Unit ad Stat at Otficaof
Environ marrtil Pro tact ion Pacticidat and Toxic Subataneaa
A9-rtCV W«hin*o„ DC 20460 September 1985
Pastictda*
<&EPA Guidance for the
Reregistration of
Pesticide Products
Containing Perfluidone
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OP PESTICIDE PRODUCTS
CONTAINING
AS THE ACTIVE INGREDIENT
PERPLUIDONE
EPA CASE NUMBER: 195
CAS: 37924-13-2
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
SEPTEMBER 26, 1985
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TABLE OP CONTENTS
Page
Introduction 1
I. Regulatory Position and Rationale it
II. Requirement for Submission of Generic Data 13
III. Requirement for Submission of Product-Specific
Data 16
IV. Submission of Revised Labeling 39
A. Label Contents 39
B. Collateral Information 45
V. Instructions for Submission . . . . 46
APPENDICES
II-l Guide to Bibliography 49
II-2 Bibliography 51
II-3 PIPRA §3Cc)(2)(B) Summary Sheet - EPA Form 8580-1 . 56
II-4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data -
EPA Form 8580-6. 57
III-l Product Specific Data Report (End-Use Products) . 58
IV-1 40 CPR 162.10 Labeling Requirements 60
IV-2 Table of Labeling Requirements. ......... 72
IV-3 Physical/Chemical Hazards Labeling Statement. . . 75
IV-4 Storage and Disposal Instructions 76
i
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. 3(g)) directs EPA to reregister all pesticides as
expeditiously as possible. £-*
To carry out this task, EPA has established the Regis-
tration Standards program, which will review all pesticide
products containing active ingredients first registered before
January 1, 1977. Pesticides will be reviewed in use clusters
which have been ranked to give earliest review to pesticides
used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. EPA's reassessment results in the development
of a regulatory position, contained in a Registration Standard,
on each pesticide and its uses. The Agency may require the
registrant to modify product labels to provide additional
precautionary statements, restrict the use of the pesticide
to certified applicators, provide reentry intervals, modify
uses or formulation types, specify certain packaging limitations,
or other requirements to assure that proper use of the pesticide
will not result in adverse effects on the environment.
The scientific review, which is not contained in this
Guidance Package but Is available from the National Technical
Information Service, concentrates on the technical grade of
the active ingredient and identifies missing generic data.
However, during the review 6f4 these data we are also looking
for potential hazards that may be associated with the end use
(formulated) products that contain the active ingredient. If we
have serious concerns, we will address end use products as
part of the Registration Standards program and will propose
regulatory actions to the extent necessary to protect the
public.
EPA has the authority under FIFRA sec. 3(c)(2)(B) to
require registrants to submit data that will answer our
questions regarding the hazard that may result from the
intended use of a pesticide. Although sec. 3(c)(2)(B) provides
that all registrants are responsible for these data, the
Agency generally Imposes generic data requirements only on the
registrants of the manufacturing use products (basic suppliers
i
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of the active Ingredient) and other producers who do not
qualify for the formulator's exemption.*
A producer who wishes „:to qualify for the formulator's
exemption may change his source of supply to a registered
source, provided the soured does not share ownership in
common with the registrant's firm. A registrant may do so
by submitting a new Confidential Statement of Formula, EPA
Form 8570-4, identifying the registered source of the active
Ingredient, to the appropriate Product Manager within 90
days of receipt of this Guidance Document. The chart on the
following page shows what is generally required of those who
do and do not qualify for the formulator's exemption in the
Registration Standards program.
If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the requirements
of this Guidance Document, please notify the Product Manager
named in the cover letter, within 90 days from the receipt
of this document. If you decide to maintain your product
registrations), you must provide the Information described In
the following pages within the timeframes outlined. EPA will
issue a notice of intent to cancel or suspend the registration
of any currently registered product which does not comply
with the requirements set forth in this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you to
submit factual Information raising concerns of possible
unreasonable adverse effects of a pesticide. You should
notify the Agency of interim results of studies in progress
if those results show possible adverse effects.
•The formulator's exemption applies to a registrant of an
product if the source of his active ingredient(s): (1) is a
registered product and (2) is purchased from a source which
does not have ownership In common with the registrant's
firm. o
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis- I
tered. To obtain reregistration,
labeling, -packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
.requirements. Affected products
'will be dealt with in a variety
-of ways, Including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
» End use products or registrants wno also produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products In "11"
above. If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements In
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B.
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I. REGULATORY ASSESSMENT
A. INTRODUCTION
This Registration Standard describes the regulatory position and
rationale of the Environmental Protection Agency ("the Agency")
for all registered manufacturing-use products (MPs) and end-use
products (EPs) containing perfluidone as the sole active ingre-
dient. The Agency bases its position and rationale on an evalu-
ation of all MPs and Section 3 uses registered for perfluidone.
EPs are reviewed only when there are no' MPs registered or when
the label has been changed significantly from the current accep-
ted label. Mixtures are included only when there is a significant
change in the label. After briefly describing the chemical and
its uses, this chapter presents the Agency's regulatory position
and rationale, the criteria for registration, acceptable ranges
and limits, labeling requirements and the tolerance reassessments
for perfluidone.
B. DESCRIPTION OP CHEMICAL
Perfluidone is the accepted common name for the compound: 1,1,1,-
trifluoro-N-[2-methyl-4-(phenylsulfonyl)phenyl] methanesulfonamide,
as determined by the British Standards Institution, International
Organization for Standardization, and the Weed Science Society of
America. PERFLUIDONE is marketed under the trade name Destun*.
The Chemical Abstracts Service (CAS) Registry number is 37924-13-2.
The Office of Pesticide Program's EPA Chemical Code Number is
108001.
Perfluidone is a solid at ro9m temperature and is odorless. The
empirical formula is Ci4Hi2p3^4s2» and its molecular weight is
379.40. The melting point is,**l43-l45°C. Perfluidone is soluble
in aromatic and chlorinated l^ydrocarbog solvents; and in water
(at 22°C) to 60.0 ug/ml.
Perfluidone is a selective preemergence herbicide registered for
control of nutsedge species, certain grasses, and broadleaf weeds
in flue-cured tobacco.
Perfluidone is mobile in the xylem but is of limited mobility in
the phloem. Its mode-of-action in the weed is inhibition of photo-
system I of the photosynthetic process.
Perfluidone was patented by the 3M Company (US Patent No. 4,005,141)
in 1974 and was first registered for use in 1976. Although per-
fluidone is registered in the United States, it has never been
commercially manufactured or marketed up to the present time.
Perfluidone is a 50.0% wettable powder end-use product.
4
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C. REGULATORY POSITION AND RATIONALE
Based on the review and evaluation of all available data and other
relevant information on perfluidone, the Agency has made the
following determinations:
1. The available data are insufficient zo indicate that any of
the risk criteria listed in § 162.11(a) of Title 40 of the
U.S. Code of Federal Regulations have been met or exceeded for
the use of perfluidone at the present time.
Rationale: Available data show that perfluidone is not highly
acutely toxic by the dermal and ocular routes of exposure:
Toxicity Category III and II respectively.
A 90-day dog feeding study showed liver disorders ( hepatic
lesions, hepatocyte vacuolatlon, hyalin degeneration and
biliary stasis) at the two highest dose levels (400 and 800
ppm) .
The absence of other toxicological data prevents the Agency
from determining the acute, subacute and chronic effects of
perfluidone. Given the lack of data, the most appropriate
action is to move quickly to fill the data gaps. When data
are submitted and reviewed, the Agency will determine the
registrability of the affected use pattern.
The Agency is requiring the following toxicological data:
acute oral, acute inhalation, and- dermal sensitization studies,
a 21-day dermal study, a teratogenicity study in both the rat
and rabbit, gene mutation^in bacteria, gene mutation in mam-
malian cells in culture,' chromosomal aberration analysis in
mammalian cells in culture, and DN'A damage in mammalian
cells in culture.
2. The data base supporting the perfluidone tolerance on cotton-
seed (0.01 ppm) has been reviewed and found to be inadequate.
However, the data, tables in the perfluidone registration
standard will notf include these data gaps attributable to the
tolerance on cottonseed: § 158.135 Toxicology. Subchronic
Testing (82-4), Chronic Testing (83-1, 83-2, 83-*0» Special
Testing (85-1); §•158 .125 Residue Chemistry. Livestock
(171-4), Animal Residues (171-4), Cottonseed (171-4) and
Meat/Milk/Poultry/Eggs (171-4). Instead, the Agency will
issue a Proposed Rule to revoke the perfluidone tolerance on
cottonseed. If there is no response to support the tolerance,
the Agency will issue a Notice of Tolerance Revocation.
5
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Rationale: When data are lacking to support a tolerance, the
normal procedure is to require the necessary data through the
registration standard. If the registrant does not agree to
develop the data to support the tolerance, the use of the
product for which the tolerance was established would be sus-
pended. In this case, §fie 3M Company is the sole registrant
of perfluidone in the United States. Although initially
registered for use on cotton, the product has never been mar-
keted for that use. In July 19844 perfluidone•s registration
on cotton was voluntarily cancelled so this pesticide chemical
no longer retains a registered food or feed crop use. There-
fore the Agency will not require data necessary to support the
tolerance at this time, but instead will publish a Proposed
Rule to revoke the tolerance for perfluidone on cottonseed
and allow 60 days for anyone wishing to support the tolerance
to identify themselves. If there is no response to support
the tolerance, the Agency will issue a Notice of Tolerance
Revocation.
