FFDCA §408(p) Order Template for Manufacturers/Importers of SD WA Chemicals Draft - September 22, 2010

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### F I R S T C L A S S M A I L



### – R E T U R N 

### R E C E I P T 

### ® Summary

Information A bout this Order and the Order Recipient: Order # : [ In sert sequential number as assigned by the sy stem.] Chemical Common Name: [ Insert chemical name.] CAS # : [ In sert number assigned to identify th e chemical named above .] Date Issued: [ In sert d ate of signature

. This serves as the issuance date. ] Due Date for Initial Response: [ In sert d ate, calculated as 90 calendar days from issuance plus 10 calendar day s for final processing and mailing (i.e., total 100 calendar day s from issuance) .] Due Date for Consortia Documentation: [ In sert date, calculated as 150 calendar day s from issuance plus 10 calendar day s for final processing and mailing (i.e., total 160 calendar day s from issuance)

. ] Due Date for Progress Report : [ Insert date, calculated as 12 months from issuance.] Due Date for Final Submission: [ In sert date, calculated as 24 months from issuance]

. Company Name: [ Insert name.] Company #(s): [ In sert number assigned to identify the company

in the s ys tem.] Address: [ In sert address where Order will be directed to.] Contact Person: [ In sert the name of the contact person.]
Dear Sir or Madam: This Order requires you and other manufacturers and importers of the chemical named above to submit cert ain data , or otherwise respond as noted herein , to the U. S. Environmental Protection Agency

(EPA, the Agency). This chemical is identified as a substance that may be found in sources of drinking water and to which EPA has determined that a substantial po pulation may

be exposed. If you do not respond to this Order, or if you fail to otherwise compl y with its requirements, you will be subject to fines in accordance with section 16 of the Toxic Substances Control Act (TSCA) [15 U.S.C. 2601]. 

### Introduct ion This Order is issued pursuant to sections 408(p)(3) and (5) of FFDCA [21 U.S.C. 346a(p)(3), (5)] based on an EPA determination under section 1457 of the Safe Drinking Water Act (SDWA) [42 U.S.C. 300j

- 17]
. To facilitate the formation of consortia to develop the data required b y this Order , and to the extent that the information is not protected as confidential business information , we have provided each Order recipient with a list of the other recipients of an O rder for th is chemical

. ( See Enclosure A ). EPA intends to announce the issuance of this Order and the availability of aPage 2 of 16

list of all O rder recipients for this chemical in the Federal Register
. The list of Order recipients for this chemical will be publicly available on the Agency 's w ebsite , along with the status of the Orders, including recipients’ responses. EPA intends to update this information with subsequent publication(s) and posting(s) as appropriate. You are encouraged to join a consortium and check on the status of responses from the other O rder recipients for this chemical on the w ebsite at www.epa.gov/endo

. If you have previousl y cl aimed your identi ty in relation to this chemical as confidential business information (C BI) , you will notice that your company is included on the list only as “Company

X
. ” EPA recommends that you either declassify your identit y i nformation so that it can be made publicl y available , or you identify an agent who will act on yo ur behalf in all matters relating to this Order s o that other Order recipi ents can identify and contact you to collaborate on responding to this Order . If you choose to designate an agent, EPA will make the name of the agent (instead of the compan y) public by including it on the list of recipients of EDSP o rders. The inform ation collection requirements described in this document have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. The In formation Collection Request (ICR) document prepared b y EPA is i dentified under EPA ICR No. 2249.01 , and OMB Control No. 2070

- 0176
. The public reporting burden for this collection of information is estimated to average ____ hours per Order recipient, or ____ hours when annualized over 3 y ears . Your feedback on this e stimate will help facilitate the Agency ’s review of the assumptions and estimates before renewal of the OMB approval for this I CR is sought

. Completing th e enclosed questionnaire is optional, and the responses provided will only

be considered in the Agenc y’s review of the burden estimates when developing the renewal request for this ICR. See Enclosure D. 

