&EPA
United States
Environmental Protection
Agency
Pesticides and
Toxic Sbustances
(H-7505Q
General Information
On Applying For
Registration Of Pesticides
In The United States
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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
JUNE, 1989
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PREFACE
This instruction manual, which is divided into 18 chapters,
is only 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 your
being notified directly, and will take precedence over the
information contained herein.
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 150-180). 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 is the first instruction manual which has been
developed in an effort to provide general guidance to applicants
and registrants on registering pesticides in the U.S. Draft
copies of the manual were sent to the Chemical Manufacturers
Association, Chemical Producers and Distributors Association,
Chemical Specialities Manufacturers Association, National
Agricultural Chemicals Association, and the state pesticide lead
agencies for review and comment. Numerous suggestions were
received and many were incorporated in the final document. We
wish to thank all of those who responded with their comments and
suggestions.
We also welcome any comments on how the current manual could
be made more useful, or suggestions for changes or additions.
Your comments should be addressed to Mr. Herbert S. Harrison,
Chief, or Mr. William H. Miller, Product Manager (16),
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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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 data compensation
requirements.
CHAPTER 3 - HOW TO APPLY 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 RFHTSTFRFD
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 SUPPLI
REGISTERED PESTICIDE
^TION OF A
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 F.XKMPTTnw FROM THE REQUIREMENT OF
A TOLERANCE OR A TEMPORARY
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 - 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 9 - 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 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 - CONFIDENTIAL BUSINESS INFORMATION AND HOW TO SUBMIT
DATA
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 OF 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 OF REGISTRATIONS AND/OR APPROVALS THAT
MAY BE NEEDED FROM OTHER FEDERAL OR STATE AGENCIES
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.
IV
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CHAPTER 1 - WHO MUST APPLY FOR REGISTRATION OF A PESTICIDE
A. GENERAL INFORMATION
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). FIFRA also provides
that the Administrator may specify devices that are subject to
the provisions of FIFRA.
Pesticide: The term pesticide 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.
Pest: 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.
Device: 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.
B. PEST CONTROL ORGANISMS. SUBSTANCES OR DEVICES NOT SUBJECT TO
REGISTRATION UNDER FIFRA
1. 40 CFR Part 152, Subpart B - Exemptions, describes those
pesticides that have been exempted by the Agency from the
registration requirements of FIFRA.
a. 40 CFR section 152.20 describes those
pesticides, such as (1) certain biological
control agents and (2) certain human drugs,
that are exempted because they are regulated
by another Agency.
b. 40 CFR section 152.25 describes those
pesticides, such as (1) treated articles or
substances, (2) pheromones in pheromone
traps, (3) preservatives for biological
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specimens, (4) vitamin-hormone horticultural
products, and (5) foods, that are of a
character not requiring regulation under
FIFRA.
c. 40 CFR section 152.30 provides information
on pesticides that may be transferred, sold,
or distributed without registration.
2. Pest control organisms such as insect predators,
nematodes, and macroscopic parasites are exempt from
the requirements of FIFRA under 40 CFR 158.65(b)(3).
3. Devices considered not subject to registration
include articles that use physical or mechanical means
to trap, destroy, repel, or mitigate any plant or
animal life declared to be a pest under 40 CFR 152.5.
Other devices are subject to regulation under the
provisions of FIFRA section 2(q)(l) or FIFRA section 7,
even though they are not required to be registered.
Refer to Chapter 10 for a more detailed discussion on
the Agency's policies and regulatory requirements for
devices.
C. 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. 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 you own application for pesticide
registration.
2. OBTAIN A SUPPLEMENTAL REGISTRATION TO DISTRIBUTE A
PRODUCT REGISTERED BY SOMEONE ELSE
If you do not wish to take the time and the expense
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necessary to register you 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. AMEND THE REGISTRATION OF A PRODUCT YOU ALREADY HAVE
RF.nTSTF.RF.n 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 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.
D. 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 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) 382-7835.
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CHAPTER 1 - REFERENCES CITED - 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 Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 2 - Definitions
Section 7 - Registration of establishments
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CHAPTER 2 - HOW TO APPLY FOR REGISTRATION OF A CONVENTIONAL
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,
i.e., a pesticide (active ingredient) that is not a
constituent of 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
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, you
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 Form - An 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 to 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 all 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.
PITFALLS TO BE AVOIDED; It is your responsibility to
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
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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 Registration Support Branch 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.
Correspondence concerning authorized agents should be
addressed to the appropriate Product Manager for your
product. (See Chapter 18 for a listing of Product
Managers)
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.
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, or to which reference is made on
the product's label or in literature accompanying the
product.
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 and
complete, and submitted on 8 1/2 x 11 inch paper. 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.
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,
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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 be required to also 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 158.115 for a discussion of the Pesticide Assessment
Guidelines and their relationship to the data requirements.
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 registrants responsibility to
ascertain that the product performs in accordance with its
labeling claims.
IMPORTANT NOTE: Efficacy data (product performance data) are
routinely required for antimicrobial products and vertebrate
pesticide products. You should refer to 40 CFR Part 158.640
for product performance data requirements.
PITFALLS TO BE AVOIDED: 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 be rejected and returned.
5. FIFRA chapter 3(c)(l)(D) data compensation requirements -
Each applicant applying for registration of a pesticide
must comply with the data compensation procedures under
FIFRA section 3(c)(l)(D). 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.
6. 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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7. Restricted use classification - The Agency has
classified some or all of the uses of certain pesticides as
a "Restricted Use Pesticide", either by regulation, as the
result of a Registration Standard, or during the
registration review of individual products. A restricted
use classification 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 Registration
Support Branch, Registration Division. See Chapter 16 for a
source of the listing.'
8. Registration standards - FIFRA section 4 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
Registration Standard is issued. The Standard sets forth
the Agency's position on the registrability of products
containing the active ingredient(s), assesses the
acceptability of existing tolerances, describes the need for
additional data or information, if any, that must be
submitted to complete the reregistration review, and
identifies labeling changes or use restrictions needed for
the product to remain in compliance with FIFRA.
If a Registration Standard has 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. Refer to Chapter 16 for the source of a
listing of Registration Standards that have been issued.
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
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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 may 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 2-1, 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)
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.
4. FIFRA section 3(c)(l)(d) 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.
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IMPORTANT NOTE; Only one complete set of the documents in
the administrative portion of your -application is
required. This information should not be bound.
PITFALLS TO BE AVOIDED; 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.
DATA PORTION OF 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 - routinely required for all antimicrobial
products and for most vertebrate pesticide products,
otherwise efficacy data may be required on a case by case
basis.
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.
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.
F. EXPEDITED REVIEW OF "ME-TOO" APPLICATIONS FOR REGISTRATION
On October 25, 1988, amendments to the Federal Insecticide,
Fungicide, and Rodenticide Act were signed into law and for the
most part became effective on December 24, 1988. One of the
amendments, section 3(c)(3)(B), 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
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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 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, new inerts, changed percentages of active
ingredients, new formulation types, 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 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 review, you should
print "EXPEDITE" at the top of the application above
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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.
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. EPA
401 M Street, s.W.
Washington, D.C. 20460
By courier or hand delivery:
Office of Pesticide Programs
Document Processing Desk (APPL)
Room 266A, 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
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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.
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 products 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 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 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.
IMPORTANT NOTE: If it is determined that
your application does not qualify for an
expedited review, you will be notified and
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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.