3. Products which are substantially similar to the registered
end-use product may be considered for registration, subject
to the terms and conditions specified in this document.
However, the Agency will not register new products or new
uses that would significantly increase exposure until such
time as the data identified in this registration standard
have been received and reviewed by the Agency.
Rationale: Under PIPRA Sections 3(c)(2)(B), 3(c)(5) and 3(c)(7),
the Agency has the authority to require registrants and appli-
cants for registration to provide data needed to support new
or existing registrations.' The issuance of this registration
standard is the mechanism.which the Agency has chosen to
identify such data. Thesje data will be reviewed and evalu-
ated when they are received. At that time, the Agency will
determine how the data will affect the registration of
perfluidone.
4. EP labels will be required to bear a revised environmental
hazard statement (See Section P. Labeling Requirements).
Rationale: Since the minimum data requirements for avian and
freshwater invertebrate species are lacking, the environmental
hazard statement is necessary to protect the non-target
species.
5. EP labels will be required to maintain a rotational crop
restriction (See Section P. Labeling Requirements).
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Rationale: Because of a lack of data regarding persistence and
mobility, it is not clear whether crops planted in soils
treated with perfluidone would acqui-re illegal and perhaps
harmful residues. To prevent this possibility, the rotational
crop restriction will b&. maintained until such time as data
are received and reviewed by the Agency. Then the Agency w?ll
decide what an appropriate restriction, if any, should be.
6.. EP labels will be required to bear protective clothing state-
ments 'for mixers, loaders, and applicators (See Section P.
Labeling Requirements).
Rationale: Perfluidone is an eye irritant and a perfluidone 90-
day study showed liver disorders in dogs. These effects and
the absence of certain acute, subacute and chronic toxicity
data on perfluidone necessitate a statement to protect the
mixers, loaders, and applicators from undue exposure to
the pesticide.
7. MP labels will be required to bear a statement regarding dis-
charge to bodies of water and sewer systems.
Rationale: These precautions will minimize the discharge of ef-
fluents from manufacturing plants and also meet the Effluent
Guideline requirements.
8. The Agency will not require a ground water advisory statement
at this time. If data indicate tljat perfluidone may cause
ground water concerns, the Agency may reponsider this decision.
Rationale: Although perfluidone is mobile in sandy loam, loamy
sand, silt loam and clay, J4oam soilg, the Agency will not
require a ground water advisory statement at this time.
Perfluidone has never been commercially manufactured or sold
in the United States and has not been identified in ground
water. Environmental chemistry data are needed to characterize
perfluidone's potential to contaminate ground water. If the
data listed below show that perfluidone is persistent such
that contamination of ground water may occur, the Agency may
reconsider this decision.
The Agency will require the following environmental fate data:
hydrolysis (§161-1), photodegradation in water (§161-2), aerobic
soil metabolism (§162-1), and mobility (§163-1).
7
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9. No endangered species label statements are required.
Rationale: Perfluidone was reviewed by the Agency under the
endangered species cotton cluster, but it did not exceed
any trigger. On flu^cured tobacco, if the maximum rate
of 1.5 pounds active *ingredient/acre were applied to six
inches of water, the resulting residues (0.75^ ppm) are
less than 0.900 ppm (1/20 of the LC50 the nost sensi-
tive fish). Therefore, perfluidone''s use on tobacco is
not expected to adversely affect endangered species.
Currently, there are no available data for aquatic inverte-
brates or avain species.
10. The Agency is not requiring a reentry interval for the
registered use of perfluidone.
Rationale: Perfluidone has low dermal toxicity (Category III)
and it is a moderate eye irritant. Additionally, the single
preemergence use per season of perfluidone on flue-cured
tobacco is less likely to lead to reentry exposure.
8
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D. CRITERIA FOR REGISTRATION UNDER THIS DOCUMENT
To be subject to this guidance document, MPs must meet the fol-
lowing conditions:
1. Contain perfluidone &?$¦ the sole active ingredient and,
2. Conform to the acute toxicity limits, product composition,
and use pattern requirements listed in Section E of this
document.
Registration of products subject to this document must comply with
all terms and conditions described in it, including commitment to
fill data gaps on a schedule acceptable to EPA and consistent with
that required of the present registrant. All registrants and
applicants for registration under this document must follow the
instructions contained in this document and complete and submit
the appropriate forms within the specified time.
E. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
Technical grade products must contain at least 50.0 percent
perfluidone as the sole active ingredient. Each MP formulation
proposed for registration must be fully described with an appro-
priate certification of limits. In addition, the active ingredient
found in the MPs must be substantially similar to that in the cur-
rently registered product. Any MP not meeting these requirements
will be considered a new product and will not be registerable
under this guidance document.
2. Acute Toxicity Limits
The Agency will consider registration of products containing
perfluidone, provided that the product labeling bear appropriate
precautionary statements for the acute toxicity category in which
each product is placed.
3. Use Patterns:
To be registered under this standard, MPs containing perfluidone
must be labeled for formulation only into end-use herbicide
products for the commodity listed below.
Perfluidone is a selective preemergence herbicide registered for
control of nutsedge species, certain grasses, and broadleaf weeds
in flue-cured tobacco.
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P. REQUIRED LABELING
All technical grade products, MPs, and EPs containing perfluidone
must bear appropriate labeling as specified in 40 CPR § 162.10.
Other portions of this guidance package contain specific infor-
mation regarding label requirements.
In addition to the requirements stated in 40 CPR § 162.10, the
following information must appear on the labeling of all products
released for shipment after October 30. 1986, and products in the
channels of trade after October 30, 19oTI
1. Ingredient Statement
The ingredient statement for MPs and EPs must list the active
Ingredient as:
Perfluidone: 1,1,l,trifluoro-N-[2-methyl-4-(phenylsulfonyl)
phenyljmethanesulfonamide, %
2• Precautionary Statements
Manufacturing-Use Product Statements
All products intended for formulation Into EPs must bear
the following environmental hazard statement:
"Do not discharge effluent containing this product directly
into lakes, streams, ponds, estuaries, oceans or public
waters unless this product is specifically identified and
addressed in a National ,Pollutant Discharge Elimination
System (NPDES) permit. Do not discharge effluent con-
taining this product into sewer systems without previously
notifying the sewage treatment plant authority. For
guidance, contact your State Water Board or Regional Office
of the Environmental Protection Agency".
End-Use Product Statements
The following environmental hazard statement must appear
on all EPs:
"Do not apply directly to water or wetlands. Do not
contaminate water by cleaning of equipment or disposal
of waste".
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The following rotational crop restriction statement must
appear on all EPs:
"Limitations: Replant only tobacco in DESTUN® herbicide-
treated soil during-3fche year of application and the follow-
ing crop year" . %¦"
The following protective clothing statement must appear on
all EPs:
"During mixing/loading or application, wear gloves imper-
meable to perfluidone. When handling the concentrated
product, wear a dust mask and chemical resistant apron
in addition to the gloves. Wash hands thoroughly with
soap and water after handling and before eating, urinating,
or smoking. Remove and wash clothing before reuse. Cloth-
ing should be laundered separately from household articles.
Replace gloves frequently. Used gloves and clothing which
has been drenched or heavily contaminated should be dis-
posed of in accordance with state or local regulations".
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G. TOLERANCE REASSESSMENT
The perfluidone registration on cotton was voluntarily cancelled
in July 1984, but the established tolerance on cottonseeds has
not been revoked. Later tfc&'s year, the Agency will notify the
registrant that it must decide whether it wants to retain the
tolerance on cotton or have the tolerance revoked.
The Agency is not conducting a tolerance reassessment on perflui-
done because the current use on flue-cured tobacco is a non-food
and non-feed use which does not require a tolerance. Therefore,
the Agency will not require residue chemistry data on the metabo-
lism of perfluidone and related metabolite(s) in crops and animals.
In the United States, a tolerance is currently established in 40
CFR § 180.165 for the residues of the herbicide, perfluidone:
1,1,1,trifluoro-N-[2-methyl-4-(phenylsulfonyl)phenyl] methane-
sulfonamide, in or on the following raw agricultural commodity:
Commodity Parts per million
Cottonseed 0.01
International Tolerances
Presently, there are no tolerances for residues of perfluidone
on cottonseed in Canada, Mexico, or in the Codex Allmentarlus.
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REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority gf FIFRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the registrability of each product.
EPA has determined that additional generic data described
in Table A must be submitted to EPA for evaluation in order
to maintain in effect the registrations) of your product(s)
identified as an attachment to the cover letter accompanying
this guidance document. As required by FIFRA sec. 3(c)(2)(B),
you are required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA how
you will satisfy the requirements of this Notice. Any such
suspension will remain in effect until you have complied with
the terms of this Notice.
B. What Generic DataiZ Must be Submitted. You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued registrability of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols (such as those* contained in the Pesticide
Assessment Guidelines £/ or data collected under the approved
protocols of the Organization for Economic Cooperation and
Development (OECD). If you ho not wish to develop data
in support of certain uses appearing in your labeling, you
may delete those uses at the time you submit your revised
labeling.
For certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA*needs data of that type
2/ 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, regardless
of the product's unique composition or specific use. Product-
specific data relate only to the properties or effects of a
product with a particular composition (or a group of products
with closely similar composition).
