PB92-221811
United States
Environmental Protection
Agency
Office of Prevention,
Pesticides and Toxic
Substances (H7505C)
EPA 737-8-92-001
August 1992
xvEPA
General Information
On Applying For
Registration Of Pesticides
In The United States
Second Edition
Printed on Recycled Paper
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GENERAL INFORMATION
ON APPLYING FOR
REGISTRATION OF PESTICIDES
IN THE
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION DIVISION
SECOND EDITION — AUGUST 1992
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PREFACE
This instruction manual, which is divided into 18 chapters,
is intended to provide a general overview and guidance for
persons seeking to register a pesticide in the United States.
Every attempt has been made to make the information contained in
this Instruction Manual accurate and current, however, changes in
the Federal pesticide law [Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA)], regulations, policies and requirements
are an ongoing process. Thus, changes may occur without you
being notified directly, and will take precedence over the
information contained herein. In this respect, changes made in
this second edition of the instruction manual make the previous
edition obsolete. Information in the first edition should be
disregarded.
If you wish to obtain more specific details on the laws and
regulations governing the use and sale of pesticides in the
United States, this information is.contained in the Federal
Insecticide, Fungicide and Rodenticide Act, as amended, and in
the Code of Federal Regulations (40 CFR Parts 150-189). Refer to
Chapter 16 for information on the source of these documents.
Applications and registration actions will be measured
against actual regulatory requirements for sufficiency.
Therefore, this manual should be considered as a summary offering
general guidance and not as a substitute for consulting
applicable regulations and law.
This second edition of the instruction manual has been
developed in an effort to provide applicants and registrants with
the most recent general guidance on registering pesticides in the
U.S. Draft copies of the second edition of the manual were sent
to a number of people for review and comment. Numerous
suggestions were received and have been incorporated in the final
document. We wish to thank all of those who responded with their
comments and suggestions.
In addition to a general updating of the original
instruction manual we have added the following entries:
1. A glossary of terms (following chapter 18);
2. A general index (following the glossary at the end
of the manual;
3. A paragraph on clearance of adjuvants (chapter 1);
4. A paragraph on clearance of inerts for products
labeled for food crops (chapter 1);
5. A clarification of "fast track" products
(chapters 2, 4);
6. A section on Reregistration Eligibility Documents
(REDs) (chapter 2);
7. A section on Data Waivers (chapter 2);
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8. Reference to the Food, Agriculture, Conservation,
and Trace Act (FACTA) of 1990 and the 1991
Amendments of FACTA making a number of amendments
to FIFRA, one of which was the redesignation of
FIFRA Section 3(c)(l)(D) as Section 3(c)(l)(F)
(chapters 2, 4, 6, );
9. A labeling appendix, with a sample label format
for restricted and non-restricted use products
(chapter 2).
10. A section on final printed labeling (chapter 4);
11. A section on "certification of compliance"
statements under "How to Submit Notifications."
(chapter 4);
12. Reference to PR Notice 91-8 regarding third party
data producers (chapter 6);
13. A note indicating that the data gap option may not
be available to certain applicants (chapter 6);
14. A section on data compensation charges/payment
disputes (chapter 6);
15. The addition of a question on repackaged technical
grade products under the "Questions and Answers"
section of Chapter 6 (question 3, chapter 6);
16. The addition of a question on how long data
submitters have to respond to an offer to pay
under the "Questions and Answers" section of
Chapter 6 (question 11, chapter 6);
17. The addition of a question on whether an applicant
is subject to the data requirements of Agency
issued Data Call-ins, Registration Standards, and
Reregistration Eligibility Documents as well as
the requirements of CFR 158 under the Questions
and Answers" section of Chapter 6 (question 18,
chapter 6);
18. A note stating that a temporary tolerance
associated with an Experimental Use Permit is not
required if the treated commodity is to be
destroyed or consumed only by experimental animals
(chapter 7);
19. The discussion of tolerance fees in Chapter 9 has
been moved to Chapter 7;
20. Chapter 9-("What Fees Are Required For
Registration and Tolerance Petition Activities)
has been redesignated as the "new" Chapter 8 and
chapter 8 (How to Apply For An Experimental use
Permit) has been redesignated as "new" Chapter 9;
21. Inclusion of an "Experimental Use Permit Summary
Worksheet" to new chapter 9;
22. A note warning against the transmittal of
confidential business over FAX machines
(chapter 12) ;
23. Addition of a section on "Grounds for EPA
Disapproval of State Registrations (chapter 14);
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24. The addition of sections on "Shipping
(Transportation) of Pesticides" and "Nonindigenous
and Genetically Engineered Microbial Products"
regulatory contacts to Chapter 15; and
25. The addition of a facsimile directory to Chapter
18.
We hope the changes we've made to the original manual will
provide you, the reader, with more information and make the
manual easier for you to use. We welcome any comments,
suggestions for changes, or additions that you believe will make
this manual more useful. Your comments should be addressed to
Mr. Herbert S. Harrison, Chief, or Mr. Harvey L. Warnick, Deputy
Chief, Insecticide-Rodenticide Branch, Registration Division,
Office of Pesticide Programs. Their addresses and phone numbers
can be found in Chapter 18 of this manual.
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TABLE OP CONTENTS OF THIS INSTRUCTION MANUAL
CHAPTER 1 - WHO MUST APPLY FOR REGISTRATION
This chapter contains information on who must file, and the
various types of registrations for which you may wish to apply.
CHAPTER 2 - HOW TO APPLY FOR REGISTRATION OF A CONVENTIONAL
PESTICIDE
This chapter contains information on how to submit an
application to register a pesticide that you wish to distribute
or sell, and the associated data and labeling requirements.
CHAPTER 3 - CONSIDERATIONS FOR REGISTRATION OF A BIOCHEMICAL OR
MICROBIAL PESTICIDE
This chapter contains information on applying for
registration of biochemical and microbial pesticides.
CHAPTER 4 - HOW TO AMEND THE REGISTRATION OF A PRODUCT THAT IS
ALREADY REGISTERED
This chapter contains information on 1) how to amend the
registration of your product after it has been registered by this
Agency, 2) changes you may make to your registered product that
do not require notification to the Agency that you have done so,
and 3) changes you may make to your registered product, but which
require prior notification to the Agency that you have done so.
CHAPTER 5 - HOW TO APPLY FOR SUPPLEMENTAL REGISTRATION OF A
REGISTERED PESTICIDE
This chapter contains information on supplemental
registration, that is your distribution and sale of a product
that is registered by another company.
CHAPTER 6 - WHAT ARE THE DATA COMPENSATION REQUIREMENTS
This chapter contains information on data compensation and
how you may comply with these requirements.
CHAPTER 7 - HOW TO SUBMIT AN APPLICATION TO REQUEST A PETITION
FOR A TOLERANCE. AN EXEMPTION FROM THE REQUIREMENT OF
A TOLERANCE OR A TEMPORARY TOLERANCE
This chapter contains information on when a petition to
establish a tolerance for residue of a pesticide on food or feed
commodities is required, and how to submit the petition.
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CHAPTER 8 - WHAT FEES ARE REQUIRED FOR REGISTRATION AND
TOLERANCE PETITION ACTIVITIES
This chapter contains information on the fees that are
required to be paid to maintain your registration, and fees for
petitions for the establishment of tolerances.
CHAPTER 9 - HOW TO APPLY FOR AN EXPERIMENTAL USE PERMIT
This chapter contains information on when you may need an
experimental use permit which allows you to test an unregistered
pesticide or a registered pesticide for an unregistered use, and
how to submit the application.
CHAPTER 10 - DEVICES - WHAT ARE THE REQUIREMENTS?
This chapter contains information concerning devices.
Although devices may not require registration under Chapter 3 of
FIFRA, they may be subject to other regulatory requirements.
CHAPTER 11 - HOW TO OBTAIN AN EPA ESTABLISHMENT NUMBER
This chapter contains information on the registration of
your pesticide producing establishment with the EPA, when you
need an establishment number, and how to obtain one.
CHAPTER 12 - HOW TO SUBMIT DATA AND CONFIDENTIAL BUSINESS
INFORMATION
This chapter contains information on the protection of
information (and data) that you submit to the Agency in support
of your registration, tolerance petition, and experimental use
permits from disclosure or release to other persons, and the
proper format for the submittal of that information and/or data.
CHAPTER 13 - TRANSFER OP REGISTRATIONS AND/OR DATA
This chapter contains information on the procedures and
information required to transfer a registration and/or data from
one company to another.
CHAPTER 14 - STATE REGULATORY AUTHORITY UNDER FIFRA
This chapter contains information on the authority of the
States to issue experimental use permits and special local need
registrations.
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CHAPTER 15 - OTHER TYPES OP REGISTRATIONS AND/OR APPROVALS THAT
MAY BE NEEDED FROM OTHER FEDERAL OR STATE AGENCIES
OTHER THAN PESTICIDE PROGRAMS
This chapter contains information on the States' regulation
of Federally registered pesticides, the regulation of the use of
pesticides in meat and poultry plants by the U.S. Department of
Agriculture, and the use of pesticides on food contact surfaces,
for paper and paperboard (food uses), on medical devices, as
human and animal drugs, and in cane-sugar and beet sugar-mills by
both the EPA and the Food and Drug Administration.
CHAPTER 16 - PUBLICATIONS AND HOW TO OBTAIN THEM
This chapter contains information on the various types of
publications concerning the registration, or regulation of
pesticides and where they may be obtained.
CHAPTER 17 - FORMS AND HOW TO OBTAIN THEM
This chapter contains information on the forms required for
various types of registration activities and where to obtain
them.
CHAPTER 18 - MAILING ADDRESSES AND WHO TO CONTACT FOR ASSISTANCE
This chapter contains a list of specific individuals or
offices to contact, if additional information is needed.
GLOSSARY OF SELECTED TERMS. ABBREVIATIONS AND ACRONYMS
INDEX
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CHAPTER 1 - WHO MUST APPLY FOR REGISTRATION OP A PESTICIDE
A. PRODUCTS THAT REQUIRE REGISTRATION
1 •
Those who develop products to control pests are subject to
regulation under several Federal laws. However, only certain
pest control products are subject to registration. The Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) requires that
before any person in any state or foreign country can sell or
distribute any pesticide in the United States, they must obtain a
registration (or license) from the U.S. Environmental Protection
Agency (EPA). The term "pesticide", as defined in FIFRA section
2(u), means any substance or mixture of substances intended for
preventing, destroying, repelling, or mitigating any pest, and
any substance or mixture of substances intended for use as a
plant regulator, defoliant, or desiccant.
It is important to understand that FIFRA and the
'"implementing regulations at 40 CFR parts 150-189, are the
governing federal law regarding the sale, distribution and use of
pesticides. Those who are subject to the law are responsible for
"'understanding and complying with the terms of the law.
Anyone who plans to sell or distribute a product that is
intended to control a pest or manipulate a plant must become
familiar with the definition of pesticide in the law and
regulations. Particular attention should be paid to the terms
"substance" or "mixtures of substances" in the definition of
pesticide. These terms provide the key to separating pesticides
from devices. If the product contains a substance that is
intended to affect a pest or plant by causing a physiological
reaction when the target organism is exposed to the substance
then the product is considered to be a pesticide and will require
registration unless exempted, as discussed below. On the other
hand, if the pest is controlled by a mechanical action the
"product will be considered a device and registration is not
required. However, devices are subject to other provisions of
the law, which are more thoroughly explained in Chapter 10.
IMPORTANT NOTE; The Agency has determined that, since humans are
not pests as defined by FIFRA, it will not register products
whose label bears claims for control of humans.
1 The term "pest", as defined in FIFRA section 2(t), means
(1) any insect, rodent, nematode, fungus, weed, or (2) any other
form of terrestrial or aquatic plant or animal life or virus,
bacteria, or other micro-organism (except viruses, bacteria, or
other micro-organisms on or in living man or other living animals)
which the Administrator declares to be a pest.
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It is also important to fully understand the term "intent".
Intent under the law can simply be demonstrated by more than
overt pesticidal claims. As set forth at 40 CFR section 152.15,
a substance is considered to be intended for a pesticidal purpose
requiring registration, if:
a) The person who distributes or sells the substance
claims, states, or,implies (by labeling or otherwise)
that 1) the substance (either by itself or in
combination with any other substance) can or should be
used as a pesticide; or 2) the substance consists of or
contains an active ingredient and that it can be used
to manufacture a pesticide; or
b) The substance consists of or contains one or more
active ingredients and has no significant commercially
valuable use as distributed or sold other than 1) use
for pesticidal purpose (by itself or in combination
with any other substance), 2) use for manufacture of a
pesticide; or
c) The person who distributes or sells the substance has
actual or constructive knowledge that the substance
will be used, or is intended to be used, for a
pesticidal purpose.
EXAMPLE; Products that have no claims to control
insects on the product label, but whose name includes
the name of a substance commonly recognized as having
pesticidal properties will be recognized as a pesticide
because the targeted consumer will know that such a
substance is a well established pesticide.
Additionally, it is important to note that the definition
for a pesticide does not make any reference to the level or kind
of toxicity that a product may exhibit in order to be considered
a pesticide. Therefore, toxicity does not have any place in
determining if a product is a pesticide. Toxicity is taken into
consideration by EPA when it requires supporting information
(i.e. data) and when it determines if a product can be
registered, and if so what limitations will be placed on it
before it can be registered. Products that have very minimal
toxicity such as garlic, red pepper, eucalyptus, mustard, citric
acid, soap, menthol and cedar wood have been required to be
registered.
It is important to become familiar with the other
definitions in the law and regulations. The definitions for
devices, active and inert ingredients and pests are terms that
will be vital in more fully understanding the definition for a
pesticide.
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IMPORTANT NOTE; If you need assistance in determining if your
product is a pesticide or device under FIFRA, you may contact the
t-appropriate Branch Chief in the Antimicrobial, Herbicide/
Fungicide and Insecticide/Rodenticide Branches in the
Registration Division. The contact should be made in writing and
should include detailed information about what is intended and
what the product is made of. Submission of a proposed label for
the product would also be helpful. The addresses and/or FAX
numbers for the Branch Chiefs are found in Chapter 18. Please
send nothing via FAX that is considered confidential.
B. PRODUCTS OR SUBSTANCES THAT DO NOT REQUIRE REGISTRATION
1. Adjuvants: An adjuvant is a subsidiary ingredient or
additive in a mixture which contributes to the effectiveness
of the primary ingredient. Adjuvants are most commonly
added to pesticides use dilutions in tank mixes by growers
•J or applicators prior to application to the crop or site to
be treated. Agricultural chemical adjuvants are grouped
according to their intended purpose in the tank mix and
include but are not limited to the following groups:
•v acidifying agents, buffering agents, anti-foam agents,
defearning agents, anti-transpirants, color adjuvants (such
as dyes and brighteners), compatibility agents, crop oil
concentrates, oil surfactants, deposition agents, drift
reduction agents, foam markers, feeding stimulants,
herbicide safeners, spreaders, extenders, adhesive agents,
suspension agents, gelling agents, synergists, wetting
agents, emulsifiers, dispersing agents, penetrants, tank and
equipment cleaners, neutralizers, water absorbants, and
water softeners. It is important to note that although
adjuvants are not subject to registration when added in tank
mixes by growers, those adjuvants intended for use in
conjunction with a pesticide in tank mixes for application
to a food or feed crop/site are required to be cleared under
the Federal Food, Drug and Cosmetic Act (FFDCA), prior to
being used. Adjuvants that are to be used with pesticides
are evaluated in a process similar to the one for inert
ingredients. Adjuvants intended for non-pesticidal uses on
a food or feed crop/site are to be cleared with the FDA
prior to being used. Refer to 21 CFR 182.99 and 40 CFR
180.1001(c) and (d).
Registrants sometimes include adjuvants as part of their
pesticide formulations. When an adjuvant is included as part of a
pesticide formulation that ingredient is included in the Agency's
review of the product for registration under 3(c)5 or 3(c)7 of
FIFRA.
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2. Devices: A device is any instrument or contrivance
(other than a firearm) intended for trapping, destroying,
repelling, or mitigating any pest or any other form of plant
or animal life (other than man and other than a bacterium,
virus, or other microorganism on or in living man or living
animals) but not including equipment used for the
application of pesticides (such as tamper-resistant bait
boxes for rodenticides),when sold separately. As stated
above in the previous section, registration is not
applicable for devices, although devices are subject to
other provisions of the law. Refer to Chapter 10 for
further information.
3. Pesticide Intermediates: Pesticide intermediates are
substances which are not themselves pesticides, but which
undergo chemical reactions resulting in the formation of a
pesticide. Pesticide intermediates are not subject to
registration under FIFRA but are subject to regulation under
the Toxic Substances Control.Act (TSCA). Questions
regarding intermediates should be referred to the Office of
Pollution Prevention and Toxics (OPPT). Pesticide
intermediates include any beginning or intermediate material
which is a chemical precursor to a pesticide active
ingredient, whether produced in situ or obtained from other
sources.
4. Pesticides and pest control organisms that have been
exempted from the registration requirements of FIFRA by the
Agency under 40 CFR Part 152, Subpart B - Exemptions.
a. Pest control organisms such as insect predators,
nematodes, and macroscopic parasites. (40 CFR section
152.20(a)).
b. Those pesticides, such as (1) certain
biological control agents and (2) certain
human drugs, that are exempted because they
are regulated by another Agency. (40 CFR
section 152.20(a)and (b)).
c. Those pesticides, such as (1) pesticide-
treated articles or substances, (2)
pheromones in pheromone traps, (3)
preservatives for biological specimens, (4)
vitamin-hormone horticultural products, and
(5) foods, that are of a character not
requiring regulation under FIFRA. (40 CFR
section 152.25)
d. Pesticides transferred between registered
establishments operated by the same producer.
(40 CFR section 152.30 (a)).
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e. Pesticides transferred between registered
establishments not operated by the same producer if the
transfer is solely for the purpose of further
formulation, packaging, or labeling into a product that
is registered and only if each active ingredient in the
- pesticide, at the time of transfer, is present as a
result of incorppration into the pesticide of either a
registered product-or a pesticide that is produced by
the registrant of the final product. (40 CFR section
152.30(b)).
f. Pesticides distributed or sold under an
experimental use permit issued under FIFRA section 5 if
the product is labeled in accordance with 40 CFR 172.6.
(40 CFR section 152.30(c)(1)).
g. Pesticides distributed or sold in accordance with
40 CFR 172.3, pertaining to use of a pesticide for
which an experimental use permit is not required.
(40 CFR section 152.30 (c)(2)).
h. Pesticides transferred within the United States
solely for export if the product is prepared and
packaged according to the specifications of the foreign
purchaser. (40 CFR section 152.30(d)). (Refer to
Section D of this chapter for a discussion on the
importation and exportation of pesticides.)
i. Pesticides distributed or sold in accordance with
the terms of an emergency exemption under FIFRA section
18. (40 CFR section 152.30(e)).
j. Unregistered, suspended, or canceled pesticides
transferred solely for purposes of disposal in
accordance with FIFRA section 19 or an applicable
Administrator's order. (40 CFR section 152.30(f)).
k. Distribution and sale of existing stocks of
formerly registered pesticides to the extent and in the
manner specified in an order issued by the
Administrator concerning existing stocks of the
pesticide. (40 CFR section 152.30(g)).
C. PESTICIDES INTENDED FOR USE ON FOOD OR FEED
No person may distribute or sell any pesticide product,
whether produced domestically or imported, that is not registered
under FIFRA, except as noted in CFR 40 sections 152.20, 152.25,
and 152.30. (Refer to Section C. of this chapter for a
discussion of pest management products that are regulated but
which do not require registration and to Section D of this
•chapter for a discussion on the importation and exportation of
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pesticides.) In addition, pesticide products intended for use on
food and/or feed crops are required to have pesticide residue
tolerances established under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
The biologically active component which is called the active
ingredient. In addition to the active ingredient, pesticide
products may contain intentionally added biologically inactive
components called inert ingredients.
As with active ingredients, inert ingredients in pesticide
product formulations are regulated under both the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended
and the Federal Food, Drug, and Cosmetic Act (FFDCA). If your
proposed labeling bears instructions for use of the product on
food or feed crops, or if the intended use of the product results
or may be expected to result, directly or indirectly, in
pesticide residues in or on food or feed (including residues of
any active ingredient, inert ingredient, metabolite, or
degradation product), you must submit a statement indicating
whether a tolerance, exemption from the requirement of a
tolerance, or a food additive regulation has been issued by the
Agency under section 408 or 409 of the Federal Food Drug and
Cosmetic Act (FFDCA). If a tolerance, exemption from the
requirement of a tolerance, or a food additive regulation has not
been issued for such residues, your application must be
accompanied by a petition for establishment of appropriate
tolerances, exemptions from the requirement of a tolerance, or
food additive regulation in accordance with 40 CFR 180.
D. IMPORTATION AND EXPORTATION OF PESTICIDES
Refer to FIFRA section 17 for information concerning the
importation and exportation requirements for pesticides. Except
for the exemptions from the requirements of FIFRA listed under 40
CFR Part 152, Subpart B (see B 1., 2., and 3 above), FIFRA
requires that before any person in any state or foreign country
can sell or distribute any pesticide in the United States, they
must obtain a registration from EPA. Pesticides produced by
foreign manufacturers and imported into the U.S. must comply with
all requirements applicable to domestic producers. In addition,
the regulations require ah importer to submit to EPA a Notice of
The active ingredient in any pesticide product is that
component which kills, or other wise controls, the target pests and
includes any substance (or group of structurally similar substances
if specified by the Agency) that will prevent, destroy, repel, or
mitigate any pest, or that functions as a plant regulator,
desiccant, or defoliant within the meaning of FIFRA section 2(a).
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Arrival of Pesticides and Devices (EPA Form 3540-1)4 for review
and determination as to whether the shipment should be sampled
-and/or permitted entry into the U.S. Applicants for importation
•of pesticides should follow the guidance on "How to Apply For
Registration of a Conventional Pesticide" in Chapter 2 of this
-manual.
FIFRA section 17 statesfthat no pesticide produced solely
for export to any foreign country, shall be deemed in violation
of FIFRA, when prepared or packaged to the specifications or
directions of the foreign producer, except that producers of such
devices are subject to sections 2(p), 2(q)(l)(A), (C), (C), (D),
(E), (G) and (H), 2(q)(2)(A), (B), (C)(i) and (iii), and (D).
FIFRA section 17(a)(2) further states that prior to the
export of any pesticide not registered under section 3 or sold
under section 6(a)(l) of FIFRA the foreign purchaser must have
-signed a Prior Informed Consent statement acknowledging that the
"purchaser understands that such pesticide is not registered for
use in the United States and cannot be sold in the United States
under FIFRA. A copy of that statement shall be transmitted to an
appropriate official of the government of the importing country.
E. TYPES OF PESTICIDE REGISTRATION YOU MAY OBTAIN
There are two general types of pesticide registrations
available. You may (1) obtain a registration for your own
product, or (2) become a supplemental registrant (often termed a
"distributor" or "subregistrant").for a product that someone else
has already registered. These types of registrations, together
with amendments to a registration, are described in more detail
below.
1. TO OBTAIN A REGISTRATION FOR YOUR OWN PRODUCT
If you wish to obtain the registration for your own
pesticide product, you are responsible for submitting
all of the information and data that are required to
support the registration. The information includes
forms, proposed product labeling, technical and
scientific data that are required on the specific
product that you intend to make (or formulate) and how
you will comply with the data compensation
requirements. See Chapter 2 for detailed instructions
on how to submit your own application for pesticide
registration.
See Chapter 17 of this manual for graphic representation of
EPA Form 3540-1.
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2. TO OBTAIN A SUPPLEMENTAL REGISTRATION TO DISTRIBUTE
A PRODUCT REGISTERED BY SOMEONE ELSE
If you do not wish to register your own product, but
would rather market a product that is currently
registered to another company and you are willing to
enter into an agreement with that company, the basic
registrant may include you as a supplemental registrant
to his registration so that you may market his product
under your name. See Chapter 5 for detailed
instructions on how to submit an application for
supplemental registration of a pesticide product.
3. TO AMEND THE REGISTRATION OF A PRODUCT YOU ALREADY
HAVE REGISTERED WITH THE EPA
If you have a product that is already registered with
the EPA, and wish to change the formulation or labeling
text (i.e., add, delete or change formulation
components or label precautionary statements, add or
change uses) you must file an application to amend the
registration of your product. There are certain
changes that you may make that do not require an
amendment application but simply require that you
notify the Agency of the change, and other changes that
require no notification at all. See Chapter 4 for
detailed instructions on how to submit an application
for amended registration of a pesticide product.
4. UNCONDITIONAL/CONDITIONAL REGISTRATION
The Agency has discretion to review applications for
registration under either the unconditional registration
criteria of FIFRA section 3(c)(5) or the conditional
registration criteria of FIFRA section 3(c)(7).
a. UNCONDITIONAL REGISTRATION: An application will be
approved under the unconditional registration criteria
only if the Agency has (1) determined that the
application is complete and is accompanied by all
materials required by FIFRA, including, but not limited
to evidence that the applicant has complied with the
data compensation requirements; (2) reviewed all
relevant data in its possession; (3) determined that no
additional data are necessary to make the
determinations required under FIFRA section 3(c)(5)
with respect to the subject product; (4) determined
that the composition of the product is such as to
warrant the proposed efficacy claims for it, if
efficacy data are required to be submitted; (5)
determined that the product will perform its intended
function without unreasonable adverse effects on the
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environment, and that when used in accordance with
widespread and commonly recognized practice, the
product will not generally cause unreasonable adverse
effects on the environment;and (6) that the product is
not misbranded according to 40 CFR 152.2(q) and
40 CFR 156; (7) determined that, if the proposed
labeling bears directions for use on food, animal feed,
or food or feed crops, or if the intended use of the
pesticide results or may reasonably be expected to
result, directly or indirectly, in pesticide residues
of any active or inert ingredient of the product in or
on food or animal feed, all necessary tolerances,
exemptions from the requirement of a tolerance, and
food additive regulations have been issued under FFDCA
section 408, section 409 or both; and (8) if the
product, in addition to being a pesticide, is a drug
within the meaning of FFDCA section 201(q), the Agency
has been notified by the FDA that the product complies
with any requirements imposed by FDA.
b. CONDITIONAL REGISTRATION;
1. Products that do not contain a new active
ingredient; The Agency may approve an application
for registration or amended registration of a
pesticide product, each of whose active
ingredients is contained in one or more other
registered pesticide products, only if the Agency
has determined that (1) it possesses all data
necessary to make the determinations required
under FIFRA sections 3(c)(7)(A) or (B), which
includes at a minimum, data needed to characterize
any incremental risk that would result from
approval of the application; (2) approval of the
application would not significantly increase the
risk of any unreasonable adverse effect on the
environment; (3) the application is complete and
is accompanied by all materials required by the
Act, including, but not limited to, evidence of
compliance with the data compensation
requirements; (4) the composition of the products
is such as to warrant the proposed efficacy claims
for it, if efficacy data are required to be
submitted; (5) the product is not misbranded
according to 40 CFR 152.2(q) and 40 CFR 156;
(6)determined that, if the proposed labeling bears
directions for use on food, animal feed, or food
or feed crops, or if the intended use of the
pesticide results or may reasonably be expected to
result, directly or indirectly, in pesticide
residues of any active or inert ingredient of the
product in or on food or animal feed, all
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necessary tolerances, exemptions from the
requirement of a tolerance, and food additive
regulations have been issued under FFDCA section
408, section 409 or both; and (7) if the product,
in addition to being a pesticide, is a drug within
the meaning of FFDCA section 201(q), the Agency
has been notified by the FDA that the product
complies with,any requirements imposed by FDA.
However, the Agency will not approve the
conditional registration of (1) any pesticide
unless it has determined that the applicant's
product and its proposed use are identical or
substantially similar to a currently registered
pesticide and use or that the pesticide and its
proposed use differ only in ways that would not
significantly increase the risk of unreasonable
adverse effects on the environment; (2) any
pesticide product for a new use if (a) the
pesticide is the subject of a special review,
based on a use of the product that results in
human dietary exposure and (b) the proposed use
involves use on a major food or feed crop, or
involves use on a minor food or feed crop for
which there is available an effective alternative
registered pesticide which does not meet the risk
criteria associated with human dietary exposure
(determined with the concurrence of the Secretary
of Agriculture).
Each registration issued for substantially similar
products and new uses shall be conditioned upon
the submission or citation by the registrant of
all data which are required for unconditional
registration of his product under FIFRA section
3(c)(5), but which have not yet been submitted, no
later than the time such data are required to be
submitted for similar pesticide products already
registered. If a notice requiring submission of
such data has been issued under FIFRA section
3(c)(2)(B) prior to the date of approval of the
application, the applicant must submit or cite the
data described by that notice at the time
specified by that notice. The applicant must
agree to these conditions before the application
may be approved.
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If any condition of the registration of the
product is not satisfied, or if the Agency
determines that the registrant has failed to
initiate or pursue appropriate action toward
fulfillment of any condition, the Agency will
issue a notice of intent to cancel under FIFRA
section 6(e) and 40 CFR 152.148.
r
2. Products that contain a new active ingredient;
An application for registration of a pesticide
containing an active ingredient not in any
currently registered product may be conditionally
approved for a period of time sufficient for the
generation and submission of certain of the data
necessary for a finding of registrability under
FIFRA section 3(c)(5) if the Agency determines
that (1) insufficient time has elapsed since the
imposition of the data requirement for those data
to have been developed; (2) all other required
test data and materials have been submitted to the
Agency; (3) the application is complete and is
accompanied by all materials required by FIFRA,
including, but not limited to evidence that the
applicant has complied with the data compensation
requirements; (4) has reviewed all relevant data
in its possession; (5) that the composition of the
product is such as to warrant the proposed
efficacy claims for it, if efficacy data are
required to be submitted; (6) that the product is
not misbranded according to 40 CFR 152.2(q) and
40 CFR 156; (7) determined that, if the proposed
labeling bears directions for use on food, animal
feed, or food or feed crops, or if the intended
use of the pesticide results or may reasonably be
expected to result, directly or indirectly, in
pesticide residues of any active or inert
ingredient of the product in or on food or animal
feed, all necessary tolerances, exemptions from
the requirement of a tolerance, and food additive
regulations have been issued under FFDCA section
408, section 409 or both; and (8) if the product,
in addition to being a pesticide, is a drug within
the meaning of FFDCA section 201(q), the Agency
has been notified by the FDA that the product
complies with any requirements imposed by FDA;
(9) the use of the pesticide product during the
period of the conditional registration will not
cause any unreasonable adverse effect on the
environment; and (10) the registration of the
pesticide product and its subsequent use during
the period of the conditional registration are in
the public interest.
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Each registration issued for a new active
ingredient shall be conditioned upon the
applicant's agreement to each of the following
conditions: (1) the applicant will submit
remaining required data (and interim reports if
required) in accordance with a schedule approved
by the Agency; (2) the registration will expire
upon a date'established by the Agency, if the
registrant fails to submit data as required by the
Agency. The expiration date will be established
based upon the length of time necessary to
generate and submit the required data. If the
studies are submitted in a timely manner, the
registration will be canceled if the Agency
determines, based on the data (alone, or in
conjunction with other data), that the product or
one or more of its uses meets or exceeds any of
the risk criteria established by the Agency to
initiate a special review. If the Agency so
determines, it will issue to the registrant a
Notice of Intent to Cancel under FIFRA section
6(e), and will specify any provisions for sale and
distribution of existing stocks of the pesticide
product; (3) the applicant will submit an annual
report of the production of the product.
If any condition of the registration of the
product is not satisfied, or if the Agency
determines that the registrant has failed to
initiate or pursue appropriate action toward
fulfillment of any condition, the Agency will
issue a notice of intent to cancel under FIFRA
section 6(e) and 40 CFR 152.148.
IMPORTANT NOTE: A Data Matrix Chart, identifying
the FIFRA Section 158 data requirements for the
product for which registration is requested, must
be submitted with your application for registra-
tion of a product containing a new active
ingredient or for registration of a new use of a
currently registered product. Failure to submit a
Data Matrix Chart with your application could
result in your application being rejected.
F. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions, or require additional information
concerning your application for registration, contact the Product
Manager assigned to the pesticide in your product. A listing of
Product Managers and a sampling of the pesticides they are
responsible for may be found in Chapter 18.
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- If you 'have questions of a general nature that do not
^pertain to any specific pesticide, or pertain to a new pesticide
^active ingredient for which you have not made an application,
^contact the Deputy Branch Chief or the Branch Chief's office for
?.the type of pesticide (i.e., insecticide, fungicide,
fantimicrobial etc.) for which you have a question. A listing of
•Ithe various Deputy Branch Chiefs, and Branch Chiefs can be found
'in Chapter 18.
If you have any questions concerning devices, whether they
are subject to the Act, or establishment registration, please
contact the Office of Compliance Monitoring, Compliance Division,
>(EN-342), Environmental Protection Agency, 401 M St., S.W.,
Washington, D.C., 20460. Telephone (202) 260-7835.
G. REFERENCES CITED IN CHAPTER 1 - Refer to Chapter 16 for
r~information on the source of these documents.
5
'&'!. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
* procedures
Part 158 - Data requirements for registration
Part 172 - Experimental Use Permits
Part 180 - Tolerances and exemptions from tolerances
for pesticide chemicals in or on raw
agricultural commodities
2. Code of Federal Regulations, Title 21
Part 182 - Substances generally recognized as safe
3. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 2 - Definitions
Section 3 - Registration of pesticides
Section 7 - Registration of establishments
1-13
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If you have questions of a general nature that do not
pertain to any specific pesticide, or pertain to a new pesticide
^active ingredient for which you have not made an application,
'contact the Deputy Branch Chief or the Branch Chief's office for
the type of pesticide (i.e., insecticide, fungicide,
antimicrobial etc.) for which you have a question. A listing of
the various Deputy Branch Chiefs, and Branch Chiefs can be found
in Chapter 18. ,
If you have any questions concerning devices, whether they
are subject to the Act, or establishment registration, please
contact the Office of Compliance Monitoring, Compliance Division,
(EN-342), Environmental Protection Agency, 401 M St., S.W.,
Washington, D.C., 20460. Telephone (202) 260-7835.
G. REFERENCES CITED IN CHAPTER 1 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
t procedures
Part 158 - Data requirements for registration
Part 172 - Experimental Use Permits
Part 180 - Tolerances and exemptions from tolerances
for pesticide chemicals in or on raw
agricultural commodities
2. Code of Federal Regulations, Title 21
Part 182 - Substances generally recognized as safe
3. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 2 - Definitions
Section 3 - Registration of pesticides
Section 7 - Registration of establishments
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CHAPTER 2 - HOW TO APPLY FOR REGISTRATION OF A PESTICIDE
A. GENERAL INFORMATION
The Agency separates pesticides into two general categories,
conventional chemical pesticides and 2) biochemical and microbial
pesticides. Refer to Chapter 3 for information on registration
requirements for biochemicals and microbial pesticides.
• B. TYPES OF PESTICIDE APPLICATIONS
The Agency categorizes pesticide applications as follows:
1. New chemical - this is an application for
registration of a product containing a new pesticide
(active ingredient) that is not an active ingredient in
a product currently registered with the Agency (40 CFR
152.114).
2. New use - this is an application for^registration of
a use for an active ingredient(s), or formulation type,
not currently included in the directions for use of any
product that contains such active ingredient(s) or
formulation type. New uses are defined in 40 CFR
152.3(p) as follows:
a. Any proposed use pattern.(i.e., one that would
result in pesticide residues in food or feed
commodities) that would require the establishment of a
tolerance, an increase in an established tolerance, or
the exemption from the requirement of a tolerance, or
food additive regulation under section 408 or 409 of
the Federal Food, Drug and Cosmetic Act (refer to
Chapter 7 for a discussion of tolerances),
b. Any aquatic, terrestrial, outdoor, or forestry use
pattern, if no product containing the active ingredient
is currently registered for that use pattern, or
c. 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 man or other
organisms to the active ingredient.
3. "Me-too" - a "me-too" is an application for registration
of a pesticide product that is substantially similar or
identical in its uses and formulation to products that are
currently registered. A more detailed discussion of a "me-
too" product is contained in Chapter 6, D., Question 1.
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IMPORTANT NOTE; If you increase the dosage rate of your
product over that which is currently registered, change a
pre-harvest interval (PHI) or make other changes which might
have an effect on the pesticide residues in food or feed
commodities or exposure to nontarget organisms, your
application is no longer considered to be a "me-too"
application. Changes^ in the inerts in your formulation,
either by varying the percent or by using inerts not
registered in a similar product, may also be a determining
factor as to whether your product is considered to be a "me-
too". If you include an unregistered source of the active
ingredient(s) in your product, the product may no longer be
considered a "me-too" product.
C. CONTENTS OF APPLICATION
Your application for registration of a pesticide must
include the following information, as applicable. For a more
detailed discussion of this information refer to 40 CFR section
152.50, Contents of Application.
1. Application Fora - An original Application for Pesticide
Registration form (EPA Form 8570-1) must be completed and
submitted with each application for registration. Detailed
instructions on completing the application form are provided
on the back of each form. It is important that you read
these instructions and that the information you provide is
complete and accurate. Be certain that the form has a red
number in the upper right hand corner since only EPA
original forms (forms with a red number in the upper right
hand corner of the document) are acceptable and also be
certain that you sign your application form.
Identity of the Applicant
Name - An applicant must identify himself. An
applicant not residing in the United States must also
designate a U.S. agent (see below), to act on his
behalf on all registration, and if necessary, tolerance
matters.
Address of record - An applicant must provide an
address in the United States for correspondence
purposes. The U.S. address provided will be considered
the applicant's address of record and the Agency will
send certain notices (i.e., those imposing legal
See Chapter 17 of this manual for graphic representation of
EPA Form 8570-1.
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requirements) and correspondence concerning the
application and any subsequent registration information
to that address. It is the responsibility of the
applicant or registrant to ensure that the Agency has a
current and accurate address.
IMPORTANT NOTE; You must keep the Agency informed of
your current name and address of record. If the
Agency's good faith attempts to contact you are not
successful, the Agency will issue in the Federal
Register a notice of intent to cancel all of your
registered products under FIFRA section 6(b) (refer to
40 CFR 152.122). You should notify the Information
Services Branch (ISB), Program Management and Support
Division (PMSD), of any changes in your company name or
address. Refer to Chapter 18 for the address.
Authorized agent - You may designate a person residing
in the United States to act as your agent. If you wish
to designate an agent, you must send the Agency a
letter stating the name and U.S. address of the agent.
You must also notify the Agency if you change your
designated agent. You may terminate a designated agent
at any time by notifying the Agency in writing.
Authorized Agent notifications are treated by the
Agency the same as company name and address changes.
Correspondence concerning authorized agents should
therefore be sent to the Information Services Branch
(ISB), Program Management and Support Division (PMSD).
2. Confidential Statement of Formula - A Confidential
Statement of Formula (EPA Form 8570-4) must be completed
and submitted with each application for registration.
Detailed instructions for completing the form and providing
acceptable information are provided on the back of the form.
Additional information can be found in 40 CFR 158.150-190.
You should also refer to 40 CFR 158.108 for additional
discussion of the product chemistry requirements.
IMPORTANT NOTE: The Confidential Statement of Formula (CSF)
is generally considered to be a document that contains
Confidential Business Information (CBI) and should not be
transmitted over FAX machines unless the sender wants to
clearly waive his or her CBI rights and states this on the
CSF.
2 See Chapter 17 of this manual for graphic representation of
EPA Form 8570-4.
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3. Draft Labeling - The product label is the written,
printed, or graphic material on, or attached to, your
pesticide product. The term "labeling" includes all labels
and all other written, printed or graphic material which
accompanies your product when sold or distributed, or to
which reference is made on the product's label or in
literature accompanying the product.
f
Five copies of your proposed draft labeling must be
submitted with your application. The draft labeling may be
typed or otherwise printed, but must be legible,
reproducible and on 8 1/2 x 11 inch paper. If bilingual
labeling is not required by the Agency and you wish to add
such text to your labeling, you may do so after notification
to the Agency. Implicit in a notification of bilingual
labeling is an assurance that the bilingual text is an
accurate translation of the English labeling text. The
Agency recognizes that translating English language terms to
Spanish may be a problem because Spanish terms from
different parts of the Spanish speaking world may have a
whole different meaning. Registrants should use the
appropriate Spanish translation for their labeling. Note
that the Agency believes the Spanish language translations
to be used for "Caution", "Warning", and "Danger" are
"Precaucion", "Advertencia", and "Peligro", respectively.
Detailed information on labeling requirements, such as the
ingredients statement, warnings and precautionary
statements, and directions for use can be found in 40 CFR
156.10. Guidance for the content and format of labels and
labeling is provided in Appendix 2-1 and Figures 1 and 2,
which are located after section I. of this Chapter.
4. Data - Three copies of all applicable data required to
support the registration of your product must be submitted
with your application. The data must be formatted in
accordance with the requirements which are provided in 40
CFR Part 158.32-34, and in PR Notice 86-5. You should also
refer to Chapter 12 of this manual, for additional guidance
on how to format your data submission. At the very minimum,
most formulated products which are substantially similar or
identical to other registered products, will be required to
submit the product specific chemistry data, which are
discussed in detail in 40 CFR Part 158.150-190. If your
product is not substantially similar or identical to another
registered product, you will also be required to submit, at
the minimum, the acute toxicity data on your product. The
toxicology data requirements can be found in 40 CFR Part
158.340. Additional information can be found in the
Pesticide Assessment Guidelines, Subdivision F. Refer to 40
CFR 158.108 for a discussion of the Pesticide Assessment
Guidelines and their relationship to the data requirements.
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In addition, the source of the active ingredient you use to
formulate your product must be registered, otherwise you
must provide, at a minimum, product chemistry data on the
technical grade of the active ingredient as well as on your
formulated product. It should be noted that although
efficacy data (product performance data) are not routinely
required to be submitted for most insecticide, fungicide or
herbicide products, it is the registrant's responsibility to
ascertain through testing that the product performs in
accordance with its labeling claims. EPA may require the
submission of the product performance data on which claims
are based.
IMPORTANT NOTE: Efficacy data (product performance data) are
routinely required to be submitted to support products that
control pests of public health significance, i.e. products
to control bacteria, viruses, mosquitoes, ticks, roaches,
fleas, rats and mice. Otherwise, efficacy data may be
required to be submitted on a case by case basis. (Note:
applicant are required to prove to themselves that the
product is efficacious when used as directed but efficacy
data need only be submitted as described above.) Refer to
40 CFR Part 158.640 for product performance data
requirements.
IMPORTANT NOTE; If you submit data that are not properly
formatted in accordance with PR Notice 86-5, or submit fewer
than the required number of copies, your application will
likely be rejected and returned.
5. FIFRA section 3(cUl)(F) [formerly 3(cUl)(D)]3 data
compensation requirements -Each applicant applying for
registration of a pesticide must comply with the data
compensation procedures under FIFRA section 3(c)(l)(F).
Refer to 40 CFR 158, especially the tables in 158.190 -
158.740, to determine what data might be required for your
particular product. No application for registration can be
approved until you comply with these requirements. Detailed
procedures are contained in 40 CFR 152.80 - 152.99. A
discussion of these requirements and the applicable forms
are discussed in Chapter 6 of this manual. You should refer
to Chapter 6 to determine how you may wish to comply with
the data compensation requirements and what forms would be
applicable for the method you choose.
The Food, Agriculture, Conservation, and Trade Act of 1990
(FACTA) and the 1991 Amendments of FACTA made a number of
amendments to FIFRA. One of those amendments was to redesignate
Section 3(c)(l)(D) as Section 3(c)(l)(F). Therefore, when citing
the data compensation section of FIFRA you should now refer to
3(c)(l)(F) and not 3(c)(1)(D).
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6. Data waivers - A waiver of data requirements occurs when
the data appear to be required by 40 CFR Part 158 but for
some scientific reason in that specific instance it is not
necessary for the data to be generated. There is often
confusion as to what a data waiver is or is not. The
regulations may say that certain data are not applicable to
a category of products such as in some of the footnoted
items in the Data Requirement Tables in 40 CFR 158.
Inapplicability of data is not a waiver of data. Or, new
data may not be necessary because there are other data that
can be substituted to fulfill the data requirement, e.g., an
applicant might submit studies done by the paint industry,
or threshold levels determined by NIOSH/OSHA to fulfil the
requirement for inhalation toxicity data for her/his
product. In this situation data are needed and appropriate,
but are already available from an existing source. Using
data from such a source is not a waiver of data.
On the other hand, waivers from the data requirements
specified in 40 CFR 158, as applicable to a category of
products, may be requested for an individual product in that
category, if that product has special features which make
the development of such data inappropriate. For example,
some products may have unusual physical, chemical, or
biological properties or atypical use patterns which would
make particular data requirements inappropriate, either
because it would not be possible to generate the required
data or because the data would not be useful in the Agency's
evaluation of the risks or benefits of the product. In
these cases the Agency will waive data requirements it finds
are inappropriate, but will ensure that sufficient data are
available to make the determinations required by the
applicable statutory standards. The Agency will also, on a
case-by-case basis, consider waiving specific data
requirements when an applicant demonstrates in writing that
the specific data are not necessary for the Agency to
address the particular concern in question. The waiver
request should be accompanied by all of the pertinent
information or references to which the applicant refers.
The applicant may, under 40 CFR 152.91, demonstrate
compliance for a data requirement by:
a) claiming that a waiver previously granted by the
Agency also applies to a data requirement for her/his
product. To document this claim, the applicant must
provide a reference to the Agency record that describes
the previously granted waiver, such as an Agency list
of waivers or an applicable Registration Standard/
Registration Eligibility Document and must explain why
that waiver should apply to his product.
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b) requesting and being granted a new waiver to satisfy
the data requirement.
An applicant who plans to request a data waiver should
discuss his plans with the EPA Product Manager responsible
for his product before developing and submitting extensive
support information for the request. To request a data
waiver, the applicant must submit a written request to the
appropriate Product Manager. The waiver request must
specifically identify the data requirement for which a
waiver is requested, and must provide specific information,
relative to each requirement for the compound in question,
explaining why the applicant thinks the data requirement(s)
should be waived, describe any unsuccessful attempts to
generate the required data, furnish any other information
which the applicant believes would support the request, and
when appropriate, suggest alternative means of obtaining
data to address the concern which underlies the data
requirement. For example, to support a waiver for
inhalation toxicity data, an applicant might submit
information showing that the product is of a nature that
precludes the potential for exposure. The Agency needs
scientifically sound information in order to make a
decisions on specific data waiver requests, simply stating
that a product is ubiquitous in nature/ or is Generally
Recognized as Safe (GRAB) is insufficient. The specific
waiver must allow the Agency to determine if the kind and
levels of exposure resulting from the proposed pattern of
use is analogous to the submitted information.
The Agency will review each data waiver request and inform
the applicant in writing of its decision. In addition, for
decisions that could apply to more than a specific product,
the Agency may choose to send a notice to all registrants or
to publish a notice in the FEDERAL REGISTER announcing its
decision. An Agency decision denying a written request to
waive a data requirement shall constitute final Agency
action for purposes of FIFRA section 16(a).
Agency decisions on data waiver requests are available to
the public at the Office of Pesticide Programs' Docket
Reading Room, Room 1132, Crystal Mall Building #2, 1921
Jefferson Davis Highway, Arlington, VA 22202 from 8:00 a.m.
to 4 p.m., Monday through Friday, except legal holidays.
7. Certification relating to child-resistant packaging - If
your product meets the criteria which requires child-
resistant packaging (refer to 40 CFR 157.20 - 157.39), you
must submit a certification that the packaging that will be
used for the product meets the child-resistant packaging
standards in 40 CFR 157.32.
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8. Restricted use classification - The Agency has classified
some or all of the uses of certain pesticides as a
"Restricted Use Pesticide". A restricted use classification
generally restricts the product "For retail sale to and use
only by Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator's certification" [40 CFR
156.10(j)(2) ]. The criteria used for determining whether
your particular product requires the restricted use
classification can be found in 40 CFR 152.170. A listing of
those pesticides that the Agency has classified for
restricted use by regulation can be found in 40 CFR 152.175.
Refer to 40 CFR 152.160 - 171 for a detailed discussion on
the classification of pesticides. A listing of all
Restricted Use Pesticides is available from the Pesticide
Information Network. See Chapter 16 for further
information.
9. Compliance With Reregistration Documents?
a. Registration Standards - Prior to the FIFRA
Amendments in 1988, the reregistration program issued
documents called Registration Standards. These
Registration Standards provided information similar to
that described under "b" below. Until the existing
Registration Standards are updated by Reregistration
Eligibility Documents, the application is to be
prepared by using the Registration Standard as
instructed under "b".
b. Rereaistration Eligibility Documents - FIFRA was
amended in 1988 and added section 4 which provides for
the reregistration of registered pesticides. As a
result, the Agency has developed a program for the
review of the pesticide active ingredient, the data
supporting the registration of products containing the
active ingredient, and their uses. Upon completion of
this review, a Reregistration Eligibility Document
(RED) is issued. The RED sets forth the Agency's
decision on whether products containing a pesticide are
eligible for reregistration. It assesses the
acceptability of existing tolerances, and describes the
need for additional data or information. Following
issuance of the RED, procedures will be implemented for
reregistration of end-use formulations. Product
specific data and revised labeling will be called in to
the Agency and evaluated during this period.
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If a RED and an accompanying data call-in (DCI) have
been issued for the active ingredient(s) contained in
your product, your application for registration must
address any data, data compensation, and labeling, or
other requirements that are applicable to your product.
D. COMPLETENESS OF APPLICATION
You are responsible for the accuracy and completeness of all
information submitted in connection with your application. The
procedures for submitting a complete application for registration
are discussed below and detailed information is contained in 40
CFR Subpart C, section 152.40 - 152.55, entitled Registration
Procedures.
A separate application for registration must be made for
each pesticide product. A pesticide product registration
;pertains to a manufacturing use product or end-use formulation
with only one set of active ingredients. Variations in active
ingredients or their percentage in the manufacturing use or end-
use formulations are considered separate products and require
separate registrations. However, EPA may approve a basic
formulation and one or more alternate formulations where only the
inert ingredients vary in a single product registration. In
addition specific types of formulated products require separate
registrations (i.e., liquids, aerosols, baits, dusts, etc.).
Your application will be screened upon receipt to determine
if it is complete. If it is determined to be complete, the
application will be processed and placed in review. Incomplete
applications will be returned without further processing. A
complete application must contain the following information which
consists of two parts, one containing administrative information
and the other containing data. As you read the information
below, you should refer to Appendix 2-2, which is located after
section H. of this Chapter, for a schematic representation of the
various documents that are required to be submitted.
ADMINISTRATIVE PORTION OF APPLICATION; The Administrative portion
of your application consists of the following documentation:
1. A properly completed Application for Pesticide
Registration/Amendment (EPA Form 8570-1, Revised 9-
88)
See Chapter 17 for graphic representation of EPA
Form 8570-4.
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2. A properly completed Confidential Statement of
Formula (EPA Form 8570-4, Revised 2-85)
3. Five legible, reproducible copies of the proposed
draft labeling for your product on 8 1/2" x 11" paper.
4. FIFRA section 3(c),(l)(F)6 data compensation forms,
as applicable. Normally the following two data
compensation forms are required to be submitted with a
typical "me-too" application for registration.
a. A properly completed Certification with
Respect to Citation of Data [EPA Form 8570-
29 (7-86)], and
b. A properly completed Formulator's
Exemption Statement [EPA Form 8570-27 (10-
86)].
You should refer to Chapter 6 of this manual for a detailed
discussion of the data compensation requirements and how
they may apply to your application.
IMPORTANT NOTE: Only one complete set of the documents in
the administrative portion of your application is required.
This information should not be bound.
IMPORTANT NOTE: The submission of obsolete editions of the
required forms is unacceptable, and will result in your
application being rejected. Unsigned forms are unacceptable
and will cause your application to be rejected.
See Chapter 17 for graphic representation of EPA
Form 8570-1.
6 The Food, Agriculture, Conservation, and Trade Act of 1990
(FACTA) and the 1991 Amendments of FACTA made a number of
amendments to FIFRA. One of those amendments was to redesignate
Section 3(c)(l)(D) as Section 3(c)(l)(F). Therefore, when citing
the data compensation section of FIFRA you should now refer to
3(c)(l)(F) and not 3(c)(l)(D).
7 See Chapter 17 for graphic representation of EPA
Form 8570-29 .
8 See Chapter 17 for graphic representation of EPA
Form 8570-27.
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DATA PORTION OP APPLICATION: The data portion of your application
must address the following types of data.
1. Product specific chemistry data - usually required for
all "me-too" applications.
2. Acute toxicity data - not required to be submitted under
the Cite-all Method of data compensation, if your product is
"substantially similar" or "identical" to another currently
registered product. Required under the Selective Method of
data compensation unless valid studies applicable to your
product are cited. Refer to footnote in Appendix 2-1.
3. Efficacy data - are routinely required to be submitted to
support products that control pests of public health
significance, i.e. products to control bacteria, viruses,
mosquitoes, ticks, roaches, fleas, rats and mice.
Otherwise, efficacy data may be required to be submitted on
a case-by-case basis. (Note:, applicants and registrants
are required to ensure through testing that the product is
efficacious when used as directed but efficacy data need
- only be submitted as described above.)
4. Generic data -these data pertain to the active ingredient
(as opposed to the total pesticide product). These data
must be submitted or cited for new uses or products not
formulated with a registered product and new chemicals.
IMPORTANT NOTE: Your application will be rejected if the
required three copies of the data are not properly bound and
formatted in accordance with PR Notice 86-5. Provide a Data
Matrix Chart of the data and corresponding EPA identifier
numbers if the Selective Method of data support is used.
See page 6-8 and Appendix 6-2.
E. INCOMPLETE APPLICATIONS
If you submit an incomplete application, the processing of
your application will not begin until the deficiencies are
corrected. The application will be returned to you, with the
deficiencies identified for correction.
IMPORTANT NOTE; New Chemical/First Food Use Screening
Process. You should be aware of PR Notice 86-4, issued
April 15, 1986, which announced the Agency policy regarding
incomplete applications for registration of pesticides under
section 3 of FIFRA. Under that policy EPA generally will no
longer accept or process any incomplete application received
after May 1, 1986, for: 1) registration of a pesticide
product containing a new active ingredient or 2)
registration of the first food use of a previously
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registered active ingredient and 3) to petitions to
establish tolerances that accompany applications for
registration of the food uses of such chemicals.
PR NOTICE 86-4 REQUIREMENTS FOR APPLICANTS. Each
application to which PR Notice 86-4 applies must be
accompanied by a transmittal document which: 1) identifies
the application as being for approval of a new chemical or
the first food use of a previously registered chemical; 2)
lists the studies and other materials required to support
the application in accordance with 40 CFR parts 152, 156,
158, and 162; 3) states that all such required studies and
other materials are submitted with or cited in the
application; 4) states which requirement each study or other
material satisfies; 5) lists the location in the application
where each item may be found; and 6) is signed by the
authorized representative of the applicant. Waivers of
specific data requirements may be requested in the
application, as provided by 40 CFR 158.45, but must be
accompanied by all information necessary to justify a
waiver.
EPA PROCEDURES UNDER PR NOTICE 86-4. 1) Screening of
applications; Before commencing full evaluation of an
application and supporting materials, the Agency will
conduct a two-stage screen of the application. In the first
stage the Agency will determine if 1) all items listed in
the transmittal document are included, 2) all material is
legible and written in English, and 3) all studies and other
materials required by regulations (40 CFR 152, 156, 158, and
162) are included. Applications found to be incomplete will
not be processed further, but will be returned to the
applicant.
Applications found during the screening process to be
incomplete or to include unacceptable studies will not be processed
further. The applicant will receive a statement of the reason(s)
for the rejection and instructions to arrange the retrieval of the
application within 10 days. If the applicant does not retrieve the
application, the Agency will send the material to the Federal
Records Center for permanent storage. The Agency may, however,
decide to retain studies included in an incomplete application for
review to aid in the evaluation of other existing or proposed
registrations.
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If the application submission passes the first-stage screen,
it will be further screened by scientific reviewers to
determine that any included studies appear to be acceptable
with regard to experimental design and conduct (see 40 CFR
158.80). If any study is found to be unacceptable in this
second-stage screen the Agency will take no further action
on the application. The application will be returned to the
applicant. ' ,
If a rejected application is resubmitted it will again be
screened as previously described.
Agency review time-tables; The Agency is committed to
perform both screening processes within 15 working days of
receipt of the application by OPP's mailroom. Applicants
will be notified by telephone when an application has been
deemed complete and acceptable for the purposes of detailed
review.
The Agency is committed to completing its review of the
studies contained in applications that pass the screen
within the following timeframes: new chemical applications
for food uses or non-food uses that require chronic toxicity
data, 375 days; new chemical applications for non-food uses
that do not require chronic toxicity data, 250 days;
applications for a first food use product, from 205 to 375
days, depending upon the amount of data that must be
submitted and reviewed. In most cases, this review will
enable the Agency to decide whether each study meets the
guideline requirements and whether there is sufficient
information to conclude that the proposed uses will not
result in unreasonable adverse effects. If the Agency finds
that additional information is required to resolve issues
that arise during its review, more time will be needed to
reach a regulatory decision.
Applications found during the screening process to be
incomplete or to include unacceptable studies will not be processed
further. The applicant will receive a statement of the reason(s)
for the rejection and instructions to arrange the retrieval of the
application within 10 days. If the applicant does not retrieve the
application, the Agency will send the material to the Federal
Records Center for permanent storage. The Agency may, however,
decide to retain studies included in an incomplete application for
review to aid in the evaluation of other existing or proposed
registrations.
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F. EXPEDITED REVIEW OF "ME-TOO" APPLICATIONS FOR REGISTRATION
Section 3(c)(3)(B) of the Federal Insecticide, Fungicide,
and Rodenticide Act requires EPA to expedite the review of "me-
too" applications for registration, i.e., products that are
"substantially similar" or "identical" to other EPA registered
pesticide products. In addition, EPA is required to (1) notify
the applicant within 45 days,of receipt of the application
whether or not the application is complete and, if it is found to
be incomplete, deny it, (2) notify the applicant within 90 days
after receiving a complete application if the application has
been granted or denied and (3) if the application is denied,
notify the applicant in writing of the specific reasons for the
denial.
l. Applications Which Qualify for Expedited Review
"Me-too" applications for registration qualify for
expedited registration under section 3(c)(3)(B) of
FIFRA. A "me-too" application for registration is one
that is "substantially similar" or "identical" to
another EPA registered product, not only in the active
and inert ingredients, but also bears the same use
pattern(s) and essentially the same use directions as
another currently registered product. You must provide
the EPA Registration Number of the currently registered
product you believe is "substantially similar" or
"identical" to your product. A "me-too" application
for registration requires only minimal supporting
product chemistry, acute toxicity and, if applicable,
efficacy data.
2. Applications Which DO NOT Qualify for Expedited Review
EPA will not expedite applications for registration of
products for which the formulation or labeling vary
from that of currently registered products, i.e., it is
not "substantially similar" or "identical" to another
EPA registered product. Examples include, but are not
limited to, products that contain (a) inerts
ingredients that do not currently exist in any other
pesticide formulation; (b) significant changes in the
percentage of active ingredient? (c) new formulation
types; (d) directions for controlling new pests; (e)
directions for new dosage rates; (f) directions for
different frequency and timing of applications; (g)
directions for use in different geographical locations
other than those previously registered; and (h)
directions for use on new sites and for new methods of
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application for that active ingredient or ingredients.
