1 

### UNIT E D S T A T ES EN VIRON M ENTAL PROTECTI O N AGENCY

WASHINGTON, D.C. 20460



### September 3 0 , 2014

GENERIC DA T A CALL

- IN N O TICE

Dear Sir or Mada m : O F FICE OF CHEMICAL SAFE T Y AND

P O LLUT I O N PREVENTI O N



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

ingredient(s) identified in Attach m ents 1 and 2 of this Notice to sub m it certain data as noted

herein to the U.S. Environ m ental Pr o tection Agency (EPA, the Agency). These data are

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

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

ingredient(s). W ithin 90 days a f ter you receive this Notice, y ou m ust respond as set forth in

Section III b elow. Your response m ust state:

1. How you w i ll co mply with the require m ents set forth in this Notice and its Attach m e nts 1

through 5; or,

2. Why you b e lieve you are exe mpt from the r e quire m 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 b e lieve EPA should not require your s u b m ission of data in the m anner specified

by this Notice (s e e se c t ion III

- D).

If you do not respond to this Not i ce, or if you do not satisfy EPA that you will co m ply with its

require m ents or should be exe mpt or excused from doing so, then the registration of your

product(s) subject to this Notice w i ll be subject to suspension. W e have provided a list of all of

your products subject to this Notice in Attach m ent 2, Generic Data Call

- In Response Forms And

Instructio ns For m , as w e ll as a list of all registrants who were sent t h is Notice (Attac h m ent 4).

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

Rodentici d e Act (FIFRA), as a m ended 7 U.S.C. s ection 136a(c)(2)( B ), sections 3(g)(2)(A) and

(B) of FIFRA, as a m ended 7 U.S.C. sections 136 (a)( g )( 2 )(A) and (B), and section 408(f)(1)(A)

of the Federal Food, Drug, and Co s m etic Act (F F DCA), 21 U.S.C. section 346a(f)(1)(A). This

notice is also authorized by 40 CFR Part 155.48 and 40 CFR 155.53(b), which are sections in the

Agency’s Registration Review regulations address i ng the use of Data Call

- In Notices as part of

Registration Review. Colle c tion of t h is in f or m ation is in co m plian c e with the Paper w ork

Reduction A ct (44 U.S.C. 3501 et seq.) as approved by the Office of Manage m ent and Budget

(OMB) under Control Nu m ber 2070

- 0174.

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 ation and instruct i ons. The six sections of the Notice are:2



### Section I. Why You Are Recei v i ng This Notice

Section II. Data Required By This Notice

Section III. Co mpliance W ith Require m ent s Of This Noti c e

Section IV. Consequences Of Failure To Co mply 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

• Confidential State m ent of Fo r m ula and Instructions

• Certi f ic a tion of Atte mpt 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 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 the continued use of products

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

containing the subject active ingredient(s).

SECTION II. 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 OTOCOL

All studies required under this Notice m ust be conducted in accordance with 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.

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, Springfield, VA 22161 (tel: 703

- 605

- 6000).3



### 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 conducted

in acc o rdance with acce p table standards. T h e OECD protocol s 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).

All new stu d ies and pro p osed protocols 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 160.3(a)(6)].

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)(f)(1)(A) 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) delete 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 mption 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 in

Section III

- D.

There are t w o fo r m s that acco mpany this Notice o f which, depending upon your respo n se,

one 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. Please 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 the4



### printed m aterial. If you have questions or need assistance in preparing your response, call or

write the c o ntact p erson identified 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 mplete.

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 th is 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.

Note: If all registrants for the subject a c tive ingredient respond to this notice by

requesting cancellation or deletion of uses, all tolera n ces as s ociated with the

registration or deleted u ses will b e r evoked pur s uant to FFDCA section 4 08( f ) (2).

3. Generic Data Exe m ption

- Under section 3(c)(2)(D) of FIFRA, an applicant for

registration of a product is exe mpt 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 ntai ning 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 mption in section 3 ( c)(2)(D) of FIFRA. T o 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

this Notice and m ust remain in co m pliance; and5 

### 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 mpleted Attach m ent 2,

Generic Data Call

- In Response Forms And Instructions Form and all supporting

docu m entation. The Generic Data Exe mption 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 mplete 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 ption, 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 compl iance w i th this Data Call

- In Notice, the Agency

will con s ider that both they and you are not in co mpliance 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 mprise 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 mpleting 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),6 

### 2. I have entered into an agree m ent with one or m ore registrants to develop data

jointly (Cost Sharing),

3. I have m ade offers to cost

- share (Offers to Cost S hare),

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, De veloping D ata

–

If you choose to develop the 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 mply with the G o od

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

Pesti c ide A s sess m ent Guidelines (P A G ), be in confo r m ance with PR Notice 86

- 5,

and, as applicable, co m

ply with 40 CFR Part 26, “Protection of Hu m an Subjects.” In

addition, certa in 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 Response 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 y our 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 protocol 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 ak ing 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 espon se

Forms and Instructions Form (Attach m ent 3) are the t i m e fra m es that the Agency is7 

### 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 itted 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 t o 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 orig inal 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 i f 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 offer, 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 soug ht 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 . In addition,8 

### 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

this 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 onse 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 y our

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 registration 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 mposed 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 mputer9 

### 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 mpleted 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.

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 st udy 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 us t

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 s uch a study. 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 Notice 86

- 5.

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,10 

### 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 mportant to note that not all studies classified as supple m ental are

upgradeable. If y ou have questions regarding the classifica t ion of a study or whether a

study m ay be upgraded, call or write the con t act person listed 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 de ficiencies 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 Notice 86

- 5.

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.

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 exi 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 pl y 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 io usly 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 th e 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

Notice 98

- 5) 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 inapplicable 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 mpl e m enting this provision EPA con s iders as l o w volu m e11



### 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 ient( 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 u se 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 writing.

To apply for a low volu m e, m i nor use waiver, you m ust sub m it the following

infor m ation, as applicable to your product(s ) , as part of your 90

- day response to this

Notice:

a. Total co mpany 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), cof fee, 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, a nd 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 edient(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 y ou (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 and

associated test) of cond u cting the testing needed to fulfill each of these data

require m ents.12 

### 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 the 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 ical

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 appli cable

to your product(s):

(a) docu m entation of the usefulness of the active in g r edie n t ( s ) in Integ r ated

Pest Manage m ent,

(b) description of the beneficial i mpacts 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 t he 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 e nts 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) or section 4(f)(1)(A). 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.13



### 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 mply with the req u ir e m ents of this Data Call

- In Notice, pursuant to F IFRA

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 mptions 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. Fai lure 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 option

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 fo r 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 ent 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 vid ed 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 data 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

.14



### 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 mption. 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 C al 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, selection 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 86

- 5. All studies m ust be s ub m itted in t he 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 n 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 t hat such disposition by registrants of existing stocks for a

suspended 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 registra nts 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 stoc ks and your

esti m ate of the ti m e required for their sale, distribution, 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 ofE P A A n t i m ic rob ials D i v i s i o n D C I A tta c h m e n t s 

# 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 tE P A A n t i m ic rob ials D i v i s i o n D C I A tta c h m e n t s DA T A CA LL

- IN CH E M I CA L S T A T U S S H EET

P l ea s e s u b m

i t a l l r espo n ses t o t he GDC I us i ng t he i n f o r m a ti on b e l o w

. T o exp e d it e p r o ces s i n g

,

p l e a se i n c l ude t he GDC I i den t i f i c a ti o n nu m ber ( e

. g

., GD C I

- 064103

- 1427 ) i n t he S ub j e c t l i ne of

a ll D C I

- r e l a t ed co r

r e s pond e nc e.