2/ The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
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for each major formulation category (e.g., emulsifiable concen-
trates, wettable powders, granulars, etc.) These are classified
as generic data and when needed are specified in Table A.
EPA may possess data on certain "typical formulations" but
not others. Note: "Typicaf£ formulation" data should not be
confused with product-specific data (Table B) which are
required on each formulation. Product-specific data are
further explained in Chapter III of this document.
c• Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II-3] for each of your products. On that form you must state
which of the following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe will
satisfy the requirement, or state that you will generate
the data by conducting testing. If the test procedures
you will use deviate from (or are not specified in) the
Pesticide Assessment Guidelines or protocols contained In
the Reports of Expert Groups to the Chemicals Group,
Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must enclose the
protocols you will use.
OR
2. Notify EPA that you have entered into an agreement
with one or more other registrants to Jointly develop (or
share in the cost of developing) the data. If you elect
this option, you must notify EPA which registrants) are
parties to the agreement.
OR
3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for Develop-
ment of Data" (EPA Form 8580-6, Appendix II-4)*/
*/ FIFRA sec. 3(c)(2)(B) authorizes Joint development of
data Hy 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 terras of
the agreement. The statute does not compel any registrant to
agree to develop data Jointly.
(Footnote continued on next page)
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OR
4. Request that EPA amend your registration by deleting
the uses for which the data are needed. (This option is
not available to applicants' for new products.)
"Sr"
OR
5. Request voluntary cancellation of the registrations)
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 intwaiting to the Product Manager.
(Footnote continued from previous page)
In EPA's opinion, Joint data development by all regis-
trants subject to a data requirement or a cost-sharing agreement
among all such registrants is clearly in the public iSteFest.
Duplication of testing could increase costs, tie up testing
facilities, and subject an unnecessarily large number of
animals to testing. <
As noted earlier, EPA has discretion to suspend the
registration of a product when a registrant fails to submit data
required under PIPRA Section 3(c)(2)(B). EPA has conc?uSei ?ha?
it should encourage Joint testing rather than duplicative
testing, and that suspension should be withheld in certain cases
to further this goal. According!,, if (1) , «gi»t?«t has
informed us of his intent to develop and submit data required
by this Noticej and (2) a second registrant informs EPA that
it has made a bona fide offer to the first
in the expenses of the tesHng Con terms to K iiJSSd upon
or determined by arbitration under PIPRA Section 3(c)(2)CB)mm.
and (3) the first registrant has declined to alree to enter '
into a cost-sharing agreement, EPA will not suspend the
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The extension request should state the reasons why you believe
that an extension is appropriate. While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
"V"
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: Unless stated otherwise in Section I, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products, not to end use products.
A necessary first step in determining which statements
must appear on your product's label is the completion and
submission to EPA of product-specific data* listed on the
form entitled "Product Specific Data Report" (EPA Form
8580-4, Appendix III-l) to fill gaps identified by EPA
concerning your product. Under the authority of FIFRA sec.
3(c)(2)(B), EPA has determined that you must submit these
data to EPA in order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
Table B—Product-Specific Data Requirements for Manufacturing
Use Products—lists the product specific data you must submit.
Data that are required to be submitted are identified in the
column of those tables entitled "Must Data By Submitted
Under §3(c)(2)(B)
*/ Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
sllne Citation and Test
of Test Substancel/
Guidelines
Status2/
Are Data
Required
Yes No
Data Must Be
Fbotnote Submitted Within
Number or Time Frames Listed
Citation Below!/
.120 Product Chemistry
xluct Identity:
-1 - Product Identity and Disclosure
of Ingredient
TGAI
R
n
[X]
00038230
-2 - Description of Beginning Materials
and Manufacturing Process
TGAI
R
[X]
[J
6 months
-3 - Discussion of Formation of
Impurities
TGAt
R
fx]
o
6 months
ilysis and Certification of Product
jredlents
-1 - Preliminary Analysis
TGAI'
CR
[X]
[ ]
00038231
00038238
12 months 5/
-2 - Certification of Limits
TGAI
CR
[X]
[J
12 Months
-3 - Analytical Method for Ehforcement
of Limits
TGAI
CR
[X]
[ ]
00038237,
00038236
00038231 12 Months 5/
ysical and Chemical Characteristics
-2 - Color
TGAI
R
n
[X]
00038230
-3 - Physical State
TGAI
R
o
np
00038230
-4 - Odor
TGAI
R
Q
[X]
00038230
-5 - Melting Point
TGAI
R
o
W
00038230
-6 - Boiling Point
TGAI
R
n
[X]
00038230
17
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
eline Citation and
of Test
Teat Guidelines
Substancel/ Status2/
Are Data
Required
Yes No
Footnote
Umber or
Citation
.120 Product Chemistry (Continued)
ical and Chemical Characteristics
tinued)
-7 - Density, Bulk Density, or
Specific Gravity
TGAI
R
m
0
-8 - Solubility
TGAI or PAI
R
n
[X]
00038230
-9 - Vapor Pressure
PAI
R
O
[X]
00038230
-10 - Dissociation constant.
PAf
R
n
[X]
00038230
-11 - Octanol/water partition
PAI
R
n
[X]
00038230
coefficient
-12 - pH
-13 - Stability
her Requirements:
- 1 - Submittal of samples
'PGAI
TGAI
TGAI, PAI
R
R
CR
n
n
[_]
[X]
ra
00038230
Lata Must Be
Submitted Within
Time Frames Listed
Belowl/
6 months
6 months
TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient,
R = Required; CR = Conditionally Required,
Data must be submitted within the indicated time frame, based on the date of the Guidance Dociment.
6 Month Due Date is March 30> 1986.
12 Month Due Date is September 30t 1986.
This compound does not require the submittal of samples at this time.
Data requirements are partially satisfied, but these data cannot stand on their own merits.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PERPLUIDONE
1/
ta Requirements
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
Nd, or* Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frames For Data
Submission 2/
>8.125 Residue Chemistry
171-2 - Chemical Identity TOAI
171-3 - Directions for Use
L71—4 - Nature of Residue (Metabolism)
- Plants PAIRA
- Livestock
71-4 - Residue Analytical Method
- Plant residues
Yes
Yes
Yes
PAIRA and Plant
Metabolites
TGAI and Metabolites
Yes
Yes
00038230
00035510, 000393H
00039578, 00039579
00088387,
00105868
00038253
00038524, 00039318
00039314, 00039491
00039315, 00077842
00039316, 00088388
No
No
No
No
No
- Animal residues
TGAI and Metabolites
Nd
No 3/
71-4 - Storage Stability Data
PAI
Yes
00039317
No
19
-------
TABx
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
a Requirements
Composition
Does EPA Have Data
To Satisfy This
1/ Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frames For Data
Submission 2/
8.125 Residue Chemistry - Continued
71-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Crop Group: Miscellaneous
Caimodlties
o Tobacco
— Non-Food/Feed
— Meat/Milk/Poultry/Efegs
J1-5 - Reduction of Residue
71-6 - Proposed Tolerance
EP
TGAI or Plant
Metabolites
Residue of
Concern
Residue of
Concern
Yes
No
N3
Ito
0088388, 00050732 N6>
GS0195-001
No 3 /
No 3/
to 3/
71-7 - Reasonable Groinds in
Support of Petition
No
No 3/-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
58.125 Residue Chemistry - Continued
Composition: TGAI = Technical grade of the active Irigredient; PAIRA = Pure active irigredient, radiolabeled; TCP =
Typical end-use product; EP = Ehd-use product.
Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
These data are not required for perfluldone because of Its non-food and non-feed use pattern.
21
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
Requirement
Composition
1/
(fee 2/
Bittern
Does EPA Have
Data To Satisfy
TWLa Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Cata
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
.130 Environmental Fate
jRADATION STUDIES-LAB:
1-1 - Hydrolysis
TGAI or
PAIRA
B
No
Yes
9 months
otodegradation
1-2 - In water
TGAI or
PA IRA
B
No
Yes
-
9 months
1-3 - Ch soil
TQAI or
PAIRA
8
No
No
L-4 - In Air
TQAI or
PAIRA
No
No
§/
PABOLISM STODIES-LAB:
?-l - Aerobic Soil
TGAI or
PAIRA
B
No
Yes
27 months
1-2 - Anaerobic Soil
TGAI or
PAIRA
B
No
No
§/
?-3 - Anaerobic Aquatic
TQAI or
PAIRA
No
No
§J
- Aerobic Aquatic
TGAI or
PAIRA
No
No
6/
ilLITY STODIES:
}-l - Leaching and
TGAI or
PAIRA
B
No
Yea k/
12 months
Adsorption/Desorption
to
No
§/
1-2 - Volatility (Lab)
TEP
No
No
6/
1-3 - Volatility (Field,)
TEP
Nb
No
6/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
Requirement
Composition
1/
Use 2/
Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional rata
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
.130 Environmental Fate - Continued
SSIPATION STUDIES-FIELD:
1-1 - Soil
U—2 - Aquatic (Sediment)
4-3 - Forestry
U—4 - Combination and
Tank Mixes
4-5 - Soil, Lorg-tenn
CUMULATION STUDIES:
5-1 - Rotational Crops
(Confined)
5-2 - Rotational Crops
(Field)
5-3 - Irrigated Crops
5-4 - In Fish
5-5 - In Aquatic Non-Target
Organisms
TEP
TEP
TEP
TEP
TEP
PA IRA
TEP
TEP
TGAI or PAIRA
TEP
B
B
B
B
B
No
to
No
No
Ito
No
No
No
No
No
Yes
No 6/
No 6 /
No 5/
No 6/
No 6/
No 6/
No 6/
No 6/
No 6/
27 months
23
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
§158.130 Environmental Fate - Continued
/ Composition: TCAI = Technical grade of the active ingredient; PA IRA = Pure active irjgredlent, radio label led;
TEP = Typical end-use product.
