5WRS-92-223
United States Office of Prevention, Pesticides
Environmental Protection And Toxic Substances
Agency ; (H-7S08W)
v>EPA Reregistration
Eligibility Document
(RED)
Ethylene
U.S. EPA Heacit,Jc.i;rs Library
Maii code 3201
1200 Pennsylvania Avenue NW
WashiiT?*on P^ 20460
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REREGISTRATION ELIGIBILITY DOCUMENT
. ETHYLENE
LISTC
CASE 3071
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C.
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ETHYLENE REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Special Review and Reregistration Division
Ruby Whiten Accelerated Reregistration Branch
Health Effects Division
Freshteh Toghrol
Roy Sjoblad
Winston Dang
Chemistry & Reregistration Support Branch II
Science Analysis Branch
Occupational and Residential Exposure
Branch
Environmental Fate and Effects Division
Concepcion Rodriguez
Bernice Slutsky
Larry Liu
Registration Division
Cynthia Giles-Parker
Leonard Cole
Mark Perry
Ecological Effects Branch
Scientific Analysis and Coordination Staff
Environmental Fate and Ground water Branch
Fungicide and Herbicide Branch
Fungicide and Herbicide Branch
Registration Support Branch
Biological and Economic Analysis Branch
James Saulmon
Eric Maurer
Biological Analysis Branch
Biological Analysis Branch
Policy and Special Projects Staff
Kennan Garvey
Office of General Counsel
Allen Corpien
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GLOSSARY OF TERMS AND ABBREVIATIONS
CAS Chemical Abstracts Service
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide and Rodenticide Act
MRID Master Record Identification (number)
EPA's system of recording and tracking studies submitted.
RED Reregistration Eligibility Document
11
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TABLE OF CONTENTS
EXECUTIVE SUMMARY
I. INTRODUCTION
H. CASE OVERVIEW
A. CHEMICAL OVERVIEW
B. USE PROFILE
C. REGULATORY HISTORY
SCIENCE ASSESSMENT OF ETHYLENE
ra.
IV.
A. PRODUCT CHEMISTRY ASSESSMENT
B. HUMAN HEALTH ASSESSMENT
1. TOXICOLOGY DATA
2.
DIETARY EXPOSURE
3. OCCUPATIONAL AND RESIDENTIAL EXPOSURE
4. HUMAN RISK ASSESSMENT
C. ENVIRONMENTAL ASSESSMENT
1. ECOLOGICAL EFFECTS DATA
2. ENVIRONMENTAL FATE DATA
3. ENVIRONMENTAL RISK ASSESSMENT
RISK MANAGEMENT AND REREGISTRATION DECISION OF
ETHYLENE
A. DETERMINATION OF ELIGIBILITY
B. LABELING REQUIREMENTS FOR MANUFACTURING-USE
PRODUCTS OF ETHYLENE
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V. ACTIONS REQUIRED BY REGISTRANTS
A. DETERMINATION OF ELIGIBILITY
B. PRODUCT-SPECIFIC DATA REQUIREMENTS
C. LABELING REQUIREMENTS FOR END-USE PRODUCTS
8
8
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VI. APPENDICES
APPENDIX A - Use Patterns Subject to Registration
APPENDIX B - Table of the Generic Data Requirements and Studies
Used to Make the Reregistration Eligibility Decision
APPENDIX C - Citations Considered to be Part of the Data Base
Supporting the Reregistration of ETHYLENE
APPENDIX D - PR Notice 91-2
APPENDIX E - Pesticide Reregistration Handbook
IV
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EXECUTIVE SUMMARY
This reregistration eligibility document (RED) is the United States Environmental Protection
Agency ("EPA" or the "Agency") regulatory position on the continued registration of the
pesticide ethylene and its uses. Products containing ethylene are currently registered as plant
growth regulators and herbicides. Commercially, ethylene is used as a ripening agent for
fruits and vegetables, a curing agent for tobacco, and to promote flower production in
pineapples. It is also used to control witchweed in corn, cotton, peanuts and soybeans. The
first registered product containing ethylene was registered in December, 1971.
The Agency has assessed the available scientific information about this compound in
relation to all its registered uses to determine its eligibility for reregistration. The data base
for ethylene is sufficient to allow the Agency to conduct a risk assessment for
all uses. Therefore, the Agency has determined that the products containing ethyiene for all
uses are eligible for reregistration.
Before reregistering each product, the Agency is requiring confidential statements of
formula and revised product labeling to be submitted within eight months from the issuance
of this document. After reviewing these confidential statements of formula and revised
labels, the Agency will determine whether or not the conditions of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) section 3(c)(5) have been met, that is,
whether confidential statements of formula and labeling are acceptable and the product's uses
will not cause unreasonable adverse effects to humans or the environment. If these
conditions are met, the Agency will reregister the products. Those products which contain
other active ingredients will be eligible for reregistration only when the other active
ingredients are determined to be eligible for reregistration.
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I. INTRODUCTION
In 1988, FIFRA was amended to accelerate the reregistration of products with active
ingredients registered prior to November 1, 1984, The amended Act provides a schedule for
the reregistration process to be completed in nine years. There are five phases to the
reregistration process. The first four phases of the process focus on identification of data
requirements to support the reregistration of an active ingredient and the generation and
submission of data to fulfill the requirements. The fifth phase is a review by the Agency of
all data submitted to support reregistration.
Section 4(g)(2)(A) of FIFRA states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before
calling in data on products under section 4(g)(2)(B), and either reregistering products or
taking "other appropriate regulatory action," under section 4(g)(2)(C) and (D). Thus,
reregistration involves a thorough review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising
from the currently registered uses of the pesticide; to determine the need for additional data
on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA section 3(c)(5).
This document presents the Agency's decision regarding the reregistration eligibility of
ethylene. This document consists of five sections. Section I is this introduction. Section II
describes ethylene, its uses and regulatory history. Section HI discusses the
human health and environmental assessment based on the data available to the Agency.
Section IV discusses the decision on eligibility for reregistration for ethylene and Section V
discusses product reregistration. Additional details concerning the Agency's review of
available data are available on request.1
1 EPA's reviews of data on the set of registered uses
considered for EPA's analysis may be obtained from the OPP Public
Docket, Field Operations Division (H7506C), Office of Pesticide
Programs, EPA, Washington, D.C. 20460.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Document.
Chemical Name: ethylene
CAS Registry Number: 74-85-1
Office of Pesticide Programs Chemical Code: 41901
Empirical Formula: C2 H4
B. Use Profile
The following is information on the current registered uses and application methods.
A detailed table of all uses of ethylene is in Appendix A.
Type of Pesticide: herbicide, plant growth regulator (to accelerate
the ripening of harvested fruits and vegetables,
curing agent for tobacco)
Target pest (herbicide): witchweed
Use Sites: Terrestrial Food - fruits, vegetables
Indoor Food - fruits, vegetables
Indoor Nonfood - tobacco
Terrestrial food/feed - (herbicide) - com, cotton
peanuts, soybeans
Formulation Types
Technical Grade: 99.9%
Formulations: 6.2%-99.5%
Method of Application:
Types of Treatment: ground soil injection (herbicide use), stored
commodity fumigation,
foliar spray
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Equipment:
Timing:
gas generator, soil injector, pressure
sprayer
postharvest (for stored commodities),
May thru July (for soil injection - herbicide
use)
Rates of Application: See Appendix A
C. Regulatory History
As stated in the Executive Summary the first product containing ethylene was
registered in December, 1971. The currently registered products (8) are used as plant
growth regulators and herbicides in the sites identified in Section n.B above.
On May 18, 1990, the Agency designated ethylene as a biochemical pesticide based
on the following scientific reasons: 1) it is a naturally occurring compound and 2) it has a
nontoxic mode of action in target pests/plants.
III. SCIENCE ASSESSMENT OF ETHYLENE
A. Product Chemistry Assessment
Ethylene is a naturally occurring plant growth regulator with a molecular weight of
28.05, It is a colorless, flammable gas. Burns with a luminous flame. One volume of
ethylene gas dissolves in about 4 volumes of water at 0°C, in about 9 volumes of water at
25°C, in 0.5 volumes of alcohol at 25°C, and in about 0.05 volume of ether at 15.5°C. It is
soluble in acetone and benzene.2
The Merck Index. Eleventh Edition, 1989. p. 597.
3
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EPA has reviewed the scientific data base for ethylene primarily relying on
information from the published literature. These sources are cited in Appendix
Band C.
B. Human Health Assessment
1. Toxicology Data
The Agency believes there are sufficient data from the published literature to make
a hazard assessment of the uses of ethylene. Therefore, the Agency is using published
sources of information, cited below, rather than requiring new studies from registrants.
Ethylene is a gas and therefore, the only relevant route of exposure of
lexicological concern is the pulmonary route. Widespread human exposure from the clinical
use of ethylene as an anesthetic in the absence of any reports of significant toxicity are
sufficient to allow the Agency to conclude that ethylene will be nontoxic to humans under the
conditions of use as a plant regulator or in a witchweed control program.
Ethylene has been used as a clinical anesthetic since 1923. Anesthesia is complete
within 20-30 minutes with 90% in oxygen. The percentage of ethylene may be reduced
toward 80% in prolonged anesthesia. If the concentration is beyond 90% in animals, death
results from respiratory failure. The lethal concentration for mice in air is 950,000 ppm
ethylene.3
During established anesthesia, respiration is practically normal...and the pulse
scarcely changed, excitability of the medullary centers is not lowered, the asphyxia is slight
and does not proceed to cyanosis, sweating and salivation are slight or absent, temperature
fall is relatively slight, renal efficiency... is not impaired, pulmonary irritation... appears to
be absent, in obstetrical use, it does not materially reduce the uterine contractions, and
permits prompt respiration to the delivered child, gastric movements are only slightly
depressed, ... movements of the small and large intestines are stimulated.4
The Merck Index. Eighth edition, 1968.
T. Sollmann, W.B. Sauders Company. Pharmacology and it's
Applications to Therapeutics and Toxicology. 8th edition, 1964,
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Ethylene is more advantageous than ether as an anesthetic because of safer
induction and more rapid recovery. It is also more advantageous than nitrous oxide because
of the practical absence of asphyxia.
The maximum exposure rate to ethylene under the current uses is 1000 ppm in the
post-harvest treatment of stored commodities. By contrast, natural internal levels of ethylene
in pineapples may reach as high as 1100 ppm and in apples as high as 2500 ppm.
