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GUIDANCE FOR THE
REREGISTRATTGN OF PESTICIES: PRODUCTS
O3OTAIN1NG AS THE ACTIVE INGREDIENT
AIACHLOR
(090501)
CASE NUMBER 0063
CAS 15972-60-8
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D. C. 20460
November 1984
33
o
EJED
EPA-
560/
1984.3
Material belongs to:
Office of Toxic Substances Library
U S Environmental Protection Agency
401 M Street, S.W.TS-793
Washington, D.C. 20460
(202) 382-3944
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TABLE OF CONTENTS
Introduction 1
I. Regulatory Position and Rationale 4
II. Requirement for Submission of Gerferic Data 17
III. Requirement for Submission of Product-Specific
Data 37
IV. Submission of Revised Labeling and Packaging
Information. 65
A. Label Contents 65
1. Product Name 65
2. Company Name and Address 65
3. Net Contents 65
4. Product Registration Number 65
5. Producing Establishment 66
Registration Number
6A Ingredient Statement 66
6B Pounds Per Gallon Statement 66
7. Front Panel Precautionary Statements 66
7A Child Hazard Warning Statements 66
7B Signal Word 66
7C Skull and Crossbones and Word Poison 67
7D Statement of Practical Treatment 6?
7E Referral Statement 67
8. Side/Back Panel Precautionary Labeling 67
8A Hazard to Humans and Domestic Animals 6?
8B Environmental Hazard 6?
8C Physical or Chemical Hazard 67
9 Misuse Statement 68
10A Storage and Disposal Block 70
10B Directions for Use 70
B. Collateral Information 70
V. Instructions for Submission 71
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APPENDICES
Page
II-l Guide to Bibliography 72
II-2 Bibliography .- 74
II-3 FIFRA S3(c)(2)(B) Summary Sheet - EPA Form 8580-1 . . . &
II-4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-2. 85
III-l Product Specific Data Report (End-Use Products). . . . **
IV-1 40 CFR 162.10 Labeling Requirements 88
IV-2 Table of Labeling Requirements 93
IV-3 Physical/Chemical Hazards Labeling Statement 96
IV-4 Storage and Disposal Instructions 97
ii
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. 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 carry out this task, we have established the Regis-
tration Standards program, which will review all pesticide
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 foo*d and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. Based on the regulatory position,
the Agency may require the registrant to modify product
labels to provide additional precautionary statements, restrict
the use of the pesticide to certified applicators, provide
reentry intervals, modify uses or formulation types, specify
certain packaging limitations, or other requirements to
assure that proper use of the pesticide poses no potential
adverse effects to human health or the environment.
The scientific review, which is not contained in this
Guidance Package but is available upon request, concentrates
on the technical grade of the active ingredient and identifies
missing generic data. However, during the review of these
data we are also looking for potential hazards that may be
associated with the formulated (end use) products that contain
the active ingredient. If we find serious concerns, we will bring
formulated products under the provisions of the Registration
Standards program to the extent necessary to protect the public.
EPA has the authority under FIFRA §3(c)(2)(B) to require
that registrants submit 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
S3(c)(2)(D)]. Normally, this means that the registrants who
are responsible for filling the data gaps are the manufacturing
use product producers (basic suppliers of the active ingredient).
However, end use producers will not qualify for the formulator's
exemption if the source of their active ingredient: (1) is
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not registered with EPA, and/or (2) is produced by the regis-
trant'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 cancel the regis-
tration of any of your products subject to the reregistration
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 timeframes outlined. EPA will
issue a notice of intent to cancel or suspend the registration
of any currently registered product if you fail to comply
with the requirements set forth in this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) 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 t
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End use products of registrants who also produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products in "11"
above. If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B. . ^_^____
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I. REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
Pursuant to the Federal Insecticide, Fungicide,and Rodenticide Act (FIFRA),
S 3(g)» the Environmental Protection Agency ("the Agency") conducts a compre-
hensive program to review the existinq data on registered pesticide active
ingredients and imposes data requirements and use conditions appropriate for
continued registration of products with those active ingredients. The result-
ing requirements for continued registration are imposed on registrants through
the Registration Standard program for each active ingredient. As a part of
that program, the Agency has evaluated the available data on alachlor.
this guidance document which includes the registration standard review, des-
cribes the current regulatory position of the Agency on alachlor based on
an evaluation of all products containing alachlor as an active ingredient.
Requests for registrations of substantially similar products will he covered
by this standard. This document provides the rationale for the Agency's
position and the criteria for continued registration. It also discusses
interim labeling requirements, tolerances, and Federal registrations
granted under Section 3 of the FIFRA.
In developing its regulatory position, the Agency determines whether available
data indicate that a pesticide has met the criteria for potential unreasonable
adverse effects found in Section 162.11 (a) of Title 40 of the U.S. Code of
Federal Regulations (CFR). A pesticide meeting the criteria is a candidate
for a Special Review, an intensive risk/benefit analysis which is a modifi-
cation of the Rebuttable Presumption Against Registration (RPAR) process, itie
Agency's determination as to whether any of the risk criteria has been met and
its rationale for any regulatory action will be summarized in the Position
Document developed through the Special Review program.
Alachlor is the accepted cannon name recognized by the ANSI for the compound
2-chloro-2',6l-diethyl-N(methoxymethyl)acetanilide. Its empirical formula is
C14H20NO2C1-
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Alachlor was patented by Monsanto Company (US Patent No. 3,442,945 and 3,547,620>
in 1967 and was first registered for use in I960. Technical alachlor is being
produced in the United States by Monsanto Agricultural Products Company of
St. Louis, Missouri and at the present time, Monsanto is the sole registrant
of products containing alachlor.
Alachlor is available as a technical material, at 90.0% active ingredient and as
a manufacturing use product containing 60* alachlor for formulation of alachlor
end-use products. Alachlor is available in granular, microencaDSulated, and
emulsifiable concentrate end-use formulations.
C. REGULATORY POSITION
Based on the review and evaluation of all available data and other relevant
information on alachlor, the Agency has made the following determinations:
1. Alachlor is an oncogen and is subject to the Agency's requirement that
it be considered through a Special Review. The registrant of alachlor
products has been made aware that alachlor has met the risk criterion
for oncogenicity in Section 162.11(a) of Title 40 of the U.S. Code of
Federal Regulations. A position document detailing the available
information about the toxicity, exposure potential, and benefits from
alachlor use will be published in connection with the Special Review.
The Agency expects to make such a document public within the next
month.
2. The potential cancer risk from exposure to persons working with alachlor
appears to be significant based on EPA's reviews of the available
studies of toxicitv and exposure. Accordingly, EPA has determined that
continued use of alachlor products under present terms and conditions
of registration appears likely to cause unreasonable adverse effects
on the environment during the period required for the administrative
process, ttie administrative process involves review of the issues
relating to whether and under what terms registrations could be continued
following final Agency determination on risks and benefits.
Like most widelv used herbicides, the bulk of the annual use of alachlor
occurs during the March throuah June period which precedes planting in
the various parts of the country. In any given location, application
occurs during an approximate two week window. Therefore, succcessful
management of risks from use during 1985 requires implementation of
measures which can be effective by the spring of 1Q85. Completion of
labeling changes and implementation of other risk reduction measures
in a manner which can be final and enforceable for the 1985 use period
can only be reliably effectuated with the cooperation of the registrant,
unless EPA takes emergency action pursuant to a finding of imminent
hazard. In an effort to ensure that the risks from exposure during the
period for administrative review are adequately managed, EPA has engaged
in discussions with Monsanto, aimed at identifying risk reduction measures
which can be implemented for the 1985 season. Minutes of the Agency's
discussion with Monsanto are in the Public Comment Pile where it will
be available for public inspection.
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EPA understands that Monsanto will promptly implement the amendments
to registrations identified here and will market alachlor products for
the 1985 season under these terms and conditions of registration.
Certain of these requirements were developed from ideas initiated by
Monsanto, but in all cases the terms have been determined by EPA to
represent appropriate approaches to managing the risks from use of
alachlor pending final determinations following the special review.
The Agency will evaluate these measures following the 1985 season to
determine whether they provide adequate management of risks for any
further interim period required to reach final action following the
Special Review.
In addition, EPA has determiner!, pursuant to FIFRA «3(c)(2)(B), that
certain data are required to maintain alachlor registrations in effect
during the period of special review, and those requirements are identi-
fied in this document.
Both the amended registration terms and the data requirements set forth
in this standard are imposed pursuant to findings tftich relate only to
continued registration during the period for Special Review of alachlor.
However, it is likely that results from and experience with these
requirements will also be available for consideration by EPA prior to
any final determination resulting from the Special Review. Therefore,
these requirements can permit a more refined assessment of the risks and
benefits of continued use of alachlor.
3. The registrant has voluntarily removed the use of alachlor on potatoes
and the Agency will not permit the use of any alachlor product on
potatoes.
4. During the Special Review, the Agency will not approve registration for
any new use.
5. Alachlor appears to leach through soil and has been found in ground water
in Nebraska and Iowa. Alachlor has been detected in surface water in
a number of locations, particularly in Iowa and Ohio. The chemical
has also been found in tap water from surface water in Ohio.
Data to more fully assess ground water contamination and runoff contami-
nation of surface water are being required on an accelerated schedule from
registrants who produce manufacturing-use products. Because of possible
water contamination, the Agency has determined that labeling should advise
users that alachlor may contaminate ground water and surface water bodies.
6. Handling and application of alachlor can result in significant exposure
to users. Consequently, a number of changes in labeling are required
to address occupational exposure. Further, a program of information
and training is required to be made available to all users of alachlor
products.
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7. Registrants of manufacturinq use products (MUPs) containinq alachlor
nust provide or agree to develop additional data as specified in the
tables in this guidance document, in order to maintain existina regis-
trations of alachlor while the administrative process relatinq to the
Special Review is underway. Registrants are also informed of additional
data which the Agency will recruire that they develop if the Special
Review is ultimately terminated in a manner which will permit continued
registration of pesticides containinq alachlor.
8. Manufacturinq-use pesticide products containinq alachlor as a sole active
ingredient mav be registered for sale, distribution and formulation
in the United States, subiect to the terms and conditions specified in
this document pending the outcome of the administrative process relatinq
to the Special Review. Registrants having products not conforming to
this document must apply to amend the registrations of those products
containinq Alachlor. Mixtures and end-use products containing alachlor
are covered by the labeling requirements set forth under this standard
and registrants of *-hose products not conforming to these labeling
requirements must also apply to amend their registrations accordingly.
D. RATIONALE FOR REGULATORY POSITION
The Agency has reviewed the available data concerning toxicology, environmental
fate, ecological effects, residue chemistry and product chemistry. Sufficient
data are available to show that alachlor causes tumors in laboratory animals
and that humans are "exposed to alachlor at levels which raise significant
concerns.
1. EPA has completed its preliminary review of the alachlor data base and
concludes that alachlor is oncogenic in laboratory rats and mice.
A two year rat feeding/oncogenic study using technical alachlor
stabilized with etoxidized soybean oil at 0.5, 2.5 and 15.0 mg/kq
bw/dav dosage levels indicated that alachlor is oncogenic in male
and female rats. Nasal turbinate tumors increased significantly
(p < 0.01) in both sexes at 15 mgAg/day. The same tvpe of tumor
occurred in one mid-dose female. An increase was noted in the
incidence of thyroid follicular cell tumors in the high dose male
group ( 13.3% in the hiqh dose compared to fi.7% in control). Two
additional kinds of tumors, thvmus lymphosarcoma and adrenal pheno-
chrcmocytoma increased significantly (p < 0.05) in the high dose
females. Nasal submucosal gland hyperplasia significantly increased
(P < 0.01) in both sexes at the high dose level.
In a two year rat feeding study, technical alachlor was tested at
the following dosages: 14.0, 42.0, and 126.0 mq/kq/day and showed
statistically significant increases in the following tumors at 42.0
mq/kg/day and above: nasal turbinates and stomach tumors occured in
both sexes; thyroid follicular tumors were observed in males at
126 mgAd/day. In additon, occular lesions and hepatotoxicity
occured at the lowest dose tested (LOT).
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In an eighteen month mouse study, the chemical was tested at the
following dosages: 26.0, 78.0, and 260.0 mg/kq/day and showed a
statistically significant increase in lung bronchioalveolar tumors
in females at 260 mg/kq/day (highest dose tested (HOT)).
In a six-month dog feeding study, technical alachlor was tested at
the following dosages: 5.n, 25.0, 50.0, and 75.0 mg/kq/day and
showed dose related hepatotoxicity at all of the above dosaoes.
The no-observable-effeet-level (NOEL) was < 5.0 mgAa/dav (LDT).
In a three generation rat reproduction study, technical alachlor
was tested at the followina dosages: 10.0 and 30.0 mqAP/day and
showed the following effects: reproduction NOEL at .10.0 ma/kq/day,
and reproduction low-effect-level (IFL) at 30.0 mg/kq/day
(kidney effects in F2 and F3 pups).
2. Although little is known about actual alachlor exposure from treated
food and feed crops, the Agency has estimated that the potential dietary
exposure (mg/kg/day) of the U.S. population to alachlor from treated
food crops may be significant. The data required through this standard
should permit meaningful conclusions about actual dietary exposure.
3. Because currently permitted use on potatoes contributes significantly
to potential exposure based on maximum potential contributions to the
diet, this Standard requires that registered alachlor products no lonoer
bear directions for use on potatoes.
4. Non-dietary exposure of people to alachlor occurs principally from agri-
culture use when it is applied primarily by around boom equipment using
the band or broadcast method. Exposure of workers to alachlor occurs
by dermal and inhalation routes during mixing, loading, sprayinq and
flagging, and during cleaning and repair of equionent. The more
significant exposures occur throuqh the dermal route and result from
mixing, loading, transfer, cleaning and repair operations. Up to
one million workers in the United States can be exposed annually to
significant levels of alachlor. Fven though only 1% or 2% of alachlor
is applied aerially, the exposure is substantially hiaher than for
other application methods.
5. Contamination of drinking water obtained both from surface water and
from ground water is an additional route of human exposure to alachlor.
Available monitoring data show the presence of alachlor in surface water
and in municipal water supplies in Ohio. Monitoring studies of several
rivers in Northwestern Ohio showed alachlor at all sampling stations
throughout the summer long sampling program during 1981, 1982, and 1983.
Average alachlor levels in the rivers during these periods ranged UP to
3.0 micrograms/liter (parts per billion) with peaks far in excess of
that value. Tap water from municipal systems drawing water from these
sources also showed alachlor levels averaging greater than 1.0 ppb.
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Limited monitoring data also show that alachlor has the potential to
contaminate ground water. In 1980, alachlor was found in two wells out
of 14 sampled in Nebraska at about 0.04 ppb. In two different counties
of Northeast Iowa, alachlor was detected in ground water sources at
levels well in excess of 1.0 ppb.
The Agency is requiring additional data on an accelerated basis on the
leaching and mobility of alachlor to examine the potential of alachlor to
contaminate ground water. In addition, a monitoring study to evaluate
the manner and extent of contamination of ground and surface water is
being required.
€. Exposure to aquatic organisms through runoff is probable, but data indi-
cate that alachlor is only moderately toxic to freshwater fish and
slightly toxic to freshwater invertebrates.
7. The Pesticide Incident Monitoring System (PIMS) indicates sixteen inci-
dents involving aaricultural uses of alachlor alone from 1979 through
1981. Of the sixteen incidents, eleven required medical attention, eight
involved dermal exposure, three involved inhalation exposure, five
involved ground application, two involved aerial application and three
involved mixer/loader exposure. PIMS does not include any details or
consequences of these exposures, nor does it attempt to validate these
voluntarily submitted reports. No fatalities were reported. TTie PIMS
data do not provide information on chronic health effects from exposure
to alachlor, but do support the need for precautions and training
relating to careful handling of alachlor products.
8. The Agency is requirina the manufacturer to provide all users of alachlor
products with an opportunity to attend a special training program which
will be available throughout the nation before the 1985 planting season.
This program will outline the precautions to be followed in handling
the alachlor products.
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E. CRITERIA FOR REGISTRATION UNDER THIS DOCUMENT
To be eligible for registration pursuant to this quidance document, manufac-
turing-use products and end-use products must meet the following conditions:
1. Contain alachlor 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 document must comply with all terms
and conditions described in it, including commitment to fill data aaps on a
schedule acceptable to EPA and consistent with that required of the present
registrant. All registrants and applicants for reaistration under this
document must follow the instructions contained in this document and complete
and submit the appropriate forms within the specified time.
P. ACCEPTABLE RANCZS AND LIMITS
1. Product Composition Standard
Technical grade products must contain at least 60.0 percent alachlor as the
sole active ingredient. Each manufacturinq-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
alachlor products must be substantially similar to that in currently registered
technical products. Any manufacturing-use product not meeting these require-
ments will be considered a new product and will not be registerable under this
guidance document.
2. Acute Toxicity Limits
During the period of administrative process relating to the Special Review,
the Agency will permit registration of technical grade and manufacturing-use
products containing alachlor with acute toxicity category IV for primary eye
irritation, toxicity category III for acute oral, dermal, and inhalation, and
category IV for primary dermal irritation, provided that the labeling of those
products bear appropriate precautionary statements.
3. Use Patterns
For continued registration under this document, manufacturing-use and end-use
products containing alachlor may be labeled for formulation only into end-use
products for herbicides used for the control of certain annual grasses, broad-
leaf weeds and yellow nutsedge on corn (all types), soybeans, peanuts, dry
beans, lima beans, red kidney beans, mung beans, grain sorghum, sunflower,
peas, cotton, and certain woody ornamentals. For most uses, alachlor is
applied as a preemergence broadcast or banded ground application. It may
also be labeled for pre-plant and shallowly incorporated application, or in-
jected into center pivot irrigation systems on some sites. However, alachlor
products must be labeled to exoressly prohibit aerial application.
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G. REQUIRED IABELING
All technical grade, manufacturing-use(MUP)f and end-use (EUP) products, con-
taining alachlor must bear appropriate labeling as specified in 40 CFR $
162.10. This section contains additional specific information regarding
label requirements.