'/ The use patterns are coded as follows: A=Terrestrlal, Pood Crop; B=Terrestrial, Non-Pood; C=Aquattc, Pood Crop;
D= Aquatic, Non-Pood; E=Greenhouse, Pood Crop; P=Greenhouse, Non-Pood; G=Porestry; H=Dcmestic Outdoor; I=Indoor.
1/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 9 Month Due Date Is June 30, 1986.
0 12 Month Due Date Is September 30, 1986.
0 27 Month Due Date is December 30, 1987.
1/ Additional data will be required on leaching of perfluidone degradation products.
1/ Data on perfluidone in combination and tank mixes are not addressed in this Guidance Document.
1/ These data requirements do not apply to the current use pattern.
-------
TABIE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
a Requirement
1/ Use 2/
Composition fettern
Does EPA Have
Data To Satisfy
TMs Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
>8.135 Toxicology
ICUTO TESTING:
tl-1 - Acute Oral Toxicity TGAI
- Rat
Si —2 - Acute Dermal Toxicity TGAI
- Rabbit
ll-3 - Acute Inhalation Toxicity TGAI
- Rat
B
B
B
No
Yes
No
000382*42
Yes
No
Yes
9 months
9 months
H-4 - Primary I$ye Irritation
TGAI
B
Yes
00038241
No
Jl-5 - Primary Skin Irritation
TGAI
B
Yes
000382^4
No
Jl-6 - Dermal Sensitization
TGAI
B
No
-
Yes
9 months
Jl-7 - Delayed
Neurotoxicity - Hen
TGAI
B
No
No 4/
jUBCHRONIC TESTING:
!2-l - 90-Day Feeding :
- Rod ait, and
TGAI
B
No
—
No 7/
- Nbn-rodent (Dog)
TGAI
B
Yes
00035574
No
12-2 - 21-Day Dermal - Rabbit
TGAI
B
No
-
Yes
12 months
12-3 - 90-Day Dermal - Rabbit
TGAI
B
No
9t;
No 7/
-------
TAB1JZ A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
Requirement
1/ Use 2/
Composition Pattern
Does EPA Have
Data lb Satisfy
Ihla Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
.135 Toxicology - Continued
-U - 90-Day Inhalation:
- Rat TCAI
-5 - 90-Day Neurotoxicity:
- Hen TCAI
-Manual TGAI
=tONIC TESTING:
-1 - Chronic Toxicity -
2 species:
- Rodent, and TCAI
- Non-rodent (Dog) TGAI
-2 - Oncogenicity -
2 species:
- Rat (preferred), and ^TOAI
- Mouse (preferred) TGAI
-3 - Teratogenicity -
2 species:
- Rat TCAI
- Rabbit TGAI
B
B
B
B
B
B
B
B
B
to
No
to
to
to
to
to
to
to
to y
to V
No V
to 7/
No 7/
to 7/
No 7/
Yes 5/ 15 Months
Yes 5/ 15 tonths
-4 - Reproduction - Rat
2-generation
TGAI
B
to
26
No 7/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
Requirement
Composition
1/
Use 2/
Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA-§ 3(c)(2)(B)?
Time Frame for Data
Submission 3/
.135 Toxicology - Continued
TAGENICITY TESTING
-2 - Gene Mutation (Ames Test)
TGAI
B
No
Yes
6/
9 months
-2 - Structural Chromosomal
Aberration
TGAI
B
No
Yes
6/
12 months
-H - Other Genotoxic Effects
TGAI
B
No
6/
12 months
ECIAL TESTING
i
-1 - General Metabolism PAI or PAIRA
B
No
No
V
-2 - Dermal Penetration
Choice
B
No
No
V
-1 - Domestic Animal
Choice
B
No
No
7/
Safety
27
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
§158.135 Toxicology - Continued
1/ Composition: PAI = Pure active Ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several
test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows: A=Terrestrlal, Pood Crop; B=Terrestrlal, Non-Pood; C=Aqautic, Pood Crop;
D=Aquatic, Non-Pood; E=Greenhouse, Pood Crop; F=Greenhouse, Non-Pood; G=Porestry; H=Dcmestic Outdoor; I=Indoor.
3/ Data must be submitted within the indicated time frame, based on the date of the Guidance Docunent....
— 0 9 Month Due Date is June 30, 1986 .
0 12 Month Due Date is September 30, 1986 .
0 15 Month Due Date is December 30, 1985^
V Perfluldone is not an organophosphate, nor is it known to cause delayed neurotoxicity.
5/ Teratology studies in both the rat and rabbit are required.
F/ The following mutagenicity data are required:
— a. In vitro mamtiallan cell point mutation [L5178Y (TK), or CHO (HGPRT), or V79 (HGPRT)] tests,
b. In vitro cytogenetic damage: both chromosomal aberration and SCE (in CHO cells, or hunan lymphocytes, or other
rodent/hunan cell lines/strains tests
c. In vitro/in vivo primary hepatocyte repair for UDS testing both in vivo and In vitro exposure of cells to
Perfluldone,
d. In vivo cytogenetics test for chromosomal aberrations using bone marrow preparations of rats,
e. Dominant lethal test in rats or mice.
7/ Hie guidelines and use pattern indicate .that these data are not required.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
Requirement
1/ Use 2/
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
3e Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
.140 Reentry Protection
!-l - Foliar Dissipation TEP
'-1 - Soil Dissipation TEP
1-3 - Dermal Exposure TEP
I-1! - Inhalation Exposure TEP
1*12 Spray Drift
-1 - Droplet Size Spectrun TEP
-1 - Drift Field Evaluation TEP
B
B
B
B
B
B
No
Ito
No
Ito
No
No
No 4 /
No 4 /
No V
No 4/
No 5/
No 5/
imposition: TEP = Typical end-use product.
e use patterns are coded as follows: A=Terrestrlal, Food Crop; B=Terrestrlal, Non-Food; C=Aquatic, Food Crop;
Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor,
ta must be submitted within the indicated time frame, based on the date of the Guidance Docunent.
sed on the criteria cited in 40 CFR §158.140, reentry data are not required for perfluidone.
ese data requirements do not apply to perfluidone's use pattern.
29
-------
TABLE A
GENEKIC DATA REQUIREMENTS FOR PERFLUIDONE
i Requirement
Composition"
1/
Use 2/
Pattern
Does EPA Have
Data lb Satisfy
Tills Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Hist Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 1Z.
3.115 Wildlife and
uatlc Organisms
HAN AND MAMMALIAN TESTING
L-l - Acute Avian Oral Toxicity TGAI
1-2 - Avian Subacute Dietary
Toxicity
- Upland Game Bird, and TSAI
- Waterfowl TGAI
1-3 - Wild Mammal Toxicity TSAI
-4 - Avian Reproduction
- Upland Game Bird, and TSAI
- Vfeterfowl TGAI
-5 - Simulated Field Testing
- Manmals, and TEP
- Birds TEP
- Actual Field Testing
- Mammals, and TEP
- Birds TEP
B
&
B
B
B
B
B
B
B
B
No
No
No
No
Reserved
Reserved
No
fo
No
to
Yes
}fes
Yes
to 7/
V
V
No 7/
No 7/
No 7/
No 7/
9 Months
9 Months
9 Months
-------
TABU? A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
a Requirement
1/ Use 2/
Composition Pattern
Does EPA Have
Data lb Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Mist Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for lata
Submission 3/
8.145 Wildlife and
uatlc Organisms - Continued
QUATIC ORGANISM TESTING
2-1 - Freshwater Fish Tbxiclty
- Warm water Fish Specle3,
- Coldwater Fish Species
2-2 - Acute Toxicity to
Freshwater Invertebrates
2-3 - Acute Toxicity to
Estuarine and Marine
Organisms
- Marine Fish
- Mollusk
- Shrimp
2-4 - Fish Early Life Stage,
and
- Aquatic Invertebrate
Life-Cycle
72-5 - Pish - Life-Cycle
TGAI
TEP
TCAI
TEP
TGAI
tEP*
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
B
B
B
B
B
B
B
B
B
B
B
B
P&rtially 5/6/
No
Partially 5/6/
No
Nd
Nd
No
Nd
No
Nd
No
No
00039574
00039574
Yes
No 7/
Yes
No 7/
Nd 7/
No 7/
Nd 7/
No 7/
Nd 7/
Nd 7/
9 months
9 months
Yes 9 months
No 7/
31
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
Requirement
Composition
1/
Use 2/
Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for* Data
Submission 3/
.1M5 Wildlife and
atlc Organisms - Continued
2-6 - Aquatic Organism
Accunulation
- Crustacean
- Fish
- Insect Nymph
- Mollusk
?-7 - Simulated Field Testing
- Aquatic Organisms
- Actual Field Tfesting
-Aquatic Organisms
TGAI, PAI OR
Degradation
Product
TEP
TEP
B
B
:B
B
9
B
No
fb
No
to
No
No
to 7/
No 7/
to 7/
No 7 /
to 7/
to 7/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
58.1*15 Wildlife and Aquatic Organisms - Continued
Composition: TGAI = Technical grade of the active Ingredient; PAI = pure active Ingredient;
TEP = Typical end-use product;
The use patterns are coded as follows: A=Terrestrial, Flood Crop; B=Terrestrlal, Non-Pood Crop; C=Aquatic, Pood Crop;
D=Aquatic, Non-Pood; E=Greenhouse, Pood Crop; F=Greenhouse, Non-Pood; G=Porestry; H=Dcmestic Outdoor; I=Indoor.
