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 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

 WASHINGTON, D.C. 20460 

 OFFICE OF CHEMICAL SAFETY AND 

 POLLUTION PREVENTION

July 17, 2013 

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 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: 
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Section I. Why You Are Receiving This Notice 

Section II. Data Required By This Notice 

Section III. Compliance With Requirements Of This Notice 

Section IV. Consequences Of Failure To Comply With This Notice 

Section V. Registrants' Obligation To Report Possible Unreasonable Adverse Effects 

Section VI. Inquiries And Responses To This Notice 

The Attachments to this Notice are: 

Attachment 1. Data Call-In Chemical Status Sheet 

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

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

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

Attachment 5. Additional Documents and Information 

• Confidential Statement of Formula and Instructions 

• Certification of Attempt to Enter into an Agreement with Registrants for 

Development of Data 

• Certification with Respect to Citation of Data 

• Paperwork Reduction Act Notification for DCI Respondents 

SECTION I. WHY YOU ARE RECEIVING THIS NOTICE 

The Agency has reviewed existing data for the active ingredient(s) identified in Attachments 2 

and 3 of this Notice, and reevaluated the data needed to support continued registration of the 

subject active ingredient(s) and the continuation of any existing tolerances or exemptions for 

such active ingredient. This reevaluation conducted as part of Registration Review identified 

additional data necessary to assess the health and safety of the continued use of products 

containing this active ingredient(s). You have been sent this Notice because you have product(s) 

containing the subject active ingredient(s). 

SECTION II. DATA REQUIRED BY THIS NOTICE

A. DATA REQUIRED

The data required by this Notice are specified in the Attachment 3, Generic Requirements 

Status and Registrant's Response Forms and Instructions Form. Depending on the results of 

the studies required in this Notice, additional testing may be required. 

B. SCHEDULE FOR SUBMISSION OF DATA

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). 
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Protocols approved by the Organization for Economic Cooperation and Development 

(OECD) are also acceptable if the OECD-recommended test standards conform to those 

specified in the Pesticide Data Requirements regulation (40 CFR Part 158.70). When using 

the OECD protocols, they should be modified as appropriate so that the data generated by the 

study will satisfy the requirements of 40 CFR Part 158. Normally, the Agency will not 

extend deadlines for complying with data requirements when the studies were not conducted 

in accordance with acceptable standards. The OECD protocols are available from 2001 L 

Street, N.W., Suite 650, Washington, D.C. 20036 (Telephone number 202-785-6323; Fax 

telephone number 202-785-0350). 

All new studies and proposed protocols submitted in response to this Data Call-In Notice 

must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)]. 

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

ISSUED BY THE AGENCY

Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the 

requirements of any previous Data Call-In(s), or any other agreements entered into with the 

Agency pertaining to such prior Notice. Registrants must comply with the requirements of all 

Notices to avoid issuance of a Notice of Intent to Suspend their affected products. 

SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

A. SCHEDULE FOR RESPONDING TO THE AGENCY

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

within 90 days after your receipt of this Notice. Failure to adequately 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 
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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 Call-In Response Forms And Instructions Form. If you 

choose this option, this is the only form that you are required to complete. 

If you choose to voluntarily cancel your product, further sale and distribution of your 

product after the effective date of cancellation must be in accordance with the Existing 

Stocks provisions of this Notice which are contained in Section IV-C. 

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

your product to which the requirements apply. If you wish to amend your registration to 

delete uses, you must submit the Attachment 3, Generic Requirements Status and 

Registrant's Response Forms and Instructions Form, a completed application for 

amendment, a copy of your proposed amended labeling, and all other information 

required for processing the application. Use deletion is option number 7 on the 

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

Instructions Form. You must also complete an Attachment 2, Generic Data Call-In 

Response Forms And Instructions Form by signing the certification, item number 8. 

Application forms for amending registrations may be obtained from the Registration 

Division (Main Office), (703) 305-5447. 

If you choose to delete the use(s) subject to this Notice or uses subject to specific data 

requirements, further sale, distribution, or use of your product after one year from the due 

date of your 90 day response, must bear an amended label. 

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

requesting cancellation or deletion of uses, all tolerances associated with the 

registration or deleted uses will be revoked pursuant to FFDCA section 408(f)(2).

3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an applicant for 

registration of a product is exempt from the requirement to submit or cite generic data 

concerning an active ingredient(s) if the active ingredient(s) in the product is derived 

exclusively from purchased, registered pesticide products containing the active 

ingredient(s). EPA has concluded, as an exercise of its discretion, that it normally will not 

suspend the registration of a product which would qualify and continue to qualify for the 

generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify, all of the following 

requirements must be met: 

a. The active ingredient(s) in your registered product must be present solely

because of incorporation of another registered product which contains the 

subject active ingredient(s) and is purchased from a source not connected with 

you; and, 

b. Every registrant who is the ultimate source of the active ingredient(s) in your 

product subject to this DCI must be in compliance with the requirements of 

this Notice and must remain in compliance; and 
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c. You must have provided to EPA an accurate and current "Confidential 

Statement of Formula" for each of your products to which this Notice applies. 