B y U S m a il : B y express o r c o u r i er s e r v i ce: D ocu m ent

P r oc e s s i ng D esk ( DC I

/ AD ) D ocu m ent P r oc e s s i ng D esk ( DC I / AD )

A tt n : R ee v a l u a t i on T e am L ead e r

, P M 3 6 A tt n : R ee v a l u a t i on T e am L ead e r

, P M 36

U S EPA ( 7510 P ) U S EPA ( 7510 P )

1200 Pen n s y l v an i a A v e. N .W. O ne P o t o m ac Y a r d ( So u t h B u il d i n g )

Was h i n g t on, D C 20 4 60 2777 S. C r y s t al D r

. A rli n g t o n, V A 22202

I f y ou ha v e che m

i cal

- spec i f

i c q u es t i o n s or need as s i s t a nce r espo n d i ng t o t he GD C I

, please

con t a ct t he che m

i c a l r e v i e w m ana g er ( CR M) m ana g i ng t he DC I : Donna Kamarei

, Kamarei.Donna@epa.gov

, ( 703 )

- 3 47

- 0443

.E P A A n t i m ic rob ials D i v i s i o n D C I A tta c h m e n t s 

# 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 sInitial 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

LANXESS CORPORATION

111 RIDC PARK WEST DRIVE

PITTSBURGH, PA 152751112 2575 - o-Phenylphenol, potassium salt

Chemical # and Name: 064108

o-Phenylphenol, potassium salt 30-Sep-2014

GENERIC

ID # GDCI-064108-1461 United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE 1 Page of 1

39967-45

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 NumberE P A A n t i m ic rob ials D i v i s i o n D C I A tta c h m e n t s I N S T RUC T I ON S: D A T A CA L L

- I N R ESP ON SE F O RM

T h e se i n s tr u c t i ons ap p l y t o t he fo rm t i tl e d “D a t a C a ll

- I n R espo n se” and a r e t o be u sed t o r e spond

t o g ene r i c D a t a C a l l

- I

ns i s s ued as pa

r t o f EP A ' s R e g i s tr a t i on R e v i ew P r o g r am under t he Fe d e r al

I nsec ti c i de, Fun g i c i d e , and R oden t i c i de A c t

. Pl ea s e r e a d t h e se i n s tr u c t i ons ca r e f u l l y be f ore f i l l i ng

out t he f o r m s.

I t e m s 1 t h r ou g h 4 ha v e b ee n p r e p r i n t e d on t he f o r m

. I t e m s 5 t h r ou g h 7 m

ust be co m

p l e t ed by t he

r e g i s t r a n t a s ap p r o p ri a t e. I te m s 8 t h r ou g h 11 m

ust be c o m

p l e t ed by t he r e g i s t r ant be f o r e

sub m itt i ng a r e s ponse t o t h e A g enc y

.

T he pu b li c r e p o r ti ng bu r d e n f or t h i s c o l l e c ti o n of i n f

o r m a ti on i s e s ti m a t ed t o a v e r a g e 15 m i nu t es

per r esp o nse, i n c l u d i ng ti me f or r e v i e w i ng i n s tr u c t i on s , se a r c h i ng ex i s t i ng da t a s o u r c e s, g a t h e ri ng

and m a i n t a i n i ng t he d a t a n e eded, a nd co m p l e ti ng and r e v i e w i ng t he c o l l e c t i on of i n f o r m a ti o n.

Send co mm

en t s r e g a r d i ng t he bu r den e s t i m a t e or any o t her as p e c t of t h i s c o l l e c ti o n of

i n f o r m a ti on, i n c l u d i ng s u g ges t i ons f o r r e du c i ng t h i s b u r den, t o C h i e f

, I n f o r m a ti on Po l i cy B r anch,

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pa n y na m e, n u m ber and a ddre s s.

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be r

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e, E PA che m

i cal n u m ber and

che m i cal n a m e.

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- i n

. P l e ase

no t e t h a t y ou a r e a l so r esp o ns i b l e f or i n f o r m i ng t he A g ency of y our r espo n se

r e g a r d i ng any p r odu c t t h at y ou be li e v e m ay be co v e r e d by t h i s D a t a C a l l

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i s n o t l i s t ed by t he A g ency i n I t em 4. Y ou m

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r e g i s t r a ti on nu m

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en t s S t a t us and R e g i s t r an t ' s R espo n s e For m s and I ns tr u c t i ons

F o r m.E P A A n t i m ic rob ials D i v i s i o n D C I A tta c h m e n t s I t e m # DA T A CA LL

- I N R ESP ON SE I n f o r m a ti on

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n i s f or g ene r i c d a t a a s i n d i c a t ed i n I t em 3 and y ou

a r e e l i g i b l e f

or a G en e r i c D a t a E x e m

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y o u a r e e li g i b l e f

o r o r c l a i m a G ene ri c D a t a E x e m p ti o n, en t er t he EPA r e g i s tr a t i o n

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r e i n co m p l i ance w i t h

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t h a t y our p r o du c t h a s a l r e a d y been t r an s f e r r ed t o a no t he r co m

pany or t h a t y ou ha v e

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de t a i l s so t h a t EPA c a n e ns ure t h a t i t s r ec o r ds a r e c o r r ec t

. I t e m 7a. N ot A pp l i c a b l e

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I t e m 8. T h i s c e r t i f

i ca t i on s t a t e m

ent m ust be s i g ned by an a u t h or i z ed r ep r es e n t a ti v e o f y our

co m pany and t he p e r son s i g n i ng m ust i nc l ude h i s / h e r ti tl e. A dd i ti o nal pa g es u s ed i n

y our r esp o nse m

ust b e i n i ti a l ed and d a t e d i n t he s p a ce p r o v i ded f or t he c e r t i f

i c a ti o n.

