540/RS-92-185
United States Office of September 1991
Environmental Protection Pesticide Programs
Agency
Reregistration
Eligibility Document
(RED)
Carbon and Carbon
Dioxide
-------
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
Rob Forrest Insecticide Rodenticide Branch
Dan Peacock Insecticide Rodenticide Branch
Dick Mountfort Insecticide Rodenticide Branch
Bill Jacobs Insecticide Rodenticide Branch
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 Reregistration Division
Bruce Sidwell Accelerated Reregistration Branch
Virginia Dietrich Accelerated Reregistration Branch
Carol Stangel Policy, Planning, and Evaluation Staff
Office of General Council - Eran Gasko
Office of Compliance Monitoring - Beverly Updike
Office of Policy, Planning/ and Evaluation - Gary Deutsch
-------
I •'
TABLE OF CONTENTS
PAGE
GLOSSARY OF TERMS AND ABBREVIATIONS i
EXECUTIVE SUMMARY ii
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 II
1. ENVIRONMENTAL FATE ASSESSMENT 11
2. ECOLOGICAL EFFECTS ASSESSMENT 11
3. ENVIRONMENTAL RISK ASSESSMENT 12
-------
IV. REREGISTRATION DECISION FOR CARBON AND CARBON DIOXIDE 13
A. DETERMINATION OF ELIGIBILITY 13
B. ADDITIONAL GENERIC DATA REQUIREMENTS 14
C. LABELING REQUIREMENTS 14
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
APPENDIX C - BIBLIOGRAPHY
1.
GUIDE TO APPENDIX C
30
2.
BIBLIOGRAPHIC CITATIONS
32
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
CAS Chemical Abstracts Service
CFR Code of Federal Regulations
CSF Confidential Statement of Formula
EPA U.S. Environmental Protection Agency
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
GRAS Generally Recognized As Safe
LEL Lowest Effect Level
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the EPA.
MSHA Mine Safety and Health Administration
NIOSH National Institute for Occupatior^l Safety and Health
OSHA Occupational Safety and Health Administration
PEL OSHA Permissible Exposure Level
ppm Parts per Million
RED Reregistration Eligibility Document
STEL OSHA Short-term Exposure Level
i
-------
Executive Summary
This Reregistration Eligibility Document addresses both
elemental carbon and carbon dioxide. The first registered
pesticide product containing carbon dates from 1948. Currently,
all six products containing carbon as an active ingredient are
registered for use as a rodenticide and predacide. These
products are formulated as pyrotechnic cartridges which are
designed to be ignited and placed in burrows inhabited by target
animals. Gaseous pyrolysis products cause asphyxiation of
animals in the burrow. Four products containing pressurized
carbon dioxide as an active ingredient are presently registered
for fumigation to control insects and rodents in enclosed areas.
The Environmental Protection Agency (EPA) has conducted a
review of the scientific data base and other relevant information
supporting the reregistration of carbon and carbon dioxide and
has determined that the data base is sufficient to allow the EPA
to conduct reasonable risk assessments. The data available to
the EPA support the conclusion that the currently registered uses
of carbon and carbon dioxide will not result in unreasonable
effects to the environment or human health. No further generic
data are required.
Carbon is used only for non-food uses so no tolerance under
the FFDCA is required. Carbon dioxide is exempt from the
requirement of a tolerance (40 CFR 180.1049). Also, carbon
dioxide is classified as Generally Recognized As Safe (GRAS) (21
CFR 184.1240).
Accordingly, the EPA has determined that all products
containing carbon or carbon dioxide as the active ingredient are
eligible for reregistration. The decision to reregister specific
products will be made after appropriate labeling and product
specific data are submitted and/or cited. Before reregistering
each product, the EPA is requiring that product specific data and
revised labeling be submitted by the registrants within eight
months of the issuance of this document. EPA has "batched"
products considered to be similar with respect to acute toxicity
testing requirements. After reviewing these data and the revised
labels, the EPA will determine whether or not the conditions of
FIFRA 3(c)(5) have been met, that is, whether product composition
and labeling are acceptable and the product's uses will not cause
unreasonable adverse effects to humans or the environment. If
these conditions are met EPA will reregister the products. Any
end-use products containing carbon or carbon dioxide in
combination with other active ingredients will not be registered
until EPA has determined that those other active ingredients are
eligible for reregistration.
ii
-------
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 (referred to as "the EPA")
of all dat.a submitted to support reregistration.
Section 4(g)(2)(A) of FIFRA states that in Phase 5 "the
Administrator shall determine whether pesticides containing
such active ingredient are eligible for reregistration"
before calling in data on products, under section
4(g)(2)(B), and either reregistering products or taking
"other appropriate regulatory action" under 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
"no unreasonable adverse effects" criterion of FIFRA section
3(c)(5).
This document presents the EPA's decision regarding the
reregistration eligibility of the active ingredients carbon
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.