Data must be submitted within the Indicated time frame, based on the date of the Guidance Docunent.
° 9 Month Due Date Is June 30» 1986.
Requirement Is reserved pending acute avian data.
Clarification is needed regarding solubility of the technical material.
Present study can oply fulfill requirement In conjunction with additional data.
The guidelines and use pattern Indicate that these data are not required.
33
-------
TABLE a
GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
Does EPA Have Mu3t Additional Data
Data lb Satisfy Be Submitted Under
1/ Use 2/ This Require- Bibliqgraphic FIFRA § 3(c)(2)(B)?
a Requlranent Composition Pattern ment? (Yes, No Citation Time Frane for Data
or Partially) Submission 3/
3.155 Nontaqget Insect
3OTARGET INSECT TESTING -
3LLINATQRS:
fJl-1 - Honey bee acute
contact toxicity TGAI B No - No 4/
41—2 - Honey bee - toxicity TEP B No No H/
of residues on
foliage
'41-4 - Honey bee subacute
feeding study
'41-5 - Field testing for
pollinators
)NTAROET INSECT TESTING -
jUATIC INSECTS:
'42-1 - Acute toxicity to
aquatic insects
42-1 - Aquatic insect
life-cycle study
42-3 - Simulated or actual
field testing for
aquatic Insects
13-1 - NONTARGET INSECT
lru
13-3 AND PARASITES
TESTING - PREDATORS
(Reserved) 6/
TEP B
(Reserved) 6/
(Reserved) 6/
(Reserved) 6/
(Reserved) 6/
No
No 5/
-------
TABLE A
-GENERIC DATA REQUIREMENTS FOR PERFLUIDONE
8.155 Nontarget Insects
/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
/ Hie use patterns are coded as follows: A=Terrestrlal, Pood Crop; B=Terrestrial, Non-Food; C=Aquatic, Fbod Crop:
D=Aqautic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse# Non-Fbod; G=Forestry; H=Domestlc Outdoor; I=Indoor.
/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
/ No additional data required because.the proposed use pattern would not result in exposure of honey bees
to perfluidone.
/ No additional data required because the proposed use pattern would not result in exposure of other pollinators
to perfluidone.
/ Reserved pending Agency3* decision as to whether data requiranent should be established.
35
-------
TABLE B
FRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PERFLUIDONE 5/
leltne Citation and
i of Test
Test Guidelines
Substancel/ Status2/
Are E&ta
Required
Yes No
Fbotnote
Nunber or
Citation
3.120 Product Chemistry
coduct Identity:
Data Must Be
Submitted Within
Time Frames Listed
Below3/
1-1 - Product Identity and Disclosure
of Ingredients
MP
R
Q
[X]
00038230
L-2 - Description of Beginning Materials
and Manufacturing Process
MP
R
ra
n
6 months
L-3 - Discussion of formation of
Impurities
MP
R
[X]
n
6 months
lalysis and Certification of Product
Tgredients
?-l - Preliminary Analysis
MP
CR
m
~
12 months
1-2 - Certification of Limits
MP
R
m
o
12 months
J-3 - Analytical Methods to Verify
Certified Limit
MP
R
m
o
12 months
lysical and Chemical Characteristics
-2 - Color
MP
R
n
[X]
00038230
-3 - Physical State
MP
R
n
[X]
00038230
;-4 - Odor
MP
R
O
[x]
00038230
[-5 - Melting Point
MP
R
o
[X]
00038230
-6 - Boiling Point
MP
R
n
[X]
00038230
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PERFLUIDONE a/
eline Citation and
of Teat
Test Guidelines
Substancel/ Status2/
.120 Product Chemistry (Continued)
leal and Chemical Characteristics
tinued)
-7 - Density, Bulk Density, or
Specific Gravity
-12 - pH
MP
MP
Are Data
Required
Yes No
R
R
[X]
[X]
n
n
Fbotnote
Number
Data Hist Be
Submitted Within
Time Frames Listed
Belowl/
6 months
6 months
her Requirements:
- 1 - Submittal of samples
MP
CR
n
[X]
8.120 Product Chemistry
Technical perfluldone also serves as a manufacturing-use product.
TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient,
R = Required; CR = Conditionally Required,
Data must be submitted within the Indicated time frame, based on the date of the Guidance Docunent.
6 Month Due Date is March 30# 1986.
12 Month Due Date is September 30, 1986.
This compound does not require the submittal of samples at the present time.
37
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PERFLUIDONE
ca Requirement
Composition
1/
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional H&ta
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 2/
58.135 Toxicology
kCUTE TESTING
il-1 - Acute Oral Toxicity MP
- Rat
il-2 - Acute Dermal Toxicity MP
- Rabbit
il-3 - Acute Inhalation Toxicity MP
- Rat
Jl —4 - Primary I$ye Irritation MP
- Rabbit
11-5 - Primary Dermal Irritation MP
- Rabbit
tl-6 - Dermal Sensitization MP
- Guinea Pig
No
Yes
No
Yes
Yes
No
00038242
00038244
00038244
Yes
Yes
No
No
Yes
9 months
9 months
9 months
158.135 Toxicology - Continued
/ Composition: MP = Manufacturing-use product.
/ Data must be submitted within the Indicated time frame, based on the date of the Guidance Document.
0 9 Month Due Date is June 30» 1986 .
58
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IV. SUBMISSION OF REVISED LABELING
Note: This section applies to end use products only to the
extent described in Section-,-I (Regulatory Position and
Rationale). Otherwise, the'- following information pertains
exclusively to manufacturing use products.
PIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CFR 162.10 (see
Appendix IV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix IV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
If you fail to submit revised labeling information
complying with this section (supplemented by requirements
described in Section I, Regulatory Position and Rationale),
EPA .may issue a notice of intent to cancel the registration
under FIFRA sec. 6(b)(1).
A. Label Contents
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items
listed below are keyed to Appendix IV-2.
Item 1. PRODUCT NAME - Ihe name, brand or trademark is
required to be located on the*front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
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Item 3» NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The ne ^.-'contents must be expressed in the
largest suitable unit, e.g?, "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed In metric units. See Appendix IV-1. [40 CFR
162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which It appears and must run parallel to It. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV-1.
[40 CPR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER- The EPA establishment
number, preceded by the phrase "EPA Est." Is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
See Appendix IV-1. [40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An Ingredients statement
Is required on 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 ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. See Appendix IV-1. [40 CPR
162.10(g)]
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Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL P!|ECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various 3ize labels.
Size of Label
on Front Panel
In Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word
Minimum Type Size
All Capitals
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
Minimum Type Size
6 point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix IV-1.
[40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[40 CFR 162.10 (h)(1)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Categoryon the .basis of oral, dermal,
or inhalation toxicity, the word "Pois.on" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. See Appendix IV-1. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV-1. [40 CFR 162 .10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix IV-1. [40 CFR 162.10(h)(1)(iii)]
41
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Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the la'ael under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix IV-1. [40 CFR 162.10
(h)(2)].
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 to be taken to avoid
accident, Injury or damage. See Appendix IV-1. [40 CFR 162.10
(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix IV-1. [40 CFR
162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammabllity statement. Precautionary statements relating
to flammabllity of a product are .required to appear on the
label if it meets the criteria in Appendix IV-3. The require-
ment is based on the results of the flashpoint determinations
and flame extension tests4*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 flammabllity statements.
2. Criteria for declaration of non-flammablllty. The
following criteria will be used to determine if a product
Is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A "non-flammable liquid" is one having a flashpoint
greater than 350°F (177°C).
42
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c. A "non-flammable aerosol" Is one which meets the
following criteria:
i. The flame extension is zero inches;
ii. There is no flashback; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°P (177°C).
3. Declaration of non-flammablllty. Products which
meet the criteria for non-flammability specified
above may bear the notation "non-flammable" or "non-
flammable (gas, liquid, etc.)" on the label. It may
appear as a substatement to the Ingredients statement,
or on a back or side panel, but shall not be highlighted
or emphasized (as with an inordinately large type
size) In any way that may detract from precaution.
4. Other physical/chemical hazard statements. When
chemistry data demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulatipns/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direc-t^upervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section I
Indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active Ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination vrill be evaluated in accordance with
the provisions of 40 CPR 162.11(c). You will be notified of
the Agency's classification decision.
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Classification Labeling Requirements
If Section I of this Guidance Document indicates that
your product has been classified for restricted use, the
following label requirements-apply:
"if'
1. Front panel statement of restricted use classification.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CPR 162.10(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terras of restriction must
appear (including the reasons for restriction if
specified in Section I). If use is restricted to
certified applicators, the following statement is
required: "For retail sale to and use only by
Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some 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 y6iT may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with Identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
44
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Item 9B [There is no Item 9B] .
