United States Office of September 1991
Environmental Protection Pesticide Programs
Agency
&EPA Reregistration
Eligibility Document
(RED)
Carbon and Carbon
Dioxide
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Carbon and Carbon Dioxide Reregistration Eligibility Team
Office of Pesticide Programs:
Jean Frane Policy and Special Projects Staff
Program Management and Support Division
John Carley Information Services Branch
Evelyn Alston Information Services Branch
Health Effects Division
Pat McLaughlin
Esther Saito
Judy Smith
Alan Nielsen
Debra Edwards -
Andrew Rathman
Christine Olinger
Toxicolgy Branch
Science Analysis
Occupational and
Occupational and
Chemistry Branch
Chemistry Branch
Chemistry Branch
II,
and Coordination Branch
Residential Exposure Branch
Residential Exposure Branch
- Reregistration Support
- Reregistration Support
- Reregistration Support
Biological and Economic Assessment Division
Karen Griffin
E. David Thomas
Alan Schreiber
Gabe Patrick
Phyllis Johnson
Steve Jarboe
Economic Assessment Branch
Biological Assessment Branch
Biological Assessment Branch
Biological Assessment Branch
Biological Assessment Branch
Biological Assessment Branch
Registration Division
Walter C. Francis Anti-Microbial Program Branch
Insecticide Rodenticide Branch
Insecticide Rodenticide Branch
Insecticide Rodenticide Branch
Insecticide Rodenticide Branch
Rob Forrest
Dan Peacock
Dick Mountfort
Bill Jacobs
Environmental Fate and Effects Division
Dan Balluff Ecological Effects Branch
Bill Schneider Science Analysis and Coordination Staff
Roy Bingham Environmental Fate and Groundwater Branch
Special Review and Rereaistration Division
Bruce Sidwell Accelerated Reregistration Branch
Virginia Dietrich Accelerated Reregistration Branch
Carol Stangel Policy, Planning, and Evaluation Staff
Office of Qeneral Council - Eran Gasko
Office of Compliance Monitoring - Beverly Updike
Office of Policy, Planning, and Evaluation - Gary Deutsch
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TABLE OF CONTENTS
PAGE
GLOSSARY OF TERMS AND ABBREVIATIONS i
EXECUTIVE SUMMARY ^
I. INTRODUCTION 1
II. ACTIVE INGREDIENTS COVERED BY THE REREGISTRATION DECISION 2
DOCUMENT
A. IDENTIFICATION OF ACTIVE INGREDIENT ' 2
B. USE PROFILE 3
C. REGULATORY HISTORY 3
III. EPA ASSESSMENT OF ACTIVE INGREDIENT 4
A. PRODUCT CHEMISTRY ASSESSMENT 4
B. HUMAN HEALTH ASSESSMENT 5
CARBON
1. TOXICOLOGY DATA 5
2. OCCUPATIONAL AND RESIDENTIAL EXPOSURE 6
3. HUMAN RISK ASSESSMENT 6
CARBON DIOXIDE
4. TOXICOLOGY DATA 6
5. DIETARY EXPOSURE 9
6. OCCUPATIONAL AND RESIDENTIAL EXPOSURE 9
7. HUMAN RISK ASSESSMENT 10
C. ENVIRONMENTAL ASSESSMENT H
1. ENVIRONMENTAL FATE ASSESSMENT 11
2. ECOLOGICAL EFFECTS ASSESSMENT 11
3. ENVIRONMENTAL RISK ASSESSMENT 12
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IV. REREGISTRATION DECISION FOR CARBON AND CARBON DIOXIDE 13
A. DETERMINATION OF ELIGIBILITY *3
B. ADDITIONAL GENERIC DATA REQUIREMENTS 14
C. LABELING REQUIREMENTS I4
V. PRODUCT REREGISTRATION 14
A. DETERMINATION OF ELIGIBILITY 14
B. PRODUCT-SPECIFIC DATA REQUIREMENTS 14
C. LABELING REQUIREMENTS 15
VI. APPENDICES
A. APPENDIX A - USE PATTERNS SUBJECT TO REREGISTRATION 19
B. APPENDIX B - GENERIC DATA REQUIREMENTS FOR REREGISTRATION
OF CARBON AND CARBON DIOXIDE AND DATA CITATIONS
SUPPORTING REREGISTRATION
1. GUIDE TO APPENDIX B 25
2. ECOLOGICAL EFFECTS (CARBON) 26
3. TOXICOLOGY (CARBON) 26
4. ENVIRONMENTAL FATE (CARBON) 26
5. ECOLOGICAL EFFECTS (CARBON DIOXIDE) 27
6. TOXICOLOGY (CARBON DIOXIDE) 28
7. ENVIRONMENTAL FATE (CARBON DIOXIDE) 28
B. APPENDIX C - BIBLIOGRAPHY
1. GUIDE TO APPENDIX C 30
2. BIBLIOGRAPHIC CITATIONS 32
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GLOSSARY OF TERMS AND ABBREVIATIONS
CAS
CFR
CSF
EPA
FFDCA
FIFRA
GRAS
LEL
MRID
MS HA
NIOSH
OSHA
PEL
ppm
RED
STEL
Chemical Abstracts Service
Code of Federal Regulations
Confidential Statement of Formula
U.S. Environmental Protection Agency
Federal Food, Drug, and Cosmetic Act
Federal Insecticide, Fungicide, and Rodenticide Act
Generally Recognized As Safe
Lowest Effect Level
Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the EPA.
Mine Safety and Health Administration
National Institute for Occupational Safety and Health
Occupational Safety and Health Administration
OSHA Permissible Exposure Level
Parts per Million
Reregistration Eligibility Document
OSHA Short-term Exposure Level
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Executive Summary
registered for use as a rodenMr- acive ingredient are
carbon dioxide as an
^iaation to
„,
ssns sarsSSara
11
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I. INTRODUCTION
* rf J? ^ ' the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) was amended to accelerate the
^registration of products with active ingredients
registered prior to November 1, 1984. The amended Act
^i??V-SCh?dUle f°r the registration prlcels to be
completed in nine years. There are five phases to the
^registration 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 (referred to as "the EPA")
of all dat.a submitted to support reregistration.
M*< ?ejtion 4(g)(2)(A) of FIFTtt states that in Phase 5 "the
™S Jf °? ^H deteraine Aether pesticides containing
such active ingredient are eligible for reregistration"
before calling in data on products, under section
4(g)(2)(B), and either reregistering products or taking
5?S w?i ?rf rOP51!m re^latory action" under FIFRA section
5(g)(2)(C) and (D) , respectively. Thus, reregistration
involves a thorough review of the scientific data base
underlying a pesticide's registration. The purpose of the
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
effects" criterion of FIFRA section
This document presents the EPA's decision regarding the
reregistration eligibility of the active ingredients ca?bon
and carbon dioxide. The document consists of five sections.
Section I is this introduction. Section II describes carbon
and carbon dioxide, their uses and regulatory history.
section III discusses the human health and environmental
assessment based on the data available to the EPA. Section
IV discusses the reregistration eligibility decision for
carbon and carbon dioxide and Section V discusses product
reregistration requirements. Additional details concerning
the review of available data are available on request/
EPA's reviews of specific reports and information on the
set of registered uses considered for EPA's analyses may
be obtained from: EPA, Freedom of Information, 401 M St.
