United StatM Office of
Environnrtntal Protection Pesticides and Toxic Substances
Agency Washinflton DC 20460
Pesticides June 1985
oEPA
Guidance for the Reregistration
of Pesticide Products
Containing Sulfuryl Fluoride
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
AS THE ACTIVE INGREDIENT
SULFURYL FLUORIDE
CASE NUMBER 0176
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
' JUNE 1985
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TABLE OF CONTENTS
Introduction
I. Regulatory Position and Rationale
II. Requirement for Submission of Generic Data . .
III. Requirement for Submission of Product-Specific
Data
IV. Submission of Revised Labeling
A. Label Contents
B. Collateral Information
V. Instructions for Submission
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APPENDICES
Page
II-l Guide to Bibliography
II-2 Bibliography
I1-3 FIFRA 53(c)(2)(B) Summary Sheet - EPA Form 8580-1 . .
II-4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-2 .
III-l Product Specific Data Report (End-Use Products) . .
IV-l 40 CFR 162.10 Labeling Requirements
IV-2 Table of Labeling Requirements
IV-3 Physical/Chemical Hazards Labeling Statement. . . .
IV-4 Storage and Disposal Instructions
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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 thorouqh
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 upon request, concentrates
on the technical grade of the active ingredient and identifies
missing generic data. However, during the review of these
data we are also looking for potential hazards that may be
associated with the 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 neces-
sary 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
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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 source 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
registration(s), you must provide the information described in
the following pages within the timeframes outlined. EPA will
issue a notice of intent to 'cancel or suspend the registration
of any currently registered product 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.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Docume nt.
8. 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 of registrants who also produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products in "II"
above. If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B.
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I. REGULATORY POSITION AND RATIONALE
INTRODUCTION
This registration standard describes the regulatory
position of the Environmental Protection Agency for all
registered Manufacturing-Use-Pesticides (MUPs) containing
sulfuryl fluoride as the sole active ingredient. End-Use-
Products (EUPs) are reviewed and re-registered under a
registration standard only when there are no MUPs containing
the chemical under review or when significant label changes
are required for the EUPs.
There are only three registered end-use-pesticides,
and no manufacturing-use-pesticides registered containing
sulfuryl fluoride as the sole active ingredient. Hence
this standard applies to the end-use-pesticides and their
registered uses for both the reasons stated above.
Sulfuryl fluoride is a gas at room temperature (25°C),
but the registered end use products are marketed as a
liquified gas in pressurized steel cylinders containing
99% pure sulfuryl fluoride and 1% inert impurities which
are part of the manufacturing process. The marketable
registered gas is of the same purity as the Technical Grade
of the Active Ingredient (TGAI). This standard applies
to the three registered products containing sulfuryl
fluoride.
Future requests for registrations of substantially
similar products will be considered under this standard.
Dissimilar products may be evaluated for registration. If
registered, the standard will be amended accordingly. After
briefly describing the chemical and its uses, this chapter
presents the regulatory position and rationale, the criteria
for registration, acceptable ranges and limits, and labeling
considerations.
In developing its regulatory position, the Agency
determines whether available data indicate that a pesticide
has met or exceeded the criteria for unreasonable adverse
effects specified in Section 162.11(a) of Title 40 of the
U.S. Code of Federal Regulations (CFR). Pesticides
meeting these criteria are candidates for a special
Review, an intensive risk/benefit analysis. The Agency's
determination as to whether any criteria have been met
and its rationale for any regulatory action are summarized
in the regulatory position of this standard.
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B. DESCRIPTION OF THE CHEMICAL AND ITS USES
1. Chemical and Physical Characteristics
The following information regarding the physical
and chemical properties of sulfuryl fluoride is
based on the primary sources supplied by the
manufacturer. Sulfuryl fluoride, S02F2* molecu-
lar weight 102.07, colorless gas at 25°C, odor-
less. Melting point -136.67°C at 760 mm Hg, boil-
ing point -55.21°C at 760 mm Hg, specific gravity
1.342 for liquid at 25°C compared to water at 4°C,
3.52 for the gas compared to air, based on molecu-
lar weight of 29 for air. Solubility 0.075 g/lOOg
of water at 24°C, 0.78 g/100 g wesson oil at 20°C,
1.74 g/100 g acetone at 22°C, 2.12 g/100 g chloro-
form at 22°C. Vapor pressure 6,255 mm Hg at -5°C,
9,150 mm Hg at 10°C, 13,442 mm Hg at 25°C, 19,646
mm Hg at 40°C.
Sulfuryl fluoride is an insecticide and/or
rodenticide sold under the trade name Vikane .
Another name for the chemical is sulfuric
oxybifluoride. The Chemical Abstract Service
(CAS) Registry Number is 2699-78-8, and the
Agency's Chemical Code Number is 078003.
Although sulfuryl fluoride is a gas at
ordinary room temperature (25° C.), the regis-
tered pesticide is shipped and marketed as a
liquified gas in pressurized steel cylinders.
When released from pressurized vessels the chemi-
cal immediately changes into a gas which is very
toxic to a wide variety of pests (insects and
rodents) within closed structures (buildings,
dwellings).
2. Registered Uses
The primary registered use of sulfuryl
fluoride is for the controlled fumigation of
closed (sealed) structures and their contents,
such as buildings, dwellings, garages, barns,
storage buildings, and other structures infested
with a variety of pests, i.e. drywood termites,
powder post beetles, old house borers, bedbugs,
and clothes moths. There are no registered
uses involving direct application of sulfuryl
fluoride to agricultural crops or to food or feed.
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Sulfuryl fluoride is not registered for the
fumigation of stored grains or cereals. For more
detailed information on the registered uses of sul-
furyl fluoride refer to the EPA Index of Pesticide
Chemicals on page 24 of this standard for the list-
ing of registered uses, sites, and pests for sul-
furyl fluoride.
C. REGULATORY POSITION AND RATIONALE
1 * Basic Product Chemistry
The available product chemistry data is insuffi-
cient to satisfy the basic chemistry data requirements
for sulfuryl fluoride. To register new products or
re-register currently registered products the data
specified in the product chemistry data tables must be
submitted.
Rationale
The available product chemistry information consists
of the physical and chemical characteristics of sul-
furyl fluoride. This information satisfies only part
of the basic chemistry data requirements, i.e. Section
158.120, Guideline Reference Nos. 63-2 through 63-21.
Data gaps consist of Product Identity and Composition
(Guideline Reference No. 61-1, -2,-3) and Analysis and
Certification of Ingredients (Guideline Reference No.
62-1, -2, -3).
This pesticide is produced by an integrated formulat-
ion system (IFST at a concentration of 99% sulfuryl
fluoride, and 1% impurities which are present as
part of the manufacturing process. The gas is prod-
uced and stored in bulk containers from which it is
transferred (repackaged), as is, into 125 pound pres-
surized cylinders for sale and use as the registered
pesticide.
All three registered end-use-pesticides are sold
under approved labels declaring 99% sulfuryl fluoride
and 1% inert ingredients. Therefore, for the purpose
of this standard the registered pesticides are ident-
ical to the Technical Grade of the Active Ingredient
(TGAI), and the information so far received, as well
as that which is lacking, would be applicable to all
other pesticide products proposed for registration
under this standard, as long as they conform to these
specifications.
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2. Human Toxicity Concerns
The available toxicological data on sulfuryl
fluoride are insufficient to dispel the Agency's
concerns about potential adverse effects to humans
(or animals) which may result from the fumigation
of households and their contents with this pesti-
cide.
These effects may result through three routes
of exposure to residues of sulfuryl fluoride, or its
degradation products, which may occur on or in house-
hold contents, or in the air of habitable structures
after fumigation with the pesticide. These routes
of exposure and the residues involved are listed
below:
a. Ingestion of residues of sulfuryl fluoride, or
its degradation products, which may occur on or
in food, feed, drink, drugs, or other edible com-
modities usually found in households and other
habitable structures? ingestion of residues by
infants who may lick treated surfaces or articles
upon re-entry of fumigated structures;
b. Dermal contact with residues of sulfuryl fluoride,
or its degradation products, which may occur on
or in furnishings and other articles such as
clothing which will come in contact with humans
when buildings or dwellings are reoccupied after
fumigation;
c. Inhalation of volatile residues of sulfuryl fluo-
ride, or its degradation products, which may be
released in the air of buildings or dwellings
inhabited by humans (or animals) after fumigation.
To address these concerns the Agency is requiring
residue data from representative household articles.
This information will be evaluated to ascertain what
relevant toxicity data will be required, if any, to
fully assess any risks which might be identified, and
to identify the test substance which should be used
to conduct such studies.
Specifically, registrants wishing to register
new products or to re-register their registered prod-
ucts must submit information to:
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(1) Identify and quantify the nature of the residues in
a representative range of food and non-food house-
hold articles, i.e. whether the residues exist as
sulfuryl fluoride, or as degradation products, when
treated with the pesticide at the recommended con-
centration for fumigating households and their con-
tents, and at ten times the highest recommended
concentration on the label.
(2) Determine the length of time after fumigation such
residues persist; specifically whether these resi-
dues persist for more than 40 days in which case
they would be regarded as permanent residues.