To apply for the Generic Data Exemption you must submit a completed Attachment 2, 

Generic Data Call-In Response Forms And Instructions Form and all supporting 

documentation. The Generic Data Exemption is item number 6a on the Attachment 2, 

Generic Data Call-In Response Forms And Instructions Form. If you claim a generic data 

exemption, you are not required to complete the Attachment 3, Generic Requirements 

Status and Registrant's Response Forms and Instructions Form. Generic Data Exemption 

cannot be selected as an option for product specific data. 

If you are granted a Generic Data Exemption, you rely on the efforts of other persons to 

provide the Agency with the required data. If the registrant(s) who have committed to 

generate and submit the required data fail to take appropriate steps to meet the 

requirements or are no longer in compliance with this Data Call-In Notice, the Agency 

will consider that both they and you are not in compliance and will normally initiate 

proceedings to suspend the registrations of both your and their product(s), unless you 

commit to submit and do submit the required data within the specified time. In such cases 

the Agency generally will not grant a time extension for submitting the data. 

4. Satisfying the Data Requirements of this Notice - There are various options available to 

satisfy the data requirements of this Notice. These options are discussed in Section III-C 

of this Notice and comprise options 1 through 6 on the Attachment 3, Generic 

Requirements Status and Registrant's Response Forms and Instructions Form and option 

6b and 7 on the Attachment 2, Generic Data Call-In Response Forms And Instructions

Form. If you choose option 6b or 7, you must submit both forms as well as any other 

information/data pertaining to the option chosen to address the data requirement. 

5. Request for Data Waivers - Data waivers are discussed in Section III-D of this Notice and 

are covered by options 8 and 9 on the Attachment 3, Generic Requirements Status and 

Registrant's Response Forms and Instructions Form. If you choose one of these options, 

you must submit both forms as well as any other information/data pertaining to the option 

chosen to address the data requirement. 

C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

If you acknowledge on the Attachment 2 Generic Data Call-In Response Forms And 

Instructions Form that you agree to satisfy the data requirements (i.e. you select option 6b 

and/or 7), then you must select one of the six options on the Attachment 2, Generic Data 

Call-In Response Forms And Instructions Form related to data production for each data 

requirement. Your option selection is to be entered under item number 9, "Registrant 

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

item 9 in the instructions for completing the Attachment 3, Generic Requirements Status and 

Registrant's Response Forms and Instructions Form. These six options are listed immediately 

below with information in parentheses to guide registrants to additional instructions provided 

in this Section. The options are: 

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

Data), 
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2. I have entered into an agreement with one or more registrants to develop data 

jointly (Cost Sharing), 

3. I have made offers to cost-share (Offers to Cost Share), 

4. I am submitting an existing study that has not been submitted previously to the 

Agency by anyone (Submitting an Existing Study), 

5. I am submitting or citing data to upgrade a study classified by EPA as partially 

acceptable and upgradeable (Upgrading a Study), 

6. I am citing an existing study that EPA has classified as acceptable or an existing 

study that has been submitted but not reviewed by the Agency (Citing an Existing 

Study). 

Option 1, Developing Data – 

If you choose to develop the required data, then it must be in conformance with the 

Agency’s deadlines and other requirements that are referenced herein and in the 

attachments. All data generated and submitted must comply with the Good 

Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the 

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

and, as applicable, comply with 40 CFR Part 26, “Protection of Human Subjects.” In 

addition, certain studies require Agency approval of test protocols in advance of study 

initiation. Those studies for which a protocol must be submitted have been identified 

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

and Instructions Form and/or footnotes to the form. If you wish to use a protocol 

which differs from the options discussed in Section II-C of this Notice, you must 

submit a detailed description of the proposed protocol and your reason for wishing to 

use it. The Agency may choose to reject a protocol not specified in Section II-C. If 

the Agency rejects your protocol, you 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 
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allowing for the submission of completed study reports or protocols. The noted 

deadlines run from the date of the receipt of this Notice by the registrant. If the data 

are not submitted by the deadline, each registrant is subject to receipt of a Notice of 

Intent to Suspend the affected registration(s) and the affected tolerances or 

exemptions are subject to revocation. 

If you cannot submit the data/reports to the Agency in the time required by this 

Notice and intend to seek additional time to meet the requirement(s), you must submit 

a request to the Agency which includes: (1) a detailed description of the expected 

difficulty and (2) a proposed schedule including alternative dates for meeting such 

requirements on a step-by-step basis. You must explain any technical or laboratory 

difficulties and provide documentation from the laboratory performing the testing. 

