1 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

### Ma y 9 , 2012

GENERIC DATA CALL

- IN NOTICE

CERTIFIED MAIL

Dear Sir or Madam:

This Notice re quires you and other registrants of pesticide products containing the active ingredient(s) identified in Attachment s 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 ar e necessary for the Re gistration 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 Notic e 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 Data2 

### Call -In Notices as part of Registration Review. Collection of this information is in compliance with th e 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:

Sect ion 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 Possibl e 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 o f All Registrants Sent t his 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 e xisting data for the active ingredient(s) identified in Attachment s 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 R eview 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 Not ice 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.3 

### 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
sp ecified in Attachment 3, Generic Requirements Status and Registrant's Response Forms and Instructions Form, within the time frames provided.

C. TESTING PROTOCOL

All studies required under this Notice must be conducted in accordance with test standards outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been established.

These EPA Guidelines are available from the National Technical Information Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, VA 22161 (tel: 703-605-6000).

Protocols approved by the Organization for Economic Cooperation and Development (OECD) are also acceptable if the OECD

- recommended test standards conform to those specified in the Pesticide Data Requirements regulation (40 CFR Part 158.70). When using the OECD protocols, they should be modified as appropriate so that the data generated by the study will satisfy the requirements of 40 CFR Part 158. Normally, the Agency will not extend deadlines for complying with data requi rements 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 AGENC Y

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 wit h 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 NOTICE4 

### A. SCHEDULE FOR RESPONDING TO THE AGENCY

The appropriate responses initially requi red 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 conta ined 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 Instru ctions Form and initial any subsequent pages. The forms contain separate detailed instructions on the response options. Do not alter the printed material. If you have questions or need assistance in preparing your response, call or write the contact person identified in Attachment 1.

1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting voluntary cancellation of your product(s) containing the active ingredient(s) that is the subject of this Notice. If you wish to volun tarily 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 Res ponse Forms And Instructions Form. If you choose this option, this is the only form that you are required to complete.5 

### 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 ingredien t 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 purchas ed from a source not connected with you; and,6 

### b. Every registrant who is the ultimate source of the active ingredient(s) in your product subject to this DCI must be in compliance with the requirements of this Notice and must remain in compliance; and

c. You must have provided to EPA an accurate and current "Confidential Statement of Formula" for each of your products to which this Notice applies.

To apply for the Generic Data Exemption you must submit a completed Attachment 2, Generic Data Call -In Respo nse 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 C all -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 t he 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. T hese 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 NOTICE7 

### If you acknowledge on the Attachment 2 Generic Data Call-In Response Forms And Instructions Form that you agree to satis fy 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 sel ection is to be entered under item number 9, "Registrant Response." The six options related to data production are the first six options discussed under item 9 in the instructions for completing the Attachment 3, Generic Requirements Status and Registrant's Response Forms and Instructions Form. These six options are listed immediately below with information in parentheses to guide registrants to additional instructions provided in this Section. The options are:

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

2. I have entered into an agreement with one or more registrants to develop data jointly (Cost Sharing),

3. I have made offers to cost

- share (Offers to Cost Share),

4. I am submitting an existing study that ha s 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 t he 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.8 

### 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 yo u 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 studi es. This 90-day progress report must include the date the study was or will be initiated and, for studies to be started within 12 months of commitment, the name and address of the laboratories or individuals who are or will be conducting the study.

In addition, if the time frame for submission of a final report is more than 1 year, interim reports must be submitted at 12 month intervals from the date you are required to commit to generate or otherwise address the requirement for the study. In addition to the other information specified in the preceding paragraph, at a minimum, a brief description of current activity on and the status of the study must be included as well as a full description of any problems encountered since the last progress report.