Item 9C. MISUSE STATEMENT - All products must bear the
misuse statement, "It 1s a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agfency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983*
Item 10B [There is no Item 10B].
Item IOC. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes, as
required for the child hazard warning. Refer to Appendix
IV-4 to determine the disposal instructions appropriate for
your products.
Item 10D. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse' Effects on the environment. See
Appendix IV-1. [40 CFR 162.1,0]
B. Collateral Labeling '
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or 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
thos£ accepted in connection with registration of the product.
It should be made part of the response to this notice and
submitted for review.
45
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V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing perfluldone as
an active Ingredient.
' "V-
1. Within 90 days from^-receipt of this document, you must
submit to the Product Manag'er in the Registration Division at
the address given at the end of this section the "FIFRA Section
3(c)(2)(B) Summary Sheet" EPA Form 8580-1. Refer to Appendix
II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within 6 months from receipt of this document you must
submit to the Product Manager on the Registration Division:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4
(Appendix III-l).
c. Two copies of any required product-specific data.
* *«
d. Two copies of draift labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such;labeling . End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. The labeling should Be either typewritten
text on 8-1/2 x 11 inch paper or a mockuj£ of the labeling
suitable for storage in 8-1/2 x 11 Inch files. The draft
label must indicate the intended colors qf the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(1)(D). Refer to 40 CFR 152.80-152.99
for latest requirements.
3. Within the times set forth in Table A. you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator's exemption. If for any reason any '
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
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B• For Manufacturing Use Products containing perfluldone in
combination with other active Ingredients
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet," EPA Form
85^0-1. Refer to Appendix 51-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a data
requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within the times set forth In Table A, you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator's exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
C. For End Use Products containing perfluldone alone or in
combination with other active Ingredients:
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix IIt3 with appropriate attachments.
» ~«
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
-Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within 6 months from receipt of this document you must
submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product-Specific Data Report, EPA Form 8580-4
(Appendix III-l).
c. Two copies of any required product-specific data.
(Refer to Table C).
47
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d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use *
product labeling must comply specifically with the instructions
in Section I (Regulatory ,Position and Rationale) of this
guidance document. Labelling should be either typewritten
text on 8 1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8 1/2 inch files. The draft label
must indicate the intended colors of the final label, clear
indication of the front panel label, and the intended type
sizes of the text.
e. Evidence of compliance with data support requirements
of PIPRA sec. 3(c)(1)(D). Refer to 40 CPR 152.80-152.99
for latest requirements.
3^ Within the time frames set forth in Table A, submit all
generic data, unless you are eligible for the formulator's
exemption.
D. For intrastate products containing perfluldone either as
the sole active ingredient or in combination with other
active ingredients
These products are being called In for full Federal
registration. Producers of these products are being sent
a letter Instructing them how to submit- an application for
registration.
E. Applications and other required information should be
submitted to the following address:
Robert J. Taylor
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 St., SW.
Washington, D.C. 20460
Phone No. (703) 557-1800
The address for submission to the Office of Compliance Monitoring
is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460
48
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Appendix II-l
Guide to Use of This Bibliography
1. CONTENT OP BIBLIOGRAPHY/ This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and it's 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.
49
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a. Author. Whenever the Agency could confidently Identify
one, the Agency has chosen to show a personal author.
When no Individual was identified, the Agency has
shown an Identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence In the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. Por 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 follpwing 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 accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volune.
Por example, within accession number 123^56, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123^56-Z; and the 27th, 123456-AA.
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under, the Perfluidone Standard
MRID CITATION
00035510 Bandal, S.K. (1974) Interim Report, Rotational Crop Study: Determi-
nation of Uptake of Destun-Derived Radiocarbon Residue frcrn a
Loamy Sand: Project No. 741113. (Unpublished study received
Mar 6, 1974 under 4G1423; submitted by 3M Co., St. Paul, Minn.;
CDL:093797-F)
00035574 Goldenthal, E.I.; Geil, R.G.; Cookson, K.M. (1973) Ninety Day Sub-
acute Oral Toxicity Study in Dogs: 102-020. (Unpublished study
received Jul 26, 1973 under 4G1423; prepared by International
Research and Development Corp., submitted by 3M Co., St. Paul,
Minn.; CDL:093796-J)
00038230 Green, C.D.; Anderson, S.C. (1975) Chemistry of Perfluidone: Report
No. 095. (Unpublished study received May 16, 1975 under 5F1631;
submitted by 3M Co., St. Paul, Minn.; CDL:094429-B)
00038231 Todd, J.W.; Crowell, J.D. (1975) Manufacturing Process and Purity
of Technical Perfluidone: Report No. I67. (Unpublished study
received May 16, 1975 under 5F1631; submitted by 3M Co., St.
Paul, Minn.; CDL:094429-C)
00038234 Todd, J.W. (1973) Determination of Destun: Report No. 082. Method
GC-2 dated Jun 1973. . .^Unpublished study received May 16, 1975
under 5F1631; submitted by 3M Co., St. Paul, Minn.; CDL:
094429-F)
00038236 Todd, J.W. (1973) Determination of Destun: Report No. 084. Method
GC-4 dated Jun 1973. (Unpublished study received May 16,-1975
under 5F1631; submitted by 3M Co., St. Paul, Minn.; CDL:
094429-H)
00038237 Todd, J.W. (1974) Determination of Perfluidone and Volatile Concom-
itants [sic] in the Technical Chemical: Report No. 089• Method
GC-6 dated Dec 1974. (Unpublished study received May 16,-1975
under 5F1631; submitted by 3M Co., St. Paul, Minn.; CDL:
094429-1)
00038238 Hagen, D.F.; Nevmark, R.A.; Stebbings, W.L. (1975) Unknown Impurity
in Technical Perfluidone: Report No. 6276. (Unpublished study
received May 16, 1975 under 5F1631; submitted by 3M Co., St.
Paul, Minn.; CDL:094429-J)
51
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under.the Perfluidone Standard
MRID CITATION
00038242 3M Company (1975) Synopsis: [Perfluidone]. Summary of studies
O9443O-B .through 094430-N. (Unpublished study received May 16,
1975 under 5F1631; CDL:094430-A)
00038244 Saunders, D.R.; Nelson, R.A. (1975) Primary Skin and Ocular Irrita-
tion Studies with Technical Perfluidone, Destun 50WP, Destun 4S:
Report No. 152. (Unpublished study received May 16, 1975 under
5F1631; submitted by 3M Co., St. Paul, Minn.; CDL:094430-C)
00038253 Bandal, S.K.; Clark, H.B. (1975) A Balance Study on the Elimination
of Orally Administered Perfluidone-l4C at Doses of 1, 10 and 100
Ms/Kg by the Rat: Report No. 099. (Unpublished study received
May 16, 1975 under 5F1631; submitted by 3M Co., St. Paul, Minn.
CDL:094430-M)
00038524 Daftsios, A.C. (1975) Determination of Destun Residues in Immature
Cottonseed: Report No. 209- Undated method 8251-GC-Residues-l.
(Unpublished study received May 16, 1975 under 5F1631; submitted
by 3M Co., St. Paul, Minn.; CDL:094434-S)
00039311 Bandal, S.K.; Clark, H.B.; Steifer," L.J. (1975) Metabolism of Per-
fluidone-l4C by Mature Cotton Plants in a Sandy Loam Soil: Re-
port No. 154. (Unpublished study received May 16, 1975 under
5F1631; submitted by .3^. Co., St. Paul, Minn.; CDL:094434-J)
00039314 Daftsios, A.C. (1974) Determination of Perfluidone in Cottonseed
Meal: Report No. 077. Undated method 8251-GC-Residues-5. (to-
published study received May 16, 1975 under 5F1631; submitted by
3M Co., St. Paul, Minn.; CDL.-094434-M)
00039315 Daftsios, A.C. (1974) Determination of Perfluidone in Cottonseed
Hulls: Report No. 078. Undated method 8251-GC-Residues-6. (Un-
published study received May 16, 1975 under 5F1631; submitted by
3M Co., St. Paul, Minn.; CDL.-094434-N)
00039316 Daftsios, A.C. (1974) Addendum to the Residue Method for Perflui-
done in Nature Cottonseed (Agrichemical Report Number 076): Re-
port No. 081. (Unpublished study received May 16, 1975 under
5F1631; submitted by 3M Co., St. Paul, Minn.; CDL:094434-Q)
00039317 Howell, S.M. (1975) Perfluidone Stability in Soil under Freezer
Storage Conditions: Report No. 160. (Unpublished study received
May 16, 1975 under 5F1631; submitted by 3M Co., St. Paul, Minn.;
CDL:094434-R)
52
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION. STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data 3ase Supporting
Registrations Under,the Perfluidone Standard
MRID CITATION
00039318 Daftsios, A.C. (1975) Commercial Pesticides Used on Cotton Grown in
Destun Treated Plots: Report No. 211. (Unpublished study re-
ceived May 16, 1975 under 5F1631; submitted by 3M Co., St. Paul,
Minn.; CDL:094434-T)
00039491 Daftsios, A.C. (1975) Residue Method for Perfluidone in Mature Cot-
tonseed: Report No. 076. Undated method 8251-GC-Residues-2.
