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 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 WASHINGTON, D.C. 20460 

 OFFICE OF CHEMICAL

 SAFETY AND 

 POLLUTION PREVENTION

March 16, 2012 

GENERIC DATA CALL-IN NOTICE

CERTIFIED MAIL

Dear Sir or Madam:

This Notice requires you and other registrants of pesticide products containing the active 

ingredient(s) identified in Attachments 1 and 2 of this Notice to submit certain data as noted 

herein to the U.S. Environmental Protection Agency (EPA, the Agency). These data are 

necessary for the Registration Review of your pesticide product(s) in its Registration Review 

case and to maintain the continued registration of your product(s) containing the active 

ingredient(s). Within 90 days after you receive this Notice, you must respond as set forth in 

Section III below. Your response must state: 

1. How you will comply with the requirements set forth in this Notice and its Attachments 1 

through 5; or, 

2. Why you believe you are exempt from the requirements listed in this Notice and in 

Attachment 3, Generic Requirements Status and Registrant's Response Forms and 

Instructions Form, (see section III-B); or,

3. Why you believe EPA should not require your submission of data in the manner specified 

by this Notice (see section III-D). 

If you do not respond to this Notice, or if you do not satisfy EPA that you will comply 

with its requirements or should be exempt or excused from doing so, then the registration of your 

product(s) subject to this Notice will be subject to suspension. We have provided a list of all of 

your products subject to this Notice in Attachment 2, Generic Data Call-In Response Forms And 

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

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 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 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. 
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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 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
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A. SCHEDULE FOR RESPONDING TO THE AGENCY

 The appropriate responses initially required by this Notice must be submitted to 

the Agency within 90 days after your receipt of this Notice. Failure to adequately 

respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice 

of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of 

NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.

 

B. OPTIONS FOR RESPONDING TO THE AGENCY

The options for responding to this Notice are: 1) voluntary cancellation, 2) delete 

use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements 

imposed by this Notice or (5) request a data waiver(s). 

A discussion of how to respond if you chose the Voluntary Cancellation option, 

the Delete Use(s) option or the Generic Data Exemption option is presented below. A 

discussion of the various options available for satisfying the data requirements of this 

Notice is contained in Section III-C. A discussion of options relating to requests for data 

waivers is contained in Section III-D. 

There are two forms that accompany this Notice of which, depending upon your 

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

Attachment 2, Generic Data Call-In Response Forms And Instructions Form and the 

Attachment 3, Generic Requirements Status and Registrant's Response Forms and 

Instructions Form. The Attachment 2, Generic Data Call-In Response Forms And 

Instructions Form must be submitted as part of every response to this Notice. 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 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, 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 And Instructions Form, indicating your election of this option. 

Voluntary cancellation is item number 5 on the Attachment 2, Generic Data CallIn Response Forms And Instructions Form. If you choose this option, this is the 

only form that you are required to complete. 
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If you choose to voluntarily cancel your product, further sale and 

distribution of your product after the effective date of cancellation must be in 

accordance with the Existing Stocks provisions of this Notice which are contained 

in Section IV-C.

2. Use Deletion - You may avoid the requirements of this Notice by 

eliminating the uses of your product to which the requirements apply. If you wish 

to amend your registration to delete uses, you must submit the Attachment 3, 

Generic Requirements Status and Registrant's Response Forms and Instructions

Form, a completed application for amendment, a copy of your proposed amended 

labeling, and all other information required for processing the application. Use 

deletion is option number 7 on the Attachment 3, Generic Requirements Status 

and Registrant's Response Forms and Instructions Form. You must also 

complete an Attachment 2, Generic Data Call-In Response Forms And 

Instructions Form by signing the certification, item number 8. 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, 
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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 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
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If you acknowledge on the Attachment 2 Generic Data Call-In Response Forms 

And Instructions Form that you agree to satisfy the data requirements (i.e. you select 

option 6b and/or 7), then you must select one of the six options on the Attachment 2, 

Generic Data Call-In Response Forms And Instructions Form related to data production 

for each data requirement. Your option selection is to be entered under item number 9, 

"Registrant Response." The six options related to data production are the first six options 

discussed under item 9 in the instructions for completing the Attachment 3, Generic 

Requirements Status and Registrant's Response Forms and Instructions Form. These six 

options are listed immediately below with information in parentheses to guide registrants 

to additional instructions provided in this Section. The options are: 

1. I will generate and submit data within the specified time frame 

(Developing Data),

2. I have entered into an agreement with one or more registrants to develop 

data jointly (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. 
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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 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 
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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, 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 
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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 
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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 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. 
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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 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 -- 
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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 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.

