GUIDANCE FOR THE REREGISTRATION
OF MANUFACTURING-USE
AND CERTAIN END-USE PESTICIDE PRODUCTS
CONTAINING MONURON-TCA (035502)
AS THE ACTIVE INGREDIENT
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, DC 204060
July lr 1983
EPA/540-RS-83-007

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This document contains information regarding_reregistration
of pesticide products containing_the subject active i"9^ie fc*
The document includes how to register under a registration
standardf regulatory position and rationale, and summaries
of data requirements and data gaps. Also includ ^
bibliography containing citations of all studies "Viewed by
EPa' in arriving at the positions and conclusion
in the standard.
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Table of Contents
Section	Page
I.	introduction		 . , .	1
II.	Regulatory Position. ........ 	 ...	3
III.	Requirement for Submission of Generic Data 	 . .	7
IV.	Requirement for Submission of Product-Specific
Data . 				31
V.	Submission of Revised Labeling and Packaging
Information. ......................	32
A.	Label Contents			32
1.	Product Name			32
2.	Company Name and Address 	 .......	32
3.	Net Contents	32
4.	Product Registration Number. 		33
5.	Producing Establishment
Registration Number	33
6A Ingredient Statement , 				33
6B Pounds Per Gallon Statement	33
7.	Front Panel Precautionary Statements 		33
7A Child Hazard Warning Statements. ........	34
7B Signal Word. .......... ........	34
7C Skull and Crossbones and Word Poison	34
7D Statement of practical Treatment . 		34
7E Referral Statement			34
8.	Side/Back Panel Precautionary Labeling .....	34
8A Hazard to Humans and Domestic Animals. .....	35
8B Environmental Hazard 		35
8C Physical or Chemical Hazard			35
9 Misuse Statement 	 .....	36
10a Storage and Disposal Block 		36
10B Directions for Use 			 .	36
B.	Collateral Information	36
VI.	Instructions for Submission			37
Appendices {see next page for complete list) at end of document
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APPENDICES
Page
II-l	B xbl log r aph y	38
II-2	FIFRA S3(c)(2)(B) Summary Sheet 	 41
II-3	Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data. ... 42
IV-1	Product Specific Data Report (End-Use Products) ...	43
V-2	Table of Labeling Requirements	45
V-3	Physical/Chemical Hazards Labeling Statement. , , , .	48
V—4	Storage and Disposal Instructions .. 		49
Note:	Appendices V-l, V-5 and V-6 are not germane to this
document and are not included.
Also attached to this document are copies of the letters used to
transmit the document to registrants and notify them of studies
required.
i i

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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) Section 3(g), as amended in 1978, directs the Environ-
mental Protection Agency (EPA) to reregister all currently
registered products as expeditiously as possible. Each regis-
trant of a currently registered product who wishes to continue
to sell or distribute that product in commerce must apply
for reregistration.
This guidance document sets forth certain of the require-
ments for registration and reregistration of all manufac-
turing-use products (MPs) containing the subject chemical as
the sole active ingredient. These requirements include;
that certain scientific data be submitted and that certain
standards of toxici ty , composi tion, labeling, and packaging
be met. Registrants of MPs are referred to all Sections and
Tables for specific information regarding their responsibili-
ties under this guidance document.
This guidance document also sets forth the data require-
ments for those end-use products which contain the subject
active ingredient and for which the source of that active
ingredient is (1) not registered with EPA or (2) produced by
the reg i strant's firm, or a firm which has ownership in
common with the registrant's firm, or (3) both (1) and (2).
Registrants of such end-use products can exempt themselves
from these requirements if they change their source of supply
to a registered source, provided the source (i.e., registered
active ingredient product) is obtained from a firm that does
not share ownership in common with the registrant's firm.
(If the end-use product registrant decides to switch sources,
a new confidential statement of formula, EPA Form 8570-4,
must be submitted to the appropriate Product Manager within
90 days of receipt of this guidance document.) Registrants
of affected end-use products are referred to only Sections
II, III, and VI and Table A for specific information regarding
their responsibilities under this guidance document.
It should be noted that end-use products containing the
subject active ingredient will not be reregistered at this
time. Any necessary labeling changes will be implemented
under the Agency's Label Improvement Program at a future
time.
EPA will issue a notice of intent to cancel or suspend
the registration of any currently registered product if the
reg i strant fails to comply with the requirements set forth
in thi s guidance document and with the requi rements contained
in subsequent information from EPA about compliance with
certain data support requirements.
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This guidance document has been prepared to provide regis-
trants with specific information on how they may reregister
their manufacturing-use products or maintain their end-use
products' registration. (Refer to the cover letter's attach-
ment for a listing of your affected products.) If for any
reason you decide to request that the Agency discontinue the
registration of any of your products subject to the registra-
tion requirements in this document, please notify the Product
Manager named in the cover letter, within 90 days from the
receipt of this document, that you wish to voluntarily cancel
the registration(s). If you decide to maintain your product
registration(s) , you must provide the information described
in the following pages within the timeframes outlined.
Registrants are reminded that Section 6(a)(2) of FIFRA
requires you at any time to submit factual information raising
concerns of possible unreasonable adverse effects of a pesti-
cide. You should notify the Agency of interim results of
studies in progress if those results show possible adverse
effects.
This guidance document will be supplemented by EPA with
additional information about compliance with data support
requirements. In Monsanto v. Administrator, EPA was recently
enjoined by the District Court for the Eastern District of
Missouri from implementing in any way the "mandatory data
licensing" aspects of §3(c)(l)(D) of FIFRA. EPA is assessing
the implications of the injunction for the reregistration
process. Because this situation is currently unresolved,
EPA has decided to proceed with the requirements in this
guidance package which do not relate to the "data licensing"
issue and to supplement the package with additional guidance
when circumstances permit.
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II. REGULATORY POSITION AND RATIONALE
A.	INTRODUCTION
This chapter describes the regulatory position of the Environmental Protection
Agency ("the Agency") on Monuron-TCA based on an evaluation of all registered
manufacturing-use products (MUP's) containing Monuron-TCA as the sole active
ingredient. Future requests for registrations of substantially similar
products will be covered by this standard. Dissimilar products will require
amendments to the standard. This document provides the rationale for the
Agency's position and the criteria for registration. It also discusses
labeling requirements and tolerances.
"Monuron-TCA" is the accepted common name for the compound, 3-(p-chlorophenyl)-
1,1-dimethylurea trichloroacetate recognized by the American National Standards
Institute. The Trade and other name for Monuron-TCA is Urox. The Chemical
Abstracts Service (CAS) Registry number is 140-41-0. The Office of Pesticide
Program's internal Control Number (EPA Shaughnessy number) is 035502.
B.	USE PROFILE
Monuron-TCA is a substituted urea herbicide for control of certain woody plants,
certain annual and perennial grasses, broadleaf weeds, and algae, to be used on
agricultural premises (around buildings, fencerows, farm roads), rights-of-way
(highway, railroad, and utility rights-of-way), commercial and industrial
premises (tank farms, lumber yards, storage areas, -plant sites, parking lots,
fencerows), domestic dwellings, schools, (fencerows, parking lots, playgrounds),
and in irrigation and drainage ditches.
It was patented by Allied Chemical Corporation in 1957, (US Patent No. 2,782,112)
and was first registered for use in 1958. The current domestic producer of
Monuron-TCA is Hopkins Agricultural Chemical Company.
Monuron-TCA is available as a sole active ingredient in granular and dust formu-
lations (5.5%, 11.0%, and 22.0%), and emulsified concentrate, pressurized liquid,
ready-to-use solutions, and soluble concentrates (3.19%, 6.40%, 12.81%, and
32.25%).
C.	REGULATORY POSITION
Based on a review and evaluation of all available data and other relevant
information on Monuron-TCA, the Agency has made the following determinations:
1. Manufacturing-use pesticide products containing Monuron-TCA as a
sole active ingredient may be registered for sale, distribution,
formulation and use in the United States, subject to the terms
and conditions specified in this standard. Applicants having
products not conforming to this standard must apply to amend
the document so those products containing Monuron-TCA may be regis-
tered and reregistered under this standard. Mixtures and end-
use products containing Monuron-TCA are not covered under this
standard.
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2.	Available data do not show that any of the risk criteria
listed in Section 162.11(a) of Title 40 of the U.S. Code of
Federal Regulations have been met or exceeded for the uses
of Monuron-TCA specified in this standard.
3.	All of the toxicity data cited as supporting data for the
registration of Monuron-TCA are considered to be supplementary
or invalid.
4.	The available Monuron-TCA environmental fate data are insufficient
to fully assess the chemical at this time. When additional envi-
ronmental fate data are submitted, a complete environmental exposure
assessment can be made.
5.	There are insufficient data to characterize the toxic effects of
Monuron-TCA on aquatic organisms, fish and wildlife. When additional
ecological effects data are submitted, a complete hazard assessment
can be made.
6.	The available Monuron-TCA product chemistry data are insufficient to
fully assess the chemical at this time. The data gaps outlined in
the product chemistry data tables are tests needed to adequately
support the registration of a Monuron-TCA product.
7.	The Agency now considers that the use of Monuron-TCA on drainage ditches
in Florida citrus groves as a food use. Residue data to support
this use are not available. Monuron-TCA residue data and/or other data
demonstrating that such use will or will not result in residues in
water or in crops receiving irrigation water will be required. If
residues occur in crops, tolerances will be required.
8.	Registrants must provide or agree to develop additional
data, as specified in the tables attached to this standard,
in order to maintain existing registrations or to permit
new Monuron-TCA registrations.
9.	Because there are no established tolerances for Monuron-TCA, residues
in food or feed will not be permitted from uses approved in any
registration under this standard,
D. REGULATORY RATIONALE
The Agency has determined the following:
1, As stated above, all of the toxicology data are considered invalid or
supplementary and therefore, do not permit conclusions as to the safety
of Monuron-TCA. However, the available supplementary data indicate that
Monuron-TCA has a low order of toxicity (TOX CAT III) by the oral and
dermal route routes of exposure, but high acute oral doses have produced
symptoms of anemia, methemoglobinemia and and pathological changes in
the spleen, bone marrow, liver and kidneys of test animals. The available
supplementary longer term studies further demonstrated a similar potential
for affecting these organs, as well as the lung and testes, at high
dietary levels.
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The closely related compound, monuran, has been evaluated as a potential
oncogen. The National Toxicology Program (NTP), Public Health Service
(PHS) tested and recently completed its evaluations in both rats and
mice. These report are under peer review within NTP/PHS and were not
available in time to be considered in this review.
2.	The Agency believes that the use of Monuron-TCA on drainage ditches
in Florida citrus groves is a food use because of the potential for
residues to be found in the crop. If this use is to be approved,
Monuron-TCA residue data and/or other data demonstrating that such use
will or will not result in residues in water or in crops receiving
irrigation water will be required. If residues occur in crops,
tolerances will be required.
3.	It is not the Agency's policy to cancel or to withhold registration
merely because data are missing or inadequate (See Sections 3(c)(2)(B)
and 3(C)(7) of the FIFRA). Rather, publication of this standard
provides a mechanism for identifying data needs and registration
under the standard and allows for the upgrading of labels during
the period 1 n which the required data are being developed. These
data will be reviewed and evaluated when they are received and the
Agency will determine at that time whether they will affect the
registration(s) of Monuron-TCA.
E.	CRITERIA FOR REGISTRATION UNDER THIS STANDARD •
To be subject to this standard, products must meet the following conditions:
1.	Contain Monuron-TCA 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.
The applicant for registration or reregistrati on of products subject to
this standard must comply with all terms and conditions described 1n.it,
including commmiting to fill data gaps on a schedule agreed to by both
this agency and the applicant, and when applicable, offering to pay
compensation for data to the extent required by Section 3(c) (1) (D) of
the FIFRA. Applicants for registration under this standard must follow the
instructions contained in this standard and complete and submit the
appropriate forms within the time specified.
F.	ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
Manufacturing use products must contain at least 32.25 percent Monuron-TCA
as the sole active ingredient. Each manufacturing-use product formulation
proposed for registration must be fully described with an appropriate
certification of limits. In addition, the active ingredient found in the
rnanufacturing-use Monuron-TCA products must be substantially similar to that
in currently registered technical products. Any rnanufacturing-use product
not meeting these requirements will be considered a new product and will
not be registerable under this standard.

