UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION

GENERIC DA T A CALL

- IN N O TICE

Dear Sir or Mada m:

This Notice requires you and other registrants of pesticide products containing the active ingredient(s) identified in Attach m ents 2 and 3 of this Notice to subm it certain data as noted
herein to the U.S. Environm ental Pr otection Agency (EPA, the Agency). These data are

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

case and to m aintain the continued registration of your product(s) containing the active ingredient(s). Within 90 days af ter you receive this Notice, you m ust respond as set forth in
Section III below. Your response m ust state:

1. How you wi ll co mply with the require m ents set forth in this Notice and its Attach ments 1 through 5; or,

2. Why you b e lieve you are exe m pt from the r equirem ents listed in this Notice and in
Attach m ent 3, Generic R equirements Status and Registrant's Response Forms and
Instructions For m , (see section III

- B); or,

3. Why you believe EPA should not require your submission of data in the m anner specified by this Notice (se e se ction III- D).

If you do not respond to this Notice, or if you do not satisfy EPA that you will com ply with its requirements or should be exempt or excused from doing so, then the registration of your product(s) subject to this Notice w ill be subject to suspension. We have provided a list of all of your products subject to this Notice in Attach ment 2, Generic Data Call-In Response Forms And
Instructions For m , as w e ll as a list of all registrants who were sent th is Notice (Attac hment 4).

You may respond to this G eneric D ata C all

- In N otice either electronically through the Central Data Exchange (CDX) or by mail as described in Attachment 1. When submission of responses is
discussed t hroughout this Notice, either method can be used.

The authority for this Notice is section 3(c)( 2 )(B) of the Federal Insecticide, Fungicide and
Rodenticid e Act (FIFRA), as a mended ; sections 3(g)(2)(A) and (B) of FIFRA, as a mended; and/or section 408(f)(1)(A) of the Federal Food, Drug, and Cosm etic Act (F FDCA). 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. Colle ction of th is in form ation is in

co m plian c e with the Paper work Reduction Act (44 U.S.C. 3501 et seq.) as approved by the Office of Management and Budget (OMB) under Control Number 2070-0174.2 This Notice is divi d ed i n to s i x sections and five Attach m ents. The Notice itself contains infor m ation and instructions applicable to a ll Data Call

- In Notic e s. The Attach m ents c ontain specific c h e m ical infor m ati on and instruct i ons. The six sections of the Notice are:

Section I. Why You Are Recei v i ng This Notice Section II. Data Required By This Notice Section III. Co m pliance W ith Require m ents Of This Noti c e Section IV. Consequences Of Failure To Co m ply W ith This Notice Section V. Registrants' Obligation To Report Possible Unreasonable Adverse Effects Section VI. Inquiries And Responses To This Notice

The Attac h m ents to this Notice a re:

Attach m ent 1. Data Call

- In Ch e m ical Status Sheet Attach m ent 2. Generic Data Call

- In Response For m s and Instructions Attach m ent 3. Generic Require m ents Status and Registrant ' s Response For m s and Instructions Attach m ent 4. List of All Registrants S e nt this D a ta Call

- In Notice Attach m ent 5. Additional Docu m ents and Infor m a tion

• Conf idential State m ent of Fo r m ula and Instructions

• Certi f ic a tion of Atte m pt to Enter into an Agree m ent with Registra n ts for Develop m ent of Data

• Certi f ic a tion with Resp e ct to Citati o n of Data

• Paperwork Reduction A ct Noti f ication for DCI Respondents

SECTION I. WHY YOU ARE RECEIVING THIS NOTICE

The Agency has reviewed existing data for the active in g redi e nt(s) ide n ti f ied in Att a c h m ents 2 and 3 of this Notice, and reevaluated the data needed to support cont i nued registration of products containing the subject acti v e ingre d ien t (s) and the continuation of any exi s ting tolerances or

exe m ptions for such active ingredie n t

. T his ree v aluation conducted as part of Registration Review
i d enti f ied 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. DA T A R E QUIRED B Y THIS NOTICE

A

. DATA REQUIRED The data r e q uired by this Notice a re s pecified in the Attach m ent 3, Generic Requirements Status and R egistrant's R esponse Forms and Instructions Form. Depending on the results of the stu d ies r equired in t h is Noti c e, a d ditio n al testing m ay be required.

B. SCH E DU L E FOR S U B MISSION OF DA T A
You are required to sub m it the data or other w ise satis f y t h e d ata r equi r ements spe c i f i e d in Attach m ent 3, Generic R equirements Status and Registrant's Response Forms and
Instructions For m , within the ti m e f r a m es provided.

C. TESTING P R OTOCOL3 All studies required under this Notice m ust be conducted in accordance with protocols which meet the purpose of the test standards outli n ed in the Pesticide Assess m ent Guidelin e s f or those s tu d ies f or whi c h guidelines have been established and which provide data of suitable quality and completeness as typified by the proto cols cited in the guidelines.

These EPA Guidelines are availa b l e from the National Tech ni cal Infor m ation Service (NTIS), Attn: Order Desk, 5285 Port Roy a l Road, Springfie ld, 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 Econo m i c Cooperation and Develop m ent (OECD) are also acceptable if the O ECD

- recom m ended test standards confo r m to those specified in the Pesticide D a ta Require m ents regulation (40 C FR Part 158.70). W hen using the OECD protocols, they should be modified as appropriate so that t h e data generated by the study will satisfy the re q uire m ents of 40 CFR Pa r t 158. Normally, the Agency will n o t extend deadlines for complying with data require m ents when the stu d ies were not c onducted in acc o rdance with acce p table standards. T h e OECD protocols are a v aila b l e from 2001 L Street, N. W

. , Suite 650, Washington, D.C. 20036 (Tel e phone nu m ber 202

- 785

- 6323; Fax telephone nu m ber 202

- 785

- 0350) and electronically on the OECD website ( http://www.oecd

ilibrary.org/environment/oecd

- guidelines

- for

- the

- testing

- of

- chemicals_chem_guide_pkg

- en )

. All new stu d ies and pro p osed pr otocols sub m itted in respon s e to t h is Data Call

- In Notice must be in accordance with Good Laboratory P ractices ( 40 CFR Part 160 )

. D

. REGIST RA NTS R E CE I V ING P R E V IOUS S E C T ION 3(c)(2)(B) OR 4 D ATA C ALL

- I N NOTICES ISSUED BY THE AGENCY Unless otherwise noted herein, this D ata Call

- In does not in any way supersede or change the require m ents of any previous Data Call

- In(s) , or any other agree m ents entered into with the Agency pertaining to such prior Notice. Registr a nts m ust comply with the require m ents 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

. SCH E DU L E FOR RE S PONDING TO THE AGEN C Y The appropriate respon s es initially required by this Notice must be sub m itted to the A gency within 90 days after your receipt of this Notice. Failure to ade q uately respond to this N otice within 90 days of your receipt will be a basis for issuing a Notice of Intent to Suspend (NOIS) aff e cting your products. T h is and other bases for issuance of NOIS due to failure to

co m ply with this Notice are p r esented in Section IV

- A and IV

- B.