(Unpublished study received May 16, 1975 under 5F1631; submitted
by 3M Co., St. Paul, Minn.; CDL:094439-C)
00039574 Fink, R. (1972) Final Report: Acute LC50—Bluegill Sunfish and
Rainbow Trout: Project Nos. 456-110 and 456-111; Report No. 177.
(Unpublished study received May 16, 1975 under 5F1631; prepared
by Envirormental Sciences Corp., submitted by 3M Co., 'St. Paul,
Minn.; CDL:094436-E)
00039578 Davis, D.G.; Dusbabek, K.E. (1974) Translocation and Effects of
Perfluidone on Cotton and Yellow Nutsedge: Report No. 98. (U.S.
Agricultural Research Service, Plant Science Research, unpub-
lished study; CDL:094436-J)
00039579 Bandal, S.K.; Steifer, L.J.; Hanes, R.E. (1975) Uptake and Trans-
location of Perfluidone-Derived Radiocarbon in Oats and Soy-
beans Grown in a Sandy»-loam Soil Nine Months after Soil-Appli-
cation of Perfluldone7l4C: Report. No. 156. (Unpublished study
received May 16, 1975 under 5F1631; prepared in cooperation
with United States .Testing Co., Inc., submitted by 3M Co.,
St. Paul, Minn.; CDL:094436-K)
00050732 3M Ccmpany (1977) Synopsis and Data Sunmary Table: [Destun]. (Com-
pilation; unpublished study received May 18, 1977 under 7182-
EX-17; CDL:230236-A)
00077842 Daftsios, A.C. (1974) Determination on Perfluidone in Crude and Re-
fined Cottonseed Oil: Report No. 080. Undated method 8251-GC-
Residues-3. (Unpublished study received May 16, 1975 under
5F1631; submitted by 3M co., St. Paul, Minn.; CDL:094434-P)
00088387 Steifer, L.J. (1975) Metabolism of Perfluidone-l4C in Tobacco
Plants (Necotiana tobacun L.): Report No. 220. (Uhpublished
study received Apr 5, 1976 under 7182-EX-17; submitted by 3M
Co., St. Paul, Minn.; CDL:227717-F)
53
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under,the Perfluidone Standard
MRID CITATION
00088388 Daftsios, A.C. (1975) Determination of Perfluidone Residues in
Cured Tobacco: Report No. 221." (Unpublished study received
Apr 5, 1976 under 7182-EX-17; submitted by 3M Co., St. Paul,
Minn.; CDL:227717~G)
00105868 Medical Products (1979) Supplement II to the Brochure Dated March
30, 1976, and Entitled: Destun Herbicide (Perfluidone): Analyt-
ical, Metabolisn, Residue and Snoke Taste Tests on Tbbacco:
Report No. 759. (Unpublished study received Oct 18, 1979 under
7182-10; CDL:241223-A)
54
-------
Citation
GS0195-001 U.S. Department of Agriculture (1983) Agricultural Statis-
tics III. Tobacco: 97-
55
-------
OMB Approval dJ'pifbs 12-31m&Q
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
DATE GUIDANCE DOCUMENT ISSUED
r*LICANT S NAME
With respect to the requirement to submit "generic" data imposetEtiy the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner
~ 1. I will submit data in a timely menner to satisfy the following requirements. If the test procedures I 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, OECO
Chemicals Testing Programme, I enclose the protocols that I will use:
~ 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
G 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
G 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
G 5. I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
.GISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
EDA Kmmu MUMl 1 lm ml
-------
Qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
APPENDIX II- 4
OMB Approval No. 2000-0468 (Expires: 12-31-83)
duly authorized to represent the following firm(s) who are subject to the require-
'ts of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
lo submit data concerning the active ingredient:
NAME OF FIRM
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
or group of firms is referred to below as "my firm".)
firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
y an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
Jvflrm has offsred in writing to sntar into such an agreement Copies of the offers an attached. That offer was irrevocable and included an offer to be
®®und 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
0 fa following firm(s) on the following data(s):
s NAME OP FIRM
DATE OP OFFER
v
^
..
SSiBf. none of tho«a firm(i) accented mv offer.
!*V fi. r-„. , ^ :
^ r#^ueltJ that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
89reed t0 subm't th* data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
Whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
* hot apply to applicants for new products.) I give EPA pergai^jon to disclose this statement upon request.
'Name
SIGNATURE
DATE
-------
Appendix III-l
EPA Registration No.
PRODUCT SPECIFIC DATA REPORT
_Guidance Docunent for_
Date
Registration
Guideline No.
• §158.20
PRODUCT
CHEMISTRY
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Submit-
ting
Data
(At-
Cltlng MRID#[tached)
(For EPA Use Oily)
Accession Numbers
Assigned
"5TT
Identity of
ingredients
Statement of
composition
Discussion of
formation of
Ingredients
"5TT
T2=F
Preliminary
analysis
T2=T
Certification of
limits
¦W2
Analytical methods
for enforcement
limits
Color
Physical state
jgpT
Odor
"53=5"
Melting point
TFT
Bailing point
"53=8"
Density, bulk-
density, or
specific gravity
Solubility
63-10
Vapor pressure
TFIT
63-12
Dissociation
constant
Octanol/water
partition
coefficient
P«
58
-------
Appendix III-l (continued)
Registration
Guideline No.
*
Name of Test
JTest not
•required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use Only)
Accession Numbers
Assigned
Citing MRID#
Submit-
ting
Data'
(At-
tached)
63-13
Stability
63-M
Oxidizing/reduc ing
reaction
63-15
Flanmability
63-16
Explodability
63-17
Storage stability
63-18
Viscosity
63-19
Miscibility
63-20
Corrosion
characteristics
63-2A
Dielectric break-
down voltage
§158.135
TOXICOLOGY
81-1
Acute oral LD-50,
rat
81-2
Acute dermal
LD-50
81-3
Acute Inhalation,
LC-50 rat
81-4
Primary eye
irritation, rabbit
81-5
Primary dermal
irritation
81—6
Dermal sensitiza-
tion
59
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§162.10 LABELING REQUIREMENTS
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations-Jin this Part. The contents of a
label must show clearly and'^prominently the following:
(1) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(vlii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility, (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render lt^likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language, versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
60
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the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label .nust
also be securely attached trog-such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CPR Parts 170-189» concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labelin'g, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act.pursuant to § 162.15, is misbranded if its labeling is
false or misleading in any particular.including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading-statement concerning the composition
of the product; .
Cii) A false or misleading' statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
61
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(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when^used as directed"; and
(x) Non-numerical and/or/^iomparative statements on the safety
of the product, Including bffb not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"
(C) "Pollution approved"
(6) Pinal printed labeling. (i) Except as provided in
paragraph (a)(6)(H) of this section, final printed labeling must
be submitted and accepted' prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(1) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to § 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the'name of the person for whom the
pesticide was produced appears*on the label, it must be qualified
by appropriate wording such as "Packed for **#," "Distributed by
***," or "Sold by ***" to show that tlie name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°P (20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
62
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(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration niunber. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or Imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or Immediate
container. It must 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.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert-ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arserif6 calculated as elemental arsenic.
The active ingredients must be* designated by the terra "active
ingredients" and the inert Ingredients .by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement.
(2) Position of ingredient statement. (1) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the Ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
63
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(3) Names to be used In Ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical najme alone shall be used. In no case
will the use of a trademark^br proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated In terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%•" If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice.. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements:
(i) In cases where it Is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(11) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. ThS'Administrator may require the name
of any inert ingredient(s) tjoVibe listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
64
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Hazard Indicators
Toxicity cataqorles
I
1I
III
IV
Oral LD
50
Inhalation LC
50
Dermal LD
50
Eye affaets
Skin affects
Up to and -5-
Including ^
SO mg/kg
Up to and
Including
.2 mg/l!ter
Up to and
Including
200 mg/kg
Corrosive;
cornaal opacity
not reversible
within 7 days
Corrosive
From 50 thru
500 ng/kg
From .2 thru
2 mg/lIter
From 200
thru 2000
Cornaal opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
From 500 thru
5000 eg/kg
From 2 thru
20 mg/Mter
From 2,000 thru
20,000
No corneal opacity;
Irritation
reversible
within 7 days
Moderate Irritation
at 72 hours
Greater than
5000 mg/kg
Greater than
20 mg/titer
Greater than
20,000
No Irritation
Ml Id or slight
Irritation at
72 hours
(i) Human hazard siqnal^word.--(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
(B) Toxicity Category II. mAll pesticide products meeting the
criteria of Toxicity Category" II shall bear on the front panel
the signal word "Warning."
(C) Toxicity Category III. All pesticide products meeting the
criteria of Toxicity Category III shall bear on the front panel
the signal word "Caution."
(D) Toxicity Category IV. All pesticide products meeting the
criteria of Toxicity Category IV shall bear on the front panel
the signal word "Caution."
65
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(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects^on. man or the environment. In no
case shall more than one huflpfcn hazard signal word appear on the
front panel of a label. ^
(ii) Child hazard warning . Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage- or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(lii) Statement of practical treatment—(A) Toxicity
Category T7 A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) of this section. The applicant may,
however, Include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph,(h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominfeilbe. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked und$r customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square Inches
Points
Required
signal word,
all capitals
"Keep out
of reach of
Children"
5 and under
6
6
Above 5 to 10
10
6
Above 10 to 15
12
8
Above 15 to 30
r
14
10
Over 30
18
12
6 k
-------
(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the label under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard" to humans and domestic animals. (A) Where a hazard
exists to humans or domestic ^animals, precautionary statements
are required indicating ttfe particular hazard, the route(s) of
exposure and the precautions to be taken to avoid acdident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
j Toxicity
Precautionary statements by toxicity category [
I category
Oral. Inhalation, or dermal toxicity
Skin and eye local effects 1
| 1 . . .
