United States
Environmental Protection
Aoency
Office of Prevention, Pesticides EPA 738-R-93-016
and Toxic Substances September 1993
(H-7508W)
&EPA Reregistration
Eligibility
Decision Document
SULFURYL FLUORIDE
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United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(H-7508W)
EPA-738-F-33-01Z
7??month77? 1992
R.E.D. FACTS
SULFURYL FLUORID
Pesticide All pesticides sold or distributed in the United States'must be
Reregistration registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered years ago be reregistered to ensure
that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this
and explains why in a Reregistration Eligibility Document, or RED. This
fact sheet summarizes the information in the RED for sulfuryl fluoride.
Use Profile
Sulfuryl fluoride is an insecticide used to fumigate closed structures
and their contents such as domestic dwellings, garages, barns, storage
buildings, commercial warehouses, ships in port, and railroad cars. It
controls numerous insect pests including termites, powder post beetles, old
house borers, bedbugs, carpet beetles, clothes moths and cockroaches, as
well as rats and mice. The end-use product is marketed as a liquid gas in
pressurized steel containers.
Regulatory
History
Sulfuryl fluoride was first registered in December 1959. In June
1985, EPA issued a registration standard entitled "Guidance for the
Reregistration of Pesticide Products Containing Sulfuryl Fluoride as an
Active Ingredient" (NTIS PB87-124392), requiring additional product
chemistry and occupational and residential exposure studies. Data Call-in
Notices issued in July 1990 and November 1992 required additional
toxicity data.
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Human Health
Assessment
Currently, no manufacturing use products and only one end-use
product containing the active ingredient sulfuryl fluoride are registered.
The single registered product, Vikane, contains 99% sulfuryl fluoride and
1% inert impurities. Vikane is classified as a restricted use pesticide due
to its inhalation toxicity.
Toxicity
In acute oral toxicity studies using rats and guinea pigs, sulfuryl
fluoride has been shown to be moderately toxic; it has been placed in
Toxicity Category II for these effects (Category I indicates the highest and
Category IV the lowest level of acute toxicity). Sulfuryl fluoride has been
placed in Toxicity Categories IE and IV for acute inhalation and Category
IV for acute dermal vapor toxicity. A two-day neurotoxicity study using
rats showed no effects at the highest dose levels.
Four subchronic toxicity studies using rats, rabbits and dogs showed
similar results including fluorosis of the teeth, decreased body weights, and
effects to the lung, nervous system and brain. In developmental toxicity
studies using rats and rabbits, at the highest dose levels or in range-finding
studies, some maternal toxicity (reduced body weight gain) and
developmental toxicity (reduced fetal body weights) were observed. A
reproductive toxicity study using rats showed parental effects to the lungs
and brain, and reduced pup weights. Sulfuryl fluoride was negative in
three mutagenicity studies.
Several humans poisonings and two deaths have been attributed to
sulfuryl fluoride exposure. All resulted from reentering treated homes
before they had adequately aerated, inconsistent with label directions.
Dietary Exposure
Sulfuryl fluoride is not registered for any food- or feed-related uses.
No tolerances or exemptions from the requirement of a tolerance have been
established, and no dietary exposure is anticipated.
Occupational and Residential Exposure
Sulfuryl fluoride is dispensed as a pressurized gas from a steel
cylinder through a hose into the interior of an enclosed, sealed structure.
People must be evacuated from the structure before it is treated;
chlorpicrin, which produces a strong odor and eye irritation, is used as a
warning agent and is released within the structure 5 to 10 minutes before
sulfuryl fluoride is applied to ensure that the site is vacated. After
treatment, the structure remains closed for a period of time (refer to the
product label for specific times regarding target pest and environmental
conditions) after which the applicator reenters and begins to aerate the
area. People not wearing a respirator may not reenter the treated structure
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until air levels of sulfuryl fluoride have declined to 5 part per million
(ppm) or less. Because sulfuryl fluoride is a Restricted Use Pesticide, it
may only be applied by or under the direct supervision of a trained,
certified applicator.
Applicators may be exposed to sulfuryl fluoride while applying the
pesticide. However, sulfuryl fluoride is introduced as a gas into the target
area through a hose, thus, negligible exposure to the applicator is expected
until the time of reentry into the treated structure to monitor air levels.
Applicators and residents may be exposed to sulfuryl fluoride through
inhalation upon reentry and/or reoccupation of treated structures.
Exposure to workers is acute and intermittent, while exposure to residents
is acute and lasting. Current product labeling requires applicators to wear
protective clothing including respirators when reentering treated structures
and prohibits other people from reoccupying treated structures until air
levels of sulfuryl fluoride have declined to 5 ppm.
Human Risk Assessment
Sulfuryl fluoride poses no human dietary risks since no food- or feed-
related uses are registered and dietary exposure is not anticipated.
EPA is concerned with neurotoxicity associated with inhalation
exposure to sulfuryl fluoride. Residents and workers reentering treated
structures may be at risk for acute neurotoxic effects from this exposure,
which currently'is limited to 5 ppm. The Agency has concern that the 5
ppm reentry level may not be appropriate based on the calculated Margins
Of Exposure (MOEs) which suggest 2 ppm for adults. In order to provide
a further safety measure for children, the current data and the limit of
detection of the monitoring devices suggest a reentry level of 1 ppm.
However, certain post treatment decline data are not available which might
enable the Agency to refine the reentry level. The sulfuryl fluoride
registrant has been given the option in the RED document to submit
exposure data and any other data that can be used to refine the decline rate
of sulfuryl fluoride. These data are due by August 1, 1994. By October
1, 1994, the Agency will make a decision on the reentry level but until
these data are evaluated the 5 ppm reentry level will remain in place. If
these new data are not useful or not received by August 1, 1994, the
reentry level will be established at 1 ppm and revised labeling will be
implemented on an accelerated basis.
In addition, a fact sheet must be provided in advance to an adult
occupant of each structure to be fumigated, describing why and how
buildings are fumigated, the potential risks and safety precautions, as well
as who to contact for more information.
Because of uncertainty about neurotoxic effects due to long term
exposure to sulfuryl fluoride, workers will be required to wear a NIOSH-
approved, self-contained breathing apparatus (SCBA) upon reentry,
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Environmental
Assessment
regardless of air levels of sulfuryl fluoride. EPA is requiring a 90-day
inhalation neurotoxicity study in rats to more fully assess human
subchronic and chronic effects. Assessment of risks to workers during
their working life span, and the need to continue wearing the SCBA upon
reentry at all air levels of sulfuryl fluoride, will be addressed after this
study is received and evaluated.
Environmental Fate
Since sulfuryl fluoride is registered for highly specialized uses, and
due to its chemical properties, EPA is not requiring the usual supporting
environmental fate data for reregistration. After fumigation and aeration of
treated structures, there is little likelihood that nontarget organisms would
be exposed to residues of sulfuryl fluoride, or that the pesticide would
leach to ground water. Residues of the parent chemical are not expected to
remain in the environment for any significant length of time.
Ecological Effects Risk Assessment
Based on its limited use sites and chemical properties, significant
environmental exposure is not expected to result from use of sulfuryl
fluoride. Therefore, wildlife toxicity data were not required for
reregistration, and an ecological risk assessment was not conducted.
Additional Data The generic data base for sulfuryl fluoride is substantially complete.
Required However, EPA is requiring a new 90-day neurotoxicity study in rats, as
confirmatory data. Method validation data for indoor air monitoring
devices are also required.
EPA is not requiring product-specific data, but is requiring a revised
Confidential Statement of Formula and revised labeling for reregistration of
the pesticide product containing sulfuryl fluoride.
Product Labeling The end-use product must comply with EPA's current pesticide
Changes Required product labeling requirements. In addition:
• The label must provide specific directions for the use of
chlorpicrin as a warning agent to be present in the structure during
fumigation at a level > 0.25%. Instructions must be provided that
the chlorpicrin must be used by persons certified to apply sulfuryl
fluoride and that applicators must observe the precautionary
statements and safety recommendations appearing on the label of this
product.
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• The label must require that a pesticide fact sheet be provided to
an adult occupant of the structure to be fumigated prior to the
initiation of the fumigation contract. This fact sheet, which is
labeling, must contain as a minimum of information the following:
a) Why buildings are fumigated.
b) How buildings are fumigated.
c) Potential health risks from overexposure.
d) Safety precautions and homeowner preparation.
e) A contact point for additional information.
• Add the following under the Environmental Hazards Statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide is a violation of Federal Law. If these wastes
cannot be disposed of by use according to the label
instructions, consult your State Pesticide or
Environmental Control Agency, or the Hazardous Waste
representative of the nearest EPA Regional Office for
guidance."
• Due to concern for neurotoxic effects from long term exposure
to sulfuryl fluoride upon reentry to treated structures, the Agency
requires the following:
Applicators must wear a NIOSH approved self-contianed
breathing apparatus (SCBA) when reentering a treated structure
regardless of air levels of sulfuryl fluoride.
Regulatory
Conclusion
Use of the currently registered pesticide product containing sulfuryl
fluoride as labeled and specified in the RED document will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of this product are eligible for reregistration.
The sulfuryl fluoride product will be reregistered once the
confirmatory generic data, revised Confidential Statement of Formula and
revised labeling are received and accepted by EPA.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Document (RED) for sulfuryl fluoride during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register.
To obtain a copy of the RED or to submit written comments, please
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contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (H-7506C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone (703)
305-5805.
Following the comment period, the sulfuryl fluoride RED document
will be available from the National Technical Information Service (NITS),
5285 Port Royal Road, Springfield, VA 22161, telephone (703) 487-4650.
For more information about sulfuryl fluoride RED document, EPA's
pesticide reregistration program, or reregistration of individual products
containing sulfuryl fluoride, please contact the Special Review and
Reregistration Division (H-7508W), OPP, US EPA, Washington, DC
20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for
assistance in recognizing and managing pesticide poisoning symptoms,
please contact the National Pesticides Telecommunications Network
(NPTN). Call toll-free 1-800-858-7378, between 8:00 am and 6:00 pm
Central Time, Monday through Friday.
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© 1
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
'"i
CERTIFIED MAIL
30 111
OFFICE OF
PREVENTION, PESTICIDES /
TOXIC SUBSTANCES
DowElanco
Quad IV
9002 Purdue Road
Indianapolis, IN 46268-1189
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has
completed its reregistration eligibility review and decisions on the pesticide
chemical case sulfuryl fluoride which includes the active ingredient sulfuryl fluoride.
The enclosed Rereaistration Eligibility Decision (RED) contains the Agency's
evaluation of the data base of this chemical, its conclusions of the potential human
health and environmental risks of the current product uses, and its decisions and
conditions under which these uses and products will be eligible for reregistration.
The RED includes the labeling requirements for products for reregistration. It may
also include requirements for additional data (generic) on the active ingredient(s) to
confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled
"Pesticide Reregistration Handbook". This handbook also refers to other enclosed
documents which include further instructions. You must follow all instructions and
submit complete and timely responses. The first set of required responses are due
90 days from the date of this letter. The second set of required responses are due
8 months from the date of this letter. Complete and timely responses will avoid
the Agency taking the enforcement action of suspension against your products.
If you have questions on the product specific labeling requirements or wish
to meet with the Agency, please contact the Special Review and Reregistration
Division representative Franklin Gee at (703) 308-8008. Address any questions on
required generic data to the Special Review and Reregistration Division
representative Robert Richards at (703) 308-8057.
Sincerely yours.
,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Enclosures
Recycled/Recyclable
Printed with Soy/Canola Ink on |
contain* at least 50% recycled fl
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REREGISTRATTON ELIGIBILITY DECISION
Sulfuryl Fluoride
LIST A
CASE 0176
ENVIRONMENTAL-EROTECTION-AGHVCY
OEFICE-OF-PES'nCroE-PROGRAMS
SPECIAL-KEVIEW-AND-KEREGISTRATION-I)IVISION
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SULFURYL FLUORIDE REREGISTRATTON ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Linda Bass
K. Griffin
Environmental-Fate-and-Effects-Division
Dana Lateulere
Man Shamim
Kathy Monk
Health • Effects • Divi sion
Nguyen B. Thoa
. Ken Dockter
Linnea Hansen
Randy Perfetti.
David Jaquith
Registration-Division
Robert Travaglini
Special Review and Reregistration Division
Robert Richards
Other Divisions and Offices
Jean Frane
Phyllis Flaherty
Phil Ross
Biological Analysis Branch
Economic Analysis Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Science Analysis and Coordination Staff
Chemical Coordination Branch
Reregistration Support Chemistry Branch
Toxicology Branch I
Tolerance Support Chemistry Branch
Occupational & Residential Exposure Branch
Antimicrobial Program Branch
Reregistration Branch
Policy and Special Projects Staff
Office of Compliance Monitoring
Office of General Counsel
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a.i.
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
HDT
LQso
LD,
'50
LDte
LEL
LOEL
MP
MPI
MKGD
GLOSSARY OF TERMS AND ABBREVIATIONS
Active Ingredient
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Highest Dose Tested
Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or volume of water or feed, e.g.,
mg/1 or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal). It is expressed as a weight of substance per unit weight of animal,
e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Lowest Observed Effect Level
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
11
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GLOSSARY OF TERMS AND ABBREVIATIONS (cont.)
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance produces a toxic effect.
TMRC Theoretical Maximum Residue Contribution.
TWA Time Weighted Average
111
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TABLE OF CONTENTS
SULFURYL FLUORIDE REREGISTRATION ELIGIBILITY TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS ii
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 3
D. Regulatory History 3
DI. SCIENCE ASSESSMENT 4
A. Product Chemistry Assessment 4
B. Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Toxicity 5
b. 2-i>ay Inhalation Neurotoxicity Study 5
c. Subchronic Toxicity 6
d. Developmental Toxicity 7
e. Reproductive Toxicity 7
f. Mutagenicity 7
g. Other toxicology information 8
2. Exposure Assessment 8
a. Dietary Exposure 8
b. Occupational and Residential 8
(1) Mixer/loader/applicator exposure 9
(2) Residential/Occupational post application reentry
exposure 9
3. Risk Assessment 11
a. Dietary 11
b. Occupational and Residential 11
C. Environmental Assessment 14
1. Environmental Fate 14
2. Ecological Effects 15
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 15
A. Determination of Eligibility 15
1. Eligibility Decision '.'.'.'.'.'.'.'.'.'.'.'.'.'. 16
2. Eligible and Ineligible Uses 16
IV
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B. Regulatory Position 16
1. Tolerance Reassessment 16
2. Restricted Use Classification 16
3. Labeling Rationale 16
V. ACTIONS REQUIRED BY REGISTRANTS 17
A. Manufacturing-Use Products 17
1. Additional Generic Data Requirements 17
2. Labeling Requirements for Manufacturing-Use Products 18
B. End-Use Products 18
1. Additional Product-Specific Data Requirements 18
2. Labeling Requirements for End-Use Products 18
C. Existing Stocks 19
VI. APPENDICES
Appendix A - Use Patterns Subject to Reregistration
Appendix B - Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision
Appendix C - Citations Considered to be Part of the Data Base Supporting the
Reregistration of Sulfuryl Fluoride
Appendix D - List of Available Related Documents
Appendix E - Pesticide Reregistration Handbook
Appendix F - Generic Data Call-in
Attachment A -
Attachment B -
Attachment C -
Attachment D -
Attachment E -
Chemical Status Sheet
Generic DCI Response Forms (Form A) plus Instructions
Requirements Status and Registrants' Response Forms
(Form B) plus Instructions
List of all Registrant(s) sent {his DCI
Cost Share/Data Compensation Forms
Appendix G - Product Specific Data Call-In
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EXECUTIVE SUMMARY
This decision document addresses the reregistration eligibility of the pesticide sulfuryl
fluoride. Sulfuryl fluoride was first registered in December 1959 as a controlled fumigant of
closed (sealed) structures and their contents, such as buildings, dwellings, garages, barns,
storage buildings, ships in port, 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. Sulfuryl fluoride is not registered for the fumigation of stored grains or cereals.
In June 1985, the Environmental Protection Agency (referred to as "the Agency") issued
a registration standard entitled "Guidance for the Reregistration of Pesticide Products Containing
Sulfuryl Fluoride as the Active Ingredient" (NTTS PB87-124392). The registration standard
summarized the available data supporting the registration of sulfuryl fluoride and required
additional data to assure that proper use of the pesticide poses no unreasonable adverse effects
to human health or the environment. Also, Data Call-in Notices issued in July 1990 and
November 1992 required additional toxicity data.