### Section I . The A uthority for this Order FFDCA section 408(p)(1) requires EPA “to develop a screening program, using appropriate validated test sy stem s and other scientifically relevant information to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturall y occurring estrogen, or such other effects as [EPA] may designate” [21 U.S.C. 346a(p)]. Section 1457 of SDWA authorizes EPA to “provide for testing under the screening program authorized b y section...[408(p)] in accordance with the provisions of section... [408(p)] of Title 21 , of an y other substance that may be found in sources of drinking w ater... if a substantial population may be exposed to such substance.” [42 USC § 300j

- 17.] Section 408(p)(5) of FFDCA provides that the Administrator shall issue an order to a registrant of a substance for which testing is required under this subsection, or to a person who manufactures or imports a substance for which testing is required under this subsection, to conduct testing in accordance with the screening program, and submit information obtained from the testing to the Administrator, within a reasona ble time period that the Administrator determines is sufficient for the generation of the information.Page 3 of 16



### Section II. Why

You a re Receiving t his Order On April 15, 2009 and ____ __, 2010 , EPA published final ized list s of the chemicals to undergo EDSP Ti er 1 s creening ( (74 FR 17560 and __ FR

____) , including chemicals that may be found in sources of drinking water (i.e., a SDWA chemical)

. The chemical identified on page 1 of this Order is a SDWA chemical included on th at list. You are receiving this Ord er because yo u are identified as a manufacturer and/or importer of the chemical identified on page 1 of this Order . As such, p ursuant to FFDCA section 408(p)(3) and SDWA section 1457 , you are subject to this Order

. 

### Section III. Data Required b y t his O rder Th is Order identifies the screening assay s that will identify substances that have the potential to interact with the endocrine s ys tem. These screening assay s are part of Tier 1 screening under the EDSP. The purpose of Tier 1 screening (also referred to as “screening”) is to identify

substances that have the potential to interact with the estrogen, androgen, or thy roid hormone sy stems using a battery of assay s. The fact that a substance may interact with a hormone sy stem, however, does not mean th at when the substance is used, it will cause adverse effects in humans or ecological sy stems. Although this Order only identifies the Tier 1 screening assay s, u pon examining the screening data submitted , EPA may issue a subsequent Order to require addi tional testing of this chemical under Tier 2 of the EDSP to:

 Determine whether a substance may cause endocrine

- mediated effects through or involving estrogen, androgen, or thyroid hormone s ys tems, or such other endocrine effect as the Administrator may

de signate;

 Determine the consequences to the organism of the activities observed in screening assay s; and

 Establish the relationship between doses of an endocrine

- active substance administered in the test and the effects observed. 

### III.A. Data Required – The Tier 1 Battery The following is a list of the EDSP Tier 1 B attery that identifies the data yo u must submit to the Agency

in response to this Order: Amphibian Metamorphosis (Frog)

- The Amphibian Metamorphosis assay involves the use of tadpoles to de termine if chemicals affect the h ypothalamic

- pituitary

- thy roid (HPT) axis during metamorphosis and consequently result in developmental effects. Androgen Receptor Binding (Rat Prostate)

- The androgen receptor (AR) is involved in the development of male s exual characteristics. The AR Binding assay identifies chemicals that affect the endocrine s ys tem by binding to hormone receptors to either mimic the action of thePage 4 of 16

natural hormone or block access of the hormone to the site and thus block hormone controlle d activity

. Aromatase (Human Recombinant)

- Aromatase is an enzy me complex responsible for estrogen biosy nthesis that converts androgens into estrogens, estradiol, and estrone. The Aromatase in vitro assay

focuses on this portion of the steroidogenic pathway to detect substances that inhibit aromatase activity

. Estrogen Receptor Binding

- The estrogen receptor (ER) is involved in female maturation and reproductive function. The ER Binding assay measures the abilit y of a chemical to bind to the estrogen receptor. Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa

- 9903))

- The estrogen receptor (ER) is involved in female maturation and reproductive function. The ER Transcriptional Activation is a cell