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 the 1988 FIFRA
amendments require EPA to review applications
for expedited registration within 90 days of
receipt, this turnaround time may not be met
immediately due to the backlog of
applications received prior to December 24,
1988. However, EPA is increasing human and
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. We
anticipate that we will be in a position to
meet the 90 day expedited review timeframe
early in 1990.
G. WHERE TO SUBMIT YOUR APPLICATION
See section F.3. of this Chapter for the address 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-
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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.
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.
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APPENDIX 2-1
A COMPLETE APPLICATION FOR REGISTRATION OF A TYPICAL "ME-TOO1*"
PRODUCT REQUIRES THE FQT.T.QhfTNG DOCUMENTS
A. ADMINISTRATIVE PORTION OF APPLICATION; (DO NOT BIND TOGETHER)
Application for Pesticide Registration
(EPA Form 8570-1)
Statement identifying the "substantially
similar" or "identical" product
Confidential Statement of Formula
(EPA Form 8570-4)
Formulator's
Exemption Statement
(EPA Form 8570-27)
Draft labeling (5 copies)
Certification with Respect to
Citation of Data (EPA Form
8570-29)
Data Matrix Chart
B. DATA PORTION OF APPLICATION:
4 ^h - Pr<
"ft '
A 1 .. j
^f^M
\--^"<'
XTV 1
Dduct Specific Chemistry
Data (3 copies)
.- Product Specific AcutP
s Toxicit/ Data (3 copies) *
if required
Legend __
Documents that are required
Documents required only under the selective
method of support of data compensation.
Not required under the cite-all method of
data compensation.
* 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 2 - REFERENCES CITED - 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
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 86-5 - 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.
5. Listing of Restricted Use Pesticides, compiled by the
Registration Support Branch, Registration Division, Office
of Pesticide Programs, EPA.
6. Listing of.Registration Standards, compiled by the Document
Management Section, Information Services Branch, Program
Management Support Division.
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CHAPTER 3 - HOW TO APPLY 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 pesticides by their unique modes
of action, low use volume, target species specificity or natural
occurrence. In addition, microbial pesticides are living
entities capable of survival, growth, reproduction and infection
(40 CFR 158.65). Included in the microbial pesticide group are
the "novel" microbial pesticides. Novel microbial pesticides
are currently defined as "genetically modified or non-indigenous
microbial pesticides."
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 set of data requirements
as specified in 40 CFR 158.690 and 158.740. The Agency has also
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 8 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 - Since policies and requirements relating to
biochemical and microbial pesticides are currently being revised
and may be in place by the time you receive this manual, it is
recommended that you contact the appropriate Product Manager (see
section E.) for additional guidance prior to initiating testing,
or filing an application for registration of a biochemical or
microbial pesticide.
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B. BIOCHEMICAL PESTICIDES
Biochemical pesticides include, but are not limited to,
products such as semi-chemicals (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.
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
158.65(b)(3)]. 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 registration 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 registration under FIFRA.
C. MICROBIAL PESTICIDES
1. Microbial pesticides - Microbial pesticides may
include bacteria, algae, fungi, viruses, and protozoa
used as pest control agents (40 CFR 152.20). The data
requirements 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.
2. Novel microbial pesticides - Novel microbial
pesticides (i.e., 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 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.
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D. SMALL-SCALE FIF.T.D TF.STTNn T.FTW.T. T
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.
l. 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
23313) .
The Agency will have up to 30 days to review the above
information 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.
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
3-3
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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 23313). 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.
E. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions or require any additional
information concerning biochemical, microbial or "novel"
microbial pesticides, contact Product Manager 17 for insecticide
products or Product Manager 21 for herbicide or fungicide
products. A listing of Product Managers may be found in Chapter
18.
3-4
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CHAPTER 3 - REFERENCES CITED - 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 23313).
3. Pesticide Assessment Guidelines, Subdivision M, Microbial and
Biochemical Pest Control Agents, October 1982, (EPA No.
540/09-82-028) Environmental Protection Agency
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 OF A PRODUCT THAT IS
ALREADY RF.nTSTF.RF.D
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, 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)(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) 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 F of
this Chapter.
a. Administrative types of amendments - 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 F 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.
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IMPORTANT NOTE: The deletion of use patterns,
pests, claims, or sites of use from your
registered labeling can no longer be accomplished
as a Notification under 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 supercedes 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.
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.
IMPORTANT NOTE; Revisions to the formulation of
antimicrobial products and most vertebrate
pesticide products require the submission of
efficacy data to support the revised formulation,
and as such are not considered to be an
administrative amendment. -Refer to the following
section on "me-too" amendments.
b. "Me-too" amendments that require supporting data -
as indicated in 1. above, these are amendments you want
to make to your product, that occur on another
currently registered substantially similar or
identical product. Refer to Appendix 4-2, which
follows section F 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.
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1) Administrative portion - includes the
following:
- Application for Pesticide Amendment (EPA Form
8570-1)
- Statement identifying the "substantially
similar" or "identical" product 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 and your product is an
antimicrobial product or a vertebrate pesticide
product, requiring efficacy data to support the
proposed change. You should contact the Product
Manager responsible for your product
registration if you have any questions as to
whether this is the case.
- Five (5) copies of your proposed draft labeling.
It would make the Agency's review go more quickly,
if you were to highlight those changes on your
proposed labeling. A light colored felt tip
marker could be used to highlight the proposed
changes.
- 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
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
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an antimicrobial product or vertebrate pesticide
product. 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.
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
On October 25, 1988, amendments to the Federal
Insecticide, Fungicide, and Rodenticide Act were signed
into law and for the most part became effective on
December 24, 1988. One of the amendments, section
3(c)(3)(B), 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.
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: depending on the type of amendment, product
chemistry, acute toxicity, or efficacy data, as
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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. Examples include, but are
not limited to, new inerts, changed 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 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
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
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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.
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) - 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 266A, 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
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.
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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, 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.
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
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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 the 1988 FIFRA
amendments require EPA to review applications
for expedited registration within 90 days of
receipt, this turnaround time may not be met
immediately due to the backlog of
applications received prior to December 24,
1988. However, EPA is increasing human and
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. We
anticipate that we will be in a position to
meet the 90 day expedited review timeframe
early in 1990.
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 F 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
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
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procedures if your application is determined to be
incomplete your application will not be processed and will
be returned.
1) Administrative portion includes the following:
- Application for Pesticide Amendment (EPA Form 8570-1)
- Five (5) copies of your proposed draft labeling. It
would make the Agency's review go more quickly, if you
were to highlight those changes on your proposed
labeling. A light colored felt tip marker could be
used to highlight the proposed changes.
- 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 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 - 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. Refer to Chapter 7 of this
manual for a discussion of tolerance petitions.
IMPORTANT NOTE: Efficacy (product performance) data
are usually required to be submitted to support your
proposed use if you are proposing a new antimicrobial
use or vertebrate pest control use. However, for most
uses, i.e., insecticides, fungicides, and herbicides,
the Agency does not require that these data be
submitted. The Agency expects the applicant to develop
efficacy data to satisfy himself that the use for which
registration is sought will be effective. 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 are
required. Refer to Chapter 8 of this manual for a
discussion of EUP's. You may wish to contact the
appropriate Product Manager to determine if additional
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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
registration, and are not subject to the data compensation
provisions of FIFRA section 3(c)(l)(D). Refer also to PR Notice
88-6.
1. NOTIFICATIONS - Changes that you can make to your
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 l2(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.
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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)
identifying the changes as a notification.
