GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
.INURON
AS THE ACTIVE INGREDIENT
EPA CASE NUMBER: £7
(035506)
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
JUNE 29, 1984
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TABLE OF CONTENTS
Pace
Introduction 1
I. Regulatory Position 4
II. Requirement for Submission of Generic Data 22
III. Requirement for Submission of Product-Specific
Data 40
IV. Submission of Revised Labeling and Packaging
Information 65
A. Label Contents £r
1. Product Name 4,,.,, ^5
2. Company 'Name and Address ......'-. &5
3. Net Contents . . • °5
4. Product Registration Number . . . °°
5. Producing Establishment
Registration Number °~?
6A Ingredient Statement • . °^
6B Pounds Per Gallon Statement °°
7. Front Panel Precautionary Statements 66
7A Child Hazard Warning Statements 6?
7B Signal Word 6?
7C Skull and Crossbones and Word Poison 6?
7D Statement of-Practical Treatment 6?
7E Referral Statement 6?
8. Side/Back Panel Precautionary Labeling 6?
8A Hazard to Humans and Domestic Animals. 68
8B Environmental Hazard ...... \ . -68
8C Physical or Chemical Hazard. . . 68
9 Misuse Statement ; 69
10A Storage and Disposal Block . . . . : 69
10B Directions for Use . , 69
B. Collateral Information 69
V. Instructions for Submission • 70
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APPENDICES
Page
II-l Bibliography ..................... 71
II-2 FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8580-1 . . QQ
II-3 Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6 ................... 81
IV-1 Product Specific Data Report (End-Use Products)
EPA Form 8580-4 ....*. .............. 82
V-2 Table of Labeling Requirements and Sample Labels. . . 39
•*_•'•.
V-3 Physical/Chemical Hazards Labeling Statement. . , . . 93
V-4 Storage and Disposal Instructions .......... 94
Note: Appendices V-l, V-5 and V-6 are not germane to this
document and are not included.
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 3(g), as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible.
Each registrant of a manufacturing use product of the active
ingredient who wishes to continue to sell or distribute that
product must apply for reregistration.
To fulfill this Congressional mandate, we have established
the Registration Standards program which will review all pesti-
cide active ingredients first registered before January 1,
1977. These pesticides will be reviewed in use clusters
which are prioritized on the basis of a ranking scheme giving
preference to pesticides used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pestico.de
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. :
i
The scientific review, which is ncit 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 thatrcontain the active
ingredient. If we find serious concerns, we will bring
formulated products under the provisions of the Registration
Standards program to the extent necessary to protect the
public.
EPA has the authority under FIFRA §3(c)(2)(B) to require
that certain registrants submit generic data that will answer
our questions regarding the hazard that may result from the
intended use of the pesticide under review. Further, §3(c)
(2)(B) provides that these data are to be submitted by
those registrants who do not qualify for the formulator's
exemption [FIFRA §3(c)(2)(D)]. Normally, this means that
the registrants who are responsible for filling the da~a
gaps are the manufacturing-use product producers (basic
o
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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 reregiatra-
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 no-tice 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 adverse effects.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis-
tered. To obtain reregistration
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time..
However, generic data required
to continue*''the registration of
the active ingredient under
review, as described in the
Registration Standards.Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
wil-1 be dealt with in a variety
of ways, including but not
limited to .the Label Improvement
Program and' special intent
to cancel notices.
* End-use products of registrants who also produce a manufacturing-
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing-use product(s). Such end-use products
will be subject to the labeling changes required for products in "11"
above. If there are no manufacturing-use products registered by any
company end-use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "II" lose their right to
[qualify for the formulator's exemption and become subject to the
I recuirements in I-A and B.
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JI. REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
This chapter describes the regulatory position of the Environmental
Protection Agency ("the Agency") on linuron based on an evaluation of all
registered manufacturing-use products (MUP's) containing linuron as the
sole active ingredient. Future requests for registration of substantially
similar products will be covered by this standard. Dissimilar products
will require amendments to the standard. This document provides the
rationale for the Agency's position and the criteria for registration. It
also discusses labeling requirements for bboth MUP's and end-use products
(EUP's) and tolerances.
In developing its regulatory position, the Agency determines whether
available data indicate that a pesticide has met the criteria for adverse
effects found in Section 162.11(a) of Title 40 of the U.S. Code of Federal
Regulations (CFR). Pesticides meeting these criteria are candidates for
a Special Review, an intensive risk/benefit analysis which is a modification
of the Rebuttable Presumption Against Registration (RPAR) process. The
Agency's determination as to whether any criteria has been met and its
rationale for any regulatory action are summarized in the regulatory
position of this standard.
"Linuron" is the accepted common name for the compound, 3-(3,4-dichlorophenyl)
1-methoxy-l-methylurea recognized by the American National Standards Institute.
Trade and other names used for linuron include: Lorox® Weed Killer, and Lorox®
4L Weed Killer. The Chemical Abstracts Service (CAS) Registry number is
330-55-2, and the Office of Pesticide Programs' Internal Control Number
(EPA Shaughnessy Number) is 035506.
B. USE PROFILE
Linuron is a substituted urea herbicide used for preemergent and postemergent
control of many annual grasses and broadleved weeds on the following
terrrestrial food crop and nonfood site: Food - soybeans, field and sweet
corn, cotton, sorghum, wheat, asparagus, carrots, celery, parsnips, and
potatoes: Nonfood-alleys, fencerows, fairways, golf tees, highway righ-of-
way, sodfields, streets and vacant lots. Linuron has been shown to
inhibit photosynthesis in plants. Linuron has a limited contact action
and is normally applied with a surfactant when used in this matter.
Linuron was patented by Farbwek Hoechst A. G. in 1960, (US Patent No. 2,960,234).
It was first registered for use in 1966. Technical linuron is currently
being producted in the United States by E. I. duPont de Nemours and
Company, Inc., Drexel Chemical Company, and Griffin Corporation.
Linuron is available as a technical material, at 05% active ingredient
and as a manufacturing ue product containing 50% linuron for formulation
of linuron end-use formulations or as manufactuing use products. As a
sole active ingredient linuron is available in wettable powders, flowabJ.es,
and liquid suspensions.
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C. REGULATORY POSITION
Based on a review and evaluation of the available data and other relevant
information on linuron, the Agency has made the following determinations:
1. Linuron has oncogenic potential. Registrants of linuron products are
hereby notified that linuron has met the risk criterion for oncogenicity
in Section 162.11(a) of Title 40 (CFR). A Notice announcing the
Agency's decision to initiate a Special Review will be published
in the Federal Register.
2. The Agency is concerned about the oncogenic potential of linuron and is
requiring that certain data needed for the Special Review be submitted
on an expedited basis. These data include the following:
a. Residue Chemistry as specified in the data tables under § 158.125,
b. Environmental Fate as specified in the data tables under § 158.130,
c. Toxicology as specified in the data tables under § 158.120.
d. Applicator exposure data as specified in the data tables
under § 158.130.
3. To reduce risk, and to maintain existing registrations, registrants
must take certain interim measures by revising the product label as
specified below. The labeling must include a statement concerning
tumors, a requirement to use protective clothing, and a restricted use
statement. (Refer to Section G. "Required Labeling" )
4. The Agency is concerned about surface water and possible groundwater
contamination by linuron. In order to characterize the potential
for linuron to enter groundwater, the Agency will require the
following studies:
a. Environmental Fate data as specified in the data tables under
§ 158.130,
b. Product Chemistry data as specified in the data tables under
§ 158.120.
5. In the absence of data to estimate reentry exposure to workers entering
areas treated with linuron, the Agency is imposing an interim 24 hour
reentry interval.
6. Within 90 days after receipt of this document, registrants must commit
to perform all of the required studies.
7. The Agency will not consider for reregistration any current products
containing linuron as a sole active ingredient until the Agency concludes
the Special Review. However, all currently registered products will
remain registered while the Special Review is in process.
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8. Registrants not qualifying for a formulator exemption must provide or
agree to develop all data specified in the tables of this standard to
maintain existing registrations. The Agency may amend this standard
or initiate further regulatory actions after it has reviewed the
submitted data. All data must be generated according to the Good
Laboratory Practices specified in 48 FR 53946.
9. Applicants having products not conforming to this standard may apply
to amend the document so those products containing linuron may be
registered and reregistered under this standard. Mixtures and end-use
products containing linuron are covered under this standard for the
purposes of labeling.
D. REGULATORY RATIONALE
The Agency has determined the following:
1. Linuron has demonstrated oncogenic potential in rats and mice. Dietary
exposure to linuron has induced dose related tumors in mice and rats,
indicating clear evidence of oncogenicity using the National Toxicology
Program (NTP) criteria.
2. Based on surrogate data, risk estimates indicate that an unreasonable
risk may exist for farmers exposed to linuron while mixing/loading and
applying linuron. Dietary risk estimates indicate that an unreasonable
risk may exist for the general population via consumption of agricultural
commodities treated with linuron.
To fully evaluate these risks during Special Review, the Agency is
requiring exposure, toxicology, and residue chemistry data. To reduce
the risk while it conducts the Special Review, the Agency is imposing
certain interim measures by restricting linuron1s use and requiring
label amendments.
3. There are no data to estimate reentry exposure to workers entering areas
treated with linuron. Coupled with the fact that linuron is an oncogen,
the Agency has set an interim time interval of 24 hours to caution any
worker from reentering the treated areas and being exposed to residual
quantities of linuron. This data gap requires the submission of linuron
reentry data in accordance with 40 CFR Part 158.140 (Reentry Protection
Data Requirements). When the data are submitted, the Agency will evaluate
the data and impose an appropriate time interval.
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4. The Agency has designated for further study, certain chemicals including
linuron which may have a potential to enter groundwater supplies in the
United States based on such factors as chemical structure, solubility
and use patterns. Exposure of humans to linuron through contamination
of groundwater is possible, depending on how the well water is used.
Exposure of humans to linuron through runoff contamination of surface
water after heavy Spring precipitation is likely. Between April and
August 1982, monitoring samplers detected linuron in six Northwestern
Ohio rivers at levels of 2.32 to 13.1 micrograms/ liter (parts per
billion). Between April and August 1983, monitoring samplers
detected linuron in tap water from the Tiffin and Bowling Green, Ohio
municipal water treatment plants (using the rivers as water sources)
at levels of 0.39 to 0.61 micrograms/ liter. The Agency will evaluate
the risks posed by runoff and the resulting contamination of surface
water as part of the Special Review process for the oncogenic potential
of linuron.
5. The available environmental fate data are insufficient to fully assess
the potential for exposure of humans and non-target organisms to linuron.
When the required studies under §158.130 are submitted, a complete
environmental exposure assessment can be made.
6. There are insufficient data to characterize the acute and chronic toxic
effects of linuron on birds, fish, and aquatic invertebrates. When
additional ecological effects data are submitted, a complete hazard
assessment can be made.
7. The available product chemistry data are insufficient to fully assess the
chemical at this time. When the required chemistry tests under § 158.120
are submitted, a complete product chemistry evaluation can be performed .
8. Available monitoring data do not indicate human or wildlife fatalities
from poisoning incidents.
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E. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
To be subject to this standard, manufacturing-use products must meet the
following conditions:
1. Contain linuron as the sole active ingredient and,
2. Conform to the acute toxicity limits, product composition, and
use pattern requirements listed in Section F of this document.
Registration of products subject to this standard must comply with all
terms and conditions described in it, including commiting to fill data
gaps on a schedule agreed to by both this Agency and the registrant. All
registrants for registration under this standard must follow the instructions
contained in this standard and complete and submit the appropriate forms
within the time specified.
F. ACCEPTABLE RANGE AND LIMITS
1. Product Composition Standard
Technical grade products must contain at least 90 percent linuron as the
sole active ingredient. Each manufacturing-use product formulation
proposed for registration must be fully described with an appropriate
certification of limits. In addition, the active ingredient found in the
manufacturing-use linuron products must be substantially similar to that
in currently registered technical products. Any manufaturing-use product
not meeting these requirements will be considered a new product and will
not be registered under this standard.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade and mnaufacturing-
use products containing linuron with Toxicity Category III for acute oral
and dermal toxicities, Toxicity Category III for dermal and eye irritation,
and Toxicity Category IV for acute inhalation, provided that the labeling
of those products bears appropriate precautionary statements.
3. Use Patterns
To be registered under this standard, manufacturing-use products containing
linuron must be labeled for formulation only into end-use products for
herbicides used for the control of a wide variety of annual grasses and
broadleaved weeds on the following terrestrial food crop and nonfood sites:
food- soybeans, field and sweet corn, cotton, sorghum, wheat, asparagus,
carrots, celery, parsnips, and potatoes; nonfood-alleys, fencerows, fairways,
golf tees, highway right-of-way, sod.fields, streets, and vacant lots.
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G. REQUIRED LABELING
All technical grade, manufacturing-use (MUP), and end-use products(EUP)
containing linuron must bear appropriate labeling as specified in 40 CFR
§ 162.10. Other portions of this guidance package contain specific
information regarding label requirements.
Existing stocks of product covered by this document, related brochures,
technical pamphlets and similar materials must be labeled to comply with
all label requirements within six months after the receipt of this guidance
document.
1. Manufacturing-Use Product Statements
Products intended for formulation into end-use products must bear the
following statement:
"The use of this product may be hazardous to your health. This
product contains linuron, which has been determined to cause tumors
in laboratory animals".
"Do not discharge effluent containing this product directly into lakes,
streams, ponds, estuaries, oceans or public waters unless this
product is specifically identified and addressed in a National Pollutant
Discharge Elimination System (NPDES) permit. Do not discharge effluent
containing this product into 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".
2. End-Use Product Statements
All end-use products must bear the following statements:
"RESTRICTED USE PESTICIDE",
"For retail sale to and application only by certified applicators or
personnel under their direct supervision"
"The use of this product may be hazardous to your health. This product
contains linuron, which has been determined to cause tumors in laboratory
animals."
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"Required clothing and equipment for mixing/loading and applying linuron:
One-piece overalls which have long sleeves and long pants constructed of
finely woven fabric as specified in the USDA/EPA Guide for Commercial
Applicators.
Wide-brimed hat.
Heavy-duty fabric work gloves.
Any article worn while applying linuron must be cleaned before reusing.
Clothing which has been drenched or has otherwise absorbed concentrated
pesticide must be disposed in a sanitary landfill, or incinerated, or
if allowed by state and local authorities, by burning.
Instead of clothing and equipment specified above, the applicator can
use an enclosed tractor cab which provides a filtered air supply (as
described by Taschenberg and Bourke, 1975)."
Non-aquatic
"Do not apply directly to water or wetlands. Do not contaminate water by
cleaning of equipment or disposal of wastes."
Rotational Crop Restrictions
"Do not rotate crops used for food or feed, which are not registered for
use with linuron onto areas previously treated with this chemical."
Reentry Restriction
"Do not reenter treated areas for 24 hours following application unless
protective clothing is worn."
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H. TOLERANCE REASSESSMENT
For linuron, the present Theoretical Maximum Residue Contribution (TMRC)
is 0.3248 mg/day/1.5 kg diet. This amounts to 86.6% of the present
Acceptable Daily Intake (ADI) of 0.00063 mg/kg/day which for a 60 kg
person is 0.3750mg/day.
This Acceptable Daily Intake (ADI) for linuron is based on blood dyscrasias.
As indicated above, these values may change because the No-Observed-Effect-
Level (NOEL) for linuron is not well established. The Agency will require
a chronic study which could affect the ADI.
Presently, in the United States, tolerances are established for residues
of linuron (§ 180.184) in or on the raw agricultural commodities listed below:
Commodities Parts per million
Asparagus 3.0
Carrots 1.0
Cattle, fat 1.0
Cattle, meat by-products 1.0
Cattle, meat 1.0
Celery 1.0
Corn, field, fodder 1.0
Corn, field, forage 1.0
Corn, fresh, (sweet) 0.25
Corn, grain (incl. pop) 0.25
Corn, pop, fodder . 1.0
Corn, pop, forage 1.0
Corn, sweet, fodder 1.0
Corn, sweet, forage 0.25
Goats, fat 1.0
Goats, meat by-products 1.0
Goats, meat 1.0
Hogs, fat 1.0
Hogs, meat by-products 1.0
Hogs, meat • 1.0
Horses, fat 1.0
Horses, meat by-products 1.0
Horses, meat 1.0
Parsnips (with or without tops) 0.5
Parsnips, tops 0.5
Potatoes 1.0
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Commodities Parts per million
Sheep, fat 1.0
Sheep, meat by-products 1.0
Sheep, meat 1.0
Sorghum, fodder 1.0
Sorghum, forage 1.0
Sorghum, grain(milo) 0.25
Soybeans (dry or succulent) 1.0
Soybeans, forage 1.0
Soybeans, hay 1.0
Wheat, forage 0.5
Wheat, grain 0.25
Wheat, hay 0.5
Wheat, straw 0.5
The available residue chemistry data are insufficient to fully assess linuron
at this time. When the required residue tests under § 158.125 are submitted,
a complete residue evaluation can be made.