 
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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) 
15

(following the parameters in item d above), and costs of data 

development pertaining to the active ingredient(s). 

h. A description of the importance and unique benefits of the 

active ingredient(s) to users. Discuss the use patterns and the 

effectiveness of the active ingredient(s) relative to registered 

alternative chemicals and non-chemical control strategies. Focus 

on benefits unique to the active ingredient(s), providing 

information that is as quantitative as possible. If you do not have 

quantitative data upon which to base your estimates, then present 

the reasoning used to derive your estimates. To assist the Agency 

in determining the degree of importance of the active ingredient(s) 

in terms of its benefits, you should provide information on any of 

the following factors, as applicable to your product(s): 

(a) documentation of the usefulness of the active 

ingredient(s) in Integrated Pest Management, (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 
16

this Notice. Within 30 days of your receipt of the Agency's written 

decision, you must submit a revised Attachment 3, Generic Requirements 

Status and Registrant's Response Forms and Instructions Form indicating 

the option chosen. 

SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS 

NOTICE

A. NOTICE OF INTENT TO SUSPEND REGISTRATION/ORDER 

REVOKING OR MODIFYING TOLERANCE OR EXEMPTION

The Agency may issue a Notice of Intent to Suspend products subject to 

this Notice or an order revoking or modifying associated tolerances or tolerance 

exemptions due to failure by a registrant to comply with the requirements of this 

Data Call-In Notice, pursuant to FIFRA section 3(c)(2)(B) or FFDCA section 

408(f). Events which may be the basis for issuance of a Notice of Intent to 

Suspend or of an order revoking or modifying associated tolerances or 

exemptions include, but are not limited to, the following: 

1. Failure to respond as required by this Notice within 90 days of 

your receipt of this Notice.

2. Failure to submit on the required schedule an acceptable proposed 

or final protocol when such is required to be submitted to the 

Agency for review.

3. Failure to submit on the required schedule an adequate progress 

report on a study as required by this Notice.

4. Failure to submit on the required schedule acceptable data as 

required by this Notice. 

5. Failure to take a required action or submit adequate information 

pertaining to any option 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.
17

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.
18

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 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.
19

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 man 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, call the contact person 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 should be submitted to the contact person 

identified in Attachment 1. If the voluntary cancellation or generic data exemption 

option is chosen, only the Attachment 2, Generic Data Call-In Response Forms And 

Instructions Form need be submitted. 

Sincerely,

Joan Harrigan-Farrelly, Director

Antimicrobials Division 

Office of Pesticide Programs

U.S. Environmental Protection Agency 
EPA Antimicrobials Division DCI Attachments

This page intentionally left blank
EPA Antimicrobials Division DCI Attachments

Attachment 1. Data Call-In Data Chemical Status Sheet
EPA Antimicrobials Division DCI Attachments

DATA CALL-IN CHEMICAL STATUS SHEET

Please submit all responses to the GDCI using the information below. To expedite processing, 

please include the GDCI identification number (e.g., GDCI-123456-789) in the Subject line of all 

DCI-related correspondence.

By US mail: By express or courier service:

Document Processing Desk (DCI/AD) Document Processing Desk (DCI/AD)

Attn: Reevaluation Team Leader, PM 36 Attn: Reevaluation Team Leader, PM 36

US EPA (7510P) US EPA (7510P)

1200 Pennsylvania Ave. N.W. One Potomac Yard (South Building)

Washington, DC 20460 2777 S. Crystal Dr.

Arlington, VA 22202

If you have chemical-specific questions or need assistance responding to the GDCI, please 

contact the chemical review manager (CRM) managing the DCI: Wanda Henson, 

Henson.Wanda@epa.gov, 703-308-6345. 
EPA Antimicrobials Division DCI Attachments

Attachment 2. Generic Data Call-In Response Form 

and Instructions 
EPA Antimicrobials Division DCI Attachments

This page intentionally left blank
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

1. Company Name and Address

 

N/A - 2,4-Imidazolidinedione, 1,3-bis(hydroxymethyl)-5,5-dimethylChemical # and Name: 115501

2,4-Imidazolidinedione, 1,3-bis(hydroxymethyl)-5,5-dimethyl16-Mar-2012

GENERIC

ID # GDCI-115501-1137

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page of 1 1

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

N/A

N/A

N/A

N/A

9. Date

11. Phone Number
This page intentionally left blank 
EPA Antimicrobials Division DCI Attachments

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. Please 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 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. 

Item # DATA CALL-IN RESPONSE Information

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 all-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 form. You do not need to complete any item on the 

Generic Requirements Status and Registrant's Response Forms and Instructions 

Form.
EPA Antimicrobials Division DCI Attachments

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 t6 the terms and 

conditions of a Generic Data Exemption as explained in the Data Call-In Notice. If 

you are eligible for or claim a Generic Data Exemption, enter the EPA registration 

Number of each registered source of that active ingredient that you use in your 

product. 