In addition to the requirements stated in 40 CFR S 162.10, the following in-
formation must appear on the labeling of MJPs.
Listing of Approved Sites
The labeling must list specific, currently approved sites on which the
product is intended to be used after being manufactured into an end-use
product.
"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."
In addition to the requirements stated in 40 CFR « 162.10, the following in-
formation must appear on the labeling of MUPs, EUPs, and mixtures where
alachlor is contained in one of the products.
1. Hazard Information
Itie following statements must be presented in a prominent place at the
beqinina of supplemental labeling booklets during the 1985 season and
must he contained in a prominent location on the label affixed to any
products marketed after the 1985 season.
"The use of this product may be hazardous to your health, this
product contains alachlor, which has been determined to cause
tumors in laboratory animals."
"Users are urged to obtain information on careful handling and use
of pesticides and to participate in [Name of Registrant for MUP
contained in product] educational program on potential hazards and
safer use of this product. For additional information, contact
[Registrant] at 1-800-XXX-XXXX."
2. Additional Warnings and Use Instructions
The following statements must appear in appropriate sections of the
labelling of products containing alachlor.
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Water Contamination Warnings
"This chemical has been identified in limited ground water sampling
and there is the possibility that it will leach through the soil to
ground water, especially where soils are coarse and ground water is
near the surface. Following application and during rainfall events
that cause runoff, this chemical may reach surface water bodies,
including streams, rivers and reservoirs."
Instructions Relating to Water Contamination
"Care must be taken when usinq this product to prevent back sip-
honing into wells, spills or improper disposal of excess pesticide,
spray mixtures or rinsate."
"Check valves or antisiphoninq devices must be used on all mixing
and/or irrigation eouipment. Disposal of excess pesticide, spray
mixtures or rinsate should be according to label use instructions
or according to the state pesticide or environmental control agency
or the hazardous waste representative at the nearest EPA regional
office."
"Do not apply directly to water or wetlands. Do not contaminate
water by cleaning of equipment or disposal of wastes."
Instructions to Reduce Applicator Exposure
"HANDLING INSTRUCTION FOR TRANSFER, MIXING, CLEANING AND
EQUIPMENT REPAIR"
"Note: Direct contact or exposure to Lasso* or spray mixtures of
Lasso should be minimized. The following instructions for transfer,
mixing, cleaning or repairing equipment should be followed in order
to minimize this exposure. Review the protective clothing require-
ments as listed in the Precautionary Statements section of this
label (front panel) and do not use this product until you have the
necessary protective clothing."
2.5 Gallon Containers
"Open pouring from these containers can result in exposure from
splashing or spilling. Special care in lifting and pouring are
strongly recommended."
55 Gallon and Bulk Containers
"Open pouring from these containers can result in exposure from
splashing or spilling and is not reconnended. This product
should be transferred from these containers to the mix or spray
tank using pumps or transfer probes. The probe or pump should
not be removed from the container or disconnected until the •
container is emptied and rinsed. Dse the pump or probe system to
rinse the empty container and transfer the rinsate directly to
the mix or spray tank."
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Equipment Cleaning and Repair
"CLeaninq and repair of transfer systems and application equipment
is a source of exposure to this product. Care should be taken to
minimize exposure during cleaning and repair of transfer sysytems
and application equipment. Vtienever possible, these systems or
equipment should be rinsed before beina cleaned or repaired.
When repairs must be made during transfer or application, the
equipment should be shutdown and special care taken to avoid
contact with the oesticide."
Protective Clothing Requirements
"Wear goggles or face shield, rubber gloves, lona trousers, long
sleeved shirt or jacket of tightly woven material along with boots
hiah enouah to cover ankles when transferring and mixing and when
adiusting, repairing or cleaning equipment. Wear rubber boots
when pourring from open containers, or when reentry is made into
fields where the product has been applied through sprinkler
irrigation systems."
"Any article worn while handling alachlor must be cleaned before
reusing. Clothing which has been drenched or has otherwise
absorbed concentrated pesticide must be disposed in a sanitary
landfill, incineration or, if allowed by state and local autho-
rities, by burning. If burned, stay out of smoke."
Prohibition on Aerial Application
"Do not apply with aerial equipment."
Directions for Use in Center Pivot Irrigation
"For users of irrigation equipment such as the center pivot system,
refer to the producer's technical bulletin on that method of
application."
Application Rates
The highest permitted label rate for soybeans must be 4 Ibs/acre.
The instructions related to label rates must include the following
statement:
"Applicators should evaluate soil and weed conditions carefully
to ensure that they choose the lowest effective application
rate."
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H. OTHER REQUIRED AMENDMENTS TO REGISTRATION TERNS AND CONDITIONS
1. Training/ Information Program
Registrations for manufacturing-use products must contain the following
conditions of registration:
a. The registrant of each MUP must develop and implement an on-qoinq
program of information and training aoproved by EPA and designed
to be readily available to all users of alachlor products prior
to use of those products during the 1985 season.
b. MUP registrant(s) must submit to EPA all training materials and
a statement of plans to ensure availability of the program to
users and to ensure that users are aware of its availability.
Submittal of materials and incorporation of EPA required modifi-
cations must be completed by a time which permits full implemen-
tation prior bo the 1985 use season.
c. Acceptable training materials must meet the following criteria:
1) Adequacy and accuracy of statements regarding toxicity of
alachlor and exposure to alachlor through handling and water
contamination,
2) Adequacy and accuracy of statements describing the labeling
changes required in the Registration Standard,
3) Balance and objectivity,
4) Avoidance of promotional content in the training materials,
5) Consistency of the training materials with Agency accepted
scientific principles.
d. Acceptable plans to make the orogram available to users must
meet the following criteria:
1) Convenience of availability bo users, including appropriate
scheduling and location,
2) Ready availability of training materials for use by the
USDA Extension Service, state and local government entities,
or other appropriate bodies,
3) Adequate public information campaign to direct users bo the
program.
e. MUP registrant(s) must contract with a competent independent
entity in the manner prescribed here. The terms of the contract,
with the exceptions of terms solely to establish amounts of
compensation, shall be provided to EPA.
14
-------
The contract terms shall include the following responsibilities
to he executed solely by the contractor or its independent sub-
contractors:
1) Appropriate independent, anonymous assessment of actual train-
ing presentations designed to assess their objectivity and
effectiveness,
2) Independent assessment of the percentage and type of users
reached by the program,
3) Development of appropriate criteria to measure program effec-
tiveness/
4) Reporting directly to a designated EPA coordinator of the
results of (1) and (2) above, at quarterly intervals begin- ,
ning April 1, 1985. Reports to EPA must be made prior to or
at the same time as such reports are supplied to the
registrant,
5) Submittal to EPA of the criteria developed in (3) above,
6) Following acceptance by EPA of criteria developed throuqh (3)
above, assessment of program effectiveness,
7) Reportino directly to EPA of the results of (fi) above, at time(s)
established by EPA. Such reports to EPA must be made prior to
or at the same time as they are supplied to the registrant.
I. TOLERANCE ASSESSMENT
The Agency is unable to complete a full tolerance reassessment because of
certain residue chemistry data gaps. The additional residue data will be
used to more fully assess dietary exposure to alachlor and may lead to
revisions in the existing tolerances.
The estimated oncogenic risk levels for persons exposed through consumption
of treated earnedities, consumption of contaminated drinking water and
occupational contact with alachlor will be presented in the Special Review
document.
In the United States, tolerances are currently established in 40 CFR S 180.
249 for the combined residues of the herbicide (2-chloro-2l-6'-diethyl-N-
(methoxymethyl)acetanilide) and its metabolites [ measurable only as those
containing the 2,6-diethylaniline moiety (calculated as alachlor)] in or on
the raw agricultural commodities listed below:
15
-------
Cornedities Parts per million
Beans, dry 0.1
Beans, forage n.2
Beans, lima(green) 0.1
Cattle, fat ' 0.02
Cattle, meat by-products n.02
Cattle, meat 0.02
Corn, fodder 0.2
Corn, forage 0.2
Corn, fresh, {sweet)(K+CWHR) 0.05
Corn, grain 0.2
Cotton, forage 0.2
Cottonseed 0.05
Eggs 0.02
Goats, fat 0.02
Goats, meat by-products 0.02
Goats, meat 0.02
Hogs, fat 0.02
Hogs, meat by-products 0.02
Hogs, meat 0.02
Horses, fat 0.02
Horses, meat 0.02
Milk 0.02
Peanuts O.OS
Peanuts, forage 3.0
Peanuts, hay 3.0
Peanuts, hulls 1.5
Peas, forage 0.2
Peas, hay 0.2
Peas, pods removed 0.1
Potatoes 0.1
Poultry, fat 0.02
Poultry, meat by-products 0.02
Poultry, meat 0.02
Sheep, fat 0.02
Sheep, meat by-products 0.02
Sheep, meat 0.02
Sorohum, fodder 1.0
Sorqhum, forage 1.0
Sorqhum, grain(milo) 0.1
Soybeans 0.2
Soybeans, forage 0.75
Soybeans, hay 0.2
Sunflower seed 0.25
16
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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 sec. 3(c)(2)(B) and describes,
in table format, the data required for maintaining the registra-
bility of each product. Additionally, a bibliography (Appendix
II-2) 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 sec. 3(c)(2)(B), you are
required to take appropriate steps to comply with this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA how
you will satisfy the requirements of this Notice. Any such
suspension will remain in effect until you have complied with
the terms of this Notice.
B. What Generic Datal/ Must be Submitted. You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued registrability of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols (such as those contained in the Pesticide
Assessment Guidelines 2/ or data collected under the approved
protocols of the OrganTzation for Economic Cooperation and
Development (OECD). If you wish not to develop data which
are necessary to support the 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
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 Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
17
-------
formulation, and in those cases EPA needs data of that type
for each major formulation category (e.g., emulsifiable concen-
trates, 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 formulations0 but
not others. Motet 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 III 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 "PIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II-3] for each of your products. On that form you must state
which of the following methods you will use to comply, with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe will
satisfy the requirement, or state that you will generate
the data by conducting testing. If the test procedures
you will use deviate from (or are not specified in) the
Pesticide Assessment 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.
OR
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 Develop-
ment of Data" (EPA Form 8580-6, Appendix II-4)V
OR
V FIFRA sec. 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued on next page)
18
-------
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.)
OR
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.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product Manager.
The extension request should state the reasons why you conclude
that an extension is appropriate. While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
(Footnote continued from previous page)
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3(c)(2)(B)(iii ) ]; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration.
19
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Sft 2hd«c to Pesueide Chemicals
AIACHIOR* 090501
TYPE PESTICIDE: Herbicide
POSMILAnONSt Tech (60%, 90%), 6 (9%, 10%. 15%), C.(2.6 lb/gal, 4 lb/gal),
-- PIC (2.5 lb/gal).
GENERAL IHFORMflTONi A preenergent herbicide with a soil persistence of 6-10
""""""""^^———— %jeeka in mediun to fine soils and less in low organic
or sandy soils.
TIME RECDTRZD FOR CPOTRDLi (Itot located).
TO TABSET WEIDSt General
tODEOP ACTION: Inhibition of protein synthesis; inhibition of root elonga-
tion*
— .~--~* TOLERANCESi 0.02 ppn (negligible residue) in milk, eggs, and the
neat, fat, and neat byproducts of cattle, goats, hogs, horses, poultry, and
BRQACLEAF WEEDS CEtTTRXLEDi
blade nightshade (•) PBAIBE
BMAB8A
lanfeequarters (b) SBCMRA
cannon purslane PECAEBA
(b) BFAZBA
(b) PCCAtBC
Florida pusley
galinsoga P3FBCAA
hairy nightshade (a) P9PJBG
ladysthunb (b) PEAASP
Pennsylvania snartweed (b) PEAAQSO
prickly sida (b) PDAAJBF
redrcot pigweed PAFMSI
2-chloro-2'. 6'-diethyl-{r-{inethaxyBethyl) acetanUide
Zssuads 3-1-82 20
-------
EBt Bidet *» Sesticide Oionicala
GRASSES AND OTHER HaUOCTS CCt/i'HULLED*
barnyerdgrass
broadleaf aignalgraa* FOARBD
Oftnchrui pauciflorui (b) FCAWBF
fall panieun POCBBD
(seedling) (b)
Jchnaong:
ara« en
rice
rdbuat purple fartail FC7CIBZ
rcteust vhlte fartail FUCDRB
•oooth crabgraaa FCABEBD'
panicua (d) KfCSL
yelln
yellow nutsedge (e)
a) Tnlnimm of 2.5 Ibe
b) reduced cotpe+dtion only %hen applied preplan* Incorporated or pr
%dthia 5 day* of last tiUage at 2.5 - 4.0 Ib ai/fe
e) ct 3-4 Ib ai/A for control vhen applied preplan*, incorporated; or for
ccnpBtitioa vhen applied preeBerjense to the the toil •xarfaca;
d) min-hnm of 3 Ib ai/A by center pivot irrigation on corn far reduced
Ziiuedx 3-1-62
21
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ES& 2hdex to Pesudde Chemicals
AUCHD3R
Site. Desaoe Tolerance. Use, Linritati
and Formulation
A.1./AJ
jKlCLJUJKAL
ttoere a dosage range is given, use the lower end of the range on
•alls ; use the higher end of the range OB fine soils . or for control
of hard-to-control weeds, or there heavy wed infestations are eA^ec'.*!
Beans, Dry 04 ppn (negligible residue) (beans) 15001AA.
0.2ppa (negligible residue) (forage and hay)
2.5-3.0 OM limited to west of ths Mississippi River,
(4 Ib/gal E) except in Kara County, California.
Breplant incorporation. Beoadcast. Apply and
incorporate uniformly into the top 2 inches of
soil within 7 days prior to planting. In the
absence of adequate moisture for herbicide activa-
tion irrigate within 7 days after application.
My be tank mixed with trifluralin.
2.0 DM limited to NZ. . Rreplant incorporation.
(4 Ib/gal E) Broadcast. Apply and incut Curate uniformly no
deeper..than ffe top 2 inches of soil within 7 days
prior td'planting. to not use on sands or lossy
sands. Hallow with a sequential, preonergenee
application of chloranban, or dinoseb, altanolanins
salts of the ethanol and isopropanol series.
Beans, Lima 0.1 ppn (negligible residue) (beans) 15002AA
0.2 ppm (negligible residue) (forage and hay)
2.5-3.0 Die limited to west of the Mississippi River,
(4 Ib/gal E) except in Kern County, California.
Preplant incorporation. Broadcast. Apply ani
incorporate uniformly into the top 2 inches of
soil within 7 days prior to planting. 3h the
absence of adequate moisture for herbicide activa-
tion irrigate within 7 days after application. .
toy be tank mi-mi with trifiuralia.
Issued: 3-1-82
22
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S& Index to Pesticide Oiemicals
Site, Dosage Tolerance, Use, Limitations
and Forauilation ——————^—^^^—
Beans, Hung 0.1 ppn (negligible residue) Cbeans) 13012AA
0*2 ppn (negligible residue) (forage and hay)
1.5-2.0 Die limited to GK Rreanergence* Broadcast or
(4 lb/gai E) band. Jfcply within 5 days of the last tillage
textured (except sand) soils, and the higher
le en mediua or fine textured soils. CD not
Beans, Red Kidney 0.1 ppa (negligible residue) (beans) 15001AA
0.2 ppoi (negligible residue) (forage and hay)
2.5-3.0 Dee limited to WZ. Freplant incorporation.
(4 lb/gal BC) Broadcast or band. Apply and incorporate
unifbsnly into the top 2 inches of soil within 7
days prior to planting. In the absence of adequate
moisture far herbicide activation irrigate within
7 days after application.
2.5-3.0 Cse-lirai*eai±D-WI. Fteemergence. Broadcast or
(4 lV?al HZ) band. Jfcply within 5 days of the last tillage
0.05 ppn (fresh com including sweet corn Oeernels 28005tA
plus cob with husk rowed)
0.2 ppm (fodderf forage* grain)
General Bifocnationt ^ply sprays in 15 or more
gallons of water or sprayable fluid fertiliser par
acre. Da not apply in fluid fertilizers after crop
emergence. Alachlor alone or in mixture with
atrazine may be applied preqnergenee by center
pivot irrigation systems. This type of application
should be made in 0.33 to 0.75 inch of water per
acre; on very sandy soils apply in a max&iun of 0.5
inch water per acre. Alachlor alone or in mixture
with atrazine may be applied aerially in 3 gallons
of water per acre. Alachlor in mixture with
2-( (4<
-------
fiidex to Pesticide Oiemieals
Site, Dosage Tolerance. Use, Limitations
and Porrmilation
Tib
Corn (continued) mixture with atra^iner or 2-((4^hlaro-€-
(athyi amino)-s-tr iazin-2-yl) anino)-2-methyl"
propionitrile and applied; the impregnation
cess oust be dene at conuereial fertilizer or
chemical dealerships eqoipped for this proce-
dure.
2.5-4.0 Preplant incorporation. Broadcast or band.
(4 It/gal E)
2.5-3.5 Preplant incorporation fcr furrow irrigated
(4 Ib/gal S) Broadcast. Apply and incorporate into the top
2 to 3 inches of soil within 7 days prior to plant-
ing. Dse a cultipacker or similar type implement to
pack the soil fcl lowing incorporation. Plant
ifflnediately after packing. SDil moisture at
application in this 2-3 inch aana most be
sufficient fcr crop and weed emergence. &rigation
within 10 days following planting nay
control.
2. 5-3. 5 Use Ilifllted~to OK and T5C. Preplant incorporation
(4 Ib/gal E) fcr when corn is planted dry and watered-ip.
Broadcast after prepared beds are knocked off
to planting height. Ti* *i'^ p?r^*^ into the top 2
inches of soil with a rolling cultivator or
similar izr^lenent within 7 days prior to planting.