In addition, linuron and diuron have certain metabolites in cannon:
l-(3,4 dichlorophenyl)-3-methylurea (DCPMU), and 3,4-dichlorophenylurea (DCPU).
Therefore, the Agency can consider diuron1s residue contribution in the full
tolerance reassessment of linuron for the following commodities: corn, sorghum
grains, wheat, asparagus, meat(red), and cottonseed.
If the complete tolerance reassessments for the above commodities are favorable,
tolerances for residues of linuron and metabolites which will hydrolyze to
form 3,4-dichloroaniline of 0.05 ppm will have to be proposed for residues in
milk and eggs.
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I. PRELIMINARY ANALYSIS OF. CURRENT BENEFITS AND RISKS
1. Current Benefits Review
a. Introduction
The Agency has conpleted a current benefits review for
linuron. The following information is preliminary in nature
and will be expanded upon during the Special Review.
b. Use Site Study
Linuron herbicide is federally registered for use on the
agricultural sites soybeans, carrots, celery, asparagus,
corn (field, sweet), cotton, parsnips, potatoes, sorghum,
and winter wheat. Registered non-food sites include golf
course fairways, golf tee areas, sodfields, fencerows, highway
rights-of-way, streets, alleys, and vacant lots. Linuron is
currently used in Michigan, under 24c registration, for weed
control in hybrid poplar plantings. In 1982, a Section 18
emergency exemption from tolerance was granted to the state
of Massachusetts for use of linuron on 300 acres of dry bulb
onions to control galinsoga and other broadleaf weeds
previously controlled by nitrofen (TOK®). Of the above
mentioned linuron use sites, the majority is used on soybeans.
For this reason, the Agency will limit this preliminary
analysis to linuron's use on soybeans.
E.I. duPont de Nemours Company, Inc. is the major producer
of the technical product. Griffin Corporation and Drexel
Chemical Company currently hold the other technical
registrations. The most common formulation is the liquid
flowable formulation (4 pounds active ingredient per gallon),
which mixes more readily in the spray tank than other linuron
formulations.
c. Benefits on Soybeans
Most linuron application as a broadleaf herbicide is in tank
mix combination with grass control herbicides. In the majority
of applications, linuron is mixed with alachlor and applied
at one fourth the application rate of alachlor. In a small
percentage of applications, linuron is mixed with metolachlor.
When mixed with either of these chemicals, the linuron application
rate drops significantly. The rate ranges drop from 0.5 to
3.0 pounds active ingredient per e,cre when applied alone to
0.33 to 1.5 pounds active ingredient per acre when used with
alachlor or metolach~..or. The linuron rate selected within
the range is dependent on soil texture. Linuron is primarily
applied to soybeans once a year as a preemergence broadcast
ground application in the spring, after planting and before
crop emergence. Linuron is not currently applied aerially
on soybeans.
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Linuron is selected over other currently available soybean
herbicides for several reasons. First, it controls persistent
annual broadleaf weeds through its 4 to 8 week residual
effect. Major weeds controlled by linuron include pigweed
species cannon lambsguarters, broadleaf signalgrass, common
ragweed, and smartweed species. Second, it consistently
controls weeds on sandy, sandy loam, and loamy sand soils
with less than 2 percent organic matter content. Third, it
provides a consistent preemergence control of triazine resistant
weeds such as pigweed and common lambsguarters. Fourth, it
is used as a tank mix with alachlor (Lasso®) or metolachlor
(Dual®) for control of black and Eastern black nightshade,
two weeds increasing in severity in the Central and Plains
states. Finally, linuron is one of the least costly herbicides
available for farmers for soybean use.
Linuron exhibits both contact and residual activity on
seedling weeds when applied as a preemergent (at planting)
treatment to wheat stubble. For this no-till use, linuron
is mixed with alachlor or metolachlor primarily for their
for preemergence grass control, plus paraquat or glyphosate
for postemergence activity on emerged weeds. The no-till
use of linuron comprises approximately 20 percent of total
linuron use on soybeans.
Linuron is also registered for use as a postemergence-directed
spray for contact control of seedling weeds, after the soybeans
are 8 inches tall. The postemergence directed, use of linuron
on soybeans comprises approximately 4 percent of total usage.
Linuron controls a different spectrum of weeds when used
postdirected as opposed to the preemergence use.
d. Other Registered Herbicides for Soybeans
Currently, a limited number of preemergence soybean herbicides
with linuron1s broad spectrum of weed control are registered.
Linuron's major competitor is metribuzin (Sencor®, Lexone®)
herbicide. Metribuzin is used on a larger number of total
soybean acres than linuron. However, metribuzin is restricted
from use on sandy and loamy soils with less than 2 percent
organic matter. Due to plant injury, it is also restricted
from use on Tracy, Semmes, Altona, Vansoy, and Coker 102
soybean varieties. In these situations, linuron is preferred
over metribuzin or the other available preemergence broadleaf
herbicide chloramben (Amiben®).
Chloramben herbicide is used to a much lesser extent by soybean
growers than linuron or metribuzin because chloramben is
registered for a much smaller spectrum of weeds. There are
no soil or varietal restrictions on chloramben1s use on soybeans.
In the Northeastern U.S., the alachlor/linuron tank mix is the
standard treatment for soybeans. There are other broadleaf
herbicides available for weed control in soybeans. These
herbicides are applied either at-cracking or over-the-top
(OT) of emerged soybeans and weeds. At-cracking (AC) refers
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to the time when soybeans crack the ground surface or emerge
fron the soil. This ranges from 5 to 7 days after planting
to before the soybean true leaves open. These alternative
herbicides include (1) naptalam plus dinoseb (Dyanap®), AC;
(2) bentazon (Basagran®), OT; (3) acifluorfen (Blazer®), OT;
(4) naptalam plus 2,4-DB (Rescue®), OT; (5) fluazifop-butyl
(Fusilade®), OT, for grass control only; and (6) BAS 9052 OH
(Poast®), OT, for grass control only. Toxaphene (Attac®) is
also available for sicklepod control. However, the Agency
has cancelled the registration of toxaphene and existing stocks
may only be used until January 1, 1986. As a result, the use
of linuron as a post directed spray for sicklepod control is
expected to increase. (A post directed spray means to spray
under the soybean plant and over the weeds). The above
listed AC and OT herbicides are efficaceous only if applied
to weeds that are in the label specified stage of growth.
Therefore, application timing is critical for successful
weed control and for minimal injury to the soybeans. The
above listed AC and OT herbicides do not provide four to
eight week residual control equal to that of linuron. Thus,
additional treatments are often necessary throughout the
growing season. Also, these individual herbicides do not
control the entire spectrum of weeds controlled by linuron.
When used as a postemergence directed spray when soybeans
are at least 8 inches tall, linuron controls a different
spectrum of weeds. Other available herbicides competitive
with this contact activity include metribuzin and chloramben.
The herbicide selected is dependent on the spectrum of weeds
infesting the field. All three herbicides control emerged
broadleaf weeds. However, claims for specific weed control
vary considerably. Once again, metribuzin is restricted
from post directed use on sandy and loamy soils with less
than 2 percent organic matter and frcm use on certain soybean
varieties. Postemergence directed use of linuron comprises
only a minor amount of total linuron used on soybeans.
e. Other Linuron Use Sites
The other linuron use sites previously listed are considered
"minor" usage sites in comparison to soybeans. The benefits
of linuron on certain of these sites, however, are quite
large. Linuron is primarily applied as a ground postemergence
over-the-top or directed treatment for control of annual
broadleaf weeds and certain grasses.
In comparison with other available broadleaf herbicides,
linuron is reportedly the only herbicide currently available
for postemergence ragweed and galinsoga control in carrots
and parsnips. Linuron is the only broadleat herbicide for
use on asparagus that can be used on seedling or established
-15-
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beds in the early stages of asparagus growth without injurying
the plants. On the other registered use sites, a number of
other herbicides appear to be available for postemergence
broadleaf weed control. In comparison to these, however,
linuron is selected in certain growing areas for specific
properties. In the Northeast U.S., linuron is selected by
celery growers for its residual properties, which allows for
double cropping. In corn, linuron is used as a post-directed
spray in combination with liquid nitrogen. The addition of
liquid nitrogen enhances the "burn-down" activity of linuron
on emerged weeds and provides residual control of emerging
weeds. Linuron is used on potatoes in courser (lighter)
soil textures in Maine, Wisconsin, and New York. The four
month soil residual allows for recropping, if necessary. In .
sorghum, linuron is used in the Southwest U.S. as a
postemergence-directed application for control of pigweeds
that have escaped other treatments. Pigweeds must be removed
before harvest to prevent interference with combining. In
wheat, linuron is applied both aerially and with ground
equipment primarily in Oregon, Idaho, and Washington to
control groundsel, knawel, wild buckwheat, and rattail fescue
species. In cotton, linuron is primarily applied as a
post-directed spray at layby for annual morningglory and
grassy weeds. Linuron1s residual properties permit planting
fall and winter crops as listed on labels as rotational crops.
In 1982, a Section 18 submission documented linuron as the
only available herbicide for control of galinsoga and the
common weeds lambsquarters, purslane, common ragweed, redrcot
pigweed, and barnyardgrass in dry bulb onions in Massachusetts.
Excessive cultivation late into the growing season would
have damaged the onion bulbs. In the same year, the Agency
received another Section 18 submission for the use of linuron
in California sugarbeets for postemergence over-the-top
control of sowthistle, common mallow, sourclover, and goosefoot
species. The action was withdrawn because of a pending
review of the mouse oncogenicity study.
Linuron usage on non-food sites is considered insignificant,
when compared to the minor food sites. Linuron may be
selected for its short-term soil residual on the non-crop
sites where this characteristic is desired. It is used on
ornamental turf sites for control of the hard to kill weed
Poa annua (annual bluegrass). Linuron is currently the only
broadleaf herbicide registered for control of weeds in hybrid
poplar plantings in Michigan (24c).
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2. Preliminary Risk Analysis
a. Introduction
Data indicate that linuron induces dose-related tumors in
rats. In a two year study conducted at Haskell Laboratory
(Kaplan, A.M. et al., MRID 00029680), researchers fed linuron
to three dose groups. A control group was also used. Male
rats developed interstitial cell testicular adenomas. Most
were discovered at the end of the study. The frequency
of these adenomas increased with the dose, and the increase
in number was statistically significant for the two high
dose groups. At the high dose group, researchers observed
losses in female body weights and increased testicular
weights.
In a two-year study (Wood, C. et al., MRID 00124195),
researchers fed linuron to mice. Researchers at Haskell
Laboratory used a control and three dose groups. Female
mice developed a statistically significant increase in
hepatocellular adenomas in the highest dose group, and male
mice developed border-line statistically significant
hepatocellular adenonas only in the lowest dose group.
Microscopic examination of mouse tissues and organs showed
abnormalities in the liver and spleen of male and female
mice. Compound related effects in the liver included
hepatocytomegaly, hepatocellular cytoplasmic alteration,
hepatocellular vacuolization, hemorrhage, and necrosis.
The Agency evaluated these studies using both the International
Agency for Research on Cancer (IARC) and National Toxicology
Program (NTP) criteria. Using IARC criteria, the weight of
evidence for carcinogenicity of linuron is "very limited."
Using the NTP criteria to evaluate the rat study, the data
indicate a "clear evidence", of carcinogenicity. The Agency
feels that the rat study provides the best model for assessing
risk. This study provides the best evidence and the most
definitive increase in tumors.
The Pesticide Registration Standard for Diuron is requiring
specially designed studies to fulfill the onccgenic data gap
for diuron. Due to diuron's structural similarity to linuron,
the Agency will reviewed the results of the diuron studies. Then
the Agency will determine whether it is appropriate to combine
regulatory actions for these two herbicides.
b. Exposure Analysis
1) Non-dietary Exposure
The Agency has limited the non-dietary exposure analysis for
linuron to the major use site, soybeans. The Agency employed
-17-
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a surrogate study based on alachlor application to soybeans to
estimate exposure (Monsanto Company, GS0063-0028). The
type of formulation and method of application of alachlor
are the same as for linuron. The application rate for linuron
is one fourth the rate of alachlor in all formulations for
soybean application. Therefore, the Agency assumes a
farmer's exposure to linuron to be one fourth the exposure to
alachlor.
A registrant submitted an exposure study on linuron, but it
did not contain adequate information for this preliminary
risk assessment. The study was based on one application to one
10-acre plot and involved three workers. The Agency considers
these data inadequate to determine exposure. In addition,
no information was provided on the analytical method. Control
samples were not included in the study report, and some
conclusions were based on samples lost during analysis.
The exposure risk may actually be higher than Agency
calculations predict. First, commercial applicator exposure
was not included in this preliminary risk analysis. The
Agency will include this exposure in the risk assessment
developed during the special review process.
The Agency used the following assumptions to estimate linuron
exposure to a soybean farmer during ground application of
linuron.
i) The farmer is a 70 kg man.
ii) As an applicator, the farmer may treat a 100
acre plot per day and may treat up to 600 acres
per year. Consequently, he may be exposed
to linuron from 1 to 6 days per year.
iii) As a mixer/loader, the farmer may be exposed for
approximately 15 minutes for every 100 acres
treated at 1 pound active ingredient per acre.
iv) Because of the application method, the Agency
assumes respiratory exposure is negligible.
v) In the absence of data, the Agency assumes
100 percent dermal penetration.
vi) The Agency assumes a lifetime exposure of 30
working years.
The Agency estimated the potential exposure for a farmer
as an applicator, mixer/loader, or both.
The Agency used three scenarios to estimate exposure to
farmers using linuron. Scenario one assumes maximum exposure
because the farmer is not wearing protective clothing.
This is the most realistic scenario for linuron since
current labeling does not require any protective clothing.
-18-
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Scenario two assumes the farmer is wearing protective
clothing, such as coveralls, which the Agency assumes reduces
exposure 80 percent. Normal work clothes are not considered
protective clothing. The Agency assumes the farmer is
wearing rubber gloves during mixing/loading, which reduces
exposure to the hands. The farmer is not wearing gloves
during application.
Scenario three assumes the farmer is wearing the same
clothing as in scenario two, but that the clothing reduces
exposure by 100 percent. Therefore, the only route of
exposure are those areas of the body not protected by
clothing.
The Agency has not presented a detailed explanation of the
non-dietary exposure analysis because it was based on
surrogate data submitted by Monsanto Company. Presently,
there is an existing injunction in Monsanto vs. Ruckelshaus,
which prohibits "any ... disclosure to any other person ...
of any [Monsanto] information, research, and test data"
without Monsanto's written permission. To avoid any possible
violation of this injunction, the Agency emitted all
calculations, figures, and other information in the exposure
assessment, which might reveal any data submitted by Monsanto.
2) Dietary
The estimates of dietary exposure to pesticide residues in the
diet are a function of several factors. These factors include
(1) the residues remaining in or on a commodity; (2) the
amount of a commodity in a daily diet of 1.5 kg (food factor);
and (3) 60 kg average body weight. The residues are measured
in ppm, and human exposure to pesticide residues in a
commodity is measured in terms of mg of pesticide per kg
of body weight per day.
The Agency's dietary estimates assume a uniform distribution
of treated crops among the U.S. population and an average
daily consumption of those crops by individuals. Although
an individual's exposure could vary considerably depending
upon eating habits and geographic location, the values
are considered representative for the total U.S. population
over a lifetime.
The Agency used three methods to calculate the potential
dietary exposure of linuron. The first method assumed the
residues are at 100 percent of the tolerance levels. The
second method used the maximum residue expected (MRE) and
is based on actual residue levels found in the field. The
third method used the MRE multiplied by a rough estimate
of percent crop treated to give an estimate of residues
which may realistically reach humans.through the diet.