The time frames in the Generic Requirements Status and Registrant's Response Forms and Instructions Form (Attachment 3) are the time frames that the Agency is allowing for the submission of completed study reports or protocols. The noted deadlines run fro m 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 su bject 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 t he 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 c ases of extraordinary testing problems9 

### 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 let ter 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 Dat a 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 p roduct 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, Certificati on of Offer to Cost Share in the Development of Data . In addition, you must demonstrate that the other registrant to whom the offer was made has not accepted your offer to enter into a cost sharing agreement by including a copy of your offer and proof of the other registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to anything else, offer to share in the burden of producing the data upon terms to be agreed or failing agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of its election of an option to develop and10 

### submit the data required by this Notice by submitting a Generic Data Call- In Response F orms 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 spe cified 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 o f 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 transcribed11 

### verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from auto mated 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 ass urance 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 co nducted 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 c ertify 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.12 

### 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

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If a study has been classified as partially acceptable and upgradeable, you may submit data to upgrade that study. The Agency will review the data submitted and determine if the requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still be required to submit new data normally without any time extension. Deficient, but upgradeable studies will normally be classified as supplemental. However, it is important to note that not all studies classified as supplemental are upgradeable. If you have questions regarding th e 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 submittin g 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 crit eria as well as a certification regarding protocol compliance with Agency requirements.

Option 6, Citing Existing Studies

--13 

### 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 woul d 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 revi ewed by the Agency, you must provide the Agency's classification of the study.

If you are citing a study of which you are not the original data submitter, you must submit a completed copy of Certification with Respect to Citations of Data (in PR Notice 98 -5) EPA Form 8570-34 .

D. REQUESTS FOR DATA WAIVERS

There are two types of data waiver responses to this Notice. The first is a request for a low volume/minor use waiver and the second is a waiver request based on your belief that the data requirement(s) are inapplicable and do not apply to your product.

1. Low Volume/Minor Use Waiver (Option 8 on the Attachment 3, Generic Requirements Status and Registrant's Response Forms and Instructions Form) Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of requiring data for low volume, minor use pesticides. In implementing this provision EPA considers as low volume pesticides only those active ingredient(s) whose total production volume for all pesticide registrants is small. In determi ning 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 f igures 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.14 

### 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 register ed product(s) containing the active ingredient(s). If applicable to the active ingredient(s), include foreign sales for those products that are not registered in this country but are applied to sugar (cane or beet), coffee, bananas, cocoa, and other such crops. Present the above information by year for each of the past five years.

b. Provide an estimate of the sales (pounds and dollars) of the active ingredient(s) for each major use site. Present the above information by year for each of the past five years.

c. Total direct production cost of product(s) containing the active ingredient(s) by year for the past five years. Include information on raw material cost, direct labor cost, advertising, sales and marketing, and any other significant costs listed separately.

d. Total indirect production cost (e.g. plant overhead, amortized plant and equipment) charged to product(s) containing the active ingredient(s) by year for the past five years. Exclude all

non- recurring costs that were directly related to the active ingredient(s), such as costs of initial registration and any data development.

e. A list of each data requirement for which you seek a waiver. Indicate the type of waiver sought and the estimated cost to you (listed separately for each data requirement and associated test) of conducting the testing needed to fulfill each of these data requirements.

f. A list of each data requirement for which you are not seeking any waiver and the estimated cost to you (listed separately for each data requirement and associated test) of conducting the testing needed to fulfill each of these data requirements.

g. For each of the next ten years, a year

- by

- year forecast of company sales (pounds and dollars) of the active ingredient(s), direct production costs of product(s) containing the active ingredient(s) (following the parameters in item c above), indirect production costs of product(s) containing the active ingredient(s)15 

### (following the parameters in item d above), and costs of data development perta ining 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 n on- 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 de rive 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 o f 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 r equest 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 tolera nce 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 y our 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 fram e provided by16 

### this Notice. Within 30 days of your receipt of the Agency's written decision, you must submit a revised Attachment 3, Generic Requirements Status and Registrant's Response Forms and Instructions Form indicating the option chosen.