(3) Determine the extent, if any, to which sealing art-
icles with polyethylene bags prevents such residues,
in those situations where i£ is practical and desir-
able to seal certain items, such as food, etc. If 4
mil polyethylene does not provide an effective bar-
rier to prevent residues in such items, the regis-
trant must provide labeling alternatives to prevent
such residues.
(4) Identify and quantify'any residues of sulfuryl fluo-
ride, or its degradation products, which may exist
on or in treated articles such as furnishings, cloth-
ing, etc. which will later come in dermal contact
with humans after fumigation; distinguish whether
such residues are transient or permanent (persisting
more than 40 days);
(5) Identify and quantify any volatile residues of sul-
furyl fluoride, or its degradation products, which
may be released in the air spaces of habitable
structures from the treated surfaces or non-food
articles, such as furniture or clothing after fumi-
gation and re-entry into these structures. Distin-
guish whether these volatile residues, if any, are
transient or permanent, i.e. persist more than 40
days.
Rationale
Residues from fumigation with sulfuryl fluoride are
of two kinds—transient or permanent. Transient residues
of the fumigant per se, are partially or totally desorbed
from treated articles or surfaces during the aeration
period prior to re-entry. Range finding studies1/ on the
fumigation of foods with sulfuryl fluoride show,-for ex-
1/Meikle and Stewart, 1962 (MRID No. 00104296).
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ample, that Corn Oil contained 24 ppm of sulfuryl flour-
ide (expressed as S0202 with a detectable limit of 0.2
ppm), initially, 5.3 ppm after 5 hours, and zero after
24 hours.
Permanent residues, on the other hand, show no signi-
ficant difference between the initial values, the 5 hour
values, and the 24 hour values. These residues may exist
as sorbed sulfuryl fluoride, or as degradation products
(sulfite, and as the authors of the cited study suggest,
as fluoride). Thus they report "permanent residues"
(persisting more than 40 days after aeration), which range
from 55 parts per million as fluoride in beef, 12 in
cheese, 6 in feathers, 3.8 in starch, 2.7 in white flour,
2.5 in wool, and 1.0 in rayon.
Furthermore, although directions on the approved la-
bels for sulfuryl fluoride recommend sealing foodstuffs
and certain articles with polyethylene, data show that
sulfuryl fluoride will penetrate 4 mil polyethylene when
used at concentrations of 35 milligrams per liter at a
rate of 6.2 mg per square meter per hour.
Therefore, to prevent the first route of exposure,
i.e. ingestion of edible commodities (food, drink, drugs,
medicines, etc.) which may contain residues of sulfuryl
fluoride or its degradation products, registrants must
revise the labeling of the registered products to recom-
mend removal of edible items from dwellings or structures
before fumigation, or provide evidence that sealing such
items with polyethylene of a certain thickness will pro-
vide an effective barrier to penetration by sulfuryl
fluoride during the fumigation process. Another likely
oral route of exposure is when infants lick treated art-
icles or surfaces. If residues are proven to be trans-
ient, the label for sulfuryl fluoride must provide in-
structions to prevent infants from licking treated art-
icles for a specified period of time until such residues
have dissipated. If the residues are demonstrated to
be permanent, i.e. persisting more than 40 days, the la-
bel must provide instructions not to allow infants to
lick treated articles or surfaces which have been fumi-
gated with sulfuryl fluoride.
The second route of exposure may result from dermal
contact with non-food surfaces or articles such as with
household furnishings and wearing apparel which will come
in contact with humans after fumigation and aeration,
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when the structures are reoccupied. In this situation
it is neither practical nor economical to remove household
furnishings or apparel from dwellings or storage structures
prior to fumigation. As a matter of fact it would be use-
less to fumigate an empty structure and later place infest-
ed articles in it.
The third route of exposure may occur through in-
halation of air by humans or pets which may contain re-
sidues of sulfuryl fluoride, or its degradation products,
which may be released into the atmosphere from treated
non-food surfaces, such as walls, floors, ceilings, or
from treated articles such as clothing or furniture, after
* structure is fumigated and and re-occupied. Hence the
requirement to test samples of air for volatile residues
within a fumigated structure containing a variety of
household articles at different intervals after aeration
*nd re-entry of fumigated structures, to determine wheth-
er such residues, if any, are transient or permanent, i.e.
persisting more than 40 days.
Registrants are required to submit protocols for
developing the required data for review and concurrence
bv the Agency before they begin to develop these data.
These orotocols must be submitted no later than 120
days from the date of issuance of this standard. After
the Drotocols have been reviewed and concurred with by
the Agency, registrants will be notified to proceed with
development of the data, and will be given 13 months to
submit the data.
3, Restricted Use Classification
The Agency has determined'that sulfuryl fluo-
ride will be classified as a restricted use pesti-
cide until such time as EPA has reassessed its overall
potential hazards.
Rationale
The use of sulfuryl fluoride requires that
applicators be protected from inhaling potentially
fatal concentrations of the pesticide by wearing
self-contained breathing apparatus. Such equip-
ment must be approved by the National Institute
of Occupational Safety and Health Administration
(NIOSH)i or by the Mine Safety and Health Admin-
istration (MSHA), and is not readily available
to the average user. Furthermore special train-
ing is required to use the equipment properly,
Sulfuryl fluoride is also a highly toxic gas.
Fatalities may occur from inhalation of the gas
for relatively short periods of time.
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Given its very high level of acute toxi-
city t it is essential that only people trained
in its hazards and proper use should be author-
ized to use it.
Label precautions
The labeling for sulfuryl fluoride must be
revised to incorporate certain precautionary state-
ments to safeguard against accidental exposure of
the user and other persons to potentially dangerous
concentrations of sulfuryl fluoride as well as other
fumigants.
Rationale
pesticide Registration Notice 84-5
(November 15, 1984) required registrants of
sulfuryl fluoride to include specific precautionary
statements on their labels by December 15, 1984.
That notice is being revised and will be re-issued.
Because the registration standard is being issued at
the same time it is appropriate to include the label
requirements in the standard rather than in the
PR Notice. Therefore, the revised version of the
PR Notice will defer to the registration standard
for label requirements for sulfuryl fluoride The
requirements are listed in Section F of this
document.
Use of Sulfuryl fluoride with a Warning Agent
Use of chloropicrin as a warning agent in con-
junction with the use of s.ulfuryl fluoride to
fumigate habitable structures will only be al-
lowed if the label for sulfuryl fluoride is ex-
panded to include the following additional
language under the section where use directions
for the use of chloropicrin are given:
Chloropicrin is registered as a res-
tricted use pesticide, whose properties
and effects are different from those of
sulfuryl fluoride, it causes smarting
of the eyes, tears, discomfort, and has
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a very disagreeable pungent odor at very
low concentrations. Fumigators using
chloropicrin as a warning agent prior
to fumigation of habitable structures
with sulfuryl fluoride must be certified
to do so or under the supervision of a
certified pesticide applicator. Fumiga-
tors must use a chloropicrin product
registered for this purpose, and observe
the precautionary statements and safety
recommendations appearing on the EPA
approved label for this product.
Rationale
The currently approved label for sulfuryl fluoride
recommends the use of another fumigant, chloropicrin, as a
warning agent (odorizing agent) in conjunction with the
use of sulfuryl fluoride for the fumigation of habitable
structures. The purpose of this practice is to drive any
humans or animals out of the structure prior to fumiga-
tion with sulfuryl fluoride. Chloropicrin is a suitable
chemical for this purpose because it causes tears, and
has a very pungent odor which is detectable by the human
sense of smell at very low concentrations, much below the
concentration at which it would cause other than transient
effects.
Because sulfuryl fluoride itself is odorless, the
use of a warning agent with sulfuryl fluoride is a neces-
sary safety precaution when it is used to fumigate habit-
able structures. However, the currently approved label
for sulfuryl fluoride is deficient and must be expanded
to include the language prescribed above to ensure the safe
use of chloropicrin. The label does not warn the user of
the potential hazards of chloropicrin, and of the conse-
quences from its misuse.
Chloropicrin is a registered pesticide with a res-
tricted use classification. The Agency believes that the
general availability of chloropicrin for non-pesticidal
purposes has fostered its use by persons other than certi-
fied pesticide applicators. The sulfuryl fluoride label
warning will alert users to use only EPA approved chloro-
picrin products for fumigation purposes.
Restriction of sulfuryl fluoride, plus inclusion of
the language prescribed above on the label for sulfuryl
fluoride will promote the safe use of both pesticides.
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Ecological Effects to Non-Target Organisms
No fish and wildlife data will be required to re-
gister new products or to re-register products covered
by this standard. However, based on the toxicity of
sulfuryl fluoride shown in the mammalian studies, pre-
cautionary ecological effects statements will be re-
quired on the labels for Manufacturing-Use-Pesticides
registered under this standard, as prescribed on page
23 of this document. This requirement does not apply
to labels for End-Use-Pesticides.
