AD Reg Review GDCI Cover Letter

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, DC 20460
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION

[DATE GENERATED UPON DCI ISSUANCE]
GENERIC DATA CALL-IN NOTICE
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachments 2 and 3 of this Notice to submit certain data as noted
herein to the U.S. Environmental Protection Agency (EPA, the Agency). These data are
necessary for the Registration Review of your pesticide product(s) in its Registration Review
case and to maintain the continued registration of your product(s) containing the active
ingredient(s). Within 90 days after you receive this Notice, you must respond as set forth in
Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its Attachments 1
through 5; or,
2. Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Generic Requirements Status and Registrant's Response Forms and
Instructions Form, (see section III-B); or,
3. Why you believe EPA should not require your submission of data in the manner specified
by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with its
requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Generic Data Call-In Response Forms And
Instructions Form, as well as a list of all registrants who were sent this Notice (Attachment 4).
You may respond to this Generic Data Call-In Notice either electronically through the Central
Data Exchange (CDX) or by mail as described in Attachment 1. When submission of responses is
discussed throughout this Notice, either method can be used.
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), as amended; sections 3(g)(2)(A) and (B) of FIFRA, as amended;
and/or section 408(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FFDCA). This notice is
issued as part of Registration Review and is also authorized by 40 CFR Part 155.40, et seq.,
which is the Agency’s Registration Review regulations. Collection of this information is in
compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) as approved by the Office
of Management and Budget (OMB) under Control Number 2070-0174.

This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I.
Section II.
Section III.
Section IV.
Section V.
Section VI.

Why You Are Receiving This Notice
Data Required By This Notice
Compliance With Requirements Of This Notice
Consequences Of Failure To Comply With This Notice
Registrants' Obligation To Report Possible Unreasonable Adverse Effects
Inquiries And Responses To This Notice

The Attachments to this Notice are:
Attachment 1.
Attachment 2.
Attachment 3.
Attachment 4.
Attachment 5.

SECTION I.

Data Call-In Chemical Status Sheet
Generic Data Call-In Response Forms and Instructions
Generic Requirements Status and Registrant's Response Forms and Instructions
List of All Registrants Sent this Data Call-In Notice
Additional Documents and Information
• Confidential Statement of Formula and Instructions
• Certification of Attempt to Enter into an Agreement with Registrants for
Development of Data
• Certification with Respect to Citation of Data
• Paperwork Reduction Act Notification for DCI Respondents
WHY YOU ARE RECEIVING THIS NOTICE

The Agency has reviewed existing data for the active ingredient(s) identified in Attachments 2
and 3 of this Notice, and reevaluated the data needed to support continued registration of products
containing the subject active ingredient(s) and the continuation of any existing tolerances or
exemptions for such active ingredient. This reevaluation conducted as part of Registration Review
identified additional data necessary to assess the health and safety of products containing this
active ingredient(s). You have been sent this Notice because you have product(s) containing the
subject active ingredient(s).
SECTION II.

DATA REQUIRED BY THIS NOTICE

A. DATA REQUIRED
The data required by this Notice are specified in the Attachment 3, Generic Requirements
Status and Registrant's Response Forms and Instructions Form. Depending on the results of
the studies required in this Notice, additional testing may be required.
B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Generic Requirements Status and Registrant's Response Forms and
Instructions Form, within the time frames provided.
C. TESTING PROTOCOL
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All studies required under this Notice must be conducted in accordance with protocols which
meet the purpose of the test standards outlined in the Pesticide Assessment Guidelines for
those studies for which guidelines have been established and which provide data of suitable
quality and completeness as typified by the protocols cited in the guidelines.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, VA 22161 (tel: 703-6056000) and on the EPA’s Chemical Safety and Pollution Prevention website
(http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances).
Protocols approved by the Organization for Economic Cooperation and Development (OECD)
are also acceptable if the OECD-recommended test standards conform to those specified in
the Pesticide Data Requirements regulation (40 CFR Part 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR Part 158. Normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not conducted in accordance
with acceptable standards. The OECD protocols are available from 2001 L Street, N.W., Suite
650, Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202785-0350) and electronically on the OECD website (http://www.oecdilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals_chem_guide_pkg-en).
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices (40 CFR Part 160).
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) OR 4 DATA CALL-IN
NOTICES ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-In(s), or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III.

COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted to the Agency
within 90 days after your receipt of this Notice. Failure to adequately respond to this Notice
within 90 days of your receipt will be a basis for issuing a Notice of Intent to Suspend
(NOIS) affecting your products. This and other bases for issuance of NOIS due to failure to
comply with this Notice are presented in Section IV-A and IV-B.
B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete use(s), (3)
claim generic data exemption, (4) agree to satisfy the data requirements imposed by this
Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option, the Delete
Use(s) option or the Generic Data Exemption option is presented below. A discussion of the
various options available for satisfying the data requirements of this Notice is contained in
Section III-C. A discussion of options relating to requests for data waivers is contained in
Section III-D.
There are two forms that accompany this Notice of which, depending upon your response, one
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or both must be used in your response to the Agency. These forms are the Attachment 2,
Generic Data Call-In Response Forms And Instructions Form and the Attachment 3, Generic
Requirements Status and Registrant's Response Forms and Instructions Form. The Attachment
2, Generic Data Call-In Response Forms And Instructions Form must be submitted as part of
every response to this Notice. Note that the company's authorized representative is required to
sign the first page of the Attachment 2, Generic Data Call-In Response Forms And Instructions
Form and the Attachment 3, Generic Requirements Status and Registrant's Response Forms
and Instructions Form and initial any subsequent pages. The forms contain separate detailed
instructions on the response options. Do not alter the printed material. If you have questions or
need assistance in preparing your response, write or email EPA as indicated in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient(s) that is the
subject of this Notice. If you wish to voluntarily cancel your product, you must submit a
completed Attachment 2, Generic Data Call-In Response Forms And Instructions Form,
indicating your election of this option. Voluntary cancellation is item number 5 on the
Attachment 2, Generic Data Call-In Response Forms And Instructions Form. If you choose
this option, this is the only form that you are required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provisions of this Notice which are contained in Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by eliminating the uses of your
product to which the requirements apply. If you wish to amend your registration to delete
uses, you must submit the Attachment 3, Generic Requirements Status and Registrant's
Response Forms and Instructions Form, a completed application for amendment, a copy of
your proposed amended labeling, and all other information required for processing the
application. Use deletion is option number 7 on the Attachment 3, Generic Requirements
Status and Registrant's Response Forms and Instructions Form. You must also complete an
Attachment 2, Generic Data Call-In Response Forms And Instructions Form by signing the
certification, item number 8. For additional instructions on how to delete a use, please refer to
the EPA webpage for “Voluntary Cancellation of a Pesticide Product or Use” at
https://www.epa.gov/pesticide-registration/voluntary-cancellation-pesticide-product-or-use.
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due date
of your 90-day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an applicant for registration of
a product is exempt from the requirement to submit or cite generic data concerning an active
ingredient(s) if the active ingredient(s) in the product is derived exclusively from purchased,
registered pesticide products containing the active ingredient(s). EPA has concluded, as an
exercise of its discretion, that it normally will not suspend the registration of a product which
would qualify and continue to qualify for the generic data exemption in section 3(c)(2)(D) of
FIFRA. To qualify, all of the following requirements must be met:
a. The active ingredient(s) in your registered product must be present solely because
of incorporation of another registered product which contains the subject active
ingredient(s) and is purchased from a source not connected with you;
b. Every registrant who is the ultimate source of the active ingredient(s) in your
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product subject to this DCI must be in compliance with the requirements of this
Notice and must remain in compliance; and
c. You must have provided to EPA an accurate and current "Confidential Statement of
Formula" for each of your products to which this Notice applies.
To apply for the Generic Data Exemption, you must submit a completed Attachment 2,
Generic Data Call-In Response Forms And Instructions Form and all supporting
documentation. The Generic Data Exemption is item number 6a on the Attachment 2, Generic
Data Call-In Response Forms And Instructions Form. If you claim a generic data exemption,
you are not required to complete the Attachment 3, Generic Requirements Status and
Registrant's Response Forms and Instructions Form. Generic Data Exemption cannot be
selected as an option for product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons to
provide the Agency with the required data. If the registrant(s) who have committed to generate
and submit the required data fail to take appropriate steps to meet the requirements or are no
longer in compliance with this Data Call-In Notice, the Agency will consider that both they
and you are not in compliance and will normally initiate proceedings to suspend the
registrations of both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will not grant a
time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice - There are various options available to
satisfy the data requirements of this Notice. These options are discussed in Section III-C of
this Notice and comprise options 1 through 6 on the Attachment 3, Generic Requirements
Status and Registrant's Response Forms and Instructions Form and option
6b and 7 on the Attachment 2, Generic Data Call-In Response Forms And Instructions
Form. If you choose option 6b or 7, you must submit both forms as well as any other
information/data pertaining to the option chosen to address the data requirement.
5. Request for Data Waivers - Data waivers are discussed in Section III-D of this Notice and are
covered by options 8 and 9 on the Attachment 3, Generic Requirements Status and
Registrant's Response Forms and Instructions Form. If you choose one of these options, you
must submit both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Attachment 2 Generic Data Call-In Response Forms And
Instructions Form that you agree to satisfy the data requirements (i.e. you select option 6b
and/or 7), then you must select one of the six options on the Attachment 2, Generic Data
Call-In Response Forms And Instructions Form related to data production for each data
requirement. Your option selection is to be entered under item number 9, "Registrant
Response." The six options related to data production are the first six options discussed under
item 9 in the instructions for completing the Attachment 3, Generic Requirements Status and
Registrant's Response Forms and Instructions Form. These six options are listed immediately
below with information in parentheses to guide registrants to additional instructions provided in
this Section. The options are:
1. I will generate and submit data within the specified time frame (Developing Data),
2. I have entered into an agreement with one or more registrants to develop data jointly
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(Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
4. I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study),
5. I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study),
6. I am citing an existing study that EPA has classified as acceptable or an existing study
that has been submitted but not reviewed by the Agency (Citing an Existing Study).
Option 1, Developing Data –
If you choose to develop the required data, then it must be in conformance with the
Agency’s deadlines and other requirements that are referenced herein and in the
attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted in accordance with the Pesticide
Assessment Guidelines (PAG), be in conformance with Pesticide Registration Notice
(PRN) 2011-3 entitled “Standard Format for Data Submitted Under FIFRA and Certain
Provisions of FFDCA” (http://www.epa.gov/pesticide-registration/pesticide-registrationnotices-year), and, as applicable, comply with 40 CFR Part 26, “Protection of Human
Subjects.” In addition, certain studies require Agency approval of test protocols in
advance of study initiation. Those studies for which a protocol must be submitted have
been identified in the Attachment 3, Generic Requirements Status and Registrant's
Response Forms and Instructions Form and/or footnotes to the form. If you wish to use a
protocol which differs from the options discussed in Section II-C of this Notice, you must
submit a detailed description of the proposed protocol and your reason for wishing to use
it. The Agency may choose to reject a protocol not specified in Section II-C. If the
Agency rejects your protocol, you will be notified in writing, however, you should be
aware that rejection of a proposed protocol will not be a basis for extending the deadline
for submission of data.
A progress report must be submitted for each study within 90 days from the date you are
required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost-share or agreeing to share in the cost of
developing that study. A 90-day progress report must be submitted for all studies. This 90day progress report must include the date the study was or will be initiated and, for studies
to be started within 12 months of commitment, the name and address of the laboratories or
individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year, interim
reports must be submitted at 12 month intervals from the date you are required to commit
to generate or otherwise address the requirement for the study. In addition to the other
information specified in the preceding paragraph, at a minimum, a brief description of
current activity on and the status of the study must be included as well as a full description
of any problems encountered since the last progress report.
The time frames in the Generic Requirements Status and Registrant's Response
Forms and Instructions Form (Attachment 3) are those allowed by the Agency for the
submission of completed study reports or protocols. The noted deadlines run begin from the
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date of the receipt of this Notice by the registrant. If the data are not submitted by the
deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the affected
registration(s) and the affected tolerances or exemptions are subject to revocation.
If you cannot submit the data/reports to the Agency in the time required by this
Notice and intend to seek additional time to meet the requirement(s), you must submit a
request to the Agency which includes: (1) a detailed description of the expected difficulty
and (2) a proposed schedule including alternative dates for meeting such requirements on a
step-by-step basis. You must explain any technical or laboratory difficulties and provide
documentation from the laboratory performing the testing. While EPA is considering your