No long-term problems have been attributed directly to the gas. The gas does not
have local toxic effects,5
2. Dietary Exposure
Ethylene is exempt from the requirement of tolerance (40 CFR 180.1016) for
residues when: a) used as a plant regulator on fruit and vegetable crops; or b) injected into
the soil to cause premature germination of witchweed in fields of a number of crops as part
of the U.S. Department of Agriculture witchweed control program. Therefore no residue
data are required because of the lack of concern for mammalian toxicity.
3. Occupational and Residential Exposure
The Agency has waived these data requirements for the following reasons: a) low
mammalian toxicity concerns and b) the high volatility of ethylene minimizes the post-
application exposure to foliage, soil, dermal and inhalation. However, there is some hazard
of dermal and ocular frost burns and of flammability posed by the compressed gas.
Therefore, protective clothing, rubber gloves and goggles are required while handling
cylinders or any application equipment under pressure.
4. Human Risk Assessment
With the exception of the physical/chemical hazards noted above, the potential
risks to humans from occupational exposure are considered negligible due to: a) low toxicity
concerns, b) ethylene's widespread use as an anesthetic and c) minimal dermal exposure.
J. Doull, C.D. Klaassen, M.O. Arodur. The Basic Science of
Poisons. 2nd. Edition, 1980. Macmillan, New York.
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C. Environmental Assessment
1. Ecjglpgical Effects Data
Ethylene is a naturally occurring gas that is produced in plants and acts on
nontarget pest(s)/plants(s) through a nontoxic mode of action. Because it is naturally
occurring and it has a nontoxic mode of action, ethylene has been classified as a biochemical.
Ecotoxicity data are usually required for indoor use of biochemicals depending upon use
pattern, production volume and other factors such as volatility. However upon these factors
and its classification as a biochemical, no ecological effects studies are required for ethylene
for indoor uses.
Data requirements for the outdoor uses have been waived because of its volatile
nature, the method of application in the case of soil injection and its relatively low rate of
application in the case of sprays to pineapples (2.5 Ib/acre). The Agency believes that for
the above reasons there will be minimal exposure to aquatic and terrestrial organisms for the
outdoor uses of ethylene.
2. Environmental Fate Data
Environmental fate studies are not required for biochemical pesticides unless
adverse effects on fish and wildlife observed as a result of acute testing (Tier I) for
ecological effects. As stated above, the ecotoxicity studies have been waived for the outdoor
uses of ethylene and therefore no environmental fate studies are required.
3. Environmental Risk Assessment
The Agency believes for the reasons stated above that the environmental risks for
ethylene products are minimal.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION FOR ETHYLENE
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA requires the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for reregistration. The Agency has waived all generic (i.e., active
ingredient specific) data requirements except for technical chemistry data and additionally has
relied on public literature for mammalian toxicology. The Agency has completed its review
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of this information data and other factors and considerations, and has determined this
information is sufficient to support reregistration of all products containing ethylene for all
uses. Appendix B identifies the data that the Agency reviewed for the determination of
reregistration eligibility for ethylene.
The Agency therefore finds that products containing only ethylene as an active
ingredient are eligible for reregistration and may be reregistered once the confidential
statements of formula and amended labeling are received and accepted by the Agency.
Products that contain additional active ingredients will be reregistered once the Agency
completes eligibility decisions on the other active ingredients and once product specific and
amended labeling are received and accepted. The reregistration of particular products is
addressed in Section V of this document ("Product Reregistration").
Although the Agency has found that all products containing ethylene are eligible for
reregistration, it should be understood that the Agency may take appropriate regulatory action
and/or require the submission of additional data to support reregistration of products
containing ethylene, if significant new information of concern comes to the Agency's
attention or if the data requirements for registration change.
B. Labeling Requirements for Manufacturine-Use Product(s) of ethvlene
1. Under the heading "Directions for Use" add the following statement.
"Only For Formulation Into An , [fill blank
with Insecticide, Herbicide, or the applicable term(s) which describe
the type of pesticidal use(s)] For (1) The Following Use(s):
; or (2) Uses For Which US EPA Has
Accepted The Required Data And/Or Citations of Data That The Formulator
Has Submitted In Support of Registration; and (3) Uses For Experimental
Purposes That Are In Compliance With US EPA Requirements."
2. The signal word is "DANGER".
3. The Precautionary Statements must read:
"Liquefied or pressurized gas can cause frost burns. Do not get in eyes
or on skin. Wear long-sleeved shirt, long pants, boots, goggles and chemical-
resistant gloves while handling cylinders or any application equipment under
pressure. Harmful if inhaled. Avoid breathing vapors. Do not enter
unventilated treatment areas unless wearing a respirator approved by NIOSH/
MSHA for this use."
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4. The Statements of Practical Treatment (First Aid) must read:
"IF IN EYES: Flush with plenty of water. Call a physician."
"IF ON SKIN: Wash with plenty of soap and water. Get medical
attention."
"IF INHALED: Remove victim to fresh air. If not breathing, give
artificial respiration, preferably mouth-to-mouth. Get medical
attention."
5. The Physical or Chemical Hazards statement must read:
[For the technical grade product]
"Contents under pressure. Do not store near heat or open
flame. Do not puncture or incinerate container. Exposure to
temperatures above 130 degrees Fahrenheit may cause bursting."
V. ACTIONS REQUIRED BY REGISTRANTS
A. Determination of Eligibility
Based on consideration of data and information submitted for the active ingredient,
ethylene and the registered use patterns, the products containing this active ingredient are
eligible for reregistration. Section 4(g)(2)(B) of FIFRA requires that the Agency obtain any
needed product-specific data regarding the pesticide following a determination of eligibility.
However, the Agency is not requiring any product specific data, it will review the
confidential statements of formula and labels of these products to determine whether they
may be reregistered.
B. Product Specific Data Requirements
The Agency is primarily relying on information from published literature to meet the
data requirements for the technical material. Because the end-use products are similar in
composition to the technical material, the Agency is not requiring any further product
specific for the products containing ethylene as an active ingredient. Additionally, the
labeling requirements prescribed in Section V.C. are sufficient to address the only product
that does not have a similar percent amount of active ingredient.
C. Labeling Requirements for End-Use Products
1. The labels and labeling of all products must comply with EPA's current
regulations and requirements. Follow the instructions in PR Notice 91-2 (Appendix
D) and the Product Reregistration Handbook (Appendix E) with respect to labels and
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labeling.
2. The labeling must include the following statement for the foliar
spray (pineapple use).
"Do not apply directly to water, or to areas where surface water
is present or to intertidal areas below the mean high water
mark. Do not contaminate water when disposing of equipment
washwater or rinsate."
3. The signal word is "DANGER".
4. The Precautionary Statements must read:
"Liquefied or pressurized gas can cause frost bums. Do not get in
eyes or on skin. Wear long-sleeved shirt, long pants, boots, goggles
and chemical-resistant gloves while handling cylinders or any
application equipment under pressure. Harmful if inhaled. Avoid
breathing vapors. Do not enter unventilated treatment areas unless
wearing a respirator approved by NIOSH/MSHA for this use."
5. The Statements of Practical Treatment (First Aid) must read:
"IF IN EYES: Flush with plenty of water. Call a physician."
"IF ON SKIN: Wash with plenty of soap and water. Get medical
attention."
"IF INHALED: Remove victim to fresh air. If not breathing, get
artificial respiration, preferably mouth-to-mouth. Get medical
attention."
6. The Physical or Chemical Hazards Statement must read:
"Extremely flammable. Contents under pressure. Keep away from
fire, sparks and heated surfaces. Do not puncture or incinerate
container. Exposure to temperatures above 130 degrees Fahrenheit may
cause bursting."
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for the
active ingredient covered by this Reregistration Eligibility Document. This appendix contains
generic data requirements that apply to the pesticide (active ingredient) in all products,
including data requirements for which a "typical formulation" is the test substance.
The data tables are generally organized according to the following format:
1. Data Requirement (Column 1). The data requirements are b'sted in the order in
which they appear in 40 CFR Part 158. The reference numbers accompanying each test refer
to the test protocols set out in the Pesticide Assessment Guidelines, which are available from
the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no MRID number has been
assigned. Refer to the Bibliography Appendices for a complete citation of the study.
12
-------
APPENDIX B
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHING TON, D.C. 204»o
PR KOTICI ll-J *nS?«!oT«
SUHTAMCCS
KOTICI TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Peraons Reaponsible for Federal Registration of
Pesticide products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notict it to clarify th« Office of
Pesticide Program'a policy with raapact to tha statement of
parcentagas in a pasticida'a label's ingradiant statement.
Specifically, tha amount (parcant by vaight) of ingradiant(c)
specifiad in tha ingradiant statement on tha labal au«t ba stated
a* tha nominal concentration of such ingredient (s), as that tars is
defined in 40 CFR 158.153(1). Accordingly, the Agency has
established tha nominal concentration as the only acceptable label
elaia for tha aaount of active ingredient in the product.
IZ. BACKGROUND
For some time the Agency has accepted two different aethods of
identifying en the labal what percentage is claimed for the
ingredient(s) contained in a pesticide. Soae applicants claimed a
percentage which represented a level between tha upper and the
lower certified liaits. This was referred to as tha nominal
concentration. Other applicants claimed tha lower liait as the
percentage of tha ingredient(s) that would be expected to ba
present in their product at the and of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, tha regulators, and tha consumers as to exactly
how auch of a given Ingradiant was in a given product. Tha Agency
has astablished the nominal concentration as tha only acceptable
labal claia for tha aaount of active ingradiant in tha product.
Currant regulations require that tha percentage listed in the
active ingredient stateaent be as precise as possible reflecting
good aanufacturing practices 40 CFR 156.10(g)(5). The certified
liaits required for each active ingredient are intended to
encoapass any such "good aanufacturing practice* variations 40
158.17S(c)(3).
-------
3.
- IV. PRODUCTS THAT REQUIRE EFFICACY OATA
All pesticides are required to be efficacious. Therefore,
the certified lower liaits aay not be lover th*n th* ainiaua
level to achieve efficacy. This is extremely important for
products which arc intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 151.640.
In those cases where efficacy Units have been established,
the Agency will.not accept certified lower limit* which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
*
As described earlier, the purpose of this Kotice is to Bake
the registration process acre unifora and sort manageable for
both the agency and the regulated coaaunity. It is the Agency's
intention to iapleaent the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority .progress, i.e., reregistratien, new chemical, or
fast track (FIFRA section 3(c)(3}(8). Therefore,
applicants/registrants are expected to comply with the
.requirements of this- Notice as follows:
(1) Beginning July 1, 1991, all new product
registrations submitted to the Agency
are to comply with the requirements of this
Kotice.