These types of changes may increase the risk to humans
or the environment through increased exposure and
therefore require more data to assess the risks.
EPA will not expedite applications for "me-too technical-
grade" or "me-too manufacturing-use" products, since
extensive product chemistry and often toxicology data are
required for these types of applications. These data are
more complex and require more time to review then the data
associated with the "me-too" applications for registration
described above in item 1.
3. How to Submit Your "Me-too" Application for Expedited
Review
If you believe your "me-too" application for
registration qualifies for expedited (fast track)
review , you should print "EXPEDITE" at the top of
the application above the words "Application for
Pesticide Registration" (EPA Form 8570-1). All
applications must be on the EPA Form 8570-1 which bears
a red unique identification number in the upper right
hand corner. You must also identify in Section II of
the application form, the EPA Registration Number and
name of the product to which you believe your product
is "substantially similar" or "identical". You must
also enclose two self-addressed, stick-on labels for
EPA to use in responding to your application. If you
are resubmitting in response to an objection letter
from EPA, your resubmission (on EPA Form 8570-1) must
be marked "Expedite-Resubmission" at the top of the
application form and must include a copy of EPA's
objection letter.
GUIDELINE FOR DETERMINING AN APPLICATION'S ELIGIBILITY FOR
FAST TRACK REVIEW; A new end-use product application
qualifies for fast track review only if the proposed
pesticide is identical or substantially similar to a
currently registered pesticide or differs only in ways that
would not significantly increase the risk of unreasonable
adverse effects on the environment, cited by EPA Reg. No.,
in your application.
An explanation of the 45/90-day expedited review process
(fast track) and detailed procedures for processing applications
under it may be found in PR Notice 89-2.
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EXAMPLES OF END USE ME-TOO APPLICATIONS THAT QUALIFY FOR
FAST TRACK REVIEW:
Applicant references similar, registered pesticide
product and submits Product Chemistry.
Applicant references similar, registered pesticide
product and submits Product Chemistry, bridging
acutes (not more than 2 studies) and confirmatory
efficacy to confirm similarity.
Applicant is repackaging a registered product.
EXAMPLES OF END USE ME-TOO APPLICATIONS THAT DO NOT QUALIFY
FOR FAST TRACK REVIEW:
Applicant references similar, registered pesticide
product and submits Product Chemistry, and
required Efficacy for Specific Formulation
purposes.
Applicant asserts similarity but does not
reference pesticide product. Submits Product
Chemistry.
Applicant references a similar pesticide product
and submits Product Chemistry and required
nitrosamine data for Specific Formulation.
Applicant does not reference a pesticide product.
Submits Product Chemistry and required nitrosamine
data for Specific Formulation.
Applicant does not reference a pesticide product.
Submits Product Chemistry and the full battery of
Acutes.
Applicant references a similar registered
pesticide product. Submits Product Chemistry, the
full battery of Acutes, and required efficacy
data.
[Mote: Applications For New Manufacturing Use Products,
including Technical Grade Products, are excluded from fast
track review by FIFRA Section 3(c)(3)(B)(i)(I).]
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You must direct your application or resubmission to the
appropriate address listed below and identify the type
of application in the address by using the abbreviation
shown below:
(APPL) - for an application for new product
registration
By Mail: -
Document Processing Desk (Appl)
Office of Pesticide Programs (H7504C)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460-0001
By courier or hand delivery:
Office of Pesticide Programs
Document Processing Desk (Appl)
Room 258, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
4. Agency Screening of Your Application for Expedited
Review
A Front End Processing Staff (FEPS) unit has been
formed to screen and process your application for
registration. The FEPS will provide an initial screen
of your application to determine if (1) it qualifies
for an expedited review in accordance with section
3(c)(3)(B), and (2) it is a complete application, i.e.,
it contains the administrative information and
applicable data identified in section D of this
chapter, and (3) the data are in compliance with the
data formatting requirements of PR Notice 86-5.
If your application passes the initial screening
process, it will be assigned a file symbol and sent to
the appropriate Product Manager Team for further
processing.
OPP uses Distribution Codes to facilitate the delivery of
mail, data submissions, etc., within the program. "APPL" is the
OPP Distribution Code for an application for new product
registration. If you are submitting an application for something
other than an application for new product registration refer to the
Distribution Codes for OPP set forth in Chapter 18 of this manual
or to PR Notice 91-5, Attachment 1. If you are unable to determine
which code is appropriate for your submission, omit the code.
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The Product Manager Team will screen the application
again, to determine that it is indeed a "me-too"
application which qualifies for the expedited review.
In addition, the Product Manager Team will determine if
the efficacy data requirements, which are routinely
required to be submitted to support products that
control pests of public health significance, i.e.,
products to control bacteria, viruses, mosquitoes,
ticks, roaches, fleas, rats and mice, have been
addressed. If the application is determined to be
complete, the application will be placed in review.
If it is determined to be incomplete, the entire
application will be returned to the FEPS. The FEPS
will notify you that the Product Manager Team has
further screened your application and determined that
your application has been determined to be incomplete.
Your application will be returned.
5. Timeframes for Agency Response to Expedited "Me-too"
Applications
a. 45 Day Response - Within 45 days of
receipt of your application, EPA will notify
you whether your application is complete or
incomplete. If your application is
determined to be complete, you will receive a
letter acknowledging receipt and the file
symbol assigned to your application. If your
application is determined to be incomplete,
you will be informed in writing of what is
needed to make the application complete. For
an incomplete application, the entire
application will normally be returned to the
address of record or to the address on the
self-addressed label, if provided. (It is
your responsibility for notifying EPA of any
changes in name or address, or of a change in
designated agent, if any, to avoid
correspondence being sent to the wrong
address). If an application is too large to
be easily mailed, EPA will contact you by
telephone and request that the application be
picked up within 10 days. If the application
is not picked up within 10 days it may be
destroyed.
IMPORTANT NOTE; If it is determined that
your application does not qualify for an
expedited review, you will be notified and
the application will be processed according
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to the regular review procedures.
Resubmissions in response to an Agency denial letter
will initiate a new 45/90 day response cycle.
b. 90 Day Response - Within 90 days of
receipt of your application which qualifies
for expedited review, EPA will conduct a full
review of the application and notify you of
the results of the review. If the initial
application was complete, the reviews are
favorable and no additional information is
required, registration will be granted. If
additional information is necessary in order
to complete our review, the application will
be denied and you will be notified in writing
of the deficiencies.
IMPORTANT NOTE: Although FIFRA requires EPA
to review applications for expedited
registration within 90 days of receipt, this
turnaround time may not be met immediately
due to a continuing backlog of applications.
However, EPA is increasing automated
resources, developing instructional aids
(this manual is one of these aids) for
applicants and making necessary procedural
changes in order to eliminate the backlog and
to meet the 90 day response time for
expedited reviews as soon as possible.
G. WHERE TO SUBMIT YOUR APPLICATION
See section F.3. of this Chapter for the address to be used
in submitting your application for expedited review to the
Agency. Refer to Chapter 18 of this manual for the address to be
used in submitting all other applications to the Agency.
H. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions, or require additional information
concerning your application for registration, contact the Product
Manager assigned the pesticide in your product. A listing of
Product Managers and a sampling of the pesticides they are
responsible for may be found in Chapter 18.
If you have any questions concerning the status of your "Me-
too" Application for Registration within the 45 day timeframe for
the Agency's notifying you of whether the application is complete
or has been denied, you should contact the Front End Processing
Staff, Registration Support Branch. Refer to Chapter 18 for the
telephone number.
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If you have questions of a general nature that do not
pertain to any specific pesticide or pertain to a new pesticide
active ingredient for which you have not made an application,
contact the Deputy Branch Chief or the Branch Chief's office for
the type of pesticide (i.e., insecticide, fungicide, herbicide,
antimicrobial, etc.) for which you have a question. A listing of
the various Deputy Branch .Chiefs and Branch Chiefs can be found
in Chapter 18. '
I. REFERENCES CITED IN CHAPTER 2 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
Part 153 - Registration policies and interpretations
Part 156 - Labeling requirements for pesticides and devices
Part 157 - Packaging requirements for pesticides and devices
Part 158 - Data requirements for registration
Part 180 - Tolerances and exemptions from tolerances for
pesticide chemicals in or on raw agricultural
commodities
2. Federal Food, Drug and Cosmetic Act, as amended
Section 408 - Tolerances for pesticide chemicals in or on
raw agricultural commodities
Section 409 - Food additives
3. Federal Insecticide, Fungicide and Rodenticide Act, as
amended, October 1988
Section 3 - Registration of pesticides
Section 4 - Reregistration of pesticides
4. PR Notice 86-4 - Submission of Incomplete Applications for
Registration of Pesticides Under Section 3 of
FIFRA. Issued by the Registration Division,
Office of Pesticide Programs, EPA, April 15,
1986.
5. PR Notice 86-5 - Standard Format for data submitted under the
Federal Insecticide, Fungicide and
Rodenticide Act, and certain provisions of
the Federal Food, Drug and Cosmetic Act.
Issued by the Registration Division, Office
of Pesticide Programs, EPA, July 29, 1986.
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6. PR Notice 89-2 - Expedited Review of Applications for
'•• Registration or Amended Registration.
§ Issued by the Registration Division, Office
i of Pesticide Programs, EPA, June 6, 1989.
"'-7. PR Notice 91-5 - Instructions for Transmitting Information to
the Office of Pesticide Programs. Issued by
the Program Management and Support Division,
Office of Pesticide Programs, EPA, September
6, 1991.
7. Listing of Restricted Use Pesticides, compiled by the
Registration Support Branch, Registration Division, Office
of Pesticide Programs, EPA.
8. Listing of Registration Standards and Reregistration
Eligibility Documents (REDs), compiled by the Document
* Management Section, Information Services Branch, Program
1 Management Support Division..
}9. Food, Agriculture, Conservation, and Trade Act of 1990,
% November 28, 1990
Subtitle H - Pesticides; Sections 1491 through 1499
10. Food, Agriculture, Conservation, and Trade Act
Amendments of 1991, December 13, -1991
Section 1006 - Amendments to FIFRA and Related
Provisions
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APPENDIX 2-1
PESTICIDE LABELING REQUIREMENTS
EPA's requirements and policies for pesticide labels and
labeling are specified in 40 CFR 156.10, Pesticide Regulatory
(PR) Notices and various decision documents for specific
chemicals (i.e., Special Reviews, Registration Standards,
Reregistration Eligibility Documents, etc.). Following are
general and specific guidelines for the contents of labels and
labeling. Sample formats are shown in Figures 1 and 2.
General Guidance
Labels and labeling must accurately communicate important
precautions and instructions to the user so that each product is
effective without causing unreasonable adverse effects to humans
or the environment. In addition, the label is a legal,
enforceable document. Therefore, labels and labeling must meet
the following general criteria:
0 Comply with EPA's regulatory requirements.
0 Be clear and understandable to the user under normal
conditions.
0 Provide accurate precautions and directions that
protect the user, other humans and the environment.
0 Contain no false or misleading statements or implied
Federal Government endorsements.
0 Clearly distinguish between language that is mandatory
and enforceable statements and language that is only
advisory and cannot be enforced.
Specific Guidance
Following is a summary of the specific items that must
appear on the label and/or labeling. The location of these items
is shown in Figures 1 and. 2, which are sample formats for
restricted use and unclassified products, respectively.
Item 1. PRODUCT NAME - The name, brand or trademark is required
to be located on the front panel, preferably centered in the
upper part of the panel. The name of a product will not be
accepted if it is false or misleading. [40 CFR 156.10(b)]
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Item 2. COMPANY NAME AND ADDRESS - The name and address of the
^producer, registrant or person for whom the product is produced
tare required on the label and should be located at the bottom of
*the front panel or at the end of the label text. [40 CFR
156.10(c)]
iItem 3. NET CONTENTS - A net contents statement is required on
all labels or on the container of the pesticide. The preferred
location is the bottom of the front panel immediately above the
company name and address, or at the end of the label text. Net
contents must be expressed in conventional American units of
fluid ounces, pints, quarts, and gallons. The net contents must
*»also be expressed in the largest suitable unit, e.g., "1 pound 10
ounces" rather than "26 ounces." In addition to American units,
net contents may be expressed in metric units. [40 CFR 156.10(dj]
Item 4. EPA REGISTRATION NUMBER - The registration number
1 assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No." or "EPA Reg. No."
The registration number must be set in type of a size and style
vsimilar to other print on that part of the label on which it
tappears and must run parallel to it. The registration number and
the required identifying phrase must not appear in such a manner
as to suggest or imply recommendation or endorsement of the
product by the Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment number,
preceded by the phrase "EPA Est." is the final establishment at
which the product was produced, and may appear in any suitable
location on the label or immediate container. It must also
appear on the wrapper or outside container of the package if the
EPA establishment number on the immediate container cannot be
clearly read through such wrapper or container. [40 CFR
156.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
required, preferably on the front panel immediately below the
product name. The ingredients statement must contain the name
and percentage by weight of each active ingredient and the total
percentage by weight of all inert ingredients, with a total of
100%. It must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the body
of other text. See Figures 1 and 2. [40 CFR 156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricultural
formulations, the pounds per gallon of active ingredient must be
indicated on the label.
Item 6C. NAMES TO BE USED IN INGREDIENT STATEMENT - The
acceptable common name, if there is one, shall be used, followed
by the chemical name. If no common name has been established,
the chemical name alone shall be used.
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Item 6D. INERT INGREDIENTS RECLASSIFIED AS ACTIVE INGREDIENTS -
If EPA has reclassified chemicals from inert ingredient status to
active ingredient status, registrants of affected products must
change the ingredient statement accordingly .If such pesticides
have food uses, tolerances may be required to be established if
the percentage of the pesticide in the product formulation
exceeds the limits set in the exemption from tolerance under 40
CFR 180.1001. (Note: If EPA has reclassified chemicals from
active ingredient status to inert ingredient status, registrants
of affected products must also change the ingredient statement
accordingly.) [40 CFR 153.125]
Item 6E. NOMINAL CONCENTRATION - The amount of active ingredient
declared in the ingredient statement must be the nominal
concentration of the product as defined in 40 CFR 158.153(i) and
described in PR Notice 91-2.
Item 7. WARNINGS AND PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together on the label
(preferably within a block outline) so as to appear with
sufficient prominence relative to other front panel text and
graphic material to make then unlikely to be over-looked under
customary conditions of purchase and use. The table below shows
the minimum type size requirements for various size labels.
Size of Label on Signal Word "Keep Out of Reach
Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement "Keep
Out of Reach of Children" must be located on the front panel
above the signal word except where contact with children during
distribution, use or storage is unlikely, or in the instances
where the pesticide has been approved for use on infants or small
children. [40 CFR 156.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement. [40 CFR 156.10(h)(1)(i)] The
signal word is also required on the side panel under Hazards to
Humans and Domestic animals (see Item 8A).
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Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
; assigned a toxicity Category I on the basis of oral, dermal, or
s inhalation toxicity, the Word "Poison" shall appear on the label
*in red on a background of distinctly contrasting color and the
: skull and crossbones shall appear in immediate proximity to the
..word POISON. [40 CFR 156. 10 (h) (1) (i) (A) ]
_* .
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the
label of pesticide products in toxicity Categories I, II, and
rill. [40 CFR 156.10(h) (1) (iii) ]
1 Item 7E. REFERRAL STATEMENT - The statement "see Side (or Back)
Panel for Additional Precautionary Statements" is required on the
front panel of all products unless all required precautionary
ts appear on the front panel. [40 CFR 156.10(h)(l)
•1
? Item 8 . SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on the
label under the heading "PRECAUTIONARY STATEMENTS." The
H preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that these
statements be surrounded by a block outline. Each of the three
hazard warning sections must be headed by the appropriate
subheadings (8A, 8B and 8C) . [40 CFR 156. 10 (h) (2) ]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route (s) of
exposure and the precautions to be taken to avoid accident,
injury or damage. These statements must be preceded by the
signal word. [40 CFR 156.10(h) (2) (i) ]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to non-
•» target organisms excluding humans and domestic animals,
# precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156. 10(h) (2) (ii) ]
During the reregistration review process the Agency may
require that the Statement of Practical Treatment include toxicity
due to skin and eye effects in addition to oral, dermal or
inhalation effects. The Agency may, in the course of that review
process,,, also require that the Statement of Practical Treatment
appear on the front panel of the label. These and other labeling
requirements resulting from the reregistration review process will
supersede the instructions in this manual.
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Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY -
Precautionary statements relating to flammability of a product
••are required to appear on the label if it meets the criteria in
40 CFR 156.10(h)(2)(iii). The requirement is based on the
results of required flashpoint determinations and flame extension
tests submitted for all products. These statements are to be
located in the side/back panel precautionary statements section,
preceded by the heading "Physical/Chemical Hazards." Note that
no signal word is used in conjunction with the flammability
statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3 (d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation). If your
product has been classified for restricted use, then these
requirements apply:
1. All uses restricted. The following statements should be
placed in a box (block outline) at the top of the front panel of
the label and labeling:
a. The statement "Restricted Use Pesticide" must appear at
the top of the front panel of the label. The statement must be
set in type of the same minimum size as required for the human
hazard signal word [see table in 40 CFR 156.10(h)(1)(iy)]. (The
signal word is determined by the product's toxicity category,
just as it is for general use products.) No statements of any
Kind may appear above this RUP statement.
b. The reason for the restricted use classification should
appear below the RUP statement. Statements may be used in
combination if there is more than one reason for the RUP
classification. Some examples of restricted use reason
statements are listed below:
1. "Acute inhalation toxicity"
2. "Acute dermal toxicity"
3. "Acute oral toxicity"
4. "Acute eye irritation"
5. "Toxic to fish and aquatic organisms"
6. "Toxic to birds"
7. "Toxic to wildlife"
2-26
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8. "Potential for groundwater contamination"
9. for teratogenicity: "Has been shown to cause birth
defects in laboratory animals"
10. for oncogenicity: "The use of this product may be
hazardous to your health. This product contains
(Chemical Name), which has been determined to
cause tumors in laboratory animals"
11. "Due to the complexity of application and use
directions"
c. A summary statement of the terms of restriction must
appear directly below this reason statement on the front panel.
If use is restricted to certified applicators, the following
.t, statement is required: "For retail sale to and use only by
' Certified Applicators or persons under their direct supervision
and only for those uses covered by the Certified Applicator's
Certification."
>2. Some but not all uses restricted. If some uses are
classified for restricted use and some are not, several courses
of action are available:
a. If you wish to include both restricted and unrestricted
uses on a single product label, you may do so, but you must label
the product for restricted use.
b. You may delete all restricted uses from your label and
submit draft labeling bearing only unrestricted uses. (Of course
you lose the uses you delete, but you may sell an unrestricted
product.)
c. You may "split" your registration, i'.e., register two
separate products with identical formulations, one bearing only
unrestricted uses, and the other bearing restricted uses. To do
so, submit two applications for registration, each containing all
forms and necessary labels. Both applications should be
submitted simultaneously. Note that the products will be
assigned separate registration numbers upon registration.
"Item 9B. MISUSE STATEMENT - All products must bear the misuse
statement, "It is a violation of Federal law to use this product
in a manner inconsistent with its labeling." This statement
appears at the beginning of the directions for use, directly
beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a restricted entry interval
(REI) has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
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Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are required
to bear storage and disposal statements. These statements are
^developed for specific containers, sizes, and chemical content.
These instructions must be grouped and appear under the heading
"Storage and Disposal" in the directions for use. This heading
must be set in the same type sizes as required for the child
hazard warning. Refer to PR Notices 83-3 and 84-1 to determine
the storage and disposal instructions appropriate for your
product(s).
Item IOC. DIRECTIONS FOR USE - Directions for use must be stated
in terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment. The directions for use must
include the following: (a) the site(s) of application, i.e.,
crops, animals, areas, or objects to be treated; (b) identifi-
cation of the target pest(s) associated with each site; (c) the
dosage rate associated with each site and pest; (d) the method of
application, including instructions for dilution, if required,
and type(s) of application apparatus or equipment required;
(e) the frequency and timing of applications necessary to obtain
effective results without causing unreasonable adverse effects on
the environment; and (f) any limitations or restrictions on use
required to prevent unreasonable adverse effects, i.e., required
intervals between application and harvest of food or feed crops,
rotational crop restrictions, warnings as required against use
in or adjacent to certain areas or on certain crops, animals or
objects. [40 CFR 156.10(i)(2)]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers or other written, printed or graphic matter which is
referred to on the label or which is to accompany the product are
called collateral labeling. Such labeling may not bear claims or
representations that substantially differ from those accepted in
connection with registration of the product. Collateral labeling
must be submitted along with the application for registration.
USE OF BILINGUAL LABELING
If bilingual labeling is not required by the Agency and you
wish to add such text to your labeling, you may do so after
notification to the Agency. Implicit in a notification of
bilingual labeling is an assurance that the bilingual text is an
accurate translation of the English labeling text. The Agency
recognizes that translating English language terms to Spanish may
be a problem because Spanish terms from different parts of the
Spanish speaking world may have a whole different meaning.
2-28
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Registrants should use the appropriate Spanish translation for
their labeling. Note that the Agency believes the Spanish
language translations to be used for "Caution", "Warning", and
•^"Danger" are "Precaucion", "Advertencia", and "Peligro",
.respectively.
MATERIAL SAFETY DATA SHEETS (MSDS)
Material Safety Data Sheets (MSDS) are Hazard Communication
Standards required by the U. S. Department of Labor's
Occupational Safety and Health Administration under 29 CFR
1910.1200. They are required for chemicals, other than
•pesticides, and serve much like the label on a pesticide product
in conveying safety information about the chemical.
FIFRA Section 2(p)(2)(A) defines labeling as "all labels and
all other written, printed, or graphic matter accompanying the
pesticide or device at any time." Including an MSDS in or on a
carton of pesticide product would meet this definition. However,
EPA does not intend to review Material Safety Data Sheets as
labeling at this time but will instead permit them to accompany a
•pesticide product under the provisions of 40 CFR 152.46(b)(3)
which permits registrants to change a product's non-mandatory
labeling or packaging, including additions or changes required by
other Federal statutes or regulations, without notification to or
approval by the EPA, providing such labeling is consistent with
the labeling requirements set forth in 40 CFR Part 156.
Registrants should note that it is possible that information on
an MSDS could conflict with a pesticide label (e.g., protective
clothing recommendations or first aid directions) and that they
should therefore assure that the MSDS and the approved pesticide
labeling are not in conflict. EPA may find a conflict to be a
misbranding violation under FIFRA section 12(a)(l)(E) as defined
in FIFRA section 2(q).
2-29
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TTgure 1. Sample Format For Restricted Use Product Label -- Products
Acute Toxicity (Toxicity Category I)
M-
{rej-
I*J-
TOA|-
ToTl—
rogj-
— >
— >
it
t(
ir
— >
>
PRECAUTIONARY STATEMENTS
> HAZARDS TO HUMANS
& DOMESTIC ANIMALS
DANGER
-> PHYSICAL OR CHEMICAL
HAZARDS
DIRECTIONS FOR USE
is a violation of Federal law
> use this product in a manner
^consistent with its labeling.
-> RE-ENTRY STATEMENT
(If Applicable)
STORAGE AND
DISPOSAL
STORAGE
DISPOSAL
SITE (CROP)
t
1
1
|3|-
1
(
1
t^r*1
RESTRICTED USE
PESTICIDE <
*
Due to (insert reason )
FOR RETAIL SALE TO AND USE ONLY BY CERTIFIED APPLICATORS
OR PERSONS UNDER THEIR DIRECT SUPERVISION AND ONLY FOR
THOSE USES COVERED BY THE CERTIFIED APPLICATOR'S
CERTIFICATION
-N
•
PRODUCT < |TJ
NAME
iCTIVE INGREDIENT: X <- &
INERT INGREDIENTS: X fjj|
OTAL 100. OOX
THIS PRODUCT CONTAINS LBS. OF PER GALLON < — [S[
— > DANGER-POISON < fTc]
• ~^— —
STATEMENT OF PRACTICAL TREATMENT <
it nu criu
SEE SIDE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
f oC"
> oE
g
SITE (CROP)
•
SITE (CROP) \
SITE (CROP)
SITE (CROP)
SITE (CROP)
,.,, _. ^ .._..
SITE (CROP)
WARRANTY STATEMENT
for example, "Due to acute oral toxicity." See page 2-20, Item 9A. 1. b. of this chapter for additional examples.
2-30
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Figure 2. Sample Format For Restricted Use Product Label -- Products With Other Than High Acute Toxicity (Toxicity Categories II, III, IV)
H-
&
(wj-
W-
w-
(wj-
— >
— >
n
tc
ir
— >
3
PRECAUTIONARY STATEMENTS
> HAZARDS TO HUMANS
I DOMESTIC ANIMALS
DANGER
> FtlVIPmiMFUTAI MA7ABUS
-> PHYSICAL OR CHEMICAL
HAZARDS
DIRECTIONS FOR USE
is a violation of Federal law
> use this product in a Manner
consistent with its labeling.
-> RE-ENTRY STATEMENT
(If Applicable)
STOIA6E AMD
DISPOSAL
STORAGE
DISPOSAL
• SITE (CROP)
*
1
1
M-
p
i
i
|TJ->I
RESTRICTED USE
PESTICIDE <
FOR RETAIL SALE TO AND USE ONLY BY CERTIFIED APPLICATORS
OR PERSONS UNDER THEIR DIRECT SUPERVISION AND ONLY FOR
THOSE USES COVERED BY THE CERTIFIED APPLICATOR'S
CERTIFICATION
-N
PRODUCT < [TJ
NAME
CTIVE INGREDIENT: X <- Sf 3C
NFRT INGREDIENTS' X 7F T*r
rOTAL 100.00X
THIS PRODUCT CONTAINS LBS. OF PER GALLON < — [iiB
— > WARNING
STATEMENT OF PRACTICAL TREATMENT <
f F CUA1 1 nUFft
it luuiiFn
If III CVFS
SEE SIDE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
IFG. tr < — \y_
HFT C^TFWTS ,. < — h
oc
H
]
... . .
SITE (CROP)
SITE (CROP)
SITE (CROP)
=^====~=
SITE (CROP)
SITE (CROP)
SITE (CROP)
WARRANTY STATEMENT
for exanple, "Due to toxicity to birds." or "Due to the complexity of application and use directions.11
this chapter for additional examples.
See page 2-20, Item 9A. 1. b. of
2-31
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Figure 3. Sample Format For Unrestricted Use Product Label.
K
PRECAUTIONARY STATEMENTS
—> HAZARDS TO HUMANS
& DOMESTIC ANIMALS
CAUTION
[SB"] > ENVIRONMENTAL HAZARDS
-> PHYSICAL OR CHEMICAL
HAZARDS
-> DIRECTIONS FOR USE
It is a violation of Federal lau
to use this product in a manner
inconsistent with its labeling.
-> RE-ENTRY STATEMENT
(If Applicable)
STORAGE AN
DISPOSAL
STORAGE
D
DISPOSAL
-> SITE (CROP)
ACTIVE INGREDIENT: X
INERT INGREDIENTS: X
TOTAL: 100.00 X
THIS PRODUCT CONTAINS IBS OF PER GALLON
KEEP OUT OF REACH OF CHILDREN
C A U T ION
STATEMENT OF PRACTICAL TREATMENT <
IF SWALLOWED
IF INHALED _
IF ON SKIN —
IF IN EYES —
SEE SIDE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
MFG. BY
CITY. STATE ===^_==
EPA REGISTRATION NO.
->ESTABLISHMENT NO.
NET CONTENTS
SITE (CROP)
SITE (CROP)
SITE (CROP)
SITE (CROP)
SITE (CROP)
SITE (CROP)
WARRANTY STATEMENT
2-32
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APPENDIX 2-2
A COMPLETE APPLICATION FOR REGISTRATION OP A TYPICAL "ME-TOO"
PRODUCT REQUIRES THE FOLLOWING DOCUMENTS
h
A. ADMINISTRATIVE PORTION OF APPLICATION! (DO NOT BIND DOCUMENTS
OR PAGES TOGETHER)
DOCUMENT 1
Application for Pesticide Registration
— (EPA Form 8570-1)
DOCUMENT 2
Statement identifying the "substantially
similar" or "identical" product
DOCUMENT 3
Confidential Statement of Formula
(EPA Form 8570-4)
DOCUMENT 4
Draft labeling (5 copies)
Formulator's
Exemption Statement
(EPA Form 8570-27)
I DOCUMENT 5
Certification with
— Respect to Citation of
Data (EPA Form 8570-29)
DOCUMENT 6
DOCUMENT 7
Data Matrix
— Chart
(Required under
the selective
method of
support ONLY)
B. DATA PORTION OF APPLICATION; (FORMATTED AS DESCRIBED IN
PR NOTICE 86-5)
Product Specific Chemistry
Data (3 copies)
DOCUMENT 1
Product Specific Acute Toxicity
Data (3 copies) *
|DOCUMENT 2 j
(Required under the selective method
of support ONLY)
TDOCUMENT 3
Efficacy Data (3 copies) if
required (routinely
required for products that
control pests of public
health significance)
* Under the selective method of support these data requirements
may be addressed by either submitting the actual data, or by
referencing EPA's Master Record Identification (MRID) number on
the Data Matrix Chart.
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CHAPTER 3 - CONSIDERATIONS FOR REGISTRATION OF A BIOCHEMICAL OR A
MICROBIAL PESTICIDE
A. GENERAL INFORMATION
The following discussion and information is a general
overview of the Agency's policies and regulations as they relate
to biochemical and microbial pesticides.
; Biochemical and microbial pesticides are generally
distinguished from conventional chemical pesticides by their
unique modes of action, target species specificity, and natural
"occurrence. In addition, low use volumes microbial pesticides
may be capable of growth and reproduction in the environment or
in suitable hosts (40 CFR 158.65). Both naturally occurring and
genetically modified microorganisms are included in the microbial
pesticide group.
Although the administrative contents of an application for
registration of a biochemical or microbial pesticide are the same
as a conventional chemical pesticide, biochemical and microbial
pesticides are subject to a different (generally reduced) set of
data requirements as specified in 40 CFR 158.690 and 158.740.
The Agency has published guidance for developing these data in
the Pesticide Assessment Guidelines, Subdivision M, Microbial and
Biochemical Pest Control Agents (see Chapter 16 of this manual
for a source.) You should also refer to Chapter 2 for general
information on submitting an application for registration, and to
Chapter 9 for additional information concerning experimental use
permits.
The Agency's policies and requirements concerning the
notification and reporting requirements for small-scale field
tests and the experimental use permit and registration
requirements for microbial pesticides under FIFRA were discussed
in detail in the Federal Register Notice of June 26, 1986 (51 FR
23313).
The Federal Register Notice of June 26, 1986, and the 40 CFR
citations provided throughout this chapter should be referred to
for detailed information on these policies and regulations.
IMPORTANT NOTE; The Agency is developing a separate registration
guidance document specifically for biochemical and microbial
pesticides that may be available by the time you receive this
manual. It is recommended that you contact the appropriate
Product Manager (see section F.) for this document and for
additional guidance prior to initiating testing, or filing an
application for registration of a biochemical or microbial
pesticide.
3-1
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IMPORTANT NOTE; Once you have obtained the data from your EUP,
follow the procedures in Chapter 2 of this manual when filing an
application for registration of a biochemical or microbial
pesticide.
B. PRODUCTS EXEMPT FROM REGISTRATION
The Agency has determined that pest control organisms such
as insect predators, nematodes, and macroscopic parasites are
exempt from the requirements of FIFRA [(see 40 CFR 152.20(a). In
addition, pheromones and identical or substantially similar
compounds labeled for use only in pheromone traps and pheromone
traps in which those chemicals are the sole active ingredient are
not subject to regulation under FIFRA [(40 CFR 152.25(b)].
IMPORTANT NOTE: The use of pheromones in traps in conjunction
with conventional pesticides, or in other application methods
(other than traps) are subject to regulation under FIFRA.
C. BIOCHEMICAL PESTICIDES
Biochemical pesticides include, but are not limited to,
products such as semiochemicals (e.g., insect pheromones),
hormones (e.g., insect juvenile growth hormones), natural plant
and insect growth regulators, and enzymes. When necessary, the
Agency will evaluate products on an individual basis to determine
whether they are biochemical or conventional pesticides.
D. MICROBIAL PESTICIDES
Microbial pesticides are microorganisms and include but
are not limited to bacteria, algae, fungi, viruses, and
protozoa used as pest control agents (40 CFR 152.20).
The data requirements in 40 CFR 158.740 apply to all
microbial pesticides, including those that are
naturally-occurring as well as those that are.
genetically modified. Each "new" variety, subspecies,
or strain of an already registered microbial pest
control agent must be evaluated, and may be subject to
additional data requirements.
Genetically modified or non-indigenous microbial
pesticides may be subject to additional (or lesser)
data requirements or information requirements on a
case-by-case basis depending on the particular
microorganism, its parent microorganism, the proposed
use pattern, and the manner and extent to which the
organism has been genetically modified. Additional
requirements may include information on the genetic
engineering techniques used, the identity of the
inserted or deleted gene segment (base sequence data or
enzyme restriction map of the gene), information on the
3-2
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control region of the gene in question, a description
of the "new" traits or characteristics that are
intended to be expressed, tests to evaluate genetic
stability and exchange, and/or selected Tier II
environmental expression and toxicology tests.
B. SMALL-SCALE FIELD TESTING LEVEL I REPORTING AND LEVEL II
NOTIFICATION REQUIREMENTS
The information provided below is a general overview of the
small-scale field testing requirements for microbial pesticides
as described in the June 26, 1986 Federal Register Notice (51 FR
23313). It is also recommended that you contact the appropriate
Product Manager listed at the end of this Chapter to determine
current policies concerning testing and registration requirements
for microbial pesticides, since these policies and requirements
are currently being revised.
Small-scale field studies are (1) terrestrial field studies
that involve 10 acres or less of land; and (2) aquatic field
studies that involve 1 surface-acre or less of water.
1. Level I reporting - Level I reporting for small-
scale field testing applies to all genetically
engineered or non-indigenous microbial pesticides not
otherwise covered by Level II notification. Detailed
information on the reporting requirements is contained
in the June 26, 1986, Federal Register Notice (51 FR
23303).
The Agency will have up to 30 days to review the above
information reported to make a preliminary determination of
the need for an experimental use permit (EUP). If, on
preliminary assessment, the test raises sufficient concerns
such that the Agency determines that additional information
or monitoring is warranted (e.g., microorganisms for which
there is limited scientific information or regulatory
experience, or that warrant specific environmental
monitoring during the test), then an EUP will be required.
In this case, the applicant has two options:
1) the applicant may apply for a permit providing the
necessary data and information required to support the
application, or
2) the applicant may provide all additional data and
information required under Level II notification.
If the latter option is chosen, the Agency will review the
full notification package and make a determination as to
whether an EUP is required.
3-3
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IMPORTANT NOTE: Since most microbial pesticides are at least
toxic to the target organism, and therefore are "pathogens", they
cannot be considered under Level I but must instead be submitted
under Level II.
2. Level II notification - Level II notification for small-
scale field testing applies to microbial pesticides:
Microbial pesticides formed by deliberately combining
genetic material from organisms of different genera,
genetically engineered microbial pesticides derived from
source organisms that are pathogens, and non-indigenous
pathogenic microbial pesticides. A pathogen is defined as
an organism that has the ability to cause disease in other
living organisms (i.e., humans, animals, plants, or
microorganisms).
Notification should include adequate background information
on the microorganism, and description of the proposed test.
Detailed information of the notification requirements is
contained in the June 26, 1986, Federal Register Notice (51
FR 23303). The Agency encourages prospective applicants to
meet with the EPA prior to submission of their notification
to discuss their field test and to determine what specific
data would be necessary to evaluate the product.
Once the supporting data have been submitted, the Agency has
up to 90 days to review each Level II notification and
determine if an EUP is required.
P. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions or require any additional
information concerning biochemical or microbial pesticides,
contact Product Manager 18 for insecticide products or Product
Manager 21 for herbicide or fungicide products. A listing of
Product Managers may be found in Chapter 18.
G. REFERENCES CITED IN CHAPTER 3 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
Part 158 - Data requirements for registration
2. Federal Register Notice, June 26, 1986 (51 FR 23303)
3. Pesticide Assessment Guidelines, Subdivision M, Microbial and
Biochemical Pest Control Agents, October 1982, (EPA No.
540/09-82-028) Environmental Protection Agency
3-4
-------
IMPORTANT NOTE: The Agency is currently revising the
Subdivision M Guidelines. The draft document dated March,
1989 is available from the Public Docket and Freedom of
Information Section, Field Operations Division. See
Chapter 18 of this manual for a contact point.
3-5
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CHAPTER 4 - HOW TO AMEND THE REGISTRATION OP A PRODUCT THAT IS
ALREADY REGISTERED
A. GENERAL INFORMATION
Except as provided below, any proposed modifications in the
; composition, labeling or packaging of a registered product must
be submitted, with an application for amended registration (EPA
Form 8570-1), to the Agency for prior approval. The application
,must contain the information required by 40 CFR 152.50, as
: applicable to the change requested. If an application for
amended registration is required, the application must be
approved by the Agency before the product, as modified, may be
legally distributed or sold.
B. AMENDMENTS THAT REQUIRE A FORMAL APPLICATION TO AMEND THE
REGISTRATION OF YOUR PRODUCT
The following types of amendments that you may wish to make
to your product registration, require that you 1) submit a formal
: application to amend the registration of your product, 2) submit
: or cite supporting data, as applicable, and 3) address the data
compensation requirements of FIFRA section 3(c)(l)(F) [formerly
3(c)(1)(D)] to the extent that they apply to your proposed
amendment.
1. "Me-Too" Amendments - "Me-too" amendments are those that
you wish to make to your product registration which include
for example, the addition of uses, revised dosage rates, or
application methods that appear on the labeling of other
currently registered products that are substantially similar
or identical to your product. Changes to your basic
formulation, other than those identified in section C. of
this Chapter, also require a formal application (EPA Form
8570-1) and Confidential Statement of Formula (EPA Form
8570-4) to amend your registration. Some of the more
general types of "me-too" amendments are discussed below.
As you read this information, you should refer to the
appropriate Appendices which are located after section H of
this Chapter.
The Food, Agriculture, Conservation, and Trade Act of 1990
(FACTA) and the 1991 Amendments of FACTA made a number of
amendments to FIFRA. One of those amendments was to redesignate
Section 3(c)(1)(D) as Section 3(c)(1)(F). Therefore, when citing
the data compensation section of FIFRA you should now refer to
3(c)(l)(F) and not 3(c)(l)(D).
4- 1
-------
a. Administrative types o* »»andmttn»« _. those
amendments, for example labeling changes (such as a
product name change) or revisions to your products
formulation which do not require supporting data,
require the following documentation. Refer to Appendix
4-1 which follows section H of this Chapter, for a
schematic representation of what documentation is
required with your application.
1) Labeling changes, other than those identified
in section C., require an Application for
Pesticide Amendment (EPA Form 8570-1), and 5
copies of the proposed labeling. Labeling changes
must comply with current regulations, policies and
format. (See Appendices 2-1 and 2-2)
IMPORTANT NOTEt The deletion of use patterns,
pests, claims, or sites of use from your
registered labeling can no longer be accomplished
as a Notificationunder PR Notice 88-6. The 1988
revisions to FIFRA [section 6 (f)], require the
Agency to publish in the Federal Register, notice
of receipt of requests to amend a registration by
deleting one or more uses from the product
labeling, in order to provide the public with
knowledge of the potential loss of a product or a
specific use of a product. This provision of the
1988 amended FIFRA supersedes this part of PR
Notice 88-6. Your application to delete uses from
your labeling must be submitted as a formal
application to amend your registration.
IMPORTANT NOTE; FIFRA section 6(F) does not apply
when a registrant simply chooses to market a
product with a subset of approved uses, but does
not formally delete the uses from its
registration. [40 CFR 152.130.]
Guidance for the content and format of labels and
labeling is provided in Appendix 2-1 and Figures 1
and 2, which are located after section H. of
Chapter 2.
2) Formula changes, revisions to your basic
formulation or alternate formula requests, other
than those identified in section C., require an
Application for Pesticide Amendment (EPA Form
8570-1), and a Confidential Statement of Formula
(EPA Form 8570-4). Five (5) copies of draft
labeling will be required if the formula revision
results in a change in the ingredient statement on
the label.
4- 2
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IMPORTANT NOTE: Revisions to the formulation of
pesticide products that control pests of public
health significance, i.e., products to control
bacteria, viruses, mosquitoes, ticks, roaches,
fleas, rats and mice, which routinely require the
submission of efficacy data to support the revised
formulation are not considered to be an
administrative amendment. Refer to the following
section on "me-too" amendments.
b. "Me-tofttl *"en'1™ent3 that require supporting data -
as indicated in 1. above, these are amendments you want
to make to your product, that already exists on another
currently registered substantially similar or identical
product. Refer to Appendix 4-2, which follows section
H of this Chapter, for a schematic representation of
what documentation is required with your application.
Depending upon your proposed amendment, your
application will require an administrative portion and
a data portion.
IMPORTANT NOTE: The discussion provided below
concerning the information to be submitted with a "me-
too" amendment is general in nature and does not cover
all possible types of "me-too" amendments. If you have
any questions as to what information should be
submitted with your application, you should contact the
appropriate Product Manager for your product.
1) A portion — includes the
following:
- Application for Pesticide Amendment (EPA Form
8570-1)
- Statement identifying the "substantially
similar" or "identical" product (by EPA
Registration No.) that is currently registered and
is labeled for the change you are proposing for
your product.
- Confidential Statement of Formula (EPA Form
8570-4), if required. This is not normally
required unless you are proposing a change in
your formulation.
- Five (5) copies of your proposed draft
labeling.lt would make the Agency's review go more
quickly if you highlight those changes on your
proposed labeling. A light colored felt tip
marker could be used to highlight the proposed
changes.
4- 3
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- Certification with Respect to Citation of Data
(EPA Form 8570-29).
- Formulator's Exemption Statement (EPA Form 8570-
27), if needed. [This is not needed if you have
already submitted it and the information is still
current and if your source is registered and your
application is not affected by PR Notice 91-8.]
- Data Matrix Chart. Required if you elect to use
the Selective Method of data compensation. The
data required to support the application may be
addressed by either submitting the actual data, or
by referencing EPA's Master Record Identification
(MRID) number on the Data Matrix Chart.
2) Data portion - includes the following data, as
applicable:
- Acute toxicity data - required if you propose a
change in the precautionary labeling or the
signal word for your product.
- Efficacy (product performance) data - may be
required if you are proposing to add a new pest
to a pesticide product that controls pests of
public health significance, i.e., products to
control bacteria, viruses, mosquitoes, ticks,
roaches, fleas, rats and mice. In addition,
changes to your basic formulation may require
additional efficacy data. You may wish to contact
the appropriate Product Manager to determine if
additional efficacy data are needed to support
your proposed amendment.
- Use specific data - may be required if you
choose not to compensate the original submitter of
the data or if the data are exclusive use.
IMPORTANT NOTE: When submitting data, 3 copies -
properly bound and formatted in accordance with PR
Notice 86-5 are required. Refer also to Chapter
12 of this manual for additional information on
submitting data.
c. Expedited Review of "Me-too" Applications for
Amended Registration
Section 3(c)(3)(B) of the Federal Insecticide,
Fungicide, and Rodenticide Act requires EPA to expedite
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the review of "me-too" applications for registration,
i.e., products that are "substantially similar" or
"identical" to other EPA registered pesticide products.
In addition, EPA is required to (1) notify the
applicant within 45 days of receipt of the application
whether or not the application is complete and, if it
is found to be incomplete, deny it, (2) notify the
applicant within 90 days after receiving a complete
application if the application has been granted or
denied, and (3) if the application is denied, notify
the applicant in writing of the specific reasons for
the denial.
1) Applications Which Qualify for Expedited Review
"Me-too" applications for amended registration
qualify for expedited registration under section
3(c)(3)(B) of FIFRA. A "me-too" application for
amended registration is one that is "substantially
similar" or "identical" to another EPA registered
product, not only in the active and inert
ingredients, but also bears the same use
pattern(s) and essentially the same use directions
as another currently registered product. You must
provide the EPA Registration Number of the
currently registered product you believe is
"substantially similar" or "identical" to your
product. A "me-too" application for amended
registration would require only minimal supporting
data (provided, of course, that the "me-too"
registrant cites existing data for that use)
depending on the type of amendment: product
chemistry, acute toxicity, or efficacy data, as
applicable.
2) Applications Which DO NOT Qualify for Expedited
Review
- EPA will not expedite applications for amended
registration of products for which the formulation
or labeling vary from that of currently registered
products, i.e., it is not "substantially similar"
or "identical" to another EPA registered product,
unless the amendment is of a nature that review of
scientific data would not be required [see FIFRA
section 3(c)(3)(B)(i)(II)]. Some examples of
products that may not be considered substantially
similar are those which involve inerts that are
(a) not currently included in registered products
or (b) will change the precautions of those
required for "similar" products; changed
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percentages of active ingredients; new pests; new
dosage rates; different frequency and timing of
applications; geographical locations other than
those previously registered; new sites; and new
methods of application. These types of changes
may increase the risk to humans or the environment
through increased exposure and therefore may
require more data to assess the risks.
- EPA will not expedite applications for amended
registration of "me-too" products proposing an
unregistered source(s) of the active ingredient,
since extensive product chemistry and often
toxicology data are required for these types of
amendments. These data are more complex and
require more time to review then the data
associated with the "me-too" applications for
amended registration described above in item 1.
- EPA will not expedite applications to amend the
labeling of your registered product to delete use
patterns, pests, claims, or sites of use. The
1988 amendments to FIFRA require the Agency to
publish in the Federal Register a notice of
receipt of such amendments, in order to provide
the public with knowledge of the potential loss of
a product or a specific use of a product.
3) How to Submit Your "Me-too" Application for
Expedited Review
If you believe your "me-too" application for
registration Qualifies for amended expedited (fast
track) review , you should print "EXPEDITE" at
the top of the application above the words
"Application for Pesticide Registration/Amendment"
(EPA Form 8570-1). All applications must be on
the EPA form 8570-1 which carries a red unique
identification number in the upper right-hand
corner. You must also identify in Section II of
the application form, the EPA Registration Number
and name of the product to which you believe your
product is "substantially similar" or "identical".
You must also enclose two self-addressed, stick-on
labels for EPA to use in responding to your
application. If you are resubmitting in response
An explanation of the 45/90-day expedited review process
(fast track) and detailed procedures for processing applications
under it may be found in PR Notice 89-2 and the examples of fast
track applications on page 4-7 of this section.
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to an objection letter from EPA, your resubmission
(on EPA Form 8570-1) must be marked "Expedite-
Resubmission" at the top of the application form
and must include a copy of EPA's objection letter.
GUIDELINE FOR DETERMINING AN APPLICATION'S
ELIGIBILITY FOR PAST TRACK REVIEW; Amend-
ments are entitled to fast track review under
two (2) conditions:
1) Any amendment (end-use product or
manufacturing-use product) that
does not require scientific review
of data;
*
2) If minimal data submitted with the
amendment for an end-use product
are for the purpose of confirming
that the changed formula or label
are identical or substantially
similar to a currently registered
pesticide cited in your amendment
application.
Minimal data could include product
chemistry, acute toxicity, or efficacy data.
Note: If your original application
qualifies for expedited review, a
resubmission of that application will
likely also qualify for expedited
review.
EXAMPLES OF AMENDMENTS THAT QUALIFY FOR PAST TRACK
REVIEW
Any amendment which asserts that the
proposed change in labeling or formula
is not significant.
.Either no data are required to be
submitted or confirming chemistry/
acute/efficacy data are submitted to
support the assertion.
Any administrative amendment (not
requiring review of data).
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EXAMPLE OF AMENDMENTS THAT DO NOT QUALIFY FOR FAST
TRACK REVIEW
Any amendment not identified above as
qualifying for fast track review will be
reviewed as a non-fast track submission.
You must direct your application or resubmission
to the appropriate address listed below and
identify the type of application in the address by
using the abbreviation shown below:
(AMEND)3 - to amend a currently registered
product
By Mail:
Document Processing Desk (AMEND)
Office of Pesticide Programs (H7504C)
U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
By courier or hand delivery:
Office of Pesticide Programs
Document Processing Desk (AMEND)
Room 258, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
4) Agency Screening of Your Application for
Expedited Review
A Front End Processing Staff (FEPS) unit has been
formed to screen and process your application for
amended registration. The FEPS will provide an
initial screen of your application to determine if
1) it qualifies for an expedited review in
accordance with section 3(c)(3)(B); and 2) it is a
complete application, i.e., it contains the
administrative information and/or applicable data
OPP uses Distribution Codes to facilitate the delivery of
mail, data submissions, etc., within the program. "AMEND" is the
OPP Distribution Code to amend a currently registered product. If
you are submitting an application for something other than an
application to amend the registration of a currently registered
product refer to the Distribution Codes for OPP set forth in
Chapter 18 of this manual or to PR Notice 91-5, Attachment 1. If
you are unable to determine which code is appropriate for your
submission, omit the code.
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identified in section B.l.b. of this Chapter; and
3) the data are in compliance with the data
formatting requirements of PR Notice 86-5.
If your application passes the initial screening
process, it will be sent to the appropriate
Product Manager Team for further processing.
The Product Manager Team will screen the
application again, to determine that it is indeed
a "me-too" application which qualifies for the
expedited review. In addition, for those
amendments that require efficacy data to be
submitted, i.e., antimicrobial products and
vertebrate pest control products, the Product
Manager Team will determine if these data
requirements have been addressed. If the
application is determined to be complete, the
application will be placed in review. If it is
determined to be incomplete, the deficiencies will
be identified and the entire application will be
returned.
5) Timeframes for Agency Response to Expedited
"Me-too" Applications for Amended Registration
a. 45 Day Response - Within 45 days of
receipt of your application, EPA will notify
you whether your application is complete or
incomplete. If your application is
determined to be complete, you will receive a
letter acknowledging receipt. If your
application is determined to be incomplete,
you will informed in writing of what is
needed to make the application complete. For
an incomplete application, the entire
application will normally be returned to the
address of record or to the address on the
self-addressed label, if provided. (It is
your responsibility for notifying EPA of any
changes in name or address, or of a change in
designated agent, if any, to avoid
correspondence being sent to the wrong
address). If an application is too large to
be easily mailed, EPA will contact you by
telephone and request that the application be
picked up within 10 days. If the application
is not picked up within 10 days it may be
destroyed.
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IMPORTANT NOTE: If it is determined that
your application does not qualify for an
expedited review, you will be notified and
the application will be processed according
to the regular review procedures.
Resubmissions in response to an Agency denial
letter will initiate a new 45/90 day response
cycle.
a. 90 Day Response - Within 90 days of
receipt of your application which qualifies
for expedited review, EPA will conduct a full
review of the application and notify you of
the results of the review. If the initial
application was complete, the reviews are
favorable and no additional information is
required, the amendment will be accepted. If
additional information is necessary in order
to complete our review, the application will
be denied and you will be notified in writing
of the deficiencies.
IMPORTANT NOTE: Although FIFRA requires EPA
to review applications for expedited
registration within 90 days of receipt, this
turnaround time may not be met immediately
due to a continuing backlog of applications.
However, EPA is increasing automated
resources, developing instructional aids
(this manual is one of those aids) for
applicants and making necessary procedural
changes in order to eliminate the backlog and
to meet the 90 day response time for
expedited reviews as soon as possible.
2. New Use Amendments - These are amendments to add "new
uses" to your product labeling that are not currently
registered for the active ingredient or combination of
active ingredients contained in your product, for example, a
new food or feed use or a change in use pattern from indoor
to outdoor use. New uses are defined in 40 CFR 152.3(p).
Your application to amend your registration should contain
an administrative portion and a data portion. Refer to
Appendix 4-3 which follows section H of this Chapter, for a
schematic representation of the types of documentation
required with your application. Your proposed amendment
will require an administrative portion and a data portion.
IMPORTANT NOTE: The discussion provided below concerning the
information to be submitted with a new use amendment is
general in nature and does not cover all possible types of
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new use amendments. If you have any questions as to what
information should be submitted with your application, you
should contact the appropriate Product Manager for your
product. You should also be aware that applications
proposing the registration of the first food use for a
previously registered active ingredient are subject to the
screening procedures in PR Notice 86-4. Under these
procedures if your application is determined to be
incomplete your application will not be processed and will
be returned.
1) Administrative portion of Amendment Application
includes the following:
Application for Pesticide Amendment (EPA Form
8570-1).
Five (5) copies of your proposed draft labeling.
In addition submit one (1) label clearly marked to
show the addition(s), deletion(s), or change(s)
you plan to make on your amended labeling. This
marked up label can be done on a copy of your
proposed label or on the label which was
previously registered. It would make the Agency's
review go more quickly, if you were to highlight
your proposed changes with a light colored felt
tip marker.
IMPORTANT NOTE: All other parts of the label
requiring prior EPA approval and not included in
your proposed amended label must remain as
previously accepted by the Agency.
Certification with Respect to Citation of Data
(EPA Form 8570-29).
Formulator's Exemption Statement (EPA Form
8570-27).
Data Matrix Chart. Required if you elect to use
the Selective Method of data compensation. The
data required to support the application may be
4 See Chapter 17 of this manual for graphic representation of
EPA Form 8570-1.
5 See Chapter 17 of this manual for graphic representation of
EPA Form 8570-29.
6 See Chapter 17 of this manual for graphic representation of
EPA Form 8570-27.
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addressed by either submitting the actual data, or
by referencing EPA's Master Record Identification
(MRID) number on the Data Matrix Chart.
2) Data portion of Amendment Application - You should
refer to 40 CFR sections 158.202 thru 158.740 to
determine what data are required to support your
proposed use. You may be required to submit data on
both the technical grade of the active ingredient and
on your formulated product. In addition, new food or
feed uses will require a petition for a tolerance or an
exemption from a tolerance. Refer to Chapter 7 of this
manual for a discussion of tolerance petitions.
IMPORTANT NOTE; Efficacy (product performance) data
are routinely required to be submitted to support your
proposed use if you are proposing a new product that
controls pests of public health significance, i.e.,
products to control bacteria, viruses, mosquitoes,
ticks, roaches, fleas, rats and mice. However, for
most uses, i.e., insecticides, fungicides, and
herbicides, the Agency does not require that these data
be submitted. Each registrant must, however, ensure
through testing that its products are efficacious when
used in accordance with label directions and commonly
accepted pest control practices. In order to generate
efficacy data for your proposed new use, it is usually
necessary to conduct large scale testing. It is
necessary to obtain an experimental use permit (EUP) in
order to carry out this testing, and if a food or feed
use is involved, temporary tolerances or exemption from
tolerance are also required. Refer to Chapter 9 of
this manual for a discussion of EUP's. You may wish to
contact the appropriate Product Manager to determine if
additional efficacy data and EUP's are needed to
support your proposed amendment.
IMPORTANT NOTE: When submitting data, 3 copies,
properly bound and formatted in accordance with PR
Notice 86-5 are required. Refer also to Chapter 12 of
this manual for additional information on submitting
data.
C. AMENDMENTS THAT DO NOT REQUIRE A FORMAL APPLICATION TO AMEND
THE REGISTRATION OF YOUR PRODUCT
As provided in 40 CFR 152.46, there are certain changes or
amendments that can be made to your registered product that do
not require you to make a formal application to amend your
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registration, and are not subject to the data compensation
provisions of FIFRA section 3(c)(l)(F) . Refer also to PR
Notice 88-6.
1. NOTIFICATIONS - Changes that YOU can make to vour
registered product that require Agency notification* but not
approval.
As provided in 40 CFR section 152.46(a), there are certain
changes, or amendments, you may make to your registration,
provided that you notify the Agency that you have made the
change before the product with the changes is distributed or
sold. You need not obtain Agency approval of such changes,
or amendments, and you may distribute or sell the product,
as changed, as soon as you submit your notification of the
change to the Agency.
You should note, however, that with each notification the
Agency reserves the right to require that you submit a
formal application for amended registration. If a formal
application is required, the Agency will notify you and
* state the reasons for requiring a formal application for
amended registration in lieu of your notification. If, as a
result of our request you fail to submit a formal
application for amended registration without good cause, the
Agency may determine that the product is no longer in
compliance with the requirements-of FIFRA, and initiate
cancellation proceeding under FIFRA section 6. In addition,
you should be aware that your notification to the Agency is
considered to be a report filed under FIFRA for the purposes
of FIFRA section 12(a)(2)(M). In part, FIFRA section 12
(a)(2)(M) states that it is unlawful for you to distribute
or sell your pesticide product, if you have knowingly
falsified any part of any application for registration
submitted to the Agency.
' a. LABELING CHANGES
The following label revisions may be accomplished by
notification. Notification of these changes must be
accomplished by submission of an Application for
Pesticide Registration/Amendment (EPA Form 8570-1)
marked "Notification".
The Food, Agriculture, Conservation, and Trade Act of 1990
(FACTA) and the 1991 Amendments of FACTA made a number of
amendments to FIFRA. One of those amendments was to redesignate
Section 3(c)(l)(D) as Section 3(c)(l)(F). Therefore, when citing
the data compensation section of FIFRA you should now refer to
3(c)(l)(F) and not 3(c)(l)(D).
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may market your product under separate brand names
provided you notify the Agency of the additional
brand name(s) you intend to use. Each name must
differ from the name of any other product that you
have registered, so as to permit clear
identification of the product in case of
emergency. However, you should continue to refer
to the product by its official name of record
(i.e., the name of your product as it appears on
the Notice of Registration, unless a product name
change was approved by the Agency) in all
correspondence with the Agency.
IMPORTANT NOTE: The additional brand name must
not be false or misleading. In accordance with 40
CFR 156.10(a)(5) and (b)(2), a product is
considered to be misbranded if its labeling is
false or misleading in any particular way.
Accordingly, product names may not contain words
such as i.e., "safe" or "natural" which are
considered to be implied safety claims. In
addition, product names may not contain words
which imply additional unapproved uses or efficacy
claims that are more promising than the product
can actually produce, such as the kinds of pest
the product will control, i.e., "ABC Fireant
Control" where the product will not control
fireants and fireant is not one of the pests on
the product label; "XYZ Six Month Roach Spray",
where there is no data to support the "six month"
efficacy claim; or "AZ Total Control Insecticide"
where the product does not offer total control.
Where appropriate data exists to support such
claims they may be submitted for consideration to
the appropriate Product Manager as a formal
application for amended registration.
In addition, claims such as "professional
strength", "extra strength" and similar statements
may not be used on your product labeling,
including in the product name. (Refer to PR
Notice 91-7 for more information).
Note that the addition of a brand name should not
be confused with supplemental registration by a
different company under agreement with you (Refer
to Chapter 5 - Supplemental Registration).
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Also note that you may not change the actual
product name of record (as opposed to the brand
name) without making a formal application to amend
your registration and receiving approval prior to
sale or distribution.