The current reentry level following sulfuryl fluoride treatment is 5 ppm. The Agency
believes that this level may not be appropriate. Calculated MOEs suggest a reentry level of 2
ppm for adults in order to reach MOEs of 100, generally considered an acceptable MOE. In
order to provide a further safety measure for children, the current data and the limit of detection
of available monitoring devices suggest a reentry level of 1 ppm. However, certain post
treatment decline data are not available which might enable the Agency to refine the reentry
level. The Agency is providing the registrant until August 1, 1994 to submit these exposure data
and any other data that can be used to refine the decline rate of sulfuryl fluoride. These data
may also be useful in establishing a reentry level for non-residential structures. Until these data
are evaluated the current 5 ppm level will remain in place. By October 1, 1994, the Agency
will make a decision on the reentry level. If these new data are not useful in making this
determination or are not received by August 1, 1994, the reentry level will be established at 1
ppm for dwellings, and 2 ppm for non-residential structures and vehicles where young children
are not expected to be exposed. Revised labeling reflecting the lower levels will then be
implemented on an accelerated schedule.
The Agency is requiring a 90-day inhalation neurotoxicity study in rats (guideline 82-5)
because subchronic/chronic exposure to workers cannot be ruled out. Method validation data
for the Miran and InterScan gas analyzers (also listed under guideline 133-4) and/or any other
method used are also required to confirm the level of detection.
Before reregistering the product containing sulfuryl fluoride, the Agency is requiring that
a revised Confidential Statement of Formula (CSF) be submitted within eight months of the
issuance of this document. Additionally, in order to remain in compliance with FIFRA, revised
labeling must also be submitted at the same time. After reviewing the revised CSF and labels
and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will
reregister the product.
VI
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I.
INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed
in nine years. There are five phases to the reregistration process. The first four phases of the
process focus on identification of data requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill the requirements. The fifth phase
is a review by the U.S. Environmental Protection Agency of all data submitted to support
reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying
a pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This decision document presents the Agency's decision regarding the reregistration
eligibility of the registered uses of sulfuryl fluoride. The document consists of six sections.
Section I is the introduction. Section H describes sulfuryl fluoride, its uses, data requirements
and regulatory history. Section HI discusses the human health and environmental assessment
based on the data available to the Agency. Section IV presents the reregistration decision for
sulfuryl fluoride. Section V discusses the reregistration requirements for sulfuryl fluoride.
Finally, Section VI is the Appendices which support this Reregistration Eligibility Document.
Additional details concerning the Agency's review of applicable data are available on request.1
JEPA's reviews of data on the set of registered uses considered for EPA's analysis may
be obtained from the OPP Public Docket, Field Operations Division (H7506C), Office of
Pesticide Programs, EPA, Washington, DC 20460.
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CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Document:
Chemical Name:
Structure:
CAS Registry Number:
sulfuryl fluoride
O
I!
F-S-F
II
O
2699-79-8
•
B.
OPP Chemical Code:
Chemical Formula:
Molecular Weight:
Trade and Other Names:
Basic Manufacturer:
Use Profile
078003
F2O2S
102.07
Vikane
DowElanco
The following is information on the current registered uses with an overview of
use sites and application methods. A detailed table of the uses of sulfuryl fluoride is in
Appendix A.
For Sulfurvl Fluoride:
Type of Pesticide: Insecticide (fumigant)
Use Sites: Terrestrial Non-Food (wood protection treatment to forest
products-seasoned), Terrestrial Non-Food and Outdoor Residential
(wood protection treatment to buildings/products outdoor), Indoor
Non-Food (commercial transportation facilities; commercial/
institutional/industrialpremises/equipment-indoor), buildinglndoor
Residential (domestic dwellings, domestic/household dwellings
contents; wood protection treatment to buildings/products indoor).
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Target Pests: Drywood termite, Formosan subterranean termite, powder
post beetle, old house borer, death watch beetle, bedbugs,
clothes moths, carpet beetle (except egg stage),
cockroaches (Oriental, American, German and Brown
Banded), rodents (rats, mice).
Formulation Types Registered: Pressurized Gas -99% sulfuryl fluoride
Method and Rates of Application:
Equipment - by cylinder and dispensing device
Method and Rate - one pound of product per 1,000 cubic feet of space for
a 24-hour exposure period with temperatures of 70° or above; 2 pounds
per 1,000 cubic feet of space for 24 hours if temperature is 55 to 65° F.
Exposure varies with the environmental conditions and the target pest.
For tarpaulin fumigation, use a highly resistant material of at least 4 mil
thickness.
Warning Agent - Chloropicrin must be present in the structure during
fumigation at a level > 0.25%.
C. Data Requirements
Data required in the June 1985 Registration Standard for sulfuryl fluoride included
studies on product chemistry, and occupational and residential exposure. These data
were required to support the uses listed in the Registration Standard. Data Call-in
Notices were also issued in July 1990 and November 1992 which required toxicology
data. Appendix B includes all data requirements identified by the Agency needed to
support reregistration for currently registered uses.
A 90-day inhalation neurotoxicity study in the rat is being required to examine
subchronic/chronic exposure to workers. Method validation data for the.Miran and
InterScan gas analyzers and/or any other method used are also required to confirm the
level of detection of the monitoring devices.
D. Regulatory History
Sulfuryl fluoride is a well known compound whose chemical and lexicological
properties are extensively documented in published literature and studies submitted to the
Agency. In June 1985, a Registration Standard was issued for sulfuryl fluoride which
summarized the available data supporting registration. The standard concluded that
additional scientific data would be necessary to support the registration or reregistration
of products which contain sulfuryl fluoride.
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At the time the Registration Standard was issued in 1985 there were only three
registered end-use products and no manufacturing use products containing sulfuryl
fluoride as the sole active ingredient. Presently, there is only one active registered
product sold under the trade name Vikane.
EPA Reg No. 62719-4
Registrant: Dow Blanco
Sulfuryl fluoride is a gas at room temperature (25 °C), but the registered end use
product is marketed as a liquified gas in pressurized steel cylinders containing 99%
sulfuryl fluoride and 1 % inert impurities which are a result of the manufacturing process.
The marketable registered gas is of the same purity as the Technical Grade of the Active
Ingredient (TGAT).
IH. SCIENCE ASSESSMENT
Sulfuryl fluoride is a structural fumigant registered for uses in closed, sealed buildings
for control of numerous pests. It is currently classified as a Restricted Use Pesticide, based on
acute inhalation toxicity to humans. OSHA has established an 8-hr Time Weighted Average
(TWA) limit of 5 ppm for sulfuryl fluoride, based on adverse health effects (FR vol. 57; # 114-
06/12/92). Sulfuryl fluoride has no food/feed uses. '
A. Product Chemistry Assessment
The physical arid chemical characteristics of sulfuryl fluoride
are described below (MRID #s 40361001, 42703701, 42703702, and
47012303):
TGAI
Color
Physical State
Odor
Helting Point
Boiling Point
Specific Gravity
Vapor Density
Solubility
Vapor Pressure
Dissoc. Constant
Oct./Water Part. Coeff.
pH
Stability
Oxidizing or
Sulfuryl fluoride
None
Gas at 25°C
None
-136.7° C at 760 mm Hg
-55.2° C at 760 mm Hg
1.34 at 25°C
3.52 (air = 1)
0.075 g/100 g water at 25°C,
0.78 g/100 cc Wesson oil at 20°C,
1.74 g/100 cc acetone at 22°C,
2.12 g/100 cc chloroform at 22°C
17.7 mm Hg at 25°C
N/A
N/A
N/A
Stable to heat. Hydrolyzes slowly
in water but rapid in basic solution
A mild oxidant
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Reducing Action
Flammability
Explodability
Storage Stability
Corrosion
Reduction potential is -.68V
Not flammable
Not explodable
For up to 6 yrs in steel cylinders
Non-corrosive in the absence of
moisture in steel cylinders
The product is sold as a pressurized liquified gas. On
contact with water, it hydrolyzes initially to chlorosulfonic
acid and hydrogen fluoride and ultimately to sulfuric acid and
hydrogen fluoride. Accordingly, it must be contained and used
with caution.
B. Human Health Assessment
1. Toxicology Assessment
Adequate animal toxicological data on sulfuryl
fluoride are available and will support reregistration
.eligibility of sulfuryl fluoride as a non-food/non-feed
use pesticide. Some confirmatory data, however, are
required (see under V.A.I). The available data are
reported below.
a. Acute Toxicity
The acute toxicity data are summarized in the table
below:
TEST
Oral LDso/rats (MRID # 00072289)
Oral LDSO/ guinea pigs (MRID # 40839901)
1 hr Inhalation LC^, in rats
(MRID # 41099001)
4 hr Inhalation LCj,, in mice
(MRID # 41769101)
4 hr Dermal Vapor LCj,, in rats
(MRID # 41712001)
RESULTS
100 mg/kg
100 mg/kg
4507 ppm (17.5 mg/L)
M = 660 ppm (2.56 mg/L)
F = 642 ppm (2.49 mg/L)
9599 ppm (37.27 mg/L)
TOZ CAT
II
II
III
IV
IV
M
F
Males
Females
b. 2-Day Inhalation Neurotoxicity Study
An acute neurotoxicity study in rats (GL # 81-8) was
required in a November 1992 Data Call-in because acute
neurotoxicity data are necessary for a determination of
short-term exposure risk following reentry into homes
fumigated with sulfuryl fluoride.
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In a 2-day inhalation neurotoxicity study, rats were
administered sulfuryl fluoride (6 hrs/day, for 2
consecutive days) at levels of 0, 100, or 300 ppm (M - 0,
97 or 290 mg/kg/day; F - 0, 109 or 326 mg/kg/day) . A
NOEL was established at greater than or equal to the high
dose (300 ppm). Parameters examined included
electrophysiological, functional and motor activity.
Other neurotoxicity parameters usually examined in this
type of study were not required since they were not
detected at these dose levels in 90-day or chronic rat
studies. The Agency considers that the requirement for
an acute neurotoxicity study in rats is satisfied by this
Study (MRID # 427720-01).
c. Subchronic Toxicity
In a general subchronic toxicity study,
administration of sulfuryl fluoride to rats by inhalation
for 6 hours/day for 90 days at doses of 30, 100, or 300
ppm (M - 29, 97, or 290 mg/kg/day; F - 33, 109, or 326
mg/kg/day) , resulted in a NOEL of 30 ppm and an LEL of
100 ppm based on fluorosis of the teeth. Signs of
toxicity at 300 ppm included decreased body weight,
lesions of the nasal passage (inflammation), lung
(alveolar histiocytosis), and brain (microscopic
vacuolation of the caudate-putamen nucleus and white
fiber tracts of the internal capsule) (M,F) ; and very
slight hyperplasia of the collecting ducts of the kidney
(F) (MRID # 408909-02).
An inhalation neurotoxicity 90-day study in rats at
the same dose levels also resulted in a NOEL of 30 ppm.
The LEL of 100 ppm also had evidence of toxicity
including fluorosis of the teeth, pale foci in the
pleura, and aggregates of macrophages in the lung. There
were also electrophysiologic signs of neurotoxicity at
this dose including slowing of the visual evoked response
and somato-sensory response (F) , and auditory brain stem
response (M). At 300 ppm there was vacuolation of the
caudate putamen which is consistent with the general 90-
day rat study (MRID #s 408399-02, 408909-03).,
Administration of sulfuryl fluoride by inhalation
for 6 hours/day for 90 days to rabbits at doses of 30,
100, or 300 ppm (11, 38, or 114 mg/kg/day) resulted in
similar signs of toxicity although brain lesions occurred
at lower levels. The NOEL was 30 ppm. The LEL was 100
ppm based on decreased body weights, decreased liver
weight and mottling of the teeth (M,F), and microscopic
vacuolation of' the white matter of the brain (F) . In
addition, at 300 ppm (M,F) there was alveolar
histiocytosis, histologic changes in the nasal
epithelium, and microscopic malacia to vacuolation of the
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internal and external capsules, putamen,
pallidus of the brain (MRID # 408909-01).
and globus
Administration of sulfuryl fluoride in a 90-day
inhalation dog study (6 hours/day) at doses of 0, 30, 100
or 200 ppm resulted in a NOEL of 100 ppm (2.5 mg/kg/day)
and an LEL of 200 ppm (5.0 mg/kg/day) based on decreased
mean body weight and body weight gain. There were also
slight histologic lesions in the caudate nucleus of the
basal ganglia midbrain (M,F) at 200 ppm. In addition,
one male with the above lesion also had transient
clinical neurologic signs including lateral recumbency,
tremors, incoordination, salivation, and tetany followed
by inactivity (MRID 422566-01).
d. Developmental Toxicity
There was no developmental qr overt maternal
toxicity associated with administration of sulfuryl
fluoride by inhalation to pregnant rats for six hours/day
on gestation days 6-15 at doses of 0, 25, 75, or 225 ppm
(27, 81, or 244 mg/kg/day) (MRID # 00090015). Maternal
toxicity of decreased body weight gain was observed at
300 ppm in the range-finding study.
When administered by inhalation to pregnant rabbits
at doses of 0, 25, 75 or 225 ppm (0, 10, 28, or 85
mg/kg/day) for six hours/day on gestation days 6-18, the
NOEL for both maternal and developmental toxicity was 75
ppm. The LEL was 225 ppm for both maternal toxicity
(reduced body weight gain) and developmental toxicity
(reduced fetal body weights and crown rump length) (MRID
# 00090015).
e.
Reproductive Toxicity
A two-generation reproduction toxicity study in rats
administered sulfuryl fluoride by inhalation at doses of
0, 5, 20, or 150 ppm (M - 0, 4, 17, or 130 mg/kg/day; F -
0, 5, 20, or 152 mg/kg/day) for 6 hours/day, 5
days/week, resulted in a parental NOEL of 5 ppm and LEL
of 20 ppm based on an increased incidence of aggregates
of alveolar macrophages in the lungs. At 150 ppm, there
was an increased incidence of vacuolation of the
myelinated caudate-putamen fiber tracts in the brain.
The reproductive NOEL of 20 ppm and the LEL of 150 ppm
were based on reduced pup weights in both the Fl and F2
generations (MRID # 421798-01).
f. Mutagenicity
Sulfuryl fluoride was negative for bacterial gene
mutations when tested at up to cytotoxic levels with and
without metabolic activation (MRID # 41603001).
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Sulfuryl fluoride did not cause chromosomal
aberrations when tested in the mouse micronucleus assay,
at doses up to 520 ppm (80% of the acute LC50) (MRID #
41448601).
Sulfuryl fluoride was negative in the UDS assay in
rat primary hepatocytes when tested at levels of 204 to
1020 ppm (MRID # 42179802).
g. Other toxicology information
Human poisonings and fatalities have been reported
after_ sulfuryl fluoride exposure. Some residents
entering sulfuryl fluoride fumigated houses 2 to 5 hours
after aeration experienced chest pains, dyspnea, nausea,
and vomiting. There have been two reports of deaths of
persons entering sulfuryl fluoride treated houses. One
entered the house illegally and was found dead in the
morning, and -a homeowner died of cardiac arrest after
sleeping in the house overnight following fumigation. A
plasma fluoride level of 0.5 mg/L (10 times normal) was
found in this individual following exposure. (ACGIH,
1971; NIOSH, 1978; Nuckolls, 1987; PIMS, 1980; Taxav,
1966). *'
2. Exposure Assessment
a. Dietary Exposure
No dietary exposure is expected from the use of
sulfuryl fluoride as a non-food/non-feed use fumigant.
Therefore, there are currently no tolerances or
exemptions from the requirements of a tolerance
established for this chemical.
b. Occupational and Residential
Sulfuryl fluoride is a structural fumigant
registered for use in closed, sealed buildings
(dwellings, garages, barns, storage buildings, etc.) for
control of numerous pests, including drywood termites,
powder post beetles, old house borers, bedbugs, and
clothes^moths. Sulfuryl fluoride is not registered for
the fumigation of stored grains or cereals. It is a gas
at 25 C. The registered end-use product is supplied as
a liquified gas in pressurized steel cylinders which
contain 99% sulfuryl fluoride ai and 1% impurities which
are present as a result of of the manufacturing process.