(2) Registrants having products subject to
reregistration under FIFRA section 4(a) are to
comply with the requirements of this Kotice when
specific products are called in by the Agency
under Phase V of the Reregistration Prograa.
(3J All other products/applications that are
not subject to (1) and (2) above will have until
July 1, 1997, to coaply with this Notice.
Such applications should note 'Conversion
to Nominal Concentration" en the application
fora. These types of amendments will not be
handled as "Fast Track" applications but
will be handled as routine requests.
VI. FOR FURTHER ZKFORKATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 557-5024.
C
Anne I. Lindsay, Director
Registration Division (H-750S
-------
e
1
2
•8
.
1
-------
-------
Pesticide
Rereglstration
Handbook
How to Respond to
the Registration
Eligibility Document
(RED)
-------
-------
BOW TO RZSPOND TO THE
RZRZGISTRATION ELIGIBILITY DOCUMENT (RZD)
Qfrzca
nmcxoi nooBBW
noncrzoff
OCTOBI* i»fi
-------
nomicr
cuu or aamn
X. Introduction
A. Purpose and Content 1
B. Rarafistratlon Eligibility Docawnt 1
C. Raragistration Proeass . i
XI. Instructions for Responding
A. How «nd Wban to Respond 2
B. Mhan No Response is Needed 5
B. tfhsrs to Respond «
III. Subaission of Data and LaJbals/tabaling
A. Ganarlc Data 6
B. Product Spacifie Data 7
l. Product cbaaistry 7
a. Acuta Toxiclty 8
3. Product Parforvanca 9
C. Labals/Labalin? 10
Appandix
• t
A. Cenfidantial fttataaant of Ponula and Instructions
B. Labal Contants s .
C. Saapla Labal Pormats—^anaral Usa i Rastrictad Usa
0. Labal Ragulations (40 CPR 156.10)
-------
WTXCXD1 UUOXf ntATXQI
2. ZVTROOOCTZOV
A.
Tfcia Handbook provide* instructions to registrant* on how to
respond to the Xareglstration Eligibility Document (hereafter
referred to aa tho *UD*> and bow to reregister product*.
Motion Z i* thi* introduction.
Soction ZZ contain* stsp-by-step instructions which mat be
followed by registrants responding to the UD.
•action ZZZ provide* additional instruction* on tho foraat,
eontant and other aapoet* of generic data, product apaeiflc data
and labala/laealing vhieh aay bo required to bo •ubaUttod.
Detailed inatruetion* are in the Appendix.
Under faction 4 of the Federal Insecticide, Fungicide and
Xodenticide Act (PZ7RA), e* aaendad in 1MI, CPA i* required to
reregister pecticide* that were fir*t registered before November 1,
If§4. The RED describe* in detail the subject chaaical, it* uses
and it* regulatory history; describe* ZFA'* decision concerning the
eligibility of the uses of the eheaieal for reregistration; and
expltins the scientific and regulatory bases for thi* decision.
KPA's reviews, of the data by ociantlfic discipline are available
upon request.' Appendices to the UD eontaini (1) a Data Da11-In
Kotica which require* *ubBi**ion of generic and product specific
data and which .givas direction* for responding, (a) a lilting of
existing vtudies that aatisfy generic data requireaenta and (3) a
bibliography of the generic studies 1PA has reviewed.
»aregi*traticn involves a thorough review of tho •eiontific
data ba*a underlying a pesticide's regiatration. The purpoae of
IPA'* review i* to reassess the potential hacarda arising from the
currently registered usea of the pesticide, to determine whether
the data baao la substantially eomplata or tbaro is noad for
additional ganarie data, and to determine whether the pasticld* la
eligibla for reregistrstion. Thi* decision 1* ia*ued aa tho JOD.
IPA'a acianca review* and information on tho registered
u*a* eonaidared for IFA't analyaa* may bo obtained from: EPA,
Freedom of Information, 401 N ft., s.W., Washington, D.C. 204«0.
-------
If tha RED daelaraa that mam* or all u*a* of th* chaaical ara
allgibla for raragiatration, affactad ragiatranta auat first
raapond within 90 days of racaipt to tha data call-in portion of
tha RED. Within 9 aonth* of racaiving tha RED, ragiatrant* mat
submit or cita any data and labala/labaling raguirad for aach
product. EPA has until 14 month* aftar tha RED im iaauad (i.a.,
6 aonth* aftar tha ragiatrant* ' • month daadlina) to raviav tha
*ubai**ion for aaeh product and dacida whathar to raragiatar it.
baaad on tha following critarias
•- whathar all of tha product apaciflc data and labala/labaling
ara accaptahla,
— vnathar all of tha uaaa on tha labal/labalin? ara aligibla,
-- vhathar all of tha activa ingradianta in tha product ara
allgibla, and
—if no Liat l toxic inart ingradiant ia eontainad in tha
product (a Liat 1 inart ia paraittad only if all data
for it hava baan aubaittad and EPA dataninaa
that tha Inart doaa not poaa any unraaaonabla advaraa
af faeta in that product) .
Product* which aaat all of thaaa critaria vill ba
raragiatarad. Producta which do not maat all of thaaa eritaria,
but which hava accaptabla product apacific data and labaling, will
ba procaaaad aa aaaadaaata in ordar to iaplaaant labal ehangaa
raquirad by tha RED..
II.
TMMtPCTIQM 1OM
A* Hov and Mhan to
Thia aaetion providaa diraction* for aubaitting tiaaly and
adaguata raaponaaa nacaaaary to raragiatar product* containing tha
activa ingradiant covarad by tha RED. Ragiatranta auat follow
thaaa atapa axactly to avoid auapanaion of thair product*. All
product* ooataiaiag tha aotiva iagradiaat ia tha UD [i.a.,
aaanfaoturiag a** product* , aad a*a product* aad apaeial local aaad
(•IV or faetioa >4«) ragi at ration*] ara *u»ja«t to tha rafuiraaaat*
of tha no. yigura l *uaaarixa* how and whan to raapond to tha
RED. A *tap-by-*tap axplajution follow*.
Labal Oianaaa Kaaulrad?
. la
in*tane**,~l*A aay concluda that cartain changa* to product
lab*l«/lab«llng »*t b« iaplaaantad rapidly. If tha R*p raguira.
aapaditad labal/labaling oaaaga*, ragi*traat* mat raba^t tha itaa*
balow by tha daadlia* apacifiad ia tha UD. Zf axpaditad labal
changa* ara not raguirad, 90 to Itap a.
a. Applioatioh for B*gi*tratioa (EPA Fora 1570-1). Coaplata
-------
•ad elgn tbe fen. Us Section II, insert the phra** «itpedited
Baeadaeat ia •••peas* to tbo Beregi*tratioa Biigibility Document
for (iMart eaae MM for eaeaioal)." Application* for expedited
label changes will bo processed aa application* for eaendod
registration. Vaa ealy aa origin*! applioatioa fora vita • rod
identifier rnabw la tbe apper rigat-bead
b. five ID oopie* ef revised draft label aad labeling.
lefer to the UD for label/labeling changes and follow tbe
instruction* in feetion III.e. and tbe Appendix ef tbi* Handbook
for reviaing tbe label and labeling for aaeb product.
Are data required? Zf tbe UD require* generic or
product •peoifie data, you Bust follow tbe directions ia tbe data
eall-ia aotioe ia tbe UD* All registrants Bust respond for all
product* witbia ** days of receipti product* for wbieb aa adequate
response i* aot reoeived oa tiae will be subject to •uspensioa. 1ft
Zf any use* ef tbe active ingredient (•) covered by tbe UD are
eligible for reregi*tration, follow tbe** instruction*. Zf nfi uses
are eligible, fifl further response aay be needed (*ee page S).
tTA'* docielen en tbe eligibility ef each ef tbe use* ef the
active ingredient(•) ie presented in tbe UD. Zf aU use* ef e
eheaioal are eligible for rorogistratioa, registrants for
aanufacturlag-u** product* (HP*), ead-u** product* (IP*) and
special loeal aeeda registrations (•!*•), Bust *ubait tb* item*
below for eaeb product witbia • aontas of tbe date of lasuaaoe of
tbe UD:
a. Applioatioa for Itregiatratioa (n** m Fora M70-1).
Coaplete and aign tb* fora. In Section II ef that fora, check the
box •other" and invert the phra** "Application for asregistration."
V*e oaly aa original application fora with a red identifier auaber
ia tbe upper right-bead ooraer.
b. Five (S) copies ef revised draft label and labeling.
Kef or to tbe UD for labeling ehangea apecific to tbe active
ingredient, follow tbe instructions in lection ZZZ.C. ef tbi*
Handbook and refer to tbe Appendix ef tbi* Handbook for guidance en
current requireaent* for label* and labeling. Zf there are
ineligible u*** en tbe label er labeling, you Bay delete aueb uses
and avoid all requireaent* and consequence* which Bay be eesociated
with ineligible use* (a.g, generic data requireaent*, cancellation,
suspension, etc.)*' Zf you delete certain uses new and those use*
beoeae eligible for ^registration later, you Bust subait an
aaendaent application to add tboae uae* back to tbo label.
-------
FXOVBB i. mn AMD nonr to BBBFOMD to m
BtioiBitur Docmanr , BXD-DII FBooocTi («•) *»d
ntM uaifrurzon
is
expedited label revisions required?
Yea
Submit application
and labela on
m* tt
•peeifled in BID.
Are data required?
BTBT 9!
Sutalt forM within
f0 day* for gtntrie
and product •pacific
data.
Ar« any of the u*aa on tba lab«l
•ligibl* for rcragiatration?
Mo
Are any uaea on the label
leliaible for rereglatratlon?
Mo
for «aoB MT
• 91M (t4o)
applioatioa vitfci*
• •oatto. If
th« •ubmiMloa
i« aceaptablo,
ta« labol will IM
•taapod aecaptad
M u uaadaaat.
will b+
for «aob M» i BT
• BUI (t4o) ntait
appliaatioa witala
B BOBtlM. If
tJM «tubmi««lon
!• accoptablo,
tb« label will tw
•taapad accaptad
and • BOtiea of
raroglatratioa
B« itanad.