I
-------
II. ACTIVE INGREDIENTS COVERED BY THIS REREGISTRATION
ELIGIBILITY DECISION DOCUMENT
A. IDENTIFICATION OF ACTIVE INGREDIENTS
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: C02
B. USE PROFILE
C3rfron:
Type of Pesticide: Rodenticide/Predacide, Insecticide
when used in combination with sodium or potassium
nitrates.
Pests Controlled: Pocket gophers, moles, ground
squirrels, rats, skunks, voodchucks, 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
2
-------
3.0 ounces) measure approximately four inches in length
and one inch in diameter. The larger cartridge (8.5
ounces) measures 12.5 inches in length and 1.5 inches
in diameter.
Methods of Application:
Use one cartridge per burrow system;
for larger animals, use more than one cartridge.
Puncture cap at the end of cartridge at points marked.
Insert fuse in one of the center holes. Hold cartridge
away from face and body, then light. Immediately place
lit cartridge inside and seal entrance to burrow.
Carbon Dioxide;
Type"of Pesticide: Insecticide.
Pests Controlled: Insects
Registered Use Groups: (See Appendix A for detailed
specific use sites)
Indoor Food
Formulation Types Registered: Pressurized liquid:
99.95% to 100% active ingredient;
pressurized gas: 99 to 99.9% active ingredient;
aerosol spray: the registrant of this 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.
Methods of Application:
Seal area to be fumigated. Adjust atmosphere in
this area to 60% carbon dioxide and maintain for
four or five days. Following fumigation,
ventilate with monitoring to assure area is safe
for reentry.
C. REGULATORY HISTORY
Carbon: The first pyrotechnic cartridge products
containing the active ingredient carbon was registered
in 1948.
In the last thirty years, the EPA has received
nine reports of injuries related to use of cartridges,
including one fatality attributed to gross misuse. In
1982, in response to concern over safety of these
3
-------
products, the 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.
Carbon 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
t:o 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 INGREDIENT AND ASSESSMENT OF
PRODUCT CHEMISTRY
ceirfrpn
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
4
-------
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 C02 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
5
-------
(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 DIOXIDE
1. 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
6
-------
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 3 0 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 Toxicity
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
7
-------
epinephrine, decreased adrenal cholesterol, higher arterial free
fatty acids, and decreased lymphocytes in the first 3 days of
exposure (3).
Rats exposed to 10 percent carbon dioxide for 30 days had a
weight loss of 14-27 percent; those exposed to 20-25 percent for
34 days had a 50 percent loss. The weight losses were attributed
to the reduced food intake. The weight was regained when the
rats returned to a normal atmosphere (3).
No effects were seen in male rhesus monkeys that spent 93
days in an atmosphere with 3 percent carbon dioxide (3).
c. Human Chronic Toxicity
A study on brewery workers suggests that there are no
significant physiological effects from chronic intermittent
exposures to carbon dioxide concentrations at about 1.08 percent
(time-weighted-average) (3).
Other Chronic Toxicolocrlcal Effects
Some deleterious effects were found when animals were given
concentrated doses of carbon dioxide 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 rats
were exposed to 6 percent carbon dioxide for one full day, 23.4
percent of the offspring had cardiac abnormalities, and there was
also an increased incidence of skeletal malformations (10.9
percent) (3). Vertebral column malformations were reported in
rabbits when the pregnant dams were exposed to 10-13 percent
carbon dioxide (3).
Pregnant guinea pigs exposed to 0.48 percent carbon dioxide
for 10 minutes daily for 20 days had a high number of
miscarriages and flaccid paralysis of the hind limbs in the pups
carried to term. Another group exposed to 0.42 percent carbon
dioxide for 1 hour daily for 30 days had no miscarriages, but
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. An
average adult human will produce more than 500 g of carbon
dioxide daily under resting conditions, and will produce much
more when active.
8
-------
Additional carbon dioxide has several effects on the body,
and responses are immediate. It stimulates breathing, which
exhales the carbon dioxide carried to the lungs from the cells by
the blood-stream. An increase in carbon dioxide concentration
stimulates the heart rate, increases the blood pressure,
increases adrenalin flow, and relaxes the vascular smooth
muscles. In addition, carbon dioxide reacts with water in the
body to form carbonic acid, which dissociates to hydrogen ion and
bicarbonate. An increase in carbon dioxide in the body increases
acidity, and then the kidneys act to restore normal acidity.
Studies on men exposed to 1.5 percent carbon dioxide in the
atmosphere for 42 days showed uncompensated respiratory acidosis
during the first 23 days. After this there was a compensatory
phase during the rest of the exposure period (3).
2. Dietary Exposure
Carbon dioxide is exempt from the requirement of a tolerance
when used post-harvest in modified atmospheres for stored insect
control on raw agricultural commodities as listed in 40 CFR
180.1049. Carbon dioxide may be used as a food additive post-
harvest in modified atmospheres for stored product insect control
on all processed agricultural commodities as described in 40 CFR
185.650.