While EPA is considering your request, the original deadline remains. The Agency 

will respond to your request in writing. If EPA does not grant your request, then the 

original deadline remains. Normally, extensions can be requested only in cases of 

extraordinary testing problems beyond the expectation or control of the registrant. 

Extensions will not be given in submitting the 90-day responses. Extensions will not 

be considered if the request for extension is not made in a timely fashion; in no event 

shall an 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, 
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you must demonstrate that the other registrant to whom the offer was made has not 

accepted your offer to enter into a cost sharing agreement by including a copy of your 

offer and proof of the other registrant's receipt of that offer (such as a certified mail 

receipt). Your offer must, in addition to anything else, offer to share in the burden of 

producing the data upon terms to be agreed or failing agreement to be bound by 

binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify 

this offer. The other registrant must also inform EPA of its election of an option to 

develop and submit the data required by this Notice by submitting a Generic Data 

Call-In Response Forms And Instructions Form (Attachment 2) and a Generic 

Requirements Status and Registrant's Response Forms and Instructions Form 

(Attachment 3) committing to develop and submit the data required by this Notice. 

In order for you to avoid suspension under this option, you may not withdraw your 

offer to share in the burdens of developing the data. In addition, the other registrant 

must fulfill its commitment to develop and submit the data as required by this Notice. 

If the other registrant fails to develop the data or for some other reason is subject to 

suspension, your registration as well as that of the other registrant will normally be 

subject to initiation of suspension proceedings, unless you commit to submit, and do 

submit the required data in the specified time frame. In such cases, the Agency 

generally will not grant a time extension for submitting the data. 

Option 4, Submitting an Existing Study – 

If you choose to submit an existing study in response to this Notice, you must 

determine that the study satisfies the requirements imposed by this Notice. You may 

only submit a study that has not been previously submitted to the Agency or 

previously cited by anyone. Existing studies are studies which predate issuance of this 

Notice. Do not use this option if you are submitting data to upgrade a study. (See 

Option 5). 

You should be aware that if the Agency determines that the existing study is not 

acceptable, the Agency will require you to comply with this Notice, normally without 

an extension of the required date of submission. The Agency may determine at any 

time that a study is not valid and needs to be repeated. 

To meet the requirements of the DCI Notice for submitting an existing study, all of 

the following four criteria must be clearly met: 

a. You must certify at the time that the existing study is submitted that the raw 

data and specimens from the study are available for audit and review and you 

must identify where they are available. This must be done in accordance with 

the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR 

Part 160. As stated in 40 CFR Part 160.3(7) "raw data means any laboratory 

worksheets, records, memoranda, notes, or exact copies thereof, that are the 

result of original observations and activities of a study and are necessary for 

the reconstruction and evaluation of the report of that study. In the event that 

exact transcripts of raw data have been prepared (e.g., tapes which have been 

transcribed verbatim, dated, and verified accurate by signature), the exact 

copy or exact transcript may be substituted for the original source as raw data. 

Raw data may include photographs, microfilm or microfiche copies, computer 
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printouts, magnetic media, including dictated observations, and recorded data 

from automated instruments." The term "specimens", according to 40 CFR 

Part 160.3(7), means "any material derived from a test system for examination 

or analysis." 

b. Health and safety studies completed after May 1984 must also contain all 

GLP-required quality assurance and quality control information, pursuant to 

the requirements of 40 CFR Part 160. Registrants must also certify at the time 

of submitting the existing study that such GLP information is available for 

post-May 1984 studies by including an appropriate statement on or attached to 

the study signed by an authorized official or representative of the registrant. 

c. You must certify that each study has been conducted according to the 

Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG 

(both available from NTIS). A study not conducted according to the PAG may 

be submitted to the Agency for consideration if the registrant believes that the 

study clearly meets the purpose of the PAG. The registrant is referred to 40 

CFR Part 158.70 which states the Agency's policy regarding acceptable 

protocols. If you wish to submit the study, you must, in addition to certifying 

that the purposes of the PAG are met by the study, clearly articulate the 

rationale why you believe the study meets the purpose of the PAG, including 

copies of any supporting information or data. You must identify each 

deviation from the PAG and you need to explain and justify why the study 

should be accepted notwithstanding such deviation(s). It has been the 

Agency's experience that studies completed prior to January 1970 rarely 

satisfied the purpose of the PAG and that necessary raw data are usually not 

available for such studies. 

d. If any existing study involves testing subject to 40 CFR Part 26, you must 

comply with all applicable requirements in EPA’s regulations at 40 CFR Part 

26 entitled “Protection of Human Subjects.” 

If you submit an existing study, you must certify that the study meets all requirements 

of the criteria outlined above. 