- based assay that measures the ability of a chemical to bind to the ER and activate transcription resulting in the sy nthesis of the enzy

me luciferase. Fish Short

- term Reproduction

- The Fish Short

- term Reproduction assay screens for disturbances in the hy pothalamic

- pituitary

- gonadal (HPG) ax is including (anti

- )estrogenic, (anti

- )androgenic, aromatase inhibition, and steroid modulating effects. The assay examines abnormalities associated with survival, reproductive behavior, secondary sex characteristics, histopathology , and fecundit y (i.e., number of spawns, number of eggs/spawn, fertility , and development of offspring) of fish exposed to test chemicals. Hershberger (Rat)

- The Hershberger assay is designed to detect androgenic and anti

- androgenic effects. In this in vivo assay, the weight of several androgen

- dependent tissues, including accessory sex glands, are measured in castrated or immature male rats. Female Pubertal (Rat)

- The Pubertal Female assay involves the use of rats to screen for estrogenic and th yroid activity in females during sexual maturation. This assay examines abnormalities associated with sex organs and puberty markers, as well as thy

roid tissue. Male Pubertal (Rat)

- The Pubertal Male assay involves the use of rats to screen for androgenic, anti

- androgenic, and th yr o id activity in males during sexual maturation. This assay examines abnormalities associated with sex organs and puberty markers, as well as thy

roid tissue

. Steroidogenesis (Human Cell Line

– H295R)

- The Steroidogenesis in vitro assay detects interference with the body's production of male and female steroid sex hormones. This assay is a cell

- based assay

using the H295R human adrenocortical carcinoma cell line which can detect inducers of enz ym es responsible for steroid s ynthesis as well as chemicals that inhibit it. Uterotrophic (Rat)

- The Uterotrophic assay involves the use of female rats to screen for estrogenic effects. In this in vivo assay , uterine weight changes are measured in ovariectomised or immature female rats.Page 5 of 16



### III. B . Conducting the Batte ry - Testing Protocols Pursuant to FFDCA section 408(p)(1) , testing conducted for the EDSP must be based on “validated test s ys tems and other scientificall y relevant information.” [ 21 U.S.C. § 346a (p)(1) ]
. “Other scientificall y relevant information” i s information that informs the determination as to whether the substance may have an effect that is similar to an effect produced by a substance that interacts with the estrogen, androgen, and/or thy roid hormonal sy stems (e.g., information that identifies substances as having the potential to interact with the estrogen, androgen, and/or thy roid s ys tem(s); information demonstrating whether substances have an effect on the functioning of the endocrine sy stem). Other scientifically relevant information may ei ther be functionally

equivalent to information obtained from the Tier 1 assay s
—that is, data from assay s that perform the same function as EDSP Tier 1 assay s
— or may include data that provide information on a potential consequence or effect that could be du e to effects on the estrogen, androgen or th yr oid sy stems. See also the discussion in Section IV. of this Order. The assay s identified in Section III.A. of this Order must be conducted using the test protocols that have been validated and made available for use b y the Order recipients that are completing the assay s to generate new data to respond to this Order . All of the applicable test ing protocols have been validated and are available on the Agency ’s W eb site at: http://www.epa.gov/ocspp/pubs/frs/pub lications/Test_Guidelines/series890.htm

. If you choose to generate the data to respond to this Order, you may not deviate from an approved testing protocol unless y ou first consult with the Agency and obtain Agency approval of an y planned deviation. I f you wish to use a protocol that differs from those identified in this Order, you must submit a detailed description of the proposed protocol (including a precise description of an y deviations from the protocol identified in this Order) and your reason fo r wishing to use it. Because FFDCA section 408(p)(1) requires that the screening be conducted with validated tests, in order for EPA to approve the use of your proposed alternate protocol, you must demonstrate that the alternate protocol has been scientif ically validated or the deviation is such that the final study

is nonetheless properly

considered to have been scientifically validated. If the Agency

rejects your alternate protocol you will be notified in writing. Moreover, you should be aware that rej ection of a proposed alternate protocol will not be a basis for extending the deadline for submission of data. If you choose to cite or submit existing data, including other scientificall y relevant information, you must indicate whether the information p rovided follows an accepted scientific methodology

or protocol, including but not limited to those presented in EPA’s harmonized test guideline compendium (see http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm ), and provide a cogent and complete rational e for wh y you believe the information is sufficient to satisfy part or all of this Order. EPA’s decisions about whether the information satisfies part or all of the Tier 1 Order will be based on the weight of evidence from all relevant information availab le to the Agency . See the instructions for submitting your response, which appear in Section IV . of this Order