2) Use off bilingual labeling. If bilingual
labeling is not required by the Agency, you may
add such text to your labeling after notification
to the Agency. Implicit in a notification of
bilingual labeling is an assurance that the
bilingual text is an accurate translation of the
English labeling text. The Agency recognizes that
translating English language terms to Spanish may
be a problem because Spanish terms from different
parts of the Spanish speaking world may have a
whole different meaning. Registrants should use
the appropriate Spanish translation for their
labeling. Note that the Agency believes the
Spanish language translations to be used for
"Caution", "Warning", and "Danger" are
"Precaucion", Aviso", and "Peligro", respectively.
3) Changes in warranty. You may, after
notification to the Agency, make changes in the
warranties or warranty disclaimers on the label.
4) other labeling revisions. You may, after
notification to the Agency, make changes in
labeling language consistent with 40 CFR Part 156,
provided the changes do not involve changes in the
ingredients statement, precautionary statements or
directions for use.
5) Final printed labeling. After acceptance of a
new product registration or labeling amendment,
final printed labeling must be submitted before
the product is sold or distributed. Such labeling
may be submitted as a notification provided that
three (3) copies of the final labeling are
submitted which incorporate any labeling changes
required by the acceptance letter.
Final printed labeling is the label or labeling
which will accompany the pesticide product when
distributed or sold and includes not only the
container label, but also all accompanying
technical information, brochures, etc., but does
not include the package of the product, unless the
labeling is an integral part of the package.
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Final printed labeling for the Agency's files
should be of a size that can be stored
conveniently in 8 1/2 x 11 inch files. The label
may be mounted or photoreduced to meet the size
requirements provided the printing is legible and
is of microfilm reproduction quality. Should
photoreduction make any of the text illegible, the
text must be typed out on an accompanying sheet of
paper.
Paste on labeling should be submitted as is,
unless it requires photoreduction.
Screen printed labeling should be printed by
taping paper on the container as it goes through
the printing process. The actual container should
not be submitted.
Embossed labeling should be photocopied.
Unusual size labeling, such as large bags or
boxes, must be photoreduced either in one
reduction or in sections so that each section is 8
1/2 x 11 inches.
IMPORTANT NOTE: The following labeling changes cannot
be submitted as a notification. A formal Application
for Amended Registration (EPA Form 8570-1) must be
submitted for Agency approval.
a) The deletion of use patterns, pests, claims, or
sites of use from your registered labeling can not
be accomplished as a notification. The 1988
revisions to FIFRA [section 6 (f)], require the
Agency to publish in the Federal Register, notice
of receipt of requests to amend a registration by
deleting one or more uses from the product
labeling, in order to provide the public with
knowledge of the potential loss of a product or a
specific use of a product. In order to delete
uses from your labeling, other than for the
distribution or sale of a product under labeling
bearing any subset of any subset of the approved
directions for use as provided for under 40 CFR
152.130, you must submit a formal application to
amend your registration and receive Agency
approval.
b) Addition of sites or uses.
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c) Deletion of precautionary language or
restrictions.
d) Any actions concerning an unregistered product
or an application for amended registration which
has not been accepted by the Agency.
b. PRODUCT CHEMISTRY CHANGES
The following product chemistry changes may be
accomplished by notification. Notification of these
changes must be accomplished by submission of a revised
Confidential Statement of Formula (EPA Form 8570-4),
together with an Application for Pesticide
Registration/Amendment Form (EPA Form 8570-1), marked
"NOTIFICATION".
1) Active ingredient - You may change the source
of an active ingredient in your product by
notification to the Agency, provided that the
alternate source(s) is an EPA-registered product.
This applies whether the alternate source is
purchased by you from another company, or is part
of an integrated system [as defined in 40 CFR
158.153(g)] used by you.
IMPORTANT NOTE: The following changes are not
acceptable as notifications; a formal Application
for Amended Registration (EPA Form 8570-1), and
EPA approval roust be obtained prior to sale and
distribution:
a. You may not make any change in the source
of an active ingredient, or any other change
in the formulation, This change will require
a formal application for amended registration
and Agency approval.
b. You may not make any change in the source
of an active ingredient which necessitates
changing either the nominal concentration of
a solvent or that of any other inert
ingredient so that it would exceed its
certified limits. This would be considered
Registrants of products containing or manufactured with
Chlorofluorocarbons (CFCs), Hydrochlorofluorocarbons (HCFCs),
Carbon tetrachloride, or Methyl chloroform should refer to
PR Notice 92-3 "Pesticides and the Clean Air Act: Stratospheric
Ozone Protection", issued March 19, 1992, for instructions
regarding amendment of such labels.
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an alternate formulation and require a formal
application for amended registration and
Agency approval. Such a change may result in
significant changes in the toxicological or
chemical properties of the product.
c. You may not change to an unregistered
source of an active ingredient without
submitting a formal application for amended
registration, with the required product
chemistry data, and obtaining EPA approval
prior to sale and distribution.
d. You may not add, delete or substitute
active ingredients by notification. The
addition, deletion, or substitution of active
ingredients constitutes a new formulation
which requires a separate registration.
e. You may not make a change in the stated
nominal concentration of any active
ingredient, or add certified limits not shown
on the previously submitted Confidential
Statement of Formula (EPA Form 8570-4). Such
changes require a formal application for
amended registration and Agency approval.
2) inert ingredients
a) If for any reason, you have been required
by the Agency to identify the source of an
individual inert ingredient whose identity
and composition are known to you, you may
change the source of that inert ingredient by
notification to the Agency.
If you have not been required by the Agency
to identify the source of an individual inert
ingredient, you may change sources freely,
without notification to the Agency.
b) Y6u may change, by notification, the
stated nominal concentration of any other
Note that the Agency believes that if you go above one-
tenth (1/10) of the concentration of that presently approved the
toxicity of the product may be affected. Appropriate acute
toxicity data may have to be generated to make this determination.
If a change does result labeling revision and data will be required
to be submitted to the Agency as a regula amendment. In some cases
you may be required to submit an application for a new product.
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inert ingredient provided the certified
limits for that ingredient are not exceeded
and the composition of the ingredient is
known to you.
IMPORTANT NOTE: Note particularly that all
of the above changes in a), b), and c) are
limited to inert ingredients whose complete
identity or specific composition is known to
you, such as specific solvents or common
commodity diluents. Changes in proprietary
ingredients, which generally are composed of
a mixture of ingredients and whose
composition is not disclosed to you, may not
be made by notification but must be made by
a formal application for amended
registration and Agency approval. Since you
do not know the composition of such inert
ingredients, the Agency must determine its
acceptability based upon information on its
composition supplied by the producer.
3) Starting materials for integrated system
products
If you produce a product by an integrated system,
[defined in 40 CFR 158.153(g)], you are required
to supply the Agency with the sources of the
starting materials.for each such ingredient. If
you propose to change the source of your starting
materials, you may do so by notification to the
Agency if the change will not result in:
a) a significant increase in the level of any
existing impurity of toxicological concern
(to exceed the upper certified limit of that
impurity), or
b) the formation of any new impurity at a
level greater than 0.1 percent by weight of
the technical grade active ingredient.
4) Change in formulation process
You may, by notification, modify a formulating
operation [defined in 40 CFR 158.153(c)], i.e., a
unit operation such as blending, diluting or
drying, as distinguished from a unit process
involving a chemical reaction, provided that the
certified limits of the active and inert
ingredients will not change as a result.
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C. HOW TO SUBMIT NOTIFICATIONS
1) To submit a notification, you must use the
Application for Registration/Amendment Form (EPA
Form 8570-1), and write the word "NOTIFICATION PER
PR NOTICE 88-6" Prominently in the explanation
part of Section II. A separate application (EPA
Form 8570-1) must be submitted for each product
registration for which you are submitting a
notification.
If a product chemistry notification is being made,
a new Confidential Statement of Formula (EPA Form
8570-4) must accompany the notification
application, together with a copy of the latest
accepted Confidential Statement of Formula.
If a labeling change notification is being made,
the revised label text should be included as an
attachment, including "before" and "after" text
for comparison. On the "after" labeling, text
which has been revised should be highlighted,
preferably with a light colored felt tip marker,
for easy comparison. A final printed label and
the latest accepted labeling are required for this
purpose.
2) Certification of Compliance - each notification
must bear in Section II of the Application for
Pesticide Registration/Amendment (EPA Form 8570-1)
the statement "This is to certify that this
notification meets every requirement of PR Notice
88-6".
IMPORTANT NOTE: Only you, the registrant or your
authorized agent may submit a notification. Each
notification must be properly signed and dated.
In accordance with 40 CFR 152.46(a) if the Agency
determines that formal application for amended
registration must be submitted rather than a
notification your application will be returned and
the Agency will require that it be resubmitted as
a formal application for amended registration.
You are also responsible for ensuring that the
labeling of any distributor or supplementally
registered product you may have is in compliance
with FIFRA. (Refer also to 40 CFR section
156.10.)
4-20
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2. NON-NOTIFICATIONS - Changes to vour registration that
can b> mad* without notifying th< agency.
In accordance with 40 CFR section 152.46(b), the following
changes can be made in the product's labeling or packaging
without notification to or approval by the Agency:
a. Correction of typographical or printing errors in
the labeling.
b. Changes in the net contents necessary to accommodate
changing package sizes or contents variability,
provided such changes would not require changes in the
use directions, or the requirement for child-resistant
packaging under 40 CFR Part 157, or other Agency
requirements pertaining to size.
c. The use of metric units in addition to standard U.S.
units for net contents, dosages and other numeric
expressions.
d. Routine changes in the name and address of the
registrant on the label. A registrant is required to
keep the Agency current as to his address of record;
therefore an address change necessitates informing the
Agency. However, such changes may be made on labeling
as soon as they occur. A separate letter must be sent
to the Information Services Branch (ISB), Program
Management and Support Division (PMSD), notifying the
Agency of the changed company name and/or address. See
Chapter 18 for the address.
IMPORTANT NOTE; If you change your name and/or
address, and fail to notify the Agency, and the
Agency's good faith attempts to contact you are not
successful, the Agency will issue in the Federal
Register a notice of intent to cancel all of vour
products under FIFRA section 6(b).
e. Revision, addition, or deletion of non-mandatory
label elements, such as the following:
1) Inclusion of the DOT hazard diamond when a
shipping container is also the immediate container
offered for sale,
2) Addition of State-required analysis of the
fertilizer component of a pesticide/fertilizer
product,
3) Inclusion of lot or batch codes, or other
production identifiers, or
4-21
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4) A date that indicates date of manufacture or
label approval.
5) Addition of State-required analysis of a wood-
preservative product.
IMPORTANT NOTE; Any statement directly or
indirectly implying that the pesticide or device
is recommended or endorsed by any agency of the
Federal Government constitutes misbranding under
FIFRA section (2)(q)(1)(A) and 40 CFR 156.10(a)
(5)(v), and is a violation of section 12(a)(l)(F)
of FIFRA.
f. Redesign of label format that does not modify
approved label text, consistent with the format
requirements of 40 CFR section 156.10. These may
include, among other things, changes in label color,
type size or style, use of space, configuration or
placement of label elements.
IMPORTANT NOTE; Changes in color or type size should
not reduce the readability of the labeling text or
minimize the precautionary statements.
D. SUBMISSION OF FINAL PRINTED LABELING
When submitting final printed labeling for Notifications or
Non-Notifications, you must use the Application for
Registration/Amendment (EPA Form 8570-1). A separate application
must be submitted for each product registration. Indicate the
reason for the submission in the explanation part of Section II.
1. Notifications and non-notifications
The final printed labeling for all notifications must be
submitted before the product, as revised, is sold or
distributed. The final printed labeling may be submitted as
the notification, thereby requiring only one submission.
The Agency expects that final printed labeling for a
notification, or a formal amendment under FIFRA section 3,
will include non-notification changes also. However, no
submission of final printed labeling is required for changes
that are only "non-notifications".
2. Labeling for amendments requiring a formal application to
amend the registration
After approval of an amendment based upon draft labeling,
final printed labeling must be submitted before the product,
as revised, is sold or distributed. The Agency expects that
4-22
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this final printed labeling will include non-notification
changes that may have been made after submission of the
f approved draft labeling, but prior to printing the final
-:- printed labeling for submission to the Agency.
•JE. INCOMPLETE APPLICATIONS
If you submit an incomplete application, the processing of
your application will not begin until the deficiencies are
corrected. Incomplete applications will be returned, with the
deficiencies identified, for correction.
P. LEGAL COMPLIANCE - ENFORCEABLE
You are reminded that you are entirely responsible for the
content and accuracy of labeling, and for compliance with
labeling requirements, whether or not the Agency chooses to
1 review and approve labeling changes. Any product that is
misbranded under FIFRA section 2(q), or that is in violation of
FIFRA section 12 may be the subject of an enforcement action.
G. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions or require any additional
information as to whether the changes you propose to make under
this chapter are appropriate, contact the Product Manager
assigned to the product in question. A listing of Product
Managers may be found in Chapter 18.
If you have any questions concerning the status of your "Me-
too" Application for Amended Registration within the 45 day
timeframe for the Agency's notifying you of whether the
application is complete or has been rejected, you should contact
the Front End Processing Staff. Refer to Chapter 18 for the
telephone number.
H. REFERENCES CITED IN CHAPTER 4 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
Part 156 - Labeling requirements for pesticides and devices
Part 157 - Packaging requirements for pesticides and devices
Part 158 - Data requirements for registration
4-23
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2. Federal Insecticide, Fungicide and Rodenticide Act, as amended
October, 1988.
Section 2 - Definitions
Section 3 - Registration of pesticides
Section 6 - Administrative review; suspension
Section 12 - Unlawful acts
3. PR Notice 86-4 - Submission of Incomplete Applications for
Registration of Pesticides Under Section 3 of
FIFRA, Issued by the Registration Division,
Office of Pesticide Programs, EPA, April 15,
1986.
4. PR Notice 88-6 - Change in Registration Procedures - Agency
Approval Not Required for Certain Amendments.
Issued by the Registration Division, Office
of Pesticide Programs, EPA, August 12, 1988.
5. PR Notice 89-2 - Expedited Review of Applications for
Registration or Amended Registration.
Issued by the Registration Division, Office
of Pesticide Programs, EPA, June 6, 1989.
7. PR Notice 91-5 - Instructions for Transmitting Information to
the Office of Pesticide Programs. Issued by
the Program Management and Support Division,
Office of Pesticide Programs, EPA, September
6, 1991.
6. PR Notice 91-7 - False and Misleading Statements.
Issued by the Registration Division, Office
of Pesticide Programs, EPA, December 30,
1991.
7. PR Notice 92-3 - Pesticides and the Clean Air Act:
Stratospheric Ozone Protection. Issued by
the Office of Pesticide Programs, EPA, March
19, 1992.
4-24
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APPENDIX 4-1
TYPICAL ADMINISTRATIVE AMENDMENTS FOR A LABELING CHANGE OR A
REVISION TO THE BASIC FORMULATION REQUIRE THE FOLLOWING DOCUMENTS
A. AMENDMENT FOR AN ADMINISTRATIVE LABELING CHANGE:
(DO NOT BIND DOCUMENTS OR PAGES TOGETHER)
DOCUMENT 1
Application for Pesticide Amendment
— (EPA Form 8570-1)
DOCUMENT 2
L
Draft labeling (5 copies)
1 marked up copy of label
showing where additions,
deletions, and changes
have been made
B. AMENDMENT FOR REVISION TO YOUR BASIC FORMULATION *;
(DO NOT BIND DOCUMENTS OR PAGES TOGETHER)
DOCUMENT 1
Application for Pesticide Registration
— (EPA Form 8570-1)
DOCUMENT 2
Confidential Statement of Formula
(EPA Form 8570-4)
DOCUMENT 3
Draft Labeling (5 copies) ,
if required
I I
1
1
1
1
1
1
1
1
1 1
1
1 1
1
(1 marked up copy of
label if labels are
required)
* Revisions to the basic formulation for antimicrobial and
vertebrate pesticide products generally require supporting
efficacy (product performance) data, and are not considered to be
administrative amendments. (Refer to Appendix 4-2)
4-25
Materials Belong To-
OPPT Library '
401 M Street, SW (TS-793)
Washington, DC 20460
-------
APPENDIX 4-2
A TYPICAL "ME-TOO" APPLICATION TO AMEND THE REGISTRATION OF A
REGISTERED PRODUCT, REQUIRES THE FOLLOWING DOCUMENTS
A. ADMINISTRATIVE PORTION OF APPLICATION; (DO NOT BIND DOCUMENTS
OR PA6ES TOGETHER)
Application for Pesticide Amendment
(EPA Form 8570-1)
Statement identifying the "substantially
i similar" or "identical" product
O"
DOCUMENT 1
Ap
DOCUMENT 2
— _
,DOCUMENT_3_j
1
DOCUMENT 4
Formulator's
Exemption Statement
(EPA Form 8570-27)
DOCUMENT 5
Confidential Statement of
Formula (EPA Form 8570-4),
if required
— Draft Labeling (5 copies)
1 marked-up copy of label
Certification with
Respect to Citation
of Data (EPA Form
, 8570-29)
DOCUMENT 6
i
DOCUMENT 7
l.
Data Matrix
Chart
(Required under
the selective
method of
support ONLY)
' ~ ~ ~" ""/-,"",." i
1 ° 1 j-
1 1
1 1 |
[DOCUMENT i ! I
i • - ~ - - i
i
YDOCUMEI
Fi
°ij-
IT 2 ! |
i
j
i
i
86-5)
Toxicity Data * (3 copies) if required
Efficacy Date * (3 copies) if
required
* Under the selective method of support these data requirements
may be addressed by either submitting the actual data, or by
referencing EPA's Master Record Identification (MRID) number on
the Data Matrix Chart.
4-26
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APPENDIX 4-3
A TYPICAL APPLICATION TO AMEND THE REGISTRATION OP A REGISTERED
PRODUCT TO ADD A NEW USE, REQUIRES THE FOLLOWING DOCUMENTS
*A. ADMINISTRATIVE PORTION OF APPLICATION; (DO NOT BIND DOCUMENTS
OR PAGES TOGETHER)
DOCUMENT 1
Application for Pesticide Amendment
- (EPA Form 8570-1)
DOCUMENT 2
L.
DOCUMENT 3
-•Formulator's
^Exemption Statement
(EPA Form 8570-27)
Draft labeling (5 copies)
1 marked copy of label
Certification with Respect to
Citation of Data (EPA Form
8570-29)
DO8UMENT 4
Data Matrix Chart
DOCUMENT 5
(Required under the
Selective method of
Support ONLY)
B. DATA PORTION OF APPLICATION; (FORMAT AS DESCRIBED IN PR NOTICE
86-5)
DOCUMENT 1
Data as required by 40 CFR 158.202 thru
— 158.740 * (3 copies)
!DOCUMENT 2 \
Efficacy Data * (3 copies) if
required
* Under the selective method of support these data requirements
may be addressed by either submitting the actual data, or by
referencing EPA's Master Record Identification (MRID) number on
the Data Matrix Chart.
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CHAPTER 5 - HOW TO APPLY FOR SUPPLEMENTAL REGISTRATION OP A
REGISTERED PESTICIDE
A. GENERAL INFORMATION
40 CFR 152.132 provides specific information on the
supplemental distribution or supplemental registration of another
registered pesticide. A supplemental registration is also
referred to as a "distributor product."
40 CFR 152.132 states that a registrant may distribute or
sell his/her registered product under another person's name and
address instead of (or in addition to) his/her own. Such
distribution and sale is termed "supplemental distribution" and
the product is referred to as a "distributor product." The
distributor is considered an agent of the registrant and both the
registrant and the distributor may be held liable for violations
pertaining to the distributor product.
IMPORTANT NOTE: 1) Supplemental registrations are only an
extension of a currently registered pesticide product. They are
a duplication of the basic registration and must reflect any
changes made to the basic registration within the same timeframe
imposed on the basic registration. 2) If the basic registration
is canceled, the supplemental registration is automatically
canceled effective the same date as the basic registration.
B. REQUIREMENTS FOR SUPPLEMENTAL DISTRIBUTION APPROVAL
Supplemental distribution is permitted upon notification to
the Agency if all the following conditions are met:
1. The registrant of the product for which the second
party wishes to obtain supplemental registration has
submitted to the Agency a statement (EPA Form 8570-5,
Notice of Supplemental Registration of Distributor)
signed by both the registrant of the basic registered
product and the second party ("the distributor"). The
following information is required on the application
form:
a. The name and address of the basic
registrant and the registration number of the
registered product;
b. The name and address of the distributor,
the distributor's company number, and the
name of the product to be used on the product
you plan to distribute. If you do not
already have a company number assigned to
your company, a company number will be
assigned by the Agency upon written request,
5-1
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to the Registration Division's Registration
Support Branch. Refer to Chapter 18 for the
address.
IMPORTANT NOTEt The second party (the "Distributor")
must have a company number prior to your notification
to the Agency of supplemental distribution. (See
section D of this Chapter.)
2. The product the "Distributor" intends to distribute
must be produced, packaged, and labeled in a registered
establishment operated by the same producer who
produces, packages, and labels the basic registered
product.
3. The "Distributor's" product may not be repackaged:
it must remain in the basic registrant's or producer's
original unopened container. However, a "Distributor"
may repackage the registered product for the
distributor's use if he/she has a contract with the
basic registrant to do so, and if the "Distributor" has
his/her establishment registered. Refer to Chapter 11
which explains how to obtain an establishment
registration.
4. The labeling associated with the product the
"Distributor's" wishes to distribute must be the same
as that of the basic registered product, except that:
a. The product name of the "Distributor's"
product may be different from that of the
basic registrant's, but it may not be
misleading;
b. The name and address of the
"Distributor's" company may appear instead of
that of the basic registrant's name and
address;
c. The EPA registration number of the
registered product must be followed by a
hyphen, followed by the "Distributor's"
company number; (For example, if the
registration number of the basic registrant's
product is EPA Reg. No. 999999-88888, and
the "Distributor's" company number is 777777,
then the "Distributor's" number that would
appear on the label would be EPA Reg. No.
999999-88888-777777);
5-2
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d. The establishment number must be that of
the final establishment at which the
registered product.was produced and/or
packaged; and,
e. Any specific claims on the basic
registrant's label, such as the sites of
application or pests to be controlled, may be
deleted from the "Distributor's" label
provided that no changes are necessary in any
of the precautionary or other labeling of the
basic product,
IMPORTANT NOTE! The "Distributor" may not make
additions to the basic registrants label (for example,
add claims, additional sites or pests), nor alter the
precautionary labeling statements or directions for
use.
C. WHERE TO SUBMIT AN APPLICATION FOR SUPPLEMENTAL REGISTRATION
OF A DISTRIBUTOR PRODUCT
The registrant of the basic product should submit the
completed application to:
Document Processing Desk (DIST)
* Office of Pesticide Programs - H7504C
U.S. EPA
401 M St., S.W.
Washington, D.C. 20460
v, D. WHERE TO REQUEST A COMPANY NUMBER AND ESTABLISHMENT
REGISTRATION
If you do not already have an EPA assigned company number,
submit your request in writing to the Registration Support
t Branch. Refer to Chapter 18 for the address. If you plan to
enter into a contract to produce a pesticide an establishment
registration for each separate location must first be obtained
from the Agency. Refer to Chapter 11.
E. REFERENCES CITED IN CHAPTER 5 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
2. EPA Form 8570-5
5-3
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CHAPTER 6 - WHAT ARE THE DATA COMPENSATION REQUIR1
A. GENERAL INFORMATION
By the late 1960's the amount of scientific data that was
^required to support the registration of a pesticide began to
increase rapidly. Applicants and registrants who were required
to generate these data, which were quite costly, asked Congress
to provide protection for their investment, since by the time
they obtained their registration or amended registration, most of
or all of the pesticide's patent life had expired. Other
registrants were then able to obtain a registration for the same
type of product by relying on the data generated by the original
data submitter, without having to share the burden of the cost of
generating the data. In response to this concern, Congress
amended the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) in 1972. Section 3(c)(l)(D) of the amended FIFRA (which
tfwas changed to 3(c)(l)(F)) placed data compensation
•t obligations on those applicants for registration of a pesticide
who would use the data submitted by another applicant or
registrant in support of their own application for registration.
Kin 1978, a second amendment to FIFRA granted "exclusive use"
rights, for a 10 year period, to the original data submitter for
certain data that were submitted to support the first
registration of a product containing a new pesticide (active
ingredient) or combination of active ingredients. An applicant
•must satisfy these data compensation requirements to obtain a
'registration, reregistration, or amend the registration, of a
registered product.
In order for the Agency to evaluate your application for
• registration or to amend the registration of a registered
'product, data must be submitted to support the application or
amendment. The applicant is responsible for supplying the data
. necessary for the Agency to make this evaluation. You may
address the data requirements in several ways. One method is to
i develop and submit all of the data necessary to support your
application, a second method would be to rely on data that has
been submitted to the Agency by other applicants in support of
their applications for registration, and a third method would be
to develop some of the data to support your application and to
rely on other's data to complete your data requirements.
The Food, Agriculture, Conservation, and Trade Act of 1990
(FACTA) and the 1991 Amendments of FACTA made a number of
amendments to FIFRA. One of those amendments was to redesignate
Section 3(c)(l)(D) as Section 3(c)(l)(F). Therefore, when citing
the data compensation section of FIFRA you should now refer to
3(c)(l)(F) and not 3(c)(1)(D).
6- 1
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If you rely on data that were developed and submitted to the
Agency in support of another persons application for
registration, you must comply with the data compensation
provisions of section 3(c)(l)(F) [formerly 3(c)(l)(D)] of FIFRA.
Section 3(c)(1)(D) [now 3(c)(1)(F)] established two
categories of data.
1. One category of data pertains to that data submitted in
support of the registration of a pesticide containing active
ingredients that were first registered after September 30,
1978, and to the data submitted with an application to add a
new use to the original registration. These data are termed
"exclusive use" data and the Agency may not consider these
data to support your application for registration for a
period of 10 years after the date of initial registration,
unless you have written authorization from the original data
submitter authorizing the Agency to use these data to
support your application. After the 10 year "exclusive use"
period has expired, you may still be required to offer to
compensate the data submitter for use of the data, but
written authorization from the data submitter is no longer
needed.
2. The second category of data pertains to data submitted
after December 31, 1969, in support of an application for
registration, experimental use permit, or amendment adding a
new use to an existing registration, to support or maintain
an existing registration, or for reregistration. The Agency
may, without the permission of the original data submitter,
consider such data to support an application by another
applicant within the 15 year period following the date the
data were originally submitted to EPA only if the applicant
has certified to the Agency that he/she has made an offer to
compensate the original data submitter.
40 CFR Parts 152.80-99 and 152.116-119 provide detailed
information on how you may comply with the data compensation
provisions of FIFRA section 3(c)(l)(F).
B. WHEN MUST YOU COMPLY WITH THE DATA COMPENSATION PROCEDURES?
1. The data compensation procedures apply to the following:
a. Each application for registration of a new product,
and
b. Each application for an amendment of a registration,
except as noted below.
2. The data compensation procedures do not apply to the
following types of registration applicationsr.
6- 2
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a. Applications for experimental use permits, or
b. Applications to make the following amendments to
existing registrations unless it is determined that
scientific data would be necessary:
1) An increase or decrease in the percentage of
one or more of the active ingredients or
deliberately added inert ingredients in a product,
2) A revision of the identity or amount of
impurities in the product,
3) The addition or deletion of one or more
deliberately added inert ingredients,
4) The deletion of one or more active ingredients,
5) A change in the source of supply of one or more
of the active ingredients used in the product, if
the new source of the active ingredient is a
product which is registered under section 3 of
FIFRA,
6) Deletion of approved uses from the label,
7) Redesign of the label format, which involve no
substantive changes in the directions for use,
claims, representations, or precautionary
statements,
8) Change in the product name, or addition of an
additional brand name,
9) Clarification of directions" for use,
10) Corrections of typographical errors,
11) Changes in the registrant's name and address,
12) Adding or deleting supplemental registrants
(distributors),
13) Changes in the package or container size,
14) Changes in warranty, warranty disclaimer, or
liability limitation statements, or addition or
deletion of such statements,
15) "Splitting" the label for the purpose of
marketing the product in different geographic
regions with appropriate labels, where each
6- 3
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amended label will contain previously approved use
instructions (and related label statements)
appropriate to a particular geographic region, and
16) Any other type of amendment, if the Agency
determines that scientific data would not be
needed in order to approve the amendment.
C. WHAT INFORMATION MUST YOU SUBMIT WITH YOUR APPLICATION FOR
REGISTRATION OR AMENDED REGISTRATION ?
1. FORMULATOR'S EXEMPTION STATEMENT (EPA Form 8570-27)
Under FIFRA section 3(c)(2)(D) you are excused (i.e.,
eligible for the femulator's exemption) from the requirement to
submit or cite data pertaining to the safety of any ingredient,
or mixture of ingredients, contained in your product if the
source(s) of each of these ingredients is an EPA registered
product, and you purchase each active ingredient from another
producer.
a. Application for registration - If your product
contains one or more active ingredients eligible for
the formulator's exemption, you need not comply with
the requirements of 40 CFR 152.90 through 152.96, with
respect to any data requirements pertaining to the
safety of these ingredients provided you submit a
completed Formulator's Exemption Statement (EPA Form
8570-27) with your application for registration.
b. Application for amended registration - You are not
required to submit a new Formulator's Exemption
Statement if your current statement on file with the
Agency is complete and accurate. However, if you
change from a registered source of any active
ingredient to an unregistered source, you are required
to submit an application for amended registration,
together with a revised Confidential Statement of
Formula. If your new source of the ingredient is not
registered, you are no longer eligible for the
formulators's exemption for that ingredient.
IMPORTANT NOTE; Since data costs associated with EPA's
reregistration program has caused many basic producers
to request the deletion of uses which are important to
many users, special provisions are made available to
third party data producers which may affect the
availability of the formulators1 exemption to certain
registrants. Refer to PR Notice 91-8 for important
details.
6- 4
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2. Certification With Respect to citation of Data (EPA Form
8570-29)
The Agency has developed this form to enable you to certify
how you will comply with data compensation requirements
under FIFRA section 3(c)(l)(F). In order to comply with the
FIFRA section 3(c)(l)(F) data compensation requirements, you
must:
a. Submit an acXnovledqement of reliance on data in
accordance with 40 CFR 152.86(d) you must include an
acknowledgement that for purposes of FIFRA section
3(c)(l)(F) your application relies on the following
data:
1) All data submitted with or specifically cited
in your application, and
2) Each item of data in the Agency's files which:
(a) concerns the properties or effects of
your product, of any product which is
identical or substantially similar to your
product, or of one or more of the active
ingredients in your product, and
(b) Is one of the types of data the Agency
would require to be submitted if you sought
initial registration under FIFRA section
3(c)(5) of a substantially similar or
identical product, at the time the Agency
approves your application for registration.
Item 1 on the Certification with Respect to Citation of
Data form (EPA Form 8570-29) satisfies this
acknowledgement requirement.
b. Exclusive use data certification - Effective
beginning September 30, 1978, exclusive use data
pertains to those data that were submitted to the
Agency in support of the registration of a new active
ingredient, a new combination of active ingredients, or
an application to amend the original registration to
add a new use, for a period of 10 years after the
initial registration has been issued. In order for the
Agency to consider these data in support of your
application for registration or amendment, you must in
accordance with 40 CFR 152.86(a) certify to the Agency
that you have obtained from each data submitter listed
on the Data Submitters List, and/or the bibliography of
6- 5
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an applicable Registration Standard, as an exclusive
use data submitter written authorization which contains
at least the following information:
1) Identification that you are the applicant to
whom the authorization is granted,
2) Written authorization has been granted to you
by the data submitter to allow the Agency to use
all applicable data to satisfy the data
requirements for the application in question, and
3) The signature and title of the original data
submitter or his authorized representative and the
date of authorization.
If the Agency identifies any exclusive use data
submitter not on the Data Submitters List or in the
bibliography of a published Registration Standard, you
will also be required to obtain written authorization
from that person.
(The Data Submitters List is a listing of data
submitters which are listed under the active ingredient
chemical code numbers. Refer to Chapter 16 of this
manual for information on how to obtain the Data
Submitters List. A source of published Registration
Standards and Registration Eligibility Documents (REDs)
is also listed in Chapter 16.)
Item 2 on the Certification with Respect to Citation of
Data form (EPA Form 8570-29) satisfies this exclusive
use certification requirement.
IMPORTANT NOTE; You must submit with your application a
copy of the letter of authorization from the exclusive
use data submitter authorizing use of these data by the
Agency, to support your application for registration.
c) Data other than exclusive usa data - You must, in
accordance with 40 CFR 152.86(b), certify to the Agency
that with respect to each other data submitter on the
Data Submitters List, and/or the bibliography of an
applicable Registration Standard [40 CFR 152.90(a)(1)]
or RED, for the active ingredient in question:
1) You have obtained from that person written
authorization containing the information
identified above under "Exclusive use data" or,
6- 6
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2) You have furnished to that person:
(a) A notification of your intent to apply
for registration, including the name and a
list of the active ingredients in the
proposed product,
(b) An offer to pay the person compensation,
to the extent required by FIPRA section
3(c)(1)(F), for any data required to support
your application,
(c) An offer to commence negotiations to
determine the amount and terms of
compensation, if any, to be paid for the use
of the data, and
(d) Your name, address, and telephone number.
Item 3 on the Certification with Respect to
Certification of Data form (EPA Form 8570-29) provides
methods for satisfying these requirements.
d. Methods for complying with th* data compensation
requirements of FIFRA section 3(c)(l)(P) - There are
two methods of complying with the data compensation
requirements, these are 1) the "cite-all" method and 2)
the "selective" method of support. These two methods
are described below. In addition, a table (Appendix
6-1 which follows section E of this Chapter) comparing
these methods is also provided.
1) THE CITE-ALL METHOD OF SUPPORT - You may comply
with the data compensation requirements under the
cite-all method (40 CFR 152.86) for your
application to register a new product or to amend
a product you already have registered by:
(a) citing all pertinent data in the Agency's
files involving "exclusive use" data only
with the written permission of the exclusive
use data submitter, or
(b) citing all pertinent data in the Agency's
files, no exclusive use data involved, with
permission of the original data submitter or
by offering to pay compensation for use of
the data in accordance with FIFRA section
3(c)(l)(F), and
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(c) submitting to the Agency a General offar
to pav statement, in accordance with 40 CFR
152.90(0), in which you state your offer and
agree to pay compensation to other data
submitters to the extent required by FIFRA
section 3(c)(1)(F).
If you check the first box in item 3 of the
Certification with Respect to Citation of Data
form (EPA Form 8570-29), and sign the General
Offer to Pay statement at the bottom of the form,
you are certifying to the Agency that you have
complied with these requirements.
IMPORTANT NOTE; In accordance with 40 CFR 158.99,
an original data submitter may petition the Agency
to deny or cancel your registration if he has
submitted a study that he claims satisfies a data
requirement and for which you have either failed
to receive authorization to use, or have not made
a proper offer to pay compensation.
2) THE SELECTIVE METHOD OF SUPPORT - You may
comply with the data compensation requirements
under the selective method by listing the specific
data requirements that apply to your product, its
active ingredients, and use patterns, and
demonstrating compliance with the data
requirements by either submitting the actual
studies, or citing individual studies, or by
demonstrating that no study has been previously
submitted to the Agency (a data gap). Refer to 40
CFR 152.90 for a detailed discussion of the
selective method, and sections 152.91 through
152.96 for specific procedures for citing or
submitting a study or for demonstrating a data
gap.
IMPORTANT NOTE: The Data Gap option may not be
available to certain applicants, i.e., those
seeking the registration of a product containing a
new active ingredient or those seeking to add a
new use pattern to a registered product.
If you chose the Selective Method of complying
with the data compensation requirements you must:
(a) submit the Certification with Respect to
Citation of Data form (EPA Form 8570-29) on
which you have checked the second box in item
3, indicating you have chosen the Selective
Method, and
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(1) sign the signature block immediately
below, or
(2) if you are using the cite all option
under the Selective Method to address
specific data requirements [see
b)(2)(iii) and (iv) below], sign the
last signature block on the form.
b) submit a data matrix chart which addresses
the items listed below. Refer to Appendix 6-
2, which follows section E. of this Chapter,
for a sample data matrix format and
instructions on how to complete it.
(1) List of data requirements applicable
to your product [see 40 CFR 152.90(a)].
The list must be based on the data
guidelines in 40 CFR Part 158 - Data
Requirements for Registration, a
Registration Standard or a
Reregistration Eligibility Document
(RED) for the active ingredient(s) in
your product, if applicable. Refer to
Chapter 16 of this manual for a source
of the Registration Standards that have
been issued.
(2) How you intend to satisfy each of
the data requirements identified on the
data matrix chart. There are several
ways to satisfy these data requirements.
(i) Reference data originally
submitted to the Agency by you, the
applicant [See 40 CFR 152.93(a)].
(ii) Reference data previously
submitted to the Agency by someone
other than you and obtain their
permission to cite the data. You
must certify that you have obtained
written authorization from the
original data submitter. For an
exclusive use procedures outlined
in section C.2.a.l), must be
followed. Refer also to 40 CFR
152.93(b)(1).
(iii) Reference data previously
submitted to the Agency by someone
other then you (that is not an
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exclusive use study) and make a
proper offer to pay to such person
(40 CFR 152.93(b)(2).
(iv) Reference all data in the
Agency's files pertinent to the
specific data requirement and make
a proper offer to pay to all data
submitters on the Data Submitter's
List for those specific data (40
CFR 152.90).
(v) Submit data not previously
submitted or submit data from the
public literature (40 CFR 152.94).
(vi) Document waivers of data
previously allowed by the Agency
(40.CFR 152.91). Refer to Chapter
15 of this manual for information
on how to obtain information on
chemicals for which data waivers
have been granted.
(vii) Demonstrate that a data
gap(s) exist. Submit a completed
EPA Form 8570-28, Certification of
Compliance with Data Gap Procedures
(see 40 CFR 152.96). Note: The
Data Gap option may not be
available to certain applicants,
i.e., those seeking the
registration of a product
containing a new active ingredient
or those seeking to add a new use
pattern to a registered product.
IMPORTANT NOTE: The Data Tables and
bibliography in an applicable
Registration Standard and/or
Reregistration Eligibility Document
can be very helpful in developing a
data matrix.
D. DATA COMPENSATION CHARGES/PAYMENT DISPUTES
40 CFR 152, Subpart E - Procedures To Ensure Protection of
Data Submitters' Rights [specifically 40 CFR 152.80; 152.86
(b)(2)(iii); 152.93 (b)(2)(iv); 152.95(b)(2)(iv); 152.99 (a)(i)
and 152.99(a)(iii)] describes the procedures by which data
submitters may challenge registration actions which allegedly
failed to comply with FIFRA section 3(c)(l)(F). Applicants
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relying on another person's data to support their registration
-^are required to certify to the Agency, with respect to each
^person on -the Data Submitters List, for the chemical in question,
; an offer to commence negotiations to determine the amount and
terms of compensation, if any, to be paid for the use of any
FIFRA sections 3 (c) (1) (F) (ii) [formerly 3 (c) (1) (D) (ii) and
3 (c) (2) (B) (iii) states that the terms and amount of compensation
may be fixed by agreement between the original data submitter and
the applicant, or, failing such agreement, by binding arbitration
under the procedure and rules of the Mediation and Conciliation
'Service. The arbitrator to be appointed from the roster of
arbitrators maintained by such Service. The findings and
determination of the arbitrator shall be final and conclusive,
and no official or court of the United States shall have power or
jurisdiction to review any such findings and determination,
^except for fraud, misrepresentation, or other misconduct by one
;>of the parties to the arbitration or the arbitrator. All parties
to the arbitration shall share equally in the payment of the fee
4and expenses of the arbitrator. Refer to 29 CFR 1440 for details
*on the arbitration procedures.
E. QUESTIONS AND ANSWERS
The following questions are those most frequently asked by
^interested persons regarding data compensation procedures:
1. Question: What is a "me-too product"?
Answer; The term "me-too product" refers to a pesticide
product that is identical or substantially similar to
another pesticide product that is currently registered
by EPA.
' The term "identical product" means a product, when
• compared to a currently registered product:
a) Contains the same active and intentionally
added inert ingredients, and in the case of a
technical grade product, the same impurities,
each ingredient being the same percentage,
and
b) Includes identical or substantially
similar uses.
The term "substantially similar product" for a non-
technical grade product, e.g., an end-use product,
means a product when compared to a currently registered
product :
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a) Contains the same active ingredients,
b) The percentages of the active ingredients
and the intentionally added inerts and their
percentages may vary only to the extent that
it is reasonable to conclude that the hazards
are not different from those associated with
the registered product, and
c) Includes identical or substantially
similar uses.
The term "substantially similar product" for a non-end-
use product, e.g., a manufacturing-use or a
formulating-use only product (including technical grade
products), means a product when compared to a currently
registered product:
a) Contains the same active ingredient,
b) The percentage of the active ingredient
and the impurities and their percentages may
vary only to the extent that it can be
reasonably established that the hazards are
not different from those associated with the
registered product, and
c) Includes identical or substantially
similar uses.
2. Question: When applying for a registration of a "me-too
product" under the Cite-all Method of Support, must I submit
additional information other than 1) a completed and signed
Application for Registration form (EPA Form 8570-1), 2) a
completed and signed Confidential Statement of Formula (EPA Form
8570- 4),3) proposed labeling, and 4) a completed and signed
Certification With Respect to Citation of Data (EPA Form 8570-
29)?
Answer; Yes, routinely more information is required.
First, you must tell us the name and EPA registration
number of the currently registered product that you
believe your proposed product is identical with or
substantially similar to. Second, since product
chemistry data are specific to each formulation, you
must submit the product chemistry required in 40 CFR
section 158.20 unless you are certain that your
proposed formulation is identical to the registered
product you have cited to support your "me-too" claim.
Please note however, that short of extensive chemical
analysis, there are only a few ways to be certain that
your proposed formulation is identical to the
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registered product you cite. These ways include
situations where the cited product's label actually
identifies each active and inert ingredient and
associated percentages, or you produce or repackage
the cited product.
An Application for Amended Registration for an
amendment involving data requirements would be a
situation analogous to an application for registration
of an identical product.
If, during our review of your application, we find that
the product you have cited as the "me-too" is not at
least substantially similar to your proposed product,
we will inform you that you are not eligible for the
Cite-All Method of Support and will have to either
identify another product as the "me- too" or proceed
under the Selective Method of Support. If you chose to
proceed under the Selective Method of Support you may
have to actually generate data to support your
application for registration.
If you are eligible for the formulator's exemption,
usually this will involve a requirement to submit
product chemistry and acute toxicology data.
Occasionally, efficacy data may also be required. In
those cases where new chemicals or changed use patterns
are involved, extensive data requirements may be
imposed.
3. Question: After reading the regulations, it is my belief that
if I simply repackage a registered technical grade,
manufacturing-use or end-use product and use the same labeling, I
need only claim the formulator's exemption under FIFRA section
3(c)(2)(D) and not submit any other information under the Cite-
all or Selective Method of Support or include any product
specific data, e.g., product chemistry, acute toxicity or
efficacy data.
Answeri You are correct provided you simply repackage
another registered product and do not change the purchased
formulation in any manner.
In this case your application for registration would consist
of an Application for Registration (EPA Form 8570-1), a
Confidential Statement of Formula (EPA Form 8570-4), the
Formulator's Exemption Statement (EPA Form 8570-27) and 5
copies of your draft labeling.
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4. Quest ion i When I submit an application for a '"me-too"
amendment to the registration of my product, and data is required
to support the proposed amendment, under the data compensation
requirements do I have to again offer to pay compensation for all
of the data necessary to support the registration of the entire
product, or only offer to pay compensation for the data necessary
to support the amendment?
Answer; Your entire product is subject to the data
compensation provisions including your amendment.
There are several reasons for this requirement. Data
(either generic data or product specific data) may have
been submitted to the Agency to fill data gaps since
you first offered to pay compensation with your initial
application for registration for your product, or when
it was last amended. Also, some of the data initially
used to support your registration may have been
determined to be unacceptable and may have been
replaced. As a result, if additional data are required
to support the proposed amendment to your registration,
your entire product including the proposed amendment is
subject to the data compensation requirements of
section 3(c)(l)(F) of FIFRA, within the limits
prescribed by your eligibility under the formulator's
exemption under section 3(c)(2)(D) of FIFRA.
There are several possible situations, as discussed below,
which are dependent on whether you choose the cite-all or
selective method of support.. It is assumed that you are
eligible for the formulator's exemption for the active
ingredient(s) in your product, and that your labeling
claims, or use patterns, do not exceed those supported by
the labeling of the product from which you are formulating.
Cite-all Method of Support; If you wish to use the
cite-all method of support (and you are eligible for
the formulator's exemption), you must make written
offers to pay to all of the data submitters listed on
the Data Submitter's List who have claimed product
specific types of data for each active ingredient in
your product. Since product-specific chemistry data is
generally required to be submitted by you to support
your initial application for registration, and is
unique to a particular formulated product, these data
which were furnished by you would not normally be
subject to the data compensation requirements. Acute
toxicity data would be compensable since these data
could support the registration of any number of similar
or identical products, and are not necessarily product
specific. If EPA has not issued a Registration
Standard or RED for one or more of the active
ingredients contained in your product, you must write
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all of the data submitters on the Data Submitters List
for each of the active ingredients contained in your
product. The offer to pay must identify your total
product as well as your amendment.
Selective Method of Support! If you wish to use the
selective method of support (and you are eligible for
the f emulator's exemption) you must submit a data
matrix chart with appropriate information as to how
each data requirement is to be satisfied for your total
product as well as for the amendment, taking into
consideration the most up to date information, i.e.,
the data tables and bibliography in the most recent
Registration Standard or Reregistration Eligibility
Document(if any) or the data tables in 40 CFR Part 158.
Since product-specific chemistry data is generally
required to be submitted by you to support your initial
application for registration, these data would not
normally be required for an amendment to your
registration. Acute toxicity data would need to be
addressed, if additional acute toxicity data were
required to support the amendment or a previously
submitted study was invalidated. If a data matrix
previously submitted in support of the product's
initial registration or amendment is still valid, and
no additional data are required, you may reference that
data matrix in support of your current application for
amended registration. If additional data are required
to support your current amendment request, an updated
data matrix should be submitted.
5. Question; I have obtained letters from companies on the Data
Submitters List who say that they do not want any compensation
for their data. May I use these letters as if they were giving
me permission to use their data?
Answer: You may not. The data submitter must
explicitly grant permission and cannot be presumed to
do so. However, only in the case of exclusive use is
explicit permission required. Otherwise, if you go
through the proper data compensation procedures,
permission from the data submitter is not required.
6. Question: I have in my files a number of letters from data
submitters that give me permission to use their data to support
my application for registration. May I use these letters to
support my application without getting new authorization?
Answer; Yes, provided those letters are written to
clearly state that they cover your present application
either specifically or generically and they also give
permission to use the relevant data to support your
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application for registration. If this is the case, you
may certify to the Agency that you have received
written permission to cite the data.
The Agency will honor the terms and conditions of an
original letter of authorization to cite data and will not
accept a letter withdrawing that authorization unless both
the original data submitter and the registrant(s) or
applicant(s) relying on the data submitter's data agree that
such authorization has been withdrawn. See PR Notice 91-6.
7. Question: If I have a product that contains multiple active
ingredients, some of which are purchased from registered sources
and others that are not, may I claim a formulator's exemption for
those active ingredients that are purchased from registered
sources?
Answer: Yes, you may, unless use patterns on your label
are not supported by your source. See PR Notice 91-8.
Submit a properly completed Formulator's Exemption
Statement (EPA Form 8570-27).
8. Question: May I use an unregistered source of an active
ingredient to formulate my product.
Answer: Yes, you may. It is not a violation of FIFRA to
purchase and use an unregistered product in the formulation of
your product. However, you should be aware that administrative
complications and data requirements are reduced if your source of
the active ingredient(s) is registered. Normally it is illegal
under FIFRA to sell or distribute an unregistered pesticide, and
this also pertains to unregistered sources of the active
ingredient. However, in accordance with 40 CFR 152.30, you may
use an unregistered source provided the source is:
a. Reformulated into a registered product within the same
registered establishment.
b. Transferred from one EPA registered establishment to
another EPA registered establishment, both of which are
owned or leased by the same company.
c. Transferred between two EPA registered establishments not
operated by the same producer if:
1) the transfer is only for the purpose of further
formulation, packaging or labeling into a product that
is registered, and
2) each active ingredient in the pesticide, at the time
of transfer, is present as a result of incorporation
into the pesticide of either:
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i) a registered product; or
ii) a pesticide that is produced by the registrant
of the final product; and
3) the product as transferred is labeled in accordance
with 40 CFR 156.
d. Transferred by a producer who does not have actual or
constructive knowledge that his product is intended to be
used or is used for pesticidal purposes (40 CFR 152.15(c)).
.Therefore, should you decide to use an unregistered source of an
active ingredient, you need to be aware that you are responsible
for providing any information or data the Agency would need to
accept that new source for registration. If the unregistered
•„ source is to replace the original registered source of an active
$ ingredient in your currently registered product, it may not be
> added to your product until the Agency has approved the new
unregistered source. Finally, you should also be aware that the
; use of an unregistered source of an active ingredient will cause
i you to be ineligible for the formulator's exemption provision
under FIFRA section 3(c)(2)(D), at least for the active
ingredient(s) from the unregistered source.
9. Question: May I use both the Selective and Cite-All Methods of
4 Support for one product application, if I have more than one
T active ingredient in my product?
Answer; Yes, you may.
$ 10. Question; If I use the Cite-All Method of Support, do I also
-have to submit a list of data requirements and references?
.-, Answer; No, the cite-all method requires-no accompanying
? list (or data matrix) such as that required for the
v selective method.
11. Question; I have sent offers to pay compensation to use data
to support my application for registration or amendment to all
data submitters listed on the most recent Data Submitter's List
i and if applicable the most recent Registration Standard or
-------
12. Question: If I write to a company on the Data Submitters'
List via certified mail and my letter is returned with an
.indication that the data submitter's company cannot be located,
how much more must I do to find the company?
Answer: It is EPA's position that if you have obtained
a certified or registered mail statement that there is
no known address for that company, you have made a
reasonable effort to notify that company. Of course,
you may pursue the matter further if you wish.
Indicate in your application what you have done to
locate the data submitter. Should a data submitter
wish to challenge a registration in the future because
of not being notified, 40 CFR 152.99 provides for that
situation.
13. Question; Who has to cite or submit residue chemistry data
under the Selective Method of Support?
Answer: Only applicants who do not qualify for the
formulator's exemption under FIFRA section 3(c)(2)(D) must
s satisfy residue chemistry data requirements. Such
applicants must obtain permission or make an offer to pay to
use these data (if data exist), if they choose the Cite-All
Method of Support. There may be exceptions, i.e., where the
source of the active ingredient has not supported the use(s)
you claim in your labeling. In such cases, applicants will
be required to generate the necessary residue data. See PR
Notice 91-8.
There are other cases when residue chemistry data may be
required, for example an applicant for registration of an
end-use product in a substantially different form (e.g., an
emulsifiable concentrate vs. a wettable powder) from that
which is currently registered, may be required to submit
additional residue chemistry data even if they are eligible
for the formulator's exemption.
14. Question: If I am eligible for the formulator's exemption do
I have to submit anything more than the Formulator's Exemption
Statement (EPA Form 8570- 27) and the Confidential Statement of
'Formula (EPA Form 8570-4)?
Answer: Yes, in addition to those forms, you must submit
information required for either the Selective or the Cite-
All Method of Support. Usually the data required for those
eligible for the formulator's exemption are the product
specific product chemistry and product specific acute
toxicology data.
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15. Question; Do I have to get permission from, or make an offer
to pay, to the person who generated the data from the public
literature that I have cited or submitted?
Answer; No.
>16. Question: If I am the first applicant/registrant to cite or
submit a public literature data source, do I acquire data
submitter's rights?
Answer: No, applicants do not need permission to cite
public literature. No one acquires "data submitters'
rights" from public literature submissions.
17. Question: If I submit an application in which I declare one
or more data gaps under the Selective Method of Support, without
having waited for the 60 day period to elapse to receive a reply
from all on the Data Submitters' List, will the Product Manager
process my application?
Answer; Yes. However, the Product Manager will not
approve your application until you have certified that
you have waited the required 60 days and no one has
disputed your assertion that one or more data gaps
exist as you have declared in your application. You
may wish to await the 60 day period and certification
before submitting your application to the Agency.
18. Question: If I submit an application to register a new
product that contains an active ingredient for which the Agency
has issued a Data Call-in (DCI), Registration Standard (RS), or
Reregistration Eligibility Document (RED), am I subject to the
data requirements in those documents as well as those in 40 CFR
158 or just those in 40 CFR 158 and am I subject to the Data
Compensation regulations?
Answer: You are subject to the all of the data requirements
and submittal times set forth in 40 CFR 158 as well as the
data requirements and submittal times set forth in any DCI
issued by the Agency in connection with a RS, or RED,
regardless of whether your new product is a technical grade
product, manufacturing use product, or an end use product.
If the timeframe for generating and submitting a given data
set has past, then you must submit those data with your
application or you may cite data submitted by someone else.
If a timeframe has not yet past, then you must submit the
required data by the date specified. If data gaps were
declared in the RS or RED, you may rely on the RS or RED for
the identification of those gaps. But, under the Selective
Method of Support you must still provide a list of the
requirements in accordance with 40 CFR 152.90(a), and may
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not simply cite the RS or RED. You may, however, indicate
on your list of data requirements that the existence of a
data gap is documented in the RS or RED.
You are also subject to the Data Compensation requirements
under 3(c)(l)(F) [formerly 3(c)(l)(D)] of FIFRA.
Refer to PR Notice 85-3, 40 CFR 152.90 through 152.96 and 40
CFR 158 for full details on data requirements and to FIFRA
Section 3(c)(l)(F) for data compensation information.
19. Question; If I am submitting a complete set of supporting
data with the application, do I need to fill out the
Certification form?
Answer; No. So long as you are not submitting required data
that has been previously submitted by another submitter. If
you have previously submitted data you should cite those
data rather than submit them .again.
20. Question; Do I have to fill out all items under 2 and 3 on
the Certification form?
Answer; Mark only those items that are appropriate for your
application.
21. Question; When does the 10 years "exclusive use" period
expire for data generated 12 years after the first registrants?
Answer; Data submitted 12 years after the original
registration are not covered by exclusive use at all.
Exclusive data rights exist only for the registrant who
obtained the first registration that contains a new active
ingredient or new mixture of active ingredients and only for
that first registration and subsequent amendments to that
original registration for a 10 year period. Data submitted
11 years after the date of the original registration are not
covered by exclusivity. These data are covered by data
compensation rights for another fifty years.
E. GOOD LABORATORY PRACTICE STANDARDS - PHYSICAL AND CHEMICAL
HAZARDS FOR PRODUCT SPECIFIC DATA.
40 CFR 160 sets forth good laboratory practices for
conducting studies that support or are intended to support
applications for registration, amended registration, or
reregistration of a pesticide product, applications for an
experimental use permit, petitions for establishment or
modification of a tolerance or food additive regulation,
exemptions from the requirement of a tolerance or food additive
regulation. Although all studies have to be conducted in
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accordance with some of the good laboratory standards, only
•physical and chemical characterization studies to determine
^solubility, octanol water partition coefficient, stability
*(product chemistry data requirement 63-8, 63-10, 63-13
^respectively), volatility, and persistence (such as
' biodegradation, photodegradation, and chemical degradation
*• (environmental fate 163-2, 163-3, 161-1; 161-2; 161-3; and 161-4
'respectively) studies are subject to the full good laboratory
practice standards. All other studies are subject only to the
good laboratory provisions set forth in 40 CFR 160.33, 41, 51,
61, 63, 83, 105(e), 107, 120(13) and (14), 130,185(a)(1) through
(4), (9), (11), (13), 190, 195(a),(b),(e),(f),(g),(h),(i).
P. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions concerning the data compensation
* procedures and whether they apply to your application, please
contact the appropriate Product Manager for your pesticide.
^Refer to Chapter 18 of this manual for a listing of the various
•Product Managers and the type of products for^ which they are
•' responsible.
?
Q. REFERENCES CITED IN CHAPTER 6 - Refer to Chapter 16 for
information on the source of these documents.
• 1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
Part 152, Subpart E - Procedures to ensure protection
of data Submitters' rights
Part 158 - Data requirements for registration
2. Code of Federal Regulations, Title 29
Part 1440 - Arbitration of Pesticide Data Disputes
3. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 3 - Registration of pesticides
4. Food, Agriculture, Conservation, and Trade Act of 1990,
November 28, 1990
Subtitle H - Pesticides; Sections 1491 through 1499
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5. Food, Agriculture, Conservation, and Trade Act
Amendments of 1991, December 13, 1991
Section 1006 - Amendments to FIFRA and Related
Provisions
6. PR Notice 85-3 - Effective Date of Data Compensation
Procedures under FIFRA, Issued by
the Registration Division, Office
of Pesticide Programs, EPA, May 14,
1985.
7. PR Notice 91-6 - EPA Policy Regarding Requests to
Withdraw Authorization to Cite
Data, Issued by the Registration
Division, Office of Pesticide
Programs, EPA, December 13, 1991.
8. PR Notice 91-8 - Revised Policy to Provide
Applicants Other Than Basic
Manufacturers An Opportunity To
Submit Generic Data and Receive
Data Compensation For It, Issued by
the Registration Division, Office
of Pesticide Programs, EPA,
December 31, 1991.
9. Data Submitters' List
10. Listing of Registration Standards
11. Listing of Chemicals for Which Data Waivers Have Been
Granted
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APPENDIX 6-1
COMPARISON OF THE CITE-ALL AND SELECTIVE METHODS OP SUPPORT
If an applicant chooses this
can he/she satisfy a data rec
by the means listed below?
1. Requesting and obtaining
a waiver
2 . Submission of a new study
3 . Citation of his/her own
study
4 . Citation of another
person's exclusive use
study
5. Citation of another
person's study that is
not exclusive use
6. Citation of all pertinent
studies in Agency files,
exclusive use studies
involved
7. Citation of all pertinent
studies in Agency files,
no exclusive use studies
involved
8. Citation of public
literature study
9. Documentation of a data
gap
[uirement
a. With per-
mission
b. With offer
to pay
a. With per-
mission
b. With offer
to pay
a. With per-
mission
b. With offer -*
to pay
a. With per-
mission
b. With offer
to pay
Cite-all
No V
No I/
No I/
No
No
No
No
Yes
No
Yes
Yes
No
No
Selective
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
I/ It should be noted that applicants under the cite-all method
will not be precluded from obtaining waivers, or submitting or
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citing their own studies, but that taking these actions would
affect neither their obligation to cite all data, nor the
.procedures that require offers to pay or in certain cases,
permission of each previous data submitter. Therefore, as the
table indicates, none of the actions would suffice in and of
itself, to demonstrate compliance under the cite-all method.
Requesting a waiver would be of concern primarily to those who
choose the selective method of demonstrating compliance. An
applicant under the cite-all method might, nonetheless, wish to
establish that a data requirement has been waived in order to
reduce the amount of data needed for an incremental risk
assessment, or to limit his obligation to pay compensation (as
contrasted to his obligation to tender offers to pay
compensation.