Rationale
The Agency normally requires that fish and wild-
life data be developed with the Technical Grade of the
Active Ingredient C TGAI) \_/ of a pesticide, if it is
feasible to develop such data in accordance with EPA
guidelines. The results of the data developed with the
TGAI determine the appropriate environmental hazard
statements for the label, consistent with Section 162.10
(h)(2)(ii) of 40 CFR, for the Manufacturing-Use-Pesticide
(MUP)£/. In the case of sulfuryl fluoride it is not
feasible to develop fish and wildlife data in accordance
with EPA guidelines because it is a gas, hence no fish
and wildlife data are required to register or re-regis-
ter sulfuryl fluoride, in accordance with Part 158 of
of 40 CFR.
The Agency routinely requires environmental hazard
statements to non-target organisms, if the data warrants
them, on MUP labels on the basis that adverse environ-
mental effects are more likely to result from spills of
large volumes of the pesticide, such as from bulk ship-
ments of MUPs, or from discharges of MUPs from pesticide
manufacturing establishments. Additionally the Agency
requires pollutants discharge elimination statements on
all MUP labels.
1/ The TGAI is defined as the highest concentration of the
active ingredient of a pesticide which is practical to
produce on a commercial scale without deliberately added
inert ingredients.
2/ The MUP is the marketable source of the active ingredient
~~ which is registered for formulating or repackaging into
an end-use-pesticide. In some cases the MUP may be iden-
tical to the TGAI. In other cases it may contain deliber-
ately added inert ingredients, such as diluents, solvents,
emulsifiers, etc.
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The Agency prescribes appropriate environmental
hazards statements on labels for End-Use-Pesticides,
as dictated by data on the TGAI, if a use is an out-
door use, as for example, recirculating cooling sys-
tems ; or if a use involves direct application to, or
discharge into, the environment causing exposure of
non-target organisms to the pesticide. An example of
this use is treatment of ponds containing fish to con-
trol aquatic weeds.
The registered uses for sulfuryl fluoride are
strictly indoor uses which do not involve exposure to
non-target organisms. Hence, no environmental hazard
statements are required on the label for end-use-pest-
icides covered by this standard.
"7 • Environmental Fate
No data are required to address the environmental
fate of sulfuryl fluoride for the registered uses.
Rationale
The registered uses for sulfuryl fluoride are
strictly indoor uses. Furthermore, the pesticide
is a liquified gas which, when released for use
immediately changes to a gas. Eventually it dis-
sipates into the atmosphere. Hence, there are no
concerns about its fate in the soil or water of
the environment.
8. Ground Water Contamination
The pattern of use for sulfuryl fluoride is strictly
an indoor use. Furthermore for the same reasons
given in item 7 above, there is ho likelihood of
contamination of ground water with sulfuryl fluoride
for the uses covered by this standard.
Tolerance Re-assessment
The need to establish a tolerance or an exemption
from the requirement of a tolerance arises when the
use of a pesticide may result in residues in food,
feed, tobacco, or other articles of food or drink
for man or animals. The registered uses of sulfuryl
fluoride do not involve direct application to food
crops, food, or feed. Hence, there is no-need for
residue data for this purpose.
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The incidental contamination of food, drugs, medicines
which may occur as a result of fumigating habitable
structures does not involve tolerance considerations.
This standard prescribes that these items be adequately
protected to prevent any residue of suifuryl fluoride,
or that these items be removed from the structures before
they are fumigated.
10. Applicator Exposure
Concerns about applicator exposure for suifuryl
fluoride have resulted in the requirement for res-
piratory protection equipment for applicators.
Rat ionale
To protect applicators from breathing suifuryl
fluoride, use of the product requires the use of
specific respiratory equipment (non air supplied
breathing apparatus) for limited periods of time
(10 minutes), if the concentration in the work area
is between 5 and 10 ppm as determined by a direct
reading device. For longer periods of time or for
higher concentrations, the applicator must use air
supplied breathing apparatus.
[The registrant must identify the specific monitoring
device to be used for establishing resiudals of sul-.
furyl fluoride, and provide or reference instructions
for its use].
D. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
To be registered under this standard products must
contain suifuryl fluoride as the only active ingredient,
conform to the product composition, acute toxicity limits,
use pattern requirements, and the required labeling as
prescribed in various sections of this standard, in addi-
tion to those prescribed in Section F of this chapter.
Applicants for registration or re-registration of prod-
ucts under this standard must comply with all terms and con-
ditions described in it, including submission of an up to
date Confidential Statement of Formula, submission of revised
labeling, and a commitment to fill data gaps on the schedule
specified in this document.
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E. ACCEPTABLE RANGES AND LIMITS
1. Product Composition
As stated in an earlier section of this standard products
covered by this standard must contain at least 99% sulfuryl
fluoride and ana no more than 1% impurities which may be
present as part of t.he manufacturing process. For the
purposes of this standard the registered End-Use-Pestic ides
are identical to each other, and to the Technical Grace
of the Active Ingredient. There are no Manufacturing-
Use—Pesticides registered containing sulfuryl fluoride;
if any is proposed for registration it must conform to
these specifications.
Registrants who wish to register products deviating
from these limits must be prepared to amend the
standard and satisfy whatever additional data
requirements such deviations may incur.
2 • Acute Toxicity Limits
The Agency will consider registration of Manufacturing-
Use-Pesticides and End-Use-Pesticides under Toxicity
Category I, based on the overall hazards associated
with highly toxic gases. The rationale for this
is given on page 11 of this standard.
3. Use Patterns
To be registered under this standard MUPs must be
labeled for formulation or repackaging into end-use-
pesticides for indoor fumigation of sealed structures
for the control of the-pests listed in the EPA Index
to Pesticide Chemicals on page 24 which lists the
uses, sites, and pests which have been approved for
sulfuryl fluoride.
F. REQUIRED LABELING
All manufacturing-use-pest icides and end-use-pest icides
must bear appropriate labeling as specified in the general
labeling requirements of Section 162.10 of 40 CFR. For more
details on these requirements see Chapter V and appendix IV-1
of this standard. The following specific requirements apply
to the labels for sulfuryl fluoride:
16
-------
1. Ingredient Statement
The ingredient statement for Manufacturing-Use-
Pesticides and End-Use-Pesticides must appear on
the front panel as follows:
ACTIVE INGREDIENT
Sulfuryl Fluoride 99%
INERT INGREDIENTS 1%
a. Manufacturing-Use-Pes ticides
The label for MUPs must state that the pesticide
is intended for formulating or repackaging
pesticides which must be registered for use only
for structural fumigation (buildings, dwellings,
etc.) for the control of the pests listed in the
EPA Index to Pesticide Chemicals starting on
page 24 of this standard. Labels for MUPs are
not required to bear complete directions for use
of the pesticide. They are required to state
that each formulator or repackager must satisfy
EPA's requirements to register each formulated
or repackaged product. Labels for MUPs are not
required by regulation to classify products as
restricted use products even if the registered
uses are classified as restricted uses since
they are not available for retail sale.
b. End-Use-Pesticides
Labels for End-Use-Pesticides containing sulfuryl
fluoride must bear complete use directions for the
registered uses either on the label for the con-
the container or as supplementary labeling accom-
panying each product.
2 . Precautionary Statements
The following statements are required on labeling
for sulfuryl fluoride as a sole active ingredient.
Labels must conform to these requirements for all
products released for shipment after June 30, 1986,
and for all products in channels of trade after
June 30, 1987.
17
-------
a. Restricted Use Statement (EUPs) The following
restricted use classification and
accessory restrictive statements must appear
on the front panel, prominently displayed in
accordance with Section 162 . 10(j)(2)(i)(A)
and (B) of 40 CFR.
RESTRICTED USE PESTICIDE
DUE TO ACUTE INHALATION TOXICITY
For sale to and use only by Certified Applicators
or persons directly under their direct supervision,
and only for those uses covered by the Certified
Applicator's certification.
b. Spanish Warning Statement (to be located on the
front panel) for MUPs and EUPs.
PRECAUCION AL USUARIO: Si usted no lee Ingles,
no use este producto hasta que la etiqueta
le haya sido explicada ampliamente.
c. Front panel signal word (MUPs and EUPs).
The English and Spanish signal words DANGER,
and PELIGRO are required on the front panel.
The word POISON and the SKULL and CROSSBONES
symbol are also required on the front panel.
Remove edible items from structures before
fumigation if they can not be adequately
sealed to prevent residues of sulfuryl fluor-
ide after fumigation. Use chloropicrin as re-
commended on the label to ensure evacuation of
structures by humans or animals before fumiga-
tion .
d. Human Hazard Precautionary Statement
(Located on the front or side panel for MUPs
and EUPs under the heading "Hazards to Humans
and in supplemental labeling).
DANGER
Extremely hazardous liquid and vapor under
pressure. Inhalation of vapors may be fatal.
Liquid may cause chemical burns, which may have
a delayed onset, or may freeze exposed skin.
Do not get in eyes, on skin or on clothing.
Sulfuryl fluoride is odorless. Exposure to
toxic levels may occur without warning or
detection by the user.
-------
(e) Practical Treatment Statement
(located on front panel for MUPs and EUPs and in
supplemental labeling)
In all cases of overexposure, such as nausea,
difficulty in breathing, abdominal pain, slowing
of movements and speech, numbness in extremities,
get medical attention immediately. Take person
to a doctor or emergency treatment facility.