I t e m s 9,

10, 11. P r o v i de d a t e o f s i g na t u r e, n a m e of co m pan y , and t e l e p hone nu m

be r

.E P A A n t i m ic rob ials D i v i s i o n D C I A tta c h m e n t s 

# 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 nsInitial 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

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 _________________________________________________________________ 835.1110

835.1230

835.1240

835.2240

835.2410

835.3110

835.3220

835.3240

835.3280 Activated sludge sorption isotherm

Sediment and soil absorption/desorption for parent

and degradates

Soil column leaching

Direct photolysis rate of parent and degradates in

water

Photodegradation of parent and degradates in soil

Ready biodegradability

Porous pot test

Simulation Test-Aerobic Sewage Treatment-Activated

Sludge 2575 - o-Phenylphenol, potassium salt

Chemical # and Name: 064108

o-Phenylphenol, potassium salt 30-Sep-2014

GENERIC

ID # GDCI-064108-1461

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R TGAI

TGAI

TGAI

TGAI

TGAI

TGAI

TGAI

TGAI

TGAI 12

12

12

12

12

12

12

12

12 1 of Page

(12)

(3, 10, 14,

17)

(2, 3, 14, 17)

(2, 3, 14, 17)

(2, 3, 14, 17) N

N

N

N

N

N

N

N

N 4OMB 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

835.4100

835.4300

835.4400

850.1350

850.1710

850.1730

850.2100

850.2300 Simulation Tests to Assess the Biodegradability of

Chemicals

Aerobic soil metabolism

Aerobic aquatic metabolism

Anaerobic aquatic metabolism

Mysid chronic toxicity test

Oyster BCF

Fish BCF

Avian acute oral toxicity test

Avian reproduction test 2575 - o-Phenylphenol, potassium salt

Chemical # and Name: 064108

o-Phenylphenol, potassium salt 30-Sep-2014

GENERIC

ID # GDCI-064108-1461

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R TGAI

TGAI

TGAI

TGAI

TGAI

TGAI

TGAI

TGAI 24

24

24

24

24

24

24

24 2 of Page

(4, 5, 8, 13)

(13, 21)

(7, 13) N

N

N

N

N

N

N

N 4OMB 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

850.3020

850.3030

850.4100

850.4150

850.6100

850.6800

870.3465

875.1700

875.2300 Honey bee acute contact toxicity

Honey bee toxicity of residues on foliage

Seedling Emergence and Seedling Growth

Vegetative Vigor

Environmental Chemistry Methods and Associated

Independent Laboratory Validation

Modified Activated Sludge Respiration Inhibition

90-day inhalation toxicity

Product Use Information

Indoor surface residue dissipation 2575 - o-Phenylphenol, potassium salt

Chemical # and Name: 064108

o-Phenylphenol, potassium salt 30-Sep-2014

GENERIC

ID # GDCI-064108-1461

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R TGAI

TGAI

TEP

TEP

TGAI

TGAI

TGAI

TGAI

TGAI 12

12

12

12

12

12

24

12

12 3 of Page

(13, 14)

(13)

(13)

(6, 9, 19, 25)

(11, 13, 15,

18)

(16)

(14)

(1) N

Y

N

N

N

N

N

N

N 4OMB 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

SS-1240

SS-1241

SS-1242

SS-1243

SS-1244

SS-1245

SS-1246

SS-1247 Leaching Study: Paint, Stain, And Coatings

Leaching Study: Cotton Textiles

Whole Sediment Chronic Toxicity - Chironomus dilutus

Whole Sediment Chronic Toxicity - Hyalella azteca

Whole Sediment Chronic Toxicity - Leptocheirus

plumulosus

Honey Bee Oral Toxicity - adults

Honey Bee Oral Toxicity - Larvae

Paint Chamber Emissions Study 2575 - o-Phenylphenol, potassium salt

Chemical # and Name: 064108

o-Phenylphenol, potassium salt 30-Sep-2014

GENERIC

ID # GDCI-064108-1461

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R

DD,S,X,T,R TEP

TEP

TGAI

TGAI

TGAI

TGAI

TGAI

TGAI 24

24

24

24

24

12

12

12 4 of Page

(22)

(22)

(22)

(24)

(20, 23) Y

Y

Y

Y

Y

Y

Y

Y 4United States Environmental Protection Agency

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

2575 - o-Phenylphenol, potassium salt

GDCI-064108-1461

1

2

3

4

5

6

7

8

9

10

11

12 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

This study is required to assess incidential oral exposures to floors treated with oPP and its salts.

This guideline study may be conducted in lieu of 835.3110.

The results of the ASRI test will determine which of these four biodegradation tests is/are required. If the ASRI test EC50 is less than or equal to 20 mg/L, then either the (i)Biodegradation in

Activated Sludge Study or (ii) Simulation Test Aerobic Sewage Treatment: A. Activated Sludge Units or (iii) the Porous Pot Test is expected to be required. If the ASRI test EC50 is greater than 20

mg/L, then the registrant would likely be required to conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test Aerobic Sewage Treatment: A.

Activated Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no further testing would be expected to be required. If, however, the

antimicrobial fails the Ready Biodegradability study, then the a) Biodegradation in Activated Sludge or b) Simulation Test Aerobic Sewage Treatment: A. Activated Sludge Units, or c) the Porous

Pot study would likely be required.

The aerobic aquatic metabolism protocol must ensure the design reflects environmentally relevant conditions which impact volatilization from water.

Submit a draft protocol, which includes a detailed study implementation timeline, to the Agency within 120 days of receipt of this DCI. The Agency must review and approve the protocol prior to

study initiation.

Studies should be modified to acommodate exposure to a volatile substance by using environmental chambers that maintain the air concentrations of the gas, see 850.4230.

Results from studies conducted using an upland game species and a waterfowl species are expected to be required to satisfy this anticipated requirement.

Protocol must be submitted to the Agency for review and approval prior to study inception. The draft protocol must be submitted to the Agency within 90 days of receipt of this DCI.

Plant toxicity data with a monocot species, rice, have been submitted. Additional data are anticipated to be needed for six species of dicots (from at least four families; one species must be

soybean) and three species of monocots (from at least two families; one species must be corn). Of the species selected to satisfy this anticipated data need, at least one test species should be

a root crop (either a monocot such as onion or a dicot such as carrot, table beet, or sugar beet).

One of three biodegradation in sludge simulation tests (835.3220, 835.3240, 835.3280) may be conducted in lieu of this study.

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.

Not required when the electronic absorption spectra, measured at pHs 5, 7, and 9, of the chemical and its hydrolytic products, if any, show no absorption or tailing between 290 and 800 nm. 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:

R - Agricultural premises and equipment

S - Food handling/storage establishments premises

and equipment

T - Commercial, institutional and industrial premises

and equipment

X - Materials preservatives

DD - Aquatic areas 2United States Environmental Protection Agency

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

2575 - o-Phenylphenol, potassium salt

GDCI-064108-1461

13

14

15

16

17

18

19

20

21

22

23

24

25 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

For conventional uses of oPP and its salts.

For antimicrobial uses of oPP and its salts.

Environmental chemistry method (ECM) and independent laboratory validations (ILV) for water are required for o-Phenylphenol.

EPA published draft guidance under guideline OPPTS 850.6800 and has since published final guidance for this study under guideline OCSPP 850.3300:

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0021. The anticipated DCI will provide that OCSPP 850.3300 may be used in place of OECD 209 if the test substance

is not sufficiently soluble to allow preparation of a concentrated stock solution in water. The Agency has included this study in 40 CFR 158(W). OECD Test Guideline 209 can also be used as

guidance for this study, available online at http://www.oecdilibrary.org/content/book/9789264070080-en.

EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0017. The biodegradation study required is based on results of an

Activated Sludge Respiration Inhibition test.

ECM/ILV information is required for both soil and water.

Data from five dicot species of at least three families (excluding soybean (Glycine max) which has already been tested), and four dicot species of at least two families, one species of which is

corn (Zea mays) are expected to be required. Additionally, of the ten species tested, at least one species should be a root crop (either a monocot such as onion or a dicot such as carrot, table

beet, or sugar beet).

Based on the White Paper in Support of the Proposed Risk Assessment Process for Bees as submitted to the FIFRA Scientific Advisory Panel, docket number

EPA-HQ-OPP-2012-0543-0004 at http://www.regulations.gov.

Avian acute oral toxicity for passerine species is required.

As indicated in 40 CFR Part 158, the registrant is required to submit a protocol for approval prior to initiating the study until such time as the OCSPP 850 chronic sediment testing guidelines are

published.

Acute and chronic oral toxicity data with larval bee may be collected in a combined study.

Acute and chronic oral toxicity data with adult bee may be collected in a combined study.

A protocol must be submitted to the Agency for approval prior to the start of the study. The draft protocol must be submitted to the Agency within 90 days of receipt of this DCI. Vegetative vigor

by vapor exposure only. Case # and Name:

DCI Number: 2 Page: of 2E P A A n t i m ic rob ials D i v i s i o n D C I A tta c h m e n t s I N S T RUC T I ON S: R E Q UI R EME N T S S T A T U S AN D R E G I S T RAN T ’ S R ESP O N SE F OR M



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, i n c l ud i ng tim e f or r e v ie w i ng i n s t ru c t i ons, s ea r c h i ng e x i s ti ng d at a

s our ce s

, g at h e r i ng a nd m a i n t a i n i ng t he d a t a n e e d e d, a nd c o m p l eti ng a nd r e v i e w i ng t he

c o l l e c ti on of i n f

or ma t i on. S e nd c o m me n t s r e g a rd i ng t he bur d e n e s t i m a t e or a n y o t h e r a s p e c t

of t h i s c o l l ec t i on of i n f

or ma t i on, i n cl u d i ng s ug g e s ti ons f or r e du ci ng t h i s bur d e n, t o C h ie f

, I n f or mati on P o l ic y Br a n c h, M ai l Co d e 2136, U

. S

. E n v i ron me n t a l P ro t e c ti on A g e n c y ,1200

P e nn s y l v a n i a A v e

. N

. W

., W a s h i n g t on, D .C. 20460; a nd t o t he O ff ic e of M a n a g eme nt a n d

Bud g et

, P a p e r w ork R e du c ti on P ro j ec t 2070

- 0107, W a s h i n g t on, D .C. 20503.

I t e m # DA T A CA LL

- I N R ESP ON SE I n f o r m a ti on

1 T h i s it em co m

p l e t ed by t he A g ency p r o v i des i d e n t if y i ng i n f o r m a ti o n f

o r t he co m

pany

su b j e ct t o t he D a t a C a l l

- I

n.

2 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 case nu m

be r

, c ase na m

e, EPA

che m i cal n u m ber and c h e m i c a l na m

e.

3 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 t y pe of D a t a C a l l

- I n. T he d a t e o f

i ss u ance i s da t e s t a m

ped.

N o t e t he u n i que i d en t i f

i c a t i on nu m

ber ( I D #) ass i g ned by t he A g enc y

. T h i s I D n u m ber

m ust be u s ed i n t he t

r ans m itt a l d o cu m

ent f o r any da t a s ub m

i ss i ons i n r e s ponse t o t h i s

D a t a C a ll

- I

n N o ti ce.

4 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 g u i d e l i ne r e f

e r e n ce nu m

ber o f s t ud i es

r eq u ir e d. T h e se gu i d e li n es, i n a d d i t i on t o t he r eq u i r e m en t s spe c i f

i ed i n t he D a

t a C a ll

- In

N o ti c e, g o v e r n t he cond u ct of t h e r equ i r ed s t u d i e s.

N o t e: R equ i r ed s t u d i e s f

or w h i ch no g u i d e l i ne ex i s t s ( i .e., “s p e c i al s t ud i es )

, r e g i s t r an t s

a r e g e n e r a l l y r e q u i r ed t o s u b m i t a p r o to c o l f

o r EPA r ev i ew p r i o r t o i n i t i a tin g t h e s tud y

. 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 A n t i m ic rob ials D i v i s i o n D C I A tta c h m e n t s I t e m # DA T A CA LL

- I N R ESP ON SE I n f o r m a ti on

6 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 c ode ass o c i a t ed w it h t h e use p a t t e r n of

t he p es t i c i de. A b r i ef d es c r i p ti o n of each code f o ll o w s:

A T e rr e s t r i al food

B T e r r es t r i al f

e e d

C T e r r es t r i al n o n

- f

ood

D A qua t i c f

o od

E A qua t i c non

- f

ood o u t do o r

F A qua t i c non

- f

ood i ndu s t r

i al

G A qua t i c non

- f

ood r es i d e n t i al

H Gr eenho u se f

ood

I G r eenhou s e non

- f

ood c r o p

J F o r e s t ry

K R e s i d e n ti al

L I ndoor f ood

M I ndoor non

- f

ood

N I ndoor m ed i cal

O I ndoor r e s i d en t i a l

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

MP I 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 l ed

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 ll e 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 l ed 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 l ed a n d P l a n t M e t abo l i t es

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 l ed

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 A n t i m ic rob ials D i v i s i o n D C I A tta c h m e n t s I t e m # DA T A CA LL

- I N R ESP ON SE I n f o r m a ti on

9 En t er t h e ap p r o p ri a t e R e s p onse C o d e or C o des t o s ho w how y ou i n t e n d t o co m p l y w it h

each d a t a r e qu i r e m

en t

. B r i e f de s c r i p t i o n s of each code f o l l o w

. T he D a t a C a ll

- li t N o t i ce

con t a i ns a f

u l l er de s c r

i p t i on of e a ch o f t h e se op t i on s

. 1

. De v el o ping D ata : I w ill c o n d u ct a n e w s t u d y a n d s u b m it it w i t h i n t h e t i m e f r a m es

' s p ec i f ied in i t e m 8 a bo v e. B y i n d icat i n g t h at I h a v e c h o s e n t h is op ti o n

, I ce r ti f y t h a t I

w i l l c o m p l y w i th a l l t h e r e q u i re m

e n ts p e r tai n i n g to t h e c o n d i ti o n s f o r s u b m ittal o f t h i s

s t u d y a s o u tl i n ed in t h e Data C al l

- I n N o tice a n d t h at I w ill pro v i d e t h e pro t o c o ls a n d

pro g r e s s r e por ts r e q u i r ed in item 5 a bo v e.

