UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION

GENERIC DATA CALL-IN NOTICE

Dear Sir or Madam:

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

ingredient(s) identified in Attachments 2 and 3 of this Notice to submit certain data as noted 

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

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

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

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

Section III below. Your response must state:

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

through 5; or,

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

Attachment 3, 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).

You may respond to this Generic Data Call-In Notice either electronically through the Central 

Data Exchange (CDX) or by mail as described in Attachment 1. When submission of responses is

discussed throughout this Notice, either method can be used.

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

Rodenticide Act (FIFRA), as amended; sections 3(g)(2)(A) and (B) of FIFRA, as amended;

and/or section 408(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FFDCA). This notice is 

issued as part of Registration Review and is also authorized by 40 CFR Part 155.40, et seq., 

which is the Agency’s Registration Review regulations. Collection of this information is in 

compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) as approved by the Office 

of Management and Budget (OMB) under Control Number 2070-0174.
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This Notice is divided into six sections and five Attachments. The Notice itself contains 

information and instructions applicable to all Data Call-In Notices. The Attachments contain 

specific chemical information and instructions. The six sections of the Notice are:

Section I. Why You Are Receiving This Notice

Section II. Data Required By This Notice

Section III. Compliance With Requirements Of This Notice

Section IV. Consequences Of Failure To Comply With This Notice

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

Section VI. Inquiries And Responses To This Notice

The Attachments to this Notice are:

Attachment 1. Data Call-In Chemical Status Sheet

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

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

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

Attachment 5. Additional Documents and Information

• Confidential Statement of Formula and Instructions

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

Development of Data

• Certification with Respect to Citation of Data

• Paperwork Reduction Act Notification for DCI Respondents

SECTION I. WHY YOU ARE RECEIVING THIS NOTICE

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

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

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

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

identified additional data necessary to assess the health and safety of products containing this 

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

subject active ingredient(s).

SECTION II. DATA REQUIRED BY THIS NOTICE

A. DATA REQUIRED

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

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

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

B. SCHEDULE FOR SUBMISSION OF DATA

You are required to submit the data or otherwise satisfy the data requirements specified in 

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

Instructions Form, within the time frames provided.

C. TESTING PROTOCOL
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All studies required under this Notice must be conducted in accordance with protocols which 

meet the purpose of the test standards outlined in the Pesticide Assessment Guidelines for 

those studies for which guidelines have been established and which provide data of suitable 

quality and completeness as typified by the protocols cited in the guidelines.

These EPA Guidelines are available from the National Technical Information Service

(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, VA 22161 (tel: 703-605-

6000) and on the EPA’s Chemical Safety and Pollution Prevention website 

(http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances).

Protocols approved by the Organization for Economic Cooperation and Development (OECD) 

are also acceptable if the OECD-recommended test standards conform to those specified in

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

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

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

for complying with data requirements when the studies were not conducted in accordance 

with acceptable standards. The OECD protocols are available from 2001 L Street, N.W., Suite 

650, Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-

785-0350) and electronically on the OECD website (http://www.oecdilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals_chem_guide_pkg-en).

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

must be in accordance with Good Laboratory Practices (40 CFR Part 160).

D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) OR 4 DATA CALL-IN

NOTICES ISSUED BY THE AGENCY

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

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

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

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

SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

A. SCHEDULE FOR RESPONDING TO THE AGENCY

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

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

within 90 days of your receipt will be a basis for issuing a Notice of Intent to Suspend 

(NOIS) affecting your products. This and other bases for issuance of NOIS due to failure to 

comply with this Notice are presented in Section IV-A and IV-B.

B. OPTIONS FOR RESPONDING TO THE AGENCY

The options for responding to this Notice are: 1) voluntary cancellation, 2) delete use(s), (3) 

claim generic data exemption, (4) agree to satisfy the data requirements imposed by this 

Notice or (5) request a data waiver(s).

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

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

various options available for satisfying the data requirements of this Notice is contained in 

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

Section III-D.

There are two forms that accompany this Notice of which, depending upon your response, one 
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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. Note that the company's authorized representative is required to 

sign the first page of the Attachment 2, Generic Data Call-In Response Forms And Instructions 

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

and Instructions Form and initial any subsequent pages. The forms contain separate detailed 

instructions on the response options. Do not alter the printed material. If you have questions or 

need assistance in preparing your response, write or email EPA as indicated in Attachment 1.

1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting 

voluntary cancellation of your product(s) containing the active ingredient(s) that is the 

subject of this Notice. If you wish to voluntarily cancel your product, you must submit a 

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

indicating your election of this option. Voluntary cancellation is item number 5 on the 

Attachment 2, Generic Data Call-In Response Forms And Instructions Form. If you choose 

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

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

product 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.