Vo fnrtbor roapoiao
aooMBary* Await
too outeea* of
SPA'* nvlav.
-------
e. Product tpoeifio Data. Toti But fellov the iaatraoti_
la tko Data call-la Votioe ia tke UB aad is leotioa nz of thia
laadboek. •eapo&aea to tke data Mil IB are due vithia ae «•»• of
receipt of tke no aad aubaieaioa or oitatioa of tot* ia daa vitkia
a aoath* of tke iafuaaoe of tke no.
t of
d. Two (t) oopiea of tke ourreat Confidential tta
Formula (It* form •S70-«, roviaed February ••} . »vo eoylotod and
•ifnod CtF forvs mnavt bo •utalttod for tho baaio formlatioa and
for oaofe altonato fonvlaUoa. Zf C*T* aro not provided for th«'
al tomato fonulaa, thoy will sot bo rarofliotorod and will no
longor bo aecoptabla. f&o Appondlx of thla BaMbook baa apocific
Inatruetiona for coaplotiag tbo csr fox*.
#
o. Cortifioatioa With koapoot to Citatioa of Data (•» fora
••ro-tl). tbla fora avat bo eoaplotod, al^nod and aubaittod for
oaeh product to aoauro taat tho data eoapanaation provioiona of
FJFRA ara Mt.
B. Bhan Wo Kaaponaa !•
Zf no naoa of a poatieldo aro oligiblo for r*rogi«tr»tion, it
ia unlikoly that you vill ba roquirod to aubait product apacific
data or labaling. Vaaa of an active ingrodiant aay bo doclarod
inaligibla for rorogiatratlon for tvo poaaibla roaaonat
—Available data indicate that ona or aoro of tha eritaria for
an in-dapth apocial roviav havo boon aot;
—Additional ganaric data aro roquirod.
In tho firat inatanea, if tha actlva ingrodiant ia placod into
apocial raviav, roroglatratlen activitiaa aaaociatad vith thoao
uaoa of tho chaaical ara atoppod until IPA aakaa a final
datoraination. At that tiaa, IPA vill indicata which naoa Bay bo
oligiblo for rorogiatratlon and which uaoa ara to bo cancallad. Zf
aoae or all of tho provioualy ineligible uaaa bocoao aligibla for
rorogiatration, BPA will atart tho rorogiatration procaaa for
producta containing only oligiblo uaaa.
In tha aocond inatanea , baaad upon tho review of atudiaa for
an ectiva Ingrodiant during reregietration, additional generic data
(e.g., aocond- or third-tier atudlaa) may ba needed (aoa tho USD).
Zn auch eaaaa, tha ehoBical'a uaaa vill not bo oligiblo for
rorogiatratlon until tha additional generic data have been
•ubaittad to and reviewed and found acceptable by m. Zf tha data
aro ravlowed and found to ba acceptable, IPA vill indicate which
oaea vill bo eligible for rarogiatratioa and vill initiate
rarogiatration of producta containing provioualy ineligible uaaa.
Zf tho data aro not aubaittod, producta containing tha active
ingrodiant aay ba auapandod*
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C.
««pend
By U.S. Mail:
Document Processing Desk (insert distribution oode)
Office of Pesticide Programs (B7504C)
Environmental Protection Agency
401 N Street, S.tf.
Washington, D.C. 30460-0001
my express mail or by band delivery:
*
Document Processing Desk (insert distribution oode)
Office of pesticide Programs (B7504C)
Room 26«A, crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 32202
ness Bailing addresses and the following distribution eodes
arest be nsed to assure the tlaely receipt and processing of jour
subaissions. Vet using tbea may significantly delay the handling
of your submissions*
UD-fUtD-xn (where nx is the case code given en the front of
the KID) —use this distribution code for all responses pertaining
to or containing generic da^a. Such responses include the 90-day
response forms for generic data or hard copies of generic data.
(where 0 is the Product Manager team number) —
use this distribution cods for all responses pertaining to or
containing product specif|a data or labeling. Such responses would
include expedited labeling amendments, 90-day responses to product
specific data requirements, hard copies of product specific data
and applications for rereglstration.
II J. SPBMySSIQM Or DATA
This section provides additional instructions concerning
responses required for generic data, product specific data and
labels/labeling.
A*
e Pat*
During IPA's evaluation of aa active ingredient for
reregistration, additional generic data requirements may be
identified that registrants must fulfill. In some instances these
data requirements would have to be satisfied before an active
ingredient or seme of its uses could be declared eligible for
reregistration. Zn other eases, these new data requirements would
not affect the eligibility of the active ingredient, but would be
necessary to confirm EPA's assessment of that chemical.
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Any nav data ragulraaanta and bow thay affact raragiatration
aligibility of a esaaical ara diacuaaad in tha RED. It nav fanaric
data raguiraaanta ara iapoaad in a Data Dall-Zn Kotica in tHa RED,
ragiatranta anaat raapond aa daaerlbad in that Ifotica. Tha RED also
eentaina inatructiona for ooaplating tbaaa foraa, a citatioo of
EPA'a lagal authority for raguiring tha nav data, a liating of
eptiena availabla to ragiatraata for aatiafying tha data
raguiraaanta and tha naaa of tha contact paraan for inguiriaa.
1.
Ufffe
ifie
Product •pacific data aay ba raqulrad for tha raragiatration
of aach paatleida product in thraa araaa— product chaaiatry, acuta
toxicity and afficacy.
Fol loving ara inatructiona for aubmitting product-apacific
data and a diacuaaion of IPA'a policy on inart ingradianta.
All data raquiraaanta for KPa, IPa and IZJfa (24c'«) ara
apacifiad in tha Data Call-in Motica in tha RED. Zn addition:
—If you cita data frea anothar idantical, ragiatarad
product, you anaat idantlfy tha IPA ragiatration nuabar of that
product.
— If tha product-apacifie data aubvittad or citad do not
partain to an idantical fonulatlon to tha product aubaittad for
raragiatration.* than nav product-apacifie data ara raquirad to ba
aubaittad by tha daadlina apacifiad in tha Data Call-in Ifotica.
Tha only axcaption ia for producta vhich EPA "groupa* togathar a
baing a.uilar anough to dapand on tha aaaa data. Such grouping*
ara diacuaaad tn tha appandix to tha RED (for acuta toxicity
purpoaaa, for axaapla), if it vaa faaalbla to do ao.
EPA baa ia^laaantad a atratagy * for ragulating inart
inoradlanta which affaeta tha raragiatration of paatleida producta.
fliia atratagy, iaauad on April 22, lit? (52 PR 13303-13309) and
updatad on Movaabar 22, 19f» (94 PR 4M14-4I316) , adoptad cart* in
policiaa daaignad to raduca tha potantial for advaraa affaeta froa
paaticida product* containing intantionally addad inart
ingradianta. EPA dividad tha known inart ingradianta into four
catagoriaa:
— Inarta of toxieological eoneam (Liat l) for which availabla
data daaonatrata toxic affaeta of concam (ineludaa about 50
ehaaicala) .
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—Potentially toxic inert* (Uat 3} tot which only liaited
data are available, but such data or the chemical structure suggest
the potential for toxlclty (ineludaa about «0 chemicals).
—Inarta of unknown toxicity (List 3) for which no data or
baaaa for euspecting toxic affacta ara availabla (ineludaa up to
2,ooo ehamieala).
—Xnarta of minimal conearn (Hat 4) which ara generally
regarded aa innoeuoua (ineludaa about 390 cbemicala).
•ban a no ia iaauad and any uaaa of an activa ingredient ara
daclarad eligible for rerogistration, all producta containing that
aetiva ingredient vill ba aubjaet to r«registration. EPA will, aa
part of tha raragiatration review, examine tha inart ingredients of
aach product prior to raragiatration to anaura that' thay do not
praaant unraaaonabla risks. In raviawing tha product chamiatry
data, BPA vill idantlfy Liat 1 inarta. BPA will eontinua to
ancouraga ragiatranta to eliminate any Liat 1 inarta praaant.
Raragiatration of producta containing only Liat 2, 3 or 4 inert*
will ba unaffactad by tha inarta atratagy.
Conaiatant with tha atratagy on inarta, a product containing
a Liat 1 iaart ingredient vill flai ba raragiatarad oatil a full
riak asssssmeat of tha produot baa been conducted, baaad oa tba
data callad ia for that iaart iagradiaat. However, tha axiating
ragiatration of a product containing a Liat 1 inart vill remain
valid aa long aa tha product baara tha required label warning and
ia in compliance with any outstanding DCX, or other activity under
tha inarta atratagy.
lay product aaataiaiag a Liat a, a or 4 laert uz ba
raragiatarad IX it aaata all other reguireaeata for raragiatratioa.
Aa tha inarta atratagy la lapleaentad and data for tha Liat 3 and
3 inarta ara reviewed, BPA may aova these inarta to tha other
Liata. If an inart ware aoved to Liat 1, producta containing that
inart would beeoae ineligible for reregiatration. Inart
ingredianta mat alao aeet noraal ragiatration and tolerance
requireaenta, aa applicable.
2* Aente To»iei,ty
Tne data call-in notice in tha KID apacifiea tha acute
toxieity data reguired for reregiatration of each Ml* or BP. It
indicate* whether any of the standard teata have been waived and,
if so, why.
Zf feasible, BPA vill "batch' product* that ara siallar with
respect to their acute toxieity ao that one aet of teata can
aupport reregiatration of aach baateh of producta. Thia approach
vill iapoaa the leaat aaouat of tea ting- neceaaary to adequately
aupport the registration and labeling for peatieide product*, foe
-------
aain benafita of thla approach are to alniaisa tha aaed for aaiaal
taatiag, reduce the «*p«naa to ragiatraata to generate too tort*
and daereaae the roaotiroee SPA auat apaad ea revleviag data.
•agietraata aay contact other regietraata vita product* la the eaae
•bateh* to decide whether to provide or tfapand en ona aat of data;
alternatively, vegletnata Bay ehooee to conduct their own etodiea.
consult taa Data Call-In action of taa «t> to
vbatbar troduet Parforaaaoa data ara raqairad.for your product.
Product parfonanoa (of f ieaey) data ara oanaratad ia atadiaa
daaignad to doeuaaat how eaadldata paatioida fonalatioaa parfon
aa paat control aganta. fbaaa data inelada taata run to dataraina
whathar a foraulatlon ia lathal to oartaia paat apoeiaa, to
docuaant taa affactivanaaa of tb« foraulatlon ia oontrolliag paat
apaciaa ia actual uaa aituationa, and to dataraina vnathar oartain
clalaa bayond aara control of a paat (a.g., •atat-aontb raaidual
of fact ,« •kill* Warfaria raaiatant houaa aiea," ate.) ara
juatifiad.