Similarly, the submission of a new study or the citation of a
previously submitted study will be of most interest to applicants
under the selective method, which involves meeting individual
data requirements rather than referencing all previously
submitted data. While no applicant is precluded from submitting
his own data, under the cite-all method submission of a new study
or citation of an old study would be in addition to the citation
of all other relevant data in EPA's files. Under the selective
method, however, the applicant may submit his own study to
satisfy a data requirement and thereby can avoid the need to
offer to pay compensation for other studies in EPA's files that
satisfy the same data requirement.
6-24
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APPENDIX 6-2
SAMPLE MATRIX FORMAT FOR DATA REQUIREMENT LISTING FOR THE
SELECTIVE METHOD OF SUPPORT
The following matrix is a sample of an acceptable matrix
format that can be used to satisfy the data requirement in 40 CFR
152.90(a). Applicants for registration using the selective
method must prepare a list of the data requirements (refer to 40
CFR 158 - Data Requirements for Registration) for their product
and indicate how those requirements are being satisfied. You may
use this sample matrix or you may develop a similar matrix to
satisfy this requirement.
The sample matrix has been developed for a typical product
where the applicant qualifies for the formulator's exemption. If
you are eligible for the formulator's exemption you may use the
data requirements shown on this sample matrix as a guide for
determining the requirements for your products.
If you are not eligible for the formulator's exemption you
may use the single page blank matrix as a guide to develop a list
of the data requirements for your products.
HOW TO COMPLETE THE SAMPLE MATRIX
Block 1. Insert the name of your product.
Block 2. Insert the EPA registration number or file symbol (if
known) as appropriate, for your product.
Block 3. Indicate whether you are eligible for the Formulator's
Exemption by checking either yes or no.
Block 4. Fill in the page number for that page as well as the
total number of pages in your listing.
Block 5. Fill in your company's name and address.
Block 6. Insert the date of your application for registration
or amended registration.
6-25
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Block 7. List the active ingredient(s) in your product. If you
have more than one active ingredient in your product
and one or more do not qualify for the formulator's
exemption, you must fill out a separate list for each
active ingredient that does not qualify for the
formulator's exemption and one for all of the rest of
the active ingredients that qualify for the
formulator's exemption. If all of the active
ingredients in your product qualify for the
formulator's exemption, you need complete only one set
of forms and list all of the active ingredients in this
box.
Block 8a. Indicate the Part 158 and guideline reference number
for each data requirement applicable to your product.
If a Registration Standard or a Reregistration
Eligibility Document has been issued, the data
requirements and their guideline reference numbers are
listed in the Standard.
Block 8b. Show the name of the test, e.g., Acute oral LD-50 -
rat. Applicants who do not qualify for the
formulator's exemption must cite or submit the acute
toxicology battery of tests for both the active
ingredient and the product as formulated (if they are
different). Those who qualify for the formulator's
exemption need cite or submit tests only for the
product as formulated.
Block 9a. Use this block if you, the applicant, are relying on
your own data to satisfy the requirement. Indicate
whether you are citing or submitting the data. See
"CITING DATA" entry below.
Block 9b. Indicate the date you originally submitted the data to
EPA.
Block 9c. Use this block if you are relying on data submitted by
another company or individual. Insert the name of the
company or individual who has rights to the data.
Block 9d. If you cite data submitted by another company or
individual you must have his permission to use the data
to support your application or you must have made a
proper offer to pay to that person. If you are
certifying to having received permission, you should
write in "P" in this block. If you are certifying to
having made an offer to pay, write in "OTP" in this
block.
6-26
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IMPORTANT NOTB: If the data you are citing are
exclusive use data, you must have permission to cite
the data. You may..not comply by making an offer to
pay.
Block 9e. If you are relying on public literature to support
your application check this block. If you check this
block you must submit a copy of the data on which you
rely.
Block 9f. Check this block, if you believe that either (1)
according to Part 158 and the guidelines, the data
requirement is not applicable (NA) or, (2) the data
requirement has been previously waived by EPA for
similar products, or (3) you can satisfy the data
requirements by some other means not provided on the
matrix. You must attach an explanation sheet to
this list which provides the rationale for using this
block.
Block 10. Insert the MRID (EPA's Master Record Identification)
number, EPA accession number, or other EPA
identification number.
CITING DATA
Applicants must indicate whether data submitted with the
application have or have not previously been provided to the
Agency by the applicant. Previously submitted data may not be
resubmitted. Rather, such data should be cited and the following
information given:
a. The title of the study, author(s), data completed, test
substance, identity of the laboratory performing the study
(if any).
b. EPA's Master Record Identification (MRID) Number or EPA's
data catalogue accession number (if known).
c. The identity of the original submitter.
d. The date on which the cited data were originally
submitted to the Agency.
e. One of the following if the data were not originally
submitted by you:
1) Evidence of transfer of ownership of rights to the
data to you.
2) Certification of written permission from the
original submitter to cite the data.
6-27
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3) Certification that a proper offer to pay has been
made to the original data submitter. (One
certification suffices for all offers to pay.)
6-28
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SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT
1. PRODUCT NAME:
5. APPLICANT'S (COMPANY) NAME AND
ADDRESS :
8. 40 CFI
DATA I
8a.
Guide-
line
Refer-
ence
Number
Section
158.190
61-1
61-2
61-3
62-1
62-2
62-3
63-3
63-5
63-6
* Part 158 -
REQUIREMENTS
8b.
Name of Test
PRODUCT CHEMISTRY
Identity of
inciredients
Statement of
composition
Discussion of
formation of
inciredients
Preliminary
analysis
Certification of
limits
Analytical method
for enforcement
limits
Physical State
Meltina Point
Boilina Point
2. EPA REG. NO. /FILE SYMBOL: 3. FORMULATOR'S EXEMPTION
SELECTED:
YES NO
4. PAGE
1 OF
6. APPLICATION FOR 7. NAME OF ACTIVE INGREDIENT (S) :
REGISTRATION DATED:
MONTH DAY YEAR
9. SOURCE OF DATA SATISFYING REQUIREMENT
9a.
Submitted
Applicant
9b.
Date
Submitted
9c.
Submitted
by another
per son/ firm
(give name)
9d.
Certificate
of Permis-
sion (P) or
Offer to
Pay (OTP)
enclosed:
indicate
9e.
Public
Litera-
ture
9f.
N.A. or
Waiver or
other
(explain)
10.
MRID Number,
EPA Accession
Number, or
other
identifying
number
6-29
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SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT
1. PRODUCT NAME:
5. APPLICANT'S (COMPANY) NAME AND
ADDRESS :
8. 40 CFR Part 158 -
DATA REQUIREMENTS
8a.
Guide-
line
Refer-
ence
Number
Section
158.190
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
8b.
Name of Test
PRODUCT CHEMISTRY
(continued)
Density, bulk-
density, or
specific aravitv
Solubility
Vapor Pressure
Dissociation
constant
Octanol/water
partition
coefficient
DH
Stability
Oxidizing/
reducincr reaction
Flammabil ity
Explodabilitv
2. EPA REG. NO. /FILE SYMBOL: 3. FORMULATOR'S EXEMPTION 4. PAGE
SELECTED: 2 OF
YES NO
6. APPLICATION FOR 7. NAME OF ACTIVE INGREDIENT (S ):
REGISTRATION DATED:
MONTH DAY YEAR
9. SOURCE OF DATA SATISFYING REQUIREMENT
9a.
Submitted
by
Applicant
9b.
Date
Submitted
9c.
Submitted
by another
person/ firm
(give name)
-
9d.
Certificate
of Permis-
sion (P) or
Offer to
Pay (OTP)
enclosed:
indicate
"P" or "OTP"
9e.
Public
Litera-
ture
4
9f.
N.A. or
Waiver or
other
(explain)
10.
MRID Number,
EPA Accession
Number , or
other
identifying
number
6-30
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SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELEC
1. PRODUCT NAME:
5. APPLICANT'S (COMPANY) NAME AND
ADDRESS :
8. 40 CFI
DATA I
8a.
Guide-
line
Refer-
ence
Number
Section
158.190
63-18
63-19
63-20
63-21
Section
158.340
81-1
81-2
* Part 158 -
REQUIREMENTS
8b.
Name of Test
PRODUCT CHEMISTRY
(continued)
Viscosity
Miscibilitv
Corrosion
characteristics
Dielectric break-
down voltaae
TOXICOLOGY
Acute oral,
toxicitv, rat
Acute dermal
Toxicitv. rabbit
2. EPA REG. NO. /FILE SYMBOL: 3. FORMULATOR'S EXEMPTION
SELECTED:
YES NO
4. PAGE
3 OF
6. APPLICATION FOR 7. NAME OF ACTIVE INGREDIENT (S ):
REGISTRATION DATED:
MONTH DAY YEAR
9. SOURCE OF DATA SATISFYING REQUIREMENT
9a.
Submitted
by
Applicant
9b.
Date
Submitted
9c.
Submitted
by another
per son/ firm
(give name)
9d.
Certificate
of Permis-
sion (P) or
Offer to
Pay (OTP)
enclosed:
indicate
11 P" or "OTP"
9e.
Public
Litera-
ture
9f .
N.A. or
Waiver or
other
(explain)
10.
MRID Number,
EPA Accession
Number , or
other
identifying
number
6-31
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SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT
1. PRODUCT NAME:
5. APPLICANT'S (COMPANY) NAME AND
ADDRESS :
8. 40 CFR Part 158 -
DATA REQUIREMENTS
8a.
Guide-
line
Refer-
ence
Number
Section
158.340
81-3
81-4
81-5
81-6
8b.
Name of Test
TOXICOLOGY
(continued)
Acute inhalation
toxic itv. rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensiti-
zation
2. EPA REG. NO. /FILE SYMBOL: 3. FORMULATOR'S EXEMPTION
SELECTED:
YES NO
4 . PAGE
4 OF
6. APPLICATION FOR 7. NAME OF ACTIVE INGREDIENT (S) :
REGISTRATION DATED:
MONTH DAY YEAR
9. SOURCE OF DATA SATISFYING REQUIREMENT
9a.
Submitted
by
Applicant
9b.
Date
Submitted
9c.
Submitted
by another
per son/ firm
(give name)
9d.
Certificate
of Permis-
sion (P) or
Offer to
Pay (OTP)
enclosed:
indicate
it pn or HOTP"
9e.
Public
Litera-
ture
•t
9f.
N.A. or
Waiver or
other
(explain)
10.
MRID Number,
EPA Accession
Number , or
other
identifying
number
-
6-32
J
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SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR* THE "SELECTIVE METHOD OF SUPPORT .
1. PRODUCT NAME:
5. APPLICANT'S (COMPANY) NAME AND
ADDRESS :
8. 40 CFR Part 158 -
DATA REQUIREMENTS
8a.
Guide-
line
Refer-
ence
Number
Section
158.
8b.
Name of Test
2. EPA REG. NO. /FILE SYMBOL:
6. APPLICATION FOR
REGISTRATION DATED:
MONTH DAY YEAR
3. FORMULATOR'S EXEMPTION
SELECTED:
YES NO
4. PAGE
5 OF
7. NAME OF ACTIVE INGREDIENT (S) :
9. SOURCE OF DATA SATISFYING REQUIREMENT
9a.
Submitted
by
Applicant
9b.
Date
Submitted
9c.
Submitted
by another
per son/ firm
(give name)
9d.
Certificate
of Permis-
sion (P) or
Offer to
Pay (OTP)
enclosed:
indicate
"P" or "OTP"
9e.
Public
Litera-
ture
9f.
N.A. or
Waiver or
other
(explain)
10.
MRID Number,
EPA Accession
Number , or
other
identifying
number
6-33
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CHAPTER 7 - HOW TO SUBMIT AN APPLICATION TO REQUEST A PETITION
FOR A TOLERANCE (PERMANENT OR TEMPORARY). OR AN
EXEMPTION FROM THE REQUIREMENT OF A TOLERANCE
A. GENERAL INFORMATION
.•
Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the
Environmental Protection Agency (EPA) is responsible for
regulating the amount of pesticide residues that can remain in or
on food or feed commodities as the result of pesticide
application. A tolerance is the legal maximum residue
concentration of a pesticide chemical allowed in food or feed.
If residues of a pesticide exceed the established tolerance, or
no tolerance has been established, the crop may be considered
adulterated and may be seized by the Food and Drug
Administration, the United States Department of Agriculture, or a
state enforcement agency.
"i1.
? Tolerances are set under the .authority of the FFDCA. FFDCA
Section 408 applies to residues on/in raw agricultural
commodities (RACs) and Section 409 applies to pesticide residues
V in processed food or feed commodities which exceed the raw food
tolerance.
40 CFR Part 180 - Tolerances and Exemptions from Tolerances
for Pesticide Chemicals in or on Raw Agricultural Commodities,
provides information on definitions and interpretative
regulations, procedures for filing petitions, temporary
tolerances, exemptions from the requirement of a tolerance,
residue data, fee requirements, specific tolerances and
exemptions which have been established for raw agricultural
- commodities.
40 CFR Part 177 - Issuance of Food Additive Regulations
provides information on definitions, procedures for filing
• petitions for establishment, modification, or revocation of a
food additive regulation, withdrawal of petitions, submission of
scientific and technical information required to support
petitions, and waiver of requirements. In addition, procedures
for filing objections and requests for hearings on food additive
regulations or petition denials under section 409(f) of the FFDCA
are found in 40 CFR Part"178; rules governing formal evidentiary
'hearings under FFDCA section 409(f) are found in 40 CFR Part 179.
40 CFR Part 185 - Tolerances for Pesticides in Processed
Food, provides a listing of tolerances established for residues
of pesticides in processed foods (food additive tolerances)
resulting from pesticide application during the growing process,
direct application to the end food product, or indirect
application to the end food product by treating the processing or
storage area. (Prior to June 29, 1988, 40 CFR Part 185 was
designated 21 CFR Part 193.)
7-1
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40 CFR Part 186 - Tolerances for Pesticides in Processed
Animal Feeds, provides a listing of tolerances established for
residues of pesticides in processed animal feeds, which may be
present as a result of application of the pesticide to growing
crops. (Prior to June 29, 1988, 40 CFR Part 186 was designated
21 CFR Part 561.)
B. WHEN ARE PETITIONS FOR TOLERANCES REQUIRED?
Tolerances and food/feed additive regulations are required
to be established to cover residues resulting from treatment
of raw agricultural commodities or processed food;
inadvertent residues in rotational or replacement crops;
primary or secondary residues in meat* milk, poultry, and
eaas; residues in processed food resulting from treatment of
the rav commodity and exceeding the rav food tolerance; and
expected residues in imported food commodities.
Registration of a pesticide is not* however* a prerequisite
for establishing a tolerance. For example, EPA may
establish a temporary tolerance under section 408(1) to
permit the experimental use of a non- registered pesticide,
or EPA may establish a tolerance for a pesticide residue
resulting from the use of the pesticide in food or feed
roduction in a foreign countr.
1. Applications for registration or
registration - Before a pesticide can be registered
for use on a food or feed crop or for use in a food
processing or storage area under FIFRA section 3, a
tolerance or the exemption from the requirement of a
tolerance must be established. In addition, if you
propose to amend a currently registered use, for
example, by increasing the dosage rates or frequency of
application, which might result in residues higher than
the established tolerance, a petition to amend the
established tolerance may be required.
2. Experimental Use Permits - An application for an
experimental use permit proposing use on a food or feed
crop or for the proposed experimental use in food
processing or storage areas, requires a temporary
tolerance for the proposed use if no tolerances are
currently established, or if the proposed experimental
use might result in residues higher than the
established tolerance or if the commodity is to be
marketed. The petition for the temporary tolerance
must be submitted with the application for the
experimental use permit.
IMPORTANT NOTE: A temporary tolerance is not required if
the commodity is to be destroyed or consumed only by
experimental animals.
7-2
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3. Importation of Pesticide Treated Pood - The requirements
of sections 408 and 409 of the Federal Food, Drug, and
Cosmetic Act (FFDCA) apply equally to domestically produced
and imported food and feed found to contain pesticide
residues. Therefore, even though the use of a pesticide in
a foreign country is not subject to EPA registration
requirements under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), a pesticide residue in imported
food or feed must be in conformity with a tolerance,
tolerance exemption, or food additive regulation established
by EPA or, where appropriate an action level established by
the Food and Drug Administration. Shipments of imported
food/feed items found to have pesticide residues for which a
tolerance, exemption from the requirement of a tolerance, or
a food additive regulation has not been issued will be held
up and the importer required to either file for a tolerance
or exemption from a tolerance, or a food additive
regulation; return the shipment to the country of origin; or
destroy the shipment.
4. Inerts - Inert ingredients in pesticide product
formulations are regulated under both the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
amended and the Federal Food, Drug, and Cosmetic Act
(FFDCA). Inert ingredients in products labeled for food use
must be cleared by EPA before the product can be registered.
40 CFR 152.55 requires that inert ingredients, metabolites.
and degradation products, as well as active ingredients, be
cleared by the Agency if your product is to be used on food
or feed crops. If your proposed labeling bears instructions
for use of the product on food or feed crops, or if the
intended use of the product results or may be expected to
result, directly or indirectly, in pesticide residues in or
on food or feed, you must submit a statement indicating
whether a tolerance, exemption from the"requirement of a
tolerance, or a food additive regulation has been issued by
the Agency under section 408 or 409 of the Federal Food Drug
and Cosmetic Act (FFDCA). If a tolerance, exemption from
the requirement of a tolerance, or a food additive
regulation has not been issued for such residues, your
application must be accompanied by a petition for
establishment of appropriate tolerances, exemptions from the
requirement of a tolerance, or food additive regulations in
accordance with 40 CFR 177 (food additive petitions) or
40 CFR 180 (tolerance or exemption petitions).
Traditionally, the Agency has recommended against the
establishment of a tolerance for a pesticide product unless
all of the inert ingredients in the product have been
cleared for use on food/feed items. Refer to 40 CFR
180.1001 for a listing of the inert ingredients that have
been cleared for use on food/feed items.
7-3
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5. Adjuvants - Although adjuvants are not subject to
registration, those adjuvants intended for use in
conjunction with a pesticide in tank mixes for application
to a food or feed crop/site are required to be cleared with
the EPA, under the Federal Food, Drug and Cosmetic Act
(FFDCA) prior to being used. Such adjuvants are evaluated
by EPA as inert ingredients and undergo the appropriate
product chemistry review. Adjuvants cleared for use on
food/feed items are listed in 40 CFR 180.1001.
C. PROCEDURES FOR FILING A PETITION
1. General - Procedures for filing a petition
requesting the establishment of a tolerance, a
temporary tolerance, or an exemption from the
requirement of a tolerance or a temporary exemption
from a tolerance, are described in detail in 40 CFR
section 180.7. Additional information concerning
requests for temporary tolerances, or a temporary
exemption from a tolerance, in conjunction with an
experimental use permit can be found in 40 CFR 180.31.
There is no application form for petitions. You must
submit your request in the format provided in 40 CFR
section 180.7.
Procedures for filing a petition for establishment,
modification, or revocation of a food additive regulation
for pesticide residues in or on a particular processed food
or group of such foods are described in detail in 40 CFR
section 177.81. Additional information concerning requests
for amendments or supplements to petitions can be found in
40 CFR 177.92. There is no application form for petitions
for food additive regulations. You must submit your request
in the format provided in 40 CFR 177.81(e).
2. Completeness of Application - The petition must
include the following information in clearly designated
sections as follows:
a« Section A ~ Th> n*m0» chemical identity and
composition of the pesticide chemical. To assess the
composition of the pesticide, information is required
on the manufacturing process, chemical analysis of the
active ingredient, certified limits for ingredients of
a product, and analytical methods to determine the
composition of the pesticide. You should also refer to
40 CFR Parts 158.150 - 190, Product Chemistry Data
Requirements and the Pesticide Assessment Guidelines,
Subdivision D - Product Chemistry for more detailed
information.
7-4
-------
IMPORTANT NOTE: The Agency evaluates the composition
data to determine whether impurities could constitute a
significant component of the residues in food and feed
commodities. Impurities that arise in the manufacture
of pesticides can become a residue problem, if they are
not identified before tolerances are established.
Dioxins and nitrosamines are the best known examples of
significant impurities of toxicological concern. If
impurities are at levels that may lead to
toxicologically significant residues in crops, then
tolerances would be established for them, as well as
for the active ingredient. Once problem impurities are
identified, adjustments to the manufacturing process or
additional purification steps may be necessary to
reduce the impurities to a safe level.
b. Section B - The amount, frequency* and time of
application of the pesticide chemical. This refers to
the directions for use, dosage rates, number of
applications, restrictions, pre-harvest intervals, and
times of application that you intend to provide on the
label of the product you intend to market.
c. Section C - Full reports on investigations made with
respect to the safety of the pesticide chemical.
40 CFR Part 158.340, Toxicology Data Requirements,
identifies the types of toxicity data that are needed
to support a petition request. The required data are
identified under the "Food Crop" headings.
d. Section D - The results of teats on the amount of
residue remaining* including a description of the
analytical method used. Information on testing for the
amount of residue remaining in the raw agricultural
commodity or processed food or feed, when the pesticide
is applied according to the proposed label directions,
is provided in 40 CFR Part 180.34 - Tests on the amount
of residue remaining, Part 158.240 - Residue Chemistry
Data Requirements, and the Pesticide Assessment
Guidelines, Subdivision 0 - Residue Chemistry. (Refer
to Chapter 16 of this manual for a source.)
Submission of analytical methods to EPA for uae in
tolerance enforcement - You will need to develop and
submit accurate and precise analytical methods for
identifying and measuring the amount of pesticide
residues in the agricultural commodity and processed
foods. Those methods need to be practical in order to
be used in tolerance enforcement and should meet all of
the requirements for pesticide residue methods
identified in the Pesticide Assessment Guidelines,
Subdivision O - Residue Chemistry. The analytical
7-5
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method for enforcement cannot be marked as Confidential
or Trade Secret. In addition, registrants need to
submit to EPA pesticide validation data showing the
results from their own laboratory as well as the
results from an independent laboratory tryout that
confirms those results. The exact procedure for
conducting an independent laboratory tryout can be
found in PR Notice 88-5.
IMPORTANT NOTE! If EPA does not receive all of the
items identified above, the petition will be considered
incomplete and returned without further notice.
a. Section E - Practical methods for removing residue
that exceeds any proposed tolerance. Tolerances are
usually set at levels which are adequate to cover
residues that are likely to result from a proposed use
without any special processing of the commodities to
reduce residues to the tolerance level. Information in
this section would provide for a necessary and useful
pesticide treatment which results in residues larger
than a safe tolerance level, but which can be reduced
to the tolerance level by washing or some other means
proposed in the petition.
f. Section P - Proposed tolerances for the pesticide
chemical if tolerances are proposed. Tolerances should
be proposed in terms which best represent the total
toxic residues on the raw agricultural commodity,
whether it be the parent pesticide or altered forms of
it, or both.
An exemption from the requirement of a tolerance may be
proposed when appropriate. According to 40 CFR
180.1001(a) " An exemption from a tolerance shall be
granted when it appears that the total quantity of the
pesticide chemical in or on all raw agricultural
commodities for which it is useful under conditions of
use currently prevailing or proposed will involve no
hazard to human health". When an exemption is
proposed, data may need to be presented to show the
level of residues to be expected.
When residues on a processed food derived from the raw
agricultural commodity exceed the proposed tolerance on
the raw agricultural commodity, appropriate tolerances
should also be proposed in this section for the
processed food under FFDCA Section 409.
g. Section Q - Reasonable grounds in support of the
petition. This section should include a rationale of
how the residue data support the proposed tolerance,
7-6
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brief discussions on the adequacy of the analytical
method with respect to sensitivity and determination of
total toxic residues, an explanation of any aberrant
residue values reported, an explanation for the
omission or substitution of required data or
information, discussion of fate of the pesticide in the
environment (i.e., soil persistence, contamination of
ground water or run-off water) and any residue
considerations applicable to the proposed use. In
addition a summary of the grounds for safety of the
proposed tolerance based on the toxicology data
submitted under Section C, may also be included.
The petition for food additive regulations must include
the following information as set forth at 40 CFR
177.102.
a. The name and composition of the food additive that
is a subject of the petition, and the chemical
composition of each component of the food additive.
The name, chemical identity, and composition of each
pesticide residue that is a subject of the petition.
The identity of the processed food(s) in question.
b. A statement of any conditions of use proposed for
the food additive, including all directions,
recommendations, and suggestions proposed regarding the
use of the food additive, i.e., the amount, frequency,
method, and time of application or other use, and copy
of its proposed labeling.
c. Full reports of investigations made with respect to
the toxicity of the food additive and of its safety for
the proposed use, including full information as to the
methods and controls used in conducting such
investigations.
d. The results of tests to determine the identity and
amount of pesticide residues in or on the processed
food resulting from the proposed use of the food
additive, including a description of the analytical
methods used, and a description of practicable methods
for measuring such pesticide residues.
e. Full reports of investigations made with respect to
the toxicity of such pesticide residues, including full
information as to the methods and controls used in
conducting such investigations.
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f. All relevant data bearing on the physical or other
technical effects such food additive is intended to
produce, and the quantity of such food additive
required to produce such effect.
g. The terms of each food additive regulation
proposed.
h. Any other information relevant to the approval of
the petition known to the petitioner that is
unfavorable to the petition.
i. A statement of why, in the petitioner's opinion, it
would be reasonable for the Administrator to approve
the petition, taking into account the terms of the
FFDCA and FIFRA, 40 CFR Part 177, the petition, the
data and information submitted or cited in support of
the petition, and other information available to the
Agency.
j. An informative summary of the petition and of the
data information, and arguments submitted or cited in
support of the petition, and a statement that the
petitioner agrees that such summary or any information
it contains may be published as a part of the notice to
the public under 40 CFR 177.88 or as part of a proposal
under 40 CFR 177.130. The summary need not refer to
any method or process that is entitled to protection as
a trade secret under FFDCA section 301(j).
3. Data - Three copies of any data required to be submitted
in support of the petition must be submited in accordance
with the data formatting requirements set forth in PR Notice
86-5.
4. Application for registration or amendment under
FIFRA section 3 - Except in certain instances, a
petition request must be accompanied with an
application for registration, an application to amend
the registration of a currently registered product, or
an experimental use permit for the uses proposed in the
petition. A request for an import tolerance generally
would not require an accompanying application for
registration.
5. Fee Requirements - Each petition request must be
accompanied by the appropriate fee as specified in 40
CFR 180.33. It would be helpful if a photo-copy of the
fee check were submitted with the petition request in
case any questions arise concerning whether the fee was
submitted as required.
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The fees will be adjusted annually in accordance with
section 180.33(o). You should refer to the February 7, 1991
Federal Register Notice (56 FR 4946) for a more detailed
discussion of tolerance processing fees.
The fees vary considerably according to type of
petition requested and its complexity. A very brief,
general discussion of some of the fees required for the
more frequently requested petitions follows:
a. For the establishment of a new tolerance or a
tolerance higher than that already established (with
certain exceptions) the fee is $52,000, plus $1,300 for
each raw agricultural commodity more than nine on which
the establishment of a tolerance is requested.
b. For the establishment of a tolerance at a lower
numerical level(s) than already established for the
pesticide, or for additional raw agricultural
commodities at the same numerical level as already
established the fee is $11,900 plus $825 for each raw
agricultural commodity on which a tolerance is
requested.
c. For requests for an exemption from the requirement
of a tolerance or repeal of an exemption the fee is
$9,575.
d. For temporary tolerances or a temporary tolerance
exemption from the requirement of a tolerance the fee
is generally $20,775, except as provided below. A
request for an extension or renewal of a temporary
tolerance or temporary exemption requires a fee of
$2,950.
The fee schedule changes annually by the same percentage as
the percent change in the Federal General Schedule (GS) pay scale.
In addition, processing costs and fees will periodically be
reviewed and changes will be made to the schedule as necessary.
When automatic adjustments are made based on the GS pay scale, the
new fee schedule will be published in the FEDERAL REGISTER as a
Final Rule to become effective 30 days or more after publication,
as specified in the rule. Normally the fee schedule for the
current fiscal year will be published in the FEDERAL REGISTER
shortly after the first of the calendar year. However, the
publication of the fee schedule may be impeded by such things as
executive regulatory relief initiatives.
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e. For requests for a temporary tolerance for a
pesticide which has a tolerance for other uses at the
same numerical level or a higher numerical level the
fee is $10,375 plus $825 for each raw agricultural
commodity on which the temporary tolerance is sought.
f. Waiver or refund request must be accompanied by
a fee of $1,300, which will be refunded if the
waiver is granted. The Agency may waive or refund
part or all of any tolerance petition fee, if it
is in the public interest to do so, or if the fee
would result in unreasonable hardship on the
applicant. A request for a waiver or a fee refund
must be submitted in writing to the Agency in
accordance with 40 CFR section 180.33(m).
IMPORTANT NOTE: Fee waiver requests affect the
processing times for the petition since the fee waiver
request must be processed before the petition is put
into review. The fee waiver review can typically take
2-3 months. To avoid this delay, petitioners can
submit the full fee with the petition and request that
the fee be returned if the Agency agrees with the
applicant that the petition is in the public interest.
The petition can then be put under review while the
refund request is being evaluated.
IMPORTANT NOTE: These fees may change without notice
being published in this manual.
All fees must be paid by money order, bank draft, or
certified check drawn to the order of the Environmental
Protection Agency. All payment of fees must be
forwarded to the following address:
Environmental Protection Agency
Headquarters Accounting Operations Branch
Office of Pesticide Programs
(Tolerance Fees)
P.O. Box 360277M
Pittsburgh, PA 15251
The payments should be specifically labeled "Tolerance
Petition Fees" and should be accompanied only by a copy
of the letter or petition requesting the tolerance.
The actual letter or petition, along with supporting
data should be forwarded within 30 days of payment of the
fee to the following address:
Document Processing Desk (PETN)
Office of Pesticide Programs - H7504C
U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
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A petition will not be accepted for processing until
the required fees have been submitted. A petition for
which a waiver of fees has been requested will not be
accepted for processing until the fee has been waived,
or if the waiver is denied, the proper fee is
submitted. A request for waiver or refund will not be
accepted after scientific review of a petition has
begun.
Refer to Chapter 8 of this manual for additional information
on tolerance petition fees and other fees.
6. Incomplete Petitions - Petitions will not be
accepted for processing if the proper fee has not been
submitted, if any of the required data are lacking or
the petition is otherwise determined to be incomplete.
If a petition is not accepted for processing because it
is incomplete, it will be returned. The original fee
amount submitted, less a charge of $1,300 for handling
and initial review, will also be returned.
If a petition is withdrawn by the petitioner after initial
processing but before significant scientific review has
begun, the original fee, less $1,300 for handling and
initial review, will be returned. If an unacceptable
petition is resubmitted, it will require the appropriate fee
that would be required if it were submitted for the first
time.
D. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions concerning 1) whether a petition
for a tolerance is required, 2) the appropriate fee, 3) how to
submit your request for a petition for tolerance and/or
application for product registration, or 4)"What data are
required to support your petition for tolerance and/or
application for product registration, please contact the
appropriate Product Manager for the pesticide. If the petition
request involves a new chemical not yet assigned to a Product
Manager, you should contact the appropriate Deputy Branch Chief,
or Branch Chief for a Product Manager assignment. Refer to
Chapter 18 of this manual" for a listing of the various Product
Managers, Deputy Branch Chiefs and Branch Chiefs.
E. REFERENCES CITED IN CHAPTER 7 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 158 - Data requirements for registration.
Part 177 - Issuance of Food Additive Regulations.
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Part 178 - Objections and Requests for Hearings.
Part 179 - Formal Evidentiary Public Hearing.
Part 180 - Tolerances and exemptions from tolerances
for pesticide chemicals in or on raw
agricultural commodities.
Part 185 - Tolerances for pesticides in food
administered by the Environmental Protection
Agency (Prior to June 29, 1988, 40 CFR Part
185 was designated 21 CFR Part 193)
Part 186 - Tolerances for pesticides in animal feeds
administered by the Environmental Protection
Agency (Prior to June 29, 1988, 40 CFR Part
186 was designated 21 CFR Part 561)
2. Federal Food Drug and Cosmetic Act
Section 408 - Tolerance for pesticide chemicals in or
on raw agricultural commodities
Section 409 - Food additives
3. Pesticide Assessment Guidelines, Subdivision D(, Product
Chemistry, EPA-540/09-82-018.
4. Pesticide Assessment Guidelines, Subdivision O(, Residue
Chemistry, EPA-540/09-82-023.
5. PR Notice 86-5 - Standard Format for data submitted under
the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) and certain
provisions of the Federal Food, Drug and
Cosmetic Act FFDCA). Issued July 29, 1986.
6. PR Notice 88-5 - Tolerance Enforcement Methods -
Independent Laboratory Confirmation by
Petitioner, Issued July 15, 1988.
7. Federal Register Notice, Regulation of Pesticides in Food:
Addressing the Delaney Paradox - Policy Statement, October
19, 1988 (53 FR 41104).
8. Federal Register Notice, Tolerance Processing Fees,
February 7, 1991 (56 FR 4946).
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CHAPTER 8 - WHAT FEES ARE REQUIRED FOR REGI8TRATK
RBREQI8TRATION AND TOLERANCE PETITION ACTIVITIES
•f
A. GENERAL INFORMATION
The 1988 amendments to the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA) require that annual maintenance fees
be paid by registrants for a period of 9 years beginning March 1,
1989, of pesticide products registered under Section 3 or 24(c)
of FIFRA, and provide for the collection of a fee for the
reregistration of pesticides. In addition, the Federal Food,
Drug and Cosmetic Act (FFDCA) provides for fees for the
processing and review of tolerance petitions. These fees are
discussed in more detail below.
IMPORTANT NOTE; Fees are not required for:
Registering a product with a new active
ingredient.
Registering a new use of a previously registered
active ingredient.
Registering a product substantially similar or
identical to a previously registered active
ingredient.
Amending a registered product label.
Obtaining an Experimental Use Permit.
B. ANNUAL REGISTRATION MAINTENANCE PEES
Section 4(i)(5) of FIFRA requires each registrant of
pesticide products to pay an annual registration maintenance fee
based on the number of registrations held. The current fee
(January 15, 1992) is $650 for the first registration held by any
registrant and $1300 for each subsequent registration. The
maximum fee for registrants holding 50 or fewer registrations is
$55,000, except for small businesses for which it is $38,500.
The maximum fee for registrants holding more than 50 1
registrations is $95,000, except for small businesses for which
it is $66,500. Registrations for which the fee is not paid by
A "small business" registrant eligible for these lower fee
payment caps is defined as one which employs 150 or fewer people
and, during the three year period prior to the most recent
maintenance fee billing cycle (i.e., December 31, 1990) had average
annual gross revenue from chemical sales not exceeding $40 million,
taking into account any parents' and subsidiaries1 employees and
gross revenues.
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January 15, 1992, will be canceled, by order and without a
hearing. If you do not pay the fee to keep a registration in
effect, you will be permitted until January 15, 1993, to dispose
of existing stocks of the pesticide, except in special
circumstances when less time may be granted. You will be billed
by the Agency at the beginning of each calendar year. If you
need assistance in interpreting the instructions for filing your
maintenance fee, you can get help from our toll-free maintenance
fee information line at 1-800-444-7255.
IMPORTANT NOTE: 1) FIFRA was amended by a 1991 amendment to the
Food, Agriculture, Conservation, and Trade Act which changed the
due date for paying the maintenance fee from March 1 to January
15 each year. 2) You should also be aware that the annual
maintenance fee may be increased each year as appropriate. 3) In
general, there are no provisions for any waiver or refund of
registration maintenance fees. However, the Food, Agriculture,
.v Conservation, and Trade Act of 1990 did amend FIFRA to allow the
Administrator to reduce or waive maintenance fees for minor
agricultural use registrations, when he determines that the fee
, would be likely to cause significant impact on the availability
of the pesticide for the use. This determination will be made
only after all the 1992 maintenance fee responses have been
received. If at that time the Agency determines that product
cancellation resulting from nonpayment of the fee would
significantly impact the availability of a particular
pesticide for a specific minor agricultural use, the Agency
will defer cancellation of the registrations in question,
and will provide affected registrants the opportunity to
maintain these registrations by paying a reduced maintenance
fee. 4) Registrations under section 24(c) of FIFRA are deemed
registration under section 3 of FIFRA and thus are subject to
this fee requirement. 5) The maintenance fee requirement does
not apply to supplemental registrations of distributors. Such
supplemental registrations are identified by a three-element
registration number in which your EPA Company Number is the third
element.
C. REREGISTRATION FEES
Section 4(i)(l-4) of FIFRA states that registrants of
pesticides shall collectively pay a fee for the reregistration of
an active ingredient. These fees vary considerably and are based
on among other things, whether the pesticide is an active
ingredient of any pesticide registered for a major food or feed
use, or is registered only for non-food or non-feed uses.
Provisions are made for the reduction or a waiver of fees for
minor use and other pesticides and for small business registrants
of pesticides. In accordance with section 4(c) of FIFRA, the
Agency has published lists of active ingredients subject to
reregistration. List A was published in the Federal Register of
February 22, 1989 (54 FR 7740), List B in the Federal Register of
8-2
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May 25, 1989 (54 FR 22706), List C in the Federal Register of
July 24, 1989 (54 FR 30846) and the last list, List D in the
Federal Register of October 24, 1989 (54 FR 43388). In addition,
:registrants will be notified of the time by which they are to
; notify the Agency whether or not they intend to seek
' reregistration. For a detailed discussion of the reregistration
of registered pesticides and the fee schedules, you should refer
to section 4 of FIFRA as amended October, 1988.
D. TOLERANCE PETITION FEES
Under section 408 of the Federal Food, Drug and Cosmetic Act
(FFDCA), fees may be charged to cover the cost of the processing
and review of tolerance petitions. Tolerances are required to be
established for residues of a pesticide whose use may result in
residues on a food or feed commodity.
''"' Refer to 40 CFR section 180.33 for a detailed discussion of
* the various fees required for the type of petition for which you
• intend to make application. The fees vary considerably according
to type of petition requested and its complexity and they will be
•* adjusted annually in accordance with section 180.33(o). You
should refer to the February 7, 1991 Federal Register Notice (56
FR 4946) for a more detailed discussion of the tolerance
processing fee requirements and to Chapter 7 of this manual for a
very brief, general discussion of some of the fees required for
the more frequently requested petitions for tolerance.
E. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions concerning 1) whether a petition
for a tolerance is required, 2) the appropriate fee, 3) how to
•" submit your application for product registration and/or a
petition for tolerance, or 4) what data are required to support
• your application for product registration and/or petition for
tolerance, please contact the appropriate Product Manager for
that pesticide. If the petition for tolerance and/or application
for product registration involves a new chemical not yet assigned
to a Product Manager, you should contact the appropriate Deputy
Branch Chief, or Branch Chief for a Product Manager assignment.
Refer to Chapter 18 of this manual for a listing of the various
Product Managers, Deputy Branch Chiefs and Branch Chiefs.
P. REFERENCES CITED IN CHAPTER 8 - Refer to Chapter 16 for
information on th« source of these documents.
1. Code of Federal Regulations, Title 40
Part 180 - Tolerances and exemptions from tolerances
for pesticide chemicals in or on raw
agricultural commodities
8-3
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2. Federal Food, Drug and Cosmetic Act
Section 408 - Tolerances for pesticide chemicals
in or on raw agricultural commodities
3. Federal Register Notices
- Tolerance Processing Fees, February 7, 1991 (56 FR
4946)
- Pesticides For Which Registration Standards Have Been
Issued (List A), February 22, 1989 (54 FR 7740)
- Pesticides Required To Be Reregistered
- (List B), May 25, 1989 (54 FR 22706)
- (List C), July 24, 1989 (54 FR 30846)
- (List D), October 24, 1989 (54 FR 43388)
4. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 4 - Reregistration of registered products
5. Food, Agriculture, Conservation, and Trade Act of 1990,
November 28, 1990
Subtitle H - Pesticides - Sections 1493
6. Food, Agriculture, Conservation, and Trade Act
Amendments of 1991, December 13, 1991
Section 1006 - Amendments to FIFRA and Related
Provisions
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• CHAPTER 9 - HOW TO APPLY FOR Ml EXPERIMENTAL USB PERMIT
,A. GENERAL INFORMATION
Experimental Use Permits (EUPs) are issued under FIFRA
'section 5 to allow prospective registrants to generate
•„ information or data necessary to register a pesticide under
section 3 of FIFRA. You should refer to 40 CFR Part 172 for
detailed information on EUPs. In general EUPs are issued for:
1. A pesticide not registered with the Agency, or
2. A registered pesticide for a use not registered with the
Agency.
Pesticides under experimental use permits may not be sold or
* distributed other than through participants in the approved
iexperimental use program. They may only be used at the
"application site of a cooperator in the program, and only in
accordance with the terms and conditions of the experimental use
ipermit.
•f
B. WHEN IS AN EXPERIMENTAL USE PERMIT REQUIRED?
1. Generally, an EUP is required before you can conduct
large scale field testing. Large scale field testing
would be any instance other than those described in
item 2 below. However, in certain cases (e.g., "novel"
microbial pesticides — certain genetically altered and
non-indigenous microbial pest control agents as
discussed in item 3 below) small scale field tests may
require an EUP.
IMPORTANT NOTE: EUPs are required for testing of pesticides
in a comparable indoor situation, for example a pesticide to
control roaches in domestic dwellings, institutions, etc.
and for field testing of swimming pool sanitizers and
disinfectants under actual use conditions.
2. EUPs are generally presumed not to be required for a
substance or mixture of substances being put through
laboratory or greenhouse tests, or limited replicated
field trials, in which the purpose is only to determine
its value for pesticidal purposes or to determine its
toxicity or other properties, under the following
circumstances:
a. Land us* - For tests conducted on a cumulative total
of not more than 10 acres involving use of the test
material against a particular pest, provided that any
food or feed crops involved in or affected by the tests
are destroyed or consumed only by experimental animals,
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unless a tolerance or exemption from a tolerance has
been established.
b. Aquatic use - For tests conducted on a total of not
more than one surface-acre of water involving use of a
test material against a particular pest, provided that
such waters involved in or affected by the tests will
not be used for irrigation, drinking water supplies, or
body contact recreational activities. In addition, no
tests may be conducted in waters that contain, or which
affect any fish, shellfish or other plants or animals
which may be taken and used for food or feed unless a
tolerance or exemption from a tolerance has been
established.
c. Animal treatments - For tests conducted only on
experimental animals. No animal may be tested if it
may be used for food or feed purposes, unless a
tolerance or exemption from a tolerance has been
established.
3. Small scale field testing for "novel" microbial
pesticides requiring an EUP - Due to concerns about the
capability of microorganisms to reproduce and multiply in
the environment and the potential for these microbials to
cause unforseen adverse impacts, the Agency may require an
EUP for small scale field testing of certain "novel"
microbial pesticides (i.e., genetically-altered and non-
indigenous microbial pest control agents). Refer also to
the section on Application Requirements for an Experimental
Use Permit, C.l.b. below.
C. APPLICATION REQUIREMENTS FOR AN EXPERIMENTAL USE PERMIT
Your-application for an experimental use permit must contain
or address the following:
1. General Requirements
«• Conventional, Biochemical* and Most Microbial
Pesticides
1) Application for Experimental Use Permit, EPA
Form 8570-17.
2) EPA Registration Number of the product to be
used, if registered.
3) Purpose or objectives of proposed testing.
4) A description in detail of the proposed testing
program including:
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a) Test parameters
b) A designation of the pest organism(s)
involved
c) The amount of pesticide product proposed
for use
d) The crops, fauna, flora, sites, modes,
dosage rates and situations of application on
or in which the pesticide is to be used
e) The states, and counties within the state,
in which the proposed program will be
conducted
f) The number of acres, number of structural
sites, or number of animals by state and
county to be treated or included in the area
of experimental use
g) The proposed dates or period(s) during
which the testing program is to be conducted
h) The manner in which supervision of the
program will be accomplished
IMPORTANT NOTE; It is very helpful in the Agency's review
process if you include a table which indicates the states to
which the product is to be shipped, and the pounds of
product to be shipped to each state for each pest or pest
complex, along with the total pounds of product to be
shipped to each state. For example:
EXPERIMENT USE PERMIT SUMMARY WORKSHEET "
COMPOUND: Cryptop
TOTAL ACRES: 700
POUNDS A.I. REQUESTED: 2300
NUMBER OF APPLICATIONS (By Site):
1-Soybeans
5-Cotton
2-Corn
STATE
AL
AR
GA
TOTALS
SITE 1 /
Cotton
ACRES
200
100
100
;: 400
SITE 2 /
Corn
ACRES
100
100
SITE 3 /
Soybeans
ACRES
50
50
100
200
SITE 4 /
ACRES
TOTAL
ACRES
250
150
300
700
TOTAL
LB. AI
SHIPPED
1050
550
700
2300
A tabular summary of this kind speeds review and processing of
the experimental use permit. (See Appendix 9-1 for blank format).
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5) The name, street address, telephone number, and
qualifications of all participants in the program
(whether or not in the employ of the applicant).
A participant is any person acting as a
representative of the permittee and responsible
for making available for use, or supervising the
use or evaluation of an experimental pesticide to
be applied at a specific application site.
6) The name and street address of all cooperators,
if available at the time the application is
submitted or as soon as possible thereafter.
Cooperators are persons who grant permission for
an experimental use pesticide to be used on
application sites which they own or control.
7) Information on prior testing - a description
and the specific results of any appropriate prior
testing of the product conducted by the applicant
to determine, (a) toxicity and effects in or on
any target organisms at the site of application,
and (b) phytotoxicity and other forms of toxicity
or effects on nontarget plants, animals and
insects, at or near the site of application, or
(c) any adverse effects on the environment.
8) The proposed method of storage and disposition
of any unused experimental pesticide and its
containers.
9) Any other additional pertinent information as
the Agency may require.
b. Small scale field testing - "novel" microbial
pesticides (i.e.. genetically altered and non-
indigenous microbial peat control agents)
Prior to the initiation of any small scale field
testing which involves genetically altered or non-
indigenous microbial pest control agents, the research
organization, company, or individual must submit a
notification to the Agency so that a determination can
be made as to whether an EUP is required.
You should also refer to Chapter 3 - Biochemical and
Microbial Pesticides, Section D., Small-scale field
testing Level I reporting and Level II notification
requirements, for a more detailed discussion of the
Agency's policy and requirements for small-scale field
testing for microbial pesticides.
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2. Tolerance requirements
If the proposed experimental use pesticide is to be
used in such a manner that any residue can reasonably
be expected to result in or on food or feed, the
applicant must either 1) submit evidence that a
tolerance or an exemption from the requirement of a
tolerance has been established for residues of the
pesticide in or on such food or feed under section 408
of the Federal Food Drug and Cosmetic Act (FFDCA), or a
regulation promulgated under section 409 of that Act,
or 2) submit a request proposing establishment of a
tolerance or a temporary tolerance under FFDCA section
408, or a regulation under section 409. Refer to
Chapter 7, for a further discussion of tolerances.
In lieu of submitting a request for a tolerance or
temporary tolerance, the applicant may certify that the
food or feed item resulting from the experimental use
program will be destroyed or fed only to experimental
animals to be used only for testing purposes (not for
food or feed).
3. Data requirements
If the proposed EUP is for an unregistered pesticide, the
following information and/or data are required:
a. Completed Confidential Statement of Formula, EPA
Form 8570-4.
b. Appropriate data in accordance with the data
requirements identified in 40 CFR Part 158 for an
experimental use permit.
c. Reentry data, if available.
d. Submitted data (3 copies) must be bound and
formatted in accordance with the requirements of PR
Notice 86-5.
IMPORTANT NOTE: Each study must be separately bound.
Confidential attachments and supplemental statements of
data confidentiality must be included within the
binding of the body of the study. All bindings must be
secure, but easily removable to permit microfilming.
(See PR Notice 86-5 and PR Notice 89-3 for specific
instructions on binding of studies.)
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All pesticides shipped or used under an experimental
use permit must be labeled with directions and
conditions for use including the following:
a. The prominent statement "For Experimental Use Only"
b. The Experimental Use Permit Number
c. The statement "Not for sale to any person other than
a participant or cooperator of the EPA-approved
Experimental Use Program"
d. The name, brand or trademark
e. The name and address of the permittee, producer, or
registrant
f. The net contents
g. An ingredient statement
h. Warning or caution statements
i. Any appropriate limitations on entry of persons into
treated areas
j. The establishment registration number, except in
those cases where application of the pesticide is
made solely by the producer
k. The directions for trial use
IMPORTANT NOTE: Refer to Chapter 2, page 2-16 for
label/labeling format information.
5. Extensions or reneval of Experimental Use Permits
Experimental Use Permits and associated temporary
tolerances are usually issued for a period of one or
two years. The permit and any associated temporary
tolerances, may be extended, renewed, or amended upon
written request to the Agency, if circumstances
warrant.
6. Fee Requirements
If your application for an Experimental Use Permit is
accompanied by a petition for a tolerance, temporary
tolerance, an exemption from the requirement of a
tolerance or a temporary tolerance exemption, the
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petition is subject to fee requirements as discussed in
Chapters 7 and 8 of this manual. An extension or
renewal request for a temporary tolerance is also
subject to a fee requirement.
IMPORTANT NOTE: 40 CFR 152.55 requires that inert
ingredients, metabolites, and degradation products, as well
as active ingredients, be cleared by the Agency if your
product is to be used on food or feed crops. If your
proposed labeling bears instructions for use of the product
on food or feed crops, or if the intended use of the product
results or may be expected to result, directly or
indirectly, in pesticide residues in or on food or feed, you
must submit a statement indicating whether a tolerance,
exemption from the requirement of a tolerance, or a food
additive regulation has been issued by the Agency under
section 408 or 409 of the Federal Food Drug and Cosmetic Act
(FFDCA). If a tolerance, exemption from the requirement of
a tolerance, or a food additive regulation has not been
issued for such residues, your application must be
accompanied by a petition for establishment of appropriate
tolerances, exemptions from the requirement of a tolerance,
or food additive regulation in accordance with 40 CFR 180.
Alternatively you may certify that the food or feed derived
from the experimental program will be destroyed or fed only
to experimental animals for testing purposes, or otherwise
disposed of in a manner which will not endanger man or the
environment.
D. WHO TO CONTACT FOR ADDITIONAL INFORMATION
Please contact the appropriate Product Manager for your
pesticide if you have any questions such as whether an
experimental use permit is required, whether a temporary
tolerance is required for the proposed use, the appropriate fee,
how to submit the application for an experimental use permit, or
data required to support the application. If you have questions
concerning the testing of "novel" microbial pesticides and/or
transgenic plants you should contact Product Manager 18 for
insecticide products and Product Manager 21 for fungicide or
herbicide products. If the EUP is for a new chemical which has
not been assigned to a Product Manager, you should contact the
appropriate Deputy Branch Chief, or Branch Chief for a Product
Manager assignment. Refer to Chapter 18 of this manual for a
listing of the various Product Managers, Deputy Branch Chiefs and
Branch Chiefs.
9-7
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E. REFERENCES CITED IN CHAPTER 9 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide Registration and Classification
Procedures
Part 158 - Data requirements for registration
Part 172 - Experimental use permits
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988.
Section 3 - Registration of pesticides
3. Federal Food Drug and Cosmetic Act
Section 408 - Tolerances for pesticide chemicals in or
on raw agricultural commodities
Section 409 - Food additives
4. PR Notice 86-5 - Standard Format for data submitted under
the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) and certain
provisions of the Federal Food, Drug and
Cosmetic Act (FFDCA). Issued July 29,
1986.
5. PR Notice 89-3 - Format standards for Reregistration
Phase 1 summaries and reformatted
versions of studies previously submitted
under the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA) and certain
provisions of the Federal Food, Drug,
and Cosmetic Act (FFDCA). Issued
December 20, 1989.
9-8
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EXPERIMENTAL USE PERMIT SUMMARY WORKSHEET
APPENDIX 9-1
COMPOUND:
TOTAL ACRES:
POUNDS A.I. REQUESTED:
NUMBER OF APPLICATIONS (By Site):
STATE
AL
AR
AZ
CA
CO
DE
GA
HI
IL
ID
KS
KY
LA
MA
ME
MD
MI
MN
MO
MS
MT
NE
NV
NM
NY
NC
ND
NH
NJ
OH
OK
OR
PA
SC
SD
TN
TX
UT
VA
WA
WI
WV
WY
TOTAL!
SITE 1 /
ACRES
•
5:
SITE 2 /
ACRES
SITE 3 /
ACRES
SITE 4 /
ACRES
,,
TOTAL
ACRES
TOTAL
LB. AI
SHIPPED
9-9
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rCHAPTER 10 - DEVICES - WHAT ARE THE REQUIREMENTS?
A. GENERAL INFORMATION
Section 25(c)(4) of FIFRA provides that the Administrator
ymay specify devices which are subject to any provision of FIFRA
.section 2(q)(l) or section 7. Devices are defined in FIFRA
Section 2(h).
The Agency's policy concerning its authority and activities
with respect to devices was published in the Federal Register of
November 19, 1976 (41 FR 51065).
B. DEFINITION OF DEVICES
40 CFR Section 153.240 defines a device as "any instrument
or contrivance (other than a firearm) which is intended for
trapping, destroying, repelling, or mitigating any pest or any
"other form of plant or animal life (other than man and other than
••bacterium, virus, or other microorganism on or in living man or
other living animals); but not including equipment used for the
application of pesticides (such as tamper-resistant bait boxes
for rodenticides) when sold separately therefrom".
In general, if an article uses physical or mechanical means
to trap, destroy, repel, or mitigate any plant or animal life
declared to be a pest at 40 CFR 152.5, it is considered to be a
device, and not subject to registration under FIFRA section 3.
However, if the article incorporates a substance or mixture of
substances intended to prevent, destroy, repel, or mitigate any
pest, it is considered to be a pesticide and as such is subject
to registration under FIFRA section 3.
C. DEVICES SUBJECT TO THE ACT
••• The Agency, in the November 19, 1976 Federal Register
cNotice, stated that devices subject to FIFRA section 2(q)(l) and
section 7 include but are not limited to:
1. Certain ultraviolet light systems, ozone generators,
water filters and air filters (except those containing
substances which are" pesticides), and ultrasonic devices,
for which claims are made to kill, inactivate, entrap, or
suppress the growth of fungi, bacteria, or viruses in
various sites,
2. Certain high frequency sound generators, carbide cannons,
foils, and rotating devices, for which claims are made to
repel birds,
10- 1
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3. Black light traps, fly traps, electronic and heat
screens, fly ribbons, and fly paper for which claims are
made to kill or entrap certain insects, and
4. Mole thumpers, sound repellents, foils and rotating
devices, for which claims are made to repel certain mammals.
IMPORTANT NOTE: Although not specifically mentioned in the
November 19, 1976 Federal Register Notice, the Agency has
determined that electromagnetic devices are also subject to
FIFRA section 2(q)(l) and section 7.
D. DEVICES NOT SUBJECT TO THE ACT
The November 19, 1976 Federal Register Notice provided the
following examples of those types of devices that are not subject
to FIFRA:
1. Devices which depend for their effectiveness more upon
the performance of the person using the device than on the
performance of the device itself, and
2. Devices which operate to entrap vertebrate animals.
Products generally falling within these two categories include
rat and mouse traps, fly swatters, tillage equipment for weed
control and fish traps.
E. REQUIREMENTS FOR DEVICES
1. Registration Not Required
A device is not required to be registered under FIFRA
section 3. However, devices are subject to certain other
requirements of FIFRA as indicated below.
2. Labeling Requirements
Devices are subject to the labeling requirements of FIFRA
section 2(q)(l) and 40 CFR Part 156. These requirements
are summarized below.
a. Under FIFRA section 2(q)(l) a device is considered
to be misbranded and subject to enforcement action if:
1) Its labeling bears any statements, designs, or
graphic representations, which are false or
misleading (see 2.b. below for examples of false
or misleading statements),
10- 2
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2) Its packaging or wrapping must conform to
standards established pursuant to FIFRA section
25(c)(3) (as of this date, such standards have yet
to be established for devices),
3) It is an imitation of, or is offered for sale
under the name of another device,
4) It's label fails to bear the establishment
number,
5) Required information is not prominently
displayed on the label,
6) It lacks adequate directions for use, or
7) It lacks an adequate warning or caution
statement.
b. 40 CFR section 156.10 (a)(5) provides the following
examples of labeling statements or representations
which constitute misbranding:
1) A false or misleading statement concerning the
composition of the product,
2) A false or misleading statement concerning the
effectiveness of the product as a pesticide or
device,
3) A false or misleading statement about the value
of the product for purposes other than as a
pesticide or device,
4) A false or misleading comparison with other
pesticides or devices,
5) Any statement directly or indirectly implying
that the pesticide or device is recommended or
endorsed by any agency of the Federal Government,
6) A true statement used in such a way as to give
a false or misleading impression to the purchaser,
7) Label disclaimers which negate or detract from
labeling statements required under the Act and
regulations, and
8) Non-numerical and/or comparative statements on
the safety of the product.
10- 3
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3.
Records
Devices are subject to the establishment registration and
reporting requirements FIFRA section 7 and Part 40 CFR Part
167. All establishments in which devices subject to the Act
are produced must be registered with the Agency as producing
establishments. This includes foreign establishments in
which devices shipped to the U.S. are produced, as well as
establishments located in the U.S. which produce devices for
export. Refer to Chapter 11 for information on how to
obtain an EPA establishment number.
FIFRA section 8 and 40 CFR 169 provide information on such
records that are required to be maintained by producers of
devices.
4. Inspection of Establishments
Refer to FIFRA section 9 for information" concerning
inspection of establishments.
5. Violations, Enforcement Activities, and Penalties
Refer to FIFRA sections 12, 13, and 14 for information
concerning violations, enforcement activities and
penalties.
6. Importation and Exportation of Devices
Refer to FIFRA section 17 for information concerning the
importation and exportation requirement for devices.
Regulations (19 CFR Part 12.1) for the implementation of
section 17 were published in the Federal Register (40 FR
32321) August 1, 1975. These regulations require, in part,
that devices produced by foreign manufacturers and imported
into the U.S. comply with all requirements applicable to
domestic producers. In addition, the regulations require an
importer to submit to EPA a Notice of Arrival of Pesticides
and Devices (EPA Form 3540-1) for review and determination
as to whether the shipment should be sampled and/or
permitted entry into the U.S.
FIFRA section 17 states that no device produced solely for
export to any foreign country, shall be deemed in violation
of FIFRA, when prepared or packaged to the specifications or
directions of the foreign producer, except that producers of
such devices are subject to sections 2(p),
2(q)(l)(A),(C),(D),(E),(G) and (H) , 2(q) (2) (A) , (B) , (C) (i)and
(iii), and (D).
10- 4
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In addition, devices are subject to the record keeping and
inspection requirements in accordance with section 8 of
FIFRA.
7. Child-resistant Packaging
Refer to FIFRA section 25(c)(3) and 40 CFR section 157.20
for information concerning child-resistant packaging
requirements.
P. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions concerning devices, whether they
are subject to the Act, or establishment registration, please
contact the Office of Compliance Monitoring, Compliance Division
(EN-342), Environmental Protection Agency, 401 M St., S.W.,
Washington, DC, 20460. Telephone (202) 260-7835.