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 
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Notice and must remain in compliance; and

c. You must have provided to EPA an accurate and current "Confidential Statement of 

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

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

Data Call-In Response Forms And Instructions Form and all supporting documentation. The 

Generic Data Exemption is item number 6a on the Attachment 2, Generic Data Call-In 

Response Forms And Instructions Form. If you claim a generic data exemption, you are not 

required to complete the Attachment 3, Generic Requirements Status and Registrant's 

Response Forms and Instructions Form. Generic Data Exemption cannot be selected as an 

option for product specific data.

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

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

and submit the required data fail to take appropriate steps to meet the requirements or are no 

longer in compliance with this Data Call-In Notice, the Agency will consider that both they 

and you are not in compliance and will normally initiate proceedings to suspend the 

registrations of both your and their product(s), unless you commit to submit and do submit the 

required data within the specified time. In such cases the Agency generally will not grant a

time extension for submitting the data.

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

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

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

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

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

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

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

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

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

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

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

to address the data requirement.

C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

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

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

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

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

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

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

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

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

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

this Section. The options are:

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

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

(Cost Sharing),
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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 in accordance with the Pesticide 

Assessment Guidelines (PAG), be in conformance with Pesticide Registration Notice

(PRN) 2011-3 entitled “Standard Format for Data Submitted Under FIFRA and Certain 

Provisions of FFDCA” (http://www.epa.gov/pesticide-registration/pesticide-registrationnotices-year), and, as applicable, comply with 40 CFR Part 26, “Protection of Human 

Subjects.” In addition, certain studies require Agency approval of test protocols in 

advance of study initiation. Those studies for which a protocol must be submitted have 

been identified in the Attachment 3, Generic Requirements Status and Registrant's 

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

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

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

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

Agency rejects your protocol, you will be notified in writing, however, you should be 

aware that rejection of a proposed protocol will not be a basis for extending the deadline 

for submission of data.

A progress report must be submitted for each study within 90 days from the date you are 

required to commit to generate or undertake some other means to address that study 

requirement, such as making an offer to cost-share or agreeing to share in the cost of 

developing that study. A 90-day progress report must be submitted for all studies. This 90-

day progress report must include the date the study was or will be initiated and, for studies 

to be started within 12 months of commitment, the name and address of the laboratories or 

individuals who are or will be conducting the study.

In addition, if the time frame for submission of a final report is more than 1 year, interim

reports must be submitted at 12 month intervals from the date you are required to commit 

to generate or otherwise address the requirement for the study. In addition to the other 

information specified in the preceding paragraph, at a minimum, a brief description of 

current activity on and the status of the study must be included as well as a full description 

of any problems encountered since the last progress report.

The time frames in the Generic Requirements Status and Registrant's Response

Forms and Instructions Form (Attachment 3) are the time frames that the Agency is

allowing for the submission of completed study reports or protocols. The noted deadlines 

run from the date of the receipt of this Notice by the registrant. If the data are not submitted 
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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 (see 

Attachment 5). In addition, you must demonstrate that the other registrant to whom the 

offer was made has not accepted your offer to enter into a cost sharing agreement by 

including a copy of your offer and proof of the other registrant's receipt of that offer (such 

as a certified mail receipt). Your offer must, in addition to anything else, offer to share in 

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

by binding arbitration as provided by 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 
8

Forms And Instructions Form (Attachment 2) and a Generic Requirements Status and 

Registrant's Response Forms and Instructions Form (Attachment 3) committing to develop 

and submit the data required by this Notice.

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

share in the burdens of developing the data. In addition, the other registrant must fulfill its 

commitment to develop and submit the data as required by this Notice. If the other 

registrant fails to develop the data or for some other reason is subject to suspension, your 

registration as well as that of the other registrant will normally be subject to initiation of 

suspension proceedings, unless you commit to submit, and do submit the required data in 

the specified time frame. In such cases, the Agency generally will not grant a time 

extension for submitting the data.

Option 4, Submitting an Existing Study –

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

that the study satisfies the requirements imposed by this Notice. You may only submit a 

study that has not been previously submitted to the Agency or previously cited by anyone. 

Existing studies are studies which predate issuance of this Notice. Do not use this option if 

you are submitting data to upgrade a study. (See Option 5).

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

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

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

a study is not valid and needs to be repeated.

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

following four criteria must be clearly met:

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

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

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

requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. 

