United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-93-008
September 1993
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Wood Oils and Gums
(Cedarwood Oil)
All pesticides sold or distributed 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 unreasonable risk to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision document, or RED.
This fact sheet summarizes the information in the RED document for the
case Wood Oils and Gums, which contain the pesticide cedarwood oil.
Cedarwood oil is a natural component of wood from the tree,
Juniperus virginiana L.. It is an active ingredient in five pesticide products
that are used as repellents and feeding depressants to control moths and fleas
and retard the growth of mildew. Three of these products are solid
cedarwood blocks used to repel moths from clothing and retard mildew
growth on fabrics. The other two products, which contain extracted
cedarwood oil, are a pet tag or collar and a liquid sprayed on animal
bedding. Both are intended to repel fleas from household pets. Cedar also is
a major component of many non-pesticidal consumer products currently
marketed in the United States.
Regulatory
History
Cedarwood oil was initially registered as a pesticide in the United
States in 1960, to repel moths from clothing. The reregistration case Wood
Oils and Gums originally included two other active ingredients (canadian
balsam and ester gum) which were cancelled after their registrants chose not
to support them through the reregistration process. The case now consists
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only of cedarwood oil, with five end-use and no technical product
registrations.
By a notice published in the Federal Register for public comment on
August 11, 1993, EPA has proposed to exempt from regulation under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), natural cedar
products which consist totally of cedar wood, are not combined or
impregnated with other substances, and are intended only to repel
arthropods other than ticks and/or to retard mildew. EPA believes it is
unnecessary to regulate these products because they pose little or no risk to
human health or the environment. Consumers are not likely to be exposed to
significant amounts of cedarwood dust or oil, either dermally or by
inhalation, when using these products. EPA is not aware of any evidence of
injury to human health or the environment due to their use. The cost and
effort involved in regulating these cedar products is not justified by the low
risk concerns associated with them.
After considering any public comments submitted, if EPA decides to
deregulate natural cedar products, the reregistration requirements discussed
in the cedarwood oil RED will not apply to registered cedarwood block
products. However, if they are not deregulated, the cedarwood block
products will be subject to the requirements of the RED.
Cedarwood oil is among those pesticides for which EPA believes a
broadly reduced set of generic data requirements is appropriate for
reregistration. The Agency therefore has waived most generic data
requirements for cedarwood oil with the exception of studies that are
considered essential, including additional information about chemical purity
and product chemistry studies. In evaluating cedarwood oil's potential risks
to human health and the environment, EPA relied on information commonly
available in scientific literature.
Cedarwood oil is a mixture of organic compounds. It is considered
Generally Recognized as Safe (GRAS) as a food additive by the Food and
Drug Administration. As a pesticide, it repels insects by a non-toxic mode
of action. EPA is not aware of any adverse effects caused by cedarwood oil
pesticide products when used in a manner prescribed by their labeling. No
incidents involving toxic effects have been reported to the Agency.
A laboratory study using mice and a study of workers in saw mills
suggest that cedarwood oil may cause liver and pulmonary toxicity.
However, these effects were associated with long term exposures to
relatively high levels of cedarwood oil. EPA does not expect such effects to
occur among users of currently registered cedarwood oil products because
their exposure is intermittent and at a low level.
EPA believes there is negligible human and environmental exposure to
cedarwood oil as a result of its registered pesticidal uses. The registered
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pesticide products generally are used at a low rate, infrequently, and
indoors. EPA therefore is requiring product specific acute toxicity testing
to develop appropriate labeling.
The Agency concludes that the use of cedarwood oil as an active
ingredient in currently-registered pesticide products should not result in
unreasonable adverse effects to human health or the environment.
Additional Data
Required
Although EPA has waived most generic studies, the Agency is
requiring additional details about the chemical characterization of the
cedarwood oil used in the formulated products. EPA also is requiring
product-specific data, including product chemistry, acute toxicity and
efficacy studies for the public health pests, fleas, as well as revised
Confidential Statements of Formula and revised labeling for reregistration.
Product Labeling The labels of all registered pesticide products containing cedarwood
ReQUired °^ must comply with EPA's current pesticide labeling requirements. In
addition, products registered for use on pets or animals must specify on
their labels which animals may be treated with the product.
Regulatory
Conclusion
The use of currently registered pesticide products containing
cedarwood oil in accordance with approved labeling will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration.
These cedarwood oil products will be reregistered once the required
physical chemistry data, product-specific data, revised Confidential
Statements of Formula and revised labeling are received and accepted by
EPA. Products containing other active ingredients will be reregistered only
when the other active ingredients also are determined to be eligible for
reregistration.
Cedarwood oil products consisting of natural cedarwood blocks are of
a character which EPA believes is unnecessary for regulation under FIFRA.
If the Agency decides to deregulate the cedarwood block products, their
reregistration will no longer be required.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for Wood Oils and Gums during a 60 day time
period, as announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED or to submit written comments,
please contact the Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
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Following the comment period, the Wood Oils and Gums 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 EPA's pesticide reregistration program,
the Wood Oils and Gums RED, or reregistration of individual products
containing cedarwood oil, please call the Special Review and Reregistration
Division (7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-free
1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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