Typically, if you purchase an EPA-registered product from one or more other 

producers (who, with respect to the incorporated product, are in compliance with 

this and any other outstanding Data Call-In Notice), and incorporate that product 

into all your products, you may complete this item for all products listed on this 

form. If, however, you produce the active ingredient yourself, or Use any 

unregistered product (regardless of the fact that some of your sources are 

registered), you may not claim a Generic Data Exemption and you may not select 

this item

Item 6b. Check this Item if the Data Call-In is for generic data as indicated in Item 3 and if 

you are agreeing to satisfy the generic data requirements of this Data Call-In. Attach 

the "Generic Requirements Status and Registrant's Response Forms and 

Instructions" Form that indicates how you will satisfy those requirements. 

Note: You may provide additional information that does not fit on this form in a 

signed letter that accompanies your response. For example, you may wish to report 

that your product has already been transferred to another company or that you have 

already voluntarily cancelled this product. For these cases, 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.
EPA Antimicrobials Division DCI Attachments

Attachment 3. Generic Requirements Status and 

Registrant's Response Form and Instructions
EPA Antimicrobials Division DCI Attachments

This page intentionally left blank
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

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 _________________________________________________________________

 

Applicator Exposure Data Requirements (Conventional Chemical)

Environmental Fate Data Requirements (Conventional Chemical)

875.1100

875.1200

875.1300

875.1400

875.1600

875.1700

875.2700

835.2120

Dermal exposure--outdoor

Dermal exposure--Indoor

Inhalation exposure--outdoor

Inhalation exposure--indoor

Application exposure monitoring data reporting

Product Use Information

Product Use Information

Hydrolysis of parent and degradates as a function of 

pH at 25 C

N/A - 2,4-Imidazolidinedione, 1,3-bis(hydroxymethyl)-5,5-dimethylChemical # and Name: 115501

2,4-Imidazolidinedione, 1,3-bis(hydroxymethyl)-5,5-dimethyl16-Mar-2012

GENERIC

ID # GDCI-115501-1137

X

X

X

X

X

X

X

X

TEP

TEP

TEP

TEP

TEP

TEP

TEP

PAIRA; TGAI

24

24

24

24

24

12

12

12

Page 1 of 

(7, 12, 16, 

24)

(7, 11, 15, 

24)

(7, 12, 16, 

24)

(7, 11, 15, 

24)

(18, 21)

(34)

Y

Y

Y

Y

N

N

N

N

4
OMB Approval 2070-0174

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

 

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Post-Application Exposure Data Requirements (Conventional 

Chemical)

Toxicology Data Requirements (Conventional Chemical)

850.4400

850.5400

875.2300

875.2500

875.2900

875.3000

870.3150

Aquatic plant toxicity test using Lemna spp. Tiers I and

II

Algal toxicity, Tiers 1 and II

Indoor surface residue dissipation

Inhalation exposure

Data reporting and calculations

Nondietary ingestion exposure

90-day oral toxicity in nonrodents

N/A - 2,4-Imidazolidinedione, 1,3-bis(hydroxymethyl)-5,5-dimethylChemical # and Name: 115501

2,4-Imidazolidinedione, 1,3-bis(hydroxymethyl)-5,5-dimethyl16-Mar-2012

GENERIC

ID # GDCI-115501-1137

X

X

X

X

X

X

X

TEP; TGAI

TEP; TGAI

TEP

TEP

TEP

TEP

TGAI

12

12

24

24

24

24

24

Page 2 of 

(23, 26)

(23, 26)

(8, 10, 14, 

24)

(6, 9, 13, 24)

(17)

(13, 24, 36)

(31)

N

N

Y

N

N

Y

N

4
OMB Approval 2070-0174

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

 

Toxicology Data Requirements (Conventional Chemical)

870.3250

870.3465

870.3700

870.3800

870.4100

870.4200

870.7600

835.1110

90-day dermal toxicity

90-day inhalation toxicity

Prenatal developmental toxicity study

Reproduction and fertility effects

Chronic toxicity

Carcinogenicity

Dermal penetration

Activated sludge sorption isotherm

N/A - 2,4-Imidazolidinedione, 1,3-bis(hydroxymethyl)-5,5-dimethylChemical # and Name: 115501

2,4-Imidazolidinedione, 1,3-bis(hydroxymethyl)-5,5-dimethyl16-Mar-2012

GENERIC

ID # GDCI-115501-1137

X

X

X

X

X

X

X

X

TGAI/TGAI & EP

TGAI

TGAI

TGAI

TGAI

TGAI

CHOICE

TGAI

24

24

24

48

48

48

24

12

Page 3 of 

(19, 25)

(4, 29)

(2, 3, 22, 35, 

38)

(3, 32, 37)

(5, 28, 33)

(1, 5, 20, 27, 

28, 33)

(30)