Pending tolerances for lettuce and sugar are not included
in any of the methods.
-19-
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It should be noted that exposure to linuron through
groundwater contamination is possible. The Agency is
requesting additional data in this standard to make a
determination of possible groundwater contamination.
c. Risk Estimates
The Agency's Interim Cancer Assessment Guidelines
(41 FR 21402) state that when the Agency judges a chemical
to be a potential human carcinogen, the Agency must estimate
its possible impact on public health at current and anticipated
levels of exposure. The Agency recognizes that the available
techniques for assessing the magnitude of cancer risk to human
populations based on animal data are crude. Uncertainties
in the extrapolation of dose response data to very low dose
levels occur. Also, animals and humans have varying levels
of susceptibility. Thus, these estimates should be viewed
as a health hazard index that reflects the degree of oncogenic
activity and human exposure to linuron.
The Agency used several mathematical models, but none provided
adequate fit to the rat data when the complete data set was used. The
Agency deleted the high dose results and use the models again. The
Multi-stage Model provided an almost perfect fit.
1) Non-dietary
The Agency's estimates of a farmer's oncogenic risk to ground
application to soybeans are presented in the following table.
Oncogenic Risk to Ground Applicators of Linuron
CONDITION RISK RISK
(100 A/yr x 30yr) (600 A/yr x 30yr)
No Protection
Mixer/loader 3.5 x 10~4 2.1 x 10~3
Applicator 1.2 x 10~5 7.4 x 10~5
Combined 3.6 x 10~4 2.2 x 10~3
80% Protection
Mixer/loader 4.2 x 10~5 2.5 x 10~4
Applicator 3.8 x 10~6 2.3 x 10~5
Combined 4.6 x 10~5 2.7 x 10~4
100% Protection
Mixer/loader 9.5 x 10~6 5.7 x 1(T5
Applicator 2.0 x 10~6 1.2 x 10~5
Combined 1.1 x 10~5 6.9 x 10~5
-20-
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2) Dietary
The Agency's estimates of dietary risk to linuron are presented
in the table below.
Oncogenic Risk from Dietary Exposure to Linuron
Assumption
100% tolerance
MRE
MRE x % of
"TMRC"
(mg/day)
0.3248
0.0790
0.0027
RISK
1.2 x ID"3
4.3 x 10~4
1.5 x 10~5
crop treated
d. Conclusions
The Agency has determined that linuron has exceeded the
oncogenicity risk criterion for special review. This determination
is based on several factors. The oral administration of linuron
to the rat indicated clear evidence of oncogenicity for male
rats using NTP criteria. Using these data the Agency calculated
nondietary risk. The most realistic scenario is a farmer
with no protection, who mixes/loads and applies this
herbicide. This calculation resulted in a risk of 3.6 x 10~4 to
2.2 x 10~3. it is possible that the actual risk may even be
higher, because commercial applicator exposure was not included.
The Agency also calculated dietary risk. The most realistic
scenario for dietary risk is the combination of MRE and percent
crop treated, which resulted in a 1.5 x 10~5.
Pending further review, the Agency cannot permit the registration
of new products and reregistration of current products containing
linuron until the Agency has reviewed the data required by this
Standard.
The Agency will not consider for reregistration any current products
containing linuron as a sole active ingredient until the Agency concludes
the Special Review. However, all currently registered products will
remain registered while the Special Review is in process.
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II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA Section 3(c)(2)(B)
and describes, in table format, the data required
for maintaining the registrability of each product.
Additionally, a bibliography (Appendix 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.
i.
\*':
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 terras of this Notice.
B. What Generic Data i Must Be Submitted . You may ascertain
which generic data you must submit by consulting Table A
at the end of this chapter. That table shows all the
generic data needed to evaluate the continued registrability
of all products, and the dates by which the data must be
submitted. The required data must be submitted and any
necessary studies must be conducted in accordance with
EPA-approved protocols, the Pesticide Registration
Guidelines 2/, or data collected under the approved
protocols of the Organization for Economic Cooperation
and Development (OECD) . If you wish not trb develop data
which are necessary to support the registration or
reregistration of certain uses appearing in. your labeling,
you may delete those uses at. the time you submit your
revised labeling.
Also for certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical-
formulation," and in those cases SPA needs data of that
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.
-22-
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type for each major formulation category (e.g., einulsifiabl
concentrates, wettable powders, granulars, etc.) These
are classified as generic data and when needed are
specified in Table A. EPA may possess data on certain
"typical formulations" but not others. Note: The "typical
formulation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Chapter IV of this document.
C. Options Available for Complying With-Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(3) Summary Sheet" [EPA Form 8530-1, Appendix
II-2] for each of your products. On that form you must
state which of the following methods you will us-e, to comply
with the. requirements of this Notice: • '-,
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe
will satisfy the. requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Registration Guidelines or protocols
contained in the Reports of Expert Groups
to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must enclose
the protocols you will use.,-
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing)•the
data. If you elect this option, you must notify EPA
which registrant(s) are parties to the agreement.
3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for
Development of Data" (EPA Form 8580-6, Appendix II-3)V
4. Request that EPA amend your registration by deleting the
uses for which the data are needed. (This option is not
available to applicants for new products.)
V FIFRA Section 3(o)(2)(3) authorizes joint development oi
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued at bottom of next page)
-23-
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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 conclusions
regarding the appropriate ways to develop the required
data or how quickly the data must be submitted. If the
test procedures you plan to use deviate from (or are not
specified in) the registration guidelines or protocols
contained in the reports of the Expert Groups to the
Chemical Groups, Organization for Economic Cooperation
and Development (OECD) Chemicals Testing Programme, you
must submit the protocol for Agency review prior to the
initiation of the test.
: I
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product
Manager. The extension request should state the reasons
why you conclude that an extension is appropriate. While
EPA considers your request, you must strive to meet the
deadline for submitting the required data.
(Footnote continued from previous page) :
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to 'submit a pertinent item
of data or a cost-sharing agreement among all such- registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3 (c) ( 2) (B ) ( ii.l) ] ; and (3) the first registrant has declined
to agree to enter into -i 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.
-24-
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EPA Index to Pesticide Chemicals
h035506
LINURON*
TYPE PESTICIDE: Herbicide
FORMULATIONS: Tech (952); FI (502); G (0.1542, 0.231%, 0.252, 0.3082,
32, 3.52, 52); WP (7.52, 12.52, 152, 202, 20.52, 252, 30.82, 502);
EC (1 Ib/gal); F1C (0.9 Ib/gal, 1.5 Ib/gal, 4.342)
GENERAL WARNINGS AND LIMITATIONS; A selective, systemic herbicide used
to control annual grasses and broadleaf weeds in certain crops. May be
applied either preemergence or postemergence. It provides nonselective
weed control on noncrop areas. Soils with a high clay or organic matter
content will require the higher dosages. Moisture is necessary to acti-
vate the chemical and move it into the soil. For best results, apply to
young, succulent weeds under conditions of high humidity and temperatures
of 70 F (21.1 C) or higher. Do not allow the chemical to come in contact
with roots of desirable plants. Reduce dosage in proportion to band area
actually treated.
Livestock Tolerances:
1 ppn: in meat, fat, and meat byproducts of cattle, goats, hogs, horses,
and sheep.
TIME REQUIRED FOR CONTROL: Not located.
PHYTOTOXICITY TO TARGET WEEDS: Chlorosis and necrosis of .the leaves.
PHYTOTOXICITY TO CROPS: Not located.
MODE OF ACTION: Inhibits the Hill reaction in photosynthesis.
BROADLEAF WEEDS CONTROLLED:
(CPAAAAAC broadleaf weeds
(3PADABBA carpe tweed
(fPAZAAAC chickweed
(jPBFDQAA cocklebur
gPAZAOBB common chickweed
(2PBFAEBA common ragweed
(SPBFBIBB dogfennel
@PARABAA fiddleneck
gPEMAEBB florida pusley
gPBFBOAA galinsoga
(3PBFCXAA groundsel
(3PAZAKBA knawel
(3PBDAEAB lambsquarters
(3PBKAAAC 'mustard
(3PBDAEBI nettleleaf goosefoot
(2PAAAA5I pigweed
(2PDAAJBF prickly sida
(apAAAABP purslane
(a)
(a)
List continued on the next page.
*3-(3,4-dichlorophenyl)-l-methoxy-l-methylurea
Issued: 6-01-79
-25-
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(3PBFAEAA
(apAFACHI
(3PCQBSAA
(3PCQAMBF
(3PEAAGAD
(3PBGAFBL
(3PDAABBB
(3PEAAGBH
@PBKBABA
EPA Index to Pesticide Chemicals
LINURON
BROADLEAF WEEDS CONTROLLED (continued)
ragweed
redroot pigweed
sesbania
sicklepod
smartweed
tall morningglory
velvetleaf
wild buckwheat
wild radish
(a)
(a)
(a)
(a) Preemergence application provides partial control.
GRASSES AND OTHER MONOCOTS CONTROLLED:
(3PCACKBA annual bluegrass
(apCAAAAB annual grasses
@PCABHBB barnyardgrass .
@PCACHBB canarygrass
(3PCABFAA crabgrass
(3PCACEBD fall panicum
@PCACUAA foxtail
@PCACUBA giant foxtail
@PCABIBA goosegrass
@PCACUBF green foxtail
@PCABFBF large crabgrass
@PCAB2BA italian ryegrass
@PCABMBB rattail fescue
(3PCABFBD smooth crabgrass
0PCACEBL texas panicum
@PCACUBD yellow foxtail
Issued: 6-01-79
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/1400300
Site. Dosage
and Formulation
(Ib a.i./A)
AGRICULTURAL CROPS
Carrot
EPA Index to Pesticide Chemicals
LINURON
Tolerance, Use, Limitations
$1400302
&050.0006
$1400301
&050.0006
0.50-1.50
(50% WP)
0.75-1.50
(50% WP)
/2800300
Celery
/2800600
Corn, Field
1 ppm
General Information: Linuron may be applied 1
day after or 2 weeks before a stoddard solvent
application. Do not apply as a tank mix with
stoddard solvent, surfactants, nitrogen solution,
other pesticides, or when temperatures exceed 85 F
(29.4 C). Multiple applications may be made, but
the total dosage should not exceed 2 pounds of
active ingredient per acre. Do not treat suscep-
tible varieties.
LA state label
Registration Number 037820-08428
Preemergence. Broadcast. Make a single applica-
tion in 25 to 40 gallons of water per acre. Use
the lower dosage for soils low in organic matter.
Apply after planting, but before crop emerges.
Postemergence. Broadcast or band. Apply in a
minimum of 25 gallons of water .per acre after
carrots are at least 3 inches in height. Use the
lower dosage for smaller weeds, and the higher
dosage for larger, established weeds. Apply
before annual grasses exceed 2 inches in height,
and before broadleaf weeds exceed 6 inches.
0.5 ppm
LA state label
Registration Number 037820-08428
0.25 ppm (grain and fresh corn including sweet
corn (kernels plus cob with husks removed))
1 ppm (forage and fodder)
LA state label
Registration Number 037820-08428
TX state label
Registration Number 006735-04820
Formulated with atrazine and related compounds.
Issued: 6-01-79
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EPA Index to Pesticide Chemicals
$2800602
&050.0006
19900300
&005.0004
&101.0012
&015.0006
&020.0006
&030.8006
&020.5006
&050.0006
Site, Dosage
and Formulation
(Ib a.i./A)
LINURON
Tolerance, Use, Limitations
Corn, Field (continued)
0.33-1.50
(50% WP)
0.33-1.50
(5% G)
0.34-1.50
(1 Ib/gal EC)
0.75-1.50
(15% WP)
(20% WP)
0.49-1.54
(30.8% WP)
0.33-1.03
(20.5% WP)
0.62-1.50
(50% WP)
Use limited to east of the Rocky Mountains. Pre-
emergence. Broadcast or band. Tank mix with
alachlor, atrazine or 2-chloro-N-isopropylacet-
anilide. Apply in 25 to 40 gallons of water per
acre after planting, but before crop emerges.
Seeds should be planted in flat or raised seed-
beds to avoid injury.
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Plant seed at least 1.75 inches deep or injury may
result. Do not use on sand or loamy sand soils,
or on soils with less than 1 percent organic mat-
ter. Apply the wettable powders and emulsifiable
concentrate in 25 to 40 gallons of water per acre.
Formulated with 2-chloro-N-isopropylacetanilide.
Preemergence. Broadcast or band. Apply in 25 to
40 gallons of water per acre after planting and
prior to crop emergence. Do not use on sand or
loamy sand soils. Plant seed at least 1.75 inches
deep or crop injury may result.
Formulated with atrazine and related compounds.
Use limited to MO. Preemergence. Broadcast or
band. Apply in. 25 to 40 gallons of water per acre
after planting and prior to crop emergence. Do
not use on sand or loamy sand soils. Plant seed
at least 1.75 inches deep or crop injury may re-
sult.
Formulated with atrazine and related compounds.
Postemergence. Directed spray. Apply in a mini-
mum of 25 gallons of water per acre after corn is
at least 15 inches in height. The chemical should
not contact upper leaves or whorls of corn. Use
the lower dosage on weeds that are less than 2
inches in height, and the higher dosage on weeds
that are less than 5 inches in height. Use with
a surfactant.
Issued: 6-01-79
-28-
-------
/1500500
Site, Dosage
and Formulation
(Ib a.i./A)
Corn, Sweet
$1500502
&050.0006
0.62-1.50
(50% WP)
/2800700
Cotton
$2800702
&050.0006
0.50-1.50
(50% WP)
/1401200
Parsnip
$1401202
&050.0006
0.75-1.50
(50% WP)
EPA Index to Pesticide Chemicals
LINURON
Tolerance, Use, Limitations
1 ppm (forage and fodder)
LA state label
Registration Number 037820-08428
Postemergence. Directed spray. Apply in a mini-
mum of 25 gallons of water per acre after corn is
at least 15 inches in height. The chemical should
not contact upper leaves or whorls of corn. Use
the lower dosage on weeds that are less than 2
inches in height, and the higher dosage on weeds
that are less than 5 inches in height.
0.25 ppm (cottonseed)
Do not graze or feed forage from treated areas to
livestock. Do not feed gin trash to livestock.
General Information: Do not use on pima cotton
varieties. Do not spray over top of cotton.
LA state label
Registration Number 037820-08428
Use limited to east of the Rocky Mountains. Post-
emergence. Directed spray. Apply in a minimum
of 25 gallons of water per acre. Use the lower
dosage when cotton is at least 15 inches in
height and the weeds are less than 2 inches in
height. A second application may be made 1 week
after initial treatment. If cotton is 20 inches
in height, make 1 application at the higher
dosage following the last cultivation. Use with
a surfactant.
0.5 ppm (tops)
0.5 ppm (with or without tops)
LA state label
Registration Number 037820-08428
Preemergence. Broadcast or band. Apply in 25 to
40 gallons of water per acre. Use the lower dos-
age on soils low in organic matter. Apply after
planting, but before crop emerges.
Issued: 6-01-79
-29-
-------
EPA Index to Pesticide Chemicals
LINURON
/1401300
19001500
$1401302
4050.0006
&050.0006
/2801900
$2801902
&050.0006
19900300
19900300
&050.0006
Site, Dosage
and Formulation
(Ib a.i./A)
Potato
Tolerance, Use, Limitations
0.75-2.00
(50% WP)
0.50-1.00
(50% WP)
Sorghum
0.30-1.00
(50% WP)
0.33-1.50
(50% WP)
1 ppm
General Information:
Apply in 25 to 40 gallons
of water per acre by ground, or 5 to 10 gallons
by air.
LA state label
Registration Number 037820-08428
Use limited to east of the Rocky Mountains and
Pacific Northwest. Preemergence. Broadcast. Do
not spray over the top of emerged potatoes. Apply
before grasses are 2 inches in height and broad-
leaf weeds are 6 inches in height. When emerged
weeds are present, use with a surfactant. Use the
lower dosage on light soils (sandy loams, silt
loams) and the higher dosage on heavy soils (clay
loams, silts).
Use limited to WI, central sands area. Preemer-
gence. Broadcast. Do not spray over the top of
emerged potatoes. Apply before grasses are 2
inches in height and broadleaf weeds are 6 inches
in height. When emerged weeds are present, use
with a surfactant. Use the lower dosage on sands,
and the higher dosage on loamy sands.