S.W., Washington, D.C. 20460.
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II. ACTIVE INGREDIENTS COVERED BY THIS REREGISTRATION
ELIGIBILITY DECISION DOCUMENT
A- IDENTIFICATION OF ACTIVE INGREDIENT?
1. Chemical Name: Carbon
CAS Number: 7440-44-0
Office of Pesticide Programs Chemical Code Number:
16001
Empirical Formula: C
2. Chemical Name: Carbon dioxide
CAS Number: 124-38-9
Office of Pesticide Programs Chemical Code Number:
16601
Empirical Formula: CO2
B. USE
Carboji ;
Type of Pesticide: Rodenticide/Predacide, Insecticide
when used in combination with sodium or potassium
nitrates .
Pests Controlled: Pocket gophers, moles, ground
squirrels, rats, skunks, woodchucks, red foxes,
coyotes, prairie dogs, and ground wasps.
Registered Use Groups: (See Appendix A for detailed
specific use sites)
Terrestrial Food Crop
Terrestrial Feed Crop
Terrestrial Non-Food Crop
Forestry
Residential Outdoor
Formulation Types Registered:
Ready to use cartridge-type bomb formulated with
other active ingredients. Designed to be ignited and
placed in pest burrow. Combustion produces pyrolysis
compounds which are toxic when inhaled by the pests
inhabiting the burrow. The smaller cartridges (0.75 to
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Methods of Application:
Use one cartridge per burrow system;
Carbon DioxiH?.
Type 'of Pesticide: Insecticide.
Pests Controlled: Insects
Registered Use Groups: (See Appendix A for detailed
specific use sites)
Indoor Food
"«""'
pressurized gas: 99 to 99.9% active ingredient-
°t cart dide for
a 1- thL
Methods of Application:
Seal area to be fumigated. Adjust atmosphere in
fSJ? Sre?^v° J°% Carb°n di°xid* ™* aaintSin for
four or five days. Following fumigation
' is safe
c- REGULATORY HTSTnpy
x»82, in response to concern over safety of these
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™, EPA issued a Notice of Intent to Cancel
(NOIC) all products unless registrants submitted
upgraded labeling and data on the burning
characteristics of cartridges. Subsequent to
compliance with the NOIC and labeling improvement
program, there have been four reports of injuries, all
involving misfiring of ignited cartridges. The EPA has
contacted the two registrants of these particular
products regarding these incidents.
Carb9n dioxide; EPA first registered a carbon dioxide
containing product, a pressurized gas product in 1981
Carbon dioxide was formulated with other active
ingredients as an aerosol spray. This spray was used
to control insects such as wasps. The registrant of
this product has recently notified EPA of their intent
not to support the reregistration of carbon dioxide for
this particular use. The first product containing
carbon dioxide for use as a fumigant was registered in
1982. The product is used as an insecticide and
miticide in stored grain. In 1980 EPA exempted carbon
dioxide from tolerances in or on raw agricultural
commodities (40 CFR 180.1049). Carbon dioxide does not
accumulate in treated raw agricultural commodities but
rather diffuses into the atmosphere following
application. Therefore, no residues of carbon dioxide
are found in or on raw agricultural commodities. In
1981, EPA established a food additive regulation for
carbon dioxide in or on all processed agricultural
commodities when used post-harvest (40 CFR 185.650).
III. EPA ASSESSMENT OF ACTIVE INGREDIENT
The EPA has reviewed the scientific data base for
carbon and carbon dioxide consisting of published
literature studies cited in the Bibliography in
Appendix C. The findings are summarized below:
A- DESCRIPTION OF ACTIVE INGREPTENT AND ASSESSMENT OF
PRODUCT CHEMISTRY w.i—•••. • .••> nvn-*vvtw * vf
Carbon
Carbon is a nonmetallic element with an atomic weight
of 12.01. Pure carbon is found in three forms:
amorphous black powder; black crystals known as
graphite and the usually colorless diamond crystal.
Carbon is found in many inorganic and all organic
compounds. It is the principal component in charcoal,
coal, and soot. The melting point for carbon ranges
from 3652-3697 C. The dust may explode when exposed to
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heat or flame or various chemical components including
nitrates, oxides, peroxides, and halogens (9).
Carbon, in the form of charcoal or sawdust, is used as
a pesticide in combination with nitrates and sulfur in
gas cartridges. These cartridges are used in burrows
to kill coyotes, woodchucks, ground squirrels, prairie
dogs, and pocket gophers and ground wasps. No data are
required concerning generic product chemistry.
Carbon dioxide
Carbon dioxide is a colorless, odorless, noncombustible
gas. Its molecular weight is 44.01. Solid carbon
dioxide is known as dry ice and the sublimation
temperature at atmospheric pressure is -74.5"C. The
solubility of CO2 in water is 0.14 g/100 g water; it is
less soluble in organic solvents. The specific gravity
relative to air at 24'C is 1.53. When added to
alkaline solutions carbonates are formed (6).
Carbon dioxide is a naturally occurring gas found in
the atmosphere which is required for plant and animal
life. It is a product of animal metabolism and is
essential for plant and animal respiration (6). It was
first identified by Joseph Priestley about two hundred
years ago and has been extensively studied since then.
Carbon dioxide is used for a wide variety of non-
pesticide applications. Probably the best known use is
for the carbonation of beverages. It may also be used
in refrigeration, fire fighting, welding operations,
rubber tumbling, mining operations, and oil well
secondary recovery. Medical applications include use
as a coma-inducing agent in psychiatric treatment and
as a constituent of therapeutic oxygen.
Carbon dioxide is used as a pesticide for insect
control in stored grain under modified atmospheres
containing approximately 60% carbon dioxide.
B. HUMAN HEALTH ASSESSMENT
Carbon
1. Toxicology - Data Base
The toxicological data on carbon available in the open
literature are adequate for assessing risk to humans. Carbon is
a natural component of all organic chemicals and all living
organisms. One form of carbon, activated charcoal, is given
orally as an adsorbent for treatment of accidental drug poisoning
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(4). Carbon, in the form of carbon black, is cleared by the Food
and Drug Administration, for use in resinous and polymeric
coatings as food-contact surfaces (21 CFR 175.300). It is also
listed for use in paper and paperboard and polymers in contact
with food.
The functional pesticidal active ingredients in animal
control cartridges are the pyrolysis products of the carbon and
other components of the formulation. The toxic properties of the
carbon bear no relationship to the toxicity of the active
compounds.
2. Occupational and Residential Exposure
Based upon available use data for carbon end-use products
(016001), gaseous pyrolysis products are generated by oxidation
of carbonaceous materials within flare-like containers for the
purpose of controlling small mammals and coyotes in burrows and
dens. When properly used for pest control in animal dens and
burrows, the fuse of the flare is ignited, the flare is placed
within the burrow within seconds after ignition, and the opening
is immediately sealed with nonflammable material such as soil to
prevent dissipation of combustion products. Based upon reported
incidents, the primary hazard posed is dermal burns following
premature flare ignition. With respect to inhalation and dermal
exposure, gas cartridges should pose very low exposure hazards to
humans.