Sulfuryl fluoride is classified as a restricted use
pesticide based on inhalation toxicity to humans and may
only _ be used by or under the supervision of certified
applicators wearing appropriate protective clothing.
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Application of • this product must be used in
conjunction with chloropicrin. Chloropicrin must be
present in the structure at a level > 0.25%.
(1) Mixer/loader/applicator exposure
Based on the method of application, use pattern, and
current label requirements for the use of respiratory
protection, worker dermal and inhalation exposure to
sulfuryl fluoride, if it occurs, will be intermittent and
very low.
(2) Residential/Occupational post
reentry exposure
application
Because of its physical nature (a gas at 25°C) , oral
and dermal exposure to residues of sulfuryl fluoride or
its degradates which may remain on/in household contents
or indoor air after the required aeration period are
expected to be very low.
There is, however, a potential for inhalation
exposure upon reoccupation/reentry of treated homes. The
exposure may be either acute (residents and workers) or
intermittent (workers during their working life span).
In response to the Registration Standard, the registrant
has submitted air monitoring data (GL # 133-4) for
sulfuryl fluoride in 10 houses fumigated at 16 g/m3.
After aeration to a level equal to or lower than 5 ppm,
the houses were closed again, and the air concentration
of sulfuryl fluoride measured. The results indicated
that average concentrations of sulfuryl fluoride remained
at or below 5 ppm (mean concentration =4.5 ppm) during
the monitoring period after aeration and closure;
however, individual maximum concentrations ranged from 5
ppm immediately following aeration to approximately 16
ppm 60 minutes after aeration and closure. Data were not
provided for airborne residues of sulfuryl fluoride
remaining in homes at levels much below 5 ppm or beyond
120 minutes (MRID # 418177-01).
In two other data submissions, a total of 22 houses
were fumigated in the usual manner and at customary
application rates, then aerated to a level equal to or
lower than 5 ppm. Indoor air was monitored for 24 hours
after closure although only a limited number of samples
were collected between 6 and 24 hours. In the first
project (four houses), of the 25 air samples collected at
or near 24 hours after closure, three were at the 1-ppm
level and all others at levels below the operational
sensitivity of the detection devices (1 ppm). In the
second project (18 houses) virtually all air samples
measured at or near 24 hours after closure were at non-
detectable levels (<1 ppm) (MRIDs 42447101 and 42447102) .
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Acute inhalation exposures of residents and workers
reentering fumigated houses after aeration may be
estimated using the following equation and assumptions:
Daily Dose (mg/kg/day) = ppm x MW x resp. vol. CL/dav)
24450 Kg body weight
Assumptions:
- Molecular Weight = 102.07,
adult body weights of 70 kg/male and
60 kg/female
- respiratory volume (resp. vol. based
on 16 hours rest + 8 hours light work;
ventilation rates (L/min) are
respectively 7.4 (M) and 4.5 (F) at rest
and 29 (M) and 16 (F) with light work,
100% pulmonary absorption, and
various air levels [5 ppm as per
current label, 4.5 ppm (mean value from
DowElanco study MRID # 418177-01), or
theoretically reduced values of 2, 1 and
0.5 ppm.
Potential exposures are shown in the table below:
Estimated 'Daily Doses at Various Levels of Sulfuryl Fluoride
Exposure
Scenario
Current label
DowElanco measurement
Exposure reduced to
Exposure reduced to
Exposure reduced to
Air
pom
5
4.5
2
1
0.5
level
mcf/m3
20.87
18.77
8.34
4.17
2.08
Daily dose
Males
6.27
5.64
2.51
1.25
0.62
(mcf/kcr/day)
Females
4.17
3.75
1.67
0.83
0.42
Assessment of intermittent exposure of workers
during their working life span will be addressed
after the required 90-day inhalation neurotoxicity
study is submitted and evaluated.
Post fumigation desorption data (GL # 133-4),
also submitted in response to the Registration
Standard, indicated that sulfuryl fluoride is
desorbed at low levels (probably in the ppb range)
from various household materials for up to 40 days
following fumigation and aeration and that there
are no degradates desorbed from these materials
(MRID # 403332-01).
10
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Based on the overall indoor air monitoring and
post fumigation desorption data, sulfuryl fluoride
residues appear to dissipate to very low levels
within 24 hours and the dissipation would be
expected to continue. Therefore, the Agency
believes that air levels of sulfuryl fluoride in
homes fumigated at recommended label rates should
be negligible within a short period of time after
fumigation and aeration. However, quantitation is
limited by the sensitivity of the analytical
instruments [Miran infrared analyzer (LOD = 1 ppm)
or InterScan gas analyzer (LOD = 1 ppm)].
3. Risk Assessment
a. Dietary
Dietary risk is not expected since there are no food
or feed uses for sulfuryl fluoride.
b. Occupational and Residential
The Agency has a concern for neurotoxicity
associated with inhalation exposure to sulfuryl fluoride.
Histopathology of one or more brain anatomical structures
has been a consistent observation in 90-day inhalation
studies in several experimental animal species including
the rat, rabbit, and dog (MRID #s 4080909-02, 4080909-01,
and 422566-01). Neurologic signs such as tremor,
incoordination, and tetany also were observed in the dog
(MRID # 422566-01) as well as slowing of several
electrophysiologically evoked responses in the rat (MRIDs
408399/02-03). In humans, poisonings and fatalities have
been reported after sulfuryl fluoride exposure. Some
residents entering sulfuryl fluoride fumigated houses 2
to 5 hours after aeration experienced chest pains,
dyspnea, nausea, and vomiting. These symptoms occurred
as a result of early reentry, not in accordance with
label aeration procedures. There have been two reports
of deaths of persons entering sulfuryl fluoride treated
houses. One entered the house illegally and was found
dead in the morning, and a homeowner died of cardiac
arrest after sleeping in the house overnight following
fumigation.
Residents and workers reentering treated houses may
be at risk for acute neurotoxic effects from exposure to
sulfuryl fluoride. Workers, but not residents, may also
be exposed intermittently over the course of their
working life span. Using the potential exposures
estimated above [B.2.b-(2)] for residents and workers,
the margin of exposures (MOEs) for acute exposure may be
estimated by the following equation:
11
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MOE = NOEL fmcf/kcr/dav)
Exposure (mg/kg/day)
Assumptions: - the NOEL is 300 ppm based on the 2-day
inhalation neurotoxicity study, which the
Agency considers to be the most
appropriate NOEL for determining
acute/subacute exposure, and
- conversion of rat ppm into mg/kg/day
based on respiratory volumes (m3/24 hours)
of 0.37 (M) and 0.26 (F) and body weight
(kg) of 0.4 (M) and 0.25(F).
The MOEs for acute exposure are presented in the
following table:
MARGINS OF EXPOSURE FOR ADULT RESIDENTS REENTERING
HOMES TREATED WITH SULFURYL FLUORIDE
Exposure Scenario
Current label
DowElanco
measurement
If exposure were
reduced to:
ppm
5
4.5
2
1
0.5
mg/ms
20.87
18.77
8.34
4.17
2.08
Daily Dose
(mg/fcg/d)
(16 hrs rest -t- 8 hrs light
work/d)
Males
6.27
5.64
2.51
1.25
0.62
Females
4.17
3.75
1.67
0.83
0.42
NOEL
ppm
' 300
300
300
300
300
NOEL
mg/kg/d
(M/F)
290/326
290/326
290/326
290/326
290/326
MOE
Males
46
51
116
232
464
Females
78
87
196
393
786
Based on the above calculations, the Agency believes that
a reentry level of less than 5 ppm may be appropriate. There
are several factors that create an element of uncertainty in
establishing a suitable level. First, the calculated MOEs
could be an over estimate of the risk to occupants for the
following reasons: (1) the NOEL was derived from a study
with a constant level of exposure, whereas, dissipation of
sulfuryl fluoride is expected to continue over time following
fumigation, and (2) a pulmonary absorption of 100% is
assumed. Another factor contributing to the uncertainty
regarding the appropriateness of the 5 ppm level is that the
available exposure data are limited for the period between 6
hours and 24 hours following beginning of aeration
procedures. At 24 hours sulfuryl fluoride residues in all
test houses were non-detectable or at very low levels.
Without these data the Agency cannot calculate a precise rate
of decline applicable to all treated structures. Additional
data may enable the Agency to estimate more accurately the
rate of decline in sulfuryl fluoride levels and determine an
12
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appropriate reentry level. The existing data suggest a
reentry level of 2 ppm to provide adequate MOEs for adults.
However, the Agency is also concerned with the possible
heightened sensitivity of children to pesticides and believes
an additional safety factor is warranted. Very young
children may be more susceptible than adults to sulfuryl
fluoride neurotoxicity because the developing brain may be
more vulnerable to chemical injury. According to a recent
report by the National Academy of Sciences, the central
nervous system (CNS) continues to develop during the
postnatal life (NAS Report, 1993) . The NAS Report also noted
that "quantitative differences in toxicity between children
and adults are usually less than a factor of 10-fold."
Although the NAS Report focused on dietary risk to children,
the Agency still believes it appropriate to apply a safety
factor in this case because of the reasons noted above. The
Agency has not yet developed guidance on what factor between
1 and 10 would be appropriate and under what circumstances.
The Agency believes that lowering the reentry level to 1 ppm,
the operational sensitivity of the monitoring devices, would
provide an adequate safety margin. Lowering the acceptable
reentry concentration to 1 ppm (the operational sensitivity
of the Miran detector in the field) would provide a margin of
exposure of approximately 500 for adult residents entering
the homes (464 for males and 786 for females) and
approximately 100 for children. These estimates were based
on an assumed air level of 0.5 ppm (according to Agency
practice, a value of half the limit of detection is used in
exposure calculations). Because of the conservative
assumptions on which the MOEs are based, and the lack of more
definitive guidance on what factor to use for additional
protection of children, the Agency believes the 1 ppm level
is adequate and will require a reentry level of 1 ppm if the
additional data mentioned above cannot be used to determine
a more suitable reentry level between 1 and 5 ppm. The
Agency believes that use of a greater MOE would result in
reentry levels below the limit of detection of current
monitoring devices.
The Agency is providing the registrant with the
opportunity to submit these exposure data and any other data
that can be used in refining the decline rate of sulfuryl
fluoride. These data may also be useful in establishing a
reentry level for non-residential structures. If the
registrant elects to submit these data, they must be
submitted by August 1, 1994. During the period between
issuance of this RED and October 1, 1994, the reentry level
will remain at 5 ppm. The Agency will make a decision on the
reentry level by October 1, 1994. If the new data are not
received by August 1, 1994 or are not useful in making this
determination, the reentry level will be established at 1 ppm
for dwellings, and 2 ppm for non-residential structures and
vehicles where young children are not expected to be exposed.
13
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Revised labeling reflecting the lower reentry levels will be
required.
The MOEs for longer term exposure to sulfuryl fluoride
will _be addressed when the required 90-day inhalation
toxicity study is submitted and evaluated. Although several
90-day inhalation studies are available, the Agency does not
consider them appropriate for long term risk assessment for
the following reasons:
- the toxicological end-point of concern is neurotoxicity,
- the 90-day inhalation studies in rats, rabbits, and dogs
were deficient (too few animals on test, inadequate
histopathology, lacking in functional observational
battery/motor activity testing, or no positive control data),
the NOEL in the 2-generation reproduction study in rats
was based on respiratory effects, not neurotoxic effects.
C. Environmental Assessment
1. Environmental Fate
Under normal circumstances the terrestrial non-food and
outdoor residential use patterns would trigger environmental
fate data requirements. However, in this case the product
containing this active ingredient is registered for highly
specialized uses which involve fumigation of barns, household
or domestic dwellings, ships, buses, railway cars, commercial
storages or warehouses, seasoned forest products and
residential building materials to control existing infestation
of various insects and pests. The Agency has decided, based
on the pesticide's chemical properties, and specialized use
patterns, that the terrestrial non-food and outdoor
residential use pattern classifications do not require
supporting data as described in 40 CFR Part 158. In
particular, the pesticide acts not as a wood protection
treatment, but simply as a fumigant to control existing
infestations. After the treatment and aeration of the
fumigated areas there is little likelihood of residues of
sulfuryl fluoride which would result in exposure to non-target
organisms or impact the environment by leaching into ground
water.
Further, sulfuryl fluoride hydrolizes very slowly in
water under neutral conditions. However, it does undergo
hydrolysis under alkaline conditions to form fluorosulfuric
acid (HSO3F) and hydrofluoride (HF). These degradation
products are easily removed from water by further reacting
with oxides and salts of oxo acids. Sulfuryl fluoride also
reacts readily with nucleophilic substances. Because sea
water is normally around pH 8 and soil contains many
nucleophilic substances, it is not expected that residues of
the intact parent would remain in the environment for any
significant time from the uses listed above.
14
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2. Ecological Effects
Based on the chemical properties of sulfuryl fluoride, no
ecological effects data were required in the 1985 Registration
Standard. Generally, basic wildlife toxicology tests are
required to support terrestrial/outdoor uses of a pesticide.
However, based upon the Agency's conclusions noted above and
the limited use sites, significant environmental exposure is
not expected to result from use of sulfuryl fluoride.
Therefore, wildlife toxicity data have not been required and
an ecological effects risk assessment was not conducted.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to
determine, after submission of relevant data concerning an
active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has
previously identified and required the submission of the
generic (i.e. active ingredient specific) data required to
support reregistration of products containing sulfuryl
fluoride active ingredients. The Agency has completed its
review of these generic data, and has determined that the data
are sufficient to support reregistration of all products
containing sulfuryl fluoride. Appendix B identifies the
generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of sulfuryl
fluoride, and lists the submitted studies that the Agency
found acceptable.
The data identified in Appendix B were sufficient to
allow the Agency to assess the registered uses of sulfuryl
fluoride and to determine that sulfuryl fluoride as currently
registered can be used according to label directions without
resulting in unreasonable adverse effects to man and the
environment. The Agency therefore finds that all currently
registered products containing sulfuryl fluoride as the active
ingredient are eligible for reregistration, so long as they
are in compliance with the requirements specified herein. The
reregistration of particular products is addressed in Section
V of this document.
The Agency makes its reregistration eligibility
determination based upon the target data base required for
reregistration, the current guidelines for conducting
acceptable studies to generate such data and the data
identified in Appendix B. Although the Agency finds that all
uses of sulfuryl fluoride are eligible for reregistration, it
should be understood that the Agency may take appropriate
regulatory action, and/or require the submission of additional
data to support the registration of products containing
15
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sulfuryl fluoride, if new information comes to the Agency's
attention or if the data requirements for registration (or the
guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active
ingredient sulfuryl fluoride, a determination that
unreasonable adverse effects to human health or the
environment are unlikely from the current registered uses of
sulfuryl fluoride if labeled and used as specified in this
document, the Agency concludes that products containing
sulfuryl fluoride are eligible for reregistration.
The Agency has determined that sulfuryl fluoride
products, labeled and used as specified in this
Reregistration Eligibility Decision document, will not pose
unreasonable risks or adverse effects to humans or the
environment.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of sulfuryl
fluoride are eligible for reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions
and rationales for sulfuryl 'fluoride. Where labeling
revisions are needed, specific language is set forth in
Section V of this document.
1. Tolerance Reassessment
There are no food uses of sulfuryl fluoride and therefore
no tolerances or exemptions from the requirement of a
tolerance established for this chemical.
2. Restricted Use Classification
The Agency is maintaining the classification of sulfuryl
fluoride as a restricted use pesticide based on inhalation
toxicity. This pesticide may only be used by or under the
supervision of certified applicators wearing appropriate
protective clothing.
3. Labeling Rationale
• The registrant has proposed an additional label amendment
to remove the following portion of the protective clothing
16
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statement from sulfuryl fluoride labels:
"Sulfuryl fluoride is heavier than air and may be trapped
inside (clothing) and cause skin injury. Wear full body
clothing and shoes or disposable protective clothing.
Immediately after application, remove clothing, shoes,
and socks."
Based on the method of application (i.e., introduction of
sulfuryl fluoride into the target area via a hose),
negligible exposure to the applicator would be expected until
time of reentry into the fumigated structure to monitor air
levels. Therefore, the Agency agrees that the above
statement may be removed from sulfuryl fluoride labels.