If inhaled: Get exposed person to fresh air.
Keep warm. Make sure person can breathe freely.
If breathing has stopped, give artificial
respiration by arm lift method, not mouth-to-
mouth resuscitation. Do no give anything
by mouth to an unconscious person.
If on skin: Immediately remove contaminated
clothing, shoes and other items covering skin.
Wash contaminated skin area thoroughly with
soap and water.
If in eyes: Flush with plenty of water. Get
medical attention.
(f) Note to Physician (located in a separate
paragraph with human hazard statements on the
label for MUPs or EUPs, or in supplemental
labeling)
Sulfuryl fluoride is a gas which has no warning
properties such as odor or eye irritation.
(Chloropicrin used as a warning indicator is
also the active ingredient in tear gas and will
cause tearing.) Early symptoms of exposure to
sulfuryl fluoride are respiratory irritation
and central nervous system depression. Excita-
tion may follow. Slowed movement, reduced aware-
ness and slow or garbled speech may be noted.
Prolonged exposure can produce lung irritation,
pulmonary edema, nausea and abdominal pain.
Repeated exposure to high concentrations can
result in significant lung and kidney damage.
Single exposures at high concentrations have
resulted in death. Treatment is symptomatic.
19
-------
(g) Use Directions
(EUPs only; on label or in supplemental labeling)
This fumigant is a highly hazardous material
and should be used only by individuals trained
in its proper use. Before using, read and
follow all label precautions and directions.
Persons working with this fumigant should
be knowledgeable of the hazards of this chemi-
cal and trained in the use of requ i red respi ra-
tory equipment and detector devices, emergency
procedures, and use of the fumigant.
When used for fumigation of enclosed spaces,
such as houses and other structures, ware-
houses, vaults, chambers, trucks, vans, boxcars,
ships, and other transport vehicles; two per-
sons trained in the use of this product must be
present at all times during introduction of
fumigant, testing, and aeration periods.
Do not fumigate with this product when commodity
temperature is below 40°F.
[Specific use directions follow. The registrant
must provide complete directions for use of the
product for fumigation of specified spaces,
commodities or structures].
(h) Protective Clothing (for EUPs only? on label
or in supplemental labeling)
Wear full-body clothing and shoes that are
cleaned after each wearing or disposable
protective clothing. Do not wear gloves or
rubber boots. Sulfuryl fluoride is heavier
than air and may be trapped inside and cause
skin injury. If full-face respiratory
protection is not required, wear goggles or
full face shield for eye protection when
handling liquid.
(i) Respiratory Protection (for EUPs only; on
label or in supplemental labeling)
If the concentration of sulfuryl fluoride in
the working area, as measured by a direct
reading detector device, does not exceed 5 ppm
(20 mg/cubic meter), no respiratory protection
20
-------
is required. If this concentration is exceeded
at any time all persons in the fumigation area
must wear a NIOSH or MSHA approved self-contained
breathing apparatus (SCBA) or combination air-
supplied/SCBA respirator.
[The registrant must identify the specific air
monitoring device to determine the levels of sul-
furyl fluoride in the workarea, and provide or
reference instructions for its use. The regis-
trant may also identify specific respirators to
be used with the fumigant.]
j. Placarding of Fumigated Areas (for EUPs only;
on label or in supplemental labeling)
The applicator must placard or post all
entrances to the fumigated area (and any sub-
sequent sites to which a treated commodity is
transferred before aeration) with signs bear-
ing, in English and Spanish:
1. The signal word DANGER/PELIGRO and the
SKULL and CROSSBONES symbol.
2. The statement, "Area under fumigation,
DO NOT ENTER/NO ENTRE".
3. The date of fumigation.
4. Name of fumigant used.
5. Name, address and telephone number of
the applicator.
Only a certified applicator may remove placard,
and only when the concentration of sulfuryl
fluoride in the treated site or commodity is
5 ppm or less.
k. Aeration and Reentry (for EUPs only, on label
or in supplemental labeling)
After fumigation, treated areas must be aerated
until the level of sulfuryl'fluoride is 5ppm
or less [the registrant must identify the speci-
fic direct reading detector device to be used
for this purpose and provide or reference in-
structions for its use] .
21
-------
No one should enter treated areas if the level
of sulfuryl fluoride is above 5 ppm unless
provided with a respiratory protection device
(SCBA or combination air supplied/SCBA).
1. Storage and Handling (for EUPs only, on label
or in supplemental labeling)
Store in dry, cool, well ventilated area under
lock and key. Post as a pesticide storage
area. Do not contaminate water, food, or feed
by storage.
Store cylinders upright, secured to a rack or
wall to prevent tipping. Cylinders should not
be subjected to rough handling or mechanical
shock such as dropping, bumping, dragging, or
sliding. Do not use rope slings, hooks, tongs
or similar devices to unload cylinders. Transport
cylinders using hand truck or fork truck to
which the cylinder can be firmly secured.
Do not remove valve protection bonnet and safe-
ty cap until immediately before use. Replace
safety cap, and valve protection bonnet when
cylinder is not in use.
When cylinder is empty, close valve, screw safe-
ty cap onto valve outlet and replace protection
bonnet before returning to shipper. Only the
registrant is authorized to refill cylinders.
Do not use cylinders for any other purpose.
Follow registrant's instructions for return of
empty or partially empty cylinders.
m. Disposal Statements (MUPs and EUPs)
[Label statements must conform to requirements
of PR Notice 83-3, March 29, 1983].
n. Spill and Leak Procedures (on label of MUPs
and EUPs)
Evacuate immediate area of spill or leak. Use
SCBA or comination air-supplied/SCBA respirator
for entry into affected area to correct problem.
Move leaking or damaged cylinders outdoors or
to an isolated location, observing strict safety
22
-------
precautions. Work upwind if possible. Wash
fumigant into soil or cover with soil or other
absorbent material, which may be disposed of on
site, or at an approved disposal facility. Do
not permit entry into spill area by unprotected
persons until concentration of fumigant is deter-
mined to be less than 5 parts per million, as
determined by a direct reading monitoring device.
[The registrant must name a specific device and
provide or reference instructions for its use.]
o. Environmental Hazards (MUPs only)
Labels for Manufacturing-CJse-Pesticides containing
sulfuryl fluoride as the only active ingredient
must bear the following statements under the ap-
propriate heading as shown below:
ENVIRONMENTAL HAZARDS; This pesticide is toxic to
fish and wildlife. Do not discharge effluent con-
taining this product into lakes, streams, ponds,
estuaries, oceans, or public waters, unless this
product is specifically identified and addressed
in a National Pollutant Discharge Elimination
System (NPDES) permit. Do not discharge effluent
containing this product to sewer systems without
previously notifying the sewage treatment plant
authority. For guidance contact your State
Water Board, or Regional Office of EPA.
The rationale for not requiring these state-
ments on labels for EUPs is on page 13 and 14 of
this document.
23
-------
EPA
Index to Pesticide Chemicals
SULFURYL FLUORIDE
TABLE OF CONTENTS
Site Name Pa ae
INDOOR 3
(Household) 3
Domestic Dwellings (including house boats, recreational vehicles
and mobile homes) 3
Domestic Dwellings Contents 3
(Wood or Wood Structure Protection Treatment) 4
Construction Materials 4
Finished Wood Products and/or Components of Buildings 4
Terrestrial Structures 4
(Commercial and Industrial Uses) 4
Commercial, Institutional, and Industrial Areas 4
Surface Ships in Port (including house boats, small pleasure
craft, and large ocean going vessels) 4
Vehicles (including automobiles, buses, rail cars, and recrea-
tional vehicles) 7
AERIAL, MOTHPROOFING AND TANK MIX APPLICATIONS 7
Mothproofing 7
Issued: 4-24-85
III-078003-i
0/1
-------
EPA Index Co Pesticide Chemicals
SULFURYL FLUORIDE
Sice and Pesc
Dosages and Tolerance, Use, Limitations
Formulation(s)
}OOA
}SOA
J
-------
^4Q00NB
abafa
aaaca
Sice and Pes t
EPA Index to Pesticide Chemicals
SULFURYL FLUORIDE
Dosages and Tolerance, Use, Limitations
Formulae ion(s)
(Wood or Wood Structure Protection Treatment)
Construction Materials
Finished Wood Products and/or
Components o f- Bu i Ld ings
Terrestrial. Structures
Deathwatch beetle 10 times
Powderpost beetles reference
dosage
(99% PrGs)
Nonsoil contact wood protection
treatment.
Refer to GENERAL WARNINGS AND LIMI-
TATIONS for appropriate preparation
and use information.
igcaga
Drywood termites
77QOOOA
7 00040A
Formosan sub-
terranean termite
Old house borer
equal to
reference
dosage
C99% PrGs)
4 times
reference
dosage
(99Z PrGs)
(Commercial and Industrial Uses)
Commercial, Institutional, and
Industrial Areas
Refer to (Household), Domestic Dwellings cluster
for use and limitation information.
Surface Ships in Port (including
house boats, small pleasure craft, Follow all applicable regulations
and large ocean going vessels) including those listed in the De-
partment of Transportation, 49 CFR
147A.1-147A.43 and any applicable
U.S. Coast Guard Regulations (46
CFR). No people, plants, or pets
may be on board during fumigation.