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

records, memoranda, notes, or exact copies thereof, that are the result of original 

observations and activities of a study and are necessary for the reconstruction and 

evaluation of the report of that study. In the event that exact transcripts of raw data 

have been prepared (e.g., tapes which have been transcribed verbatim, dated, and 

verified accurate by signature), the exact copy or exact transcript may be 

substituted for the original source as raw data. Raw data may include photographs, 

microfilm or microfiche copies, computer printouts, magnetic media, including 

dictated observations, and recorded data from automated instruments." The term

"specimens", according to 40 CFR Part 160.3(7), means "any material derived 

from a test system for examination or analysis."

b. Health and safety studies completed after May 1984 must also contain all GLPrequired 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.
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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 PRN 2011-3.

Option 5, Upgrading a Study –

If a study has been classified as partially acceptable and upgradeable, you may submit data 

to upgrade that study. The Agency will review the data submitted and determine if the 

requirement is satisfied. If the Agency decides the requirement is not satisfied, you may 

still be required to submit new data normally without any time extension. Deficient, but 

upgradeable studies will normally be classified as supplemental. However, it is important 

to note that not all studies classified as supplemental are upgradeable. If you have 

questions regarding the classification of a study or whether a study may be upgraded, write

or email EPA as indicated in Attachment 1. If you submit data to upgrade an existing 

study, you must satisfy or supply information to correct all deficiencies in the study 

identified by EPA. You must provide a clearly articulated rationale of how the deficiencies

have been remedied or corrected and why the study should be rated as acceptable to EPA. 

Your submission must also specify the MRID number(s) of the study which you are 

attempting to upgrade and be in conformance with PRN 2011-3.

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

unacceptable and determined by the Agency as not capable of being upgraded.
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This option should also be used to cite data that has been previously submitted to upgrade 

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

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

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

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

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

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

Agency requirements.

Option 6, Citing Existing Studies –

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

have been previously classified by EPA as acceptable or it must be a study which has not 

yet been reviewed by the Agency. Acceptable toxicology studies generally will have been 

classified as "core-guideline" or "core minimum." For ecological effects studies, the 

classification generally would be a rating of "core." For all other disciplines the 

classification would be "acceptable." With respect to any studies for which you wish to 

select this option you must provide the MRID number of the study you are citing and, if 

the study has been reviewed by the Agency, you must provide the Agency's classification 

of the study.

If you are citing a study of which you are not the original data submitter, you must submit 

a completed copy of Certification with Respect to Citations of Data (in PRN 2011-3) 

EPA Form 8570-34.

D. REQUESTS FOR DATA WAIVERS

There are two types of data waiver responses to this Notice. The first is a request for a low 

volume/minor use waiver and the second is a waiver request based on your belief that the 

data requirement(s) are inapplicable and do not apply to your product.

1. Low Volume/Minor Use Waiver (Option 8 on the Attachment 3, Generic Requirements 

Status and Registrant's Response Forms and Instructions Form) Section 3(c)(2)(A) of 

FIFRA requires EPA to consider the appropriateness of requiring data for low volume, 

minor use pesticides. In implementing this provision EPA considers as low volume

pesticides only those active ingredient(s) whose total production volume for all pesticide 

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

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

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

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

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

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

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

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

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

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

remain qualified for such waiver. If granted a waiver, a registrant will be required, as a 

condition of the waiver, to submit annual sales reports. The Agency will respond to 

requests for waivers in writing.

To apply for a low volume, minor use waiver, you must submit the following 
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information, as applicable to your product(s), as part of your 90-day response to this 

Notice:

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

the active ingredient(s). If applicable to the active ingredient(s), include foreign 

sales for those products that are not registered in this country but are applied to 

sugar (cane or beet), coffee, bananas, cocoa, and other such crops. Present the 

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

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

for each major use site. Present the above information by year for each of the 

past five years.

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

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

cost, advertising, sales and marketing, and any other significant costs listed 

separately.

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

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

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

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

development.

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

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

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

these data requirements.

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

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

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

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

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

containing the active ingredient(s) (following the parameters in item c above), 

indirect production costs of product(s) containing the active ingredient(s) 

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

pertaining to the active ingredient(s).

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,
12

(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). If EPA determines that the data are

required for your product(s), you must choose a method of meeting the requirements of this 

Notice within the time frame provided by this Notice. Within 30 days of your receipt of the 

Agency's written decision, you must submit a revised Attachment 3, Generic Requirements 

Status and Registrant's Response Forms and Instructions Form indicating the option chosen.

SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS

NOTICE

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

MODIFYING TOLERANCE OR EXEMPTION

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

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

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

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

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

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

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

Notice.