» Because of uncertainty about neurotoxic effects from-long
term exposure to sulfuryl fluoride,.workers will be required
to wear a NIOSH approved, self-contained breathing apparatus
(SCBA) upon reentry, regardless of air levels of sulfuryl
fluoride. The Agency is requiring a 90-day inhalation
neurotoxicity study in rats to more fully assess human
subchronic and chronic effects. Assessment of risks to
workers during their working life span, and the need to
continue wearing the SCBA upon reeentry at all levels of
sulfuryl fluoride, will be addressed after this study is
received and evaluated.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses
necessary for the reregistration of both manufacturing-use (MP) and
end-use products (EUP).
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of
sulfuryl fluoride for the above eligible uses has been
reviewed and determined to be substantially complete for
issuance of a Reregistration Eligibility Decision document.
However, the Agency considers the following new data
requirements confirmatory. (Refer to Appendix F for further
information regarding these requirements.)
A neurotoxicity study was not required by the
Registration Standard for reregistration of this chemical.
However, a 90-day neurotoxicity study in the rat submitted
voluntarily by the registrant demonstrated slowing of the
visual evoked response (VER) and somatosensory response (SER)
wave forms in females and the auditory brain stem response
(ABR) in males at 100 ppm, as well as lesions of the caudate-
putamen nuclei at the high dose level. However, functional
17
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observation batteries and motor activities were not monitored
adequately. Ninety-day inhalation toxicity studies in rats,
rabbits and dogs at the same exposure concentration levels
demonstrated similar neurohistologic lesions at similar
(higher in dogs) doses. In addition, the dogs displayed
signs consistent with neurologic toxicity. Because of
concern that the chemical may produce other neurotoxic
responses, and because subchronic/chronic exposure of workers
cannot be presently ruled out, a new 90-day neurotoxicity
study in rats (GL # 82-5B) is required using the Subdivision
F Neurotoxicity Guidelines.
Method validation data for the Miran and InterScan gas
analyzers (also listed under GL # 133-4) and/or any other
method used are also required.
2. Labeling Requirements for Manufacturing-Use Products
There are currently no manufacturing-use products
registered for sulfuryl fluoride.
B. End-Use Products
l. Additional Product-Specific Data Requirements
No additional product-specific data are required for the
one registered sulfuryl fluoride end-use product.
2. Labeling Requirements for End-Use Products
It is the Agency's position that, in order to remain in
compliance with FIFRA, all products must comply with the
following label specifications:
• The labels and labeling of all products must comply with
EPA's current regulations and requirements as specified in 40
CFR §156.10, with PR Notice 84-5 "Label Improvement Program
for Fumigants" and with Supplement # 4 of PR Notice 93-7
"Worker Protection Standard Guidance for Fumigants".
Registrants should follow the instructions in the Pesticide
Reregistration Handbook with respect to labels and labeling.
• The_label must provide specific directions for the use of
chloropicrin as a warning agent to be present in the
structure during fumigation at a level > 0.25%.
Instructions must be provided that the chlorpicrin must
be used by persons certified to apply sulfuryl fluoride and
that applicators must observe the precautionary statements
and safety recommendations appearing on the label of this
product.
18
-------
• The label must require that a pesticide fact sheet be
provided to an adult occupant of the structure to be
fumigated prior to the initiation of the fumigation contract.
This fact sheet, which is labeling, must contain as a minimum
of information the following:
a) Why buildings are fumigated.
b) How buildings are fumigated.
c) Potential health risks from overexposure.
d) Safety precautions and homeowner preparation.
e) A contact point for additional information.
• Add the following under the Environmental Hazards
Statement:
Pesticide wastes are toxic. Improper disposal of
excess pesticide is a violation of Federal Law. If
these wastes cannot be disposed of by use according
to the label instructions, consult your State
Pesticide or Environmental Control Agency, or the
Hazardous Waste representative of the nearest EPA
Regional Office for guidance.
• Due to concern for neurotoxic effects from long term
exposure to sulfuryl fluoride upon reentry to treated
structures, the Agency requires the following:
Applicators must wear a NIOSH approved self-contianed
breathing apparatus (SCBA) when reentering a treated
structure regardless of air levels of sulfuryl fluoride.
C. Existing Stocks
Registrants may generally distribute and sell products
bearing old labels/labeling for 26 months from the date of the
issuance of this Reregistration Eligibility Decision Document
(RED). Persons other than the registrant may generally
distribute or sell such products for 50 months from the date
of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the
number of products involved, the number of label changes, and
other factors. Refer to "Existing Stocks of Pesticide
Products; State of Policy"; Federal Register. Volume 56, No.
123, June 26, 1991.
The Agency has determined that registrants may distribute
and sell sulfuryl fluoride products bearing old
labels/labeling for 26 months from the date of issuance of
this RED. Persons other than the registrant may distribute or
sell such products for 50 months from the date of the issuance
of this RED. If the Agency decides to establish a 1 ppm
reentry level on October 1, 1994, then the policy will be
reconsidered to establish an accelerated label change
schedule.
19
-------
APPENDIX A
Table of Use Patterns
Subject to Reregistration
20
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APPENDIX B
Table of the Generic Data Requirements
and Studies Used to Make the
Reregistration Decision
23
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the
reregistration for the pesticide sulfuryl fluoride covered by this
Reregistration Eligibility Document. It contains generic data requirements
the apply to sulfuryl fluoride in all products, including data requirements
for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Recruirement (Column 1) . The data requirements are listed in the
order in which they appear in 40 CFR, Part 158. The reference number
accompanying each test refer to the test protocols set in the
Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield,
Virginia 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use pattern for
which the data requirements apply. The following letter designations
are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential outdoor
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has accepted data
in its files, this column lists the identifying number of each study.
This normally is the Master Record Identification (MRID) Number, but
may be a "GS" number if no MRID number has been assigned. Refer to
the bibliography appendix for a complete citation of the study.
24
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APPENDIX C
Bibliography
Citations Considered to be Part of the Data Base
Supporting Reregistration
29
-------
APPENDIX C
SDLFDRYL FLUORIDE BIBLIOGRAPHY
Citations Considered to be Part of the
Data Base Supporting Reregistration
CHEMICAL NAMEi
SULFURYL FLUORIDE
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).
40333201 Scheffrahn, R; Spenkel, R. (1987) Post-fumigation Fate of
Sulfuryl Fluoride: Desorption from Structural
Commodities and Transient and Permanent Residues in
Projected and Exposed Foodstuffs: Project Identification
GH-C 1939. Unpublished'study prepared by Dow Chemical
U.S.A. 77 p.
40361001 Wichman, K. (1987) Sulfuryl Fluoride*..: Physical and
Chemical Characteristics. Unpublished study prepared by
Agricultural Chemistry R&D Laboratories. 4 p.
40839901 Miller, R.; Calhoun, L. ; Keyes, D.; et. al. (1980)
Sulfuryl Fluoride (Vikane Fumigant): An LC50
Determination: Project ID K-016399-013. Unpublished
study prepared by the Dow Chemical Co. 244 p.
40839902 Miller, J.; Albee, R.; Eisenbrandt, D.; et. al. (1986)
Neurological Examination of Fischer 344 Rats Exposed to
Sulfuryl Fluoride (Vikane Gas Fumigant) for 13 Weeks:
Project ID: K-016399-026. Unpublished study prepared by
the Dow Chemical Co. 110 p.
40890901 Nitschke, K.; Zimmer, M.; Eisenbrandt, D. (1987) Sulfuryl
Fluoride (Vikane Gas Fumigant); 13-Week Inhalation
Toxicity Study with Rabbits; Study ID K-016399-025B.
Unpublished study prepared by the Dow Chemical Co. 135
P.
30
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40890902 Nitschke, K. ; Dittenber, D. ; Eisenbrandt, D. (1987)
Sulfuryl Fluoride (Vikane Gas Fumigant); 13-Week
Inhalation Toxicity Study with Rats: Study ID K-016399-
025R. Unpublished study prepared by the Dow Chemical Co.
158 p.
40890903 Miller, J. ; Albee, R.; Eisenbrandt, D. ; et. al. (1987)
Subchronic Neurotoxicity in Rats of the Structural
Fumigant, Sulfuryl Fluoride. Neurotoxicology and
Teratology 10(2):127-133.
41448601 Gollapudi, B. ; McClintock, M. ; Nitschke, K. (1990)
Evaluation of Sulfuryl Fluoride in the Mouse Bone Marrow
Micronucleus Test: Lab Project No.: TXT:K-016399-033.
Unpublished study prepared by the Dow Chemical Co. 37 p.
41603001 Gollapudi, B.; Samson, Y.; Zempel, J. .(1990) Evaluation
of Sulfuryl Fluoride in the Ames Salmonella/Mammalian-
Microsome Bacterial Mutagenicity Assay: Lab Project No.:
TXT:K-016399-037. Unpublished study prepared by the Dow
Chemical Co. 41 p.
41769101 Nitschke, K. (1990) Sulfuryl Fluoride: Acute LC50 Study
with CD-I Mice: Lab Project No.: K-016399-031: K-016399-
03IB. Unpublished study prepared by the Toxicology
Research Laboratory/Dow Chemical Co. 56 p.
41817701 Indoor Airborne .Residues of Methyl Bromide and Sulfuryl
Fluoride in Fumigated Houses After Aeration.
42179801 Breslin; Liberacki; Kirk; Bradley; and Crissman (1992)
Two Generation Inhalation Reproduction Study in Sprague
Dawley Rats; Study ID# K-016399-042.
42179802 Gollapudi, B.; McClintock, M. ; Zempel, J. (1991)
Evaluation of Sulfuryl Fluoride in the Rat Hepatocyte
Unscheduled DNA Synthesis (UDS) Assay; Study ID# K-
016399-043.
42703701 Reregistration of Sulfuryl Fluoride Product and Residue
Chemistry Review; Study ID# KJB51292, 4 p. and Study ID#
KJB5129CA, 5 p.
42703702 Series 62: Analysis and Certification of Product
Ingredients of Vikane Gas Fumigant; Study ID# GH-C 2977
83 p.
42772001 Albee, R.; Spencer, P.; Bradley, G. (1993) Sulfuryl
Fluoride: Electrodiagnostic, FOB and Motor Activity
Evaluation of Nervous System Effects From Short Term
Exposure; Study ID# K-016399-045. 164 p.
31
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APPENDIX D
List of Available Related Documents
32
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APPENDIX D
The following is a list of available documents related to sulfuryl
fluoride. Its purpose is to provide a path to more detailed
information if it is required. These accompanying documents are
part of the Administrative Record for Sulfuryl Fluoride and are
included in the EPA's Office of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Sulfuryl Fluoride RED Fact Sheet (included in this RED)
4. PR Notice 91-2 (Included in this RED) Pertains to the Label
Ingredient Statement
The following Federal publications on sulfuryl fluoride are
available and may be purchased from the National Technical
Information Service (NTIS), 5285 Port Royal Road, Springfield, VA
22161.
1. Guidance for the . Reregistration of Pesticide Products
Containing Sulfuryl Fluoride as the Active Ingredient (The
1985 Registration Standard): NTIS Stock No. PB86-173937
Pesticide Fact Sheet (No.
Stock No. PB87-124392
26) for sulfuryl fluoride: NTIS
33
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APPENDIX E
Pesticide Reregjstration Handbook
34
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&EPA
UnfttdStctes Offiwof
Envirenm«nt«I Prelection P«*tJcid» Programs
October 1991
Pesticide
Reregistration
^ff
Handbook
How to Res
Dondto
the Reregistration
Eligibility Document
(RED)
-------
PRODUCT REREGISTRATIOK HANDBOOK
TABLE OF CONTENTS
I. Introduction
A. Purpose and Content
B. Reregistration Eligibility Document
C. Reregistration Process
IX. Instructions for Responding
A. Eov and When to Respond
B. When No Response Is Needed
B. Where to Respond
III. Submission of Data and Labels/Labeling
A. Generic Data
B. Product Specific Data
1. Product Chemistry '
2. Acute Toxicity
3. Product Performance
C. Labels/Labeling
Appendix
A. Confidential Statement of Formula and Instructions
B. Label Contents
C. Sasple Label Formats—General Use t Restricted Use
D. Label Regulations (40 CFR 156.10)
-------
PESTICIDE RZREGI8TRATION HANDBOOK
I. IKTRODUCTION
A. Purpose and Content of this Handbook
This Handbook provides instructions to registrants on how to
respond to the Reregistration Eligibility Document (hereafter
referred to as the "fcZD") and how to reregister products.
Sevvfon I is this introduction.
Section II contains step-by-step instructions which must be
followed by registrants responding to the RED.
Section III provides additional instructions on the format,
content and other aspects of generic data, product specific data
and labels/labeling which nay be required to be submitted.
Detailed instructions are in the Appendix.
B. The Rereaistration Eligibility Doeunenl: (REp)
Under Section 4 of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), as amended in 1988, EPA is required to
reregister pesticides that were first registered before November i.
1984. The RED describes in detail the subject chemical, its uses
a?f i^s regulatory history; describes EPA's decision concerning the
eligibility of the uses of the chemical for reregistration; and
explains the scientific and regulatory bases for this decision.
EPA«s reviews of the data by scientific discipline are available
upon request. Appendices to the RED contain: (l) a Data Dall-ln
Kotice which requires submission of generic and product specific
data and which gives directions for responding, (2) a listing of
f^f^ing ctudies «"* satisfy generic data requirements and (3) a
bibliography of the generic studies EPA has reviewed.
C. The Rereqistraticn Process
Reregistration involves a thorough review of the scientific
data base underlying a pesticide's registration. The purpose of
EPA's review is to reassess the potential hazards arising from the
f£rr
-------
If the RED declares that some or all uses of the chemical are
eligible for reregistration, affected registrants must first
respond within 90 -days of receipt to the data call-in portion of
the RED. Within 8 months of receiving the RED, registrants must
submit or cite any data and labels/labeling required for each
product. EPA has until 14 months after the RED is issued .(i.e.,
6 months after the registrants' 8 month deadline) to review the
submission fo?- each product and decide whether to reregister it
based on the 'following criteria:
—whether all of the product specif ic data and labels/labeling
are acceptable,
--whether all of the uses on the label/labeling are eligible,
—whether all of the active ingredients in the product are
eligible, and
—if no List 1 toxic inert ingredient is contained in the
product (a List 1 inert is permitted only if all data
for it have been submitted and EPA determines
that the inert does not pose any unreasonable adverse
effects in that product).
Products which meet all of these criteria will be
reregistered. Products which do not meet all of these criteria,
but which have acceptable product specific data and labeling, will
be processed as amendments in order to implement label changes
required by the RED..
II. INSTRUCTIONS FOR RESPOHPIMS
A. Hov and When to Respond
This section provides directions for submitting timely and
adequate responses necessary to reregister products containing the
active ingredient covered by the RED. Registrants must follow
these steps exactly to avoid suspension of their products. All
products .containing the active ingredient in the RED [i.«.,
manufacturing use products, end use products and special local n«ed
(*I:H «r Sscties 24c) registrations] are subject to the requirements
of the RED. Figure 1 summarizes how and when to respond to the
RED. A step-by-step explanation follows.
Step 1. Are Expedited Label Changes Required^ in some
instances, EPA may conclude that certain changes to product
labels/labeling must be implemented rapidly. Zf the RED requires
•zpedited label/labeling changes, registrants must submit the items
bftlow by the deadline specified in the RED. if expedited label
changes are not required, go to Step 2.
a. Application for Registration (EPA Form 8570-1). Complete
-------
and sign the form. In Section II, insert the phrase "Expedited
Amendment la Response to the Reregistration Eligibility Document
for (insert ease name for chemical) ••* Applications for expedited
label changes vill be processed as applications .for amended
registration. Use only an original application fora with a red
identifier .number in the upper right-hand corner.
b. rive (5) eopies of revised draft label and labeling.
Refer to 'the RED for label/labeling changes, and follow the
instructions in Section III.C. and the Appendix of this Handbook
for revising the label and labeling for each product.
Pt*P 2» Are data required? if the BED requires generic or
product specific data, you must follow the directions in the data
call-in notice in the RED. All registrants must respond for all
products within 90 dav» of receipt; products for which an adequate
response is not received en time will be subject to suspension. Ko
«xtep8jpap vill be given for
**!P ?> *E! Uses of a Pesticide Eligible
any «ses of the active ingredient (s) covered by the RED are
eligible for reregistration, follow these instructions. If no uses
are eligible, &£ further response may be needed (see .page 5) .