Fatal (poisonous) If swallowed (Inhaled or
absorbed through skin!. Do not braatha
vapor (dust) or spray alstl. Do not gat
In ayes, on skin, or on clothing (Front
panel statement of practical treatnent
requlred.l.
Corrosive, causes eye and skin damage [or f
skin Irritation). Oo not get In ayes, on |
skin, or on clothing. Wear goggles or face \
shield and rubber gloves when handling. |
Harmful or fatal If swallowed. |
(Appropriate first aid statement required.) |
| II . . .
May be fatal If swallowed [Inhaled or
absorbed through the skin]. Oo not breathe
vapors (dust or spray alstl. Oo not get In
eyes, on skin, or on clothing. (Appropriate
first aid statements required.].
Causes eye (and skin] Irritation. Oo not |
get In eyes, on skin, or on clothing. |
Harmful If swallowed. (Appropriate first }
aid statement required.]. }
| III . . .
* * i
Harmful If swallowed 1 Inhaled or absorbed
through the sklnl. Avoid brrMthtng vapors
(dust or spray alstl. Avoid, contact with
skin (eyes or clothing]. (Appropriate
first aid statement required.].
Avoid eontaet with skin, eyes or elothlng. [
In case of contact Immmdlately flush (
eyes or skin with plenty of water. Get |
' medical attention If Irritation persists, j
I IV . . .
(No precautionary statements required.).
(No precautionary statements requlred.l. [
f r
(ii) Environmental hazards. Where a hazard exists to non-
target organisms excluding huxnans and domestic animals, precautionary
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident, injury or
67
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damage. Examples of the hazard statements and the circumstance®
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an activ<
ingredient with a mammalian acute oral LD50 of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an activ
ingredient with a fish^acute LC50 of 1 ppm or less, the statemefl
"This Pesticide is To^ic to Fish" is required.
(C) If a pesticide ^intended for outdoor use contains an activ
ingredient with an avian acute oral LD50 of 100 mg/kg or less* 0
a subacute dietary LC50 of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streak*'
Da not contaminate water by cleaning of equipment or disposal 0
wastes." t
(iii) Physical or chemical hazards. Warning statements on
flammability or explosive characteristics of the pesticide are
required as follows:
Flash point
1 .
1
Reoulred text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20*F; if there
flashback at any valve opening.
' *4
Is a
Flash point above 20*F and not over 80*F or If
the flaaw axtanslon is Mora than 16 in. long
at a dlstanea of 6 In. fro* tha fli
All other pressurized containers
| Extremely flamMble. Contents under pressure,
j Ke»p away from fire, sparks, and heated
j surfaces. Do not puncture or Incinerate
| container. Exposure to temperatures above
j 130*F aay causa bursting,
j Ftamable. Contents under pressure. Keep •«»Y
j from heat, sparks, and open flame. Do not
| puncture or Incinerate container. Exposure f0
| temperatures above 130*F My cause bursting.
. | Contents under pressure. Do not use or store
| near heat or open flame. Do not puncture or
j Incinerate container. Exposure to tempera-
I tures above 130*F My cause bursting. ^
(BJNONPRESSURIZED CONTAINERS
At or below 20*F
Above 20*F and not over 80*F .
Above 80 *F and not over 150*F
.| Extremely flamMble. Keep away from fire,
j sparks, and heated surfaces.
,| FlamMble. Keep away from heat and opan flama.
11 Do not use or store near heat or open fIame.
t O
-------
(1) Directions for Use—(1) general requirements—(1) Adequacy
and clarity of directions. Directions for use must be stated In
terras 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 \>e adequate to protect the public
from fraud and from persona?#injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(1_) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product Involved and its proper use in manufacturing processes;
(3) The product will not d$fie into the hands of the general
public except after incorporation into -finished products; and
(it) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(.1) The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(3) The product is also a drug and regulated under the provisions
of the Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use ^nly by formulators
in preparing pesticides for sale to the public, provided that:
(1) There is information readily available to the formulators
on "Ehe composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
69
-------
(2) The label clearly states that the product is intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(^) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(£) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use" :
(i) The statement of use classification as prescribed in
162.10(J) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CPR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CPR Part 165• These instructions shall be grouped and appear
under the heading "Storage an'd Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in § 162.10(h)(l)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
70
-------
(P) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described-^in paragraphs (j)(l) and (2) of this
section. Any pesticide proauct for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162 .10(J)(2) .
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear, statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement, of restricted use classification.
(A) At the top of the front panel of;the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in § 162.10(h)(l)(^v)), and appearing with sufficient
prominence relative to other- text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: "For retail
sale to and use only by (Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions 'are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation.
(k) Advertising. [Reserved]
[40 FR 28268, July 3, 1975; *0 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978]
7t
-------
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
APPENDIX IV-2
hem
L/VRPT. RTRMRKFP
APPLICABILITY
OF REQUIREMENT
PLACEMENT
REQUIRED
ON LABEL
PREFERRED
C0M4ENPS
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
Bottcm front
panel or end
of label text
Ffey be In metric inits in addition to
U.S. units
k
EPA Reg. No.
All products
None
Front panel
Must be in similar type size and run
parallel to other .
5
EPA Est. 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 Fteach
of Children
(Child hazard
warning)
All products
Front panel
Above signal
word
Note type size requirements.
7B
Signal word
1
All products
Front panel
Immediately
below child
hazard
warning
Note type size requirements.
-------
APPENDIX IV-2 (continued)
APPLICABILITY
PLACEMENT ON LABEL
ITEM
LABEL EES©®
OF REQUIREMENT
REQUIRED
PREFERRED
COJMENTS
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,
pthers:
Front panel
for all.
Grouped with
side panel
precautionary
statements.
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
Tbp or side
of back panel
preceding
directions
for use
Mist 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
Eftvlrormental
hazards
All products
None
Same as above
Environmental hazards include bee
caution where applicable.
-------
APPENDIX IV-2 (continued)
[TEN
LABEL ELEMENT
APPLICABILITY
OP REQUIREMENT
PLACEMEN
REQUIRED
ON LABEL
PREFERRED
COfWEMTS
BC
Physical or
chemical
hazards
All pressurized
products, others
with flash
points under
150°P
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. Hie words "RESTRICTED USE
FESTICIDE11 must be same type size as
signal word.
9C
"si
Misuse
statement
All products
]hmediately
following
heading of
directions
for use
10A
Reentry
statement
All
cholinesterase
inhibitors
In the
directions
for use
Immediately
after misuse
statement
IOC
Storage and
disposal block
1
All products
In the
directions
for"use
Itmed lately
before
specific
directions
for use or
at tiie end of
directions
for use
Must be set apart and clearly distin-
guishable frcm from other directions
for use.
10D
Directions
for use
All products
None
None
May be In metric as well as U.S. units
-------
Appendix IV-3
Criteria
PHYSICAL-CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20°P; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°Fj or
If the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
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 causei bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
"Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
75
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Appendix IV-4
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required tjjsf bear specific label instructions
about storage and disposal.5'' Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
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 requir-ed to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
Size of label
front panel in
square Inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under .
Above 10 to 15
Above 15 to 30
Over 30. . . .
.6 point
.8 point
10 point
12 point
7 A
-------
Appendix IV-4
(continued)
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container onljn 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,XI 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, MO CFR
261 for a hazardous waste must btar the following pesticide
disposal statement:
77
-------
Appendix IV-4
(continued)
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at?*the nearest EPA Regional Office
for guidance."
Labels for all other' products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
3. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products Intended for domestic use must bear one
of the following container disposal statements:
Container Type Statement
Non-aerosol products
(bottles, cans, Jars)
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.
79,
-------
Appendix IV-4
(continued)
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type s Statement
Metal
.containers
(non-aerosol)
TrJgJkLe-rinse (or equivalent). Then offer
foi*3recycling or reconditioning, oi puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
.Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of In a sanitary landfill or by other
approved state and local procedures.
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!., 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)
1/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
79
-------
Appendix IV-4
(continued)
Pesticides that are hazardous wastes under 40 CPR 261.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no lnert3):
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl O-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl O-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Gndosulfan
Endothai1
Endrin
Pamphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
80
-------
Appendix IV-4
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued:
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azlde
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
81
-------
Appendix IV-4.
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients:
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluldine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
5-3,3-(Dichloroallyl dlisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12 )
3,5-Dichloro-N-(l,l-dimethyl-2-propynyl) benzamide (pronamide.Kerb)
Dichloro diphenyl dichloroethane (DDDO
Dichloro diphenyl trichloroetharie (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1.2-Dichloropropane
1.3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
82
-------
Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients:
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1.2.4.5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2.3.4.6-Tetrachlorophenol
Thlram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Preon 11 )
2.4.5-Trichlorophenol
2.4.6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
83
-------
Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients:
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane (Preon 12®)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Melelc anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1.1.1-Trichloroethane
1.1.2-Trichloroethane
Trichlorofluoromethane (Freon
Vinyl chloride
Xylene
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