N

N

N

N

N

N

N

N

4
OMB Approval 2070-0174

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

 

835.3110

850.6800

Ready biodegradability

Modified Activated Sludge Respiration Inhibition

N/A - 2,4-Imidazolidinedione, 1,3-bis(hydroxymethyl)-5,5-dimethylChemical # and Name: 115501

2,4-Imidazolidinedione, 1,3-bis(hydroxymethyl)-5,5-dimethyl16-Mar-2012

GENERIC

ID # GDCI-115501-1137

X

X

TGAI

TGAI

12

12

Page 4 of 

N

N

4
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - 2,4-Imidazolidinedione, 1,3-bis(hyd

GDCI-115501-1137

1

2

3

4

5

6

7

8

9

10

11

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

A 90-day range-finding study in both rats and mice is required to determine dose levels if carcinogenicity studies are required. If the mouse carcinogenicitiy study is not required, the 90-day mouse

subchronic study is likewise not required.

Additional testing by other routes may be required if the pesticide is determined to be a prenatal developmental toxicant after oral dosing.

An information-based approach to testing is preferred, which utilizes the best available knowledge on the chemical (hazard, pharmacokinetic, or mechanistic data) to determine whether a standard 

guideline study, an enhanced guideline study, or an alternative study should be conducted to assess potential hazard to the developing animal, or in some cases to support a waiver for such 

testing. Registrants should submit any alternative proposed testing protocols and supporting scientific rationale to the Agency prior to study initiation.

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.

Based on the results of the acute and subchronic neurotoxicity studies, or other available data, a combined chronic toxicity and neurotoxicity study may be required.

Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data provided the human pharmocokinetics of the pesticide and/or metabolite/analog 

compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for a back-calculation to the total internal dose.

Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data, provided the human pharmocokinetics of the pesticide and/or metabolite/analog 

compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for the back calculation to actual dose.

Bridging applicable residue dissipation data to dermal exposure is required.

Data are required for occupational sites if the human activity data indicate that workers are likely to have post-application exposures while participating in typical activities.

Data are required for occupational sites if the pesticide is applied to or around on non-plant surfaces, e.g., flooring or countertops, and if the human activity data indicate that workers are likely to 

have post-application dermal contact with treated indoor surfaces while participating in typical activities.

Data are required for occupational sites if the product is applied indoors.

Data are required for outdoor occupational site if the product is applied outdoors.

Data are required for residential sites if post-application exposures are likely.

Data are required for residential sites if the pesticide is applied to or around non-plant surfaces, e.g., flooring and countertops.

Data are required for residential use sites if the product is applied indoors.

Data are required for residential use sites if the product is applied outdoors.

Data reporting and calculations are required when any post-application exposure monitoring data are submitted. 

Data reporting and calculations are required when handler exposure data are submitted.

EP testing is required if the product, or any component of it, may increase dermal absorption of the active ingredient(s) as determined by testing using the TGAI, or increase toxic or pharmacologic 

effects.

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:

X - Materials preservatives

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - 2,4-Imidazolidinedione, 1,3-bis(hyd

GDCI-115501-1137

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

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

If this study is modified or waived, a subchronic 90-day oral study (guideline 870.3100) conducted in the same species may be required.

In accordance with 40 CFR 158.1020, OPPTS Guideline 875.1600 is required to accompany OPPTS Guidelines 875.1100 (Dermal Outdoor Exposure), 875.1200 (Dermal Indoor Exposure), 

875.1300 (Inhalation Outdoor Exposure), and 875.1400 (Inhalation Indoor Exposure). When all four GLNs are listed, the registrant is only required to perform two of the four tests, one dermal 

exposure and one inhalation exposure.

May be combined with the two-generation reproduction study in rodents (870.3800) by utilizing a second mating of the parental animals in either generation. The dams are to undergo a cesarean 

section at one day prior to expected delivery date and evaluated separately as specified in guideline 870.3700.

Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.

Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.

Required for food uses if either of the following criteria is met: (i) the use pattern is such that the dermal route would be the primary route of exposure; or (ii) the active ingredient is known or 

expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite is the toxic moiety.

Required if an aquatic species exhibits a 50 percent or greater detrimental effect in Tier 1.

Required if any of the following, as determined by the Agency, are met: (i) the use of the pesticide is likely to result in significant human exposure over a considerable portion of the human life span 

which is significant in terms of either time, duration, or magnitude of exposure; (ii) the use requires a tolerance or an exemption from the requirement of a tolerance be established; or (iii) the active 

ingredient, metabolite, degradate, or impurity (a) is structurally related to a recognized carcinogen, (b) causes mutagenic effects as demonstrated by in vitro or in vivo testing, or (c) produces a 

morphologic effect in any organ (e.g., hyperplasia, metaplasia) in subchronic studies that may lead to a neoplastic change.