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2.	Acute Toxicity Limits
The Agency will consider registration of technical grade and manufacturing-
use products containing Monuron-TCA within acute toxicity category III provided
that the labeling of those products bears appropriate precautionary statements.
3.	Use Patterns
To be registered under this standard, manufacturing-use products containing
Monuron-TCA may be labeled for formulation only into end-use products for use
as herbicides to control certain woody plants, annual and perennial grasses,
broadleaf weeds, and algae, to be used on agricultural premises (around
buildings, fencerows, farm roads,), rights-of-way (highway, railroad, and
utility rights-of-way), commercial and industrial premises (tank farms,
lumber yards, storage areas, plant sites, parking lots, fencerows), domestic
dwellings, schools, (fencerows, parking lots, playgrounds), and in irrigation
and drainage ditches.
G.	REQUIRED LABELING
All technical grade, manufacturing-use, and end-use products containing
Monuron-TCA must bear appropriate labeling as specified in 40 CFR 162.10.
Other portions of the guidance package contain specific information
regarding label requirements.
H.	TOLERANCE REASSESSMENT
There are no established tolerances for Monuron-TCA in the United States and
no pending registrations or requests for establishment of tolerances or
exemptions from requirements of a tolerance for Monuron-TCA.
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Ill. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A.	This portion of the guidance document is a Notice
issued under the authority of PIFRA Section 3(c)(2)(B)
and describes, in table format, the data required
for maintaining the registrability of each product.
Additionally, a bibliography (Appendix 111-1} is
included that identifies that data considered as
part of the data base supporting this standard. EPA
has determined that additional generic data described
in this Notice must be submitted to EPA for evaluation
in order to maintain in effect the registration(s)
of your product(s) identified as an attachment to
the cover letter accompanying this guidance document.
As required by FIFRA Section 3(c)(2)(B), you are
required to take appropriate steps to comply with
this Notice.
EPA may suspend the reg i strat ion 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 suspens i on will remai n in effect until you have
complied with the terms of this Notice.
B.	What Generic Data 1/Must Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this section. That table shows all the
generic data needed to evaluate the continued registrability
of all products, and the dates by which the data must be
submitted. The required data must be submitted and any
necessary studies must be conducted in accordance with
EPA-approved protocols, the Pesticide Registration
Guidelines 2/, or data collected under the approved
protocols of the Organization for Economic Cooperation
and Development (OECD). If you wish not to develop data
which are necessary to support the registration or
reregistration of certain uses appearing in your labeling,
you may delete those uses at the time you submit your
revised labeling.
Also for certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
and in those cases EPA needs data of that
1/ 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 un i que composition or use. Product-spec i f i c data relate
only to the properties or effects of a product with a parti cular
composition (or a group of products with closely similar composition]
2/ The Pesticide Registration Guidelines were reproposed on
November 24, 1982 in 47 Federal Register 53192.
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type for each major formulation category (e.g., emulsifiable
concentrates, wet table powders, granulars, etc.) These
are classified as generic data and when needed are
specified in Table A. EPA may possess data on certain
"typical formulations" but not others. Note: The "typical
formulation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Section IV of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "PIPRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
111— 2] for each of your products. On that form you must
state which of the following methods you will use to comply
with the requirements of this Notice:
1.	(a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe
will satisfy the requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Registration Guidelines or protocols
contained in the Reports of Expert Groups
to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must enclose
the protocols you will use.
2.	Notify EPA that you have entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing) the
data. If you elect this option, you must notify EPA
which registrant(s) are parties to the agreement.
3.	File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for
Development of Data" (EPA Form 8580-6, Appendix III-3)V
4.	Request that EPA amend your registration by deleting the
uses for which the data are needed. (This opt ion is not
available to applicants for new products.)
V FIFRA Section 3(c)(2)(B)	authorizes joint development of
data by two or more registrants,	and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail	to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
( Footnote cont. inued at bottom of next page)
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5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed, (This
option is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required
data or how quickly the data must be submitted. If the
test procedures you plan to use deviate from (or are not
specified in) the registration guidelines or protocols
contained in the reports of the Expert Groups to the
Chemical Groups, Organization for Economic Cooperation
and Development (OECD) Chemicals Testing Programme, you
must submit the protocol for Agency review prior to the
initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product
Manager. The extension request should state the reasons
why you conclude that an extension is appropriate. While
EPA considers your request, you must strive to meet the
deadline for submitting the required data.
(Footnote continued from previous page)
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B), EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3(c)(2)(B)(iii)]; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration. While the first firm is
not required to agree to jointly develop data, EPA is not required
to force the second firm to engage in economically inefficient
duplicative testing in order to maintain its registration.
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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
Does EPA Have Data
To Satisfy This
1/ Requirement? (Yes,
Composition	No or Partially)
Data Requirement
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)??/
§158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients	TGAI
61-2 - Statement of Composition	TGAI
61-3	- Discussion of Formation of	TGAI
Ingredients
Analysis and Certification of Product
Ingredients
62-1	- Preliminary Analysis	TGAI
62-2 - Certification of Limits TGAI
62-3	- Analytical Methods for	TGAI
Enforcement of Limits
Physical and Chemical	Characteristics
63-2	- Color	TGAI
63-3 - Physical State	TGAI
63-4 - Odor	TGAI
63-5 - Melting Point	TGAI
63-6 - Boiling Point	TGAI
63-7 - Density, Bulk Density, or	TGAI
Specific Gravity
No
No
No
No
No
No
No
Partial
No
No
n/a
No
005021075
Yesjfy
Yesjty
Yes3/
Yesjty
Yesjty
Yes_Jty
YesV
Yesf/
YesV
Yes 4/
YesV
10