SPA aaa atandard protoeola for oartaia aff ieaey taata. Zn
ganaral, atandard aathoda bava baan davalopad for taata aaadad to
aubatantlata elaiaa that hava baan aada fraquantlV for paatieida
producta. Aa tha acopa of potantial paatieidal elaiaa ia axtraaaly
broad, tha Aganey doaa not hava atandard aathoda for taata aaadad
to aubatantlata aany paatieida elaiaa, aapaeially thoaa that ara
nncoaaon. tna Product Parfonianea Ouldaliaaa, ffubdiviaion 9, of far
ganaral guidanea for davalopiag protoeola for aff ieaey teat ing.
Propoaad protoeola ehould ba aubaittad to SPA for ravlav bafera
taata ara initiatad.
Kffieaev
Polic
PIPIU givaa tha AdaiMatrator of tPA authority "to vaiva data
raquiraaanta partaining to effieacy* but doaa not raguira that
of f ieaey -data raquiraaanta ba vaivad for any elaaa of paatieida
product raglatgrad undar faction 3 of tha Act. Aa a Mttar of
pel ley, EPA doaa not raguira eubaiaalea of aff Ieaey data to support
**ny typaa of paatieidal elaiaa but doaa raguira aubaiaaioa of auch
data for eartaia typaa of elaiaa. Aa notad ia 40 CPR 13i.«40, thia
valvar appllaa to tha fu|«i««ion of aff ieaey data rather than to
tha f«MrStion of aff ieaey data. SPA expeeta aaeh ragiatrant to
•anaura through taating that hla producta ara aff ieacioua whan oaad
ia aeeordanea vith eoaaoaly accepted paat control praeti
Thia ganaral policy notvlthataadiag, SPA aay, at any tiae,
roguira a ragiatrant to aubait aff ieaey data to aupport aay elaia
•ada for a product. SPA also say raguira that certain elaiaa of
affactivanaaa be eetabllthed before a faction $ ragiatration ia
granted.
-------
b.
10
for Whi
Submisaion of efficacy data at ^registration typically 1*
required for the following types of products:
1. products claimed to control microorganisms that
POM potantial threats to public health;
3. product* claimed to control vertebrate pests that
•ay diractly or Indirectly transmit disaasas to
humans;
3. potantially vary haxardous products for which EPA
dataminas that it is naeaasary to conduct a "risfc-
beneflts* analysis;
4. products of typas for which EPA has raasons (e.g.,
consumer complaints, unlikaly claims, unusual usa
pattarns, ate.) to question claiss; and
C. Irflbalj and Labeling
To ra»ain in cosplianea with rxniA, tha labal and labaling of
aach product mist ba ravisad to aaat tha raquiraaants for
raragistratlon as dascribad balow. •Labaling1' includas tha
eontalnar labal and -any writtan, printad or graphic sattar that
aceoapanias tha pasticlda in U.0. cosaarca at any ti»a (such as
technical bullatins, collataral labaling, ate.). Applieatieaa for
aav nsss or labaling ehaagaa that do sot partaia to raragistratioa
mst ba filad saaagataiy fres tha applieatioa for raragistratioa
tfaaoribad la «tap I aarliar. Changas to labaling which »ust ba
•ads for raragistration includa, but ara not limitad tot
1. Labaling ehangas spacifisd in tha WED. Such changas say
includa stataaants. on RESTRICTED USE, groundwatar hazards,
protactiva clothing/aquipaant, andangarad spaclaa, anvironaantal
hazards, ate. *
2. Tha fonat and contant of labaling as dascribad in 40 CFR
154.10. Whan further acuta tasting is naadad, tha eurrantly
accaptad pracautionary stataawnts will usually ba ratainad until
tasting is cosplatad and tha data arc raviawad.
3. Labaling changas raqulrad -by Pasticida Ragulatory (PR)
Koticas, regulations, ragulatory decisions and pollcias issued by
EPA which ara relevant to tha pestlcids. Your product's labaling
•ust reflect any applicable requirements which are in effect at the
ti»e tha RED is issued. Some existing notices are referred to in
Section B. of the Appendix.
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*
••
c.
«
for
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-------
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for Coalatin
Confidential
Foraula
The Confidential Statement of Formula (CSF) Form 1570-4 must
be used. Tvo legible, signed copies of the form ere required.
Following are basic instructions}
a. All the blocks on the form must be filled in and answered
completely.
b. Zf any block is not applicable, mark it N/A.
e. The CSF must be signed, dated and the telephone number of
the responsible party must be provided. •
d. All applicable information which is on the product-
specific data submission must also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per
gallon for liquids and pounds per cubic feet for solids.
f. Flashpoint must be
extension in inches.
in degrees Fahrenheit and flame
g. For all active ingredients, the EPA Registration Numbers
for the currently registered source products must be reported under
column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all
actives and inerts and all common names for the trade names must be
reported.
1. For the active ingredients, the percent purity of the
source products must be reported under column 10 and must be
exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in
pounds, kilograms, or grams. In no case will volumes be accepted.
Do not mix English' and metric system units (i.e.,. pounds and
kilograms).
k. All the items under column 13.b. must total 100 percent*
1. All items under columns 14.a. and 14.b. for the active
ingredients must represent pure active form.
m. The upper and lower certified limits for all active and
inert ingredients must follow the 40 CFR 151.175 instructions. An
explanation must be provided if the proposed limits are different
than standard certified limits.
n. When new CSFs are submitted and approved, all previously
submitted CSFs become obsolete for that specific formulation. •
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40 CPR ISC.10 and Pesticide Regulatory (P.I.) Motioes require
that specific labeling etstements appear at certain location, on
| the label. The sample label formats la Appendix C show where these
I
statement* are to be placed,
Item l. PRODUCT AXE - The name, brand or trademark is required to
be located en the front panel, preferably centered in the upper
pert of the panel. The name of a product vill not be accepted if
It is falsa or misleading. [40 CPR ISC.10(b))
Item 2. COMPANY MANE AMD ADDRESS • The BOM and addreee of the
producer, registrant or person for whoa the product is produced are
required on the label and should be located at the bottom of the
front panel or at the end of the label text. [40 CF1 ISC.10(c)}
Item 3. MET CONTENTS - A net contents statement is required en all
labels or on the container of the pesticide. The preferred
location is the bottom of the front panel immediately above the
company name and address, or at the end of the label text, the net
contents must be expressed in the largest suitable unit, e.g., «l
pound 10 ounces11 rather than *2C ounces.11 In addition to English
units, net contents may be expressed in metric units. [40 CTR
ISC.10(d)]
•
Item 4. EPA REGISTRATION NUMBER - The registration number assigned
to the pesticide product must appear on the label, preceded by the
phrase -XPA Registration Mo.,a or "EPA Reg. Mo." The registration
number must be set in type of a site 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. [40 CPR ISC.lO(e)]
Item 5. . EPA ESTABLISHMENT MDMBER - The EPA establishment number,
preceded by the phrase "IPX Est.- is the final establishment at
which the product was produced, and may appear in any suitable
.location on the label or immediate container. Zt must also appear
en the wrapper or outside container of the package if the EPA
establishment number on the immediate container cannot be clearly
read through such wrapper or container. [40 CPR ISC.10(f)]
Item CA. ZMOREDIEMTS STATEMENT - An Ingredients statement is
normally required en the front panel. The ingredients statement
must contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredient*. The preferred location is immediately below the
product name. The Ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CPR ISC. 10(g)]
Item CB. POUNDS PER GALLON STATEMENT * Per liquid agricultural
-------
formulations, the pound* per gallon of active ingredient mat be
indicated en the label. [40 CFR 15«.10(h)(iv)j
Itea tfC. JOKES TO BI USED IN INGREDIENT STATEMENT - The acceptable
common MM, if there is OIM, •ball be used, followed by the
chemical MM. if no common MM MB been established, the
chemical MM alone shall be used. Chemicals related to the active
ingredient are allowed to be listed «iiy if «ffieaey data
supporting such claim* ara subaittsd or rafarsnesd. If such data
ara provided, the related chemicals Bust be listed Mparataiv and
not as a portion of the active ingredient.
%
Itaa CD. INERT INGREDIENTS RECXASSIFICO Aft ACTIVE INGREDIENTS - If
EPA has reclassified ehealeals from inert Ingredient status to
active ingredient status, registrants of affected products snist
change the ingredient statement accordingly (See 92 7R 13307-1,
April 22r 19S7). if such pesticides have food uses, tolerances
Bust either be established for such uses, or an exeaption from the
reguireaent for tolerances sust be obtained.
Itea
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Xtaa 7C. 0KDLL
aaaigned a toxicity category I
ABD MHO *POI*OB* - On product*
on tha basis of oral, deraal, or
inhalation toxicity, the word "Poleon" •hall appear on tha label in
rod on a background of distinctly contracting color and tha akull
•nd crosabonaa ah* 11 appear ia iaaediata proximity to tha word
WOI90H. [40 CHI lS«.10(h)U)(i)J.
itaa TO. tTATwnrr or PRACTICAL TREATMENT - A atataaent of
practical traataaant (firat aid or othar) ahall appaar on tha label
of paaticida producta in tozleity Catagoriaa I, II, and III. [40
cm i96.io(b)U)(iii)J
Itea 71. REFERRAL STATEMENT - The etateaent "aee lida (or Back)
Panal for Additional Precautionary ftataaents* ia required on tha
front panel for all producta, onlaaa all required precautionary
etataaenta appaar on tha front panel. [40 en 136.10(b) (1) (iii) J.