B. OPTIONS F OR R E SPONDING T O THE AGENCY The options for responding to this N otice are: 1) voluntary cancellation, 2) del ete use(s), (3) claim generic data exemption, ( 4 ) agree to satisfy the data require m ents imposed by this Notice or ( 5 ) reque s t a d ata waiv e r( s ).
A discussion of how to respond if you chose the Voluntary Cancellation option, the Delete Use(s) option or the Generic Data Exe m ption o p tion is presented below. A discussion of the various options available for satisfying the data require m ents of this Notice is contained in Section III

- C. A discussion of options relating to requests for d a ta w a iv e rs is co n t a i n ed i n Section III

- D.

There are t w o fo r m s that acco m pany this Notice o f which, depending upon your respo n se, one4 or both must be used in your response to the Agency. These for m s are the Attach m ent 2, Generic Data Call

- In Response Forms And Instructions Form and the Attach m ent 3, Generic Requirements Status and Registran t 's Response Forms and Instructions F or m . The Attach m ent 2, Generic Data Call

- In Response Forms And Instructions Form must be sub m itted as part of every response to this Not i ce. N o te that the c o mpany ' s au t horized representative is required to sign the first page of the Attach m ent 2, Generic Data C all

- In Response Forms And Instructions
F orm and the Attach m ent 3, Generic R equirements Status and Registrant's Response Forms and Instructions Form and initial any subsequent pages. The fo r m s contain separate detailed instruct i ons on the response options. Do not alter the printed m aterial. If you have questions or need assistance in preparing your response, write or email EPA as indicated in Attach m ent 1.

1. Voluntary C ancellation

- You m ay a void the require m ents 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 vo l untarily cancel your product, you must sub m it a

co m pleted Attach m ent 2, Generic Data Call

- In Response Forms And Instructions For m , indicating your election of this option. Voluntary cancellation is item number 5 on the Attach m ent 2, Generic Data Call

- In Response Forms And Instructions For m

. I f you choose this option, this is the only form that you are required to co m plete.
If you choose to voluntarily ca n cel your product, f urther sale and distribution of your product after the effecti v e date of ca n cellat i on m ust be in acc o rdance with the Existing Stocks provisions of this Notice w h ich are contained in Section IV

- C.

2. Use Deleti o n

- You m ay avoid the require m ents of this Noti c e by eli m inating t h e uses of your product to which the require m ents apply. If you wish to a m end your registration to delete

uses, you m ust sub m it the Attach m ent 3, Generic Requirements Status and Registrant's Response Forms and Instructions F or m , a co m p leted application for a m end m ent, a copy of your proposed a m ended labeling, and all other infor m ation required for processing the application. Use deletion is option nu m ber 7 on the Attach m ent 3, Generic R equirements Status and Registrant's Response Forms and Instructions For m . You must also complete an
A ttach m ent 2, Generic Data Call

- In Response Forms And Instructions F orm by signing the certification, item nu m ber 8. Application fo r m s for a m ending registrations may be obtained from the Registration Division (Main Office), (703) 305

- 5447.
If you choose to delete the use ( s) subject to t his Notice or uses subject to specific data require m ents, further sale, distribution, or u s e of your product after one year from the due date of your 90 day response, m u st bear an a m ended label.

3. Generic Data Exe m ption

- Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is exe m pt from the require m ent to sub m it or cite generic data concerning an active ingredient(s) if the a c tive ingredient(s) in the product is derived exclusively from purchased, registered pesticide products c o ntaining the active ingredient(s). EPA has concluded, as an exercise of its discretion, that it nor m ally will not suspend the registration of a product which

w ould qualify and continue to qualify for the generic data exe m ption in section 3 ( c)(2) (D) of FIFRA. To qualify, all of the following require m ents m ust be met:

a. The active ingredient(s) in your registered product m ust be present solely because of incorporation of another registered pr oduct which contai n s the subject active ingre d ient(s) and is purchased from a source not connected with you; and,
b. Every registrant who is the ulti m ate s ource of the acti v e ing r edient(s) in your product subject to this D CI m ust be in co m pliance with the require m ents of this5 Notice and m ust remain in co m pliance; and

c. You m ust have provided to EPA an accurate and curre n t "C o nfidential State m ent of
For m ula" for each of y our products to which t h is Notice ap p lies.
To apply for the Generic Data Exemption you must sub m it a co m pleted Attach m ent 2, Generic Data Call

- In Response Forms And Instructions Form and all supporting docu m entation. The Generic Data Exe m ption is item number 6a on the Attach m ent 2, Generic Data Call

- In Response Forms And Instructions Form. If you claim a generic data exe m ption, you are not required to co m plete the Attach m ent 3, Generic R equirements Status and R egistrant's
R esponse Forms and Instructions Form. Generic Data Exe m ption cannot be selected as an option for product specific data.
If you are granted a Generic Data Exe m p tion, you rely on the efforts of other persons to provide the Agency with the req u ir e d data. If the regi s tra n t( s ) who have com m itted to generate and sub m it the required data fail to take appropriate steps to m eet the require m ents or are no longer in compliance w i th this Data Call

- In Notice, the Agency will con s ider that both they and you are not in co m pliance and will nor m ally initiate procee d ings to suspend the registrations of both your and their product(s), unless you com m it to sub m it and do sub m it the required data within the speci f ied ti m e. In such cases the Agency gener a lly will not g rant a ti m e extension f or sub m itting the d a ta.

4. Satis f ying t h e Data Req u ire m ents of this Noti c e

- There are various options available to satis f y t h e d ata r equi r ements of this Notice. These options are disc u ssed in Section III

- C of this Notice and co m prise options 1 through 6 on the Attach m ent 3, Ge n eric Requirements Status and Registran t 's Response Forms and Instructions F orm and option 6b and 7 on the Attachment 2, Generic Data Call

- In Response Forms And Instructions
For m

. I f you choose option 6b or 7, you m ust sub m it both for m s as well as any other infor m ation/data pertaining to the option chosen to address the data require m ent.

5. Request for Data W aivers

- Data waivers are di sc ussed in Se c tion III

- D of this Notice and are covered by options 8 and 9 on the Attach m ent 3, Generic Requirements Status and Registrant's Response Forms and Instructions F or m . If you choose one of these options, you

m

ust sub m it bot h for m s as well as any oth e r infor m ation/data pertaining to the option chosen to address the data require m ent.