In 21 CFR 184.1240 carbon dioxide is listed as a substance
Generally Recognized As Safe (GRAS) for use in food. Carbon
dioxide has been consumed in naturally carbonated or "mineral"
water for centuries, and in manufactured carbonated beverages for
many years. Thus, humans naturally have continual exposure to
carbon dioxide without any indications of toxic effects from such
ordinary exposures to carbon dioxide. Furthermore, since carbon
dioxide is a normal constituent of the atmosphere at about 0.03
percent (300 ppm), there is continuous human exposure by
inhalation and on the skin.
3. Occupational and Residential Exposur#
Indoor 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.
Primary exposure hazards are associated with worker reentry 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
exposed to high levels of carbon dioxide in 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
9
-------
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.
4. Human Risk Assessment
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
-------
1. Environmental Fate Assessment
Carbon: The physical and chemical properties of
carbon, a naturally occurring substance, are well
understood. The pyrolysis of carbon in the presence of
the other active ingredients such as sodium and
potassium nitrates results in simple organic and
inorganic compounds, mostly in the form of gases, which
cause asphyxiation of pests in burrows. These
pyrolysis products eventually diffuse through the
burrow opening or into soil. Exposure to the
environment can be characterized as limited and
localized rather than widespread or broadcast. EPA
normally requires many of the environmental fate
studies on pesticides in order to assist with its
assessment of risk to living organisms. Given EPA's
ecological effects assessment, there is no need for
such data. Therefore, all environmental fate data
requirements have been waived.
Carbon dioxide: Carbon dioxide is also a naturally
occurring substance whose physical and chemical
properties are well understood. Carbon dioxide is used
indoors as a fumigant to asphyxiate insects. Since
carbon dioxide is used indoors, EPA believes its use
will not adversely effect the environment. Therefore,
all environmental fate data requirements have been
waived.
2. Ecological Effects Assessment
Carbon: The gas cartridges are intended for control of
woodchucks, ground squirrels, prairie dogs, pocket
gophers, moles, red foxes, coyotes, and ground wasps.
Carbon is formulated with other active ingredients,
sodium or potassium nitrates and sulfur, during
manufacture of the gas cartridges. Pest species are
not exposed to carbon or to the other active
ingredients, but rather to the products of their
pyrolysis.
Carbon dioxide: Carbon dioxide is used as a gas
fumigant for control of insects in raw and processed
agricultural commodities in storage bins, trucks,
trailers, and on ships. The products generally contain
over 99% carbon dioxide.
Since this is an indoor use pattern, exposure to
nontarget organisms is not expected. Therefore, no
generic ecological effects data have been required or
are being required.
11
-------
4. Environmental Risk Aaaaaamant
Carbon; Application of the gas cartridges is
subsurface, to burrows, and precludes exposure to avian
populations and aquatic organisms. EPA realizes,
however, that any organism in a properly treated burrow
will likely be killed, and that there is a potential
impact on endangered species which use burrows. Gas
cartridges have been the subject of several formal and
informal consultations with the US Fish and Wildlife
Service (USFWS), which has identified six endangered or
threatened species that use burrows have been
identified as being at risk. Current labeling detailed
in Appendix A includes provisions to protect these
species.
• The open literature indicates that several non-
target organisms, including burrowing owls, may inhabit
the burrows of target pests (10, 11). Due to the
potential risk to non-target organisms, the EPA is
currently developing more extensive labeling regarding
timing of application and observation of signs
indicating the presence or absence of target and non-
target organisms. These instructions will be explicit
concerning actions users must take before applying the
product.
The use of these products may also result in a
potential impact on endangered species which utilize
burrows. The EPA is currently consulting with the
USFWS to re-evaluate the existing Biological Opinions,
incorporate species newly identified as. threatened or
endangered^ and account for incidental take
provisions . EPA will inform affected registrants of
any changes needed in their gas cartridge labeling at
that time.
Registrants are reminded of their responsibility,
under section 6(a)(2) of FIFRA, to submit any data
regarding unreasonable adverse effects, including
incidents involving non-target organisms, to EPA. As
more information becomes available regarding endangered
and non-target species, the EPA may need to address
this issue further.
Carbon dioxide; Since use of carbon dioxide as a
fumigant is an indoor use pattern, exposure to
nontarget organisms is not expected. Therefore, no
2 Indicates the number of individuals that are permitted to be
harmed as a result of, or incidental to, the EPA's action.
12
-------
generic ecological effects data have been required or
are being required.
IV. REREGISTRATION 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 B 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.
13
-------
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
-------
C. 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 o£ 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 o£ 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 C02 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 C02 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
-------
(NIOSH) and the Mine Safety and Health
Administration (MSHA)] must be worn if 15 or more
minutes are spent in the treated area."
c) "if 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 self-
contained breathing apparatus (SCBA) or
combination air-supplied SCBA respirator]."