2.0-3.0 Preplant incorporation. Broadcast. Tank mix with
(4 Ib/gal S)
2.5-3.0 Preplant incorporation. Broadcast. Tank mix with
(4 Ib/gal E) 2-( (4-
-------
Tnisx ra Pesticide Oiemicals
AUCSLDR
Site, Dosage Tolerance. Use. Limitations
anT
aTWAj
AGRICULTURAL CHOPS
Com (continued)
.0-4.0 Preemergence. Apply to the aoil surface after
4 lb/gal ZC) planting, but before weeds and crop •nerge and
within 5 days after the last preplan*, tillage
operation. DBS a miniimn of 3.0 Ib ai/A when
applying through center pivot irigation
1.5-2.5 Peeemergence. Broadcast. Tank mix with atrazine.
(4 lb/gal EC) Use a minima of 2.0 Ib ai/A vfcen applying through
pivot irrigation systems.
2.0-2.5 % Preamergence. Broadcast. Co not apply to sands
(4 lb/gal EC) with less than 2% organic matter. "BsnJc mix with
2-( (4-chloto-6-( ethyl amino-s-triari n-2-yl)amino)-
2-^nethyipropionitrile.
2.0-4.0 Early postemergenee. Apply to the soil surface
(4 lb/gal O after crop emergence until the crop is no more than
3 inchea tall, applications more than 5 days after
last tillage operation must be followed innediately
with rotary hoe or shallow cultivation to remove
which are,geminated and near emergence.
1.5-2.5 Early postemergenee. Broadcast. Apply befcre crop
(4 lb/gal EC) is 5 inches tall. Co not apply on sweet corn. Tank
mix with atrazine.
(field coin, hybrid seed com* silage corn, sweet corn)
2.19-3.13 Preplant incorporation. Broadcast. Apply and
(2.5 lb/gal PIC) iuuui.tjua.-ate into the top 2 inches of soil within 7
daya prior to planting, formulated with atrazine.
2.25-3.13 Preplant or preemergence. ..Broadcast. EOT use in
(2.5 lb/gal F1C) minima tillage systems. Sank mix with glyphoeate,
isopropylamine salt; or paraquat dichloride. Apply
in 20-60 gallons of water per acre by ground eqiiip-
Xoxsulated with atrazine.
Xsauedi 3-1-82
-------
ZSft Index -» Pesticide Oienicals
AUC3U3R
Site. Dcsace Tolerance, Use, Limitations
and Focmlation ~~~~~""~""~~1~~~"~^^^~~~"~
AOUCUUTURAL OOPS
Corn (continued)
2.4 Freemergence. Broadcast or band. Xbr lister
(15% G) or deep furrow planted corn. If heavy rains
fallow application, weed control on the top
and sides of the furrow may not be as good as that
in the bottan of the furrow. 2h deep lister
plantings only partial control can be expected on
the steep furrow sides. It is suggested that a 7
inch band be applied at the bottom of the furrow.
2.4—3.9 Frflemergence 11 >.*OL po* a LI on for furrow irrigated
(15% G) corn, Apply and incorporate with a harrow, finger
waeder or rotary hoe into the top 0.5 to 2 inches of
soil. Incorporation depth must be kept above the
seed. Sail moisture at application must be sufficient
far crop and waed emergence, irrigation within 10
days following planting may improve veed control.
(field corn, hybrid seed corn, silage corn)
2.O-2.5 Preemergenoe* Broadcast or band. Xbr lister or
(20% G) deep furrow planted corn. If heavy rains fallow
application* weed central en the top and sides of the
2.43 furrow nay not be as good as that in the bottom of
(9% G) the furrow. Jh deep lister plantings only partial
control CTn be expected en the steep furrow sides •
It is suggested that a 7 inch band be applied at
the bottcra of the furrow, tfey be fboulated with
atrarine.
2.0-3.5 Preemergence incorporation for furrow irrigated corn.
(10% G) apply and
-------
S& Index to Pesticide Qiemicals
Site, Dosage Toleranea> Use, Linitati
and Fonmlation
(ib
dnued)
2.25-3.13 ttrly postemergence. Broadcast or band,
(2.5 Ib/gal PIC) up until the crop reaches 5 inches in height.
Zbsnilated with atrazine.
(field earn aid silage corn)
2.5-4.0 Prepiant or premergence. Broadcast in 15^0
(4 Ib/gal E) gallons of water per acre. Rv use in minima
tillage system. Jfey be tank mixed with
glvphosata, iaopropylamine salt; or atrazine and
paraquat dichloride for control of emerged weeds;
or with atrazine; or 2-{ (4-chloro-6-(a*hylanino)-
s-triaa±n-2^1)amino)-2-«e*hyipropionii»xile; or
staazine for preeitezgent %«ei control. Glyphoeate,
iaopropylanine salt may be added to the latter three
preesezgent vwed control tank mixes to expand
control to include emerged weeds.
2.5 OM TtirrUfrt.fln fiat-planted field corn in II. ZA. MN.
(4 ib/gal S) and WI. Freatnergence or early poetemergence.
Breadeast. ^pply after planting and be fere the crop
is 3 inches tall. If rain does not occur within 3
days after an early postonezgence application* rotary
hoe to control emerged vceds. Cae on fine taxtured
soils only, lank mix with dicartoa.
A sacpen^ial poetemergent directed application of
2«4-dichlorophenoxyacetic acid (low volatile esters
amines) may follow alachlor applications.
0.05 ppn (negligible residue) (cotton seed) 28007AA
0.2 ppa (negligible residua) (forage)
General 3hfcnnation: ^pply in 15 or more gallons
of water per acre. CD natr use on sands. Do not
replant within 6 weeks of application in soil
broadcast treated with alachlor. If replanting is
in band treated fields, replant in un-
9il; for furrow planted cotton, open new
furrows and plant in soil not previously treated.
If sprinkler irrigation is used, irrigate before
planting, plant into moisture and apply. After
cotton has emerged and is growing wall, sprinkling
may be done as needed.
Issued: 3-1-82
2?
-------
S& Index *D Ftsticide Oiemicals
AXACELCR
Site. Doaage Tolerance. Use. Liadtati
and Fcnrailation
(Ib a.i ./A)
Cotton (continued)
1.0-2.0 Use limited to OK and certain TX counties.
(4 lb/gal E) Breemergence. Broadcast or band. Apply within
5 days after last preplant tillage operation.
Delay of application until cotton Healings have
geminated but not emerged through the soil sur-
face may reduce potential flbr crop injury. If
a band treatment is used the spray nozzles must
be located behind the drags or the covering
mechanism of the planter.
Peanuts 0.05 ppn (neglible residue) (peanuts) 28015A&
1.5 ppn (hulls)
3.0 ppn (forage and hay)
General Ih&rmatioiu Apply sprays in 15
gallons of %
3.5-4.0 Preplant or postplant. Incorporation. Apply
(4 lb/gal E) within 7 days prior to planting up to inmadiately
after-pi anting. Siallowty inmipuia'je into the
upper 1-2 inches of soil prior to crop germination.
^3^^SCQn30^^&^M^3Q 9^K QjQ^t FQ^*^3TaTkflRQ0Q ^3K^ ^^^B ^•'^30^^98
soils of the southeastern states.
3.0-4.0 Preemergenee. Broadcast or band. Apply within
(4 lb/gal E) 5 days after the last preplant tillage operation.
2.0-4.0
(10%G)
3.0-3.9
2.0-4.0 Preemergenee to cracking stage. Broadcast or
(4 It/gal S) band. Apply innediately after planting until
the majority of the peanuts reach the cracking
stage, this is normally 5-7 days after planting.
D9 not cultivate be&re applying. Delaying
application until cracking tine will frequently
improve weed control. Tank mix with sediua
S-1-naphthyiphthalanate and sediua dinoseb.
This tank mix-tore may be applied as a sequential
treatment after application of any labeled
preplant incorporated herbicide.
Xnueds 3-1-82
28
-------
ESt, Bides to Pesticide Chemical a
Site, Dosage
and Formulation
(ID a.i./Aj
Tol
. Use, tigdtatiens
TORAL CRQE5
Peanuts (continued)
3.0-3.0
(4 Ib/gal C)
Pcaa, Gi
(for processing)
2.0-2.5
(4 Ib/gal
2.5-3.0
(4 Ib/gal S)
QraeJdng stag*. Broadcast or band. lank
with dinoseb, aUcanolamina salts of the ethanol
and isopropanol series:. CO not add watting
agoots or other adjutants to this miztir*.
0.1 ppn (negligible readdue) (peas vdth pads
(dateznined on peas after ranoving any pod
1SDOAA
0.2ppa (negligible residue) (farage aid hay)
Ose limited to Won peas gxowi fbr processing.
Breonergenea. Broadcast, flpply in 15 or more
gallons of %a4er per acre within 5 days after
last prcplant tillage operation, fay be applied
aerially in 3 gallons of
OJ. ppn (negligible residue)
General" 2nS~xnations Apply in 15 or more
gallons of water per acre. Machlor alone or in
mixture with 4^araino-6-(l,l-dJme*3iylethyl)-3-
(nethylthio)-l, 2,4-
-------
S& 2fcdex to Pesticide C*.enieals
Site. Dosage
and Formal axicn
jySCCULTlUAL vStJtS
•^^fc^U^^^^^fc f.^K^^^B^^J ^^^^b^\
anbTCeV^O CGGR^2J*uBQJ
2.0-3.0
(4 Ib/gal E)
Tolerance. Use, Limitations
2.0-3.0
(4 Ib/gal E)
2.0-3.0
(4 Ib/gal E)
D§« limited to fedoc and SlsJdjou Oaunties, A and
all other states except the Bad River Valley areas
ef m and HD. Freemergence. Broadcast or bend.
feply after final drag-off or after early hilling
if these practice* are used, (fee the higher rate
when applied through center pivot irrigation. Oka
the lower rate In the New ftgland states including
KD aad PA northward or ia other areas where cold,
wet conditions are litely to persist, lank mix
with 4-anino-&-(l,l-d±Bethylethyl)-3-(nethylthio)-
1 , 2. 4-*riazin-5 (4R >-cne.
Gee limited to all states except CA, ID, OR, WA
and the Red River. Valley areas of W and HD.
Rreonergence. Broadcast or band, Jfeply after
final drag-off or after early hilling if these
practices are .used. Eb not use on sands or on
soils with less than 1% organic matter, lank mix
with linuron.
Use limited to those states east of the Mississippi
River, ffceaoergence. Broadcast or band. DD not
applywuntil-after final drag-off. CD not use on
sands, on soils with less than 1% organic wetter ,
or when potatoes are grown under furrow irrigation.
lank mix with direseb, alkanolaaine salts of the
ethanol and isopropanol series.
0.2 ppm (negligible residue) (soybeans)
0.75 ppm (forage) .
General Information* Apply sprays in 15 or more
gallons of water or sprayable fluid fertilizer per
acre* Machlor alone or in mixture with linuron;
or chloitttunurcn; or 4-aminD-6-(l,l-dJmethyie4iyl)-
3-phthalaaic acid and
ecdiuB dlnnefb may be applied aerially in 5 gallons
ef water per acre. DD not apply aerially in mini-
ma tillage systems, try bulk fertilizer may be
with alachlor alone or in mixture vdth
4-aBino-6-(l« 14iaethylethyl)-3-(methylthioM. 2
triaxin-5(4H}-one and applied; tha |mpre?nation
cess must be dene at ceamercial fertilizer or chemi-
cal dealerships equipped for this procedure.
2ssueds 3-1-82
30
-------
Index to Pesticide Qiemicals
Site, Dosage
and Fonaulation
llto a J../A)
JCULTVJRAL CSDES
Soybeans (continued)
2.5-4.0
(4 It/gal C)
2.0-2.4
(4 Ib/gal HZ)
Tolerance, Use. Limitations
2.11-3.25
(2.6 Ib/gal E)
2.0-3.5
(1016)
2.4-3.9
2.0-3.5
(10% 6)
2.4-3.9
(15% G)
2.0-4.0
(4
Freplant. Incorporation. Broadcast or _
Apply within 7 days prior to planting and
incorporate into the top 1-2 inches of soil. ._,
be tank mixed with 4-aaino 6 (1,1-dfaethylethyl)-
3-(nethyithio) -1.2,4-triazln-5 (4R }-cns.
gallons of «ater per acre, for use in mininun
tillage system. My be tank mixed %dth
gl^phosata* isopropylanine salt; or lintroa and
PL aqiat dichlorioe; or 4-anino-6-(l,l-d±i»rt3iyl»
ethyl) -3-(methyi tMo) -1,2.4->riazin-5 (4H )-one
and glyphosata, isopzcpyiaBine salt.
Wb planting or preonergeoee. droadcast. Ibr use
in mininun tillage systaas. ^pply in 20-30 gallons
of %ater by ground eqiipneat. lank mix vdth 4-onine
6-(l,l-dinethylethyl)-3-(inethylthio)-l« 2,4-*riazin-
5(4H)rone; or 1-iniaren. .!baviated with glyphosats*
isopcopyiamlne salt.
lergence. aroadcast or band.
ra uon.
k^ajuv* ,nwu&£
-------
S& Index to Pesticide Giemicals
ALACSZO5
Site, Dosage Tolerance. Use, Limitati
and FcBiulation
(ib a a./A
Soybeans (continued)
2.0 Preemergence. Broadcast or bend, J£ply within
(4 Ib/gal E) 5 days after last preplant tillage operation.
Tank mix with aodiun dinoeeb and sodiun N-l-
naphthylphthalaaic acid.
1.5-4.0 Preemergence. Broadcast or band, ^ly within
(4 Ib/gal E) 5 days after last preplant tillage operation.
Tank mix with linuron.
1.5-2.5 PreoBergenee. Broadcast or band. Xpply within
(4 Ib/gal E) 5 day* after last.preplant tillage operation.
Tank mix with chlorbroauton.
2.0-3.0 Preonergenee. Broadcast or band, ffcy also be
(4 Ib/gal E) used to oontrol merged weeds and waeis that will
germinate later in fields prepared for planting
several weeks earlier. Tank mix with dinoseb,
alkanolamiae salts of tha ethane! and isopropanol
1.5-3.0 ttrly postemerg^ence. Broadcast or bend,
(4 Ib/gal E) after crop and weeds emerge, but before first
soybean leaves expand to expose buis. to not apply
if soil surface is very wet. Tank mix with diroseb,
alkanolamine salts of the ethanol and isopropanol
ries.
Sequential treatment of bentaan. Bentaaon may be
(4 iVgal E) applied following prc«nergence aplicaticns of
alachlor; or alachlor and linuron; or alachlor and
scdiuB d1m>i»h and acdiun W-1-naphthylpnthalanie
acid; or alachlor and 4-eulr»^-(l,l-diiiethylethyl)-
3-(methylthio)-l( 2.4-triazin-5 («>-cne.
GZHS9VL XNFCFMAT3DN* fepeat applications maybe necessary for sustained
long-tern weed control, to not «cc«d 3 applications per year, to not re-
treat within 21 days. Topical applications are not recanmended. Overhead
irrigation applied within one hour after treatment will minimi a any
potential injury caused by accidental contact of the crop ^dth the chemical.
to not use in greenhouses or other enclosed structures.
Issued s 3-1-82
32
-------
281 Jhdex to Pesticide. Qiemicals
Situ, Dosage Tolerance, Use, Limitations
and Foraulation
(Ib a .i ./A)
Cotaneaster 34045*
DC? god 3S043DA
Eusnymus 34053DA
erabapple 3505€DA
Yew 3513GDA
4.05 Broadcast to field or liner grew plants in
(151 6) netdy planted or established fields. Apply anytime
after transplanting and before weeds enetge, or
after existing weeds have been renewed.
Euonynus See Gbtoneaster cluster.
Plowering erabapple Sae Odtoneaster cluster.
Holly 34070DA
Juniper
4.05 Broadcast to^newly planted or established field.
(151 6) liner or container grow* plants, Apply anytime
after transplanting and before weeds emerge, or
after existing wneis have been razored.
Juniper 3S073DA
Yew 3513CC*
4.0 Directed spray to newly transplanterl or established
(4 lb/gal E) plants. Apply in 15 or more gallons of veter per
acre anytime after transplanting and before weeds
enesge. or after existing vceds have been rsnoved.
Do not apply through irrigation systems or nixed
%dth sprayable fluid fertilij
to ally cluster for additional Juniper infor-
mation.
Yew See Gbtoneaster and Juniper clusters.
SMueds 3-1-52
33
-------
fiidoc to RestJcide Qiemicals
ftUOOOR
Site, Dosage Tolerance. Use, Limitations
and Poanmilaticn
(lb a.i./A)
MO TMK MIX APPLICRTIQC
Aerial Applications 9001SQ-
— Jfcfer to
M3KXCUI2URAL OCPS
990030
to
KSRTCDLTURAL QCP8
B«ans« dry; Beans, Ilmar Oarn? Peanuts, Jbta*»t
Issued: 3-1-63
34
-------
B& 2*5**- to Bisticida Qiamlcala
AUCBD3R
listing of Registered Etosticdda ftoiucts by {boulation.
60% Technical Chemical
Alachlor (090501)
000524-00315
901- Tee*udcal Chodeal
Al ashlar (090501)
000524-00316
9% Granular
Alsrhlor (090501) plus Jtrazine (083803)
000524-00304
10% Granular
Alachlor (090501)
000524-00287
15% Graxular
Al ashlar (090501)
000524-00296
Ib/gal Baalalfiable Ceneafrtrata
Alachlor (09C501) plu» glyphoin?, iaoprcpylaninc salt (103601)
000524-00341
4 Ib/gal Bnulsifaable Coneantrata
ALachlcr {0*90501j •
000^24-00285 000524-00314
2.5 IbAal Ploabla Cencentrata
Al ashlar (090501) plus atrazTna (083803)
000524-00329
Sta*.a Label Regiatrationa
CO Bag. Hb«
000524-10307
C£ teg. Ib.
OOOS24-10297
IS
000524-10303 000524-10304
16 Rag. Bb.
000524-10286
JS Pag. S3.
000524-10305
Issued* 3-1-82
35
-------
SA Jhdec » Pesticide Cmieals
ALX2LDR
State Label Re&straftienj (ocrrtinuod)
XA
001339-06934 037820-08430 037820-08431
MO Fag. ».
CCOS24-10299
000524-10306 000524-10479
000524-10301
OH feg. Ito.