C. SATISFYING THE DATA REQU I REMENTS OF THIS NOTICE If you acknowledge on the Attach m ent 2 Generic Data Call

- In Response Forms And
Instructions Form that you agree to satisfy the data r e quire m ents (i.e. you select option 6b and/or 7), then you m ust select one of the six options on the Attach m ent 2, Generic Data Call

- In Res p onse Forms And Instructions Form related to data production for each data require m ent. Your option selection is to be entered under item nu m ber 9, "Registrant Response." The six options related to data prod u ction are the first six options discussed under item 9 in the instr u ctions f or co m pleting the Att a ch m ent 3, Generic Requirements Status and Registrant's Response Forms and Instructions F or m . These six options are listed im m ediately below with in f or m ation in parent h es e s to guide r e gist r ants to a dditio n al i ns t ru c tions p r o vided in this Section. The options are:

1. I will g ener a te and sub m it data within the spe c i f i e d ti m e f r a m e (Developi n g Data),

2. I have entered into an agree m ent with one or m ore registrants to develop data jointly (Cost Sharing),6 3. I have m ade offers to cost

- share (Offers to Cost S har e),

4. I am sub m itting an existing study that has not b een sub m itted previou s ly to the Agency by anyone (Sub m itting an Existing S t u d y),

5. I am sub m itting or citing data to up g rade a study clas s i fied by EPA as partially acceptable and upgradeable (Upgra d ing a Study),

6. I am citing an existing study that E P A 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 D ata

– If you choose to develop th e required data, t h en it m ust be in confo r m ance with the Agency’s deadlines and other require m ents that are referenced herein a n d in the

att a ch m ents. All data ge nerated and sub m itted must co m ply with the G o od Laboratory Practice ( G LP) rule (40 CFR Part 160), be conducted in accordance with the Pesti c ide
A s sess m ent Guidelines (P A G ), be in confo r m ance with P esticide R egistration Notice (PRN) 2011

- 3 entitled “ Standard Format for Data Submitted Under FIFRA and Certain Provisions of FFDC A ” ( http://www.epa.gov/pesticide

- registration/pesticide

- registration

notices

- year ), and, as applicable, co m ply with 40 CFR Part 26, “Protection of Hu m an Subjects.” In addition, certain studies require Agency approval of test protocols in advance of study initiation. T hose studies for which a protocol m u st be sub m itted have been identified in the Atta c h m ent 3, Generic Requirements Status and Registrant's
Re sponse Forms and Instructions Form a nd/or footnotes to the form. If you w i sh to use a protocol which differs from the options disc u ssed in Se c t ion II

- C of t h is Noti c e, y o u m ust sub m it a detailed description of the proposed protocol and your reason for wishing to use it. The Agency m ay choose to reject a prot oc ol not specified in Secti o n II

- C. If the Agency rejects yo u r protoc o l, y o u will be n o tified in writing, however, you should be aware that rejection of a proposed protoc ol will not be a basis for extending the deadline for sub m ission of data.
A progress report m ust be sub m itted for each st u dy within 90 days from t he date you are required to com m it to generate or und e rtake so m e other m e a n s to address that study require m ent, such as m aking an offer to cost

- share or agreeing to share in the cost of developing that study. A 90

- day p r ogre s s report m ust be sub m itted for all studies. T h is 90

- day pro g ress report must inclu d e the date t h e study was or will b e initiated and, for studies to be started w ithin 12 months of commi t m ent, the na m e and address of t h e laboratories or indi v i d u als who are or will b e c o nducting the study.

In addition, if the ti m e fra m e for sub m ission of a final report is m ore than 1 year, interim reports m ust be sub m itted at 12 m onth intervals from the date you are required to com m it to generate or otherwise address the require m ent for the study. In addition to the other infor m ation specified in the prece d ing p aragraph, at a m i n i m u m, a brief description of current activity on a nd the status of the study m ust be included as well as a full description of any proble m s encountered since the last progress report.

The ti m e fra m es in the Generic Requirements Status and Registrant's R esponse Forms and Instructions Form (Attach m ent 3) are the t i m e fra m es that the Agency is allowing for the sub m ission of co m p l eted 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 su b m itted7 by the deadline, e ach re g istr a nt is su b je c t to re c eipt of a Notice of Inte n t to Su s pend the affected regi s t ratio n ( s) and the a ff ected tol e rances o r exe m ptions are subject to revocation.
If you cannot sub m it the data/reports to the Agency in the ti m e required by this Notice and intend to seek additional ti m e to m eet the require m ent(s), you m ust sub m i t a
reque s t to the Agency which incl u des: ( 1 ) a detailed descri p tion of the expected difficulty and (2) a proposed schedule i n cluding alternative dates for m eeting such require m ents on a step

- by

- step basis. You m ust explain any technical or laboratory difficulties and provide d ocu m entation from the laborat o ry perfor m i ng the testing. While EPA is considering your request, the original deadline re m ains. The Agency will respond to your re q uest in writing. If EPA does not gra n t your req u est, then the origi n al de a dline re m ains. Nor m ally,

exten s ions can be requested only in cases of extraordinary testing proble m s beyond the

e xpectation or control of the registrant. Extensions will not b e g iven in su b m itting the 9 0

- day resp o nses. Exten s ions will not be considered if the request for extension is not m ade in a ti m ely fashion; in no event shall an ext e nsion requ es t be con s ide r ed if it is s u b m itted a t or

a f

ter the la p se of the subject dea d line.
Option 2, Agree m ent to Share in Co s t to Develop Data

– If you choose to enter into an agree m ent to share in the cost of producing the required data but will not be su b m itting the d ata your s elf, you m ust provide the na m e of the regi s t ra n t who will be s ub m itting t h e d a ta. You must also p r ovide EPA with docu m entary evidence that an a g ree m ent has been fo r m ed. Such evide n ce m ay be your letter offering to join in an

agree m ent and the other registrant ' s acceptance of your o ffer, or a written state m ent by the parties that an a g reement exists. T he agree m ent to produce the data need not spe c i f y all of the te r m s of the f i nal arran g e m ent between the parties or t h e m echanism to resolve the

t e r m s. FIFRA section 3( c ) ( 2)(B) pro v i d es th a t if the parties can n ot res o lve t h e ter m s of the

agree m ent they m ay resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Develop m ent

– If you have m ade an offer to pay in an att e m pt to enter into an agree m ent or a m end an existing agree m ent to meet t h e req u ire m ents of this Notice and have been unsuccessful,

you m ay request EPA (by selecting this option) to exercise its discretion not to suspend your registration(s), although you do not co m ply with the data sub m ission require m ents of this Notice. E P A has deter m ined that as a general policy, absent other r e levant 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 d ata dev e lo p m ent/cost s h ar i ng program, but the other registrant(s) developing the data has refused to accept your o f fer. To qualify for this option, you must sub m it docu m entation to the Agency proving that you have m ade an offer to another registrant (who has an obli g ation to su b m it data) to share in the burden of developing that data. You m u st also sub m it to the Agency a co m pleted EPA
Fo r m 8570

