. The available data do not support the established tolerances for grapes, dried panice, and raisin waste.
The following additional data are required: Residue analyses on raisin waste, Wet and dry pomace, and juice
processed from field-treated grapes which contain residues at or near the established tolerance.
14. A crop-group tolerance is not appropriate for the following reasons: 1) data gaps exist for the grains of corn,
rice, and sorghum, 2) data pertaining to phenolic metabolite residues in or on wheat grain were translated to
barley and oats, and 3) data from four representative commodities of this group were not submitted.
15. The available data do not support the established tolerance for the combined residues of carbofuran and its
carbamate and phenolic metabolites which may result in or on fresh corn (kernels plus cobs with husks removed
(K + CWHR)) and in or on corn grain from use of the registered formulations at the maximum application rate
because phenolic residues were not determined. The following additional residue data are required: 1) A single
soil application at-planting with one of the granular formulations at 3 Ibs. a.i./A and a single soil
application followed by two foliar applications at a total of 3 Ibs. a.i./A (1 Ib a.i./A/application) using
ground and aerial equipment and subsequent residue analysis of the grain of field corn and popcorn and of fresh
corn (K + CWHR) for carbofuran residues including phenolic metabolites of carbofuran, 2) no less than four
foliar applications with the 4 Ibs/gal flowable concentrate at 0.5 Ibs. a.i./A using ground and aerial equipment
and subsequent residue analysis of the grain of field and popcorn and of fresh corn (K + CWHR) for carbofuran
residues including phenolic metabolites of carbofuran, and 3) fractionation studies are required, if residues
are deatected in corn grain, to determine the necessity of food/feed additive tolerances for cannery waste
(sweet corn only), milled products, and oil (crude and refined).
16. The available data do not support the established tolerance for carbofuran residues in or on rice due to the
absence of data on phenolic metabolites and processed products. The following additional data are required:
1) data pertaining to carbofuran residues, including carbamate and phenolic metabolites, in or on rice grain
from the following treatments: (a) a single postplant, broadcast water application of one of the granular
formulations at 0.6 Ib a.i./A within 21 days after flooding in one of the following states-AR, LA, MS, and/or
TX and (b) a single preplant, broadcast soil application of a granular formulation at 0.5 Ib a.i./A prior to
flooding in CA. Either aerial or ground equipment may be used. 2) Data pertaining to carbamate and phenolic
residues of carbofuran in the following processed products of rice grain: polished rice, hulls, milled products,
and milled by-products.
-------
GENERIC DATA REQUIREM^^POR CARBOFURAN
§ 158.125 Residue Chemistry
(continued)
17. The available data do not support the established tolerance for carbofuran residues in or on sorghum grain
because phenolic metabolites were not determined. The following additional data are required: 1) carbamate and
phenolic residues of carbofuran must be determined in or on sorghum grain following a single, at-planting, band
or furrow application of a granular formulation at 2 Ib a.i./A (the product must be soil-incorporated), and 3)
a fractionation study will be required, if residues are detected in sorghum grain, to determine carbamate and
phenolic residues of carbofuran in flour and milled products.
18. A crop group tolerance is not appropriate for the following reasons: a. Data gaps exist for corn and sorghum
forage and fodder and rice straw, b. Data pertaining to phenolic metabolite residues in or on wheat straw were
translated to barley and oat straws. Data from one of five representative commodities of this group are insuffi-
cient to translate to the entire group.
19. The available data do not support the established tolerance for the combined residues of carbofuran and its
carbamate and phenolic metabolites in or on corn forage and fodder resulting from use of the registered form-
ulations at the maximum application rate because phenolic residues were not determined. The following additiona.1
residue data are required: 1) a single soil application at-planting with one of the granular formulations at
3 Ibs. a.i./A and a single soil application followed by two foliar applications at a total of 3 Ib ai/A
(1 Ib. a.i./A/application) using ground and aerial equipment and subsequent residue analysis of the forage and
fodder of either field, pop-, or sweet corn for carbofuran residues including phenolic metabolites of carbofuran,
and 2) no less than four foliar applications with the 4 Ibs./gal flowablel concentrate at 0.5 Ibs. a.i./A using
ground and aerial equipment and subsequent residue analysis of the forage and fodder of either field, pop-, or
sweet corn for carbofuran residues including phenolic metabolites of carbofuran.
20. The available data do not support the established tolerance for carbofuran residues in or on rice straw because
geographic representative data was inadequate and because data were not presented for phenolic metabolites. The
following additional data are required: Carbamate and phenolic residue data for rice straw following: (i) a
single post-plant water application of a granular formulation at 0.6 Ib ai/A within 21 days of flooding
(conducted in one of the following states: AR, LA, MS, and/or TX) and (ii) a single preplant soil application
of a granular formulation at 0.5 Ib. a.i./A prior to flooding (conducted in CA). Either aerial or ground equipment
may be used.
21. The available data do not support the established tolerances for carbofuran residues in or on sorghum forage and
fodder. The following additional data are required: 1) Carbamate and phenolic residues of carbofuran must be
determined in or on sorghum forage and fodder following a single, at-planting, band or furrow application of a
granular formulation at 2 Ib. a.i./A (the product must be soil-incorporated), and 2) carbamate and phenolic
residues must be determined in sweet sorghum syrup to determine the necessity of a food additive tolerance.
22. A crop-group tolerance is not appropriate for the following reasons: 1) residue data are required for one
additional member of this group (clover), ane 2) additional data are required to support the currently
established tolerances for residues of carbofuran and its metabolites in or on alfalfa forage and hay.
68
-------
TABLED
GENERIC DATA REQUIREM^^FOR CARBOFURAN
§ 158.125 Residue Chemistry
(continued)
23. The available data do not support the tolerances for carbofuran and its carbamate and phenolic metabolites in
or on alfalfa forage and hay. Data for two unregistered formulations (50% WP and 4% F1C) were apparently
submitted in lieu of data for the registered 4 Ibs./gal flowable concentrate and/or the 75% wettable powder.
These data are insufficient to support the tolerances. The following additional data are required: 1) two
foliar applications of the 4 Ibs./gal flowable concentrate and 75% wettable powder both at consecutive rates
of 1 and 0.5 Ibs. a.i./A applied with aerial and ground equipment. Tests must be conducted in central and
southern geographical locations. Forage and hay must be analyzed for both carbamate and phenolic residues.
Alternatively the labels can be amended to restrict the number of applications'to one per season. 2) Analyses
are required to determine residues in alfalfa meal to determine the necessity of a feed additive tolerance.
24. The available data do not support the established tolerance for carbofuran in or on bananas. The following
additional data are required: Phenolic residues of carbofuran in or on bananas following two hand-applied
treatments with the 5% granular at 2.8 Ibs. a.i./A.
25. The available data do not support the established tolerance for carbofuran residues in or on coffee beans. The
following additional data are required: 1) concentrations of phenolic residues of carbofuran in or on coffee
beans following the last of two hand-applied treatments with the 5% granular at 1.5 grams a.i./plant at Brazilian
and Central American locations, and 2) if residues are detected in coffee beans, then a processing study will be
required to determine carbamate and phenolic residues in roasted beans and instant coffee.
26. The available data support the established tolerances for carbofuran residues in or on peanut nutmeats and hulls,
and no additional data are required for this commodity. However the established tolerances for carbofuran
residues in or on peanuts and hulls were established based on the residues resulting from two seasonal
applications (at-planting plus at-pegging) of carbofuran. Only one application per season is permitted at this
time. The residues resulting from a single application are about 10 times less than those resulting from two
treatments. Therefore, the tolerances should be reduced as follows: a) for peanuts, 0.6 parts per million (ppm)
(of which no more than 0.2 ppm is carbamates); b) for peanut hulls, 1.5 ppm (of which no more than 0.3 ppm is
carbamates); and c) for fatty acids of peanut soapstock, 6 ppm, of which no more than 1 ppm is carbamates,
reflecting 2 ppm phenolic metabolites and 0.33 ppm carbamates in alkaline soapstock.
27. The available data do not support the established tolerance for carbofuran residues in or on sugarcane. The
following additional data are required: 1) carbofuran residues in the processed commodities of sugarcane
(molasses, refined sugar, and bagasse), 2) foliar applications (four or more)of the 4 Ibs./gal flowable
concentrate formulation 0.75 Ib.a.i./A on sugarcane with aerial and ground equipment, 3) residue data for
sugarcane following a single banded application of the 10 or 15% granular made to established cane after
harvest, and 4) phenolic metabolites of carbofuran in addition to carbamates must be determined in or on
sugarcane and its processed products from all of the above tests.
69
-------
TABLED
GENERIC DATA REQUIREMJ^^ FOR CARBOFURAN
§ 158.125 Residue Chemistry
(continued)
28. The available data are not adequate to assess the exposure of man to residues of carbofuran in or on tobacco
and its products. The following additional data are required; 1) both carbamate and phenolic residues must.
be determined in or on green tobacco following a single, soil-incorporated, preplant application of a granular
or the flowable concentrate formulation at 6 Ibs. a.i./A., and 2) pyrolysis products must be characterized.
This must include carbamates, phenolic metabolites, and any pyrolysis products if different from the above.
29. The maximum expected dietary intake of carbofuran and its carbamate and phenolic metabolites in dairy catt.le
is 39 ppm based on a diet consisting of 80% alfalfa hay and 20% soybean forage or hay. A more reasonable diet
of 80% alfalfa hay and 20% corn grain would result in a maximum combined dietary intake of 32 ppm carbofuran
and metabolites. The cattle feeding data submitted in pesticide petitions 2F1283, 8F0711, and 1F1150 do not
support the established tolerance for residues of carbofuran and metabolites in milk because dietary intake of
carbofuran by dairy animals is higher now than at the time the tolerance for milk was established. The tolerance
must be increased to 0.2 ppm, of which no more than 0.05 ppm is carbamates.
70
-------
TABLE
GENERIC DATA REQUIREM
.ENTS E
FDR CARBOFURAN
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Use 2 Requirement? (Yes,
Pattern No or Partially)
Must Additional
Data Re Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)? 3
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
TGAI or PAIRA A,B,C,G
Yes
*Data submitted by FMC Corporation. These data maybe compensable.