EPA's decision on the eligibility of «ach of the uses of the
active ingredient (s) is presented in the RED. If aav uses of a
chemical are eligible for ^registration, registrants for
manufacturing-use products (KPs), end-use products (EPs) and
special local needs registrations (6LKs), must submit the items
*elov for each product within 8 months of the date of issuance of
the RED:
„„ -,*; fcPPifeation for. Reregistration (use EPA Perm 8570-1).
Complete and sign the form. In Section II of that form, check the
box -other" and insert the phrase "Application for Reregistration."
Use only an original application form with a red identifier number
.in the upper right-hand corner. •««»«
b. Five (5) eopies ef revised draft label and labeling.
Refer to the RED for labeling changes specific to the active
ingredient, follow the instructions in Section IIl.cT of this
Handbook and refer to the Appendix of this Handbook for guidance on
current requirements for labels and labeling, if there are
i^fj1?;?' Jfmm °n, **e *f bel f r labcling» you may delete such uses
and avoid all requirements and consequences which may be associated
with ineligible uses (e.g, generic data requirements; cancellation;
suspension, etc.). If you delete certain uses now and those uses
become eligible for reregistration later, you must «£mit T an
amendment application to add those uses back to the label
-------
FIGURE 1. HOW AND WEEN TO RESPOND TO THE REREGISTRATION
ELIGIBILITY DOCUMENT (RED) TOR MANUFACTURING
PRODUCTS (KPfl), END-USE PRODUCTS (EPS) And SPECIAL
LOCAL NEEDS JiEGIBTRATIONS (SLNs).
STEP is Are expedited label revisions required?
Yes S' No
Submit application
and labels 01*
expedited schedule
specified in RED
STEP 2:
STEP 3S
Are data required?
Yes ^ No
r
Submit forms within
90 days for generic
and product specific
data.
Are any of the uses on the label
eligible for reregistration?
Yes
Are any uses on the label
ineligible for reregistration?
Yes
Do you wish to
delete ineligible
uses from label?
For eaefc KP t IP '
£ SLN (24e) submit
application vithin
8 month*, if
the submission
is acceptable,
the label will be
stamped accepted
as an amendment.
£to reregistratien
vill be issued.
No
.Yes
For each HP c EP
& SLN <24c) submit
application within
8 month*, if
the submission
is acceptable,
the label will be
stamped accepted
and a notice of
reregistratioa
vill be issued.
No further response
aeeessary. Await
the outcome of
EPA's review.
-------
c. Product specific Data. Yon Bust follow the instruction*
in the Data Call-in notice in the RED and in section ill of this
Handbook. suspenses to the data call in are du« within 90 dav« of
receipt of the RED and submission or citation of data is due within
8 aenthy of ths issuance of th* SZD.
d. Two (2) copies of ths currsnt Confidential statement of
±* UPA Form 8570-4, revised February 85). Two completed and
signed CSF forms must be submitted for the basic formulation and
for each alternate formulation, if cSFs are not provided for the
alternate fonr«\as, they vill set be reregistered and will no
longer be acceptable. The Appendix of this Handbook has specific
instructions for completing the CSF fora.
C"S3fi?tl011 »*** a««P«et to citation of Data (EPA Form
This form must be completed, signed and submitted for
B. When Ko Response *« Ffftflffl
of a Pcsticide are eligible for reregistration, it
dt* y°ufrni *? required to submit prodult speSif ie
?^?<2?M Jllng* 4Ufes ?f an actlve ingredient may be declared
ineligible for reregistration for two possible reasons:
»« <,TIAvailable
-------
C. Where to Respond
By U.S. Mail:
Document Processing Desk (iasert distribution ebde)
Office c£ Pesticide Program (H7504C)
Environmental Protection Ajency
401 M Street, S.H.
Washington, D.c. 20460-0001
By express nail 01= fey hand delivery:
Document Processing Desk (insert distribution code)
Office of Pesticide Programs (E7504C)
Room 266A, Crystal Hall 2
1921 Jefferson Davis.Highway
Arlington, VA 22202
'These mailing addresses and the following distribution codes
must be used to assure the timely receipt and processing of your
submissions. Mot using them may significantly delay the handling
of your submissions:
RBD-SRRD-aooc (vhere zzx is the ease code given on the front of
the RED)—use this distribution code for all responses pertaining
to or containing generic data. Such responses include the 90-day
response forms for generic data or hard copies of generic data.
RED-RD-PMXX (vbere aoc is the Product Manager team number)~
use this distribution code for all responses pertaining to or
containing product specific data or labeling, such responses would
include expedited labeling amendments, 90-day responses to product
specific data requirements, hard copies of product specific data
and applications for reregistration.
III. SUBMISSION OF DATA AND IABEI,S/IABELTNG
This section provides additional instructions concerning
responses required for generic data, product specific data and
label js/lsbeling.
A. Generic Data
During EPA'c evaluation of an active ingredient for
reregistration, additional generic data requirements may be
identified that registrants must fulfill, in some instances these
data requirements would have to be satisfied before an active
ingredient or come of its uses could be declared eligible for
reregistration. In other cases, these new data requirements would
not affect the eligibility of the active ingredient, but would be
necessary to confirm EPA's assessment of that chemical.
-------
Any new data requirements and how they affect reregistration
eligibility of a chemical are discussed in the RED. If new generic
data requirements are imposed in a Data Dall-In Notice in the RED,
registrants must respond as described in that Notice. The RED also
contains instructions for completing these forms, a citation of
EPA's legal authority for.requiring the new data, a listing of
options available to registrants for satisfying the data
requirements and the n&ae of the contact person for inquiries.
B. Product Specific Pata
Product specific data nay -be -required for the rereslrtration
of each pesticide product in th^se areas—product chemistry, acute
toxicity and efficacy.
1. Product Chemistry
Following are instructions for submitting product-specific
data and a discussion of EPA's policy on inert ingredients.
a. Data
All data requirements for KPs, EPs and SLNs (24c*s) are
specified in the Data Call-In Kotice in the RED. In addition:
--If you cite data from another identical, registered
product, you must identify the EPA registration number of that
product.
--If the product-specific data submitted or cited do not
pertain to an identical formulation to the product submitted for
reregistration, then new product-specific data are required to be
submitted by the deadline specified in the Data Call-in Notice.
The only exception is for products which EPA "groups" together a
being similar enough to depend on the same data. Such groupings
are discussed in the appendix to the RED (for acute toxicity
purposes, for example), if it was feasible to do so.
b. Inert Ingredients
EPA has implemented a strategy for regulating inert
ingredients which affects the reregistration of pesticide products.
This strategy, issued on April 22, 1987 (52 FR 13305-13309) and
updated on November 22, 1989 (54 FR 48314-48316), adopted certain
policies designed to reduce the potential for adverse effects from
pesticide products containing intentionally added inert
ingredients. EPA divided the known inert ingredients into four
categories:
—Inerts of toxicological concern (List 1) for which available
data demonstrate toxic effects of concern (includes about 50
chemicals).
-------
—Potentially toxic inerts (List 2) for which only limited
data are available, but such data or the chemical structure suggest
the potential for toxicity (includes aboui 60 chemicals).
—Inerts of unknown toxicity (List 3) for which no data or
bases for suspecting toxic effects are available (includes up to
2,000 chemicals).
—Inerts of minimal concern (List 4) which are generally
regarded as innocuous (includes about 290 chemicals).
When a RED is issued and any uses of an active ingredient are
declared eligible for reregistration, all products containing that
active ingredient will be subject to reregistration. EPA will, as
part of the reregistratiort review, examine the inert ingredients of
each product prior to reregistration to ensure that they do not
present unreasonable risks. In reviewing tfcr producfc chemistry
data, EPA will identify List a inerts. EPA will tcontinue to
encourage registrants to eliminate any List 1 inerts present.
Reregistration of products containing only List 2, 3 or 4 inerts
will be unaffected by the inerts strategy.
Consistent with the strategy on inerts, a product containing
a List 1 inert ingredient will j££ be reregistered until a full
risk assessment of the product has been conducted, based en the
data called in for that inert ingredient. However, the existing
registration of a product containing a List 1 inert will remain
valid as long as the product bears the required label warning and
is in compliance with any outstanding DCI, or other activity under
the inerts strategy.
Any product containing a List 2, 3 or 4 inert aav be
reregistered if it Beets all ether requirements for reregistration.
As the inerts strategy is implemented and data for the List 2 and
3 inerts are reviewed, EPA may move these inerts to the other
Lists. If an inert were moved to List 1, products containing that
inert would become ineligible for reregistration. Inert
.ingredients nust also neet normal, registration and tolerance
requirements, as applicable.
2. Asata Texieitv
The data call-in notice in the RED specifies the acute
toxicity data required for reregistration of each HP or EP. It
indicates whether any of the standard tests have been waived and,
if so, why.
If feasible, EPA will "batch" products that are similar with
respect to their acute toxicity so that one set of tests can
support reregistration of each baatch of products. This approach
will impose the least amount of testing necessary to adequately
support the registration and labeling for pesticide products. The
-------
main benefits of this approach are to minimize the need for animal
testing, reduce the expense to registrants to generate the tests
and decrease the resources EPA must spend on reviewing data.
Registrants may contact other registrants with products in the same
"batch" to decide whether to provide or depend en one set of data;
alternatively, registrants may chcase to conduct their own studies.
3« Product Performance
Consult the Data Call-in section of the RED to determine
whether Producjt Performance data .are required tor your product.
Product performance (efficacy) data are generated in studies
designed to document how candidate pesticide formulations perform
as pest control agents. These data include tests run to determine
whether a formulation is lethal to certain pest species, to
document the effectiveness of the formulation in controlling pest
species in actual use situations, and ?*> determine whether certain
claims beyond mere control of a pest (e.g., "six-month residual
effect," "kills Warfarin resistant house mice," etc.) are
justified.
EPA has standard protocols for certain efficacy tests. In
general, standard methods have been developed for tests needed to
substantiate claims that have been made frequently for pesticide
products. As the scope of potential pesticidal claims is extremely
broad, the Agency does not have standard methods for tests needed
to substantiate many pesticide claims, especially those that are
uncommon. The Product Performance Guidelines, Subdivision 6, offer
general guidance for developing protocols for efficacy testing.
Proposed protocols should be submitted to EPA for review before
tests are initiated.
a. Efficacy Data Submission Waiver Peliev
FIFRA gives the Administrator of EPA authority "to waive data
•requirements pertaining to efficacy" but does not require that
efficacy data requirements be waived for any class of pesticide
product registered under Section 3 of the Act. As a matter of
policy, EPA does not require submission of efficacy data to support
many typ** of pesticidal claims but does require submission of such
data for certain types of claims. As noted in 40 CFR 158.640. this
waiver applies to the submission of efficacy data rather than to
the generation of efficacy data. EPA expects each registrant to
"ensure through testing that his products are efficacious when used
in accordance with commonly accepted pest control practices."
This general policy notwithstanding, EPA may, at any time,
require a registrant to submit efficacy data to support any claim
made for a product. EPA also may require that certain claims of
effectiveness be established before a. Section 3 registration is
granted.
-------
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b. Claims and Products for Which Effieaev Data generally
Are Required
Submission of efficacy data at reregistration typically is
required for the following tyres of products:
1. products claired to control microorganisms that
pose potential threats to public health;
2. products claimed to control vertebrate pests, that
&ay directly :©r i/.-Krectly transmit diseases to
humans;
3. potentially very hazardous products for which EPA
determines that it is necessary to conduct a "risk-
benefits" analysis;
4. products of types for which EPA nas reasons (e.g.,
consumer complaints, unlikely claims, unusual use
patterns, etc.) to question claims; and
C* Labels and Ijabeli.no
To remain in compliance with FXFRA, the label and* labeling of
each product must be revised to meet the requirements for
reregistration as described below. "Labeling" includes the
container label and-any written, printed or graphic matter that
accompanies the pesticide in U.S. commerce at any time (such as
technical bulletins, collateral labeling, etc.). Application* for
new uses or labeling changes that do not pertain to reregistration
must be filed separately from the application for reregistration
described in Step 3 earlier. Changes to labeling which must be
made for reregistration include, but are not limited to:
1. Labeling changes specified in the RED. Such changes may
include statements on RESTRICTED USE, groundwater hazards,
protective clothing/equipment, endangered species, environmental
hazards, etc.
2. The format and content of labeling as described in 40 CFR
?.*6-10: When further acute testing is needed, the currently
accepted precautionary statements will usually be retained until
testing is completed and the data are reviewed.
3. Labeling changes required -by Pesticide Regulatory (PR)
Notices, regulations, regulatory decisions and policies issued by
EPA which are relevant to the pesticide. Your product's labeling
must reflect any applicable requirements which are in effect at the
time the RED is issued. Some existing notices are referred to in
Section B. of the Appendix.
-------
APPENDIX
A. Confidential Statement of Formula and Instructions
B. Instructions for Label Contents
C. Sample Label Formats—General Use I Restricted Use
D. Label Regulations (40 CFR 156.10)
-------
Instructions for- Completing the Confi??ntj»l Statenfint__ef
Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must
be used. Two legible, signed copies of the form are required.
Following are basic instructions:
a. All the blocks on the form must be filled in and answered
completely. . . .
b. Zf any block is not applicable, mark it N/A.
. c. The CSF must be signed, dated and the telephone number of
the responsible party *. rt be provided.
A. All applicable information vhich is on the product-
specific data submission must also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per
gallon for liquids and pounds per cubic feet for solids..
f. Flashpoint must be in degrees Fahrenheit and flame
extension in inches.
g. For all active ingredients, the EPA Registration Numbers
for the currently registered source products must be reported under
column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all
actives and inerts and all common names for the trade names must be
reported.
i. For the active ingredients, the percent purity of the
source products must be reported under column 10 and must be
exactly the same as on the source product's label.
^ the Wei9hts in columns 13.a. and 13.b. must be in
pounds, kilograms, or grams, in no'case will volumes be accepted.
Do not mix English and metric system units (i.e.,. pounds and
kilograms)•
k. All the items under column 13.b. must total loo percent.
* L' -?11 items under columns 14.a. and I4.b. for the active
ingredients must represent pure active form.
, _*; The, uPPcr and lower certified limits for all active and
inert ingredients must follow the 40 CFR 158.175 instructions! An
?Sia££iS~2U^?*?rr£?e?*if toc Pr°P°sed «»it. are different
than standard certified limits.
•
n. When new CSFs are submitted and approved, all previously
submitted CSFs become obsolete for that specific formulation?
-------
B. INSTRUCTIONS FOR IABEL CONTENTS
40 CFR 156.10 .and Pesticide Regulatory (P.R.) notices require
that specific labeling statements appear at certain locations on
the label. The sample label formats in Appendix C chow where these
statements are to be placed.
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. [40 CFR 156.10(b)]
Item 2. COMPANY NAME AND ADDRESS - The name and address of the
producer, registrant or person for whom the product is produced are
required on the label and should be located at the bottom of the
front panel or at the end pf the label text. £40 CFR 156.10(c)3
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 oust 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. [40 CFR
156.10(d)3
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 jnust run
parallel to it. The registration number and the required
identifying phrase must not appear in such a manner as to suggest
or imply recommendation or endorsement of the product by the
Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment number,
preceded by the phrase "EPA Est." is the final establishment at
which the product was produced, and nay appear in any suitable
location on the label or immediate container. It must also appear
oh the wrapper or outside container of the package if the EPA
establishment number on the immediate container cannot be clearly
z«aJ £i*i:wi*yii ituch wrapper or container. [40 CFR 156.10(f) 3
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
normally required on the front panel. The ingredients statement
must contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with.
and be clearly distinguished from, other text on the panel. It
aust not be placed in the body of other text. [40 CFR 156.10(g) 3
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricultural
-------
formulations, the pounds per gallon of active ingredient must be
indicated on the label. [40 CFR 156.10(h)(iv)J
Item 6C. NAMES TO BE USED IN INGREDIENT STATEMENT - The acceptable
common name, if there is one, shall be used, followed by the
chemical name. If no common name has been established, the
chemical name alone shall ba used. Chemicals related to the active
ingredient are allowed to be listed enlv if efficacy data
supporting such claims art submitted or referenced. If such data
are provided, the related chemicals must be listed separately «»a
not as a portion of the active ingredient.