- 32, Certific a tion of Offer to C o st Share in the Develo p ment of Data (see Attachment 5) . In addition, you m ust demonstrate that the other registrant to whom the offer was m ade has not accepted y o ur offer to enter into a cost s h aring agree m ent by inclu d ing a copy of your offer and proof of the other re g i stra n t ' s recei p t of that offer ( s uch as a certified m ail rec e ipt). Y o ur o ff er m ust, in ad d ition to a nyt h ing else, o ff er to share in the burden of producing the data upon ter m s to be agreed or failing agreement to be bound by binding arbitration as provided by FIFRA se c tion 3(c)(2)(B)(iii) and m ust not qualify th is offer. The other registrant m ust also inform EPA of its election of an option to develop and sub m it the data r equi r ed by this Notice by sub m itting a Generic Data Call

- In Res p onse8 Forms And Instructions Form (Attach m ent 2) and a Generic Requirements Status and Registran t 's Response Forms and Instructions F orm (Attach m ent 3) com m itting to devel o p and sub m it the d a ta re quired by this Notice.
In order for you to avoid suspension und e r this option, you may not withdraw your offer to share in the burdens of developing the data. In addition, the other registrant must f ul f ill its

com m itment to de v elop and submit t h e data as requi r ed by this Notice. If the other registrant fails to develop the data or for so m e other reason is subject to suspension, your regis tration as well as that of the other regi s tra n t will n o r m ally be subject to i n itiation of

s u spension pr o ceedings, u n less you c o mmit to sub m it, and do sub m it the required d ata in the s p ecified ti m e fra m e. In such cases, t h e Agency gener a lly will not g r ant a ti m e

e x tension f or sub m itting the d a ta.
Option 4, Sub m itting an Existing S t u dy

– If you choose to sub m it an existing study in response to this Notice, you must deter m ine that the study satisfies the require m ents i m posed by this Notice. You m ay only sub m it a study t h at has not been previou s ly s ub m itted to the Agency or previously cited by anyone. Existing studies are s t udies which predate iss u ance of this Notice. Do not use t h is option if

y o u are sub m itting data to upgrade a st udy. (See Option 5).

You should be aware that if t h e Agency deter m ines that the e xisting study is not acceptable, the Agency will require you to c o m p ly with t h is Notice, nor m ally without an extension of the required date of sub m ission. The Agency m ay determine at any ti m e that

a study is not valid and needs to be repeated.

To m eet the require m ents of the DCI Not i ce for s ub m itting an existing st u dy, all of the following four criteria m ust be clearly m e t :

a. You m ust certi f y at the ti m e that the existing stu d y is sub m itt e d that the r a w data and speci m ens from the study are available f or audit and review and you must identify where they are available. This m ust be done in accordance with the require m ents of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR Part 160.3(7) " raw data m eans any laboratory worksheets, records, m emoranda, notes, or e x act copies thereof, that are the result of original observ a tions and activi ties of a study and are necessary for the reconstruction and evaluation of the r e port of that study. In the event that exact transcripts of raw d a ta have been prepared (e.g., tapes w hich have been transcri b ed verbati m , dated, and verif i ed accurate by sign a t u re), t h e exact copy or exact transcript m ay be substit u t e d for t h e ori g inal s o urce as raw data. Raw data may include photographs,

m i crofi l m or m icrofiche copies, co m puter printouts, magnetic m edia, including dictated observations, and recorded data from automated i n stru m ents." The term "speci m e ns", acc o rding to 40 CFR Part 160.3(7), m eans "any m aterial derived from a test system for exa m in a tion or analysis."
b. Health and safety studies co m pleted after May 1984 m ust also contain all GLP

required quality assurance and qua l ity control infor m ation, pursuant to the require m ents of 40 CFR Part 160. Registrants must also certify at the ti m e of sub m itti n g the existi n g study that such GLP info r m ation is available for post

- May 1984 studies by including an appropriate state m ent on or attached to the study signed by an authorized official or representative of the registrant.9 c. You m ust certify that each study has been conducted acc o rdi n g to the Pesti c ide A s sess m ent Guidelines (P A G) or m eets the purpose of the PAG (both available from NTIS). A study not conducted accor d i n g to the PAG m ay be sub m itted to the Ag e ncy f or consider a tion if the regi s t r ant belie v es th a t the study clearly m eets the purpose of the P AG. The registrant is referred to 40 CFR Part 158.70 which states the A g ency ' s policy regar d ing acceptable protocols. If you wish to sub m it the study, you must, in addition to certifying that the

pur p oses of the PAG are m et by the study, clearly articulate the rationale why you believe the study m eets the purpose of the PAG, including copies of a n y supporting infor m ation or data. Y o u m ust 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 c o mpleted prior to January 1970 rarely satisfied the purpose of the PAG and that necessary raw data are usually not available for such studie s

. d. If any existing study involves testing subject to 40 CFR Part 26, you m ust co m ply with all ap p li c a b le req u ire m ents in EPA’s regul a tions at 40 CFR Part 26 entitled “ Prote c tion of Hu m an Subjects.”
If you sub m it an existing study, you must certify that the study m eets all require m ents of the criteria outlined above.
If EPA has previou s ly reviewed a protocol for a study you are sub m ittin g , you m ust 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 f i nal protocol and study.
If you know of a study pertaining to any require m ent in this Notice which does not m eet the criteria outlined above but does contain factual infor m ation regarding unreasonable adverse effects, you m ust notify the Agency of such a stud y. If such a study is in the Agency ' s files, you need on l y cite it along with t h e notification. If not in the Agency ' s files, you m ust sub m i t a sum m ary and copies as per PR N 2011

- 3

. Option 5, Upgrading a S t udy

– If a study has been classified as partially acceptable and upgradeable, you m ay sub m it data to up gr ade th a t stu d y. The Agency will revi e w the data s ub m itted a n d deter m ine if the

req u i r e m ent is satis f ied. If the Agency decides the require m ent is not satisfied, you m ay still be required to sub m it new data nor m ally without any ti m e extension. Deficient, b ut upgradeable stu d ies will nor m ally be clas s i fied as supple m ental. However, it is i m portant to note that not all studies classified as supple m ental are upgradeable. If you have questions reg arding the classifica t ion of a study or whether a study m ay be upgraded, write or email EPA as indicated in Attach m ent 1. If you sub m it data to upgrade an existing study, you m u st satisfy or supply infor m ation to correct all deficiencies in the study ide n tified by EPA. You must provide a clearly articulated rationale of how the deficiencies have been re m edied or corrected and why the study s h ould be rated as acce p table to EPA. Your sub m i ssion m ust also specify the MRID nu m ber(s) of the study which you are
atte m pting to upgrade and be in confo r m ance with PR N 2011

- 3

. Do not sub m it additio n al data for t h e purpose of upgrading a study classified as unacceptable and deter m ined by the Agency as not capa b le of being upgraded.10 This option should also be used to cite d a ta that has been previously su b m itted to upgrade a study, but has not yet been reviewed by the Agency. You m ust provide the MRID number of the data sub m ission as well as the MRID nu m ber of the study being upgraded.