3. Risk Assessment
The toxicity data usually necessary for pesticide
registration are not required for this use of carbon. There are
some factors unique to this case which indicate that specific
studies to fulfill the usual data requirements are not necessary
to regulate this substance as a pesticide. Carbon is a basic
component of all organic chemicals and all living organisms, and
is truly ubiquitous. Human exposure is expected to be negligible
for carbon when it is used as one component in gas-producing
cartridges placed in animal burrows. Ignited cartridges are to
be quickly placed into burrows which are then covered to entrap
the generated fumes. Improperly covered burrows could result in
inhalation exposure to the fumes if the applicator remains in
close proximity to the burrow.
CARBON DIOXIPp
l. Toxicology
All toxicology data requirements are satisfied. No further
data are required by EPA. A number of studies have been
conducted with carbon dioxide, but in most instances the purposes
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of these studies were not to determine the major endpoints of
toxicity by using the protocols recommended in EPA guidelines for
evaluating these effects. However, there is a substantial volume
of information on carbon dioxide in the literature which covers
major biological considerations.
a. Acute Toxicity
EPA has a number of adequate acute toxicological studies on
carbon dioxide. All the available acute studies use the
inhalation route of administration. In one study (3) dogs were
given 30 percent carbon dioxide for 2 hours, then 40 percent
carbon dioxide, and then abruptly returned to normal air. Eleven
dogs died within 10 minutes with ventricular fibrillation. Four
survived with cardiac arrhythmias, and two had no cardiac
symptoms (3). -
In a second study rats exposed to an atmosphere containing
50 percent carbon dioxide died within 6 hours. Rats exposed to
25 percent died within 36 hours. Deaths were a result of
pulmonary injury. Atmospheres as low as 20 percent carbon
dioxide caused cerebral depression. All rats exposed to 10
percent carbon dioxide survived (3).
In a third experiment, rats were exposed to 20 percent
carbon dioxide for 2 hours followed by increasing concentrations
up to 43 percent. The animals died in 2.5 to 19.3 hours and
showed severe brain and spinal cord damage in proportion to the
exposure (3).
The first effect of human inhalation of excessive carbon
dioxide occurs at concentrations of about 2 percent (20,000 ppm)
when the breathing becomes deeper and the tidal volume is
increased. At 4 percent the depth of respiration is markedly
increased and at 4.5-5 percent breathing becomes labored and, for
some individuals, distressing (2). Human inhalation of 8-10
percent concentrations for periods up to 1 hour showed no evident
harmful effects (2). Other effects of increased carbon dioxide
levels are increased heart rate, headache, sweating, shortness of
breath, dizziness, shaking, convulsions, and unconsciousness (5).
Deaths from accidental exposure to extremely high levels of
carbon dioxide have been reported, but generally analyses of the
atmospheres for carbon dioxide concentration or the possible
presence of other deleterious gases have not been performed (3).
b. Subchronic Toxicitv
Subchronic exposure of laboratory animal species to various
concentrations of carbon dioxide have resulted in different
effects. Guinea pigs exposed to 15 percent carbon dioxide for 7
days lost weight at first but later returned to normal weight.
They also had higher blood corticosteroids, lower adrenal
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fat?vPaciS«' dnSTSed ad5e?al chol*8t«rol, higher arterial free
exposure ?!)'. dec«ased lymphocytes in the first 3 days of
Rats exposed to 10 percent carbon dioxide for 30
1ht S °f14-27 P^cent; those exposed to 20-25
H*VC ?!! fffects were seen in male rhesus monkeys that spent 93
days in an atmosphere with 3 percent carbon dioxide (3) .
C. Human Chronic
StUdy ?" brewe?y workers suggests that there are no
cant physiological effects from chronic intermittent
rt **°»* —
Other Chronic Toxicologic^ Effects
CQn^«nHteri°U! effects were found when animals were given
n«™?? £ fuS!S,°f carbon dloxid« higher than the levels
normally breathed in air. Deleterious effects on sperm of
various animal species have been reported (3) following exposure
to high carbon dioxide atmospheres. Also, when pregnant Sts
were exposed to 6 percent carbon dioxide for one full day 23 4
percent of the offspring had cardiac abnormalitie^and there 'was
also an increased incidence of skeletal malformations Uo 9
SbbT^J3'-^6^"1 C°1Umn »al*>rmations^ere reported in
carbon h"nan
for lo^TUISL'S1??* P^3 exposed to 0.48 percent carbon dioxide
for 10 minutes daily for 20 days had a high number of
carrieI1?!e?™d ^tt* ParalVsis of th« hind limbs in the pups
carried to term. Another group exposed to 0.42 percent carbon
mav h 3° days had no ^scarriages bu
many of the offspring were microsomic and many of these had
neuromuscular defects of the hind limbs (3).
e. Metabolism
Carbon dioxide is produced by the body's metabolism and is
always present in the body at about 6 percent concentration In
average adult human will produce more than 500 g of carbon
conditions' and »i" Produce much
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Additional carbon dioxide has several effects on the body
and responses are immediate, it stimulates breathing, which
?Sab?ood It-1*011 dioxide carried to the lungs from the cells by
£imS???i Jh "?' J" lncrease in carbon dioxide concentration
stimulates the heart rate, increases the blood pressure
mulcl-65 ? *SS-i? fl°W' and relaxes the vascula? smooth
muscles. In addition, carbon dioxide reacts with water in th*
;™ Carb?nic aCid' Which Associates Jo hydrogen ion and
and tJS ^"u^ ln Carb°n dio*id* ^ thebod? ?nc?
and then the kidneys act to restore normal acidity.
studies on men exposed to 1.5 percent carbon dioxide in
phase during the rest of the exposure period (3).
1* — Dietary
Carbon dioxide is exempt from the requirement of a t
when used post-harvest in modified atmospheres lor stored
°n arU
IS 19 Carb in 40 CFR
180.1049. Carbon dioxide may be used as a food additive cost-
harvest in modified atmospheres for stored product inslct control
OCe Agricultural commodities as described in To CFR
DCFR 1?4'i240 carbon dioxide is listed as a substance
« Recognized As Safe (GRAS) for use in food. Carbon
™°Xid? aS been. consumed in naturally carbonated or "mineral"
water for centuries, and in manufactured carbonated beveraaes
for
continai exose to
r-,
Sa5b°n^10Xlde Wlthfut any indications of toxic effects from such
ordinary exposures to carbon dioxide. Furthermore, since carbon
percen? SoS nn^a^^nSt^Uent ?f ^ atmosphere at about ofo3
percent (300 ppm) , there is continuous human exposure by
i
,
inhalation and on the skin.
?, Occupational and
fn^ ^door use of carbon dioxide end-use products as a fumigant
for postharvest treatment of raw and processed food commodities
and cargo areas poses potential exposure risks for workers
roif?^/?0?""^^"^3 are ass°ciated with worker reentr^ into
confined/enclosed spaces. Carbon dioxide gas may collect and be
present in significantly higher concentrations in poorly
ventilated depressions in grain bins, shafts, etc. and sites
where recirculation of air is minimal. Studies of workers
?S?rd ?„ i9h ^T618 °f Carbon dioxide i« other industries
indicate that confirmatory air monitoring is essential in
confined spaces. Even with ventilation systems present to purge
areas of excess carbon dioxide, some system design may be
inadequate to reduce levels to the OSHA permissible exposure
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level (PEL) of 10,000 ppm. Ventilation systems need to be
periodically tested to determine system adequacy.