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

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

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

required by this Notice.

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

5. Failure to take a required action or submit adequate information pertaining to any option 
13

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

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

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

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

comply with any terms of a data waiver).

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

required by Section III-C of this Notice.

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

8. Failure of the registrant to whom you have tendered an offer to share in the cost of 

developing data and provided proof of the registrant's receipt of such offer, or failure of a 

registrant on whom you rely for a generic data exemption either to:

a. Inform EPA of intent to develop and submit the data required by this Notice 

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

Form and an Attachment 3, Generic Requirements Status and Registrant's 

Response Forms and Instructions Form; or,

b. Fulfill the commitment to develop and submit the data as required by this

Notice; or,

c. Otherwise take appropriate steps to meet the requirements stated in this 

Notice, unless you commit to submit and do submit the required data in the 

specified time frame.

9. Failure to take any required or appropriate steps, not mentioned above, at any time 

following the issuance of this Notice.

B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE

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

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

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

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

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

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

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

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

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

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

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

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

any changes required by the Agency following review.

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

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

including, but not limited to, requirements referenced or included in this Notice and that 

set forth in PRN 2011-3. All studies must be submitted in the form of a final report; a 

preliminary report will not be considered to fulfill the submission requirement.

4. Requirements, as applicable, set forth in 40 CFR Part 26 entitled “Protection of Human
14

Subjects.”

C. EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS

EPA has statutory authority to permit continued sale, distribution and use of existing stocks 

of a pesticide product which has been suspended or canceled if doing so would be consistent 

with the purposes of FIFRA.

The Agency has determined that such disposition by registrants of existing stocks for a 

suspended registration when a FIFRA section 3(c)(2)(B) data request is outstanding would 

generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates 

granting registrants permission to sell, distribute, or use existing stocks of suspended 

product(s) only in exceptional circumstances. If you believe such disposition of existing 

stocks of your product(s) which may be suspended for failure to comply with this Notice 

should be permitted, you have the burden of clearly demonstrating to EPA that granting such 

permission would be consistent with the Act. You must also explain why an "existing stocks" 

provision is necessary, including a statement of the quantity of existing stocks and your 

estimate of the time required for their sale, distribution, and use. Unless you meet this burden, 

the Agency will not consider any request pertaining to the continued sale, distribution, or use 

of your existing stocks after suspension.

If you request a voluntary cancellation of your product(s) as a response to this Notice and 

your product is in full compliance with all Agency requirements, you will have, under most 

circumstances, one year from the date your 90 day response to this Notice is due, to sell, 

distribute, or use existing stocks. Normally, the Agency will allow persons other than the 

registrant such as independent distributors, retailers and end users to sell, distribute or use 

such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of

voluntarily canceled products containing an active ingredient(s) for which the Agency has 

particular risk concerns will be determined on a case-by-case basis.

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

this Notice will not result in the Agency granting any additional time to sell distribute or

use existing stocks beyond a year from the date the 90 day response was due unless you 

demonstrate to the Agency that you are in full compliance with all Agency requirements, 

including the requirements of this Notice. For example if you decide to voluntarily cancel

your registration six months before a 3 year study is scheduled to be submitted, all

progress reports and other information necessary to establish that you have been

conducting the study in an acceptable and good faith manner must have been submitted to

the Agency, before EPA will consider granting an existing stocks provision.

SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE 

UNREASONABLE ADVERSE EFFECTS

Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide

is registered a registrant has additional factual information regarding unreasonable adverse

effects on the environment by the pesticide the registrant shall submit the information to the

Agency. Registrants must notify the Agency of any factual information they have, from

whatever source, including but not limited to interim or preliminary results of studies
15

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, contact EPA as listed in Attachment 1, the Data Call-In Chemical Status Sheet.

All responses to this Notice (other than voluntary cancellation requests and generic data 

exemption claims) must include a completed Attachment 2, Generic DataCall-In Response 

Forms And Instructions Form and a completed Attachment 3, Generic Requirements Status and 

Registrant's Response Forms and Instructions Form and any other documents required by this

Notice, and must be submitted either electronically through CDX or by mail as identified in

Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only

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

submitted.

Sincerely,

Yu-Ting Guilaran

Director

Pesticide Re-evaluation Division

Office of Pesticide Programs

U.S. Environmental Protection Agency
EPA Data Call-In Notice Attachment

Attachment 1. Data Call-In Data Chemical Status Sheet
EPA Data Call-In Notice Attachment

DATA CALL-IN CHEMICAL STATUS SHEET

Submit all responses to the GDCI using the information below. To expedite processing, include

the GDCI identification number (e.g., GDCI-555555-5555) in the Subject line of all DCI-related

correspondence.