2. Spill and Leak Procedure Statement
"Evacuate immediate area of leak. Use SCBA or
.combination air-supplied/SCBA respirator for entry
into affected area to correct problem. Move
leaking of damaged cylinders outdoors or to an
isolated location, observing strict safety
precautions. When completely empty, return to
manufacturer if instructed or dispose of leaking
or damaged cylinders or containers in accordance
with State and Local waste disposal regulations."
"Do not permit entry into spill area by
unprotected persons until concentration of carbon
dioxide is determined to be less than 10,000 ppm."
4. Placarding Statement
The applicator must placard or post all entrances
to the fumigated area with signs conforming to the
following requirements:
a) The sign shall be at least 14 inches by 16
inches in size and the letters shall be at least l
inch in height unless a smaller size sign is
necessary because the treated area is too small to
accommodate a sign of this size. Letters shall be
clearly legible.
b) The signal word: "DANGER/PELIGRO" and the skull
and crossbones symbol must be on the placard.
c) The statement, "Area under fumigation, DO NOT
ENTER/NO ENTRE."
d) The date of fumigation.
e) The name of the fumigant (carbon dioxide).
f) Name, address and telephone number of the
applicator or pesticide handler.
16
-------
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.
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)."
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 AND C02
SITE
Application Type. Application Timing. Application Equipment
Form
Maximum
Application
Rate
(al)
Max. #
Apps.
Max. #
App5. @
Max. Rate
Min. Interval
Between Apps.
® Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Use Limitations
(Days)
Allowed
Olsallowed
active Ingredient • CARBON
FOOD/FEED USES
AGRICULTURAL CROPS
(UNSPECIFIED)(CROPLAND)
Fumigation, When needed. Hand placed cartridge
IMPR
0.1852 b
al/cartridge 1
not
spec
not spec
not spec
not spec
none
none
endangered species restrictions; do
not use inside buildings
RANGE LAND (UNSPECIFIED)
Fumigation, When needed. Hand placed cartridge
IMPR
0.1852 lb
ai/cartrldge 1
not
spec
not spec
5
not spec
none
none
endangered species restrictions; do
not use inside buildings
NONFOOOUSES
AGRICULTURAL UNCULTIVATED AREAS
Fumigation, When needed, Hand placed cartridge
IMPR
0.1852 lb
al/cartridge 1
not
spec
not spec
not spec
not spec
none
none
endangered species restrictions; do
not use inside buildings
FOREST PLANTINGS
(REFORESTATION PROGRAMS)
Fumigation. When needed. Hand placed cartridge
IMPR
0.0325 K>
al/cartridge 1
not
spec
not spec
not spec
not spec
none
none
endangered species restrictions;do
not use inside buildings
GOLF COURSE TURF
Fumigation, When needed. Hand placed cartridge
IMPR
0.0325 lb
ai/cartridge 1
not
spec
not spec
5
not spec
none
none
endangered species restrictk>ns;do
not use inside buildings
NONAGRICULTURAL UNCULTIVATED AREAS
Fumigation, When needed. Hand placed cartridge
IMPR
0.1852 to
ai/cartridge 1
not
spec
not spec
not spec
not spec
none
none
endangered species restrictions; do
not use inside buildings
ORNAMENTAL LAWNS AND TURF
Fumigation, When needed. Hand placed cartridge
IMPR
0.0325 lb
ai/cartridge 1
not
spec
not spec
5
not spec
none
none
endangered species restrictions; do
not use inside buHcfings
at
-------
SITE
Application Type. Application Timing. Application Equipment
Form
Maximum
AppRcatlon
Rate
(al)
Max. *
Apps.
Max. #
Apps. 9
Max. Rate
Mia Interval
Between Apps.
@ Max. Rate
(Days)
Restricted
Entry
Interval
(Days)
Geographic
Limitations
Use limitations
Allowed
Olsallowed
active ingredient - CARBON DIOXIDE
FOOO/FEED USES
COMMERCIAL TRANSPORTATION FACILITIES
Fumigation. When needed. Cylinder
PROS
60* (i.10%)
aiAreated
volume
not
spec
not spec
not spec
not spec
none
none
do not fumigate If grain temperature is
less than 40 f7 or 60 f (depending on
product)
FEED/FOOD CONTAINERS-EMPTY/FULL
Stored commodity fumigation. When needed,
Cylinder
PROS
60% (i.10%)
aiAreated
volume
not
spec
not spec
not spec
not spec
none
none
do not fumigate If grain temperature is
less than 40 T orW^ (depending on
product)
GRAIN/CEREAL/FLOUR BINS. FEED/FOOD-FULL
Stored commodity fumigation, When needed.
Cylinder
PRGS
60% (i10%)
aiAreated
volume
not
spec
not spec
not spec
not spec
none
none
do not fumigate If grain temperature Is
less than 40^ or 60^ (dependbig on
product)
PROCESSED FOOD AND FEED PRODUCTS
Stored commodity fumigation. When needed.