0.25 ppm (grain)
1 ppm (forage and fodder)
Do not graze or feed sorghum forage or silage from
treated fields to dairy animals.
LA state label
Registration Number 037820-08428
Use limited to the Southwest. Preemergence.
Broadcast or band. Tank mix with propazine.
Apply in 25 to 40 gallons of water per acre after
planting, but before crop emerges.
Use limited to the Great Plains. Preemergence.
Broadcast. Tank mix with 2-chloro-N-isopropyl-
acetanilide. Apply in 25 to 40 gallons of water
per acre after planting, but before crop emerges.
Issued: 6-01-79
-30-
-------
EPA Index to Pesticide Chemicals
/2400600
Site, Dosage
and Formulation
(Ib a.i./A)
Sorghum (grain crop)
F
F
F
F
F
$2400602
&101.0012
F
0.34-1.50
(1 Ib/gal EC)
/2802300
Soybeans
$2802302
&050.0006
0.50-3.00
(50% WP)
LINURON
Tolerance, Use, Limitations
0.25 ppm (grain)
1 ppm (forage and fodder)
Do not graze or feed forage or silage from
treated areas to livestock.
TX state labels
Registration Number 006735-04809
Formulated with propazine.
Registration Number 006735-04810
Formulated with*propazine.
Registration Number 006735-04821
Formulated with propazine.
Registration Number 006735-04822
Formulated with propazine.
Registration Number 006735-04823
Formulated with propazine.
Use limited to the Great Plains. Preemergence.
Broadcast or band. Apply after planting and prior
to emergence of crop or weeds. Plant seed at
least 1 inch deep. Do not use on sand or loamy
sand soils, or on soils with less than 1 percent
organic matter. Apply in 25 to 40 gallons of
water per acre.
Formulated with 2-chloro-N-isopropylacetanilide.
1 ppm (dry or succulent soybeans)
1 ppm (forage, hay)
Do not apply within 60 days of harvest. Do not
feed forage or hay from treated fields to live-
stock.
LA state labels
Registration Number 001339-06934
Formulated with alachlor.
Registration Number 037820-08428
MO state label
Registration Number 010371-07538
Formulated with 4-(2,4-dichlorophenoxy)butyric
acid, dimethylamine salt.
Preemergence. Broadcast or band. Apply in 25 to
40 gallons of water per acre. Use the lower dos-
age on sandy loam soils with low organic matter
content (0.5 to 2 percent), and the higher dosage
on clay loam soils with moderate organic matter
content (2 to 5 percent). When weeds have
emerged, use with a surfactant.
Issued: 6-01-79
-31-
-------
EPA Index to Pesticide Chemicals
19900300
&050.0006
&050.0006
&012.5006
&003.0004
&007.5006
&050.0006
Site, Dosage
and Formulation
(Ib a.i./AJ
Soybeans (continued)
0.50-1.50
(50% WP)
0.25-1.25
(50% WP)
0.50
(12.5% WP)
0.45-1.00
(3% G)
0.45-1.01
(7.5% WP)
0.50-1.00
(50% WP)
LINURON
Tolerance, Use, Limitations
Use limited to east of the Rocky Mountains. Pre-
emergence. Broadcast or band. Tank mix with
alachlor. Apply in 25 to 40 gallons of water per
acre. Use the lower dosage on silt loam soils
with low organic matter content (0.5 to 3
percent), and the higher dosage on clay loam
soils with moderate organic matter content (3 to
6 percent).
Preemergence. Broadcast or band. Sequential
application following preplant incorporation of
trifluralin. Apply in 25 to 40 gallons of water
per acre. Use the lower dosage on sandy loam
soils with low organic matter content (0.5 to 2
percent), and the higher dosage on clay loam —
soils with over 5 percent organic matter content.
Preemergence. Broadcast or band. Apply at plant-
ing in 25 to 40 gallons of water per acre. Use on
loam soils only. Plant seed at least 1.5 inches
deep on flat or raised beds.
Formulated with chloramben, sodium salt.
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Apply the wettable powder in a minimum of 20 gal-
lons of water per acre. Do not apply over the top
of emerged soybeans. Plant seed at least 1.5 to
1.75 inches deep. Avoid use on loamy sand, sand
or gravely soils, or on soils with less than 1
percent organic matter, as injury may result.
Formulated with dimethyl tetrachloroterephthalate.
Use limited to the Midsouth and Southeast. Post-
emergence. Directed spray. Apply in a minimum
of 25 gallons of water per acre when soybeans are
at least 12 inches in height and weeds do not
exceed 4 inches in height. Do not spray higher
than 3 inches on soybean stem. When applying as
a single application, use with a surfactant. A
split application of the lower dosage can be made
1 week apart. Do not use on soils with less than
0.5 percent organic matter. Do not apply more
than 1 pound active ingredient per acre per
growing season.
Issued: 6-01-79
-32-
-------
EPA Index to Pesticide Chemicals
Site, Dosage
and Formulation
(Ib a.i./A)
/2802300
$2802305
&050.0006
19900300
0.33-1.50
(502 WP)
&005.0004
&101.0012
/2400700
0.33-1.50
(5% G)
0.34-1.50
(1 Ib/gal EC)
Wheat (winter)
(drill planted)
LINURON
Tolerance, Use, Limitations
Soybeans (seed crop) N.F.
Do not feed forage or hay from treated fields to
livestock.
Preemergence. Broadcast or band. Tank mix with
propachlor. Apply in 25 to 40 gallons of water
per acre. Use the lower dosage on sandy loam
soils with low organic matter content (1 to 3
percent), and the higher dosage on clay loam
soils with moderat» organic matter content (3 to
6 percent).
Preemergence. Broadcast or band. Apply after
planting and prior to emergence of crop or weeds.
Plant seed at least 1.75 inches deep. Do not use
on sand or loamy sand soils, or on soils with less
than 1 percent'organic matter. Apply the emulsi-
fiable concentrate in 25 to 40 gallons of water
per acre.
Formulated with 2-chloro-N-isopropylacetanilide.
0.25 ppm (grain)
0.5 ppm (forage)
Do not graze or feed immature plants to livestock.
General Information; Do not apply on sand or
loamy sand soils, on gravelly or sandy loams with
less than 1 percent organic matter, or on thinly
covered or exposed subsoil areas. Do not treat
wheat planted less than 1 inch deep. Do no apply
when daily temperatures exceed 60 F (15.6 C), or
when winter climatic conditions have produced
heaving of plants. Do not treat when crop lacks
vigor. Do not use in conjunction with other
pesticides, surfactants or nitrogen solutions
after wheat has emerged. Do not treat after the
boot stage. Do not replant treated areas with
any rotation crop within 6 months after last
application.
LA state label
Registration Number 037820-08428
Issued: 6-01-79
-33-
-------
$2400702
&050.0006
19001500
19001500
&050.0006
19001500
&050.0006
$2400701
&050.0006
EPA Index to Pesticide Chemicals
LINURON
Site, Dosage Tolerance, Use, Limitations
and Formulation
"(lb a.i./A)
Wheat (winter) (drill planted) (continued)
0.50-0.75
(50% WP)
0.50-0.75
(50% WP)
1.00-1.75
(50% WP)
0.50-0.75
(50% WP)
Use limited to ID, OR and WA, east of the Cascade
Range where the average annual rainfall is 10 to
16 inches. Preemergence. Broadcast. Fall or
winter treatment. Apply after wheat is planted
in the fall, when there is sufficient moisture
available to germinate wheat seed, and when weeds
are less than 2 inches in height. Do not apply
if the soil temperature is below freezing. Apply
in 25 to 40 gallons of water per acre by ground,
or 5 to 10 gallons by air.
Use limited to ID, OR and WA, east of the Cascade
Range where the average annual rainfall exceeds
16 inches. Preemergence. Broadcast. Fall treat-
ment. Apply to early planted wheat (seeded before
September 10) before weeds are 2 inches in height.
Do not apply after soil freezes. Apply in 25 to
40 gallons of water per acre by ground, or 5 to
10 gallons by air. If fall planted wheat fails
to grow due to adverse growing conditions after
treatment, wait 4 months before planting spring
wheat. Do not retreat the same field within 1
year.
Use limited to OR and WA, west of the Cascade
Range. Preemergence. Broadcast. Apply in 25 to
40 gallons of water per acre by ground, or 5 to
10 gallons by air. Chlorosis may occur if applied
to actively growing plants. Apply as soon as
possible after planting, using the lower dosage
on soils low in organic matter. If weeds and
wheat have emerged, apply before weeds are 3 to 4.
inches in height.
Use limited to ID, OR and WA, east of the Cascade
Range where the average annual rainfall exceeds
16 inches. Postemergence. Broadcast. Fall
treatment. Apply to early planted wheat (seeded
before September 10) before weeds are 2 inches in
height. Do not apply after soil freezes. If
fall planted wheat fails to grow due to adverse
growing conditions after treatment, wait 4 months
before planting spring wheat. Do not retreat the
same field within 1 year.
Issued: 6-01-79
-34-
-------
&050.0006
$2400715
&050.0006
19001500
EPA Index to Pesticide Chemicals
LINURON
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
Wheat (winter) (drill planted) (continued)
0.50-0.62
(50% WP)
1.00-1.75
(50% WP)
Use limited to ID, OR and WA, east of the Cascade
Range where the average annual rainfall exceeds
16 inches. Postemergence. Broadcast. Spring
treatment. Apply as soon as wheat emerges, and
before weeds are 2 inches in height.
Use limited to OR and WA, west of the Cascade
Range. Semi-dormant application. Broadcast.
Apply in 25 to 40 gallons of water per acre by
ground, or 5 to 10 gallons by air. Chlorosis may
occur if applied to actively growing plants. Use
the lower dosage on soils low in organic matter.
/6600100
AGRICULTURAL PREMISES
Fencerows
(agricultural)
$6600101
&050.0006
1.00-3.00
(50% WP)
&025.0006
1.00-2.00
(25% WP)
N.F.
LA state label
Registration Number 037820-08428
Broadcast. Apply in 40 to 100 gallons of water
per acre. To control established annual weeds
use with a surfactant. Apply when daily tempera-
tures exceed 70 F (21.1 C), and before weeds
exceed 8 inches in height.
Use limited to CA. Broadcast. Apply in 20 to 100
gallons of water per acre in early spring or at
the start of the rainy season, before weeds are 8
inches in height. Use the higher dosage when
weeds are 6 to 8 inches in height. A surfactant
may, be used.
Formulated with amitrole.
Issued: 6-01-79
-35-
-------
/3303400
$3303401
&003.5004
/3303400
$3303401
&003.5004
Site, Dosage
and Formulation
(Ib a.i./A)
EPA Index to Pesticide Chemicals
LINURON
Tolerance, Use, Limitations
ORNAMENTALS
General Warnings and Limitations: Do not use on bentgrass, fescue,
fescue mixtures, ryegrass or ryegrass mixtures. Delay application until
after the third mowing on newly seeded bluegrass. No more than 8.92
pounds active ingredient should be applied per acre per year. Soil
moisture that is adequate for active growth, and temperatures of 70 F
(21.1 C) or higher, will enhance control.
Kentucky Bluegrass
(golf course
fairways, tees)
2.21-2.94
(3.5Z G)
Kentucky Bluegrass
(sod production
fields)
2.94-4.42
(3.5% G)
N.F.
Broadcast. Apply by spreader when annual blue-
grass is growing actively. Water immediately fol-
lowing application. Two applications per year,
for 2 to 3 years, are required. Wait at least 4
weeks before retreating. Seeding should be
delayed for 2 months following these applications.
N.F.
Broadcast. Apply by spreader when annual blue-
grass is growing actively. Water immediately fol-
lowing application. Repeat applications may be
necessary in cooler weather. Use the higher dos-
age on organic soils such as muck or peat, and
the lower dosage on mineral soils. Seeding
should be delayed for 3 months after application
on organic soils, and 2 months after application
on mineral soils. Do not cut treated sod within
10 weeks after application.
RIGHTS-OF-WAY
/6700400 Highway Rights-of-Way N.F.
General Information: Highway rights-of-way in-
clude alleys, streets and roadsides.
— LA state label
Registration Number 037820-08428
$6700401 Broadcast. Refer to AGRICULTURAL PREMISES, Fence-
S6600101 rows (agricultural) for use and limitation infor-
mation.
Issued: 6-01-79
-36-
-------
/6701500
$6701501
S6600101
/6700000
$6700001
&025.0006
F
Site, Dosage
and Formulation
(Ib a.i./A)
COMMERCIAL AND INDUSTRIAL PREMISES
EPA Index to Pesticide Chemicals
LINURON
Tolerance, Use, Limitations
Fencerows
Vacant Lots
1.00-2.00
(25% WP)
N.F.
LA state label
Registration Number 037820-08428
Broadcast. Refer to AGRICULTURAL PREMISES,
Fencerows (agricultural) for use and limitation
information.
N.F.
Use limited to CA. Broadcast. Apply in 20 to
100 gallons of water per acre in early spring or
at the start of the rainy season, before weeds are
8 inches in height. Use the higher dosage when
weeds are 6 to 8 inches in height. A surfactant
may be used.
Formulated with amitrole.
AERIAL AND TANK MIX APPLICATIONS
Aerial Application
Tank Mix
Refer to
AGRICULTURAL CROPS
Potato, Wheat (winter)(drill planted)
Refer to
AGRICULTURAL CROPS
Corn (Field), Sorghum, Soybeans, Soybeans (seed
crop)
Issued: 6-01-79
-37-
-------
EPA Index to Pesticide Chemicals
LINURON
Listing of Registered Pesticide Products by Formulation
&095.0001 952 technical chemical
# linuron (035506)
000352-00326
&050.0002 50% formulation intermediate
# linuron (035506)
000352-00339
&000.1504 0.154% granular
# linuron (035506) plus propazine (080808)
006735-04822
&000.2304 0.2312 granular
# linuron (035506) plus propazine (080808)
006735-04821
&000.2504 0.25% granular
# linuron (035506) plus atrazine and related compounds (080803)
006735-04820
&000.3104 0.308Z granular
# linuron (035506) plus propazine (080808)
006735-04823
&003.0004 32 granular
# linuron (035506) plus dimethyl tetrachloroterephthalate (078701)
000677-00307
&003.5004 3.5% granular
# linuron (035506)
000538-00110
&005.0004 52 granular
# linuron (035506) plus 2-chloro-N-isopropylacetanilide (019101)
000352-00334 000524-00289
&007.5006 7.52 wettable powder
# linuron (035506) plus dimethyl tetrachloroterephthalate (078701)
000677-00285
&012.5006 12.52 wettable powder
# linuron (035506) plus chloramben, sodium salt (029906)
000264-00254
&015.0006 152 wettable powder
* linuron (035506) plus 2-chloro-N-isopropylacetanilide (019101)
000524-00288
&020.0006 202 wettable powder
# linuron (035506) plus 2-chloro-N-isopropylacetanilide (019101)
008461-00003
Issued: 6-01-79
-36-
-------
EPA Index to Pesticide Chemicals
LINURON
Listing of Registered Pesticide Products by Formulation (continued)
&020.5006 20.51 wettable powder
# linuron (035506) plus atrazine and related compounds (080803)
008461-00029
&025.0006 25% wettable powder
# linuron (035506) plus amitrole (004401)
000264-00246
&030.8006 30.8% wettable powder
# linuron (035506) plus atrazine and related compounds (080803)
000595-00268 001386-00493 003770-00158 006735-04810
008461-00001 008590-00271
&050.0006 50% wettable powder
# linuron (035506)
000352-00270 002749-00158 037820-08428
&101.0012 1 Ib/gal emulsifiable concentrate
tf linuron (035506) plus 2-chloro-N-isopropylacetanilide (019101)
000352-00345
&100.9014 0.9 Ib/gal flowable concentrate
# linuron (035506) plus propazine (080808)
006735-04809
&101.5014 1.5 Ib/gal flowable concentrate
# linuron (035506) plus alachlor (090501)
001339-06934
&204.3414 4.34% flowable concentrate
linuron (035506) plus 4-(2,4-dichlorophenoxy)butyric acid, dimethylamine
# salt (030819)
010371-07538
Issued: 6-01-79
-39-
-------
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This chapter applies only to manufacturing-use produces,
not end-use products.
