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 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 WASHINGTON, D.C. 20460 

 OFFICE OF CHEMICAL

 SAFETY AND 

 POLLUTION PREVENTION

 

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 Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, 

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 Plus 

Instructions Form, as well as a list of all registrants who were sent this Notice (Attachment 4). 

The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide 

and Rodenticide Act (FIFRA), as amended 7 U.S.C. section 136a(c)(2)(B), sections 3(g)(2)(A) 

and (B) of FIFRA, as amended 7 U.S.C. sections 136 (a)(g)(2)(A) and (B), and section 

408(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. section 

346a(f)(1)(A). This notice is also authorized by 40 CFR Part 155.48 and 40 CFR 155.53(b), 

which are sections in the Agency’s Registration Review regulations addressing the use of Data 
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Call-In Notices as part of Registration Review. 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 - 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 Plus 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 - Cost Share/Data Compensation (links to forms/attention DCI respondents) 

SECTION I. WHY YOU ARE RECEIVING THIS NOTICE 

The Agency has reviewed existing data for the active ingredient(s) identified in 

Attachment 1 of this Notice, Data Call In Chemical Status Sheet, and reevaluated the data needed 

to support continued registration of 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 the 

continued use 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
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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 test 

standards outlined in the Pesticide Assessment Guidelines for those studies for which 

guidelines have been established. 

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). 

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 202-785-0350). 

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 160.3(a)(6)]. 

D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) OR (4)(f)(1)(A) 

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 
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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 or both must be used in your response to the Agency. These forms are the 

Attachment 2, Generic Data Call-In Response Forms Plus 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 Plus 

Instructions Form must be submitted as part of every response to this Notice. Please note 

that the company's authorized representative is required to sign the first page of the 

Attachment 2, Generic Data Call-In Response Forms Plus 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, call or write the contact person 

identified 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 Plus Instructions Form, indicating your election of this option. 

Voluntary cancellation is item number 5 on the Attachment 2, Generic Data CallIn Response Forms Plus 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.
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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 Plus 

Instructions Form by signing the certification, item number 8. Application forms 

for amending registrations may be obtained from the Registration Division (Main 

Office), (703) 305-5447. 

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. 

Note: If all registrants for the subject active ingredient respond to this 

notice by requesting cancellation or deletion of uses, all tolerances 

associated with the registration or deleted uses will be revoked pursuant 

to FFDCA section 408(f)(2).

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; and, 

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 
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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 Plus Instructions Form and 

all supporting documentation. The Generic Data Exemption is item number 6a on 

the Attachment 2, Generic Data Call-In Response Forms Plus 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 Plus 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 

Plus 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, 
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Generic Data Call-In Response Forms Plus 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 (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 according to the 

Pesticide Assessment Guidelines (PAG), be in conformance with PR Notice 86-5, 

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 
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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 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 the time frames that 

the Agency is allowing for the submission of completed study reports or 

protocols. The noted deadlines run 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 
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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. 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 and 

submit the data required by this Notice by submitting a Generic Data Call-In 

Response Forms Plus Instructions Form (Attachment 2) and a Generic 

Requirements Status and Registrant's Response Forms and Instructions Form 
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(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, 
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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 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 
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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 PR Notice 86-5. 

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, call or 

write the contact person listed 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 PR Notice 86-5. 

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 
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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 PR Notice 98-5) 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 information, as applicable to your product(s), as part of your 90-day 

response to this Notice: 

 
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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). 
15

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. 

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) or section 4(f)(1)(A). 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 
16

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 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.
17

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 Plus 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.
18

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 PR 86-5. 

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 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 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, 

ATTACHMENT 2

GENERIC DATA CALL-IN RESPONSE FORMS PLUS 

INSTRUCTIONS
Initial to indicate certification as to information on this page

(full text of certification is on page one).

Date

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.