Item 6D. INERT INGREDIENTS RECLASSIFIED AS ACTIVE INGREDIENTS - If
EPA has reclassified chemica? * from inert ingredient status to
active ingredient status, regiswants of affected products must.
change the ingredient statement accordingly (See 52 FR 13307-8,
April 22, 1987). If such pesticides have food uses, tolerances
must either be established for such uses, or an exemption from the
requirement for tolerances must be obtained.
Item 6E. NOMINAL CONCENTRATION - The amount of active ingredient
declared in the ingredient statement must be the nominal
concentration of the product as defined in 40 CFR 158.153 (i) and
described in P.R. Notice 91-2.
Item 7. WARNINGS AND 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 Signal Word "Keep Out of Reach
Front Panel Minimum Type Size of Children*!
JTl Sgyarf Inches All Capitale Minimum TyBe_aiML_
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
•above 10 to 15 12 point a point
above 15 to 30 14 point 10 point
=*'sr 20 is point . 12 point
Item 7Ai CHILD HAZARD WARNING STATEMENT - The statement "Keep Out
of Reach of Children" aust be located on the front panel above the
signal word except where contact with children during distribution
or use is unlikely. £40 CFR 156.lO(h) (1) (ii)] wr«»uw.0«
5S5r,2?%' < SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the child
hazard warning statement. [40 CFR 156.10(h)(1)(i)3.
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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* [40 CFR 156.10(h)(l)(i)3.
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. [40
CFR 156.10(h)(1)(iii)3
Item 7E.r REFERRAL STATEMENT - The statement "see Side (or Back)
Panel -for Additional Precautionary Statements" is required on the
za.'"nt panel for all products, unless all.required precautionary
statements appear on the front panel. [40 CFR 156.10(h) (1) (iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The precautionary
statements listed b,e.low must appear together on the label under the
heading "PRECAUTIONARY STATEMENTS." The preferred location is at
th« 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. [40 CFR 156.10(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.. [40 CFR 156.10(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. [40 CFR 156.lO(h)(2)(ii)j
Item 8C. PHYSICAL-OR CHEMICAL HAZARD - FLAMMABILITY Precautionary
statements relating to flammability of a product are required to
appear on the label if it meets the criteria in the PHYS/CHEM
Labeling Appendix. The requirement is based on the results of the
flashpoint determinations and flame extension tests required to be
submitted for all products. These statements are to be located in
me siae/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.
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). if your product has been
classified for restricted use, then these requirements apply:
-------
1.
All uses restricted. The following statements must be placed
in a black box at the top of the front panel of the label and
labeling:
b.
a. The statement "Restricted Use Pesticide1* oust appear at
the top of the front panel of the label. The statement
aust be set in type of the came minimum size as required
for human hazard signal word [see iiable in 40 CFR
156. 10 (h) (1) (iv)]. NO statements of any kind nay appear
above this RUP statement.
The reason .for the the restricted use classification must
appear below the RUP statement. The RED will prescribe
*his statement.
c. A summary statement of the terms of restriction must
appear directly below this reason statement on the front
panel. 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." The RED
will specify what statement must be used.
2. Borne but act all uses restricted. If the RED states that some
uses are classified for restricted use, and some are
unclassified, several courses of action are available:
a. You may label the product for Restricted use. If you do
so, you may include on the label uses that are
unrestricted, but you may not distinguish them on the
label as being unrestricted.
You may delete all restricted uses from your label and
submit draft labeling bearing only unrestricted uses.
You may "split" your registration, i.e., register two
separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted
simultaneously. Note that the products will be assigned
separate registration numbers.
Item 9B. 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 restricted entry interval fREI)
has been established by the Agency, it must be included on the
label. Additional worker protection statements may be required in
b.
c.
-------
accordance with PR Notice 83-2, March 29, 1983.
Item 10B. 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 P.R. Notices 83-3 and 84-1 to determine the
storage and disposal instructions appropriate for.your products.
f ' :' . ' '
Item IOC. DIRECTIONS FOR USE - Directions for use nust.be stated
in terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions Bust be adequate to protect the public
from fraud 'and from personal injury and to prevent unreasonable
adverse effects on the environment. £40 CFR 156.10(i)(2)]
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. Collateral labeling must be made part
of the response to the RED and submitted for review.
-------
LABEL FORMAT FOR UNCLASSIFIED PRODUCTS
-------
LABEL FORMAT FOR PRODUCTS CLASSIFIED FOR RESTRICTED USE
-------
Protection Agency
•ubmitter has asserted a confidential
business information claim concerning
SJematerial).
(5) A copy of each document, propos-
al or other item of written material
concerning the Registration Standard
provided by the Agency to any person
or party outside of government
(within 15 working days < Jter the item
is made available to si.ch person or
party).
(6) A copy of the Registration Stand-
(7> With respect to a Registration
Standard for which the Agency has
determined that a substantial!, 'Com-
plete chronic health and teratology
data base exists, a copy of the FEDERAL
REGISTER notice concerning availabil-
ity of a proposed Registration Stand-
ard, and a copy of each comment re-
ceived in response to that notice
(within 10 working days after receipt
by the Agency, or 15 working days if
the submitter has asserted a confiden-
tial business information da1m con-
cerning the material).
(8) A copy of the Forma REGISTER
notice announcing the issuance of the
Registration Standard (within 10
working days after the publication of
the notice).
(c) Index of the docket The Agency
will establish and keep current an
index to the docket for each Registra-
tion Standard. The index will include.
but is not limited to:
(1) A list of each meeting between
the Agency and any person or party
outside of government, containing the
date and subject of the meeting, the
names of participants and the name of
the person requesting the meeting.
(2) A list, of each document in the
docket by title, source or recipientts).
and the date the document was re-
ceived or provided by the Agency.
(d) Availability of docket and indi-
ces. CD The Agency will make avail-
able to the public for inspection and
copying the docket and index for any
Registration Standard.
(2) The Agency wffl establish and
H»f. of perSOttB Who
have specifically requested that they
receive indices for Registration Stand-
ard dockets. On a quarterly basis. EPA
will distribute the indices of new mate-
rials placed in the public docket to
§156.10
these persons. Annually. EPA will re-
quire that persons on the list renew
their requests for inclusion on the list.
(8) The Agency will issue annually in
the FEDERAL REGISTER (in conjunction
with the annual schedule notice speci-
fied in 1155.25) a notice announcing
the availability of docket indices.
(4) Each FEDERAL REMSTER notice of
availability of a Registration Standard
will announce the availability of the
docket index for that Staadard. :-
* * '
I1S&S4 Notice of availability.
(a) The Agency will issue Li the PEEK,
XRAL REGISTER a notice announce the~
issuance and availability of Registra-
tion Standard which:
(1) Concerns a previously unregis-
tered active ingredient; or
(2) Concerns a previously registered
active ingredient, and the Registration-
Standard states that registrants will
be required (under FIFRA section
SCCX2KB)) to submit chronic health
(including, but not limited to. chronic
feeding, oncogenicity and reproduc-
tion) or teratology studies.
(b) Interested persons may submit
comments concerning any Registra-
tion Standard described by paragraph
(a) of this section at any time.
(c) The Agency will issue in the FED-
ERAL REGISTER a notice announcing the
availability of, and providing opportu-
nity for comment on, each proposed
Registration Standard which concerns
a previously registered active ingredi-
ent for which the Agency has deter-
mined that a substantially complete
chronic health and teratology data
base exists. Following the comment
period and issuance of the Registra-
tion Standard, the Agency will issue in
the FEDERAL REGISTER a notice of avail-
ability of the Registration Standard.
PART 156—LABELING REQUIRE-
MENTS FOR PESTICIDES AND DE-
VICES
Atrrmourr. 7 U.S.C. 116-lS6y.
1156.10 Labeling nqatemeata.
(a) GeneroZ-U) Content* 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
whom produced as prescribed in para-
graph of this section;
,iii) The net content* as prescribed
in paragraph (d) of this section;
(iv) The product registration
number *s prescribed in paragraph (e)
of this st£*
of this section;
Cvi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed in paragraph Ch)
of this section;
(vlii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classif icatlon(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
"ary conditions of purchase and use.
(ii) All required label text must:
f *? *? tet to 6-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be lued. All required
label or labeling text shall appear in
the **»g""«* language. However, the
40 CHI Ch. I (7.149
other-language versions of the label.
ing.
(4) Placement of Label-ti) General
The label shall appear on or be secure.
ly attached to the immediate contain.
er of the pesticide product. For pur-
poses of this Section, and the mi*.
branding provisions of the Act, "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the ixn.
mediate container is enclosed within a
wrapper or outside, container through
which the label cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily distributed or sold.
(ii) Tank can and other bulk con-
tainer*— (A) Trantportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189, concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, fyrftyyiny u>d placarding of haz-
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary.
all labeling requirements will be ap-
plied equally to both the English and
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank ear, tank truck or
other mobile or portable bulk contain-
er. a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers.
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) Falte or misleading ttatement*.
Pursuant to section 2(qXlXA) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
1 153.240. is misbranded if its labeling
is false or misleading in any particular
including both pesticidal and non-pes-
ticidal claims. Examples of statements
or representations in the labeling
which constitute misbrandlng include:
(i) A false or *»««i««*«~g statement
concerning the composition of the
product;
-------
Protection Ag«nry
(ID A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device;
A false or misleading comparisrn
with other pesticides or devices;
(v) Any statement directly or toil-
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;
(vil) 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; »••«•••
Ox) Claims as to the safety of the
pesticide or its ingredients,
$ 156.10
Cb) Name, brand, or trademark, m
-he name, brand, or trademark under
which the pesticide product itTaold
•hall appear on the front panel of the
label. c
(2) No name, brand, or trademark
xnay appear on the label which:
(i) Is false or misleading, or
Has not been approved by the
Administrator through registration o£
supplemental registration as an addi-
tional name pursuant to 1152.182.
CO Name and address of producer
registrant, or person for whom pro^
duced. An unqualified name and ad-
$~*t given on the label shall be con-
sidered as the name and address of the
producer. 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.
such as "packed for • • v •fDpSr?*
S?to£• V or "Sold by • •••*,•
teat tee name is not teat of tee
ducer.
L7^4 A_..^ff_*..* _
con*
ous," "noninjurious," "harmless" or
«?^?^?°.imnanfi,,*nd ***" ^th
«« ^on*numerical «nd/or compara-
tive statements on the safety of the
product, including but not limited tcr
(A) "Contains all natural togredi-
toxlc Cheml-
.
net weight or measure
of content shall be exclusive of wrap:
pers or other materials and shall be
tec* *verit*c content unless explicitly
stated as a tnfntm^fp quantity
(2) If the pesticide is a liquid, the
net content statement shall be in
terns of liquid measure at 68' P (20*C)
and shall be expressed in conventional
ounccs'
(C) "Pollution approved"
(6) Final printed labeling, (i) Except
as provided in paragraph (aXCXil) of
"us aecuon, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
?bSft8Llwed not *• «wbmitted until
draft label texts have been provision.
•% J2f»tod by the Agency. *w*¥*Km
Clearly legible reproductions or
Photo reductions will be accepted for
unusual labels such as those Hlk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction Quality.
. XLthe **&<*& te »olid or semi-
aolid, viscous or pressurized, or is a
mixture of liquid and soSdT the net
wntent statement shaH be to terms of
<4> In all cases, net content aha21 be
* Iar»e8t »uitable
10
In addition to the required units
•Pecified. net content »iyibe^»>
pressed to metric units.
(6) Variation above mtetmM^ eon-
. —"•»»•«•• •••rwv^ Miiliilifi |LlLf-it^U^Q wPfl
tent or around an average is penatesl
ble only to tee extent that St^^-
sents deviation unavoidable to good
SJJ^^wrinf practice. Variation
oeiow a stated minimum is not permit-
ted. In no case shall tee average con-
-------
§15*10
tent of the packages in a shipment fall
^•below the stated average content.
(e) Product registration nM>Ti not appear in such a manner as
to suggest or imply recommendation
or endorsenwft of the ^9duct by the
Agency.
(f) Producing establishment* 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—U) 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-
piikvc. 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>Fo*itton o/ ingredient statement
(i) The ingredient statement is nor-
mally required on the front panel of
40 C« Ch. I (7-1-to Edition)
the labeL If there to 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.
(11) The text of the ingredient state-
ment must run parallel with other
text on the panel oh which it appears,
and must be clearly distinguishable
from and must not be placed in the
body of other text
(8) Name* to be wed in ingredient
statement The name used for »sch 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(cX6).
<4) Statements o/ 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 ahall 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
CS) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting coed 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:
-------
Protection Agency
in cases where it is determined
* pesticide formulation changes
etnical composition significantly.
fhe product must bear the following
.tktement in a prominent position on
label: "Not for sale or use after
(ii) The product must meet all label
claims up to the expiration time indi-
Sted on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredientts) to be listed in the
ingredient statement if he determines
t&*t such ingredienUs) may pose a
hazard to man or the environment.
(h) Warning* end precautionary
statement*. Required warnings and
precautionary statements concerning
the general areas of toxicologies!
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type si*',-, iand prominence are given"
below.
€1) R- wired front panel statement*.
With ihe 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 oh tht haste of the highest
hazard shown by any of the indicators
in the table below:
1
IV
Omllfi.
Dun
UptocntfinehttfnBSO
wg/kg.
UptoandfadudrQj
mg/KMT.
Up to and Mutfng 200
Kern SO fvu HO n«/kg
Fram^vmtng/lMr
ftwn 100 Vvu 2000 _
fiom 100 tnj SOOO «g/
««-
ftem 2. «m SO mg/fctr..
CerrMNc; camwl
epMMynet
OeniMi epMMy
WMnfeto vtMn 7
Mutennwvi
Cttnvftaeti
••"•tug tor 7 d*ys.
!•*•» W*6on tt 72
torn.
Modcnt* inlulM) ct 72
OfMtsrtanSOSOing/
Onttirtwi 20 mg/Her.
OneMrttw 204)00.
^fak ^•AbaEMAA
IW WnBIOn.
MHertfgmintt^ct
72neun.
(i) Human fcaeanf tignal v>on2--CA)
Toriciiy 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 toxidty (as
distinct from akin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the word "poison,"
-------
§156.10
that it Is approved for use on infant*
or small children, may the Administra-
tor waive this requirement.
(ill) Statement of practice! treat-
ment—m»nu by taddty category
woKonoui) » ewtfewed (Inhaled or ».
ugh akin}. Do net eraatht vapor (duct or
«W. Do net eat to eyes, en akin, or en
ir.-uu panel awemem ef aractta
«*ad.l.
May oa fetal I e»a»o»ad (tohaiid er _
trough t» aUn]. Do net tractht vapen (duct or
to eyat, en akin, er en
HtmM If awtfoMd Ctohalad er aewrbad tvwghtw
akin]. Avoid traEMne vapen (duct er aprtyinW.
Avoid coRtaet vtm akh (ayw er etoBW. '
Co net eat in ayat. en aUn. er en
. Waar eogolai er tao» ahMd and wbbar
fllovat whan hand&ig. Harmful er Mai V i
tAppnspnat* ftrt aid CMamant mqutad.1
ayt (and akh] citatien. Do net gat to
ta er en efeMng. HarmU V -
AMW
««h sun, •»«• «r
-— -—— —— * 1J •• v> 1HHWWK. d) OaM Of
let jknmadMaV luah ayw er akto «Nh ptonty el
' *- —•— «antten I titatan
Wo pnKMfenvy sMMMnto iaqutad.1
-------
ditntat Protection Agency
/in Environmental hazard*. Where a
exists to non target organisms
e*
__ humans and domestic anl-
preeautionary statements are re-
j stating the nature of the
SEird and the appropriate precau-
***?* avoid potential accident.
or damage. Examples of the
statements and the drcurn-
Stances under which they are required
'° if * pesticide intended for out-
door use contains an active ingredient
Zjth * mtmmtUtn acute oral LD* of
100 or less, the statement •This Festi-
dde is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCH 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 LD» of 100
mf/kg or less, or a subacute dietary
§ 156.10
of 600 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate*
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
For all outdoor uses ,*her than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ill) Phytical or efceroicoJ hazard*.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
FtainpoM
-------
fi 156.10
(B) The label bears a reference to
the directions for use In accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular:" and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(ill) Exception* to requirement for
direction for tac—(A) Detailed direc-
tions for use may be omitted from la-
beling; of pesticides which are intended
for use only by manufacturer* of prod-
uct* other than pesticide products in
their regular manufacturing processes.
provided that: •
CD The label clearly shows that the
product is Intended for use onlr in
manufacturing processes and specifit*
the typed) 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;
' C3> The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts; and
tt> The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on mim or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
(1) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
CJ) The product is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
CO Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by f emulators in preparing
pesticides for sale to the public. pro-
Tided that:
CD There is information readily
available to the formulators on the
composition, toxidty. methods of use.
applicable restrictions or limitations.