2

. A g re e m e nt t o C o s t Sh a re: I h a v e e n te r ed i n to an a g r e e m e n t w i t h o n e o r m or e

r e g i s t r a n ts to d e v el o p d ata j o i n t l y

. B y i n d icat i n g t h at I h a v e c h o s en t h i s op ti o n

, I ce r ti f y

t h at I w ill c o m

p l y w i t h all t h e r e q u i r e m

e n ts p e r tai n i n g to sh a r i n g i n t h e c o s t o f

d e v el op i n g d ata as ou tl i n ed in t h e Data C a ll

- I n N o tice.

3

. Off er t o C o s t Sh a re: I h a v e m a d e an of f er to e n ter i n to an a g r e e m e n t w i t h o n e o r m

or e

r e g i s t r a n ts to d e v el o p d ata j o i n t l y

. I a m al s o s u b m i tt i n g a c o m

p leted " C e r ti f

icati o n o f

o ff er to C o s t S h a r e i n t h e D e v el op m e n t o f D a ta" f

or m

. I a m su b m itt i n g e v i d e n ce t h at I

h a v e m a d e an of

f er to a n o t h er r e g i s t r a n t ( w h o h a s an ob li g a t i o n to su b m it d ata) to sh a r e

in t h e c o s t o f t h a t d ata. I am i n cl u d i n g a c o p y o f m y of f er a n d pr o o f o f t h e o t h er

r e g i s t r a n t ' s r ecei p t o f t h at of f e r

. I am i d e n t i f

y i n g t h e p a r t y w h ich i s c o mm i t ti n g to

su b m it o r pro v i d e t h e r e q u i r ed d ata; if t h e r e q u i r ed s t u d y i s no t su b m i tted o n t i m e, m y

prod u ct m a y b e su b

j ect to su s p e ns i o n

. I u n d e r s t a n d t h at o t h er te r m s u n d er O p ti o n 3 in

t h e Data C a ll

- I n N o tice a pp l y as w e ll.

4

. Su b m i tt i ng E x i s t ing D ata : I w i l l s u b m it a n e x i s t i n g s t u d y b y t h e s p ec i f ied d u e d ate

t h at h a s n e v er b e f

or e b een s u b m itted to E P A

. B y i n d ica t i n g t h at I h a v e c h o s e n t h is

op ti o n

, I ce r ti f

y t h a t t h i s s t u d y m

eets all t h e r e q u i r e m e n t s p e r tai n i n g to t h e c o n d iti on s

f o r su b m ittal o f e x i s t i n g d ata o u tli n ed i n t h e D a ta C al l

- I n N o tice a n d I h a v e atta c h ed t h e

n ee d ed su ppor ti n g i n f

o r m ati o n al on g w i t h t h i s r e s po ns e.

5

. Up g r a ding a S t ud y : I w ill s ub m it b y t h e s p eci f ied d u e d ate, o r w

i ll cite d ata t o

- u p g r a d e

a s t u d y t h at ' E P A h as cl a ss i f i e d as p a r tially acce p ta b le a n d p o te n tial l y u p g r a d ea b le. B y

i n d icat i n g t h at I h a v e c h o s e n t h is op ti o n

, I ce r ti f y t h a t I h a v e m

et all t h e r e q u i r e m

e n ts

p e r tai n i n g to t h e c o n d iti o n s f o r su b m i t ti n g o r citi n g e x i s t i n g d ata to u p g r a d e a s t u d y

d e s c r i b ed in t h e Data C a l l

- I n N o tice. I am i n d icat i n g o n att a c h ed c orr e s po n d e n ce t h e

M a s ter R ec or d Id e n ti f

icati o n N u m

b er (M R I D) t h at E P A h as a ss i gn ed to t h e d ata t h a t I

a m ' cit i n g a s w ell as t h e M R I D o f t h e s t u d y I a m att e m p ti n g to u p g r a d e.

6

. Ci t ing a S t ud y : I am cit i n g an e x i s t i n g s t u d y t h at h a s b een p r e v i o us l y cl a ss i f ied b y

E P A as acce p ta b le, c or e, c o r e m i n i m u m

, o r a s t u d y t h at h as n o t y et b een r e v i e w ed b y

t h e A g e n c y

. I f r e v i e w e d

, I am pro v i d i n g t h e A g e n c y 's cla s s i f ic a ti o n o f t h e s t u d y

. 7

. Dele t ing U s e s : I a m atta c h i n g an a pp licati o n to a m e n d m y p rod u ct ’ s (o r prod u ct s ’ )

la b eli n g to d elete t h e us e s f o r w h i c h t h e d ata a r e r e q u i r e d

. 8

. L o w V o l u m

e/ M in o r U s e W a i v er Reque s t : I h a v e r ead t h e s tat e m e n t s c o n ce rn i n g l o w

v o l u m e

- m i n o r u s e d ata w a i v e r s in t h e Data C a l l

- I n N o tice a n d I r e q u e s t a l o w

- v o l u m e

m i n o r us e w a i v er o f t h e d ata r e q u i r e m e n t. I a m atta c h i n g a d etailed j us ti f ic a ti o n to

su ppor t t h is w a i v er r e q u e s t i n c l u d i n g

, a m o n g o t h er t h i n gs

, all i n f

o r m ati o n r e q u i r ed to

su ppor t t h e r e q u e s t. I u n d e r s t a n d t h at un l e s s t h e A g e n c y pro v i d es a w r itt e n r e s po ns e

w a i v i n g t h e r e q u i r e m e n t to s ub m it d ata, t h e d ata r e m a i n r e q u i r ed a n d a r e to be

su b m itted acc ord i n g to t h e ti m eli n es s p eci f ied i n t h e D a ta C a ll

- I n N o tice.

9. Reque s t fo r W ai v er o f D a t a : I h a v e r ead t h e s tat e m e n ts c o n ce r n i n g d ata w a i v e r s o t h er

t h an l o w v o l u m e m i n or

- u s e d ata w a i v e r s i n t h e D a ta C al l

- I n N o tice a n d I r e q u e s t a

w a i v er o f t h e d ata r e q u i r e m e n t

. I am atta c h i n g a r ati o n a le e xp lai n i n g w h y I b eli e v e t h e

d ata r e q u i r e m

e n t s d o n o t a pp l y

. I a m al s o s u b m i tt i n g a c o p y o f m y c u rr e n t la b e l s

. ( Y ou

m u s t al s o s u b m it a c o p y o f y o u r C on f i d e n tial Stat e m e n t o f F or mu la i f n o t al r ea d y o n

f ile w i t h E P A )

. I u n d e r s ta n d t h at u n l e s s t h e A g e n c y pro v i d e s a w r itt e n r e s pon s e w ai v i ng

t h e r e q u i r e m

e n t to s u b m it d ata, t h e d ata r e m ain r e q u i r ed a n d a r e to b e su b m i tted

acc ord i n g to t h e t i m el i n es s p e ci f ied in t h e Data C al l

- I n N o t i ce.E P A A n t i m ic rob ials D i v i s i o n D C I A tta c h m e n t s 

# 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

2575 - o-Phenylphenol, potassium salt Case # and Name: 1 Page: of 1

Co. Nr. Company Name Agent For Company Address City ZIP OMB Approval 2070-0174

State DCI Number: GDCI-064108-1461

# 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 on

# &EPA 0



## 0 

# D D I Confident/Ill Buaine• • lnform•tion: Doea Not Cont•ln N•tion.J Securinl lnform•tion (E

. 0. 12065) Form Approved. OMB No. 2070

- o d f Print Form J

- 31

- 98

United States A. Basic Formulation B. 