2. Case # and Name 3. Date and Type of DCI and Number

4. EPA Product 

Registration

5. I wish to cancel 

this product 

registration 

voluntarily

6. Generic Data 7. Product Specific Data

6a. I am claiming a Generic Data 

Exemption because I obtain the 

active ingredient from the source 

EPA registration number listed 

below.

6b. I agree to satisfy Generic Data

Requirements as indicated on the 

attached form entitled 

"Requirements Status and 

Registrant's Response."

7a. My product is an MUP and I 

agree to satisfy the MUP 

requirement on the attached form

entitled "Requirements Status and

Registrant's 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."

OMB Approval 2070-0174

EPA FORM 6300-4

1. Company Name and Address

ISK BIOSCIENCES CORPORATION

7470 AUBURN ROAD, SUITE A

CONCORD, OH 44077

N/A - Flonicamid

Chemical # and Name: 128016

Flonicamid

05-Jan-2016

GENERIC

ID # GDCI-128016-1528

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page 1 of 1

71512-7

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.

Signature and Title of Company's Authorized Representative ______________________________________________________

10. Name of Company

N/A N/A

9. Date

11. Phone Number 
Instructions For Completing The "Data Call-In Response Forms" For The Generic Data Call-In

INTRODUCTION

These instructions apply to the Generic "Data Call-In Response Forms" and are to be used by 

registrants to respond to generic Data Call-Ins issued as part of EPA's Registration Review Program 

under the Federal Insecticide, Fungicide, and Rodenticide Act. Please read these instructions carefully 

before filling out the forms. 

EPA has developed these forms individually for each registrant, and has preprinted these 

forms with a number of items. DO NOT use these forms for any other active ingredient. 

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 public reporting burden for this collection of information is estimated to average 15 

minutes per response, including time for reviewing instructions, searching existing data 

sources, gathering and maintaining the data needed, and completing and reviewing the 

collection of information. Send comments regarding the burden estimate or any other aspect of this 

collection of information, including suggestions for reducing this burden, to Chief, Information Policy 

Branch, Mail Code 2136, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. N.W., 

Washington, D.C. 20460; and to the Office of Management and Budget, Paperwork Reduction Project 

2070-0107, Washington, D.C. 20503. 
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS

Generic Data Call-In

Item 1. 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.

Item 3. 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. Please 

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 forms. You do not need to complete any item on the Generic Requirements 

Status and Registrant's Response Forms and Instructions Form. 

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.
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS

Generic Data Call-In

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, please 

supply all relevant details so that EPA can ensure that its records are correct.

 

Item 7a. NOT APPLICABLE 

Item 7b. 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. 
ATTACHMENT 3- 

GENERIC REQUIREMENTS STATUS AND REGISTRANT'S 

RESPONSE FORMS AND INSTRUCTIONS
Initial to indicate certification as to information on this page (full text of certification is on page one) 

13. Phone Number

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.

12. Name of Company

11. Date

OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

Signature and Title of Company's Authorized Representative _________________________________________________________________

ISK BIOSCIENCES CORPORATION

7470 AUBURN ROAD, SUITE A

CONCORD, OH 44077

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

850.4100

850.4150

850.1010

850.1025

850.1035

850.2100

850.3020

850.3030

Seedling Emergence and Seedling Growth

Vegetative Vigor

Aquatic invertebrate acute toxicity, test, freshwater 

daphnids

Oyster acute toxicity test (shell deposition)

Mysid acute toxicity test

Avian acute oral toxicity test

Honey bee acute contact toxicity

Honey bee toxicity of residues on foliage

N/A - Flonicamid

Chemical # and Name: 128016

Flonicamid

05-Jan-2016

GENERIC

ID # GDCI-128016-1528

C,B,A

C,B,A

C,B,A

C,B,A

C,B,A

C,B,A

C,B,A

C,B,A

TEP

TEP

TGAI

TGAI

TGAI

TGAI

TGAI

TEP

12

12

12

12

12

12

12

12

Page 1 of 

(6)

(6)

(17)

(17)

(17)

(18)

(2, 4, 9)

(1)