OOOS24-103Q2
ER. Reg. Bb.
000524-10298
TA Itag. Zb.
000524-10300
Xssueds 3-1-82
36
-------
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: Unless stated otherwise in Section I, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products* not to 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 sec.
3(c)(2)(B), EPA has determined that you must submit these
data to EPA in order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
"Product-Specific Data Requirements for Manufacturing
Use Products" appearing in Table B permit you to determine
which product-specific data you must submit. This can be
done by examining the entries in the column of those tables
entitled "Must Data By Submitted Under S3(c)(2)(B)."
^J Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
37
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
V
Data Requirement Composition
§158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Ingredients
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density , Bulk Density, or
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA Have Data
To Satisfy This
Requirement? (Yes
No or Partially)
Yes
Partially
Partially
No
No
Partially
No
Yes
No
No
N/A 3/
No
Must Additional
Data Be Submitted
, Bibliographic Under PIPRA Sectioi
Citation 3(c)(2)(B)?
GS0063-0001 No
GS0063-0002 Yes 2/
GS0063-0003 Ye8 2/
Yes y
Yes y
GS0063-0004 Yes 2/
GS0063-0005
Yes y
GS0063-0005 No
Yes y
Yes y
Yes y
Specific Gravity
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
I/
Data Requirement Composition
Does EPA Have Data Must Additional.
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Sectioi
No or Partially) Citation 3(c)(2)(B)7
S158.120 Product Chemistry
63- 8
63- 9
63-10
63-11
63-12
63-13
Other
(continued)
- Solubility TGAI
• Vapor Pressure PAI
- Dissociation constant PAI
- Cctanol/water partition PAI
coefficient
- pH TGAI
- Stability TGAI
Requirements t
Partially
No
No
No
No
No
(50063-0005 Yes 2/4/
Yes 2/4/
Yes 2/
Yes 2/4/
Yes y
Yes 2/
64- 1 - Subnittal of sanples
Choice
N/A3/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
5158.120 Product Chemistry
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAI « Pure active ingredient; Choice » Choice of
several test substances determined on a case-by-case basis.
2/ Data must be submitted no later than six months from the receipt date of this guidance package.
3/ N/A- Not required for the purposes of this standard.
4/ Chemistry data are indicated because of Agency's concern for ground water contamination by alachlor*
LO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Requirement? (Yesr Bibliographic Under FIFRA Sectii
Data Requirements Comrosition No, or Partially) Citation 3(c)(2)(B)7
$158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants PAIRA Yes
- Livestock PAIRA and plant Partially
metabolites
171-4 - Residue Analytical Method
- Plant residues TGAI and metabolites Partially
- Animal residues TGAI and metabolites Partially
171-4 - Storage Stability Data PAI No
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
0 Beans(dried 6 succulent) TEP Partially
0 Lima Beans TEP Partially
Lima beans TBP Partially
(Forage and hay)
0 Corn
(Field and Sweet) TEP Partially
G50063-0006 ,650063-0037
GS0063-0007
GS0063-0008
GS0063-0009
GS0063-0006
GS0063-0011
GS0063-0010
-
GS0063-0011
GS0063-0012
GS0063-0011
GS0063-0013
(50063-0014
(50063-0011
(50063-0014
(50063-0006
(50063-0015
080063-0011
No
Yes 7/
Yes 3/6/
Yes 6/T/
Yes J/
Yes 3/6/
Yes 3/6/
Yes 3/6/
yey
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
!/
Data Requirements Composition
SI 58. 125 Residue Chemistry
171-4 - Magnitude of the Residue-
Residue Studies for Each
Pood Use
0 Corn
(forage and fodder) TEP
0 Cotton, forage TCP
(Cottonseed)
0 Peanuts TCP
(forage* hay, hulls)
0 Peas TCP
Peas TCP
(Forage and hay)
0 Potatoes TCP
0 Sorghun(grain) TCP
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Sectioi
No, or Partially) Citation 3(c)(2)(B)7
Partially
Partially
Partially
Partially
Partially
Partially
Partially
GS0063-0006 ,GS0063-0015
GS0063-001 1 , 00028563
GS0063-0007
GS0063-0007 ,(50063-0019
GS006 3-0016 ,GS0063-0033
GS0063-0011
GS0063-0012
GS006 3-0011
Gs006 3-0012
GS0063-0017
00028556,00028558
Yes 3/6/
Yes 3/6/
Yes 3/6/
Yes 3/6/.
Yes 3/6/
Yes 3/6/
Yes 3/6/
0 Sorghum
(fodder 6 forage)
TCP
Partially
00028557
00068044,00068045
GS0063-0018
Yes J/6/
-------
TABLE A
GENERIC DATA
FOR ALACHLOR
Data
S158
Requirement
.125 Residue Chemistry
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
Must Additional
Data Be Submitted
Under FIFRA Sectioi
3(c)(2)(B)7
(continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
0 Soybeans
0 Soybeans
(Forage)
0 Sunflower Seed
- Potable Hater
- Fish
- Irrigated Crops
— Field trials
— Processed Food/Feed
0 Soybean Hulls, Meal,
TEP
TEP
TEP
EP
EP
EP
EP
EP
EP
Partially GS0063-0006
Partially GS0063-0006
GS0063-0012
Partially GS0063-0020
Reserved 4/
N/A 5/
N/A
N/A
-
Partially GS0063-0006
Yes 3/6/
Yes 3/6/
Yes 3/6/
Yes 3/6/
Oil(crude & refined)
and Soap Stock
0 Corn Oil and Other
Processed Products
Sorghum Grain Processed
Products
EP
EP
Partially
GS0063-0011
Partially 00068044
00068045
Yes
Yes
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR AIACHLOR
Data Requirement
I/
Compos it ion
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Secti<
3(c)(2)(B)7
171-4 - Magnitude of the Residue -
Residue Studies (continued)
— Processed Food/Feed
0 Cottonseed Hulls, Meal,
Oil, and Soapstock
0 Peanut Meal, Oil,
0 Sunflower Meal, Oil,
and Soapstock
- Food Handling
- Meat/milk/poultry/eggs
0 Cattle
• Goats
0 Poultry
• Eggs
EP
EP
TGAI
TGAI
TGAI
TGAI
Partially
N/A5/
NO
Partially
Partially
Partially
GS0063-0007
GS0063-0021
GS0063-0022
GS0063-0022
Yes 3/6/
EP
EP
Partially
Partially
GS0063-0033
GS006 3-0020
Yes 3/6/
Yes 3/6/
Yes 3/6/
Yes 3/6/
Yes 3/6/
Yes 3/6/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
<15fl.l25 Residue Chemistry
(continued)
I/ Composition: THAI » Technical qrade of the active ingredient; PAIRA » pure active ingredient, radiolabelled: TEP •
Typical end-use product: EP « End-use product.
2/ Data required by this registration standard to be held in abeyance pending outcome of the Special Review.
J/ Data necessary to maintain registration during the period of Special Review and any hearings: must be submitted as
soon as practicable in light of ongoing work and in any case no later than one year from the receipt date of this
guidance package.
4/ Reserved: Residue chemistry testing for potable water is indicated because of the potential for alachlor to reach
groundwater.
5/ N/Ar> Not applicable for the purposes of this standard.
6/ Additional metabolism data (submitted with PPt 3F2832 and OP234) reviewed on 4/28/84, and the Special Review
process indicate the presence of metabolites in plants convertible to 2-ethylaniline which cannot be measured
by the present analytical methodology. Consequently additional residue data and analytical methodology data may
be required.
7/ The analytical methodology for meat, milk and eqgs must be submitted in January, 1985. The registrant committed
to this date in its letter dated 9/21/84.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
Data Requirement
I/ Use
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIPRA Section
3(c)(2)(B)7
S158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradat ion
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LABt
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
TGAI or PAIRA A,B,H
TGAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A,B,H
TGAI or PAIRA A
162-3 - Anaerobic Aquatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
MOBILITY STUDIES;
163-1 - Leaching and TGAI or PAIRA A,B,H
Adsorption/Desorption
163-2 - Volatility (Lab) TEP A
163-3 - Volatility (Field) TEP A
Yes
Yes
Yes
N/A ID/
Reserved 4/
Yes
Yes
Yes
GS0063-0036
No
Yes
Yes
Yes
00023012
GS0063-0036
00091044
GS0063-0038
No
No
•*>
00023014,00101531 No 7/
00100795,GS0063-0036
00100795,00101531
GS0063-0036
No
00027139,00078301 No
00027140,GS0063-0036
00100075,00101531 No 5/
00091044
00101531 No 5/
-------
TABLE A
GENERIC DMA REQUIREMENTS FOR AIACHDOR
Data Requirement
Composition
Use "if
Pattern
Does EPA Have Data
""o Satisfy This
Requirement'' (Yes,
No or Partially)
Bihliooraphic
Citation
Must additional
Data Re Submitted
Under FIFRA Section
3(c)(?)(B)7
jg.158.130 Environmental Fate
(continued)
DISSIPATION STUDIES-FIELD!
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCtlMULATION STUDIES!
165-1 - Rotational Crops
(Confined)
165-7 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Pish
165-5 - In Aquatic Non-Taroet
Organisms
SPECIAL MONITORING STUDY!
166-1 - Ground and Surface
Hater Monitoring
TEP A,B,H
TEP
TEP
TEP
TEP A
PAIRA A
TEP A
TEP
TGAI or PAIRA A,B
TEP
TEP
A,B
Yes
N/A ID/
Reserved 6/
Yes
Partially
in/
YPS
NO
00100795,00101531 *>
00023015,00101531
00100705
00087855
NO y
Yes 3/B/5/
Yes V
No
Yes V
Yes ll/
-------
A
GENERIC DATA REQUIREMENTS FOR AIACHLOR
S1.5P.130 Environmental Pate
(continue?)
i
I/ OcmDosition: TGAI * Technical grade of the active ingredient: PAIRA = pure active ingredient, radiolabelled?
TRP = Typical end-use product.
2/ Tlie use patterns are coded as follows: A=Terrestrial, Food Crop: B^Terrestrial, Non-Pood: OAauatic, Food Crop:
D=Aquatic, Non-Food: 15=<3reenhouse, Pood Crop; F=Oreenhouse, Non-Pood: G=Forestry: H=Damestic Outdoor; I=Indoor.
3/ Data required by this registration standard to be held in abeyance pending outcome of the Special Review.
7/ Aerobic aquatic data have been submitted but previously were not required (Currently in Agency files).
V itie exposure studies cited, will satisfy data requirements for 161-4: Photodeqradation in Air, 163-2: volatility
(Lab), and 163-3: volatility (Pield).
6/ itie requirement for combination and tank mix data is reserved.
i/ The results of the aerobic soil metabolism study and field dissipation studies indicate that data will n6t he
necessary.
8/ Data on j^C uptake by corn seedlings at the four pound per acre rate and on uptake into other crops at the one
pound per acre rate are acceptable. Additonal data are needed at actual use rate levels including the
chemical identification of plant residuest
9/ For crops rotated on treated areas, any one of the following will apply:
a. A tolerance must be obtained for the rotated crop,
b. Ttie product label must include a restriction against the rotation of crops used for food or feed, which are
not registered for use with alachlor onto areas previously treated with this chemical.
c. Data must be provided to determine time intervals at which rotated crops used for food or feed, which are not
registered for use with alachlor but rotated onto areas previously treated with this chemical will be free of
pesticide residues. If data are supplied, they must be submitted no later than four months from the
issuance of this standard.
10/ N/fc* Not applicable for the purposes of this standard.
ll/ A protocol must he designed to study the means and extent of alachlor's potential to leach to ground water and
of alachlor1 s potential to run off to surface water bodies and to contaminate drinking water drawn from surface
sources, itie protocol must he submitted by 90 davs from the issuance date of this standard.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Sec tier
Data Requirement Composition Patterns No or Partially) Citation 3(c)(2)(B)7
SI 58. 135 Toxicology
ACUTE TESTING!
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Acute Inhalation Toxicity
Rat
- Primary Eye Irritation
- Primary Skin Irritation
- Dermal Sensitization
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
AfB
A,B
A,B
A,B
A,B
A,B
Yes GS0063-0021 No
Yes GS0063-0022 No
Yes GS0063-0023 No
Yes GS0063-0024 No
Yes GS0063-0025 No
Partially GS0063-0026 Yes 3/
N/A ll/
SUBCHRONIC 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
Partially GS0063-0034 Yes 8/ 9/
N/A
N/A
Rat
82-5 - 90-Day Neurotoxicity-
Hen/Mannal
TGAI
A,B
N/A
-------
TABLR A
GENERIC DATA RFDniRFMENTS FOR AIACHLOR
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Use 2/ Requirement? (Yes, Bibliographic Under PIFRA Section
Data Requirement Composition Patterns No or Partially) Citation 3(c)(2)(B)?
5158.135 Toxicology
(continued)
CHRONIC TESTING:
83-1
83-2
83-3
83-4
- Chronic Toxicity - TGAI A,B
2 species: Rat and
Dog
- Oncoqenicity Study - TGAI A,B
2 species: Rat and
Mouse
- Teratoqenicitv - TGAI A,B
2 species: Rat and
Rabbit
- Reproduction, TGAI A,B
2-oeneration
Yes
Partially
Partially
Yes
Yes
Partially
Yes
wrrAGENicrry TESTING
84-2
84-2
84-2
- Gene Mutation TGAI A,B
- Chromosomal Aberration TGAI A,B
- Other Mechanisms of TGAI A,B
Partially
NO
Partially
00064546,00091050 No
GS0063-0027 , GS0063-0028
00028564,000064547 Yes 10/
00087479
00064546,00091050 Yes 4/
00091043,
GS0063-0027,GS0063-0029
GS0063-0028,GS0063-0042
00075709 No
00043645 No
GSn063-0041 Yes V
00075062 No ^ ^j
GS0063-0035 Yes £/ ^ | p
"~~ ° so
Yes6/ 3|3
si
GS0063-0035,GS0063-0043 Yes 6/12/
Mutaqeniciry
50
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TABLE A
GENERIC DKTA REQUIREMENTS FOR ALACHLOR
Data Requirement
I/ Use
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)?
5158.135 Toxicology
(continued)
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA A,B
85-2 - Dcmestic Animal Safety Choice
85-3 - Dermal Absorption Study PAIRA A,B
Yes
N/A ll/
Partially
GS0063-0030
00091046,00091047
No
Yes 7/
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TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
S158.135 Toxicology
I/ Composition! PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelied; Choice » dioice of sever
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; G*Aquatlc, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Pood Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; 1=Indoor.
3/ A skin sensitization study in guinea pigs (Ace.252772, March 1984) has been submitted to the Agency and it is being
reviewed.
4/ A new chronlc/oncogenicity study in rats (Part I, Study* ML-80-186) Ace.252496, 252497, 252498, Feb. 1984)
has been submitted to the Agency, and it has been reviewed by HED. * Recently, a full report on rats dosed at the
126 mg/kg/day dosage level (FJLH-800219, Study* ML-80-224, accessions: I 253306, I2533U7 ) was submitted by the
registrant. The Agency has reviewed the study and found it acceptable.
5/ A teratology study of a second animal species, rabbit (Ace.252570, Feb. 1984) was reviewed by the Agency, and it was
found to be supplementary. This teratology study must be revised in order to fulfill the data gap.
It is data necessary to maintain registration during the period of Special Review and any hearings; it must be
submitted as soon as practicable in light of ongoing work and in any case no later than eighteen months from the
receipt date of this guidance package.
6/ The following nutagenicity data are required:
a. In vitro mammalian cell point mutation [L5178Y (TK), or CHO (HGPRT), or V79 (HGPRT)J tests,
b. In vitro cytogenetic damage: both chromosomal aberration and SCE (in CHO cells, or human lymphocytes, or other
rodent/human cell lines/strains tests,
** c. Iji vivo cytogenetics test for chromosomal aberrations using bone marrow preparations of rats,
d. Dominant lethal test in rats or mice.
These data are necessary to maintain registration during the period of Special Review and any hearings; they must be
submitted as soon as practicable in light of ongoing work and in any case no later than eighteen months from the
receipt date of this guidance package.
7/ A dermal absorption study must be submitted. It is data necessary to maintain registration during the period of
Special Review and any hearings; it must be submitted in January, 1985. Monsanto committed to this date in
its letter dated 9/21/84.
8/ A 21-day dermal study must be submitted.
9/ Data required by this registration standard to be held in abeyance pending outcome oE the Special Review.
10/ A one-year feeding study in dogs with a demonstrated NOEL is required.
It is data necessary to maintain registration during the period of Special Review and any hearings; it must be
submitted as soon as practicable in light of ongoing work and in any case no later than eighteen months from the
receipt date of this guidance package.
ll/ N/A3 Not applicable for the purposes of this guidance package.
12/ Two nutagenicity studies (Ace.253308, April 1984) were submitted to the Agency and they were reviewed.
The Agency found the study involving in vitro/ Ir» vivo primary hepatocyte repair for UDS testing acceptable, but
the Agency found the second study** involving In vivo cytogenetics test for chromosomal aberrations using bono
marrow preparations ot rats incomplete and unacceptable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
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 FIPRA Section
3(c)(2)(B)7
SI58.145 wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral Toxicity TGAI A,B
71-2 - Acute Avian Dietary TGAI A,B
Toxicity
71-3 - Wild Mammal Toxicity TGAI
71-4 - Avian Reproduction TGAI
71-5 - Simulated and Actual TCP
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Acute Freshwater Fish TGAI A,B
Toxicity
72-2 - Acute Freshwater TGAI A,B
Invertebrates Toxicity
72-3 - Acute Estuarine and TGAI
Marine Organisms
Toxicity
72-4 - Fish Early Life TGAI
Stage and Aquatic
Invertebrate Life-Cycle
Yes
Reserved 3/
N/A 4/
N/A
N/A
Yes
Yes
Reserved 3/
N/A
00079523
00023615,00028554
00023616,00031521
00028550,00031522
00028551,00031524
00028553,00031525
00028549,00031523
00028552,00031526
00028555
No
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c)(2)(B)7
§158.145 Wildlife and
atic Organisms
continued)
72-5 - Fish - Life-Cycle TCAI N/A 4/
72-6 - Aquatic Organism TGAI, PAI OR N/A
Accumulation Degradation
Product
72-7 - Simulated or Actual TCP N/A
Field Testing -
Aquatic Organisms
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR AIACHLOR
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c)(2)(B)7
S158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute TGAI A,B Yes 00028772 No
contact toxicity 00074486
141-2 - Honey bee - toxicity TEP N/A 4/
of residues on
foliage
141-3 - Mild bees important in TEP N/A
alfalfa pollination -
toxicity of residues
on foliage
141-4 - Honey bee subacute (Reserved)5/
feeding study
141-5 - Field testing for TEP N/A
pollinators
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALALCHLOR
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c)(2)(B)?