G. REFERENCES CITED IN CHAPTER 10 - Refer to Chapter 16 for
information on the source of these documents.
l.Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
Part 153 - Statement of policies and interpretations
Part 156 - Labeling requirements for pesticides and
devices
Part 157 - Packaging requirements for pesticides and
devices
Part 167 - Registration of pesticide-producing
establishments, submission of pesticide
reports, and labeling
Part 169 - Books and records of pesticide production
and distribution
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 2 - Definitions
Section 3 - Registration of pesticides
Section 7 - Registration of establishments
Section 8 - Books and records
Section 12 - Unlawful acts
Section 13 - Stop sale, use, removal, and seizure
Section 14 - Penalties
Section 17 - Imports and exports
Section 25 - Child resistant packaging
3. Federal Register Notice (40 FR 32321), August 1, 1975.
10- 5
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4. Federal Register Notice, Pest Control Devices and Device
Producers, (41 FR 51065), Nov. 19, 1976.
10- 6
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.CHAPTER 11 - HOW TO OBTAIN AN EPA ESTABLISHMENT NUMBER
A. GENERAL INFORMATION
, If you produce or formulate your own pesticide, then the
•»• place(s) [or establishment(s) ] in which you produce a pesticide,
\or device, is subject to registration. ( Refer to FIFRA section
7). However, if you produce the pesticide only for application
by yourself and not for sale or distribution, you are not
required to register your establishment.
40 CFR Part 167 entitled "Registration of Pesticide-
Producing Establishments, Submission of Pesticide Reports, and
Labeling", provides detailed information concerning definitions,
registration procedures, labeling, and reporting requirements.
> An "establishment" is defined as any site where a pesticide
or device is produced, regardless of whether:
v
I 1) the site is independently owned or operated, or
{••••
2) the site is domestic (located in the U.S.) and is
producing the pesticide or device only for export, or
3) the site is located in a foreign country and is producing
the pesticide or device for importation into the United
States.
The term "produce" is defined as the manufacture, preparation,
propagation, compounding, or processing of any pesticide or
device, (including pesticides produced for use under an
Experimental Use Permit), or the repackaging or the changing of
the container of any pesticide or device.
€ You should refer to 40 CFR Part 167 for*more detailed
*• information regarding the registration of your establishment,
labeling and reporting requirements.
B. APPLICATION FOR REGISTRATION OP PESTICIDE-PRODUCING
ESTABLISHMENTS
1. Complete the application form EPA Form 3540-8,
Application for Registration of Pesticide-Producing
Establishments.
2. Where to submit your application:
a. Domestic Establishments - Submit your application
to the EPA Regional Office having jurisdiction over the
State in which the headquarters of your company is
located. Refer to Chapter 18 for a listing of the
various EPA Regional Offices.
11-1
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b. Foreign Establishments -Foreign companies should
submit their application to EPA's headquarters office
at the address listed below:
Environmental Protection Agency
Office of Compliance Monitoring (EN-342)
401 M St., S.W.
Washington, D.C. 20460 U.S.A.
C. INFORMATION REQUIRED
Your application for the registration of your establishment
requires the following information:
1) The name and address of your company,
2) The type of ownership (individual, partnership,
cooperative association, corporation, or any organized
* group of persons whether incorporated or not), and
3) The names and addresses of all producing
establishments.
D. WHERE TO OBTAIN APPLICATION FORMS
EPA Form 3540-8, Application for the Registration of
Pesticide-Producing Establishments may be obtained from your EPA
Regional Office (see Chapter 18), or from the Office of
Compliance Monitoring (EN-342), Environmental Protection Agency,
401 M Street, S.W., Washington, D.C. 20460.
E. REFERENCES CITED IN CHAPTER 11 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 167 - Registration of pesticide-producing
establishments, submission of pesticide
reports, and labeling
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 7 - Registration of Establishments
11-2
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CHAPTER 12 - HOW TO SUBMIT DATA AND CONFIDENTIAL BUSINESS
INFORMATION
A. GENERAL INFORMATION
Some of the information (and data) you must submit to EPA is
protected by FIFRA from disclosure or release to certain persons
under certain circumstances. These protections are found in
FIFRA Section 10. A brief synopsis is given below.
You may also make confidentiality claims covering
information other than that described in FIFRA Section
10(d)(l)(A), (B), or (C). If such claims are made, you will have
to substantiate each claim, and the EPA General Counsel will rule
on each claim before any disclosure or release of the information
is made. The substantiation process is provided to afford
protection to certain information that is not explicitly
described in FIFRA or EPA Regulations. Consider making claims of
confidentiality only after carefully reading the citations listed
in section B. of this chapter. Normally, we see very few claims
of this type that qualify for confidential treatment.
Data submitted in support of your application for
registration, amendments to a registration, petitions for
tolerance, experimental use permit, etc., must be submitted in a
standard format in accordance with 40 CFR 158.32-33 and PR Notice
86-5. Refer to section C. of this chapter for a general
discussion of these requirements.
B. SYNOPSIS OF FIFRA SECTION 10 - CONFIDENTIAL BUSINESS
INFORMATION
In brief, Section 10 provides that health and safety data on
registered or previously registered pesticides shall be made
available to the public, except that it does not authorize the
release of the following information cannot be released:
1. Information that discloses manufacturing or quality
control processes.
2. Information that discloses testing for and measuring the
quantity of deliberately added inert ingredients, and
3. Information that discloses the identity or percentage
quantity of deliberately added inert ingredients.
When data are submitted, information of the types 1, 2, and 3,
above must be physically separated from the rest of the data
(study) and placed in a confidential attachment to the study.
(See PR Notice 86-5 for specific instructions about study
formatting.)
12-1
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FIFRA Section 10(b) protects certain confidential business
information, such as trade secrets and commercial or financial
information.
FIFRA Section 10(e) permits EPA to give confidential
business information (CBI) you submit to its contractors who are
helping to do the work of the Agency. Such contractors are bound
to protect this information to the same extent as EPA staff. We
provide notification to submitters of CBI that their data will be
provided to a contractor. This is usually done by publishing a
Notice in the Federal Register and always precedes giving the CBI
to the contractor.
FIFRA Section 10(g) prohibits the disclosure of information
submitted by an applicant or registrant to any representative of
a multinational pesticide producer or to anybody who intends to
deliver such information to a multinational pesticide producer.
FIFRA provides that in certain circumstances the EPA
Administrator may disclose information that is otherwise
protected. Such action is rare, and is described in FIFRA
Section 10(b), 10(d)(3), and 10(g).
Information about registered pesticide products that can be
released is normally not released until 30 days after the product
is registered. See FIFRA Section 3(c)(2)(A).
This has been a very brief review of certain points about
CBI that may be of special interest to you. Please also see;
FIFRA Section 10, 40 CFR 2.307, and the citations listed in 40
CFR 2.307(c).
IMPORTANT NOTE; Documents containing CBI, i.e., a Confidential
Statement of Formula (CSF), should not be transmitted over FAX
machines unless the sender wants to clearly waive his or her CBI
rights and states this on the documents being "FAXed."
C. HOW TO SUBMIT DATA
The following discussion highlights some of the more
important points that you should follow when submitting data.
You should also refer to 40 CFR 158.32-33 and PR Notice 86-5 for
a more detailed discussion of how to format your data submission
When you submit data, the data will be reviewed to determine
whether it meets the data formatting requirements set forth in PR
Notice 86-5. If major problems are found during this screening
process, the studies will be returned to you for correction.
Studies that meet the formatting requirements will be assigned a
12-2
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The following individuals in the Information Services Branch
of OPP's Program Management and Support Division may be contacted
for assistance in answering questions or to provide guidance
concerning the data formatting procedures as required by PR
Notice 86-5:
Theresa Downs (703) 305-5363,
Maureen Sherrill (703) 305-5361,
Kris Pappajohn (703) 305-5316.
Master Record Identifier (MRID) number and entered into the
Agency's Pesticide Document Management System. These studies are
then able to be retrieved by the MRID number at any time. You
may refer to these MRID numbers in lieu of sending in additional
copies of these data to support additional applications for
registration.
The following diagrams are meant to provide guidance on how
to format your data submission. Again you should refer to PR
Notice 86-5 for more detailed information.
FORMAT OF THE SUBMITTAL PACKAGE
APPLICATION TRANSMITTAL
(submit one copy only)
(submit
3 copies)
1—>
(copy #1)
DATA TRANSMITTAL
Studies submitted as unique
physical entities, according
to the format below.
(copy #2)
(copy #3)
NOTE: As indicated in the above illustration, three identical
copies of the data transmittal must be submitted.
LEGEND: STP = Study title page.
SOCC = Statement of confidentially claims.
GLP/FS = Good Laboratory Practice (GLP) and flagging*,
BOS = Body of study, in English.
ATS = Appendices to the study.
* Refer to 40 CFR 158.34.
12-3
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FORMAT OP THE SUBMITTED STUDIES
Study title page.
Statement of confidentially claims.
Good Laboratory Practice (GLP) and flagging*
statements (as appropriate).
3-7 Body of study, in English.
Appendices to the study
ATS
Title Page of the
Confidential
Attachment.
LEGEND
| |
o- Confidential Attachment.
l~ ~i
| o—| Supplemental Statement
j | of Confidentiality
1 1— ' | Claims.
'*'Refer to 40 CFR 158.34
Miscellaneous documents submitted
at your option.
Documents which must be submitted as appropriate
to meet established requirements.
1. APPLICATION TRANSMITTAL
The application transmittal may include any or all of the
following:
a. Application forms
b. Formulator's exemption statements
c. Confidential Statement of Formula
d. Certification with Respect to Citation of Data
e. Data requirement matrices
f. Data waiver request and supporting rationales
g. Labeling
IMPORTANT NOTE: PR Notice 86-5 does not change the
registration requirements for applications for
registration or amendments as set forth in 40 CFR 152
and elsewhere. PR Notice 86-5 only applies when you
submit data to support the application, and then only
to the data. All of the items listed in this sub-
section address non-data requirements for registration,
and are filed in the Agency's registration jacket
(file) for your product. Thus they need not be
submitted in three copies like the data.
12-4
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2. DATA TRXNSMITTAL DOCUMENT
You should provide a copy of the Data Transmittal for
each set of studies. Bind it separately, and be
certain that it itemizes all studies that are
physically included in the submittal. You will be sent
a copy of your data transmittal document with the MRID
numbers assigned to each piece of data or study. Refer
to PR Notice 86-5 for a sample transmittal document.
3. BIND STUDIES SEPARATELY
If a study addressed several data requirements, do not
include it in your submittal more than once. Identify
its full subject scope on its title page, and then cite
the same study in your application in all appropriate
contexts.
Each study must be separately bound. Confidential
attachments and supplemental statements of data
confidentially must be included within the binding of the
body of the study. All bindings must be secure, but easily
removable to permit microfilming.
4. WHAT TO INCLUDE IN A STUDY
All study-specific supplements, addenda, supporting
analyses, protocols, or correspondence submitted at the
same time as the report of the study itself should be
included within the binding and pagination of the
primary study.
5. IDENTIFYING SUPPLEMENTS TO PREVIOUSLY SUBMITTED STUDIES
Whenever you submit information to supplement a
previously submitted study, whether at your own
initiative or in response to a request by EPA, it must
be prepared in the format required by PR Notice 86-5.
Submit three complete sets under an appropriate
transmittal document, including supplemental
information for only one study in each binding, and
identifying the previously submitted study in
supplements as clearly as possible, i.e., by EPA
Accession Number or (preferably if you know it) the
Master Record Identifier (MRID) number on its title
page.
6. STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Each submitted study must have this Statement. The
exact text of one of the two alternative forms of the
statement (Refer to PR Notice 86-5) must appear on page
12-5
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2 of the study. You may add to the required text a
reference to the proprietary nature of the document,
and you may assert that it may not be copied, quoted,
etc. by any recipients other than EPA. You may not,
however, assert a right of prior approval for use,
copying, or distribution of the data by EPA, as
required and constrained by Sections 3 and 10 of FIFRA.
If there are markings (such as "Company Confidential")
in your study documents, you must add to the required
text an explicit statement that over-rides the implicit
supplemental claims of confidentiality that result from
these markings. This over-ride statement may specify
that it applies only to use of the data by EPA in
connection with the provisions of FIFRA.
IMPORTANT NOTE; Documents for which a statement of data
confidentiality claim has been made should not be
transmitted over FAX machines unless the sender wants to
clearly waive his or her CBI .rights and states this on the
documents being "FAXed."
D. WHO TO CONTACT FOR ADDITIONAL INFORMATION!
If you have any questions concerning confidential business
information as it may concern your application or how to format
and submit supporting data, please contact the Information
Resources Development Section, Information Services Branch,
Program Management and Support Division. Refer to Chapter 18 of
this manual.
B. REFERENCES CITED IN CHAPTER 12 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 2 - Public information
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 3 - Registration of pesticides
Section 10 - Protection of trade secrets and other
information
3. PR Notice 86-5 - Standard format for data submitted under
the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) and certain
provisions of the Federal Food, Drug and
Cosmetic Act (FFDCA), Issued July 29,
1986.
12-6
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4. PR Notice 89-3 - Format standards for Reregistration
Phase 3 summaries and reformatted
versions of studies previously submitted
under the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA) and certain
provisions of the Federal Food, Drug,
and Cosmetic Act (FFDCA). Issued
December 20, 1989.
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iCHAPTER 13 - TRANSFER OF PRODUCT REGISTRATIONS AND/OR DATA
?• RIGHTS FROM ONE PERSON OR COMPANY TO ANOTHER
*
?A. GENERAL INFORMATION
40 CFR 152.135 provides information necessary for the
transfer of the registration of a product from one person or
company to another. Applications for the registration of
products which are still pending registration (not registered)
may also be transferred. 40 CFR 152.98 provides information for
the transfer of data rights from one person or company to
another. You should refer to these references for specific
details on the transfer of registrations and/or data rights.
A discussion of transfer requirements is provided below.
B. TRANSFER OF PRODUCT REGISTRATIONS
# A registrant may transfer the registration of a product to
another person, and the registered product may be distributed and
sold without the requirement of a new application for
registration by that other person, if the parties submit to the
Agency the documents as described in 40 CFR 152.135 and receive
approval by the Agency.
1. Persons seeking approval of a transfer of a product
registration must provide a document (a Transfer Document)
signed by the authorized representative of the registrant
of the product to be transferred (the transferor) and of the
person to whom the product registration is to be transferred
(the transferee) that contains the following information:
a. The name, address, phone number, EPA-assigned
company number, and State of incorporation (if any) of
the transferor,
b. The name, address, phone number, EPA-assigned
company number, and State of incorporation of the
transferee (If the transferee does not have an EPA-
assigned company number, he or she should request that
one be assigned),
c. The product name(s) and EPA registration number(s),
or the EPA File Symbol for pending products, of the
products to be transferred,
d. A statement that the transferor transfers
irrevocably to the transferee all right, title, and
interest in the EPA registration(s) listed by product
name and EPA Registration Number in the document,
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e. A statement that the transferred registration(s)
shall not serve as collateral or otherwise secure any
loan or other payment arrangement or executory promise,
and that the registration(s) shall not revert to the
transferor unless a new transfer agreement is submitted
to and approved by the Agency,
f. A description of the general nature of the
underlying transaction, e.g., merger, spinoff,
bankruptcy transfer (no financial information need be
disclosed),
g. A statement that the transferor and transferee
understand that any false statement may be punishable
under 18 U.S.C. 1001, and
h. An acknowledgement by the transferee that his rights
and duties concerning the registration under FIFRA and
this chapter will be deemed by EPA to be the same as
those of the transferor at the time the transfer is
approved.
2. In addition, the transferor must submit to the Agency as
required by 40 CFR 152.135(c) a notarized statement
affirming that:
a. The person signing the transfer agreement is
authorized by the registrant to bind the transferor,
b. No court order prohibits the transfer, and that any
required court approvals have been obtained, and
c. The transfer is authorized under all relevant
Federal, State and local laws and all relevant
corporate charters, bylaws, partnerships, or other
agreements.
IMPORTANT NOTE; Notary rules do not generally allow a
person to notarize their own signature. Therefore, it is
recommended that the same person not sign both the transfer
document and the notarized statement.
IMPORTANT NOTE: in the event that the original documents
cannot be submitted for the attachments to the transfer
document, each of the copied documents must be notarized and
certified as a true copy of the originals.
13-2
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3. If the required documents are submitted, and no
information available to the Agency indicates that the
information is incorrect, the Agency will approve the
transfer without requiring that the transferee obtain a new
registration(s). The Agency will notify the transferor and
the transferee of its approval.
4. The transfer will be effective on the date of Agency
approval. Thereafter, the transferee will be regarded as
the registrant for all purposes under FIFRA.
5. The rights to exclusive use of data or data compensation
under FIFRA section 3(c)(l)(D) are separate from the product
registration itself and may be retained by the transferor,
or may be transferred independently in accordance with
40 CFR 152.98. If the registrant as the original data
submitter wishes to transfer data rights at the same time as
he transfers the registration, he may submit a single
transfer document containing the information required by
this section for both the registration and the data.
IMPORTANT NOTE: When product registrations are transferred from
one registrant to another, all restrictions, data requirements,
conditions of registration, including timeframes for the
submittal of data or other information, suspensions or any other
requirements existing on the registration are transferred with
the registration. The new registrant (transferee) is responsible
for adhering to or complying with all such restrictions, data
requirements, conditions of registration, timeframes, suspensions
or any other requirements that have been imposed on the acquired
product registration.
With respect to timeframes for the submittal of data or
other information, the new registrant is responsible for the
submittal of all required data according to the schedules already
established by the Agency as a result of a data call-in under
FIFRA section 3(c)(2)(B), or a condition of the registration
under FIFRA section 6(e), for the acquired product registrations.
Failure to comply with these timeframes, may result in the
issuance of a Notice of Intent to Suspend the registration of the
affected product under FIFRA section 3(c)(2)(B), or a Notice of
Intent to Cancel the registration of the affected product under
FIFRA section 6(e).
Requests for the extension of time to submit required data
or other information from the new registrant, merely because they
acquired the registration after the 3(c)(2)(B) data call-in was
issued, or after the conditions of registration under section
6(e) were imposed will not be granted. If the new registrant has
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other valid reasons for delays in the testing which were clearly
outside their control, then such a request for time extensions
will be considered in accordance with established procedures. If
such delays are expected to be encountered, and a time extension
is believed to be necessary, the Agency should be informed as
soon as possible, and in any event prior to the due date.
Transfers that occur while a 3(c)(2)(B) data call-in is
being issued or during the 90 day response time to the data call-
in are subject to the same conditions expressed above.
C. TRANSFER OF DATA RIGHTS
A person who possesses rights to exclusive use data or data
compensation under FIFRA section 3(c)(l)(F) may transfer such
rights to another person in accordance with 40 CFR 152.98. In
order for the Agency to process a request for the transfer of
data rights, certain documentation is required.
1. The original data submitter must submit to the Agency a
transfer document that contains the following information:
a. The name, address, phone number and State of
incorporation (if any) of the original data submitter
(the transferor),
b. The name, address, phone number and State of
incorporation of the person to whom the data rights are
being transferred (the transferee),
c. Identification of each item of data transferred
including:
1) The name of the study or item of data,
2) Whether the study is an exclusive use study,
and, if so, when the period of exclusive use
protection expires,
3) The name of the person or laboratory that
conducted the study,
4) The date the study was submitted to the Agency,
5) The EPA document number assigned to the item of
data [the Master Record Identification Number
(MRID) or Accession Number], if known. If not
known, the EPA administrative number (such as the
EPA Registration Number, petition number, file
symbol, or permit number) with which the item of
data was submitted, such that the Agency can
identify the item of data.
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6) A statement that the transferor transfers
irrevocably to the transferee all rights, and
interest in the items of data named,
7) A statement that the transferor and transferee
understand that any false statement may be
punishable under 18 U.S.C. 1001, and
8) The names, signatures and titles of the
transferor and transferee, and the date signed.
2. In addition, the transferor must submit to the Agency as
required by 40 CFR 152.98, a notarized statement from a
company official or from the company legal counsel affirming
that:
a. The person signing the transfer agreement is
authorized by the original data submitter to bind the
data submitter,
b. No court order prohibits the transfer, and any
required court approvals have been obtained, and
c. The transfer is authorized under Federal, State and
local laws and relevant corporate charters, bylaws or
partnership agreements.
IMPORTANT NOTE; Notary rules do not generally allow a
person to notarize their own signature. Therefore, it is
recommended that the same person not sign both the transfer
document and the notarized statement.
3. The Agency will acknowledge the transfer of the data by
notifying both transferor and transferee, and will state the
effective date of the transfer. Thereafter the transferee
will be considered to be the original data submitter of the
items of data transferred for all purposes under FIFRA
section 3(c)(l)(F), unless a new transfer agreement is
submitted to the Agency.
D. WHO TO CONTACT FOR FURTHER INFORMATION: If you have any
questions or require additional information concerning the
transfer of product registrations or data rights please contact
the Administrative Processing Section, Registration Support
Branch. Refer to Chapter 18 of this manual.
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REFERENCES CITED IN CHAPTER 13 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 152 - Pesticide registration and classification
procedures
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 3 - Registration of pesticides
Section 6 - Administrative review; suspension
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CHAPTER 14 - STATE REGULATORY AUTHORITY UNDER
fA. 8TATB ISSUANCE OF EXPERIMENTAL USB PERMITS
Section 5 of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) authorizes any State to issue an
experimental use permit for a pesticide in accordance with a
State plan approved by the Agency. 40 CFR Part 172, Subpart B -
State Issuance of Experimental Use Permits, provides detailed
information on state experimental use permits. In general,
authorized states can issue experimental use permits for the
purpose of gathering data necessary to support the State
sregistration of a pesticide to meet special local needs under
'FIFRA Section 24(c) and for the purpose of experimentation.
To date, Idaho, Florida and Vermont have received
authorization from the Agency to issue state experimental use
•;'• permits.
.WHO TO CONTACT; For additional information concerning state
EUPs, you should contact the pesticide regulatory authority in
the state in which you wish to obtain a state EUP. A listing of
the state regulatory agencies can be found in Chapter 18.
B. STATE REGISTRATION OF SPECIAL LOCAL NEEDS
FIFRA Section 24(c) authorizes a State to provide
registration for additional uses of federally registered
pesticides formulated for distribution and use within that State
to meet special local needs in accordance with the provisions of
the Act. 40 CFR Part 162, Subpart D - Regulations Pertaining to
State Registration of Pesticides to Meet Special Local Needs,
provides detailed information on the scope and authority of the
states to issue registration of pesticide products.
Under FIFRA Section 24(c), states are authorized to register
new end-use products or additional uses of federally registered
pesticides if the following conditions exist:
1. a special local need for that product use,
2. the use, if a food or feed use, is covered by an
appropriate tolerance or has been exempted from the
requirement of a tolerance,
3. registration for the same use has not previously been
denied, disapproved, suspended, or canceled by EPA, or
voluntarily canceled by the registrant because of health or
environmental concerns about an ingredient contained in the
product, unless EPA has reversed the original action,
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4. the registration is in accord with the purposes of FIFRA.
24(c)s which amendments federal registrations (new uses).
States may register:
1. subject to the limitations set forth in 40 CFR Part
162, any new use of a federally registered pesticide
product.
2. any use of a federally registered product for which
registration of other uses of the product was denied,
disapproved, suspended, or canceled by the EPA,
provided that the proposed use was not considered by
the EPA in reaching such a determination and only after
the State consults with appropriate EPA personnel on
its acceptability.
3. any use of a federally registered product for which
registration of some or .all uses has been voluntarily
canceled by the registrant unless such voluntary
cancellation follows the issuance of an EPA Notice of
Intent to cancel for human health or environmental
reasons. States may only grant 24(c) registrations for
voluntarily canceled uses of products after consulting
with appropriate EPA personnel.
IMPORTANT NOTE: A State may not register an amendment
to a federally registered manufacturing-use product.
24(c)s which are new products (not previously federally
registered). States may register:
1. a product which is identical in composition to a
federally registered product, but which has differences
in packaging, or in the identity of the formulator,
2. a product which contains the same active and inert
ingredients as a federally registered product, but in
different percentages,
3. a product containing a new combination of active,
or active and inert, ingredients only if each of the
active ingredients in the new product is present
because of the use of one or more federally registered
products and if each of the inert ingredients in the
new product is contained in a federally registered
product,
4. a product containing an ingredient that (1) has had
one or more of its formulations or uses denied,
disapproved, suspended, or canceled by EPA because of
human health or environmental concerns or (2) the
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registrant has voluntarily canceled a formulation or
use following the issuance of an EPA Notice of Intent
to Cancel because of health or environmental concerns,
provided the 24(c) formulation and/or use was not
considered in EPA's action and was not included in a
Notice of Intent to Cancel and only after the State
consults with appropriate EPA personnel regarding the
acceptability of the 24(c) application.
IMPORTANT NOTE: A State may not register a new
manufacturing-use product.
? Requests for Special Local Need (SLN) registrations are
generally made by pesticide companies to the specific state.
Once a state approves the application, the state then forwards
notification of the SLN registration to EPA for review. Provided
the state has complied with the requirements of FIFRA section
£24(c) and 40 CFR Part 162, the registration becomes effective
immediately.
The EPA has 90 days from receipt of the SLN notification
from the state to disapprove the registration. Otherwise it
becomes a Federal registration under FIFRA section 3 for the use
only within the state.
General Disapproval of State Registration
EPA may disapprove any state registration on any reasonable
grounds (excluding solely lack of essentiality), any state
registration which, when compared to a federally registered
product, does not have both a similar composition and use
pattern. Grounds for disapproval may include, but are not
limited to:
1. the 24(c) will probably create an unreasonable
adverse effect upon man and/or the environment;
2. the refusal of the registering State to submit
information supporting the registration, i.e.,
application form (within 10 working days), Labeling for
the 24(c), 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" findings
by the State (within 15 working days);
3. Failure of the information submitted by the State
to support the State decision to issue the 24(c);
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Special Disapproval of State Registrations
EPA may disapprove any SLN registration at any time
(even beyond the 90 day period) if it is determined
that the 24(c):
(a) would constitute an imminent hazard;
(b) may result in a residue on food or feed
exceeding, or not covered by, a tolerance,
exemption, or other clearance under the FFDCA.
Once the SLN is registered under FIFRA, it is subject to any
additional data requirements that may be required by the EPA
either as the result of a Registration Standard or any other
FIFRA Section 3(c)(2)(B) data call-in.
FEE REQUIREMENTS FOR SLN'8
The 1988 amendments to FIFRA requiring that annual
maintenance fees be paid by registrants of pesticide products
apply to registrations under Section 24(c) of FIFRA. You should
refer to Chapter 8 for a discussion of registration maintenance
fees.
C. EMERGENCY EXEMPTIONS
FIFRA section 18 authorizes the Administrator to exempt
State and Federal agencies from any provision of FIFRA, if he
determines that emergency conditions exist which require an
exemption. The regulations in 40 CFR Part 166 establish
procedures by which the Administrator may exempt a Federal or
State agency from the provisions of FIFRA which regulate the
manner in which a pesticide is made available for use or is used.
There are four types of emergency exemptions which may be
authorized:
1. Specific exemption. A specific exemption may be
authorized in an emergency condition to avert a significant
economic loss, or a significant risk to endangered species,
threatened species, beneficial organisms, or the environment.
EPA shall allow the use of a pesticide under a specific exemption
for as long a period as is reasonably expected to be necessary
but in no case for longer than 1 year.
2. Quarantine exemption. A quarantine exemption may be
authorized in an emergency condition to control the introduction
or spread of any pest new to or not theretofore known to be
widely prevalent or distributed within and throughout the United
States and its territories. EPA shall allow use of a pesticide
under a quarantine exemption for as long a period as is deemed
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'necessary but in no case for longer than 3 years. Quarantine
^exemptions may be renewed. Interim reports containing the
^information specified in 40 CFR 166.32(b) to the extent available
1'shall be filed annually.
?
<• 3. Public health exemption. A public health exemption may
be authorized in an emergency condition to control a pest that
will cause a significant risk to human health. EPA shall allow
'the use of a pesticide under a public health exemption for as
long a period as is reasonably expected to be necessary but in no
case for longer than 1 year.
2 4. Crisis exemption. A crisis exemption may be utilized in
an emergency condition when the time from discovery of the
emergency to the time when the pesticide use is needed is
insufficient to allow for the authorization of a specific,
quarantine, or public health exemption. The crisis provisions
may not be utilized to authorize a pesticide use if any of the
•*'following has occurred:
- EPA has informed the head of the Federal or State agency,
the Governor, or their official designee, not to issue
such an exemption;
- The pesticide use has been suspended under section 6(c) of
FIFRA;
- The pesticide use has been canceled following a notice
issued under section 6(b) of FIFRA;
- The pesticide contains a new chemical; or
- The application proposes the first food use of a
pesticide.
A crisis exemption may be authorized for: (a) only as long
as is necessary to control the pest or conditions causing the
emergency; (b) no longer than 15 days, unless an application
, requesting a specific, quarantine, or public health exemption for
?this use has been submitted to the Agency.
The documents EMERGENCY EXEMPTIONS UNDER SECTION 18 OF THE
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT: I. Guidance
for state and Federal Agencies, and II. Instructions for
submission of emergency exemption applications can be obtained
from the National Technical Information Service (NTIS) by calling
(703) 487-4650. If you have any questions, or require any
further information, please call the Communications Branch in
OPP's Field Operations Division at (703) 305-5017.
.WHO TO CONTACT; Additional information concerning applications
for a state special local need registration should be addressed
to the state in which you wish to make an application for a SLN
registration. A listing of the various state pesticide agencies
*can be found in Chapter 18 of this manual.
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D. REFERENCES CITED IN CHAPTER 14 - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 162 - State registration of pesticide products
Part 166 - Exemption of Federal and State agencies for
use of pesticides under emergency conditions
Part 172 - Experimental use permits
2. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 3 - Registration of pesticides
Section 5 - Experimental use permits
Section 18 - Exemption of Federal and state agencies
Section 24 - Authority of states
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CHAPTER 15 - OTHER TYPES OF REGISTRATIONS AND/OR APPROVALS THA.T
MAY BE NEEDED PROM FEDERAL OR STATE AGENCIES OTHER
Mr. THAN EPA'« PESTICIDE PROGRAMS
" A. GENERAL INFORMATION
Although you may have obtained a Federal registration for
your pesticide product, which allows you to distribute and sell
your product in the U.S., there are state regulations that you
may have to comply with before you can distribute and/or sell the
product within that state.
-. In addition, there may be other Federal, State, or local
requirements that you must satisfy. The following listing is
intended only to provide general information on some of these
requirements, or to provide a point of contact. It should be
noted that the listing is not all inclusive, nor is it complete.
$,-. It is your responsibility to comply with all federal, state or
.:.'-' local regulations.
B. STATE REGULATION OF FEDERALLY REGISTERED PESTICIDES
FIFRA Section 24(a) states that "A State may regulate the
sale or use of any federally registered pesticide or device in
the State, but only if and to the extent the regulation does not
permit any sale or use prohibited by this Act".
Even though you have obtained a Federal registration for
your pesticide product which allows you to distribute and sell
the product within the U.S., the various states in which you may
wish to distribute and sell your product may have additional
requirements for the regulation of pesticides within the state.
The requirements vary from state to state, and may include
additional data requirements, additional restrictions on
pesticide use within their jurisdiction, and licensing
requirements. You should contact each state in which you intend
to market your product to determine what additional requirements
may affect the sale, distribution or use of your product.
WHO TO CONTACT: For additional information concerning state
registration requirements for your Federally registered pesticide
product, you should contact the pesticide regulatory authority in
the state in which you intend to market your product. A listing
of state regulatory authorities can be found in Chapter 18 of
this manual.
C. USE OP PESTICIDES IN MEAT AND POULTRY PLANTS
Federally registered pesticides intended for use in
federally inspected meat and poultry plants must be
appropriately labeled and authorized by the U. S. Department of
Agriculture (USDA).
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The Federal Meat Inspection Act, as amended by the Wholesome
Meat Act of 1967, and the Poultry Products Inspection Act, as
amended by the Wholesome Products Act of 1968, require the
maintenance of safe and sanitary conditions in federally
inspected meat and poultry plants. These Acts are enforced by
the Animal and Plant Health Inspection Service through the Meat
and Poultry Inspection Program (MPIP).
The Inspection Program calls for the authorization of the
use of substances and compounds in the plants, because use of
such materials may result in adulteration or unwholesomeness of
meat and poultry being processed. All chemicals produced in the
U.S. for marketing to federally inspected meat and poultry plants
must be evaluated by the USDA in order to provide assurance that
the chemicals used in federally inspected plants are authorized
for use and that their proper use will not result in adulteration
or contamination of food products.
1. Labeling Requirements - Before directions for use in
federally inspected meat and poultry plants can be accepted under
the Federal Insecticide, Fungicide and Rodenticide Act, (FIFRA),
you must obtain authorization from the USDA. Upon receipt of
confirmation of USDA authorization, your product labeling can be
amended to include the following statement:
"Authorized by USDA for use in federally inspected meat and
poultry plants."
2. Application for USDA Authorization - If you wish to have
your product approved for use in a federally inspected meat or
poultry plant, you must make an application to obtain
authorization from the USDA.
WHO TO CONTACT: For additional information on the use of
pesticides in federally inspected meat and poultry plants, and
where to obtain application forms for authorization from the
USDA, contact:
Product Assessment Division
Compounds and Packaging Branch
RP, FSIS, U.S. Department of Agriculture
Building 306, BARC-East
Beltsville, MD 20705
(301) 504-8566
D. USE OF PESTICIDES ON POOD CONTACT SURFACES, FOR PAPER AND
PAPERBOARD (FOOD USES). ON MEDICAL DEVICES. AS HUMAN AND ANIMAL
DRUGS, AND IN CANE-SUGAR AND BEET SUGAR MILLS
The Food and Drug Administration (FDA) and the Environmental
Protection Agency (EPA) have several areas of mutual regulatory
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"responsibility which may require review by one or both agencies.
The following is a brief summary of these areas:
l. Sanitizers (pesticides used en food contact surfaces)
Any pesticide product intended for sanitizing inanimate food
contact surfaces must be approved by the FDA pursuant to 21
CFR 178.1010. Ingredients in these products are considered
to be Indirect Food Additives. EPA will not register
sanitizer products unless a food additive regulation has
been issued for the active and inert ingredients or the
ingredients are "generally recognized as safe" by FDA.
s Persons who wish to obtain FDA approval must submit a Food
Additive Petition or similar request to:
Division of Food and Color Additives (HFF-330)
Food and Drug Administration
200 C Street, S.W.
Washington, D.C. 20204
2. Microbiocides in paper and paperboard (food use)
Other than EPA responsibilities under FFDCA and FIFRA, FDA
evaluates the safety and efficacy of pesticides used in
paper or other materials which are not themselves regulated
as pesticides which come into contact with food. FDA must
approve the ingredients of a pesticide as indirect food
additives under 21 CFR Part 176 before EPA will approve
a registration. Petitions or requests may be sent to the
same address as in 1. above.
3. Antimicrobial pesticides used on medical devices
An antimicrobial agent used on medical devices is considered
by FDA to be an accessory to a medical device. Accordingly,
FDA requires premarket notification under section 510(k) of
the FFDCA for marketing of such agents. FDA reviews the
safety and efficacy of these antimicrobial products.
Approval by both FDA and EPA must be obtained before these
products may be sold or distributed. Section 510(k)
petitions may be submitted to:
Division of Gastroenterology-Urology
and General Use Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration (HFZ-332)
8757 Georgia Avenue
Silver Spring, MD 20910
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4. Human and Animal Drugs
FDA and EPA have areas of mutual responsibility with respect
to applications for drugs under FFDCA and for registration
of pesticides under FIFRA. In 1971, FDA and EPA issued a
Memorandum of Agreement stating which agency has primary or
secondary responsibility on specific matters (See Federal
Register Notice, 36 FR 24234). This agreement was updated
in 1973 (38 FR 24233) and in 1979 (44 FR 63749). Briefly,
EPA has primary jurisdiction for disinfectants and
sanitizers, treatments of certain pests on animals, aquatic
treatments solely for algae or bacterial slime, sanitizers
for aquarium equipment, and sanitizers for inanimate
surfaces or drinking water of animals which do not claim
disease control. FDA has primary jurisdiction for new human
or animal drugs, and products which are intended to: control
parasites on humans, relieve the effect of insect bites,
prevent diaper rash through treatment of diapers, treat
athletes foot, treat certain animal diseases and pests,
treat water for fish parasites or diseases, and treat
drinking water to control animal parasites or diseases.
Questions on these areas of jurisdiction may be referred to
the EPA's Antimicrobial Program Branch. Refer to Chapter
18 of this manual.
5. Cane-sugar and beet-sugar mills
Pesticides used for controlling microorganisms in cane-sugar
and beet-sugar mills must be approved by the FDA under 21
CFR 173.320. Petitions may be directed to the following
address:
Division of Food and Color Additives (HFF-330)
Food and Drug Administration
200 C Street, S.W.
Washington, D.C. 20204
E. ANTIMICROBIAL FUEL ADDITIVES
Any pesticide product intended for use in aviation fuel must
have the approval of the Federal Aviation Administration (FAA)
for use in aircraft engines. Persons who wish to obtain FAA
approval must submit their request to:
FAA Flight Standards Service
Engineering and Manufacturing Division
Federal Aviation Administration
Washington, D.C. 20591
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UP. SHIPPING (TRANSPORTATION) OP PESTICIDES
m. The U.S. Department of Transportation (DOT) and the
-------
EPA Office of Pollution Prevention and Toxics
Chemical Control Division
Program Development Branch
Kathleen Bailey (202) 260-5591 or
David Giamporcaro (202) 260-6362
2. U.S. Department of Agriculture (USDA). Any organism
(including plants) may be considered a potential plant
pest. Such organisms may be regulated under either the
Plant Pest Act and/or the Plant Quarantine Act. Such
organisms may require a permit for import and/or
introduction testing, and use. For information on
USDA permit requirements contact:
USDA
Animal and Plant Health Inspection Service
Sally McCammon (301) 436-8761
John Payne (301) 436-8378
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CHAPTER 16 - HOW TO OBTAIN PUBLICATIONS
*A. DOCUMENTS AVAILABLE FROM THE NATIONAL TECHNICAL INFORMATION
^SERVICE
The listing entitled "Availability of OPP Publication
Listings" includes information on various OPP documents that are
available at the National Technical Information Service (NTIS).
The listing includes information on the following:
1. Information for Ordering OPP Publications from the
National Technical Information Service
2. Registration Standards Report (includes Reregistration
Eligibility Documents (REDs)
3. Pesticide Fact Sheets (includes Pesticide R.E.D. Fact
£' Sheets)
.*•
; 4. Special Review Position Documents
,!'
V 5. Hazard Evaluation Division (HED) - Pesticide Assessment
Guidelines
6. Hazard Evaluation Division (HED) - Standard Evaluation
Procedures
7. Pesticide Product Information
- Compact Label File
8. Miscellaneous Publications/Documents
9. Pesticide Data Submitters List by Chemical (listed under
Miscellaneous Publications/Documents)
Copies of the listing, which includes the NTIS Document order
number, the EPA Document Number and the cost of the document on
either microfiche or hard copy, are available from the following
address:
U.S. EPA
Document Management Section (H7502C)
Information Services Branch, PMSD
Office of Pesticide Programs
401 M Street, S.W.
Washington, D.C. 20460
Telephone: (703) 305-5240
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B. DOCUMENTS AVAILABLE FROM THE U.S. GOVERNMENT PRINTING OFFICE
The following documents are for sale, and are available from
the Superintendent of Documents, U.S. Government Printing Office,
Washington, D.C. 20402.
Code of Federal Regulations, Title 40 (40 CFR)
- 40 CFR, Part 2 - Public information
- 40 CFR, Parts 150 to 189 - Protection of
Environment
The Code of Federal Regulations is also available for
examination at Government depository libraries and many other
libraries. A complete listing of only Government Depository
Libraries is available without charge from The Library, U.S.
Government Printing Office, 5236 Eisenhower Avenue, Alexandria,
VA 22304. A listing of libraries where the Code of Federal
Regulations is available, which includes both Government
depository libraries and other libraries that maintain copies of
the Code of Federal Regulations can be found in the Federal
Register of April 18, 1989 (54 FR 15608).
EPA Headquarters Telephone Directory
A copy of an order form for ording the EPA Headquarters
Telephone Directory can be found at the end of this chapter.
C. DOCUMENTS AVAILABLE FROM THE ENVIRONMENTAL PROTECTION AGENCY
The following documents are available from the Environmental
Protection Agency:
1. Federal Insecticide, Fungicide and Rodenticide Act, as
amended. October 1988. EPA 540/09-89-012.
Copies of the FIFRA are available from the following
address:
Environmental Protection Agency
Office of Pesticide Programs
Registration Division
Registration Support Branch (H7505C)
401 M Street, S.W.
Washington, D.C. 20460
Telephone: (703) 305-7700
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2. List of all federally r^qiatared ptsticida products
classified aa "Restricted Us> Pesticides" (RUPI.
This listing is available through the Pesticide Information
Network (PIN), an on-line, no cost computer bulletin board
operated by OPP. This system can be reached with a PC by
data-phone (modem), similar to many popular PC-to-PC
bulletin boards. Completely menu driven, it is very "user
friendly" and contains several informative data bases, such
as the "Restricted Use Products" file, which is a monthly
updated listing of all RUPs.
Questions about the PIN may be referred to the User Support
Group at 703-305-7499 between the hours of 7:00 AM to 4:00
PM EST. The phone number for accessing the PIN is: 703-305-
5919, 24 hours a day, except for some periods of time
between 1:00 PM to 3:00 PM any weekday for updating and
maintenance.
3. chemicals for Which Data Waivers Have Been Granted
As outlined in 40 CFR Part 158.45(d), Agency decisions on
data waivers are available to the public at the following
location:
Environmental Protection Agency
Office of Pesticide Programs
Docket Reading Room, Room 1132
Crystal Mall #2
1921 Jefferson Davis Highway
Arlington, VA 22202
Office hours are from 8:00 AM to 4:00 PM, Monday through
Friday, except legal holidays. Telephone: (703) 305-5805
Written Requests: Any person may obtain a copy of any waiver
decision by written request to the following address:
Environmental Protection Agency
Freedom of Information (A-101)
401 M Street, SW
Washington, DC 20460
4. LISTING OF REGISTRATION STANDARDS MID REREGISTRATION
ELIGIBILITY DOCUMENTS ISSUED
This listing, entitled the "Registration Standard Report"
provides information of all registration standards and
reregistration eligibility documents which have been issued,
is contained in a general listing entitled "OPP Publication
Listings" (see above).
16-3
-------
5. PR NOTICE8
Pesticides Regulation Notices (PR Notices) are mailed to
registrants of record when issued. Additional copies, or
back copies are available from:
U.S. EPA
Document Management Section (H7502C)
Information Services Branch, PMSD
Office of Pesticide Programs
401 M Street, S.W.
Washington, D.C. 20460
Telephone: (703) 305-5240
D. FEDERAL REGISTER NOTICES
The Federal Register is available for examination at
Government depository libraries and many other libraries. A
complete listing of only Government Depository Libraries is
available without charge from The Library, U.S. Government
Printing Office, 5236 Eisenhower Avenue, Alexandria, VA 22304.
A listing of libraries where the Federal Register is available,
which includes both Government depository libraries and other
libraries that maintain copies of the Federal Register, can be
found in the Federal Register of April 18, 1989 (54 FR 15608).
16-4
-------
Superintendent of Documents Subscriptions Order Form
Order Processing Code:
t* 6629
YES, enter my subscription(s) as follows:
Subscriptions to EPA HEADQUARTERS TELEPHONE
DIRECTORY (EPATD) for $15 per year ($18.75 foreign).
.The total cost of my order is $ . Price includes
^regular domestic postage and handling and is subject to change.
_ Charge
(Company or Personal Name) (Please type or print) your
order
_ It's
(Additional address/attention line) Easy
(Street address) MasterCard
(City, State, ZIP Code) VISA
(Daytime phone including area code)
(Purchase Order No.)
YES NO
Hay we make your name/address available to other mailers? I—I LJ
To fax
your orders
(202) 512-2233
please Choose Method of Payment:
'—' Check Payable to the Superintendent of Documents
'—' GPO Deposit Account ' ' ' ' ' ' ' ' ~ ' '
'—' VISA or MasterCard Account
'—H ' ' ' (Credit card expiration date) Thank you for
your order!
(Authorizing Signature)
Mail To: Superintendent of Documents,P.O. Box 371954,Pittsburgh, PA 15250-7954
-------
CHAPTER 17 - FORMS. AND HOW TO OBTAIN THEM
The various forms required to be submitted with various
types of applications for registration, experimental use permits
and distributors are listed below.
Copies of the following forms may be obtained, FREE OF
CHARGE. from the Registration Support Branch, Registration
Division (H7505C), Office of Pesticide Programs, Washington, D.C.
20460. Telephone: (AC 703) 305-7700.
EPA FORM
8570-1
8570-4
8570-5
8570-17
8570-20
8570-25
8570-27
8570-28
8570-29
8570-31
8570-32
TITLE
Application for Pesticide
Registration/Amendment (Revised 12-90,
previous editions are obsolete)
Confidential Statement of Formula (Revised
12-90, previous editions are obsolete)
Notice of Supplemental Registration of
Distributor (Revised 8-91, previous editions
are obsolete)
Application for an Experimental Use Permit to
Ship and Use a Pesticide for Experimental
Purposes Only (Revised 2-91, Previous
editions may be used until supply is
exhausted)
Data Reference Sheet (1-91)
Application for/Notification of State
Registration of a Pesticide to Meet a Special
Local Need (12-87)
Formulator's Exemption Statement (7-91)
Certification of Compliance with Data Gap
Procedures (1-91)
Certification with Respect to citation of
Data (7-91)
Certification With Respect to Data
Compensation Requirements (4-90)
Certification of Offer to Cost Share in the
Development of Data with Other Registrants
(05-91)
17-1
-------
EPA FORM TITLE
8580-1 FIFRA Section 3(c)(2)(B) Summary Sheet
8580-4 Product Specific Data Report
The following forms may be obtained, FREE OF CHARGE, from
the Office of Compliance Monitoring (EN-342), 401 M Street, SW,
Washington DC, 20460, or your EPA regional office. See Chapter
18 for a listing of the Regional Offices.
EPA FORM TITLE
3540-1 Notice of Arrival of Pesticides or Devices
3540-8 Application for Registration of Pesticide-
Producing Establishments
Graphic representation copies of the above forms are
presented below in Figures 17-1 through 17-15. You should note
that the forms represented below are for ILLUSTRATION PURPOSES
ONLY and should not be used when submitting an application to the
Agency.
17-2
-------
FIGURE 17-1.
REPRESENTATIVE COPY OT EPA FORM 8570-1
FOR ILLUSTRATION PURPOSES ONLY
Please'read instructions on reverse before completing form Form Approved OMB No. 2070-0060, Approval expires 11-30-93
(A)
EPA
(.
United States Environmental Protection Agency
Office of Pesticide Programs (H750SC)
Washington, DC 20460
Application for Pesticide:
Registration
Amen*
Other
OPP Identifier Number
169993
Section I
1. Company/Product Number
4. Company/Product (Name)
2. EPA Product Manager
PM*
3. Proposed Classification
None
Restricted
5. Name-and Address of Applicant (include Zip Code)
6. Expedited Review. In accordance with FIFRA Section 3(c)(3)
(b)(i), my product is similar or identical in composition and labeling
to:
EPA Reg. No.
I Check if this is a new address
Product Name
Section II
Amendment - Explain below.
Resubmission in response to Agency letter dated_
Notification - Explain below.
Final printed labels in response to I
Agency letter dated_
I
•Me Too" Application
Other - Explain below
I
F I
0 U
R S
T_
P
U
R
P
0
Explanation: Use additional page(s) if necessary. (For section I and Section II.)
R
A
T
I
0
Section 111
1. Material This Product W 11 Be Packaged In;
Child-Resistant Packaging
Yes
No
* Certification must be
submitted.
Unit Packaging
Yes
No
If "Yes,"
Unit Package wgt.
No. Per
container
Water Soluble Packaging
Yes
No
If "Yes,"
Package wgt. I
No. Per
container
2. Type of Container
Metal
Plastic
Glass
Paper
Other (Specify).
3. Location of Net Contents Information
Label
Container
4. Size(s) of Retail Container
5. Location of Label Directions
On Label
On Labeling accompanying product
6. Manner In Which Label Is Affixed To Product
Lithograph
Paper glued
Stenciled
Other (
Section IV
1. Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process
this application.)
Name
Title
Telephone No. (Include Area Code)
Certification
I certify that the statements I have made on this form and all attachments thereto are true,
accurate and complete. I acknowledge that any knowingly false or misleading statement may be
punishable by fine or' imprisonment or both under applicable law.
. Signature
4. Typed Name
3. Title
S. Date
6. Date Application
Received
(Stamped)
EPA Form 8570-1 (Rev. 12-90) Previous editions are obsolete.
17-3
-------
FIGURE 17-2. REPRESENTATIVE COPY OP EPA FORM 1T5?0-4 FOR ILLUSTRATION PURPOSES ONCTT
Confidential Business Information: Does Not Contain National Security Information (E.O. 12065) Form Approved OMB No. 2070-0060. Approval Expires 11-30-93
United States Environmental Protection Agency
Office of Pesticide Programs (H7505C)
EPA Washington, OC 20460
Confidential Statement of Formula
1. Name and Address of Applicant/Registrant (Include ZIP Code)
3. Product Name
EPA USE ONLY
10. Components in Formulation (List as actually
introduced into the formulation. Give commonly
accepted chemical name, trade name, and CAS
number)
S
A
H
P
L
E
11. Suppl
A.
| | Basic Formulation
| | Alternate Formulation
B.
Pane
of
See Instruction on Back
2. Name and Address of Producer (Include ZIP Code)
4. Registration No. /File Symbol
7. Pounds/Gal or Bulk Density
er Name and Address
F I
0 L
R L
U
S
T
R
A
T
1
5. EPA Product Mgr/Team No.
8. pH
12. EPA Reg. No.
P
U
R
P
0
S
0
N
16. Typed Name of Approving Official
18. Signature of Approving Official
13. Each C<
in Fon
a. Amount
0
E
S
17.
19. Title
Total
Weight
vnponent
Mil at ion
b. X by
weight
N
L
Y
100X
6. Country Where Formulated
9. Flash Point/Flame Extension
U.Certifi*
X by U«
a. Upper
Limit
id Limits
sight
b. Lower
Limit
15. Purpose
in
Formulation
20. Phone No. (Include Area
Code)
21. Date
EPA Form 8570-4 (Rev. 12-90) Previous editions are obsolete.
White - EPA File Copy (Original) Yellow - Applicant Copy
17-4
-------
FIGURE 17-3.
REPRESENTATIVE COPY OF EPA FORM 8570-5
FOR ILLUSTRATION PURPOSES ONLY
Please Read All Instructions Before Completing This Form (Form Must be typed)
Form Approved. OMB No. 2070-0044
Approval expires 1-51-95
United States Environmental Protection Agency
Office of Pesticide Programs (H7505C)
••E PA 401 M Street SW
Washington, DC 20460
.,- Notice of Supplemental Distribution of a Registered Pesticide Product
Instructions
After a registrant has obtained final registration for the basic product, the registrant may then supplementally
distribute his/her product. One form must be submitted for each distributor product and must be signed by the
distributor involved. The basic registration number and the distributor company number must be shown.
If a registrant has a potential distributor who does not have a company number assigned, she/he should have the
distributor apply, on letterhead stationary, to the Registration Division to have a number assigned prior to submitting
this form to the agency.
This Notice of Supplemental Distribution must be submitted by the basic registrant. The completed form must have
the concurrence and signature of both the registrant and the di tributor.
EPA Registration Number of Product
Distributor Company Number
Name of
Registered
Product
(basic
product
name accepted
by
EPA)
Distributor
Product
I
L P
Name
Name and Address of Distributor (Type; include ZIP code)
Read All Conditions Before Signing
1
1. The distributor product must have the same composition as the basic product. N
2. The distributor product must be manufactured and packaged by the same person who manufactures and packages the
registered basic product.
3. The labeling for the distributor product must bear the same claims as the basic product, provided, however, that
specific claims may be deleted if by doing so, no other changes to the label are necessary.
4. The product must remain in the manufacture's unbroken container.
5. The label must bear the EPA registration number of the basic product, followed by a hyphen and the distributor's
company number.
6. Distributor product labels must bear the name and address of the distributor qualified by such terns as "packed
for,..., "distributed by..."; or sold by..." to show that the name is not that of the manufacturer.
7. All, conditions of the basic registration apply equally to distributor products. It is the responsibility of the basic
registrant to see that all distributor labeling is kept in compliance with requirements placed on the basic product.
Distributor
We intend to market our product under the Distributor Product Na
on this Notice.
Signature and Title of Distributor
specified above, subject to the conditions specified
Date
Registrant
I agree that the distributor named above may distribute and sell the Distributor Product specified above, subject to the
conditions specified on this Notice.
Signature and Title of Registrant
Date
EPA Form 8570-5 (Rev. 2-92) Previous editions are obsolete.
17-5
-------
FIGURE 17-4.
REPRESENTATIVE COPY Of EPA FORM 8570-17
FOR ILLUSTRATION PURPOSES ONLY
Please read instructions on reverse before completing form Fora Approved OMB No. 2070-0040, Approval expires 11-30-
United States Environmental Protection Agency
Office of Pesticide Programs (H7505C)
-EPA Washington, DC 20460
Application for an Experimental Use Permit to Ship
and Use a Pesticide for Experimental Purposes Only
1. Type of Application
|~~| New |~~j Amendments (See No. 11)
| | Extension (Give Permit Number below)
Permit Number
3. Name and Address of Firm/Person to Whom the
Experimental Use Permit is To Be Issued (include
ZIP Code) (Type or Print)
S IPO
A F L U N
M 0 L R L
P R U P Y
L SO
E T S
5. Name of Product R E
A S
T
I
0
N
OPP Identifier Number "*
002808
2. EPA Company Number
4. Name and Address of Shipper (if shipment is intended and if different
from applicant's name and address) (include ZIP Code) (Type or Print)
6. Is Product Registered with EPA?
| | Yes (Give registration number or file symbol below). | | No
Refl. No.
File Svmbol
7. Total Quantity of Product Proposed for 8. Acreage or Area to be Treated 9.
Shipment/Use
A. Pounds of formulated product
8. Pounds of active ingredient
10. Places from which Shipped
12. Specify the name & telephone no. of the
individual most familiar with this application who
can be contacted directly, if necessary to process
this application.
Proposed Period of Shipment/Use
11. Briefly explain (attach separate sheet if necessary)
13. Signature of applicant or authorized firm representative
14. Title
15. Date Signed
Cert fication
This is to certify that food or feed derived from the experimental program Mill not be used or offered for consumption or
sale for consumption except by laboratory or experimental animals if illegal residues are present in or on such food or
feed.
I certify that the statements I have made on this form and all attachments thereto are true, accurate, and complete. 1
acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under
aoolicable law.
•,-.:'.•< >i .-.. ,<. fffta? for fpft !tat flnftf %: •->-••.-.
Ift any correspond***^
Normal r«vi&* $ii* iitficatw that pr
-------
FIGURE 17,-5. REPRESENTATIVE COPY OF EPA FORM 8570-20
FOR ILLUSTRATION PURPOSES ONLY
form Approved OMB No. 2070-0060. Approval Expires 11-30-93
U.S. ENVIRONMENTAL PROTECTION AGENCY
REGISTRATION DIVISION (H7S05C)
EPA WASHINGTON. D.C. 20460
DATA REFERENCE SHEET
(See instructions on the back of the last oaqe before conoletina)
3. APPLICANT'S NAME AND ADDRESS
7. NAME OF STUDY
4. PRODUCT NAME
5. PRODUCT MANAGER
1 PAGE
OF
2. EPA REGISTRATION NO. /FILE
SYMBOL
6. TO ACCOMPANY APPLICATION
FOR REGISTRATION DATED:
SOURCE OF STUDY
a.
A C S m
P 0 T a
P N U r
L D 0 k
I U Y
C C x
A T
N E
T D
b.
0 F m
B R a
T 0 r
A N k
I
N E x
E P
D A
c. OBTAINED FROM ANOTHER FIRM OR SOURCE
(give name and address)
S
A
M
P
L
E
d. OBTAINED FROM
PUBLIC LITERATURE
(give reference)
1
L
F L
0 U
R S
/|\
If you marked MX" in this column, do you wish your name | | YES
I — placed on the Data Submitters List?
lUl NO
e. OTHER
(explain)
P
U
R
P
T 0
R S
A E
T
0
N
L
Y
S
I
0
N
f. ACCESSION
NUMBER
(if known)
EPA Form 8570-20 (Rev. 1-91)
APPLICANT - RETAIN THE LAST COPY
EPA COPY
17-7
-------
FIGURE 17-6
REPRESENTATIVE COPY OF EPA FORM 8570-25
FOR ILLUSTRATION PURPOSES ONLY
Form Approved. OMB Mo. 2070-0055. Approval expires 6-30-90,
United States Environmental Protection Agency
Office of Pesticide Programs (H7505C)
Washington, DC 20460
EPA Application for/Notification of State Registration
of a Pesticide To Meet a Special Local Need
(Pursuant to Section 24(C) of the Federal Insecticide,
Fungicide, and Rodent icide Act. as Amended)
1. Name and Address of Applicant for Registration
4. Product Name
6. Type of Registration (Give details in Item 12
or a separate page, properly identified and
attached to this form):
a. To permit use of a new product.
b. To amend EPA registrations for one or more of
the following purposes:
(DTo permit use on additional crops or
animals.
(2)To permit use at additional sites.
(3)To permit use against additional pests.
(4)To permit use of additional application
technioues or eouioment.
(5)To permit use at different application rates
(6)0ther (specify below)
10. Has a FIFRA Section 24
-------
FIGURE 17-7 REPRESENTATIVE COPY 01 EPA FORM 8570-27
FOR ILLUSTRATION PURPOSES ONLY
Fonn Approved. OMB No. 2070-0060. Approval expires 11-30-93
EPA
United States Environmental Protection Agency
Washington, DC 20460
Fonulator's Exemption statement
(40 CFR 152.85)
Applicant's Names and Address
EPA File Symbol/Registration Number
Product Name
Date of Confidential Statement of Formula
(EPA Form 8570-4)
As an authorized representative of the applicant for registration of the product identified above, I here certify that:
(1) This product contains the following active ingredient(s):
(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that active
ingredient in the manufacturing, formulation or repackaging of another product which contains that active ingredient,
which is registered under FIFRA Section 3, is purchased by us from another producer, and is labeled for at least each
use for which my product is proposed to be labeled.
'(3) Indicate by checking (A) or (B) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for the above identified product is attached
to this statement. That formula statement indicate, by company name, registration number, and product name, the
source of the active ingredient(s) listed in paragraph (1).
OR
(B) The Confidential Statement of Formula (CSF) (EPA Form 8570-4) referenced above and on file with the EPA is
complete, current, and accurate and contains the information required on the current CSF.
(4) The following active ingredients in this product qualify for the formulator's exemption.