N

N

Y

Y

Y

N

Y

Y

3
OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

ISK BIOSCIENCES CORPORATION

7470 AUBURN ROAD, SUITE A

CONCORD, OH 44077

Toxicology Data Requirements (Conventional Chemical)

870.3465

850.3040

850.6100

SS-1155

SS-1254

SS-1256

SS-1257

SS-1314

90-day inhalation toxicity

Field testing for pollinators

Environmental Chemistry Methods and Associated 

Independent Laboratory Validation

Residues in Pollen and Nectar/Field Residue Analysis

Adult honeybee chronic oral toxicity

Acute oral toxicity--honeybee adult

Acute oral toxicity--honeybee larvae

Honey bee larvae chronic oral toxicity

N/A - Flonicamid

Chemical # and Name: 128016

Flonicamid

05-Jan-2016

GENERIC

ID # GDCI-128016-1528

C,B,A

C,B,A

C,B,A

C,B,A

C,B,A

C,B,A

C,B,A

C,B,A

TGAI

TEP

TGAI

TEP

TGAI

TGAI

TGAI

TGAI

24

24

12

24

12

12

12

12

Page 2 of 

(19)

(3, 8)

(15)

(3, 5)

(10)

(7)

(12, 13)

(11, 13)

N

Y

N

N

Y

Y

Y

Y

3
Date

OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

ISK BIOSCIENCES CORPORATION

7470 AUBURN ROAD, SUITE A

CONCORD, OH 44077

SS-1319 Semi-field testing for pollinators (tunnel or colony 

feeding studies)

N/A - Flonicamid

Chemical # and Name: 128016

Flonicamid

05-Jan-2016

GENERIC

ID # GDCI-128016-1528

C,B,A TEP 24

Page 3 of 

(3, 14, 16) Y

3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Flonicamid

GDCI-128016-1528

1

2

3

4

5

6

7

8

9

10

11

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

USEPA. 2012b. "Honey Bee Toxicity of Residues on Foliage." Ecological Effects Test Guidelines OCSPP 850.3030. EPA 712-C-018. Web. http://www.regulations.gov/#!documentDetail;D=EPAHQ-OPPT-2009-0154-0017

USEPA. 2012a. "Honey Bee Acute Contact Toxicity" Ecological Effects Test Guidelines OCSPP 850.3020. EPA 712-C-019 Web: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT2009-0154-0016

Tier II and III (semi-field and full field colony-level studies). The need for a higher tier test for pollinators will be determined based upon lower-tiered tests and/or other lines of data and the need 

for a refined pollinator risk assessment.

Tier I (laboratory-based study).

The following elements should be considered when developing study protocol(s) for the monitoring of residues in pollen/nectar. (1) Consideration of the range of application methods and 

environmental conditions (e.g., soil and hydric regimes) that the target crop(s) may be under. (2) Consideration of the attractiveness of the selected crop to pollinators (3) Consideration of a 

collection schedule sufficient to allow for an understanding of the character of residues, in the pollen/nectar and/or plant tissues, over time. (4) Consideration of data sufficient to determine 

whether residues of the active ingredient and/or degradation product(s) accumulates in soil and is/are bioavailable for plant to uptake in a following planting, and therefore result in potential 

exposure to pollinators. (5) Consideration of the market proportion of the selected target crop(s).

Test to assess the potential effects of the maximum seasonal application rate (0.268 lbs a.i./A) on non-target terrestrial plants.

See the OECD 213: OECD Guidelines for the Testing of Chemicals. Honeybees, Acute Oral Toxicity Test. 213. http://www.oecd-ilibrary.org/environment/test-no-213-honeybees-acute-oraltoxicity-test_9789264070165-en

See information and guidance identified in the EPA documents, (i) USEPA. 2012. White Paper in Support of the Proposed Risk Assessment Process for Bees. Submitted to the FIFRA Scientific 

Advisory Panel for Review and Comment September 11 - 14, 2012. Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs Environmental Fate and Effects Division, 

Environmentally Protection Agency, Washington, DC; Environmental Assessment Directorate, Pest Management Regulatory Agency, California Department of Pesticide Regulation. June 19, 2014. 

http://www2.epa.gov/sites/production/files/2014-06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf and USEPA. 2012c. "Field Testing for Pollinators." Ecological Effects Test 

Guidance OCSPP 850.3030. EPA 712-C-017. Web. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0018.