1) Addition or substitution of brand names. You
may market your product under separate brand names
provided you notify the Agency of the additional
brand name(s) you intend to use. 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.
PITFALLS TO BE AVOIDED; The additional brand name
must not be false or misleading. Examples of
false or misleading names would be those that
imply a safety claim, or imply use of the product
in areas or on pests that are not approved on the
product's label, or make excessive claims for
control of pests. Also, the addition of brand
names is not the same as supplemental registration
by a different company under agreement with you
(Refer to Chapter 5 - Supplemental Registration).
You may not change the official product name of
record without making a formal application to
amend your registration and receiving approval
prior to sale or distribution.
2) Bilingual text on labeling may be added under
the notification provision unless such labeling is
required by the Agency.
PITFALLS TO BE AVOIDED; It is your
responsibility to make certain that the second
language text will be an accurate translation of
the English text on the accepted label.
3) The use of symbols in conjunction with label
text. Symbols may not be substituted for label
text, but may be used in conjunction with and in
close proximity to existing explanatory label
text.
4) You may combine labeling statements to remove
redundancy. provided all required information is
maintained.
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5) Changes in warranty or warranty disclaimer
statements.
6) Any other revision of label language
consistent with 40 CFR Part 156, which involves no
change in the ingredients statement,
precautionary statements or directions for use.
IMPORTANT NOTE: The deletion of use patterns, pests,
claims, or sites of use from your registered labeling
can no longer be accomplished as a Notification under
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 supercedes 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.
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)
identifying the change as a 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.
If changing the source of the active ingredient
would necessitate changing the nominal
concentration [as defined in 40 CFR 158.153(1)]
of an inert ingredient, an alternate formulation
may result, and the action would be considered an
amendment to add an alternate formulation. (See
also Part b.2)b) of this Chapter for changes in
non-proprietary inert ingredients that are
notifications.)
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PITFALLS TO BE AVOIDED: 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.
You may not change the stated nominal
concentration of any active ingredient without
submitting a formal application for amended
registration and obtaining EPA approval prior to
sale or distribution.
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.
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, provided
the composition of the inert is not changed.
b) You may change the stated nominal
concentration of any particular inert
ingredient by notification to the Agency,
provided that:
(1) the certified limits for that
ingredient are not exceeded, and
(2) the composition of the ingredient is
known to you.
PITFALLS TO BE AVOIDED: Note
particularly that both of the above
changes are limited to inert ingredients
whose complete composition is known to
you, such as specific solvents or common
commodity diluents. Changes in
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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 accomplished by a formal
application for an amendment. Since you
do not know the composition of such
inert ingredients, the Agency must
review the composition of the new
proprietary inert based on information
supplied by its producer to determine
its acceptability.
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 modify a formulation process, [defined in
40 CFR 158.153(c)], i.e., a blending or dilution
process involving no chemical reactions —
distinguished from a production process (described
in 40 CFR 158.162) by notification, provided that
the certified limits of the active and inert
ingredients would not change as a result.
C. HOW TO SUBMIT NOTIFICATIONS
To submit a notification, you must use the Application
for Registration/Amendment Form (EPA Form 8570-1), and
write the word "NOTIFICATION" 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. A Confidential Statement of Formula
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(EPA Form 8570-4) should accompany the notification
application if changes in product composition are
being made. If a labeling change 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 may be used for this purpose.
PITFALLS TO BE AVOIDED; If the notification that you
submit is determined not to be a notification in
accordance with 40 CFR section 152.46(a), 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.)
?.. NON-NOTIFICATIONS - Changes to vour registration that can
be made without notifying the agency.
In accordance with 40 CFR section 152.46(b), the following
changes can be made in the product's composition, 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 should be
sent to the Registration Support Branch, notifying the
Agency of the changed company name and/or address. See
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Chapter 18 for the address.
PITFALLS TO BE AVOIDED; 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 your
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) Date of manufacture or label approval.
5) Addition of State-required analysis of a wood-
preservative product.
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 color, type
size or style, use of space, configuration or
placement of label elements.
PITFALLS TO BE AVOIDED: Changes in color or type size
should not reduce the readability of the labeling text.
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.
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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
this final printed labeling will include non-notification
changes that may have been made after submission of the
approved draft labeling, but prior to printing the final
printed labeling for submission to the Agency.
E. 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.
E. ENFORCEMENT
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
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.
F. 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.
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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 TOGETHER)
Application for Pesticide Amendment
(EPA Form 8570-1)
Draft labeling (5 copies)
(DO NOT BIND TOGETHER)
Application for Pesticide Registration
(EPA Form 8570-1)
Confidential Statement of Formula
(EPA Form 8570-4)
Draft labeling (5 copies), if
required
Leaend
Documents that are required
Documents which may be 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)
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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 TOGETHER)
Application for Pesticide Amendment
(EPA Form 8570-1)
Statement identifying the "substantially
similar" or "identical" product
Confidential Statement of Formula
(EPA Form 8570-4), if required
Draft labeling (5 copies)
Formulator's
Exemption Statement
(EPA Form 8570-27)
Certification with Respect to
Citation of Data (EPA Form
8570-29)
Data Matrix Chart
B. DATA PORTION OF APPLICATION:
Legend
Product Specific Acute
Toxicity data * (3 copies) if required
Efficacy data * (3 copies) if
required
Documents that are required
Documents required only under the selective
method of support of data compensation.
Not required under the cite-all method of
data compensation.
* 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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APPENDIX 4-3
A TYPICAL APPLICATION TO AMEND THE REGISTRATION OF A REGISTERED
PRODUCT TO ADD A NEW USE, REQUIRES THE FOLLOWING DOCUMENTS
A. ADMINISTRATIVE PORTION OF APPLICATION: (DO NOT BIND TOGETHER)
Application for Pesticide Amendment
(EPA Form 8570-1)
Draft labeling (5 copies)
Certification with Respect to
Citation of Data (EPA Form
8570-29)
Data Matrix Chart
Formulator's
Exemption Statement
(EPA Form 8570-27)
B. DATA PORTION OF APPLICATION:
Legend
. Data as required by 40 CFR 158.202 thru
158.740 * (3 copies).
Efficacy data * (3 copies) if
required
Documents that are required
Documents required only under the selective
method of support of data compensation.
Not required under the cite-all method of
data compensation.
* 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 4 - REFERENCES CITED - 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
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.
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CHAPTER 5 - HOW TO APPLY FOR SUPPLEMENTAL REGISTRATION OF 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 registered product under another person's name and
address instead of (or in addition to) his 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. 2) If the basic
registration is cancelled, the supplemental registration is
automatically cancelled.
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 you wish 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
you "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,
to the Registration Support Branch. Refer to
Chapter 18 for the address.
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IMPORTANT NOTE; You must have a company number prior to
your notification to the Agency of supplemental
distribution. (See section D of this Chapter.)
2. The product you intend 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 product you wish to distribute may not be
repackaged: it must remain in the basic registrant's or
producer's original unopened container. However, you
may repackage the product if you have a contract with
the basic registrant to do~so, and if your
establishment is registered.
4. The labeling associated with the product you wish to
distribute must be the same as that of the basic
registered product, except that:
a. The product name of your product may be
different from that of the basic
registrant's, but it may not be misleading;
b. The name and address of your 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 your company's number;
(For example, if the registration number of
the basic registrant's product is EPA Reg.
No. 999999-88888, and your company number is
777777, then your distributor number that
would appear on your label would be EPA Reg.