Product labels must recommend air monitoring while treated
areas are being ventilated to reduce ambient levels of carbon
dioxide. This monitoring will permit determination of post-
application inhalation exposure levels at indoor use sites.
During and following ventilation activities, short-term reentry
of more than 15 minutes into treated areas may not occur prior to
carbon dioxide levels falling below the OSHA short-term exposure
limit, STEL = 30,000 ppm, within the breathing zone for workers.
Monitoring shall also be required for the lowest work areas
within enclosed/confined spaces.
There are many factors unique to carbon dioxide which
suggest that specific studies to fulfill the usual data
requirements for pesticide registration are not necessary in
order for EPA to regulate this substance as a pesticide. As
discussed above there are many natural exposures to carbon
dioxide from normal respiratory and metabolic processes,
inhalation of normal ambient carbon dioxide, and consumption of
carbonated beverages and other foods. In moderate increases of
carbon dioxide exposure, the human body has rapid compensatory
mechanisms to restore the normal balances through increased
respiration to exhale it and restoration of normal acidity by the
kidneys (8). Humans ordinarily consume carbon dioxide in foods
and beverages daily.
Serious teratological effects from acute exposure to
atmospheres containing more than 10% carbon dioxide have been
reported in toxicological studies. However, such atmospheres are
not likely to be encountered by applicators using this product in
accordance with the label.
The only risk from pesticide usage is to workers who enter
fumigated enclosures which have not received sufficient aeration.
However, the EPA believes that this risk is low if proper product
application and area ventilation are made.
C. ENVIRONMENTAL ASSESSMENT
EPA has not required and does not intend to require any
generic environmental fate or ecological effects data on the
active ingredient carbon considering the registered product
formulations and uses. All data requirements for these
disciplines that are specified in 40 CFR section 158 are waived.
The rationale for this decision is presented below in the
"Environmental Risk Assessment."
10
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l'
Environmental
Sarfean: The physical and chemical properties of
carbon, a naturally occurring substance are w«n
SS*££00d' Jhe Pvr°W of carbon JS'tSe presence of
the other active ingredients such as sodium and
nitrates resu^s in simple organic and
is "- vhich
pyrolysis products eventually difuse through the
burrow opening or into soil/ Exposure to the
iSSSJJ?? ^n beKcha««=terized as limited and
n™it? rat**r than widespread or broadcast. EPA
normally requires many of the environmental fate
studies on estic
quires many of the environmental fate
studies on pesticides in order to assist with its
Uving °^««i«-. Given E?A's
~ .
ISS^iS ^eCt! assessment, there is no need for
such data. Therefore, all environmental fate data
requirements have been waived. ™nenta-L rare data
Carbon dioxide is also a
&SSL
2'
Jajfeon: The gas cartridges are intended for control of
woodchucks, ground squirrels, prairie dogs pocket
gophers moles, red foxes, coyotes, and ground wisps
Carbon is formulated with other active ingredient '
sodium or potassium nitrates and sulfur, during
manufacture of the gas cartridges. Pest speciL are
not exposed to carbon or to thl other IctiS!
t0 the Products of their
Carbon dioxide is used as a gas
nn iS a" lndoor usa patt«rii, exposure to
nontarget organisms is not expected. Therefore, no
11
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4, gnyirotiMiit.1 y^ A»amBtnt
Martian: Application of the gas cartridaes Is
Jus ssvnssi a
incidents involving non-targe organises
„.
to
12
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generic ecological effects data have been required or
are being required.
IV. RERE6I8TRATIOM DECISION FOR ACTIVE INGREDIENT
A. DETERMINATION OF ELIGIBILITY
Section 4(g)(2)(A) of FIFRA requires EPA to determine,
after submission of relevant data concerning an active
ingredient, whether products containing the active
ingredient are eligible for reregistration. The EPA has
previously identified and required submission of generic
(i.e., active ingredient specific) data required to support
reregistration of products containing carbon and carbon
dioxide as an active ingredients. EPA has also consulted
and relied upon published literature as a source for
technical information. EPA has completed its review of
these generic data, and has determined that the data are
sufficient to support reregistration of products containing
carbon and carbon dioxide. Appendix 8 identifies generic
data requirements that EPA reviewed as part of its
determination of reregistration eligibility of carbon and
carbon dioxide, and lists the submitted studies that EPA
found acceptable.
The data identified in Appendix B as well as
information from the open literature are sufficient to allow
the EPA to conduct a risk assessment for the registered uses
of carbon and carbon dioxide. The data available to the EPA
support the conclusion that the registered uses of carbon
and carbon dioxide will not result in unreasonable adverse
effects to the environment. The EPA has determined that all
products containing carbon or carbon dioxide as the active
ingredient are eligible for reregistration. The
reregistration of particular products is addressed in
section V of this document ("Product Reregistration"}.
The EPA made 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 EPA has found that
products containing carbon and carbon dioxide are eligible
for reregistration, it should be understood that the EPA may
take appropriate regulatory action, and/or require the
submission of additional data to support reregistration of
products containing carbon or carbon dioxide, if new
information comes to the EPA's attention or if the data
requirements for registration (or the guidelines for
generating such data) change.
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B. ADDITIONAL GENERIC DATA REQUIREMENTS
The generic data bases supporting the reregistration of
products containing carbon and fumigation products
containing carbon dioxide have been reviewed and determined
to be complete for reregistration. Carbon dioxide is
currently registered as an active ingredient in two aerosol
spray products used for the control of insects such as
wasps. One product is currently listed for cancellation due
to non-payment of 1991 maintenance fees. The registrant of
the remaining product has recently notified EPA of their
intent not to support the reregistration of carbon dioxide
for this particular use. EPA is not considering this use of
carbon dioxide for reregistration. No further generic data
are required.
C. LABELING REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
CONTAINING CARBON OR CARBON DIOXIDE
The labels and labeling of all products must comply
with EPA's current regulations and requirements. Follow the
instructions in the Product Reregistration Handbook with
respect to labels and labeling. Any product label which
allows both manufacturing and end use must be amended to
specify either manufacturing or end use, not both. No
product may bear both manufacturing and end use labeling.
In this situation, if a registrant amends the label to
specify manufacturing use only and wishes to retain end use
registration, he/she must apply for a separate end-use
product registration.
V. PRODUCT REREGISTRATION
A. DETERMINATION OF ELIGIBILITY
Based on the reviews of the generic data for the active
ingredients, carbon and carbon dioxide, the products
containing this active ingredient are eligible for
reregistration. Section 4(g)(2)(B) of FIFRA calls for the
EPA to obtain any needed product-specific data regarding the
pesticide after a determination of eligibility has been
made. The EPA will review these data when they have been
submitted and/or cited and determine whether to reregister
individual products.
B. PRODUCT SPECIFIC DATA REQUIREMENTS
The product-specific data requirements are stated in
Attachment C.
14
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LABELING REQUIREMENTS FOR END-USE PRODUCTS CONTAINING
THE ACTIVE INGREDIENT CARBON
The labels and labeling of all products must
comply with EPA's current regulations and
requirements. Follow the instructions in the
Product Reregistration Handbook with respect to
labels and labeling. Any product label which
allows both manufacturing and end use must be
amended to specify only manufacturing or end use.