S158.155 Nontarget Insect
(continued)
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to (Reserved)**/
aquatic insects
142-2 - Aquatic insect (Reserved)6/
life-cycle study
142-3 - Simulated or actual (Reserved)6/
field testing for
aquatic insects
143-1 - NONTARGET INSECT (Reserved)6/
TESTING - PREDATORS
thru AND PARASITES
143-3
56
-------
TABLE A
GENERIC CATA REQUIREMENTS FOR ALACHLOR
S158.145 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, Pood Crop; B=3terrestrial, Non-Food Crop; C=Aquatic, Food Crop
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=<5reenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I-Indoor.
3/ Data requirements pending receipt of environmental fate data. These data may be necessary to support cotton,
corn and soybeans uses*
4/ N/A=Not applicable for the purposes of this standard.
5/ [Reserved] Requirement reserved pending development of test methodology.
6/ [Reserved] Pending decision as to whether data requirement should be established.
-------
JZ B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALACHLOR (60% FI)
I/
Data Requirement Composition
$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
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
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)?
Yes
Partially
Partially
No
No
Yes
No
Yes
No
N/A 4/
N/A
No
GS0063-0001 No
GS0063-0002 Yes 2/
GS0063-0003 Yes 2/
Yes y
Yes y
GS006 3-0004, GS0063-0005 No
GS006 3-0029, GS006 3-0030
GS0063-0031 ,GS0063-0032
Yes y
GS0063-0005 No
Yes y
Yes y
Specific Gravity
58
-------
TABLE B
PRODUCT SPECIFIC DATA
Data Requirement
SI 58. 120
63- 8 -
63- 9 -
63-10 -
63-11 -
63-12 -
63-13 -
63-14 -
63-15 -
63-16 -
63-17 -
63-18 -
63-19 -
Product bhemistry
(continued)
Solubility
Vapor Pressure
Dissociation constant
Octanbl/water partition
coefficient
pH
Stability
Oxidizing or Reducing
Action
Flanmability
Explodability
Storage Stability
Viscosity
Miscibility
REQUIREMENTS FOR
Composition
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MANUFACTURING-USE PRODUCTS CONTAINING ALACHLOR
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
No
No
N/A
No
No
N/A
No
No
No
No
No
No
(60% PI)
Must Additional
Data Be Submitted
Under FIFRA Sectii
3(c)(2)(B)? L
yes yy
Yes yy
Yes yy
Yes y
Yes y
Yes y
Yes y
Yes y
Yes y
Yes 2/
Other Requirements;
64- 1 - Submittal of samples
Choice
N/A
-------
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALACHLOR (90% Technical)
Data Requirement Composition
S158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Ingredients
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density r Bulk Density , or
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Yes
Partially
Partially
No
No
No
No
Yes
No
N/A4/
N/A
NO
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Sectii
Citation 3(c)(2)(B)7
GR0063-0001 No
GS0063-0002 Yes 2/
GS0063-0003 Yes 2/
Yes y
Yes 2/
Yes y
Yes y
GS0063-0005 No
Yes y
Yes 2/
Specific Gravity
60
-------
fiLE C
PRODUCT SPECIFIC DATA
Data Requirement
5158.120
63- 8 -
63- 9 -
63-10 -
63-11 -
63-12 -
63-13 -
63-14 -
63-15 -
63-16 -
63-17 -
63-18 -
63-19 -
Product Chemistry
(continued)
Solubility
Vapor Pressure
Dissociation constant
Octanol/Water partition
coefficient
PH
Stability
Oxidizing or Reducing
Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
REQUIREMENTS FORTH
I/
Composition
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
INUFACTURING-USE PRODUCTS CONTAINING ALACHLOR
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
No
No
N/A
No
No
N/A
No
NO
No
No
No
NO
(90% Technical)
Must Additional
Data Be Submitted
Under FIFRA Sect!
3(c)(2)(B)?
Yes 2/3/
Yes^S/
Yes 2,3,
tea 2/
Yes y
Yes y
Yes y
Yes y
Yes y
Yes y
Other Requirements!
64- 1 - Subtnittal of samples
Choice
N/A
61
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALACHLOR
S158.120 Product Chemistry
(continued)
I/ Composition! HP « Manufacturing-use product; Choice » Choice of several test substances determined on a case-by-
case basis.
y Data must be submitted no later than six months from the receipt date of this guidance package.
3/ Chemistry data are indicated because of the Agency's concern for groundwater contamination.
4/.N/A- Not applicable for the purposes of this standard.
-------
BLE B
PRODUCT SPECIFIC DMA REQUIREMENTS FOR HANUFACTURING-USE PRODUCTS CONTAINING AIACHLOR
Data Requirement
Conpoeition~
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIPRA Section
3(c)(2)(B)?
S158.135 Toxicology
ACUTE-TESTING
81-1 - Acute Oral Tbxicity - Rat HP
81-2 - Acute Dermal Tbxicity HP
81-3 - Acute Inhalation Toxlcity HP
Rat
81-4 - Primary Eye HP
Irritation - Rabbit
81-5 - Primary Dermal HP
Irritation
81-6 - Dermal Sensitizatlon MP
Yes
Yes
Yes
Yes
Yes
Partially
GS0063-0021
GS0063-0022
GB0063-0023
G60063-0024
GS0063-0025
GB006 3-0026
No
No
No
No
NO
Yet
63
-------
TABLE B
PRODUCT SPECIFIC DKTA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALACHLOR
5158.135 Toxicology
(continued)
I/ Ooqpositiont MP • Manufacturing-use product*
2/ Data required by this registration standard to be held in abeyance pending outcome of the Special Review.
3/ A skin sensitization study in guinea pigs (Ace.252772, March 1984) has been submitted to the Agency and it is being
reviewed.
-------
IV. SUBMISSION OP REVISED LABELING INFORMATION
Note; This section applies to end use products only to the
extent described in Section I (Regulatory Position and
Rationale). Otherwise, the following information pertains
exclusively to manufacturing use products.
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CFR 162.10 (see
Appendix IV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix IV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
If you fail to submit revised labeling information
complying with this section and/or Section I, EPA may issue
a notice of intent to cancel the registration under FIFRA
sec. 6(b)(l).
A. Label Contents
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items
listed below are keyed to Appendix IV-2.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
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.
Item 3. NET CONTENTS - A net contents statement is
require on all labels or on the container of the pesticide.
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 expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
•26 ounces.* In addition to English units, net contents may
be expressed in metric units. See Appendix IV-1. [40 CFR
162.10(d)J
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
65
-------
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product* by the Agency. See Appendix IV-1.
[40 CFR 162.10(e))
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
See Appendix IV-1. [40 CFR 162.10(f>]
Item 6. INGREDIENTS STATEMENT - An ingredients 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 ingredients
statement must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the
body of other text. See Appendix IV-1. [40 CFR 162.10(g)]
Item 6A. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary stateraent-s must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word as Re- "Keep Out of Reach
on Front Panel quired Minimum Type of Children"
in Square Inches Size All Capitals as Required
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to IS 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be 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)(l)(ii)]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[40 CFR 162.10 (h)(l)(i)]
66
-------
Item 7C. SKULL 6 CROSS BONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation 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 162.10(h) (1) (i~) ]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV-1. [40 CFR 162.10(h) (1) ( iii) ]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix IV-1. [40 CFR 162.10(h)(l) (iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix IV-1. [40 CFR 162.10
-------
2. Criteria for declaration of non-flammability. The
following criteria will be used to determine if a product
is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A "non-flammable liquid" is one having a flashpoint
greater than 350°P (177°C).
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches;
ii. There is no flashback; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°P (177°C).
3. Declaration of non-flanunability. Products which
meet the criteria for non-flammability specified
above may bear the notation "non-flammable" or "non-
flammable (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 demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
Item 9. PRODUCT CLASSIFICATION - Section 3(d) of FIFRA
requires that all pesticide formulations/uses be classified
for either general or restricted use, and that those uses
classified as restricted be limited to use by certified
applicators or persons under their direct supervision (or
subject to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses to be restricted, based either on a
previous classification determination made through the optional
procedures of 40 CPR 162.30 or based on data already available
to the Agency, or (2) reserved any classification decision until
appropriate data are submitted.
68
-------
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you wish to propose that your product should not be
classified for restricted use, you must submit any information
and rationale with your application for reregistration.
During the Agency's review of your application, your proposed
classification determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.'
A. Classification Labeling Requirements
1. All Uses Restricted - Pesticide products bearing
directions for use for formulations or uses classified
restricted shall bear statements of restricted use classi-
fication on the front panel as described below:
a. The statement "RESTRICTED USE PESTICIDE,
must appear at the top of the front panel of the
label, set in type of the same minimum sizes as
required for human hazard signal words (see table in
40 CFR 162.10(h)(l)(iv).
b. Directly below this statement on the front
panel, a summary statement of the terms of restric-
tion shall appear. If use is restricted to certified
applicators, the following statement is required:
"For retail sale to and use only by Certified Applicators
or persons under their direct supervision and only
for those uses covered by the Certified Applicator's
Certification."
2. Some But Not all Uses Restricted - If the Regula-
tory Position and Rationale states that some uses are
classified for restricted use and some uses are unclassified,
several courses of action are available:
a. You may label the product for restricted use.
If you do so, you may include those uses that are
unrestricted, but you may not distinguish them on
the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unres-
tricted uses.
69
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c. You may "split" your registration, i.e.,
register two separate products with identical formula-
tions, one containing only unrestricted uses, and
the other restricted uses. To do so, submit two
applications for reregistratidn, each containing all
forms and necessary labels. Both applications should
be submitted simultaneously. Mote that the product
names will be assigned separate registration numbers.
B. Compliance Schedules
No product with a use classified for restricted use
under this Standard may be released for shipment by the
registrant or producer after one year from the date of
issuance of this Standard, unless such product bears the
restricted use classification. All products still in
channels of trade after two years from the date of issuance
of this Standard must be labeled for restricted use.
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. 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-4 to determine the disposal instructions appropriate for
your products.
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 Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or 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.
70
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V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Rooert J. Taylor
Product Manager 25
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington. D.C. 20460
Phone No. (703) 557-1800
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 d580-l. Refer to Appendix II-2 with appropriate
attachments.
2. Within 6 mo.iths from receipt of this document registrants
must submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific -Data Report, EPA Form 8580-4 (Appendix
III-l).
c. Two copies of any required product-specific data.
d. Two copies of draft labeling including the label and
associated brochures. If current labeling conforms
to the requirements of this guidance document and the
results of the short-term data, the registrant may
_s_ubmi_t suchm labeling. j( End-use product labeling
needs to comply specifically with the instruction in
Section II of this guidance document.) The labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for
stortage in 8-1/2 x 11 inch files. The draft label
must indicate the intended,.colors of The' final labej.,
clear indication of the front panel label, and the
intended type sices of the text.
3. Within the time set forth in Table A', all generic data
must be submitted by tne affected registrant(s).
Note; If for any reason any required test is delayed or aborted
so that meeting the agreed submission time will be delayed.
notify the Product Manager listed above.
After the Supreme Court has ruled on the Mor.sS^.o Decision,
you will be informed as to when you must submit your Application
for Amended Pesticide Registration (EPA Form 8570-1) and the
associated data support information.
.71
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Appendix II-l
Guide to Use of This Bibliography
1. CONTENT OP BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OP ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all NRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
72
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Appendix II-l (continued)
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration numb ~, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
73
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Appendix II-2
MRID Nunber
Alachlor Bibliography
00023012 Sutherland, M.L.; Curtis, T.G.; Darlington, W.A.; -et al. (1972)-
Final Report on Lasso and the Environment: Part 4: Photolysis of
Lasso on soil and in Water: Agricultural Research Report No 262
(Unpublished study received June 29, 1973 under 3F1372; submitted
by Monsanto Co., Washington, D.C.; CDL:093660-L)
00023014 Sutherland, M.L.; Curtis, T.G.; Darlington, W.A.; et al. (1972)
Final Report on Lasso and the Environment: Part 6: Soil Dissipa-
tion of Lasso: Agricultural Research Report No 264 (Unpublished
study received June 29, 1973 under 3F1372; submitted by Monsanto
Co., Washington, D.C.; CDL:093660-N)
00023015 Sutherland, M.L.; Curtis, T.G.; Darlington, W.A.; et al. (1972)
Final Report on Lasso and the Environment: Part 7: Soil Binding
and Phytotoxicity of Lasso Residues: Agricultural Research Report
No. 265 (Unpublished study received June 29, 1973 under 3F1372;
submitted by Monsanto Co., Washington, D.C.; CDL:09366U-O)
00023615 Thompson, C.M.; Forbis, A.D.; McAllister, W.A. (1978) Acute
Toxicity of Technical Alachlor (AB-78-166) to Bluegill Sunfish
(Lepcmis macrochirus). (Unpublished study received Aug. 16,
1978 under 524-285; prepared by analytical Biochemistry Labora-
tories, Inc., submitted by Monsanto Co., Washington, D.C.;
CDL: 234628-C)
00023616 Forbis, A.D.j McAllister, W.A. (1978) Acute Toxicity of Technical
Alachlor to Rainbow Trout (Salmo qairdineri). (Unpublished
study received Aug. 16, 1978 under 524-285; prepared by Analytical
Biochemistry Laboratories, inc., submitted by Monsanto Co.,
Washington, D.C.; CDL: 234628-D)
00027139 Weidner, C.W. (1974) Degradation in Groundwater and Mobility of
Herbicides. Master's thesis, Univ. of Nebraska, Dept. of Agronomy
(Unpublished study received Jul 19, 1978 under 201-403; submitted
by Shell Chemical Co., Washington, D.C.; CDL:234472-0)
00027140 Lavy, T.L. (1974) Mobility and Deactivation of Herbicides in Soil-
Water Systems: Project A-024-NEB. (Available from: National
Technical Information Service, Springfield, VA:PB-238 632; un-
published study received Jul 19, 1978 under 201-403; prepared by
Univ. of Nebraska. Water Resources Research Institute, sub-
mitted by Shell Chemical Co.., Washington, D.C. CDL:234472-P)
00028549 McAllister, W.A.j Forbis, A.D. (1978) Acute Toxicity of Technical
Alachlor (AB-7B-200) to Daphnia magna. (Unpublished study
received Dec. 28, 1979 under 524-285; prepared by Analytical Bio
Chemistry Laboratories, Inc., submitted by Monsanto Co., Wash-
ington, D.C.; CDL:241535-A)
74
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00028550 Thompson, C.N.; Forbis A.D. -(1978) Acute Toxicity of Lasso (MCB/
Gg) (AB-78-111) to Rainbow Trout (Salmo gairdneri). (Unpub-
lished study received Dec. 28, 1977 under 524-285; prepared by
Analytical Bio Chemistry Laboratories, Inc., submitted by Monsanto
Co., Washington, D.C.; CDL:241535-P)
00028551 Thompson, C.M.: Forbis A.D. (1978) Acute Toxicity of Lasso (NCR/
CgM AB-78-111) to Bluegill Sun fish (Leponis macrochirus).
(Unpublished study received Dec. 28, 1979 under 524-285; prepared
by Analytical Bio Chemistry Laboratories, Inc., submitted by
Monsanto Co., Washington, D.C.; CDL-.241535-C)
00028552 McAllister, W.A.; For is, A.D. (1978) Acute Toxicity of Lasso
(MCB/Cg) (AB-78-111) to Daphnia magna. (Unpublished study received
Dec 28, 1979 under 524-285; prepared by Analytical Bio Chemistry
Laboratories, Inc., submitted by Monsanto Co., Washington, D.C.
CDL:241535-D)
00028553 Thompson, C.M.; Forbis, A.D. (1978) Acute Toxicity of Lasso EC
(MCB) (AB-78-167B) to Rainbow Trout (Salmo gairdneri).
(unpublished study received Dec. 28, 1979 under 524-285;
preparedd by Analytical Bio Chemistry Laboratories, Inc.,
submitted by Monsanto Co., Washington, D.C.; CDL241535-E)
00028554 Thompson, C. M.; Forbis, A.D. (1978) Acute Toxicity of Lasso EC
(MCB) (AB-78-167) to Bluegill Sunfish ( Leponis macrochirus).
(Unpublished study received Dec. 28, 1979 under 524-285; pre-
pared by Analytical Bio Chemistry Laboratories, Inc., submitted
by Monsanto Co., Washington, D.C.; CDL:241535-F)
00028555 McAllister, W.A.; Forbis, A.D. (1978) Acute Toxicity of Lasso EC
(MCB) (AB-78-167) to Daphnia magna. (Unpublished study received
Dec. 28, 1979 under 524-285; prepared by Analytical Bio Chemistry
Laboratories, Inc., submitted by Monsanto Co., Washington, D.C.;
CDL:241535-G)
00028556 Lauer, R.; Arrans, D.D.; Stranz, J.L,; et al. (1979) Residues of
Alachlor and Atrazine in Field Treated Sorghum following Pre-
or Postemergent Applications with Lasso-(R) i or a Lasso-(R) * +
Atrazine Tank Mix: Report No. MSL-1033. Rev. (Unpublished
study received Mar 25, 1980 under 524-285; prepared in coopera-
tion with ABC Laboratories, Inc., submitted by Monsanto Go.,
Washington, D.C.; CDL-.099326-A)
00028557 Monsanto Company (19??) Analytical Residue Method for Alachlor
in Sorghum Forage, Fodder and Grain. Two undated methods.