SECTION IV

. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

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

The Agency may issue a Notice of Intent to Suspend products subject to this Notice or an order revoking or modifying associated tolerances or tolerance exemptions due to failure by a registrant to comply with the requirements of this Data Call -In Notice, pursuant to FIFRA section 3(c)(2)(B) or FFDCA section 408(f). Events which may be the basis for issuance of a Notice of Intent to Suspend or of an order revoking or modifying associated tolerances or exemptions include, but are not limited to, the following:

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

2. Fa ilure 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 Noti ce.

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

5. Failure to take a required action or submit adequate information pertaining to any option chosen to address the data requirements (e.g., any required action or information pertaining to submission or citation of existing studies or offers, arrangements, or arbitration on the sharing of costs or the formation of Task Forces, failure to comply with the terms of an agreement or arbitration concerning joint data development or failure to comply with any terms of a data waiver).

6. Failure to submit supportable certifications as to the conditions of submitted studies, as required by Section III- C of this Notice.17 

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

8. Failure of the registrant to whom you have tendered an offer to share in the cost of developing data and provided proof of the registrant's receipt of such offer, or failure of a registrant on whom you rely for a generic data ex emption 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 Form s 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 requir ed data in the specified time frame.

9. Failure to take any required or appropriate steps, not mentioned above, at any time following the issuance of this Notice.

B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE

The Agency may determine t hat 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 ar e 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 Ge neTox Health Effects Test Guidelines) regarding the design, conduct, and reporting of required studies. Such requirements include, but are not limited to, those relating to test material, test procedures, selection of species, number of animals, sex and distribution of animals, dose and effect levels to be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.18 

### 2. EPA requirements regarding the submission of protocols, including the incorporation of any changes required by the Agency following review.

3. EPA requirements regarding the reporting of data, including the manner of reporting, the completeness of results, and the adequacy of anyrequired supporting (or raw) data, including, but not limited to, requirements referenc ed 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 C FR 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 canc eled 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 pertain ing to the continued sale, distribution, or use of your existing stocks after suspension.

If you request a voluntary cancellation of your product(s) as a response to this Notice and your product is in full compliance with all Agency requirements, you will have, under most circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will allow persons other than the registrant such as independent distributors, retailers and end users to sell, distribute or use such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily canceled products containing an active ingredient(s) for which the Agency has particular risk concerns will be determined on case

- by

- case basis.19 

### Requests for voluntary cancellation received after the 90 day response period required by this Notice will not result in the Agency granting any additional time to sell, distribute, or use existing stocks beyond a year from the date the 90 day response was due unless you demonstrate to the Agency that you are in full compliance with all Agency requirements, including the requirements of this Notice. For example, if you decide to voluntarily cancel your registration six months before a 3 year study is scheduled to be submitted, all progress reports and other information necessary to establish that you have been conducting the study in an acceptable and good faith manner must have been submitted to the Agency, before EPA will consider granting an existing stocks provision.

SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE ADVERSE EFFECTS

Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide is registered a reg istrant 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 Da ta Call-In Response Forms And Instructions Form need be submitted.

Sincerely,

Joan Harrigan

- Farrelly, Director Antimicrobials Divisio n Office of Pesticide Programs U.S. Environmental Protection AgencyEPA Antimicrobials Division DCI Attachments This page intentionally left blankEPA Antimicrobials Division DCI Attachments 

# Attachment 1. Data Call

- In Data Chemical Status SheetEPA Antimicrobials Division DCI Attachments DATA CALL

- IN CHEMICAL STATUS SHEET

Please submit all responses to the GDCI using the information below. To expedite processing, please include the GDCI identification number (e.g., GDCI-123456-789) in the Subject line of all DCI

- related correspondence.