In this situation, if a registrant amends the
label to specify manufacturing use only and wishes
to retain end use registration, he/she must apply
for a separate end-use product registration.
'The EPA is currently developing detailed guidance
on labeling for gas cartridge products, which will
further address concerns about applicator safety
and potential impact to endangered and non-target
organisms. This guidance will be sent to
registrants prior to submission of labeling which
is required eight months after issuance of this
document. Registrants will be required to follow
this guidance in revising their labels.
D. LABELING REQUIREMENTS FOR END-USE PRODUCTS
CONTAINING CARBON DIOXIDE
1. Any product label which allows both manufacturing
and end use must be amended to specify only
manufacturing or. end use. In this situation, if a
registrant amends his label to specify end-use
registration and wishes to retain manufacturing
use registration, he must apply for a separate
manufacturing use product registration.
2. Required Human Hazard Precautionary Statements:
a) "After fumigation, aerate treated areas until
the level of CO2 as measured by [the registrant
must identify one or more direct-reading detection
devices suitable for use with the product and
provide or reference instructions on its use], is
below 10,000 ppm."
b) "Short term entry into the treated area is
permitted when measured CO2 levels are between
10,000 and 15,000 ppm; respiratory protection
[registrant must specify a self-contained
breathing apparatus (SCBA) or combination air-
supplied/SCBA respirator approved by the National
Institute for Occupational Safety and Health
15
-------
•*"?•*** Mine safet* and
Administration (MSHA) ] must be worn if 15 or more
minutes are spent in the treated area."
£ir!nn measured C02 levels exceed 15,000 ppm, no
person shall enter the treated areas without a
respiratory protection device [registrant must
specify either a NIOSH/MSHA approved seif-
S£H? ?? b^fthing apparatus (SCBA) or
combination air-supplied SCBA respirator]."
2. Spill and Leak Procedure Statement
™x?Ua*f laune
-------
These signs must be posted at eye level and must
be visible from all visible points of entry to the
treated area. They must remain posted during
application and throughout the restricted-entry
interval until the concentration of carbon dioxide
is below 10,000 ppm. Each separate treated area
(i.e., boxcar, silo, ship container) must be
posted or placarded with this sign.
The applicator or person responsible for
monitoring levels of carbon dioxide may remove the
placard when the concentration of carbon dioxide
is at or below 10,000 ppm.
5. Precautionary Statements for End-Use Products
" Intended for Structural, Transportation, Space or
Commodity Fumigation.
In addition to the placarding directions specified
under Section 4 above, the following statements
must appear on all end-use products intended f r
structural, transportation, space or commodity
fumigation:
"All persons working with this product should
be knowledgeable of the hazards of this
chemical, and trained in the use of required
respirator equipment and detector devices,
emergency procedures and use of the product.
When used for fumigation of enclosed spaces,
[boxcars, silos, ship containers, and other
transport vehicles], two persons familiar
with the use of this product must be present
during introduction of the fumigant,
initiation of aeration, and after aeration
when testing for reentry. Two persons do not
need to be present if monitoring is conducted
remotely (outside of area being fumigated).11
6. Required Storage and Handling Statements
"Store in dry, cool, well-ventilated area under
lock .and key. Post as a pesticide storage area.
Do not contaminate water, food or feed by
storage."
"Store cylinders upright, secured to a rack or
wall to prevent tipping. Cylinders should not be
subjected to rough handling or mechanical shock
such as dropping, bumping, dragging or sliding.
Do not use rope slings, hooks, tongs or similar
devices to unload cylinders. Transport cylinders
17
-------
using hand truck or fork truck to which the
cylinder can be firmly secured."
"Do not remove valve protection bonnet and safety
cap until immediately before use. Replace safety
cap and valve protection bonnet when cylinder is
not in use."
"When cylinder is empty, close valve, screw safety
cap onto valve outlet and replace protection
bonnet before returning to shipper. Only the
registrant is authorized to refill cylinders. Do
not use cylinders for any other purpose. Follow
registrant's instruction for return of empty or
partially empty cylinders."
18
-------
APPENDIX A
USE PATTERNS SUBJECT TO REREGISTRATION
FOR
CARBON AND CARBON DIOXIDE
19
-------
APPENDIX A: USE PATTERNS SUBJECT TO REREGISTRATION FOR CASE 4019: CARBON ANDTn? I
SITE
Application Type, Application Timing. Application Equipment
j-
FOOOjFEED USES
AGRICULTURAL CROPS
(UNSPECIFIED)(CROPLAND)
Fumigation, When needed, Hand placed cartridge
RANGELAND (UNSPECIFIED)
Fumigation, When needed. Hand placed cartridge
NONFOOD USES
AGRICULTURAL UNCULTIVATED AREAS
Fumigation, When needed, Hand placed cartridge
F OREST PLANTINGS
(REFORESTATION PROGRAMS)
Fumigation, When needed. Hand placed cartridge
GOLF COURSE TURF
Fumigation. When needed. Hand placed cartridge
NONAGRICULTURAL UNCULTIVATED AREAS
Fumigation. When needed. Hand placed cartridge
ORNAMENTAL LAWNS AND TURF
Fumigation. When needed, Hand placed cartridge
-
Form
±=E====
IMPR
IMPR
IMPR
IMPR
IMPR
IMPR
IMPR
Maximum
Application
Rate
(X)
=!==:==
ac
0.1852 b
al/cartrtdge 1
0.1852 fc
at/cartridge 1
0.1852 fc
at/cartridge 1
0.0325 to
•I/cartridge 1
0.0325 to
al/cartridge 1
0.1B52to
ai/cartrtdge 1
0.0325 Ib
ai/cartridge 1
Max*
Apps.
'
live kigr<
^•^-^^_
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Max.*
Apps.O
Man. Rate
==^=
xilent - C>
~^~^^W^M^_
not spec
not spec
Mln. Interval
Between Apps.
® Max. fete
(D«ys)
Restricted
Entry
Interval
(Days)
Geographic
Limitations
Allowed | Disallowed
Use Limitations.
\RBON
not spec
5
not spec
not spec
not spec
not spec
not spec
not spec
not spec
5
not spec
5
not spec
not spec
not spec
not spec
not spec
not spec
not spec
none
none
none
none
none
none
none
none
none
none
none
none
none
none
endangered species restrictions; do
not use inside buildings
.
not use Inside buildings
endangered species restrictions; do
not use kialda htildkin*
endangered species restrictions; do II
not U3e Ins Ida hullrlnn« II
endangered species restrictions;do II
not use inside buildings 11
endangered species restrictions; do
not use inside buildings ||
-------
SITE
Appicwlon Type, Application Timing. Application Equipment
^ -— —
FOOQrFBED USES
CXJMMERCIALTRANSPORTAT1ON FACILfTlES
Fumigation, When needed. Cylinder
FEED/FOOD CONTAINERS^MFTY/FULL
Stored oommodKyKimigallon. Whan needed.
Cyfinder
GRAIN/CEREAL/FLOUR BINS. FEED/FOOD-FULL
Stored commodity fumigation. When needed.
