United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
APRIL 199
•8-ERA R.E.D. FACTS
DEET
Pesticide
Reregistration
Use Profile
All pesticides sold or distributed in the United States must be regis-
tered 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 before November 1, 1984, 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 develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information hi the RED document for
reregistration case 0002, N,N-diethyl-meta-toluamide and other isomers
(DEBT).
N,N-diethyl-meta-toluamide (DEET) is an insect repellent used hi
households/domestic dwellings, on the human body and clothing being
worn, on cats, dogs, horses and pet living/sleeping quarters. There are no
food uses. It is used to control biting flies, biting midges, black flies,
chiggers, deer flies, fleas, gnats, horse flies, mosquitoes, no-see-ums, sand
flies, small flying insects, stable flies, and ticks. Formulations include
liquids, pressurized liquids, ready-to-use formulations and impregnated
material. DEET is applied by aerosol can, by hand, non-aerosol pump
sprayer, package applicator, and pump spray bottle.
Regulatory DEET was first registered in the U.S. hi 1957 after first being devel-
History °Pe(^ by me U.S. Army in 1946 for use by military personnel in
insect-infested areas. A Registration Standard for DEET was issued in
December, 1980 (PB81-207722), and a subsequent Data Call-in (DCI)
for DEET (issued September, 1988) required additional animal and avian
toxicity data.
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Human Health
Assessment
Environmental
Assessment
Currently, 225 DEBT products are registered. DEBT products that
are applied directly to the skin and/or clothing are available in numerous
formulation types (e.g. aerosol and non-aerosol sprays, creams, lotions,
sticks, foams, and towelettes). Product concentrations range from -4% a.i.
to 100% a.i.
Toxicity
In studies using laboratory animals, DEBT generally has been shown
to be of low acute toxicity. It is slightly toxic by the eye, dermal and oral
routes and has been placed in Toxicity Category HI (the second lowest of
four categories) for these effects.
[NOTE: For acute oral, dermal, ocular and inhalation toxicity:
Category I = very highly or highly toxic
Category n = moderately toxic
Category HI = slightly toxic
Category IV = practically non-toxic]
Dietary Exposure
Because of its use pattern, people are not exposed to residues of DEBT
through the diet.
Occupational and Residential Exposure
Based on DEET's indoor/residential use pattern, handlers (mixers,
loaders, and applicators) are not exposed to DEBT.
Human Risk Assessment
DEBT generally is of low acute toxicity, and, based on the available
lexicological data, the Agency believes that the normal use of DEBT does
not present a health concern to the general U.S. population (the Agency's
human risk assessment has identified no lexicologically significant effects in
animal studies.) DEBT has been classified as a Group D carcinogen (not
classifiable as a human carcinogen.)
Although DEET's use has been implicated in seizures among children,
the Agency believes lhal Ihe incident data are insufficient to establish DEBT
as the cause of the reported effects. However, because of DEET's unusual
use pattern (direct application to human skin and clothing) and its association
with seizure incidents, the Agency believes it is prudent to require clear,
common sense use directions and improved label warnings and restrictions
on all DEBT product labels.
Environmental Fate
. j
Because of its limited use pattern, the only environmental fate study
required for DEBT was hydrolysis. From that data, it was concluded that
DEBT is stable to hydrolysis at pH levels found hi the environment.
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Risk Mitigation
Additional Data
Required
Ecological Effects
Because DEBT is only applied directly to the human body/clothing,
cats, dogs, pet quarters and household/domestic dwellings, it is considered
to be an "indoor residential" use. A limited set of toxicity data for indoor-
use pesticides is required to determine precautionary label statements and for
assessing environmental hazards hi case of spills. The available data charac-
terize DEBT as slightly toxic to birds, fish, and aquatic invertebrates and as
practically nontoxic to mammals.
Ecological Effects Risk Assessment
Ecological risk assessments are not conducted for pesticides with
exclusively indoor use patterns. Application of DEBT to the human
body/clothing, cats, dogs, pet quarters, and household/domestic dwellings,
is not likely to adversely affect terrestrial wildlife or aquatic organisms.
DEBT is a personal insect repellent that is widely used among the U.S.
population, including children, and is one of the few residential-use
pesticides that is applied directly to the skin. Although the available
toxicological data to not indicate a health concern under normal use
conditions, DEET's use has been associated with possible adverse effects.
For all of these reasons, the Agency believes it is prudent to require
improved label warnings and product restrictions. A listing of the required
labeling statements for DEBT formulations is included in the RED, Section
V. The Agency had deferred its decision on the combination
DEET/sunscreen products until it has solicited the views of various
governmental agencies and other groups. Sunscreen products are intended
for frequent, generous use, and DEET products are intended for spare,
infrequent use. The Agency is concerned that use of the combination
products may promote greater use of DEET than is needed for pesticidal
efficacy and thus pose unnecessary exposure to DEET. In addition, child-
safety claims must be removed from all end-use product labels in order to be
reregistered. Child-safety claims are misleading and irreconcilable with the
intended use and pesticidal ingredients of DEET products. From the
toxicological data reviewed by the Agency for DEET, and from DEET
incident data, there appears to be no correlation between the percent active
ingredient hi the product and its safety. Therefore, the Agency does not
believe that certain DEET formulations are inherently safer for children.
DEET uses/formulations with labels that make cosmetic claims must be
labeled such that label statements and use directions regarding insect
repellency appear first and more prominently on the label.
EPA is not requiring additional generic studies for DEET to confirm
its regulatory assessments and conclusions.
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The Agency is requiring product-specific data including product
chemistry and acute toxicity studies, product efficacy data, revised
Confidential Statements of Formula (CSFs), and revised labeling for
reregistration.
Product Labeling All DEBT end-use products must comply with EPA's current pesticide
Changes Required product labeling requirements and with those labeling requirements imposed
in this RED. For a comprehensive list of labeling requirements, please see
section V. of the DEBT RED document.
1. All products must incorporate a series of 14 statements informing the
consumer on the method of application, special precautions for children, and
directions for medical attention.
2. For aerosol and pump spray formulations: labels must direct the
consumer not to spray hi enclosed areas, avoid direct spray ing on the face
and must be packaged in containers which will ensure the product will not be
inadvertently sprayed hi the eyes.
3. Other labeling requirements include: specifying percent active ingredient
hi terms of DEBT; use of the term "first aid"; addition of a toll-free number
for consumer support; requirement to use permanent labels; all cosmetic
claims must be less prominent that the term "Insect repellent"; and all direct
or indirect claims of child safety must be removed.
Regulatory
Conclusion
With the exception of products/formulations that combine DEBT and
sunscreen, all uses/formulations of DEBT are eligible for reregistration
provided all labels are amended as specified hi the RED. The use of
currently registered products containing DEBT hi 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. The Agency will defer its decision regarding the
reregistration eligibility of products/formulations that combine DEBT and
sunscreen until the Agency has solicited the views of various governmental
agencies and other groups. Additionally, the Agency will not act on any
pending registration applications under section 3 until that time.
DEBT products will be reregistered once the required product-specific
data, including efficacy data, revised Confidential Statements of Formula,
and revised labeling are received and accepted by EPA. Products which
contain active ingredients hi addition to DEBT will be reregistered when all
of then: other active ingredients also are eligible for reregistration.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for DEBT during a 60-day tune period, as
announced hi a Notice of Availability published in the Federal Register. To
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obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket^ Pjublic Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA. GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone 513-
489-8190, fax 513-489-8695.
Following the comment period, the DEET RED document also 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 DEET RED, or reregistration of individual products containing DEET,
please contact 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
hi recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call
toll-free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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