. You must also adhere to the good laboratory practice (GLP) standards

. Good Practices have been set out both in FIFRA for pesticides in 40 CFR 160 and for TSCA chemicals in 40 CFR 792. Test order recipients would need to follow appropriate GLPs, including protocol requirements and procedures for submitting the data described in this O rder

. When you submit data to EPA you must provide a GLP co mpliance statement indicating a) that the data werePage 6 of 16

generated using GLPs; or b) describe in detail “all differences” between the GLPs and the practices used; or c) confirm that you did not sponsor or conduct the stud y and do not therefore know whether the study

was conducted in accordance with the GLPs. 

### III.C
. Generating the Data – Applicable Timeframes You are required to submit the data or otherwise satisfy the data requirements specified in this Order , and submit the data to EPA no later than 24 month s from issuance of this Order (see page 1 of this Order)

. The Agency set this due date after considering the amount of time one might reasonabl y expect i s needed to complete each assay , including the planning activities before beginning the test, actual p erformance of the test, anal yz ing test results, and completing the final study

report for that assay (see Table 1) . EPA also included several months for overall planning, and several months after the last test is completed to allow ample time for you to p repare the final report for submission to EPA. Table 1

– Estimated Timeframes for Completing the Individual Assay Reports Assay Timeframes Am phibian Metamorphosis (Frog) 15 months Androgen Receptor Binding (Rat Prostate) 6 months Aromatase (Human Recombinant) 6 months Estrogen Receptor Binding 6 months Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa

- 9903)) 6 months Fish Short

- term Reproduction 12 months Hershberger (Rat) 9 months Female Pubertal (Rat) 15 months Male Pube rtal (Rat) 15 months Steroidogenesis (Human Cell Line

– H295R) 6 months Uterotrophic (Rat) 9 months There is no set sequence for completing these assay s, and the due date for submitting the final report to EPA provides y ou with ample flexibility to jo in forces and complete this battery within the timeframe provided. You may also submit data before the due date. 

### Section IV. Responding to t h e Order You must respond to this O rder within the timeframes established pursuant to S ection IV
. A
. of this Ord er , and the specific a pplicable dates as identified on page 1 of this Order . I f you do not respond to this Order, or if you fail to otherwise comply with its requirements, you will be subject to fines in accordance with section 16 of the Toxic Substances Control Act (TSCA) [15 U.S.C. 2601]. To comply

with this Order, y ou are expected to engage in the following activities: (1) Read this Order. (2) Determine and p lan a ctivities necessary to respond to the order. (3) Submit an Initial R esponse Form t o EPA , identifying the response option y ou intend to use. See S ection IV. B . of this Order

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(4) If you decide to generate the data, Read and , if applicable, discuss the protocols. See S ection III.B . of this Order

. (5) Submit a Progress Report. See S ect ion V I . of this Order

. (6 ) Generate the data. ( 7 ) Compile and review the d ata for submission

. See S ection V . of this Order

. (8 ) Complete paperwork to assemble the submission package

. See S ection V . of this Order

. (9 ) Submit F inal Report/D ata to EPA
. See S ection V . of this Order

. (10 ) Maintain records

. See S ection VI I . of this Order

. 

### IV . A. Schedule f

or Responding to t

he Order Your schedule for responding may vary based on the response option s discus sed in more detail in the next S ection of this O rder

. Please note that in calculating the due date for the Initial Response, the Agency

has included an additional 10 calendar day s to account for processing the final order package for delivery to the Post Office. Y our basic schedule is summarized on pa ge 1 of this Order and is based on the timeframes identified in Table 2 : Table 2

– Basis for Establishing the Due Dates in this Order Timeframes for Due Dates : What is Due: Within 90 calendar days of the Order’s issuance ( plus 10 calendar days for proce ssing) Individual Recipient’s Initial Response Within 15 0 calendar days of the Order’s issuance ( plus 10 calendar days for processing) Consortia Documentation & Consortia’s Initial Response Within 12 months from Order’s issuance A Progress Report descri bing the status of an Order Recipient’s compliance with the Order. On or before 6 (six) months of the Order’s issuance A Manufacturer/Importer that chooses to cease all manufacture and import of the chemical has agreed to do so