(Unpublished study received Mar 25, 1980 under 524-285; CDL:
099326-B)
00028558 Monsanto Company (19??) Reasonable Grounds in Support of the Re-
guest: Lasso, (unpublished study received Mar 25, 1980 under
524-285; CDL: 099326-C)
75
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00028563 Danhaus, R.G.; Stranz, J.L.; TDubelman, S. (1980) Residues of
Alachlor and Atrazine in Field Treated Corn following Preemer-
gent and Lay-by applications of Lasso-(R) or Lasso-(R) +
Atrazine Tank Mixes; Report No. MSL-1105. (Unpublished study
received Apr 24, 1980 under 524-285; prepared in cooperation
with ABC Laboratories, Inc., submitted by Monsanto Co.,
Washington, D.C.; CDL:099396-A)
00028564 Ahmed, P.E.; Underwood, P.C.: Tegeris, A.S. (1980) Alachlor: Six
Month Study in the Dog: Opthalmological Findings to Date.
(Unpublished study received April 29, 1980 under 524-314;
prepared by Pharmacopathics Research Laboratories, Inc.,
submitted by Monsanto Co., Washington, D.C.; CDL;242371-B)
00028772 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1973) Toxicity
of Pesticides and Other Agricultural Chemicals to Honey Bees:
Laboratory Studies. Rev. By Univ. of California—Riverside,
Dept. of Entomology. Riverside, Cali.: UC, Agricultural Extension
Service. (Also-In_unpublished submission received April 2, 1980
under 464-556; submitted by Dow Chemical U.S.A.; Midland, Mich.;
CDL:242149-Z)
00031521 Thompson, C.M.; Forbis, A.D.; Oleson, F.B.; et al. (1979) Acute
Toxicity of Lasso-(R) NF-79-WB (AB-79-173) to Rainbow Trout
(Saline gairdneri); Static Acute Bioassay Report #24529. (Unpub-
lished study received Jan 17, 1980 under 524-EX-491. Prepared
in cooperation with Analytical Bio Chemistry Labs., Inc., sub-
mitted by Monsanto Co., Washington, D.C.; CDL:241619-B)
00031522 Thompson, C.M.; Forbis, A.D.; Oleson, F.B; et al. (1979) Acute
Toxicity of Lasso - (R) NF-79-WB (AB-79-174) to Bluegill Sunfish
(Lepomis macrochirus): Static Acute Bioassay Report *24530.
(Unpublished study received Jan. 17, 1980 under 524-EX-49; pre-
pared in cooperation with analytical Bio-Chemistry Laboratories,
Inc., submitted by Monsanto Co., Washington, D.C.; CDL: 241619-C)
00031523 Thompson, C.M.; Forbis, A.D.; Oleson, F.B. (1979) Acute Toxicity
of Lasso NF-79-WB (AB-79-175) to Daphnia magna; Static Acute
Bioassay Report 24531. (Unpublished study received Jan 17, 1980
under 524-EX-49; prepared in cooperation with Analytical Bio
Chemistry Laboratories, Inc., submitted by Monsanto Co., Wash-
ington, D.C.; CDL:241619-D).
00031524 Thompson, C.M.; Forbis, A.D.; Oleson, F.B.; et al. (1979) Acute
Toxicity of Lasso-(R)NF-79-WB (AB-79-068) to Rainbow Trout
(Salmo gairdneri); Static Acute Bioassay Report 124007. (Unpub-
lished study received Jan 17, 1980 under 524-EX-491. Prepared
in cooperation with Analytical Bio Chemistry Labs., Inc., sub-
mitted by Monsanto Co., Washington, D.C.; CDL:241619-E)
76
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00031525 Thompson, C.M.? McAllister, W.A.; Oleson, P.B; et al. (1979)
Acute Toxicity of Lasso - (R)t NF-79-WB (AB-79-069) to Blue-
gill Sunfish (Lepomis macrochirus)* Static Acute Bioassay
Report 124008, (Unpublished study received Jan. 17, 1980 under
524-EX-49; prepared in cooperation with analytical Bio-Chemistry
Laboratories, Inc., submitted by Monsanto Co., Washington, D.C.;
COL: 241619-F)
00031526 Thompson, C.M.; Forbis, A.D. Oleson, F.B. (1979) Acute Toxicity
of Lasso - (R)t NF-79-WB (AB-79-070) to Daphnia magna; Static
Acute Bioassay Report 124009. (Unpublished study received
Jan 17, 1980 under 524-EX-49; prepared in cooperation with
Analytical Bio Chemistry Laboratories, Inc., submitted by
Monsanto Co., Washington, D.C.; CDL:241619-G)
00043645 Rodwell, D.E.: Tasker, B.J. (1980) Teratology Study in Rats: IRDC
No. 401-058; IR-79-020. (Unpublished study including submitter
summary, received Oct. 16, 1980 under 524-385; prepared by
International Research and Development Corp., submitted by
Monsanto Co., Washington, D.C.; CDL:243506-A)
Rubin, L.F. (1980) Ocular Lesions: Project No. 77-1065. (Unpub-
lished study received Dec. 1, 1980 under 524-385; submitted by
Monsanto Co., Washington, D.C.; CDL:243857-A)
Pharmacopathics Research Laboratories, Incorporated (1980)
OphthaLnological Examination of Dogs. (Compilation: unpublished
study received Dec. 10, 1980 under 524-385; submitted by
Monsanto Co., Washington, D.C.; CDL:243857-B)
00068044 Wilson, G.R. et al. (1981) Residues of Alachlor in Sorghum Forage,
Stover, and Grain. Report No. MSL-1577. ( Unpublished study received
May 27, 1981 under 524-285; prepared by ABC Laboratories, Inc.,
submitted by Monsanto Co., Washington, D.C.; CDL:245225-A)
00068045 Monsanto Company (19??) Reasonable Grounds in Support of the Request:
Lasso. (Unpublished study received May 27, 1981 under 524-285;
CDL:245225-B)
00074486 Atkins, E.L.: Kellun, D. (1980) Effect of Pesticides on Apiculture:
Maximizing the Effectiveness of Honey Bees as Pollinators:
Project No. 1499. 1980 annual rept. (Unpublished study received
June 8, 1981 under 2141-159; prepared by Univ. of California-
Riverside, Citrus Research Center and Agricultural Experiment
Station, Dept of Entomology, submitted by American Cyanamid Co.,
Princeton, N.J.: CDL:070148-G
00064546
00064547
77
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00075062 Schroeder, R.E.: Hogan,G.K.; Shock, M.E.; et al. (1981) A Three
Generation Reproduction Study in Rats with Alachlor: Project No.
77-2066. Final rept. (Unpublished study received Jul 10, 1981
under 524-285; prepared by Bio/dynamics, Inc., submitted by
Monsanto Co., Washington, D.C.; CDL:070177-A)
00075709 Daly, I.W.; Hogan, G.K.; Plutnick, R.; et al. (1981) An Eighteen
Month Chronic Feeding Study of Alachlor in Mice: Project No.
77-1064. Final rept. (Unpublished study received Jul 1, 1981
under 524-285; prepared by Bio/dynamics, Inc., submitted by
Monsanto Co., Washington, D.C.; CDL:U70168-A; 070169)
00078301 Guth, J.A. (1975) CGA-24705 Leaching Model Study with the Herbicide
CGA-24705 in Four Standard Soils: Nr. SPR 3/75. (Unpublished
study received Jul 23, 1981 under 100-587; prepared by Ciba-
Geigy, Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, NC.; CDL: 245628-E.
00079523 Fink, R.; et al. (1979) Final Report: Acute Oral LDsQ-Bobwhite Quail:
Project No. 139-179. (Unpublished study received June 2, 1981
under 524-285; prepared by Wildlife International, Ltd., submitted
by Monsanto Co., Washington, D.C.; CDL:245260-A)
00087479 Ahmed, F.E.; Tegeris, A. S.; Underwood, P.C.; et al. (1981) Ala-
chlor: Six Month Study in the Dog: Testing Facility's Report
No. 7952; sponsors Report No. PR-80-015. (Unpublished study
including submitter surrmary, received Dec. 1, 1981 under 524-316;
prepared by Pharmacopathics Research Laboratories, Inc., submit-
ted by Monsanto Co., Washington, D.C.; CDL:246229-A; 246293)
00087855 Malik, J.M. (1981) Bioconcentration of Alachlor in Channel Catfish
under Static Conditions: Report No. MSL-1910. Final Report
(Unpublished study received Dec. 23, 1981 under 524-285; submitted
by Monsanto Company, Washington, DC.; CDL:246506-A)
00091043 Street, R.W. (1982) Assessment of Oncogenc Risk for Lasso*
Herbicide: Special Report MSL-1983. (Unpublished study received
Jan 5, 1982 under 524-2R5; submitted by Monsanto Co., Washington,
D.C.,: CDL:0870585-C)
00091044 Lauer, R.; Arras, D.D.; Adams, S.A. (1981) Aerial and Ground
Applicator Exposure Studies with Lasso® herbicide under Actual
Field Conditions. Report No. MSL-1889. Final Report. (Unpublished
study received Jan. 5, 1981 under 524-285; submitted by Monsanto
Company, Washington, DC.; CDL:07U591-A)
00091U46 Maibach, H.I. (1981) Elimination of 14C Alachlor in Rhesus Monkeys
following a Single Parenteral Dose: Study MA-81-261. (Unpublished
study received Jan b, 1982 under 524-285; prepared by Univ. of
California; San Francisco, School of Medicine, submitted by
Monsanto Company, Washington, DC.; CDL:()80592-B)
-------
00091047 Franz, T.T. (1981) Evaluation of the Percutaneous Absorption of
Alachlor Technical and Lasso* Formulations in Man Using an In Vitro
Technique: Study No. UW-81-262. Final rept. (unpublished study
received Jan 5, 1982 under 524-285; prepared by Univ. of Washington,
Dermatopharmaoology Laboratory, submitted by Monsanto Co.;
Washington, D.C.j CDL:070592-C)
00091050 Daly, I.W.; McCandless, J.B.; Jonassen, H.; et al. (1981) A Chronic
Feeding Study of Alachlor in Rats; Project No. 77-2065. Final
rept. (Unpublished study received Jan 5, 1982 under 524-285;
prepared by Bio/dynamics, Inc., submitted by Monsanto Co.,
Washington, D.C.; CDL:070586-A: 070587; 070588; 070589; 070590)
00100795 Monsanto Company (1982) Environmental Fate of Microencapsulated Alachlor
Vbl. I. (Unpublished study received May 26, 1982 under 524-344;
prepared by Monsanto Agricultural Products Company; submitted by
Monsanto Co.; Washington, D.C.; CDL:070839, 070840, 070842)
00101531 Monsanto Company (1982) Environmental Fate of Microencapsulated Alachlor
Vol. II. (Unpublished study received May 26, 1982 under 524-344;
prepared by Monsanto Agricultural Products Company; submitted by
Monsanto Co.; Washington, D.C.; CDL:070841)
79
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GS0063-0001 Pesticides Process Encyclopedia 1977. Marshall Sit tig, Noyes Data
Corp., Park Ridge* N.J., p.5
GS0063-0002 Monsanto Company (1973) Section A of PP*3F1406: Lasso (unpublished
study received 1973 under 524-???} CDL: 118284)
GS0063-0003 Monsanto Company (1975) Appendix Ar Confidential Statement of Formula
for EPA Reg. No. 524-315 and 524-316: Lasso (received 1975)
GS0063-0004 Monsanto Company (1974) Correspondence to PW3F1406 (received 1974,
CDL: 118776)
GS0063-0005 Monsanto Company (1979) Section A of PPt9F2144 (received 1979,
CDL: 225417)
GS0063-0006 Monsanto Company (1967) Metabolism Section-soybeans and corn. Section
D-II of PPt7F0622. Lasso.(Unpublished study received 1967 under
524-???; CDL:115143)
GS0063-0007 Monsanto Company (1969) Metabolism Section-peanuts and cotton. Section
D-II of PP49F0776. Lasso.(Unpublished study received 1969 under
524-???; CDL:115827)
GS0063-0008 Monsanto Ccnpany (1984) Metabolism of Synthetic 14C- Labeled Plant
Metabolites of Alachlor in Laying Hens, Part I: Distribution of 14C-
Metabolites in Eggs, Tissues, and Excretia. RD. No. 532 (unpublished
study received 1984 under 524-314; CDL: 252792)
GS0063-0009 Monsanto Company (1984) Metabolism of Synthetic 14C- Labeled Plant
Metabolites of Alachlor in Lac tat ing Goats, Part I: Distribution of 14C-
Metabolites in Milk, Tissues, and Excretia. RD. No. 531 (unpublished
study received 1984 under 524-314; CDL:252793)
GS0063-0010 Monsanto Company (1969) Section D, Part III of PP*9F0740-Supplement
(Received 1969. CDL: 115685)
GS0063-0011 Monsanto Company (1971) Section D, Part B of PP*lFl009-Supplenent
(Received 1971. CDL: 116791)
GS0063-0012 Monsanto Company (1972) Chemical Residue Studies. Section D-l of
PP*2G1176 (Received 1972. CDL:117410)
GS0063-0013 Monsanto Company (1973) Chemical Residue Studies. Section D-l of
PPt2G1176 (Received 1973. CDL:118284)
GS0063-0014 Monsanto Company (1973) Section D PM3F1406 (Received 1973.
CDL:118776)
80
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GS0063-0015 Monsanto Company (1967) Section D of PPI9F0740 (Received 1967.
CDL:115690)
GS0063-0016 Monsanto Company (1973) Section D of PPI3F1334 (Received 1973.
CDL:118044)
GS0063-0017 Monsanto Company (1973) Section D of PPI3F1372 (received 1973,
CDL:118178)
GS0063-0018 Monsanto Company (1981) Section D of PPI1F2447 (received 1981,
CDL:243785)
GS0063-0019 Monsanto Ocnpany (1977) Section D of PP#7G2002 (received 1977,
CDL:101562)
GS0063-0020 Monsanto Company (1975) Appendix A, Confidential Statement of
Formula for EPA Reg. No. 524-315: Lasso (unpublished study
received 1975 under 524-???; CDL: 118284)
GS0063-0021 Monsanto Ccnpany (1978) Acute Oral 11)50 - Rat. Submitted by
Bio/Dynamics, Inc., PD-77-433 on June 28, 1978 (unpublished study
received 1978; CDL:241273)
GS0063-0022 Monsanto Ccnpany (1979) Acute Dermal LDso - Rabbit. Submitted by
Bio/Dynamics, Inc., PD-77-433 on April 30, 1979 (unpublished study
received 1979; CDL:241273)
GS0063-0023 Monsanto Company (1981) Acute Inhalation 0)50 - Rat. Submitted by
Bio/Dynamics, Inc., PD-81-183 on Dec. 3, 1981 (unpublished study
received 1981; CDL:248053)
GS0063-0024 Monsanto Company (1981) Primary Eye Irritation - Rabbit. Submitted by
Bio/Dynamics, Inc., PD-77-433 on May. 25, 1978 (unpublished study
received 1978; CDL:241273)
GS0063-0025 Monsanto Company (1978) Primary Dermal Irritation - Rabbit. Submitted
by Bio/Dynamics, Inc., PD-77-433 on March 22, 1978 (unpublished study
received 1978; CDL:241273)
GS0063-0026 Monsanto Company (1984) Dermal Sensitization - Guinea Pig. Submitted
on March 24, 1984 (Unpublished study received 1984; CDL:252772)
GS0063-0027 Stout, L.D. et al. (1983) A Chronic Study of Alachlor Administered
in Feed to Long-Evans Rats. EHL 1800218, Project IML-80-186, Report
MSL-3282/3284. Vol. I of III (Unpublished study received Feb. 28,1984
under 524-316; prepared by Monsanto Environmental Health Laboratory
(EHL); submitted by Monsanto Co., Washington, D.C.; CDL:252496)
-------
GS0063-0028 Stout, L.D. et al. (1983) A Chronic Study of Alachlor Administered
in Feed to Long-Evans Rats. EHL #800218, Project tML-80-186, Report
MSL-3282/3284. Vol. II of III (Unpublished study received Feb. 28,1984
under 524-316; prepared by Monsanto Environmental Health Laboratory
(EHL); submitted by Monsanto Co., Washington, D.C.; CDL:252497)
GS0063-0029 Stout, L.D. et al. (1983) A Chronic Study of Alachlor Administered
in Feed to Long-Evans Rats. EHL 1800218, Project tML-80-186, Report
MSL-3282/3284. Vol. Ill of III (Unpublished study received Feb. 28,
1984 under 524-316; prepared by Monsanto Environmental Health Labo-
ratory (EHL); submitted by Monsanto Co., Washington, D.C.; CDL:252498)
GS0063-0030 Monsanto Company (1983) Rat Metabolism Study. MSL-3198,R.D. 493
Part I and II (Unpublished study received Oct. 1983 under 524-316;
prepared by Monsanto Agricultural Products Company; submitted by
Monsanto Co., Washington, D.C.; CDL:251543 and 251544)
GS0063-0031
GS0063-0032
GS0063-0033
GS006 3-0034
GS0063-0035
GS0063-0036
GS0063-0037
Environmental Protection Agency (1976) EPA Manual of Chemical Methods
for Pesticides and Devices. Vol. I ( Prepared by Chemical and Bio-
logical Investigations, Chemistry Laboratory; Beltsville, MD;
received unknown date under 524-316; CDL: none)
Environmental Protection Agency (1976) EPA Manual of Chemical Methods
for Pesticides and Devices. Vol. II ( Prepared by Chemical and Bio-
logical Investigations, Chemistry Laboratory; Beltsville, MD;
received unknown date under 524-316; CDL: none)
Monsanto Company (1982) Alachlor Residues in Peanut Fractions.
Amendment to PPIOF2313 (Received 1982, CDL:070864)
Monsanto Company (1982) 21-Day Dermal Ibxicity in Rabbit. IRDC 1401-
164 (IR-81-036) (Unpublished study received May 13, 1982 under 524-
316. Prepared by International Research and Development Corp.; sub-
mitted by Monsanto Co., Washington, D.C.; CDL:247960)
Shirasu et al. (1980) Microbial Mutagenicity Study (Received Feb.