No. 999999-88888-777777);
d. The establishment number must be that of
the final establishment at which the
registered product was produced and/or
packaged, (see Chapter 11 - How to Obtain an
EPA Establishment Number); 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 your label provided that no
changes are necessary in any of the
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precautionary or other labeling of the basic
product.
PITFALLS TO BE AVOIDED: You may not make additions to
the basic registrants label (for example, add
additional sites or pests), nor can you 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
D. WHERE TO REQUEST A COMPANY NUMBER
If you do not already have an EPA assigned company number,
submit your request in writing to the Registration Support
Branch. Refer to Chapter 18 for the address.
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CHAPTER 5 - REFERENCES CITED - 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
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CHAPTER 6 - WHAT ARE THE DATA COMPENSATION REQUIREMENTS
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 placed
data compensation 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. In 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
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.
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)(D) of FIFRA.
Section 3(c)(l)(D) 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
6- 1
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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. After
the 10 year "exclusive use" period has expired, you must
still offer to compensate the data submitter for use of the
data, but written authorization 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 only if the applicant 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)(D).
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 applications:
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,
6- 2
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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
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 ?
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1. FORMULATOR'S EXEMPTION STATEMENT (EPA Form 8570-27}
Under FIFRA section 3(c)(2)(D) you are excused (i.e.,
eligible for the formulator'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 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.
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)(D). In order to comply with the
FIFRA section 3(c)(l)(D) data compensation requirements, you
must:
a. Submit an acknowledgement 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)(D) 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
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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 l on the Certification with Respect to Citation of
Data form (EPA Form 8570-29) satisfies this
acknowledgement requirement.
b. Exclusive use data certification - 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, after September 30, 1978 for a period of
10 years after the registration. 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 an applicable Registration Standard, as an exclusive
use data submitter written authorization which contains
at least the following information:
l) 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 listed by chemical code numbers. Refer to
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Chapter 16 of this manual for information of how to
obtain the Data Submitters List. A source of published
Registration Standards 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 use 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)], 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,
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 FIFRA section
3{c)(l)(D), 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 the data compensation
requirements of FIFRA section 3(c)(l)(D) - There are
two methods of complying with the data compensation
requirements, these are 1) the "cite-all" method and 2)
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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)(1)(D) and 3(c)(2)(D), and
(c) submitting to the Agency a General offer
to pay statement, in accordance with 40 CFR
152.90(c), in which you state your offer and
agree to pay compensation to other data
submitters to the extent required by FIFRA
section 3(c)(l)(D).
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 data,
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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.
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
(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, or a
Registration Standard 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)].
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(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
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).
IMPORTANT NOTE; The Data Tables and
bibliography in an applicable
Registration Standard can be very
helpful in developing a data
matrix.
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D. 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:
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
technical grade product, e.g., a manufacturing-use or a
formulating-use only product, 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
6-10
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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
registered product you cite. These ways include
situations where the cited product's label actually
identifies each active arid 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
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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; 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
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)(D) of FIFRA, within the
limits prescribed by your eligibility under the
formulator's exemption. You may address the data
compensation requirements as indicated below.
Cite-all Method of Support; If you wish to use the
cite-all method of support, you must make offers to pay
to all of the data submitters listed in the
bibliography of the most recent Registration Standard
issued by EPA (if any) and in addition write those data
submitters listed on the Data Submitter's List who have
claimed product specific types of data on the Data
Submitter's List. If EPA has not issued a Registration
Standard for one or more of the active ingredients
contained in your product, you must write 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; 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.,
6 ~ 12
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the data tables and bibliography in the most recent
registration standard.
4. 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.
5. 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
application for registration. If this is the case, you
may certify to the Agency that you have received
written permission to cite the data.
6. 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. Submit a properly completed
Formulator's Exemption Statement (EPA Form 8570-27).
7. Question; May I use an unregistered source of an active
ingredient to formulate my product.
Answer; Administrative complications and data requirements
are reduced if your source of the active ingredient(s) is
registered. As you may know, normally it is illegal under FIFRA
to sell or distribute an unregistered pesticide, which also
pertains to unregistered sources of the active ingredient.
However, in accordance with 40 CFR 152.30, you may use an
unregistered source under certain circumstances. An
unregistered source may be used 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.
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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:
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).
Should .you decide to use an unregistered source of an active
ingredient, you are responsible for providing any information or
data the Agency would need to accept that new source. 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 understand that
the use of an unregistered source of an active ingredient will
cause 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.
8. Question; May I use both the Selective and Cite-All Methods
of Support for one product application, if I have more than one
active ingredient in my product?
Answer; Yes, you may.
9. 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 selective
method.
10. 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,
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how much more must I-,,<3o to find the company?
Answer; We generally believe 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.
11. 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
reference and satisfy residue chemistry data requirements.
These same applicants must obtain permission or make an
offer to pay to use these data, if they choose the Cite-All
Method of Support.
There are other cases when residue chemistry data may be
required, for example an application 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.
12. 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.
13. 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.
14. Question; If I am the first applicant/registrant to cite or
submit a public literature data source, do I acquire data
submitter's rights?
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Answer; No, applicants do not need permission to cite
public literature. No one acquires "data submitters'
rights" from public literature submissions.
15. 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.
E. 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.
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APPENDIX 6-1
COMPARISON OF THE CITE-ALL AND SELECTIVE METHODS OF SUPPORT
— — 1
If an applicant chooses
Can he satisfy a data
requirement by this means?
i
i
v
1. Requesting and obtaining
a waiver
2. Submission of a new study
3. Citation of his 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
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
i 1
Cite-all
No !/
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.
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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.
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 and one for all
of the rest of the qualifying active ingredients. 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.
6-19
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Block 8a. Indicate the Part 158 and guideline reference number
for each data requirement applicable to your product.
If a Registration Standard has been issued, the data
requirements and their guideline reference numbers are
listed in the Standard.
Block 8t>. 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.
IMPORTANT NOTE; 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
sample matrix. You must attach an explanation sheet to
6-20
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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
(i f 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.
3) Certification that a proper offer to pay has been
made to the original data submitter. (One
certification suffices for all offers to pay.)
6-21
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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:
2. EPA REG.NO./FILE SYMBOL;
6. APPLICATION FOR
REGISTRATION DATED:
MONTH
DAY
YEAR
3. FORMULATOR'S EXEMPTION
SELECTED:
YES
NO
4. PAGE
OF
7. NAME OF ACTIVE INGREDIENT(S):
8. 40 CFR Part 158 -
DATA REQUIREMENTS
8a.
Guide-
line
Refer-
ence
Number
Section
158.190
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
8b.
Name of Test
PRODUCT CHEMISTRY
Identity of
inaredients
Statement of
composition
Discussion of
formation of
inaredients
Preliminary
analysis
Certification of
limits
Analytical method
for enforcement
limits
Color
Physical State
Odor
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 (DTP)
enclosed:
indicate
"P" or "DTP"
9e.
Pub lie
Litera-
ture
9f .
N.A. or
Waiver or
other
(explain)
10.
MRID Number ,
EPA Accession
Number , or
other
identifying
number
I
NJ
-------
SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT
1. PRODUCT NAME: 2. EPA REG. NO. /FILE SYMBOL: 3. FORMULATOR'S EXEMPTION 4
SELECTED :
5. APPLICANT'S (COMPANY) NAME AND
ADDRESS:
YES NO
. PAGE
_2 OF
6. APPLICATION FOR 7. NAME OF ACTIVE INGREDIENT ( S) :
REGISTRATION DATED:
8. 40 CFR Part 158 -
DATA REQUIREMENTS
8a. |8b.