Source
Active Ingredient
*
S
'A F
M 0
P R
L
E
'
Signature
Product Name
I P
L U
L R 0
UP N
S 0 L
T S Y
R E
A S
T
I
0
N
Name and Title
Registration Number
Date
EPA Form 8570-27 (Rev. 7-91)
White - EPA copy
Yellow - Applicant copy
17-9
-------
FIGURE 17-8
REPRESENTATIVE COPY OF EPA FORM 8570-28
FOR ILLUSTRATION PURPOSES ONLY
EPA
United States Environmental Protection Agency
Washington, DC 20460
Certification of Compliance
with Data Gap Procedures
(40 CFR 152.96)
Form Approved.
OMB No. 2070-0060
Approval expires 11/30/93
Applicant's Names and Address
EPA File Symbol/Registration Number
Product Name
Date of Application
I certify that:
1. I have notified in writing each person on the Pesticide Data
Submitters' List for each active ingredient in this product, in
accordance with the requirements of 40 CFR 152.96; and
2. I have waited 60 days following such written notice; and
3. I have received no response indicating that any person has
submitted a valid study that would satisfy any of the require-
ments for which a data gap is claimed, and therefore, I have no
basis for believing that such data have been submitted to EPA by
any other person.
I P
S L U
A F L R 0
MO U P N
PR S 0 L
L T S Y
E R E
A S
T
I
0
N
Signature
Name and Title
Date
EPA Form 8570-28 (Rev. 1-91)
17-10
-------
FIGURE 17-9
REPRESENTATIVE COPY OF EPA FORM 8570-29
FOR ILLUSTRATION PURPOSES ONLY
EPA
United States Environmental Protection Agency
Washington, DC 20460
Certification with Respect to Citation of Data
For* Approved
OMB No. 2070-0060
Approval Expires 11-30-93
Applicant's Name and Address
S ... I P 0
A F L UN
M 0 L R L
P R U P Y
L SO
E T S
R E
... A S_
EPA File Symbol/Registration Number
Product Name
Date of Application
!->T 1 0 N
NOTE: If your product is a 100X repackaging of another EPA-registered product that you purchase, and
Ms labeled for the same uses, you do not need to submit this form. You must submit the Formulator's
Exemption Statement (EPA Form 8570-27).
1. This application is supported by all data submitted or cited in the application. In addition, if cite-all
options are indicated, this application is supported by all data in the Agency's files that concern the
properties or effects of this product that is identical or substantially similar, and that is one of the types
of data that would be required to be submitted if this application sought the initial registration of a
product of identical or similar composition and intended uses under the data requirements in effect on
the date of approval of this application. (Check the appropriate boxes, in items 2 and 3 below, that
pertain to your application.)
2. I certify that, for each study cited in support of this application for registration that is an exclusive use
study,
| | I am the original submitter*; or
| | I have obtained the written permission of the original data submitter to cite that study*
3. I certify that, for each study cited in support of this application for registration that is not an exclusive use
study:
a. | | I am the original data submitter*; or
| | I have obtained the written permission of the original data submitter to cite that study*; or
t b. | | I have notified in writing the companies that have submitted data I have cited to support this
application and have offered to: (a) Pay compensation for those data in accordance with section
3(c)(1(D) and 3(c)(2)(D) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA);
and (b) Commence negotiations to determine which data are subject to the compensation
requirement of FIFRA and the amount and terms of compensation due, if any. The companies I
have notified are: (Check one)
| | All companies listed on the Pesticide Data Submitters List for all active ingredients contained
in my product (cite-all method or cite-all option under Selective Method*). (Also sign the
General Offer Statement below.)
| | Those companies that have submitted the studies which I have cited (Selective Method*).
* A Data Matrix identifying these studies is attached. (Note: A Data Matrix is not required under the
cite-all method.)
Signature
Name and Title
Date
General Offer to Pay: I hereby offer and agree to pay compensation to other
persons, with regard to the approval of this application, to the extent required.
Signature
Name and Title
Date
EPA Form 8570-29 (Rev. 7-91)
17-11
-------
FIGURE 17-10
REPRESENTATIVE COPY OF EPA FORM 8570-31
FOR ILLUSTRATION PURPOSES ONLY
EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0106
Approval Expires 12-31
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
I
Please fill in blanks below.
Company Name P SO
1 T S
Chemical Name E RE
A S
Company Number
EPA Chemical Number
I Certify that: I
0
N
1. For each study cited in support of registration or reregistration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter,
I have notified in writing the company(ies) that submitted data 1 have cited and have offered to: (a) Pay
compensation for those data in accordance with section 3(c)(1)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, if any. The companies I have notified are: (check one)
[ ] All companies on the data submitters' list for the active ingredient listed on this form (Cite-All
Method or Cite-All Option under the Selective Method). (Also sign the General Offer to Pay
below.)
[ ] The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form."
3. That I have previously complied with section 3(c)(1)(D) of FIFRA for the studies I have cited in support of
registration or reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or reregistration of my products, to the extent required by FIFRA sections 3(c)(1)(D) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
i
EPA Form 8570-31 (4-90)
17-12
-------
FIGURE 17-11
REPRESENTATIVE COPY OF EPA FORM 8570-32
FOR ILLUSTRATION PURPOSES ONLY
EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Fora Approved
OMB No. 2070-0106
Aooroval Exofres 12-31
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.U., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Chemical Name
Company Number
EPA Chemical Number
I Certify that:
Hy company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
items could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
I
L P
S F L U 0
A 0 U R N
N R S P L
P TOY
L R S
E A E
T S
I
0
N
Date of Offer
Certification;
I certify that I am duly authorized to represent the company name above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name arid Title (Please Type or Print)
EPA Form 8570-32 (5-91)
Replaces EPA Fora 8580-6, which is obsolete
17-13
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FIGURE 17-12 REPRESENTATIVE COPY OF EPA FORM 8580-1
FOR ILLUSTRATION PURPOSES ONLY
For* Approved. OMB Not 2070-0057. Approval expires 11-30-89.
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANT'S NAME
EPA REGISTRATION NO.
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(c)(2)(B) notice contained in the
referenced Guidance Document, 1 am responding in the following manner:
| | 1. I will submit data in a timely manner to satisfy the following requirements, if the test procedures I will
use deviate from (or are not specified in) the Registration Guidelines or the Protocols contained in the Report
of Expert Groups to the Chemicals Group, OECD Chemicals Testing Programme, I enclose the protocols that I will
use.
| | 2. I have entered into an agreement with one or more other registrants under FIFRA
satisfy the following data requirements. The tests, and any required protocols,
section 3(c)(2)(B)(ii) to
will be submitted to EPA by:
NAME OF OTHER REGISTRANT
| | 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with
Development of Data" with respect to the following data requirements:
Other Registrants for
| | 4. I request that you amend my registration by deleting the following uses (this option is not available to
applicants for new products): I
L
S IP
A F U U 0
M 0 S R N
P R T P L
L ROY
E AS
T E
I S
0
N
|~| 5. I request voluntary cancellation of the registration of this product. (This option is not available to
applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE SIGNATURE
DATE
EPA Form 8580-1 (10-82)
17-14
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FIGURE 17-13
REPRESENTATIVE COPY OF EPA FORM 8580-4
FOR ILLUSTRATION PURPOSES ONLY
US Environmental Protection Agency Registration Standard for:
Washington, DC 20460
EPA
Product Specific
Data Report
Registration
Guideline No.
Sec. 158,120
Product
Chemistry
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
I 63-12
1 63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.135
Toxicology
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Identity of ingredients
Statement of composition
Discussion of formation of ingredients
Preliminary analysis
Certification of limits
Analytical methods for enforcement limits
Color
Physical state
Odor
Melting ooint
Boiling ooint
Density, bulk-density, or specific gravity
Solubility
vaoor pressure
Dissociation constant
Octanol/water oartition coefficient
DH
Stability
Oxidizing/reducing reaction
F I amiability
Exolodability
Storage stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage
Acute oral toxicity. rat
Acute dermal toxicity. rabbit
Acute inhalation toxicity. rat
Primary eve irritation, rabbit
Primary dermal irritation
Dermal sensitization
Testing not
required for my
product listed
above
(check below)
S
A
M
P
L
EPA Registration Number
I am complying with
Data Requirement bv -
Citing
HRID No.
I
L
L
f
0
R
E
Submitting
Data
(Attached)
(Check below)
P
U U
S R
T
R
A
T
I
Form Approved
OMB * 2070-0057
Expires 11-30-89
(For EPA Use
Only)
Accession
numbers
assigned
0
N
P L
0 Y
S
E
S
0
N
Certification
1 certify that the statements I have made on this form and all attachments thereto are
true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
REGISTRANT'S AUTHORIZED REPRESENTATIVE SIGNATURE
DATE
EPA Form 8580-4 (Rev. 5-88) Previous edition is obsolete.
17-15
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FIGURE 17-14 REPRESENTATIVE COPY OF EPA FORM 3540-1
FOR ILLUSTRATION PURPOSES ONLY
U. S. Environmental Protection Agency
NOTICE OF ARRIVAL OF
PESTICIDES AND DEVICES
NOTE: Read instructions on reverse before completing form.
PART 1 TO BE COMPLETED BY
1. NAME AND ADDRESS OF IMPORTER OR AGENT (Include Zip
Code) S I P
A F L U 0
M 0 L R N
P R U P
L SO
E T S
3. NAME AND ADDRESS OF SHIPPER R E
A
T
I
0
7. MAJOR ACTIVE INGREDIENTS AND PERCENTAGE OF EACH
8. UNIT SIZE 9. QUANTITY 10. TOTAL NET UGT.
12. PORT OF ENTRY
Form Approved. OMB No. 2070-0020. Expires 3-31-88
SEND COMPLETED FORM TO:
MPORTER OR HIS AGENT
2. NAME AND ADDRESS OF CONSIGNEE (Include Zip Code
L
Y
4. EPA REGISTRATION NO. 5. EPA PRODUCER ESTABLISHMENT
S NO.
6. BRAND NAME OF PRODUCT
N
11. COUNTRY OF ORIGIN
13 CARRIER
14. ENTRY NUMBER IS. ENTRY DATE 16 MARKS AND NUMBERS
17. LOCATION OF GOODS FOR EXAMINATION
21. REMARKS
INVOICE DATA
18. NUMBER 19. DATE 20. PLACE
22. I ASSERT THAT INFORMATION CONSTITUTING CONFIDENTIAL
BUSINESS INFORMATION IS SHOW* IN THE ABOVE BLOCKS
NUMBERED:
23. SIGNATURE OF IMPORTER OR AGENT 24. DATE
PART II TO BE COMPLETED BY U.S. ENVIRONMENTAL PROTECTION AGENCY
Action to be taken on shipment by U.S. Customs:
Release shipment.
Detain shipment for inspection by EPA
Release shipment to consignee under bond. Shipment must be held intact pending EPA inspection.
Sample desired under provisions of the Federal Insecticide, Fungicide, and Rodent icide Act, as amended and Customs
Regulations 19 CFR 12.116. Please forward a sample of the merchandise identified above, together with all
accompanying labels, circulars, and advertising matter pertaining to such merchandise, to the address shown above.
If it is necessary to take subsamples from bulk containers, contact the EPA office for sampling instructions.
_ Other (Specify):
REMARKS
SIGNATURE AND TITLE OF EPA OFFICIAL DATE
PART II TO BE COMPLETED BY U.S. CUSTOMS SERVICE
The information shown in Part I was compared with the entry papers for this shipment and no discrepancies were noted. The
shipment was handled as instructed by EPA in Part II. Any deviations should be brought to the attention of EPA before
releasing shipment and also be noted in remarks.
REMARKS
SIGNATURE OF DISTRICT DIRECTOR OF CUSTOMS DATE
EPA Form 3540-1 (Rev. 5-77) Previous editions are obsolete.
17-16
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FIGURE 17-15 REPRESENTATIVE COPY OF EPA FORM 3540-8
FOR ILLUSTRATION PURPOSES ONLY
U. S. ENVIRONMENTAL PROTECTION AGENCY
APPLICATION FOR REGISTRATION OF PESTICIDE - PRODUCING ESTABLISHMENT
(SECTION 7, FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT,
AS AMENDED, 86 Stat. 973.999)
P
NOTE: READ ALL INSTRUCTIONS BEFORE COMPLETING. U
Font Approved
OMB No. 2070-0045
Approval expires 11-30-89
DOCUMENT NUMBER
0. TRANS. TYPE (EPA USE ONLY)
1. COMPANY NAME
I
|6. EPA REGISTRANT NUMBER
2. STREET ADDRESS
17. COMPANY DUNS NUMBER
3. CITY
11. COMPANY HEADQUARTERS (if different from Nuifcer 1) I
4. STATE
S. ZIP CODE
8. ENTER APPROPRIATE OWNERSHIP C00f_
1 - INDIVIDUAL
2 - PARTNERSHIP
3 - COOPERATIVE ASSOCIATION
4 - CORPORATION
5 - OTHER
12. STREET ADDRESS
9. DATE OF INCORPORATION (Mo.Day.Year)
I
I
13. CITY
14. STATE 15. ZIP CODE 10. STATE OF INCORPORATION
NAME. SITE LOCATION. AND MAILING ADDRESS OF EACH PRODUCING ESTABLISHMENT
16.
W.
NAME OF ESTABLISHMENT
17. ESTAB. NO. (EPA Use Only)
18. DUNS NUMBER
LOCATION (Street, City)
20. STATE
21. ZIP CODE
22. CUSTOM BLENDER
23. MAILING ADDRESS OF ESTABLISHMENT (Street, City)
24. STATE
25. ZIP CODE
26. SIC CODES
16. NAME OF ESTABLISHMENT
17. ESTAB. NO. (EPA Use Only)
18. DUNS NUMBER
19. LOCATION (Street, City)
20. STATE
21. ZIP CODE
22. CUSTOM BLENDER
23. MAILING ADDRESS OF ESTABLISHMENT (Street, City)
24. STATE
25. ZIP CODE
26. SIC COOES
16.
W.
NAME OF ESTABLISHMENT
17. ESTAB. NO. (EPA Use Only)
18. DUNS NUMBER
LOCATION (Street, City)
20. STATE
21. ZIP CODE
22. CUSTOM BLENDER
23. MAILING ADDRESS OF ESTABLISHMENT (Street, City)
24. STATE
25. ZIP CODE
26. SIC CODES
16. NAME OF ESTABLISHMENT
17. ESTAB. NO. (EPA Use Only)
18. DUNS NUMBER
19..LOCATION (Street, City)
23. MAILING ADDRESS OF ESTABLISHMENT (Street, City)
20. STATE
21. ZIP CODE
22. CUSTOM BLENDER
24. STATE
25. ZIP CODE
26. SIC CODES
16.
W.
237
NAME OF ESTABLISHMENT
17. ESTAB. NO. (EPA Use Only)
18. DUNS NUMBER
LOCATION (Street, City)
20. STATE
21. ZIP CODE
22. CUSTOM BLENDER
MAILING ADDRESS OF ESTABLISHMENT (Street, City)
24. STATE
25. ZIP CODE
26. SIC CODES
CONTINUED ON ATTACHED SHEET
27. SIGNATURE OF COMPANY OFFICER
28. NAME AND TITLE
29. DATE (Mo.Day.YD
I I I I I
30. TELEPHONE NUMBER
31. DATE APPLICATION RECEIVED
III
32. SIGNATURE
THE ESTABLISHMENTS ASSIGNED NUMBERS ABOVE
HAVE BEEN REGISTERED IN ACCORDANCE WITH
SECTION 7, FIFRA AS AMENDED
EPA
USE
ONLY
33. EPA REGIONAL OFFICE
34. DATE REVIEWED
EPA FORM 3540-8 (REV. 10-81)
PREVIOUS EDITIONS ARE OBSOLETE
17-17
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CHAPTER 18 - WHO TO CONTACT FOR ASSISTANCE AND WHERE TO SEND
YOUR APPLICATIONS AND SUBMISSIONS
A. GENERAL INFORMATION
The Registration Division, Office of Pesticide Programs,
consists of three pesticide product branches, the Insecticide-
Rodent icide Branch, the Fungicide-Herbicide Branch, the
Antimicrobial Program Branch, and one support branch, the
Registration Support Branch. The pesticide product branches are
further subdivided into Product Manager Teams which are
responsible for the review and processing of applications for
registration, amended registration, petitions for tolerances, and
experimental use permits.
B. WHERE TO SUBMIT YOUR APPLICATION
1. Applications for registration, petitions, experimental
use permits, etc., must be mailed to the following address:
Document Processing Desk (Distribution Code) **
Office of Pesticide Programs (H7504C)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
** Insert Appropriate Distribution Code identified
below.
2. Hand-delivered applications must be delivered to the
following address:
U.S. Environmental Protection Agency
Crystal Mall, Bldg. #2, Rm. 258
Document Processing Desk (Distribution Code) **
1921 Jefferson Davis Highway
Arlington, VA 22202
** Insert appropriate Distribution Code identified
below.
3. Distribution Codes
When you send mail to either of the above addresses, we will
be able to process your application more expeditiously if you
indicate the type of application you are submitting. The
following Distribution Codes are designed to enable the Agency to
identify, route and process your incoming mail more quickly and
accurately. The Distribution Code should be used as indicated in
the addresses cited above.
18-1
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SECTION 3 PRODUCT REGISTRATIONS
DISTRIBUTION
CODE
APPL
AMEND
CAN/WD
CERT
LIP
XFER
TYPE OF APPLICATION
Application for Product Registration
Amendment to Registration
Request to Cancel a Registered Product
or to Withdraw a Pending Registration
Certifications of Product Registration
Label Improvement Program Response
Transfer Products to a Different Company
OTHER ACTIONS
BIOTECH Biotech Applications and Pre-EUP Notifications
EMEX Emergency Exemption
EUP Experimental Use Permit
IR4 Minor Use Petition
PETN Petition for Tolerance
SLN Special Local Need Registration
INFORMATION PERTAINING TO ADVERSE EFFECTS
6(a)(2) Unreasonable Adverse Effects Data
COMPANY NAME AND ADDRESS
COADR Company Name and Address Change
DIST Supplemental (Distributor) Registration
NEWCO Request for a Company Number (Register an
Establishment)
DATA CALL-IN RESPONSES (PRODUCT SPECIFIC)
DCI-RD-PMXX
RED-RD-PMXX
Response to a Data Call-In
Response to a Reregistration Eligibility
Document
(xx identifies the PM Team)
DATA CALL-IN RESPONSES (GENERIC)
DCI-SRRD-XXX
RED-SRRD-XXX
Response to a Data Call-in
Response to a Registration Eligibility
Document
(xxx identifies the regulatory case number or chemical name as
as specified in individual OPP instructions)
18-2
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RS-XXX
OTHER REGULATORY RESPONSES
Response to a Registration standard (including
Second Round Reviews)
(xxx identifies the regulatory case number or chemical name as
as specified in individual OPP instructions)
OFFICE OF PREVENTION. PESTICIDES AND
C. ORGANIZATIONAL CHARTS;
TOXIC SUBSTANCES
This section contains organizational charts for the Office
of Prevention, Pesticides and Toxic Substances, including names
and telephone numbers for the heads of each organization.
Detailed charts are provided for the Office of Pesticide Programs
and the Office of Compliance Monitoring but not for the Office of
Pollution Prevention and Toxics.
OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES
ASSISTANT ADMINISTRATOR FOR PREVENTION PESTICIDES AND
TOXIC SUBSTANCES
LINDA J. FISHER, Assistant Administrator (202) 260-2902
VICTOR J. KDW, Deputy Assistant Administrator (202) 260-2910
OFFICE OF POLLUTION
PREVENTION
AND TOXICS
MARK A. GREENWOOD
Director
(202) 260-3810
JOSEPH S. CARRA
Deputy Director
(202) 260-1815
[No detailed charts
provided for this
organization.]
OFFICE OF
PROGRAMS
DOUGLAS D. CAMPT
Director
(703) 305-7090
SUSAN H. WAYIAND
Deputy Director
(703) 305-7092
[Refer to detailed
charts below for
breakdown of this
organization.]
OFFICE OF COMPT-TANTF;
MONITORING
MICHAEL M. STAHL
Director
(202) 260-3807
CONNIE A. MUSGROVE
Chief Executive Officer
(202) 260-7833
[Refer to detailed
charts below for
breakdown of this
organization.]
18-3
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OFFICE OF PREVENTION, PESTICIDES & TOXIC SUBSTANCES
OFFICE OF PESTICIDE PROGRAMS (OPP)
DOUGLAS D. CAMPT, Director <703) 305-7090 SUSAN H. UAYLAND, Deputy Director (703)305-7090
Responsible for the overall management of the Pesticide Program. Activities of the OPP include
control and regulation of pesticides and reduction in their use to assure human safety and
protection of environmental quality; establishment of tolerance levels for pesticides which occur
in or on food; monitoring of pesticide residue levels in food, humans, and nontarget fish and
wildlife and their environments; and investigation of pesticide accidents.
BIOLOGICAL & ECONOMIC
ANALYSIS DIVISION (BEAD)
ALLEN L. JENNINGS, Director
(703) 308-8200
Responsible for pesticide use
and benefit analysis and data
gathering support for the OPP.
_L
FIELD OPERATIONS DIVISION (FOP)
STEPHEN L. JOHNSON, DIRECTOR
(703) 305-7410
Oversees the implementation of
EPA's pesticide regulatory actions,
policies and programs.
ENVIRONMENTAL FATE AND
EFFECTS DIVISION (EFED)
ANNE L. BARTON, Director
(703) 305-7695
Reviews, evaluates, and validates all
data submitted on the toxicological
and adverse effects on fish and wild-
life, and other biological species
resulting from the use of pesticides.
POLICY AND SPECIAL PROJECTS STAFF
WILLIAM JORDAN, Chief (703) 305-7102
(PSPS)
Analyzes and responds to external critiques of
program activities and policies; analyzes the
impact of legislative amendments; analyzes and
responds to activities of other Federal Agencies
as they may affect the pesticide program.
PROGRAM MANAGEMENT AND
SUPPORT DIVISION (PHSD)
ALLAN S. ABRAMSON, Director
(703) 305-5440
Responsible for administrative manage-
ment, information resources management
and services, automated system
development and management, and OPP
budget formulation and management.
HEALTH EFFECTS DIVISION HEP)
PENELOPE FENNER-CRISP, Director
(703) 305-7351
Reviews, evaluates, and validates all
data submitted on the toxicological
and adverse effects on humans and
domestic animals resulting from the
use of pesticides and performs risk
assessments on proposed and existing
pesticide uses.
_L
SPECIAL REVIEW AND
REREC1STRAT10N DIVISION (SRRD)
DANIEL M. BAROLO, Director
(703) 308-8000
Manages the special review and
reregistration of pesticide products
under the authority of sections 3 and
6 of the Federal Insecticide, Fungi-
cide and Rodenticide Act (FIFRA).
REGISTRATION DIVISION (RO)
ANNE E. LINDSAY, Director
(703) 305-5447
Manages the registration of pesticide
products, under the authority of section
3 of FIFRA and establishes tolerances
for pesticide residues on food and animal
feed under the Federal Food, Drug and
Cosmetic Act. Issues experimental use
permits under FIFRA section 18.
18-4
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OFFICE OF PESTICIDES PROGRAMS
J_
GROUNDWATER PROTECTION AND
SPECIAL REVIEW CHEMICALS SECTION (GPSRCS)
JAMES ROELOFS, Section Head (703) 305-7102
Responsible for issues involving pesticides in
special review process (except chemicals
raising issues primarily involving the Federal
Food, Drug and Cosmetic Act), as well as
issues involving the protection of grounduater
from unacceptable pesticide contamination.
POLICY AND SPECIAL PROJECTS STAFF (PSPS)
WILLIAM JORDAN, Chief (703) 305-7102
FOOD SAFETY AND REGULATIONS SECTION (FSRS)
DEBORAH SISCO, Section Head (703) 305-7102
Responsible for functions relating to issues
of food safety, arising principally under the
Federal Food. Drug, and Cosmetic Act, as well
as issues involving EPA regulations affecting
pesticides (except regulations primarily
involving groundwater).
REREGISTRAT10M AND
INTERNATIONAL ACTIVITIES SECTION (R1AS)
CATHLEEN BARNES, Section Head (703) 305-7102
JANE HOPKINS, Section Head (703) 305-7102
Responsible for functions relating to
international pesticide issues and issues
involving the pesticide reregistrati on
process.
18-5
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OFFICE OF PESTICIDE PROGRAMS
BIOLOGICAL AND ECONOMIC ANALYSIS DIVISION (BEAD)
ALLEN L. JENNINGS, Director (703) 308-8200
KATHLEEN F. KNOX, Deputy Director (703) 308-8200
BIOLOGICAL ANALYSIS BRANCH (BAB)
JANET ANDERSON, Chief (703)308-8181
Provides biological and technical data
relevant to the use and performance of pesti-
cide products in terms of crop yield or
quality. Provides comprehensive use data
assessments which predict the duration and
frequency of worker exposure for use in
support of Pesticide Risk Assessments.
Participates in the assessment of new and
innovative developments in the field of
Integrated Pest Management and Biotechnology.
PLANNING AMD EVALUATION STAFF (PES)
VACANT , Chief (703)308-8141
Responsible for formulation of BEAD budgets
and program plans, administrative management
science integration and program evaluation,
and coordination of preparation for hearings.
Also evaluates biological and economic
assessments, produced in support of Section
18 and Special Review decisions and for
coordinating BEAD support to FIFRA hearings.
ECONOMIC ANALYSIS BRANCH (EA8)
ARNOLD L. ASPELIN, Chief (703) 308-8111
Provides economic analysis as part of EPA's
pesticide regulatory program. EAB focuses on
the benefits of pesticide use versus focusing
on the health and environmental risk hazards.
EAB gathers economic data and does economic
impact analyses of pesticide regulatory
actions affecting industrial, home and garden,
governmental, urban, institutional, forestry,
aquatic and other natural resources, and
agricultural sectors.
ANALYTICAL CHEMISTRY BRANCH (ACB)
DONALD A. MARLOU, Chief (703) 308-8198
Provides analytical and environmental
chemistry services to the OPP by supporting
the pesticide registration, special review
and tolerance petitions programs. ACB also
provides support to the Office of General
Counsel for hearings, the Regional Enforcement
Program, and the National Groundwater
Monitoring Program.
18-6
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OFFICE OF PESTICIDES PROGRAMS
1
ECOLOGICAL EFFECTS BRANCH (EEB)
DOUGLAS J. URBAN, Chief (Acting)(703) 305-7347
Responsible for determining the impact of
pesticides to non- target organisms through the
examination and analysis of data from a wide
variety of documents. These data are assimi-
lated and analyzed to determine the adverse
effects to individual species of fish.
shellfish, invertebrate, wildlife, microbes.
plants, and beneficial insects; on populations
of species and their community assemblages;
and to overall aquatic and terrestrial toxi-
cology, environmental chemistry, environmental
fate and transport of pesticides, agronomy and
agricultural practices, wildlife ecology.
aquatic ecology, statistics, botany and plant
ecology, and microbiology.
ENVIRONMENTAL FATE AND EFFECTS DIVISION (EFED)
ANNE L. BARTON. Director (703) 305-7695
PAUL F. SCHUOA, Deputy Director (703) 305-7695
1
ENVIRONMENTAL FATE AND GROUNDWATER BRANCH (EFGWB)
HENRY JACOBY, Chief
(703) 305-5734
Evaluates data on the fate and transport of
pesticide chemicals and on the exposure of
humans and non-target organisms to pesticides.
EFGWB has responsibility for management and
coordination of human i
md environmental
monitoring activities in support of the pesti-
cide regulatory program. Reviews data on
aspects of pesticide leachability and ground-
water effects and related environmental
chemistry and exposure.
EFGWB also prepares
portions of the pesticide guidelines related
to these areas of expertise.
SCIENCE ANALYSIS AND COORDINATION STAFF (SACS)
AMY S. RISPIN. Chief (703) 305-5327)
Supports the assessment of pesticide hazard
through the integration of individual
discipline-specific review components into an
overall statement of risk. Provides OPP lead
for biotechnology and pesticide disposal.
18-7
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OFFICE OF PESTICIDE PROGRAMS
FIELD OPERATIONS DIVISION (FOO)
STEPHEN L. JOHNSON, Director (703) 305-7410
JUDY K. HECKMAN, Deputy Director (703) 305-7410
PUBLIC RESPONSE AND
PROGRAM RESOURCE BRANCH (PRPRB)
SUSAN H. LAWRENCE, Chief (703) 305-5805
Works to increase public awareness and under-
standing of pesticide issues and regulatory
decisions and policies and thus functions as
an OPP information center. Manages the
National Pesticide Telecomnunications Network
(NPTN) which provides a variety of information
about pesticides through a toll-free 24 hour
telephone service. Handles Freedom Of Infor-
mation (FOI) requests and public docketing.
LIAISON AND ADMINISTRATIVE STAFF (IAS)
THERESE MURTAGH, Chief (703)305-7410
Provides special liaison with the agricul-
tural community. Responsible for development
of issues involving Integrated Pest Manage-
ment (IPM).
CERTIFICATION AND TRAINING BRANCH (CTB)
ARTHUR-JEAN WILLIAMS, Chief (703) 305-7371
Responsible for the direction and implementa-
tion of EPA's regulatory and non-regulatory
pesticide applicator training and certifica-
tion activities under FIFRA sections 4 and 23
and assists in the upgrading of states,
federal and Indian tribe pesticide applicator
certification training programs and the
supporting applicator training activities
conducted cooperatively between EPA and USDA
with State Cooperative Extension Services.
COMMUNICATIONS BRANCH (CB)
MAJORIE FEHRENBACH. Chief (703) 305-5017
Responsible for formulating communication
strategies and plans for communicating OPP
regulatory decisions to affected and interested
parties.
REGIONAL OPERATIONS BRANCH (ROB)
(CATHERINE TAYLOR, Chief (703) 305-5239
Provides the EPA regions and state lead
agencies, on a regular basis, information on
pesticide strategic initiatives and pesticide
regulatory decisions. Coordinates groundwater
and endangered species activities with EPA
regions and state lead agencies. Coordinates
Integrated Pest Management (IPM) activities
within OPP. Directs OPP activities concerning
pesticide disposal, storage and transportation
(including1the preparation of nationwide
assessments of pesticide disposal problems).
OCCUPATIONAL SAFETY BRANCH (OSB)
JAMES J. BOLAND, Acting Chief (703) 305-7666
Coordinates and directs the pesticide user
safety programs (including farm safety) for
OPP. Develops and recommends Agency policy
for pesticide occupational safety. Develop*
general information on farm workers, pesticide
applicators and others who, in the course of
their employment, may be routinely exposed to
pesticides.
18-8
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OFFICE OF PESTICIDE PROGRAMS
HEALTH EFFECTS DIVISION (HEP)
PENELOPE FENNER-CRISP, Director (703) 305-7351
RICHARD SCHMITT, Deputy Director (703) 305-7351
PROGRAM PLANNIMG AND SUPPORT STAFF (PPSS)
GLENN WILLIAMS. Staff Chief (703) 305-7560
Performs services in the area of personnel
and administrative management. Performs the
financial management functions relating to
the Document Control Register.
SCIENCE ANALYSIS AND COORDINATION BRANCH (SACB)
WILLIAM BURNAN. Acting Chief (703) 305-6193
Provides scientific analysis and evaluation in
the areas of statistical analysis of biologi-
cal data, evaluation of laboratory animal
pathology and genetic engineering. Coordina-
tion and integration of human and animal toxi-
cological data along with dietary and non
dietary exposure data to determine risk of
pesticides in the registration and reregistra-
tion processes. Conducts assessments of
potential dietary exposures to pesticides.
Coordinates the Tolerance Assessment System.
SCIENTIFIC ADVISORY PANEL (SAP)
ROBERT B. JAEGER, Senior Science Advisor
(703) 305-5369
CHEMISTRY BRANCH 1
DEBRA EDWARDS, Acting Chief
(CB 1)
(703) 305-7484
Responsible for the evaluation of analytical
methods, residue data, and metabolism data
leading to recommendations for or against
proposed permanent and temporary pesticide
residue tolerances in food or feed, and appli-
cations for pesticide product registration
under sections 3,5.18, and 24(c) of FIFRA.
Branch responsibilities are carried out under
FIFRA and sections 408 and 409 of the Federal
Food, Drug and Cosmetic Act (FFDCA).
TOXICOLOGY BRANCH 1
KARL P. BAETCKE, Chief
(TB 1)
(703) 305-7712
Evaluates and analyzes the full range of toxico-
logical data on pesticides and related exposure
information to determine risks and hazards
associated with pesticide uses. Examples
include mutagenic, reproductive, neurotoxic,
and teratogenic reviews.
CHEMISTRY BRANCH II
EDWARD ZAGER, Chief
(CB 11)
(703) 305-7324
Evaluates the residue chemistry data support-
ing tolerances for pesticide residues in foods
under the provisions of sections 408 and 409
of the Federal Food, Drug and Cosmetic Act,
submitted to support reregistrat ion under the
provisions of FIFRA and develops Reregistra-
tion Eligibility Documents (REDs) and special
review technical support documents. The
Branch also conducts dietary exposure analyses
as part of the Agency's pesticide risk
assessments.
TOXICOLOGY BRANCH II
MARCIA VAN GEMERT, Chief
(TB II)
(703) 305-6300
Evaluates and analyzes the full range of lexi-
cological data on pesticides and related
exposure information to determine risks and
hazards associated with pesticide uses.
Examples include mutagenic, reproductive,
neurotoxic, and teratogenic reviews.
OCCUPATION AND RESIDENTIAL EXPOSURE BRANCH (OREB)
CHARLES L. TRICHILO, Chief (703) 305-6094
Evaluates and analyzes data on the occupational
and residential exposure of humans to pesticides.
Provides scientific recommendations and technical
advice for pesticide registration under sections
3, 5, 18, and 24(c) of FIFRA. Responsible for
reviewing human applicators and post-application/
reentry exposure data in order to determine
conditions under which pesticides should be
registered for use.
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OFFICE OF PESTICIDE PROGRAMS
PROGRAM MANAGEMENT AND SUPPORT DIVISION (PMSD)
ALLAN S. ABRAMSON, Director (703) 305-5440
NORMAN W. CHLOSTA, Deputy Director (703) 305-5440
SPECIAL PROJECTS AND COORDINATIOH STAFF (SPCS)
KATHRYN S. BOUVE, Chief (703) 305-5440
Responsible for the Agency's Four Year
Strategic Planning process. Also serves as
the Agency's coordinator for 6(a)(2)
(unreasonable adverse) data.
ADMINISTRATION BRANCH (AB)
SHERRI Y. SHEPPARD, Chief
(703) 305-5725
Provides personnel and administrative
management functions for both the
Office Director (and staff) and for
the Divisions within OPP. In addition
the financial management functions
relating to the Document Control
Register are provided for the Office
Director (and staff) and for the PMSD
staff. The Branch also provides
overall OPP training courses,
maintenance of the personnel roster,
telephone listing, staffing plans,
and reviews all personnel actions.
INFORMATION SERVICES BRANCH (1SB)
JOHN M. CARLEY. Chief
(703)305-5613
Provides information management
support to the OPP regulatory program
in carrying out certain information-
related provisions of FIFRA and the
FFDCA. Information services are
provided to OPP staff, registrants,
and other governmental agencies. The
Branch maintains central collections
of technical and administrative docu-
ments and provides information and
open literature retrieval services to
OPP staff. The Document Management
Section (Headed up by Clare Grubbs,
(703) 305-7460)) has responsibility
for document management and mainte-
nance of the Company Name and Address
file. The Information Resources
Section (Headed up by John Jamula
(703) 305-6426)) provides consulting
assistance for compliance with data
formatting requirements.
_L
RESOURCE MANAGEMENT AND
EVALUATION BRANCH (RMEB)
DENNIS J. O'CONNOR, Chief
(703) 305-5047
Assists the Office Director and the
OPP Division Directors in the prepara-
tion of program plans and related
budget proposals and evaluates the
costs and the effectiveness of program
activities, program alternatives and
policy positions.
SYSTEMS BRANCH (SB)
GERALD 0. MILLER, Chief
(703) 305-5484
The central point within OPP for all
automated system requirements. The
Branch provides systems analysis
design, systems data banks, ADP
facilities and hardware. Support
services are available in the Branch
to all organizational elements within
OPP and as directed, to other
organizations within the Office of
Prevention, Pesticides and Toxic
Substances.
18-10
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OFFICE OF PESTICIDE PROGRAMS
AHT1-M1CROB1AL PROGRAM BRANCH (APB)
JAUMITA WILLS. Chief
WALTER C. FRANCIS, Deputy Chief
(703) 305-6661
Responsible for the registration
activities of pesticides uses as
hospital s ten" I ants, disinfectants.
water treatment products, anti-
fouling paints, swimming pool
chemicals, and fumigants.
Product Manager 31;
JOHN H. LEE
Product Manager 32;
RUTH G. DOUGLASS
(703) 305-5676
(703) 305-7964
See Section D. 3. ANTIMICROBIAL
PROGRAM BRANCH below for a listing
of the types of products within the
area of responsibility of each
Product Manager.
REGISTRATION DIVISION (RO)
ANNE E. LINDSAY, Director (703) 305-5447
STEPHANIE R. IRENE, Deputy Director (703) 305-5447
_L
FUNG1C10E-HERB1CIDE BRANCH (FHB)
FRANK T. SANDERS, Chief
THOMAS E. ADAMCZYK, Deputy Chief
(703) 305-6250
Responsible for the registration
activities of pesticides used for
fungus and plant disease control,
weed control (herbicides), fungicides,
nematicides, wood preservatives,
defoliants, desiccants, plant growth
regulators, and some genetically
engineered products.
Product Manager 21;
SUSAN LEWIS
(703) 305-6900
Product Manager 22;
CYNTHIA GILES-PARKER (703) 305-5540
Product Manager 23;
JOANNE MILLER
Product Manager 25;
ROBERT TAYLOR
(703) 305-7830
(703) 305-6600
See Section D. 2. FUNGICIDE-HERBICIDE
BRANCH below for a listing of the types
of products within the area of respon-
sibility of each Product Manager.
INSECTIC1DE-ROOENTIC1DE BRANCH (IRB)
HERBERT S. HARRISON, Chief
HARVEY L. WARNICK, Deputy Chief
(703) 305-5200
Responsible for the registration and
tolerance activities of pesticides used
to control insects, mites, snails and
slugs, and vertebrate pests (such as
rats and mice), and used for animal
repellents (such as deer, rabbit, dog
and cat), and insect repellents, and
used for biochemical, microbial, and
genetically engineered insecticide
control agents.
Product Manager 10;
DICK MOUNTFORT
Product Manager 13;
GEORGE LaROCCA
Product Manager 14;
ROB FORREST
Product Manager 18;
PHIL MUTTON
Product Manager 19;
DENNIS EDWARDS
(703) 305-6502
(703) 305-6100
(703) 305-6600
(703) 305-7690
(703) 305-6386
See Section D. 1. INSECTICIDE-RODENT1CIDE
BRANCH below for a listing of the types
of products within the area of responsi-
bility of each Product Manager.
_L
REGISTRATION SUPPORT BRANCH (RSB)
[NOTE: Telephone Numbers Will Change]*
DONALD R. STUBBS. Chief
JAMES TOMPKINS. Deputy Chief
(703) 305-7700
Responsible for the processing and
review of Section 18 Emergency Exemp-
tion requests, minor use (IR-4)
petitions, inert ingredient clearance,
and the review of product chemistry
and precautionary labeling (acute
toxicology) data. Also responsible
for tolerance reassessment, policy and
regulation development and Office of
Management and Budget (OMB) clearance,
the processing of product registration
transfer requests, and registration
cancellation requests, and front-end
application processing.
Front End Processing Staff;
EDITH MINOR
(703) 305-6978
Precautionary Review Section;
TOM ELLWANGER (703) 305-7783
Product Chemistry Review Section:
DONALD R. STUBBS (Acting) (703) 305-7700
Emergency Response and Minor Use Section:
REBECCA S. COOL
(703) 305-5806
See Section D. 4. REGISTRATION SUPPORT
BRANCH below for a listing of the types
of functions within the area of
responsibility of each Section.
* In late summer or early fall of 1992 all members of the Registration Support Branch (RSB) will move to Crystal Station Building 1 (CS-1) and their telephone numbers and
room numbers will change from those listed in this manual. However, you can continue to call their old telephone number for a period of time after the move occurs and you
will be given the new telephone number. Otherwise, you may call the EPA's Directory Assistance/Personnel Locator number (202) 260-2090.
18-11
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OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION (SRRO)
DANIEL BAROLO. Director (703) 308-8000
PETER P. CAULKINS, Deputy Director <703) 308-8000
SPECIAL REVIEW BRANCH (SRB)
JACK E. HOUSENGER, Chief (703) 308-8010
Responsible for managing the special review
for chemicals which have met or exceeded the
risk criteria of unreasonable adverse effects
as set forth in 40 CFR 154. The special
review process provides a procedure for risk/
benefit reviews of pesticide products and
preparation of documents stating the Agency's
position. Regulatory action includes risk
reduction measures, cancellation of some or
all uses, and suspension. SRB issues Grassley
Allen notifications to registrants that
initiation of a special review is under con-
sideration. Coordinates the SAP on proposed
Agency decisions. Responsible for providing
support to the OGC for hearings resulting from
special review actions. Responsible for pre-
paring other Federal Register Notices relating
to special reviews such as amendments to
proposed or final decisions or notices that
a special review was considered but not
initiated.
POLICY. PLANNING AND OPERATIONS STAFF (PPOS)
JAMES H. KEARNS, Chief (703) 308-8009
Formulates policies, plans, and procedures for the
reregistration of pesticides and the review of chemicals
which have the potential to cause unreasonable adverse
effects on human health and the environment; ensures
consistent development and application of pesticide policy •
in carrying out SRRO's regulatory responsibilities; manages
the development of pesticide regulations related to the
reregistration and special review processes; evaluates and
recomnends solutions to pesticide policy problems or issues
of a conceptual nature; serves as the focal point for
division liaison activities.
REREGISTRATION BRANCH (RB)
LOIS A. ROSSI, Chief (703) 308-8080
Manages the reregistration process for selected
existing chemicals. This process, authorized
under section 3(g) of FIFRA, provides for the
review of all pesticides registered prior to
1984. Management of the process includes
planning, scheduling, and coordinating HED,
EFED, PMSD, RD, and BEAD inputs; conducting the
review; and preparing and issuing documents.
ACCELERATED RERECISTRAT10N BRANCH (ARB)
JAY S. ELLENBERGER, Chief (703) 308-8064
Manages the reregistration and data call-in
processes authorized under sections 3 and 4 of
FIFRA. The reregistration process provides
for the reregistration of all pesticides first
registered before November 1984. Of these
pesticides, ARB is responsible for those for
which a registration standard was not
completed (these are commonly referred to as
List B, C, and D chemicals). The data call-in
process includes the identification of neces-
sary data for pesticide regulation, notifying
the registrants of these requirements, review-
ing data upon receipt, and corresponding with
registrants about the adequacy of the data.
Management of these processes includes plan-
ning, scheduling, and coordinating input from
.the PMSD, HED, EFED, BEAD, and OCM; conducting
reviews; and preparing and issuing regulatory
documents.
18-12
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OFFICE OF PREVENTION. PESTICIDES & TOXIC SUBSTANCES
OFFICE Of COMPLIANCE MONITORING (OCM)
MICHAEL M. STAHL, Director (202) 260-3807 KATRINA CHERRY, Special Assistant to Director (Regional Liaison) (202) 260-7457
CONNIE A. MUSGROVE, Chief Executive Officer (202) 260-7833
JOHN MACKENZIE, Western Conpliance Director (415) 744-1091) [OCM coordinator with Regions VI through X; OCM liaison with SFIREG
and AAPCO activities; OCM manager of UC-Davis Pilot Program and Executive Secretary of Steering Committee.]
OCM directs and coordinates national compliance monitoring activities under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), the Toxic Substances Control Act (TSCA), the Emergency Planning and Community Right-to-Know Act (EPCRA).the Asbestos
Hazard Emergency Response Act (AHERA), and the Organotin Antifoul ing Paint Control Act (OAPCA). Provides compliance overview and
program policy direction to the Regions and States, establishes national compliance priorities, develops enforcement response
policies and national inspection/guidance documents, offers technical support for litigation activity, concurs on enforcement
actions, maintains liaison with the National Enforcement Investigations Center (NEIC), collects/analyzes national enforcement
data for the aforementioned statutes, develops annual fiscal budgets for the national programs, and manages fiscal and personnel
resources for the Headquarters programs. Coordinates with the Office of General Counsel (OGC) and the Office of Enforcement (OE)
in an attorney-client relationship. Also coordinates with the Office of Pesticide Programs (OPP) in the implementation of
pesticide regulatory and compliance programs under FIFRA, and with the Office of Pollution, Prevention and Toxics (OPPT) in the
implementation of regulatory and compliance programs under TSCA, AHERA, and EPCRA.
POLICY AND GRANTS DIVISION (PtGD)
JOHN J. NEYLAND III. Director (703) 308-8383
and (202) 260-7825
Responsible for developing compliance monitor-
ing policies and strategies, and federal
enforcement response policies for the Region/
States under FIFRA, TSCA, AHERA, EPCRA and
OAPCA. Also responsible for representing OCM
views at regulatory workgroup meetings, and
for reviewing regulatory documents to assure
their enforceabiIity. Develops and revises
procedures and programs under FIFRA and TSCA
state cooperative enforcement agreement
programs, and assists the Regions in the
implementation and management of these
programs. Revises policy, guidance,
priorities, and strategies following program
evaluations made by Divisions within the OCM.
OCM PROGRAM SUPPORT STAFF (PSS)
ROBERTA MILLER. Chief (202) 260-7691
LABORATORY DATA INTEGRITY ASSURANCE DIVISION (LD1AD)
DAVID L. DULL, Director (703) 308-8300
FRANCIS LIEN, Special Assistant to (703) 308-8265
Division Director
ROBIN NOGLE, International Activities (703) 308-8269
liaison
Develops and executes Good Laboratory Practice (GLP)
compliance programs under both FIFRA and TSCA.
Validates studies submitted to the Agency as required
by either FIFRA or TSCA and monitors compliance to
requirements published under both regulations.
Provides compliance, data audit guidance, policies
and procedures for the operations of FIFRA Section
3(c) and TSCA Section 4. 5(e) compliance monitoring
programs and for the conduct and reporting of the
results of GLP compliance inspections and data audits.
Assesses the quality and effectiveness of these
programs and provides normal administrative support
for the Program Support and Compliance Referral Branch
and the Scientific Support Branch. Provides national
and international liaison with other Federal Agencies,
and foreign governments to conserve resources and
standardize procedures.
COMPLIANCE D1V1SIOM (CO)
MICHAEL F. WOOD, Director (202) 260-7835
Responsible for developing procedures for
controlling imminent hazards involving pesti-
cides and toxic substances. Develops national
conpliance monitoring procedures and regional
coordination functions in support of TSCA,
AHERA, FIFRA, EPCRA, and OAPCA. Performs
Regional coordination functions for the purpose
of compliance monitoring, provides guidelines
for training programs for the regions and the
states, promulgates guidelines concerning
administrative rules in case preparation pro-
cedures for enforcement cases, and provides
case development support for Headquarters and
Regional enforcement cases. Coordinates intra-
and inter- agency case development efforts, and
provides scientific and technical support to
Headquarters, the Regions and the States for
investigations and case development efforts.
Manages contracts for inspection support and
sample analysis, develops or revises reference
manuals, publishes FIFRA Notices of Judgement.
18-13
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OFFICE OF COMPLIANCE MONITORING
1
PESTICIDES ENFORCEMENT POLICY BRANCH (PEPB)
PHYLLIS FLAHERTY. Chief (703) 308-8383
Develops Headquarters and Regional compliance monitor-
ing policies, strategies and priorities relating to
FIFRA and OAPCA. Develops regulations, federal
enforcement response policies, and strategies in
support of FIFRA and OAPCA. Mentors of the branch
serve as OCM representatives on FIFRA regulatory work-
groups, and serve as expert witnesses during hearings.
See Section E. 1. PESTICIDES ENFORCEMENT POLICY BRANCH
below for a listing of the types of functions within
the area of responsibility of each staff person.
POLICY AND GRANTS DIVISION (P&GO)
JOHN J. NEYLAND III, Director (703) 308-8383
and (202) 260-7825
I
GRANTS AND EVALUATION BRANCH (G&EB)
LINDA FLICK, Acting Chief (202) 260-7841
Responsible for developing, reviewing and revising
policy and procedures for FIFRA and TSCA state
cooperative enforcement agreement programs.
Assists the regions in implementing and managing
state cooperative enforcement agreement programs
and develops procedures for information flow.
See Section E. 2. GRANTS AND EVALUATION BRANCH
below for a listing of the types of functions
within the area of responsibility of each staff
person.
TOXICS ENFORCEMENT POLICY BRANCH (TEPB)
JANET BEARDEN, Chief (202) 260-7832
Develops compliance monitoring and strategies,
proposed legislation and regulations, and
guidance to the states and the regions concerning
the national toxic substances, AHERA and EPCRA
compliance programs. Provides OCM policy input
for agency-wide enforcement special projects and
the four-year strategic plan.
See Section E. 3. TOXICS ENFORCEMENT POLICY
BRANCH below for a listing of the types of
functions within the area of responsibility of
each staff person.
18-14
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OFFICE OF COMPLIANCE MONITORING
LABORATORY DATA INTEGRITY ASSURANCE DIVISION (LDIAD)
DAVID L. DULL, Director (703) 308-8300
FRANCIS LIEN, Special Assistant to (703) 308-8265
Division Director
ROBIN NOGLE, International Activities (703) 308-8269
liaison
J_
SCIENTIFIC SUPPORT BRANCH (SSB)
FRANCES LIEN, Acting Chief (703) 308-8333
Responsible for the detailed planning of all national and
international inspections and data audits, both regularly
scheduled and priority. Provides liaison with the Food and
Drug Administration (FDA) field investigators to coordinate
joint inspections and audits, and prepares training programs
and Manuals for inspection, and audit activities.
DAWN BANKS (703) 308-8251
Biology
ASHUTOSH DIUAN (703) 308-82S7
Biology
CLINTON FLETCHER (703) 308-8261
CheMistry
ELNER GRIFFIN (703) 308-8263
Chemistry
JOHN HcCANN (703) 308-8266
Ecotoxicology
BRENDA F. NOSLEY (703) 308-8268
Chemistry
FREDERICK SIEGELNAN (703) 308-8272
Chemistry
EVA ZUREK (703) 308-8279
Mammalian Toxicology/Histopathology
The Scientific Support Branch employees listed above conduct
Good Laboratory Practice (GLP) compliance inspections of
laboratories and other test facilities and performs data
audits in the disciplines indicated above.
PROGRAM SUPPORT AND COMPLIANCE REFERRAL BRANCH (PS&CRB)
ROBERT ZISA, Chief (703) 308-8400
Provides operational and information management support for LDIAD'a GLP
inspection and FIFRA/TSCA testing requirement compliance programs. Supports
the GLP inspection program by targeting laboratories for inspection through
Neutral Administrative Inspection Scheme (NAIS) selection procedures,
identifying relevant FIFRA and TSCA studies to audit, and participating in the
review of inspection/data audit reports for compliance. Operates the Labora-
tory Inspection and Study Audit (LISA) computer system in support of these
activities. Supports the FIFRA/TSCA testing requirement program by monitoring
documentation submitted by registrants, chemical manufacturers, and labora-
tories for compliance with FIFRA and TSCA testing requirements. This includes
monitoring compliance with FIFRA '88 product reregistration requirements,
issuing Notices of Intent to Suspend (NOITS) for pesticide product registra-
tions, and working with OPP and OGC to settle NOITS actions. PSCRB operates
the Pesticide Registration Enforcement System (PRES) data base in support of
of these activities.
See Section F. 1. PROGRAM SUPPORT AND COMPLIANCE REFERRAL BRANCH below for a
listing of the types of functions within the area of responsibility of each
staff person.
18-15
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OFFICE OF COMPLIANCE MONITORING
COMPLIANCE DIVISION (CO)
MICHAEL F. WOOD, Director (703) 260-7835
MAUREEN T. LYDON, Chief
COMPLIANCE BRANCH (CB)
(202) 260-5567
Develops national compliance monitoring procedures, inspection guidance, and
targeting lists to help ensure compliance with FIFRA, TSCA, EPCRA, AHERA, OAPCA,
and associated specific regulatory actions. Issues investigation Requests, and
coordinates with the Regions on compliance monitoring activities initiated from
the HQ level, as well as follow-up to GAO/IG audits. Working with the Regions,
the Branch collects/analyzes national enforcement data for the aforementioned
statutes by developing/using national automated data processing (ADP) systems.
Develops STARS measures and coordinates STARS input at the national level for
OPTS enforcement activities. Serves as the liaison with the Office of Criminal
Investigations and the national program coordinator for TSCA enforcement AARP
grants, and coordinates national toxics enforcement conferences. The Compliance
Branch includes the OCM document control officer, the OCM Coordinator for
Regional reviews, and the office coordinator for enforcement/certified statement
requests.
See Section G. 1. COMPLIANCE BRANCH below for a listing of the types of
functions within the area of responsibility of each staff person.
CASE SUPPORT BRANCH (CSB)
GERALD STUBBS, Chief (202) 260-7861
Provides case development support in relation tc the
enforcement of TSCA, FIFRA, and EPCRA. Responsible
for promulgating guidelines, administrative rules or
case preparation procedures for enforcement cases,
providing Regional coordination for case development
purposes, coordinating intra- and inter-agency case
development efforts, providing scientific and technical
support to Headquarters, the Regions and the states for
case development purposes, and providing Headquarters
concurrence on enforcement cases. Makes revisions to
the Case Proceedings Manual, Publishes Notices of Judge-
ment, and updates publication of the Suspended, Canceled
and Restricted Pesticide List (SAC List) under FIFRA.
See Section G. 2. CASE SUPPORT BRANCH below for a
listing of the types of functions within the area of
responsibility of each staff person.
18-16
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ID. REGISTRATION DIVISION. WASHINGTON P.O.
1. INSECTICIDE - RODENTICIDE BRANCH
*." BRANCH CHIEF - Herbert S. Harrison (703) 305-5200
DEPUTY BRANCH CHIEF - Harvey Warnick (703) 305-5200
The various Product Manager Teams that are responsible for
certain types of products are indicated below.
PRODUCT MANAGER 10 - Dick Mountfort (703) 305-6502
TYPE OF PRODUCTS: Pyrethrins, Insect Repellents,
Certain Synthetic Pyrethroids (including
Resmethrin, Allethrin, Tetramethrin,
d-Phenothrin
PRODUCT MANAGER 13 - George LaRocca (703) 305-6100
TYPE OF PRODUCTS; Chlorinated Organic
Insecticides, Drug/Pesticide Combinations,
Dichlorvos, Endosulfan, Fenthion,
Fensulfothion, Disulfoton,
Second Generation Pyrethroids (i.e., Permethrin
and Cypermethrin)
PRODUCT MANAGER 14 - Rob Forrest (703) 305-66QO
TYPE OF PRODUCTS; Most Organo-Phosphorus
products i.e., malathion, dimethoate,
except those listed with PMs 13 and 19,
Boric Acid, Vertebrate Pesticides,
Animal and Bird Repellents
PRODUCT MANAGER 18 - Phil Button (703) 305-7690
TYPE OF PRODUCTS; Microbials, Biologicals,
Insect Growth Regulators, Most Botanicals
PRODUCT MANAGER 19 - Dennis Edwards (703) 305-6386
TYPE OP PRODUCTS; Carbamates, Miticides,
Toxaphene, Carbaryl, Chlorpyrifos,
Parathion, Azinphos-methyl
18-17
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2. FUNGICIDE - HERBICIDE BRANCH
BRANCH CHIEF - Frank Sanders (703) 305-6250
DEPUTY BRANCH CHIEF - Thomas Adamczyk (703) 305-6250
The various Product Manager Teams and their area of
responsibility are listed below.
PRODUCT MANAGER 21 - Susan Lewis (703) 305-6900
TYPE OF PRODUCTS: Fungicides, Nematicides, Wood
Preservatives, Microbials
PRODUCT MANAGER 22 - Cynthia Giles-Parker
(703) 305-5540
TYPE OF PRODUCTS; Fungicides, Herbicides which
include Arsenicals, Copper, and some Plant
Growth Regulators
PRODUCT MANAGER 23 - Joanne Miller (703) 305-7830
TYPE OF PRODUCTS: Herbicides: Phenoxys, Aquatics
PRODUCT MANAGER 25 - Robert Taylor (703) 305-6800
TYPE OF PRODUCTS: Herbicides, Plant Growth
Regulators (shared with PM Team 22),
Desiccants, Defoliants
3. ANTIMICROBIAL PROGRAM BRANCH
The Antimicrobial Program Branch is responsible for the
registration activities of pesticides used as hospital
sterilants, disinfectants, water treatment products, anti-
foul ing paints, swimming pool chemicals, and fumigants.
BRANCH CHIEF - Juanita Wills (703) 305-6661
DEPUTY BRANCH CHIEF - Walter C. Francis (703) 305-6661
PRODUCT MANAGER 31 - John H. Lee (703) 305-5676
TYPE OF PRODUCTS - Anti-fouling Paints, Quaternary
Ammonium and Water Treatment Compounds, Hospital
Sterilants
PRODUCT MANAGER 32 - Ruth G. Douglas (703) 305-7964
TYPE OF PRODUCTS - Hypochorites, Halides,
Chlorophenolics, Swimming Pool Chemicals,
Fumigants
18-18
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4. REGISTRATION SUPPORT BRANCH (Th«se telephone numbers will
chang«)
The Registration Support Branch is responsible for the
processing and review of Section 18 Emergency Exemption
requests, minor use (IR-4) petitions, inert ingredient
clearances, and the review of product chemistry and
precautionary labeling (acute toxicology) data. Additional
responsibilities include tolerance reassessment, policy and
regulation development and Office of Management and Budget (OMB)
clearance, the processing of product registration transfer
requests, and registration cancellation requests, and front-
end application processing.
BRANCH CHIEF - Donald R. Stubbs (703) 305-7700
DEPUTY BRANCH CHIEF - James Tompkins (703) 305-7700
FRONT END PROCESSING STAFF
STAFF LEADER - Edith Minor (703-305-6978)
AREA OF RESPONSIBILITY; Front-end applications
processing. Processing and status of expedited review
applications. When inquiring about the status of your
application, you must be able to provide the red number
in the upper right-hand corner of the Application for
Registration/Amendment form^EPA Form 8570-1).
PRECAUTIONARY REVIEW SECTION
SECTION HEAD - Tom Ellwanger (703) 305-7783
AREA OF RESPONSIBILITY; Precautionary labeling
(acute toxicity) reviews.
PRODUCT CHEMISTRY REVIEW SECTION
SECTION HEAD - Donald R. Stubbs (Acting) (703) 305-7700
AREA OF RESPONSIBILITY; Review of product
chemistry data.
In late summer or early fall of 1992 all members of the
Registration Support Branch (RSB) will move to Crystal Station
Building 1 (CS-1) and their telephone numbers and room numbers will
change from those listed in this manual. However, you can continue
to call their old telephone number for a period of time after the
move occurs ' and you will be given the new telephone number.