### Environmental Protection Agency See Instructions on Back

Washington, DC 20460 Alternative Formulation Page of 

## I

Office of Pesticide Programs (7505CI

- Confidential Statement of Formula

1

. Nama and Address of Applicant/Registrant (Include ZIP Code/ 2. Name and Address of Producer (Include ZIP Code/

r

----- - 

### · --

3

. Product Name 4

. Registration No./File Symbol 5

. EPA Product MgrfTeam No. 6. Country Where Formulated

7

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

EPA USE ONLY 10. Components in Formulation (List as actuslly 13. Each Component in 1 4

. Certifie d Limill

introduced into the formulation. Give commonly Fonnulation %by Weight 16. Purpoee

1 1 • Supplier Name & Address 12. EPA Reg

. No.

b

. "by e.u

- b

. Lower in

accepted chemical name, trade name, and CAS

number

. I a. Amount Weight Limit Limit Formulation



### - 

## -- ·· --- · -- 

### - -- 

### ---

- 

### - . .

_ .... -



### --

-

1 6. Typed Name of Approving Official 17

. Total Weight 100%



## --

18. Signature of Approving Official [19. Title

_ 1 20. Phone No. Pntlude Aroo Codal 121. Date



### .. EPA Farm 8670

- 4 (Rev. 8

- 941 White

- EPA File Copy Congmall Pmk

- Applicant

### Instructions and Paperwork Act Notice

Please Read Carefully Before Completing This Form

Paperwork Reduction Act Notice

The public reporting burden for this collection of

information is estimated to average 1.0 hour per

response, including familiarization with the form,

organizing the necessary information, and

completing the form. Send any comments

regarding the burden estimate or any other aspect

of this collection of information, including

suggestions for reducing this burden to: Chief,

Information Policy Branch, 2136, U.S.

Environmental Protection Agency, 401 M Street,

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



### Instructions

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

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

Rodenticide Act, as amended.

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

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

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

revision involves a formula change

.

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

form.

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

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

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

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

address of your firm or authorized agent.

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

the address of the site where this product will be produce d

.

3

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

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

on the application form. 4. Rcgistlation Number/File Symbol: Enter the EPA registration number

or file symbol, if known for this product

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

number of the EPA Product Manager assigned to this produc t

, if known.

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

formulated

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

gallon of formulated product. For a powder or granular product, enter the

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

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

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

dispersible or soluble in water. If not applicable enter "N / A •.

9. Flash Point/Flame Extension: Specify the flash point as determined by

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

to bur n

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

including positive flashbacks.

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

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

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

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

CAS numbers may be obtained from the Chemical Abstract Service of the

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

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

purity of the manufacturing use product, technical produc t

, or other source

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

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

in blocks I 0, II, and 12 or on a separate attachment.

Attention : (Special Instructions for Columns 70, 7 J, and 74) Any impurities

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

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

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

use P.roduct produced bv an integrated formulations system should also be

listed in column I 0, and the corresponding amount, percent by weight, and

upper certified limits in column s 13 and 14.

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

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

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

of the alternate sources also. 12. EPA Reg. No.: Specify the EPA registration number, if any, for each

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

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

data required under 40 CFR Part 158.

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

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

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

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

specific gravity or the pounds per gallon of the

component.

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

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

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

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

Attention: Producers of Microbial Products: Special Instructions for

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

International Units (B!Us). International Toxic Units (ITUs). Polyhedral

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

appropriate, and include an equivalent statement of active ingredient per milligram, ounce, pound, etc. of product (e.g., a 50% active Bacillus

thuringiensis product may have an equivalency value of 1.59 million

Aedis aegypti ITU per pound of product

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

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

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

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

he permitted in the product.

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

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

15. Purpose In Formulatio• : Specify the purpose of each ingredient both

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

defoamer, sequestrant, et c

. ) If space is insufficient, abbreviat e

.

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

identification of individual to he contacted if necessary

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

18

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

necessary

EPA Form 8570

- 4 (Rev

. 8

- 94) Reverse *U.S. GOP: 2000

- 519

- 239/94558Unite d State s E nvironmenta l P rotectio n A gency

Washington

, D.C

. 20460

C E R T IFICA T IO N O F AT T E M P T T O E N T E R I N T O AN

A G RE E MEN T W I T H R E G I STR A NT S FO R

DEV E LOPMEN T O F D A T A F o r m Ap p rov e d.

O M B N os

. 2 07 0

- 00 5 7;

2070

- 0107 ; 2070

- 0122;

2070

- 0164

Paperwor k Reductio n Ac t Not i ce : T h e p u bli c re p ortin g bur d e n f o r thi s c o llectio n o f infor m atio n i s esti m ate d to

averag e 1 5 minute s pe r respons e i nclud i n g t i m e fo r read i n g th e i nstr u ct i ons

, sea r chin g e xis t in g d a t a sou r ces

, ga t her i ng

an d mainta i nin g t h e dat a n eede d an d comple t in g a n d rev i ewin g t h e col l ect i o n o f i nformat i on

. Sen d com m ent s r egard i ng

th e bu r de n est i mat e o r an y othe r aspec t o f th i s col l ect i o n o f i nformat i on

, i nclud i n g suggest i on s fo r r educin g th e bu r den

to : Direc t or

, Col l ect i o n Str a teg i e s Div i sio n ( 2822T)

, U

. S

. Env i ronmenta l Protec t io n Agenc y

, 120 0 Penns y lv a ni a A v enue,

N. W

. , W ashing t on

, D C 20460

. D o no t sen d t h e for m t o t hi s ad d ress.

Pl e as e f i l l i n b l ank s be l o w

Compan y Name Compan y Number

Chemi c a l Name EP A C hemica l Number

I C e rtif y that:

M y compan y is wi l l i n g t o de v elo p a n d submi t t h e dat a r equi r e d b y EP A unde r th e autho r i t y o f th e Fede r a l I nsect i cide,

Rodent i cid e a n d Fungic i d e Ac t ( FIFRA)

, i f necessar y

. Howeve r, m y compan y wou l d prefe r t o en t e r i nt o a n a g reement

wi t h on e o r mor e reg i stra n t s t o deve l o p jo i nt l y o r shar e i n th e cos t o f deve l opin g data.