INQUIRIES AND RESPONSES TO THIS NOTICE

All responses to this notice for the GDCI data requirements are to be submitted electronically 

through the Central Data Exchange (CDX) or by mail as described below.

If You Choose to Respond through the Central Data Exchange (CDX):

The DCI receipt acknowledgement, 90-day response, and data can be submitted through CDX 

via the DCI application of the Pesticide Submission Portal (PSP). If you have a CDX account 

with access to the PSP, you may follow the link below to sign in, acknowledge receipt, and 

access your DCI(s): https://cdx.epa.gov/.

A user guide is available for instructions on what to do if you do not have a CDX account (page 

16 in the link below) or if you need to add PSP to your account (page 55 in the link below):

https://cdx.epa.gov/content/documents/PSP/OPP_CDX_Pesticide_Submission_PortalRegistratio

n_UserGuidev1.0p.pdf.

If You Choose to Respond by Mail:*

By US mail: By express or courier service:

Document Processing Desk (DCI/PRD) Document Processing Desk (DCI/PRD) 

Attn: Attn:

US EPA (7508P) US EPA (7508P)

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

Washington, DC 20460 2777 S. Crystal Dr.

Arlington, VA 22202

*NOTE: If this DCI was sent to you via email, you may acknowledgement receipt via 

email.
EPA Data Call-In Notice Attachment

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

EPA FORM 6300-4

1. Company Name and Address

DREXEL CHEMICAL COMPANY

P.O. Box 13327

MEMPHIS, TN 381130327

0001 - Metolachlor

Chemical # and Name: 108801

Metolachlor

25-Feb-2016

GENERIC

ID # GDCI-108801-1506

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page 1 of 1

19713-539

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 Data Call-In Notice Attachment

INSTRUCTIONS: DATA CALL-IN RESPONSE FORM

These instructions apply to the form titled “Data Call-In Response” and are to be used to 

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

the Federal Insecticide, Fungicide, and Rodenticide Act. Read these instructions carefully

before filling out the forms.

Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed 

by the registrant as appropriate. Items 8 through 11 must be completed by the registrant

before submitting a response to the Agency.

The 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 # GENERIC 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. 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 Data Call-In Notice Attachment

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, 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 Data Call-In Notice Attachment

Attachment 3. Generic Requirements Status and

Registrant's Response Form and Instructions
Initial to indicate certification as to information on this page (full text of certification is on page one) 

13. Phone Number

10. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 

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

12. Name of Company

11. Date

OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

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

Signature and Title of Company's Authorized Representative _________________________________________________________________

DREXEL CHEMICAL COMPANY

P.O. Box 13327

MEMPHIS, TN 381130327

Environmental Fate Data Requirements (Conventional 

Chemical)

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

835.4100

835.4200

835.4300

835.4400

850.4100

850.2100

850.3040

Aerobic soil metabolism

Anaerobic soil metabolism

Aerobic aquatic metabolism

Anaerobic aquatic metabolism

Seedling Emergence and Seedling Growth

Avian acute oral toxicity test

Field testing for pollinators

0001 - Metolachlor

Chemical # and Name: 108801

Metolachlor

25-Feb-2016

GENERIC

ID # GDCI-108801-1506

K,C,A

K,C,A

K,C,A

K,C,A

K,C,A

K,C,A

K,C,A

TGAI

TGAI

TGAI

TGAI

DEGR

TGAI

TEP

24

24

24

24

12

12

24

Page 1 of 

(2, 19)

(3, 19)

(10, 19)

(10, 19)

(20)

(6, 8, 19)

N

N

N

N

N

N

Y

3
OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

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

DREXEL CHEMICAL COMPANY

P.O. Box 13327

MEMPHIS, TN 381130327

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

Toxicology Data Requirements (Conventional Chemical)

870.3465

850.6100

SS-1155

SS-1254

SS-1315

90-day inhalation toxicity

Environmental Chemistry Methods and Associated 

Independent Laboratory Validation

Residues in Pollen and Nectar/Field Residue Analysis

Adult honeybee chronic oral toxicity

Semi-field testing for pollinators 

0001 - Metolachlor

Chemical # and Name: 108801

Metolachlor

25-Feb-2016

GENERIC

ID # GDCI-108801-1506

K,C,A

K,C,A

K,C,A

K,C,A

K,C,A

TGAI

TGAI

TEP

TGAI

TEP

24

12

24

12

24

Page 2 of 

(1, 5, 9, 19, 

22)