The criteria for sub m itting an ex i s ti n g study, as s pecified in Option 4 a b ove, apply to all data sub m issions intended to upgrade studies. Additionally your sub m ission of data i n tended to upgrade studies m ust be acco m panied by a certification that you co m ply with each of tho s e criteria as well as a certification regarding pr ot ocol co m pliance with Agency require m e nts.
Option 6, Citing Existing Studies

– If you choose to cite a study that has been previously sub m itted to EPA, that study must have b een pre v iously classified by EPA as accepta b l e or it m ust 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 m ini m u m." For ecological effects studies, the clas s i fication generally would be a rating of "core." For all o ther d i s ciplines t h e clas s ificati o n w ould be "acceptable

. " W ith respect to any studies for which you wish to select this option you m ust provide the MRID number of the study you are citi n g a nd, if the study has been reviewed by the Agency, you must provide the Agency ' s classification of the study.
If you are citing a s t udy of which you are not the origi n al data sub m itter, you m ust sub m it a completed co p y of Certi f i c ation with Respect to Citations of Data (in PR N 2011

- 3 ) EPA Fo r m 8570

- 34

. D

. REQUESTS FOR DATA WAIVERS

There are t w o types of data waiver responses to this Notice. The first is a request for a low volu m e / m i nor use waiver and the second is a w a iver request based on y o ur belief that the data require m ent(s) are inapplic able and do not apply to your product.

1. Low Volume/Min o r Use W aiver (Option 8 on the Attach m ent 3, Generic Requirements Status and R egistrant's R esponse Forms and Instructions For m ) Section 3(c)( 2 )(A) of FIFRA requires EPA to consi d er the appropriateness of r e quiring data for low volu m e,

m inor use pesticides. In i m pl e m enting this provision EPA con s iders as l o w volu m e pesticides only those active ingredient(s) whose total production volu m e for all pesticide registrants is s m all. In deter m ining whether to grant a low volu m e, m i nor use waiver the Agency will consider the extent, pattern a nd volu m e of use, the econo m ic incentive to conduct the testing, the importance of the pesticide, and the exposure and risk from u s e of the pe s ti c id e . If an acti v e ingre d ien t( s ) is used for both high volu m e and low volu m e uses, a low volu m e exemption will not be appr o ved. If all u s es of an active ingre d ie n t(s) are low vol u m e and the co m bined volu m es for all uses are also low, then an exe m ption

m ay be granted, depen d ing on revi e w of other in f or m ation outli n ed below. An exemption will not b e g ranted if any regi s tra n t of the a c tive ingredie n t ( s ) ele c ts to

co n duct the testing. Any registrant receiving a low volu m e minor use waiver m ust

re m ain within the sales figures in their forecast supporting the w a iver request in order to

re m ain qualified f or such waiver. If gra n ted a waiver, a regi s t r ant will be required, as a

co n dition of the waiver, to s ub m it annual sales rep o rts. The Agency will res p ond to requests for waivers in writin g.

To apply for a low volu m e, m i nor use waiver, you m ust sub m it the following11 infor m ation, as applicable to your product(s ) , as part of your 90

- day response to this Notice:

a. Total co m pany sales (pounds and dollars) of all registered product(s) contai n ing the active in g redie n t( s ). If appli c able to the a c tive ingre d ient(s ) , include foreign sales for those products t h at a r e n ot re g i st e r ed in this cou n try but are applied to sugar (cane or beet), coffee, bananas, cocoa, and other such crops. Pre s ent the abo v e infor m ation by year for each of the past five years.

b. Provide an esti m ate of the sales (pounds and dollars) of the active ingre d ient(s) for each m a jor 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. Inc l ude infor m ation on raw material cost, direct labor cost, adve r tising, sales and m arketing, and any other significant costs listed separately.

d. Total indirect production cost (e.g. plant overhead, a m ortized plant and equip m ent) charged to product(s) containing the active ing r edient(s) by year for the past f i ve years. E xclude all n on

- rec u rring costs t h at w ere dire c tly rel a ted to

t h e active in gr ed ient(s), s u ch as costs o f initi a l re g i s tr a tion and a ny data develop m ent.

e. A list of each data require m ent for whi c h you seek a waiver. Indicate the type of waiver sought and the esti m ated cost to you (listed separately for each data require m ent and associated test) of c onducting the testing needed to fulfill each of the s e data require m ents.

f

. A list of each data require m ent for w h ich you are not seeking any waiver and the

e s ti m ated cost to y o u (li s ted s e p arately f or e ach data re q uire m ent an d associated test) of cond u cting the testing needed to fulfill each of these data require m ents.

g. For each of the next ten years, a y ear

- by

- year forecast of company sales (pounds and dollars) of the active ingre d ient(s), direct production costs of product(s) containing the active ingredi e nt(s) (following the para m eters in item c above), indirect production costs of product(s) containing the active ingredient(s) (following the para m eters in item d above), and costs of data develop m ent pertaining to t he active ingredient(s).
h. A description of the i m portance and unique benefits of the active ingre d i e nt(s) to users. Di s cuss the u s e patt e rns and the e ff ectiv e ness of the a ctive ingredient(s) relative to registered alternative che m icals and non

- che m ica l control strategies. Focus on benefits unique to t h e active in gr edient(s), providing info r m ation that is as quantitative as p o ssible. If you do not have quantitative data upon which to base your esti m ates, then present the reasoning used to derive your esti m ates. To assist the Agency in deter m ining the degree of i m portance of the active i ngredient(s) in

ter m s of its benefits, you should provide infor m ation on any of the following factors, as applicable to your product(s):

(a) docu m entation of the useful ness of the active in g r edie n t ( s ) in Integ r ated
Pest Manage m ent,12 (b) description of the beneficial i m pacts on the environ m ent of use of the active ingredient(s), as opposed to its registered alternatives,

(c) infor m ation on the breakdown of the active ingredient(s) after use and on its

p e rsi s te n ce in t h e en v iron m ent, and
(d) description of its usefulness against a pest(s) of public health significance.

Failu r e to s u b m it su ff i ci e nt in f or m ation f or the Agency to m ake a det e r m ination regarding a request for a low volu m e m i nor use waiver will r e sult in d eni a l of the req u est for a waiver. Low volume m i nor use waivers m a y not be available for data required for continuation of tolerances or exe m ptions.

2. Request for Waiver of Data (Option 9 on the Attach m ent 3, Generic Requirements Status and Registrant's Response Forms and Instructions For m ). This option may be used if you belie v e that a particular data require m ent should not apply b ecause the correspon d i n g use is no longer registered and no t o lerance or tolerance exe m pt i on exists or the require m ent is inappropriate.
You m u st sub m it a rat i onale explaining why you believe the data require m ents should not apply. You must a l so sub m it the curre n t label(s) of your product(s) and, if a current c opy of

your Confidential Stateme n t of Formula is not already on file you must sub m it a current copy.