Pre-fumigation Procedures:
1. Prior to fumigating a vessel for
intransit cargo fumigation, the mas-
ter of the vessel or his representa-
tive, and the fumigator must deter-
mine whether the vessel is suitably
designed and configured so as to
allow for safe occupancy by the
ship's crew throughout the duration
of the fumigation. If it is deter-
mined that the design and configura-
Issued: 1-04-84
III-078003-4
26
-------
EPA Index to Pesticide Chemicals
SULFURYL FLUORIDE
Site and Pest Dosages and Tolerance, Use, Limitations
Formu1 at ion(s)
Surface Ships in Port (continued)
tion of the vessel does not allow
for safe occupancy by the ship's
crew throughout the duration of the
fumigation, then the vessel will not
be fumigated unless all crew members
are removed from the vessel. The
crew members will not be allowed to
reoccupy the vessel until the vessel
has been properly aerated and a de-
termination has been made by the
master of the vessel and the fumiga-
tor that the vessel is safe for oc-
cupancy •
2. The person responsible for the
fumigation must notify the master
of the vessel, or his representa-
tive, of the requirements related
to personal protection equipment*,
detection equipment and that a per-
son qualified in the use of this
equipment must accompany the vessel
with cargo under fumigation. Emer-
gency procdures, cargo ventilation,
periodic monitoring and inspections,
and first aid measures must be dis-
cussed with and understood by the
master of the vessel or his repre-
sentative .
~Personal protection equipment means
a gas mask or respirator for the
fumigant approved jointly by the
National Institute of Occupational
Safety and Health (NIOSH) and the
Mine Safety and Health Administra-
tion (MSHA).
3. During fumigation, or until a
manned vessel leaves port or the
cargo is aerated, the person in
charge of the fumigation shall in-
sure that a qualified person using
gas or vapor detection equipment
tests spaces adjacent to the fumi-
gated cargo area and all regularly
occupied spaces for fumigation leak-
age. If leakage of the fumigant is
detected, the person in charge_of
the fumigation shall take action to
correct the leakage, or shall inform
Issued: 1-04-84 III-078003-5
")*7
-------
EPA Index Co Pescicide Chemicals
SULFUKYL FLUORIDE
Site and Pest Dosages and Tolerance, Use, Limitations
Forinu lat ion( s )
Surface Ships in Port (continued)
the master of the vessel, or his
representative, of the leakage so
that corrective action can be taken.
4. If the fumigation is not com-
pleted and the vessel aerated before
the manned vessel leaves port, the
person in charge of the vessel shall
insure that at Least two units of
personal protection equipment and
one gas or vapor detection device,
and a person qualified in their
operation, be on board the vessel
during the voyage.
Precautions and Procedures During
Voyage:
Using appropriate gas detection
equipment, monitor spaces adjacent
to areas containing fumigated cargo
and all regularly occupied areas for
fumigant leakage. If Leakage is
detected, the area should be evacu-
ated of all personnel, ventilated,
and action taken to correct the
Leakage, before allowing the area
to be reoccupied. Do not enter
fumigated areas except under emer-
gency conditions. If necessary to
enter a fumigated area, appropriate
personal protection equipment must
be used. Never enter fumigated
areas aLone. At Least one other
person, wearing personal protection
equipment, should be avaiLabLe to
assist in case of an emergency.
Precautions and Procedures During
Discharge:
If necessary to enter hoLds prior
to discharge, test spaces directLy
above cargo surface for fumigant
concentration, using appropriate gas
detection and personaL protection
equipment. Do not aLLow entry to
fumigated areas without personaL
protection equipment, unLess fumi-
gant concentrations are at safe
levels, as indicated by a suitable
detec tor.
Issued: L-04-84 III-078003-6
28
-------
EPA Index to Pesticide Chemicals
SULFURYL FLUORIDE
Site and Pest Dosages and Tolerance, Use, Limitations
Formula t ion(s)
Surface Ships in Port (continued)
Refer to (Household), Domestic Dwellings cluster
for use and limitation informaton.
,(J80A Vehic les (including automobiles,
buses, rail cars, and recrea- Do not apply to aircraft,
tional vehicles)
Refer to (Household), Domestic Dwellings cluster
for use and limitation information.
AERIAL, MOTHPROOFING AND TANK MIX APPLICATIONS
0900 Mothproofing
^vAA
Refer to
INDOOR
(Household)
All sites
(Commercial and Industrial Uses)
All sites
Issued: 1-04-84 III-078003-7
-------
EPA Index Co PesCLCi.de Chemicals
SULFURYL FLUORIDE
Listing of Regiscered Pesticide Products by Formulation
2 9 9.0018 99% pressurized gas
sulfuryl fluoride (078003)
000464-00236 002749-00272
999999 State Label Registration
CA Reg. No.
005785-03694
Issued: 1-04—8-4
III-078003-8
30
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EPA Index to Pesticide Chemicals
SULFURYL FLUORIDE
Appendix B
Listing by Site/Pest and Sice/Formu1 ation/Reg istration Number
INDOOR
(Household)
^QQOA Domestic Dwellings
•ACJ American cockroach (adults)
•ACH American coackroach (nymphs)
'AAA Bed bug complex
*ABJ Brownbanded cockroach (adults)
^ABH Brownbanded cockroach (nymphs)
*AFJ Carpet beetle (adults)
•AFC Carpet beetle (larvae)
N r
;AFI Carpet beetle (pupae)
*ABA Clothes moths
•*ACA German cockroach
J-BDA Mice
;AGJ Oriental cockroach (adults)
j*
'AGH Oriental cockroach (nymphs)
*I3BA Rats
(99% PrGs)
000464-00236 002749-00272
^Q70A Domestic Dwellings Contents
^ACJ American cockroach (adults)
*ACH American coackroach (nymphs)
JAAA Bed bug complex
^ABJ Brownbanded cockroach (adults)
^ABH Brownbanded cockroach (nymphs)
^AFJ Carpet beetle (adults)
^AFC Carpet beetle (larvae)
^AFI Carpet beetle (pupae)
^ABA Clothes moths
^ACA German cockroach
^BDA Mice
^AGJ Oriental cockroach (adults)
^AGH Oriental cockroach (nymphs)
^BBA Rats
(99% PrGs)
000464-00236 002749-00272
Issued: 1-04-84
III-078003-9
-------
EPA Index Co Pesticide Chemicals
SULFURYL FLUORIDE
Appendix B
Listing by Site/Pest and Site/Formulation/Reg istration Number (continued)
(Wood or Wood Structure Protection Treatment)
)A0U2NB Construction Materials
4000NB Terrestrial Structures
JABAFA Deathwatch beetle
1GCAGA Drywood termites
1GDABA Formosan subterranean termite
IALANA Old house borer
¦IAAACA Powderpost beetles
(99% PrGs)
000464-00236 002749-00272
(Commercial and Industrial Uses)
;70000A Commercial, Institutional, and Industrial Areas
¦IRE AC J American cockroach (adults)
•tREACH American coackroach (nymphs)
}AFAAA Bed bug complex
¦1RDABJ Brownbanded cockroach (adults)
4RDABH Brownbanded cockroach (nymphs)
WTAFJ Carpet beetle (adults)
JATAFC Carpet beetle (larvae)
IATAFI Carpet beetle (pupae)
'BSABA Clothes moths
1RDACA German cockroach
'.GHBDA Mice
1REAGJ Oriental cockroach (adults)
(REAGH Oriental cockroach (nymphs)
1GHBBA Rats
(99% PrGs)
000464-00236
Issued: 1-04-84
111-078003-10
-------
EPA Index to Pesticide Chemicals
SULFURYL FLUORIDE
Appendix B
Listing by Sice/Pest and Site/FormuLation/Registration Number (continued)
OA Surface Ships in Port
'•'Cj American cockroach (adults)
American coackroach (nymphs)
Bed bug complex
Brownbanded cockroach (adults)
Brownbanded cockroach (nymphs)
Carpet beetle (adults)
Carpet beetle (larvae)
^£"1 Carpet beetle (pupae)
V}JA Clothes moths
^CA German cockroach
^£)A Mice
Oriental cockroach (adults)
Oriental cockroach (nymphs)
^iiA Rats
(99% PrGs)
000464-00236
^ BOA Vehicles
American cockroach (adults)
American coackroach (nymphs)
Bed bug complex
Brownbanded cockroach (adults)
Brownbanded cockroach (nymphs)
Carpet beetle (adults)
Carpet beetle (larvae)
Carpet beetle (pupae)
Clothes moths
German cockroach
Mice
Oriental cockroach (adults)
Oriental cockroach (nymphs)
Rats
(992 PrGs)
000464-00236
Issued: 1-04-84 III-078003-11
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR SULFURYL FLUORIDE
Guideline Citation and
Name of Test
Test
Substance
Guidelines
Status
Are Data
Required
Yes No
Footnote
Number
Data Must Be
Submitted Within
Time Frames Listed
Below
§158.120 Product Chemistry
Product Identity:
61-2 - Description of Beginning Materials TGAI
and Manufacturing Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis TGAI
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
CR
R
R
R
R
R
[X]
[X]
[ ]
[ ]
[ ]
[_]
[X]
[X]
IX]
[X]
[X]
6 Months
6 Months
12 Months
34
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR SULFURYL FLUORIDE
Guideline Citation and
lame of Test
Test Guidelines
Substance Status
Are Data
Required
Yes No
Footnote
Number
Data must Be
Submitted Within
Time Frames Listed
Below
5158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
[Continued )
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13 - Stability
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
R
R
R
R
R
R
[X]
[X]
[X]
[X]
[X]
[X]
TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient; R = Required; CR = Conditionally Required
J_/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
° 6 Month Due Date is December 31,1985 .