A necessary first step in determining which statements must
appear on your product's label is the completion and submission
to EPA of product-specific data* listed on the form entitled
"Product Specific Data Report" (EPA Form 8580-4, Appendix III-l)
to fill "gaps" identified by EPA concerning your product. Under
the authority of FIFRA Section 3(c)(2)(B), EPA has determined
that you must submit these data to EPA in order to register or
reregister your product(s). All of these data must be submitted
not later than six months after you receive this guidance document.
"Product-Specific Data Requirements for Manufacturing-Use
Products" appearing in Table 3 permit you to determine which
product-specific data you must submit. This can be .gone by
examining the entries in 'the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B)."
_VProduct specific data pertains to data that support the
formulation which is marketed; it usually includes product
chemistry -data and acute toxicology data.
-40-
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR LINURON
Data Requirement
§158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Ingredients
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
V
Composition
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
Partially 00018443, 00018446
00018444, 00018447
Partially 00018443, 00018446
00018444, 00018447
No
No
No
No
No
No
No
No ,
N/A 5/
No
-41-
Must Additional
Data Be Submitted
Under FIFRA Sectio
3(c)(2)(B)?2/
Yes 3/
Yes 3/
Yes V
Yes 3/
Yes 3/
Yes 3/
Yes 3/
Yes _3/
Yes V
Yes V
Yes 3/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
Data Requirement
Conposition
I/
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/
§158.120 Product Chemistry
(continued)
63- 8 - Soluoility
63- 9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
64- 1 - Submittal of samples
TGAI
PAI
PAI
PAI
TGAI
TGAI
Choice
No
No
No
NO
No
No
N/A 5/
Yes
Yes 3/i/
Yes V
Yes 3/4/
Yes 3/
Yes 3/
-42-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
SI58.120 Product Chemistry
(continued)
_!/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; Choice = Choice of
several test substances determined on a case-by-case basis.
_2/ Data must be submitted no later than six months from the receipt date of this guidance package.
3/ Physical/chemical properties for which data were not submitted constitute product chemistry data gaps.
_£/ Chemistry data are required because of the Agency's concern for possible groundwater contamination.
_5/ N/A= Not applicable for purposes of this standard.
-43-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
Data Requirements
Composition
I/
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
171-4 - Nature of Residue (Metabolism)
- Plants PAIRA
Partially
00018173,00027624 Yes 3/
00018176
- Livestock
171-4 - Residue Analytical Method
- Plant residues
PAIRA and plant
metabolites
Yes
TGAI and metabolites Yes
00029932
No
00018087,00018176 No
00018089
- Animal residues
TGAI and metabolites Yes
00018127
No
171-4 - Storage Stability Data
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
PAI
No
Yes
0 Asparagus
0 Carrots
(With, without tops)
TEP
TEP
Partially
Partially
00018089,00018087 Yes 4/
00018172,00027635 Yes 4/
Celery
TFP
Partally
00018443
Yes 4/
-44-
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR LINURON
Data Requirements
Composition
I/
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
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
0 Corn
(Field and Sweet)
TEP
Partially
( Cottonseed )
0 Parsnips
(With, without tops)
0 Potatoes
0 Sorghum
0 Soybeans
TEP
TEP
TEP
TEP
TEP
Partially
Partially
Partially
Partially
Partially
00018171,00018206
00018375,00018382
00018450
00018067
00018171
00027635
00018171,00018148
00018076,00018206
00027635
Yes 4/
Yes 4/
Yes 4/
Yes _4/
Yes 4/
Yes 4/
0 Wheat
TEP
Partially
00018171,00018175
Yes 4/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted .
Under FIFRA Section
3(c)(2)(R)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
Potable Water
Fish
Irrigated Crops
— Field trials
— Processed Food/Feed
Food Handling
Meat/milk/poultry/eggs
EP
EP
EP
EP
EP
EP
N/A 6/
N/A
N/A
N/A
No
N/A
Yes 5/
Cattle
0 Poultry
Eggs
TGAI
TGAI
TGAI
Yes
Yes
Yes
00018209,00018210
00018375,00018450
00018775
00029932
00018383
No
No
No
-Z,6-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
SI58.125 Residue Chemistry
(continued)
JY Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP
Typical end-use product; EP = End-use product.
2/ Data must be submitted no later than one year from the receipt date of this guidance package.
3/ The Agency will decide shortly whether data on 3,3,4',4'-tetrachloroazobenzene formation is required or not.
_4_/ Residue data for asparagus, carrots, celery, corn, cottonseed, parsnips, potatoes, sorghum, soybeans, and
wheat are required to reflect uses of the 50%, dry flowable (DF) and 4 Ib/gal, flowable concentrate (FIC)
formulations. Data reflecting uses of the 50% DF are required for the following commodities: carrots (aerial
applications), potatoes (aerial applications), soybeans (preemergence), sorghum (forage), wheat (forage and hay),
asparagus (preemergence), and cottonseed (two applications per season).
_5/ Data pertaining to residues in dehydrated potato products are required.
6/ N/A= Not applicable for the purposes of this standard.
-47-
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TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
Data Requirement
Conposition
I/
Use 2/
Pattern
Does EPA Have Data
To Satisfy This
Requ irement? (Yes,
No or Partially)
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?3/
$158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradation
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES;
163-1 - Leaching and
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TGAI or PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA A,B
TEP
TEP
A
A
No
No
NO
No
NO
NO
N/A 10/
N/A
Partial
No
No
05016640
05019500
Yes 4/
Yes A/
Yes A/
Yes
Yes 5/
Yes 5/
Yes 4/ 6/
Yes
Yes
-43-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
t
I/ Use 2/
Data Requirement Composition Pattern
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
No or Partially) Citation 3(c) (2) (B)?3/
§158.130 Environmental Fate
DISSIPATION STUDIES-FIELD:
164-1
164-2
164-3
164-4
164-5
- Soil TEP A,B
- Aquatic (Sediment) TEP
- Forestry TEP
- Combination and
Tank Mixes
- Soil, Long-term TEP A
No
N/A 10/
N/A
N/A
No
Yes 5/
Yes
ACCUMULATION STUDIES:
165-1
165-2
165-3
165-4
165-5
- Rotational Crops PAIRA A
(Confined)
- Rotational Crops TEP A
(Field)
- Irrigated Crops TEP
- In Fish TGAI or PAIRA A,B
- In Aquatic Non-Target TEP
No
No
N/A
No
N/A
Yes 7/
Yes 7/
Yes
Organisms
SPECIAL TESTING;
- Applicator Exposure
SSubpart K- Reentry
TEP
TEP
A
8/
No
Yes 9/
Yes
-49-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINUPON
§158.130 Environmental Fate
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = pure active ingredient, radiolabelled,
TEP = Typical end-use product. s
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D= Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Data must be submitted no later than two years from the receipt date of this guidance package, unless otherwise
noted.
4/ Data must be submitted no later than six months from the receipt date of this guidance package (Agency groundwater
data requirements)
j>/ Data must be submitted no later than two years from the receipt date of this guidance package (Agency groundwater
data requirements)
6/ Additional data are needed to assess the mobility of linuron degradation products. Data on the parent compound
are acceptable.
7/ For crops rotated on treated areas, any one of the following will apply:
a. A tolerance must be obtained for the rotated crop,
b. The product label must include a restriction against the rotation of crops used for food or feed on treated
areas,
c. Data must be provided to determine time intervals at which rotated crops planted on treated areas will be
free of pesticide residues.
8/ Until data are submitted and evaluated, reentry into treated fields (post emergence) is restricted for 24 hours
following the application of linuron unless protective clothing is worn.
9/ Dermal and inhalation applicator exposure data are required by the Agency. Data must be submitted in one year
from the receipt date of this guidance package. The Agency needs these data for the special review of linuron.
The registration should contact the Agency when designing studies.
10/ N/A= Not applicable for the purposes of this standard.
-50-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
I/ Use
Data Requirement Composition Patterns
Does EPA Have Data
To Satisfy This
2/ Requirement? (Yes, Bibliographic
No or Partially) Citation
Must Additional
Data Be Submitted
Under FIFRA Secti<
3(c)(2)(B)
§158.135 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Oral Toxic ity-Rat
- Dermal Toxic ity
- Inhalation Toxicity-Rat
- Primary Eye Irritation
- Primary Skin Irritation
- Dermal Sensitization
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Yes 00027625, 05016511
Yes 00027625
Yes 00018181
Yes 00018178, 00018183
00018179, 00018196
Yes 00018180
Partially GS0047-0001
N/A 9/
NO
NO
NO
NO
NO
Yes
SUBCHKONIC TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding -
Rodent, Non- rodent
- 21-Day Dermal
- 90-Day Dermal
- 90-Day Inhalation -
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
N/A
N/A
N/A
N/A
Rat
82-5 - 90-Day Neurotoxicity-
Hen/Mammal
TGAI
A,B
N/A
-51-
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TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
Data Requirement
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)
SI58.135 Toxicology
(continued)
CHRONIC TESTING:
83-1 - Chronic Toxicity -
2 species: Rodent
and Non-rodent
83-2 - Oncogenicity Study -
2 species: Rat and
Mouse preferred
83-3 - Teratogenicity -
2 species
TGAI
TGAI
TGAI
A,B
A,B
A,B
Yes
Yes
Partially
00018374, 00029680 No
00029679
00029680, 00124195 No
00029679
00018167, 00018170 Yes 4/
83-4 - Reproduction,
2-gcneration
TGAI
A,B
Partially
00018169
Yes '3/ 5/
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Other Mechanisms of
Mutagenicity
TGAI
84-2 - Chromosomal Aberration TGAI
TGAI
A,B
A,B
A,B
Partially
Partially
NO
00029933
00029933
_
Yes 6/ 8/
Yes 6/ 8/
Yes 6/ 8/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
Data Requirement
Does EPA Have Data
To Satisfy This
JY Use 2/ Requirement? (Yes,
Ccmposition Pattern No or Partially)?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)
S158.135 Toxicology
(continued)
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA A,B
85-2 - Domestic Animal Safety Choice
Partially
N/A 9/
05016511
Yes 10/
Special Dietary Exposure
PAIRA
A,B
No
Yes 3/ 7/
-53-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
§158.135 Toxicology
(continued)
_!_/ Composition: PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several
test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
V Data must be submitted no later than two years fron the receipt date of this guidance package.
_4_/ Two teratogenicity studies are reguired, one in rat and one in another species (rabbit). Data must be submitted no
later than one year frcm the receipt date of this guidance package. The Agency needs these data for the special
review of linuron.
5_/ A two-generation reproduction study in rats is required; this study must be designed to incorporate concerns
regarding the significance of interstitial cell adenomas. Note that in the former studies (rat and dog),
reticulocytes and erythroid precursors were not measured. This is a data gap, since at the high dose level (625ppm),
hemosiderin was observed in rats and also at 125 and 625 ppm in the dog.
(This data may be filled by appropriate design inclusion into the required reproduction study above. The registrant
must consult with the Agency on the appropriate protocol.)
6/ Mutagenicity and related data are required, which (1) satisfy the 3 mutagenicity testing category requirements,
(2) adequately identify the risks , and where possible identify the mechanisms associated with positive findings
in rodent chronic studies. Data must be submitted no later than six months from the receipt date of this guidance
package. The Agency needs these data for the special review of linuron.
7/ The Agency is requiring data, relating levels of sulf- and methemoglobin following dietary exposure for
certain substituted phenyl urea compounds such as linuron. This testing may be combined with other testing
involving dietary exposure, such as the reproduction study. Dose levels must be such that a NOEL may be established.
_8_/ The following four mutagenicity studies have been received and are in Agency review:
~ a. "Mutagenicity Evaluation In (Salmonella typhimurium)",HLR 106-83, 5/5/83,
b. "Unscheduled DNA Synthesis/ Rat Hepatocytes In Vitro", HLR 190-83, 6/3/83,
c. "CHO/HGPRT Assay for Gene Mutation", HLR 540-83, 12/16/83,
d. "In Vivo Bone Marrow Chromosome Study in Rats", HLO 378-83, 9/1/83.
9/ N/A= Not applicable for the purposes of this standard.
10/ Data must be submitted no later than six months frcm the receipt date of this guidance package. The Agency needs
these data for the special review of linuron.
-5k-
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR LINURON
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?V
S158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-3
71-4
71-5
- Avian Oral Toxicity
- Avian Dietary Toxicity
- Wild Mammal Toxicity
- Avian Reproduction
- Simulated and Actual
TGAI A,B
TGAI A,B
TGAI
TGAI
TEP
No
Yes
N/A 6/
N/A
5/
Yes
00034769 No
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Acute Toxicity Freshwater TGAI
Fish
72-2 - Acute Toxicity Freshwater TGAI
Invertebrates
72-3 - Acute Toxicicy Estuarine TGAI
and Marine Organisms
72-4 - Fish Early Life TGAI
Stage and Aquatic
Invertebrate Life-Cycle
A,B
A,B
No
No
N/A
5/
Yes
Yes
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
_!/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c) (2) (B)?j/
§158.145 Wildlife and
Aquatic Organisms
(continued)
72-5 - Fish - Life-Cycle TGAI 5/
72-6 - Aquatic Organism TGAI, PAI OR 5/
Accumulation Degradation
Product
72-7 - Simulated or Actual TEP JS/
Field Testing -
Aquatic Organisms
-56-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honey bee acute
contact toxicity
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
TGAI
TEP
TEP
A,B
(Reserved)4/
TEP
Yes
N/A 6/
N/A
00018842
No
N/A
-57-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINURON
Data Requirement
I/ Use 2/
Conposition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.155 Nontarget Insect
(continued)
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects
142-2 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
TESTING - PREDATORS
143-1 - NONTARGET INSECT
thru AND PARASITES
143-3
(Reserved )J5/
(Reserved )J3/
(Reserved )J5/
(Reserved)5/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR LINUPQN
§158.145 Wildlife and Aquatic Organisms
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient;
TEP = Typical end-use product;
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; C=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 two years after the receipt of this guidance package.
_4/ [Reserved] Requirements reserved pending development of test methodology.
_5/ [Reserved] Pending decision as to whether data requirement should be established.
6/ N/A= Not applicable for the purposes of this standard.
-59-
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING LINURON
Data Requirement
I/
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.120 Product Chemistry
Product Identity;
61-1 - Identity of Ingredients MP
61-2 - Statement of Composition MP
61-3 - Discussion of Formation of MP
Ingredients
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods for MP
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
63-5 - Melting Point MP
63-6 - Boiling Point MP
63-7 - Density, Bulk Density, or MP
Specific Gravity
Partially
Partially
No
No
No
No
No
No
No
No
N/A 4/
No
-60-
00018443, 00018446
00018444, 00018447
00018443, 00018446
00018444, 00018447
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING LINURON
Data Requirement
Composition
I/
Does EPA Have Data
To Satisfy This
Requ irement? (Yes,
No or Partially)
coefficient
63-12 - pH
63-13 - Stability
Other Requirements;
64- 1 - Submittal of samples
MP
MP
Choice
No
No
N/A 4/
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.120 Product Chemistry
63- 8
63- 9
63-10
63-11
(continued)
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
MP
MP
MP
MP
No
No
No
No
Yes 3/
Yes 3/
Yes
Yes 3/
Yes
Yes
-61-
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING LINURON
§158.120 Product Chemistry
(continued)
V Composition: MP = Manufacturing-use product; Choice = Choice of several test substances determined on a case-by-
case basis.
_2/ Data must be submitted no later than six months from the receipt date of this guidance package.
_3/ Chemistry data are required because of the Agency's concern for possible groundwater contamination.
4/ N/A= Not applicable for purposes of this standard.
-62-
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING LINURON
Data Requirement
Composition
I/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliograph ic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
$158.135 Toxicology
ACUTE TESTING
81-1 - Oral ^c-'icity-Rat MP
81-2 - Dermal Toxicity MP
81-3 - Inhalation Toxicity-Rat MP
81-4 - Primary Eye MP
Irritation - Rabbit
81-5 - Primary Dermal MP
Irritation
81-6 - Dermal Sensitization .MP
Yes
Yes
Yes
Yes
Yes
Partially
00027625, 05016511
00027625,
00018181
00018178, 00018183
00018179, 00018196
00018180
GS0047-0001
No
NO
NO
NO
NO
Yes
-63-
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING LINURON
S15R.135 Toxicology
(continued)
I/ Composition: MP = Manufacturing-use product.
2/ Data must be submitted no later than six months from the receipt date of this guidance package.