You will be infor m ed of the A g ency ' s deci s ion in writing. If the Agency deter m ines t h at the data re q uire m ents of this Notice do not apply to your pr o duct( s ), you will not b e required to supply the data pursuant to FIFRA s ection 3(c)(2)(B). If EPA determines that the data are required for your product(s), you m ust choose a m ethod of m eeting the requirements of this Notice w ithin the ti m e f r a m e provided by this Notice. W ithin 30 days of your recei p t of the
A g ency ' s written decision, you m ust sub m it a revised Attach m ent 3, Generic Requirements Status and Registrant's R esponse Forms and Instructions Form indicating the option chosen.

SECTION IV. CONSEQUENCES OF F A ILURE TO COMPLY WITH THIS NOTICE

A

. NOTICE OF INTENT TO SU S P E ND R E GI S TRATION/ORD E R R E VOKING OR MODIFYING TOLERANCE OR EXEMPTION
The Agency m ay issue a Notice of Intent to Suspend products subject to this Notice or an order revoking or m odifying associated tolerances or tolerance exe m ptions due to failure by a regi s tra n t to co m ply with the req u ir e m ents of this Data Call

- In Notice, pursuant to FIFRA section 3(c)(2)(B) or F F DCA section 408(f). Events which m ay be the basis for issuance of a Notice of Intent to Suspend or of an order revoking or m odify i ng associated tolerances or

exe m ptions include, but are not li m ited to, the following:
1. Failure to respond as re q uired by this Notice wit h in 90 days o f your recei p t of this Notice.

2. Failure to sub m it on the required schedule an a c ceptable proposed or final protocol when such is r equired to be s u b m itted to t h e Agency f or review.

3. Failure to sub m it on the required schedule an adequate progr e ss report on a study as required by this Notice.

4. Failure to sub m it on the required schedule a c ceptable data as required by this Notice.
5. Failure to take a required action or sub m it a d equate infor m ation pertaining to any option13 chosen to address the data require m ents (e.g., any required action or infor m ation pertaining to sub m ission or c i tation of existing studies or offers, arrange m ents, or arbitration on the sharing of c o sts or the for m ation of Task Forces, failure to co m ply with the ter m s of an agree m ent or ar b i tration co n cer ni ng joint d ata develop m en t or f ail u re to

co m ply with any ter m s of a data waiver).

6. Failure to sub m it supportable cer t ifications as to the condit i ons of sub m itted studies, as required by Section III

- C of this Notice.

7. W ithdrawal 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 p r o vided proof of the regi s t rant ' s recei p t of such offe r , or failure o f a registrant on whom you r ely for a generic dat a exemption either to:

a. Inform EPA of intent to develop and sub m it the data required by this Notice on an Attach m ent 2, Generic Data C all

- In Resp o nse Forms And Instructions
Form and an Attach m ent 3, Generic Requirements S t atus and Registrant's Response Forms and Instructions F or m ; or,

b. Ful f ill t h e c o m m it m ent to develop a nd sub m it the data a s re q uired by this
No tice; o r,

c. Otherwise take appropriate steps to m eet t h e req u ire m ents stated in t h is Notice, unless you com m it to sub m it and do sub m it the required data in the specified ti m e fra m e. 9. Failure to take any required or appropr i ate steps, not m entioned above, at any ti m e f

ollowing t h e issuan c e o f this Notic e

.

B. BASIS F OR DETERM I NATION T HAT S U BMITTED S TUDY IS UNACCEP T ABLE
The Agency m ay determine th a t a s t u dy (even if s ub m itted within the required ti m e) is unacceptable and constitutes a ba s i s for issuance of a Notice of Intent to Suspend or an order revoking or modifying a tolerance or toler a nce exe m ption. The grounds for suspension include, but are not li m ited to, failure to m eet any of the following:
1. EPA require m ents specified in the Data Cal l

- In Notice or other docu m ents incorporated by reference (including, as applicable, EPA Pesticide Assess m ent Guidelines, Data Reporting G uidelines, and GeneTox Health E ff ects Test Gui d elin e s) r ega r ding the design, conduct, and reporting of required s t udies. Such require m ents include, but are not li m ited to, those relati n g to te s t m ateri a l, t e st procedures, se lection of species, nu m ber of ani m als, sex and distribution of animals, dose a n d effect levels to be tested or attained, duration of test, and, as applicable, G ood Laboratory Practices.
2. EPA require m ents regarding the sub m ission of protocols, including t h e incorporation of any changes required by the Agency following review.
3. EPA require m ents regarding the reporting of data, including the m anner of reporting, the

co m pleteness of results, and the ade q uacy of any required supporting (or raw) data, including, but not li m ited to, require m ents ref e renced or included in this Notice and that set forth in PR N 2011

- 3 . All studies m ust be s ub m itted in the form of a final report; a preli m inary report will n ot be con s i d ered to f ul f ill the sub m ission req u ir e m ent.
4. Require m ents, as applicable, set forth in 40 CFR Part 26 entitled “ P rotection of Hu m a n14 Subjects.”

C. EXISTING STO C KS OF SUSP E NDED OR C ANC E LED PRODUC T S
EPA has statutory authority to per m it continued sale, distribution and use of existing stocks of a pesticide product w hich has been suspended or canceled if doing so would be consistent with the purposes of FIFRA.

The Agency has deter m ined that such disposition by registrants of existing stocks for a

s uspended registration when a FIFRA section 3(c)( 2 )(B) d ata request is outstanding would generally not be consistent with the Act ' s purposes. Accordingly, the Agency anticipates granting registrants per m ission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional circu m stances. If you believe such d i sposition of existing stocks of your product(s) which m ay be suspended for failure to co m ply with this Notice should be per m itted, you have the b u rden of clearly de m onstrating to EPA that gra n ting such

per m ission would be consistent with the Act. Y ou m ust also explain w h y an "existing stocks" provision is necessary, including a state m ent of the quantity of existing stocks and your esti m ate of the ti m e required for their sale, dist ribution, and use. Unless you m eet this burden, the Agency will not consider any request pertaining to the continued sale, distribution, or use of your exi s ting 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 require m e nts, you will have, under m ost circu m stances, one year from the date your 90 day response to this Notice is due, to sell, dist r i bute, or use exi s ting stocks. No r m ally, the Agency will a llow persons other than the registrant such as independent distributors, retailers and end u s ers to sell, distribute or use such existing stocks until the stocks are exhau s ted. Any sale, distribution or use of stocks of voluntarily c anceled products containing an active ingredient(s) for which the Agency has particular risk concerns will be determ ined 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 unle ss 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 i n 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 studies15 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 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 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,

Steve Knizner
Director
Antimicrobials Division
Office of Pesticide Programs
U.S. Environmental Protection AgencyE P A Data C all

- I n Notice A tta c h m e n t 

## A tta c h m e n t 1. D ata C a ll

- I n D ata Ch e m ic a l S t a t u s Sh ee tEPA Data C all -I n Notice A tta chment DA TA CA LL

- IN CH EMI CA L STATUS SH EET

Submit all r espo n ses to the GDC I using the informa ti on below. To exped it e pro ces sing, include the GDC I i den tifica ti o n nu mber (e.g., GD CI- 555555 -5555) in the S ub ject li ne of a ll D CI-relat ed

co rresponde nc e.