M y f i r m ha s offere d i n wr i t i n g t o en t e r i nt o suc h a n agreement

. Tha t of f e r wa s i rrev o cabl e a n d inc l ude d a n of f e r to be

boun d b y arb i tra t io n u n de r sec t io n 3 ( c)(2 ) (B)( i i i ) o f F I FR A i f f i na l a g reemen t o n a l l t erm s coul d no t b e reached

otherwise

. Thi s offe r wa s m ad e t o th e followin g fi r m (s ) o n th e followin g date(s):

Nam e o f Firm(s) Dat e o f O f fer

Cert i f i cat i on:

I ce r t i f y tha t I a m dul y autho r i z e d t o r epresen t th e compan y nam e above

, an d tha t th e s t atement s t ha t I hav e mad e on

th i s for m an d al l at t achment s there i n ar e t rue

, accura t e an d complete

. I acknow l edg e tha t an y know i ngl y fa l s e or

mis l ead i n g s t at e men t ma y b e p un i shab l e b y f i n e o r impr i sonmen t o r bo t h unde r app l ic a b l e l aw.

Signatur e o f C ompany’ s Au t horize d Repres e ntative Date

Nam e an d Ti t l e (Pleas e Prin t o r T y pe)

EP A For m 8570

- 3 2 (12

- 2003)UNITE D STATE S ENVIRONMENTA L PROTECTIO N AGENCY

1200 Pennsylvania Avenue, N.W.

WASHINGTON, D.C. 20460

Paperwor k Reductio n Ac t Notice : Th e publi c reportin g burde n fo r thi s collectio n o f informatio n i s estimate d t o averag e 1.2 5 hour s pe r respons e fo r registration an d

0.2 5 hour s pe r respons e fo r reregistratio n an d specia l revie w activities

, includin g tim e fo r readin g th e instruction s an d completin g th e necessar y forms

. Send

comment s regardin g burde n estimat e o r an y othe r aspec t o f thi s collectio n o f information

, includin g suggestion s fo r reducin g th e burde n to : Director

, Collection

Strategie s Divisio n (2822T)

, U.S

. Environmenta l Protectio n Agency

, 120 0 Pennsylvani a Avenue

, N.W.

, Washington

, D C 20460

. D o no t sen d th e complete d form t o

thi s address.

Certificatio n wit h Respec t t o Citatio n o f Data

Applicant's/Registrant' s Name

, Address

, an d Telephon e Number EP A Registratio n Number/Fil e Symbol

Activ e Ingredient(s ) and/o r representativ e tes t compound(s) Date

Genera l Us e Pattern(s ) (lis t al l thos e claime d fo r thi s produc t usin g 4 0 CF R Par t 158) Produc t Name

NOTE : I f you r produc t i s a 100 % repackagin g o f anothe r purchase d EPA

- registere d produc t labele d fo r al l th e sam e use s o n you r label

, yo u d o no t nee d to

submi t thi s form

. Yo u mus t submi t th e Formulator' s Exemptio n Statemen t (EP A For m 8570

- 27).

I a m respondin g t o a Data

- Call

- I n Notice

, an d hav e include d wit h thi s for m a lis t o f companie s sen t offer s o f compensatio n (th e Dat a Matri x for m should

b e use d fo r thi s purpose).

SECTIO N I : METHO D O F DAT A SUPPOR T (Chec k on e metho d only)

I a m usin g th e cite

- al l metho d o f support

, an d hav e include d wit h thi s form

a lis t o f companie s sen t offer s o f compensatio n (th e Dat a Matri x form

shoul d b e use d fo r thi s purpose). I a m usin g th e selectiv e metho d o f suppor t (o r cite

- al l option unde r

th e selectiv e method)

, an d hav e include d wit h thi s for m a

complete d lis t o f dat a requirement s (th e Dat a Matri x for m mus t be

used).

SECTIO N II : GENERA L OFFE R T O PAY

[Require d i f usin g th e cite

- al l metho d o r whe n usin g th e cite

- al l optio n unde r th e selectiv e metho d t o satisf y on e o r mor e dat a requirements]

I hereb y offe r an d agre e t o pa y compensation

, t o othe r persons

, wit h regar d t o th e approva l o f thi s application

, t o th e exten t require d b y FIFRA.

SECTION III: CERTIFICATION

I certif y tha t thi s applicatio n fo r registration

, thi s for m fo r reregistration

, o r thi s Data

- Call

- I n respons e i s supporte d b y al l dat a submitte d o r cite d i n the

applicatio n fo r registration

, th e for m fo r reregistration

, o r th e Data

- Call

- I n response

. I n addition

, i f th e cite

- al l optio n o r cite

- al l optio n unde r th e selectiv e metho d is

indicate d i n Sectio n I

, thi s applicatio n i s supporte d b y al l dat a i n th e Agency' s file s tha t (1 ) concer n th e propertie s o r effect s o f thi s produc t o r a n identica l or

substantiall y simila r product

, o r on e o r mor e o f th e ingredient s i n thi s product ; an d (2 ) i s a typ e o f dat a tha t woul d b e require d t o b e submitte d unde r th e data

requirement s i n effec t o n th e dat e o f approva l o f thi s applicatio n i f th e applicatio n sough t th e initia l registratio n o f a produc t o f identica l o r simila r compositio n and

use s

.

I certif y tha t fo r eac h exclusiv e us e stud y cite d i n suppor t o f thi s registratio n o r reregistration

, tha t I a m th e origina l dat a submitte r o r tha t I hav e obtained

th e writte n permissio n o f th e origina l dat a submitte r t o cit e tha t study.

I certif y tha t fo r eac h stud y cite d i n suppor t o f thi s registratio n o r reregistratio n tha t i s no t a n exclusiv e us e study

, either : (a ) I a m th e origina l data

submitter ; (b ) I hav e obtaine d th e permissio n o f th e origina l dat a submitte r t o us e th e stud y i n suppor t o f thi s application ; (c ) al l period s o f eligibilit y for

compensatio n hav e expire d fo r th e study ; (d ) th e stud y i s i n th e publi c literature ; o r (e ) I hav e notifie d i n writin g th e compan y tha t submitte d th e stud y an d have

offere d (I ) t o pa y compensatio n t o th e exten t require d b y section s 3(c)(1)(F ) and/o r 3(c)(2)(B ) o f FIFRA ; an d (ii ) t o commenc e negotiation s t o determin e the

amoun t an d term s o f compensation

, i f any

, t o b e pai d fo r th e us e o f th e study.

I certif y tha t i n al l instance s wher e a n offe r o f compensatio n i s required

, copie s o f al l offer s t o pa y compensatio n an d evidenc e o f thei r deliver y in

accordanc e wit h section s 3(c)(1)(F ) and/o r 3(c)(2)(B ) o f FIFR A ar e availabl e an d wil l b e submitte d t o th e Agenc y upo n request

. Shoul d I fai l t o produc e such

evidenc e t o th e Agenc y upo n request

, I understan d tha t th e Agenc y ma y initiat e actio n t o deny

, cance l o r suspen d th e registratio n o f m y produc t i n conformit y with

FIFRA.