Guide- |Name of Test
line !
Refer- j
ence j
Number |
i
i
i
Section ]
158.190 1 PRODUCT CHEMISTRY
! (continued)
i
63-5 iMeltina point
63-6 iBoilina Doint
63-7 ! Density, bulk-
! density, or
'specific aravity
63-8 ISolubilitv
63-9 ! Vapor Pressure
63-10 i Dissociation
I constant
63-11 ! Octano I/water
'partition
! coefficient
63-12 !DH
63-13 i Stability
63-14 ] Oxidizing/reducing
! reaction
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 (DTP)
enclosed:
indicate
"P" or "OTP"
9e.
Pub lie
Litera-
ture
9f .
N.A. or
Waiver or
other
(explain)
10.
MRID Number ,
EPA Accession
Number , or
other
identifying
number
OJ
-------
SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT
1. PRODUCT NAME: 2. EPA REG. NO. /FILE SYMBOL: 3. FORMULATOR ' S EXEMPTION 4.
SELECTED:
5. APPLICANT'S (COMPANY) NAME AND
ADDRESS :
YES NO
PAGE
3 OF
6. APPLICATION FOR 7. NAME OF ACTIVE INGREDIENT ( S ):
REGISTRATION DATED:
8. 40 CFR Part 158 -
DATA REQUIREMENTS
8a. |8b.
Guide- 'Name of Test
line i
Refer- j
ence |
Number |
i
i
i
i
i
Section j
158.190 ! PRODUCT CHEMISTRY
I (continued)
i
63-15 i Flammability
63-16 [Explodability
63-17 ! Storaqe stability
63-18 Iviscosity
63-19 iMiscibility
63-20 ! Corrosion
63-21 [Dielectric break-
i down volt aae
Section j TOXICOLOGY
158.340 i
81-1 I Acute oral
Itoxicity. rat
81-2 ! Acute dermal
'toxicity, rabbit
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
II T> M i~\Y" " OrP"D "
c O J. \J JL Jr
9e.
Pub lie
Litera-
ture
9f .
N.A. or
Waiver or
other
(explain)
10.
MRID Number ,
EPA Accession
Number , or
other
identifying
number
-------
SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT
1. PRODUCT NAME:
5. APPLICANT'S (COMPANY) NAME AND
ADDRESS:
2. EPA REG.NO./FILE SYMBOL:
6. APPLICATION FOR
REGISTRATION DATED:
MONTH
DAY
YEAR
3. FORMULATOR'S EXEMPTION
SELECTED:
YES NO
4. PAGE
4 OF
7. NAME OF ACTIVE INGREDIENT(S):
8. 40 CFR Part 158 -
DATA REQUIREMENTS
8a.
Guide-
line
Refer-
ence
Number
Section
158.190
81-3
81-4
81-5
81-6
8b.
Name of Test
TOXICOLOGY
(continued)
Acute inhalation,
toxicity. rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensiti-
zation
9. SOURCE OF DATA SATISFYING REQUIREMENT
9a.
Submitted
by
Applicant
9b.
Date
Submitted
9C.
Submitted
by another
person/firm
(give name)
1
I
9d.
Certificate
of Permis-
sion (P.) or
Offer to
Pay (OTP)
enclosed:
indicate
up ii or H OTP"
9e.
Pub lie
Litera-
ture
9f .
N.A. or
Waiver or
other
(explain)
10.
MRID Number,
EPA Accession
Number , or
other
identifying
number
-------
SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT
1. PRODUCT NAME:
5. APPLICANT'S (COMPANY) NAME AND
ADDRESS:
2. EPA REG.NO./FILE SYMBOL:
6. APPLICATION FOR
REGISTRATION DATED:
MONTH
DAY
YEAR
3. FORMULATOR'S EXEMPTION 4. PAGE
SELECTED:
YES
NO
7. NAME OF ACTIVE INGREDIENT(S):
8. 40 CFR Part 158 -
DATA REQUIREMENTS
8a.
Guide-
line
Refer-
ence
Number
Section
158.
8b.
Name of Test
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 (DTP)
enclosed:
indicate
lip II or HQTP"
9e.
Public
Litera-
ture
9f .
N.A. or
Waiver or
other
(explain)
10.
MRID Number ,
EPA Accession
Number , or
other
identifying
number
-------
CHAPTER 6 - REFERENCES CITED - 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 Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 3 - Registration of pesticides '
3. Data Submitters' List
4. Listing of Registration Standards
5. Listing of Chemicals for Which Data Waivers Have Been
Granted
6-27
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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.
By establishing tolerances at safe levels EPA minimizes concerns
about residues in our foods. It should be noted that a
tolerance is not necessarily the maximum safe level, since
tolerances are set no higher than necessary. 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.
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 processed food or
feed commodities. FFDCA Section 409 includes the so-called
Delaney Clause. EPA's position concerning the Delaney Clause is
that the FFDCA section 409's so-called Delaney Clause - which,
read literally, purports to bar absolutely the issuance of a
food additive regulation for a food additive that has been found
to induce cancer in test animals - is subject to a de minimis
exception where the human dietary risk from residues of the
pesticide is at most negligible. The Agency's policy regarding
rulemaking under FFDCA section 409 is set forth in the Federal
Register Notice of October 19, 1988 (53 FR 41104).
40 CFR Part 180 - Tolerances and Exemptions from Tolerances
for Pesticide Chemicals in or on Raw Agricultural Commodities,
provides comprehensive 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 185 - Tolerances for Pesticides in Food
Administered by the EPA, provides a listing of tolerances
established for residues of pesticides in 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 Animal Feeds
Administered by the EPA, provides a listing of tolerances
established for residues of pesticides in animal feeds, which
may be present as a result of application of the pesticide to
growing crops which may also be used for animal feed. (Prior to
June 29, 1988, 40 CFR Part 186 was designated 21 CFR Part 561.)
B. WHEN ARE PETITIONS FOR TOLERANCES REQUIRED?
1. Applications for registration or amended
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. The petition for the temporary
tolerance must be submitted with the application for
the experimental use permit.
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.
2. Completeness of Application - The petition must
include the following information in clearly designated
sections as follows:
7-2
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a. Section A - The name, 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.
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. 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 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 tests 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
7-3
-------
Chemistry. (Refer to Chapter 16 of this manual for a
source.)
Submission of analytical methods to EPA for use 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 0 - Residue Chemistry. The analytical
method for enforcement cannot be marked as Confidential
or Trade Secret. In addition, registrants need to
submit to EPA pesticide residue 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.
e. 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 F - 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
7-4
-------
hazard to human health". When an exemption is
proposed, data must 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 G - Reasonable grounds in support of the
petition. This section should include a rationale of
how the residue data support the proposed tolerance,
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.
3. Data - Three copies of any data required to be submitted
in support of the petition must be submitted 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 copy of the fee
check were submitted with the petition request in case
any questions arise concerning whether the fee was
submitted as required. Refer to Chapter 9 of this
manual for detailed information on tolerance petition
fees.
6. Incomplete Petitions - Petitions will not be
accepted for processing if the proper fee has not been
7-5
-------
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 for handling and
initial review, will also be returned. Refer to
Chapter 9, Section C.4. - Incomplete Petition
Applications.
D. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions concerning whether a petition for
a tolerance is required, the appropriate fee, how to submit the
request for a petition, or data required to support the petition,
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.