40 CFft Ch. 1 (7-1-89 Edition)
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product is intended for use only in
manufacturing, formulating, mixing,
or repacking for use as a pesticide and
specifies the typed) of pesticide prod-
•ucts involved;
(J) The product as finally manufac-
tured. formulated, mixed, or repack-
aged is registered; and
U> The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Content* of Direction* for U*e.
The directions for use -shall include
the following, under the headings "Di-
rections for Use":
CO The statement of use classifica-
tion as prescribed in paragraph (J) of
this section immediately under the
heading "Directions for Use."
(U) immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(Ill) The sited) of application, as for
example the crops. •«h™«-i», areas, or
,
objects to be treated.
. (iv) The target pestd) associated
with each site.
(v) The dosage rate associated with
each site and pest.
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environmental Protection Agency
«) Any limitations or restrictions on
required to prevent unreasonable
e effects, such as:
Required Intervals between ap-
plication and harvest of food or feed
Rotational crop restrictions.
(C) warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) ^Reserved]
(E) For restricted use pesticides, a
statement that the pesticide may be
Applied under the direct supervision of
it certified applicator who is not phys-
ical? 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-
^icator who is physically present
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
W Statement of U*e Clarification.
By October 22, 1976. all pesticide prod-
ucts must bear on their labels a state-
ment of use Classification as described
in paragraphs (j) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general useCs) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
useCs), both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions or paragraph (JX2) of this
section.
(1) General U»e Clarification. Pesti-
cide products bearing directions for
usecs) classified general shall be la-
beled with the exact words "General
Classification" immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use wDl be
8 156.10
considered a false or misleading state-
ment under the statutory definitions
of misbranding.
(2) Restricted U*e Clarification.
Pesticide products bearing direction
for use(s) classified restricted ahaU
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(i) Front panel statement o/ restrict-
ed ute classification. CA) At t'ae top of
the front panel of the label. i*t in type
of the same i*»
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APPENDIX F
Generic Data Call-in
35
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DATA CALL-IN NOTICE
CERTIFIED MAIL
SEP 30 1993
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-in Chemical Status
Sheet, to submit certain data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
produces) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section HI below. Your response must state:
1. how you will comply with the requirements set forth in this Notice and its
Attachments A through E; or
2. why you believe you are exempt from the requirements listed in this Notice and
in Attachment C, Requirements Status and Registrant's Response Form, (see
section HI-B); or
3. why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section m-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will
comply with its requirements or should be exempt or excused from doing so, then the
registration of your produces) subject to this Notice will be subject to suspension. We have
provided a list of all of your products subject to this Notice in Attachment B, Data Call-In
Response Form, as well as a list of all registrants who were sent this Notice (Attachment
D).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide,
Fungicide and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B).
Collection of this information is authorized under the Paperwork Reduction Act by OMB
Approval No. 2070-0107 (expiration date 12-31-92).
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This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section n - Data Required By This Notice
Section m - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment A - Data Call-In Chemical Status Sheet
Attachment B - Data Call-in Response Form
Attachment C - Requirements Status And Registrant's Response Form
Attachment D - List Of All Registrants Sent This Data Call-In Notice
Attachment E - Cost Share And Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. This
reevaluation identified additional data necessary to assess the health and safety of the
continued use of products containing this active ingredient. You have been sent this Notice
because you have produces) containing the subject active ingredient.
SECTION n. DATA REQUIRED BY THIS NOTICE
n-A. DATA REQUIRED
The data required by this Notice are specified in Attachment C, Requirements Status
and Registrant's Response Form. Depending on the results of the studies required in this
Notice, additional testing may be required.
H-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified
in Attachment C, Requirements Status and Registrant's Response Form, within the timeframes
provided.
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H-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which guidelines
have been established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CER § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 1750
Pennsylvania Avenue N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-in
Notice must be in accordance with Good Laboratory Practices [40 CER Part 160.3 (a) (6)].
H-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or
change the requirements of any previous Data Call-In(s). or any other agreements entered into
with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend then* affected
products.
SECTION HI. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
IH-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted to the
Agency within 90 days after your receipt of this Notice. Failure to adequately respond to this
Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent to Suspend
(NOIS) affecting your products. This and other bases for issuance of NOIS due to failure to
comply with this Notice are presented in Section IV-A and IV-B.
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m-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete use(s),
(3) claim generic data exemption, (4) agree to satisfy the data requirements imposed by this
Notice or (5) request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion
of the various options available for satisfying the data requirements of this Notice is contained
in Section HI-C. A discussion of options relating to requests for data waivers is contained in
Section IH-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the
Data-Call-in Response Form. Attachment B and the Requirements Status and Registrant's
Response Form, Attachment C. The Data Call-In Response Form must be submitted as part
of every response to this Notice. Please note that the company's authorized representative is
required to sign the first page of the Data Call-in Response Form and Requirements Status
and Registrant's Response Form (if this form is required) and initial any subsequent pages.
The forms contain separate detailed instructions on the response options. Do not alter the
printed material. If you have questions or need assistance in preparing your response, call
or write the contact person identified in Attachment A.
1- Voluntary Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your produces) containing the active ingredient that is
the subject of this Notice. If you wish to voluntarily cancel your product, you must submit
a completed Data Call-In Response Form, indicating your election of this option. Voluntary
cancellation is item number 5 on the Data Call-in Response Form. If you choose this option,
this is the only form that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by eliminating the uses
of your product to which the requirements apply. If you wish to amend your registration to
delete uses, you must submit the Requirements Status and Registrant's Response Form, a
completed application for amendment, a copy of your proposed amended labeling, and aU
other information required for processing the application. Use deletion is option number 7
011 the Requirements Status and Registrant's Response Form. You must also complete a Data
Call-in Response Form by signing the certification, item number 8. Application forms for
amending registrations may be obtained from the Registration Support and Emergency
Response Branch, Registration Division, (703) 557-2126.
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If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due
date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of F1FRA, an applicant for
registration of a product is exempt from the requirement to submit or cite generic data
concerning an active ingredient if the active ingredient in the product is derived exclusively
from purchased, registered pesticide products containing the active ingredient. EPA has
concluded, as an exercise of its discretion, that it normally will not suspend the registration
of a product which would qualify and continue to qualify for the generic data exemption in
section 3(c)(2)(D) of FIFRA. To qualify, all of. the following requirements must be met:
a. The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active
ingredient and is purchased from a source not connected with you;
b. Every registrant who is the ultimate source of the active ingredient in your product
subject to this DCI must be in compliance with the requirements of this Notice and
must remain in compliance; and
c. You must have provided to EPA an accurate and current "Confidential Statement
of Formula" for each of your products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a completed Data Call-in
Response Form. Attachment B and all supporting documentation. The. Generic Data
Exemption is item number 6a on the Data Call-In Response Form. If you claim a generic data
exemption you are not required to complete the Requirements Status and Registrant's
Response Form. Generic Data Exemption cannot be selected as an option for product specific
data.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons
to provide the Agency with the required data. If the registrant® who have committed to
generate and submit the required data fail to take appropriate steps to meet the requirements
or are no longer in compliance with this Data Call-In Notice, the Agency will consider that
both they and you are not in compliance and will normally initiate proceedings to suspend the
registrations of both your and then* product(s), unless you commit to submit and do submit
the required data within the speckled tune. In such cases the Agency generally will not grant
a time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice There are various options available
to satisfy the data requirements of this Notice. These options are discussed hi Section ffl-C
of this Notice and comprise options 1 through 6 on the Requirements Status and Registrant's
Response Form and option 6b and 7 on the Data Call-In Response Form. If you choose option
6b or 7, you must submit both forms as well as any other information/data pertaining to the
option chosen to address the data requirement.
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5. Request for Data Waivers. Data waivers are discussed in Section IH-D of this Notice
and are covered by options 8 and 9 on the Requirements Status and Registrant's Response
Form. If you choose one of these options, you must submit both forms as well as any other
information/data pertaining to the option chosen to address the data requirement.
HI-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
data requirements (i.e. you select option 6b and/or 7), then you must select one of the six
options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information
in parentheses to guide registrants to additional instructions provided in this Section. The
options are:
(1) I will generate and submit data within the specified timeframe
(Developing Data)
(2) I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously
to the Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study)
Option 1. Developing Data - If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide
Assessment Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-
5. In addition, certain studies require Agency approval of test protocols in advance of study
initiation. Those studies for which a protocol must be submitted have been identified in the
Requirements Status and Registrant's Response Form and/or footnotes to the form. If you
wish to use a protocol which differs from the options discussed in Section II-C of this Notice,
you must submit a detailed description of the proposed protocol and your reason for wishing
to use it. The Agency may choose to reject a protocol not specified in Section H-C. If the
Agency rejects your protocol you will be notified in writing, however, you should be aware
that rejection of a proposed protocol will not be a basis for extending the deadline for
submission of data.
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8
A progress report must be submitted for each study within 90 days from the date you
are required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost share or agreeing to share in the cost of
developing that study. A 90-day progress report must be submitted for all studies. This 90-
day progress report must include the date the study was or will be initiated and, for studies
to be started within 12 months of commitment, the name and address of the laboratory(ies)
or individuals who are or will be conducting the study.
In addition, if the tune frame for submission of a final report is more than 1 year,
interim reports must be submitted at 12 month intervals from the date you are required to
commit to generate or otherwise address the requirement for the study.
In addition to the other information specified in the preceding paragraph, at a minimum, a
brief description of current activity on and the status of the study must be included as well
as a full description of any problems encountered since the last progress report.
The tune frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing for the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the
registrant. If the data are not submitted by the deadline, each registrant is subject to receipt
of a Notice of Intent to Suspend the affected registration®.
If you cannot submit the data/reports to the Agency in the tune required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost to Develop Data — If you choose to enter into
an agreement to share in the cost of producing the required data but will not be submitting
the data yourself, you must provide the name of the registrant who will be submitting the
data. You must also provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an agreement
exists. The agreement to produce the data need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
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Option 3. Offer to Share in the Cost of Data Development - If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting
this option) to exercise its discretion not to suspend your registration®, although you do not
comply with the data submission requirements of this Notice. EPA has determined that as a
general policy, absent other relevant considerations, it will not suspend the registration of a
product of a registrant who has in good faith sought and continues to seek to enter into a joint
data development/cost sharing program, but the other registrant^) developing the data has
refused to accept your offer. To qualify for this option, you must submit documentation to
the Agency proving that you have made an offer to another registrant (who has an obligation
to submit data) to share in the burden of developing that data. You must also submit to the
Agency a completed EPA Form 8570-32, Certification of Offer to Cost Share in the
Development of Data, Attachment E. In addition, you must demonstrate that the other
registrant to whom the offer was made has not accepted your offer to enter into a costsharing
agreement by including a copy of your offer and proof of the other registrant's receipt of that
offer (such as a certified matt receipt). Your offer must, in addition to anything else, offer
to share in the burden of producing the data upon terms to be agreed or failing agreement to
be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(m) and must not
qualify this offer. The other registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a Data Call-in Response
Eprm and a Requirements Status and Registrant's Response Form committing to develop and
submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burdens of developing the data. In addition, the other registrant must
fulfill its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit the required data in the
specified time frame. In such cases, the Agency generally will not grant a tune extension for
submitting the data.
Option 4, Submitting an Existing Study - If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed
by this Notice. You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone. Existing studies are studies which predate issuance of
this Notice. Do not use this option if you are submitting data to upgrade a study. (See Option
5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
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10
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met;
a. You must certify at the tune that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
As stated in 40 CFR 160.3(j):
11 '[r]aw data' means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and activities of a study
and are necessary for the reconstruction and evaluation of the report of that study.
In the event that exact transcripts of raw data have been prepared (e.g., tapes which
have been transcribed verbatim, dated, and verified accurate by signature), the exact
copy or exact transcript may be substituted for the original source as raw data. 'Raw
data' may include photographs, microfilm or microfiche copies, computer printouts,
magnetic media, including dictated observations, and recorded data from automated
instruments." The term "specimens", according to 40 CFR 160.3(k), means "any
material derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the tune of
submitting the existing study that such GLP information is available for post-May 1984
studies by including an appropriate statement on or attached to the study signed by an
authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Registration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the Agency
for consideration if the registrant believes that the study c,learly meets the purpose of
the PAG. The registrant is referred to 40 CFR 158.70 which states the Agency's policy
regarding acceptable protocols. If you wish to submit the study, you must, in addition
to certifying that the purposes of the PAG are met by the study, clearly articulate the
rationale why you believe the study meets the purpose of the PAG, including copies of
any supporting information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied the purpose of the PAG and that
necessary raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
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11
If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study - If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement
is not satisfied, you may still be required to submit new data normally without any tune
extension. Deficient, but upgradeable studies will normally be classified as supplemental.
However, it is important to note that not all studies classified as supplemental are
upgradeable. If you have questions regarding the classification of a study or whether a study
may be upgraded, call or write the contact person listed in Attachment A. If you submit data
to upgrade an existing study you must satisfy or supply information to correct all deficiencies
in the study identified by EPA. You must provide a clearly articulated rationale of how the
deficiencies have been remedied or corrected and why the study should be rated as acceptable
to EPA. Your submission must also specify the MRID number(s) of the study which you are
attempting to upgrade and must be in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
of those criteria as well as a certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies - If you choose to cite a study that has been
previously submitted to EPA, that study must have been previously classified by EPA as
acceptable or it must be a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-guideline" or "core minimum,"
For ecological effects studies, the classification generally would be a rating of "core." For all
other disciplines the classification would be "acceptable." With respect to any studies for
which you wish to select this option you must provide the MRID number of the study you are
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12
citing and, if the study has been reviewed by the Agency, you must provide the Agency's
classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form
8570-31, Certification with Respect to Data Compensation Requirements.
m-D REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request for
a low volume/minor use waiver and the second is a waiver request based on your belief that
the data requirement(s) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver - Option 8 on the Requirements Status and Registrant's
Response Form. Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness
of requiring data for low volume, minor use pesticides. In implementing this provision EPA
considers as low volume pesticides only those active ingredients whose total production volume
for all pesticide .registrants is small. In determining whether to grant a low volume, minor
use waiver the Agency will consider the extent, pattern and volume of use, the economic
incentive to conduct the testing, the importance of the pesticide, and the exposure and risk
from use of the pesticide. If an active ingredient is used for both high volume and low volume
uses, a low volume exemption will not be approved. If all uses of an active ingredient are low
volume and the combined volumes for all uses are also low, then an exemption may be
granted, depending on review of other information outlined below. An exemption will not be
granted if any registrant of the active ingredient elects to conduct the testing. Any registrant
receiving a low volume minor use waiver must remain within the sales figures hi their forecast
supporting the waiver request hi order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the waiver, to submit annual sales
reports. The Agency will respond to requests for waivers hi writing.
To apply for a low volume, minor use waiver, you must submit the following information,
as applicable to your product(s), as part of your 90-day response to this Notice:
a(i). Total company sales (pounds and dollars) of all registered product(s) containing the
active ingredient. If applicable to the active ingredient, include foreign sales for those
products that are not registered in this country but are applied to sugar (cane or beet),
coffee, bananas, cocoa, and other such crops. Present the above information by year
for each of the past five years.
(ii). Provide an estimate of the sales (pounds and dollars) of the active ingredient for each
major use site. Present the above information by year for each of the past five years.
b. Total direct production cost of product(s) containing the active ingredient by year for
the past five years. Include information on raw material cost, direct labor cost,
advertising, sales and marketing, and any other significant costs listed separately.
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13
c. Total indirect production cost (e.g. plant overhead, amortized plant and equipment)
charged to produces) containing the active ingredient by year for the past five years.