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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
Data Requi rement
Does EPA Have Data
To Satisfy This
1/ Requirement? (Yes,
Composition	No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.120 Product Chemistry
(continued)
63- 8 - Solubility
63- 9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13	- Stability
Other Requirements:
64-	1 - Submittal of samples
TGAI OR PAI
TGAI	OR PAI
TGAI	OR PAI
PAI
TGAI
TGAI
Choice
Partial
No
No
Partial
No
No
n/a5/
005021082
005018258
Yesfy
Yesfy
Yesfy
Yesfy
Yesfy
Yesfy
U

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TABLE A
GENERIC DATA REQUIREMENTS FOR MonurorvTCA
§158.120 Product Chemistry
(continued)
1/ 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.
1) Data must be submitted no later than six months from the issue date of the guidance package.
3/ Certain of the required data are available to the Agency in previously submitted Confidential Statements of
Formula. The Agency, however, has noted that in most cases these data are both incomplete or are in need
of updating. The Agency, therefore, will require the submission of data for each technical compound under-
going registration or reregistration.
4/ Elements of the indicated data have been located by the Agency within standard references. The Agency cannot,
however, apply this information to currently produced technical products due to possible variations in
synthesis processes. The indicated physical chemical properties data will, therefore, be required for each
technical product undergoing registration or reregistrati on.
5/ N/a: Not applicable= Data requirement is not necessary for purposes of this standand.
12

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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
_1/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement	Composition	No or Partially) 	Citation	3(c)(2)(B)?2/
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism) [Reserved]^/
-	Plants
-	Livestock
171-4 - Residue Analytical Method	[Reserved]^/
-	Plant residues
-	Animal residues
171-4 - Storage Stability Data	[Reserved]^/
171-4 - Magnitude of the Residue-	[Reserved]^/
Residue Studies for Each
Food Use
-	Crop Group #1 - (Name)
o Crop 1 (Name)
/
—	Crop field trials
-- Processed Food/Feed
o Crop 2, etc.
—	Crop field trials
-- Processed Food/Feed
-	Crop Group 2, etc.
-- Potable Water
13

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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
Data Requirement
Does EPA Have Data
To Satisfy This
1/ Requirement? (Yes,
Composition	No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)??/
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
--	Fish
--	Irrigated Crops
--	Field trials
--	Processed Food/Feed
--	Food Handling
--	Meat/milk/poultry/eggs
[Reserved]^/

14

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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
§158.125 Residue Chemistry
(continued)
\J Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP
Typical end-use product.
2/ Data must be submitted no later than forty eight months from the issue date of the guidance package.
2/ The Agency is reserving all residue chemistry requirements until such time as those data necessary for an
evaluation of Monuron-TCA's toxicology have been received and evaluated. Although the Agency does not have
adequate data characterizing Monuron-TCA potential chronic effects, there are indications within the available
literature that Monuron-TCA may pose some level of health risk. Should those data requested elsewhere within
this standard indicate that Monuron-TCA does present a significant health risk, the Agency will make a
determination as to whether or not petitions for tolerance will be necessary for the use in drainage ditches
in Florida citrus groves.
J
15

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TABLED
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
|	Does EPA Have Data	Must Additional
)	To Satisfy This	Data Be Submitted
|	1/ Use 21 Requirement? (Yes, Bibliographic Under FIFRA Section
j	Data Requirement	Composition Pattern	No or Partially)	Citation	3(c)(2)(B)?3/	
)
!	§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:






161-1 - Hydrolysis
TGAI
or
PAIRA
A,B,C
No
Yes
Photodegradation






161-2 - In water
TGAI
or
PAIRA
A,B,C
No
Yes
161-3 - On soil
TGAI
or
PAIRA
A
n/a 5/

161-4 - In Air
TGAI
or
PAIRA
A,C
n/a

METABOLISM STUDIES-LAB:




,

162-1 - Aerobic Soil
TGAI
or
PAIRA
A,C
No
[Reserved]^/
162-2 - Anaerobic Soil
TGAI
or
PAIRA
A,C
n/a

162-3 - Anaerobic Aquatic
TGAI
or
PAIRA
B
No
[Reserved]^/
162-4 - Aerobic Aquatic
TGAI
or
PAIRA
B
No
[Reserved]^/
MOBILITY STUDIES:






163-1 - Leaching and
TGAI
or
PAIRA
A,B,C
No
[Reserved]^/
Adsorption/Desorption
163-2 - Volatility (Lab)	TEP	A,C	n/a
163-12- Volatility (Field) TEP	A,C	n/a
16