See also OECD 213: OECD Guidelines for the Testing of Chemicals. Test Number 214, Acute Contact Toxicity Test. http://www.oecd-ilibrary.org/environment/test-no-214-honeybees-acutecontact-toxicity-test_9789264070189-en;jsessionid=43gvto47wnue9.delta

OECD has not yet finalized test guidelines for chronic studies, and efforts are underway to develop standardized guidelines for assessing the effects from chronic exposure to adult and larvae 

in the laboratory. Discussion of the study design elements for the 10-day adult toxicity test can be found in Appendix O of the European Food Safety Authority (EFSA) guidance document: 

EFSA. Guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees. EFSA Journal 2013;11(7):3295, 266 pp. 

doi:10.2903/j.efsa.2013.3295. Available online at: http://www.efsa.europa.eu/en/efsajournal/doc/3295.pdf

OECD has not yet finalized test guidelines for chronic studies with honey bee larvae. OECD draft guidance is being developed, see OECD Draft Guidance Document Honey Bee (Apis mellifera) 

Larval Toxicity Test, Repeated Exposure, http://www.oecd.org/env/ehs/testing/Draft_GD_honeybees_rep_exp_for_2nd_CR_25_November_2013.pdf

Case # and Name:

DCI Number:

Page: 1 of

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.

Use Categories Key:

A - Terrestrial food crop

B - Terrestrial feed crop

C - Terrestrial nonfood crop

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Flonicamid

GDCI-128016-1528

12

13

14

15

16

17

18

19

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

OECD Test Guideline 237 may be used to develop a protocol for this study (OECD. 2013 Guidelines for Testing Chemicals. Honey bee (Apis mellifera) larval toxicity test, single exposure.) See: 

http://www.oecd-ilibrary.org/environment/test-no-237-honey-bee-apis-mellifera-larval-toxicity-test-single-exposure_9789264203723-en

In some cases, information pertaining to acute toxicity to honey bee larvae may be obtained with the chronic honey bee larvae test thereby negating the need for separate acute and chronic 

larval toxicity tests.

Formal guidelines for semi-field tests do not yet exist; however, information that can help guide the development of either a semi-field tunnel test protocol can be found at OECD 75, see: OECD. 

2007. Series on Testing and Assessment Number 75. Guidance document on the honey bee (Apis mellifera L.) brood test under semi-field conditions. Environmental Directorate Joint Meeting of 

the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. ENV/JM/MONO(2007)22. August 31, 2007. 

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2007)22&doclanguage=en

For water.

For field-feeding studies see the following: Oomen et al. 1992: Oomen, P. A. A. DeRuijter and J. Van der Steen. 1992. Method for honey bee brood feeding tests with insect growth-regulating 

insecticides. Bul OEPP/EPPO Bulletin 22: 613-616.

Extend the observation period beyond 96 hours to address potential delayed toxicity.

Data are preferred on the passerine species.

Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, e.g., 21 or 28-days, may be sufficient to satisfy this requirement. Registrants should consult 

with the Agency to determine whether studies of shorter duration would meet this requirement.

Case # and Name:

DCI Number:

Page: 2 of 2
INSTRUCTIONS FOR COMPLETING THE "GENERIC REQUIREMENTS STATUS AND 

REGISTRANT'S RESPONSE FORMS AND INSTRUCTIONS” FORM

INTRODUCTION

These instructions apply to the “Generic Requirements Status and Registrant's Response Forms and 

Instructions" Form and are to be used by registrants to respond to generic Data Call-In's 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. 