request, the original deadline remains. The Agency will respond to your request in writing.
If EPA does not grant your request, then the original deadline remains. Normally,
extensions can be requested only in cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in submitting the 90day responses. Extensions will not be considered if the request for extension is not made in
a timely fashion; in no event shall an extension request be considered if it is submitted at or
after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data –
If you choose to enter into an agreement to share in the cost of producing the required data
but will not be submitting the data yourself, you must provide the name of the registrant
who will be submitting the data. You must also provide EPA with documentary evidence
that an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of
the terms of the final arrangement between the parties or the mechanism to resolve the
terms. FIFRA section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development –
If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful,
you may request EPA (by selecting this option) to exercise its discretion not to suspend
your registration(s), although you do not comply with the data submission requirements of
this Notice. EPA has determined that as a general policy, absent other relevant
considerations, it will not suspend the registration of a product of a registrant who has in
good faith sought and continues to seek to enter into a joint data development/cost sharing
program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you
have made an offer to another registrant (who has an obligation to submit data) to share in
the burden of developing that data. You must also submit to the Agency a completed EPA
Form 8570-32, Certification of Offer to Cost Share in the Development of Data (see
Attachment 5). In addition, you must demonstrate that the other registrant to whom the
offer was made has not accepted your offer to enter into a cost sharing agreement by
including a copy of your offer and proof of the other registrant's receipt of that offer (such
as a certified mail receipt). Your offer must, in addition to anything else, offer to share in
the burden of producing the data upon terms to be agreed or failing agreement to be bound
by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify
this offer. The other registrant must also inform EPA of its election of an option to develop
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and submit the data required by this Notice by submitting a Generic Data Call-In Response
Forms And Instructions Form (Attachment 2) and a Generic Requirements Status and
Registrant's Response Forms and Instructions Form (Attachment 3) committing to develop
and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer to
share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit the required data in
the specified time frame. In such cases, the Agency generally will not grant a time
extension for submitting the data.
Option 4, Submitting an Existing Study –
If you choose to submit an existing study in response to this Notice, you must determine
that the study satisfies the requirements imposed by this Notice. You may only submit a
study that has not been previously submitted to the Agency or previously cited by anyone.
Existing studies are studies which predate issuance of this Notice. Do not use this option if
you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the existing study is not
acceptable, the Agency will require you to comply with this Notice, normally without an
extension of the required date of submission. The Agency may determine at any time that
a study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following four criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
As stated in 40 CFR Part 160.3(7) "raw data means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed verbatim, dated, and
verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. Raw data may include photographs,
microfilm or microfiche copies, computer printouts, magnetic media, including
dictated observations, and recorded data from automated instruments." The term
"specimens", according to 40 CFR Part 160.3(7), means "any material derived
from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLPrequired quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
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c. You must certify that each study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40
CFR Part 158.70 which states the Agency's policy regarding acceptable protocols.
If you wish to submit the study, you must, in addition to certifying that the
purposes of the PAG are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including copies of any
supporting information or data. You must identify each deviation from the PAG
and you need to explain and justify why the study should be accepted
notwithstanding such deviation(s). It has been the Agency's experience that
studies completed prior to January 1970 rarely satisfied the purpose of the PAG
and that necessary raw data are usually not available for such studies.
d. If any existing study involves testing subject to 40 CFR Part 26, you must comply
with all applicable requirements in EPA’s regulations at 40 CFR Part
26 entitled “Protection of Human Subjects.”
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were
addressed in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such a study is in the
Agency's files, you need only cite it along with the notification. If not in the Agency's
files, you must submit a summary and copies as per PRN 2011-3.
Option 5, Upgrading a Study –
If a study has been classified as partially acceptable and upgradeable, you may submit data
to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may
still be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important
to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, write
or email EPA as indicated in Attachment 1. If you submit data to upgrade an existing
study, you must satisfy or supply information to correct all deficiencies in the study
identified by EPA. You must provide a clearly articulated rationale of how the deficiencies
have been remedied or corrected and why the study should be rated as acceptable to EPA.
Your submission must also specify the MRID number(s) of the study which you are
attempting to upgrade and be in conformance with PRN 2011-3.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
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This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with
each of those criteria as well as a certification regarding protocol compliance with
Agency requirements.
Option 6, Citing Existing Studies –
If you choose to cite a study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable or it must be a study which has not
yet been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the
classification would be "acceptable." With respect to any studies for which you wish to
select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification
of the study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of Certification with Respect to Citations of Data (in PRN 2011-3)
EPA Form 8570-34.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request for a low
volume/minor use waiver and the second is a waiver request based on your belief that the
data requirement(s) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver (Option 8 on the Attachment 3, Generic Requirements
Status and Registrant's Response Forms and Instructions Form) Section 3(c)(2)(A) of
FIFRA requires EPA to consider the appropriateness of requiring data for low volume,
minor use pesticides. In implementing this provision EPA considers as low volume
pesticides only those active ingredient(s) whose total production volume for all pesticide
registrants is small. In determining whether to grant a low volume, minor use waiver the
Agency will consider the extent, pattern and volume of use, the economic incentive to
conduct the testing, the importance of the pesticide, and the exposure and risk from use
of the pesticide. If an active ingredient(s) is used for both high volume and low volume
uses, a low volume exemption will not be approved. If all uses of an active ingredient(s)
are low volume and the combined volumes for all uses are also low, then an exemption
may be granted, depending on review of other information outlined below. An
exemption will not be granted if any registrant of the active ingredient(s) elects to
conduct the testing. Any registrant receiving a low volume minor use waiver must
remain within the sales figures in their forecast supporting the waiver request in order to
remain qualified for such waiver. If granted a waiver, a registrant will be required, as a
condition of the waiver, to submit annual sales reports. The Agency will respond to
requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the following
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information, as applicable to your product(s), as part of your 90-day response to this
Notice:
a. Total company sales (pounds and dollars) of all registered product(s) containing
the active ingredient(s). If applicable to the active ingredient(s), include foreign
sales for those products that are not registered in this country but are applied to
sugar (cane or beet), coffee, bananas, cocoa, and other such crops. Present the
above information by year for each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active ingredient(s)
for each major use site. Present the above information by year for each of the
past five years.
c. Total direct production cost of product(s) containing the active ingredient(s) by
year for the past five years. Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other significant costs listed
separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient(s) by year for
the past five years. Exclude all non-recurring costs that were directly related to
the active ingredient(s), such as costs of initial registration and any data
development.
e. A list of each data requirement for which you seek a waiver. Indicate the type of
waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill each of
these data requirements.
f. A list of each data requirement for which you are not seeking any waiver and the
estimated cost to you (listed separately for each data requirement and associated
test) of conducting the testing needed to fulfill each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of company sales (pounds
and dollars) of the active ingredient(s), direct production costs of product(s)
containing the active ingredient(s) (following the parameters in item c above),
indirect production costs of product(s) containing the active ingredient(s)
(following the parameters in item d above), and costs of data development
pertaining to the active ingredient(s).
h. A description of the importance and unique benefits of the active ingredient(s) to
users. Discuss the use patterns and the effectiveness of the active ingredient(s)
relative to registered alternative chemicals and non-chemical control strategies.
Focus on benefits unique to the active ingredient(s), providing information that is
as quantitative as possible. If you do not have quantitative data upon which to base
your estimates, then present the reasoning used to derive your estimates. To assist
the Agency in determining the degree of importance of the active ingredient(s) in
terms of its benefits, you should provide information on any of the following
factors, as applicable to your product(s):
(a) documentation of the usefulness of the active ingredient(s) in Integrated
Pest Management,
11