. 24 months from Order’s i ssuance Final Study Report and submission of the data to EPA In general, the Agency

will not consider any

requests for extending the deadlines for the Initial Response or Progress Report. However, the Agency will consider extending the final report due date when the circumstances warrant it. If you cannot submit the data/reports to the Agency in the time frame required by this Order and intend to seek additional time to meet the requirement, you must submit a written request to the Agency before the ap plicable deadline. Your written request must include: (1) a detailed description of the expected difficulty and (2) proposed schedule including alternative dates for meeting such requirements on a step

- by

- step basis. You must explain any technical or la

boratory difficulties and provide documentation from the laboratory

performing the testing. While EPA is considering your request, the original deadline remains. The Agency will respond to your request in writing; extensions can onl y be granted in writin g. If EPA does not grant your request, the original deadline remains. Normally, extensions can be requested only in cases of extraordinary testing problems beyond the expectation or control of the registrant, manufacturer, or importer. Extensions will n ot be considered if the request for extension is not made in a timely fashion; in no event shall an extension request be considered if it is submitted at or after the lapse of the subject deadline.Page 8 of 16



### IV . B. Options f

or Responding to t

he Order You have seve ral options for responding to this O rder. To report your commitment to act in response to this Order , you must submit an Initial Response to EPA within 90 day s of the issuance of this Order

. Please complete the Initial Response Form for Individual Orde r Recipients (Enclosure B), which EPA has pre - populate d with basic information about this Order, the chemical and your contact information. Foll ow the mailing instructions in S ection V.D. of this Order to submit this form to EPA by the due date for the in itial response that is indicated on page 1 of this Order. You have several potential response actions from which to choose , each response option involves specific procedures that you must follow if you choose that response option

. Option 1: Generate Data (corresponds to 2.1

. A

. in the Initial R esponse F orm) If you choose to individually generate new data for each test specified in this Order, you must comply

with the procedures prescribed in this Order. All data generated and submitted must comply

with G LP and the tests must be conducted according to protocol requirements identified in Section III.B . of this Order . In submitting the data, you must follow the procedures described in Section V. of this Order

. Option 2: Submit or Cite Existing Data (corresp onds to 2.1 .B., 2.1.C., and 2.2. in the Initial R esponse F orm) If you choose to submit or cite an existing study in response to this Order (including data previously

submitted to the Agency and / or other scientificall y relevant information ) , your Initial Response must include either the data or a reference to the data for each test that is required, along with a rationale that explains how the study yo u cited or submitted satisfies part or all of this Order. Existing studies are studies that predate issuance of this Order. In order to be accepted as satisfaction of the requirements imposed in this Order, the Agency expects that any such hazard

- related data would be of high quality and achieves the objective of Tier 1 assay s to provide reasonable assurance that a chemical does or does not have the potential to interact with the estrogen, androgen, or thy roid s ys tems. EPA’s decisions about whether the data cited or submitted satisfies part or all of the Tier 1 Order will be based on the weight of evidence f rom all relevant information available to the Agency

. The submitted or cited study must have been conducted in accordance with accepted scientific methodology

or protocol, including but not limited to those presented in EPA’s harmonized test guideline co mpendium (see http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm ). Deviations from the protocols validated for the Tier 1 assay s, must be identified, along with an explanation for the deviations, including an explanation as to why , notwithstanding the de viations, the protocol used should still be considered as providing an accepted scientific methodology or protocol, and any

other information you think the Agency should consider in deciding whether to accept the data in satisfaction of this Order.Page 9 of 16

If EP A has previously

reviewed a protocol for a study you are submitting or citing, you must identify

an y action taken b y the Agency on the protocol and must indicate the manner in which all Agency

comments, concerns or issues were addressed in the final protoc ol and study

. If you choose to cite a study that has been previously submitted to EPA, that study must have been previousl y classified by EPA as acceptable (i.e., the stud y was not rejected b y the Agency for any reason related to completeness or quality) or it must be a study which has not y et been reviewed b y the Agency