By US mail : By express or courier service: Document Processing Desk (DCI/AD) Document Processing Desk (DCI/AD) Attn: Reevaluation Team Leader, PM 36 Attn: Reevaluation Team Leader, PM 36 US EPA (7510P) US EPA (7510P) 1200 Pennsylvania Ave. N.W. One Potomac Yard (South Building) Washington, DC 20460 2777 S. Crystal Dr. Arlington, VA 22202

If you have chemical

- specific questions or need assistance responding to the GDCI, please

con tact the chemical review manager (CRM) managing the DCI : Wanda Henson
, Henson.Wanda @epa.gov , 703-308-6345.EPA Antimicrobials Division DCI Attachments 

# Attachment 2

. Generic Data Call

- In Response Form and InstructionsEPA Antimicrobials Division DCI Attachments This page intentionally left blankInitial 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 3070 - 2-((Hydroxymethyl)amino)ethanol Chemical # and Name: 099001 2-((Hydroxymethyl)amino)ethanol 09-May-2012 GENERIC ID # GDCI-099001-1076 United States Environmental Protection Agency

Washington, D.C. 20460 DATA CALL-IN RESPONSE 1 Page of 1

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

10. Name of Company N/A

N/A N/A

N/A

9. Date

11. Phone NumberThis page intentionally left blan kEPA 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 unde r 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. It ems 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 fo r 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 ident ifies 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 an y 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. Ch eck 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 yo u 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 c omplete 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 w ish 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. Item s 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 InstructionsEPA Antimicrobials Division DCI Attachments This page intentionally left blankInitial to indicate certification as to information on this page (full text of certification is on page one)
13. Phone Number 10. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.

12. Name of Company 11. Date OMB Approval 2070-0174 United States Environmental Protection Agency

Washington, D.C. 20460 REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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

4. Guideline Requirement Number 5. Study Title Progress Reports

2 3 1 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)

Nontarget Plant Protection Data Requirements (Conventional Chemical) 875.1100

875.1200

875.1300

875.1400

875.1600

875.1700

875.2700

850.4400 Dermal exposure--outdoor

Dermal exposure--Indoor

Inhalation exposure--outdoor

Inhalation exposure--indoor

Application exposure monitoring data reporting

Product Use Information

Product Use Information

Aquatic plant toxicity test using Lemna spp. Tiers I and II 3070 - 2-((Hydroxymethyl)amino)ethanol Chemical # and Name: 099001 2-((Hydroxymethyl)amino)ethanol 09-May-2012 GENERIC ID # GDCI-099001-1076

X,Z

X,Z

X,Z

X,Z

X,Z

X,Z

X,Z

X,Z TEP

TEP

TEP

TEP

TEP

TEP

TEP

TEP; TGAI 24

24

24

24

24

24

8

12 1 of Page

(1) N

N

N

N

N

N

N

N 3OMB 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

2 3 1 6. Use

Pattern 7. Test Substance 8. Time Frame (Months) 9. Registrant

Response P R O T O C O L 1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

Nontarget Plant Protection Data Requirements (Conventional Chemical)

Post-Application Exposure Data Requirements (Conventional Chemical)

Toxicology Data Requirements (Conventional Chemical) 850.5400

875.2800

875.2900

870.3150

870.3465

870.3700

870.3800 Algal toxicity, Tiers 1 and II

Description of human activity

Data reporting and calculations

90-day oral toxicity in nonrodents

90-day inhalation toxicity

Prenatal developmental toxicity study

Reproduction and fertility effects 3070 - 2-((Hydroxymethyl)amino)ethanol Chemical # and Name: 099001 2-((Hydroxymethyl)amino)ethanol 09-May-2012 GENERIC ID # GDCI-099001-1076

X,Z

X,Z

X,Z

X,Z

X,Z

X,Z

X,Z TEP; TGAI

TEP

TEP

TGAI

TGAI

TGAI

TGAI 12

12

12

24

24

48

48 2 of Page

N

N

N

N

N

N

N 3Date 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

2 3 1 6. Use

Pattern 7. Test Substance 8. Time Frame (Months) 9. Registrant

Response P R O T O C O L 1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

Toxicology Data Requirements (Conventional Chemical)