° 12 Month Due Date is June 30,1986 .
35
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR SULFURYL FLUORIDE
1/
Data Requirement
Composition
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
§158.135 Toxicology
ACUTE TESTING:
81-1 - Acute Oral Toxicity - Rat TGAI
81-2 - Acute Dermal Toxicity TGAI
- Rabbit
81-3 - Acute Inhalation Toxicity TGAI
- Rat
81-7 - Delayed TGAI
Neurotoxicity - Hen
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding : TGAI
- Rodent, and
- Non-rodent (Dog)
82-2 - 21-Day Dermal - Rabbit TGAI
82-3 - 90-Day Dermal - Rabbit TGAI
82-4 - 90-Day Inhalation: TGAI
- Rat
82-5 - 90-Day Neurotoxicity: TGAI
- Hen
No
No
Yes
No
No
No
No
No
No
No^/
NojV
00072289 No
No*/
Reserved 15 months
Reserved V 12 Months
Reserved £/ 15 Months
Reserved -V 15 Months
No V
15 Months
-Mammal
No 4/
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR SULFURYL FLUORIDE
1/
)ata Requirement
Composition
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
>158.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Toxicity - TGAI
2 species:
- Rodent, and
- Non-rodent (Dog)
83-2 - Oncogenicity - TGAI
2 species:
- Rat (preferred), and
- Mouse (preferred)
83-3 - Teratogenicity - TGAI
2 species:
- Rat
- Rabbit
83-4 - Reproduction - Rat TGAI
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI
84-2 - Structural Chromosomal TGAI
Aberration
84-4 - Other Genotoxic Effects TGAI
No
No
Yes
No
No
No
No
00090015
Reserved jV 50 Months
Reserved £_/ 50 Months
Reserved 50 Months
Reserved jV 50 Months
No
No
Reserved V 39 Months
Reserved _V 9 Months
Reserved 12 Months
Reserved -V 12 Months
37
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TABLE A
GENERIC DATA REQUIREMENTS FOR SULFURYL FLUORIDE
1/
Data Requirement
Composition
Use y
Pat tern
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/
§158.135 Toxicology - Continued
SPECIAL TESTING
85-1 - General Metabolism
PAI or PAIRA
No
Reserved -*/ 24 Months
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=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aqautic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ This chemical is a gas at 25°C.
4/ This chemical is not an organophosphorous compound nor does it produce cholinesterase inhibition.
_5/ Additional toxicity data are contingent upon the characterization and quantitative determination of the residues
deposited on household items as the result of structural fumigation at 1 and 10 times the use concentration.
38
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TABLE A
GENERIC DATA REQUIREMENTS FOR SULFURYL FLUORIDE
Does EPA Have Must Additional Data
Data To Satisfy B2 Submitted Under
J_/ Use 2/ This Require- Bibliographic FIFRA § 3(c)(2)(B)?
Data Requirement Composition Pattern ment? (Yes, No Citation Time Frame for Data
or Partially) Submission 3/
§158.140 Reentry Protection
132-1
- Foliar Dissipation
TEP
I
No
No V
132-1
- Soil Dissipation
TEP
I
No
No V
133-3
- Dermal Exposure
TEP
I
No
Yes -V
18
Months
133-4
- Inhalation Exposure
TEP
I
No
Yes V
18
Months
J_/ Composition: TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
°18 Month Due Date is December 31, 1986 .
Indoor ues only. No expected exposure.
5/ For specific instructions in the development of this data, refer to pages 7-10 of the document.
Protocols for conducting these tests must be submitted on a case-by-case basis because the Pesticide Registration
Guidelines do not provide protocols for developing these data.
39
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING SULFURYL FLUORIDE
jideline Citation and
irae of Test
Test Guidelines
Substance Status
Are Data
Required
Yes No
Footnote
Number
Data Must Be
Submitted Within
Time Frames Listed
Below
158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure MP
of Ingredients
61-2 - Description of Beginning Materials MP
and Manufacturing Process
61-3 - Discussion of Formation of MP
Impurities
Analysis and Certification of Product
Ingredients
62-1 — Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
CR
R
R
R
R
R
IX]
[X]
[X]
[X]
[X]
[X]
[X]
[X]
[X]
[ ]
[_]
0
U
[ ]
[ ]
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING SULFURYL FLUORIDE
Data Must Be
Guideline Citation and Test Guidelines Are Data Footnote Submitted Within
Name of Test Substance Status Required Number Time Frames Listed
Yes No Below
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
MP
R
£x]
[J
6 Months
63-12 - pH
MP
CR
[J
[x]
2
63-14 - Oxidizing or Reducing
Action
MP
CR
IX]
0
6 Months
63-15 - Flammability
MP
CR
(X]
Q
6 Months
63-16 - Explodability
MP
R
[X]
[J
6 Months
63-17 - Storage Stability
MP
R
[X]
Q
15 Months
63-18 - Viscosity
MP
CR
[J
[x]
2
63-19 - Miscibility
MP
CR
[J
[x]
2
63-20 - Corrosion Characteristics
MP
R
[X]
[J
15 Months
MP = Manufacturing-use Product; R = Required; CR = Conditionally Required
JJ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
° 6 Month Due Date is December 31,1985 .
° 12 Month Due Date is June 30,1986 .
° 15 Month Due Date is September 30, 1986
2/ These physical chemical property data requirements are not needed to support the registration of products under this
standard because the active ingredient is a gas at 25°C.
41
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING SULFURYL FLUORIDE
1/
ata Requirement
Composition
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Ci tation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dermal Toxicity
- Rabbit
MP
MP
No
No
No 3/
No 3/
81-3 - Acute Inhalation Toxicity MP
- Rat
81-4 - Primary Eye MP
Irritation - Rabbit
81—5 - Primary Dermal MP
Irritation - Rabbit
81-6 - Dermal Sensitization - MP
Guinea Pig
No
No
No
No
Yes 9 Months
No 3/
No 3/
Reserved V 9 Months
\J Composition: MP = Manufacturing-use product.
2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
9 Month Due Date is March 31, 1986 .
3/ This chemical is a gas at 25°C and causes freezing of skin and eye tissue on contact.
4/ Additional toxicity data are contingent upon the characterization and quantitative determination of the residues
deposited on household items as a result of structural fumigation at 1 and 10 times the use concentration.
49
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REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA sec. 3(c)(2)(B). 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 Data!/ 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 do 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
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).
The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
43
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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: "Typical formulation" data should not be
confused with product-specific data (Table B) which are
required on each formulation. Product-specific data are
further explained in Chapter III of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
11 — 3] for each of your products. -On that form you must state
which of the following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe will
satisfy the requirement, or state that you will generate
the data by conducting testing. If the test procedures
you will use deviate from (or are not specified in) the
Pesticide Assessment Guidelines or protocols contained in
the Reports of Expert Groups to the Chemicals Group,
Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must enclose the
protocols you will use.
OR
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly develop (or
share in the cost of developing) the data. If you elect
this option, you must notify EPA which registrant(s) are
parties to the agreement.
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 by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued on next page)
44
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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.)
OR
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This option
is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required data
or how quickly the data must be submitted. If the test
procedures you plan to use deviate from (or are not specified
in) the registration guidelines or protocols contained in
the reports of the Expert Groups to the Chemical Groups,
Organization for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must submit the protocol
for Agency review prior to the initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product Manager.
(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 interest.
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 FIFRA Section 3(c)(2)(B). EPA has concluded that
it should encourage joint testing rather than duplicative
testing, and that suspension should be withheld in certain cases,
to further this goal. Accordingly, if (1) a registrant has
informed us of his intent to develop and submit data required
by this Notice; and (2) a second registrant informs EPA that
it has made a bona fide offer to the first registrant to share
in the expenses of the testing [on terms to be agreed upon
or determined by arbitration under FIFRA Section 3 ( c ) ( 2 ) ( B) ( i i i ) ] ;
and (3) the first registrant has declined to agree to enter
into a cost-sharing agreement, EPA will not suspend the
second firm's registration.
45
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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.
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 111 — 1) 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)."
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.
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CFR 162.10 (see
Appendix IV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix IV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
*/ Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
46
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If you tail 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 - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel oc at the end of the label text.