1980 under 524-316. Prepared by Institute of Environmental
Toxicology; Kodaira, Japan; submitted by Monsanto Co., Washington,
D.C.; CDL:248053)
Monsanto Company (1979) Environmental Chemistry of Alachlor
(Unpublished study received Oct. 17, 1979 under 524-285, -296, -314
prepared by Monsanto Agricultural Products Company; submitted
by Monsanto Co., Washington, D.C.; CDL:241135 and 241136)
Monsanto Company (1983) Additional Corn and Soybean Metabolism Studies
to Support the Registration of Lasso*, EC, II, and ME. R.D. No. 489,
Special Report MSL-3132. (Unpublished study received Sept. 16, 1983
under 524-285, -296,- 314, and -344; prepared by Monsanto Agricultural
Products Company; submitted by Monsanto Co., Washington, D.C.;
CDL:251375)
82
-------
GS0063-0038
GS0063-0039
GS0063-0040
GS0063-0041
GS0063-0042
GS0063-0043
Zahner, A.J. (1984) Summary of Data Supporting Bronco* R.D. 503
(Unpublished study received Feb. 23, 1984 under 524-285, -296,
-314, and -344; prepared by Monsanto Agricultural Products Company:
submitted by Monsanto Co., Washington, D.C.; CDL:252489)
Datta, P.R. (1984) Memorandum sent to David J. Severn dated March
26, 1984. Review of Six Documents Regarding Monitoring of Pesti-
cides in Northwestern Ohio Rivers.
Offutt, C.K. (1984) Memorandum sent to Diane lerley dated May 10,
1984. Monitoring Data for Alachlor in Chio and Iowa.
Monsanto Company (1984) A Teratology Study in Rabbits: IR-83-045
(Unpublished study including submitter summary, received Mar.
1, 1984 under 524-285, -296, -314, and -316; prepared by
Monsanto Agricultural Products Company; submitted by Monsanto
Co., Washington, D.C.; CDL:252570)
Scott, L.D. et al. (1984) A Special Chronic Feeding Study with
Alachlor in Lonq-Evans Rats. 3HL 1800219, Proiect 4ML-RO-224,
Report MSL-3292. (Unpublished study received April 23, 1984
under 524-316; prepared by Monsanto Environmental Health Labo-
ratory (EHL); submitted by Monsanto Co., Washington, D.C.;
CDL:253306, 253307)
Mirsalis, J.C. et al. (1984) An Evaluation of the Potential of
Alachlor to Induce Unscheduled DN& Synthesis in the In vitro-In
Vivo Hepatocyte-DNA Repair Assay. Project No. SRI LSC 83-201,
6642, Study No. SR-83-293. (Unpublished study received April
1984, under 524-316: prepared by SRI International, Menlo Park,
CA ; submitted by Monsanto Co., Washington, D.C.; GDL:253308)
-------
OMB
. 2GGO-GS.63 .'
FIFHA SECTION 3(C)(2J(B) SUMMARY SHEET
EPA Af QiSTMAi ION NQ.
PftOOUCTNAME
APPLICANT'S NAME
OATl GUIDANCE DOCUMENT ISSUES
Whn nagact a till nqunraant to aiboit "gviiHe* dra import by at FIFRA acdoa 3(0(2(8) nctia caaaiatd in tiu rtfruind
Cutdana Ooeunvit. I aa rvpendmg IB ttf follwioj ai
Q L I win Mitmh tea in • *ntJy muuur a Mtirfy tti feflowinj nqnnmin& M tti mt praadura I win in dtvitu frem (em net
tfti Rtginntian Gutdilina or^u Preracsta camiMd in flu Ripara af EzptR Srevpi a tw Chonicalf Graup, OEC9
Otamieali Tcoing Prsanfflflt, I andea ttt arsaesU Ait I wffl i
I havt annnd ion in tqrmmmn win em ar men atiur rostrum lindir FIFRA ausan 3(C](2](B)(Ii} a aniify tha foOewing di
fawinman& Th« wa, and tny nquind pmsesii, win bi ubmhad a E?A by:
NAMC Of OTHCA AEfilSTRANT
Ol. I andov i esmplmd *C«rtiflatiea ef Aanpt a Eitar Ints in *gntm«nt win OnirRtgannafar OwtJapmint ef Oia" with
B«et a mi fallowing dra nqulnmaos
G 4. I fi^uan 0i«t you imind my rtsaurrJoa by tftlning tfit faltewiflg aau (tf>a apden • net mibbli a i^pCcanu far ntw preducsi:
O L I novan wiunary onoflitien af thi rcpnrrtiofl af nit praduai (Tbi> apden a net tviaabii a csficann for IMW praducaJ
AEClSTTtAATTS AtrTMCHJZSC
OATI
-------
QMS
1S-31-SS
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FTo oaWTrY. eawrfVALL *ur rramri 'OR DEVELOPMENT OF DATA
* * Mn duly autfwnxad to noraum SM following finndl who in uejac: to wa recuira*
am ef a Nctica linear FIFRA Section 3(&)O3(B) eonainto in • Guidana Doeunant
1NAMI 0* PIMM
auiOAMC^ aeeuMiMT SAT*
ACTIVC IMeASOllMT
MA C3MPAMY NMACR
1
(This firm or qrouo of fimu ii irfitrid to btlew M "mv firm".) •
My firm a willing to dtvtlep and jutomh lh« dra « nquirtd by that Netia. if menury. Hewtvtr, my firm would prefer to enter
tme an aytamant with en* or mera ether itfcauarm to dtvtiop jointly, or to rfiara in th« can of dtvcloptng. tha following nquirtd
tern* or dan:
3. My firm hu offind la wriring ts mar inta weh u atmmint Ccpto ef *• offin in itachtd. That offer w« imveaali ind Indadii an effar a ba
ftaund fry an trtrtntjon daiaian undtr FIFXA Smea SldffltBJRii) if final a^iaraam an all arm eauld aet ba mdiad atfiirwia. Tha effir WB nuii
a flu faOawing fimtal an Di faflewing tfinb):
NAMC Of PIMM
-OAT* of
of
firni
-------
Appendix III-l
EPA Registration No._
PRODUCT SPECIFIC DATA REPORT
Guidance Docunent for_
Date
Registration
Guideline No.
5158.20
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
Name of Test
Identity of
ingredients
Statement of
,- - _-_g{ fr| M.
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
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRIDt
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
86
-------
Appendix III-l (continued)
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
S 158. 135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flarmability
Explodability
Storage stability
Viscosity
Miscibillty
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
Test .not
required
for my
product
listed
above
(check
below)
I an complying with
data requirements by
Citing HRIDt
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
87
-------
I M1.1t
•••*. and **f*ly of Iho formwUUd
** praihicl. M*y n*| con*ld*r »ny
»• *nppatllng Ib*
•*Mp| lit* fallawlni dtl*:
III Tli*
Dane la ••ceiUln Ih* omoiinl »n4
Icrme of cainp*ne*l|an lo bo p*ldj *n4
III Th* *|tpllr.*nr* n*m*. *ddt*M,
ftnJ Iclcplian* rnimli*r.
III If |h* •pplleenl** product con.
Ulne »ny *c!U* litMcdlMt olh*r lh*n
|h*i* lh*l «i* iireeenl *a|*ly heceue*
of Hi* |iiroi|toi*llaii Inlo Ih* proilnct,
ili|iht| fariniilkllnn. pi Mip Of
oilier r*|lel*i*«l |K*Hr.liU
fiani •nnlh*r |irmhic*».
ii.. ......It*.M! •(••li •!•• rM«<»lti
Illl*
wllb | III • I •• I* eueh edlte bigr**-
•nl. end Hie application *h*l| ooi|Ubj
en, ecknawlademaitl lh*t for purpaetf
of flPIIA eectlan llpN|NDI lite epp||.
C*tlon relle* en lend eny |*eul|lni tee.
(•Italian ehanld be regarded ee || ||
weie beeed an.llie Admhtbttalor* can-
•ldce*llan oil Hi* follawhif iUrV.
III All dela eubmlllad or epeclll
tiled by the *ppllc*n| In Btippa|| of
111 r*ch pih*r (Urn of *?•!• h Ih*
'
III Oaneerne the ptonetlle* or *(f*c||
ol *ny *ne|i *ct|r* |pe,r*itl*nl; eml .
Illl le on* of Ih* lype* of del* |he|
fir A would raqiilt* lo bo BiibmllUd for .
•cfontlfl* review by KPA If Hi* appli-
cant eoueht Ih* |nl|lel fMlelrotbn
under rim A. flecllon lUNII el ft
pioducl wllli oampaelllan end Inland-
Od naa* M«|tllca| |o HIM* propoeed for
HI* applicant**, product, under Ib*
dale reqiihemenl* In oiled on Ib*
dele TM'A* epp'iovc* Hi* ei
Cbtjfmb •/ fM
I Mill
«•» i .... .-.- . „
|al«L limy peelklde prodiulf *h*l|
l»er • Ulicl oofcilalnlno; Ih* Inform**
Han •pecllled by, lite Ael and Ih* r*|t|*
(•Hen* In Ihb t*iL Tli* eonlepb) e| *
|*b*l htuil eliow obeilf *n4 Ploml-
panlly HI* following!
Ill Hi* nemej brand, or |r*demeik
under which th*,prodMd b enld •• pr**
•eillMd In paragraph |b| of Ihb *re>
lion;
Illl Th* name end *ddr*** of Ih*
producer. rigbtVenl, or pereon for
whom piedMotil ke pNacitbod, 1*111*1"*
•Mplifolellhbkecllon;
Illll Tli* net clmlenU e* pre*crlbt4
In perMi*ph Id! of Ihb ••alien;
l!r) The |«mhi*t |*|le|r*ll*ll
number ee preeeilbed In peieitaph f*l.
of Ilile ••clloit;
1*1 Hi* produclnf «*J»blbhiMii|
number •• prcM|lb*4 In p«l*f teph III
•f Ihb Mclleiii '
(•II An Inircdlenl •Ul*m*nl *• ple>
•cilbeil |q f*l*ir*ptt. Ill *| Hilt
lion:
APPENDIX IV-1
CKopf*! |—f *jv(i*nMenlol holei||en A|*ncy
• 1*111 Wirnlni or proeoHlloMry *UI*>
pienl* *• pr*ec||b*d |t| p»i*|t*pli Itil
p| ihb *ecl|on: i
|*llll The dlrecllon* for nee *• pr*-
•cilbe4 In p»iB|tBp|| III of ||ib eec|lon;
Hit The Me* c|*Mllle*ll*ni*l •• pr
*e|lb*d |n per«ii*pli III el IliU Mclla
III ffoni|n«nc« and fcolklllly. ||| A
*
an.1
A||
•ante. •Ulcmcnl*.
(lent. ilceUne pr oilier |nfaim*|laii re-
atilrcd on Ilia (•belln* )>y !!•• Act or;
|h* leiiiUllon* |n Ilili p*i| miul b*
clceilv |e*lbl* la * petMMi w|||i norm*!
llilan, f>nil ntuel lie placed will) *itc|t
cane|i|c|iouencM (•• competed with
•||i«r worde, *U|*mert|e. dcelBn*. or
•leplil* mailer on Ui« bbelhtit en4
••piMeed In eiich Ictroi M la lander ||
|lh*|y lo b* lead end iiiideielaoil by
lit* pn|ln*ry |nillv|i|tul under ciulam*
•ry COIM||||OIM ol pwrchee* »n4 IIB*.
(Ill All reqiilf *4 |eb«l (••! mm|: 1
IAI II* «el |n I point or '
id |eb«l Uei miu|:
I point or |M*er Irpel
III) Appear en f clear conlroelliif
bacVfiaiin4;»n4
IOI Hot b* obeaiir*4 Pr crowded.
Ill (L*N0M*0« fa ft* uteit Al| teqiilred
lebct or labeling \»n\ e|itl| e|ipeer In
Hie rcmlUli laniueie. However. Ih*
Aeenef may rcqulr* or Hi* applicant
inay propoeo edilll|one| !••! In olhar
pro|
Ing.
(II ffoeemeMf «/ Looc|-l|l OeneroL
Hi* lebel ehall appear on or bo *eeut*«
If •llachce] lo Hi* Immcilbl* aoiilaln*
tr of Ih* peellcld* pia«liict. Pof piif.
PMC* o| Ihb dccllen. »n4 Iho mil-
t>inndii| piovlilane of |ho Act. "•*•
Gtcly •lUcheit" ehall mcen that •
»e| crfn reeeonably bo oipecled I*
|enieln *|||ied itmlng Hi* foroeceable
Comlllleni *nd pailqd of lie*. If the ihv
picdlel* con|elner |l cncloecd wllhln q
Wiapifer or oulelde cenlelner Hiroilgh
• wdlch Hie label cennol he elearly read.
Hi* labc| tniiil aleo be eecnrely •!-
Uchcd |o euc.li ouUld* wrapper or win-
lalner; If It |i * p.it pf ||M p«eheie M
Miileieailly illi|||biiUa pr • -14 '
HI) flint MM onil pf/icr bulk con.
I-IAI Tr*mporfolloii. Wlille «
lleMf pindiicl b |n lr»n*lt. (lie *u-
I lit !•
of •• era r«|u
|1*-llt.conc*inlnv Hi* |IOHHMH|*||MN
p| hauidau* m-.lciUI*. ond •pccll!* •!
ly l|io** piovlilon* cancel mini ||t« U
belln«. m»illni •ml iiUc*idln« al |i»t
•itfatl* |n*l*il*l* Mini Hi* •iilililii c«i
Ifliifl Iliein. ilclln* Ilia likt
fequlicinciil*. In ••MMIon. «|i«n
|C|ltl*f«d |ic*l|cld* |i|04luc|
pot|c4 In • l*nk MI. l»nk liurk or
*lti*r piobll* 01 poiltlil* bulk itiultin
•I. • copy ol Ilia •cci|i|til Ubol mini
b* olUclwd la ||»« •Mi>|iln« |«*|ici*.
»nd lc|l wllli Hi* cwiuUnc* •! l|i« Mm*
p| <|e|l**f y.
ID) SfufatM, Xyrtcn pcalldd* |no.|
Mel* oro slated In bulk c*nUln«i«.
«r|i*ll»r malill* or •Ull*n*iy. *likh
Iftnaln In III* *M*lailr ol Hi* n»r. •
Copy ol Ilio UUI ol Ulxllm. |nrlii.llnf
fII *pprapiUlo i|lf«c|lun* far »••. •hall
b* *CMlicly •lUclictl la III* caiiUlnci
In |li* ImmcilUU tlclnlly al l|i*
-------
I rill A IHM iU;amaol IBM* In Math a
•y •• U |h>a • fab* M BablMdlng IBB*
iB*tl*n U llw puicbatar*
IVlllt l-abal dltclalmaia tfllfcll MMt*
r 4*li*cl lr*m labeling alalaaaauU ia-
nil ad undar Ih* Act and HIM* |cgula«
(out;
III I ClaraM M U III* aafaty •! In*
ttllclda or lla Inaraillanla. Including
UUincnlt Mich aa "MIX," "nonpaban-
\u." •*ita|ihi|iiilaiM.w •'haiintoaa'* *r
JMMlUfel* U hMMtana and pala* »IIH
r without Midi * qualifying p|i|aaa M
*>haii utad at directed"; *ne)
IB) If on numerical and/ar comnata-
!«• tltlamenla MI Ilik aaftly •( ||i«
loducl. Including but no| llmllad la:
U| MltewUI|i« all natural fngi*df>
IMt «4-ri*ia4ii
b* •juatlfbd by! *ppr*ptbl* vordfaM
•uoh •* Tackcdtfay • t •." Ttblilhul.
•d by t • •.- of -flald by • • f to t|ia»
that Ilia narn* if not Hit! of |h* p.*.
ducar. i
Idl Jfef ftMlaU or *u*ivr« */ «•«.
fall ||| Tha nit welihl or puttura
of coqUnl aliall ba ••duel** of vmp.
Cm or oilier mMailab and elialj b*
i avaraga canlenl milaea ••p||c|||*
flalad at • mlnliMim quant II y.
fl| |f Hi* pcatlcIJa b a flquld. |b*
Ml content eUlament ahaD b* b|
bat of Ihuihl lAeaeut* al If IT WC|'
•hall ba ••pikeaed In con»enlbiu|
Ameileam nolle of flub) ounce*. HitU.
.• A.liAA^. *
till "Among III* |BM» i*Hl* ftham|*
la lm«*uM
«•! final piloted labels* in B«MPI
i |iio*|dad In patagrapH laMMIII *J
lilt ttcllaii. rinal pilnlad, (abating
n»| b* ettbmlllad •ltd acccplAd pilof
a lealtliallan. HoMBVar. final pilnUd
labeling naad nal ba aiihmlllad tmlfl
ill * II lelial !••!• liat* baan piovblon-
»lly accepted by Mi* Agenay.
fill Clceily legible repiodnettoM Ot
plinU •ciliMllMtt whl b* *c««pl*d far
|llllltllBl lebcb Midi BB Ill0e*.tflk>
•fliecned jUicflly ••»•• •'••• •» metal
r>nlai.'»ci« w/laiga bag 01 ilium UUla.
Illicit IBIIIOhllcllOlM IMial b* «f !»!«••
Illin ititiadiwll0il outllly.
«r Iffl4«m«rl. Ill
•naila. and ••llatia.
1 III if |li* pMlUMa b Mil.) 6f
114. flacoiia ar pifMUika4. «f U
lura af llquM and Mild. Hi* ti.l can-
Ian! aU|amaiit aliall ba |M |ai*M *f
Valaht aipf*M*«| •* •vafabipaU
ounila and •uncaa.
Ill In *N caaca, nat canlant •hall b*
UU4 In |«rm« a| Ih* |at|cal aiilUtlt
linfl*. | •.. "I pauiid U Min*a«* |«|b«r
han"Minc«a.>>'
.III In addition In Ib* raqulrad imlU **
•paalflad. «•! conlcnt anay ba •!•
Maaacd In ma|i|a unlla.