870.4100

870.4200

835.1110

835.3110

850.6800 Chronic toxicity

Carcinogenicity

Activated sludge sorption isotherm

Ready biodegradability

Modified Activated Sludge Respiration Inhibition 3070 - 2-((Hydroxymethyl)amino)ethanol Chemical # and Name: 099001 2-((Hydroxymethyl)amino)ethanol 09-May-2012 GENERIC ID # GDCI-099001-1076

X,Z

X,Z

X,Z

X,Z

X,Z TGAI

TGAI

TGAI

TGAI

TGAI 48

48

12

12

12 3 of Page

N

N

N

N

N 3United States Environmental Protection Agency Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS 3070 - 2-((Hydroxymethyl)amino)ethanol
GDCI-099001-1076

1 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

In accordance with 40 CFR 158.1020, OPPTS Guideline 875.1600 is required to accompany OPPTS Guidelines 875.1100 (Dermal Outdoor Exposure), 875.1200 (Dermal Indoor Exposure), 875.1300 (Inhalation Outdoor Exposure), and 875.1400 (Inhalation Indoor Exposure). When all four GLNs are listed, the registrant is only required to perform two of the four tests, one dermal exposure and one inhalation exposure. Case # and Name:
DCI Number: 1 Page: of 1

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

Z - Industrial processes and water systems - not once throughEPA 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 th e fo rm in a signed letter that accompanies this response. For example, you may wish
to report that your product has al read y 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 t ransmittal 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 Dat a 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 ite m 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 Cal l-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 Instructio ns 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 th e 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 I ngredient 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 Ingred ient 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 you r 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 the se 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 jointl y. 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 ob ligation 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 nev er 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 need ed 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. By indicating that I have ch osen 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 delet e 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 justif ication to support this waiver request including, among other things, all information required to support the request. I understand that unless the Agency provides a written response waiving the requirement to submit data, the data remain required and are to be submitted according to the timelines specified in the Data Call

- In Notice. 9. Request for Waiver of Data: I have read the statements concerning data waivers other than low volume minor

- use data waivers in the Data Call

- In Notice and I request a waiver of the data requirement. I am attaching a rationale explaining why I believe the data requirements do not apply. I am also submitting a copy of my current labels. (You must also submit a copy of your Confidential Statement of Formula if not already on file with EPA). I understand that unless the Agency provides a written response waiving the requirement to submit data, the data remain required and are to be submitted according to the timelines specified in the Data Call

- In Notice.EPA Antimicrobials Division DCI Attachments This page intentionally left blankEPA Antimicrobials Division DCI Attachments 

# Attachment 4. List of All Registrants Sent t his Data Call

- In NoticeEPA Antimicrobials Division DCI Attachments This page intentionally left blankUnited States Environmental Protection Agency Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
3070 - 2-((Hydroxymethyl)amino)ethanol Case # and Name: 1 Page: of 1

5383 TROY CHEMICAL CORP Co. Nr. Company Name Agent For Company

8 VREELAND ROAD, P.O. Box 955 Address City ZIP

FLORHAM PARK 079324200 OMB Approval 2070-0174

State

NJ DCI Number: GDCI-099001-1076This page intentionally left blan kEPA Antimicrobials Division DCI Attachments 

# Attachment 5. Additional Documents and Informat ionEPA Antimicrobials Division DCI Attachments This page intentionally left blank-- .... 

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. 

## 0 Basic Formulation B. 

# Gr**Environment~1** Protection Agency 

## 0 

# D D Saa Instructions on Back Washington, DC 20460 Alternative Formulation Page of
Office of Pesticide Programs (7505C)

- Confidential Statement of Formula

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

. Name and Address of Producer (Include ZIP Codel

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

7. Pounds/Gal or Bulk Density 8.pH 

# 9. Flash Point/Flame Extension

10. Components in Formulation (List BS Bctuslly 13. Each Component in 14. Certified L i mit. introduced into ths formu/Btion. Givs commonly fomtulation 'J(, byW.ight 16. Purpoae EPA USE ONLY sccspted chemicsl nsme, trsds nsms, Bnd CAS 11

. Supplier Name & Address 12. EPA Reg. No

. b

. % by a

. Upper b.lower in
e. Amount Weight limit L i m i t Formulltion number. I



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

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.