(7)

(18, 19)

(14, 19, 21)

(11, 19, 22)

(4, 16, 17, 

19, 22)

N

N

Y

Y

Y

3
Date

OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

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

DREXEL CHEMICAL COMPANY

P.O. Box 13327

MEMPHIS, TN 381130327

SS-1323

SS-1324

Pollinator Acute Oral Toxicity honeybee larvae

Pollinator Chronic Oral Toxicity honeybee larvae

0001 - Metolachlor

Chemical # and Name: 108801

Metolachlor

25-Feb-2016

GENERIC

ID # GDCI-108801-1506

K,C,A

K,C,A

TGAI

TGAI

12

12

Page 3 of 

(13, 15, 19, 

22)

(12, 15, 19, 

22)

Y

Y

3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

0001 - Metolachlor

GDCI-108801-1506

1

2

3

4

5

6

7

8

9

10

11

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

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

USEPA. 2012c. "Field Testing for Pollinators." Ecological Effects Test Guidelines OCSPP 850.3040. EPA 712-C-017. Web. http://www.regulations.gov/#documentDetail;D=EPA-HQ-OPPT-2009-

0154-0018

Two additional soils are needed to fulfill the data requirement.

Three additional soils are needed to fulfill the data requirement.

The need for a semi-field test for pollinators (i.e., either a field-feeding test or a tunnel test) will be determined based upon lower-tiered tests and/or other lines of evidence, and the need for a 

refined pollinator risk assessment.

The need for a field test for pollinators will be determined based upon lower-tiered tests and/or other lines of data and the need for a refined pollinator risk assessment.

The OCSPP 850.2100 guideline currently recommends the submission of a protocol for EPA review prior to initiation of tests conducted with passerine species. Data submitters are encouraged 

to consider the recommendations contained in relevant EPA reference documents (i.e., OCSPP 850.2100, EFED Guidance for Reviewing OCSPP 850.2100 Avian Oral Toxicity Studies Conducted 

with Passerine Birds, EFED Guidance for Use when Regurgitation is Observed in Avian Acute Toxicity Studies with Passerine Species) when preparing test protocols. A protocol does not need

to be submitted to EPA for review prior to test initiation if it reflects these recommendations. If a data submitter elects to submit a protocol to EPA, in order to facilitate the review process, any 

aspects of a proposed study design that differ from this guidance should be noted and accompanied by a descriptive rationale which addresses why they are not expected to adversely impact 

the quality of the resulting study.

http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/terrestrial_biology_tech_team/passerine_ocspp850_2100_avian_oral_tox.pdf

The 90-day inhalation toxicity study (870.3465) protocol should be followed, but the duration of exposure should be for only 28 days.

Testing with passerine species is required.

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

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

Environmental Protection Agency, Washington DC; Environmental Assessment Directorate, Pest Management Regulatory Agency, Health Canada, Ottawa, CN; California Department of Pesticide 

Regulation http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2012-0543-0004; (ii) 2014 Guidance for Assessing Pesticide Risks to Bees. Office of Pesticide Programs United States 

Environmental Protection Agency, Health Canada Pest Management Regulatory Agency, California Department of Pesticide Regulation. June 19, 2014.

One additional sediment-water system is needed to fulfill the data requirement.

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

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

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

pp.doi:10.2903/j.efsa.2013.3295.

Case # and Name:

DCI Number:

Page: 1 of

Footnotes: The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. 

These footnotes apply in addition to any test notes included in 40 CFR Part 158 with respect to the particular data requirement.

Use Categories Key:

A - Terrestrial food crop

C - Terrestrial nonfood crop

K - Residential

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

0001 - Metolachlor

GDCI-108801-1506

12

13

14

15

16

17

18

19

20

21

22

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

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

OECD has not yet finalized test guidelines for chronic studies with honey bee larvae. OECD draft guidance has is being developed, see OECD 2013b. OECD Draft Guidance Document Honey 

Bee(Apis mellifera) Larval Toxicity Test, Repeated Exposure. http://www.oecd.org/env/ehs/testing/Draft_GD_honeybees_rep_exp_for_2nd_CR_25_November_2013.pdf

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

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

Measurements of residues in the pollen/nectar are needed based upon lower-tiered tests and/or other lines of evidence, and the need for a refined pollinator risk assessment.

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

larval toxicity tests.

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

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

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

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

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

OEPP/EPPO Bulletin 22: 613 - 616.