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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
Data Requirement
1/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.130 Environmental Fate
(continued)
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5	- Soil, Long-term
ACCUMULATION STUDIES:
165-1	- Rotational Crops
(Confi ned)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Organi sms
TEP
TEP
TEP
A,C
B
A
A.C
TEP
PAIRA
TEP
TEP	B
TGAI or PAIRA A,B
TEP	B
No
No
n/aj7
n/a
n/a
n/a
n/a
No
No
No
[Reserved]V
[Reserved]^/
[Reserved]fy
[Reserved]^/
[Reserved]^/
17

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TABLE A
GENERIC DATA RTEQUIREMENTS FOR Monuron-TCA
§158.130 Environmental Fate
(conti nued)
\J Composition: T6AI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Non-Food; B=Aquatic, Non-Food; C=Domestic Outdoor.
3/ Data must be submitted no later than forty months from the 'issue date of the guidance package.
4/ The data for this chemical, Monuron-TCA, are being reserved, pending the evaluation of the corresponding data
for monuron.
5/ N/a: Not applicable= Data requirement is not necessary for the purposes of this standard.
18

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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
Data Requirement
1/
Composition
Use 2/
Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? 3/
§158.135 Toxicology






ACUTE TESTING:






81-1 - Oral LD50 - Rat
TGAI
A,B,C
No

-
Yes
81-2 - Dermal LD50
TGAI
A,B,C
No

-
Yes
81-3 - Inhalation LC^q - Rat
TGAI
A,B,C
n/a®/



81-7 - Acute Delayed
Neurotoxicity - Hen
TGAI
A,B,C
n/a



SUBCHRONIC TESTING:






82-1 - 90-Day Feeding -
Rodent, Non-rodent
TGAI
C
No

-
YesV
82-2 - 21-Day Dermal
TGAI
A,B,C
No

-
[Reserved]^/
82-3 - 90-Day Dermal
TGAI
A,B»C
n/a
¦


82-4 - 90-Day Inhalation -
Rat
TGAI
A,B,C
n/a



82-5 - 90-Day Neurotoxicity-
Hen /Mammal
TGAI
A,B,C
n/a



19

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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
1/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Sectidn
Data Requirement	Composition Pattern	No or Partially)?	 Citation	3(c)(2)(B)?3/
§158.135 Toxicology
(conti nued)
CHRONIC TESTING:
83-1
- Chronic Toxicity -
2 species: Rodent
and Non-rodent
TGAI
A,B,C
No
-
Yes^/
83-2
- Oncogenicity Study -
2 species: Rat and
Mouse preferred
TGAI
A,B,C
No
-
Yes£/
83-3
- Teratogenicity -
2 species
TGAI
A,B
No
-
Yes
83-4
- Reproduction,
2-generation
TGAI
A,B,C
n/afy


MUTAGENICITY TESTING





84-2
- Gene Mutation
TGAI
A,B,C
No
-
Yes
84-2
- Chromosomal Aberration
TGAI
A,B,C
No
-
Yes
84-2
- Other Genotoxic
TGAI
A,B,C
Partial
05009139
Yes9/
Effects
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA A,B,C	No	-	Yes
- Sulf and	TGAI	A,B,C	No	-	YesiO/
Methemoglobin
20

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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
§158.135 Toxicology
(conti nued)
\J Composition: PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabeled; Choice = Choice of several
test substances determined on a case-by-case basis.
y The use patterns are coded as follows: A=Terrestrial, Non-Food; B=Aquatic, Non-Food; C=Domestic Outdoor.
y Data must be submitted no later than forty eight months from the issue date of the guidance package.
4/ These data will not be required should other data be submitted to the Agency which demonstrates the absence of
detectable residues in crops receiving irrigation water from monuron treated ditches.
5/ This data requirement is reserved pending the receipt and evaluation of data relevant to Monuron-TCA dermal LD50.
6/ N/a: Not applicable= Data requirement is not necessary for the purposes of this standard.
7/ Studies designed to simultaneously meet the requirements of both the chronic feeding and oncogenicity studies
can be conducted.
y The Agency has become aware that the National Cancer Institute is concluding an oncogenicity study utilizing
monuron. Until such time that this study may be received and evaluated, however, it may not be concluded
that the study will satisfy Agency requirments. Registrants are, therefore, cautioned that they may remain
liable for the satisfactory fulfillment of this data requirement.
y In vivo evaluations are required for the following tests: DNA damage and repair, numerical chromosomal aberrations,
mammalian cell transformation, and target organ/cell analysis.
10/ Data relating the levels of sulf and methemoglobin following dietary exposure are being required by the Agency for
all substituted phenylurea compounds. While this testing may be combined other required testing involving dietary
exposure, dose levels must be such that a no observable effect level may be established.
21

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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? 3/
Data Requi rement
1/ Use 2/
Composition Pattern
Bibliographic
Citation
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1
- Avian Oral LD5q
TGAI
A,B,C
No
-
Yesf/
71-2
- Avian Dietary LC50
TGAI
A,B,C
No
-
Yes
71-3
-Wild Mammal Toxicity
TGAI
A,B ,C
n/aV


71-4
- Avian Reproduction
TGAI
A,B,C
n/a


71-5
- Simulated and Actual
Field Testing -
Mammals and Birds
TEP
A,B,C
n/a


AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish LC5q
TGAI
A,B,C
Partial
000030631
Yes£/


TEP
B
Partial •
000034214
Yesfy
72-2
- Acute LCr0 Freshwater
Invertebrates
TGAI
TEP
A,B,C
B
No
xNo
\
-
Yes7/
Yes_7/
72-3
- Acute LCgQ Estuarine
and Marine Organisms
TGAI
TEP
A,B,C
B
Nox
No
-
Yes8/
Yes^/
22

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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
Data Requirement
1/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bi bliographi c
Citation
AQUATIC ORGANISM TESTING
72-4 - Fish Early Life
Stage and Aquatic
Invertebrate Life-
Cycle
72-5 - Fish - Life-Cycle
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honey bee acute
contact LD50
141-2 - Honey bee toxicity of
residues on foliage
141-3 - Wild bees important in
alfalfa pollination-
toxicity of residues
on foliage
141-4 _ Honey bee subacute
feeding study
141-5 - Field testing for
pollinatorse study
TGAI
TGAI
TGAI.PAI
Degradation
Product
TEP
A,B,C
A,B,C
A,B,C
A,B,C
TGAI	A
TEP	A
TEP	A
[Reserved]^/
TEP	A
n/afy
n/a
n/a
n/a
Yes
n/a
n/a
00001999
No
n/a /
23

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TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
Data Requirement
1/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
NONTARGET INSECT TESTING -
AQATIC INSECTS:
142-1 - Acute toxicity to
aquatic insets
142-2 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
[Reserved]!^/
[Reserved]!^/
[Reserved]10/
143-1- NONTARGET INSECT TESTING [Reserved]10/
thru PREDATORS AND PARASITES
143-3
0
24

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0
TABLE A
GENERIC DATA REQUIREMENTS FOR Monuron-TCA
§158.145 Wildlife and Aquatic Organisms
(continued)
y 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, Non-Crop; B=Aquatic, Non-Food; C=Domestic Outdoor.
3/ Data must be submitted no later than forty eight months from the issue date of the guidance package.
4/ N/a: Not applicable= Data requirement is not necessary for purposes of this standard.
y Data are required for an avian acute oral LD50 on one species of upland gamebird (preferably Bobwhite quail).
6/ Walker, C.R. (1965) (MRID 5018708) may be reconsidered by the Agency for fulfillment of the data requirment
for a 96-hour warmwater fish bioassay. In order for the Agency to make full use of the Walker study, satisfactory
information regarding the dose related mortality and the percent active ingredient of both the technical and
formulated products utilized in the study must be obtained and submitted for review. Should these data be either
unavailable or unsuitable for Agency use, a 96-hour warmwater fish bioassay will remain as a data requirment.
7/ Data are required for a 48-hour freshwater invertebrate bioassay (preferably Daphnia magna).
8/ Data are required for a 48-hour marine invertebrate bioassay (preferably oyster larvae and shrimp).
y Reserved pending development of test methodology.
101/ Reserved pending decision as to whether data requirement should be established.
35