7-6
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CHAPTER 7 - REFERENCES CITED - 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 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 0, 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, October 19, 1988, Regulation of
Pesticides in Food: Addressing the Delaney Paradox -
Policy Statement (53 FR 41104).
7-7
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CHAPTER 8 - HOW TO APPLY FOR AN EXPERIMENTAL USE 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
experimental 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
permit.
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 field testing of
pesticides in an indoor situation, for example a pesticide
to control roaches in domestic dwellings, institutions, etc.
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 use - 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,
unless a tolerance or exemption from a tolerance has
been established.
8-1
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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
a. Conventional, Biochemicalf 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:
a) Test parameters
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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
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.
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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 pest 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.
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 for testing purposes.
3. Data requirements
If the proposed EUP is for an unregistered pesticide, the
following information and/or data are required:
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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.
4. Labeling requirements
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
5. Extensions or renewal 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
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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
petition is subject to fee requirements as discussed in
Chapter 9. An extension or renewal request for a
temporary tolerance is also subject to a fee
requirement.
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 you should
contact Product Manager 17 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.
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CHAPTER 8 - REFERENCES CITED - 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 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.
Material belongs to:
Office of Toxic Substances Library """"
3_7 U.S. Environmental Protection Agency
401M Street, S.W.TS-793
Washington, D.C. 20460
(202) 382-3944
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7740), and list B in the Federal Register of May 25, 1989 (54 CFR
22706). The remaining lists, List C and List D are scheduled to
be listed by July 24 and October 24, 1989. 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
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.
1. GENERAL FEE SCHEDULE - EFFECTIVE March 15. 1989
(revised annually)
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 will be adjusted annually in accordance with
section 180.33 (o). You should refer to the March 15,
1989 Federal Register Notice (54 FR 10962) for a more
detailed discussion of tolerance processing fees.
The fees vary considerably according to type of
petition requested and its complexity. Again, you
should refer to 40 CFR 180.33 for a detailed discussion
of fee requirements. 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 $48,225, plus $1,200 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 $11,025 plus $775 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
$8,875.
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d. For temporary tolerances or a temporary tolerance
exemption from the requirement of a tolerance the fee
is generally $19,250, except as provided below. A
request for an extension or renewal of a temporary
tolerance or temporary exemption requires a fee of
$2,725.
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 $9,625 plus $775 for each raw agricultural
commodity on which the temporary tolerance is sought.
2. WAIVERS AND REFUNDS
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). The
waiver or refund request must be accompanied by a fee
of $1,200.
3. WHERE TO SUBMIT YOUR FEE AND YOUR PETITION REQUEST
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
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.
4. INCOMPLETE PETITION APPLICATIONS
If a petition is not accepted for processing because it is
determined to be incomplete, the fee, less $1,200 for
handling and initial review will be returned. If a petition
is withdrawn by the petitioner after initial processing but
before significant scientific review has begun, the fee,
less $1,200 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.
E. WHO TO CONTACT FOR ADDITIONAL INFORMATION
If you have any questions concerning whether a petition for
a tolerance is required, the appropriate fee, how to submit the
application for a petition, or data required to support the
application, please contact the appropriate Product Manager for
that pesticide. Refer to Chapter 18 of this manual for a listing
of the various Product Managers.
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CHAPTER 9 - REFERENCES CITED - Refer to Chapter 16 for
information on the 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
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, March 15, 1989 (54 FR
10962)
- 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)
4. Federal Insecticide, Fungicide and Rodenticide Act, as
amended October, 1988
Section 4 - Reregistration of registered products
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VT ARE THE REOU
A. GENERAL INFORMATION
Section 25(c)(4) of FIFRA provides that the Administrator
may 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, viru;s, 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
Notice, 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,
3. Black light traps, fly traps, electronic and heat
screens, fly ribbons, and fly paper for which claims are
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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 the 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),
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),
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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.
3. Establishment Registration and Reporting. Books and
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
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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
(i i i ) , and (D).
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
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requirements.
F. 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) 382-7835.
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CHAPTER 10 - REFERENCES CITED - 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.
4. Federal Register Notice, Pest Control Devices and Device
Producers, (41 FR 51065), Nov. 19, 1976.
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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:
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 OF 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.
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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, B.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, B.C. 20460.
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CHAPTER 11 - REFERENCES CITED - 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
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CHAPTER 12 - CONFIDENTIAL BUSINESS INFORMATION AND HOW TO SUBMIT
DATA
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 confidentiality of this type.
Data submitted in support of your application for
registration, amendments to a registration, petitions,
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 says that health and safety data on
registered or previously registered pesticides shall be made
available to the public, except that 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.)
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FIFRA Section 10 (b) protects certain confidential business
information, such as trade secrets and commercial or financial
information.
FIFRA Section I0(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 just like the EPA staff is
required to protect it. We provide notification to submitters
of CBI that their data will be used by 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).
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).
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 Master Record Identifier number (MRID) and entered
into the Agency's 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.
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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)
DATA TRANSMITTAL
Studies submitted as unique
physical entities, according
to the format below.
FORMAT OF THE SUBMITTED STUDIES
Submit three identical copies
of the data submittal.
Study title page.
Statement of confidentially claims.
Good Laboratory Practice (GLP) and flagging*
statements (as appropriate).
Body of study, with English
language translation if required.
, 1
Title Page of the
Confidential
Attachment.
LEGEND
Appendices to the study.
Confidential Attachment.
Supplemental Statement of
Confidentiality Claims.
* Refer to 40 CFR 158.34
Documents submitted at your option.
Documents which must be submitted as appropriate
to meet established requirements.
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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 above address
non-data requirements for registration, and are filed
in the registration jacket for your product. Thus they
need not be submitted in three copies like the data.
2. DATA TRANSMITTAL 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.
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 STUDIEi
Whenever you submit information to supplement a
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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
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.
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.
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CHAPTER 12 - REFERENCES CITED - 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.
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CHAPTER 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,
e. A statement that the transferred registration(s)
shall not serve as collateral or otherwise secure any
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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 transferer,
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; In the event that the original documents
cannot be submitted for the attachments to the transfer
dociiment, each of the copied documents must be notarized and
certified as a true copy of the originals.
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
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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
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)(D) may transfer such
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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.
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 affirming
that:
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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.
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)(D), 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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CHAPTER 13 - REFERENCES CITED - 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 FIFRA
A. STATE ISSUANCE OF EXPERIMENTAL USE 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
registration 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 there is:
l. 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 cancelled by EPA, and
4. the EPA has registered products that contain the active
ingredient(s), and each of the inert ingredients is
contained in a federally registered product.
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Requests for Special Local Need (SLN) registrations are
generally made by pesticide companies to the specific state. If
the state approves the application, the (SLN) registration issued
by the state is then forwarded to the EPA for acknowledgement.
The EPA has 90 days from receipt of the SLN application from
the state to either disapprove or deny the application.
Otherwise it becomes a Federal registration under FIFRA section
3.
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'S
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 9 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.
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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CHAPTER 14 - REFERENCES CITED - Refer to Chapter 16 for
information on the source of these documents.
1. Code of Federal Regulations, Title 40
Part 162 - Regulations for the enforcement of the
Federal Insecticide, Fungicide and
Rodenticide Act
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 THAT
MAY BE NEEDED FROM OTHER FEDERAL OR STATE AGENCIES
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 approvals that you must
obtain in order to use the product in a specific area. 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 PF.STTrTnF.S
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 and 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 OF 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:
Compound Evaluation Laboratory
Scientific Services, FSQS
Food Ingredient Assessment Division
U.S. Department of Agriculture
Building 306, BARC-East
Beltsville, MD 20705
D. 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
The Food and Drug Administration (FDA) and the Environmental
Protection Agency (EPA) have several areas of mutual regulatory
responsibility which may require review by one or both agencies.