Xtea f. SIDE/BACK PANEL PRECAUTIONARY LABELING - the precautionary
•tateaenta Hated belov auat appear together on the label under the
beading 'PRECAUTIONARY STATDBNTS.* The preferred location ia at
the top of the aide or back panel preceding the direetiona for aaa,
and it la preferred that theae atataaenta be aurrounded by a block
outline. Bach of the three hazard warning atateaente auat be
headed by the appropriate hasard title. [40 CPU 13«.10(h>(2))
Itea tA. HAZARD TO HUKANS AKD DOMESTIC AKIKAL6 * Vhere a hacard
axiata to huaana or doaeatic anlaala, precautionary atataaenta are
required indicating the particular hatard, the route (a) of expoeura
and the precautiona to be taken to avoid accident, injury or
daaage. [40 CFR 156.10(b)(2)(i)]
Itea IB. BKVIROliKEHTAL BAZARD - Where a hasard axiata to non-
target organiaaa excluding huaana and doaeatic aniaala,
precautionary atateaenta are required atating the nature of th«
haiard and tha appropriate precautiona to avoid potential accident,
injury, or daaaga. [40 CPR 15(.10(h)(2)(ii))
Itea «C. • PBYSIda OR CBZNICAL HAZARD • PZANKABILITY Precautionary
atataaenta relating to flaaaablllty of a product are required to
appaar on tha label if it aeeta the criteria in the PHYS/CHEM
labeling Appendix. The requireaent it baaed on the raeu}ta of tha
flaahpoint datarainationa and flaaa extenalon taata required to be
aubaitted for all producta. Theae atateaenta are to be located in
the aide/back panel precautionary atataaenta eection, preceded by
the heading •Phyaical/Chaaical Basarda." Bete that no aignal word
ia uaed ia conjunction with the flaamability atataaenta.
Itea tA. RMTRICT1D Ofll CIAJfllPICATZOB » PXFKA MO. J(d) requirea
that all peaticide foraulationa/uaea be olaaaified for either
general or restricted nee. Producta elaaaifiad for restricted uae
•ay be Halted to uae by certified applicator* or persona tinder
their direct auperviaioa (or aay be subject to other restrictions
that say be iapcsed by regulation). Zf your product has been
elaaaifiad for restricted uae, than thaaa requireaenta apply:
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1. All uses restricted. The following statements must ba placed
in a black box at the top of the front panel of the labal and
labeling:
e. The statement "Restricted Dee Pesticide* must appear at
the top of tha front panel of the label. The statamant
must be set in type of the same minimum siss as required
for human hasard signal word [see table in 40 CTR
ISC. 10(h) (1)(lv)j. vo statements of any kind may appear
'above this RUP statement.
b. The reason.for the the restricted use classification must
appear below the BOP statement. The KID vill prescribe
this statement.
e. A summary statement of the terms of restriction must
appear directly belov this reason statamant on the front
panel. If use is restricted to certified applicators,
the folloving statement is required! "For retail sale to
and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered
by the Cartlfiad Applicator's Certification." The RZD
vill specify vhat statement must be used.
2. feme but mot all vses rsstrlsted. If the RED states that some
uses are classified for restricted use, and seme are
unclassified, several courses of action are available:
a. You may label the product for Restricted use. If you do
so, you may include on the label uses that are
unrestricted, but you may not distinguish them on the
label as being unrestricted.
b. You may delete all restricted uses from your laipl and
submit draft labeling bearing only unrestricted uses.
c. You may "split* your registration, i.e., register tvo
separate products vith identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit tvo applications for
rereglstration, each containing all forms and necessary
labels. Both applications should be submitted
simultaneously. Vote that the products vill be assigned
separate registration numbers.
Item ft. MXSOBI fTATZXZHT - All products must bear the misuse
statement, "It is a violation of Federal lav to use this product in
a manner inconsistent vith its labeling." This statement appears
at the beginning of the directions for use, directly beneath the
heading of that section.
Item 10A. RBKNTRY fTATEXEMT - If a restricted entry Interval (RII)
has been established by the Agency, it must be Included on the
label. Additional worker protection statements may be required in
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vith P* Votioa M-a, march If, !§•).
Ztaat 101. •VMM! MD BXSTOUL BLDCJC - All labolo aro roopirod to
;ifio aantainoro, oisoo, and ebaaieal oontont.
fnaaa inatruotiona moat -bo grouped and appair vndar tba baadlng
•tterag* and DlvpoMl* ia th« «ir«otia0* for ooo. ttio hoatfiag
•art bo Mt IB tho MM tfpo lisos u roqnind for tbo ofclld hosard
mraiag. Bofor to F.I. Votloo* tio «nd M-i to tfotoni&o to*
•tongo lad di^poMl iaotnetlono *pproj>rUt« for four product*.
xtoa ioc. ozncnon ret on - Birootioa* for «M >ut bo otatod
la torM vbleb o*a bo ooilly road and ondantood by tbo anrarag*
MTOOB lifcoljr to ooo or to onporrioo tbo «oo of tbo Motieida.
ihaa follovod, direction* wamt bo adoquato to protoet tbo public
from fraud and from pononal injury and to provant onraaaoaabla
advaM* of facto on tna onviroaaant. (40 CF1 i5«.10(i) (2)]
OOL1ATDUL IABHIMC .
•ullatina, loaflota, circular*, brochure*, data ohaato, flyora, or
othar vrlttan or graphic printod aattar whieb ia rafarrod to on tba
labal or which ia to accompany tba product aro tanod oollataral
laballng. tucb laboling may not boar claim* or rapraaantationa
that diffar in oubstaneo from tboaa aecaptad in oonnoction vith
rogiatration of tba product. Collateral labaling mat ba aada part
of tha roaponao to tba UO and aubmittod for roviav.
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nun FDI wcussrniD
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IIM.M
m A copy of* __.......__—..—.—
• - other MOB of wrtttea SMttrwJ
M tat Itofffstradon •ttadard
i by the Agency to any
S£
that
flat Ttotaui. RsBxtm cto
wtth ti» saaiifti tehtdult
fledm ilMJl) a notice
the rafuttiitr of docket
or P«ty fJIMI. «* •ovtraneat tht ftv«Jl*bfflty of docket ma
ivlthla If vorkmt days after tht tttn (4) Bsca Ftocmu. Rseism
H ••* available to each ptnee or avftflftbfUty of ft Rcflstrfttlon
Cf)W»fc
to a Retistntton
for which tht Aitney feat
«dcU, » copy of th«
_ —
of ft pfopooifl RofiitimUeB
ard, ftod ft OOPT of ofteh eoo
odvtd fa ntpooM to tlut
(wtthto 10 vorktot dftys ftfttr
fef ih* Aftaer, or If worktaff
tht wbmlttar hftt ftiwrtod •
ttel biiifnofti tafomutioo
• UU4
(a) Tht Afuey wffl taat to th* Vt»»
amu, Raeum » aotiot ftBDouDdnc tht
avuaaet and avftQahfltty of '
(1) CoDotrat a prvrlooftly vartfto-
CD 1 oopy of tho Ptoflus,
oodot ftnnoimrtng th« teumaet of tho
lUflitrmUcn tuadard (wtthto 10
.vorklat daji ftfUr UM pubUcukn of
— - •*-* — — ^
(f) Ooootr&t a prtvfouity rtftottrtd
ftetiTt tefrtditat, ft&d tht Btfiftrfttton
BUadftrd tuttt that rtilitrmnt* wfil
bt rtqufrod (uadtr RFRA ttedon
KeXSXB)) to tubmlt ehroale htftlth
Cladudiaf , but not ttmittd to, ehroale
fttdlBt. oaoottaietty aad rtprodue-
(e) Jtadcr. of Out doefert. The Aftney
wffl establish sad keep current an
Index to tht docket for tach Xctlstra*
tfea Standard Tht Index wffl Include,
but Is act limited to:
(1) A Hit of tach mtttlai
the Aftncy aad any person i
outside of government, oontalataf tht
dfttt aad subject of the mttttaf. tht
names of partJdpsats aad tht neae of
tht person rtouettiaff the metttat.
tt) A Ust of each document In tht
ttoa) or Uratolofy ftudita.
(b) tattrttttd ptnoai ouy tubmlt
comment* eonoernmf any lUttetrm-
tfoa SUadftrd deeertbtd by pftrftgnpb
(a) of this stetioB at aay time
(e) The Ateaey wffl Issue m the Fto-
nAi Rsozsm ft aotiot ftaaoundnf the
aTftOabfflty of, aad provldtaf opportu-
any for eooimtat OB. oseh pfoposed
Xtflstrfttloa 8taadftrd which eoactns
a previously rttlsttrtd ftettre tagredl.
ant for which tht Aieaey ass deter.
Hitnnl thst a substaatlaDy complete
ttratokcy dat*
doektt by title, source or rtdptentcs),
and tht datt tht document was ft*
otived or provided by the Actaey.
jMOaMWy o/tfoc*sf cud widi-
cm (1) Tht Afeney wffl maks avail*
able to tht public-tor Inspection and
eopytnc tht dock< ad fades for any
bast tUsts. FoDowtot tht comment
period aad istumnot of tht IUflitr»-
ttoa StftBdard, the Aftaey wffl awut to
the FDtXAt maoism ft notice of ftfafi-
abfllty of tht HtflstntloB tuadard.
•AIT !5t-4AMUNv UOINU.
MINTS rot runaots AHO
•3?
The Aftaoy wffl establish aad
tate a nuflaiff Hst of persons who
have spertncsflj reojutsted that they
fieelvtbxaotsTor fttflstrfttloa Stand*
ard dockets. On a ojuarterly basts. «PA
wffl distribute tht todJcet of new mfttt-
ffals placed to tht pubUe doektt to
llfUt
fft) 0eM»*)- Content* e/ 9a
laosi BvMT^psstlddt products shall
btftr aJabtl oontalaiat tht i&fonas,
tfoa specified by tht Act tad tht rtiu-
-------
IIM.1t
. to thto Fart The ooBteafci of a
label most show dearly and proml-
aantiy the f oOowtet:
CD The BUM, brand, or trademark
vBdtrwhteh the product to sold at pre-
scribed ID paragraph (b) of thto oso*
of thetabav
(It) Tht name tad address of the
producer, rtftotraat, or ptnoo for
whom produced as prescribed In para-
fnph (e) of tuft section;
Ott) Tht net contents at prescribed
ID paragraph (d) «f thto ssntlna
Or) HM product rtftotrattoa
Dumber u prescribed to paragraph
of thto section;
(v> Tht produdat tftfMlthmimt
comber u prescribed to paragraph (f)
of this section;
(fl) AD ingredient statement u pre-
scribed ID paragraph (f) of thto
(fll) Warning or precautionary suts-
meat* u prescribed la paragraph (A)
of this section;
(rill) The directions f or OM M prt-
terlbtd IB p«nfnph (1) of thii Metioa;
and
of thii Metloo.