Cylinder
PROS
60% (£I0%)
aiAreated
volume
not
spec
not spec
not spec
not spec
none
none
do not fumigate if grain temperature is
less than 40^ or 60 (depending on
product)
Header max. • maximum; mln. « minimum; apps. • apptcatktns; not spec.» not specified
Form; IMPR - Impregnated matertal; PROS • pressurized gas
Rate; al ¦ active ingredient
Footnotes
1. Number of cartridges used per burrow varies wtth size of animal and burrow.
-------
APPENDIX B
Generic Data Requirements for Reregistration
of Carbon or Carbon Dioxide and Data Citations
Supporting Reregistration
24
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which
support the reregistration for the pesticide covered by this
Reregistration Eligibility Document.
Appendix B contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
The data table are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158. The
reference numbers accompanying each test refer to the test
protocols set-out in the Pesticide Assessment Guidelines, which
are available from the National Technical Information Service,
5285 Port Royal Road, Springfield, VA 22161.
2. Use Pattern (Column 2). This column indicates the use
patterns to which the data requirement applies. 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 crop
J
Forestry
K
Residential
L
Indoor food
M
Indoor non-food
N
Indoor medical
0
Indoor residential
Any other designations will be defined in a footnote to the
table.
3. Bibliographic citation (Column 3). If the EPA has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no MRID
number has been assigned. Refer to the Bibliography Appendices
for a complete citation of the study.
25
-------
APPENDIX B
DATA SUPPORTING GUIDELINE REQUIREMENTS FOR REREGI8TRATION OF CARBON
GUIDELINE TITLE OF U8E BIBLIOGRAPHIC
CITATION 8TUDY 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 USE BIBLIOGRAPHIC
CITATION STUDY PATTERNS CITATION
Product Chemistry
61-1
Product Identity
ABL
94049-999
63-2
Color
ABL
94049-999
63-3
Physical State
ABL
94049-999
63-4
Odor
ABL
94049-999
63-5
Melting Point
ABL
94049-999
63-6
Boiling Point
ABL
94049-999
63-7
Density
ABL
94049-999
63-8
Solubility
ABL
94049-999
63-9
Vapor Pressure
ABL
94049-999
63-10
Dissociation Constant
ABL
94049-999
63-11
Oct./Water Part. Coef.
ABL
94049-999
63-12
PH
ABL
94049-999
63-13
Stability
ABL
94049-999
27
-------
1 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 ENTRY. The unit of entry in this bibliography is
called a ."study". In the case of published materials, this
corresponds closely to an article. In the case of
unpublished materials submitted to the 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 a last resort, the EPA has shown the first submitter
as author.
b. Document date. When the date appears as four digits
with no question marks, the EPA took it directly from
the document. When a four-digit date is followed by a
question mark the bibliographer deduced the date from
evidence in the document. When the date appears as
(19??), the EPA was unable to determine or estimate the
date of the document.
c. Title. In some cases, it has been necessary for EPA
bibliographers to create or enhance a document title.
Any such editorial insertions are contained between
square brackets.
d. Trailing parentheses. For studies submitted to the EPA
in the past, the trailing parentheses include (in
addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
31
-------
OFFICE OF PESTICIDE PROGRAMS
REREGISTRATION ELIGIBILITY DOCUMENT
BIBLIOGRAPHY
The following are the sources of the references cited in this
document:
(1) Carbon dioxide. 1989. Federal Register 54 (12):2650-2651.
January 19 (Thursday), 1989.
(2) Clayton, G. D., and Clayton, F. E., eds., 1982. Pattv1s
Industrial Hygiene and Toxicology. 3rd Revised Edition,
Vol 2c. Wiley Interscience, NY.
(3) FASEB, 1979. "Evaluation of the Health Aspects of Carbon
Dioxide as a Food Ingredient." NTIS 80-104615
(4) Gilman, A.G., Goodman, L. S., and Gilman, A. (1980) The
Pharmacological Basis of Therapeutics. 6th Edition.
Macmillan, New York, p. 954.
(5) Jacobs, D. E., and Smith, M. S. (1988). "Exposures to Carbon
dioxide in the Poultry Processing Industry." American
Industrial Hygiene Association Journal 49:624.
(6) The Merck Index. Eleventh edition, (1989), p. 274.
(7) National Institute for Occupational Safety and Health.
NIOSH/OSHA Occupational Health Guidelines for Chemical
Hazards DHHS Publication No. 81-123. Cincinnati, Ohio:
National Institute for Occupational Safety and Health,
1981.
(8) NIOSH Pocket Guide to Chemical Hazards. 1990. U.S.
Department of Health and Human Services, Public Health
Service, Publication No. 90-117.
(9) Sax, N. I., and Lewis, R. J. SR. 1989. Dangerous Properties
of Industrial Materials. 7th Edition. Van Nostrand
Reinhold, New York, p. 710.
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.
11) Vaughan, T.A. 1961. Vertebrates Inhabiting Pocket Gopher
Burrows in Colorado. J. Mammal. 42(2):171-174.