Ill failallan *bav* tabilmtun *an-
anl M aiMind an *»at aia la paiyalu|-
la
M
«L t»* «
. lM*nil. M l»ilMMik
- pcillabU |iiMlucl to
•lull •|>|i»»r •» Hi* Irml p»n*l •! UIA
'
111 ||a nftM*. brtnd. «r
ay »|ip*«r •« ill* l»l>«l vltlctll
III ft MM u mUl(B »IM| •d«••« BII llw Ulwl •in! Ui« itiUlunl It
lial III* piai|iw«r. *l If Ik* IUIIM •( Hi*
|Ki«an fnr •tr>~ "'• RMlhiM* »•••
|n«i|iic«4 *|M'M !•• Ulicl, U Mini
la only to Id* aalenl lha| It fepia-
•enl* dtfletloti unawaldabl* In gaad
Cinulaclililng piaallc*. Vailellen
I4w o al*|ad minimum M nal permit-
led] In no MM •hall th* ft**i*g* «*•>
lcn( of Hi* packaita |« ft alilpmenl fall
bale}*; Ilia alalad Malaga content.
I*) fradHcf uelilralldH ntmlttv
Tli* reiUliallan number aeilintd I*
||ia B>cillc|da pioducl at Ilia lima af
laabliallan tli*l| appear on Iha I
piacaded by Hi* phieca MKI*A I
Italian II*..- or Iha pliiata "tirA lle|.
Mo." Tli* r*|bliallan ntimbar tlull ba
eel In lypa of • tlte and elyle tlmllti I*
•l|iar pilnl on that pail of Ih* |tbtl
pn which II appaMB and ehall pin ptr-
•Hal la |L Th* railillallan number
ftnd HI* faqiilrad -Idenllfylng pluMt
•hall nal appear In •ueti • manner al
|o auiiatt or Imply |*conimandilletj
•r anilmtement ol lit* piottxcl Jiy l|if
Agency. "
III frtwIiKliig ••f.gMltnmtNfl !•»(»'
.
fralla* numltr. Hi* ptadiwlni nUV
lilimonl |*|ltliallan numUr prc
••I iir.ibi piiuM -r-r* **", «r
R-t
(oontlnueil)
Ctfltfl-
f|na| aUtWUbmtnl M «.|ibh III* piad-
pel vaa praditced may appear In any
•iillabb locallan MI III* |abel or ftmm*.
4U|a canlelntr. |t muel appear an Ih*
wrapper or ouleld* container of Hi*
neckei* |f Iha KPA Beleblbhmanl lag-
•liUtllnn number PH Ilia ImmcdleU
raplalncr cannot Ua clcaily read
|hioii|l| •uch viappar or coiilalnar.
Ill iNBMilltMf tlalfM«Hl~||| n«N«r-
•t T|M |eual of *acli pcellclda product
mutt beef » alalamant which canlelna
||ia nema and peiecnlaga by welihl af
Itch acllra Innadlaiit. Iha |A|a| par-
' ccnlBi* by w«l||i) of el) Ineil faiBredl-
inlt; tnd II |h* petllclile canlalna ar-
Itnla In apy faim. o alalameiit of Hi*
pticenleict of |ola| and walei-aehibl*
»l**nb caUnltlad aa elemental ar-
atfile. Tlia acllo* Iniiaitlenle mutt b*
4(tlimUd by Ih* (era "eet|»e Innedl-
tnle" and Ilia hi«i| Ingradlenla by Ilia]
leim "(nail Innedlenle." qr Ih* •|niu'
|*r fauna of (haea |»rma whan appia-'
pilel*. nalh laim* ahal| ba In |h*
i- tame lyp* tlu. ba allpned |o Iha earn*
kiaiejit and ba aojually pram|n*nl. Tlia
•Ulcmant -fncil Inueillcnla. nanaL b
nal rtqiilitil lor ncellelde* w||lch can.
Itln |0tt paiceiil «cl|v* |nBiMl|eiil*.
llnltet Hi*. Innadlenl •lalameut b •
•am*ltla analyela of Ilia pcellclda. |h*
Itim -analytic* ahill not be need •• *
bcedlnf far Ilia lnBtedlcn| eUlcmenl.
.•' . 'Bl!1'11" 0/lnpiBdleof tlal*M«ni
III Ilia, liifiadlent eleleinent |e nor-
pielly Mjiuliad on Ih* fianl penal of
Ib* libel. || Ihet* b an ouleld* cAn-
Jtlntr or wieiipar |hroiiBh which Iha
Iniiedltnl elkUmcnl cannot ba claaily
Ift4. Iha Intfadlenl elalement miw|
tue appa^r «.| knr.U oiitalda tonlelner
•r wiBniier. || 1Kb eU* *r loim of |h*
' lh- lll«l1"en»
on Hi*
*'
>ai*H*l «ati olbar
»n which U appaai*.
4 km.! «« i»..jly .lltllnmU.1,1*
. '. ».6t U |»Ue*d bi Ilia
'" " •»• •
„
iiwro ktftii., f«|
I H1.lt
nun* may b* naad .IM. only
If II to vail tnown. If no
.
I'M bam aalablbtiad. Ih. <|..mlc.|
SSTit*1^ ^ U lttil1 '•» "° «•-
fill Ilia IIM of • ||*4c
IIM of • ||*4cNiaik 01 piopil
•Ury iiam* ba paimllltd IM.UM. .,«•,
nam* IM btan accapUd aa * comman
naiiia by Ih* 4dmliil.|,.iar uwlci Iha
aulhof lly of Utcllon llUMti
Sl«l«n|an|| ay iMrcanfaact Tlia
nlMe* of Iniudlcula tli.ll ba
•lalad In laima ol «alt|,| |o «(|a|,|.
Ilia aum al |iaicanla|M af Iha acllva
fiid Iha |nai| InHadlaMa tliall ba IB*.
TaicanlBiaa aliall na| ha a«|ii*M«l by
ft lania of vahin aucli aa "M U%.- ||
|h* |itca of |ha patllelda luoducl aia
•Bpiaaiad a* «tUhl ol acllva liiBit.ll
•ill par unl| ataa, o alalantanl al Iha
»*l|h| *f «cl|v* Ingiadlcnl iict unit
lAliim* af |ha |i*elUhla fiNOiiilalloi*
•hall aUo appfar In Ilia |nBiedlenl
•leUmcnl.
Th* ttatoanlagc* given ehall bo aa'p/a-
*l*a at poatlbla |alballnB Bo«.l menu.
faalnibi* piacllca. If |b«ie mey ba tin-
ftyoldabla vaibllon between meiiula*.
luting balcliaa. ||i* «elu* alelcd lur
•acli aatlva faigtadlanl ah*l| ba Ilia
|awM| pei*anlaBa which May h* piee-
• III .l>«f«rforaf|*aj. Pcellcbtct which
•hang* In chemical compotlllon'el|.
nlflcahUy |niul meet Iha fallowhig U-
baling rc^nlicinenle:-
III In caeca whcia It b daicimlnad
Ibet » paaltolda formulallaii change*
chemlcel compoellun atBnl|lcan!ly.
Iha pioiluat mutt tiaar Iha fallowing
•lalaman! In o prominent path Inn on
Iha labaU ''Not |or t.le or lit* aller
|da|al.M
Illl Th* Mo4ua| mm! meet all |eU|
fUlma up |a Iha *ipli*||on lime hull-
•alad on III* |ebt|.
Ill f«*i| (ndicatlenli. The admlnlt-
Iralor may ramilr* Ida iiama of any
(nail Ingiadleiillal |o b* Idled In Ida
Intredlent Blelamanl II ha iU|«imlnet
Ibet aiien hitiadlanlUI m»» pne* ft
httard I* men «r Iha anHianiNrnt.
(laltMinlt. lUatilud weinhut<>Vii4
lifccaiitlonary ualen»eii|* cnncainlni
Ib* panml *raaa ul lokbulAdcal
. liiitnl litcliiillng liBtaid |o chf
•iivlionmcntkt litfiki.l • •.•' Uvt|
flit n|ci>| |i Mid (alt d i.
-------
1 Id*
* iMiilr
Uticlliii
HIM* i*qu|f«4 MI Ih* frml p»n*l of
•n4 I|IOM »|ikh •*•»
•• »An**lfI* r coiilf o*
i M«uU CMiMinln*; *OM*MI. pU*4
M-MMMMHIf
i i '%• « |i» ^% i
! . l|| ffHMon . . -.,
' .' Ta*f«f|M r«f«»0fv f7An'pullcl4* pio4-
1 1 ncU MMlIm Hi* «ill*iU of
i!
• < panel Hi* tliiul «»*id "n«nt«f." In *4-
* dllliin If Hi* piodiicl w*« *ulfn«4 lo
- - - - - - «„ ||l( {,••!• of II*
Uimtl loilclly I**
*n4 *v* loctl *f-
feclil ||i* wonl ••Ptthan" •lt*ll *P»«»r
In t«4 mi • Iwcfciiaund of dltllnclly
fmilMillng calar *n4 (It* «fcwll *n4
CI*«I|IMIM *h»ll *pp**r hi *
piOMliMlly lo Hi* void Hp*ba
11)1 TfciUlftf C*ltt*n If. -. - .
cld« proilucla MMlIni Ih* cilUrl* of
T*«lc|ly O.l««aiy II *l»ll h**r on l|t*
|i fionl |Miul III* •lin*l
\
li:i Toilally C*f If. -r . .
! 5 • eld. pl..lud. MMM lh.V«»V!» •!
••hpt vliMi Ih* J|*Mf 4al*mtM|
Ih4l *uc|t UUIIng If MCMM» U pi*>
V*A| |HIIM**mbl* *4«MB* *fl*tU *f)
|H*n M |ll* •IHllMIMMll. In »• MM
•hall m*r* l|i*n '•«• liimian |i*Mi4
•lin«J void *PP**I on Ih* Itenl D*IK|
•UUUI. •, q
Illl CMI4 h*Hr4*.*i«niliiA Bvny PM-
IUI4* pimliicl Ulicl *lwll b**» Ml Hi* •
|r*nl ptnal Hi* aUUmtnl "fc««p Mil *l
|c*c|i mt clilMrMt." Only In *»•*»
«ilicf* Ih* llb>llli*«4 •! MnUrt »Hh
fthllilfkn 4ui|n| dMilbullan. **ik«l-
Inf. •!•!••• or lw« b 4«momli*U4 Vf
)h* *p|ille»nl U »• ••li*mcly i«meU.
•r If Hi* mlui* •! Ih* pullcia* U*u C*U*ary I •• M»f
•••!• of •!•!. lnh«UII*n or d«m»l !•••
Icily. Hi* Ai*n*y m*y. ha«Mii;
pcimll r**Mnab|* v»iUII*M
pl*ccni*nl of
-
l •"»•'»•» iMMiUUil wllli • lil|h*»
i:»uioir U no
*UI*m*ni *l P»«'|;
lmml b Mm* i*f*wn«« •"*"
*• -n** *UUm«nt *f pr*clic*l In"'
|n*n| »n li*ck pin*!* *pp*»«| M IM
APPENDIX |V-1
(oontliutod)
lin.it
-v~»—•—
— — ah.^hfc4
f*«f*ffv •ar<0o'rfcA Tli* ' f •"•' '
— - ^...fb M "or
dt.t.lb.4 In p.,.,,.,,'^-"" "Mpl M
llSfi IP
|°«k*4 iimur MMlomiry condition* of •••loioto, («> u>
•MdhM
twlHM
EllUltl Of
.«• |. L.
hwy or
l.bl.
•— f H- ••iHiwinf lanii McpfcU |V|i|.
. frIljjtt"ttll"M:r.iUU—M|« •"'«••
f •UUincnU Mn.t U MMIUU4 or <••
-------
*«*I4 Mlwlhl ffccMcnf.
»|ury M 4MMI*. BitftinlM *l Ih*
i«i«(4 •UlcmcnU *n4'|b* fir****
)••!«•• under vltlch |h*y pi* M«uliH
•IU*:
141 II * pMlkM* InUmM IM Ml*
IMI tu. CMiUln. M »cllv. but edlcpl
Illl ft INMMMftlUN ftMll* Mftl M>- *f
I HA «f |«M. |li* •Ul«m«n| *^fcto f M||-
1,1. U !•••!• to WlldllU- U Mrl'H
Illl ll • i»«ll«hM InUndcd far fu|-
*cllv* bt*r*dUn|
u»* cattUiiM *n *cv* t*r*n|
•lltl ft |l*h ft«Ml. UU «l I MM* •! I*"*.1
Ill* •UUmciit -I liU V««l|cM* If T««l«
UM.h"l.l.aulie,l.
ICI II ft pullcM* InUndcd Mr •*•!•
daar MM Mitl.lm an telly* Iniiedltnl
Mllli .11 ft»Un ftcul* •§•! UK. al IM
•»••/>• •' I"'. «r • «uUMiU dlcUif
1-rfX. al lfe» |ipra ar !•••. Ill* •UUm«nl
"I III. lUilUlds U T«il« I* IHI*" «*
ini If »HM» tccMtBl MriMf w (I«M
•luillct 4cM«mli*U Iliftl tuft of |h*
»»•> IMUH in f«uiiir i*
k. IUh *i MftminftkL Ik* •I
hU pc«ilot4« (• ••lr*m*1y
MIii. if uiir N i^Ml|*4. '
y«r U.M ln«*h|nf f*ll«r
I* ••ilAillmrt «f*rX I*
•liftil* IMM. «r |*r wH1'11
inciil |ic*|m*nl*. fiMllct4M
tMllliiftllni InMcli pimljbwf •lH>r«p|f-
iri far ftll MililMT MM •Ahftt ||ni|
l* *|i|illc«lloM Hi* Ub
lb*l IMy M*
i ii- "y ^i,V;ii.Vi"ni^iiM f*r «U K.^UTli1 wi^!^^
HiHH^x1.: SueSSSis
!•.,;?;. if,. IM. if Ib* pMlkbl*. When 11 A) If r*«f A 4»lnb|,,
iteMijpjSiChaT" """"i
IIIJIi taMii.., |« waMlMaw.1 j,r
|l|««ffa« *f PUHAI lUUIl7j JlrZ-
ras^TOj&ft
RWftsadftsrfi
Kaffi11"11^""^
PSSfSSflht "-"11-
^JtUtf.^tt'tt
SSSffT '-"^M-"* A5
SLSn rt.'jlf f* MM " * HrfW4. .i!d
yflzsg***'1 ****••"«
lilfV" |l|t*»6i »• I*""* »««Uc.
KtLtZSttSt- T"* "• ••»••••
•V.IUW. |. ||M 11.4.
IfP* »f pio4iwl
ri*w t»* In
•*
for
MM
, «« Tlw W^Mrt ,|tl M|
Ib. btMd. «| " -
Ibm M ptcMillic4 IH Ml
fill HiMitUUIr UUv
. . ..
fide PtoduaU (or which U|. U llaaij *i
KSSatt*"*"1«^
•!•»•. M
•MMI.U4
• *cMd.|.4 •Illl
cm
under
-------
(esrti:
ttttrT- «* tt*
tor :&• csild
CU AS tte tso of
oil* to i i«i-ia
-------
APPENDIX IV-2
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
LABEL ELEMENT
Product name
company name
and address
Net contents
EPA ESt. NO.
EPA Rag. No.
ing enta
statement
Pounds ga on
statement
Front pane
precautionary
statements
Keep Out or Re
of Children
(Child hazard
warn! )
Signal word
APPLICABILITY
OF REQUIREMENT
All products
Al products
Ai products
Al p
Al p
3tS
CtS
ts
L quid products
where dosage
given as Ibs.
ai unit area
Ail products
Al products
All products
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front pane
Front panel
Front panel
Front panel
Front panel
ON LABEL
PKEb'UKKEU
Center tront
anel
Bottom rent
panel or end
of label text
Bottom tront
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediate y
following
roduct name
Directly be •M
the main
ingredients
statement
Above signa
word
Immediately
below child
hazard
war nil
COMMENTS
I registrant s not the producer, must
be qualified by "Packed for . . .,'
"Distributed . . .," etc.
May be m metric units in addition to
U.S. units
Must be in sun lar type size and run
arallel to other type.
May appear on the container instead of
the label.
Text must run para* 9 wfth" other text
on the panel.
Ail tront panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
93
-------
APPENDIX IV-2 (continued)
1
ITEM
7C
70
7B.
a
8A
88
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
f
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to.
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products •
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category Is
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.
QJi
-------
APPENDIX W-2 (continued)
ITEM
BC
9A
0C
10A
IOC
100
LABEL ELEMENT
Physical 'or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
All pressurized
products, others
with flash
points under
150°P
All restricted
products
All products
All
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Sane 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 USB
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
95
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
.Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F* or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F» or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150*F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture oc 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.
-------
Appendix TV-4
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label .instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
•STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel* in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under . . .". 6 point
Above 10 to 15 8 point
Above 15 to 30 10 point
Over 30 • 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container In storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while ^opening or closing container.
97
-------
Appendix IV-4
(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,
S. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions!
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statements
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
98
-------
ppen ix iv-«
(continued)
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. if these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide .or .Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance.*
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
•Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
3. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
99
-------
Appendix IV-4
(continued)
2. The labels for all other products must bear container disposal
instructions, based on container type* listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
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.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent)* Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Container Type
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^-, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording).
1-Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix.
100
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Appendix IV-4
{continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (£)
when discarded.
•Acutely Hazardous* Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts):
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-l2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Diraethyl 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
Pamphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomy1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
101
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Appendix IV-4
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium aside
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
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Appendix IV-4
(continued)
•Toxic" Commercial Pesticide Products (RCRA "P" List)
Active Ingredients:
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene _
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d)-pentalen-2-one
(kepone, chlordecone)
l,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3f3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12*)
3,5-Dichloro-N-(1,1-dimethy1-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (ODD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
103
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Appendix IV-4
(continued)
•Toxic* Commercial Pesticide Products (RCRA "F" List)
Active Ingredients!
Isobutyl alcohol
Lead acetate
Lindane
Naleic 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
Sa£role
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11*)
2,4,5-Tr i chlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
104
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