(2) frominmct and fe*Mttfe (1) All
words, fUteneati, mphfe rtpr«Mota>
t*on», dMi aad
txpreawd to roth ttnu u to rtadtr tt
Kkaly to bt rtad aad vadcntood by
tht ordtoary todMdual uadtr euitom*
. ooadfUoBiofpurehaMaDdttM.
(fl) An raojulrtd labol ttxtmutt:
U) Bt Mt to trpotot or lamr typt:
(B) Appear OB a clear oootmttaf
CO Hot bt ohtcurtd or erowdtd.
MLc*ff*oittobi*»d.AUnq
labtl or itbtllaf text than apptar to
tht BafUih la&fuaf*. Howtrtr, tht
Aftocy Buy rtqulrt or tht appUoaat
Buy propott addldoaal text to othtr
tanffuatei ai to eoaddtrtd Btcttavy to
W ^ ""'^ ^™F ^IF •^'^••^^••'wr^'w m ^ ^w^^r^^B«F«»M (T 1^^
protect tht public. Wbta additional
text to aaothtr laaffoagt to Btoawary.
an labtltof rafnirtoitati wffi bt ap-
ptltd oquaQy to both tht Caffllab and
other-language
(4) JfooflflMftl o/£«otf- rtofuporte/ton. Whfle a
pesticide product to to transit, the ap.
proprlate provudoas of 49 CPR Farts
1TO-1M, ooneeralnf the transportation
of hasardous materials, and spedflcal-
ly those provisions oonoemlnf the la-
bellat, marktof aad plaeardtof of hat-
ardous materials and tht rehicles ear-
rytof them, define the basic Federal
requirements. la addition, whea any
registered pestidde product to trans-
ported to a tank ear. tank truck or
other mobfle or portable bulk contain-
er, a copy of the accepted label must
be attached to tht ahipptof papers.
and left with the eoastfnee at the time
of delivery.
(B> jrcomf*. Whea pesticide
acts art stored to bulk coatai
whether mobflt or stationary, which
remain to tht custody of tht user, a
copy of tht labtl of labeling. Including
all appropriate directions for use, ahall
bt securely attached to tht container
to tht immediate vtetotty of tht i*4f-
eharre eoatrol valra,
(I) /Wat or mt*t*9dinf slaismeiUa
Pursuant to section XqXIXA) of the
Act. a pestidde or a device declared
subject to the Act pursuant to
110I.MO. to mlsbraadtd tt Its labeling
to false or mlsleadtof to any;
lpfi|tMM^y both pestiddal
ffffjffl ff^%nf EBuaplet of gtatemeats
or representations to tht labeling
which constitute mlsbraodlng toclude:
(1) A false or tuM***^ gtatemoat
uataff the coapodtion of tht
-------
ODAftdator
the
ra
the __
MpoMi other thao o7a
OWWS
«•* WT
which the
..
trademark
CD
oftbo
ADF fffiftmont
or
di
tb
^
appear
fl) ft flUat
OI) KM not boon
or mJafeaiHnt . or
flr •oppJ«m«tal
^^ ^ .' -
m>
„•
Snaps'*
oioai Una OD the label ohan bo ono-
atderodat the oame aad addnat of the
producer. If the retlrtrant1* Dame op-
pean OD the label aad the roftotnet ft
Dot the producer, or If the •»•*—-* •*•-
——- for whom the
,4 ^. -
^n«
* .* L^
tfft itaumoDti OD thi Duoty o
product, tedudfar bat Dot ItoUttd
_iA) "OoatatBf aO Datura! t
T
, ar at Dot ItoUttd to:
_iA) "OoatatBf aO Datura! tocrodj*
T^DVo^VA
^^^^^^
poiutltk ft toBd or
tf ^^M ^ftO^^^^H
fttf ^^M ^ftO^^^^HMOrfl^^^^l ^^B 0M ^
^oVDv^DV OB D^^kW^E^^M^L Oo> ^B B
adnuro of Ifcufd and 00114 tho Dot
oootoot ftatoBODt ahaO bo to Una* of
volfht iipraaid
. ^ oootoot ftatoBODt
oDtrt«oc appt of ad" volfht iipraaid M aroirdupoia
(f > /tw/ pHufotf teoor<««. (I) toofpt pound* aod ouooai.
profldod ID pantraph (aXCXtf) of (4) Za aO eaon, Dot oootoDt than bo
hft oootloo. final prtotod tehoUoff ttatod to turn* of tho lanoit onitablo
omit bo mbarttod aad aoooptod prior unto, to* *i pound 10 ouncof rathor
to roflrtntkn. Bowovor, ftoal prtatod Hun "it mmm "
iabiliaff oood oet bt ovbomod notfl (f) to addftfoD to tho roQutrod nnlU
drift labol toxto hart booa profftloa> apodflod, Dot oootoot o»r bo ox-
oHyaoooptotfbfthoAffODOj. pr amd to aotrto uatta.
Ctt) Ooarly loffblo ropndue
— r-*—-r opodflod. Dot content DMT bo «•
•^MiepcoaBfthoAnDOf. premd m metric uniti.
Ctf) Clearly loffblo reprodnetJoDi or cf) TarlattoD abort minimum ORB*
photo roduetfoBf wffl bo accepted lor toot or around ao artraft ft ponDftal-
umuual laboli ooeh ej tboee oft. Mo oofr to tho extent that ft ropro*
•erooood directly onto flaw or metal atntt detlattoo unAToJdab1- ** -^^
omtafDoif or larie bar or dn» tot-*- —lufaetartnt pncttot.
fe*«fc> —— ^ •- w a etatod *t^f*f|*'Mt<| (•
8uoh
n
-------
HM.10
J«fl[tbtpaekag« in aihipnt&t fan
*tlow fet ttattd average cowST
iff t££*'**'^**»''
SrrSR*yiOB number itttgntd to
the ptttlddt product at tht that of
itraUta shall appear oa the label
40 CM Ck I (f *14f MMoo)
tht labtL tf thort to an ootaldt coo-
Sor or wrapper tbroufh whkh tht
taartdJtat fUUonent eaaaot bt dearly
road, tht tBfrodltat atattmaat aunt
alto appear oa tueb ont
tratloa Jf*," or the phratt "0A Keg.
Wo.- Tht rtgiftratlOB number ahaO bt
ttt to type of a atoe and ttylt attnflar to
other print oa that part of tht label
on which it appean and than r*™ «•—
aOal to ft. The regtotratioa
aad tht required Identifying
than aot apoear to «*•* • —<
•too apptar oa tueTw
or wrapper, if thTafr,
S**« **•«L**
«« Product by the
u/ rrvBVCt*9 9»taWihmt*t» npf*
trajfoft *«in6er. Tbt producing ettab-
Itohmtat rtftotratioa number preoeoV
ed by tht phratt "XPA fct". of tht
final tttabltohmtat at which tht prod-
act WM produotd Buy appear te any
tuitable location oa tbt label or JBUBO»
dlatt eontalner. It mutt apptar oa tbt
wrapper or outafdt eontaintr of tbt
package if tbt IPA tttabltohmtat rog•
totratkm number OB tbt Immediate
cumtafner eaaaot bt clearly road
through twti wrapper or ****ntatrwri
Sfcfrwfftn* «te*tm«n*<-U> Otfitrt
•L The label of each ptttlddt product
mutt bear a ttatement which contaiat
tbt namt and percentage by weight of
each active tagredlent, tht total par-
etatagt by weight of an inert mgredl*
enter aad tf tht pottiddt oontam* ar-
atale to aay fora, a ttatemtat of tho
ptreeatagtt of total aad water-eolublt
antaJe calculated at elemental ar>
—' ~lw active taaredfente -— --
L— -* +-
eaulattd ai elem
atnle. Tat actrrt tacrodiaati
deelfnaud by tht term "aedv
oatt* aad tin Inert lart
M
i moat bt
eefnaud by tht term "aedvt ta«redl-
oatt* aad tin Inert lafrtdlaatt by tht
film Mtatrt ^f^dtfttta.** or ** **t*
l
t
tr f^dtfttta.** or **if **t*pt-
lar fonat of thttt tonat whan appro-
priata. Both ttrmt
ttt tonat whan appro-
priata. Both ttrmt ahaO bt In tho
MBM typt "ftt. bt "fffntif to tbt BUBO
BurftD aad bt tonall
B ho
aemeat MXaort mfredJenta, aoao" to
aot rtqulred for petUddtt which OOD»
tala 100 poroaat a«ttrt tnaredtenta,
UftJeaf tht mtrwttent fUtetneat to a
totnplttt anal/ate o* M»- — — -"- "
.or form of tht
aVCBIgt BUktt tt *"1]*pBfHfaMt tO
place tbt ingredient ttatement on the
front panel of tho label ptralttioa
may bo granted for tbt ingredient
ttaWH+pj to appear eltewbere.
(ii) Tbt tost of tbt iBgredtant ttatt»
BMBt mutt rua parallel with other
text oa the panel oa which ft appean,
must mint bg clearly to-weight.
Tbt turn of percentages of tbt active
and tbt Inert ingredlenti ahaD bt 100.
Percentage* than aot bt txpnoMd by
a range of valuta tucb at "*3-2t%." If
tbt utee of tbt peetlddt product are
tipretted at weight of active tngredj-
tot par ualt area, a ttatonttnt of tbt
weight of active ingredient par unit
volume of tht ptttlddt formulation
•ban alto appear to the ingredient
etatOBMBt,
*•*
*
practice. If there may be un-
Afofdabk fftitettoa between manufac-
torteg batchta, tht ralut ttattd for
each actirt toffadtaat ahafl bt tht
jgwut percentage which may bt
«»» — •
-------
II li dtton&lBtd Hut
_ _. BQ* boar tbt faOowfaf obtBloal baaard fan htto «*»
SieB* to » proBtooBt poaWoa OB tboM vanfnd OB tht front
STSSi: *V« for MJt or BM afttr tht tobStnt •
product Butt attt an MM atonta
op to.tht «ptrmttoo
gpt_
/Mrt i*e*di**tt. n* AdmtDto- (I)
«»f fwtfrt tbt HUM of aay WttH
««i«df«nui) to bt teud IB tho haard
itaunoBt tf te dttoimlMt tolnd OB tt» front ptaoi of tot
tap^dltata) BAJ POM ft to d«Uimlnod by to* ttaidty Cat»to
BOBL nr of to* pMtkfd*. Th« outtorr to w-
cvMoMfir MJBM! OB «b* bMto of tbt tiljtiMT
Roovlnd warotaM sod fcaaard ihovn or uj of th*
(I) JT«mai»
fteteUy CW*ponr £ AD poftiddt prod-
aeti nttttBi too orlUm of Twddty
OUtiary I taiO bow OB tbo treat
paaol tht ftgnal word "Da&ior.1* to id-
OtttOB tf tlM prOdUCt VM M^fBOtf 10
ToxJdtr Ofttotory I OB too bull otto
oni. tnhatatlflB or doraal toxidty (M
dtitinrt fron itti asd oyo looal of*
f«et*) tht word -Fotooa" taaO appoar
to nd OB » baekfrooBd of tftodwt^
ootor tad tht atuD aod
IB Imm^llifa
^HB ^^^B^^^^^i^^^^^V
(B>
CWoMty JX AD .