71
00092799,* 00092800*
00092695*
No
Photodegradat ion
161-2 - In water TGAI or PAIRA
161-3 - On soil TGAI or PAIRA
161-4 - In Air TGAI or PAIRA
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA
162-2 - Anaerobic Soil TGAI or PAIRA
162-3 - Anaerobic Aquatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA
Adsorpt ion/Desorp t ion
163-2 - Volatility (Lab) TEP
163-2 - Volatility (Field) TEP
A,B,C,G
A,G
A,G
A,B,G
A
C,G
C
A,B,C,G
A,B
A,B
Yes
NO
No
Partially
No
No
No
Partially
No
No
00092801* No
Yes
Yes
00092723,* 00092756* Yes4
00092758*
Yes
Yes
Yes
GS0101104, GS0101105 Yes5
Yes
Yes
-------
GENERIC
1
Data Requirement Composition P
§158.130 Environmental Fate
(continued)
DISSIPATION STUDIES-FIELD:
164-1 - Soil TEP
164-2 - Aquatic (Sediment) TEP
164-3 - Forestry TEP
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term TEP
ACCUMULATION STUDIES:
165-1 - Rotational Crops PAIRA
(Confined)
165-2 - Rotational Crops TEP
(Field)
165-3 - Irrigated Crops TEP
165-4 - In Fish TGAI or PAIRA
165-5 - In Aquatic Non-Target TEP
Organisms
SPECIAL STUDIES
- Monitoring of Groundwater TEP
*Data submitted by Stauffer Chemical Company.
TABLE1
DATA REQUIREMENTS FOR CARBOFURAN
Does EPA Have Data Must Additional
To Satisfy This Data Re Submitted
Use 2 Requirement? (Yes, Bibliographic Under FIFRA Section
attern No or Partially) Citation 3(c)(2)(B)?3
A,B Partially '" 00090871* Yes6
C No Yes
G No - Yes
N/A - NcB
A,B,C,G No - Yes
A,C No - Yes
A,C No - Yes
C No - Yes
A,B,C,G No - Yes
C,G No - Yes
A,B,C,G No - Yes
These data maybe compensable.
72
-------
TABLE
GENERIC DATA REQUIREMENTS" FDR CARBOFURAN
§158.130 Environmental Fate
(continued)
1. Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolab^lled:
TEP = Typical end-use product.
2. The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop:
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Donestic Outdoor; I=Indoor.
3. Data must be submitted no later than the following time after the date of this standard 161-3 December 31, .1.984;
162-1 June 30, 1986; 162-2 June 30, 1986; 162-3 June 30, 1986; 163-1 December 31, 1984;
164-1 June 30, 1986; 164-3 June 30, 1986.
4. Although the half-life of degradate 7-phenol was shown,and 3-hydroxycarbofuran was identified as an extactahle
degradate, identification and rate of decline of other degradates are still required.
5. A batch equilibrium study on one aquatic sediment from a representative use site and an aged leaching study are
still needed.
6. One additional terrestrial field dissipation study with a granular formulation and studies on two sites with
flowable concentrate and wettable powder formulations are required.
7. This Guidance Document deals only Iwith single active ingredients.
73
-------
Data Requirement^
§158.135 Toxicology
ACUTE TESTING;
81-1 - Oral
- Rat
TABLE
GENERIC DATA REQUIREMENTS' FDR CARBOFURAN
lENT^F
Does EPA Have Data Must Additional
To Satisfy This Data Re Submitted
I/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Composition Patterns No or Partially) Citation 3_(_cH2) (B)?V
81-2 - Dermal LE>50
81-3 - Inhalation
81-4 - Primary Eye Irritation-
Rabbit
81-5 - Primary Dermal
Irritation
81-6 - Dermal Sensitization
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,C,G
A,B,C,G
A,B,C,G
A,B,C,G
A,B,C,G
A,B,C,G
Yes
Yes
Yes
No
No
No
00063255, 00045107*
00063254, 00077329
00063258, 00063256
00077330, GS0101201**
GS0101202**
00063259, 00063260
00092562, 00092611
00092612, 00092613
00063250, 0006325R
00083097, 00092614
00092616
No
No
No
No4/
No5/
*Data submitted by FMC Corporation. These data maybe compensable.
*Data submitted by Farbenfabriken Bayer, A.G. These data maybe compensable.
-------
Data Requirement
§158.135 Toxicology
(continued)
Acute Testing; (cont.)
TABLE «
GENERIC DATA REQUIREMENTS FOR CARBOFURAN
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Composition Patterns No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
81-7 - Acute Delayed
Neurotoxicity - Hen
TGAI
A,B,C,G
No
No7/
SUBCHRONIC TESTING;
82-1 - 90-Day Feeding -
Rodent, Non-rodent
82-2 - 21-Day Dermal TGAI
82-3 - 90-Day Dermal TGAI
82-4 - 90-Day Inhalation - TGAI
Rat
82-5 - 90-Day Neurotoxicity- TGAI
Hen/Mammal
A,B,C,G
A,B,C,G
A,B,C,G
A,B,C,G
No
No
No
No
No*/
Yes
No7/
75
-------
TABLE
GENERIC DATA REQUI
BLE i^B
REMENTS F
FOR CARBOFURAN
Does EPA Have Data f
To Satisfy This I
I/ Use 2/ Requirement? (Yes, Bibliographic I
Data Requirement Composition Pattern No or Partially)? Citation
§158.135 Toxicology
(continued)
CHRONIC TESTING:
83-1
83-2
83-3
83-4
- Chronic Toxicity -
2 species:
Rodent TGAI A,B,C,G Yes
Non- rodent TGAI A,B,C,G Yes
Dog (1 yr. ) TGAI A,B,C,G Yes
- Oncogenicity Study -
2 species:
Rat (2 yr.) TGAI A,B,C,G Yes
Mouse (2 yr.) TGAI A,B,C,G Yes
- Teratogenicity -
2 species
Rat TAIG A,B,C,G Yes
Rat TAIG A,B,C,G Yes
Rabbit TAIG A,B,C,G Yes
- Reproduction, TGAI A,B,C,G Yes
2-generation
Rat
t S
00030512, 00030513
00030516
GS0101203*
GS0101203*
00030516*
00030512,* 00030513*
00058609*
00058610*
00076762*
00030514*
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
*Data submitted by FMC Corporation. These data maybe compensable.
76
No
No
No
No
No
No
No
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CARBOFURAN
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)?
Bibliographic
Citation
§158.135 Toxicology
(continued)
MUTAGENICITY TESTING;
84-2 - Gene Mutation TGAI
-Point mutation in
S. typhimurium (Ames
Test)
84-2 - Chromosomal Aberration TGAI
-Induction of
Mitotic Recombination
84-2 - Other Mechanisms of
Mutagenicity
-DMA Repair TGAI
-Unscheduled DNA TGAI
Synthesis
SPECIAL TESTING;
85-1 - General Metabolism TGAI
A,B,C,G
A,B,C,G
A,B,C,G
A,B,C,G
A,B,C,G
Yes
Yes
Yes
Yes
Yes
00059749*
00059749*
00059749*
00059749*
05008717
Must Additional
Data Re Submitted
Under FIFRA Section
3(c)(2)(B)?3/
No
No
No
No
No
*Data submitted by FMC Corporation. These data maybe compensable.
77
-------
TABLE
GENERIC DATA REQUIREMENTS FDR CARPOFURAN
§158.135 Toxicology
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop:
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor;
I=Indoor.
3/ Data must be submitted no later than December 31, 1984 .
4/ A Primary Eye Irritation Study on the technical does not need to be done since the acute dermal toxicity of
carbofuran technical is Category I toxicity. This is because levels to asses's irritation could not be reached
because death would occur before eye irritation could be achieved. The data requirement is waived.
5/ Primary Dermal Irritation is not a data gap since carbofuran acute toxicity is Category I. Levels high enough
to cause dermal irritation would cause death. The data requirement is waived.
6/ A dermal sensitization study is required if repeated contact with human skin is expected to occur. However,
it is believed that cholinergic poisoning signs pre-empt observation of skin sensitization by technical
carbofuran. This test is waived.
7/ Only organophosphorous pesticides are required for delayed neurotoxicity ( acute or 90-day) in accordance with
§158.135.
8/ Prolonged or purposeful exposure to the skin is not expected. It is expected that a 21-day dermal study will
be adequate to assess repeated dermal exposure expected for worker exposure.
9/ Certain use patterns of carbofuran can result in multiple applications per season and certain types of field
work, such as, handpicked crops and operations like detassling corn for hybrid seed production can lead to
significant dermal exposure. Accordingly, repeated dermal exposure (21-dermal) must be tested. This test
will replace a previous dermal test (20 days on the backs of rabbits) done by IBT (IR3891) which was
subsequently invalidated.
10/ Not required if valid chronic studies have been reviewed (see 83-1, 83-2, 83-3, and 83-4).
78
-------
TABLE
GENERIC DATA REQUIREMENTS bUR CARBOFURAN
Use
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
Bibliographic
Must Additional
Data Be Submitted
Under FIFRA Section
Data Requirement Composition1 Pattern^
No or Partially)
Citation 3(c)
(2MB)?
§158.140 Reentry Protection
132-1 -
132-2 -
132-3 -
132-4 -
Foliar Dissipation TEP
Soil Dissipation TEP
Dermal Exposure TEP
Inhalation Exposure TEP
A,B,G
A,B,G
A,B,G
A,B,G
Partially
Partially
Partially
Partially
00092777,*
00092779*
00092777,*
00092779*
00092777,*
00092779*
00092777,*
00092778*
00092778*
00092778*
00092778*
Yes4
Yes
Yes
Yes
00092779*
1. Comosition: TGAI = Technical grade of the active ingredient; PAIA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2. The usepatterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic,Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food-Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3. Data must be submitted no later than June 30, 1986 .
4. Data are required on human exposure expected from dislodgeable residues shown at different time intervals.
Decline in micrograms/an2 leaf surface is insufficient.
*Data submitted by FMC Corporation. These data maybe compensable.