Required if either of the following are met: (i) the use of the pesticide is likely to result in repeated human exposure over a considerable portion of the human lifespan, as determined by the Agency;

or (ii) the use requires a tolerance or an exemption from the requirement of a tolerance be established.

Required if there is the likelihood of significant repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol.

Required if toxic effects are identified in the oral or inhalation study. A risk assessment assuming that dermal absorption is equal to oral absorption must be performed to determine if the study is 

required, and to identify the doses and duration of exposure for which dermal absorption is to be quantified.

Required in rat for nonfood use pesticides if oral exposure could occur, such as through drinking water.

Required unless there is no significant human exposure, as determined by the Agency.

Studies which are designed to simultaneously fulfill the requirements of both the chronic oral and carcinogenicity studies (i.e., a combined study under guideline 870.4300) may be conducted. 

Minimum acceptable study durations are: (i) chronic rodent feeding study (food use) - 24 months; (ii) chronic rodent feeding study (nonfood use) - 12 months; (iii) chronic nonrodent feeding study - 

12 months; (iv) mouse carcinogenicity study - 18 months; (v) rat carcinogenicity study - 24 months.

Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites include, but are not limited to, agricultural premises, in or around farm buildings, barnyards, 

and beehives.

Testing in two species is required for all uses.

The selection of a sampling method will depend on the nondietary pathway(s) of interest. Data must be generated to consider all potential pathways of nondietary ingestion exposure that are 

applicable (e.g., soil ingestion, hand-to-mouth transfer, and object-to-mouth transfer of surface residues).

The use of a combined study that utilizes the two-generation reproduction study in rodents (870.3800) as a basic protocol for the addition of other endpoints or functional assessments in the 

immature animal is encouraged.

Unless the chemical or physical properties of the test substance, or the pattern of exposure, suggest a more appropriate route of exposure, the oral route, by oral intubation, is preferred.

Case # and Name:

DCI Number:

Page: 2 of 2
EPA Antimicrobials Division DCI Attachments

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 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 # DATA CALL-IN RESPONSE Information

1 This item completed by the Agency provides identifying information for the company 

subject to the Data Call-In. 

2 This item completed by the Agency identifies the case number, case name, EPA 

chemical number and chemical name.

3 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.

4 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.
EPA Antimicrobials Division DCI Attachments

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

7 This item completed by the Agency identifies the code assigned to the substance that 

must be used for testing. A brief description of each code follows: 

MP: Manufacturing-Use Product 

MPITGAI: Manufacturing-Use Product and Technical Grade ActiveIngredient

PAI: Pure Active Ingredient

PAI/M: Pure Active Ingredient and Metabolites

PAI/PAIRA: Pure Active Ingredient or Pure Active Ingredient

Radiolabelled

P AIRA: Pure Active Ingredient Radiolabelled

PAIRA/M: Pure Active Ingredient Radiolabelled and Metabolites

P AIRA/PM: Pure Active Ingredient Radiolabelled and Plant 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

8 This item completed by the Agency identifies the time frame allowed for submission of 

the study or protocol identified in item 5. The time frame runs from the date of your 

receipt of the Data Call-In notice.
EPA Antimicrobials Division DCI Attachments

Item # DATA CALL-IN RESPONSE Information

9 Enter the appropriate Response Code or Codes to show how you intend to comply with 

each data requirement. Brief descriptions of each code follow. The Data Call-lit 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.
EPA Antimicrobials Division DCI Attachments

This page intentionally left blank
EPA Antimicrobials Division DCI Attachments

Attachment 4. List of All Registrants Sent this Data 

Call-In Notice
EPA Antimicrobials Division DCI Attachments

This page intentionally left blank
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - 2,4-Imidazolidinedione, 1,3-bis(hyd

Page: 1 of 1

6836

88089

5383

47371

LONZA INC

BIOMED PROTECT, LLC

TROY CHEMICAL CORP

H & S CHEMICALS DIVISION

Co. Nr. Company Name Agent For Company

LANDIS INTERNATIONAL INC

90 BOROLINE ROAD

P.O. Box 5126

8 VREELAND ROAD, P.O. Box 955

90 BOROLINE ROAD

Address City ZIP

ALLENDALE 

VALDOSTA

FLORHAM PARK

ALLENDALE

07401 

316035126

079324200

07401 

OMB Approval 2070-0174

State

NJ

GA

NJ

NJ

 DCI Number: GDCI-115501-1137
This page intentionally left blank 
EPA Antimicrobials Division DCI Attachments

Attachment 5. Additional Documents and Information 
EPA Antimicrobials Division DCI Attachments