-64-
-------
IV. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This chapter applies only to manufacturing-use products,
not end-use products.
The Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate, complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are suffi-
ciently standardized to avoid user confusion.
, As part of your application, you will be required to submit
drift labeling consistent with: applicable product-specific
da~ca; the precautionary statements and use directions; and the
regulations concerning classification [40 CFR §162.11(c)], pack-
aging [40 CFR §162.16], and labeling [40 CFR §162.10, Appendix
IV-1 an IV-2], as indicated by the following paragraphs of this
chapter of the guidance document. . *-"••. _
You will be informed later when you must submit the revised
labeling set forth in this guidance package.
A. Label Contents
40 CFR §162.10 (Appendix IV-1) requires that certain spe-
cific labeling statements must appear at certain locations
on the label. This is referred to as format labeling.
Specific label items listed below are keyed to Tables D, E,
and F (Appendix IV-2).
Item 1. PRODUCT NAME - The .name, brand, or trademark is
required to be located on the fnont panel, preferably centered
in the upper part of the panel. J.' The name of a product will
not be accepted if it is false or misleading..- See Appendix
IV-1. [40 CFR §162.10(b)j
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
.See Appendix IV-1. [40 CFR §162.10(c)]
Item 3» NET CONTENTS - A net content statement is required
on all labels. The preferred location is the bottom of the
front panel immediately above the company name and address,
or at the end of the label text. The net contents must be
stated in terms of weight, expressed as avoirdupois pounds
-65-
-------
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 Apoendix IV-1. [40 CFR
§162.10(d)]
Item 4. EPA'REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded .by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV-1.
[40 CFR §162.10(e)]
Item 5. -EPA ESTABLISHMENT NUMBER - The E2A-establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and* may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment registration number on
the immediate container cannot be clearly read through such
wrapper or container. See Appendix IV-1. [40 CFR §162.10(f)j
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and must contain the name and
percentage by weight of each active ingredient and the total
percentage by weight of all inert ingredients. The preferred
location is immediately below the product name. The ingredient
statement must run parallel with!/ and be clearly distinguished
from, other text on the panel, jit mus.t not be placed in the
body of other text. See Appendix IV-1. [40 CFR 162.10(g)j
Item 6A. POUNDS PER GALLON STATEMENT - For liquid
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on 'the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, preferably within a block outline. The
table below shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
-66-
-------
Size of Label Signal Word as Re- "Keep Out of Reach
on Front Panel . quired Minimum Type of Children"
in Sauare Inches Size All Caoitals as Reauired
5 and under 6 point 6 point
above 5 to 10 .10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 . 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - All labels are
required to have the statement "Keep Out of Reach of Children"
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
See Appendix IV-1 . [40 CFR §162 . 10 (h ) ( 1 ) ( ii ) ]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Aooencix IV-1.
[40 CFR §162.10 (h) (l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, or dermal toxicity, the word "Poison" shall appear on
the label in red on a background of distinctly contrasting
color and the skull and crossbones shall appear in immediate
proximity to the word poison. See Appendix IV-1. [40 CFR
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in ,-toxicity Categories I,
II, and III. See Appendix IV-1. £40 CFR §162. 10(h) (1) (iii) ]
Item 7E. REFERRAL STATEMENT - The statement •' "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements apoear on the front panel.
See Appendix IV-1. [40 CFR §162. 10 (h ) (1 ) (iii ) ]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
approoriate hazard title. See Appendix IV-1. [40 CFR §162.10
(h)(2*)]
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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 Aooendix IV-1. [40 CFR §162.10
Item SB. 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 damaae. See Appendix IV-1. [40 CFR
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements
relating to f lammability of a product are _ required
to appear on the label if it meets the criteria in
Appendix IV-3. The requirement is based on the results
of the flashpoint determinations and flame extension
tests required to be submitted for all products .
These statements are to be located in the side/back
panel precautionary statements section, preceded by
the heading "Physical/Chemical Hazards." Note that
no signal word is used in conjunction with the flam-
mability statements .
2. Criteria for declaration of non-f lammability . The
following criteria will be used to determine if a
product is non-flammable:
i
a. A "non-flammable gas" is a gas (or mixture of
gases) that will not ignite when a. lighted match
is placed against the open cylinder Valve.
b. A "non-flammable liquid" is one having a flash-
point greater than 350°.F (177°C) as determined
by the method specified in 40 CFR §163 . 61-8 (c) ( 13 )
(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the
method specified in 40 CFR §163 . 61-8 ( c ) ( 13 ) (ii ) ;'
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C),
determined by ~he method specified in 40 CFR
§163.6l-8(c) (13) (i) .
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3. Declaration of ncn-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 mix-ing with
other substances to produce toxic fumes. '-,
Item 9. MISUSE STATEMENT - The following statement is
required on your label: "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling."
See Appendix IV-1. [40 CFR §162.10(1)(2)(ii)]
Item 10A. STORAGE AND DISPOSAL. BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. Make certain that the statement you use
pertains specifically to your product. These instructions
must be grouped and appear under the heading "Storage and
Disposal" in the directions for use,. This heading must be
set in the same type sizes as required for the child hazard
warning. Refer to Appendix IV-5 fbr the•latest specific
storage and disposal product label statements.
Item 10B. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV-1. [40 CFR §162.10]
B. Collateral: Information
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, and other graphic printed matter which is referred to
on the label or which is to accompany the product are termed
collateral labeling. Such labeling may not bear claims or
representations that differ in substance from those accepted
in connection with registration of the product. It should be
made part of the response to this notice and submitted for review
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V. INSTRUCTIONS FOR SUEMlSSlOi:
All acclications crecarec in resccr.se to this Notice shcul;
be'addressed as follows:
Eobert J. Taylor
Phone Nc. (7C3) 557-1800
Registration Division(TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, B.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 S5SC-4 (Accencix
III-l). .
c. Two copies of any required product-specific data.
2. Within the time, set forth in Table A, all generic data
must be submitted by the affected reci
i
Note:
so that meeting the agreed submission'time will be delayed,
notify the Product Manager listed above.
You will be informed -at a later date when you must submit your
Application for Amended Pesticide Registration (EPA Form 6570-1)
and the revised labelinc set forth in this Guidance cackace.
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Guide to Use of This Bibliography
1. Content of Bibliography: This bibliography contains citations of all the
studies reviewed by EPA in arriving at the positions and conclusions stated
elsewhere-in the Standard. The bibliography is divided into two sections:
(1) citations that contributed information useful to the review of the chemical
and that are considered to be part of the -data base supporting registrations
under the Standard, and (2) citations examined and judged to be inappropriate
for use in developing the Standard. This second part of the bibliography
exists in the Agency's files and does not accompany this Standard. Interested
parties may request a copy from the Agency. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its
predecessor agencies in support of past regulatory decisions, and the published
technical literature.
2. Units of Entry: The unit of entry in this bibliography is called a "study".
In the case of published materials, this corresponds closely to an article.
In the case of unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to the published
article from within the typically larger volumes in which they were submitted.
The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review, and can be described with a
conventional bibliographic citation. The Agency has attempted also to unite
basic documents and commentaries upon them, treating them as a single study.
3. Identification of Entries: The entries in this bibliography are sorted by
author, date of the document, and title. Each entry bears, to the left of the
citation proper, an eight-digit numeric identifier. This number is unique to
the citations, and should be used at any time specific reference is required.
This number is called the "Master Record Identifier", or "MRID". It is not
related to the six-digit "Accession Number" which has been used to identify
volumes of submitted data; see paragraph 4(d)(4) below for a further
explanation. In a few cases, entries added to the bibliography late in the
review may be preceded by an eight-character temporary identifier. This is
also to be used whenever specific reference is needed.
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4. Form of the Entry: In addition to the Master Record Identifier (MRID),
each entry consists of a bibliographic citation containing standard elements
followed, in the case of materials submitted to EPA, by a description of the
earliest known submission. The bibliographic conventions used reflect the
standards of the American National Standards Institute (ANSI), expanded to
provide for certain special needs. Seme explanatory notes of specific
elements follow;
a. Author: Whenever the Agency could confidently identify one, the
Agency has chosen to show a personal author. When no individual was
identified, the Agency has shewn an identifiable laboratory or
testing facility as author. As a last resort, the Agency had shown
the first known submitter as author.
b. Document Date: When the date appears as four digits with no question
marks, the Agency took it directly from the document. When a four
digit date is followed by a question mark, the bibliographer deduced
the date from evidence in the document. When the date appears as
(19??), the Agency was unable to determine or estimate the date of
the document.
c. Title: This is the third element in the citation. In some cases it
has been necessary for Agency bibliographers to create or enhance a
document title. Any such editorial insertions are contained between
square brackets.
d. Trailing Parentheses: For studies submitted to the Agency in the
past, the trailing parentheses include (in addition to any self-
explanatory text) the following elements describing the earliest
known submission:
(1) Submission Date: Immediately following the word 'received'
appears the date of the earliest known submission.
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(2) Administrative Number: The next element, immediately following
the word 'under', is the registration number, experimental
permit number, petition number, or other administrative number
associated with the earliest known submission.
(3) Submitter: The third element is the submitter, following the
phrase 'submitted by'. When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification: The final element in the trailing
parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six
digit accession number follows the symbol 'CDL', standing for
"Company Data Library". This accession number is in turn
followed by an alphabetic suffix which shows the relative
position of the study within the volume. For example, within
accession number 123456, the first study would be 123456-A; the
second 123456-B; the 26th, 123456-2, and the 27th 123456-AA.
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Appendix li-l
Office of Pesticide Programs
Registration Standard Bibliography
Citations Considered to be Part of the Data Base
Supporting Registration Under the Linuron Standard
00018067 E. I. du Pont de Nemours & Co., Inc. (1961) Residue Data—
Linuron— Sweetcorn, (unpublished study received April 8, 1963
Under unknown admin, no.; CDL:124702-B) •
00018087 California, Department of Food and Agriculture (19??)
Determination of Linuron Residues on Asparagus. Undated
method. (Unpublished study/received March 20. 1975 under
3E1373; CDL:093663-8)
00018089 California, Department of Agriculture (1974) Linuron Recoveries
from Asparagus by Alkaline Hydrolysis (200 gram samples).
Method dated July 31, 1974. (Unpublished study received on
unknown date under 3E1373; CDL:093662-B)
00018127 E. I. du Pont de Nemours & Co., Inc. (1962) Determination of
3-(3,4-Dichlorophenyl)-l-methoxy-l-methylurea (Linuron) in
Soils and Plant Tissue. (Unpublished study received Nov. 8, 1962
under 352-270; CDL:026676-D)
00018148 E. I. du Pont de Nemours & Co., Inc. (1970) Residue Data: Table A,
(Unpublished study received Sept. 16, 1971 under 352-270; CDL:
125817-A)
00018167 E.I. du Pont de Nemours & Co., Inc. (1978) Teratogenicity Study of
Linuron in Rats: Haskell Laboratory Report No. 33-79.
(Unpublshed study received Sept. 13, 1979 under 352-270: CDL:
240982-B)
00018169 Hodge, H.C.; Downs, W.L.; Maynerd, E.A. (1963) Second Reproduction
Study of Rats Fed Linuron. (Unpublished study received Oct. 5,
1966 under 7F0542; prepared by Univ. of Rochester, Dept. of
Pharmacology, submitted by E. I. du Pont de Nemours & Company,
Inc., Wilmington, DE.; CDL:090665-A)
00018170 Powers, M.B. (1965) Reproduction Study-Rabbits. (Unpublished
study received Oct. 5, 1966 under 7F0542; prepared by Hazelton
Laboratories, Inc., submitted by E. I. du Pont de Nemours &
Company, Inc., Wilmington, DE.; CDL:090665-B)
00018171 E. I. du Pont de Nemours & Co., Inc. (1966) Results of Tests
on the Amount of Residue ir- Crops Grown on Treated Soil.
(Unpublished study received Oct. 5, 1966 under 7F0542; CDL:
090665-C)
00018172 E. I. du Pont de Nemours & Company, Inc., (1963) Residue Data:
Linuron-Carrots: Preemergence Treatment. (Unpublished study
study received Oct. 5, 1966 under 7F0542; CDL: 090665-D)
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00018173 Belasco, I.J. (1967) Absence of Tetrachloroazobenezene in Soils
Treated with Diuron and Linuron. (Unpublished study received
on unknown date under 7F0542; submitted by E. I. du Pont de
Nemours & Company, Inc., Wilmington, DE.; CDL:092830-A)
00018175 E. I. du Pont de Nemours & Company, Inc., (19??) Residue Data:
Linuron-Diuron: Cereal Grains. (Unpublished study received
Oct. 14, 1966 under 7F0542; CDL: 092830-D)
00018176 Reasons, K.M.; Furtick, W.R.; Atkeson, G.A.; et al.(1966) Additional
Data in Support of Petition. (Unpublished study received Oct.
14, 1966 under 7F0542; submitted by E. I. du Pont de Nemours
& Company, Inc., Wilmington, DE.; CDL:092830-G)
00018178 Kapp, R.W. (1975) Final Report: Acute Eye Irritation Potential Study
in Rabbits: Project No. 915-104. (Unpublished study received
Dec. 19, 1977 under 33660-11; prepared by Hazelton Laboratories
America, Inc., submitted by Industrie Prodotti Chimici s.p.a.;
Novate Milanese, Italy; CDL:232505-B)
00018179 Reno, F.E. (1976) Final Report: Acute Eye Irritation Potential Study
in Rabbits: Project No. 915-118. (Unpublished study received
Dec. 19, 1977 under 33660-11; prepared by Hazelton Laboratories
America, Inc., submitted by Industrie Prodotti Chimici s.p.a.;
Novate Milanese, Italy; CDL:232505-C)
00018180 Kapp, R.W. (1975) Final Report: Primary Skin Irritation Study in
Rabbits: Project No. 915-105. (Unpublished study received
Dec. 19, 1977 under 33660-11; prepared by Hazelton Laboratories
America, Inc., submitted by Industria Prodotti Chimici s.p.a.;
Novate Milanese, Italy; CDL:232505-D)
00018181 Kapp, R.W. (1975) Final Report: Acute Inhalation Toxicity Study in
Rats: Project No. M915-103. (Unpublished study received Dec.
19, 1977 under 33660-11; prepared by Hazelton Laboratories
America, Inc., submitted by Industria Prodotti Chimici s.p.a.;
Novate Milanese, Italy; CDL:232505-E)
00018183 Seaman, L.; Doyle, P.E. (1979) Primary Eye Irritation: Laboratory
No. 9E-4148. (Unpublished study received Mar 14, 1979 under
1812-245; prepared by Cannon Laboratories, Inc., submitted
by Griffin Corp., Valdosta, GA.; CDL:237806-B)
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00018196 Edwards, D.F. (1979) Eye Irritation in Rabbits-EPA Pesticide
Registration: Haskell Laboratory Report No. 2-79. (Unpublished
study received June 21, 1979 under 352-394; submitted by E. I.
du Pont de Nemours & Company, Inc., Wilmington, DE.;
CDL:238656-D)
00018206 E. I. du Pont de Nemours & Co., Inc. (1962) Results of Tests on
the Amount of Residue in Crops Grown on Treated Soil: Linuron.
(Unpublished study received April 13, 1963 under PP0356; CDL:
092640-E)
00018209 E. I. du Pont de Nemours & Co., Inc. (19??) Feeding Study at
1 PPM in Corn Fodder. (Unpublished study received April
13, 1963 under PP0356; CDL: 092640-1)
00018210 E. I. du Pont de Nemours & Co., Inc. (1954?) Feeding Study at
50 PPM in Total Daily Diet. (Unpublished study received
April 13, 1963 under PP0356; CDL:092640-J)
00018374 Hodge, H.C.? Downs, W.L.; Maynerd, E.A. (1963) Chronic Feeding Studies
of Linuron (Herbicide 326) in Dogs. (Unpublished study received
Feb. 7, 1966 under PP0356; prepared by Univ. of Rochester, Dept. of
Pharmacology, submitted by E. I. du Pont de Nemours & Company,
Inc., Wilmington, DE.; CDL:090386-A)
00018375 E. I. du Pont de Nemours & Co., Inc. (1962) Linuron Livestock
Feeding Studies: Milk and Meat. (Unpublished study received
Feb. 7, 1963 under PP0356; CDL:090386-B)
00018382 E. I. du Pont de Nemours & Co., Inc. (1962) Residue Data; Linuron—
Sweetcorn 1962. (Unpublished study received April 13, 1962
under 352-270; CDL: 090385-D)
00018383 E. I. du Pont de Nemours & Co., Inc. (1963) Linuron: Poultry Feeding
Studies: Residue Data — Tissues and Eggs. (Unpublished study
received April 13, 1962 under 352-270; CDL: 090385-E)
00018443 E. I. du Pont de Nemours & Co., Inc. (1970) The Results of Tests on
the Amount of Linuron Residue Remaining on or in Celery including
a Description of the Analytical Method Used. (Unpublished
study received April 18, 1971 under 1E1148; submitted by
Interregional Research Project No. 4, New Brunswick, N. J.;
CDL: 090935-A)
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00018444 IR-4 Project at Rutgers, the State University (19??) Annual Weeds
Controlled at rates of 0.5 to 2 Pounds Actual Linuron per Acre.