79
-------
TABLE
GENERIC DATA REQUIREM
|R CARBOFURAN
Use
Data Requirement
Does EPA Have Data
To Satisfy This
Requ i rement? (Yes,
Composition! Pattern^ No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LI>50
71-2 - Avian Dietary LC5Q
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish 1X50
TGAI
TGAI
TGAI
TEP
A,B,C,G
A,B,C,G
A,B,C,G
A,B,C,G
Yes
Yes
Yes
Partial
72-2 - Acute LCso Freshwater
Invertebrates
TGAI
TEP
TGAI
AfB,C,G
A,C,G
A,B,C,G
Yes
Partial
Partial
05003462,* GS0101301
GS0101302, 05003191
00025997,**00025998**
00088881, 00092739*
00129509***00129501*
00038261,* 00057295
00096742,**00130418*
00130419,* GS0101307
GS0101308, GS0101309
00025999,**GS0101306
00092703, 00092704
00092705, 00092706
00092707, GS0101306
00025999,**00092708
*Data submitted by FMC Corporation. These data maybe compensable.
**Data submitted by Chevron Chemical Company. These data maybe compensable.
***Data submitted by S.C. Johnson and Sons. These data maybe compensable.
80
No
No
No
Yes3'4
No
72-3 - Acute LCcg Estuarine
and Marine Organisms
72-4 - Fish Early Life
Stage and Aquatic
Invertebrate Life-Cycle
TGAI
TEP
TGAI
A,B,C
A,C
A,B,C,G
No
No
Yes
GS0101303, GS0101304
GS0101305
Yes
Yes6
Reserved^
No
-------
TABLE
GENERIC DATA REQUIREMENTS~FOR CARBOFURAN
Data Requirement
Use
Composition1 Pattern*
Does EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2
§158.145 Wildlife and
Aquatic Organisms (cont.)
72-5 Fish life cycle -
estuarine
72-7 Simulated or Actual
Field Testing-
Aquatic Organisms
TGAI
TEP
A,B,C,G
A,B,C,G
No
No
Reserved^
Reserved^
81
-------
TABLE
GENERIC DATA REQUIREMENTS FDR CARBOFURAN
§158.145 Wildlife and Aquatic Organisms (cont.)
1 Composition of the material to be tested is technical grade unless otherwise specified. The compositions and use
patterns are coded as follows: TGAI=Technical Grade Active Ingredient; TEP=Typical End use Products; A=Terrestrial,
Food Crop; B=Terrestrial, Non-Food; OAquatic; G=Forestry; H=Domestic Outdoor; I=Indoor.
2 Data must be submitted no later than December 31, 1985.
3 Available data indicate that granular formulations will result in primary and secondary poisoning of avian
species. Extensive multi-year monitoring of avian populations,with special emphasis on raptorial birds,is
required in areas of heavy use (i. e. corn belt) and in areas of early planting where high densities of winter-
ing birds utilize treated fields.
4 The methodology employed in the field study with 4F on alfalfa is inadequatly described. Before a final decision
is made on the study certain questions must be answered.
5 Acute toxicity testing on representative end use products is required for sugarcane, rice, and forest uses.
6 Required to support such uses as sugarcane and rice.
7 Sheepshead minnow early life-stage, mysid shrimp life-cycle and formulated product test requirements are reserved
pending receipt of estuarine acute toxicity data and environmental fate data.
8 The requirement for simulated or actual field testing for aquatic organisms is reserved pending review of the
environmental fate data for carbofuran.
82
-------
TABLE
GENERIC DATA REQUIREM
>R CARBOFURAN
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Composition Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Re Submitted
Under FIFRA Section
3(c)(2)(B)
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact
141-2 - Honey bee - toxicity
of residues on
foliage
141-3 - Wild bees important in
alfalfa pollination -
toxicity of residues
on foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
NONTARGET INSECT TESTING-
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects
142-2 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
TGAI
TEP
TEP
(Reserved)4
TEP
A,B,C,G
A,B,C,G
A,B,C,G
Yes
Yes
Yes
A,B,C,G
No
(Reserved)5
(Reserved)5
(Reserved)5
00036935*
00001361, 00060628
00077415
00045046**
No
No
No
No3
*Data submitted by FMC Corporation. These data maybe compensable.
**Data submitted by Ciba-Geigy Corporation. These data maybe compensable.
83
-------
TABLE
GENERIC DATA REQUIREMENTS FOR CARBOFURAN
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirment Composition! Pattern2 No or Partially) Citation 3(c)(2)(B)?3
143-1 - MONTARGET INSECT TESTING-
thru PREDATORS AND PARASITES
143-3 (Reserved)5
t \
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=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food, G=Forestry; H=Donestic Outdoor; I=Indoor.
3/ Data required only if product is intended for foliar application to alfalfa grown for seed.
4/ Reserved pending development of test method; when established, this requirement will be
imposed on a case-by-case basis.
5/ Reserved pending decision as to whether data requirement should be established.
84
-------
TABLE ^^^
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFAClMl.NG-USE PRODUCTS CONTAINING CARJROFURAN1
K^TONt
Guideline Citation and
Name of Test
§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
Character is t ics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, bulk density, or
Test2
Substance
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Guidline
Status
R
R
R
R
R
R
R
R
R
R
Are Data3 Footnote
Required Number
Yes No
[x]
[x]
[x]
[x]
[x]
[x]
[x]
[x]
[x]
[x]
t 1
n
n
n
n
n
n
n
n
specific gravity
85
-------
TABLE
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CARBOFURAN1
Guideline Citation and Test2
Name of Test Substance
o
Guidlines Are Data Footnote
Status Required Number
Yes No
§158.120 Product Chemistry
(continued)
63-12 - pH
63-14 - Oxidizing or reducing
action
63-15 - Flammability
63-16 - Explodability (Combustible
Liquids Only)
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
Other Requirements
64- 1
- Submittal of Samples
MP
MP
MP
MP
MP
MP
MP
MP
PAI
R [x] [ ]
CR [x] M
CR [x] [~]
R [xl t~l
R [xi n
CR [x] n
CR [xi n
R [xi n
CR M [x]
1 - If current information has been submitted to the Agency/ the applicant should refer to it or resubmit the data.
2 - Composition: MP= Manufacturing-Use Product; PAI= Pure Active Ingredient.
3 - Data must be submitted no later than November, 1984 .
86
-------
TABLE
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CARBOFURAN
Data Requirement
Composition
I/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Re Submitted
Under FIFRA Section
3(c)(2)(B)?
§158.135 Toxicology
ACUTE TESTING
81-1 - Oral LD50 -Rat
81-2 - Dermal LD5Q
MP
MP
Yes
Yes
00063255, 00045107
000N63254, 00077329
00063258, 00063256
00077330, GS0101201
GS0101202
00063259, 00063260
00092562, 00092611
00092612, 00092613
No
No
81-3 - Acute Inhalation Toxicity- MP
Rat
81-4 - Primary Eye Irritation- MP
Rabbit
Yes
No
00063250, 00063258
00083097, 00092614
00092616
No
No2
81-5 - Primary Dermal
Irritation
MP
No
No3
81-6 - Dermal Sensitization
MP
No
No4
87
-------
TABLE _
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CARPOFURAN
§158.135 Toxicology
(continued)
I/ Composition: MP = Manufacturing-use product.
2/ A Primary Eye Irritation Study on the technical does not need to be done since the acute dermal toxicity of
carbofuran technical is Category I toxicity. This is because levels to assess irritation could not he reached
because death would occur before eye irritation could be achieved.
3/ Primary Dermal Irritation is not a data gap since carbofuran acute toxicity is Category I. Levels high enough
to cause dermal irritation would cause death.
4/ A Dermal Sensitization Study is required if repeated contact with human skin is expected to occur. It is believed
that a dermal sensitization test would be difficult to achieve in the laboratory and that cholinergic poisoning
signs pre-empt observation of skin sensitization by technical carbofuran. This test is waived.
B8
-------
TABLE
PRODUCT SPECIFIC DATA REQUIREMENTS FDR END-USE PRODUCTS CONTAINING CARROFURAN
Data Requirement
Composition!
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity-
Rat
EP
No
Bibliographic
Citation
Must Additional
Data Re Submitted
Under FIFRA Section
3(c)(2)(B)?2
Yes
81-2 - Acute Dermal Toxicity- EP
Rabbit
No
Yes
81-3 - Acute Inhalation EP
Toxicity
81-4 - Primary Eye Irritation EP
No
No
Yes
Yes
81-5 - Primary Dermal
Irritation
81-6 - Dermal Sensitization
EP
EP
No
No
Yes
Yes
I/ Composition: EP = End-Use Product
2/ Data must be submitted no later than December 1984.
89
-------
TABLE
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-1
^^3
PRODUCTS CONTAINING CARBOFURAN
Data Requirement
Composition!
Does EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Re Submitted
Under FIFRA Section
3(c)(2)(B)?2
§158.120 Product Chetnistry
Other Requirements;
Particle assessment
EP
No
Yes3
I/ Composition: EP = End-Use Product
2/ Data must be submitted no later than December 1984.
_3/ Data are needed on a quantative assessment of the "fines" particles that could be respirable to
mixer/loader applicators. These data will aid the Agency in determining inhalation exposure
and the need for inhalation toxicity data.
90
-------
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 re-
registration 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 sufficiently
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 class-
ification [40 CFR §162.ll(c)], packaging [40 CFR 15162.16],
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
specific 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).
I tern 1. PRODUCT NAME - The name, brand, or trademark
is required to be located on the front panel, pre-
ferably 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 §162.10(b)]
Item 2. COMPANY NAME AND ADDRESS - The name and
address of the registrant or distributor is required
on the label. The name and address should preferably
be located at the bottom of the front panel or at
the end of the label text. See Appendix IV-1. [40
CFR 5162.10(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
91
-------
company name and address, or at the end of the label
text. The net contents must be stated in terms of
weight, expressed as avoirdupois pounds and ounces,
and stated in terms of the largest suitable unit,
i.e., "1 pound 10 ounces"- rather than "26 ounces."