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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING Monuron
-TCA
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)??/
Data Requirement
Composition
1/
Bibliographic
Citation
§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
Characteri sties
63-2	- Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, bulk density, or
specific gravity
MP
MP
MP
No
No
,No
MP
MP
MP
¦No
No
No
MP
MP
MP
MP
No
Partial
No
No
005021075
Yes2/
Yes_fy
Yes3/
YesjV
Yesjty
Yes 3/
Yes£/
YesV
Yes V
Yes3/
26

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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING Monuron-TCA
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
_1/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement	Composition	No or Partially)	Citation	3(c)(2)(B)?2/
§158.120 Product Chemistry
(continued)
63-12 - pH
MP
No
YesV
63-14 - Oxidizing or reducing
MP
No
YesV
action



63-15 - Flammability
MP
¦ No
Yes 5/
63-16 - Explodability
MP
No
YesV
63-17 - Storage Stability
MP
No
Yes V
63-18 - Viscosity
MP
•No
Yes 4/
63-19 - Miscibility
MP
Yes
No
Other Requirements



64- 1 - Submittal of Samples
Choice
n/a£/

27

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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING Monuron-TCA
§158.120 Product Chemistry
(continued)
y Composition: MP = Manufacturing-use product; Choice = of several test substances determined on a case-
by-case basis.
2/ Data must be submitted no later than six months from the issue date of the guidance package.
y Certain of the required data are available to the Agency in previously submitted Confidential Statements
of Formula. The Agency, however, has noted that in most cases these data are both incomplete and are in
need of updating. The Agency, therefore, will require the submission of data for each manufacturing-use
product undergoing registration or reregistration.
4/ Elements of the indicated data have been located by the Agency within standard references. The Agency cannot,
however, apply this information to currently produced manufacturing use products due to possible variations
in manufacturing processes. The indicated physical chemical properties data will, therefore, be required
for each manufacturing use product undergoing registration or reregistration.
y Flammability data required for combustible liquids only.
y N/A: Not applicable= Data requirement is not considered necessary for purposes of this standard.
28

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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING Monuron-TCA
Data Requirement
Composition
1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
§158.135 Toxicology
ACUTE TESTING
81-1 - Oral LD50 - Rat
81-2 - Dermal LD50
81-3 - Inhalation LC50- Rat
81-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation
81-6 - Dermal Sensitization
MP
MP
MP
MP
MP
MP
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
29

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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING Monuron-TCA
§158.135 Toxicology
(conti nued)
y Composition: MP = Manufacturing-use product.
y Data must be submitted no later than six months from the issue date of the guidance package.
30

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IV- REQUIREMENT for submission of product-specific data
Note: This section applies only to manufacturing-use products
not end-use products.
A necessary first step in determining which statements must
appear on your product's label is the completion and submission
to EPA of product-specific data* listed on the form entitled
"Product Specific Data Report" (EPA Form 8580-4, Appendix IV-1)
to fill "gaps" identified by EPA concerning your product. Under
the authority of FIFRA Section 3(c)(2)(B), EPA has determined
that you must submit these data to EPA in order to register or
reregister your product(s). All of these data must be submitted
not later than six months after you receive this guidance document
"Product-Specific Data Requirements for Manufacturing-Use
Products" appearing in Table B permit you to determine which
product-specific data you must submit. This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B)."
V Product specific data pertains to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicology data.

-------
V. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This section applies only to manufacturing-use products,
not end-use products.
The Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate, complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are suffi-
ciently standardized to avoid user confusion.
As part of your application, you will be required to submit
draft labeling consistent with; applicable product-specific
data; the precautionary statements and use directions; and the
regulations concerning classification [40 CFR §162.11(c)], pack-
aging [40 CFR §162.16], and labeling [40 CFR §162.10, Appendix
V-1 and V-2] , as indicated by the following paragraphs of this
section of the guidance document.
You will be informed later when you must submit the rev i sed
labeling set forth in this guidance package.
A. Label Contents
40 CFR §162.10 (Appendix V-l) requires that certain spe-
cific labeling statements must appear at certain locations
on the label. This is referred to as format labeling.
Specific label items listed below are keyed to Tables D, E,
and F (Appendix VI-2).
Item 1. PRODUCT NAME - The name, brand, or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading. See Appendix
V-l. [40 CFR §162.10(b)]
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
See Appendix V-l. [40 CFR §162.10(c)]
Item 3. NET CONTENTS - A net content statement is required
on all labels. The preferred location is the bottom of the
front panel immediately above the company name and address,
or at the end of the label text. The net contents must be
stated in terms of weight, expressed as avoirdupois pounds
32

-------
and ounces, and stated in terms of the largest suitable unit,
i.e., "1 pound 10 ounces" rather than "26 ounces." In
addition to the required units specified, net contents may be
expressed in metric units. See Appendix V-l. [40 CFR
§162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg, No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix V-l.
[40 CFR §162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment registration number on
the immediate container cannot be clearly read through such
wrapper or container. See Appendix V-l. [40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An i ngredient statement
is required on the front panel and must contain the name and
percentage by weight of each active ingredient and the total
percentage by weight of all inert ingredients. The preferred
location is immediately below the product name. The ingredient
statement must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the
body of other text. See Appendix V-l. [40 CFR 162.10(g)]
Item 6A. POUNDS PER GALLON STATEMENT - For liquid
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, preferably within a block outline. The
table below shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
33

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Size of Label
on Front Panel
in Square Inches
Signal Word as Re-
quired Minimum Type
Size All Capitals
"Keep Out of Reach
of Children"
	as Required
above 5 to 10
above 10 to 15
above 15 to 30
over 30
5 and under
6	point
10	point
12	point
14	point
18	point
6	point
6	point
8	point
10	point
12	point
Item 7A. CHILD HAZARD WARNING STATEMENT - All labels are
required to have the statement "Keep Out of Reach of Children"
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
See Appendix V-l. [40 CFR §162.10{h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Appendix V-l.
[40 CFR §162.10 (h)(1)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, or dermal toxicity, the word "Poison" shall appear on
the label in red on a background of distinctly contrasting
color and the skull and crossbones shall appear in immediate
proximity to the word poison. See Appendix v-l. [40 CFR
§162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix V-l. [40 CFR §162.10(h) ( 1) ( iii) ]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix V-l. [40 CFR §162,10(h)(1)(iii)]
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 V-l. [40 CFR §162.10
(h)(2)]
34

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Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions taken to avoid
accident, injury or damage. See Appendix v-1. [40 CPR §162.10
(h) ( 2 ) {i) ]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix V-1. [40 CFR
§162.10(h)(2)(ii>]
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1.	Flammability statement. Precautionary statements
relating to flammability of a product are required
to appear on the label if it meets the criteria in
Appendix V-3. The requirement is based on the results
of the flashpoint determinations and flame extension
tests required to be submitted for all products.
These statements are to be located in the side/back
panel precautionary statements section, preceded by
the heading "Physical/Chemical Hazards." Note that
no signal word is used in conjunction with the flam-
mability statements.
2.	Criteria for declaration of non-flammability. The
following criteria will be used to determine if a
product is non-flammable:
a.	A "non-flammable gas" is a gas (or mixture of
gases) that will not ignite when a lighted match
is placed against the open cylinder valve.
b.	A "non-flammable liquid" is one having a flash-
point greater than 350 °F (177 °C) as determined
by the method specified in 40 CFR § 163.61-8(c)(13)
(i i) of Subpart D.
c.	A "non-flammable aerosol" is one which meets the
following criteria;
i. The flame extension is zero inches, using the
method specified in 40 CFR §163,61-8(c)(13)(ii) ;
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177QC),
determined by the method specified in 40 CFR
§163.61-8(c)(13)(i).
35