(Unpublished study received April 18, 1971 under 1E1148; CDL:
090935-B)
00018446 Agamalian,H.; Ries, S.K.; Boyd, W.I.;et al. (1969) Weed Control
Record Sheet: Celery. (Unpublished study received April 18, 1971
under 1E1148; prepareed by Univ. of Calif., Agricultural Extension
Service in Cooperation with Michigan State Univ., Barker Chemical
Co. nad Univ. of Florida, Everglades Experiment Station, submitted
by IR-4, New Brunswick, NJ; -CDL:090935-D)
00018447 Orsenigo, J.R. (1966) Postemergence Herbicide for Celery Seedbeds,
Pages 159-165, Proceedings of the Florida State Horticultural
Society; Oct 24-27, 1966, Miami, FL. N.P. (Also "In" unpublished
submission received April 18, 1971 under 1E1148, submitted by
IR-4, New Brunswick, NJ; CDL:090935-E)
00018450 E. I. du Pont de Nemours & Co.,Inc. (1961) Du Pont Herbicide 326
Corn. (Unpublished study received on unknown date under PP0356;
CDL: 0098656-A)
00018775 E. I. du Pont de Nemours & Co.,Inc. (1961) Linuron-Livestock
Feeding Studies. (Unpublished study received on unknown
date under PP0356; CDL: 0098656-B)
00018842 Atkins, E. L., Jr.; Anderson, L. D.: Greywood, E. A. (1969) Effect
of Pesticides on Apiculture: Project No. 1499; Research Report
CF-7501. (Unpublished study received May 8f 1971 under 1F1174;
prepared by Univ. of California—Riverside, Dept. of Entomology,
submitted by Ciba Agrochemical Co., Summit, N. 3~t; CDL: 090973-8)
00027624 E. I. du Pont de Nemours & Co., Inc. (1966) Name, Chemical Identity,
and Composition: Linuron. (Unpublished study received Oct.
14, 1966 under 7F0542; CDL:092830-E)
00027625 Consultox Laboratories, Limited. (1974) Linuron: Acute Oral and
Dermal Toxcity Evaluation: CL74: 46: 996G.
(Unpublished study received Dec.19,1977 under 33660-11; submitted by
Industrial Prodotti Chimici s.p.a., Nocate Milanese, Italy;
CDL:232505-A)
00027635 E. I. du Pont de Nemours & Co.,Inc. (1963) Results of Tests on the
Amount of Residue in Crops Grown on Linuron Treated Soils.
(Unpublished study received Feb 18. 1963 under PP0413;
CDL:090447-B)
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00029679 Everett, R.M.; Graepel, G.J.; Blanchfield, T.F.; et al. (1980)
3(3,4-Dichlorophenyl)-l-methoxy-l-methylurea: INZ-326; Lorox®
Linuron: Two-year Feeding Study-C6R-CD Rats (Two year Sacrifice).
(Unpublished study received Feb. 29, 1980 under 352-270; submitted
by E. I. du Pont de Nemours & Co., Inc. Wilmington, Del.; CDL241898-A)
00029680 Kaplan, A.M.; Mclack, J.W.; Hall, C.L.; et al. (1980) Long-Term
Feeding Study in Rats with 3(3,4-Dichlorophenyl)-l-methoxy-l-methylurea:
INZ-326; Lorox® Linuron: Haskell Laboratory Report No.100-80,
(Unpublished study received Feb. 29, 1980 under 352-270; submitted
by E. I. du Pont de Nemours & Co., Inc. Wilmington, Del.; CDL241897-A)
00029932 Belasco, I. J. (1979) The Metabolism of 14C-Phenyl Labeled Linuron
in the Lactating Nanny Goat. (Unpublished study received
Jan. 21, 1980 under 352-270; submitted by E. I. du Pont de
Nemours & Co., Inc. Wilmington, Del.; CDL241635-C)
00029933 Shirasu, Y.; Moriya, M.; Watanabe, Y. (1976) Mutagenicity Testing
on Linuron in Microbial Sysytems. (Unpublished study received
Jan. 21, 1980 under 352-270; prepared by Institute of Environmental
Toxicology, Toxicology Div., submitted by E. I. du Pont de Nemours
& Co., Inc. Wilmington, Del.; CDL:241635-D)
00034769 Hill, E. F.; Heath, R. G.; Spann, J. W.; et al. (1975) Lethal
Dietary Toxicities of Environmental Pollutants to Birds. By
U. S. Fish and Wildlife Service, Patuxent Wildlife Research
Center, Washington, D.C.: U. S. FWS. (Special Scientific Report—
Wildlife No. 191; report no. 33423a; also In unpublished
submission received March 28, 1979 under 3125-236; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:237905-B)
00124195 Wood, C.; Rickard, R, ;.Hall, C. ? et al. (1982)' Long-Term Feeding Study
with (Lorox®; Linuron; INZ-326) in Mice. Haskell Laboratory Report
No. 758-82 (Unpublished study received on Jan. 13, 1983 under 352-326,
submitted by E. I. du Pont de Nemours & Co.,Inc., Wilmington, DE;
CDL: 249255-A)
05016511 Hodge, H.C.; Downs, W.L.; Maynerd, E.A.; et al. (1968) Oral Toxicity
of Linuron in Rats and Dogs. Food and Cosmetics Toxicology 6(2):
171-183.
05016640 Grover,R. (1975) Adsorption and desorption of urea herbicides on soils.
Can. Journal of Soil Science 55(2): 127-135..
05019500 Abernathy, J.R. (1972) Linuron, Chlorbromuron, Nitrofen, and
Fluorodifen Adsorption and Movement in Twelve Selected Illinois Soils.
Doctoral dissertation. Uroana, II: Univ. of Illinois at Urbana-
Campaign. Univesity Microfilms, Ann Arbor, MI; 73-9861.
-78-
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GS0047-0001 E. I. du Pont de Nemours & Co., Inc. (1961) Skin Sensitization/
Irritation: Guinea Pig (Unpublished study received Oct. 1961
Under unknown admin, no.; submitted by Haskell Laboratory;
CDL:114108)
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A?P£VDIX XI-2
OMB "Apcrr>valNo."2000-0463 (Expirai
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With repect to the requirement to submit "jsneric" deta impoad by thi F1FRA action 3(C)(2)(B) notica contained in the refsrencsd
Guidance Document, I im responding in tht following manner
Q 1. I wilt submit data in a timely manner to satisfy the following requirements. If tha ten procedures I will use deviate from (or art not
specified in) the Registration Guideline or the Protocol! contained in tha Reports of Expert Group] to the Chamrcah Group, OECD
Chtmicali Teting Programme, I encioa tha protocolt that I will us:
Q 2. I have afltarrd into an afrtemarrt with on* or more other rtg'utrantj under F1FRA notion 3(C)(2)(B)(ii) to tstirry the following data
nquirtmerra. Tha tsro, and any required pnnocalt, will ba Rifamrrad to EPA by:
NAME OF OTHER REGISTRANT
01 I melon a complatad "Certrficrtion of Ammpt to Ermr Into in Agreement with Other Registrant] for Development of Data" with
mptct to the following data requirements:
Q 4. I request that you amend my registration by delating tht following utu (tha option a not available to applicants for new products):
Q 5. I request voluntary cancailation of tha registration of this product. (This option is not available to applicants for MW products)
\
REGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8680-1 (1C-S2)
-80-
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APrBDIX II-3
Approval No. 20CO-0463 fExpires: 12-
(To qualify, certify ALL four hems)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. 1 »m duly authorized to represent the following firm(j) who are subject to the require-
ments of t Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
1
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into »n agreement with one or more other registrants tp develop jointly, or to share in the cost of developing, the following required
items or data:
1 My firm raj offend in writing to inter into such tn •crwment Copiu of tht offin an attached. That offer wsi imvocable ind induded an offer to be
Sound by an arbitration derision under FIFHA Section 3(c)(2)(B)(iii) if final tyttmtnt on all tsrmJ could not be reached otherwise, Thij offer wa made
to the following firm(j) on the following dated):
NAME Of FIRM
DATE OF OFFER
However, none of those firm(s) accepted fry offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s). if any of the firm* named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid'suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
NAJHE
SIGNATURE
DATE
EPA Form 8S30-€ (10-821
—Ol—
-------
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
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Stability
Oxidizing/reducing
reaction
Flammability
Exolodability
Storage stability
Viscosity
Miscibility
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID*
w.
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
.
-82-
-------
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
-83-
-------
9
cacy, A tut safety of (ha formulated
end nan product. may nof consider any
((«(• a* supporting the application.
except (he following data:
(I) The data (ho applicant I>M sub-
mitted (o EPA under paragraph (b) of
(hl> section;
<1> Other If (ho applicant's product eon-
Ulna any active Ingredient other than
(lioje dial are present solely because
of the Incorporation Into (he product,
dtfrlng formulation, pf one of more
other reilalored pesticide products
purchased from another producer.
then (ho applicant ahull alao comply
fill* 40— Pf«fs (he appli-
cation relies on (and any resulting reg-
istration should bo regarded M If It
were ba«ed on (ho Adm!nUtra(or'a cor)-
slderadon of) tho following; dark;
(|) All dala submitted or specifically
cited by the applicant In support of
Hie registration; and
(3) Each other Item of dale \t\ (•;»
'Agency's files which:
(I) Concerns (ho properties or effects.
of any such actjyo Ingredient; and .
(II) Is one of tho type* of daU that
pPA would require to be submitted for .
scientific review by fcPA If (ho appli-
cant sought lh» lnltla| registration
under FIFIIA Section KoHl) of A
product with composition and Intend-
ed uses Identical to those proposed for
tho applicant'* product, under Iho
data requirements In effect on Ihs
data EPA' approve* the appllcan^'f
present application. '<
**-"""
Cnnplsr |—pfn.v|ronm*nlol frol«c|lon Agency
APPENDIX IV-1
(Seca. I. f. an| the vchlr-Us car"
rylng (hem. define the btalo Pcdcial
requirements. In addition, when any
registered pesticide product Is Irana-
ported In a lank car. lank (ruck or
o(her mobile or portable bulk contain-
er, a copy of (he accepted label mint
be attached (o (|ie shipping papeia.
and left with the consignee at Ipo lime
pf i|c|lvery.
(D) S(orage. When peal|chlo pro.l
tlcls are stored hi bulk conlalnura.
Whether mobile or stationary, which
remain In the custody of tho iu«r. n
copy of (he label of labeling. |nclmllng
f II appropriate directions for uso. shall
bo securely attached lo (he container
In (he Immediate vicinity of l|ie
-------
f U1.IO
(vll) A true statement used In auch «
way aa to §lvo a false or misleading hn-
preulon to tlio purchaser;
I-abcl dlsclalmera which negate
or detract from labeling statements re-
qnlreil under (he Act an<| these regula-
tions;
(Ix) Clilms a* to Ili0 aafety of the
pesticide or Ha Ingredient*. Including
statement* auch (u "safe." "nonpolson-
oiii." "nonlnjurlous." "harmless" or
"nnntokla to human* and pela" with
or without inch • qualifying p|irM« M
"when used *i directed"; and
/ .. % **—
(x) N.on numerical and/or compara-
tive statements; on the aafety of the
product, Including l>ul not limited, to:
(A) "(JonUlnn nil natural Ingredi-
ents";
(It) "Among tha least toxic chemi-
cal* known"
(C) "pollution approved/'
16} final printed labeling. (I) Except
•• provided In paragraph, (aMflWll) of
tlila •ectlon, final printed, labeling
must bo submitted ."id accepted prior
to registration. However, final printed
labeling need not be submitted Until
diaft Ubel texla have been provision-
ally accepted by the Af ency.
.
(c) Name und addre*a of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
dresa given on the label ahalt be eon-
tldercd aa Hie name and address of the
producer. If the registrant'* name ap-
pear* on Iho label and the registrant I*
not the producer, or If the name of the
o
Tllle 4Q—frolacllftn »f Invl/ennun|
be qualified by appropriate wording
such a* "Packed for • ? V "Distribut-
ed by » • V or "Bold by • • ?" to s|tow
(hat the name U pot that of the pro-
ducer.
(d) Afaf tMfpM or tneaturt o/ cosj-
/«nf«. (I) The net weight or measure
of content shall be exclusive of wrap-
pera or other material* and, aha|| be
the average content unleaa explicitly
staled aa ft minimum quantity.
()) If tha pesticide I* ft liquid, thfl
net content statement shall be In
term* of liquid measure at 64* Tf (26'C)'
and ahall bo expressed |n conventional
Ameilcan unit* of flultj ounces, pfnls,
quarla. and galloits.
' (1) If tha pesticide I* aolld, br *eml*o-
lld. vUcous or pressurized, or U ft ml«-
lure of liquid and solid, the net con-
tent statement ahall be |o term*, of
T/elght expressed aa ayolrdiipcts
pounds and ounce*.
(4) In f'l caaea. net content ahall be
stated. In term* of the |arge«t aultabla
iinlla. | e., "I pound 10 ounoea" father
(ban "34 ounces."
(I) In addition to the required units '•
apeolfled. net content may be ex-
pressed In pnelrlo unit*. .
(•) Vsr'sllon above minimum oon-
lent or around an average I* permissi-
ble only to the extent that It repre-
sent* deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum I* not permit-
ted- In no case ahall the average con-
tent of the packagea In ft shipment fall
below the atated average content.
(e) Product replication tmmbtr.
The registration number assigned ta
the pestlcfde product at the time of
registration *ha)| appear on the label.
preceded by the phrase "EPA ItegU-
(ration No.." or the phrase "EPA Reg.
No." The registration number shall b*
set In type of a size and atyle similar to
other print on that part of the label
on which It appear* and ahall run par-
allel to IL The registration number
and the required Identifying phras*
ahall not appear In such ft manner M
|o auggest or Imply recommendation,
or endorsement ol the product .by Ihfl
Agency.
(f) producing eelabltthminti teglt-
trallon number. The producing estab-
ti.t.m«..i — «-•--"--
Chapter |—li»vir»it»a)n|ol fro
final establishment el which the prod-
pel waa pro~ •
-------
IP
llioac required on Ilia front panel of
(lie labeling and those which max
appear pliewhere. Speclflo require-
ment* concerning content. placement.
type »lto. and promjnence arc given
below.
(I) llcqultcit front panel tlatcmentt.
With the exception of t|ic child
IllU 40—fro»atl|or» *f Envlr*nM*n|
hatard warning statement, tha (c«l re-
quired on |he front panel of Ihe label
la determined by tha To»Icily Catego-
ry of the peitlclde. The category la a*-
afgned on the baala of the hlgheit
harard ahown by any of (he Indicator*
III Ihe table below:
' •
fy*««*cl« __________ Cona^M. tomtit
fa* *IM KM* »*/ O»Mtw *>•* WOO M/
.
1.004 (MI M.OOO. OlMUf fvM I0.064.
•?«<** . H* MU*M
l/uman /katanf tlanat t«onf—i:t waa aaatfned to
To»|clly C-lnory I on the buU of lla
oral. ln|tal»tlr>:t u" dermal toilclly (aj
dlallncl from akin and eye local ef-
fect*) the word "I'olaon" ihall appear
In red on a background of distinctly
conlraallni color and (he akull and
croa^bonoa ahall appear In Immediate
proximity to the word "polaon."
(I)) Toxlctlv Category It. Al\ peat I
clde products mer.Mrif the criteria of
Toxlcity Cateuory II aoall bear on the
fionl panel the algna| word "Warn-
ing."