INQUIRIES AND RESPONSES TO THIS NOTICE

If you have specific questions or need assistance responding to the GDCI, contact the
A ntimicrobials D ivision Reevaluation team at OPP_AD_Reevaluation_DCI_Team@epa.gov

.
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

a ccess 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 ma il : By express or couri er servi ce: Document Processing D esk ( DC I/ AD ) Document Processing D esk ( DC I/ AD )
A tt n: R ee valuation Te amL ead er, P M 36 A tt n: R ee valuation Te am L ead er, P M 36
U S EPA (7510P) U S EPA (7510P) 1200 Pennsylv an ia Av e. N .W. One Potom ac Yard ( So uth Bu il ding )
Was hington, DC 20460 2777 S. Cryst al Dr. A rli ngton, VA 22202

*NOTE: If this DCI was sent to you via email, you may acknowledgement receipt via email.E P A Data C all

- I n Notice A tta c h m e n t 

## A tta c h m e n t 2. Ge n er i c D a t a C a l l

- I n R e spo n s e F o r m

a nd I n s t r u c t i o n sINSTRUCTIONS: 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
3074 - Hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine
Chemical # and Name: 083301 Hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine 06-May-2016
GENERIC
ID # GDCI-083301-1554 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 9. Date

11. Phone NumberE P A Data Call

- In Notice A tta c h m e n t 

## A tta c h m e n t 3. Ge n er i c R e qu i r e m e n ts S t a tu s a nd R e g i s t r a nt ' s Respo n s e F o r m a nd Ins t r u c t i o ns13. 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

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 _________________________________________________________________

Nontarget Plant Protection Data Requirements

Terrestrial and Aquatic Nontarget Organisms Data Requirements

Toxicology Data Requirements 850.4400

850.1300

850.1400

870.6200

870.7485

870.7800 Aquatic Plant Toxicity Using Lemna spp

Daphnid chronic toxicity test

Fish early-life stage toxicity test

Neurotoxicity screening battery

Metabolism and pharmacokinetics

Immunotoxicity 3074 - Hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine
Chemical # and Name: 083301 Hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine 06-May-2016
GENERIC
ID # GDCI-083301-1554

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z TGAI

TGAI

TGAI

TGAI

PAIRA

TGAI 12

12

12

12

24

12 1 of Page

(8)

(8)

(8)

(6, 8, 14)

(8)

(8) N

N

N

Y

N

N 3OMB 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

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

835.1110

835.1230

835.2120

835.3110

835.3220

835.3240

835.3280

835.4300

850.3300 Activated sludge sorption isotherm

Sediment and soil absorption/desorption for parent and degradates

Hydrolysis of parent and degradates as a function of pH at 25 C

Ready biodegradability

Porous pot test

Simulation Test-Aerobic Sewage Treatment-Activated Sludge

Simulation Tests to Assess the Biodegradability of
Chemicals

Aerobic aquatic metabolism

Modified Activated Sludge, Respiration Inh bition Test 3074 - Hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine
Chemical # and Name: 083301 Hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine 06-May-2016
GENERIC
ID # GDCI-083301-1554

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z COMMENT

COMMENT

COMMENT

COMMENT

COMMENT

COMMENT

COMMENT

COMMENT

COMMENT 12

12

12

12

12

12

12

24

12 2 of Page

(5, 8, 11)

(5, 8)

(5, 8)

(1, 5, 8)

(1, 5, 8)

(1, 5, 8)

(1, 5, 8)

(5, 8)

(5, 8, 10) N

N

N

N

N

N

N

N

N 3OMB 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

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

850.4500

850.4550

875.1200

875.1400

875.1700

875.2400

875.2500

SS-1218

SS-Migration Algal Toxicity

Cyanobacteria (Anabaena flos-aquae) Toxicity

Dermal exposure--Indoor

Inhalation exposure--indoor

Product Use Information

Dermal exposure

Inhalation exposure

Nature of Residue on Surfaces

Migration studies 3074 - Hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine
Chemical # and Name: 083301 Hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine 06-May-2016
GENERIC
ID # GDCI-083301-1554

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z

X,Y,Z TGAI

TGAI

TEP

COMMENT

TEP

TEP

COMMENT

TGAI

TEP 12

12

24

24

12

24

24

24

12 3 of Page

(7, 8)

(7, 8)

(8, 12, 14)

(2, 8, 12, 14)

(8)

(3, 8, 14)

(2, 8, 9, 14)

(4, 8, 14)

(4, 8, 13, 14) N

N

Y

Y

N

Y

Y

Y

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

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

3074 - Hexahydro-1,3,5-tris(2-hydroxye

GDCI-083301-1554

1

2

3

4

5

6

7

8

9

10

11

12

13 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

The results of the Activated Sludge, Respiration Inhibition Test (ASRI), GLN 850.3300, will determine which of the four biodegradation tests are required. *If the ASRI test results in an EC50 of less than or equal to 20 mg/L, then either the (i) Simulation tests to assess the biodegradability of chemicals discharged in wastewater, GLN 835.3280, (ii) the Simulation Test *Aerobic Sewage Treatment -*A. Activated Sludge Units, GLN 835.3240, or (iii) the Porous Pot Test, GLN 835.3220 is required. *If the ASRI test results in an EC50 greater than 20 mg/L, then the registrant is required to conduct either the (i) Ready Biodegradability, GLN 835.3110, (ii) Simulation tests to assess the biodegradability of chemicals discharged in wastewater, (iii) the Simulation Test *Aerobic Sewage Treatment *A. Activated Sludge Units, or (iv) the Porous Pot Test. *If the Ready Biodegradability Study is conducted and passes, then no further testing is required. If, however, the pesticide fails the Ready Biodegradability study, then the (i) Simulation tests to assess the biodegradability of chemicals discharged in wastewater, (ii) the Simulation Test *Aerobic Sewage Treatment *A. Activated Sludge Units, or (iii) the Porous Pot Test is required.
TEP and degradate: formaldehyde.

Required for manufacturing settings of material preservatives uses only.

Required for hard surface cleaner and dish detergent material preservative uses only.

Parent TGAI and degradate: 1,3,5-trimethyl triazine.