. With respect to any studies for which you wish to select this option you must provide EPA with a copy of the title page along with the identification number of the study

you are citing, and, if the study has been reviewed by

the Agency , you must provide the Agency 's classification of the study . Do not resubmit a study that has previously

been submitted to EPA for another purpose. EPA will review an y existing study submitted or cited in response to this Order to determine whether the study is acceptable and whether the study satisfies the requirements of this Order. The Agency

will notify

you in writing of its determination. If the Agency determines that the study

is acceptable, the Initial Response Form is the only response you are required to complete to satisfy

this Order and EPA will notify you in writing that the Order is satisfied . If, however, EPA determines that the study is not acceptable, you must still satisfy the requirem ents of this Order. You should be aware that if the Agency determines that the study is not acceptable, the Agency

will require you to comply with this Order, normally without an extension of the required due date for submission of the data . The Agency m ay determine at any time that a study

is not valid and needs to be repeated. If you are citing a stud y of which you are not the original data submitter, you may need to submit an offer to pay

compensation to the original data submitter. Consequently , you should simultaneously

include an offer to pay

[which includes an offer to resolve any dispute over the recipients’ shares of the test costs by submitting the dispute to a neutral third party with authority to bind the parties (e.g., through binding arb itration or through a state or federal court action)], unless you have received confirmation from EPA that no such compensation is necessary

. Option 3 : Form a Consortium or Offer to Join a Consortium (corresponds to 2.1 .D. in the Initial R esponse F orm) If you choose to form a consortium to share in the cost of producing the required data, all participants of the consortium must submit their own Initial Response Form for Individual Order Recipients providing the name of the part y who will be submitting the data on your behalf. The designated lead for the consortium must complete the Initial Response Form for Consortium (Enclosure C) to provide the primary contact for the consortium, the list of participants, and an indication of the consortium’s plann ed response for each assay , along with documentation of its formation (such as a cop y of the joint agreement or a written statement b y all the parties that an agreement exists). The joint agreement to produce the data need not specify all of the terms of the final arrangement between the parties or the mechanism to resolve the terms. The designated lead for the consortium must follow the mailing instructions in S ection V.D. of this Order to submit th e consortium initial response and accompan yi ng informati on to EPA by

the due date for the consortia response that is indicated on page 1 of this Order.Page 10 of 16

Once the consortium submits the data and EPA has completed its initial review to accept the data in satisfaction of this Order, EPA will provide written notifi cation to the contact for the c onsortium that this Order has been satisfied, which in turn will close out the Orders for each of the participants in the consortium

. If you are unable to join a consortium, you must provide EPA with documentary evidence th at you made a reasonable offer to join or share in the testing costs. Such evidence may be (1) your letter offering to join in an agreement, or (2) your letter that contains a legall y binding offer to join in an agreement and provide a reasonable share of the test costs, and that includes a reasonable process for resolving an y disputes of the appropriate share of the test costs

. If th e consortium fails to submit the data or meet the requirements of the Order in a timely and adequate manner, you will norm ally be subject to penalties, unless you commit to submit, and do submit, the required data b y the dates specified in this Order. In such cases, the Agency will generall y not grant time extensions for the submission of data. Thus, if you agree to jointly submit the data, each Order recipient is still subject to penalties, unless some part y with whom you are in agreement makes a commitment to generate the data and submits the data in accordance with the deadlines and all other requirements set forth in thi s Order. The Agency

has provided a list of the other manufacturers and/or importers, to the extent permi tted by

confidentiality

requirements , that have received an EDSP Order for this chemical

. (Enclosure A). This l ist is intended to help order recipients identify other companies with whom they could form agreements to develop data jointly , or otherwise collaborate on a response to satisfy the requirements in this Order