The public reporting 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. Send comments regarding the burden estimate or any other aspect of this collection of 

information, including suggestions for reducing this burden, to Chief, Information Policy Branch, Mail 

Code 2136, U.S. Environmental Protection Agency,1200 Pennsylvania Ave. N.W., Washington, D.C. 

20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107, 

Washington, D.C. 20503. 

Item 1. 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.

Item 3. This item identifies the type of Data Call-In. The date of issuance is date stamped. 

Note the unique identifier 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.

Item 4. This item 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 

Item 5. This item 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. 
Item 6. This item identifies the code associated with the use pattern of the pesticide. A brief 

description of each code follows: 

A Terrestrial food crop S Food handling/storage establishments, premises, & equipment 

B Terrestrial feed crop T Commercial, institutional & industrial premises, & equipment 

C Terrestrial non-food U Residential and public access premises 

D Aquatic food crop V Medical premises and equipment 

E Aquatic non-food outdoor W Human drinking water systems 

F Aquatic non-food industrial X Materials preservatives 

G Aquatic non-food residential Y Industrial processes and water systems – once through 

H Greenhouse food crop Z Industrial processes and water systems – not once through 

I Greenhouse non-food crop AA Antifouling coatings 

J Forestry BB Wood preservatives 

K Residential CC Swimming pools 

L Indoor food DD Aquatic areas

M Indoor non-food EE Indoor use 

N Indoor medical FF High exposure antimicrobial 

O Indoor residential GG Low exposure antimicrobial 

P Aquatic non-food crop HH Occupational use conventional chemical

Q Residential outdoor II Residential use conventional chemical

R Agricultural premises and equipment 

Item 7. This item 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 Indredient or Pure Active Ingredient Radiolabelled 

PAIRA Pure Active Ingredient Radiolabelled

PAIRA/M Pure Active Ingredient Radiolabelled and Metabolites

PAIRA/PM Pure Active Ingredient Radiolabelled 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 Radiolabelled

TGAI/TEP Technical Grade Active Ingredient or Typical End-Use Product 

MET Metabolites

IMP Impurities

DEGR Degradates
Item 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. 

Item 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. 

Option 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. 

Option 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.

Option 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. 

Option 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. 

Option 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. By 

indicating 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.
Option 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. 

The following three options (Numbers 7, 8, and 9) are responses that apply only to the “Generic 

Requirements Status and Registrant's Response Forms and Instructions” form. 

Option 7. (Deleting Uses) I am attaching an application for amendment to my registration deleting 

the uses for which the data are required. 

Option 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 modified by the Agency in writing, the 

data requirement as stated in the Notice governs.

Option 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 modified by the Agency in writing, the data 

requirement as stated in the Notice governs. 

NOTE: You may provide additional information that does not fit on this 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 you have already voluntarily cancelled. 
ATTACHMENT 4- 

LIST OF ALL REGISTRANTS

SENT THIS DATA CALL-IN NOTICE
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Flonicamid

Page: 1 of 1

71512 ISK BIOSCIENCES CORPORATION

Co. Nr. Company Name Agent For Company

7470 AUBURN ROAD, SUITE A

Address City ZIP

CONCORD 44077

OMB Approval 2070-0174

State

OH

 DCI Number: GDCI-128016-1528
ATTACHMENT 5 – 

COST SHARE/DATA COMPENSATION 

(LINKS TO FORMS/ATTENTION DCI RESPONDENTS) 
LINKS TO FORMS: 

The pesticide registration forms that are listed below can be found 

at: 

http://www2.epa.gov/pesticide-registration/pesticide-registration-manualchapter-20-forms-and-how-obtain-them

or 

http://www2.epa.gov/pesticide-registration/pesticide-registration-manualblank-forms

Link to Confidential Statement of Formula and Instructions (Form # 8570-4)

http://www2.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://www2.epa.gov/sites/production/files/2015-10/documents/8570-32.pdf

Certification With Respect to Citation of Data (Form # 8570-34)

http://www2.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. 2288.01).

 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/Forward?SearchTarget=PRA&textfield=2070-0174