Exclude all non-recurring costs that were directly related to the active ingredient, such
as costs of initial registration and any data development.
d(i). A list of each data requirement for which you seek a waiver. Indicate the type of
waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill each of these
data requirements.
(ii). A list of each data requirement for which you are not seeking any waiver and the
estimated cost to you (listed separately for each data requirement and associated test)
of conducting the testing needed to fulfill each of these data requirements.
e. For each of the next ten years, a year-by-year forecast of company sales (pounds and
dollars) of the active ingredient, direct production costs of product(s) containing the
active ingredient (following the parameters in item 2 above), indirect production costs
of produces) containing the active ingredient (following the parameters in item 3
above), and costs of data development pertaining to the active ingredient.
f. A description of the importance and unique benefits of the active ingredient to users.
Discuss the use patterns and the effectiveness of the active ingredient relative to
registered alternative chemicals and non-chemical control strategies. Focus on benefits
unique to the active ingredient, providing information that is as quantitative as
possible. If you do not have quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To assist the Agency in
determining the degree of importance of the active ingredient in terms of its benefits,
you should provide information on any of the following factors, as applicable to your
product(s): (a) documentation of the usefulness of the active ingredient in Integrated
Pest Management, (b) description of the beneficial impacts on the environment of use
of the active ingredient, as opposed to its registered alternatives, (c) information on the
breakdown of the active ingredient after use and on its persistence in the environment,
and (d) description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the request for
a waiver.
2. Request for Waiver of Data — Option 9 on the Requirements Status and Registrant's
Response Form. This option may be used if you believe that a particular data requirement
should not apply because the corresponding use is no longer registered or the requirement is
inappropriate. You must submit a rationale explaining why you believe the data requirements
should not apply. You must also submit the current label(s) of your product(s) and, if a
current copy of your Confidential Statement of Formula is not already on file you must submit
a current copy.
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14
You will be informed of the Agency's decision in writing. If the Agency determines
that the data requirements of this Notice do not apply to your product(s), you will not be
required to supply the data pursuant to section 3(c)(2)(B). If EPA determines that the data
are required for your productfe). you must choose a method of meeting the requirements of
this Notice within the time frame provided by this Notice. Within 30 days of your receipt of
the Agency's written decision, you must submit a revised Requirements Status and
Registrant's Response Form indicating the option chosen.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-In Notice,
pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice
of latent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or
offers, arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section IH-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure
of a registrant on whom you rely for a generic data exemption either to:
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15
a. inform EPA of intent to develop and submit the data required by this Notice on
a Data Call-In Response Form and a Requirements Status and Registrant's
Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this Notice,
unless you commit to submit and do submit the required data in the specified tune
frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required tune)
is unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The
grounds for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels
to be tested or attained, duration of test, and, as applicable, Good Laboratory
Practices.
2. EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, and the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted in the form of a final
report; a preliminary report will not be considered to fulfill the submission
requirement.
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16
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for
a suspended registration when a section 3(c)(2)(B) data request is outstanding would generally
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only
in exceptional circumstances. If you believe such disposition of existing stocks of your
product(s) which may be suspended for failure to comply with this Notice should be permitted,
you have the burden of clearly demonstrating to EPA that granting such permission would be
consistent with the Act. You must also explain why an "existing stocks" provision is necessary,
including a statement of the quantity of existing stocks and your estimate of the tune required
for their sale, distribution, and use. Unless you meet this burden the Agency will not consider
any request pertaining to the continued sale, distribution, or use of your existing stocks after
suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the .date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required
by this Notice will not result in the Agency granting any additional tune to sell, distribute, or
use existing stocks beyond a year from the date the 90 day response was due unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study
in an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
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17
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person listed in Attachment A, the Data Call-in Chemical Status
Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form (Attachment B) and
a completed Requirements Status and Registrant's Response Form (Attachment C) and any
other documents required by this Notice, and should be submitted to the contact person
identified in Attachment A. If the voluntary cancellation or generic data exemption option is
chosen, only the Data Call-in Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Daniel M. Barolo,
Special Review and
Reregistration Division
:or
Attachments
A - Data Call-In Chemical Status Sheet
B - Data Call-In Response Form
C - Requirements Status and Registrants
Response Form
D - List of Registrants Receiving This Notice
E - Cost Share and Data Compensation Forms
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18
ATTACHMENT A
STJLFURYL FLUORIDE: DATA CALL-IN STATUS SHEET
INTRODUCTION
You have been sent this Data Call-In Notice because you have products containing
sulfuryl fluoride.
This attachment, the Data Call-In Chemical Status Sheet, contains the reregistration
regulatory history of sulfuryl fluoride, an overview of data required by this notice, and point
of contact for inquiries. This attachment is to be used in conjunction with (1) the Data Call-In
Notice, (2) Attachment B, the Data Call-In Response Form. (3) Attachment C, the
Requirement Status and Registrant's Response Form. (4) Attachment D, List of All
Registrants Receiving This Notice, and (5) Attachment E, the Cost Share and Data
Compensation Forms in replying to this sulfuryl fluoride Data Call-in. Instructions and
guidance accompany each form.
REREGISTRATION HISTORY
In June 1985, EPA issued a Registration Standard on Sulfuryl Fluoride. In the
Registration Standard, EPA identified data required to support existing uses of the pesticide
and determined whether existing data were acceptable and sufficient to satisfy the
requirement. Under the 1985 Registration Standard, registrants were required to generate
data to fill in data gaps and replace unacceptable studies. Data Call-In Notices were also
issued in July 1990 and November 1992 which required additional toxicology data.
The Agency has reviewed the data submitted in response to the 1985 Registration
Standard and the July 1990 and November 1992 Data Call-In Notices and has reevaluated its
position on data needed to support the continued registration of sulfuryl fluoride. A
Reregistration Eligibility Document is being issued for Sulfuryl Fluoride with this Data Call-in
Notice which states the Agency has determined the available data shows that use of sulfuryl
fluoride will not pose an unreasonable adverse risk to human health or the environment.
However, the RED also identifies confirmatory data the Agency needs to complete the
database for sulfuryl fluoride.
DATA REQUIRED BY THIS NOTICE
The Agency's findings regarding the adequacy of the database for sulfuryl fluoride are
contained in the Requirements Status and Registrant's Response. Attachment C.
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19
The Agency has concluded that additional data on sulfuryl fluoride are needed in the
following areas: toxicology and occupational and residential exposure. The required
additional data are listed in Attachment C. These data are confirmatory.
Depending on the results of the studies required in this Notice and in the Registration
Standard and subsequent DCI's, additional testing may be required.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, please contact Robert Richards, Chemical Review Manager, at (703) 308-8057.
All Response to this Notice should be submitted to:
Robert Richards, Chemical Review Manager
Reregistration Branch
Special Review and Reregistration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Sulfuryl Fluoride
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20
SPECIFIC INSTRUCTIONS FOR TBDE DATA C AtHN RESPONSE FORM
This form is designed to be used to respond to data call-ins for generic and product
specific data for the purpose of reregistering pesticides under the Federal Insecticide,
Fungicide and Rodenticide Act. Fill out this form each tune you are responding to a data call-
in for which EPA has sent you the form entitled "Requirements Status and Registrant's
Response."
Items 1 through 4 will have to be preprinted on the form. Items 5 through 7 must be
completed by the registrant as appropriate. Items 8 through 11 must be completed by the
registrant before submitting a response to the Agency.
Public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect
of this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, PM-223, U.S. Environmental Protection Agency, 401 M Street.
S.W., Washington, D.C. 20460; and to the Office of Management and Budget, Paperwork
Reduction Project 2070-0107, Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data call-in.
Please note that you are also responsible for informing the Agency of your response
regarding any product that you believe may be covered by this data call-in but that
is not listed by the Agency in Item 4. You must bring any such apparent omission
to the Agency's attention within the period required for submission of this response
form.
Item 5. Check this item for each product registration you wish to cancel voluntarily. If a
registration number is listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of that request. You do not
need to complete any item on the Requirements Status and Registrant's Response
Form for any product that is voluntarily cancelled.
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21
Item 6a.
Item 6b.
Item 7a.
Item 7b.
Item 8.
Item 9.
Item 10.
Check this item if this data call-in is for generic data as indicated in Item 3 and if
you are eligible for a Generic Data Exemption for the chemical listed in Item 2 and
used in the subject product. By electing this exemption, you agree to the terms
and conditions of a Generic Data Exemption as explained in the Data Call-in
Notice. If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient you use in
your product.
Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance with
this and any other outstanding Data Call-in Notice), and incorporate that product
into all your products, you may complete this item for all products listed on this
form. If, however, you produce the active ingredient yourself, or use any
unregistered product (regardless of the fact that some of your sources are
registered), you may not claim a Generic Data Exemption and you may not select
this item.
Check this Item if the data call-in is a generic data call-in as indicated hi Item 3
and if you are agreeing to satisfy the generic requirements of this data call-in.
Attach the Requirements Status and Registrant's Response Form that indicates how
you will satisfy those requirements.
Check this Item if this call-in is a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing use
product for which you agree to supply product-specific data. Attach the
Requirements Status and Registrant's Response Form that indicates how you will
satisfy those requirements.
Check this Item if this call-in is a data call-in for an end use product (EUP) as
indicated i Item 3 and if your product is an end use product for which you agree
to supply product-specific data. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
This certification statement must be signed by an authorized representative of your
company and the person signing must include his/her title. Additional pages used
in your response must be initialled and dated in the space provided for the
certification.
Enter the date of signature.
Enter the name of the person EPA should contact with questions regarding you
response.
Item 11. Enter the phone number of your company contact.
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SPECIFIC INSTRUCTIONS FOR COMPLETING
THE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-ins for generic and
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion of uses or (2) request
for a low volume/minor use waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each
registrant, and has preprinted this form with a number of items. DO NOT use this form for
any other active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form.
complete all other items on this form by typing or printing legibly.
.You must
Public reporting burden for this collection of information is estimated to average 30
minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect
of this collection of information, including suggesting for reducing this burden, to Chief,
Information Policy Branch, PM-223, U.S. Environmental Protection Agency, 401M St., S.W.,
Washington, D.C. 20460; and to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3.
Item 4.
Item 5.
Item 6.
This item identifies the date and type of data call-in.
This item identifies the guideline reference numbers of studies required to support
the produces) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-In Notice, govern the conduct of the required studies.
This item identifies the study title associated with the guideline reference number
and whether protocols and 1, 2, or 3-year progress reports are required to be
submitted in connection with the study. As noted in Section m of the Data Call-In
Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's Response
Form.
This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
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Item?.
ItemS.
Item 9.
This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows:
End-Use Product
Manufacturing-Use Product
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active Ingredient
Technical Grade Active Ingredient or Pure Active Ingredient
Radiolabelled
Metabolites
Impurities
Degradates
See: guideline comment
EP
MP
PAI
PAI/M
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP _%
TEP/MET
TEP/PAI7M
TGAI
TGAI/PAI
TGAI/PAIRA
MET
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This item identifies the time frame allowed for submission of the study or protocol
identified in item 5. The time frame runs from the date of your receipt of the Data
Call-In Notice.
Enter the appropriate Response Code or Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data
Call-In Notice contains a fuller description of each of these options.
1. (Developing Data) I will conduct a new study and submit it within the tune
frames specified hi item 8 above. By indicating that I have chosen this option,
I certify that I will comply with all the requirements pertaining to the conditions
for submittal of this study as outlined in the Data Call-In Notice and that I will
provide the protocols and progress reports required in item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or more
registrants to develop data jointly. By indicating that I have chosen this option,
I certify that I will comply with all the requirements pertaining to sharing in the
cost of developing data as outlined hi the Data Call-in Notice.
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3. (Offer to Cost Share) I have made an offer to enter into an agreement with one
or more registrants to develop data jointly. I am submitting a copy of the form
"Certification of Offer to Cost Share in the Development of Data" that describes
this offer/agreement. By indicating that I have chosen this option, I certify that
I will comply with aU the requirements pertaining to making an offer to share
in the cost of developing data as outlined in the Data Call-In Notice.
4. (Submitting Existing Data) I am submitting an existing study that has never
before been submitted to EPA. By indicating that I have chosen this option, I
certify that this study meets all the requirements pertaining to the conditions for
submittal of existing data outlined in the Data Call-la Notice and I have
attached the needed supporting information along with this response.
5. (Upgrading a Study) I am submitting or citing data to upgrade a study that EPA
has classified as partially acceptable and potentially upgradeable. By indicating
that I have chosen this option, I certify that I have met all the requirements
pertaining to the conditions for submitting or citing existing data to upgrade a
study described in the Data Call-In Notice. I am indicating on attached
correspondence the Master Record Identification Number (MRID) that EPA has
assigned to the data that I am citing as weU as the MRID of the study I am
attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously classified
by EPA as acceptable, core, core minimum, or a study that has not yet been
reviewed by the Agency. If reviewed, I am providing the Agency's classification
of the study.
7. (Deleting Uses) I am attaching an application for amendment to my registration
deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements concerning
low volume-minor use data waivers in the Data Call-In Notice and I request a
low-volume minor use waiver of the data requirement. I am attaching a detailed
justification to support this waiver request including, among other things, all
information required to support the request. I understand that, unless modified
by the Agency in writing, the data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low-volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data requirement. I am attaching a
rationale explaining why I believe the data requirements do not apply. I am
also submitting a copy of my current labels. (You must also submit a copy of
your Confidential Statement of Formula if not already on file with EPA). I
understand that, unless modified by the Agency in writing, the data requirement
as stated in the Notice governs.
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Item 10. This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages
of this form.
Item 11. Enter the date of signature.
Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
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LIST OF REGISTRANTS
RECEIVING THIS DATA CALL-IN
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r/EPA
United States Environmental Protection Agency
Washington, OC 20450
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0108
Approval Expires 12-31-92
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch. PM-223. U.S. Environmental Protection Agency. 401 M St.. S.W.. Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106). Washington. DC 20503.
Pleas* fill In blanks below.
Company Nam*
Company Number
Chemical Name
EPA Chemical Number
1 Certify that:
I For each study cited in support of registration or reregistratton under the Federal Insecticide. Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
> That for each study cited in support of registration or reregistratton under FIFRA that is NOT an exclusive use
study I am the original data submitter, or! have obtained the written permission of the original data submitter, or I
have notified in writing the companypes) that submitted data I have tiled and have offered to: (a) Pay
compensation for those data in accordance with sections 3(0(1 )(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, if any. The companies I have notified are: (check one)
[1
(I
AH companies on the data submitters' fist for the active ingredient fisted on this form (Cite-All
Method or Cite-All Option under the Selective Method). (Also sign the General Offer to Pay
below.)
The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached 'Requirements Status and Registrants' Response Form,'
3. That I have previously compfied with section 3(c)(1)(0) of FIFRA for the studies I have cited in support of
registration or reregistratfen under FIFRA.
Signature
Name and Title (Please Type or Print)
GENERAL-OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or reregistratton of my products, to the extent required by FIFRA sections 3(0(1 )(D) and 3(c)(2)(D)-
Signature
Date
Name and Title (Please Type or Print)
EPA Form 1570-31 (4-»0)
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?/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approvtd
OMB No. 2070-010«
Approval Expires 12-31-92
Pubfc reporting burden for this collection of informatton.is estimated to average 15 minutes per response, including
time tor reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
asoectof this collection of information, including suggestions for reducing this burden, to Chief, information Pohcy
Branch PM-223, U.S. Environmental Protection Agency. 401 M St., S.W.. Washinpon, DC 20460: and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Nam*
Chemical Nam*
Company Number
& Chemical Number
1 Certify that:
My company is willing to develop and submit the data required by-EPA under the authority of the Federal
insecticide. Fungicide and Rodenticide Act (F1FRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to b© bound by arbitration decision under section 3(c){2){B)(iu) of F1FRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Kara* of Flim(a)
Oat* of Offer
Certffieattefl:
I certify that I am dufy authorized to represent the company named above, and that the statements that I hayt made on
this form and aD attachments therein art true, accurate, and complete. I acknowledge that any knowingly false or
misleading statementmay b« punishable by fine or Imprisonment or both under applicable law.
SFgnatut* of Company'* Aytnorixed Representative
Nam* and Title (Pleat* Typo or Print)
Oat*
5»A Form 8570*32 (4>IO)
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