United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-R-93-004
June 1993
R.E.D. FACTS
Biobor
Pesticide
Registration
All pesticides sold or used in the United States must be registered by
EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing undue hazards to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Document, or RED. This fact
sheet summarizes the information in the RED for the active ingredients 2,2'-
(l-methyltrimethylenedioxy)bis(4-methyl-l,3,2-dioxaborinane) and 2,2-
oxybis(4,4,6-trimethyl-l,3,2-dioxaborinane), which comprise the
reregistration case Biobor.
Biobor is a fungicide used in the fuel tanks and fuel lines of vehicles,
farm equipment and industrial engines to prevent the growth of microbial
organisms such as slime-forming bacteria and fungi, which could interfere
with the unloading, use and quality of non-gasoline fuels. Biobor products
are formulated as ready-to-use liquids.
Regulatory Biobor was initially registered as a pesticide in the United States in
History 1965. EPA required additional information regarding the health and
environmental effects of Biobor during the Antimicrobial Data Call-in
issued in 1987, and through a second data call-in 1992.
Currently, six end use products are registered which contain the active
ingredients include in the Biobor reregistration case.
Use Profile
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Human Health Toxicity
AsS6SSm6nt Biobor is of relatively low acute toxicity by the oral, dermal and
inhalation routes of exposure; it has been placed in Toxicity Categories III
and IV (indicating the lowest degree of acute toxicity) for these effects.
However, Biobor does produce severe irritation to the eyes, and is placed in
Toxicity Category I (signaling a high degree of acute toxicity) for this
effect.
Developmental toxicity studies using rats showed reduced fetal weights
and reduced or incomplete ossification of parts of the skeleton. Studies in
rabbits showed similar skeletal effects. However, Biobor showed no
evidence of mutagenicity in a first-tier battery of studies.
Dietary Exposure
Boric acid esters, including Biobor, undergo rapid hydrolysis in the
presence of water, forming boric acid or borate ion. These substances are
essential to plant life, and small amounts are normally present in the human
diet. Therefore, EPA does not anticipate that low levels of exposure to
Biobor are associated with any significant degree of risk. Biobor is not
registered for use on food, feed or processed commodities. Therefore,
dietary exposure or risk is not expected.
Occupational and Residential Exposure
Minimal occupational exposure can be expected based on the currently
registered uses of Biobor. A ready-to-use liquid which is added to fuel
tanks, Biobor is available in one quart, five gallon, and 55 gallon sizes.
Although there is the potential for minimal exposure while using the smaller
sized containers of Biobor, use of a closed system metering pump is
required by product labeling for delivery of the 55 gallon drum contents into
large storage or fuel tanks.
Applicator Exposure
Biobor does not pose human dietary risks since no food-related uses
are registered and dietary exposure is not anticipated.
A closed system must be used during application of large quantities of
Biobor, and the chemicals generally are of low acute toxicity. Thus the risk
to workers from exposure to Biobor is expected to be very low. Biobor can
cause severe eye irritation. Therefore, to protect the eyes of mixers,
loaders and applicators, product labeling will require the use of goggles and
face shields. Animal studies using Biobor showed some developmental
effects. However, there is little likelihood of a developmental toxicity risk
to workers because Biobor's pattern of use results in minimal occupational
exposure.
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Environmental
Assessment
Additional Data
Required
Product Labeling
Changes Required
Regulatory
Conclusion
For More
Information
Environmental Fate
Biobor is used inside fuel and oil storage tanks, and exposure to the
environment should not result as long as Biobor products are used in
accordance with approved label directions. EPA has required few
environmental fate studies.
Ecological Effects
For the reasons discussed above, EPA is not requiring extensive
ecotoxicity studies on Biobor products. The Agency is requiring acute
toxicity studies on birds, fish and invertebrates, to characterize Biobor's
acute toxicity to these species in case of accidents and to develop appropriate
product labeling.
Ecological Effects Risk Assessment
EPA did not conduct a risk assessment for Biobor since it is registered
only for use inside enclosed fuel containers. Exposure to the environment
resulting from the use of this pesticide is expected to be negligible.
EPA is requiring product-specific data, including product chemistry
and acute toxicity studies, as well as revised labelling for reregistration of
pesticide products containing Biobor. Three confirmatory ecotoxicity
studies also are required to develop appropriate environmental labeling
precautions, for normal use situations and in case of accidents.
The labels of all registered pesticide products containing Biobor must
comply with EPA's current pesticide labeling requirements. Additional
labeling is also required to ensure the Federal Aviation Administration is
consulted regarding the fuel additive use.
Technical Biobor is a severe eye irritant but because there are no EPA
registered manufacturing-use products, changes to current labels do not
apply. Changes to current product labeling may be made after the end-use
product toxicology data have been submitted and reviewed.
The use of currently registered pesticide products containing Biobor in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of
products containing Biobor are eligible for reregistration.
These Biobor products will be reregistered once the required product-
specific data and revised labeling are received and accepted by EPA.
Products which contain other active ingredients in addition to Biobor will be
eligible for reregistration only when all of their other active ingredients are
also determined to be eligible for reregistration.
EPA is requesting public comments on the Reregistration Eligibility
Document (RED) for Biobor during a 60-day time period, as announced in a
Notice of Availability published in the Federal Register. To obtain a copy
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of the RED or to submit written comments, please contact the Pesticide
Docket, Public Response and Program Resources Branch, Field Operations
Division (7506C), Office of Pesticide Programs (OPP), U.S. EPA,
Washington, D.C. 20460, telephone (703) 305-5805.
Following the comment period, the Biobor RED will be available
from the National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA. 22161, telephone (703) 487-4650.
For more information about Biobor or about EPA's pesticide
reregistration program, please contact the Special Review and Reregistration
Division (7508W), OPP, U.S. EPA, Washington, D.C. 20460, telephone
703-308-8000. For information about reregistration of individual products
containing Biobor, please contact Marshall Swindell, Product Manager,
Registration Division (7505C), OPP, U.S. EPA, Washington, D.C. 20460,
telephone (703) 308-6908.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide health symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free 1-
800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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