FIFRA
SECTION 25 (b) PRODUCTS |
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| 1. |
How does a product qualify for the FIFRA 25(b)? |
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Criteria 1: |
The
product
must
contain only those active ingredients that are listed in the regulation. Active
ingredients are those ingredients that destroy, repel, or mitigate a
pest. The active ingredient list is attached. The official location
is Title
40 Code of Federal Regulations, Part 152.25(g)(1). The amount of active
ingredient or the sum of active ingredients in a product may add up to 100%. |
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Criteria 2: |
The
product
must
contain only those inert (other) ingredients that have been classified
by
EPA as List 4A “Inert Ingredients of Minimal Concern”. List 4A was undergoing
revision in 2001. It is strongly recommended that the list be viewed on
the
Agency’s website to ensure that a correct and up-to-date list is used:
http://www.epa.gov/opprd001/inerts. |
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Criteria 3: |
All
of
the
ingredients (both inert and active) must be listed on the label. The active
ingredient(s) must be listed by name and percentage by weight. Each inert
(other) ingredient must be listed by name. |
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Criteria 4: |
The
product
must
not make public health claims. For example, the label may refer to controlling
ticks or mosquitoes, but may not in any way refer to or claim to prevent any
specific disease carried by those pests, such as Lyme disease, encephalitis,
or West Nile Virus. |
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Criteria 5: |
The label
cannot
include any false or misleading statements. For example, label language
implying Federal registration, review or endorsement such as “It is a violation
of Federal law to use this product in a manner inconsistent with the label”,
or
the use of an EPA registration or establishment number are not allowed. Persons
intending to manufacture or market FIFRA Section 25(b) products should carefully
consult EPA Pesticide Regulation Notices 2000-6 and 2002-XX for a discussion
of
false and misleading label claims. |
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| 2. |
What if my product does not meet all of the criteria listed
above? |
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If
a product does
not meet all five of the criteria listed above, it is in violation of
the
Federal law. The producer and distributor may be subject to enforcement
penalties. If a producer cannot or does not wish to meet all the criteria,
it
remains an option to apply to EPA for a Federal pesticide registration. The
necessary forms and instructions for a registration application may be obtained
from the Agency website at www.epa.gov/pesticide. |
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| 3. |
Do State governments regulate these exempted pesticide
products? |
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Yes,
Indiana and
many other states continue to regulate these products. The FIFRA
section
25(b)
exemption is for Federal registration only. |
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| 4. |
Can
other
substances be added to the active ingredient list? |
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It is possible,
but the U.S. EPA would require information adequate to demonstrate minimal
toxicity and risk, which the Agency could
review and evaluate. Also, since these minimal risk active ingredients
are in the Code of Federal Regulations, the Agency would have to undertake
a rule-making process requiring public notice and comment to amend 40 CFR
to add new substances. |
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| 5. |
What
about
adding inert ingredients to the 4A List? |
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The addition must
be a minimal risk inert ingredient and must be substantiated for
U.S. EPA review
and evaluation. List 4A, however, can be changed by publication of a Federal
Register Notice. It should be noted that the Agency is in the process of
restructuring the 4A List. This restructuring will expand the number of
substances on List 4A, as well as providing better definition and increased flexibility
but will also remove several substances from List 4A. You should consult
EPA’s website at: http://www.epa.gov/opprd001/inerts to
be sure of using a correct, up-to-date list. |
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| 6. |
Why are some ingredients on both the active ingredient
list and the inert (other)
ingredient
list? |
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It is possible
for a chemical to be an active ingredient in one pesticide product
and an inert
ingredient in another pesticide product. Active ingredients function as
the
ingredient that kills, repels, or mitigates the pest. Inert (or “other”)
ingredients are defined as all ingredients that are not active ingredients. Determining
whether an ingredient in a pesticide product is inert or active requires information
on the concentration and purpose of the ingredient in the
formulation. As an example, citric acid is a disinfectant, sanitizer, and
fungicide (an active ingredient) when used in combination with other active
ingredients. However, citric acid can also perform as a buffer, thus functioning
as an inert ingredient. Thus, to determine whether an ingredient is inert
or active requires an understanding of the purpose of these chemical substances
in the formulation. The ingredients on the two lists are not
interchangeable. If the substance is only on the inert (other) ingredient
list, then it may only be used as an inert (other) ingredient, and similarly
for
active ingredients. |
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| 7. |
Where
can
I get
more information? |
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For more information regarding the federal pesticide regulatory
programs, contact
EPA or
any of its Regional Offices: EPA
Office of
Pesticide Programs Telephone: 703-305-5017 Fax: 703-305-5558
E-mail: opp-web-cmments@epa.gov Web
site: http://www.epa.gov/pesticides |
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