This page intentionally left blank
--.... _ .......... _. -.... _-- ...... _ ..... --_... -- .... _. -_ ... _ ....... -........... --.., ... ...... -..... _ ..... -.... -.-. . _--- . _ ...... ~ .-...... _. _ .... .. _. n._ JJ int]= m . __ ~ EPA United Stat as A. 0 Basic Formulation B. Gr Environment~1 Protection Agency 0 D D Saa Instructions on Back 

Washington, DC 20460 Alternative Formulation Page of 

Office of Pesticide Programs (7505C) - Confidential Statement of Formula 

1. Name and Address of Applicant/Registrant (lncluds ZIP Codsl 2. Name and Address of Producer (Include ZIP Codel 

3. Product Name 4. Registration No./File Symbol 5. EPA Product MgrfTeam No. 6. Country Whera Formulated 

7. Pounds/Gal or Bulk Density 8.pH 9. Flash Point/Flame Extension 

10. Components in Formulation (List BS Bctuslly 13. Each Component in 14. Certified Limit. 

introduced into ths formu/Btion. Givs commonly fomtulation 'J(, byW.ight 16. Purpoae 

EPA USE ONLY sccspted chemicsl nsme, trsds nsms, Bnd CAS 11 . Supplier Name & Address 12. EPA Reg. No. b. % by a . Upper b.lower in 

e. Amount Weight limit Limit Formulltion 

number. I 

-- .. _---,-- -

, 

. --_ .. -

_. 

, 6. Typed Name of Approving Official 17. Total Weight 100% 

- 18. Signature of Approving Official 1'9. Title 1 20. Phone No. "".Iude Ar •• Cod.1 j 21. Date 

EPA Form 8570-4 IRev. 8-941 White· EPA File Copy 10rigi08I) Pink· Applicant 

* U.&QPO: 1~20120414 
Instructions and Paperwork Act Notice 

Please Read Carefully Before Completing This Form 

Paperwork Reduction Act Notice 

The public reporting burden for this collection of 

information is estimated to average 1.0 hour per 

response, including familiarization with the form, 

organizing the necessary information, and 

completing the form. Send any 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, 2136, U.s. 

Environmental Protection Agency, 401 M Street, 

S.W., Washington, D.C. 20460. 

Instructions 

The complete chemical composition of each pesticide must be known so it can 

he evaluated for registration under the Federal Insecticide, Fungicide, and 

Rodenticide Act, as amended. 

This form is designed for reporting the ingredients used in the formulation of 

a pesticide product. It must be completed and submitted with each application 

for new registration of a pesticide and application for amended registration if 

the revision involves a formula change. 

Block A: Check the appropriate action for which you are submitting the 

form. 

Block B: Number all pages consecutively. Enter on each page the total 

number of pages submitted. If more than one page is required, number them 

"I of 2", "2 of2", "3 of3", etc. 

1. Name and Address of ApplicantlRegistrant: Enter the name and 

address of your firm or authorized agent. 

2. Name and Address of Producer: Specify the name of the producer and 

the address of the site where this product will be produced. 

3. Product Name: Specify the complete name of this pesticide product as it 

will appear on the label. This name must be the same as that which appears 

on the application form. 

4. Rcgistlation NumberlFilc Symbol: Enter the EPA registration number 

or file symbol, if known for this product 

S. EPA Product Managerffeam Number: Enter the name and team 

number of the EPA Product Manager assigned to this product, if known. 

6. Country Wbere Formulated: Specify the country where this product is 

formulated 

7. Weigbt per GalloDlBulk Density: For a liquid product specify pounds per 

gallon offormulated product. For a powder or granular product, enter the 

hulk density of formulated product (as used). Enter weight per unit if the 

product is produced as a tablet, briquette, or other uniformly shaped product 

8. pH: Enter the pH of aqueous formulations and products which are either 

dispersible or soluble in water. If not applicable enter "NI A'. 

9. Flasb PointIFlame Extension: Specify the flash point as determined by 

the regulations for pressurized products and/or products known or suspected 

to bum. State the results of the flame extension test for pressurized products 

including positive flashbacks. 

10. Components in Formulation: List as actually introduced into the 

formulation. For each component in your formulation, provide the product 

name, commonly accepted chemical, the trade name, and the Chemical 

Abstract (CAS) number for each identifiable ingredient present in the product. 

CAS numbers may be obtained from the Chemical Abstract Service ofthe 

American Chemical Society, Columbus, OH. For each original and 

alternate source of each active ingredient in the product, indicate the percent 

purity of the manufacturing use product, technical product, or other source 

of active ingredient. If one or more components will be obtained from more 

than one source, enter all alternate sources and all alternate EPA Reg. Nos. 

in blocks 10, II, and 12 or on a separate attachment. 

Attention: (Special Instructions for Columns 70, 13, and 14) Any impurities 

greater than or equal to 0.1% (or less than 0.1% if the impurity is 

toxicologically significant) which are associated with the active ingredient(s) 

ofn technical grade (manufacturing or reformulating use) product or an end 

use p'roduct produced by an integrated formulations system should also be 

listea in column 10, and the corresponding amount, percent by weight, and 

upper certified limits in columns I3 and 14. 