In addition to the required units specified, net
contents may be expressed in metric units. See
Appendix 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 re-
commendation or endorsement of the product by the
Agency. See Appendix IV-1. [40 CFR §162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA estab-
lishment number, preceded by the phrase "EPA Est."
is the final establishment 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.
[40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient state-
ment 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
92
-------
minimum type size requirements on various size labels,
as set forth in the Regulations.
Size of Label
on Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word as Re-
quired Minimum Type
Size All Capitals
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
as Required
6 point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - All labels
are required to have the statement "Keep Out of
Reach of Children" located on the front panel above
the signal word except where contact with children
during distribution or use is unlikely. See Appendix
IV-1. [40 CFR S162.10(h)(l)(ii)]
Item 7B.
Warning,
immediately below the child
See Appendix IV-1. [40 CFR
SIGNAL WORD - The signal word (Caution,
or Danger) is required on the front panel
hazard warning statement
§162.10 (h)(l)(i)]
- On
Item 7C. SKULL & CROSSBONES AND WORD "POISON"
products assigned a toxicity Category I on the
basis of oral, inhalation, 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 S162.10(h)(l)(i)J
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A state-
ment 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 5l62.10(h)(l)(iii)J
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)(l)(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
93
-------
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 (h)(2)J
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 (h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists
to non-target organisms excluding humans and domestic
animals, precautionary statements are required
stating, the nature of the hazard and the appropriate
precautions to avoid potential accident, injury, or
damage. See Appendix IV-1. [40 CFR §162.10{h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements
relating to flammability of a product are required
to appear on the label if it meets the criteria in
Appendix IV-3. The requirement is based on the re-
sults of the flashpoint determinations and
flame extension tests required to be submitted
for all products. These statements are to be
located in the side/back panel precautionary
statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no
signal word is used in conjunction with the flam-
mability statements.
2. Criteria for declaration of non-flammability.
The following criteria will be used to determine
if a product is non-flammable:
a. A "non-flammable gas" is a gas (or mixture
of gases) that will not ignite when a lighted
match is placed against the open cylinder
valve.
b. A "non-flammable liquid" is one having a
flashpoint 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);
94
-------
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C),
determined by the method specified in 40 CFR
§163.61-8(c)(13)(i).
3. Declaration of non-flammability. Products which
meet the criteria for non-flammability specified
above may bear the notation "non-flammable" or
"nonflammable (gas, liquid, etc.)" on the label.
It may appear as a substatement to the ingredients
statement, or on a back or side panel, but shall
not be highlighted or emphasized (as with an
inordinately large type size) in any way that
may"detract from precaution.
4. Other physical/chemical hazard statements. When
chemistry data submitted in accordance with 40 CFR
§163.61-10(c) demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such
statements may address hazards of explosivity,
oxidizing or reducing capability, or mixing with
other substances to produce toxic fumes.
Item 9. PRODUCT CLASSIFICATION: CLASSIFICATION
LABELING REQUIREMENTS AND COMPLIANCE SCHEDULE -
Section 3(d) of FIFRA requires that all pesticide
formulations/uses be classified for either general
or restricted use, and that those uses classified
as restricted be limited to use by certified appli-
cators or persons under their direct supervision
(or subject to such other restrictions as may be
imposed by regulation).
In the Registration Standard, the Agency has: (1)
indicated certain formulations/uses to be restricted,
based either on a previous classification determination
made through the optional procedures of 40 CFR
§162.30 or based on data already available to the
Agency, or (2) indicated certain formulations/
uses to be unrestricted, based on data already
available to the Agency, or (3) reserved any classi-
fication decision until appropriate short-term data
are submitted. Uses have not been classified for
general use at this time because such a decision
requires an evaluation of chronic data, most of which
has yet to be generated.
95
-------
The product-specific data required by the Standard
should be used by each registrant to make a classi-
fication determination following the criteria of
40 CFR §162.11(c) (Appendix V-4). The draft label(s)
submitted to the Agency as part of your application
should reflect this determination, and must be
consistent with the terms of 40 CFR §162.10 and
this guidance package with respect to label language
and format for restricted use products. (No label
changes with respect to classification are required
for products with unrestricted uses.) The rationale
supporting a classification proposal by the registrant
that differs from a classification determination
found in the Standard should be submitted with your
application.
• /•
During the Agency's review of your application, your
proposed classification determination will be evaluated
in accordance with the provisions of 162.11(c). You
will be notified of the Agency's classification
evaluation.
A. Classification Labeling Requirements
1. Unrestricted Uses - No label changes with
respect to a classification statement are
necessary for those formulations/uses that
are unrestricted.
2. Restricted Uses - Pesticide products bearing
directions for use for formulations/uses
classified restricted shall bear statements
of restricted use classification on the
front panel as described below:
a. Front panel statement of restricted use
classification.
i. 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
40 CFR S162.10(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 conditions of purchase and
use, the statement "Restricted Use
Pesticide" shall appear.
96
-------
ii. Directly below this statement on the
front panel, a summary statement of
the terms of restriction shall
appear. If use is restricted to
certified applicators, the following
statement is required: "For retail
sale to and use only by Certified
Applicators or persons under their
direct supervision and only for those
uses covered by the Certified
Applicator's certification." If,
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
3. Some But Not All Uses Restricted - If you determine
that some uses should be classified RESTRICTED
and some uses should be unrestricted, several
courses of action detailed below are available:
i. You may delete all RESTRICTED uses and submit
a draft label of the registration of your
product to reflect only those uses that are
unrestricted.
ii. Unrestricted uses may appear on a RESTRICTED
label, but not vice versa. Therefore you
have the option of using a RESTRICTED USE
label bearing all of your directions for use.
If you choose this option, you may not
distinguish those uses that are not unrestricted
from those that are RESTRICTED.
iii. You may register two separate products with
identical formulations, one containing only
unrestricted uses and the other RESTRICTED
uses. To do so, submit two applications for
reregistration, each containing all forms
and necessary labels. Both applications
should be submitted simultaneously. Note
that the product names will be assigned
separate registration numbers.
B. Compliance Schedules
1. Unclassified uses - None.
2. Restricted uses - The compliance schedule for
restricted use products is as follows:
97
-------
No product with a use classified for restricted use
under this standard may be released for shipment by
the registrant or producer after September 1, 1985,
unless such product bears the restricted-use classi
fication. All products still in channels of trade
after September 1, 1986, must be labeled for
restricted-use.
Item 10. MISUSE STATEMENT - The following statement
is required on your label: "It is a violation of
Federal law to use this product in a manner
inconsistent with it's labeling." See Appendix IV-1.
[40 CFR §162.10 (l)(2)(ii)]
Item 11A. 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 11B. 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.
98
-------
V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Jay Ellenberger
Product Manager 12
Phone No. (703) 557-2386
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D. C. 20460
For each product for which continued registration is desired:
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA
Form 8580-1. 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.
99
-------
Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0101001 Ashworth, R.J., T.J. Sheets. 1970. Uptake and translocation
of carbofuran in tobacco plants. Econ. Entonol. 63:1301-
1304. Submitted by FMC Corp. under 1F1150 (117332).
GS0101002 Dorough, H.W. 1968. Fate of Furadan (NIA-10242) in bean
plants. Bull. Environ. Contam. Tox. 3(3):164-173.
Submitted by FMC Corp. under 1F1150.
GS0101003 FMC Corp. 1968. Metabolism of Furadan insecticide in corn
plants. III. Fractionation and quantitative determination
of radioactive residues. Report M-2212. Submitted by FMC
Corp. under 8F0711 (115563).
GS0101004 FMC Corp. 1968. Metabolism of Furadan in com plants. IV.
Identification of radioactive metabolites. Report M-2246.
Submitted by FMC Corp. under 8F0711 (115563).
GS0101005 FMC Corp. 1968. Metabolism of Furadan in corn plants. V.
Fractionation, quantitative determination and identification
of radioactive Furadan and its metabolites in corn plants
(addendum to Report M-2246). Report M-2267. Submitted by
FMC Corp. under 8F0711 (11563).
GS0101006 FMC Corp. 1969. Metabolism of Furadan in alfalfa. I.
Fractionation and quantitative determination of radioactive
residues. Report M-2272. Submitted by FMC Corp. under
9G0738 (115683).
GS0101007 FMC Corp. 1969. Metabolism of Furadan in alfalfa. II.
Identification of radioactive metabolite. Report M-2292.
Submitted by FMC Corp. under 9G0738 (115683).
GS0101008 FMC Corp. 1969. Metabolism of carbofuran in alfalfa. III.
Report M-2332. Submitted by FMC Corp. under 9G0738
(115683).
GS0101009 FMC Corp. 1971. Carbofuran metabolism in sugar beet. I.
Reporet M-3114. Submitted by FMC Corp. under 1F1163
(117373).
100
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0101010 FMC Corp. 1971. Carbofuran metabolism in sugar beet. II.
Extraction of residues and metabolite identification in
sugar beet root. Report M-3199. Submitted by FMC Corp.
under 1F1163 (117373).
GS0101011 FMC Corp. 1971. Metabolism of carbofuran in the potato.
Report M-2764. Submitted by FMC Corp. under 1F1150 (117332)
GS0101012 FMC Corp. 1972. Carbofuran metabolism in tomato. I. Report
M-3161. Submitted by FMC Corp. under 2F1283.
GS0101013 Dorough, H.W. 1968. Metabolism of Furadan in rats and
houseflies. J. Agric. Food Chem. 16(2):319-325. Submitted
by FMC Corp. under 9F0822 (116040).
GS0101014 Knaak, J.B., D.M. Munger, and J.F. McCarthy. 1969. The
metabolism of carbofuran alfalfa residues in the rat.
Paper presented at the 158th meeting of the American
Chemical Society, New York, 1969. Submitted by FMC Corp.
under OF0898 (116345).
GS0101015 Knaak, J.B., D.M. Munger and J.F. McCarthy. 1970. Metabolism
of carbofuran alfalfa residues in the dairy cow. Submitted
by FMC Corp. under OF0898 (116347).
GS0101016 Ivie, G.W., and H.W. Dorough. Furadan-l4C metabolism in a
lactating cow. J. Agric. Food Chem. 16(5):849-855.