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



### - 18. Signature of Approving Official 

# 1'9. Title 1 20. Phone No. "".Iude Ar •• Cod.1 

### j 21. Date

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



## * U.&QPO:**1~20120414**

### Instructions and Paperwork Act Notice Please Read Carefully Before Completing This Form

Paperwork Reduction Act Notice

The public reporting burden for this collection of information is estimated to average 1.0 hour per response, including familiarization with the form, organizing the necessary information, and completing the form. Send any comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Chief, Information Policy Branch, 2136, U.s. Environmental Protection Agency, 401 M Street, S.W., Washington, D.C. 20460.



### Instructions

The complete chemical composition of each pesticide must be known so it can he evaluated for registration under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended.

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

a pesticide product. It must be completed and submitted with each application for new registration of a pesticide and application for amended registration if the revision involves a formula change

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

Block B: Number all pages consecutively. Enter on each page the total number of pages submitted. If more than one page is required, number them "I of 2", "2 of2", "3 of3", etc.

1. Name and Address of ApplicantlRegistrant: Enter the name and address of your firm or authorized agent.

2. Name and Address of Producer: Specify the name of the producer and the address of the site where this product will be produced.

3. Product Name: Specify the complete name of this pesticide product as it will appear on the label. This name must be the same as that which appears

on the application form. 4. Rcgistlation NumberlFilc Symbol: Enter the EPA registration number

or file symbol, if known for this product

S. EPA Product Managerffeam Number: Enter the name and team number of the EPA Product Manager assigned to this product, if known. 6. Country Wbere Formulated: Specify the country where this product is formulated

7. Weigbt per GalloDlBulk Density: For a liquid product specify pounds per gallon offormulated product. For a powder or granular product, enter the
hulk density of formulated product (as used). Enter weight per unit if the product is produced as a tablet, briquette, or other uniformly shaped product 8. pH: Enter the pH of aqueous formulations and products which are either dispersible or soluble in water. If not applicable enter "NI A'

.

9. Flasb PointIFlame Extension: Specify the flash point as determined by the regulations for pressurized products and/or products known or suspected
to bum. State the results of the flame extension test for pressurized products including positive flashbacks.

10. Components in Formulation: List as actually introduced into the formulation. For each component in your formulation, provide the product

name, commonly accepted chemical, the trade name, and the Chemical Abstract (CAS) number for each identifiable ingredient present in the product. CAS numbers may be obtained from the Chemical Abstract Service ofthe American Chemical Society, Columbus, OH. For each original and alternate source of each active ingredient in the product, indicate the percent purity of the manufacturing use product, technical product, or other source of active ingredient. If one or more components will be obtained from more than one source, enter all alternate sources and all alternate EPA Reg. Nos. in blocks 10, II, and 12 or on a separate attachment.

Attention: (Special Instructions for Columns 70, 13, and 14) Any impurities greater than or equal to 0.1% (or less than 0.1% if the impurity is toxicologically significant) which are associated with the active ingredient(s) ofn technical grade (manufacturing or reformulating use) product or an end

use p'roduct produced by an integrated formulations system should also be listea in column 10, and the corresponding amount, percent by weight, and
upper certified limits in columns I3 and 14.

11. Supplier Name and Address: Provide the name and address of the supplier of each component in the formulation. If one or more components will be obtained from more than one source, specify the names addresses of the alternate sources also.

EPA Form 8570-4 (Rev. 8-94) Reverse ·U

. S

. GOP: 2000-519-239/94558 12. EPA Reg. No.: Specify the EPA registration number
, if any, for each active ingredient in the formulation

. If an unregistered active ingredient is used, have the suppliers submit the chemical specifications, as well as any data required under 40 CFR Part 158.

13. Each Component in Formulation a. AmouDt: Specify the quantity of each component as actually introduced into the formulation. Units (e.g., pounds
, grams, gallons
, liters) should be expressed as used in the formulation. If the quantity is a liquid measure, enter the volume and the specific gravity or the pounds per gallon of the component.