Cylinder
PROCESSED FOOD AND FEED PRODUCTS
Stored commodity fumigation, When needed
Cylinder
^"^— ^^•^^-^^¥^^•1
Fwm
=7===
PROS
PROS
PROS
PROS
•B^aataKKB
Maximum
App*catk>n
Hate
<*)
=^===
active In gr
Mm.*
Apps.
=1=:
edient «
Max*
App*.e
Max. ftate
=
CARBC
M In. Internal
Between Apps.
OMajuFMe
(t>«ys)
)N DIOXID
Rtilrfcttd
Entry
Interval
(Oayi|
=
E
Geographic
Umttatkxw
Allowed | CMnallQvwd
^===^ .—
Use Limitations
60% (+10%)
aftreated
volume
60% (+10%)
al/kreated
volume
60% (+10%)
aVtreated
volume
80% (+10%)
at/treated
volume
g^EH=m=
not
spec
not
spec
not
spec
not
spec
aaoc^a
not spec
not spec
not spec
notapec
!^=S^=
not spec
not spec
not spec
notapec
— —
not spec
not spec
not spec
not spec
none
none
none
none
none
none
none
none
do not fumigate If grain temperature Is
toss than ^Ofot&O^f (depending on
product)
do not fumigate If grain temperature Is
less than «
-------
APPENDIX B
Generic Data Requirements for Reregiatration
of Carbon or Carbon Dioxide and Data citations
Supporting Reregistration
24
-------
GUIDE Tr>
Registration Eli,lbi£i tooentf °°v*r<>* "* this
aPPly to
which . i'S'ss 2%
'"
'enerally organized according to the
are
sss sjr -« "tffsj?- -
are available fro» the Nations? ?L ^"8f°?nt Guid«"n«s. which
5285 Port Royal Road,Sprin°tael^Ch2lc»2lJJf°™"°n Service,
Patterns t i'1 in
-------
APPENDIX B
DATA SUPPORTING GUIDELINE REQUIREMENTS FOR REREGISTRATION OF CARBON
GUIDELINE TITLE OP USE BIBLIOGRAPHIC
CITATION STUDY PATTERNS CITATION
PRODUCT CHEMISTRY
EPA waived 40 CFR 158 requirements for reasons discussed in section III.
ECOLOGICAL EFFECTS
EPA waived 40 CFR 158 requirements as discussed in section III.
TOXICOLOGY
EPA waived 40 CFR 158 requirements for reasons discussed in section III.
ENVIRONMENTAL FATE
EPA waived 40 CFR 158 requirements for reasons discussed in section III.
The citations listed in the bibliography (Appendix C) were used to support these
decisions.
26
-------
APPENDIX B
DATA SUPPORTING GUIDELINE REQUIREMENTS FOR REREGISTRATION
OF CARBON DIOXIDE
GUIDELINE TITLE OF
CITATION STUDY
Product
61-1
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Chemistry
Product Identity
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Oct. /Water Part. Coef.
PH
Stability
USE
PATTERNS
— •
ABL
•jk TST
ABL
ABL
JL Of
ABL
ABL
ABL
ABL
ABL
ABL
ABL
ABL
ABL
ABL
BIBLIOGRAPHIC
CITATION
— " 7
94049-999*
94049-999
94049-999
94049-999
94049-999
94049-999
94049-999
94049-999
94049-999
94049-999
94049-999
94049-999
94049-999
27
-------
Information was obtained from correspondence with Phase 3 package for company no. 51877
MRID no. for package is cited.
ECOLOGICAL EFFECTS
EPA waived 40 CFR 158 requirements as discussed in section III.
TOXICOLOGY
EPA waived 40 CFR 158 requirements as discussed in section III.
ENVIRONMENTAL FATE
EPA waived 40 CFR 158 requirements as discussed in section III.
The citations listed in the bibliography (Appendix C) were used to support these
decisions.
28
-------
APPENDIX C
CARBON AND CARBON DIOXIDE BIBLIOGRAPHY
Citations Considered to be Part of the
Data Base Supporting Reregistration
29
-------
GUIDE TO APPENDIX C
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. Primary sources
for studies in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support of
past regulatory decisions. Selections from other sources
including the published literature, in those instances where
they have been considered, will be included.
2. UNITS OF EKTRY. The unit of entry in this bibliography is
called a "study", m the case of published materials, this
corresponds closely to an article. In the case of
unpublished materials submitted to the EPA the EPA has
sought to identify documents at a level parallel to the
published article from within the typically larger volumes
in which they were submitted. The resulting "studies"
generally have a distinct title (or at least a single
subject), can stand alone for purposes of review, and can be
described with a conventional bibliographic citation. The
EPA has attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by Master Record Identifier, or MRID
number. This number is unique to the citation, and should
be used at any time specific reference is required. It is
not related to the six-digit "Accession Number" which has
been used to identify volumes of submitted studies; see
paragraph 4(d)(4) below for further explanation. In a few
cases, entries added to the bibliography late in the review
may be preceded by a nine-character temporary identifier.
These entries are listed after all MRID entries. This
temporary identifier number is also to be used whenever
specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the EPA could confidently identify
one, the EPA has chosen to show a personal author.
When no individual was identified, the EPA has shown an
identifiable laboratory or testing facility as author.
30
-------
as auor/680' EPA haS ShOWn the "«t submitter
w"??hmnnt dat^: When the date aPPears as four digits
with no question marks, the EPA took it direct! JfrL
if SS do"""18 " deteralne «^-«»;: the
... U ha= besn necessary for
-
d-
2=2
or other administrative
submission. Wlth th6 earliest *nown
(3) Submitter. The third element is the submitter
fSSSSW^: 5h"sf/pitted **•" ^
this
(4) volume Identification (Accession Numbers) The
denti«h ,
in 2ht5i JK fP* accessio» "umber of the volume
in which the original submission of the study
appears The six-digit accession number follows
1 "
SSr^S1 ™?L'" standin* *or "Company Daa
Library." This accession number is in turn
rela?iv nLf f • alphf !^ic suffix which shows the
For eiamnlf ^?H-°f th6 S?Udy within the vol™e
XaKe' Wlthln accession number 123456, the
heS26?? T^^%123456-A; the second' i2345
the 26th, 123456-Z; and the 27th, 123456-AA.
31
-------
OFFICE OF PESTICIDE PROGRAMS
REREGISTRATION ELIGIBILITY DOCUMENT
BIBLIOGRAPHY
are the S°UrCes °f the ^erences cited in this
(1) Carbon dioxide. 1989. Federal Register 54 (12) -2650-2651
January 19 (Thursday), 1989. -2650-2651
(2) Clayton, G. D. , and Clayton, F. E., eds., 1982
(4) Oilman, A.G., Goodman, L. s., and Oilman, A. (1980)
piiti - 6th
(5) Jacobs^ ^ E and Smith M. S. (1988). "Exposures to Carbon
aioxide in the Poultry Processing Industry » Ameriran
industrial Hygiene Association jSurnal 49?«4.
Th? M?rcK Tndpx- Eleventh edition, (1989), p. 274.
Occupational Safety and Health
T - TT *t*n A ii^gx uii vjm^y j. nigs for
TT ^-,4.1 .nr..^ -H- » ^T - TT *t*n A ii^gx uii vjm^y j. nigs for Cri^Ttt i cs 1
National ^r^^f10^ ^ flVlfl. Cincinnati; Ohio
National Institute for Occupational Safety and Health,
f8> NIOSP PockPt Guide to rhPmical »**»^r 1990.
s?