32
-------
EPA'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 toxicological 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 toxicological 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 complete 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 will 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.
33
-------
-2-
Table I lists 1 batch including 4 products containing the active ingredient carbon dioxide.
Table I.
Batch
EPA Reg. No.
% Carbon
Dioxide
Formulation Type
1.
2548-82
99.0
Gas
11491-7
99.9
Gas
38719-5
99.9
Gas
51877-1
99.9
Gas
Table II lists 4 products with the active ingredient carbon/charcoal/sawdust and other active ingredients
and were considered to be a batch.
Table II.
Batch
EPA Reg. No.
% Carbon/Charcoal/Sawdust
& Other Active Ingredients
Formulation Type
1.
192-49
8.0 Carbon
45.0 Sulfur
45.0 Potassium nitrate
2.0 Dextrin
Smoke Cartridge
358-137
8.7 Sawdust
34.8 Sulfur
46.2 Potassium nitrate
Smoke Cartridge
10551-1
8.7 Charcoal
34.8 Sulfur
46.2 Sodium nitrate
Smoke Cartridge
56228-2
17.34 Charcoal
3.52 Sawdust
10.84 Sulfur
3.25 Red phosphorus
43.36 Sodium nitrate
Smoke Cartridge
Table III lists one product that was considered not to be similar for purposes of acute toxicity. The
registrant of the product not batched is responsible for meeting the acute toxicity data requirements.
Table III.
EPA Reg. No.
% Carbon/Charcoal/Sawdust
& Other Active Ingredients
Formulation Type
56228-21
35.0 Charcoal
65.0 Sodium nitrate
Smoke Cartridge
34
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
For* Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Picas* typa or print in ink. Pleas* reed carefully the attacked instructions and supply the information requested on this fona.
Usa additional sheet(s) If nacassary.
1. Coaaparry nana and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Casa § and Naaw
4019 Carbon and C02
3. Data and Typa of DC I
PRODUCT SPECIFIC
4. GuideI in*
Requirement
Number
S. Study Titla
Progress
Reports
6. Us*
Pattarn
7. Tast
Sifcstanc*
8. Time
9. Registrant
Response
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
Prod Ow - Regular Ctieaiical
Product identity t coaposition(l)
Descrip of starting «ateri*l*.(1,2,50>
production t formilation
proc
Certification of limits (1,5)
Analytical method (1)
Color
Physical stat*
Odor
Oenaity
Oxidizing or reducing action (10)
Cxplodabillty ( (12)
Storage stability'
Corrosion characteristic*
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
8 DOS.
8 mos.
8 BOS.
8 mos.
8 BOS.
8 mos.
8 BOS.
8 BOS.
8 BOS.
8 BOS.
8 mos.
8 BOS.
10. Certification
1 certify that the statements mode on this form and alt attachamnts are true, accurate, and complete.
1 acknowledge that any knowingly falsa or misleading statement nay be punishable by fine, imprisonment
or both inter applicable law.
Signature and Title of Company's Authorized Representative
11. Data
12. Name of Coapany Contact
13. Phone Nuaber
-------
Page 1 of 2
United States Environmental Protection Agency
Form Approved
Washington,
D. C. 20460
OM No. 2070-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Approval Expires 12-31-92
INSTRUCTIONS: Plan* type or print in ink. Pitas* read carefully the attached instructions and supply tha informa
tion requested on this form.
Ui* additional sheet(s)
if necessary.
1. Company name and Address
2.
Case # a
nd Mama
3. Date and
Type of DCI
SAMPLE COMPANY
4019
Carbon and C02
PRODUCT SPECIFIC
NO STREET ADDRESS
NO CITY, XX
00000
*. Guideline
S. Study Title
K
Progress
6. Use
7. Test
8. Time
9. Registrant
Requirement
1
Reports
Pattern
SUietance
Fraa
M
Response
Niafcer
r
k
1
2
3
Prod Chem - Regular Chemical
61-1
Product identity 1 composition(1)
ABCDEFGHIJKLMNO
EP
8 mos.
61-2(a)
pescrip of starting materials^ >2,50)
ABCDEFGHIJKLMNO
EP
8 mos,
production t formulation
proc
62-2
Certification of limits (1,5)
ABCDEFGHIJKLMNO
EP
8 DOS.
62-3
Analytical method (1)
ABCDEFGHIJKLMNO
EP
8 *OS,
63-2
Color
ABCDEFGHIJKLMNO
EP
8 BOS.
63-3
Physical state
ABCDEFGHIJKLMNO
EP
8 mos.
63-4
Odor
ABCDEFGHIJKLMNO
EP
8 mos.
63-7
Density
ABCDEFGHIJKLMNO
EP
8 mos.
63-14
Oxidizing or reducing action (10)
ABCDEFGHIJKLMNO
EP
8 mos.
63-16
Cxplodability • (12)
ABCDEFGHIJKLMNO
EP
8 mos.
63-17
Storage stability
ABCDEFGHIJKLMNO
EP
8 mos.