(b) description of the beneficial impacts on the environment of use of the
active ingredient(s), as opposed to its registered alternatives,
(c) information on the breakdown of the active ingredient(s) after use and on its
persistence in the environment, and
(d) description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination regarding a
request for a low volume minor use waiver will result in denial of the request for a waiver.
Low volume minor use waivers may not be available for data required for continuation of
tolerances or exemptions.
2. Request for Waiver of Data (Option 9 on the Attachment 3, Generic Requirements Status and
Registrant's Response Forms and Instructions Form). This option may be used if you believe
that a particular data requirement should not apply because the corresponding use is no longer
registered and no tolerance or tolerance exemption exists or the requirement is inappropriate.
You must submit a rationale explaining why you believe the data requirements should not
apply. You must also submit the current label(s) of your product(s) and, if a current copy of
your Confidential Statement of Formula is not already on file you must submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency determines that the
data requirements of this Notice do not apply to your product(s), you will not be required to
supply the data pursuant to FIFRA section 3(c)(2)(B). If EPA determines that the data are
required for your product(s), you must choose a method of meeting the requirements of this
Notice within the time frame provided by this Notice. Within 30 days of your receipt of the
Agency's written decision, you must submit a revised Attachment 3, Generic Requirements
Status and Registrant's Response Forms and Instructions Form indicating the option chosen.
SECTION IV.

CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
NOTICE

A. NOTICE OF INTENT TO SUSPEND REGISTRATION/ORDER REVOKING OR
MODIFYING TOLERANCE OR EXEMPTION
The Agency may issue a Notice of Intent to Suspend products subject to this Notice or an
order revoking or modifying associated tolerances or tolerance exemptions due to failure by a
registrant to comply with the requirements of this Data Call-In Notice, pursuant to FIFRA
section 3(c)(2)(B) or FFDCA section 408(f). Events which may be the basis for issuance of a
Notice of Intent to Suspend or of an order revoking or modifying associated tolerances or
exemptions include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol when
such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any option
12

chosen to address the data requirements (e.g., any required action or information
pertaining to submission or citation of existing studies or offers, arrangements, or
arbitration on the sharing of costs or the formation of Task Forces, failure to comply with
the terms of an agreement or arbitration concerning joint data development or failure to
comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies, as
required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer, or failure of a
registrant on whom you rely for a generic data exemption either to:
a. Inform EPA of intent to develop and submit the data required by this Notice
on an Attachment 2, Generic Data Call-In Response Forms And Instructions
Form and an Attachment 3, Generic Requirements Status and Registrant's
Response Forms and Instructions Form; or,
b. Fulfill the commitment to develop and submit the data as required by this
Notice; or,
c. Otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend or an order
revoking or modifying a tolerance or tolerance exemption. The grounds for suspension
include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the
design, conduct, and reporting of required studies. Such requirements include, but are not
limited to, those relating to test material, test procedures, selection of species, number of
animals, sex and distribution of animals, dose and effect levels to be tested or attained,
duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting, the
completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice and that
set forth in PRN 2011-3. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
4. Requirements, as applicable, set forth in 40 CFR Part 26 entitled “Protection of Human
13

Subjects.”
C. EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or canceled if doing so would be consistent
with the purposes of FIFRA.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a FIFRA section 3(c)(2)(B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. You must also explain why an "existing stocks"
provision is necessary, including a statement of the quantity of existing stocks and your
estimate of the time required for their sale, distribution, and use. Unless you meet this burden,
the Agency will not consider any request pertaining to the continued sale, distribution, or use
of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90-day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily canceled products containing an active ingredient(s) for which the Agency has
particular risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90-day response period required by
this Notice will not result in the Agency granting any additional time to sell distribute or
use existing stocks beyond a year from the date the 90-day response was due unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all
progress reports and other information necessary to establish that you have been
conducting the study in an acceptable and good faith manner must have been submitted to
the Agency, before EPA will consider granting an existing stocks provision.
SECTION V.

REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS

Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide
is registered a registrant has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide the registrant shall submit the information to the
Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies
14

regarding unreasonable adverse effects on human health or the environment. This
requirement continues as long as the products are registered by the Agency.
SECTION VI.

INQUIRIES AND RESPONSES TO THIS NOTICE

If you have any questions regarding the requirements and procedures established by this
Notice, contact EPA as listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Attachment 2, Generic Data Call-In Response
Forms And Instructions Form and a completed Attachment 3, Generic Requirements Status and
Registrant's Response Forms and Instructions Form and any other documents required by this
Notice, and must be submitted either electronically through CDX or by mail as identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only
the Attachment 2, Generic Data Call-In Response Forms And Instructions Form need be
submitted.