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

. Check Your Calculations. Note that the weight percentage in many cases will not agree with that shown on the label ingredient statement where the weight percentage of the per active ingredient(s) must he declared. Attention: Producers of Microbial Products: Special Instructions for

Column 13b.) Please state the percent of active ingredient in British International Units (BIUs). International Toxic Units (ITUs). Polyhedral Inclusion Bodies (PIBs)(viruses), Colony Forming Units (CFUs)(Fungi), as appropriate, and include an equivalent statement of active ingredient per milligram, ounce, pound, etc. of product (e.g., a 50% active Bacillus thuringiensis product may have an equivalency value of 1.59 million Aedis aegypti lTV per pound of product.

14. Certified Limits: These limits are to be set based on representative sampling and chemicnl analysis (i.e., quality control) of the product.

a. Upper Limit: Specify the maximum percentage of each active ingredient, intentionally added inert ingredient, and any impurities greater than 0.1 % to he permitted in the product.

b. Lower Limit: Specify the minimum percentage of each active ingredient and intentionally added inert ingredient to he permitted in the product.

IS. Purpose In Fonnulation: Specify the purpose of each ingredient both active and inert. (For example, disinfectant, herbicide, synergist s urfactant
, defoamer, sequestrant, etc.) If space is insufficient, abbreviate.

16. Typed Name of Approving Offirial: Complete this item for identification of individual to he contacted if necessary

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

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

.

# &EPA United States Environmental Protection Agency Form Approved. Washington, D.C. 20460 OMB Nos. 2070-0057; CERTIFICATION OF ATTEMPT TO ENTER INTO AN AGREEMENT WITH REGISTRANTS FOR 2070-0107; 2070-0122;

DEVELOPMENT OF DATA 2070-0164

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 15 minutes per response including time for reading the instructions, searching existing data sources , gathering and maintaining the data needed and completing and reviewing the collect i on of information

. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, Collection Strategies Division (2822T), U

. S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460

. Do not send the form to this address.

Please fill in blanks below
Company Name Company Number

Chemical Name EPA Chemical Number

I Certify that:

My company is willing to develop and submit the data required by EPA under the authority of the Federal Insecticide, Rodenticide and Fungicide Act (FIFRA), if necessary. However

, my company would prefer to enter into an agreement with one or more registrants to develop jOintly or share in the cost of developing data

. My firm has offered in writing to enter into such an agreement

. That offer was irrevocable and included an offer to be bound by arbitration under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all terms could not be reached otherwise

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

Name of Flrm(s) Date of Offer

Certification :

I certify that I am duly authorized to represent the company name above, and that the statements that I have made on this form and all attachments therein are true, accurate and complete

. I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative Date

Name and TIUe (Please Print or Type)

EPA Form 8570-32 (12-2003)EPA Antimicrobials Division DCI Attachments This page intentionally left blankForm Approved OMB Nos

. 2070-0060' 2070-0057 ; 2070-0107 ; 2070-0122 ' 2070-0164


### "'ft" UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

# ~~ 1200 Pennsylvania Avenue, N.W. WASHINGTON, D.C. 20460

Paperwork Reduction Act Notice: The publ i c 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

, includ i ng suggestions for reducing the burden to : Director, Collection Strategies D i v i sion (2822T), U.S

. Environmental Protection Agency, 1200 Pennsylvania Avenue

, N

. W

. , Washington

, DC 20460

. Do not send the completed form to th i s addr e ss

. Certification with Respect to Citation of Data

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

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

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

NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label

, you do not need to submit this form

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

# D I am responding to a Data-Call-In Notice, and have i ncluded with this form a list of companies sent offers of compensation (the Data Matrix form should be used for this purpose)

.

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

# D I am using the cite-all method of support

, and have included with this form 

# D I am using the selective method of support (or cite-all option

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

. completed list of data requirements (the Data Matrix form must be used).

