Pesticides
- information that discloses manufacturing or quality control processes, - information that discloses
methods for testing and measuring the quantity of deliberately added inert ingredients (FIFRA; and
-information that discloses the identity or percentage quantity of deliberately added inert ingredients. -
✔✔Confidential Business Information
•An active ingredient that is not currently contained as an active ingredient in any registered pesticide
product. - ✔✔New Active Ingredient
•EPA Form 8570‑1, Application for Pesticide Registration/Amendment (with box checked [X] for
Amendment);
•For an "identical/substantially similar" amendment, a statement identifying the currently registered
product that is "substantially similar" or "identical" or "differs only in ways that would not significantly
increase the risk of unreasonable adverse effects on the environment" by its EPA Registration
Number and product name, and a description of the labeled change being proposed for the product;
•EPA Form 8570‑4, Confidential Statement of Formula, if proposing a change in the formulation;
•EPA Form 8570-27, Formulator's Exemption Statement, if applicable;
•Five copies of the proposed draft labeling (Agency review is faster if the changes in the proposed
labeling are: 1.highlighted in a way that can be photocopied; or
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2.computer edited, with italics, shading, and strike-out; or
3.hand marked on one copy; if a te - ✔✔Administrative Portion of the Registration Amendment
Package
•New use, when used with respect to a product containing a particular active ingredient, means:
◦any proposed use pattern that would require the establishment of, the increase in, or the exemption
from the requirement of a tolerance regulation under section 408 of the Federal Food, Drug, and
Cosmetic Act;
◦any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient
is currently registered for that use pattern; or
◦any additional use pattern that would result in a significant increase in the level of exposure, or a
change in the route of exposure, of the active ingredient to man or other organisms. - ✔✔New Use
1. Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating
any pest. 2. Any substance or mixture of substances intended for use as a plant regulator, defoliant or
desiccant 3. any nitrogen stabilizer - ✔✔Pesticides
,1.are naturally occurring chemicals or are synthetically derived equivalents;
2.have a history of exposure to humans and the environment demonstrating minimal toxicity, or in the
case of synthetically derived biochemical pesticides, are equivalent to a naturally occurring chemical
that has such a history; and
3.have a nontoxic mode of action to the target pest(s)
Biochemical pesticides include, but are not limited to:
1.semiochemicals (insect pheromones and kairomones),
2.natural plant and insect regulators,
3.naturally occurring repellents and attractants, and
4.enzymes.
Biochemical pesticides include substances, such as insect sex pheromones, which interfere with
mating, as well as various scented plant extracts that attract insect pests to traps. Because it is
sometimes difficult to determine whether a substance meets the criteria for classification as a
biochemical pesticide, EPA has established the Biochemica - ✔✔Biochemical pesticides
40 CFR 162.154(a) sets forth the process and requirements for disapproving a state registration that
involves products with composition or use patterns that are not similar to a currently registered
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product. Reasons for disapproving these types of special local need registrations include, but are not
limited to:
•probable creation of unreasonable adverse effects on man or the environment by the registered use;
•refusal of the registering state to submit information supporting the registration, i.e., application form
(within 10 working days), labeling for the section 24(c) registration, Confidential Statement of Formula
(new product only), final printed label (within 60 days), state revocation notice with date of revocation
and reason(s) for revocation, and scientific studies supporting a no unreasonable adverse effects
finding by the state (within 15 working days);
•failure of the information submitted by the state - ✔✔Grounds for Disapproving a State Registration
General Disapprovals
40 CFR 172.6 requires that all pesticides shipped or used under an experimental use permit must be
labeled with directions and conditions for use, including the following:
•the prominent statement "For Experimental Use Only";
•the Experimental Use Permit Number;
•the statement "Not for sale to any person other than a participant or cooperator of the EPA‑approved
Experimental Use Program";
,•the name, brand, or trademark;
•the name and address of the permittee, producer, or registrant;
•the net contents;
•an ingredient statement;
•warning or caution statements;
•any limitations on entry of persons into treated areas;
•the establishment registration number, except in those cases where application of the pesticide is
made solely by the producer; and
•the directions for trial use.
In the case of a registered pesticide, EPA may permit a pesticide to be used under an experimental
use permit with approved supplemental labe - ✔✔Labeling Requirements
A "company number" is a unique identifier assigned to a company that wishes to register a pesticide
(e.g., herbicide, rodenticide, or antimicrobial) with the U.S. Environmental Protection Agency (EPA).
These companies are commonly called registrants.
A "company number" is also necessary for a company that plans to "produce" pesticides or devices.
Such production requires the company to obtain a "Pesticide-Producing or Device-Producing
Establishment Number." The company number is part of the establishment number. - ✔✔What is an
EPA Company Number
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A business confidentiality claim covering part or all of the information in the application may be
claimed at the time it is submitted to the Agency. Information on such claims may be found in Chapter
10 and Chapter 15 describes how to submit Confidential Business Information (CBI). - ✔✔CBI
Claims
A determination by the Agency that it cannot grant the application completes the Agency's review of
the application under PRIA 3. Usually, it is a determination that on account of missing or deficient
data, the Agency has determined that the application does not meet the standard for registration and,
therefore, the application cannot be granted. It is not, however, a denial of the application pursuant to
FIFRA section 3(c)(6). Once the Agency makes a determination that it cannot grant the application,
the applicant may withdraw the application, continue to address any deficiencies without a PRIA 3
timeframe, or request a denial. If the applicant does not request the Agency to initiate denial
proceedings or withdraw the application, the Agency may continue to diligently work with the
applicant without a PRIA 3 timeframe or due date. - ✔✔PRIA 3 "Cannot Grant" Determination
A fee or a waiver from paying the fee is required for the following types of actions (refer to Chapter 2
for additional information):
, •new active ingredients,
•new uses,
•new products,
•certain amendments,
•certain tolerances,
•certain inert ingredients,
•certain combination products,
•cancer reassessments and certain ecological/endangered species assessments,
•manufacturing use products (MUPs),
•experimental use permits (EUPs),
•human study protocols and completed studies that require review by the Human Studies Review
Board,
•certain covered actions that require external review by the FIFRA Science Advisory Panel,
•Gold Seal letters,
•Exclusive use of data extension requests.
Actions not covered by fees include but are not limited to:
•the re-establishment of a time-limited tolerance;
•review of confirmatory data submitted in support of an already-issued registration (excluding efficacy
data);
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•Agency-initiated - ✔✔Actions that Require a Fee
A first step for the applicant is to determine whether an EUP is required for the particular testing being
considered. If the product is not intended to be used as a pesticide, an EUP would not be needed to
test the product. Additionally, certain pesticide testing operations may not require an EUP if the
criteria of 40 CFR 172.3 are met, as discussed below.
In general, EUPs are issued for:
•pesticides containing any chemical or combination of chemicals that have not been included in any
previously registered pesticide; and
•registered pesticides for which a use, e.g., application to a particular crop, is not registered with the
Agency.
However, there are certain tests and circumstances that are exempt from the requirements of an EUP
because they are presumed not to involve unreasonable adverse effects. These exemptions are
summarized below and described in detail in 40 CFR 172.3(b) and (c). - ✔✔Requirements for an
Experimental Use Permit