Submitted by FMC Corp. under 9F0822 (116038).
GS0101017 FMC Corp. 1969. Carbofuran poultry-egg residue study.
Submitted by FMC Corp. under 9F0738 (115683).
GS0101018 FMC Corp. 1973. Chicken feeding study. Three phenolic
metabolites of carbofuran. Submitted by FMC Corp. under
2F1283.
GS0101019 FMC Corp. 1973. Determination of the phenolic metabolites
of carbofuran in eggs and poultry tissues. Analytical
Report M-3387 submitted by FMC Corp. under 2F1283.
101
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0101020 Bowman, M.C., M. Beroza. 1967. Determination of Niagara NIA-
10242 and its phenol degradation product in corn silage
and milk and the determination of other carbamates by GLC
of their thiophosphoryl derivatives. Journal of the
A.O.A.C. 50(4):926-933. Submitted by FMC Corp. under
8F0711 (115563).
GS0101022 FMC Corp. 1968. Method M-2292: Identification of carbofuran
and 3-hydroxy carbofuran by thin layer chrcmatography.
Submitted by FMC Corp. under 8F0711.
GS0101023 FMC Corp. 1968. Method M-2328: Determination of carbofuran
and 3-hydroxy carbofuran residues in milk and cow tissue.
Submitted by FMC Corp. under 8F0711 (115562).
GS0101024 EPA. 1971. Method tryouts for carbofuran and its 3-hydroxy
metabolite in corn grain, and alfalfa hay and for the 3-
hydroxy metabolite in milk. Dated November 23, 1971.
Filed under 8F0711 (115561).
GS0101025 FMC Corp. 1968. Analytical report R-1096: Furadan residue
time studies on alfalfa. Analytical Method pp. 3-8.
Submitted by FMC Corp. under 9G0738 (115683).
GS0101026 FMC Corp. 1969. Analytical method: carbofuran and 3-hydroxy
carbofuran—potatoes and sugarcane. Submitted by FMC Corp.
under 9F0829 (116060).
GS0101027 Cook, R.F., R.P. Stanovick, and C.C. Cassil. 1969.
Determination of carbofuran and its carbamate metabolite
residues in corn using a nitrogen-specific gas chronatographic
detector. Submitted by FMC Corp. under OF0870.
GS0101028 FMC Corp. 1973. Method M-3350: Determination of the phenolic
metabolites of carbofuran in or on potato tubers. Submitted
by FMC Corp. under 1F1150 (117332).
GS0101029 FMC Corp. 1971. Analytical method. (Carbofuran and 3-
hydroxy carbofuran in sugar beets and sugar beet tops.)
Submitted by FMC Corp. under 1F1163 (117371).
102
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0101030 FMC Corp. 1973. Method R-1230: Determination of the phenolic
metabolites of carbofuran in or on sugar beet foliage.
Submitted by FMC Corp. under 1F1163.
GS0101031 PAM Volume II. Pesticide Reg. Sec. 180.254. Transmittal No.
78-3 (7/78). p. 3. (Garments on EPA method trials for
methods IV, V, and VI.)
GS0101032 FMC Corp. 1972. Analytical method. (Carbofuran and 3-
hydroxy carbofuran in sorghum silage, stalks, and grain.)
Submitted by FMC Corp. under 2F1283 (117873).
GS0101033 FMC Corp. 1973. Analytical report M-3386; Determination of
phenolic metabolites of carbofuran in milk and cow tissue.
Submitted by FMC Corp. under 2F1283 (117873).
GS0101034 FMC Corp. 1973. Analytical Report R-1231: Analytical
procedure for phenolic carbofuran residues in/or green and
dry alfalfa. Submitted by FMC Corp. under 2F1283.
GS0101035 FMC Corp. 1974. Analytical Report W-0001. Determination of
the phenolic metabolites of carbofuran in or on grapes.
Submitted by FMC Corp. under 4G1484 (118803).
GS0101036 Hazleton Laboratories. 1974. Determination of carbofuran
and 3-hydroxy carbofuran residues in grapes, wine, lees,
and pomace - final report. Submitted by FMC Corp. under
4G1484 (118803).
GS0101037 FMC Corp. 1973. Analytical Report M-3334. Determination
of carbofuran and 3-hydroxy carbofuran residues in
cottonseeds, meats, hulls, and cotton plants. Submitted
by FMC Corp. under 5F1530 (118935).
GS0101038 FMC Corp. 1974. Analytical Report M-3502: Determination of
the phenolic metabolites of carbofuran in cottonseeds.
Submitted by FMC Corp. under 5F1530.
103
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0101039 Hazleton Laboratories. 1973. Determination of phenolic
carbofuran residues in soybeans - final report. Submitted
by FMC Corp. under 5F1557 (119022).
GS0101040 FMC Corp. 1974. Analytical Report W-0012: Determination of
phenolic carbofuran residues in soybeans. Submitted by
FMC Corp. under 5F1557 (119022).
GS0101041 FMC Corp^. 1974. Analytical Report W-0013: Determination of
carbamate and phenolic carbofuran residues in soybeans,
soybean meal, soapstock, and soybean oil from a soybean
processing study. Submitted by FMC Corp. under 5F1557
(119022).
GS0101042 FMC Corp. 1975. Analytical Report W-0044: Determination of
carbofuran and its metabolites in/on cucurbits. Submitted
by FMC Corp. under 6F1789.
GS0101043 FMC Corp. 1976. Analytical Report M-3840: Determination of
carbofuran and its carbamate residues in small grains.
Submitted by FMC Corp. under 6F1803.
I
GS0101044 FMC Corp. 1977. Analytical Report M-4045: Determination of
carbofuran phenolic metabolite residues in winter wheat.
Submitted by FMC Corp. under 6F1803 (096078).
GS0101045 FMC Corp. 1977. Analytical Report M-4047: Determination of
phenolic metabolites of carbofuran in winter wheat straw.
Submitted by FMC Corp. under 6F1803 (096078).
GS0101046 FMC Corp. 1975. Analytical Report W-0029: Determination of
carbofuran and its metabolites in raisins and raisin waste.
Submitted by FMC Corp. under 6G1668.
GS0101047 IR-4 Project No. 19. 1981. Section D of 1E2526 (070114).
GS0101048 FMC Corp. 1969. Report M-2427. Submitted by FMC Corp.
under 5F1610.
GS0101049 FMC Corp. 1969. Report M-2437. Submitted by FMC Corp.
under 9F0829 (116062).
GS0101050 FMC Corp. 1973. Report M-3350. Submitted by FMC Corp.
under 1F1150 (117332).
104
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0101051 FMC Corp. 1974. Report M-3477. Submitted by FMC Corp.
under 6F1875 (098049).
GS0101052 FMC Corp. 1975. Report M-3634. Submitted by FMC Corp.
under 5F1610.
GS0101053 State of New York-Department of Agriculture and Markets.
1975. Series of memorandums (5) from Dr. E. George, Jr.
to Deputy Commissioner Bernard Potter, dated January 9,
10, 13, 15 and 31. Submitted by FMC Corp. under 5F1610.
GS0101054 FMC Corp. 1975. Interoffice memo from J.M. Shuttleworth to
J.F. McCarthy, dated January 22. Submitted by FMC Corp.
under 6F1875 (098049).
GS0101055 FMC Corp. 1978. Report M-4229. Submitted by FMC Corp.
under 6F1875 (098049).
GS0101056 FMC Corp. 1971. Report M-2857, R-1164, and M-3199 of 1F1163
(117371).
GS0101057 FMC Corp. 1974. Section D and Reports W-0012 and W-0013 of
5F1557 (119022).
GS0101058 FMC Corp. 1972. Reports MC-702, Tl, T2, T4, T5, T7, and T8;
and MC-691, Tl. Submitted by FMC Corp. under 2F1219
(117660).
GS0101059 FMC Corp. 1976. Report W-0044 in Section D of 6F1789.
GS0101060 FMC Corp. 1976. Report W-0044 in Section D of 6F1789.
GS0101061 IR-4 Project No. 19. 1981. Section D of 1E2526 (070114).
GS0101062 Hazleton Laboratories. 1974. Cooperator report EC-0101.
Submitted by FMC Corp. under 4G1484 (118803).
GS0101063 FMC Corp. 1974. Analytical Report W-0001. Submitted by FMC
Corp. under 4G1484 (118803).
GS0101064 Hazleton Laboratories. 1974. Cooperator report EC-0102.
Submitted by FMC Corp. under 6F1787.
105
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0101065 FMC Corp. 1974. Analytical Report W-0009. Submitted by FMC
Corp. under 6F1787.
GS0101066 FMC Corp. 1975. Analytical Report W-0028. Submitted by FMC
Corp. under 6F1787.
GS0101067 FMC Corp. 1974. Analytical Report W-0004. Submitted by FMC
Corp. under 6G1668.
GS0101068 FMC Corp. 1975. Analytical Report W-0024, W-0029, and W-0031.
Submitted by FMC Corp. under 6G1668.
GS0101069 Kiigemagi U., E.J. Cooley and L.C. Terriere. 1973. Cooperator
Report EC-0109. Submitted by FMC Corp. under 4F1482
(118798).
GS0101070 Kiigemagi U., L.C. Terriere. 1973. Cooperator Report EC-
0109. Submitted by FMC Corp. under 4F1482 (118798).
GS0101071 FMC Corp. 1971. Report M-2658. Submitted by FMC Corp.
under 1F1146.
GS0101072 FMC Corp. 1976. Report Nos. MC-1264 and M-3591. Submitted by
FMC Corp. under 6F1672.
GS0101073 FMC Corp. 1976. Analytical Report M-3840. Submitted by FMC
Corp. under 6F1803.
GS0101074 FMC Corp. 1969. Report R-1114 in Section D of 9F0822
(116037).
GS0101075 FMC Corp. 1972. Section D of 2F1283 (117873).
GS0101076 FMC Corp. 1973. Report R-1229 submitted under 2F1283
(Amendment).
GS0101077 FMC Corp. 1977. Analytical Report M-4045. Submitted by FMC
Corp. under 6F1803 (096078).