(C) ToiMtv Category Iff. All peatl-
clde prodticla meeting the criteria of
Toklr.lty Calegory III ahall bear on
the front pane) the algnal wore) "Cau-
tion."
l-
clde prodncta meellns the criteria of
Toxlclly Calegory IV thai! bear on the
front panel tha algnal word "Caution."
If K) Vie o/ tlgnal loo nit. U*o of any
Ignal wni(i(>) a&noclatecl with ft higher
Category la not permitted
r—
except when the Agency determine^
that aiic|) labellni la neceaaary to pre-
vent unreasonable advene effocU oq
man or (he environment. In no eaaip
ahall more t)ian one human |tasar<|
algn^l word appear on the front panel
of • label. n
(II) Child ha*ard loarntng. Kvery pea-
tlclde product label ahall b«ar on tha
front panel tlie atatement "keep out of
reach of children." Only In ca*«f
where tha likelihood of contact wllh
children during dlalrlbiitlon. market-
ing, alorage or liae U demonalrated b'f
tha applicant to be extremely remoia.
or If tho nature of the peatlclde la aueh
that It I* approved, for uie on Infant*.
or amall children, may the Adrnlnblra-
(pr waive Ihla requirement. '
(III) Statement oj practical lnt(-
m«ni-(A) Toslclty Category '• *
atatement of practical treatment (fir*!
kid or oilier) ahall appear on lha front
panel of the label of All peallcldea fall-
Ing Into Toxlclly Category I on tbf
bajla of oral. Inhalation or dermal toi-
lclly. The Agency may. howe«r.
permit reasonable variation* In !H*
placement of (he atatement of practi-
cal treatment la 80me reference aw)
M "dee atatement of practical trttl-
pient on back panel" «ppear$ on |n»
-86-
Cfiap(er I— Environmental frolactlor)
front panel near the word "Poison"
and the akull and croaabonea.
(D) Other (osfctly categories Tito
ftatemonl of practical treatment la not
required on the front panel except aa
described In paragraph (liKlMIIIXA) of
(|iU aectlon. The applicant may. how-
ever. (nchide auch. a front panel atale-
ment fit hU option. Statenienta of
practical treatment are. however, re-
quired eluewhorp on t|ie (abel In
accord with paragraph (jikl) of |hla
•ecflpi) |f they do noj. appear on |ha
front panel.
(Iv) Placement ffntf prominence. All
Ihe require front pane) warning atate-
rnenl*. ahall be grouped, together on
tha lapel, and ahall appear with auffl-
elent prornlnenoe relative |p other
ffont panel tex( find grap|tlo fnaterla)
to make then) unlikely to be over-
looked under cualomary condltlona of
purchaae and liae. T|ie following table
ahowa the mln|mum typo alze reijiilre-
|ti«nU for the front panel warnlfif
alatement^f on yarloua aUe* of labela:
APPENDIX IV- 1
(oontlnvied)
I Ul.|0
AlKM Ml.
a
•a
it
(3) Other required toarnlnpi a nit pn-
faultonarv tlaletnenfi. 7'lie warnlnga
mid precautionary atalernenla aa re-
quired below ahall appear together on
the label under the general heading
"Precautionary filateniertla'* and
under appropriate aubheadlriga of
"llanard to Humana and Domollc Ani-
mal*." "Environmental llarard" and
-------
} 1*1.10
lion* to avoid potential accident.
Injury or damage. Example* of th'o
hazard •lalemeni* and (ho c|rcum-
atancea ititder which they are required,
follow:
(A) |f a peatlclde Intended for out-
door uao contain* an active Ingredient
with a mammalian acute oral I.D_, of
100 or lean, the statement "ThU l'e«t|-
clde la Toxlo to Wildlife- U required..
(11) If a peatlclde Intended for put-
. door use contains an active Ingredient.
with a f lah acute IXX* of 1 pptrt or Jew. •
the *lalemcnt "Thl* Ve*t|cldd U Toxlo
to Flah" U required.
(C) It a peatlclde Intended for out-
door use contain- an active Incredlcnt
with an avlan acute oral MX. of 104
mg/Vg or leai, or a aiibacule dietary
1/L. of 600 ppm or lea*, the atatement
"Thin I'catlclde ta Toilo to \YI)dIlfo" U
required:
— f r«Ucllon »f f nylr«nm«nf
f D) If either accident history or f|eld
•tudle* demonstrate thai U*e of U>Q
pe*llcfde (nay result In fatality to
bird*. fUt) or mammal*. (he ilatement
•'ThU pesticide U extremely to«|q fo
wildlife « || f >i-^i«c* .1 |_t
UMIM CoMIIUMWt
M-t >«-li« Ml-
Aiov« W f in4 not e~« |l«' f
((D r*,V..!ioni /or I/ia—It) O«nucl>
printed or traplilc matter U aecurclr
attached to each packaco of the
cldo. or placed fllhln the
Wrapper or bag;
(II) live label bear. * referenc* U
tlio dlreotloru for uie In accompanjrlnl
leatleU or circular*, aiicli M "^ ".
recllona In the pnotoaed, circular:" aivd
-87-
. . T.... ,.„ ..MMi>r determine*,
that It uj not pecewary fqr au.e|| djreq-'
lion* fo appear pn l|ie I'abef. I
fll|) fxceptloni fa rtqu(temtnl for.
fffrtcffoi) /pr tad—(A} Detailed dlrco-
jloiii for |ue may be qmltted from la-
beling of peitlclde*, which "Te Intended}
for uaa only by manufacturer* of prod |
pet* other than peitlclde product* In
jhelr regular manufacturing proceaaea,
provided tjiat:
1 if) The label clearly ahowa (hat fho
product U Intended for uae only In
manufacturing procewes atnd apeclflef
°||ie type(a) of product* Involved.
(1) Adequate Information *uc|i a*
technical data aheeU or bulletin*. I*
available to the trade apeclfylrig the
type of product Involved and It*
' proper use In manufacturing proceaa-
e*
HI The product w|ll not coma Into
the pand* of the general nubile except
after Incorporation Into flnUhed prod-
uct*; and,
(/> The Admlnlatrator determine*
that aucti direction* are not; peceasary
to prevent unreasonable adyerae ef-
fect* on man or the environment.
(fl> Detailed direction* for uae. may
be omitted from the labeling of peatl-
clde product* for which **le I* limited.
|o physician*, veterinarian*, pr driig-
glita. provided that:
tf) The label clearly itate* that the
product U for uae only by phyalclan*
Of veterinarian*;
(I) The Administrator determine*
t|i*t auch direction* are not nece*aary
(o prevent unreaaonable adverse ef-
fect* on man or the environment; and
(3) The product U alao a drug and
regulated under the provision* of t|io
Federal flood. Drug and Cosrnello Act.
«C) Detailed directions for uae may
bo omitted from the labeling of pest I
fide product* which are Intended for
u«e only bv formulatora In preparing
fxallclde* for aale to Ihe public, pro-
vided thai:
f 1M.IO
.•"i.W.le|ro th, rormTV011 rMdlly
^position, toxlclt," M°r! °1 ih*
»"P"c.t>,e reatr^lo^1^,.!,-;
and cffecllveneaa of the product for
peatlclde purpoaca;
(1) Ttie |abe| cjearly slate* that the
product U Intepdcd for uae only In
rpa|iufac|t|rlng. formulating, nil.Inf.
pr repacking for use a* a peallcldo aT»i
•peclfjc* the typef*) of peallclde prod
ifc|* Involved;
(4> The product a* finally manufac-
tured, formulated, mixed, or repacli-
aged U registered.: and
4<) The Adnri|nlatrator delerinliica
thaf aiich direction* are not necessary
to prevent unreasonable advene ef-
fect* on pian or l|io environment.
(3) Conlenli aif Direction* far Vte.
The direction* for use shall Inchido
the following, under the headlrita "IX
reel Ion* for I'se":
(|> The (latement of uae claa.lflca
tlon f)« prescribed In Ifll IO The frequency and timing of ap-
plication* necessary to obtain effective
fe*ult* without causing unreasonable
ajdyerao effect* on the environment.
(vlll) Specific llmllalloiu on reentry
(o area* where the pesticide ha« been
applied, meeting the requirement*
concerning reentry provided by 40
CPH I'art 170.
<|x) fipeclflo direction* concerning
the storage and disposal of Ihe |>cstl-
clde and It* container, meeting the re-
quirement* of 40 CKlt Part 145. These
Instruction* shall be grouped and
appenr tinder the heading "Hlortao
and Disposal." Tills licadlno muul l>a
-------
APPENDIX IV-1
(continued)
beyond these purposes And uses ccr
tAined in theDLrecUcm for Use onU b
the
TFHe-40 '?r 3 (action
A* required lor the child hasard warn-
in* (See Table In }
CO Any limitations or restrictions oa
use recuired to prereac
adverse elfeess. «ich ac
OU Required. internUs between ap-
plication «jsrt harrest of food or feed:
• •
'*1 crop rescrictians.
(O Wanrtngr A* required tyaJarc u»e
on. certain- crops, animals. objects, or
to. or yijtrrat to certain areaa-
03) Oleaerred]
(S3 For restricted as*- pesxiddes. a
may be
applied under the direct, supervision of'
c certified Applicator who is sac phr>-
. ie&Oy present it the site of agplicirion
bet • B*^?*^^*)^*^ tTailaile to th»
petaca icrpiytn^ the pessirirtf; unless.
th*- •Af*f"*r hut deten '
za&y only b* applied
(31 Ratrictfd. U-tf
Pesticide product bearing din
for usetsJ duxtfled restricted
betx staiemenn of rescncted- u«
pjfi»^«Hon on the. front- p^p^i *T de-
scribed beiowT
CD front ptmri ttnttment a/ reririci-
ed. %M ciasv%csL£i0t(. CAJ At the t0p of
the iront paneJ of the label set in type
Of tft* !t"« »"rf use, the state*
menc "Resdcted. T7"nt Pesticide"
appear.
CB) Clreetly beio^r t>t» ata
(77 Other pertmeac. tefonmticnr
which the Administrator- determine
"to b#- necEsary for the procecdoa of.
the front p»,nH. & summary stat
o^ s^ift wcy33& ~ of rcsc^icf^oiz ^B^pos^d
jk> nrpffopw-Lwon. Co
Ui Sttitfmsni. of Usr Clarriflraftim.
Sr Ocuber 22. 1578. AH pesticide prod-
am; bear on their libels &
appear. If- use is restricted, to certified.
the follcwlnr ir*r*
to. psnxrxphs CXI) And (2) of this
HJ^T Any pTjrtgl'j^ product for which:
•erne UMS we dasx&ed for reserxl use-
and others for ieametgd ase •»**" be~
sundards' set fcrth n this sab-
•tction: And »><«JT be garigted u
Tor retail sale to «"«f use
onlr 07 Certified Applicatorr or per-
sons T"^*^ their ^ the- promioot
Of. i IKUOCJXSX
(3J CcJirroi t/w Cosri/!ca£on. Pwtl-
dde» products, be&rinx directions'- for
taeCi) H«_^/}^«J general y>^*.n be- IA-
b*led with the exact words- "General.
the-
tw m 2S2M. July i irra: « PR 37:73.
Au«. 1. 1*75; 40 7S 04371. Aut 31. «7i. is-
AB«ad«tia£ C 7K JTM. Pro. j. 1977]
"Dlreetiocs for Use." And ref-
to the- rcnerxl ciaalflcatian
thAt susrt3ts or implies that the ren-
erti atUitr of the pesticide- extends
34
\
-88-
-------
APPENDIX IV-2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (REFER TO THE SAMPLE LABELS FOLLOWING)
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Est. No.
EPA Reg. No.
Ingredients
statement
Pounds /gal Ion
• statement
Front panel
precau t ionary
statements
Keep Out o£ Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-89-
-------
APPENDIX IV-2 (continued)
ITEM
1C
ID
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
.1
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Envi ronmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-90-
-------
APPENDIX IV-2 (continue*].)
ITEM
8C
9A
9C
10A
IOC
10D
U.S.
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statfanent
Storage and
'disposal block
i
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
All
chol i nes terase
inhibitors
All products
All products
PLACEMEN!
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
* ON LABEL
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
T, Larval word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
-91-
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RESTRICTED USE PESTICIDE
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
(4 DOMESTIC ANIMALS)
DANGER SA)
ENVIRONMENTAL HAZARDS/
PHYSICAL OR CHEMICAL;
HAZARDS fTf\
DIRECTIONS FOR USE (\
It 4 a woenon of Feeeral 6w to use
ma product n I ma/vw mconsjsienl
«nm IB Qtwtng.
RE-ENTRY STATEMENT
(If AooScaStel l\0/i(]
CATEGORY OF APP'JCATOR
.STORAGE AND
DISPOSAL (fo<
STORAGE ==
DISPOSAL :
CROP:
RESTRICTED USE
PESTICIDE
FOR RETAIL SALE TO AND APPLICATION ONLY 3Y
CERTTFiED AFPLCATORS OR PSSSCNS UNCES THHifl
DIRECT SUPERVISION
PRODUCT
NAME
ACTIVE MGREDIENT:
INERT INGREDIENTS.
TOTAL:
100.00%
THIS PRODUCT CONTAINS IBS Cf PER GALLON
KEEP OUT OF REACH OF CHILDREN
DANGER — POISON
STATEMENT OF PRACTICAL TREATMENT
IF SWALLOWEO^
IF INHALED =
IF ON SKIN
IF IN EYES =
SEE SIDE PANEL FOR ACOmONAL PRECAUTIONARY STATEMENTS
3Y
TOWN. STATE ==
ESTABLISHMENT NO.
EPA REGISTRATION NO.
NET CONTENTS:
CROP:
CROP:
CROP:
CROP:
CROP:
WARRANTY STATEMENT
-92-
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Apoendix 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°;
and over 80"F.
C. Flashpoint over 80"F
and not over 150°F.
D. Flashpoint above
150°F.
Reauired 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. Keen,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.
-93-
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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:
I I Required type size I
I Size of label I for the heading |
I front panel in I STORAGE AND DISPOSAL | -
I square inches I (all capitals) I
i ; s ~r
I 10 and under 6 point '-, I
I Above 10 to 15 8 point • |
I Above 15 to 30 10 point I
I Over 30 12 point |
I ; [
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 har.dling the pesticide container,
including Movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to mini/raze exposure
while opening or closing container.
-94-
-------
Appendix IV-5
(continued)
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled/ and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions:
V. '•.
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 Categor^y 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 oi. the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
-95-
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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 I
(bottles, cans, jars)I
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash
Non-aerosol produces
(bags)
Do not: reuse bag. Discard bag in trash
j
I Aerosol oroducts
Replace cap and discard containers in
trash. Do nor incinerate or.nuncture.
2. The labels for all other prcduqts must bear container disposal
instructions, based-on container type, listed below:
Container Tvoe
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 punctur?
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
aoorovec stare and local procedures.
-96-
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Container Type
Appendix IV-5
(continued)
Statement
Fiber drums
with liners
'
Paper and
plastic bags
Compressed gas
cylinders
Completely empny liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities .
If drum is contaminated and cannot be
reused-^- , dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording).
^•Manufacturer
and how fiber
V-
may replace this phrase with one indicating whethe:
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.
-97-
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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 oentoxide
•*• . ' ***'*••
Arsenic trioxide • • -,
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phpsphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts ;
4, 6-Dinitro-o-cyclohexylphenol |.
2,4 Dinitrophenol ' •
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacatamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramice- (OMPA, schradan)
Parathion
-98-
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Appendix IV-5
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmercuric acetate (P.MA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox . ^.,
Toxaphene • -,
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List-(RCRA "E" List).
-99-
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Appendix- IV-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Acetone
Acrylcnitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride • *" '•
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP) " —
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12®)
3, 5-Dichloro-N-(1,l-dimethyl-2-propynyl) benzamide (prcnamide,Kerb)
Dichloro diphenyl dichloroethane (DDD) -,
Dichloro diphenyl trichloroethane (DDT)fe
Dichlorethyl ether '* •
2,4-Dichiorophenoxyacetic, 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
-100-
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Appendix IV-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients:
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex i
1, 2, 4, 5-Tetrachlorobenzene ;•
1,1,2,2-Tetrachloroethane J '
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
-101-
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Appendix IV-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Inaredients:
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane (Freon 12®)
Diethy1 phthaiate
Dimethylarnine
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, l-Trichlo
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