Sincerely,

Anita Pease
Acting Director
Antimicrobials Division
Office of Pesticide Programs
U.S. Environmental Protection Agency

15

Attachment 1. Data Call-In Data Chemical Status Sheet

EPA Data Call-In Notice Attachment

DATA CALL-IN CHEMICAL STATUS SHEET
Submit all responses to the GDCI using the information below. To expedite processing, include
the GDCI identification number (e.g., GDCI-555555-5555) in the Subject line of all DCI-related
correspondence.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have specific questions or need assistance responding to the GDCI, contact the
Antimicrobials Division Reevaluation team at [email protected].
All responses to this notice for the GDCI data requirements are to be submitted electronically
through the Central Data Exchange (CDX) or by mail as described below.
If You Choose to Respond through the Central Data Exchange (CDX):
The DCI receipt acknowledgement, 90-day response, and data can be submitted through CDX
via the DCI application of the Pesticide Submission Portal (PSP). If you have a CDX account
with access to the PSP, you may follow the link below to sign in, acknowledge receipt, and
access your DCI(s): https://cdx.epa.gov/.
A user guide is available for instructions on what to do if you do not have a CDX account (page
16 in the link below) or if you need to add PSP to your account (page 51 in the link below):
https://cdx.epa.gov/content/documents/PSP/OPP_CDX_Pesticide_Submission_PortalRegistratio
n_UserGuidev1.0p.pdf.
If You Choose to Respond by Mail:*
By US mail:
US EPA, OPP/Antimicrobials Division (7510P)
c/o Front End Processing
Attn: Reevaluation Team Leader, PM 36
1200 Pennsylvania Ave NW
Washington, DC 20460

By express or courier service:
US EPA, OPP/Antimicrobials Division (7510P)
c/o Front End Processing
Room S-4910, One Potomac Yard (South)
Attn: Reevaluation Team Leader, PM 36
2777 South Crystal Drive
Arlington, VA 22202

*NOTE: If this DCI was sent to you via email, you may acknowledgement receipt via
email.

EPA Data Call-In Notice Attachment

Attachment 2. Generic Data Call-In Response Form
and Instructions

EPA Data Call-In Notice Attachment

INSTRUCTIONS: DATA CALL-IN RESPONSE FORM
These instructions apply to the form titled “Data Call-In Response” and are to be used to
respond to generic Data Call-Ins issued as part of EPA's Registration Review Program under
the Federal Insecticide, Fungicide, and Rodenticide Act. Read these instructions carefully
before filling out the forms.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed
by the registrant as appropriate. Items 8 through 11 must be completed by the registrant
before submitting a response to the Agency.
The respondent burden for this collection of information is estimated to average 15 minutes
per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. This is a mandatory collection under 40 CFR 158. An agency may not conduct
or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control number for this collection
of information is 2070-0174. Please send comments regarding the burden estimate or any
other aspect of this collection of information, including suggestions for reducing this burden,
to the Director, Regulatory Support Division, U.S. Environmental Protection Agency
(2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control
number in any correspondence. Do not send the completed form to this address.
Item #
Item 1.

GENERIC DATA CALL-IN RESPONSE Information
This item identifies your company name, number and address.

Item 2.

This item identifies the case number, case name, EPA chemical number and chemical
name.
This item identifies the type of Data Call-In. The date of issuance is date stamped.
This item identifies the EPA product registrations relevant to the data all-in. Note that
you are also responsible for informing the Agency of your response regarding any
product that you believe may be covered by this Data Call-In but that is not listed by
the Agency in Item 4. You must bring any such apparent omission to the Agency's
attention within the period required for submission of this response form.

Item 3.
Item 4.

Item 5.

Check this item for each product registration you wish to cancel voluntarily. If a
registration number is listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of that request. Since this Data
Call-in requires both generic and product specific data, you must complete item 5 on
both Data Call-In response form. You do not need to complete any item on the
Generic Requirements Status and Registrant's Response Forms and Instructions Form.

EPA Data Call-In Notice Attachment

Item #
Item 6a.

DATA CALL-IN RESPONSE Information
Check this Item if the Data Call-In is for generic data as indicated in Item 3 and you
are eligible for a Generic Data Exemption for the chemical listed in item 2 and used in
the subject product. By electing this exemption, you agree t6 the terms and conditions
of a Generic Data Exemption as explained in the Data Call-In Notice. If you are
eligible for or claim a Generic Data Exemption, enter the EPA Registration Number
of each registered source of that active ingredient that you use in your product.
Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance with
this and any other outstanding Data Call-In Notice), and incorporate that product
into all your products, you may complete this item for all products listed on this
form. If, however, you produce the active ingredient yourself, or Use any
unregistered product (regardless of the fact that some of your sources are
registered), you may not claim a Generic Data Exemption and you may not select
this item

Item 6b.

Check this Item if the Data Call-In is for generic data as indicated in Item 3 and if
you are agreeing to satisfy the generic data requirements of this Data Call-In. Attach
the "Generic Requirements Status and Registrant's Response Forms and
Instructions" Form that indicates how you will satisfy those requirements.
Note: You may provide additional information that does not fit on this form in a
signed letter that accompanies your response. For example, you may wish to report
that your product has already been transferred to another company or that you have
already voluntarily cancelled this product. For these cases, supply all relevant details
so that EPA can ensure that its records are correct.