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 net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. See Appendix IV-1. [40 CFR
162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV-1.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The 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 oc 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)]
47
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Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the fcont 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 CFR
162.10(g)]
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 PRECAUTIONARY 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 size 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
All Capitals
S i ze
6
10
12
14
18
po
po
po
nt
nt
nt
poi nt
poi nt
'Keep Out of Reach
of Children"
Minimum Type Size
6
poi nt
6
poi nt
8
poi nt
10
poi nt
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 Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. See Appendix IV-1. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV-1. [40 CFR 162.10(h)(1){iii)]
48
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Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel foe 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)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix IV-1. [40 CFR 162.10
(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. Flammability statement. Precautionary statements relating
to flammability 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 tests required to be submitted for all
products. These statements are to be located in the side/back
panel precautionary statements section, preceded by the
heading "Physical/Chemical Hazards." Note that no signal
word is used in conjunction with the flammability statements.
2. Criteria for declaration of non-flammability. The
following criteria will be used to determine if a product
is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A "non-flammable liquid" is one having a flashpoint
greater than 350°F (177°C).
49
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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°F (177°C).
3. Declaration of non-flammabi1ity. 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 flammabi1ity, 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 formulations/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 direct supervision (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 will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
c r\
-------
A. 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:
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 CFR 162 . 10(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms 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
foe 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 you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate pcoducts 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 pcoducts will be assigned
separate registration numbers.
51
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B. Compliance Schedules
No product with a use classified foe restricted use
under this Standard may be released for shipment by the
registrant or producer after one year from the date of
issuance of this Standard, unless such product bears the
restricted use classification. All products still in
channels of trade after two years from the date of issuance
of this Standard must be labeled for restricted use.
Item 9B [There is no Item 9B].
Item 9C. MISUSE STATEMENT - All products must bear the
misuse statement, "It is 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 Agency, 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 iread and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV-1. [40 CFR 162.10]
B. Collateral Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other 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
those accepted in connection with registration of the product.
It should be made part of the response to this notice and
submitted for review.
52
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V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing sulfuryl
fluoride as an active ingredient.
1. Within 90 days from receipt of this document, you must
submit to the Product Manager 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 111—1) .
c. Two copies of any required product-specific data.
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, 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 mockup of the labeling
suitable for storage in 8-1/2 x 11 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 FIFRA sec. 3(c)(1)(D). Refer to 40 CFR 15 2.80-152.99
(enclosed) 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.
53
-------
B. For Manufacturing Use Products containing sulfuryl fluoride
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 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 the times set forth in Table A, you must submit
to the Reg i s trat ion 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 sulfuryl fluoride alone
or in combination with other active ingredients;
1. Within 90 days from receipt of this document, you must
submit tKe "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:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product-Specific Data Report, EPA Form 8580-4
(Appendix 111-1) .
c. Two copies of any required product-specific data.
(Refer to Table C).
54
-------
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. Labeling 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 FIFRA sec. 3(c)(1)(D). Refer to 40 CFR 152.80-152.99
(enclosed) 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
exempt ion.
D. For intrastate products containing sulfuryl fluoride
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:
A. E. Castillo
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460
Phone No. (703) 557-3964
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
55
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Appendix II-l
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
56
-------
Appendix II-l (continued)
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.
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.
Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"rece ived."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
C-7
-------
Appendix II-2
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Sulfuryl Fluoride Standard
00072289 Dow Chemical Company (1959) The Acute Vapor Toxicity
of Vikane As Determined on Male and Female Rats:
Single Exposures of Groups of Rats to High
Concentrations of Vikane in Air. (Unpublished study
received on unknown date under 464-236; CDL:022799-F).
00090015 John, J.A.: Hanlye, T. R., Jr.; Ovellette, J. H.; et
al. (1981) Vikane (TM): Inhalation Teratology Study
in Rats and Rabbits: Lab. No. 917. Final report.
(Unpublished study received December 16, 1981 under
464-236; submitted by Dow Chemical U.S.A., Midland, MI.;
CDL:246489-A).
00104296 Meikle, R.; Stewart, D. (1962) The residue potential
of sulfuryl fluoride, methyl bromide, and methanesulfony1
fluoride in structural fumigations. Agricultural and
Food Chemistry 10(5): 393-397. (Also in unpublished
submission received 1962 under unknown admin, no.;
submitted by Dow Chemical U.S.A., Midland, MI; CDL:
121956-A).
58
-------
OMB Approval **c. 2CC0-04S3 APPENDIX II-3
F1FHA SECTION 3(C)(2)(B) SUMMARY SHEET
E?A REGISTRATION NO. ,
3^CT
NAME
''^ANT"S
NAME
DATE GUIDANCE DOCUMENT ISSUED
i^^ect to the rcquiremtnt to submit "generic" data imposed by the FIFRA taction 3(C)(2)(B) notica cotitainad in the rafwancad
'^ca Qocument, i am responding in the following mannan
^ 1. i will submit data in a timely mannar to satisfy the following requirements. If the test procedures I will usa daviata from (or are not
specified in) the Registration Guidelines or the Protocols containad in the Rapora of Expert Groups to ttia Chemicals Group, OECO
Chemicals Tasting Programme, I anciosa ttia protocols ttiat I will usa:
a
2- I have antarad into an agraamant with ona or mora othar ragistrants under FIFRA action 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
OF OTHER REGISTRANT
| «nclosa a completed "Cirtifiution of Attampt to Enter Inta in Agreement with Othar Registrants for Development of Qata" with
respect to the following data requirements:
07
request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
^ I request voluntary cancellation of tha ragistration of this product (This option is not available to applicants for new products.)
ANT-S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
-------
APPENDIX II-4 ,
OMB AporovBt No. 2QO0-0468 ,
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
To qualify, cmify^kL four inmsl FOR DEVELOPMENT OF DATA
1. 1 am duly authorized reprrwnt the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGftEDIENT
NAME OF FIRM
EPA COMPANY NUMBER _
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following reflu
items or data:
3. My firm has offered in writing to enter into such an agreement Copies of the offers are attached. That offer wes irrevocable and included an
bound by an arbitration decision under FIFRA Section 3lcM2MB)(iii) if final agreement on all terms could not be reached otherwise. This oHtr
to the following firm(j) on the following datt(s):
NAME OF FIRM
DATE OF OFFER ^
•
4. My firm requests that EPA not suspend the registration^) of my firm's product(s), if any of the firms named in paragraph '*/
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will prompi'V
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (Thi* ^
does not apply to applicants for new products.) 1 give EPA permission to disclose this statemertt upon request.
TYPED NAME
SIGNATURE
DATE
-------
Appendix III-l
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for
Date
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use Only)
Accession Numbers
Assigned
Citing MRID#
Submit-
ting
Data
(At-
tached)
§158.20
PRODUCT
CHEMISTRY
61-1
Identity of
ingredients
61-2
Statement of
composition
61-3
Discussion of
formation of
ingredients
62-1
Preliminary
analysis
62-2
Certification of
limits
62-3
Analytical methods
for enforcement
limits
63-2
Color
63-3
Physical state
63-4
Odor
63-5
Melting point
63-6
Boiling point
63-7
Density, bulk-
density, or
specific gravity
63-8
Solubility
63-9
Vapor pressure
63-10
Dissociation
constant
63-11
Octanol/water
partition
coefficient
63-12
PH
61
-------
Appendix III-l (continued)
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID#
Submit-
ting
Data
(At-
tached )
(For EPA Use OnU
Accession Numbed
Assigned „
63-13
Stability
63-14
Oxidizing/reducing
reaction
63-15
Flanmability
63-16
Explodability
63-17
Storage stability
63-18
Viscosity
63-19
Miscibility
63-20
Corrosion
characteristics
63-21
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
62
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§ 162.10
APPENDIX IV -1
T1tf« 40—Protection of Environment
8162.10 Labeling requirement*.
(a) General—(1) Contents of the
label Every pesticide products shall
bear a label containing the Informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(I) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this sec-
tion;
(II) The name and address of the
producer, registrant, or person for
63
-------
Appendix IV-1 (continued)
Chapter I—Environmental Protection Agancy
whom produced as prescribed In para-
graph (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
-------
Appendix IV-1 (continued)
§ 162.10
(v) Any statement directly or Indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment;
(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 im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe," "nonpoison-
ous," "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 compara-
tive statements on the safety of the
product, including but not limited to;
(A) "Contains all natural ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
"Pollution approved"
(6) Final printed labeling. (1) Except
as provided In paragraph (aXSXli) 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 provision-
ally accepted by the Agency.
(11) 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 micro-
film 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:
(i) Is false or misleading, or
(11) Has not been approved by the
Administrator through registration or
Till# 40—Protection of Environment
supplemental registration as an addi-
tional name pursuant to J 162.6(b)(4).
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidf-i'ed as the name and address of the
pri cucer. If the registrant's name ap-
pears 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 • • V "Distribut-
ed by • " or "Sold by • • •" to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers 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* F (20*C)
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) II the pesticide is solid or semi*
solid, 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 "28 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated minimum is not permit-
ted. In no case shall the average con-
tent of the packages In a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label,
preceded by the phrase "EPA Regis-
tration No.," or the phrase "EPA Reg.
No." The registration number shall be
set in type of a size and style similar to
65
-------
Appendix IV-1 (continued)
Chapter I—-Environmental Protection Agency § 162.10
other print on that part of the label
on which it appears and shall run par-
allel 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 regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(1) Gener-
al. The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients," or the singu-
lar forms of these terms when appro-
priate. 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 con-
tain 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
(i) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer 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 state-
ment 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.