If EPA has previously reviewed a protocol for a study you are submitting, you must 

identify any action taken by the Agency on the protocol and must indicate, as part of 

your certification, the manner in which all Agency comments, concerns, or issues 

were addressed in the final protocol and study. 

If you know of a study pertaining to any requirement in this Notice which does not 

meet the criteria outlined above but does contain factual information regarding 

unreasonable adverse effects, you must notify the Agency of such a 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, 
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you may still be required to submit new data normally without any time extension. 

Deficient, but upgradeable studies will normally be classified as supplemental. 

However, it is important to note that not all studies classified as supplemental are 

upgradeable. If you have questions regarding the classification of a study or whether a 

study may be upgraded, call or write the contact person listed in Attachment 1. If you 

submit data to upgrade an existing study, you must satisfy or supply information to 

correct all deficiencies in the study identified by EPA. You must provide a clearly 

articulated rationale of how the deficiencies have been remedied or corrected and why 

the study should be rated as acceptable to EPA. Your submission must also specify 

the MRID number(s) of the study which you are attempting to upgrade and be in 

conformance with PR Notice 86-5. 

Do not submit additional data for the purpose of upgrading a study classified as 

unacceptable and determined by the Agency as not capable of being upgraded. 

This option should also be used to cite data that has been previously submitted to 

upgrade a study, but has not yet been reviewed by the Agency. You must provide the 

MRID number of the data submission as well as the MRID number of the study being 

upgraded. 

The criteria for submitting an existing study, as specified in Option 4 above, apply to 

all data submissions intended to upgrade studies. Additionally your submission of 

data intended to upgrade studies must be accompanied by a certification that you 

comply with each of those criteria as well as a certification regarding protocol 

compliance with Agency requirements. 

Option 6, Citing Existing Studies – 

If you choose to cite a study that has been previously submitted to EPA, that study 

must have been previously classified by EPA as acceptable or it must be a study 

which has not yet been reviewed by the Agency. Acceptable toxicology studies 

generally will have been classified as "core-guideline" or "core 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 
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pesticides only those active ingredient(s) whose total production volume for all pesticide 

registrants is small. In determining whether to grant a low volume, minor use waiver the 

Agency will consider the extent, pattern and volume of use, the economic incentive to 

conduct the testing, the importance of the pesticide, and the exposure and risk from use of 

the pesticide. If an active ingredient(s) is used for both high volume and low volume 

uses, a low volume exemption will not be approved. If all uses of an active ingredient(s) 

are low volume and the combined volumes for all uses are also low, then an exemption 

may be granted, depending on review of other information outlined below. An exemption 

will not be granted if any registrant of the active ingredient(s) elects to conduct the 

testing. Any registrant receiving a low volume minor use waiver must remain within the 

sales figures in their forecast supporting the waiver request in order to remain qualified 

for such waiver. If granted a waiver, a registrant will be required, as a condition of the 

waiver, to submit annual sales reports. The Agency will respond to requests for waivers 

in writing. 

To apply for a low volume, minor use waiver, you must submit the following 

information, as applicable to your product(s), as part of your 90-day response to this 

Notice: 

a. Total company sales (pounds and dollars) of all registered product(s) 

containing the active ingredient(s). If applicable to the active ingredient(s), 

include foreign sales for those products that are not registered in this country 

but are applied to sugar (cane or beet), coffee, bananas, cocoa, and other such 

crops. Present the above information by year for each of the past five years. 

b. Provide an estimate of the sales (pounds and dollars) of the active 

ingredient(s) for each major use site. Present the above information by year 

for each of the past five years. 

c. Total direct production cost of product(s) containing the active ingredient(s) 

by year for the past five years. Include information on raw material cost, 

direct labor cost, advertising, sales and marketing, and any other significant 

costs listed separately. 

d. Total indirect production cost (e.g. plant overhead, amortized plant and 

equipment) charged to product(s) containing the active ingredient(s) by year 

for the past five years. Exclude all non-recurring costs that were directly 

related to the active ingredient(s), such as costs of initial registration and any 

data development. 

e. A list of each data requirement for which you seek a waiver. Indicate the type 

of waiver sought and the estimated cost to you (listed separately for each data 

requirement and associated test) of conducting the testing needed to fulfill 

each of these data requirements. 

f. A list of each data requirement for which you are not seeking any waiver and 

the estimated cost to you (listed separately for each data requirement and 

associated test) of conducting the testing needed to fulfill each of these data 

requirements. 
12

g. For each of the next ten years, a year-by-year forecast of company sales 

(pounds and dollars) of the active ingredient(s), direct production costs of 

product(s) containing the active ingredient(s) (following the parameters in 

item c above), indirect production costs of product(s) containing the active 

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

development pertaining to the active ingredient(s). 

h. A description of the importance and unique benefits of the active ingredient(s) 

to users. Discuss the use patterns and the effectiveness of the active 

ingredient(s) relative to registered alternative chemicals and non-chemical 

control strategies. Focus on benefits unique to the active ingredient(s), 

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

quantitative data upon which to base your estimates, then present the 

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

the degree of importance of the active ingredient(s) in terms of its benefits, 

you should provide information on any of the following factors, as applicable 

to your product(s): 

(a) documentation of the usefulness of the active ingredient(s) in Integrated 

Pest Management, 

(b) description of the beneficial impacts on the environment of use of the 

active ingredient(s), as opposed to its registered alternatives, 

(c) information on the breakdown of the active ingredient(s) after use and on 

its persistence in the environment, and 

(d) description of its usefulness against a pest(s) of public health significance. 