Only Acute (study due 12 months after receipt of DCI) neurotoxicity study is required.

On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 * Ecological Effects Tests * including renumbering and other designations or changes for some guideline studies. See *Final Test Guidelines; OCSPP 850 Series; Notice of Availability* 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028
Information on the degradate 1,3,5-trimethyl triazine which remains after the release of formaldehyde may potentially be available from information on other triazines. The registrants could propose triazine data and bridging information if appropriate in lieu of guideline studies on the degradate.
Formaldehyde inhalation exposures are expected to occur to as a result of HHT material preservative (household cleaner, paint, detergent, and oil field) application. Currently, no data are available to assess these exposures, and therefore, monitoring data are needed.
EPA published draft guidance under guideline 850.6800 and has since published final guidance for this study under guideline 850.3300: http://www.regulations.gov/#!documentDetail;D=EPA-HQOPPT-2009-0154-0021. OECD Test Guideline 209 can also be used as guidance for this study, available online at http://www.oecd-il brary.org/content/book/9789264070080-en.
EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0003.

Data required on exposure scenarios: Machinist, Brush/Roller, Airless Sprayer, Mop, Spray and Wipe, Liquid Pour, and Solid Pour WP.

Based on the results of the nature of the residue on surfaces study, if residues of concern are identified, then migration studies are required and protocols must be approved by the Agency prior to the initiation of the study. Case # and Name:

DCI Number: 1 Page: of

Footnotes: The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These footnotes apply in addition to any test notes included in 40 CFR Part 158 with respect to the particular data requirement. Use Categories Key:

X - Materials preservatives

Y - Industrial processes and water systems - once through

Z - Industrial processes and water systems - not once through 2United States Environmental Protection Agency Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

3074 - Hexahydro-1,3,5-tris(2-hydroxye

GDCI-083301-1554

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

A protocol must be submitted to the agency prior to conducting the study. Case # and Name:

DCI Number: 2 Page: of 2E P A Data Call

- In Notice A tta c h m e n t 5 T h i s it em co m p l e t ed by t he A g ency id e n t i f i es th e s tu d y tit l e a s s o c i a t ed w i t h the

g u i de l i ne r e f e r e n ce nu m ber and w h e t h e r p r o t o c o l s and 1, 2, or 3

- y ear pro g r e s s

r ep o rt s a r e r eq u i r ed t o be s ub m itt e d i n c o nne c t i on wi t h t he s t u d y

. A s no t ed i n S e c t i on II I o f t h e D a t a C a ll

- I n N o ti ce, 9 0

- day p r o g r ess r e po r t s a r e r eq u i r ed f o r a l l

s t u d i e s.

I f an as t e ri sk ap p ea r s i n I t em 5, E PA has a t t ach e d i n f o r m a ti on r e l e v ant t o t h i s g u i de l i ne

r e f e r e nce n u m ber t o t he G e ne r i c R eq u i r e m en t s S t a t u s and R e g i s t r a n t ' s R espon s e For m s and I ns tr u c ti o n s F o r m.E P A Data Call

- In Notice A tta c h m e n t 7 T h i s it em co m p l e t ed by t he A g ency i den t i f i es t he code a s s i g ned t o t he sub s t a n ce t hat m ust be used f or t e s t i n g . A b ri e f d es c ri p t i on of ea c h c o de f o ll o w s: MP: Man u f a c t u r i n g

- U se P r oduct EUP : End

- Use Product
MP : Manufacturing

- Use Product MP/ T G A I : Manu f ac t u r i ng

- U se P r od u ct and T e ch n i c a l G r ade A c ti v e I n g r ed i ent P A I : Pure A c ti v e I n g r ed i e n t P A I /M : P u r e A c ti v e I n g r ed i e n t a nd M e t ab o l i t e s P A I / P A I RA : Pure A c t i v e I n g r ed i e n t o r Pu r e A c t i v e I n g r ed i e n t R ad i o l ab e l e d
P A I RA : Pure A c t i v e I n g r ed i e n t R a d i o l ab e le d
P A I RA /M : Pu r e A c t i v e I n gred i ent R ad i o l a be l e d and Me t abo l i t es P A I RA / P M : Pu r e A c t i v e I n g r ed i e n t R a d i o l ab e l e d a n d P l a n t M e t abo l i t es 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
T GA I : T ec h n i c al G r ade A c ti v e I n g r ed i e n t T GA I / P A I : T ech n i c al G r a d e A c t i v e I n g r ed i ent or P u r e A c ti v e I n g r ed i ent T GA I / P A I RA : T ech n i c a l G r ade A c t i v e I n g r ed i ent or P ure A c ti v e I n g r ed i ent R ad i o l a b e l e d T GA I / T EP : Tech n i c a l G r a d e A c t i v e I n g r e d i ent or T y p i cal E n d

- U se P r oduct
MET : Me t ab o l i t es I MP : I m pu r iti e s D E GR : D e g r a d a t e s

8 T h i s it em co m p l e t ed by t he A g ency i den t i f i es t he ti m e fr a m e a l l o w ed f or sub m i ss i on of

t he s t udy or p r o t oc o l i d e n t i f i ed i n i t em 5. T h e t i m e fr a m e r uns fr om t he d a t e of yo ur

r ec e i p t of t he D a t a C a l l

- I n no t i ce.E P A Data Call

- In Notice A tta c h m e n t 

## A tta c h m e n t 4. L i s t of A l l R e g i s t r a n ts S e n t t h i s D ata Ca ll

- I n No tic eUnited States Environmental Protection Agency Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

3074 - Hexahydro-1,3,5-tris(2-hydroxye Case # and Name: 1 Page: of 1

1448

68868

1839

1258

1529

365

5383 BUCKMAN LABORATORIES INC.

SURETY LABORATORIES

STEPAN COMPANY

ARCH CHEMICALS, INC.

INTERNATIONAL SPECIALTY PRODUCTS

TROY CHEMICAL COMPANY LIMITED

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

1256 NORTH MCLEAN BLVD

2 STEWART COURT

22 W. FRONTAGE RD.

1200 BLUEGRASS LAKES PARKWAY

1005 U.S. 202/206

8 VREELAND ROAD

8 VREELAND ROAD Address City ZIP

MEMPHIS

DENVILLE

NORTHFIELD

ALPHARETTA

BRIDGEWATER

FLORHAM PARK

FLORHAM PARK 38108

07834

60093

30004

08807

07932

079324200 OMB Approval 2070-0174

State

TN

NJ

IL

GA

NJ

NJ

NJ DCI Number: GDCI-083301-1554E P A Data Call

- In Notice A tta c h m e n t 

## A tta c h m e n t 5. Add i t i o n al D o c u m e n ts a n d In f o r mat i onE P A Data Call

- In Notice A tta c h m e n t 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

- and

how

- 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 Res pect 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 C all

- 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

.