" "'
10) Schmeltz L .L and Whitaker, J.o., Jr. 1977. Use of
Woodchuck Burrows by Woodchuck and Other Mammals.
Trans. Kentucky Acad. Sci. 38(1-2) :79-82. is>
11) Vaughan, T.A. 1961. Vertebrates Inhabiting Pocket Gopher
Burrows in Colorado, j. Mammal. 42 (2): 171-174?
32
-------
ERA'S BATCHING OF CARBON AND CARBON DIOXIDE END-USE PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data
requirements for reregistration of end-use products containing either the active ingredients carbon or carbon
dioxide, the Agency has batched products which can be considered similar for purposes of acute toxicity
Factors considered in the sorting process include each product's active and inert ingredients (identity
percent composition and biological activity), type of formulation (e.g., emulsifiable concentrate aerosol'
wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary labeling
etc.). Note that the Agency is not describing batched products as "substantially similar" since some
products within a batch may not be considered chemically similar or have identical use patterns.
Batching has been accomplished using the readily available information described above. Frequently
acute toxicity data on individual end-use products has been found to be incomplete. Notwithstanding the
batching process, the Agency reserves the right to require, at any time, acute toxicity data for an individual
end-use product should the need arise.
Registrants of end-use products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicologicai studies to represent all the products within that batch, it is the
registrants' option to participate in the process with all other registrants, only some of the other registrants,
or only their own products within a batch, or to generate all the required acute toxicologicai studies for each
of their own products. If a registrant chooses to generate the data for a batch, he/she must use one of the
products within the batch as the test material. If a registrant chooses to rely upon previously submitted
acute toxicity data, he/she may do so provided that the data base is compiete and valid by today's
standards (see acceptance criteria attached), the formulation tested is considered by EPA to be similar for
acute toxicity, and the formulation has not been significantly altered since submission and acceptance of
the acute toxicity data.
In deciding how to meet the product specific data requirements, registrants must follow the directions
given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice contains two
response forms which are to be completed and submitted to the Agency within 90 days of receipt. The first
form, "Data Call-In Response," asks whether the registrant will meet the data requirements for each product.
The second form, "Requirements Status and Registrant's Response," lists the product specific data required
for each product, including the standard six acute toxicity tests. A registrant who wishes to participate in
a batch must decide whether he/she wil! provide the data or depend on someone else to do so. If a
registrant supplies the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option
5) or Citing an Existing Study (Option 6). If a registrant depends on another's data, he/she must choose
among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If
a registrant does not want to participate in a batch, the choices are Options 1, 4. 5 or 6. However, a
registrant should know that choosing not to participate in a batch does not preclude other registrants in the
batch from citing his/her studies and offering to cost share (Option 3) those studies.
-------
-2-
Table I lists 1 batch including 4 products containing the active ingredient
Table I.
carbon dioxide.
Batch
•MH
1.
:^=sz^=:
===^=^=^=
EPA Reg. No.
•^^^•IMHMH^^M
192-49
358-137
1055M
56228-2
=S^==B^=S^==
^=^=
%Carb
&Othe
••^•i
60Ca
45.0 Si
45.0 PC
2.0 Oe
8.7 Sa
34.8 Su
46.2 Po
8.7 Ch
34.8 Su
46.2 So
17.34 C
3.52 &
10.84 Su
3.25 Re
43.36 &
—
% Carbon/Charcoal/Sawdust
Formulation Type
Smoke Cartridge)
Smoke Cartridge
Smoke Cartridge
Smok* Cartridge
registrant
Table 111.
"I!?8 °"! pr0
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in Ink. Please read carefully the attached infractions and supply the inforastion requested
Use additional sheet(s) if necessary.
1 . Coapeny nan* and Address 2. Case * and Nam
SAHPLE COHPANY 4019 Carbon and CO2
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
•equireMont
61-1
61-2 (a)
62-2
62-3 •••:•:•:•••'•'-.:•, :•-
63-2
63-3
63-4
63-7
63-14
63-16
63-17
63-20
S. Study Title
Prod DM* - teautar Chearical
Product identity t, coaposltion(l)
p«*crip of starting Materials, (1,2,50)
production 1 fonmilation
' proe'. . ....:•;. '
Certification of Units (1,5)
Analytical Method d)
Color
Physical state :
Odor
Density •• • : •.';..;•;:. '.;•:.••• '/. ,-: :.!:/
Oxidizing or reducing action (10)
Explodabiltty ; •• . ; (12)
Storage stability *
Corrosion characteristic*
>
Progress
Reports
1 j 2
1
3
6. Use
Pattern
ABCDEFGHIJKLHNO
ABCDEFGHIJKLHNO
ABCDEFGHIJKLHNO
ABCDEFGHIJKLHNO
ABCDEFGHIJKLHNO
ABCDEFGHIJKLHNO
ABCDEFGHIJKLHNO
ABCDEFGHIJKLHNO
ABCDEFGHIJKLHNO
ABCDEFGHIJKLHNO
ABCDEFGHIJKLHNO
ABCDEFGHIJKLHNO
on this fora.
3. Date and
Fora Approved
(MB Ho. 207Q-0107
Approval Expires 12-31-92
Tyos of OCI
PRODUCT SPECIFIC
7. Test
Substance
EP
EP
EP
EP
EP
EP
EP
EP ';•":•. !.::-:;-
EP
EP:::V. •;•:;
EP
EP. ••: .-:;•;
10. Certification —
1 certify that the statements amtie on this for* and all attachments are true, accurate, and coaplete.
1 acknowledge that any knowingly false or Misleading statement a*y be punishable by fine, isprisonaent
or both under applicable law.
Signature and litle of Coapeny's Authorized Representative
12. Haw of Company Contact ~~~ - ' —
v ::,::•:. •
:;:<::- "•••
'-'-S '.'••
.:'. :.-:..-': "'
•-.-:- -: • • : • !
^:-:.-.-.;:
S. Tia»
framt
8
8
8
8
8
8
8
8
6
8
8
8
•OS.
•OS.
BOS.
•OS.
•OS.
nos.
•OS.
•OS.
•OS.
•OS.
•OS,
9. Registrant
Response
11. Date
13* PnOfM llUalwr
-------
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print In Ink. Please read carefully the attached Instruction* and supply the Infonsstion requested
Use additional sheet(s) if necessary.
1 . Conveny nsa* end Address 2. case * and HMM
SAMPLE COMPANY 4019
NO STREET ADDRESS
Carbon and CO2
NO CITY, XX 00000
*. Guideline
Requirement
Mueber
61-1
61-2 (a)
62-2
62-3
63-2
63-3
63-4
63-7
63-14
63-16
63-17
63-20
S. Study Title
Prod Choa - Reoutw Otoica^
Product Identity t co»positlon
-------
United States Environnental Protection Agency Fora Approved
Washington, D. C. 20460
OHi Ho. 2070-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Approval Expires 12-31-92
INSTRUCT IONS: Please type or print In Ink. Please read carefully
U>e additional sfteetU) If necessary.