Failure to submit sufficient information for the Agency to make a determination 

regarding a request for a low volume minor use waiver will result in denial of the request 

for a waiver. Low volume minor use waivers may not be available for data required for 

continuation of tolerances or exemptions. 

2. Request for Waiver of Data (Option 9 on the Attachment 3, Generic Requirements Status 

and Registrant's Response Forms and Instructions Form). This option may be used if you 

believe that a particular data requirement should not apply because the corresponding use 

is no longer registered and no tolerance or tolerance exemption exists or the requirement 

is inappropriate. You must submit a rationale explaining why you believe the data 

requirements should not apply. You must also submit the current label(s) of your 

product(s) and, if a current copy of your Confidential Statement of Formula is not already 

on file you must submit a current copy. 

You will be informed of the Agency's decision in writing. If the Agency determines that 

the data requirements of this Notice do not apply to your product(s), you will not be 

required to supply the data pursuant to FIFRA section 3(c)(2)(B) or section 4(f)(1)(A). If 

EPA determines that the data are required for your product(s), you must choose a method 

of meeting the requirements of this Notice within the time frame provided by this Notice.

Within 30 days of your receipt of the Agency's written decision, you must submit a 

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

and Instructions Form indicating the option chosen. 
13

SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS 

NOTICE

A. NOTICE OF INTENT TO SUSPEND REGISTRATION/ORDER REVOKING OR 

MODIFYING TOLERANCE OR EXEMPTION

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

order revoking or modifying associated tolerances or tolerance exemptions due to failure by a 

registrant to comply with the requirements of this Data Call-In Notice, pursuant to FIFRA 

section 3(c)(2)(B) or FFDCA section 408(f). Events which may be the basis for issuance of a 

Notice of Intent to Suspend or of an order revoking or modifying associated tolerances or 

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

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

Notice. 

2. Failure to submit on the required schedule an acceptable proposed or final protocol when 

such is required to be submitted to the Agency for review. 

3. Failure to submit on the required schedule an adequate progress report on a study as 

required by this Notice. 

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

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

chosen to address the data requirements (e.g., any required action or information 

pertaining to submission or citation of existing studies or offers, arrangements, or 

arbitration on the sharing of costs or the formation of Task Forces, failure to comply with 

the terms of an agreement or arbitration concerning joint data development or failure to 

comply with any terms of a data waiver). 

6. Failure to submit supportable certifications as to the conditions of submitted studies, as 

required by Section III-C of this Notice. 

7. Withdrawal of an offer to share in the cost of developing required data. 

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. 
14

B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE

The Agency may determine that a study (even if submitted within the required time) is 

unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend or an order 

revoking or modifying a tolerance or tolerance exemption. The grounds for suspension 

include, but are not limited to, failure to meet any of the following: 

1. EPA requirements specified in the Data Call-In Notice or other documents incorporated 

by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data 

Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the 

design, conduct, and reporting of required studies. Such requirements include, but are not 

limited to, those relating to test material, test procedures, selection of species, number of 

animals, sex and distribution of animals, dose and effect levels to be tested or attained, 

duration of test, and, as applicable, Good Laboratory Practices. 

2. EPA requirements regarding the submission of protocols, including the incorporation of 

any changes required by the Agency following review. 

3. EPA requirements regarding the reporting of data, including the manner of reporting, the 

completeness of results, and the adequacy of any required supporting (or raw) data, 

including, but not limited to, require-ments 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 detennined on case-by-case basis. 

Requests for voluntary cancellation received after the 90 day response period required by this 

Notice will not result in the Agency granting any additional time to sell~ 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 marmer must have been submitted to the Agency, before EPA 

will consider granting an existing stocks provision. 

SECTIONV. 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, 

~~ci~ Susan Lewis, Acting Director 

Antimicrobials Division 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

15 
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: 

Document Processing Desk (DCI/AD)

By express or courier service:

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: Seiichi Murasaki, 

Murasaki.Seiichi@epa.gov, 703-347-0163. 
EPA Antimicrobials Division DCI Attachments

Attachment 2. Generic Data Call-In Response Form 

and Instructions 
Initial to indicate certification as to information on this page

(full text of certification is on page one).