-------
3.	Declaration of non-flammability. Products which meet
the criteria for non-flammability specified above may
bear the notation "non-flammable" or "nonflammable
(gas, liquid, etc.)" on the label.
It may appear as a substatement to the ingredients
statement, or on a back or side panel, but shall not
be highlighted or emphasized (as with an inordinately
large type size) in any way that may detract from
precaution.
4,	Other physical/chemical hazard statements. When
chemistry data submitted in accordance with 40 CFR
§ 163.61-10(c) demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such
statements may address hazards of explosivity,
oxidizing or reducing capability, or mixing with
other substances to produce toxic fumes.
Item 9. MISUSE STATEMENT - The following statement is
required on your label: "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling."
See Appendix V-l. [40 CFR §162.10(1) (2)(ii)]
Item 10A. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. Make certain that the statement you use
pertains specifically to your product. These instructions
must be grouped and appear under the heading "Storage and
Disposal" in the directions for use. This heading must be
set in the same type sizes as required for the child hazard
warning. Refer to Appendix V-5 for the latest specific
storage and disposal product label statements.
Item 10B, DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from persona 1 injury and to
prevent unreasonable adverse effects on the environment. See
Appendix V-l. 140 CFR §16 2.10]
B. Collateral Information
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, and other graphic printed matter which is referred to
on the label or which is to accompany the product are termed
collateral labeling. Such labeling may not bear claims or
representations that differ in substance from those accepted
in connection with registration of the product. It should be
made part of the response to this notice and submitted for review.
36

-------
VI. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Mr, William H. Miller
Product Manager 16
Registration Division (TS-767)
Office of Pesticide Programs
Environmental protection Agency
Washington, D.C. 20460
Phone No. (703) 557-2600
A.	For each manufacturing-use product for which continued
registration is desired;
1.	Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet".
Refer to Appendix III-2 with appropriate attachments.
2.	Within 6 months from rece ipt of th is document registrants
must submit:
a.	Confidential Statement of Formula, EPA Form 8570-4 .
b.	Product Specific Data Report (Appendix IV-1).
c.	Two copies of any required product-specific data.
3.	Within the time set forth in Table A, all generic data
must be submitted by the affected registrant(s).
Note: If for any reason any required test is delayed or
aborted so that meeting the agreed submission time
will be delayed, notify the Product Manager listed
above.
B.	For each affected product for which continued registration
is desired, within 90 days from receipt of this document
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1 , Appendix 111-2) with appropriate attachments.
C.	You will be informed at a later date when you must submit
your Application for Amended Pesticide Registration (EPA
Form 8570-1) and the revised labeling set forth in this
guidance package.
37

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Appendix II-l
Guide to Use of This Bibliography
1.	CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources 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 OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3.	IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4.	FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
38

-------
Appendix II-l
(continued)
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 number, 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 access ion 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-
Bj the 26th, 123456-Z? and the 27th, 123456-AA.
39

-------
Appendix II-l
(continued)
CASE BIBLIOGRAPHY
MRID
000001999 Atkins, L. Jr.? Anderson L. D. (1967) Toxicity of Pesticides
and Other Agricultural Chemicals to Honey Bees: Laboratory
Studies. (Unpublished study received January 30, 1969
under 9G0802; prepared by Univ. of California-Riverside,
Dept. of Entomology, submited by Hercules, inc., Agricultural
Chemicals, Wilmington, DE; CDL:093111-D.
0000030631 Pitcher, A. (1972) Urox: Toxicity to Rainbow Trout. (U.S.
Department of Agriculture, Pesticide Regulation Division,
Animal Biology Laboratory, Unpublished Report).
0000034214 Swabey, Y« H.; Schenk, C.F. (1963) Report on Algicides and
Aquatic Herbicides. (Unpublished study received January 5,
1968 under 201-118; prepared by Ontario Water Resources
Cortmission, submitted by Shell Chemical Co., Washington,
D.C.; CDL: 000755-N).
005009139 Simmon, V. F.; Mitchell, A. D.; and Jorgenson, T. A. (1977)
Evaluation of Selected Pesticides as Chemical Mutagens: In
Vitro and In Vivo Studies? Research Triangle Park, N.C.:
U.S. Environmental Protection Agency, Health Effects Research
Laboratory. (EPA Report No. 600/1-77-028; available from
National Technical Information Service, Springfield, VA:
PB-268-647)
005018258 Voss, G. (1978) Simple semi-automated procedure for
determining the lipophilic nature of organic compounds.
Analyst (london) 103(1224):233-237.
005021075 Takada, H. (1956) CMU no gosei - Synthesis of CMU-1 Pages
42-43, "In Takamine Kenkyusho Nempo," Annual Report of Takamine
Laboratory 1, Vol. 8. Tokyo, Japan: Takamine Kenkyusho.
005021082 Zhuravlev, E. Z.; Domoratskaya, N. S.; Serukhina, S. Y.;
Konstantinov, I. I. (1969) Rastvorimost' monurone i diurone
v vode - The solubility of monuron in water - 1 Agrokhimiya.
Agricultural Chemistry. 1 (1):141-143.
40

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Appendix II-2
OMB Approval No. 2000-0468 (Expires 12-31-83)
|EPA REGISTRATION NO.
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
~ l. I will submit data in a timely manner to satisfy the following requirements. If the test procedures 1 will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
Cj 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
~ 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the foliowing data requirements:
~ 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products!:
~ 5, I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1 (10-82)
41

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Appendix II-3
OMB Approval No. 2000-0468 (Expires: 12-31-83,
(To qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)

2, My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm wouid prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on thB following dats(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EFA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
S GNATURE
EPA Farm 8560*6 110-82)
42

-------
Appendix IV-1
PRODUCT SPECIFIC DATA REPORT
EPA Registration No,	Guidance Document for	
Date
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am ocmplying with
data requirements by
(For EPA Use Only)
Accession Numbers
Assigned
Citing MRIE#
Submit-
ting
Data
{At-
tached )
§158.20
PRODUCT
CHEMISTRY





61-1
Identity of
ingredients




61-2
Statement of
composition




61-3
Discussion of
formation of
ingredients




62-1
Preliminary-
analysis




62-2
Certification of
limits




62-3
Analytical methods
for enforcement
limits




63-2
Color




63-3
Physical state




63-4
Odor




63-5
Melting point




63-6
Boiling point




63-7
Density, bulk-
density, or
specific gravity




63-8
Solubi1i ty




63-9
Vapor pressure




63-10
Dissociation
constant




43

-------
Appendix IV-1
PRODUCT SPECIFIC DATA REPORT
EPA Registration No.	Guidance Document for	
Date
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
-------
APPENDIX V-2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (REFER TO THE SAMPLE LABELS FOLLOWING)


APPLICABILITY
PLACEMENT ON LABEL

ITEM
LABEL ELEMENT
OF REQUIREMENT
REQUIRED
PREFERRED
COMMENTS
1
Product name
All products
Front panel
Center front
panel