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The following is a brief summary of these areas:
1. Sanitizers (pesticides used on food contact surfaces)
Any pesticide product intended for sanitizing inanimate
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 the active and inert ingredients have been
specifically approved or "generally recognized as safe" by
FDA. 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)
FDA evaluates the safety and efficacy of pesticides used in
paper or other materials 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 l. above.
3. Antimicrobial pesticides used on medical devices
An antimicrobial agent 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
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
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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 Frogram 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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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
3. Pesticide Fact Sheets
4. Special Review Position Documents
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) 557-4474
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
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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).
C. DOCUMENTS AVAILABLE FROM THE ENVIRONMENTAL PROTECTION AGENCY
The following documents are available from the Environmental
Protection Agency:
1. Federal Insecticide, Rodenticide and Fungicide Act, as
amended. October 1988. EPA 540/09-89-012.
2. LISTING OF FEDERALLY REGISTERED "RESTRICTF.n USE
PESTICIDES"
The listing provides, by active ingredient, information on
those active ingredients and products that have been
classified as "Restricted Use" pesticides.
Copies of the two documents listed above 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) 557-7700
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 236
Crystal Mall #2
1921 Jefferson Davis Highway
Arlington, VA 22202
Office hours are from 8:00 AM to 4:00 PM, Monday through
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Friday, except legal holidays. Telephone: (703)557-2805
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 ISSUED
This listing, entitled the "Registration Standard Report"
provides information of all registration standards which
have been issued, is contained in a general listing entitled
"OPP Publication Listings" (see above).
5. PR NOTICES
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) 557-4474
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).
16-3
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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.
EPA FORM
8570-1
8570-4
8570-5
8570-6
8570-17
8570-20
8570-27
8570-28
8570-29
TITLE
Application for Pesticide
Registration/Amendment (Revised 9-88,
previous editions are obsolete)
Confidential Statement of Formula (Revised
2-85, previous editions are obsolete)
Notice of-Supplemental Registration of
Distributor (Revised 4-83, previous editions
are obsolete)
Certification of Attempt to Enter Into an
Agreement with Other Registrants for
Development of Data (10-82)
Application for an Experimental Use Permit to
Ship and Use a Pesticide for Experimental
Purposes Only (Revised 2-85, Previous
editions may be used until supply is
exhausted)
Data Reference Sheet (1-81)
Formulator's Exemption Statement (10-86)
Certification of Compliance with Data Gap
Procedures (10-86)
Certification with Respect to Citation of
Data (7-86)
Copies of these forms may be obtained from the Registration
Support Branch, Registration Division (H5704C) Office of
Pesticide Programs, Washington, D.C. 20460. Telephone; (AC 703)
557-7700.
The following forms may be obtained 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.
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EPA FORM TITLE
3540-1 Notice of Arrival of Pesticides or Devices
3540-8 Application for Registration of Pesticide-
Producing Establishments
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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-
Rodenticide 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 ( ) **
Office of Pesticide Programs
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. 266A
Document Processing Desk ( ) **
1921 Jefferson Davis Highway
Arlington, VA 22202
** Insert appropriate Distribution Code identified
below.
3. Distribution Codes
When you send mail that to either of the above addresses,
we will be able to process your application more expeditiously if
you indicate the type of application your 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.
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DISTRIBUTION
CODE TYPE OF APPLICATION
APPL Application for Product Registration
AMEND Application to Amend a Product Registration
BIOTECH Biotech Applications and pre-EUP Noticifactions
DIST Supplemental (Distributor) Registration
EUP Application for an Experimental Use Permit
PETN Petition Request for Tolerance/Exemption
SLN Special Local Need Registration
CAN/WD Request to Cancel a Registered Product or to
Withdraw a Pending Application for
Registration, Experimental Use Permit,
Petition, etc.
NEWCO Request for a Company Number (Register an
Establishment)
COADR Company Name and Address Change
XFER Transfer Products to a Different Company
C. REGISTRATION DIVISION. WASHINGTON D.C.
1. INSECTICIDE - RODENTICIDE BRANCH
The Insecticide-Rodenticide Branch is 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. The various Product Manager Teams that
are responsible for certain types of products are
indicated below.
BRANCH CHIEF - Herbert S. Harrison (703) 557-2200
DEPUTY BRANCH CHIEF - Harvey Warnick (703) 557-2200
PRODUCT MANAGER 12 - Dennis Edwards (703) 557-2386
TYPE OF PRODUCTS; Carbamates, Miticides,
Toxaphene, Carbaryl, Chlorpyrifos,
Parathion
PRODUCT MANAGER 15 - George LaROCCa (703) 557-2400
TYPE OF PRODUCTS; Chlorinated Organic
Insecticides, Drug/Pesticide
Combinations, Dichlorvos, Endosulfan,
Fenthion, Fensulfothion, Disulfoton,
Second Generation Pyrethroids (i.e., Permethrin
and Cypermethrin)
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PRODUCT MANAGER 16 - William H. Miller (703) 557-2600
TYPE OF PRODUCTS: Most Organo-Phosphorus
products i.e., malathion, dimethoate,
except those listed with PMs 12 and 15,
Boric Acid, Vertebrate Pesticides,
Animal and Bird Repellents
PRODUCT MANAGER 17 - Phil Mutton (703) 557-2690
TYPE OF PRODUCTS; Biologicals, Insect Repellents,
Pyrethrins, First Generation Pyrethroids (i.e.,
Resmethrin), Herbs, Botanicals and Natural Oils
2. FUNGICIDE - HERBICIDE BRANCH
The Fungicide-Herbicide Branch is 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. The various Product Manager Teams and
their area of responsibility are listed below.
BRANCH CHIEF - Frank Sanders (703) 557-1650
DEPUTY BRANCH CHIEF - Thomas Adamczyk (703) 557-1650
PRODUCT MANAGER 21 - Lois ROSSI (703) 557-1900
TYPE OF PRODUCTS: Fungicides, Nematicides, Wood
Preservatives, Microbials
PRODUCT MANAGER 23 - Richard Mountfort (703) 557-1830
TYPE OF PRODUCTS; Herbicides: Arsenicals,
Phenoxys, Aquatics
PRODUCT MANAGER 25 - Robert Taylor (703) 557-1800
TYPE OF PRODUCTS; Herbicides, Plant Growth
Regulators
3. ANTIMICROBIAL PROGRAM BRANCH
The Antimicrobial Program Branch is responsible for the
registration activities of pesticides used for
disinfectants, water treatment, anti-fouling paints,
swimming pool chemicals, sterilants and fumigants.
BRANCH CHIEF - Juanita Wills (703) 557-3661
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PRODUCT MANAGER 31 - John Lee (703) 557-3676
TYPE OF PRODUCTS - Anti-fouling Paints, Quaternary
Ammonium and Water Treatment Compounds,
Sterilants
PRODUCT MANAGER 32 - Jeff Kempter (703) 557-3964
TYPE OF PRODUCTS - Hypochorites, Halides,
Chlorophenolics, Swimming Pool Chemicals,
Fumigants
4. REGISTRATION SUPPORT BRANCH
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, company name and address changes, and
registration cancellation requests, and front-end
application processing.