SECTION II: GENERAL OFFER TO PAY

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

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

.

SECTION III: CERTIFICATION

I certify that this application for registration, this form for reregistration

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

. In addition, if the cite-all option or cite-all option under the selective method is indicated in Section I, this application is supported by all data in the Agency's files that (1) concem the properties or effects ofthis product or an identical or substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar compOSition and

uses

.

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

.

I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study

, either: (a) I am the original data submitter ; (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) all periods of eligibility for compensation have expired for the study ; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study and have offered (I) to pay compensation to the extent required by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA; and (Ii) to commence negotiations to determine the amount and terms of compensation

, if any , to be paid for the use of the study

.

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in accordance with sections 3(c)(1 )(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should I fail to produce such evidence to the Agency upon request, I understand that the Agency may initiate action to deny

, cancel or suspend the registration of my product in conformity with FIFRA

.

I certify that the statements I have made on this fonn and all attachments to It are true, accurate, and complete. I acknowledge that any knowingly false or misleading statement may be punishable by fine or Imprfsonment or both under applicable law.

Signature Date Typed or Printed Name and Title

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

### ATTENTION DCI RESPONDENTS

Under the Paperwork Reduction Act (PRA), 44 U.S. C. 3501 

### et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The approval of an information collection can only be valid for up to three years, at which time the agency must**ob~in** 

### a renewal of that approval. The**c~ently** 

### valid OMB control numbers for the EPA regulations that appear in 40 CFR, after initial display in the final rule, are listed in 40 CFR part 9 and are included on the response form or collection instrument.

For forms, in addition to the required i'nclusion of the OMB control number for the Information Collection Request (ICR) containing the form, EPA has traditionally included the lCR expiration date on the form. When forms remain substantively unchanged for many years, the printed inventory of the form may not

- be exhausted before the expiration date used on the form. If the same form is approved as part of the renewal
process, the agency may continue to use the remaining stocks of the paper form, even though that form contains

aIJ. 

### obsolete**~xpiration** 

### date.

Although all of the attached forms that you are asked to utilize in responding to this DCI are currently approved by OMB, some contain obsolete expiration dates,or address and per response burden information in the PRA Notice

. EPA is currently in the process 'of updating the electronic files of these forms, which are available on the internet at http: // www.epa.gov / opprdOOllforms, at which time EPA will als

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

.

The public reporting and record keeping burden for this collection is estimated to average about 1063 hours per response for OPP's Registration Review DCls and 596 hours for OPP's Reregistration DCls. This includes the time for review of the instructions, read and discuss test requirements, discuss test and protocol with the Agency, plan activities, search existing data sources, ' gather and maintain the data needed, create information, compile, process, complete and review the collection of information, complete written forms, record, disclose, and display information, and store, file or maintain information. This information (under Docket ID No. No. EPA-HQ-OPP-2007-0923-004).from Table 1 and Table Ib of the Final Supporting Statement for an Information Collection Request (ICR) for the Pesticide Data Call-In Program may be accessed via: htt p:/ / www. r eg ul ati on s.g o v , or by:

htt p ://www.re g ul a ti o n s.go v/sear ch/Regs/home.html#docketDe tail ?R == EPA

- HO-O PP

- 2007 -0923

Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Director, Collection Strategies Division (Mail Code 28221), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence, but do not submit the fqrm or report to this address. The actual information or form should be submitted in accordance with the instructions accompanying the information or form, specified in the corresponding regulation.

The supporting statement for the Information Collection Request (ICR) covering this DCI request is entitled 

### "Pesticides Data Call-In Program" (OMB No. 2070-0174;

. EPA No. 2288.01). OMB No. 2070-0174 expires on May 31, 2012.

For more information about the Agency's burden estimates, please go to the following RegInfo.gov website produced by the Office of Management and Budget (OMB): ' htt p ://www.re g info. g ov/ p ublic/do/PRAMain. From this site location go to the blue bar and select "advanced search

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