2
Company name
and address
All products
None
Bottom front
panel or end
of label text
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
3
Net contents
All products
None
Bottom front
panel or end
of label text
May be in metric units in addition to
U.S. units
4
EPA Est. No.
All products
None
Front panel
Must be in similar type size and run
parallel to other type.
5
EPA Reg. No.
All products
None
Front panel,
immediately
before or
following
Reg. No.
May appear on the container instead of
the label.
6A
Ingredients
statement
All products
Front panel
Immediately
following
product name
Text must run parallel with other text
on the panel.
6B
Pounds/gallon
statement
Liquid products
where dosage
given as lbs.
ai/unit area
Front panel
Directly below
the main
ingredients
statement

7
Front panel
precautionary
statements
All products
Front panel

All front panel precautionary statements
must be grouped together, preferably
blocked.
7A
Keep Out of Reach
of Children
(Child hazard
warning)
All products
Front panel
Above signal
word
Note type size requirements.
7B
Signal word
All products
Front panel
Immediately
below child
hazard
warning
Note type size requirements.
45
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APPENDIX V-2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
7C
Skull & cross-
bones and word
POISON (in red)
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
Front panel
Both in close
proximity to
signal word

7D
Statement of
practical
treatment
All products
in Categories
I, II, and III
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
for all.

7E
Referral
statement
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
Front panel


8
Side/back panel
precautionary
statements
All products
None
Top or side
of back panel
preceding
directions
for use
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
8A
Hazards to
humans and
domestic
animals
All products
in Categories
I, II, and III
None
Same as above
Must be preceded by appropriate signal
word.
8B
Env i ronmental
hazards
All products
None
Same as above
Environmental hazards include bee
caution where applicable.
46
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APPENDIX V-2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
8C
Physical or
chemical
hazards
All pressurized
products, others
with flash
points under
150°F
None
Same as above

9A
Restricted
block
All restricted
products
Top center
of front
panel
Preferably
blocked
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
9C
Misuse
statement
All products
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use


10A
Re-entry
statement
All
choli nesterase
inhibitors
In the
directions
for use
Immediately
after misuse
statement

IOC
Storage and
disposal block
All products
In the
directions
for use
Immediately
before
specific
directions
for use or
at the end of
directions
for use
Must be set apart and clearly distin-
guishable from from other directions
for use.
10D
U.S.
Directions
for use
All products
None
None
May be in metric as well as U.S. units
-------
Appendix V-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
I, Pressurized Containers
Required Label Statement
A. Flashpoint at or below
20°Fj or if there is a
flashback at any valve
opening.
Flashpoint above 20°F
and not over 8 0 ° F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
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.
A. Flashpoint at or below
2 0 ° F.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
B. Flashpoint above 20°F
and over 80°F.
Flammable. Keep away from
heat and open flame.
C.	Flashpoint over 80°F
and not over 150°F.
D.	Flashpoint above
150 ° F.
Do not use or store near
heat and open flame.
None required.
48
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Appendix V-5
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL, Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size 1isted below:

1 Required type size
Size of label
1 for the heading
front panel in
1 STORAGE AND DISPOSAL
square inches
1 (all capitals)
10 and under 	

Above 10 to 15 ... .

Above 15 to 30 ... .
• « « , , • • ,10 po i n t
Over 30	
..12 po x n t
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,	Speci fications for handling the pesticide contai ner,
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.
49
-------
Appendix V-5
(continued}
4.	instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5.	General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed,
6.	General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions:
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products;
1.	The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2,	Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional office for guidance."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
50
-------
Appendix V-5
{conti nued)
"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 i ntended for domestic
following disposal statement;
container in several layers of
trash."
use only must bear the
"Securely wrap original
newspaper and discard in
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)
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Non-aerosol products
(bags)
Do not reuse bag. Discard bag in trash.
Aerosol products
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type	Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent), Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
author i t ies.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.