Date

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. 

Use additional sheet(s) if necessary.

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

4. EPA Product 

Registration

5. I wish to cancel 

this product 

registration 

voluntarily

6. Generic Data 7. Product Specific Data

6a. I am claiming a Generic Data 

Exemption because I obtain the 

active ingredient from the source 

EPA registration number listed 

below.

6b. I agree to satisfy Generic Data

Requirements as indicated on the 

attached form entitled 

"Requirements Status and 

Registrant's Response."

7a. My product is an MUP and I 

agree to satisfy the MUP 

requirement on the attached form

entitled "Requirements Status and

Registrant's Response."

7b. My product is an EUP and I 

agree to satisfy the EUP 

requirement on the attached form 

entitled "Requirements Status and 

Registrant's Response."

OMB Approval 2070-0174

1. Company Name and Address

 

3095 - 4,4-Dimethyloxazolidine

Chemical # and Name: 114801

4,4-Dimethyloxazolidine

17-Jul-2013

GENERIC

ID # GDCI-114801-1339

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

9. Date

11. Phone Number 
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
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)

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

875.1100

875.1300

875.1700

835.4300

835.4400

850.4225

Dermal exposure--outdoor

Inhalation exposure--outdoor

Product Use Information

Aerobic aquatic metabolism

Anaerobic aquatic metabolism

Seedling emergence, Tier II

3095 - 4,4-Dimethyloxazolidine

Chemical # and Name: 114801

4,4-Dimethyloxazolidine

17-Jul-2013

GENERIC

ID # GDCI-114801-1339

X

X

X

X

X

X

TGAI

TGAI

TGAI

DEGR

DEGR

DEGR

24

24

24

24

24

12

Page 1 of 

(14, 15, 19)

(14, 15, 19)

(10)

(10)

(1, 10, 14)

Y

Y

N

N

N

Y

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

 

Post-Application Exposure Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

875.2300

875.2500

850.1010

850.1025

850.1035

850.1055

850.1075

850.1300

Indoor surface residue dissipation

Inhalation exposure

Aquatic invertebrate acute toxicity, test, freshwater 

daphnids

Oyster acute toxicity test (shell deposition)

Mysid acute toxicity test

Bivalve acute toxicity test (embryo larval)

Fish acute toxicity test, freshwater and marine

Daphnid chronic toxicity test

3095 - 4,4-Dimethyloxazolidine

Chemical # and Name: 114801

4,4-Dimethyloxazolidine

17-Jul-2013

GENERIC

ID # GDCI-114801-1339

X

X

X

X

X

X

X

X

TGAI

TGAI

DEGR

DEGR

DEGR

DEGR

DEGR

DEGR

24

24

12

12

12

12

12

12

Page 2 of 

(6, 14)

(5)

(10, 12)

(8, 10)

(10)

(8, 10)

(2, 4, 10)

(10, 12)

Y

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

 

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

Toxicology Data Requirements (Conventional Chemical)

850.1350

850.1400

850.2100

870.3465

835.1110

835.3110

835.3220

Mysid chronic toxicity test

Fish early-life stage toxicity test

Avian acute oral toxicity test

90-day inhalation toxicity

Activated sludge sorption isotherm

Ready biodegradability

Porous pot test

3095 - 4,4-Dimethyloxazolidine

Chemical # and Name: 114801

4,4-Dimethyloxazolidine

17-Jul-2013

GENERIC

ID # GDCI-114801-1339

X

X

X

X

X

X

X

DEGR

DEGR

DEGR

TGAI

DEGR

DEGR

DEGR

12

12

12

24

24

24

24

Page 3 of 

(9, 10)

(3, 10)

(10, 11)

(10, 18)

(10, 16, 17)

(10, 16, 17)

N

N

N

N

N

N

N

4
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

 

835.3240

835.3280

850.4400

850.5400

850.6800

870.4300

SS-1218

SS-Migration

Simulation Test-Aerobic Sewage Treatment-Activated

Sludge

Simulation Tests to Assess the Biodegradability of 

Chemicals

Aquatic plant toxicity test using Lemna spp. Tiers I 

and II

Algal toxicity, Tiers 1 and II

Modified Activated Sludge Respiration Inhibition

Combined chronic toxicity/carcinogenicity

Nature of Residue on Surfaces

Migration studies

3095 - 4,4-Dimethyloxazolidine

Chemical # and Name: 114801

4,4-Dimethyloxazolidine

17-Jul-2013

GENERIC

ID # GDCI-114801-1339

X

X

X

X

X

X

X

X

DEGR

DEGR

DEGR

DEGR

DEGR

TGAI

TGAI

TGAI

24

24

12

12

24

48

24

24

Page 4 of 

(10, 16, 17)

(10, 16, 17)

(10, 20)

(10, 13, 20)

(10, 16)

(7, 14)

(7, 14)

N

N

N

N

N

N

Y

Y

4
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

3095 - 4,4-Dimethyloxazolidine

GDCI-114801-1339

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

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

Testing with one species, rice (Oryza sativa), must be submitted to satisfy this data requirement.