BMttt&f tht ertUrta of
porrnihafl
(D) ftetetty ftfojorw T. An
oldo product* BottiBf tot crtUrl* of
<•) Cat ofrtffHol TMfrfi. VM of any
atgaal «ord(t) aModattd wttb a blibtr
ttakftf CMtfory to not permitted
ontpt WBOB tbt Aftaey dtunnton
Itttltnf to BteoMary to
maa or tbt tailiwuBtBt ID ao out
•K«tt fBort ttirif ffttf btttBaa aaaard
•Ignal word apptar OB tbt front paati
tht
CM)
botfOBtht tfddtprodottIftDtlabafl
of ob
CO Jbrtctfr OtfoMff m AO
otdt producU aMtttat tat
Twbdty OUttory OI than
tba front paatl tbt atmal word "Cto-
vbtft tbt Kktlibood of
obfldrtB durtof dUtribatJoc,
tag. ftontt or OM to dtBOBftratod by
tbt appUatat to bt •xtmotly r^
or tf tht aaunt of tbt ptfdefdt to i
-------
fufcit
r on OB mranti meats for Jbf_£ent panel
1 A
"-»
**Jntp Twaaty Cttenty Ion the •
^WftSSSWUSkS .«_.
.«- At««r .at. howem. -gj..^
•3J »£•»:
M wavKuu anacrca
<•> Otter tefci*
venerai h«^««
4 wj% BV^DBLV
(rr> AoMffun/ end promintnet. AD
the require front panel warnint ttate*
menu thafl be grouped tocetber on
the label, and thill appear with fuffl*
dent prominence relative to other
front panel text and graphic material
to make them unlftelj to be —
jftftfc^d uy***** «••*'••—•—
««rtm«lt7 M^F *i^M BWWV^ ^^B^V !•••• ^F BIP^B/
•^•M^dJ ^hft eMlt. *•* a^aT hflMflto ••••• fdkeM eV
v^vomvi inaT enane* ejv neja nraiwiv ^IBJIBW avNew ••>
(99 MHL Ol Mi J> H f|Ma\ *JH MV 9 iP i
fl a^^^a^fe^ M^^^^^BJ^^^^ ff^kft^aaa^ ^" -*-"* J " " ~
» •
M|. o* MI M * «im « Mi «r m
>oja^a» ^H^B^Btt ^ <••• aBftjM omel a^e^a*
^.^^^ ^3P^*. ^ ^^* T^J^ O^ -^^?
BMI •!• r«f Mftl
«^|BV •§• MM rtaAi
•"^"k V
-------
rlomttM
li Itafe to Wndttfo" fc
to
CB> For mm terohtof f ottftr i
ttoa to ajrtcultoral <
If o poitJoldf tattBdod ttf oat" Bbodo ftrftto* or for
ooato oral IA. of pontaattaf taoteti i
~ " att Iftfrt! wf**n
(F) For ftQ outdoor
If ft pioUddt B)UBdod~for _
^or'ow ooatfttBf ftB oottvo iojrodloBt boar tho oratta "Coop oat of team
^frT A M«k M^tO iJCm Of 1 PPB OT feOJk fKTfVfc OT StTMBtt. Do BOt ffHt>ffltlHt^
, -TWi FartJddo li T«do wator by doantef of •qulpmot or dte-
pooal of vftotoa>**
"icTu • ptitleldt teUBdod for oat- CM) JftyHoaf or otanlool lUt***.
*0t Oft* OOBtftfBt ftB ftCtlTt fDfTOdJOBt WftRllBf ftatOBUBtl OB thf fl*""^*>ff'
•ttb an ftvfaa fteuto oral UXi of 100 tty or txploalrt eharaeurlitki of tho
M /if or lorn or ft wbaeuto dtoury porttddt ftn roqnlrod ai f ollovc
1
*" ' •* m ** *** '****
-------
llfa.10
Tat label bean ft rtftn
the dlreetiuua for on IB aeeompanytnf
leaflet! or tfrciilan, fueli at It* di-
rection* tn the tnclottd circular" and
(O Tht Adminletrator deteralnea
that tt to not ninuMjy for tuch dlrtc-
Cltt) ftetpMoM It twfv Detailed direc-
tion* for uat may bt omitted frocn la*
belter of ptttJddciwnkb art intended
for ute only by manufacturer! of prod-
uct* other than ptttJddt product* ID
thtir ftfttlar mantifacturmt proettJtt,
provided that:
«) At label dearly thowi out ttM
product to intended for an only to
BurafMturtaff procttiti and epedflea
the typefa) of product* Involved.
(1) Adequate Information each ftt
Uehaleal dau ihMti or buDtttoa. to
fttaflabto to th« tnd* apMtfriaff ttM
tjpt of product IttvolTtd ftnd It*
propor oat ID manufacturtoff
to tad tfftcttventti of tht product for
(1) Th« product vffl not OOOM toto
tht haadj of th« fftacnl public txotpt
tftar toeoiporatJoD toto fl&lahad prod-
uctK aod
(*) Tht Administrator dtt«raioat
that fueb dtraetleat art not atotamr
to prtvant uartafonablt adrtnt «f-
ftcti on man or tnt tnrlronmtnt.
Ottafitd dlrtcUoai for oat may
bt omttttd from tat labtUnf of poatt*
ddt product! for which aalt to Umttad
to phmdaaa, ftttrfnartant, or druv-
ftete. provldod that
11) Tht labtl dtarlr atatta that tht
*BAA ^^t^ fthfl* •.Dk^Htf^A^kA
^BM OBv mf PQyVKUBp
CD
that each direction* art not
IBO flNW*9ti l*iea^ntPt*aB)Oe^^*VDKI •%•
fectt OB aaa or tht environment; and
f 1) Tht product to alto a drat tad
rtfulatttf under tht pravittoai of tht
Federal Pood, Oruf and Coametie Act
(O Dttafltd direction* for ntt may
bt (Knitted from tht lahelmgof peatt-
oat only by fomralaton m pitpaitoi
pcttJBMta for talt to ttw ffiiMlfl. pfO»
vldtdthafc
U) Thtrt to mformation readily
avaflablt to tht formnlatora on tht
oompoattion, toUdty, method* of nee,
applicable
tl) Tht labal daariy atatta that tha
product to mttndtd for oat only to
manufacturlnt, formulatmt. mizmt.
or rapaealnf for oat w a ptatkidt and
aptdflw tht typtca) of ptattcJdt prod-
Beta Intotvadf
(f} Tht product at finally maaufae>
turtd, formulatad, mixtd,
atad to rtflattrtd: and
Tht
that auch diracUona art not
to prtfcnt unrtaaoniMa
ftctt on man or tht environment
(S) Cental* «/ Dincti&u fur {7aa
Tht dlrtctlonc for oat ahall Include
tht following. under the headlnej "Dl-
racUona for Uat":
(1) Tht statement of uat riaerifki-
tion at preacrlbed In parairaph (J) of
tMf atctlon Immediately vn^rr the
headlnt "Dlrtctiona for Uat."
(tt) Immediately below the etete-
of uat claaalflcatlcn. tht atate»
tt to a flolaaon of Faderal law
to uat tola product in a manner. Ineon-
alatent with ita Ubeltof.-
-------
it tbt ant or
avaflablt 10
applytar tht pofttddt.
taer hai dtttralatd thai tht
mitirnf aw only bt appUod oadar
jbtdlrtettuptrvfateaofattftlfltdap-
riixal
<£xi xro of
Wftb
to «b« tot tad
•raphfe material OB tht froat pml to
•ate ft nUkaty to to
If) Other parttaMBt ttkfomatten
A
tlM
••B jgd Utt tDTtrOBBMOt.
(/> StAttmnt o/Cte O***(fie*X*L
•7 October tt. Iftf, an poitlddt prod-
«(• mwt Mar oo tbt IP labeli a atato-
Bcnt of oat daadfleaUoD ai Jam tod
to panirapbj u> CD and (1) of thto
4ay pafUddt product for
daatiflod lor
«omt oaw art
era! vat and otbtn for notrfetod oat
•biO bt atparattly labtltd aooordtat
to tbt labtltoff ftaDdardt aft forth to
tbH wbttcttoo. aad ahaO bt markttod
os atparato product* with dttftnot
ftfMrattoB BUBbtra, oat btartag a>
vacttom only for ttnoral ovota) and
tbt otbor btartaff dtroetioat lor rt-
------
«> Dlrtctly bttow thto
tbt front pabtL a tumoury
of tht ttnat of raftriottoa &
• proooadltloB to rofittratfea
apptar. If ait if rtotrtotod to
applicator*, tht foBovfat i
iMulrod: "Ibr rttafl aut to aad
aoai uadtr thttr dtnet auparflaloa aad
oaly for thott ntat oortrtd by tht Oar*
ttfltd AppUoatorn oanttkatioa.M If,
hovtrtr. otbtr rtfulatory rtotrlcirtoai
art tepoaod, tht artmtnlitritflr «ffl
dtflat tht appropriato wordlni Car tht
torn of rtttrtetfea by rtfuSaoo.
cti m mat, Mr 1 ifffc *• i«
i. itvi; «• IR mn. **. n. i§m at
*
aai both rattrtcUd aitCf) aad
vtdx both of thttt
ta a product labtltd
•oeh produeti ahaO bt oohjtot to tht
provwoai at paragraph (|XD at thai
tott
II)
at H rm HIM. uatt,
«M(f > dAMtfltd ftatnl afeaO bt b>
baltd with tht tact vorda •Otatral
" ftnmtrfltuiy btlov tht
. to tht ftatral ctaoHfloHioa
ttutt ncftfti or BBptfat that tht tjaa-
anl Salty of tht ptttfefdo
btroDd thott
tafetdtothtr
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I
i hi J!
Mil HI
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