Environmental Chemistry Methods (ECM) and Independent Laboratory Validation (ILV) are needed on metolachlor/S-metolachlor in soil. ILV is also needed for metolachlor/S-metolachlor in water.

Data may be performed with either metolachlor or S-metolachlor.

Data are needed for the metolachlor degradates ethanesulfonic acid (ESA) and oxanilic acid (OA). For ESA, data are needed specifically on ryegrass, tomato, and carrot while OA requires data

only on onion.

A study protocol must be submitted to, and reviewed by EPA, prior to study initiation. The following elements should be considered when developing study protocol(s) for the monitoring of 

residues in pollen/nectar.

- Consideration of the range of application methods and environmental conditions (e.g., soil and hydric regimes) that the target crop(s) may be under.

- Consideration of the attractiveness of the selected crop to pollinators.

- Consideration of a collection schedule sufficient to allow for an understanding of the character of residues, in the pollen/nectar and/or plant tissues, over time.

- Consideration of data sufficient to determine whether residues of the active ingredient and/or degradation product(s) accumulates in soil and is/are bioavailable for plant to uptake in a following

planting, and therefore result in potential exposure to pollinators.

- Consideration of the market proportion of the selected target crop(s).

A study protocol must be submitted to, and reviewed by EPA, prior to study initiation.

Case # and Name:

DCI Number:

Page: 2 of 2
EPA Data Call-In Notice Attachment

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.
EPA Data Call-In Notice Attachment

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 Data Call-In Notice Attachment

Item # DATA CALL-IN RESPONSE Information

6 This item completed by the Agency identifies the code associated with the use pattern of

the pesticide. A brief description of each code follows: 

 A Terrestrial food

B Terrestrial feed

C Terrestrial non-food

D Aquatic food

E Aquatic non-food outdoor

F Aquatic non-food industrial 

G Aquatic non-food residential 

H Greenhouse food

I Greenhouse non-food crop

J Forestry

K Residential

L Indoor food

M Indoor non-food

N Indoor medical

O Indoor residential

P Aquatic non-food crop 

Q Residential outdoor 

R Agricultural premises and equipment 

S Food handling/storage establishments, premises, & equipment 

T Commercial, institutional & industrial premises, & equipment

U Residential and public access premises

V Medical premises and equipment

W Human drinking water systems

X Materials preservatives

Y Industrial processes and water systems – once through

Z Industrial processes and water systems – not once through

AA Antifouling coatings

BB Wood preservatives

CC Swimming pools

DD Aquatic areas

EE Indoor use

FF High exposure antimicrobial

GG Low exposure antimicrobial

HH Occupational use conventional chemical

II Residential use conventional chemical
EPA Data Call-In Notice Attachment

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

EUP: End-Use Product

MP: Manufacturing-Use Product

MP/TGAI: Manufacturing-Use Product and Technical Grade Active Ingredient

PAI: Pure Active Ingredient

PAI/M: Pure Active Ingredient and Metabolites

PAI/PAIRA: Pure Active Ingredient or Pure Active Ingredient Radiolabeled

PAIRA: Pure Active Ingredient Radiolabeled

PAIRA/M: Pure Active Ingredient Radiolabeled and Metabolites

PAIRA/PM: Pure Active Ingredient Radiolabeled and Plant Metabolites

TEP: Typical End-Use Product

TEP ___%: Typical End-Use Product, Percent Active Ingredient Specified

TEP/MET: Typical End-Use Product and Metabolites

TEP/PAI/M: Typical End-Use Product or Pure Active Ingredient and 

Metabolites

TGAI: Technical Grade Active Ingredient

TGAI/PAI: Technical Grade Active Ingredient or Pure Active Ingredient 

TGAI/PAIRA: Technical Grade Active Ingredient or Pure Active

Ingredient Radiolabeled

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

MET: Metabolites

IMP: Impurities

DEGR: Degradates

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

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

receipt of the Data Call-In notice.
EPA Data Call-In Notice Attachment

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-In Notice 

contains a fuller description of each of these options.

1. Developing Data: I will conduct a new study and submit it within the time frames

specified in item 8 above. By indicating that I have chosen this option, I certify that I 

will comply with all the requirements pertaining to the conditions for submittal of this 

study as outlined in the Data Call-In Notice and that I will provide the protocols and 

progress reports required in item 5 above.

2. Agreement to Cost Share: I have entered into an agreement with one or more 

registrants to develop data jointly. By indicating that I have chosen this option, I certify 

that I will comply with all the requirements pertaining to sharing in the cost of 

developing data as outlined in the Data Call-In Notice.