Item 7a.
Item 7b.
Item 8.

Not Applicable
Not Applicable
This certification statement must be signed by an authorized representative of your
company and the person signing must include his/her title. Additional pages used in
your response must be initialed and dated in the space provided for the certification.

Items 9,
10, 11.

Provide date of signature, name of company, and telephone number.

EPA Data Call-In Notice Attachment

Attachment 3. Generic Requirements Status and
Registrant's Response Form and Instructions

EPA Data Call-In Notice Attachment

INSTRUCTIONS: REQUIREMENTS STATUS AND REGISTRANT’S RESPONSE FORM
These instructions apply to the form titled “Requirements Status and Registrant’s
Response” and are to be used to respond to generic Data Call-Ins issued as part of EPA's
Registration Review program under the Federal Insecticide, Fungicide, and Rodenticide
Act.
Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency. You may provide additional information that does not
fit on the form in a signed letter that accompanies this response. For example, you may
wish to report that your product has already been transferred to another company or that the
product has already been voluntarily cancelled.
The respondent burden for this collection of information is estimated to average 30
minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. This is a mandatory collection under 40 CFR 158. An agency
may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. The OMB control
number for this collection of information is 2070-0174. Please send comments regarding
the burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden, to the Director, Regulatory Support Division,
U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW,
Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not
send the completed form to this address.
Item #
1
2
3

4

DATA CALL-IN RESPONSE Information
This item completed by the Agency provides identifying information for the company
subject to the Data Call-In.
This item completed by the Agency identifies the case number, case name, EPA chemical
number and chemical name.
This item completed by the Agency identifies the type of Data Call-In. The date of
issuance is date stamped.
Note the unique identification number (ID#) assigned by the Agency. This ID number
must be used in the transmittal document for any data submissions in response to this
Data Call-In Notice.
This item completed by the Agency identifies the guideline reference number of studies
required. These guidelines, in addition to the requirements specified in the Data Call-In
Notice, govern the conduct of the required studies.
Note: Required studies for which no guideline exists (i.e., “special studies), registrants
are generally required to submit a protocol for EPA review prior to initiating the study.

EPA Data Call-In Notice Attachment

5

This item completed by the Agency identifies the study title associated with the
guideline reference number and whether protocols and 1, 2, or 3-year progress
reports are required to be submitted in connection with the study. As noted in
Section III of the Data Call-In Notice, 90-day progress reports are required for all
studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this guideline
reference number to the Generic Requirements Status and Registrant's Response Forms
and Instructions Form.

EPA Data Call-In Notice Attachment

Item #
6

DATA CALL-IN RESPONSE Information
This item completed by the Agency identifies the code associated with the use pattern of
the pesticide. A brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
P Aquatic non-food crop
Q Residential outdoor
R Agricultural premises and equipment
S Food handling/storage establishments, premises, & equipment
T Commercial, institutional & industrial premises, & equipment
U Residential and public access premises
V Medical premises and equipment
W Human drinking water systems
X Materials preservatives
Y Industrial processes and water systems – once through
Z Industrial processes and water systems – not once through
AA Antifouling coatings
BB Wood preservatives
CC Swimming pools
DD Aquatic areas
EE Indoor use
FF High exposure antimicrobial
GG Low exposure antimicrobial
HH Occupational use conventional chemical
II Residential use conventional chemical

EPA Data Call-In Notice Attachment

7

This item completed by the Agency identifies the code assigned to the substance that must
be used for testing. A brief description of each code follows: MP: Manufacturing-Use
Product
EUP: End-Use Product
MP: Manufacturing-Use Product
MP/TGAI: Manufacturing-Use Product and Technical Grade Active Ingredient
PAI: Pure Active Ingredient
PAI/M: Pure Active Ingredient and Metabolites
PAI/PAIRA: Pure Active Ingredient or Pure Active Ingredient Radiolabeled
PAIRA: Pure Active Ingredient Radiolabeled
PAIRA/M: Pure Active Ingredient Radiolabeled and Metabolites
PAIRA/PM: Pure Active Ingredient Radiolabeled and Plant Metabolites
TEP: Typical End-Use Product
TEP ___%: Typical End-Use Product, Percent Active Ingredient Specified
TEP/MET: Typical End-Use Product and Metabolites
TEP/PAI/M: Typical End-Use Product or Pure Active Ingredient and
Metabolites
TGAI: Technical Grade Active Ingredient
TGAI/PAI: Technical Grade Active Ingredient or Pure Active Ingredient
TGAI/PAIRA: Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabeled
TGAI/TEP: Technical Grade Active Ingredient or Typical End-Use Product
MET: Metabolites
IMP: Impurities
DEGR: Degradates

8

This item completed by the Agency identifies the time frame allowed for submission of
the study or protocol identified in item 5. The time frame runs from the date of your
receipt of the Data Call-In notice.