63-20
Corrosion characteristics
ABCDEFGHIJKLMNO
EP
8 mos.
10. Certification
11.
Date
1 certify that the statements made on this for* and alt attachments are true.
accurate.
and complete.
1 acknowledge that any knowingly false or Misleading statement may be pwishable fay fine, imprisonment
or both under applicable law.
Signature and Title of Coaoony's Authorized Representative
12. Name of Company Contact
13.
Phone thmter
-------
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Page 2 of 2
Form Approved
0MB No. 2070-0107
Approval Expire* 12-31-92
INSTRUCTIONS: Pleas* type or print In Ink. Picas* read carefully the attached Instruction* and supply th* Information requested on this for*.
Use additional sheet(s) If necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case ff and Nam
4019 Carbon and C02
3. Date and Type of DCI
PRODUCT SPECIFIC
4. Guideline
Requirement
Number
S. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Tim
9. Registrant
Response
81-1
81-2
81-3
81-4
81-5
81-6
95-8,9
96-8
96-13
96-17
Acute toMc ~ Reautar Chemical
: Acute oral toxicity-rat (1,51)
Acute dermal (1,2,51)
toxlcityrabbit/rat
Acute Inhalation toxicity-rat (3,SI,52)
Prlmsry eye irritation-rabbit (2,51)
Primary dermal irritation (1,2,51)
Dermal sensitization (4.51)
(Efficacy - lm*rt«brat« Control 1
Treatments
Comparative field ttat (51,53,54)
Efficacy - Vertebrate Control Agents
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
EP
EP
EP
EP
EP
EP
Mola toxicants
Rodent fimii gents
Manual Ian predacides
<1,51,53.55)
(1.51.53.56)
(1.51.53.57)
C
C
C
JK
JKMO
K
EP
EP
EP
EP
Initial to Indicate certification as to information on this page
(full text of certification is on page one).
8 »OS.
8 mos.
8 mos.
8 jnos.
8 mos.
8 mos.
8 MOS.
8 mos.
8 mos.
Date
-------
Page 2 of 2
United States Environmental Protection Agency
, Washington, 0. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Fona Approved
am No. 2070-0107
Approval Expiree 12-31-92
INSTRUCTIONS: Please type or print in ink. Pleaae read carefully the attached Inetructl
Use additional sheet(a) if neceaaary.
one and supply the Inforaa
tion requested
en thia fona.
1. Company nana and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000 f 1
2.
Case # a
4019
nd Haaa
Carbon and C02
3. Oate and Type of DC1
PRODUCT SPECIFIC
4. Guide Una
Requi rttnt
S. Study Title
E
Progreaa
Reporta
6. Usa
Pattern
7. Teat
StAatance
8. Tim
9. Regiatrant
Response
Number
0
1
2
3
81-1
81-2
81-3
81-4
81-5
81-6 .
Acute oral toxlcfty-rat (1,51)
Acute denial (1,2,51)
toxicityit/rat
Acute inhalation toxicity-rat (3,51,52)
Primary eye irritation-rabbit (2,51)
Priaary denial irritation (1,2,51)
pafMl senaitization (4,51)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
EP
EP
EP
EP
EP
EP
8 BIOS.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
Ell Isxt. - r?l,
95-8,9 U
Treatments
Comparative fiald teat (51,53,54)
»
C K
EP
8 mos.
EtttfcK:
96-8
96-13
96-17
Note toxicants (1,51,53,55)
Rodent fualganta (1,51,53,56)
Haaaalian predacidaa (1,51,53,5/)
C JK
C JK M O
C K
EP
EP
EP
8 mos.
8 mos*
Initial to indicata certification aa to infonaation on this page
(full text of certification ia on page one).
Date
-------
Page 1 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFIHATIOMS FOR GUIDELINE REQUIREMENTS
Case # and Naae: 4019 Carbon and C02
Key: MP ¦ aonufocturIng-use product; EP ¦ end-use product; provided fonauletors purchase thilr active ingredient(s) from • registered sourcet they need not wbilt or cite
deta pertaining to the purchased product.(NOTE: If a product ia • 100 percent repackage of another registered product that la purchased, and any use for the product doee
not differ frcai thoae of the purchased and registered source, users are not subject to any data requirements identified In the tables.1; TEP • typical end-use product;
TCAl ¦ technical grade of the active Ingredient; Ml • "pure* active Ingredient; PAIRA " "pure" active ingredient, radiolabeled.
Wm Mqorln Key:
A - Terrestrial food crop ¦ - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
f • Aquatic nonfood Industrial G • Aquatic nonfood residential N • greenhouse food crop I • Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical 0 • Indoor resldwitlal
Footnotes: (The following notes are referenced in columt two (S. Study Title) of the REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE for*.)