11. Supplier Name and Address: Provide the name and address of the 

supplier of each component in the formulation. If one or more components 

will be obtained from more than one source, specify the names addresses 

of the alternate sources also. 

EPA Form 8570-4 (Rev. 8-94) Reverse ·U.S. GOP: 2000-519-239/94558 

12. EPA Reg. No.: Specify the EPA registration number, if any, for each 

active ingredient in the formulation. If an unregistered active ingredient is 

used, have the suppliers submit the chemical specifications, as well as any 

data required under 40 CFR Part 158. 

13. Each Component in Formulation a. AmouDt: Specify the quantity of 

each component as actually introduced into the formulation. Units (e.g., 

pounds, grams, gallons, liters) should be expressed as used in the 

formulation. If the quantity is a liquid measure, enter the volume and the 

specific gravity or the pounds per gallon of the 

component. 

b. Percent by Weight: Specify the weight percentage of each component in 

your formulation. Check Your Calculations. Note that the weight percentage 

in many cases will not agree with that shown on the label ingredient statement 

where the weight percentage of the per active ingredient(s) must he declared. 

Attention: Producers of Microbial Products: Special Instructions for 

Column 13b.) Please state the percent of active ingredient in British 

International Units (BIUs). International Toxic Units (ITUs). Polyhedral 

Inclusion Bodies (PIBs)(viruses), Colony Forming Units (CFUs)(Fungi), as 

appropriate, and include an equivalent statement of active ingredient per 

milligram, ounce, pound, etc. of product (e.g., a 50% active Bacillus 

thuringiensis product may have an equivalency value of 1.59 million 

Aedis aegypti lTV per pound of product. 

14. Certified Limits: These limits are to be set based on representative 

sampling and chemicnl analysis (i.e., quality control) of the product. 

a. Upper Limit: Specify the maximum percentage of each active ingredient, 

intentionally added inert ingredient, and any impurities greater than 0.1 % to 

he permitted in the product. 

b. Lower Limit: Specify the minimum percentage of each active ingredient 

and intentionally added inert ingredient to he permitted in the product. 

IS. Purpose In Fonnulation: Specify the purpose of each ingredient both 

active and inert. (For example, disinfectant, herbicide, synergist surfactant, 

defoamer, sequestrant, etc.) If space is insufficient, abbreviate. 

16. Typed Name of Approving Offirial: Complete this item for 

identification of individual to he contacted if necessary 

17. Total Welgbt: Specify the total weight of the batch (column 13a.) 

18-21: Complete these items for identification of individual to be contacted if 

necessary. 
&EPA United States Environmental Protection Agency Form Approved. 

Washington, D.C. 20460 

OMB Nos. 2070-0057; CERTIFICATION OF ATTEMPT TO ENTER INTO AN 

AGREEMENT WITH REGISTRANTS FOR 2070-0107; 2070-0122; 

DEVELOPMENT OF DATA 2070-0164 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to 

average 15 minutes per response including time for reading the 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 the burden 

to: Director, Collection Strategies Division (2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, 

N.W., Washington, DC 20460 . Do not send the form to this address. 

Please fill in blanks below 

Company Name Company Number 

Chemical Name EPA Chemical Number 

I Certify that: 

My company is willing to develop and submit the data required by EPA under the authority of the Federal Insecticide, 

Rodenticide and Fungicide Act (FIFRA), if necessary. However, my company would prefer to enter into an agreement 

with one or more registrants to develop jOintly or share in the cost of developing data . 

My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an offer to be 

bound by arbitration under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all terms could not be reached 

otherwise. This offer was made to the following firm(s) on the following date(s): 

Name of Flrm(s) Date of Offer 

Certification: 

I certify that I am duly authorized to represent the company name above, and that the statements that I have made on 

this form and all attachments therein are true, accurate and complete. I acknowledge that any knowingly false or 

misleading statement may be punishable by fine or imprisonment or both under applicable law. 

Signature of Company's Authorized Representative Date 

Name and TIUe (Please Print or Type) 

EPA Form 8570-32 (12-2003) 
EPA Antimicrobials Division DCI Attachments

This page intentionally left blank
Form Approved OMB Nos. 2070-0060' 2070-0057; 2070-0107; 2070-0122' 2070-0164 

"'ft" UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

~~ 1200 Pennsylvania Avenue, N.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for registration 

and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send 

comments regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, Collection 

Strategies Division (2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. Do not send the completed form 

to this address. 