Otherwise, iyou may call the EPA's Directory Assistance/Personnel
Locator number (202) 260-2090.
18-19
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EMERGENCY RESPONSE AND MINOR USE SECTION (These telephone
numbers will change)
SECTION HEAD - Rebecca S. Cool (703) 305-5806
AREA OF RESPONSIBILITYt Emergency Exemptions
(Section 18's) and Minor Use (IR-4)
petitions.
PROJECT COORDINATION SECTION
SECTION HEAD - Tina Levine (703) 305-5179
AREA OF RESPONSIBILITY: Inert clearance requests,
tolerance revocation, regulation and standard
operating procedures development, Office of
Management and Budget (OMB) clearance of programs,
and intra and intercoordination of lab audits and
other media programs within the Agency.
ADMINISTRATIVE PROCESSING SECTION
SECTION HEAD - Donald R. Stubbs, Acting (703) 305-7700
AREA OF RESPONSIBILITY: Product registration
transfers, cancellation requests, program status
and reporting, and ADP processing.
E. OFFICE OF COMPLIANCE MONITORING; POLICY AND GRANT DIVISION
1. PESTICIDE ENFORCEMENT POLICY BRANCH
BRANCH CHIEF - Phyllis Flaherty (703) 308-8383
The types of functions within the area of responsibility of each
staff person are indicated below:
DAN HELFGOTT (703) 308-8288
FUNCTIONS; FIFRA Section 6(g) Policy; FIFRA ERP;
Labeling, including State-Labeling Issues
Committee; Existing Stocks.
In late summer or early fall of 1992 all members of the
Registration Support Branch (RSB) will move to Crystal Station
Building 1 (CS-1) and their telephone numbers and room numbers will
change from those listed in this manual. However, you can continue
to call their old telephone number for a period of time after the
move occurs and you will be given the new telephone number.
Otherwise, you may call the EPA's Directory Assistance/Personnel
Locator number (202) 260-2090.
18-20
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STEPHEN HOWIE (703) 308-8290
FUNCTIONS: Export and Biotechnology; Policy
Support for Record Keeping Regulations and GLP
Standards.
VIRGINIA LATHROP (703) 308-8292
FUNCTIONS; Pesticides and Groundwater
Coordination; Revised Policy Compendia (5
Volumes); Contract Coordinator; Generic Compliance
Monitoring Strategy for Cancellations/Suspen-
sions; FIFRA section 6(g) Outreach Plan; FIFRA
Policy Search System.
GINAH MORTEN8EN (703) 308-8293
FUNCTIONS; Worker Protection Standards;
Endangered Species.-
DAVID STANGEL (703) 308-8295
FUNCTIONS; FIFRa section 19/Disposal; Section
19(d)(4)/Primacy; Worker Protection Regulation;
Communication Strategies; State Labeling
Improvement Committee; FIFRA: Contract
Manufacturing and Custom Blending; FIFRA section
6(g) Policy; Special Review Chemical.
BEVERLY UPDIKE (703) 308-8296
FUNCTIONS; Develop Compliance Strategies for
FIFRA Enforcement of Maintenance Fee
Cancellations; Special Review Chemical;
Advertising.
2. GRANTS AND EVALUATION BRANCH
BRANCH CHIEF - Linda Flick (Acting) (202) 260-7841
The types of functions within the area of responsibility of each
staff person are indicated below:
LORILYK MCKAY (202) 260-6733
FUNCTIONS: Regional Liaison: VII, & IX; Asbestos
and Multi-Media Branch Lead; Groundwater Branch
Lead; TSCA Enforcement Decentralization Branch
Lead; Co-lead on State Pesticide Lab Issues.
18-21
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CURTIS FOX (202) 475-8318
FUNCTIONS; Regional Liaison: IV, VIII, & X;
FOSTTA Work Coordinator; QUIPE (Pesticides
Inspector Newsletter) Editor; Worker Protection
Branch Lead.
SUSAN KAVANAUGH (202) 475-7008
FUNCTIONS; FIFRA '88; Regional Liaison: I & III;
PCB Branch Lead; Lawn Care Initiative Lead; OCM
Tribal Contact.
MARY ELLEN PODNIE8NISKI (202) 382-7422
FUNCTIONS: Regional Liaison: II, V, & VI; EPCRA
Branch Lead; Endangered Species Protection
Program; Hexavalent Chromium; Enforcement
Special Projects; Pesticide Grant Allotments;
Branch Lead on State Pesticide Lab Issue; Branch
Lead for Pesticide Project Officer Oversight
Manual.
3. TOXICS ENFORCEMENT POLICY BRANCH
BRANCH CHIEF - Janet Bearden (202) 260-7832
The types of functions within the area of responsibility of each
staff person are indicated below:
KENNETH O'REILLY (202) 260-6747
FUNCTIONS; Asbestos Ban and Phase Out Rule; EPA
Asbestos Worker Protection Rule; TSCA Good
Laboratory Practices; TSCA Section 4 and Section
21; Asbestos in Public and Commercial Buildings.
SALLY SRSNETT (202) 260-1376
FUNCTIONS; Biotechnology (TSCA); AHERA; Pollution
Prevention (ITP); Geographic TSCA; New Chemical
Exposure Limits.
GARY 8ECRE8T (202) 260-8660
FUNCTIONS; PCBs; Manager, Ability to Pay Study;
OCM Representative, PCB Steering Committee; Dioxin
in Sludge.
BRIDGET SULLIVAN (202) 260-8418
FUNCTIONS; EPCRA Section 313; TSCA Section 5 and
Section 8; Hazardous Communications Rule; Lead
Acid Batteries; Pollution Prevention Act.
18-22
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PETER PAQANO (202) 260-4889
FUNCTIONS: Hexavalent Chromium; Lead in Solder,
Lead in Brass Fittings; Clean Air Act Amendments;
Acrylamide; TSCA Export/Import.
P. OFFICE OF COMPLIANCE MONITORING: LABORATORY DATA INTEGRITY
ASSURANCE DIVISION
1. PROGRAM SUPPORT AND COMPLIANCE REFERRAL BRANCH
BRANCH CHIEF - Robert Zisa (703) 308-8400
The types of functions within the area of responsibility of each
staff person are indicated below:
RAY BROWN (703) 308-8252
FUNCTIONS; Post-GLP Inspection/Data Audit
Monitoring; Review of GLP Inspection Reports;
Requests to OPP/OPPT for Regulatory Review of
Audited Studies; Response to FOIA Requests.
STEPHEN BROZENA (703) 308-8267
FUNCTIONS; FIFRA '88 pesticide Reregistration
Compliance Program; Issuance of Notice of Intent
to Suspend (NOITS) Actions for Non-Compliance with
Pesticide Testing Requirements; Liaison with OGC
and OPP for Settlement of NOITS Actions;
Assistance with GLP Inspection/Data Audit
Targeting.
CAROL BUCKINGHAM (703) 308-8254
FUNCTIONS; Assistance with FIFRA '88 Registration
Compliance Program; Operation of LDIAD Computer
Tracking Systems; Response to FOIA Requests.]
DORIS DYSON (703) 308-8260
FUNCTIONS; Computer Contract Administration;
Systems Support.
YVETTE HELLYER (703) 308-8256
FUNCTIONS; Pre-GLP Inspection/data Audit
Activities; GLP Inspection/data Audit Targeting;
OPPT Chemical Testing Monitoring; Memoranda of
Understanding (MOU) with Foreign Governments for
GLP Programs. FDA Liaison for GLP Inspection/
data audit Program.
18-23
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FRANKLIN SMITH (703) 308-8273
FUNCTIONS; ADP Systems Support; ADP Extramural
Budget Management; Computer Contract
Administration; Local Area Network (LAN)
Administration.
G. OFFICE OF COMPLIANCE MONITORING; COMPLIANCE DIVISION
1. COMPLIANCE BRANCH
BRANCH CHIEF - Maureen T. Lydon (202) 260-5567
The types of functions within the area of responsibility of each
staff person are indicated below:
MIKE CALHOUN (202) 260-3375
FUNCTIONS; Team Leader for PCBs and Pesticides;
PCB General Information and PCB Natural Gas
Pipelines; Pesticides General Information and
Pesticide Exports; OCM Criminal Liaison.
ANN CLAVIN (202) 260-9438
FUNCTIONS; Mercury in Paints; PCB Co-lead;
Hexavalent Chromium Rule; Enforcement Requests.
KENNETH GUTTERMAN (202) 260-6902
FUNCTIONS; FOIA Coordinator, Credentials Officer,
Regional Review and National Meeting Coordinator,
Inspection Forms Coordinator, Inspection Manual
Custodian.
RICHARD KRATOFIL (202) 382-3487
FUNCTIONS; FIFRA Section 7 Foreign Establishment
Registration and Product Distribution; FIFRA DCO.
TERESA LITTLE (202) 260-4985
FUNCTIONS; Asbestos (AHERA) Regional Coordinator,
AHERA Compliance Monitoring; OCM TSCA Document
Control Officer.
JOHN MASON (202) 260-2301
FUNCTIONS; FIFRA Related Activities such as
Canceled and Suspended Products and Initiatives
(e.g., Dinoseb, Lawn Care, Malathion); Section
6(g) Compliance; Foreign Purchaser Acknowledgement
Statements tracking; Deliver, Order, Project
Officer.
18-24
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DAVID MEREDITH (202) 260-7864
FUNCTIONS; Project Manager for the National
Compliance Database, FIFRA/TSCA Tracking System,
and the EPCRA Targeting System; OCM Coordinator
for Strategically Targeted Activities for Results
System (STARS); Project Officer for CSC Contract
Support to FTTS and SSTS in Regional Offices, ADP
Issues.
PHILIP MILTON (202) 260-8598
FUNCTIONS: TSCA Sections 4,5,8,12 and 13 Regional
Coordinator; Hexavalent Chromium Rule; Asbestos
Ban and Phase out Rule; OCM Enforcement
Coordinator.
PAMELA 8AUNDER8 (202) 260-1809
FUNCTIONS; Inspector Training; Contract
Management/extramural Funding Support; FIFRA
Section 7 Tracking System Manager; Pesticide
Export (USDA/FDA issues); AHERA AARP Inspectors
Grants; Canadian Liaison Issues; Project Officer
for General Programming Support Contract (PRC).
AMAR SINGH (202) 260-3868
FUNCTIONS; FIFRA General, including: Worker
Protection Standards, Endangered Species,
Groundwater, Disinfectants.
JULIE VANDENBO8CH (202) 260-9335
FUNCTIONS; EPCRA Compliance Monitoring; EPCRA
Regional Coordinator - all regions; Investiga-
tion Requests under EPCRA; EPCRA AARP Grants for
Inspectors.
2. CASE SUPPORT BRANCH
BRANCH CHIEF - Gerald Stubbs (202) 260-7861
The types of functions within the area of responsibility of each
staff person are indicated below:
ROSE BURGESS (202) 260-4328
FUNCTIONS; TSCA Section 5/8 Case Development;
Region IV Coordinator; FIFRA Section 8 - Books and
Records.
18-25
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CINDY COLDIRON (202) 382-3801
FUNCTIONS; Program Attorney - Advisor; General
TSCA Issues (Section 5 PMN, Section 8 NOC, Self
Confessors); FIFRA Section 3 Registration
(3(c)(2)(B)); Region V Coordinator; FIFRA -
Water Purifiers; TSCA Section 5/8 Case
Development; TSCA and FIFRA GLP Case
Review/Enforcement; Multi-media Issues.
BETH CROWLEY (202) 260-8464
FUNCTIONS; TSCA Section 5/8 Development; Region
II Coordinator; PCS Issues; Contract Issues.
BRIAN DYER (202) 260-3477
FUNCTIONS; FIFRA Devices; FIFRA NOJ; TSCA Section
8(c) and 8(d); FTTS Case Tracking; TSCA Section
5/8 Case Development; Region VII Coordinator.
H. ABBREVIATED HEADQUARTERS FACSIMILE DIRECTORY
Many of the program offices at EPA Headquarters have
purchased facsimile machines and fax users can now send urgent
information directly to the program office. Priority letters,
drawings, charts, forms, labels, and photographs are particularly
appropriate for facsimile communications. However, you are
requested to limit your transmission of information to 12 pages
or less in order to prevent the facsimile machine from being tied
up for long periods of time by a single user. Documents
containing more than 12 pages should be sent to the Agency by
express mail. For best results use only black ink on white
paper.
IMPORTANT NOTE; Confidential Business Information (CBI), i.e.,
Confidential Statement Formula (CSF) should not be transmitted
over the facsimile machine unless the sender wants to clearly
waive his or her CBI rights and states this on the CSF.
If the FAX Number for the office to which you wish to send
information is not listed below, please call the intended
recipient of your document to obtain the appropriate transmission
number.
PROGRAM OFFICE FAX NUMBER
Office of Pesticide Programs (703) 305-6244
Registration Division (703) 305-6920
Antimicrobial Program Branch (703) 305-5786
18-26
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Fungicide- Herbicide Product Branch
Insecticide-Rcdenticide Branch
Registration Support Branch
Special Review and Reregistration Division
Program Management and Support Division
Information services Branch
Office of Pollution. Prevention and Toxics
(703) 308-1825
(703) 305-6596
(703) 308-1848
(703) 308-8773
(703) 305-7670
(202) 260-0575
Office of Compliance Monitoring (Immediate Office) (202) 260-1474
Compliance Division
Policy and Grants Division
Pesticide Enforcement Policy
Branch
Laboratory Data Integrity Assurance
Division
Referral Branch
(202) 260-0646
(202) 260-0641
(703) 308-8218
(703) 308-8285
(703) 308-8286
Office of General Counsel
Pesticides and Toxic substances Division (202) 260-2432
Science Advisory Board
Office of Administrative Lav Judges
Office of Ground Water and Drinking Water
Emergency and Remedial Responses (8UPERFUMD)
Associate Administrator for Communication.
Education and Public Affairs
Press Relations Division
(202) 260-9232
(202) 260-3720
(202) 260-4383
(202) 260-4386
(202) 260-4309
18-27
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I. EPA REGIONAL OPPICE8
REGION 1
Jurisdiction: Connecticut, Maine, Massachusetts, New
Hampshire, Rhode Island, Vermont
Environmental Protection Agency
John F. Kennedy Federal Building, RM 2203
Boston, MA 02203
(617) 565-3420
REGION 2
Jurisdiction: New Jersey, New York, Puerto Rico, Virgin
Islands
Environmental Protection Agency
26 Federal Plaza
New York, NY 10278
(212) 264-2657
REGION 3
Jurisdiction: Delaware, District of Columbia, Maryland,
Pennsylvania, Virginia, West Virginia
Environmental Protection Agency
841 Chestnut Street
Philadelphia, PA 19107
(215) 597-9800
REGION 4
Jurisdiction: Alabama, Florida, Georgia, Kentucky,
Mississippi, North Carolina, South Carolina,
Tennessee
Environmental Protection Agency
345 Courtland Street, N.E.
Atlanta, GA 30365
(404) 347-4727
REGION 5
Jurisdiction: Illinois, Indiana, Michigan, Minnesota, Ohio,
Wisconsin
Environmental Protection Agency
230 South Dearborn Street 5 SPT 7
Chicago, IL 60604
(312) 353-2000
18-28
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REGION 6
Jurisdiction: Arkansas, Louisiana, New Mexico, Oklahoma,
Texas
Environmental Protection Agency
1445 Ross Avenue
12th Floor, Suite 1200
Dallas, TX 75202
(214) 655-6444
REGION 7
Jurisdiction: Iowa, Kansas, Missouri, Nebraska
Environmental Protection Agency
726 Minnesota Avenue
Kansas City, KS 66101
(913) 551-7000
REGION 8
Jurisdiction: Colorado, Montana, North Dakota, South Dakota,
Utah, Wyoming
Environmental Protection Agency
999 18th Street
Suite 500
Denver, CO 80202-1603
(303) 293-1603
REGION 9
Jurisdiction: Arizona, California, Hawaii, Nevada, American
Samoa, Guam
Environmental Protection Agency
215 Fremont Street
San Francisco, CA 94105
(415) 744-1305
REGION 10
Jurisdiction: Alaska, Idaho, Oregon, Washington
Environmental Protection Agency
1200 Sixth Avenue
Seattle, WA 98101
(206) 442-1200
18-29
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H. STATE AGENCIES WITH LEAD PESTICIDE RESPONSIBILITY
Alabama
Alaska
American Samoa
Arizona
Arkansas
California
Colorado
Commonwealth of
the Northern
Mariana Islands
Director
Ag Chemistry/Plant Industry Division
Alabama Dept. of Agriculture & Industry
P.O. Box 3336
Montgomery, AL 36193
(205) 242-2631
Pesticide Specialist
Alaska Dept. of Environmental Conservation
500 S. Alaska St., Suite A
Palmer, AK 99645
(907) 745-3236
Director, American Samoa EPA
Office of the Governor
Pago, American Samoa
96799
State Chemist
Office of State Chemist
P.O. Box 1586
Mesa, AZ 85211-1586
(602) 542-3579
Director
Division of Feed, Fertilizer & Pesticides
Arkansas State Plant Board
P.O. Box 1069
Little Rock, AR 72203
(501) 225-1598
Chief, Pesticide Registration Branch
Division of Pest Management
California Dept. of Food & Agriculture
1220 N Street, Room A-447
Sacramento, CA 95814
(916) 322-6315
Chief, Pesticide Applicator Section
Division of Plant Industry
Colorado Dept. of Agriculture
4th Floor, 1525 Sherman Street
Denver, CO 80203
(303) 239-4140
Chief, Division of Environmental Quality
Commonwealth of the Northern Mariana
Islands (CNMI)
P.O. Box 1304
Saipan, MP 96950
18-30
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'Connecticut
Delaware
District of
Columbia
Florida
Georgia
Guam
Hawaii
Idaho
Senior Environmental Analyst
Pesticide Control Section
Department of Environmental Protection
State Office Building
Hartford, CT 06106
(203) 566-5148
Pesticide Compliance Supervisor
Delaware Dept. of Agriculture
2320 South DuPont Highway
Dover, DE 19901
(302) 739-4811
Section Chief, Pesticide Section
Environmental Control Division
Dept. of Consumer & Regulatory Affairs
5010 Overlook Avenue, S.W., Room 114
Washington, D.C. 20023
(202) 404-1167-
Administrator
Pesticide Registration Section
Bureau of Pesticides
Division of Inspection
Florida Dept. of Agric. & Consumer Services
3125 Doyle Conner Blvd.
Tallahassee, FL 32399-1650
(904) 487-2130
Ag. Manager II
Entomology & Pesticide Division
Georgia Dept. of Agriculture
Capitol Square
Atlanta, GA 30334
(404) 656-4958
Director, Air & Land Programs Division
Guam Environmental Protection Agency
Harmon Plaza Complex, Unit D-107
130 Rojas St.
Harmon, Guam 96911
Registration Specialist, Pesticides Branch
Plant Industry Division
Hawaii Dept. of Agriculture
1428 South King Street
Honolulu, HI 96814
(808) 548-7119
Supervisor, Pesticide Programs
Division of Plant Industries
Idaho Dept. of Agriculture
P.O. Box 790
Boise, ID 83701-0790
(208) 334-3243
18-31
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Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Chief, Bureau of Plant & Apiary Protection
Illinois Dept. of Agriculture
State Fairgrounds
Springfield, IL 62791-9281
(217) 782-3817
Pesticide Compliance Officer
Indiana State Chemist Office
Dept. of Biochemistry
Purdue University
West Lafayette, IN 47907
(317) 494-1492
Supervisor, Pesticide Section
Iowa Dept. of Agriculture
Wallace Bldg.
East 7th Street and Court Avenue
Des Moines, IA 50319
(515) 281-8591.
Administrator, Pesticide Registration
Plant Health Division
Kansas Dept. of Agriculture
109 S.W. Ninth Street
Topeka, KS 66612-1281
(913) 296-2263
Director
Kentucky Dept. of Agriculture
Capitol Plaza Tower
Frankfort, KY 40601
(502) 564-7274
Director, Pesticides & Environmental
Programs
Louisiana Dept. of Agriculture
P.O.Box 44153
Baton Rouge, LA 70804-4153
(504) 925-3763
Pesticides Registrar
Board of Pesticides Control
Maine Dept. of Agriculture
State House Station #28
Augusta, ME 04333
(207) 289-2731
Registrar, State Chemist Section
Plant Industries & Resource Conservation
Maryland Dept. of Agriculture
0233 Chemistry Bldg.
College Park, MD 20742
(301) 841-5710
18-32
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Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
Manager, Technical Assessment Sect.
Pesticides Bureau
Maine Dept. of Food and Agriculture
100 Cambridge Street, 21st Floor
Boston, MA 02202
(617) 727-3020
Supervisor, Product Registration
Pesticide & Plant Management Div.
Michigan Dept. of Agriculture
P.O. Box 30017
Lansing MI 48909
(517) 373-1087
Pesticide Control Specialist
Agronomy Services Division
Minnesota Dept. of Agriculture
90 West Plato Blvd.
St. Paul, MN 55107
(612) 296-1161
Pesticide Registration
Division of Plant Industry
Dept. of Agriculture and Commerce
P.O. Box 5207
Mississippi State, MS 39762
(601) 325-3390
Supervisor, Bureau of Pesticide Control
Plant Industries Division
Missouri Dept. of Agriculture
P.O. Box 630
Jefferson City, MO 65102-0630
(314) 751-2462
Chief, Technical Services Bureau
Environmental Management Division
Montana Dept. of Agriculture
Agriculture-Livestock Bldg.
Capitol Station
Helena, MT 59620-0205
(406)" 444-2944
Director, Bureau of Plant Industry
Nebraska Dept. of Agriculture
301 Centennial Mall
Lincoln, NE 68509
(402) 471-2394
Director, Division of Plant Industry
Nevada Dept. of Agriculture
P.O. Box 11100
Reno, NV 89510-1100
(702) 688-1180
18-33
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New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Director, Division of Pesticide Control
New Hampshire Dept. of Agriculture
Caller Box 2042
Concord, NH 03301
(603) 271-3550
Chief, Bureau of Pesticide Control
NJ Dept. of Environmental Protection
401 East State Street CN 411
Trenton, NJ 08265
(609) 530-4123
Chief, Bureau of Pesticide Management
Division of Agric. & Environmental Sciences
New Mexico Dept of Agriculture
P.O.Box 30005, Dept 3AQ
Las Cruces, NM 88003
(505) 646-2133
Director, Bureau of Pesticide Management
Dept. of Environmental Conservation
Rm. 404, 50 Wolf Road
Albany, NY 12233-7254
(518) 457-7482
Assist. Pesticide Administrator
Food & Drug Protection Division
North Carolina Dept. of Agriculture
P.O. Box 27647
Raleigh, NC 27611-0647
(919) 733-3556
Director, Registration Division
North Dakota Dept. of Health and
Consolidated Labs
P.O. Box 937
Bismarck, ND 58502
(701) 221-6149
Specialist in Charge
Pesticides Regulation
Ohio Dept. of Agriculture
Division of Plant Industry
8995 East Main Street
Reynoldsburg, OH 43068-3399
(614) 866-6361
Program Manager
Pesticide Registration Program
Oklahoma Dept. of Agriculture
2800 North Lincoln Blvd.
Oklahoma City, OK 73105-4298
(405) 521-3864
18-34
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GLOSSARY OF SELECTED TERMS, ABBREVIATIONS AND ACRONYMS
USED IN THE OFFICE OF PESTICIDE PROGRAMS
AA - Assistant Administrator
AAPCO - Association of American Pesticide Control Officials. An
association of state pesticide regulatory officials dedicated to
the effective enforcement of laws and implementation of programs
that relate to proper and safe use of pesticide chemicals.
ACS - The Analytical Chemistry Branch (ACB) within the Biological
and Economic Analytical Division (BEAD) of the Office of Pesticide
Programs (OPP). ACB provides analytical and environmental
chemistry services in support of pesticide registration, special
review, and tolerance petition programs. ACB also provides support
to the Office of General Counsel, the EPA Regional Enforcement
Program, and the National Ground Water Monitoring Program. There
are two laboratories in this branch, one in Beltsville, Maryland
-and one in Bay St. Louis, Mississippi.
ACCELERATED REREGISTRATION BRANCH - The Accelerated Reregistration
- Branch (ARB) within the Special Review and Reregistration Division
(SRRD) of the Office of Pesticide Programs (OPP) is responsible for
the reregistration activities of List B, C, And D Chemicals. ARB
staff manage data requirements, issue Data Call-in Notices, process
industry's data and requests, and coordinate internal
reregistration eligibility decisions. .,
ACCEPTABLE DAILY INTAKE - ADI. A now defunct term for reference
dose.
ACCESSION NUMBER - An identification number that used to be
assigned (for cataloging purposes) to physical volumes of studies
submitted to the Office of Pesticide Programs; this numbering
system has been replaced by the Master Record Identification (MRID)
7 system, which identifies each individual study.
ACTIVE INGREDIENT - In any pesticide product, the active ingredient
is the component which kills, or other wise controls, the target
pests and includes any substance (or group of structurally similar
substances if specified by the Agency) that will prevent, destroy,
repel, or mitigate any pest, or that functions as a plant
regulator, desiccant, or defoliant within the meaning of FIFRA
section 2(a). Pesticides are regulated primarily on the basis of
active ingredients. Abbreviated AI.
G- 1
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ACUTE TOXICITY - The ability of a substance to cause poisonous
effects resulting in harm or death soon after exposure. Acute
toxicity is established through scientifically verifiable data from
animal or human exposure tests. Values are usually expressed as
LD50 or LC50 and mg/kg. Acute toxicity studies include oral, dermal,
and inhalation studies.
ADI - See Acceptable Daily Intake.
ADDRESS OP RECORD - The applicant's or registrant's United States
address for correspondence purposes. It is the address to which
the Agency will send certain notices (i.e., those imposing legal
requirements) concerning the application and any subsequent
registration information. It is the responsibility of the
applicant or registrant to ensure that the Agency has a current and
accurate address.
ADJUVANT - A subsidiary ingredient or additive in a mixture which
contributes to the effectiveness of the primary ingredient.
Adjuvants are added to pesticides use dilutions in tank mixes by
growers or applicators prior to application to the crop to be
treated. Agricultural chemical adjuvants are grouped according to
their intended purpose in the tank mix and include but are not
limited to the following groups: acidifying agents, buffering
agents, anti-foam agents, defoaming agents, anti-transpirants,
color adjuvants, dyes, brighteners, compatibility agents, crop oil
concentrates, oil surfactants, deposition agents, drift reduction
agents, foam markers, gustatory stimulants, feeding stimulants,
herbicide safeners, spreaders, extenders, adhesive agents,
suspension agents, gelling agents, synergists, tank and equipment
cleaners, neutralizers, water absorbants, and water softeners.
Adjuvants intended for pesticidal use in tank mixes are required to
be cleared under the Federal Food, Drug and Cosmetic Act prior to
being used. Adjuvants intended for non-pesticidal uses are to be
cleared with the FDA prior to being used.
ADMINISTRATIVE PORTION OF APPLICATION FOR REGISTRATION - That
portion of the Application Package comprised of the administrative
paperwork, i.e., the Application for Registration/Amendment (EPA
Form 8570-1) ; the Confidential Statement of Formula (EPA Form 8570-
4) ; the Certification with Respect to Citation of Data (EPA Form
8570-29); the Formulator's Exemption Statement (EPA Form 8570-27);
the Draft Labeling; the Statement identifying the "substantially
similar" or "identical" product (if a "me-too" amendment); and the
Data Matrix Chart (if the selective method of support is used).
The administrative documents are not to be bound together.
ADMINISTRATOR - The Administrator of the United States
Environmental Protection Agency or his/her delegate.
AGENCY - The United States Environmental Protection Agency (EPA),
unless otherwise specified.
G- 2
-------
- See Active ingredient.
$
iANALYTICAL CHEMISTRY BRANCH - See ACB.
lAOAC - Association of Official Analytical Chemists.
iAPPLICANT - A pesticide chemical company or person who intends to
or has applied to the Agency (Office of Pesticide Programs,
Registration Division) for a registration, amended registration, or
reregistration for registration of a pesticide product, under FIFRA
section 3.
ARB - See Accelerated Reregistration Branch.
ASTRO - Association of State and Territorial Health Officials.
ASSOCIATION OF AMERICAN PESTICIDE CONTROL OFFICIALS - See AAPCO.
ASSOCIATION OF OFFICIAL ANALYTICAL CHEMISTS - See AOAC.
AUTHORIZED AGENT - A person residing in the United States who is
designated by an applicant or registrant to act as their agent in
matters pertaining to pesticide registration.
BAB - The Biological Analysis Branch (BAB) within the Biological
and Economic Analysis Division (BEAD) of the Office of Pesticide
Programs (OPP) . BAB is responsible for. the preparation of use-data
software programs for exposure assessments, qualitative use
assessments, and biological analyses of pesticides.
Bilingual labeling.
BEAD - The Biological and Economic Analysis Division (BEAD) is one
of the seven Divisions that constitutes the Office of Pesticide
Programs (OPP). BEAD conducts analyses on pesticide use and
benefits; acquires, validates, and interprets technical data
t relative to pesticide use; conducts economic analyses on the
impacts of regulatory options; and validates analytical chemistry
methods. BEAD is comprised of the Planning and Evaluation Staff,
and three branches: Biological Analysis Branch (BAB), Economic
Analysis Branch (EAB), and Analytical Chemistry Branch (ACB).
BIOCHEMICAL PESTICIDES - Biochemical pesticides include, but are
not limited to, products such as semiocheroicals (e.g., insect
pheromones), hormones (e.g., insect juvenile growth hormones),
natural plant and insect growth regulators, and enzymes.
BIOLOGICAL ANALYSIS BRANCH - See BAB.
BIOLOGICAL AND ECONOMIC ANALYSIS DIVISION - See BEAD.
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CB - The Communications Branch (CB) within the Field Operations
Division (FOD) of the Office of Pesticide Programs (OPP) develops
and operates programs that disseminate pesticide and OPP
information to the public. CB also manages the OPP public docket
(see docket file).
CB I - See Chemistry Branch I and II.
CB II - See Chemistry Branch I and II.
CBI - Confidential Business Information - material that contains
trade secrets or commercial or fiancial information that been
claimed as confidential by the submitter (usually the registrant).
Procedures for handling CBI material can be found in the OPP and
the OPTS CBI manuals. CBI material should not be sent over FAX
machines unless the sender wants to clearly waive his or her CBI
rights and so states on the CBI material being FAXed.
CERCLA - The Comprehensive, Environmental, Response, Compensation,
and Liability Act (CERCLA). Commonly known as "Superfund," this
statute includes provisions for the cleanup of existing hazardous
waste sites and requires that releases of hazardous substances in
quantities greater than established reportable quantities be
reported to the National Response Center. Under CERCLA section
103, the application of a pesticide product registered under FIFRA
is exempt from regulation. CERCLA in implemented by the Office of
Solid Waste and Emergency Response, Office of Emergency and
Remedial Response. Also see the Superfund Amendments and
Reauthorization Act of 1986 (SARA).
CERTIFICATION AND TRAINING BRANCH - The Certification and Training
Branch (CTB) within the Field Operation Division (FOD) of the
Office of Pesticide Programs (OPP) is responsible for directing and
implementing the Agency's regulatory and non-regulatory pesticide
applicator training and certification activities under section 4
and section 23 of FIFRA. CTB also acts as OPP's liaison to state
governments and tribal governments.
CFR - The Code of Federal Regulations. A codification of the
general and permanent rules published in the Federal Register by
the Executive departments and agencies of the Federal Government.
The Code is divided into 50 titles which represent broad areas
subject to Federal regulation. Each title is divided into chapters
which usually bear the name of the issuing agency. Each chapter is
further subdivided into parts covering specific regulatory areas.
Regulations that pertain to EPA are at 40 CFR. Thus, 40 CFR 152.40
refers to title 40, part 152, section 40; the section on who may
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*apply for new registration of a pesticide product. Each volume of
^the Code is revised at least once each calendar year and issued on
¥a quarterly basis approximately as follows:
Title 1 through Title 16 as of January 1
* Title 17 through Title 27 as of April 1
Title 28 through Title 41 as of July 1
Title 42 through Title 50 as of October 1
The appropriate revision date is printed on the cover of each
^volume.
CHEMICAL CASE - For purposes of review and regulation, individual
active ingredients that are chemically similar (e.g., salts and
esters of the same chemical) are grouped into chemical cases by the
Agency.
CHEMICAL MANUFACTURERS ASSOCIATION - The Chemical Manufacturers
5r Association (CMA) .
CHEMICAL PESTICIDES - Synthetic or natural occurring chemicals that
exhibit pesticidal properties and are formulated into products
intended for preventing, destroying, repelling, or mitigating a
pest, or intended for use as a plant regulator, defoliant, or
desiccant.
CHEMICAL PRODUCERS AND DISTRIBUTORS ASSOCIATION - The Chemical
Producers and Distributors Association (CPDA).
CHEMICAL SPECIALTIES MANUFACTURERS ASSOCIATION - The Chemical
Specialties Manufacturers Association (CSMA); was originally named
the National Association of Insecticide and Disinfectant
Manufacturers.
CHEMISTRY BRANCH I AND II - Chemistry Branch I (CB I) ~ Tolerance
£ Support and Chemistry Branch II (CB II) — Reregistration Support
* are two branches within the Health Effects Division (HED) of the
Office of Pesticide Programs (OPP) that were formerly known as the
Dietary Exposure Branch (DEB). CB I and CB II evaluate analytical
methods and residue, metabolism, and dietary exposure data. These
analyses are used to estimate dietary exposure to pesticides and
may lead to recommendations for or against proposed pesticide
residue tolerances in food or feed, and reassessment of tolerances.
CHILD-RESISTANT PACKAGING - (CRP) - Packaging that is designed and
constructed to be significantly difficult for young children to
open. Registrants of pesticide products required to be in child-
resistant packaging are required to certify to the Agency that the
package meets the standards of 40 CFR 157.32.
CHRONIC TOXICITY - The capacity of a substance to cause long-term
poisonous human health effects.
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CITE-ALL METHODS OF SUPPORT - One of two methods by which an
applicant for registration may comply with the data compensation
requirements of FIFRA section 3(c)(l)(F). Under this method the
applicant, where "exclusive use" data is involved, cites all
pertinent data in the Agency's files only with the written
permission of the exclusive use data submitter; where there is no
exclusive use data involved, the applicant cites all pertinent data
in the Agency's files with permission of the original data
submitter or by offering to pay compensation for use of the data in
accordance with FIFRA sections 3(c)(l)(F) and submits a general
offer to pay statement to the Agency stating his or her offer and
agreeing to pay compensation to other data submitters t the extent
required by FIFRA section 3(c)(1)(F).
CMA - See Chemical Manufacturers Association.
CODE OF FEDERAL REGULATIONS - See CFR.
COLLATERAL LABELING - Collateral labeling must be submitted along
with the application for registration and includes bulletins,
leaflets, circulars, brochures, data sheets, flyers or other
written, printed or graphic matter which is referred to on the
label or which is to accompany the product.
COMMUNICATIONS BRANCH - See CB.
COMPREHENSIVE ENVIRONMENTAL, RESPONSE, COMPENSATION, AND LIABILITY
ACT - See CERCLA.
CONFIDENTIAL BUSINESS INFORMATION - See CBI.
CONFIDENTIAL STATEMENT OF FORMULA - (CSF). A list showing the
identity of the ingredients contained in a pesticide formulation.
The list is submitted by a registrant or applicant, on the
Confidential Statement of Formula form (EPA Form 8570-4), at the
time of application for registration or change in formulation.
CORT STUDIES - The set of toxicology studies of chronic feeding,
oncogenicity (which is now referred to as carcinogenicity),
reproduction, and teratology. These studies are required for all
food/feed use pesticides and one or more may also be required for
nonfood/feed use pesticides.
CPDA - See Chemical Producers and Distributors Association.
CRP - See Child-Resistant Packaging.
CSF - See Confidential Statement of Formula.
CSMA - See Chemical Specialties Manufacturers Association.
CTB - See Certification and Training Branch.
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DAA - Deputy Assistant Administrator.
*DATA CALL-IN NOTICE - (DCI). As provided by FIFRA section
~-3(c) (2) (B), data call in is a notice/letter that is issued by the
Reregistration Division and/or Registration Division to pesticide
if-, registrants requiring them to submit specific data or scientific
.studies to support the registration of a pesticide. Failure to
submit this data can result in suspension of the registered
products.
DATA GAP - The absence of any valid study or studies in the
Agency's files which would satisfy a specific data requirement for
a particular pesticide product.
DATA MATRIX CHART - A matrix chart showing all of the data required
to support the application for registration. The applicant
indicates on the matrix how he/she is satisfying the data
requirements, i.e., by submitting the actual data or by referencing
ft EPA1s Master Record Identification (MRID) number. The Data Matrix
> Chart is required to be submitted only if the applicant elects to
* use the Selective Method of Support for his/her application.
DATA PORTION OF APPLICATION FOR REGISTRATION - The portion of the
Application Package comprised of the actual data required to
support your application for registration, i.e., product specific
chemistry data, acute toxicity data, efficacy data, generic data
(if the application is for a new use or a new active ingredient).
Applicants are required to submit three copies of the data,
properly bound and formatted in accordance with PR Notice 86-5.
DATA REVIEW RECORD - A form attached to material (e.g., data
submitted by a registrant) transferred from one Office of Pesticide
Programs (OPP) Division to another for review. The material is
assigned a record number and a bar code which are used to track the
• material in the Pesticide Registration Action Tracking System
y (PRATS) (formerly the On-Line Tracking System (OLTS)).
v
DATA SUBMITTER'S LIST - The current Agency list, entitled
Pesticide Data Submitters by Chemical," of persons who have
submitted data to the Agency.
DCI - See Data Call-In Notice.
DEB - See Chemistry Branch I and II.
DESIGNATED U.S. AGENT - See Authorized Agent.
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DEVICE - Any instrument or contrivance (other than a firearm)
intended for trapping, destroying, repelling, or mitigating any
pest or any other form of plant or animal life (other than man and
other than a bacterium, virus, or other microorganism on or in
living man or living animals) but not including equipment used for
the application of pesticides (such as tamper-resistant bait boxes
for rodenticides) when sold separately.
DIETARY EXPOSURE BRANCH - (DEB) - See Chemistry Branch I and II.
DIETARY RISK EVALUATION SYSTEM - The Dietary Risk Evaluation System
(ORES) is a computerized tool for analyzing human dietary exposures
to individual pesticides and comparing the exposures to known
toxicity levels. The ORES is the responsibility of the Science
Analysis and Coordination Branch (SACB) within the Health Effects
Division (HED) of the Office of Pesticide Programs (OPP). ORES was
formerly known as the Tolerance Assessment System (TAS).
DOCKET FILE - A file maintained in the public docket (Room 1128,
Crystal Mall Building 2 (CM2), for the Office of Pesticide Programs
(OPP)) for materials that pertain to Special Review and
Reregistration of pesticides. Instructions for docketing can be
found in 40 CFR 155. Materials in the docket are available for
public inspection unless they are marked as confidential business
information. It is the responsibility of the OPP product managers
and review managers to submit materials to the docket.
DOMESTIC APPLICATION - Pesticide application in and around houses,
office buildings, motels and other living or working areas; now
termed residential use. See residential use.
DRES - See Dietary Risk Evaluation System.
EAB - The Economic Analysis Branch (EAB) within the Biological and
Economic Analysis Division (BEAD) provides economic analyses for
EPA's pesticide regulatory program, including analyses of economic
impacts of pesticide regulatory policies and of individual program
actions under the various sections of FIFRA.
EC - An Emulsifiable Concentrate (EC) is a type of pesticide
formulation that contains the active ingredient, one or more
petroleum solvents, and an emulsifier that allows the formulation
to be mixed with water. The strength of this concentrate usually
is stated in pounds of active ingredient per gallon of concentrate.
ECOLOGICAL EFFECTS BRANCH - The Ecological Effects Branch (EEB)
within the Environmental Fate and Effects Division (EFED) of the
Office of Pesticide Programs (OPP) is responsible for assessing
pesticide effects on non-target species including fish, birds,
small mammals, beneficial insects, and plants.
ECONOMIC ANALYSIS BRANCH - See EAB.
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tEDP - The Environmental Defense Fund (EOF).
4
,iEEB - See Ecological Effects Branch.
EEC - Estimated Environmental Concentration. An estimate of the
^concentration of a pesticide occurring in or on various media
(i.e., soil, water, air) aftr pesticide application, as determined
from the results of environmental fate or environmental expression
testing.
•EFED - The Environmental Fate and Effects Division (EFED) is one of
seven Divisions that constitutes the Office of Pesticide Programs
(OPP) and is responsible for assessment of pesticide effects on
-non-target animal and plant species in the natural environment and
groundwater. EFED is made up of the Science Analysis and
Coordination Staff (SACS), the Ecological Effects Branch (EEB), and
, the Environmental Fate and Groundwater Branch (EFGWB). This
^Division was created by the OPP reorganization of July 1988 when
vthe Hazard Evaluation Division was split into the Environmental
Fate and Effects Division (EFED) and the Health
Effects Division (HED).
EFFICACY DATA - Data showing that the pesticide is effective in
controlling the pests for which control claims are made on the
product label.
EFGWB - The Environmental Fate and Groundwater Branch (EFGWB)
within the Environmental Fate and Effects Division (EFED) of the
Office of Pesticide Programs reviews and evaluates data on :
pesticide fate and transport; aspects of pesticide leachability;
and ground water effects. EFGWB also manages and coordinates human
and environmental monitoring activities in support of the pesticide
regulatory program.
ELI - The Environmental Law Institute (ELI) conducts research on
fcurrent developments in environmental law; publishes the
^"Environmental Reporter."
EMERGENCY EXEMPTION - A provision in FIFRA (Section 18) which
permits the Administrator to exempt any Federal or State agency
form any of the requirements of FIFRA if emergency conditions
exist. The term "emergency conditions" is defined at 40 CFR
166.3(d). Pursuant to the provisions of FIFRA section 18, EPA has
promulgated regulations at 40 CFR Part 166 under which EPA can
grant an emergency exemption to a state or another federal agency
that allows, subject to certain restrictions, the use for a limited
period (usually one year) of a pesticide product that is not
registered for that particular use.
EMERGENCY SUSPENSION - Suspension of registration under FIFRA
section 6(c) due to an imminent hazard. See Suspension of
Registration also.
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EMULSIFIABLE CONCENTRATE - See EC.
EMULSIFIER - A chemical that aids in suspending one liquid in
another, usually an organic chemical in an aqueous solution.
END-USE PRODUCT - EP - A pesticide product whose labeling bearing
instructions for using or applying the product (as packaged and
sold, or after dilution by the applicator) for controlling pests or
regulating plant growth. The term excludes products with labeling
wich allows663Xusef the product to formulate other pesticide
products.
ENVIRONMENTAL DEFENSE FUND - See EOF.
ENVIRONMENTAL EXPRESSION - The extent and manner in which a
microorganism establishes and maintains its presence in an
ecological habitat.
ENVIRONMENTAL FATE DATA - Scientific data that characterize a
pesticide's fate in the ecosystem, considering its degradation
inducers (light, water, microbes), pathways, and resultant
degradation products.
ENVIRONMENTAL FATE AND EFFECTS DIVISION - See EFED.
ENVIRONMENTAL FATE AND GROUNDWATER BRANCH - See EFGWB.
ENVIRONMENTAL LAW INSTITUTE - See ELI.
EP - See End-Use Product.
EPA - The Environmental Protection Agency.
EPA COMPENDIUM OF ACCEPTABLE USES - A list of federally registered
pesticides with their uses and approved maximum acceptable
application rates and other use restrictions; this outdated system
was replaced by the use index. The use index has subsequently been
replaced by LUIS. See LUIS.
EPA ENDANGERED SPECIES BULLETIN - A bulletin that contains lists of
endangered species (including birds, fish, mammals, and plants)
which may be exposed to a pesticide or pesticides in a given
county. The bulletin also contains pesticide use information
necessary to protect the species from exposure to pesticides.
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ESTABLISHMENT REGISTRATION - The assignment of a registration
$ number to a site where a pesticide or device is produced. The
% number is a two part hyphenated number referred to as an EPA
vEstablishment Number. The first part of the number is series of
,numerals that identifies the company and the second part is a two
fletter code identifying the state or country in which the
establishment is located. The establishment number is required to
be on the product label.
.ESTIMATED ENVIRONMENTAL CONCENTRATION - See EEC.
EUP - See Experimental Use Permits.
EXCLUSIVE USE DATA - Beginning September 30, 1978, Exclusive Use
Data pertains to those data that were submitted to the Agency in
support of the registration of a new active ingredient, a new
: combination of active ingredients, or an application to amend the
"toriginal registration to add a new use, for a period of 10 years
.*• after the initial registration has been issued. In order for the
; Agency to consider such data in support- of an applicant's
< application for registration or amendment, the applicant must
' obtain for each data submitter listed on the Data Submitters List,
as an exclusive use data submitter, written authorization
identifying the applicant as the applicant to whom authorization
has been granted to allow the Agency to use all applicable data to
satisfy the data requirements for the application in question.
EXPERIMENTAL USE PERMITS - EUP - A permit authorized under FIFRA,
section 5, which is granted to applicants allowing them to conduct
testing of a new proposed pesticide product and/or use outside of
the laboratory and generally on 10 acres or more of land or water
surface. EUPs are most commonly used for larger scale testing of
efficacy and gathering of crop residue chemistry data. EUPs are
processed by Product Manager (PM) Teams in the Office of Pesticide
. Programs' Registration Division Product Branches.
FACTA - Food, Agriculture, Conservation, and Trade Act of 1990.
PDA - The Food and Drug Administration. This agency is
responsible for carrying out the provisions of the Federal Food,
Drug, and Cosmetic Act (FFDCA), which includes pesticide tolerance
v enforcement. See FFDCA.
FEDERAL FOOD, DRUG, AND COSMETIC ACT - FFDCA - The Federal Food,
Drug and Cosmetic Act. The law which regulates, among other
things, the use of drugs (human and veterinary), chemicals in
cosmetics, and human and animal foods; this includes the legal
requirement of tolerances for pesticide residues (Sections 408 and
409) in. or on food and feed items. These tolerances are
•., established by EPA.
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FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT - The Federal
Insecticide, Fungicide And Rodenticide Act. The law which sets
forth the regulation of the sale, distribution and use of
pesticides in the United States.
FEDERAL RECORD CENTER - The Federal Records Center provides
economical storage of and access to noncurrent records. The agency
stores noncurrent, inactive, and permanent records at the Center.
FEDERAL REGISTER - (FR) A daily government publication where all
federal regulatory actions, including proposed rules, final rules,
and notices are published.
FEEDING STIMULANT - When Included in a pesticide formulation,
feeding stimulants are treated as inert ingredients and are
required to go through the same Agency clearance under FIFR2100Xand
the FFDCA that inert ingredients are subject to. When feeding
stimulants are added to a pesticide in a tank mix at a use site
they do not require registration but are subject to the FFDCA.
FFDCA - See Federal Food, Drug, and Cosmetic Act.
FHB - The Fungicide-Herbicide Branch (FHB) within the Registration
Division (RD) of the Office of Pesticide Programs (OPP) carries out
regulatory responsibilities on herbicide and fungicide products.
FHB is responsible for processing applications for registration,
experimental-use permits, and petitions for tolerances for these
classes of pesticides.
FIELD OPERATIONS DIVISION - The Field Operations Division (FOD) is
one of seven Divisions that constitutes the Office of Pesticide
Programs (OPP). It oversees implementation of OPP regulatory
actions, directs pesticide applicator training and certification,
and manages the public docket. Within FOD there are five branches:
the Regional Operations Branch (ROB); the Public Response and
Program Resources Branch (PRPRB); the Communications Branch (CB);
the Occupational Safety Branch (OSB); and the Certification and
Training Branch (CTB).
FIFRA - See Federal Insecticide, Fungicide and Rodenticide Act.
FIFRA SCIENTIFIC ADVISORY PANEL - The FIFRA Scientific Advisory
Panel (SAP) is an independent group of scientists, authorized under
FIFRA, to comment on notices of intent issued under FIFRA section
6 and final form regulations issued under FIFRA section 25 (a) . The
SAP also comments, evaluates, and makes recommendations regarding
the scientific analyses made by the Agency.
FIFRA SECTION 18 - See Emergency Exemption.
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vFIFRA SECTION 24(C) - (Special Local Need (SLN)) - Authorizes a
state lead agency to register additional uses of federally
,,registered pesticides. Special Local Needs (SLNs) may only be used
in the registering state, but otherwise have full federal
registration status. All SLNs must be submitted to EPA for review
subsequent to registration by a state.
FINAL PRINTED LABELING - The label or labeling which will accompany
the pesticide product when distributed or sold.
FLOWABLE - A formulation in which the active ingredients are finely
ground insoluble solids . mixed with a liquid as a suspension.
Flowables are mixed with water for application.
FOD - See Field Operations Division.
,.. FOIA - The Freedom of Information Act (FOIA) ; legislation that
4 generally makes available to the public, documents possessed by the
federal government.
, FR - See Federal Register.
FREEDOM OF INFORMATION ACT - See FOIA.
FUNGICIDE-HERBICIDE BRANCH - See FHB.
GENETIC ENGINEERING - Directed transfer of permanent genetic
information between species. This may include organisms that the
Agency considers to be microbial pest control agents. Some higher
plants have been "genetically engineered" to produce a pesticide or
other compound not produced by the native plant.
GENERIC DATA - Generic Data pertain to the properties or effects
of a particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients.
Generic Data may also be data on a "typical formulation" of a
product. "Typical formulation" testing is often required for
ecological effects studies and applies to all products having that
formulation type. Any registrant who does not qualify for the
formulator's exemption (FIFRA section 3(c)(2)(D) and 40 CFR 152.85)
is required to submit generic data to support the his/her product
registration.
GLP - Good Laboratory Practices (GLP) are standards established in
40 CFR 160 to assure the quality and integrity of data submitted by
registrants. Provisions of the GLP standards include record
keeping, personnel, and laboratory equipment requirements.
GOOD LABORATORY PRACTICE - See GLP.
GPO - U.S. Government Printing Office, 16-2
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HEALTH EFFECTS DIVISION - The Health Effects Division (HED) is one
of the seven Divisions that constitutes the Office of Pesticide
Programs (OPP). It is responsible for assessment of pesticide
effects on human health. This Division was created by the OPP
reorganization of July 1988 when the Hazard Evaluation Division was
split into the Environmental Fate and Effects Division (EFED) and
the Health Effects Division (HED). HED is made up of six branches:
the Science Analysis And Coordination Branch (SACB) ; the Toxicology
— Insecticide and Rodenticide Support Branch; Toxicology —
Herbicide, Fungicide, and Antimicrobial Support Branch; Chemistry
Branch I — Tolerance Support; Chemistry Branch II
Reregistration Support; and the Occupational and Residential
Exposure Branch (OREB).
HED - See Health Effects Division.
ICR - An Information Collection Request (ICR) is prepared pursuant
to the requirements of the Paperwork Reduction Act (PRA) for rules,
proposed rules, surveys, or other documents that contain
information gathering requirements. The ICR is a description of
what information is needed, why the information is needed, how it
will be collected, and how much the information collection will
cost. An ICR is submitted to OMB for approval.
IDS - Incident Data System. A computerized system, currently under
development in the Information Services Branch of the Office of
Pesticide Programs' Program Management Support Division, for
receiving incident reports.
INCIDENT DATA SYSTEM - See IDS.
IMMINENT HAZARD - A situation that exists when the continued use of
a pesticide during the time required for a cancellation proceeding
would be likely to result in unreasonable adverse effects on humans
or the environment or will involve unreasonable hazard to the
survival of an endangered species.
INDEMNIFICATION - A provision of FIFRA section 15 that requires EPA
to pay certain persons for the cost of stock on hand at the time a
pesticide registration is suspended.
INERT INGREDIENT - Pesticide components such as solvents, carriers,
and surfactants that are not active against target pests and
includes any substance (or group of structurally similar substances
if designated by the Agency), other than an active ingredient,
which is intentionally included in a pesticide product.
Inert ingredients in pesticide product formulations are regulated
under both the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended and the Federal Food, Drug, and Cosmetic Act
(FFDCA).
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Oregon
Pennsylvania
Puerto Rico
Republic of Palau
Rhode Island
South Carolina
South Dakota
Tennessee
Program Coordinator, Plant Division
Oregon Dept. of Agriculture
635 Capitol Street, N.E.
Salem, OR 97301
(503) 378-3776
Use & Investigation Specialist
Bureau of Plant Industry
Division of Agronomic Services
Penna. Dept. of Agriculture
2301 N. Cameron Street
Harrisburg, PA 17110
(717) 787-4843
Director, Analysis & Registration of
Agricultural Materials
Puerto Rico Dept. of Agriculture
P.O. Box 10163
Santurce, PR 00908
(809) 796-1710, 1735
Executive Officer
Palau Environmental Quality Protection Board
Republic of Palau
P.O. Box 100
Koror, Palau 96940
Senior Plant Pathologist
Division of Agriculture & Marketing
Dept. of Environmental Management
22 Hayes Street
Providence, RI 02908
(401) 277-2782
Department Head
Dept. of Fertilizer & Pesticide Control
256 Poole Agricultural Center
Clemson, SC 29634-0394
(803) 656-3171
Supervisor, Pesticide Activity
Division of Regulatory Services
South Dakota Dept. of Agriculture
Anderson Bldg., 445 East Capitol
Pierre, SD 57501
(605) 773-3724
Pesticide Registration
Division of Plant Industries
Tennessee Dept. of Agriculture
P.O.Box 40627, Melrose station
Nashville, TN 37204
(615) 360-0130
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Texas
Utah
Vermont
Virginia
Virgin Islands
Washington
West Virginia
Wisconsin
Director
Texas Dept. of Agriculture
P.O. Box 12847
Austin, TX 78711
(512) 463-7549
Director, Division of Plant Industry
Utah Dept. of Agriculture
350 North Redwood Road
Salt Lake City, UT 84116
(801) 538-7180
Director, Plant Industry
Laboratory & Standards Division
Vermont Dept. of Agriculture
116 State St., State Office Bldg.
Montpelier, VT 05602
(802) 828-2435
Supervisor
Office of Pesticide Regulation
VA Dept. of Agriculture & Consumer Service
P.O. Box 1163
Richmond, VA 23209
(804) 371-6558
Director, Pesticide Programs
Division of Natural Resources Management
Dept. of Conservation and Cultural Affairs
P.O. Box 4340
St. Thomas, VI 00801
(809) 774-6420
Chief, Registrations & Services
Washington Dept. of Agriculture
406 General Administration Bldg. AX-41
Olympia, WA 98504
(206) 735-5062
Administrator
Regulatory & Inspection Division
W. Va. Dept. of Agriculture
Charleston, WV 25305
(304) 348-2209
Certification & Licensing
Wisconsin Dept. of Agriculture, Trade &
Consumer Protection
P.O. Box 8911
Madison, WI 53708
(608) 266-7131
18-36
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Wyoming Manager, Technical Services
Wyoming Dept. of Agriculture
2219 Carey Avenue
Cheyenne, WY 82002-0100
(307) 777-6590
THE END
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'INFORMATION COLLECTION REQUEST - See ICR.
•*-
fINFORMATION SERVICES BRANCH - The Information Services Branch (ISB)
vwithin the Program Management and Support Division (PMSD) of the
Office of Pesticide Programs (OPP) provides inomation management
'support to the OPP regulatory program. These services include
assessing information needs, directing the OPP security program,
and maintaining liaison with information contacts and organizations
outside OPP.
INSECTICIDE-RODENTICIDE BRANCH - The Insecticide-Rodenticide Branch
(IRB) within the Registration Division (RD) of the Office of
Pesticide Programs is responsible for processing applications for
registration, experimental-use permits, and petitions for
tolerances for pesticides in these use classes.
INSTITUTIONAL USE - Any application of a pesticide in or around any
property or facility that functions to provide a service to the
? general public or to public or private organizations, including but
not limited to hospitals and nursing homes; schools other than
preschools and day care facilities; museums and libraries; sports
facilities; and office buildings.
INTEGRATED PEST MANAGEMENT - Integrated Pest Management (IPM) is
the concept and practice of using a variety of methods (cultural,
pesticidal, biological, etc.) to control pests.
INTERMEDIATES: Pesticide intermediates are substances which are
not themselves pesticides, but which undergo chemical reactions
resulting in the formation of a pesticide. Pesticide intermediates
are subject to regulation under TSCA. Pesticide intermediates
include any beginning or intermediate material which is a chemical
precursor to a pesticide active ingredient, whether produced in
situ or obtained from other sources.
; INTERREGIONAL RESEARCH PROJECT NO. 4 - The Interregional Research
Project Number 4 (IR-4) is a program sponsored by the U.S.
Department of Agriculture (USDA). IR-4 provides national
leadership and coordination for information on the clearance of
minor use pesticides and generates data to support minor-use
registrations.
INTRASTATE PRODUCT - A pesticide product that was registered by a
state for sale and use only in that state. new intrastate
registrations are no longer permitted, and existing products must
be converted to full federal registration or canceled. Because
these products are not federally (EPA) registered, they may only
distributed or sold in the state of registration. Intrastate
products were identified by a product number greater than 3000
(e.g., 1573-4880).
IPM - See Integrated Pest Management.
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IR-4 - See Interregional Research Prct No. 4.
IRB - See Insecticide-Rodenticide Branch.
ISB - See Information Services Branch.
LABEL USE INFORMATION SYSTEM - See LUIS.
LUIS - The Label Use Information System (LUIS) is a computer data
base of label directions for pesticide usage. Information
contained in LUIS includes: use sites, application type, timing,
equipment, dosage, application frequency, reentry and preharvest
restrictions, geographic limitations, and selected limitations to
use. Data are extracted by product but may be aggregated by active
ingredient. The system currently focuses on information needed to
support reregistration. Additional information (e.g., pests, more
use limitations) will be added to the system to support special
reviews and other reregistration activities.
MAINTENANCE FEE - An annual fee required of registrants for each
pesticide product retained for registration.
MANUFACTURING-USE PRODUCT - A Manufacturing-Use Product (MP or MUP)
is any product intended (labelled) for formulation or repackaging
into other pesticide products.
MARGIN OF SAFETY/MARGIN OF EXPOSURE - The Margin of Safety/Margin
of Exposure (MOS/MOE) is a numerical value that characterizes the
amount of safety to a toxic chemical — a ratio of exposure to a
toxicological endpoint, usually the NOEL.
MASTER RECORD IDENTIFICATION NUMBER - See MRID Number.
"ME-TOO" PRODUCT - An application for registration of a pesticide
product that is substantially similar or identical in its uses and
formulation to products that are currently registered. See Chapter
6, D., Question 1 of this manual for a more detailed discussion of
a "me-too" product.
MICROBIAL PESTICIDES - Microbial pesticides are microorganisms and
include but are not limited to bacteria, algae, fungi, viruses, and
protozoa used as pest control agents (40 CFR 152.20).
MISCIBLE - Capable of being mixed. Often used to describe certain
pesticide formulations.
MOS/MOE - See Margin of Safety/Margin of Exposure.
MP- See Manufacturing-Use Product.