1 . Company noae and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
*. Guideline
Requirement
Nuaber
81-2
81-3
81-4
81-5
81-6
95-8,9
96-13
96-17
5. Study Title
Acute tonic * Regular Oumluil
; Acute oral toxlcity-rat (1,51)
Acute dermal (1,2,51)
toxtcftyr«bt>lt/r«t
Acute Inhalation toniclty-rtt (3,51,52)
Prlaary eye Irritation-rabbit (2,51)
Prlaary denail irritation (1,2,51)
Dtrm*l tens! tlutfoh (4,51)
£ff tcaev • inWftcbrate Control Aoenta '•
•loaaulto. tlactf Iv. •rtlm Mldae •",','••: •"
Treatments
the attached instruct torn and supply the information requested on this for*.
2. Case * and Name
4019 carbon and CO2
Comparative field tWl (51,53,54)
ETTftttcv *" YM*TC|N 4yWe pontpo^n^wijej
Hole tout cants (1,51,53,55)
Rodent fualgants (1,51,53,56)
Hawaiian predaclde* (1,51,53,57)
1
Progress
Report*
1
2
••
3
3. Data and Type of DCI
PRODUCT SPECIFIC
A. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
C • ' • • A • ' ••: ' -: '••• -. '•••
C JK
C JK M 0
C- • . • ;•' .-...'."•. .• ^f '. • '. '.• '• •.>:•.•
** • '.'''• '. •-. '. ! :
Initial to indicate certification as to Information on this page
(full text of certification Is on page one).
7. Test
substance
EP
EP
EP •">:.--:.'" •-. -'
EP
fip^tggpgsipp:
Et»
EP
EP
a. Tin*
8 nos.
8 mos.
8 mos.
8 MOflv
8 nos.
8 nos.
™*t
8 nos.
':;ri.8 nos.'
9. Registrant
Response
•;'-'.:: ;:-:.::':-'-'-V.- ".:;.
Date
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Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Pleas* read carefully
Use additional sheet(s) if necessary.
1 . Ccnpany nene and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Mustier
81-1
81-2
81-3
81-4
81-5
81-6
95-8,9
96-8
96-13
96-17
S. Study Tftl*
Acute Toxjc - R^fl^er Chearicfi <:
Acute oral toxlcf ty-Nt;
Efficacy- fnyef^ebraff- Confffl Aoefftf
m**.-***;-**.**
the attached instructions and supply the inforaetlon raquasted
2. Case f and MSB*
4019 Carbon and CO2
CMptrstly* field test ';; (51,55,54)
Molt toxicants : (1,51,55,55)
Rodent fuiigants (1,51,55.56)
MaaMllan pred*cldes : : (1,51,53,57)
initial to indicate certification as to inforwtton on this page
(full text of certification is on page one).
Progress
Reports
1
2
-•;
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
C K
C JK
C JK M 0
-;:,C,;:.:;-i . ::' K
7. Test
Substance
form Approved
am to. 2070-0107
Approval Expires 12-31-92
on this fora.
3. Date and Type of DCI
PRODUCT SPECIFIC
EP ••'.-•'
EP
EP
EP - ::.;•": . . -•-::;:
EP
BP '""
8. Tine
8 JBOS.
8 mos.
8 BIOS.
8 nos.
8 DOS.
8 BOS.
9. Registrant
Respona*
'::i:-;:.:;.:-:.-:- ..•
Oat*
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United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DBFIMATIONS FOR GUIDELINE REQUIREMENTS
Case / and Name: 4019 Carbon and CO2
Page 1 of 3
12
5061
°f
i
If product U pot«ntl.lty .«plo.fv».
2 Because of past incidents involving units exploding, rocketing, prematurely igniting, and burning
excessively and in the wrong places, the Agency wants as detailed a description of^he «nStC?
tSS8^*? P°SSlblfi:.tIn ««itionf the Agency wants the registrants of thefe f^^^Sl^
taken to insure quality control of the units, such as periodic sampling to insure that units meet the
burning requirements imposed in 1982. "wuie tnac units meet tne
•owU talc - tafulor
ral
1 Hot r«qu(r«d If t««t MterUI 1. . gM or highly vol.tll*.
51Not required for CO2 products
-3 The test must he conducted on the ignition gases.
and approved, before initiation of test.
A test protocol must be submitted to the Agency
«y«*-y
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Page 2 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFIHATIOHS FOR GUIDELINE REQUIREMENTS
Case § and Naae: 4019 Carbon and CO2
Footnote (oont.):
Efficacy - liwertabrat* Control Aaenta
Not required for CO2 products.
53For Gas Cartridge products, registrants must resubmit the data on burn times for fuses and the
cartridges, originally requested in the Agency's 1982 Label Improvement Program and Data Call-In, so that
these data can be assigned an HRID Number.
5495-9 Field data are required on ground wasps because currently registered products appear to be too wide
to fit into wasp entrances, thus creating an unnecessary risk to potential users, some of whom
could have life-threatening reactions to stings. A protocol must be submitted within 3 months, and
approved, before work is begun. As part of the protocol, the registrant must document the entrance sizes
of major wasp species, and their geographic distribution, in the United States. If actual testing is
done, any reports of units that malfunction, or were too big to fit into burrows, must be reported.
Efficacy - Vtrtabrate Contra! «e*nte
1 The aaency haa waived at I r«*ilr«MnU to cUnlt efficacy data for vertebrate control agent* unlea* the peatlclde product boar* a del* to control vertebrate* (ouch
ao rodonto, bird*, bat*, conld*. and okunko) that «ay dlractly «r Indirectly trenealt df*ee*e* to hum*. NOMVM-. ooch real*trent wot emure throutfi teattnf that
Ma product! ara efflcaelou* *wn uMd In accordance with labal direction* and m utly accoptod prat control practice*. Tho reentrant auat dtvclop and Maintain
tha relevant data upon *lch the dcteralnatlon of efficacy la baaad. The Aatncy reaanm the rialit to retail re. on a caaa-bycaaa baata (e.g.. aipntf leant nan UH«
or benefit* oata In caaa* of opoclal review) tubilaalon of efficacy data for any peatlcld* product, reflUtered or prapoaad for registration uhan naeeaaary.
51Not required for CO2 products.
53For Gas Cartridge products, registrants must resubmit the data on burn times for fuses and the
cartridges, originally requested in the Agency's 1982 Label Improvement Program and Data Call-in, so that
these data can be assigned an MRID Number.
5596-8 Field data are required on one species of mole. A protocol must be submitted within 3 months, and
approved, before work is begun. Any reports of units that malfunction, or were too big to fit
into burrows, must be reported.
5696-13 Field data are required on Norway rat, ground squirrel, and woodchuck. If none of these species
is claimed, field data will be required for one rodent species, if any are claimed. A protocol
must he submitted within 3 months, and approved, before work is.begun. Any reports of units
that malfunction must be reported.
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Page 3 of
United States Environmental Protection Agency
Washington, D. C. 20460
TNOTES AND KEY DEPINATIONS FOR GUIDELINE REQUIREMENTS
Case i and Nave: 4019 Carbon and CO2
Footnotes (cont.):
Efficacy - Mrt*r*t« bntral
5796~17 Field data are required on the coyote, skunk, and red fox. A protocol must be submitted within
3 months, and approved, before work is begun. Any reports of units that malfunction must be reported.
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