Certification with Respect to Citation of Data 

Applicant'sJRegistrant's Name, Address, and Telephone Number EPA Registration NumberlFile Symbol 

Active Inllredient(s) and/or representative test compound(s) Date 

General Use Pattem(s) (list all those claimed for this product using 40 CFR Part 158) Product Name 

NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to 

submit this form . You must submit the Formulator's Exemption Statement (EPA Form 8570-27). 

D I am responding to a Data-Call-In Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form should 

be used for this purpose). 

SECTION I: METHOD OF DATA SUPPORT (Check one method only) 

D I am using the cite-all method of support, and have included with this form D I am using the selective method of support (or cite-all option 

a list of companies sent offers of compensation (the Data Matrix form under the selective method), and have included with this form a 

should be used for this purpose). completed list of data requirements (the Data Matrix form must be 

used). 

SECTION II: GENERAL OFFER TO PAY 

[Required if using the cite-all method or when using the cite-all option under the selective method to satisfy one or more data requirements] 

D I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA. 

SECTION III: CERTIFICATION 

I certify that this application for registration, this form for reregistration, or this Data-Call-In response is supported by all data submitted or cited in the 

application for registration, the form for reregistration, or the Data-Call-In response. In addition, if the cite-all option or cite-all option under the selective method is 

indicated in Section I, this application is supported by all data in the Agency's files that (1) concem the properties or effects ofthis product or an identical or 

substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data 

requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar compOSition and 

uses . 

I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the original data submitter or that I have obtained 

the written permission of the original data submitter to cite that study. 

I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, either: (a) I am the original data 

submitter; (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) all periods of eligibility for 

compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study and have 

offered (I) to pay compensation to the extent required by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA; and (Ii) to commence negotiations to determine the 

amount and terms of compensation, if any, to be paid for the use of the study. 

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in 

accordance with sections 3(c)(1 )(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should I fail to produce such 

evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity with 

FIFRA. 

I certify that the statements I have made on this fonn and all attachments to It are true, accurate, and complete. I acknowledge that any 

knowingly false or misleading statement may be punishable by fine or Imprfsonment or both under applicable law. 

Signature Date Typed or Printed Name and Title 

EPA Form 8570-34 (12-2003) ElectrOniC and Paper versions available. Submit only Paper version. 
ATTENTION DCI RESPONDENTS 

Under the Paperwork Reduction Act (PRA), 44 U.S. C. 3501 et seq., 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 approval of an information collection can only be valid for up to three years, at 

which time the agency must ob~in a renewal of that approval. The c~ently valid OMB control numbers for the 

EPA regulations that appear in 40 CFR, after initial display in the final rule, are listed in 40 CFR part 9 and are 

included on the response form or collection instrument. 

For forms, in addition to the required i'nclusion of the OMB control number for the Information 

Collection Request (ICR) containing the form, EPA has traditionally included the lCR expiration date on the 

form. When forms remain substantively unchanged for many years, the printed inventory of the form may not 

-be exhausted before the expiration date used on the form. If the same form is approved as part of the renewal 

process, the agency may continue to use the remaining stocks of the paper form, even though that form containsaIJ. obsolete ~xpiration date. 

Although all of the attached forms that you are asked to utilize in responding to this DCI are currently 

approved by OMB, some contain obsolete expiration dates,or address and per response burden information in 

the PRA Notice. EPA is currently in the process 'of updating the electronic files of these forms, which are 

available on the internet at http://www.epa.gov/opprdOOllforms, at which time EPA will als.o update the contents 

of the PRA Notice included on each form or as. part of the instructions for the form. 

The public reporting and record keeping burden for this collection is estimated to average about 1063 

hours per response for OPP's Registration Review DCls and 596 hours for OPP's Reregistration DCls. This 

includes the time for review of the instructions, read and discuss test requirements, discuss test and protocol with 

the Agency, plan activities, search existing data sources, 'gather and maintain the data needed, create 

information, compile, process, complete and review the collection of information, complete written forms, 

record, disclose, and display information, and store, file or maintain information. This information (under 

Docket ID No. No. EPA-HQ-OPP-2007-0923-004).from Table 1 and Table Ib of the Final Supporting 

Statement for an Information Collection Request (ICR) for the Pesticide Data Call-In Program may be 

accessed via: http://www.regulations.gov , or by: 

http://www.regulations.gov/search/Regs/home.html#docketDetail ?R ==EPA -HO-O PP -2007 -0923 

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

including suggestions for reducing the burden, to Director, Collection Strategies Division (Mail Code 28221), 

U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the 

OMB control number in any correspondence, but do not submit the fqrm or report to this address. The actual 

information or form should be submitted in accordance with the instructions accompanying the information or 

form, specified in the corresponding regulation. 

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). OMB No. 2070-0174 

expires on May 31, 2012. 

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 go to the blue bar and select "advanced 

search." Type the control ntimber (2070-0174) in the "control number box" then click on "search at the bottom 

center of the page.