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MRID NUMBER - The Master Record Identification (MRID) Number is a
unique cataloging number assigned to an individual study at the
ftime of submission to the Agency. It is EPA's system of tracking
studies used in support of pesticide product registration.
MUP - See Manufacturing-Use Product.
NACA - The National Agricultural Chemicals Association (NACA).
NARA - The National Agrichemical Retailers Association.
NAS - The National Academy of Sciences (NAS).
'NASDA - The National Association of State Departments of
Agriculture.
-NATIONAL ACADEMY OF SCIENCES - See NAS.
•},
^NATIONAL AGRICULTURAL CHEMICALS ASSOCIATION - See NACA.
'NATIONAL COALITION AGAINST THE MISUSE OF PESTICIDES - The National
'Coalition Against the Misuse of Pesticides (NCAMP).
NATIONAL INSTITUTE FOR ENVIRONMENTAL HEALTH SCIENCES - As part of
the National Institute of Health, the National Institute for
Environmental Health Sciences (NIEHS) performs basic research,
including genetic and cancer studies, that relates to environmental
health sciences.
NATIONAL PEST CONTROL ASSOCIATION - The National Pest Control
Association (NPCA).
NATIONAL PESTICIDE INFORMATION RETRIEVAL SYSTEM - The National
Pesticide Information Retrieval System (NPIRS), located at Purdue
University, is the commercially-available version of the Pesticide
Product Information System (PPIS). In addition to PPIS
•' information, NPIRS also includes Pesticide Document management
System data (e.g., MRID number, study title, title page from
submitted study). Also see Pesticide Product Information System.
NATIONAL PESTICIDE TELECOMMUNICATIONS NETWORK - The National
Pesticide Telecommunications Network (NPTN), located at Texas Tech
" University, is a network from which the public can get answers to
their pesticide-related questions by calling a toll-free phone
number (1-800-858-7378) that is funded by EPA.
NATIONAL TECHNICAL INFORMATION SERVICE - (NTIS). An organization
that sells certain government publications including EPA documents
such as testing guidelines. Orders can be placed at NTIS,
Attention: Order Desk, 5285 Port Royal Road, Springfield, VA 22161.
Telephone: (703) 487-4650.
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MRID NUMBER - The Master Record Identification (MRID) Number is a
unique cataloging number assigned to an individual study at the
time of submission to the Agency. It is EPA's system of tracking
studies used in support of pesticide product registration.
MDP - See Manufacturing-Use Product.
NACA - The National Agricultural Chemicals Association (NACA).
NARA - The National Agrichemical Retailers Association.
NAS - The National Academy of Sciences (NAS).
NA8DA - The National Association of State Departments of
Agriculture.
NATIONAL ACADEMY OF SCIENCES - See NAS.
NATIONAL AGRICULTURAL CHEMICALS ASSOCIATION - See NACA.
NATIONAL COALITION AGAINST THE MISUSE OF PESTICIDES - The National
Coalition Against the Misuse of Pesticides (NCAMP).
NATIONAL INSTITUTE FOR ENVIRONMENTAL HEALTH SCIENCES - As part of
the National Institute of Health, the National Institute for
Environmental Health Sciences (NIEHS) performs basic research,
including genetic and cancer studies, that relates to environmental
health sciences.
NATIONAL PEST CONTROL ASSOCIATION - The National Pest Control
Association (NPCA).
NATIONAL PESTICIDE INFORMATION RETRIEVAL SYSTEM - The National
Pesticide Information Retrieval System (NPIRS), located at Purdue
University, is the commercially-available version of the Pesticide
Product Information System (PPIS). In addition to PPIS
information, NPIRS also includes Pesticide Document management
System data (e.g., MRID number, study title, title page from
submitted study). Also see Pesticide Product Information System.
NATIONAL PESTICIDE TELECOMMUNICATIONS NETWORK - The National
Pesticide Telecommunications Network (NPTN), located at Texas Tech
University, is a network from which the public can get answers to
their pesticide-related questions by calling a toll-free phone
number (1-800-858-7378) that is funded by EPA.
NATIONAL TECHNICAL INFORMATION SERVICE - (NTIS). An organization
that sells certain government publications including EPA documents
such as testing guidelines. Orders can be placed at NTIS,
Attention: Order Desk, 5285 Port Royal Road, Springfield, VA 22161.
Telephone: (703) 487-4650.
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NATURAL RESOURCES DEFENSE COUNCIL - The Natural Resources Defense
Council (NRDC).
NCAMP - See National Coalition Against the Misuse of Pesticides.
NEW CHEMICAL - An application for registration of a product
containing a new pesticide (active ingredient) that is not an
active ingredient in a product currently registered with the Agency
(40 CFR 152.114).
NEW USE - An application for registration of a use for an active
ingredient(s), or formulation type, not currently included in the
directions for use of any product that contains such active
ingredient(s) or formulation type. When used with respect to a
product containing a particular active ingredient "New Use" means
(1) any proposed use pattern that would require the establishment
of, increase in, or exemption from the requirement of a tolerance
or food additive regulation under section 408 or 409 of the FFDCA;
(2) any aquatic, terrestrial, outdoor, or forestry use pattern, if
no product containing the active ingredient is currently registered
for that use pattern; or (3) any additional use pattern that would
result in a significant increase in the level of exposure, or a
change in the route of exposure, to the active ingredient of man or
other organisms. (See 40 CFR 152.3(p)).
NIEHS - See National Institute for Environmental Health Sciences.
NOAEL - No Observable Adverse Effect Level.
NOEC - No Observed Effects Concentration.
NOEL - No Observed Effects Level.
NOIC - The Notice of Intent to Cancel (NOIC).
NOIS - The Notice of Intent to Suspend (NOIS).
NOMINAL CONCENTRATION - The amount of an ingredient which is
expected to be present in a typical sample of a pesticide product
at the time the product is produced, expressed as a percentage by
weight.
NO OBSERVED ADVERSE EFFECT LEVEL - See NOAEL.
NO OBSERVED EFFECT CONCENTRATION - See NOEC.
NO OBSERVED EFFECT LEVEL - See NOEL.
NOTICE OF INTENT TO CANCEL - See NOIC.
NOTICE OF INTENT TO SUSPEND - See NOIS.
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NPCA - See National Pest Control Association.
NPIRS - See National Pesticide Information Retrieval System.
NPTN - See National Pesticide Telecommunications Network.
NRDC - See Natural Resources Defense Council.
NTIS - See National Technical Information Service.
OCCUPATIONAL AMD RESIDENTIAL EXPOSURE BRANCH - The Occupational and
Residential Exposure Branch (OREB), within the Health Effects
Division (HED) of the Office of Pesticide Programs (OPP) is
responsible for review and evaluation of data in the exposure of
people to pesticides.
OCCUPATIONAL SAFETY BRANCH - The Occupational Safety Branch (OSB)
within the Field Operations Division (FOD) of the Office of
Pesticide Programs (OPP) develops and recommends Agency policy and
implements a strategy for pesticide occupational safety programs.
Through cooperative agreements, grants, or contracts, OSB manages
external efforts that contribute to a better understanding of the
phenomena of worker exposure to pesticides, the health problems
created, and identification and demonstration of practicable and
effective means to reduce exposure.
OCM - The Office of Compliance Monitoring.
OD - Office Director.
ODW - Office of Drinking Water (ODW) is the former name of the
Office of Drinking Water and Ground Water. The Office of Drinking
Water and Ground Water promulgates drinking water standards (MCLs)
and/or issues Health Advisories for pesticides known or suspected
to contaminate groundwater.
OECD GUIDELINES - Guidelines prepared by the Organization of
Economic and Cooperative Development of the United Nations; these
guidelines assist in the preparation of protocols for
toxicological, environmental fate, etc. studies.
OES - The Office of Endangered Species (OES) is part of the Fish
and Wildlife Service of the Department of Interior.
OFFICE OF DRINKING WATER - See ODW.
OFFICE OF DRINKING WATER AND GROUND WATER - See ODW.
OFFICE OF ENDANGERED SPECIES - See OES.
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•r NPCA - See National Pest Control Association.
*
*•«
$NPIRS - See National Pesticide Information Retrieval System.
\
•NPTN - See National Pesticide Telecommunications Network.
NRDC - See Natural Resources Defense Council.
NTIS - See National Technical Information Service.
OCCUPATIONAL AND RESIDENTIAL EXPOSURE BRANCH - The Occupational and
Residential Exposure Branch (OREB), within the Health Effects
Division (HED) of the Office of Pesticide Programs (OPP) is
responsible for review and evaluation of data in the exposure of
people to pesticides.
OCCUPATIONAL SAFETY BRANCH - The Occupational Safety Branch (OSB)
within the Field Operations Division (FOD) of the Office of
? Pesticide Programs (OPP) develops and recommends Agency policy and
implements a strategy for pesticide occupational safety programs.
Through cooperative agreements, grants, or contracts, OSB manages
external efforts that contribute to a better understanding of the
phenomena of worker exposure to pesticides, the health problems
created, and identification and demonstration of practicable and
effective means to reduce exposure.
OCM - The Office of Compliance Monitoring.
OD - Office Director.
ODW - Office of Drinking Water (ODW) is the former name of the
Office of Drinking Water and Ground Water. The Office of Drinking
Water and Ground Water promulgates drinking water standards (MCLs)
and/or issues Health Advisories for pesticides known or suspected
:y to contaminate groundwater.
V
'-• OECD GUIDELINES - Guidelines prepared by the Organization of
Economic and Cooperative Development of the United Nations; these
guidelines assist in the preparation of protocols for
toxicological, environmental fate, etc. studies.
-». OES - The Office of Endangered Species (OES) is part of the Fish
and Wildlife Service of the Department of Interior.
OFFICE OF DRINKING WATER - See ODW.
OFFICE OF DRINKING WATER AND GROUND WATER - See ODW.
OFFICE OF ENDANGERED SPECIES - See OES.
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OFFICE OF PESTICIDE PROGRAMS - The Office of Pesticide Programs
(OPP) and the Office of Pollution Prevention and Toxics comprise
the two offices within the Office of Prevention, Pesticides, and
Toxic Substances. OPP is comprised of seven Divisions: the
Biological and Economic Analysis Division (BEAD); the
Environmental Fate and Effects Division (EFED); the Field
Operations Division (FOD); the Health Effects Division (HED); the
Program Management and Support Division (PMSD); the Registration
Division (RD);and the Special Review and Reregistration Division
(SRRD) .
OLTS - The On-Line Tracking System (OLTS) is a computerized
tracking system used to track data review records. OLTS was
replaced by the Pesticide Registration Activity Tracking System
(PRATS). See PRATS also.
OMB - The Office of Management and Budget.
ON-LINE TRACKING SYSTEM - See OLTS and PRATS.
OPM - The Office of Personnel Management.
OPP - See Office of Pesticide Programs.
OREB - See Occupational and Residential Exposure Branch.
ORGANIZATION OF ECONOMIC AND COOPERATIVE DEVELOPMENT - An
organization of the United Nations that prepares guidelines that
assist in the preparation of protocols for toxicological,
environmental fate, etc. studies. Also see OECD Guidelines.
OSB - See Occupational Safety Branch.
PAG - Pesticide Assessment Guidelines (PAG) are protocols
referenced in 40 CFR 158 that provide registrants with guidance on
how to conduct required studies. Copies of the Guidelines can be
obtained from the National Technical Information Service.
PAI - A Pure Active Ingredient (PAI) is a test substance required
for certain pesticide studies. PAIs do not have inert ingredients
added.
FBA - A Preliminary Benefit Analysis (PBA) is a summary of a
pesticide's uses and benefits; developed by the Biological and
Economic Analysis Division (BEAD) of the Office of Pesticide
Programs (OPP) for the preliminary determination (PD 2/3) stage of
a Special Review.
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PCO - Pest Control Operator. A term not employed by FIFRA which is
often used to describe a person or company that applies pesticides
as a business (e.g., exterminator); often used to describe such a
service for household applications as compared to agricultural
applications.
PDMS - The Pesticide Document Management System (PDMS) is a
collection of documents of regulatory significance to pesticides,
including submitted studies, maintained by the Agency. The
documents are microfiched and indexed by an on-line retrieval
system that anyone in the Office of Pesticide Programs (OPP) can
use.
PE8 - The Planing and Evaluation Staff (PES) within the Biological
and Economic Analysis Division (BEAD) of the Office of Pesticide
Programs (OPP) is primarily responsible for formulating BEAD budgets
and program plans, administrative management, science integration
and program evaluation, and coordination of preparation for
hearings.
PEST - any insect, rodent, nematode, fungus, weed, or any other
form of terrestrial or aquatic plant or animal life or virus,
bacteria, or other micro-organism (except viruses, bacteria, or
other micro-organisms on or in living man or other living animals)
that is injurious to health or the environment. (See FIFRA section
2(t) and 25(c)(1).
PEST CONTROL OPERATOR - see PCO.
PESTICIDE - Any substance or mixture of substances intended for
preventing, destroying, repelling, or mitigating any pest, and any
substance or mixture of substances intended for use as a plant
regulator, defoliant, or desiccant.
PESTICIDE ASSESSMENT GUIDELINES - see PAG.
PESTICIDE DOCUMENT MANAGEMENT SYSTEM - See PDMS.
PESTICIDE INCIDENT MONITORING SYSTEM - The Pesticide Incident
Monitoring System (PIMS) is a collection of human and environmental
poisoning events related to specific pesticides that were reported
to the Office of Pesticide Programs (OPP). PIMS was discontinued
in 1981 due to budgetary constraints and the unverifiable nature of
its data; it was based on volunteered information.
PESTICIDE INTERMEDIATES: See Intermediates.
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PESTICIDE PRODUCT INFORMATION SYSTEM - The Pesticide Product
Information System (PPIS) is a data base that provides information
on more than 60,000 currently and formerly federally registered
pesticide products and other non-pesticide chemicals. For each
federally registered product, PPIS can provide the product name,
registrant name and address, EPA registration number, type of
formulation, signal word, types of pesticide activity, active
ingredient names and percentages, application sites, and pests
controlled. PPIS also contains information on whether the product
has been classified for restricted or general use.
PESTICIDE REGISTRATION ACTIVITY TRACKING SYSTEM - See PRATS.
PESTICIDE REGULATION NOTICE - See PR Notice.
PHI - The Pre-harvest Interval (PHI) is the time between the last
pesticide application and harvest of the treated crop.
PIMS - See Pesticide Incident Monitoring System.
PLANNING AND EVALUATION STAFF - See PES.
PM - Product Manager. See Product Manager Team.
PMSD - The Program Management and Support Division (PMSD) is one of
the seven Divisions that constitutes the Office of Pesticide
Programs (OPP). PMSD provides administrative support to all OPP
Divisions; prepares program plans and budget proposals; manages the
indemnification process; and provides overall leadership for OPP
management program. PMSD is comprised of four branches: the
Administrative Branch (AB) ; the Resources Management and Evaluation
Branch (RMEB); the Information Services Branch (ISB); and Systems
Branch (SB).
POLICY AND SPECIAL PROJECTS STAFF - The Policy and Special Projects
Staff (PSPS) within the Office of Pesticide Programs (OPP) serves
as the Office Director's primary means for analyzing and responding
to external critiques of program activities and policies.
PPIS - See Pesticide Product Information System.
PRATS - The Pesticide Registration Activity Tracking System (PRATS)
is an on-line tracking system to monitor the science reviews of
data submissions. PRATS is also used to request actions (e.g.,
risk assessments, DRES runs, etc.) from the science divisions.
PRATS replaced the On-Line Tracking System (OLTS).
PRE-HARVEST INTERVAL - See PHI.
PRELIMINARY BENEFIT ANALYSIS - See PBA.
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PR NOTICE - A Pesticide Regulation (PR) Notice is a written notice
generally issued by the Registration Division to pesticide
registrants that communicates important changes in regulatory
policy or procedures. Each PR Notice is assigned a two part number
beginning with the year issued and the cardinal number issued
within that year (e.g., 87-1, 87-2, 92-1, etc.). The name of the
notice derives from the Pesticide Regulation Division, a precursor
organization to the Registration Division of the Office of
Pesticide Programs.
PRODUCT MANAGER TEAM - PM Team - An organizational unit in each
of the three Registration Division Product Branches which is
primarily responsible for processing applications for new and
amended product registration, petitions for tolerances,
experimental use permits, special local need applications, and
reregistration of currently registered pesticides. There are
currently 11 PM Teams, each headed by a product manager and staffed
by 4 - 7 reviewers. Each PM Team has a number (e.g., PM 10; PM 21;
PM 31) . There are currently five teams in the Insecticide-
Rodenticide Branch, four teams in the Fungicide-Herbicide Branch,
and two teams in the Antimicrobial Branch.
PROGRAM MANAGEMENT AND SUPPORT DIVISION - see PMSD.
PROTOCOL - A study plan or method.
PSPS - See Policy and Special Projects Staff.
PURE ACTIVE INGREDIENT - See PAI.
RAC - See Raw Agricultural Commodity.
RAF - See Risk Assessment Forum.
RAW AGRICULTURAL COMMODITY - Raw Agricultural Commodities (RAC)
include, among other things, fresh fruits, whether or not they have
been washed and colored or otherwise treated in their unpeeled
natural form; vegetables in their raw or natural state, whether or
not hey have ben stripped of their outer leaves, waxed, prepared
into fresh green salads, etc.; grains, nuts, eggs, raw milk, meats,
and similar agricultural produce. It does not include foods that
have ben processed, fabricated, or manufactured by cooking,
freezing, dehydrating, or milling.
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RB - The Reregistration Branch (RB) within the Special Review and
Reregistration Division (SRRD) of the Office of Pesticide Programs
(OPP) manages the reregistration process that provides for the
review of all List A pesticides. Management of the process
includes planning, scheduling, and coordinating Health Effects
Division (HED), Environmental Fate and Effects Division (EFED),
Program Management and Support Division (PMSD), and Biological and
Economic Analysis Division (BEAD) inputs, conducting the
administrative review, and preparing and issuing documents. These
documents include Reregistration Eligibility Documents (REDs) and
Tolerance Reassessments.
RCRA - The Resource Conservation and Recovery Act (RCRA) is a law
under which EPA regulates the transportation, storage, and disposal
of hazardous waste, it is implemented by the Office of Solid Waste
and Emergency Response's Office of Solid Waste.
RD - Registration Division of the Office of Pesticide Programs.
The Registration Division is primarily responsible for implementing
the provisions of FIFRA relating to the registration of pesticide
products.
REBUTTABLE PRESUMPTION AGAINST REGISTRATION - Rebuttable
Presumption Against Registration (RPAR) is the former name for
Special Review.
RED - Reregistration Eligibility Document (RED) - A document
issued at the completion of the Agency's reregistration review of
a registered pesticide active ingredient. The RED sets forth the
Agency's decision on whether products containing a pesticide are
eligible for reregistration. The RED also assesses the
acceptability of existing tolerances, and describes the need for
additional data or other information. It is accompanied by a data
call-in if additional data are required.
REENTRY INTERVAL - The Reentry Interval (REI) is t!9$OXrequire
has been treated with a pesticide; required in order to reduce or
avoid real or perceived toxicity risks to field workers.
REFERENCE DOSE - The Reference Dose (RfD) is an estimate of the
acceptable daily exposure of humans to a pesticide. RfDs are
derived for the noncarcinogenic effects of substances which may
also be carcinogenic. Formerly called the acceptable daily intake
(ADI).
REGISTRANT - The term given to a person or entity that has
registered a pesticide product under FIFRA.
REGISTRATION DIVISION - See RD.
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;• REGISTRATION NUMBER - The EPA registration number is a hyphenated,
jtwo part number assigned by the Registration Division to identify
t^each product registration (e.g., 1253-79); the first number is the
^assigned company number and the second number is the specific
^product number. The registration number is required by FIFRA to
appear on the product's label.
REGISTRATION PROCESS - The process and final Agency action
authorizing the legal sale, distribution, and use of a pesticide
product. The process includes OPP's consideration of scientific,
legal, and regulatory requirements of the product and results in
the Agency issuing either a Notice of Registration or a denial to
the applicant.
REGISTRATION STANDARD - Registration Standard (RS) is a document
issued in connection with the Agency's reregistration program prior
to the enactment of FIFRA '88 that characterizes a pesticide's
t<. available scientific data base and the Agency's position on the
registered uses of that pesticide. Registration Standards were
> accompanied by data call-ins requiring submission of additional
, data. All chemical cases that had Registration Standards issued
•prior to the enactment of FIFRA '88 are on reregistration List A.
REGISTRATION SUPPORT BRANCH - The Registration Support Branch (RSB)
within the Registration Division (RD) of the Office of Pesticide
Programs (OPP) is responsible for: the emergency exemption program
under section 18 of FIFRA; review of. state issued section 24 (c)
special local needs registrations; the clearance requests for
exemption from a tolerance for inert ingredients; the tolerance
revocation program; the management and coordination of minor or
specialty use tolerance petitions submitted under the Federal Food,
Drug, and Cosmetic Act; and child-resistant packaging.
REI - See Reentry Interval.
| REREGISTRATION - Section 4 of FIFRA requires EPA to reregister all
•• pesticides originally registered before 1984 on specified
timetables. Reregistration priority is given to chemicals with the
highest potential for exposure — high-volume and food-use
chemicals (i.e., List A chemicals). Through this priority process,
four lists of pesticides (Lists A, B, C, and D), were established
under FIFRA '88.
* The reregistration process consists of: the Agency identifying the
studies necessary to conduct human health and environmental risks
assessments; obtaining and reviewing these studies; and determining
whether the pesticide's uses do not pose unreasonable adverse
risks.
Also see Reregistration Branch; Accelerated Reregistration Branch;
CData Call-in; and List A, B, C, and D Pesticides.
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REREGISTRATION BRANCH - See RB.
REREGISTRATION ELIGIBILITY DOCUMENT - See RED.
RESIDENTIAL USE - Pesticide application in and around houses,
apartment buildings, motels, and other living areas.
RESOURCE MANAGEMENT AND EVALUATION BRANCH - The Resource Management
and Evaluation Branch within the Program Management and Support
Division (PMSD) of the Office of Pesticide Programs (OPP) provides
overall management, direction, guidance, and support to divisions
and offices on the development and implementation of program and
budget plans.
RESTRICTED USE PESTICIDE - (RUP) - If the Agency determines that a
pesticide, when applied in accordance with its labeling or in
accordance with widespread and generally recognized practices may
generally cause, without additional restrictions, unreasonable
adverse effects on the environment. EPA will classify the
pesticide or the particular use or uses to which the determination
applies for restricted use. Restricted-use pesticides may generally
be applied only by trained, certified applicators or those under
their direct supervision, and may be subject to other regulatory
restrictions.
RESOURCES CONSERVATION AND RECOVERY ACT - See RCRA.
REVIEW MANAGER - A Review Manager (RM) is an employee in the
Special Review Branch (SRB) or Reregistration Branch (RB) of the
Special Review and Reregistration Division (SRRD) whose
responsibility is to coordinate the review process for one or more
pesticide chemicals. This includes leading review teams for
pesticides or issues under review.
RfD - See Reference Dose.
RISK ASSESSMENT - In general, a risk assessment (RA) is a
determination of the likelihood of a hazard to occur from
population exposed to pesticide chemicals. This likelihood may be
expressed as a numerical probability or as a margin of
safety/margin of exposure. Simply stated: RISK = Hazard x
Exposure.
RISK ASSESSMENT COUNCIL - The Risk Assessment Council reviews the
policy and procedural aspects of the Risk Assessment Forum's (RAF)
technical findings. After approval by the RAC and the
Administrator, the Forum's findings become policy.
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f RISK ASSESSMENT FORUM - The Risk Assessment Forum (RAF) consists of
^Agency risk assessment (RA) expert scientists who study technical
$Agency-wide RA issues and refer their findings to the Risk
•.Assessment Council. The RAF was established to promote consensus
.1 on RA issues within the Agency.
RM - See Review Manager.
RMEB - See Resource Management and Evaluation Branch.
RPAR - See Rebuttable Presumption Against Registration.
RS - See Registration Standard.
RSB - See Registration Support Branch.
RUP - See Restricted use Pesticide.
;*SAB - The Science Advisory Board (SAB) is an Agency-wide series of
committees that advises the Administrator on scientific issues.
SACB - The Science Analysis and Coordination Branch (SACB) within
the Health Effects Division (HED) of the Office of Pesticide
Programs (OPP) coordinates and integrates human and domestic animal
toxicological data along with dietary and non-dietary exposure to
determine the risk for pesticides.
SACS - The Science Analysis and Coordination Staff (SACS) within
the Environmental Fate and Effects Division (EFED) of the Office of
Pesticide Programs supports the assessment of environmental
pesticide hazards by integrating individual discipline-specific
review components into an overall statement of risk. The SACS also
generally reviews EFED's scientific output, analyzes science policy
issues, and recommends resolution of issues.
* SAFE DRINKING WATER ACT - The Safe Drinking Water Act (SDWA)
requires the Agency to set health standards for water sources used
for public drinking water systems. It directs the EPA
administrator to develop: (1) National primary drinking water
regulations that incorporate maximum contaminant levels; (2)
Underground Injection Control regulations to protect underground
sources of drinking water; and (3) Groundwater protection grant
programs for the administration of sole source aquifer
demonstration projects and for wellhead protection area programs.
SAP - See FIFRA Scientific Advisory Panel.
SARA - The Superfund Amendments and Reauthorization Act of 1986
(SARA) is the legislation that reauthorized the Superfund program
in 1986. In addition, this law made several amendments to CERCLA
and established the provisions for SARA Title III — Emergency
Planning and Community Right-to-Know.
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SB - The Systems Branch (SB) within the Program Management and
Support Division (PMSD) of the Office of Pesticide Programs (OPP)
is the central point within OPP for automatic data processing
systems analysis and design. Services provided include: Automated
Data Processing (ADP) facilities and hardware, data input, and
retrieval support from the computerized data bases.
SCIENCE ADVISORY BOARD - See SAB.
SCIENCE ANALYSIS AND COORDINATION BRANCH - See SACB.
SCIENCE ANALYSIS AND COORDINATION STAFF - See SACS.
SDWA - See Safe Drinking Water Act.
SECTION 18 - See FIFRA Section 18 (Emergency Exemption).
SECTION 24(c) - See FIFRA section 24(c) (special local need).
SELECTIVE METHOD OF SUPPORT - One of two methods by which an
applicant for registration or amended registration may comply with
the data compensation requirements of FIFRA section 3(c)(l)(F).
Under this method the applicant lists the specific data
requirements that apply to his or her product, its active
ingredients, and use patterns, and demonstrates compliance with the
data requirements by either submitting the actual studies, or
citing individual studies, or by demonstrating that no study has
bously submit20Xto the Aency (a datp!680Xgap).
SETAC - The Society for Environmental Toxicology and Chemistry
(SETAC) is a professional society for environmental toxicologists
and chemists; publishes a journal entitled Environmental Toxicology
and Chemistry and sponsors symposia on various environmental issues
that relate to toxicology and chemistry.
SFIRE6 - The State FIFRA Issues, Research Evaluation Group (SFIREG)
is a group of state regulatory officials who work with Office of
Pesticide Programs (OPP) staff to identify and resolve overlapping
state and federal regulatory and research issues.
SLN - See FIFRA Section 24(c).
SMALL BUSINESSES - The term "small business" in regard to
eligibility for reduced registration maintenance fees means a
business that employees 150 or fewer people and, during the three
year period prior to the most recent maintenance fee billing cycle
(i.e., December 31, 1990) had average annual gross revenue from
chemical sales not exceeding $40 million, taking into account nay
parents' and subsidiaries' employees and gross revenues.
SOCIETY FOR ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY - see SETAC.
G-28
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SOLUTION - A formulation or use dilution of a pesticide that
^dissolves in the carrier liquid or diluent and will not settle out
«3Or separate in an aqueous medium.
i.SOP - A Standard Operating Procedure (SOP) is a written procedure
that conveys procedures for various functions performed by Office
of Pesticide Programs (OPP) staff. SOPs address both technical and
administrative matters.
SPECIAL LOCAL NEED - See FIFRA Section 24(c).
SPECIAL REVIEW - The purpose of the Special Review (SR), formerly
•known as Rebuttable Presumption Against Registration (RPAR),
process is to help the Agency determine whether to initiate
procedures to cancel, deny, or reclassify registration of a
pesticide product because uses of that product may cause
unreasonable adverse effects on the environment, in accordance with
sections 3(c)(6) and 6 of the Federal Insecticide, Fungicide, and
^Rodenticide Act (FIFRA). The process is intended to ensure that
-f the Agency assesses risks that may be posed by. pesticides, and the
benefits of use of those pesticides, in an open and responsive
manner. The issuance of a Notice of Special Review means that the
Agency has determined that one or more uses of a pesticide may pose
significant risks and that, following completion of the Special
Review process, the Agency expects to initiate formal proceedings
seeking to cancel, deny, reclassify, or require modifications to
the registration of the product(s) in question unless it has been
shown during the Special Review that the Agency's initial
determination was erroneous, that the risks can be reduced to
acceptable levels without the need for formal proceedings, or that
the benefits of the pesticide's use outweigh the risks. Following
completion of the Special Review process, a pesticide in question
may be returned to the registration process. Regulations
pertaining to Special Review procedures are at 40 CFR 154.
SPECIAL REVIEW BRANCH - The Special Review Branch (SRB) within the
Special Review and Reregistration Division (SRRD) of the Office of
Pesticide Programs (OPP) is responsible for managing the Special
Review process for chemicals that have been placed in Special
Review. The Special Review process provides a framework for
risk/benefit reviews of pesticide products and preparation of
documents stating the Agency's position (i.e., Position Documents) .
Subsequent action may include risk reduction measures, cancellation
of some or all uses, emergency suspension/cancellation.
G-29
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SPECIAL REVIEW AND REREOISTRATION DIVISION - The Special Review and
Reregistration Division (SRRD) is one of the seven Divisions that
constitutes the Office of Pesticide Programs (OPP). It manages
special reviews and reregistration of pesticide products; issues
data call-ins related to the special review and reregistration
processes; and issues position documents and follow-up reports.
This Division is comprised of the immediate office staff and three
branches: the Special Review Branch (SRB); the Reregistration
Branch (RB); and the Accelerated Reregistration Branch (ARE).
SR - See Special Review.
SRB - See Special Review Branch.
SRRD - See Special Review and Reregistration Division.
STANDARD OPERATING PROCEDURES - See SOP.
STATE FIFRA ISSUES, RESEARCH EVALUATION GROUP - See SFIRE6.
SUPERFUND AMENDMENTS AND REAUTHORIZATION ACT OF 1986 - See SARA.
SUPPLEMENTAL REGISTRATION - Common term for a process through which
a registrant may permit the distribution or sale of his or her
registered product under another's name and address. Such
distribution or sale is termed a supplemental distribution under
EPA regulations at 40 CFR 152.132. Also called distributor
registrations/products. A supplemental registration is identified
by a three part number (e.g.,1342-6-2) in which the first and
second numbers make up the primary registrant's registration
number, followed by the third part which is the supplemental
registrant's company number.
SURROGATE DATA - Data from studies which involve test organisms on
a test substance that are used to estimate the characteristics or
effects on another organism or of another substance.
SUSPENSION - Finely divided solid particles mixed in a liquid.
SUSPENSION OF REGISTRATION - An action authorized under FIFRA
section 3(c)(2)(B) or section 4 that temporarily halts further
distribution and sales of a pesticide product. Suspension under
3(c)(2)(B) or section 4 is imposed because the registrant has
failed to meet data submission requirements. The registrant can
request a hearing to challenge the notice. Suspension can be
lifted when the requirements are met.
A suspension of registration also can be issued under FIFRA section
6(c) due to an imminent hazard. The registrant has the right to an
expedited hearing on the question of whether an imminent hazard
exists. Also see NOIS and Emergency Suspension.
G-30
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SYSTEMS BRANCH - See SB.
TECHNICAL GRADE ACTIVE INGREDIENT - A Technical Grade Active
Ingredient (TGAI) is the pesticide chemical in pure form (usually
95 - 100% active ingredient) as it is manufactured by a chemical
company prior to being formulated (i.e., wettable powders,
granules, emulsifiable concentrates).
TECHNICAL GRADE PRODUCT - A registered manufactured-use product
that is composed of technical grade active ingredient.
TEP - A Typical End-use Product (TEP) is a term used in data
requirements to convey direction to a data producer to use a
commonly used end-use product as the test substance.
TGAI - See Technical Grade Active Ingredient.
THE ACT - In this manual this term refers to FIFRA (the Federal
Insecticide, Fungicide, and Rodenticide Act).
THEORETICAL MAXIMUM RESIDUE CONTRIBUTION - The Theoretical Maximum
Residue Contribution (TMRC) is the theoretical maximum amount of a
pesticide in the daily diet of an average human. This theoretical
amount assumes that the diet is composed of all food items for
which there are tolerance-level residues of the pesticide. The
TMRC unit is expressed as mg (of pesticide)/kg (of body
weight)/day.
TMRC - See Theoretical Maximum Residue Contribution.
TOLERANCE - The maximum permissible residue levels for pesticides
in raw agricultural produce and processed foods. Whenever a
pesticide is registered for use on a food or a feed crop, a
tolerance (or exemption from the tolerance requirement) must be
established. EPA establishes the tolerance levels, which are
enforced by the Food and Drug Administration and the Department of
Agriculture. Whenever a pesticide is registered for use on a food
or feed crop, a tolerance or an exemption from the tolerance must
be established. Established tolerances and exemptions from
tolerances for pesticide chemicals in or on raw agricultural
commodities are listed in 40 CFR Section 180; tolerances for food
additives in food for human consumption are listed in 40 CFR
Section 185; and tolerances for feed additives in animal feed are
listed in 40 CFR Section 186.
TOLERANCE PETITION - A formal request to establish a new tolerance
or modify (raise, lower or revoke) existing tolerances.
G-31
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TOXIC SUBSTANCES CONTROL ACT - The Toxic Substances Control Act
(TSCA) is a law administered by the Office of Pollution Prevention
and Toxics that governs the manufacture processing distribution,
use and disposal of chemical substances. Pesticides, tobacco and
tobacco products, nuclear materials, foods, food additives, drugs
and cosmetics are excluded from TSCA's coverage.
TSCA - See Toxic Substances Control Act.
TYPICAL END-USE PRODUCT - See TEP.
USE INDEX - A compilation of everything on a label for each
pesticide product including the sites the pesticide is used on and
the application rate. The Use Index is prepared by the Biological
and Economic Analysis Division (BEAD).
VOLTILITY - The property of a substance to become a vapor or gas
without chemical change.
WATER SOLUBLE PACKAGING - Packaging that dissolves in water; this
type of packaging is used to reduce exposure risks to mixers and
loaders.
"WEIGHT OF EVIDENCE" APPROACH - Evaluation based on a qualitative
assessment of the available scientific evidence.
WETTABLE POWDER - Wettable Powder (WP) is a dry formulation
materials that must be mixed with water or other liquid before it
is applied.
WP - See Wettable Powder.
G-32
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INDEX
Page
Active Ingredient (AI)
Claiming formulator' s exemption for 6-16
Formulating products with unregistered source of 6-16
Requirement for registration 1-2
Acute toxicity data 2-18;
4-4
Additional brand names
must not be false or misleading 4-13
Address of record 2-2
Adjuvants 1-3
Administrative amendments; types of
Labeling changes 4-2
Formula changes 4-2
Administrative portion of application for registration 2-9
Administrative Processing Section, RSB, RD, OPP 18-20
Agency screening of applications for expedited review 2-17;
4-8
Amendments to product registration 1-8
Not requiring a formal application
Notifications 4-13
Requiring notification but not approval 4-13
Labeling changes 4-13
Additional or substitution of brand names...4-13
Use of bilingual labeling 4-15
Changes in warranty 4-15
Other labeling revisions 4-15
Final printed labeling 4-15
Product chemistry changes 4-17
Active ingredient 4-17
Inert ingredients 4-18
Starting materials for integrated system
products 4-19
Change in formulation process 4-19
Requiring a formal application
"Me-Too" amendments 4-1
New use amendments 4-10
Labeling for 4-22
INDEX-1
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INDEX (Continued)
Page
Annual registration maintenance fees 8-1
Antimicrobial fuel additives
Who to contact 15-4
Antimicrobial Program Branch, RD, OPP 18-11;
18-18
Applicant's name 2-2
Application for Experimental Use Permit
(EPA Form 8570-17) 9-2
Application for Pesticide Amendment (EPA Form 8570-1) 2-2;
4-2; 4-10; 7-5
Application for Registration of Pesticide-Producing
Establishments (EPA Form 3540-8) 11-1
Application, transmittal of 12-4
Applications which
Do not qualify for expedited review 2-14
Qualify for expedited review 2-14
Authorized agent 2-3
Bilingual labeling
Use of 2-28
Biochemical pesticides 2-1
Considerations for registration; general information..3-1
Exempt from registration 3-2
Biological control agents
Not subject to FIFRA 1-4
Certification of products as Restricted Use 2-8
Certification with Respect to Citation of Data (EPA Form
8570-29) 2-7;
4-4; 4-11
INDEX-2
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INDEX (Continued)
Page
Changes that can be made to a registration without notifying the
Agency
Changes in the net contents to accommodate changing
package sizes or contents variability if such
changes do not require changes in the use
directions 4-21
Correction of typographical or printing errors
in labeling 4-21
Use of metric units in addition to standard U.S.
units for net contents, dosages and other
numeric expressions 4-21
Redesign of label format that does not modify
approved label text, consistent with 40 CFR 156.10
format requirements 4-22
Revision, addition, or deletion of non-mandatory
label elements 4-21
Chemical pesticides 2-1
Child-resistant packaging 10-5
Certification relating to 2-7
Cite-all method of support 6-7;
6-14
Comparison with selective method of support ....6-23
Claims not allowed to be used on product labeling 4-13
Classification of products as restricted use 2-8
Collateral labeling 2-21
Completeness of applications for registration 2-9
Completeness of applications for petitions for tolerance...7-4
Conditional registration 1-9
Confidential Business Information 12-1
How to submit 12-2
Information that can not be released to the public...12-1
Confidential Statement of Formula (EPA Form 8570-4) 2-3;
4-3
Contact See "Who To Contact" in this Index
INDEX-3
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INDEX (Continued)
Page
Contents of an application for registration 2-2
Data
Chemicals for which waivers have been granted 16-3
Compensation charges/payment disputes 6-10
Compensation requirements 2-5;
6-1
In support of products first registered
after 9/30/78 6-2
Regarding data submitted after 12/31/69 6-2
Methods for complying with;
The cite-all method of support 6-7
The selective method of support 6-8
Compensation procedures applicable to
Applications for an amendment of a
registration 6-2
(Also see "Data compensation procedures do not
apply".)
Applications for registration of a new product...6-2
Compensation procedures not applicable to
Applications adding or deleting deliberately
added inert ingredients 6-3
Applications adding or deleting supplemental
registrants (distributors) 6-3
Applications to increase or decrease the
percentage of one or more active ingredients
or deliberately added inert ingredients 6-3
Applications making a change in the package or
container size 6-3
Applications making a change in the product
name, or adding an additional brand name 6-3
Applications making a change in the
registrant' s name and address 6-3
Applications making a change in the source of
supply of active ingredients 6-3
Applications making a change in the warranty,
warranty disclaimer, or liability limitation
statements, or addition or deletion of such
statements 6-3
Applications clarifying the directions for use...6-3
Applications correcting typographical errors 6-3
Applications deleting an active ingredients 6-3
Applications to delete an approved use from
the label 6-3
Applications for experimental use permits 6-3
INDEX-4
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INDEX (Continued)
Page
Data (continued)
Applications to redesign the label format,
which involves no substantive changes in
the directions for use, claims,
representations, or precautionary statements..6-3
Applications to revise the identity or amount
of impurities in the product 6-3
Applications for amendment where the Agency
determines that scientific data would not
be needed in order to approve the amendment...6-4
Applications "splitting" the label for the
purpose of marketing the product in different
geographic regions with appropriate labels,
where each amended label will contain
previously approved use instructions
appropriate to a particular geographic
region 6-3
Efficacy data requirements 2-5;
2-11
Format
for data 2-4
for submittal package 12-3
for submitted studies 12-4
Generic 2-11
How to submit .~ 12-1;
12-2
In support of the petition for tolerance 7-8
Number of copies required 2-4
Portion of Application for registration 2-11
Requirements for efficacy 2-5
2-11
Requirements for experimental use permits 9-5
Transmittal document 12-4
Data Matrix Chart 4-4;
4-11
Designated U.S. agent 2-3
Devices
Child-resistant packaging for 10-5
Definition of 1-4;
10-1
Establishment registration and reporting, books
and records 10-4
Importation and exportation of 10-4
Inspection of establishments 10-4
Label ing requirements 10-2
INDEX-5
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INDEX (Continued)
Page
Devices (continued)
Not subject FIFRA 1-4;
10-2
Registration requirements for 10-1
Subject to FIFRA 10-1
Violations, enforcement activities and penalties 10-4
Distributor product
Labeling
Must be same as basic registered product (see
exceptions also) 5-2
Exceptions to being the same as the basic
registered product 5-2 ;
5-3
May not be repackaged 5-2
Must be produced, packaged, and labeled in a
registered establishment operated by basic
registrant 5-2
Document Management Section, ISB, PMSD, OPP 18-10
Documents
Available from the Environmental Protection Agency...16-2
Available from the National Technical Information
Service 16-1
Available from the U.S. Government Printing Office...16-2
Dosage rate 2-2
Draft labeling 2-4
Efficacy data
Required for pesticide products that control
pests of public health significance 4-2;
. 4-4; 4-11
Requirements for 2-5 ;
2-11
Emergency exemptions 14-4
Emergency Response and Minor Use Section, RSB, RD, OPP....18-11;
18-20
Enforcement 4-23
Environmental Protection Agency (EPA)
Documents available from 16-2
EPA Regional Offices 18-28
INDEX-6
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INDEX (Continued)
Page
-Establishment number
Application for 11-1
How to obtain 11-1
Information required 11-2
Where to obtain application forms 11-2
Where to submit application:
For Domestic establishments 11-1
For Foreign establishments 11-2
Establishment of tolerance 2-1
Exclusive use data certification 6-5
Exemption from requirement of tolerance 2-1
>
Expedited review
Agency screening of applications for 4-8
How to submit an application for 4-6
Of "Me-Too" applications for amended registration 2-14;
4-4
"Me-Too" Applications which do not qualify for 4-5
"Me-Too" Applications which qualify for 4-5
Experimental Use Permits
Application requirements 9-2
Data requirements for 9-5
Extension or renewal of 9-6
Fee requirements for 9-6
How to apply for 9-1
Labeling requirements for 9-6
Required for
Animal treatments 9-2
Aquatic use 9-2
Before conducting large scale field testing 9-1
Laboratory testing, greenhouse testing, or
limited replicated field trials 9-1
Land use 9-1
Small scale fild testing "novel"
pesticides 9-2
Summary worksheet for 9-3
State issuance of 14-1
Tolerance requirements for 9-5
Exportation
of pesticides 1-6
Facsimile directory 18-27
FACTA 2-5;
2-7; 4-1; 6-1
INDEX-7
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INDEX (Continued)
Page
Federal Insecticide, Rodenticide and Fungicide Act
(FIFRA) 16-2
State regulatory authority under 14-1
Federal Register Notices 16-4
Fees
Annual registration maintenance 8-1
For experimental use permits 9-6
Requirements for SLNs 14-2
Reregistration 8-2
Small businesses 8-1
Definition of small business 8-1
Tolerance petition 7-5;
7-6; 7-7; 8-2
Field Operations Division, OPP 18-8
Final printed labels
Submission of 4-22
Food Additive regulation 2-1
Food, Agriculture, Conservation, and Trade Act of 1990
(FACTA) 2-5;
2-7; 4-1; 6-1
Foods
Not subject to FIFRA 1-4
Format
For Administrative Portion of Application 2-33
For Data Portion of Application 2-33
For Restricted Use Product Label 2-30;
2-31
For Unrestricted Use Product Label 2-32
Forms
How to obtain them..'. 17-1
Formulator's Exemption Statement (EPA Form 8570-27) 2-10;
4-4; 4-11; 6-4
Front End Processing Staff, RSB, RD, OPP 18-11;
18-19
Fungicide-Herbicide Branch, RD, OPP 18-11;
18-18
INDEX-8
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INDEX (Continued)
Page
Generic data 2-11
Government Printing Office (GPO)
Documents available from 16-2
Guideline for determining an application's eligibility for
fast track (expedited) review 2-15;
4-7
*>How to
Amend the registration of a product 4-1
Apply for an experimental use permit .9-1
Apply for registration of a pesticide 2-1
Apply for supplemental registration 5-1
*'• Obtain anA establishment number 11-1
Obtain Forms 17-1
Obtain publications 16-1
Submit an exemption from the requirement of a
tolerance 7-1
Submit "Me-Too" applications for expedited review 2-15;
4-6
Submit notifications 4-20
Submit petitions for a tolerance 7-1
Human drugs
Not subject FIFRA 1-4
Importation
of pesticides 1-6
Incomplete applications 2-11;
4-21
; Incomplete petitions 7-11
Inert ingredients 1-6;
4-17
vInformation Resources Development Section, ISB, PMSD, OPP.18-10
Information Services Branch, PMSD, OPP 18-10
Insect predators
Not subject FIFRA 1-4
Insecticide-Rodenticide Branch, RD, OPP 18-11;
18-17
Intermediates •. 1-4
INDEX-9
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INDEX (Continued)
Page
Labeling
Changes that cannot be submitted as a notification....4-13
Claims not allowed to be used on 4-14
Deletions not permitted by Notification 4-2;
4-15
Submission of final printed labeling for
Notifications and non-notifications 4-22
For amendments requiring a formal application 4-22
Requirements for experimental use permits 9-6
Listing of
Federally registered pesticide products classified
as "Restricted Use Pesticides (RUP) 16-3
Registration Standards issued 16-3
Reregistration Eligibility Documents issued 16-3
Macroscopic parasites
Not subject to FIFRA 1-4
Material Safety Data Sheets (MSDS) 2-29
Matrix format for data requirements listing
Sample of * 6-29
"Me-too" registration
Amendments that require supporting data 4-3
Applications not qualifying/for expedited review 4-5
Applications qualifying for expedited review 4-5
Definition of 2-1
Expedited review of "Me-Too" applications for
amended registration 4-4
How to submit an application for expedited review 4-6
"Me-too product"? ,
What is a 6-11
Methods for complying with the data compensation
requirements of FIFRA 6-7
Cite-all 6-7
Selective ~. 6-8
Microbial pesticides 2-1
Considerations for registration; general information..3-1
Considered under Level I reporting 3-3
Considered under Level II notification for
small-scale field testing . 3-4
Exempt from registration , 3-2
MRID number 12-3
INDEX-10
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INDEX (Continued)
Page
National Technical Information Service (NTIS)
Documents available from 16-1
Nematodes
Not subject to FIFRA 1-4
New chemical.
Definition 2-1
New use.
Definition 2-1
Amendments 4-10
^.Non-indigenous and genetically engineered microbial products
Who to contact 15-5 ;
15-6
Non-notifications 4-21
Notice of Supplemental Registration of Distributor
(EPA Form 8570-5) 5-1
Notifications
How to submit * 4-20
Label deletions not permitted by 4-2 ;
4-15
Labeling changes that cannot be submitted as
Actions concerning an unregistered product 4-16
Addition of sites or uses .4-16
Deletion of precautionary language or
restrictions 4-16
Deletion of use patterns, pests, claims,
or sites of use 4-16
Submission of final printed labeling for 4-22
Not subject to FIFRA
Biological control agents 1-4
Devices 1-4
Foods 1-4
Human drugs 1-4
Insect predators 1-4
Macroscopic parasites 1-4
Nematodes 1-4
Pheromones in pheromone traps 1-4
Preservatives for biological specimens 1-4
Treated articles 1-4
Vitamin-hormone horticultural products 1-4
INDEX-11
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INDX (Continued)
Page
Other types of registrations and/or approvals that may be
needed from federal or state agencies other than EPA's
pesticides program .................................... 15-1
Pest
Definition of ......................................... l^l
Pesticide
Definition of ...... ................................... l-l
Labeling requirements
General guidance ................................. 2-22
Specific guidance
Child hazard warning statement .............. 2-24
Company name and address .................... 2-23
Directions for use .......................... 2-28
Environmental hazard ........................ 2-25
EPA establishment number .................... 2-23
EPA registration number ..................... 2-23
Hazard to humans and domestic animals ....... 2-25
Inert ingredients reclassified as active
ingredients ............................... 2-24
Ingredients statement ....................... 2-23
Minimum type size ........................... 2-24
Misuse statement ........................ • • • • 2-27
Name to be used in ingredient statement ..... 2-23
Net contents ..... ........................... 2-23
Nominal concentration ....................... 2-24
Physical or chemical hazard - flammability. .2-26
Pounds per gallon statement ................. 2-23
Product name ................................ 2-22
Reentry statement ........................... 2-27
Referral statement. ... ............... ....... 2-25
Restricted use classification ............... 2-26
All uses restricted ...................... 2-26
Some but not all uses restricted ......... 2-27
Side/back precautionary labeling ............ 2-25
Signal word ....................... .......... 2-24
Skull & crbssbones and word "Poison" ........ 2-25
Statement of practical treatment. . . ......... 2-25
Storage and disposal block .................. 2-28
Warnings and precautionary statements ....... 2-24
Registrations/approvals needed from other federal
state agencies .................................. 15-1
Shipping (Transportation) of ................ .......... 15-5
State regulation of federally registered ............. 15-1
INDEX-12
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INDEX (Continued)
Page
Pesticide (continued)
Use of in/on
Antimicrobial fuel additives 15-4
Beet sugar mills 15-2;
15-4
Cane sugar mills 15-2;
15-4
Food contact surfaces 15-2
Sanitizers 15-3
As Human and animal drugs 15-2 ;
15-3; 15-4
Medical devices 15-3
Antimicrobials 15-3
Microbials
Non-indigenous and genetically engineered..15-5;
15-6
Paper and paperboard (food uses) 15-2
Microbiocides 15-3
Meat and poultry plants 15-1
Pesticide Intermediates 1-4
Petition for a tolerance
How to submit an application to request 7-1
Pheromones
In pheromone traps; not subject to FIFRA 1-4
Precautionary Labeling Review Section, RSB, RD, OPP 18-11;
18-19
Pre-harvest interval (PHI) 2-2
Preservatives
For biological specimens; not subject to FIFRA 1-4
PR Notices 16-4
Product Chemistry Review" Section, RSB, RD, OPP 18-11;
18-19
Product Manager Team 10 18-11;
18-17
Product Manager Team 13 18-11;
18-17
..Product Manager Team 14 18-11;
18-17
INDEX-13
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INDEX (Continued)
Page
Product Manager Team 18 18-11;
18-17
Product Manager Team 19 18-11 ;
18-17
Product Manager Team 21 18-11;
18-18
Product Manager Team 22 18-11;
18-18
Product Manager Team 23 18-11;
18-18
Product Manager Team 25 18-11;
18-18
Product Manager Team 31 18-11;
18-18
Product Manager Team 32 18-11;
18-18
Product specific chemistry data 2-11
Project Coordination Section, RSB, RD, OPP 18-20
Publications
How to obtain 16-1
Public Response and Program Resources Branch, FOD, OPP....18-8
Questions and answers about data compensation 6-11
RED (Registration Eligibility Document) 2-8
Listing of issued 16-3
Regional Offices - EPA 18-28
Region 1 18-28
Region 2 18-28
Region 3 18-28
Region 4 18-28
Region 5 18-28
Region 6 - 18-29
Region 7 18-29
Region 8 18-29
Region 9 18-29
INDEX-14
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INDEX (Continued)
Page
Region 10 18-29
Regional Operations Branch, FOD, OPP 18-8
Registration
Changes allowed without Agency notification
In the net contents to accommodate changing
package sizes or contents variability if
such changes do not require changes in
the use directions 4-21
Correction of typographical or printing
errors in labeling 4-21
Use of metric units in addition to standard
U.S. units for net contents, dosages and
other numeric expressions 4-21
Redesign of label format that does -not
modify approved label text, consistent
with 40 CFR 156.10 format requirements 4-22
Revision, addition, or deletion of
non-mandatory label elements 4-21
Of a date that indicates date of
manufacture or label approval 4-22
Addition of State-required analysis of
fertilizer component of pesticide-
fertilizer products.... ". .4-21
Addition of State-required analysis of
wood-preservative product 4-22
Inclusion of the DOT hazard diamond 4-21
Inclusion of lot or batch codes, or other
production identifiers 4-21
Routine changes in the name and address of the
registrant on the label 4-21
Of your own product 1-7
How to amend the registration of a product 4-1
Registration Division, OPP 18-11
Registration Standard
Listing of issued 16-3
Registration Support Branch, RD, OPP 18-11;
18-19
Reregistration Eligibility Documents (REDs) 2-8
Listing of issued 16-3
. Reregistration Fees 8-2
INDEX-15
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INDEX (Continued)
Page
Restricted use
Classification of products as 2-8
List of 16-3
Screening of applications for expedited review 4-8
Selective method of support 6-8;
6-15
Comparison with cite-all method of support 6-23
Who has to cite or submit residue chemistry data? 6-18
Small businesses
Definition of 8-1
Small-scale field testing
Level I reporting requirements for 3-3
Level II notification requirements for 3-4
Special Local Needs
Fee requirements for 14-2
State registration of 14-1
State agencies with lead pesticide responsibility 18-30
Alabama 18-30
Alaska 18-30
American Samoa 18-30
Arizona 18-30
Arkansas 18-30
California 18-30
Colorado 18-30
Commonwealth of the Northern Mariana Islands 18-30
Connecticut 18-31
Delaware 18-31
District of Columbia 18-31
.Florida 18-31
Georgia 18-31
Guam 18-31
Hawaii 18-31
Idaho 18-31
Illinois 18-32
Indiana 18-32
Iowa 18-32
Kansas 18-32
Kentucky 18-32
Luisiana 18-32
Maine 18-32
Maryland...- 18-32
Massachusetts 18-33
Michigan 18-33
INDEX-16
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INDEX (Continued)
Page
State agencies (Continued)
Minnesota 18-33
Mississippi 18-33
Missouri 18-33
Montana 18-33
Nebraska 18-33
Nevada 18-33
New Hampshire 18-34
New Jersey 18-34
New Mexico , 18-34
New York 18-34
North Carolina .18-34
North Dakota 18-34
Ohio 18-34
Oklahoma 18-34
Oregon 18-35
Pennsylvania 18-35
Puerto Rico 18-35
Republic of Palau 18-35
Rhode Island 18-35
South Carolina 18-35
South Dakota 18-35
Tennessee 18-35
Texas 18-36
Utah 18-36
Vermont 18-36
Virginia 18-36
Virgin Islands 18-36
Washington 18-36
West Virginia 18-36
Wisconsin 18-36
Wyoming 18-37
State issuance of experimental use permits 14-1
State registration of special local needs 14-1
State regulation of federally registered pesticides
Who to contact 15-1
State regulatory authority under FIFRA 14-1
Grounds for EPA disapproval of State registrations...14-3
Shipping (Transportation) of pesticides 15-4
Who to contact 15-5
Statement of data confidentiality claims 12-5
Statement of substantiality, similarity, or identicality...4-3
INDEX-17
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INDEX (Continued)
Page
Studies
Bind separately 12-5
Format of 12-3
Identifying supplements to previously submitted 12-5
What to include in 12-5
Submission of final printed labeling
Notifications and non-notifications 4-21
Amendments requiring a formal application 4-22
Supplemental registration 1-8
How to apply for 5-1
Requirements for approval of. 5-1
Timeframes for Agency response to expedited "Me-Too"
applications
45 day response 2-18;
4-9
90 day response 2-19;
4-9
Tolerance
Data in support of the petition for 7-8
Establishment of 2-1
Exemption from requirement of 2-1
Fees
Requirements for 7-8;
8-2
Adjusted annually 7-9
For establishment of a new tolerance 7-9
For establishment of a tolerance at a
lower numerical level . 7-9
For an exemption from the requirement
of a tolerance , 7-9
For a temporary tolerance 7-10
For a temporary tolerance exemption. 7-9
For waiver or refund request 7-8
How to submit an exemption from the requirement of
a tolerance 7-1
How to submit a petition for a tolerance..... 7-1
Incomplete petitions , 7-11
Procedures for filing a petition for 7-4
Requirements for experimental use permits...« 9-5
When required 7-2
Transfer of
Product registrations 13-1
Data rights 13-4
INDEX-18
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INDEX (Continued)
Page
Treated articles
Not subject to FIFRA 1-4
Types of pesticide registration
Amendment to your own registration 1-7
To distribute a product registered by someone else....1-8
Registration of your own product 1-7
Unconditional registration 1-8
Use of bilingual labeling 2-4;
2-28
Use of pesticides in meat and poultry plants 15-1
Application for USDA authorization 15-2
Labeling requirements 15-2
Who to contact 15-2
Use of pesticides on food contact surfaces, for paper
and paperboard (food uses), on medical devices, as
human and animal drugs, and in cane-sugar and beet
sugar mills 15-2
Sanitizers (pesticides used on food contact
surfaces) 15-3
Who to contact 15-3
Microbiocides in paper and paperboard (food use).15-3
Who to contact... 15-3
Antimicrobial pesticides used on medical devices.15-3
Who to contact 15-3
Human and animal drugs 15-4
Who to contact 15-4
Cane-sugar and beet-sugar mills 15-4
Who to contact 15-4
Vitamin-hormone horticultural products
Not subject to FIFRA 1-4
What to include in a study 12-5
When is an experimental use permit required 9-1
When is a petition for tolerance required 7-2
Amended registration for use on food/feed crops 7-2
Experimental use permit for food/feed crops .7-2
Importation of pesticide treated food 7-3
Inerts in products labeled for food use 7-3
Adjuvants for application to food crops 7-4
When must data compensation procedures be complied with....6-2
INDEX-19
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INDEX (Continued)
Page
Where to hand deliver applications 18-1
Where to mail applications 18-1
Where to obtain application forms 11-2
Where to request a company number and establishment
registration 5-3
Where to submit applications or resubmissions. 4-7;
4-8
Where to submit applications for expedited review 2-17;
2-19
Where to submit applications for supplemental registration.5-3
Who must apply for registration of a pesticide 1-1
Who to contact for assistance for:
Antimicrobials (Antimicrobial Program Branch) 18-11
Data formatting requirements (Program Management and
Support Division) 18-10
Disinfectants (Antimicrobial Program Branch) 18-11
Document distribution (Program Management and
Support Division) 18-10
Document management (Program Management and Support
Support Division) 18-10
Freedom of Information (Field Operations Division)...18-8
Fumigants (Antimicrobial Program Branch) 18-11
Fungicides (Fungicide-Herbicide Branch) 18-11
Herbicides (Fungicide-Herbicide Branch) 18-11
Inert ingredient clearance (Registration Support
Branch) 18-11
Insecticides (Insecticide-Rodenticide Branch) 18-11
Minor use-petitions (Registration Support Branch).... 18-11
Precautionary labeling review (Registration Support
Branch) 18-11
Product chemistry review (Registration Support
Branch) 18-11
Regional Services (Field Operations Division) 18-8
Rodenticides (Insecticide-Rodenticide Branch) 18-11
Section 18 emergency exemptions (Registration
Support Branch) 18-11
INDEX-20
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