3. Offer to Cost Share: I have made an offer to enter into an agreement with one or more 

registrants to develop data jointly. I am also submitting a completed "Certification of 

offer to Cost Share in the Development of Data" form. I am submitting evidence that I 

have made an offer to another registrant (who has an obligation to submit data) to share 

in the cost of that data. I am including a copy of my offer and proof of the other 

registrant's receipt of that offer. I am identifying the party which is committing to

submit or provide the required data; if the required study is not submitted on time, my

product may be subject to suspension. I understand that other terms under Option 3 in 

the Data Call-In Notice apply as well.

4. Submitting Existing Data: I will submit an existing study by the specified due date 

that has never before been submitted to EPA. By indicating that I have chosen this 

option, I certify that this study meets all the requirements pertaining to the conditions

for submittal of existing data outlined in the Data Call-In Notice and I have attached

the needed supporting information along with this response.

5. Upgrading a Study: I will submit by the specified due date, or will cite data to-upgrade 

a study that EPA has classified as partially acceptable and potentially upgradeable. Byindicating that I have chosen this option, I certify that I have met all the requirements 

pertaining to the conditions for submitting or citing existing data to upgrade a study 

described in the Data Call-In Notice. I am indicating on attached correspondence the 

Master Record Identification Number (MRID) that EPA has assigned to the data that I 

am citing as well as the MRID of the study I am attempting to upgrade.

6. Citing a Study: I am citing an existing study that has been previously classified by 

EPA as acceptable, core, core minimum, or a study that has not yet been reviewed by 

the Agency. If reviewed, I am providing the Agency's classification of the study.

7. Deleting Uses: I am attaching an application to amend my product’s (or products’)

labeling to delete the uses for which the data are required.

8. Low Volume/Minor Use Waiver Request: I have read the statements concerning low 

volume-minor use data waivers in the Data Call-In Notice and I request a low-volume 

minor use waiver of the data requirement. I am attaching a detailed justification to 

support this waiver request including, among other things, all information required to 

support the request. I understand that unless the Agency provides a written response 

waiving the requirement to submit data, the data remain required and are to be 

submitted according to the timelines specified in the Data Call-In Notice.

9. Request for Waiver of Data: I have read the statements concerning data waivers other 

than low volume minor-use data waivers in the Data Call-In Notice and I request a 

waiver of the data requirement. I am attaching a rationale explaining why I believe the

data requirements do not apply. I am also submitting a copy of my current labels. (You 

must also submit a copy of your Confidential Statement of Formula if not already on file 

with EPA). I understand that unless the Agency provides a written response waiving the

requirement to submit data, the data remain required and are to be submitted according

to the timelines specified in the Data Call-In Notice.
EPA Data Call-In Notice Attachment

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: 0001 - Metolachlor

Page: 1 of 1

19713

60063

11603

DREXEL CHEMICAL COMPANY

SIPCAM AGRO USA, INC.

ADAMA AGAN LTD.

Co. Nr. Company Name Agent For Company

MAKHTESHIM-AGAN OF NORTH 

AMERICA INC

P.O. Box 13327

2525 MERIDIAN PKWY., SUITE 350

3120 HIGHWOODS BLVD., SUITE 100

Address City ZIP

MEMPHIS

DURHAM

RALEIGH

381130327

27713 

27604 

OMB Approval 2070-0174

State

TN

NC

NC

 DCI Number: GDCI-108801-1506
EPA Data Call-In Notice Attachment

Attachment 5. Additional Documents and Information
EPA Data Call-In Notice Attachment

LINKS TO FORMS:

The pesticide registration forms that are listed below can be found at:

http://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-20-forms-andhow-obtain-them

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

http://www.epa.gov/sites/production/files/2013-07/documents/8570-4_0.pdf

Certification of Attempt to Enter Into an Agreement With Registrants for Development of Data 

(Form # 8570-32):

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

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

http://www.epa.gov/sites/production/files/2013-08/documents/8570-34.pdf

ATTENTION DCI RESPONDENTS:

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

entitled

“Pesticides Data Call-In Program” (OMB No. 2070-0174; EPA No. 2288.01).

For more information about the Agency’s burden estimates, please go to the following RegInfo.gov 

website produced by the office of Management and Budget (OMB): 

http://www.reginfo.gov/public/do/PRAMain.

From this site location, under the “Information Collection Review” heading, submit a search by the 

agency name, or, in the blue bar area at top right of the page, select “ICR” and in the search window 

nearby type the OMB control number (2070-0174), then click on the “Go” button at the right of the 

search window.

Specifically the ICR associated with the DCI request is located at:

http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=2070-0174.