EPA 730-N-97-007
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
SEP 1 1 193?
PR NOTICE 97-6
NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, AND
REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible for the Registration of
Pesticides
SUBJECT: Use of Term "Inert" in the Label Ingredients Statement
This notice announces a change in EPA policy regarding the label ingredients
statement. Effective immediately, the phrase "Inert ingredients," may be replaced by the
term "Other ingredients." Although no registrant is required to make this change, EPA
encourages registrants to do so. Provided the term "Other ingredients" is used, the change
may be made at any time without notification to the Agency.
I. BACKGROUND
The terms "active ingredient" and "inert ingredient" have been defined in FIFRA
since 1947 and pesticide labeling regulations require that the ingredients statement use the
terms "Active ingredients" and "Inert ingredients" as the headings for the ingredients
statement information. An active ingredient is one that prevents, destroys, repels or
mitigates a pest, and each active ingredient must be identified by name on the label
together with its percentage by weight. An inert ingredient is simply any ingredient in the
product that is not pesticidally active. Unless an inert ingredient is determined to be
highly toxic, it is not required to be identified by name or percentage on the label, but the
total percentage of such ingredients must be declared. Neither FIFRA nor the regulations
define the term "inert ingredient" on the basis of toxicity, hazard or risk to humans, non-
target species, or the environment.
Most "inert" ingredients are not known to pose health or environmental concerns;
however, EPA has long known and acknowledged that some inert ingredients are not
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benign to human health or the environment. The "inert" ingredients in some products
may be more toxic or pose greater risks than the active ingredient. Since 1987, EPA has
been actively evaluating new and existing inert ingredients for their toxicity before allowing
their use in pesticide products. EPA will also be reassessing food tolerances for existing
inert ingredients in pesticide products. EPA has not taken the additional step, however, of
departing from its traditional use of the term "inert ingredient" on pesticide labeling.
In 1996, EPA began a Consumer Labeling Initiative (CL1), which has as its goal the
improvement of consumer labeling (focussing on pesticide products). In the first phase of
the CLI, one-on-one interviews were conducted with users of household pesticides (indoor
insecticides, outdoor pesticides, and household hard surface cleaners) and non-pesticide
cleaning agents. Among other things, the interviews demonstrated that many consumers
have a misleading impression of the term "inert ingredient," believing it to indicate water
or other harmless ingredients. A number of comments from the public and the consumer
interviews recommended that EPA discontinue the use of the term. By this notice, EPA is
implementing that recommendation with respect to pesticide labeling.
H. POLICY
Effective immediately, EPA will permit (and encourages) registrants and applicants
for registration to substitute the more neutral term "Other ingredients" on their pesticide
labels and in other materials describing the pesticide product. EPA will initiate rulemaking
to revise its labeling regulations in 40 CFR 156.10 to make this change binding; however,
EPA believes that it should proceed immediately to permit registrants to make this change
voluntarily.
Accordingly, any registrant or applicant for registration may revise product labels to
substitute the phrase "Other ingredients" as the heading for the "inert" ingredients in the
product ingredients statement.
This change affects only the heading "Inert ingredients" used in the label ingredients
statement. It does not affect the status of any ingredient in a product as an "inert
ingredient" under FIFRA sec. 2(m). It does not affect an Agency determination as to
whether an ingredient is an "active" or pesticidally inert ingredient under 40 CFR 153.125.
Nor does it relieve the registrant of other requirements of FIFRA or the Federal Food,
Drug and Cosmetic Act pertaining to "inert ingredients" as defined by FIFRA.
HI. PROCEDURE
Provided that the term "Other ingredients" is used, a registrant may revise its label
at any time without notification to the Agency. The format, type style and size of the
heading "Other ingredients" must be the same as is currently approved by EPA for "Inert
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ingredients." All other requirements pertaining to the label ingredients statements remain
the same.
At this time, EPA is not considering other terms to substitute for "inert
ingredients"; however, when EPA revises its regulations, it may consider other terms.
IV. COMPLIANCE
No registrant is required to make this change. However, EPA strongly encourages
registrants to make this change as labels are routinely revised. EPA will not consider a
product bearing the term "Other ingredients" instead of "Inert ingredients" to be
misbranded within the meaning of FIFRA sec. 12 solely because of that change.
V. FOR FURTHER INFORMATION
If you wish further information on this notice, you may contact Jean M. Frane,
Field and External Affairs Division, at 703-305-5944, or by e-mail to
Frane.Jean@epamail.epa.gov.
Daniel M. Barolo , Director
Office of Pesticide Programs
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