GS0101078 FMC Corp. 1968. Sample Nos. 495, 520, 580, 583, 599, 600,
601, 46, and 672. Submitted by FMC Corp. under PP#8F0711
(115564).
106
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0101079 FMC Corp. 1971. Report No. M-2658. Submitted FMC Corp.
under 1F1146.
GS0101080 FMC Corp. 1976. Report Nos. MC-1264 and M-3591. Submitted
by FMC Corp. under 6F1672.
GS0101081 FMC Corp. 1968. Report Nos. M-2246 and M-2267. Submitted
by FMC Corp. under 8F0711 (115563).
• /•
GS0101082 FMC Corp. 1969. Report No. R-1114 in Section D of 9F0822
(116037).
GS0101083 FMC Corp. 1972. Section D of 2F1283 (117873).
GS0101084 FMC Corp. 1973. Report R-1229. Submitted by FMC Corp.
under 2F1283 (Amendment).
GS0101085 FMC Corp. 1977. Analytical Report M-4047. Submitted by FMC
Corp. under 6F1803 (096078).
GS0101086 FMC Corp. 1969. Residue time studies on alfalfa. Report R-
1096. Submitted by FMC Corp. under 9F0738 (115683).
GS0101087 FMC Corp. 1971. Section D of 2E1205 (117612).
GS0101088 FMC Corp. 1974. Report R-1204 and R-1233 in Section D of
4E1483 (118801).
GS0101089 FMC Corp. 1974. Reports M-3334 and M-35022 on Section D of
5F1530 (118935).
GS0101090 FMC Corp. 1969. Section D of OF0870.
GS0101091 FMC Corp. 1975. Reports M-2482, M-2621, M-2798, M-3536, and
W-0045 in Section D of 6F1701.
GS0101092 FMC Corp. 1969. Report M-2444 in Section D of 9F0829 (116062),
GS0101093 FMC Corp.. 1970. Tables 1 through 21 in summary of residue
data. Unpublished study received 6/29/70 under 279-2712;
CDL:002476-F (MRID 00035201).
107
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0101094 FMC Corp. 1968. Carbofuran meat milk residue study.
Submitted by FMC Corp. under 8F0711 (115562).
GS0101095 FMC Corp. 1973. Determination of the phenolic metabolites
of carbofuran in milk and cow tissues. Analytical Report
No. M-3386 submitted by FMC Corp. under 2F1283.
GS0101096 Hazelton Laboratories, Inc. 1973. Project No. 104-182. Cow
feeding study. Three phenolic residues of carbofuran.
Final Report. Submitted by FMC Corp. under 2F1283 (Protocol
only for the above-cited 1973 FMC study).
GS0101097 FMC Corp. 1968. Carbofuran meat-milk residue study.
Submitted by FMC Corp. under 8F0711 (115562).
GS0101098 Leuck, D.B., M.C. Bowman, J.C. Johnson Jr., E.W. Beck, and
R.S. Lowery. 1968. Niagara NIA-10242 residues: their
persistence and effect on lactating cows. (Draft of paper
submitted to J. Econ. Entomol.) Submitted by FMC Corp.
under 8F0711 (115564).
GS0101099 FMC Corp. 1973. Determination of the phenolic metabolites
of carbofuran in milk and cow tissue. Analytical report M-
3386 submitted by FMC Corp. under 2F1283.
GS0101100 Hazleton Laboratories, Inc. 1973. Cow feeding study. Three
phenolic residues of carbofuran. Submitted by FMC Corp.
under 2F1283 (contains description of the protocol used to
conduct the 1973 FMC Corp. study cited above).
GS0101101 FMC Corp. 1969. Carbofuran poultry-egg residue study.
Submitted by FMC Corp. under 9F0738 (115683).
GS0101102 FMC Corp. 1973. Determination of the phenolic metabolites
of carbofuran in eggs and poultry tissues. Anaytical
report M-3387. Submitted by FMC Corp. under 2F1283.
GS0101103 Hazleton Laboratories, Inc. 1973. Chicken feeding study.
Three phenolic metabolites of carbofuran. Submitted by
FMC Corp. under 2F1283 (provides only the protocol for the
1973 FMC Corp. study listed above).
108
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0101104
GS0101105
GS0101201
EPA. 1977. Carbofuran EPA-1, In Manual of Chemical Methods
for Pesticides and Devices. EPA, OTS.
GS0101202
GS0101203
GS0101301
GS0101302
GS0101303
GS0101304
GS0101305
Sittig, Marshall.
p. 86-88.
1977. Pesticides Process Encyclopedia.
Gronning, P. and Kimnerle, G. Toxicity Tests with Carbofuran.
Unpublished Reports from Institute for Toxicology. Submit-
ted to the World Health Organization by Farbenfabriken
Bayer, A. G.
Kimmerle, G. Toxikologische Untersuchungen met dem Wirkstoff
Bayer 70143. Unpublished Report from Institute for
Toxicology. Submitted by Farbenfabriken Bayer, A. G.
Toxigenics, Inc., 1983. One-year feeding study in beagle dogs.
Submitted by FMC Corp. (250740-250744).
Schafer, E.W., Jr. and R.B. Brunten, 1979. Indicator bird
species for toxicity determinations: Is the technique
usable in test method development? Pages 157-168 _in J.R.
Beck ed. Vert. Pest. Control and Manage., Am. Sec. Test
and materials, ASTM STP 680, Philadelphia, PA. GEOCAR03.
Tucker, R.K. and G.D. Crabtree 1970. Handbook of toxicity of
pesticides to wildlife, U.S. Department of Interior, Fish
and Wildlife Service, Resource Publ. No. 84, 131 pp.
GEOCAR04.
New York State Department of Environmental Conservation,
1981. Toxic substances in fish and wildlife: 1979 and
1980 annual reports. 4(1). 6/30/81, 139 pp. GEOCAR08.
National Research Council of Canada, 1979. Carbofuran:
criteria for interpreting the effect of its use on
environmental quality. NRCC. 16740. GEOCAR09.
U.S. Environmental Protection Agency 1976. Substitute Chemical
Program: Initial Scientific and Minieconomic Review of
Carbofuran, EPA-540/1-76-009, Washington, DC, July 1976,
187 pp GEOCARIO
109
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
GS0101306 Johnson, W.W. and M.T. Finley, 1980. Handbook of acute
toxicity of chemicals to fish and aquatic invertebrates.
U.S. Department of Interior, Fish and Wildlife Service,
Resource Publication 137. Washington, DC, 98 pp. GS0003503.
GS0101307 Flickinger, E.L., K.A. King, W.F. Stout, and M.M. Mohn. 1980.
Wildlife Hazards from Furadan 3 Applications to Rice in Texas.
J. Wildl. Manage. 44 (1): 190-197.
GS0101308 Balcomb-, R. 1983. Secondary Poisoning of Red-Shouldered Hawks
with Carbofuran. J. Wildl. Manage. 47 (4): 1129-1132.
GS0101309 Balcomb, R., C.A. Bowen II, D. Wright and M. Law. 1984. Effects
on Wildlife of At-planting Corn Applications of Granular
Carbofuran. J. Wildl. Manage. 48: (In Press).
110
-------
Appendix II-1A
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
00001361 Johansen, C., Eves, J. (1965) Bee Poisoning Investigations,
1965. (Unpublished study including table 12, received
Feb 23, 1967 under 7G0566; prepared by Washington State
Univ., submitted by American Cyanainid Co., Princeton,
N.J.; CDL:090712-S.)
00025997 Fink, R. 1976. Final Report: Eight-Day Bietary LCso -
Bobwhite Quail: Project No. 104-119. Unpublished study
including unofficial analytical report received December
13; 1979 under 239-EX-76; prepared by Wildlife Interna-
tional, Ltd., submitted by Chevron Chemical, Richmond
Calif.; CDL:099143-E
00025998 Fink, R. 1976. Final Report: Eight-Day Bietary LCso -
Bobwhite Quail: Project No. 104-120. Unpublished study
including unofficial analytical report received December
13, 1979 under 239-EX-76; prepared by Wildlife Interna-
tional, Ltd., submitted by Chevron Chemical, Richmond
Calif.; CDL:099143-F.
00025999 Union Carbide Corporation, 1976. The acute toxicity of
of carbofuran Technical code 2843 Act 62, 11, 12 to the
water flea (Daphnia magna), bluegill sunfish (Leponis
macrochirus), and rainbow trout (Salmo gairdneri):
Project nos. 7600-500, 7601-500, 7602-500. Unpublished
study received December 13, 1979 under 239-EX-76;
submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:099143-G)
00030512 Arceo, R.J., Marshall, P., Goldenthal, E.I., et al. 1980.
2-Year Dietary Toxicity and carcinogenicity study in
Mice. IRDC No. 167-116. (Unpublished study)
00030513 Research Pathology Services, Incorporated. 1979. 2-Year
Dietary Toxicity and carcinogenicity Study in Mice;
Histopathology. Project No. ACT 150.52. (Appendices
II and III; unpublished study)
00030514 Schwartz, C., Rodwell, D.E., Goldenthal, E.I., et al. 1979.
Three Generation Reproduction Study in Rats. IRDC No.
167-114; Project No. 131.53. (Unpublished study including
submitter summary)
111
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
00030516 Rapp, W.R. 1980. 24-Month Dietary Toxicity/Carcincgenicity
Study of Carbofuran in Rats: Pathology Report (Terminal
Phase). IRDC No. 167-115: Project No. ACT 13.51.
(Unpublished study including submitter summary)
00036935 Atkins, E.L., E.A. Greywood, and R.L. Macdonald. 1975.
Toxicity of pesticides and other agricultural chemicals
to honeybees. Laboratory studies. Univ. of Calif.,
Div. Agric. Sci. Leaflet 2287. 38 pp.