I certif y tha t th e statement s I hav e mad e o n thi s for m an d al l attachment s t o i t ar e true

, accurate

, an d complete

. I acknowledg e tha t any

knowingl y fals e o r misleadin g statemen t ma y b e punishabl e b y fin e o r imprisonmen t o r bot h unde r applicabl e law.

Signature Date Type d o r Printe d Nam e an d Title For m Approve d OM B Nos

. 2070

- 0060 ; 2070

- 0057 ; 2070

- 0107 ; 2070

- 0122 ; 2070

- 0164

EP A For m 8570

- 3 4 (12

- 2003 ) Electroni c an d Pape r version s available

. Submi t onl y Pape r version.

## A TTE N T I ON DC I R ES P O ND E N TS

Und e r the P a p er wo r k Re du c tion A c t ( PR A ) , 44 U

. S

. C . 3501 e t s e q

., a n a g e n c y m a y not c ond u c t

or sponso r

, a nd a p er son is not re qui re d to re spond to, a c oll ec tion of in f o r m a tion unl e ss it displ a y s a

c u rre nt l y v a lid O M B c o n t r ol numb er . The a p p r ov a l of a n in f o r m a tion c oll e c tion ca n on l y b e v a lid f or up

to th re e y e a r s, a t whi c h t i me the a g e n c y must obt a in a re n e w a l of th a t a pp r o v a l. The c u r re nt l y v a lid OMB

c ont r ol numb er s f

or the E P A r e g ul a tions th a t a p p ea r in 40 C F R

, a f t e r initi a l displ a y in the f

i n a l r ul e

, ar e

list e d in 40 C F R p ar t 9 a nd ar e in c lud e d on t h e r e sponse f o r m or c oll e c tion inst r um e nt.

F or f o r ms, in a ddition to the re qui re d i n c lusion of the OMB c on t r ol numb e r f or the I n f o r m a tion

C oll ec tion R e qu e st ( I

CR ) c ont a ining the f

o r m, E P A h a s t ra dition a l l y i n c lud e d the I C R e x pi ra tion d a te on

the f o r m. W h e n f

o r ms r e m a in subst a ntiv e l y un c h a n g e d f or m a n y y e ar s, the p r int e d inv e nto r y of the f o r m

m a y not be e x h a ust e d b e f o r e the e x pi ra tion d a te u s e d on the f o r m. I f the s a me f

o r m is a pp r ov e d a s p ar t of

the re n e w a l p r o c e ss, the a g e n c y m a y c ontinue to use the re m a ini n g sto c ks of the p a p e r f o r m, e v e n t hou g h

th a t f o r m c ont a ins• a n o b sol e te e x pi ra tion d a t e

.

Althou g h a ll of the a tt ac h e d f o r ms th a t y ou a r e a s k e d to utili z e in re spondi n g to this D C I a r e

c u rre nt l y a p p r ov e d b y O M B , some c ont a in obsol e te e x pi ra tion d a t e s, or a d d re ss a nd p e r re spon s e b u r d e n

in f o r m a tion in the PR A Noti ce . E P A is c u r r e nt l y in the p r o ce ss of up d a ting the e l ec t r onic f il e s of t h e se

f o r ms, whi c h a r e a v a il a ble on the int er n e t a t http://www. e p a

. g ov/op p r d001/ f o r ms, a t whi c h time E P A

will a lso upd a te the c ont e nts of the PR A Noti c e in c lud e d on e a c h f o r m or a s p ar t of the inst r u c tions f or

the f o r m.

The public re po r ti n g a nd rec o r d k ee pi n g bu r d e n f o r this c oll ec tion is e stim a t e d to a v er a ge a bout

1063 hou r s p e r r e sponse f or O PP ' s Re g ist ra tion R e vi e w D C I s a nd 596 ho u r s f or O PP ' s Re r e g ist ra ti o n

D C I s. This in c lud e s the t ime f or re vi e w of the ins t r u c tions, rea d a nd dis c u s s t e st re qui re m e nts, dis c u ss

t e st a nd p r oto c ol with the Ag e n c y , pl a n ac tiviti e s, s earc h e x isting d a ta sou r ce s, g a th e r a nd m a int a in the

d a ta n ee d e d, c r ea te in f

or m a tion, c ompil e , p r o ce s s

, c ompl e te a nd r e vi e w t h e c oll ec tion of in f o r m a tion,

c ompl e te w r itt e n f

o r ms, r ec o r d, dis c los e

, a nd displ a y in f o r m a tion, a nd sto r e

, f

ile or m a int a in in f

o r m a tion.

This in f o r m a tion ( und e r Do c k e t I D No. E P A

- H Q

- O PP

- 2007

- 0923

- 004) fr o m T a ble 1 a nd T a b l e 1b of the

F i n al Supp o rt i n g S t a teme n t f or a n I n f o r m a t i o n Coll ect ion R e qu e st ( I CR ) f or the P e sti c ide D a t a C a ll

I n P r o g ra m m a y be ac c e s s e d vi a : http://www. r e g u l a tions. g ov

, or b y:

http://www. re g ul a tions

. gov/# ! do c k e tD e t a il;D

= E P A

- HQ

- O PP

- 2007

- 0923;d c t =F R % 25 2 B PR % 252 B N % 252 B O % 25 2 B S R

S e nd c omm e nts r e g ar di n g this bu r d e n e stim a te or a n y ot h e r a s p ec t of this c oll ec tion of

in f o r m a tion, in c luding s u g g e stions f or re d u c ing t h e bu r d e n, to Di r ec to r

, C o ll ec tion S t ra t e g i e s Division

( M a il C ode 2822T ) , U. S

. Envi r onm e nt a l P r ot ec tion Ag e n c y , 1200 P e nn s y l v a nia Av e ., N W

, W a shin g ton,

D. C . 20460. I

n c lude the OMB c ont r ol numb e r in a n y c o rr e spond e n ce , but do not submit the f o r m or

re po r t to this a dd re ss. T h e ac tu a l in f o r m a tion or f

o r m should be submitt e d i n acc o r d a n c e with the

inst r u c tions acc omp a n y

i ng the in f

o r m a tion or f

o r m, sp ec i f

i e d in the c o r re s ponding r e g ul a tion.

The suppo r ting st a t e m e nt f or the I n f o r m a tion C oll ec tion R e qu e st ( I CR ) c o v er ing this D C I re qu e st

is e ntitl e d " P e sti c id e s D a ta C all

- I n Program " ( O MB No. 2070

- 0174; E P A No. 2288.01 ) . O M B N o.

2070

- 0174 e x pi re s on July 31, 2013.

F or mo r e i n f

o r m a tion a b out the Ag e n c y 's bu r d e n e stim a t e s, pl ea se g o to t h e f ollowing

R e g I n f o

. g ov w e bsite p r o du ce d b y the O ff i c e o f M a n a g e m e nt a nd B u d g e t ( OM B ) :

http://www. re g in f

o

. g ov/ p ubli c /do/ PR AM a in a nd s earc h f or the c ont r ol numb e r ( 2070

- 017 4 )

.