Testing with one estuarine/marine species, preferably a silverside sp., is required to satisfy the estuarine/marine acute fish data requirement.

Testing is required with one freshwater species; results for a study using the same species used in the acute toxicity test (i.e., bluegill sunfish) must be submitted to satisfy this requirement.

Testing is required with one freshwater species; results for a study using the most sensitive (i.e., bluegill sunfish) must be submitted to satisfy this requirement.

Study is required for the following scenario: post-application inhalation exposure to treated paints.

Study is required for following scenario: post-application exposure to floors and carpets cleaned with preserved household cleaners. In the absence of acceptable data, a default transfer 

factor of 100% is expected to be used.

Results from residue chemistry studies to determine (1) DMO transfer to food from treated food contact surfaces and (2) the nature/identity of such residues, must be submitted to satisfy this 

requirement. Studies are required to support the following uses: preservation of inks, emulsions, adhesives, mineral slurries, dispersed colors, and surfactants which may contact food or be 

used to manufacture food packaging materials. The agency may consider waiving this study if labels are amended to clearly prohibit use of the pesticide to preserve materials that may contact 

food, feed, or drinking water.

Results from only one mollusk study, either the embryo-larvae or shell deposition, must be submitted to satisfy the mollusk testing data requirement.

Results for studies conducted using the same species as used in the acute mysid study must be submitted to satisfy this requirement.

Results for studies conducted using the major degradate, 2-amino-2-methyl-1-propanol (AMP, CAS No. 124-68-5), must be submitted to satisfy this requirement.

Results for studies conducted using bobwhite quail must be submitted to satisfy this requirement.

Results for studies conducted using Daphnia magna must be submitted to satisfy this requirement.

Results for studies conducted for (i) the freshwater green alga, Selenastrum capricornutum, (ii) the freshwater diatom, Navicula pelliculosa, (iii) the marine diatom, Skeletonema costatum, and 

(iv) the cyanobacteria species Anabaena flos-aquae, must be submitted to satisfy this requirement. Final 850 guidelines for the algal testing were posted in June 2012. The Public Draft OPPTS 

850.5400 Algal Toxicity guideline was split into two separate guidelines and renumbered with the cyanobacteria species separated into OCSPP 850.4550 and the other three species under 

OCSPP 850.4500.

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

Exposure studies are required for following scenarios: open-pour liquids for material preservation or oil-field treatments; application of preserved paints using brush/roller or airless sprayer; use

of treated metalworking fluids; and trigger sprayer, wipe, and mop application of preserved cleaners. If labels are amended to require closed mixing/loading, then any required exposure study 

for open-pour scenarios may be waived.

EPA published draft guidance under guideline 850.6800 and has since published final guidance for this study under guideline 850.3300: http://www.regulations.gov/#!documentDetail;D=EPA-HQOPPT-2009-0154-0021. OECD Test Guideline 209 can also be used as guidance for this study, available online at http://www.oecd-ilibrary.org/content/book/9789264070080-en. The results of 

the Activated Sludge Respiration Inhibition Test (ASRI) will determine which of the four biodegradation tests is/are required. If the ASRI test EC50 is less than or equal to 20 mg/L, then either the 

(i)Biodegradation in Activated Sludge Study or (ii) Simulation Test - Aerobic Sewage Treatment: A. Activated Sludge Units or (iii) the Porous Pot Test is required. If the ASRI test EC50 is greater 

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

3095 - 4,4-Dimethyloxazolidine

GDCI-114801-1339

17

18

19

20

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

than 20 mg/L, then the registrant must conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test - Aerobic Sewage Treatment: A. Activated 

Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no further testing is required. If, however, the antimicrobial fails the Ready 

Biodegradability study, then the a) Biodegradation in Activated Sludge or b) Simulation Test - Aerobic Sewage Treatment: A. Activated Sludge Units, or c) the Porous Pot study is required.

EPA has published final guidelines for biodegradation studies; the required biodegradation study for DMO is based on results of an Activated Sludge Respiration Inhibition test.

EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0003.

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

A Tier II definitive dose-response test is required to satisfy this data requirement.