00038261 Harris, J.M., Applewhite, C.D., Caffey, H.R., et al. 1969.
Duck Field Study with Furadan 2 Granular and Furadan 3
Granular insecticide. (Unpublished study)
00045046 Johansen, C.; Mayer, D.; Madson, R.; et al. (1975) Bee Research
Investigations, 1975. (Unpublished study received Dec 20,
1976 under 100-EX-53; prepared by Washington State Univ.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:095990-E)
00045107 Kimmerle, G. 1971. Comparison of the Antidotal Actions of
Tetraethyl Ammonium Chloride and Atropine in Acute Poisoning
of Carbamate Insecticide in Rats. Arch. Toxicol. 27:311-14.
00057295 Shellenberger, T.E. 1971. Letter sent to John F. McCarthy
dated Nov. 29, 1971: A simulated field toxicity evaluation
of Furadan 10G formulation with bobwhite quail. GSRI Project
No. NC-496. (Unpublished study)
00058609 Rodwell, D.E., McMeekin, S.O., Jessup, D.C. 1980. Teratology
Study in the Rat with Carbofuran. IRDC No. 167-155.
(Unpublished study)
00058610 Rodwell, D.E., Bowman, K.J., Thorstenson, J. H., et al. 1980.
Pilot Teratology study in the rat with Carbofuran in the
Diet. IRDC No. 167-153. Includes undated method entitled:
Analytical method for the determination of Carbofuran in
Rats. (Unpublished study)
00059749 FMC Corporation. 1979. In vitro Microbial Mutagenicity and
unscheduled DMA Synthesis Studies: Report No. EPA 600/1-79-041;
Contract No. US EPA 68-01-2458. (Unpublished study)
112
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
00060628 Johansen, C.A.; Eves, J. (1965a) Bee Poisoning Investigations,
1965: Reporty No. G-1705; Report No. 17338. (Unpublished
study, including letter dated Jun 12, 1973 from C.A.
Johansen to A.D. Cochick, received Mar 27, 1974 under
4F1485; prepared by Washington State Univ., Dept. of
Entomology, submitted by Chemagro Corp., Kansas City, Mo.;
CDL:092011-1)
00063250 Hathaway, D., Fancher, O.E. and Calandra, J.C. (1967e) Acute
Dust; Inhalation Toxicity Study on Furadan Insecticide 75
W.P. Unpublished Report from the Industrial Bio-Test
Laboratories, Inc. submitted to the World Health Organization
by the FMC Corporation.
00063254 Kohn, F.E. (1967a) Comparative Acute Oral Toxicity of 6
Compounds. Unpublished Report from Lifestream Laboratories.
00063255 Baran, J., Fancher, O.E. and Calandra, J.C. (1966a) Acute
Oral Toxicity and Cholinesterase Determination of NIA
10242 in Beagle Dogs. Unpublished Report from the Industrial
Bio-Test Laboratories Inc. Submitted to the World Health
Organization by FMC Corporation.
00063256 Palazzolo, R.J., Fancher, O.E. and Calandra, J.C. 1966.
Acute Oral Toxicities - Chickens NIA10242. Unpublished
Report from the Industrial Bio-Test Laboratories Inc.
submitted to the World Health Organization by FMC Corporation.
00063258 Palazzolo, R.J. and Kay, J.H. (1963b) Toxicity Studies on
NIA10242. Unpublished Report from the Industrial Bio-Test
Laboratories, Inc. submitted to the world Health Organization
by FMC Corporation.
00063259 Schoenig, G., Fancher, O.E. and Calandra, J.C. (1967c)
Acute Dermal Toxicity Study on NIA10242-10G. Unpublished
Report from the Industrial Bio-Test Laboratories, Inc.
submitted to the World Health Organization by FMC
Corporation.
00063260 Schoenig, G., Fancher, O.E. and Calandra, J.C. (1967c) 20-
Day Subacute Percutaneous Toxicity of NIA10242 - Albino
Rabbits. Unpublished Report from Industrial Bio-Test
Laboratories, Inc. submitted to the World Health Organization
by FMC Corporation.
113
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
00076762 Laveglia, J., Spencor, A.G., Schardein, J.L. 1981. Teratology
Study in the Rabbit with Carbofuran. IRDC No. 167-156.
(Unpublished study)
00077329 Palazzolo, R.J. and Kay, J.H. (1963a) Acute Oral Toxicity
Studies on NIA10242. Unpublished Report fron the Industrial
Bio-Test Laboratories, Inc. submitted to the World Health
Organization by FMC Corporation.
• f
00077330 Schoenig, G., Fancher, O.E. and Calandra, J.C. (1967a)
Comparative Acute Oral Toxicity of NIA 10242. Unpublished
Report from the Industrial Bio-Test Laboratories, Inc.
submitted to the World Health Organization by FMC Corporation.
00077415 Johansen, C.; Eves, J. (1964) Bee Poisoning Investigations,
1964. (Unpublished study received Sep 30, 1966 under
6F0463; prepared by Washington State Univ., submitted by
Geigy Chemical Corp., New York, N.Y.; CDL:090513-C)
00083097 Hathaway, D., Fancher, O.E. and Calandra, J.C. (1967d)
Acute Dust Inhalation Study on NIA10242 50 WT. Unpublished
report from industrial Bio-Test Laboratories, Inc. submitted
to the World Health Organization by the FMC Corporation.
00088881 Hile, E.F.; R.G. Heath; J.W. Spann and J.D. Williams. 1975.
Lethal dietary toxicities of environmental pollution to
birds. U.S. Fish and Wildlife Service Special Scientific
Report—Wildlife No. 191. U.S. Fish and Wildlife Service,
Washington, DC.
00090871 Talekar, N.S., L.T. Sun, E.M. Lee, and J.S. Chen. 1977.
Persistence of some insecticides in subtropical soil. J.
Agric. J. Agric. Food Chem. 25(2):348-352. Also In
unpublished submission received Dec. 13, 1977 under 76-
1995; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:232469-M.
00092562 Mastri, C., Keplinger, M.L. and Fancher, O.E. (1969a) Acute
Dermal Toxicity Study on Furadan Technical in Albino
Rabbits. Unpublished Report from the Industrial Bio-Test
Laboratories Inc. submitted to the World Health Organization
by FMC Corporation.
114
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
00092611 Palazzolo, R.J. and Kay, J.H. and Calandra, J.C. (1964c) Acute
Dermal Toxicity Studies on NIA10242. Unpublished Report
from the Industrial Bio-Test Laboratories, Inc. submitted
to the world Health Organization by FMC Corporation.
00092612 Schoenig, G., Fancher, O.E. and Calandra, J.C. (1967c)
Acute Dermal Toxicity Study on NIA10242-75 WP. Un-
published Report from the Industrial Bio-Test Laboratories,
Inc. submitted to the World Health Organization by FMC
Corporation.
• /•
00092613 Schoenig, G., Fancher, O.E. (1967a) Acute Dermal Toxicity
of Furadan 4 Flowable Paste. Unpublished Report from the
Industrial Bio-Test Laboratories, Inc. Submitted to the
World Health Organization by FMC Corporation.
00092614 Hathaway, D., Fancher, O.E. and Calandra, J.C. (1967a)
Acute Aerosol and Acute Dust Inhalation Toxicity Studies on
NIA10242. Unpublished report from Industrial Bio-Test
Laboratories, Inc. Submitted to the World Health Organiza-
tion by the FMC Corporation.
00092616 Hathaway, D., Fancher, O.E. and Calandra, J.C. (1967a)
Acute Aerosol Inhalation Toxicity Study on Furadan
Insecticide. Unpublished report from Industrial Bio-Test
Laboratories, Inc. Submitted to the World Health Organiza-
tion by the FMC Corporation.
00092695 Cook, R.F., R.A. Robinson, E.G. Brandau, G.E. Lover, L.M.
Doge, and J.M. Shuttleworth. 1974. Carbofuran—hydrolysis
study: M-3552. Unpublished study received Sep. 10, 1974
under 279-2712; submitted by FMC Corp., Philadelphia, Pa.;
CDL:120431-G.
00092703 McCann, J.A. 1970. Report on the toxicity of Furadan 10
granular to bluegill sunfish. (U.S. EPA Animal
Biology Laboratory, Beltsville, MD, Test No. 324, Jan. 27,
1971, unpublished report.)
00092704 McCann, J.A. 1970. Report on the toxicity of Furadan 75 WP
to bluegill sunfish. (U.S. EPA Animal Biology Laboratory,
Beltsville, MD, Test No. 329, Dec. 9, 1970, unpublished
report.)
115
-------
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
00092705 McCann, J.A. 1970. Report on the toxicity of Furadan 75 WP
to rainbow trout. (U.S. EPA Animal Biology Laboratory,
Beltsville, MD, Test No. 348, Mar. 20, 1971, unpublished
report.)
00092706 McCann, J.A. 1970. Report on the toxicity of Furadan 4
Flowable to bluegill sunfish. (U.S. EPA Animal Biology
Laboratory, Beltsville, MD, Test No. 316, Mar. 20, 1971
unpublished report.)
00092707 McCann, J.A. 1970. Report on the toxicity of Furadan 75 WP
to bluegill sunfish. (U.S. EPA Animal Biology Laboratory,
Beltsville, MD, Test No. 315, Dec. 20, 1970 unpublished
report.)
00092708 Graves, J.B., Crayfish bioassay with Furadan. Unpublished
study received Sep. 24, 1969 under 279-2791; prepare by
Louisiana State Univ., submitted by FMC Corp., Philadelphia,
Pa.; CDL:132235-A.
00092723 Getzin, L.W. 1973. Persistence and degradation of carbofuran
in soil. Environ. Enton. 2(3):461-467. Also In
unpublished submission received Sep. 4, 1975 under 2792712;
submitted by FMC Corp., Philadelphia, Pa.; CDL:223931-B.
00092739 Shellenberger, T.E. and B.J. Gough. 1972. Acute Toxicity
Evaluations of Carbofuran with Bobwhite Quail Chicks and
Young Adults, and Mallard Ducklings: GSRI Project no. NC-
496; NCT 429-62. (Unpublished study received December 22,
1976 under 279-2712; prepared by Gulf South Research
Institute, submited by FMC Corp., Philadelphia, Pa.;
CDL:227306-D.)
00092756 Getzin, L.W. 1973. Persistence and degradation of carbofuran
in soils. Unpublished study including letter dated Feb.