(3) Names to be used in ingredient
statement The name used for each in-
gredient shall be the accepted
common name, if there is one, fol-
lowed 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
name alone shall be used. In no case
will the use of a trademark or proprie-
tary 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 percentages 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 ingredi-
ent 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 pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing 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 sig-
nificantly must meet the following la-
beling requirements:
(1) 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]."
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the label.
66
-------
Appendix IV-1 (continued)
§ 162.10
(7) Inert ingredients. The Adminis-
trator may require the name of any
Inert ingredient(s) to be listed in the
Ingredient statement it 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 toxicologic*]
hazard including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
Titfo 40—Protection of Environment
the labeling and those which may
appear elsewhere. Specific require-
ments 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 re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Hazard nt»cator»
Toacrty eatagonaa
II
HI
IV
Ora» LD„
Mtattaon LC,
Darmal ID»..
Era aftaeta....
Sinn affacts...
Up lo and incuang 50
mg/kg.
Up lo and ncldng .2
rug/War.
Up lo and ncfextng 200
mg/kg.
Conoamr. comaal
opacity not ravaratta
«dw 7 days.
CorreauM
From 50 Sou 500 mg/kg.
From 2 Ovu 3 nig/Mar....
From 200 mru 2000
Cwnaal opacrty
nevemdie mow 7
days; mutton
par—ang lor 7 daya.
Savara rntaoon at 72
hour*.
from iOO Ovu 5000 mg/
From 2. Kvu 20 mg/War...
From 2.000 ttvu 20.000 ...
No eomaal opacity;
in nation rmnM
withm 7 daya.
ModaraM irritation at 72
hour*.
Qraatar man
kg,
Graatar man
Graaiar man
No untation.
MM or Uigm
72 hour*.
(i) Human hazard signal word—(A)
Toxicity Category I. All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition 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 ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
cross bones shall appear in immediate
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing."
• (C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
5000 mg/
20 mg/Wtar.
20.000.
irritation at
(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 pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(11) Child hazard warning. Every pes-
ticide 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, market-
ing, 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 Administra-
tor waive this requirement.
(iii) Statement of practical treat-
ment—(A) Toxicity Category I. A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing into Toxicity Category I on the
67
-------
Appendix IV-1 (continued)
Chapter I—Environmental Protection Agoncy § 162.10
basis of oral, inhalation or dermal tox-
icity. The Agency may, however,
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment 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 (hXlXiiiXA) of
this section. The applicant may, how-
ever. include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired 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 prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Sizt of labat front panai in square
men—
Potfiu
Raqurad
signal
•RWO, (N
capital*
"Kaeo out
Of reach of
CMdren
5 and undar
a
6
Abdwa S 18 10
10
6
Above 10 to IS
12
S
Above 15 to 30
14
10
Ovar 30
1S
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
routet swallowed (inhaled or absorbed
through stun). Oo not breath* vapor (dual or sprey
mat]. Oo not gat in eyes, on akin, or on dotting
(Front panal statement of practical treatment re-
quired.].
May ba fatal tf swallowed (inflated or absorbed
tnrougn ma akin]. Oo not braatna vapors [dual or
spray mat]. Oo not gat in ayaa. on skin. or on
doming. (Appropriate first aid statements raqurad.].
Harmful if swallowed (inflated or absorDed through the
skm], Avoid breathing vapors (dust or spray nval).
Avad contact with skin (ayaa or doming]. (Appro-
pnata first aid statement required.].
Corrosiv*. causas aya and skm damage (or uur
mtaaon). Oo not get m ayaa. on skin, or on
clotmig. Waar gogglaa or faca sNatd and rubber
gloves whan handling. Harmful or fatal rf swaitaned.
(Appropnata Vat aid statement raqurad.)
Cauaaa ay* (and skin] irritation. Oo not gat in ayaa.
on skin, or on dottvng. Harmful if swallowed. (Ap-
propnata first atd statamant raqurad.]
AvokJ contact with skm. ayaa or doming. In casa of
contact imma&ataty flush aya* or ikin with plenty oi
watar. Gat madical attention if mtabon parsiati.
(No precautionary statamants raqurad.]
II
ill
IV
•
(ii) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
Injury or damage. Examples of the
hazard statements and the circum*
68
-------
Appendix IV-1 (continued)
§ 162.10
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LD„ of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active Ingredient
with a fish acute LC« of 1 ppm or less,
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LOh of 100
mg/kg or less, or a subacute dietary
LCm of 300 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
If either accident history or field
studies demonstrate that use of the
nun mm
nam pom at ar Mow 20' F; * tnara m a
my opaoatg.
Raaft pant KM 20* F and not ovar 10* i
flam aaMnaen • mora than 11 n tong at
alt* from tfta flame.
Al otnar graaauraad comamaia...-.
A) or beto» 30* F
Above 20* F and not ow 80* F._
*to»l (0* F and not owar ISO* F
(i) Direction* for Use—(I) General
retruiremtnts—i i) Adequacy and clar-
ity of directions. Directions for use
must be stated In terms which can be
easily read and understood by the av-
erage person likely to use or to super*
vise the use of the pesticide. When fol-
lowed. directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(11) Placement of directions for vat.
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
Title 40—Protection of Environment
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
-------
Appendix IV-1 (continued)
Chapter I—Environmental Protection Agency § 162.10
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing 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 process-
es:
(J) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts: and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
-------
Appendix IV-1 (continued)
§ 16X11
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically 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 ap-
plicator who is physically present.
(F) 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 prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (j)(l) and (2) of this sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth in this sub-
section, and shall be marketed as sepa-
rate products with different registra-
tion numbers, one bearing directions
only for general use
-------
APPENDIX IV-2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
1
Product name
All products
Front panel
Center front
panel
2
Company name
and address
All products
None
Bottom front
panel or end
of label text
If registrant is not the producer, must
be qualified by "Packed for . .
"Distributed by. . .," etc.
3
Net contents
All products
None
Bottom front
panel or end
of label text
May be in metric units in addition to
U.S. units
4
EPA Reg. No.
All products
None
Front panel
Must be in similar type size and run
parallel to other type.
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
precaut ionary
statements
All products
Front panel
All front panel precautionary statements
must be grouped together, preferably
blocked.
7A
Keep Out of Reach
of Children
(Child hazard
warning)
All products
Front panel
Above signal
word
Note type size requirements.
7B
Signal word
All products
Front panel
Immediately
below child
hazard
warning
Note type size requirements.
-------
APPENDIX IV-2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
7C
Skull & cross-
bones and word
POISON (in red)
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
Front panel
Both in close
proximity to
signal word
7D
Statement of
practical
treatment
All products
in Categories
I, II, and III
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precaut ionary
statements.
Front panel
for all.
7E
Referral
statement
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
Front panel
8
Side/back panel
precautionary
statements
All products
None
Top or side
of back panel
preceding
directions
for use
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
8A
Hazards to
humans and
domestic
animals
All products
in Categories
I, II, and III
None
Same as above
Must be preceded by appropriate signal
word.
8B
Environmental
ha sards
All products
None
Same as above
Environmental hazards include bee
caution where applicable.
-------
APPENDIX IV-2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
8C
Physical or
chemical
hazards
All pressurized
products, others
with flash
points under
150°F
None
Same as above
9A
Restricted
block
All restricted
products
Top center
of front
panel
Preferably
blocked
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
9C
Misuse
statement
All products
Immediately
following
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
All products
In the
directions
for use
Immediately
before
specific
directions
for use or
at the end of
directions
for use
Must be set apart and clearly distin-
guishable from from other directions
for use.
10D
Directions
for use
All products
None
None
May be in metric as well as U.S. units
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. pressurized Containers
Required Label Statement
A.
B.
Flashpoint at or below
20°F; or if thece is a
flashback at any valve
opening.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not ovec 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 cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
75
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Appendix IV-4
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Required type size
Size of label
for the heading
front panel in
STORAGE AND DISPOSAL
square inches
(all capitals)
10 and under
Above 10 to 15
Above 15 to 30
Over 30
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions:
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
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.
76
-------
Appendix IV-4
(conti nued)
4. instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. pesticide Disposal Instructions:
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxici'ty must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
77
-------
Appendix IV-4
(continued)
"Pesticide wastes ace 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 trasj^
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.
78
-------
Appendix IV-4
(continued)
2. The labels for all othec products must bear container disposal
instructions, based on container type, listed below:
Container Type Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
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 cinse (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 CFR 261.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts):
Acrolein
Aldicarb
Aldri n
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 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,O-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomy1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
-------
Appendix IV-4
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued:
Phenylmeccuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,O-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfari n
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-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d]-pentalen-2-o
(kepone, chlordecone)
1,2-Dibcomo-3-chloropropane (DBCP)
Dibutyl phthalate
5-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12 )
3,5-Dichloro-N-(1,l-dimethyl-2-propynyl) benzamide (pronamide,K
Dichloro diphenyl dichloroethane ( DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1.2-Dichloropropane
1.3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 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
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11®)
2.4.5-Trichlorophenol
2.4.6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
83
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