-------
Appendix v-5
(continued)
Container Type			Statement
Fiber drums
with liners
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^ f dispose of in the same manner.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording).
^Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix.
52
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Appendix V-5
(conti nued)
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);
Acrole i n
Aldi carb
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-d i ni trophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethy1 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
Faraphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octaraethylpyrophosphorainide (OMPA, schradan)
Parathion
53
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Appendix ¥-5
< continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
54
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Appendix V-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients:
Acetone
Acrylonitrile
Amitrole
Benzene
Bi s(2-ethylhexy1)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
Deeachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d|-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
5-3,3-(Dichloroallyl	diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12 )
3,5-Dichloro-N-(1,l-dimethyl-2-propyny1) benzamide (pronamide, Kerb)
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1.2-Dichloropropane
1.3-Dichloropropane	(Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4r41-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentad i ene
Hexachloroethane
Hydrofluoric acid
55
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Appendix V-5
(continued)
"Toxic" Commercial pesticide Products (RCRA "F" List)
Active Ingredients:
Isobuty1 alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,21-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methy1-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2 ,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6~Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11 )
2,4 ,5-Trichlorophenol
2 ,4,6-Trichlorophenol
2,4, 5-Trichlorophenoxyacet i c acid (2,4, 5-T)
Xylene
56
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
CERTIFIED MAIL
SUBJECT: Initiation of Reregistration Process for Manufacturing-
Use Products and Certain End-Use Products Containing
Monuron TCA as the Single Active Ingredient
Dear Registrant:
In accordance with the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended, EPA's Office of
Pesticide Programs has begun the reregistration process for
pesticide products containing the subject ingredient. Signifi-
cant changes to the statute were made in 1972, 1975, and
1978; thus, current requirements may be substantially different
from those in effect at the time your product(s) were registered.
The first phase of reregistration requires that you (1) make
a commitment to the Agency regarding data development and
(2) subsequently submit revised product labeling and associated
information.
This mailing contains the Guidance Document for prepara-
tion of submissions, as well as a listing of your affected
product(s} (Attachment A), and a separate list of registrants
with products subject to this manufacturing-use standard and
which contain this active ingredient (Attachment B). The
latter list is for the purpose of cooperative data development.
The Guidance Document sets out the Agency's evaluation
of all available data pertaining to the subject chemical and
its registered uses, and its rationale for the regulatory
actions being taken at this time. Additionally, the Guidance
Document contains instructions describing certain of the
57
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steps you must take to maintain registration for your product(s).
Products not brought into compliance with the Guidance Document
as supplemented by subsequent information from EPA about compliance
with certain data support requirements will be subject to suspension
and/or cancellation.
Specifically, the enclosed Guidance Document does the
following:
1.	Introduces the purpose of this document.
2.	Explains the Agency's policy regarding data submis-
sion and identifies, in table format, the data
that must be submitted to complete the Agency's
evaluation of each product. In addition, a
bibliography identifying the data which is considered
part of the data base supporting the registration
standard is included.
3.	Sets out time-frames for submission of required
data.
4.	Explains how to revise labeling for maufacturing use
products. (As the Guidance Document explains,
labeling is not required at this time.)
5.	Provides submission instructions.
Because of the variety and complexity of the requirements,
and the short statutory time-frames available for certain
actions, it is essential that you understand the specific require-
ments and procedures in order that you may respond in a correct
and timely manner. Since a part of these requirements is under
Section 3(c)(2)(B) of FIFRA, your first response may be required
within 90 days from receipt of this letter. Please note that
if you do not respond or do not comply fully with the requirements,
your application may be rejected or your product registration
cancelled or suspended.
If, after reviewing this material, you do not understand
what you must do or how or when you must respond, please contact
the Product Manager listed below who will assist you in every
reasonable way. If you wish to discuss the data requirements
or request that certain data be waived, you must write to the
Agency and indicate those data requirements with which you take
issue and your rationale for doing so. After the Agency has
had a chance to review your submission, the Product Manager will
contact you to set up a meeting for the purpose of resolving all
issues relative to data requirements.
58
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Please note that this guidance document will eventually
be supplemented by EPA with additional information about
compliance with data support requirements. In Monsanto v»
Administrator, EPA was recently enjoined by the District
Court for the Eastern District of Missouri from implementing
in any way the "mandatory data licensing" aspects of §3(c)(l)(D)
of FIFRA. EPA is assessing the implications of the injunction
for the reregistration process. Because of this unresolved
situation, EPA has decided to proceed with the requirements in
this guidance package which do not relate to the "data licensing"
issue and to supplement the package with additional guidance
when circumstances permit.
If you have any questions concerning this Guidance Document,
you may contact the Product Manager listed below:
Mr. Robert J. Taylor
Product Manager 25
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
Telephone: 703/557-1800
Sincerely,
Douglas D. Campt, Director
Registration Division (TS-767)
Enclosure
59
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^eosr%
A \
| UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
, 
-------
A new review procedure has been developed. Under it,
EPA has issued Guidance Documents, each of which discussed a
particular pesticide active ingredient. Each Guidance Doc-
ument summarizes all the data available to the Agency on a
particular active ingredient and its current uses, and sets
forth the Agency's comprehensive position on the conditions
and requirements for registration of all existing and future
products which contain that active ingredient. These condi-
tions and requirements, all of which must be met to obtain
or retain full registration or reregistration under Section
3(c)(5) of FIFRA, include the submission of needed scientific
data which the Agency currently does not have, compliance
with standards of toxicity, composition, labeling, and packag-
ing? and satisfaction of the data compensation provisions
of FIFRA Section 3(c)(1)(D). Registrants of manufacturing-
use products and certain end-use products have already received
or will receive a copy of this enclosed Guidance Document.
FIFRA requires that a data submission requirement under
Section 3(c)(2)(B) must be imposed on the registrants of all
products to which the data are pertinent. Some of the data
we have required persons subject to the reregistration program
to submit are "generic" data which pertain to the safety of
the active ingredient of a product, and thus are relevant to
all products containing that ingredient (or to all products
which contain that ingredient and have certain use patterns
or formulation characteristics).
Since these data also may be pertinent to the registrability
of your product containing the subject chemical, we are
required by Section 3(c)(2)(B) to send you this notice. You
are required to comply with this notice, but you are not
required at this time to take steps to reregister your product,
e.g., relabel your product.
II. What You Must Do to Comply With This Notice
Within 90 days of your receipt of this Notice, you must
furnish to EPA a completed copy of the "FIFRA Section 3(c)(2)(B)
Summary Sheet" (EPA Form 8580-1, Attachment B) with appropriate
attachments for each of your products. Agency records indicate
that you do not qualify for the FIFRA Section 3(c)(2)(D)
data exemptions, since the source of subject active ingredient
is (1) not registered with EPA or/and (2) is not purchased
from a firm other than your own. Since you are not exempt,
you must determine what data you are required to submit [see
paragraph (A) below] and how you will comply with the require-
ment [see paragraphs (B) through (D) below].
A. What Generic Data Must Be Submitted
You may ascertain which generic data you must submit
by consulting the generic data table (Table A in the
61
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Guidance Document). That table shows the generic data
needed to evaluate the continued registrability of all
products containing the subject chemical and the dates
by which the data must be submitted. The required data
must be submitted and any necessary studies must be
conducted in accordance with EPA-approved protocols, in
the Pesticide Registration Guidelines^/, or data collected
under protocols approved and issued by the Organization
for Economic Cooperation and Development (OECD). If
you wish not to develop data which are necessary to
support the continued registration of certain uses
appearing in your current labeling, you may submit an
application to have your registration amended by deleting
those uses.
After determining whether you are required to
cnKni i t* /I a f- a an/^ *i c a wVi i' nh a ~* a	aocq	q a •ni^KAnv* i afo
oU,L/IU4.U Ua La ; CtllCJ X JL bU f wn ivll G Ct u q, f LllUUbc Ullc	L up L J- d l-fc;
option for each of your affected products.
B. Options Available for Complying With Requirements
to Submit Data
You must submit to EPA within 90 days of your receipt
of this Notice a completed copy of the form entitled
11FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form 8580-1,
Attachment B) for each of your products. On that form
you must state which of the following methods you will
use to comply with the requirements of this Notice:
1.	(a) Notify EPA that you will submit the data,
and
(b) either submit the existing data you believe
will satisfy the requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Registration Guidelines or protocols
contained in the Reports of Expert Groups
to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must enclose
the protocols you will use.
2.	Notify EPA that you have entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing) the
data. If you elect this option, you must state
which of the parties to the agreement will
respond to this Notice in the manner specified
by paragraph c.2. above. A list of registrants
with products containing this active ingredient
is included for your information (see Attachment
C) .
The Pesticide Registration Guidelines were reproposed
on November 24, 1982 in 47 Federal Register 53192.
62
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3.	File with EPA a completed "Certification of
Attempt to Enter Into an Agreement With Other
Registrants for Development of Data." (EPA Form
8580-6, Attachment D)V
4.	Request that EPA amend your registration by
deleting the uses for which the data are needed.
5.	Change the source of your active ingredient to one
that is (1) registered with EPA and {2) purchased
from a firm that does not have ownership in common
6.	Request voluntary cancellation of the registration(s)
of your product(s) for which the data are needed.
*/ FIFRA Section 3(c)(2)(B) authorizes joint development
of data by two or more registrants, and provides a mechanism
by which parties can obtain an arbitrator's decision if they
agree to jointly develop data but fail to agree on all the
terms of the agreement. The statute does not compel any
registrant to agree to develop data jointly.
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 between all such
registrants is clearly in the public interest. Duplication
of testing could increase costs, tie up testing facilities,
and subject an unnecessarily large number of animals to
testing.
EPA has discretion not to suspend the registration of a
product when a registrant fails to submit data required under
FIFRA Sect ion 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 Sect ion 3(c){2)(B)(iii)]; and (3) the first registrant
has declined to agree to enter into a cost-sharing agreement,
EPA will not suspend the second firm's registration. While
the first firm is not required to agree to jointly develop
data, EPA is not required to force the second firm to engage
in economically inefficient duplicative testing in order to
maintain its registration.
63
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C. Timeframes for Development and Submission of Required
Data
The periods listed in Table A of the Guidance Document
are the periods which the Agency will allow for development
and submission of the data (measured from the date of
receipt of this Notice)•
D. Procedures for Requesting Changes In Testing
Methodology and Extensions of Time
EPA recognizes that you may disagree with our conclu-
sions 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) registration guidelines or
protocols contained in the reports from the Expert Groups
to the Chemical Groups, Organization for Economic Coopera-
tion and Development (OECD) Chemicals Testing Programme,
you must submit the protocol for Agency review prior to
the initiation of the test.
If you want, or think that you will need, more time
to generate the required data than is allowed by EPA's
schedule, you must submit a request for an extension of
time. The extension request must be submitted in writing
to the Product Manager named below. The extension
request should state the reasons why you conclude that
an extension is appropriate. You must strive to meet
the deadline for submitting the required data while EPA
considers your request.
If, after reviewing this Notice, you do not understand
what you must do, or how or when you must respond, please
contact the Product Manager listed below who will assist you
in every reasonable way.
Mr. Robert J. Taylor
Product Manager 25
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
Telephone: 703/557-1800
Sincerely yours,
Douglas D. Campt, Director
Registration Division (TS-7 67 )
64
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