EPA Data Call-In Notice Attachment

Item # DATA CALL-IN RESPONSE Information
9
Enter the appropriate Response Code or Codes to show how you intend to comply with
each data requirement. Brief descriptions of each code follow. The Data Call-In Notice
contains a fuller description of each of these options.
1.

2.

3.

4.

5.

6.

7.
8.

9.

Developing Data: I will conduct a new study and submit it within the time frames
specified in item 8 above. By indicating that I have chosen this option, I certify that I
will comply with all the requirements pertaining to the conditions for submittal of this
study as outlined in the Data Call-In Notice and that I will provide the protocols and
progress reports required in item 5 above.
Agreement to Cost Share: I have entered into an agreement with one or more
registrants to develop data jointly. By indicating that I have chosen this option, I certify
that I will comply with all the requirements pertaining to sharing in the cost of
developing data as outlined in the Data Call-In Notice.
Offer to Cost Share: I have made an offer to enter into an agreement with one or more
registrants to develop data jointly. I am also submitting a completed "Certification of
offer to Cost Share in the Development of Data" form. I am submitting evidence that I
have made an offer to another registrant (who has an obligation to submit data) to share
in the cost of that data. I am including a copy of my offer and proof of the other
registrant's receipt of that offer. I am identifying the party which is committing to
submit or provide the required data; if the required study is not submitted on time, my
product may be subject to suspension. I understand that other terms under Option 3 in
the Data Call-In Notice apply as well.
Submitting Existing Data: I will submit an existing study by the specified due date
that has never before been submitted to EPA. By indicating that I have chosen this
option, I certify that this study meets all the requirements pertaining to the conditions
for submittal of existing data outlined in the Data Call-In Notice and I have attached
the needed supporting information along with this response.
Upgrading a Study: I will submit by the specified due date, or will cite data to-upgrade
a study that EPA has classified as partially acceptable and potentially upgradeable. Byindicating that I have chosen this option, I certify that I have met all the requirements
pertaining to the conditions for submitting or citing existing data to upgrade a study
described in the Data Call-In Notice. I am indicating on attached correspondence the
Master Record Identification Number (MRID) that EPA has assigned to the data that I
am citing as well as the MRID of the study I am attempting to upgrade.
Citing a Study: I am citing an existing study that has been previously classified by
EPA as acceptable, core, core minimum, or a study that has not yet been reviewed by
the Agency. If reviewed, I am providing the Agency's classification of the study.
Deleting Uses: I am attaching an application to amend my product’s (or products’)
labeling to delete the uses for which the data are required.
Low Volume/Minor Use Waiver Request: I have read the statements concerning low
volume-minor use data waivers in the Data Call-In Notice and I request a low-volume
minor use waiver of the data requirement. I am attaching a detailed justification to
support this waiver request including, among other things, all information required to
support the request. I understand that unless the Agency provides a written response
waiving the requirement to submit data, the data remain required and are to be
submitted according to the timelines specified in the Data Call-In Notice.
Request for Waiver of Data: I have read the statements concerning data waivers other
than low volume minor-use data waivers in the Data Call-In Notice and I request a
waiver of the data requirement. I am attaching a rationale explaining why I believe the
data requirements do not apply. I am also submitting a copy of my current labels. (You
must also submit a copy of your Confidential Statement of Formula if not already on file
with EPA). I understand that unless the Agency provides a written response waiving the
requirement to submit data, the data remain required and are to be submitted according
to the timelines specified in the Data Call-In Notice.

EPA Data Call-In Notice Attachment

Attachment 4. List of All Registrants Sent this Data
Call-In Notice

EPA Data Call-In Notice Attachment

Attachment 5. Additional Documents and Information

EPA Data Call-In Notice Attachment

LINKS TO FORMS:
The pesticide registration forms that are listed below can be found at:
http://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-20-forms-andhow-obtain-them
Link to Confidential Statement of Formula and Instructions (Form # 8570-4):
http://www.epa.gov/sites/production/files/2013-07/documents/8570-4_0.pdf
Certification of Attempt to Enter Into an Agreement With Registrants for Development of Data
(Form # 8570-32):
http://www.epa.gov/sites/production/files/2015-10/documents/8570-32.pdf
Certification With Respect to Citation of Data (Form # 8570-34):
http://www.epa.gov/sites/production/files/2013-08/documents/8570-34.pdf

ATTENTION DCI RESPONDENTS:
The supporting statement for the Information Collection Request (ICR) covering this DCI request is
entitled
“Pesticides Data Call-In Program” (OMB No. 2070-0174; EPA No. 2288).
For more information about the Agency’s burden estimates, please go to the following RegInfo.gov
website produced by the office of Management and Budget (OMB):
http://www.reginfo.gov/public/do/PRAMain.
From this site location, under the “Information Collection Review” heading, submit a search by the
agency name, or, in the blue bar area at top right of the page, select “ICR” and in the search window
nearby type the OMB control number (2070-0174), then click on the “Go” button at the right of the
search window.
Specifically the ICR associated with the DCI request is located at:
http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=2070-0174.

EPA Data Call-In Notice Attachment