Prod Om - Regular Chearical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are Retailed further In the following sections: *158.155 for
product identity and composition (61-1); *158.160, 158.162, and 158.165 for description of starting materlols and Manufacturing process (61-2); *158.167 for
discussion of formation of lapM-itles (61-3); *158.171) for preliminary enalysls (62-1); *158.175 for certification of tl*lta (62-2); end *158.180 for enforcement
analytical Methods (62-3).
2 A schematic diegrma and/or brief description of the production process Mill suffice If the pesticide Is not already under full scale proAjctlon and an experimentel
use penalt is being sought.
5 Certified lisiite are not required for inert ingredients in products proposed for experimental use.
10 Required if product contains an ox I di zing or reducing agent.
12 Required if product Is potentially explosive.
5061-2 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 the manufacturing
process as possible. In addition, the Agency wants the registrants of these products to list any steps
taken to insure quality control of the units, such as periodic sampling to insure that units meet the
burning requirements imposed in 1982.
Acute Tonic - Regular CtMeiul
1 Not required if test Material is a gas or highly volatile.
2 Not required If test Materiel is corrosive to skin or has pN less than 2 or greater than 11.5; such a product Mill be classified as Toxicity Category I on the basis
of potentiol eye and dermal irritation effects.
3 Required if the product consists of, or wider conditions of use will result in, sn inhalable Material (e. g., gas, volatile siAatsnces, or aeroaol/partlculate).
4 Required unless repeated denaal exposure does not occur under conditions of use.
^Not required for CC>2 products
5281-3 The test must be conducted on the ignition gases. A test protocol must be submitted to the Agency,
and approved, bpfore initiation of test. t
-------
• Page 2 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFIHATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4019 Carbon and C02
PootnotM (oont.):
Efficacy - Invertebrate Control l|nti
^lMot required for C02 products.
^For Gas Cartridge products, registrants must resubmit the data on burn times for fuses and the
cartridges, originally requested in the Agency's 1982 Label Inprovement Program and Data Call-in, so that
these data can be assigned an MRID Number.
54gs_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 * Vertebrate Control Ifmtf
1 The agency has Halved all requlreaenta to aubalt efficacy data for vertebrate control agenta unlets the pesticide product beara a clala to control vertebrate* (audi
as rodents, birds, beta, canfds, and akuiks) that aay directly or Indirectly transalt diseases to huaana. However, each registrant Bust anaura through test In# that
hia products ara efficacious uhen used In accordance tilth label dlrectiona and coMsenly accepted peat control practices. The registrant Bust develop and Maintain
the relevant data ipon uhich the determination of efficacy la baaed. The Agency reserves the right to require, on a caee-by-caee baais (e.g., algnlflcant nan uses
or banefIts data In cases of special revlewe) submission of efficacy data for any pesticide product, registered or propoaad for reglatretion Mhan necessary.
51Not required for C02 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.
5695-13 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.
-------
Page 3 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEPINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Nbm: 4019 Carbon and C02
Footnotes (cont.):
Efficacy - \NrUknt* CaHrtl >|«m
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.
-------
30272-101
TORT DOCUMENTATION
PAGE
1. REPORT NO.
4. Title end Subtitle
Reregistration Eligibility Document (R.E.D.)
Carbon and Carbon Dioxide
7. AuthoKs)
EPA, Office of Pesticide Programs. Special Review & ReRea. Div
PB92-161926
S. Report Date
9/91
8. Performing Organization Rept. No.
540/RS- Q9-1PS
9. Performing Organization Name and Address
10. Project/Task/Worfc Unit No.
U.S. Environmental Protection Agency
Office of Pesticide Programs
Special Review and Reregistration Division
401 M Street, S.W.
Washington, D.C. 20460
11. Contract(C) or Grant(G) No.
(C)
(G)
12. Sponsoring Organization Name and Address
same as #9
13. Type of Report & Period Covered
14.
15. Supplementary Notes
16. Abstract (Limit: 200 words)
EPA is directed by the Federal Insecticide, Fungicide, and
Rodenticide Act as amended in 1988 (FIFRA *88) to review all
pesticide products containing active ingredients initially
registered before November 1, 1984, and to reregister those
products that have a substantially complete data base and do not
pose unreasonable adverse effects to people or the environment.'"
This pesticide reregistration program is to be completed by thfe
late 1990*s.
The Reregistration Eligibility Document (or RED) discusses
the scientific data and other information supporting EPA's
regulatory conclusion that products containing a pesticide do not
pose unreasonable risks when used as directed by Agency-approved
labeling, and are eligible for reregistration.
17. Document Analysis a. Descriptors
Pesticides, standards regulations, manufacturing, chemistry, toxicology,
residues, ecology, path of pollutants.
b. Identifiers/Open-Ended Terms
c. COSATI Field/Group
IS. Availability Statement
Publicly Available
19. Security Class (This Report)
unclassified
20. Security Class (This Pag«)
unclassified
21. No. of Pages
47
22. Price
_
(See ANSI-Z39.18)
See Instructions on Reverse
OPTIONAL FORM 272 (4-77)
(Formerly NTIS— 35)
Department of Commerce
------- |