BRANCH CHIEF - Ferial S. Bishop (703) 557-7700
DEPUTY BRANCH CHIEF - Donald R. StubbS (703) 557-1806
AREA OF RESPONSIBILITY; Front-end applications
processing.
FRONT END PROCESSING STAFF
STAFF LEADER - (vacant) (703-557-8977)
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) 557-1700
AREA OF RESPONSIBILITY: Precautionary labeling
(acute toxicity) reviews.
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PRODUCT CHEMISTRY REVIEW SECTION
SECTION HEAD - Lynn Bradley (703) 557-7700
AREA OF RESPONSIBILITY: Review of product
chemistry data, inert clearance requests.
EMERGENCY RESPONSE AND MINOR USE SECTION
SECTION HEAD - Donald R. StUbbS (703) 557-1806
AREA OF RESPONSIBILITY; Emergency Exemptions
(Section 18 *s) and Minor Use (IR-4)
petitions.
PROJECT COORDINATION SECTION
ACTING SECTION HEAD - Mark Dow (703) 557-7700
AREA OF RESPONSIBILITY; 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 - Art Donner (703) 557-2126
AREA OF RESPONSIBILITY; Product registration
transfers, cancellation requests, program status
and reporting, and ADP processing.
D. FIELD OPERATIONS DIVISION
PUBLIC INFORMATION BRANCH
PUBLIC DOCKET AND FREEDOM OF INFORMATION SECTION
SECTION HEAD; Marcia Humbaugh (Acting)
(703) 557-4457
AREA OF RESPONSIBILITY; Freedom of information
requests, public docketing.
E. PROGRAM MANAGEMENT AND SUPPORT DIVISION
INFORMATION SERVICES BRANCH
DOCUMENT MANAGEMENT SECTION
18- 5
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SECTION HEAD; Catherine Grimes (703) 557-4460
AREA OF RESPONSIBILITY; Document management and
distribution.
INFORMATION RESOURCES DEVELOPMENT SECTION
SECTION HEAD; John Carley (703) 557-2315
AREA OF RESPONSIBILITY; Consulting assistance for
compliance with data formatting requirements.
The following individuals may be contacted for
assistance in answering questions or to provide
guidance concerning the data formatting procedures
as required by PR Notice 86-5:
Kris Pappajohn (703) 557-2316, or
Maureen Sherrill (703) 557-2361
F. EPA REGIONAL OFFICES
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) 565-3715
REGION 2
Jurisdiction: New Jersey, New York, Puerto Rico, Virgin
Islands
Environmental Protection Agency
26 Federal Plaza
New York, NY 10278
(212) 264-2525
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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, FJ.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) 353-2192
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
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REGION 7
Jurisdiction: Iowa, Kansas, Missouri, Nebraska
Environmental Protection Agency
726 Minnesota Avenue
Kansas City, KS 66101
(913) 236-2800
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) 974-7054
REGION 10
Jurisdiction: Alaska, Idaho, Oregon, Washington
Environmental Protection Agency
1200 Sixth Avenue
Seattle, WA 98101
(206) 442-5810
F. STATE AGENCIES WITH LEAD PESTICIDE RESPONSIBILITY
Alabama Director
Ag Chemistry/Plant Industry Division
Alabama Dept. of Agriculture & Industry
P.O. Box 3336
Montgomery, AL 36193
(205) 261-2631
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Alaska
American Samoa
Arizona
Arkansas
California
Colorado
Commonwealth of
the Northern
Mariana Islands
Connecticut
Pesticide Specialist
Alaska Dept. of Environmental Conservation
500 5. Alaska St., Suite A
Palmer, AK 99645
(907) 745-3236
Director, American Samoa EPA
Office of the Govenor
Pago Pago, American Samoa
96799
State Chemist
Office of State Chemist
P.O. Box 1586
Mesa, AZ 85211-1586
(602) 833-5442
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) 322-5130
Chief, Pesticide Applicator Section
Division of Plant Industry
Colorado Dept. of Agriculture
4th Floor, 1525 Sherman Street
Denver, CO 80203
(303) 866-2838
Chief, Division of Environmental Quality
Commonwealth of the Northern Mariana
Islands (CNMI)
P.O. Box 1304
Saipan, MP 96950
Senior Environmental Analyst
Pesticide Control Section
Department of Environmental Protection
State Office Building
Hartford, CT 06106
(203) 566-5148
18- 9
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Delaware
District of
Columbia
Florida
Georgia
Guam
Hawai i
Idaho
Pesticide Compliance Supervisor
Delaware Dept. of Agriculture
2320 South DuPont Highway
Dover, DE 19901
(302) 736-4811
Section Chief, Pesticide Section
Environmental Control Division
Dept. of Consumer & Regulatory Affairs
5010 Overlook Avenue, S.W., Room 114
Washington, D.C. 20023
(202) 727-7432
Administrator
Pesticide Registration Section
Bureau of Product Data Evaluation
Division of Inspection
Florida Dept. of Agric. & Consumer Services
Mayo Building, Rm. 208A
Tallahassee, FL 32399-0800
(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) 548-7125
Supervisor, Pesticide Programs
Division of Plant Industries
Idaho Dept. of Agriculture
P.O. Box 790
Boise, ID 83701-0790
(208) 334-3243
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Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Chief, Bureau of Plant & Apiary Protection
Illinois Dept. of Agriculture
State Fairgrounds
Springfield, IL 62791-9281
(217) 785-2427
Pesticide Compliance Officer
Indiana State Chemist Office
Dept. of Biochemistry
Purdue University
West Lafayette, IN 47907
(317) 494-1585
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. o'f 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
18-11
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Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Registrar, State Chemist Section
Plant Industries & Resource Conservation
Maryland Dept. of Agriculture
0233 Chemistry Bldg.
College Park, MD 20742
(301) 454-2722
Manager, Technical Assessment Sect.
Pesticides Bureau
Maine Dept. of Food and Agriculture
100 Cambridge Street, 21st Floor
Boston, MA 02202
(617) 727-7712 or 2863
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) 297-2530
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
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Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Director, Bureau of Plant Industry
Nebraska Dept. of Agriculture
301 Centennial Mall
Lincoln, NE 68509
(402) 471-2341
Director, Division of Plant Industry
Nevada Dept. of Agriculture
P.O. Box 11100
Reno, NV 89510-1100
(702) 789-0180
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) 530-4134
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
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Ohio
Oklahoma
Oregon
Pennsylvania
Puerto Rico
Republic of Palau
Rhode Island
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
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
18-14
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South Carolina
South Dakota
Tennessee
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
Texas
Utah
Vermont
Virginia
Virgin Islands
Director
Texas Dept. of Agriculture
P.O. Box 12847
Austin, TX 78711
(512) 463-7526
Director, Division of Plant Industry
Utah Dept. of Agriculture
350 North Redwood Road
Salt Lake City, UT 84116
(801) 533-4107
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) 786-3798
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
18-15
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Washington
West Virginia
Wisconsin
Wyoming
Chief, Registrations & Services
Washington Dept. of Agriculture
406 General Administration Bldg. AX-41
Olympia, WA 98504
(206) 735-5064
Administrator
Regulatory & Inspection Division
W. Va. Dept. of Agriculture
Charleston, WV 25305
(304) 348-2208
Certification & Licensing
Wisconsin Dept. of Agriculture, Trade &
Consumer Protection
P.O. Box 8911
Madison, WI 53708
(608) 267-9148
Manager, Technical Services
Wyoming Dept. of Agriculture
2219 Carey Avenue
Cheyenne, WY 82002-0100
(307) 777-6590
*******************
THE END
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