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

Attachment 4. List of All Registrants Sent this Data 

Call-In Notice
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: 3095 - 4,4-Dimethyloxazolidine

Page: 1 of 1

1529

464

5383

INTERNATIONAL SPECIALTY PRODUCTS 

DOW CHEMICAL CO., THE

TROY CHEMICAL CORP

Co. Nr. Company Name Agent For Company

THE DOW CHEMICAL COMPANY

1361 ALPS ROAD

1500 EAST LAKE COOK ROAD

8 VREELAND ROAD, P.O. Box 955

Address City ZIP

WAYNE

BUFFALO GROVE

FLORHAM PARK

07470

60089 

079324200

OMB Approval 2070-0174

State

NJ

IL

NJ

 DCI Number: GDCI-114801-1339
EPA Antimicrobials Division DCI Attachments

Attachment 5. Additional Documents and Information 
Confident/.! Bu•1iHt•• lnform•tion: Doe. Not Cont•ln N•tion•l Security_/nform•tion (E. 0 . 12065) Form Approved. OMB No. 2070 0d~l, ""Print Forll'l 1

1·31 -98 

&EPA United States A. 0 Basic Formulation B. 

Environmental Protection Agency D D D See Instructions on Back 

Washington, DC 20460 Alternative Formulation Page of 

Office of Pesticide Programs (7505CI - Confidential Statement of Formula 

1 . Name and Address of Applicant/Registrant (lncluds ZIP Gods} 2. Nama and Address of Producer (Include ZIP Gods} 

-· 3 . Product Name 4 . Registration No./Fite Symbol 5. EPA Product Mgr!Team No. 6. Country Where Formulated 

7. Pounds/Get or Bulk Density B. pH 9 . Flesh Point/Flame Extension 

10. Components in Formulation (List as actually 13. Each Component in 14. Certified Limit• 

introducsd into ths formulation. Givs commonly f ormulation %by Weight 16. Purpoae 

EPA USE ONLY accsptad chemical namB, trads nsme, and CAS 1 1. Supplier Name & Address 12. EPA Reg . No. b. 'J(, by a. Upper b. l ower in 

a. Amount Weigh! limit limit Formulation 

number.} 

-- ··------ -

- ---··-

-· 

16. Typed Nama of Approving Official 17. Total Weight 100% 

-- 18. Signature of Approving Official I 19. Title 1 20. Phone No. Pn<lude Areo Codel 121 . Data 

EPA Form 8670-41Rev. 8-941 .. Wh1te • EPA F1la Copy longmall Pmk - Apphcant 

* U.&QPO: 1~20/20414 
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 of2", "2 of2", "3 of3", etc. 

1. Name and Address of Applicant/Registrant: Enter the name and 

address of your finn 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 Number/File 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 Where Formulated: Specify the country where this product is 

formulated 

7. Weight per Gallon/Bulk Density: For a liquid product specify pounds per 

gallon of formulated 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 "N/ A" . 

9. Flash Point/Flame 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 Fonnulation: 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 of the 

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 10, 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) 

of n 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 I 0, and the corresponding amount, percent by weight, and 

upper certified limits in columns 13 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. Amount: 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 l3b.) Please state the percent of active ingredient in British 

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

Inclusion Bodies (P!Bs)(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 ITU 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 

15. 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 Weight: Specify the total weight of the batch (column l3a.) 

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

necessary. 
United States Environmental Protection Agency 

Washington, D.C. 20460 

CE RT IFICAT ION OF ATT EM PT TO ENTE R IN TO AN 

AGREEMENT WITH REGISTRANTS FOR 

DEVELOPMENT OF DATA 

Form Approved. 

OM B Nos. 2070-0057; 

2070-0107; 2070-0122; 

2070-0164 

Paperwork Reduction Act Notice: The public reporting burd en fo r this co llection of inform ation is estim ated 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 comm ents 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 ., W ashington, 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. , 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. m ade to the following firm (s) on the following date(s): 

However

This offer was

Name of Firm(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 Title (Please Print or Type) 

EPA Form 8570-32 (12-2003) 
Form Approved OMB Nos. 2070-0060; 2070-0057; 2070-0107; 2070-0122; 2070-0164

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's/Registrant's Name, Address, and Telephone Number EPA Registration Number/File Symbol

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

General Use Pattern(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).

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)

I am using the cite-all method of support, and have included with this form 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] 

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) concern the properties or effects of this 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 form 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 imprisonment 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 obtain a renewal of that approval. The currently 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 inclusion of the OMB control number for the Information 

Collection Request (ICR) containing the form, EPA has traditionally included the ICR 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 contains• an obsolete expiration 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/opprd001/forms, at which time EPA 

will also 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 DCIs and 596 hours for OPP's Reregistration 

DCIs. 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. EPA-HQ-OPP-2007-0923-004) from Table 1 and Table 1b of the 

Final Supporting Statement for an Information Collection Request (ICR) for the Pesticide Data CallIn Program may be accessed via: http://www.regulations.gov , or by:

http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPP-2007-

0923;dct=FR%252BPR%252BN%252BO%252BSR 

 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 2822T), 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 form 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 July 31, 2013.

 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 and search for the control number (2070-0174).