2288.21 Attachment A- Sample Data Call

EPA ICR No. 2288

Attachment A

OMB Control No. 2070-0174

[DCI ISSUANCE DATE]
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, 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:
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Section I. Why You Are Receiving This Notice
Section II. Data Required By This Notice
Section III. Compliance With Requirements Of This Notice
Section IV. Consequences Of Failure To Comply With This Notice
Section V. Registrants' Obligation To Report Possible Unreasonable Adverse Effects
Section VI. Inquiries and Responses To This Notice
The Attachments to this Notice are:
Attachment 1. Data Call-In Chemical Status Sheet
Attachment 2. Generic Data Call-In Response Forms and Instructions
Attachment 3. Generic Requirements Status and Registrant's Response Forms and Instructions
Attachment 4. List of All Registrants Sent this Data Call-In Notice
Attachment 5. 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
SECTION I. 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
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: 703-605- 6000) 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,
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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 202- 785-0350) and
electronically on the OECD website (
https://www.oecd.org/en/topics/sub-issues/testing-of-chemicals/test-guidelines.html ).
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, and depending upon your response, one or both
of those forms 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(s)
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.
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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 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
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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." Submitters can discuss with EPA how
best to meet the data needs and the objective of FIFRA and FFDCA’s data requirements under 40
CFR 158. EPA encourages registrants to consult with the Agency on proposals to use alternative
test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to
generate data intended to satisfy the DCI requirements. Similarly, EPA strongly encourages
registrants, before performing any testing, to consult with the Agency pertaining to any
nonguideline protocols. For more information on alternative test methods and strategies to reduce
vertebrate animal testing, visit https://www.epa.gov/chemical-research/new-approach-methodswork-plan. 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
(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 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-registration-notices-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 90-day
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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 begin from the 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 90-day 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, where 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
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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 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 GLP-required
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.
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
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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.
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
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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 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).

Page 9

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,
(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.

Page 10

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 that 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.

Page 11

5. Failure to take a required action or submit adequate information pertaining to any option 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
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
Page 12

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 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.

Page 13

Sincerely,
Name: TBD
Title: TBD
Division: TBD
Office: TBD
Agency: TBD
[DCI ISSUANCE DATE]

Page 14

Attachment 1. Data Call-In Data Chemical Status Sheet

Page 15

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 Chemical
Review Manager: [Chemical Review Manager] at: 111-222-3344 or at: [crm.name]@epa.gov.
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_PortalRegistration_
UserGuidev1.0p.pdf

If You Choose to Respond by Mail:*
By US mail, express or courier service:
Document Processing Desk (DCI/OPP)
Attn: [Chemical Review Manager]
US EPA (7504M)
1200 Pennsylvania Ave. N.W.
Washington, DC 20460
*NOTE: If this DCI was sent to you via email, you may acknowledge receipt via email.

Page 16

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

Page 17

Page 1 of 1

United States Environmental Protection Agency
Washington D.C. 20460
DATA CALL-IN RESPONSE

OMB Approval 2070-0174
Expiration Date 12/31/2025
EPA FORM 6300-4

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address

6. Generic Data

5. I wish to cancel
4. EPA Product

this product

Registration

registration
voluntarily

3. Date and Type of DCI and Number

2. Case # and Name

6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA
registration number listed
below.

7. Product Specific Data
7a. My product is an MUP and I
6b. I agree to satisfy Generic

agree to satisfy the MUP

Data Requirements as indicated

requirement on the attached

on the attached form entitled

form entitled "Requirements

"Requirements Status and

Status and Registrant's

Registrant's Response."

Response."

7b. My product is an EUP and I agree to satisfy the EUP
requirement on the attached form entitled "Requirements
Status and Registrant's Response."

8. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any knowingly
false or misleading statement may be punishable by fine, imprisonment or both under applicable law.

9. Date

Signature and Title of Company's Authorized Representative
10. Name of Company

11. Phone Number

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 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 Information Engagement Division Director, 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 #

GENERIC DATA CALL-IN RESPONSE Information

Item 1.

This item identifies your company name, number and address.

Item 2.
Item 3.

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.

Item 4.

This item identifies the EPA product registrations relevant to the data call-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 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.

Item #

DATA CALL-IN RESPONSE Information

Item 6a.

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 to 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

Page 18

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.

Not Applicable
Not Applicable

Item 8.

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.

Page 19

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

Page 20

Page 1 of 1

United States Environmental Protection Agency
Washington, D.C. 20460

OMB Approval 2070-0174

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

Expiration Date 12/31/2025

Paperwork Reduction Act Notice: This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et. seq. OMB Control No. 2070-0174. Responses to this collection of
information are mandatory 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
public reporting and recordkeeping burden for this collection of information is estimated 20 to 8128 hours per response. Send comments on the Agency’s need for this information, the accuracy of the provided
burden estimates and any suggested methods for minimizing respondent burden to the Information Engagement Division Director, 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.
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.
1. Company Name and Address

4. Guideline
Requirement

5. Study Title

Number

2. Case # and Name

P
R
O
T
O
C
O
L

Progress
Reports

3. Date and Type of DCI and Number

6. Use Pattern

7. Test Substance

10. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine, imprisonment or both under applicable law.

Signature and Title of Company's Authorized Representative

8. Time Frame

9. Registrant

(Months)

Response

11. Date

12. Name of Company
EPA FORM 6300-3

13. Phone Number

Page 1 of 1

United States Environmental Protection Agency
Washington D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name:
DCI Number:
Key: [Degr] = Degradate; [d-EP] = diluted End-use product; [EP] = End-use product; [MET] = Plant metabolite; [MP] = Manufacturing-use product; [PAI] = Pure Active Ingredient; [PAIRA] = Pure active ingredient
radio-labelled; [RAMET] = Radio-labeled plant metabolite; [ROC] = Residue of Concern; [TEP] = Typical end-use product; [TGAI] = Technical grade of the active ingredient; [TW] = Treated wood
Use Categories Key:

Footnotes: The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These footnotes apply in addition to any test notes included in 40 CFR
Part 158 with respect to the particular data requirement.

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 Information Engagement Division Director, 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.

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.

Page 24

Item #

DATA CALL-IN RESPONSE Information

6

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

Page 25

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:
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, Percent Active Ingredient Specified
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/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.

Page 26

Item #

9

DATA CALL-IN RESPONSE Information
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. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.

9. 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.

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

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Page 1 of 1

United States Environmental Protection Agency
Washington D.C. 20460

OMB Control No.
2070-0174

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name:
DCI Number:
Co. Nr.

Company Name

Agent For Company

Address

City

State

Zip

Attachment 5. Additional Documents and Information

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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-formsand-how-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 .

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