10, 1972 from L.W. Getzin to John McCarthy, received Mar. 30,
1977 under 279-2712; prepared by Washington State Univ., Western
Washington Research and Extension Center, submitted by
FMC Corp., Philadelphia, Pa.; CDL:229240-C.
00092758 Brandau, E.G. 1977. Persistence of carbofuran in silt loam
soils. Unpublished study received Mar. 30, 1977 under
279-2712; submitted by FMC Corp., Philadelphia, Pa.;
CDL:229240-G.
116
-------
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
00092777 Allsup, T.L., J.R. Chow, B.C. Leppert, and O.H. Fulliper.
1974. Determination of carhofuran and 3-hydroxycarbofuran
as total and dislodgeahle residues in or on orange leaves:
Analytical Report W-0019. Method dated Nov. 15, 1974.
Unpublished study received Mar. 30, 1977 under 279-2712;
submitted by FMC Corp., Philadelphia, Pa.; CDL:229241-S.
00092778 Hinstridge, P.A., B. Cardenas, A.D. De la Torre, and O.H.
Fullzner. 1975. Determination of carhofuran and 3-hydroxy
carbofuran as dislodgeable and total residues in or on
grape leaves: Analytical Report W-0033. Unpublished
study received Mar. 30, 1977 under 2792712; submitted by
FMC Corp. Philadelphia, Pa.; CDL:229241-T.
00092779 Shuttleworth, J.M., D.J. Duhow, M.H. Gruenauer, and T.F.
Uebler. 1977. Determination of carbofuran and 3-hydroxy
carbofuran and its carbamate metabolites in or on corn
plants: Analytical Report W-4032. Method dated Jan. 27,
1977. Unpublished study received Mar. 30, 1977 under
2792712; submitted by FMC Corp. Philadelphia, Pa.; CDL:229-
241-U.
00092800 Capps, T.M., J.L. Reynolds, and R.A. Robinson. 1978.
Hydrolysis of carbofuran in distilled water: Analytical
Report M-4233. Method dated June 6, 1978. Unpublished
study received Aug. 2, 1978 under 279-2712; submitted by
FMC Corp., Philadelphia, Pa.; CDL:234572-C.
00092801 Palmere, R.M., M. Persicketti, C.L. Fitzgerald, and P.A.
Cruickshank. 1978. Photodecomposition of carbofuran:
Analytical Report P-0157. Unpublished study received Aug.
2, 1978 under 279-2712; submitted by FMC Corp., Philadelphia,
Pa.; CDL:234572-D.
00096742 House, R.L., Klaich, M. 1971. Field Toxicity Trials on
Mallard Ducks (Anas platyrhynchus). (Unpublished study)
00129501 Roberts, N., Phillips, C., Chanter, D., et al. 1983. The
Effects of Dietary Inclusion of FMC 10242 on Reproduction
in the Bob White Ouail. HRC Report No. FCC33WL/82494/3.
FMC Study No. A81-514. (Unpublished study)
00129509 S.C. Johnson and Sons, Inc. 1983. Raid Fire Ant Killer:
Formula 2. SCJ Code 5391D152. Compilation. (Unpublished
study)
117
-------
OFFICE OF PESTICIDE PRDGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under this Guidance Document
00130418 Booth, G., Carter, M., Jorgensen, C., et al. 1983. Effects
of Furadan Formulations 10G and 15G on Avian Populations
Associated with Corn Fields. Final Report. (Unpublished
study)
00130419 Booth, G., Jorgensen, C., Carter, M., et al. 1983. Effects
of Furadan 4F on Avian and Insect Populations in Alfalfa
(Medicago sativa). Final Report. (Unpublished study)
' x
05003191 Schafer, E.W., Jr.; Brunton, R.B.; Lockyen, N.F.; DeGrazio,
J.W. (1973). Conparative toxicity of seventeen pesticides
to the Quelea, house sparrow, and redwinged blackbird.
Toxicology and Applied Pharmacology 26(1):154-157.
05003462 Hudson, R.H.; R.K. Tucker and M.A. Haegele. 1972. Effect of
age sensitivity: acute oral toxicity of 14 pesticide to
mallard ducks of several ages. Toxicology and Applied
Pharmacology 22(4):556-561.
05008717 Dorough, H.W. 1977. Metabolism of Carbamate Insecticides.
Environmental Health Effects Research Series PB 266 223.
EPA Report No. EPA-600/1-77-012.
118
-------
AP5E25S H-2
QMBAmmni /Vo. ZCOG-Q4S3 /Stains
F1FRA SSCT10N 3(C)(2)(B) SUMMARY SHEET
8?A flEGtSTKATION NO.
wooucr
APf UCAMTS .NAMt
OATS QUIOANd OOCUMINT 1SSUIO
Witt rants TO tin i iwMfiniont TO siowt "jaw" dn unooad by ttw FiFHA action 3(G(2(B) wrtci i iiiuiiind in tin nhnMBd
Siadana Ooaanar. I am raoondimj in on faitowimj manmin
«. 1. I will aiomt dm in • nm«y mm* to atttfy an fatiowinq ftmorwwDn. If •» as arecwum I wiU iu§ amnm from (or «• not
anofitd in) «• fagiuiiuuii GuidMim or HM Pratocnii canau»o in ou fltoom of exam Groun n tin Cnmiatt firms, OEC3
C*Httvvt T MDB9 ^BQmmniw 1 BIFJOM TAV Qretoc&te UM 1 wiU UMI
I Inw «mnd into n qraHmnr witt am or man oinar naama undtr ?IFHA astan 3(C3(2)(B)(u3 n atatfy
Wfflnnnna Th« ao. aid my noaind omocatt, wil to aiotmoM to EPA ay:
MAMS QP OTHtH RCOISTRANT
I MOM i camtnM "Cnufluuun ot AtnmortB UAH into wAqmram witn Qt&w Atostmrsfor Qwwuwmi of Oto witn
I ^^u^r ^Mc you mvnd ny fVQtttnooii oy UilwiiQ ini TOUOWOQ uvi (ttui uouon A not iWMfita to 406iiGjnu tor nw onouct&t
LJ & I rtwMK voturary anadnon of m nqiamaa of •3»« orotuci (Ttia otrton it not ntrt«a« to aeiiomsfor ntw preaueaJ
fleCJSTaAAm AUTHCWI2S2 HE?nESS.NTAT!VG ; SIGNATJUB
OATS
110-43]
112.
-------
AFFS3DIS H-3
OMB Aoarm* No. 20004*68 tere/rar
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To ouarffrV. cam* ALL four immi «3B DEVELOPMENT OP DATA
1. 1 am duly autnorizad to raoiaaant aw following flrmii) wno art ainiact ta ttw raeuira-
mams of a Ncoca unoar RFRA Section 3(cH2MB) carainad in 'a Guidarct Document
NAMCOP HUM
(This firm or grouo of firms is t
2. My firm is willing to aawte
(tarns or uaias
aUIOANCy 3OCUM8-NT 3ATS
ACT1VI INOMIOIIMT
IPA COMPANY NUMUH
-
mnte to oaraw as "my firm".)
B and wontir tna dao as raouirao by Jiai >NctiOB« if nacasaar^
r. Howa»ar. my firm would arafar to cmar
• east of davatooing, tna following raouirad
3» My nnn haa offirad in writing to tmar into SB& an aojfasfntfiL Cdoias of tna offvn am anacnad* Tnat unaf was imvocaola ano induoad an Uifai TO oa
uand by an arohnmn daosisn unaar F1FRA Section 3(d(2J(BJ(ui) if final agnareant on all arms could not aa nacaao otnanma. This offer was maoa
NAMMOIimilM
How^vijr. nontf or *.noia) n^H^isi
4. ,Vly firm raauasn tnat s?A
have agrwa to womit tna o
ma wnatnar my firm must
Ooaa not aooty to aociicara
OATH OP O^PIW
aujuttu mv offsr.
rat lusoana ttw ragtstmonts) of my firm's produens). if any of tna firms namad in oaragraon {3} aoov«
ata Hjtaa in aangnon (2) aoova in acearoanea wiin ttw Nottos. 1 unoamand E?A '«nil aromonv inform
submit oara to avoid 'auoanson of in ngisvationis) unoar FiF^A Saetion 3(d(2)(B). (This natemtnt
for naw srooucs.) 1 gtva S?A parmtstion to aisaosa via »umnem uoon raquosi.
TfW«O NAMa 3»OH*TU«B I BATS
SPA
on
-------
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
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specif ic jjravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Test not
required
for my
product
listed
above
( check
below)
I am complying with
data requirements by
Citing MRID#
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
121
-------
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
122
-------
APPENDIX IV-2
LABELING K&guiKfc'MliNl'b Ut iHt, KLFRA, AS AMENDED (REFER TO TOE SAMPLE LABELS FOLLOWING)
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Est. No.
EPA Reg. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
iirmed lately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
i \
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
123
-------
APPENDIX IV-2 (continued)
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
precaut ionary
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 jDanel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT
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
ON LABEL
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
»\
r.
Must be grouped under the headings in
8A, 8B, and RC; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
124
-------
APPENDIX IV-2 (continued)
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
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
»N
r.
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must he same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May he in metric as well as U.S. units
125
-------
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.
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.
126
-------
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 j
(Over 30 12 point I
I L
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.
127
-------
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.
• s
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:
128
-------
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:
Container Type
Statement
| Non-aerosol products
((bottles, cans, jars)
| Non-aerosol products
| (bags)
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
(Aerosol products
I.
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.
-------
Container Type
Appendix IV-5
(continued)
Statement
Fiber drums
with liners
Paper and
plastic bags
' S
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) .
1-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.
130
-------
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 trioxidei
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-nitropheny1 phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Pamphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
131
-------
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 c
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
132
-------
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)
l,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-DiChlorobenzene
Dichlorodifluoromethane (Freon 12®)
3,5-Dichloro-N-(1,1-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
133
-------
Appendix IV-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredientsf
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
134
-------
Appendix IV-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients;
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluorpmethane (Freon 12®)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluoromethane (Freon 11®)
Vinyl chloride
Xylene
135
------- |