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Pesticide Registration (PR) Notice 97-6: Use of Term "Inert" in the Label Ingredients Statement
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Notice To: Manufacturers, Producers, Formulators, 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 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 (CLI), 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.
II. 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.
III. 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 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