. Option 4: Claim Not Subject t o t he Order (corresponds to 2. 3. in the Initial R espo nse F

orm) You may claim that you are not subject to this O rder if you do not manufacture or import the chemical or substance identified on page 1 of this Order or you believe the O rder was otherwise sent to you in error. An explanation of the basis for the claim, along with appropriate information to substantiate that claim, must accompany your Initial Response so that EPA can evaluate the claim. The Agency intends to make a determination and respond to your request in writing within 90 day s of receipt

. If EPA can not verify your claim , the original requirements and deadline s in this Order remain. If your claim is verified, EPA will consider your response to be satisfaction of the Order and will close out this Order. Option 5: Discontinue the Manufac ture or Import of the Chemical (corresponds to 2. 4. in the Initial R esponse F orm) If you have alread y, or otherwise are in the process of discontinuing the manufacture or import of this chemical, you may satisfy the Order by

submitting documentation to this effect with your Initial R esponse. If EPA can not verify your claim, the original requirements and deadlines in this Order remain. If your claim is verified, EPA will consider your response to be satisfaction of the Order and will close out this Orde r. Option 6 : Other Response OptionsPage 11 of 16

As part of your Initial Response, you may also ask EPA to reconsider some or all of the testing specified in this Order if: a) You can demonstrate (supported by appropriate data) that the chemical is an endocrine disru

ptor and that additional Tier 1 screening under the EDSP is unnecessary . b) You can demonstrate (supported b y appropriate data) that the chemical meets the standard for an exemption under FFDCA section 408(p)(4) ( i.e., “that the substance is not anticipated to produce an y effect in humans similar to an effect produced by a naturally occurring estrogen”). c) Your chemical was used by EPA as a ‘‘positive control’’ to validate one or more of the screening assay s. EPA will only accept th ese data in satisfaction o f that part of the O rder related to those assay s for which the chemical was used to complete the testing as part of the validation effort. The Agency

intends to make a determination on your claim and respond to you in writing within 90 day s of receipt. If EPA can not verify y our claim, the original requirements and deadlines in this Order remain. If your claim is verified, EPA will consider your response to be satisfaction of the Order and will close out this Order. 

### IV.D. Procedures f

or Challenging th is Order If you wish to challenge the validity of the factual predicate for issuance of the Order, specificall y the EPA determination that the chemical or substance for which testing is required by this Order is a “substance that may be found in sources of drinking water” and/or that “a substantial population may be exposed to such substance,” y ou may do so under SDWA section 1448 [42 U.S.C. 300j

- 7(a)] by filing a petition for review in the United States Court of Appeals for the circuit in which you reside or transact business within 45 day s of the date that begins 10 day s after the date of this Order. If you wish to challenge the validity of an y other the provisions of this Order, including the requirement to conduct any test or use the specific test proto cols required by this Order, you must submit to the Agency a detailed explanation of the basis for your challenge that provides sufficient information for the Agency to evaluate the issue. While EPA is considering y our submission, the original deadline re mains. The Agency intends to respond to your request in writing within 90 day s of receipt . If EPA does not grant your request, the original deadline remains. 

### IV . E . Procedures f

or Cost Sharing Cost sharing is the process by which two or more recipients of an Order contribute to the generation of data (or the compensation for existing data). Contributions may be in cash or in kind and apportionment of costs is subject to negotiation between the participants . EPA encourages all recipients of an O rder fo r a particular substance to jointly submit data and share data generation costs. All other parties who are also subject to this Order are listed in Enclosure A , unless that information is protected as confidential business information , and will be made publicly available on the Agency ’s Web site

.Page 12 of 16

EPA has not established specific coordination procedures b y which you must collectively generate data. You may

therefore determine the procedures that are best suited to your individual circumstances, and the m ost acceptable approach to identifying and sharing costs. If you are aware of another manufacturer or importer of the chemical listed on page 1 of this Order who is not listed on Enclosure A , and you provide EPA with this information, EPA intends to send that manufacturer or importer an O rder for this chemical within 90 day s of your notification. Note that EPA does not intend to send test orders to manufacturers or importers who meet the de minimis criteria discussed in the EDSP Revised Policies and Proced ures for Screening SDWA Chemicals (XX FR XXXXX). 

### IV . F. Procedures f

or Data Protection All confidential business information submitted in response to a 408(p) O rder is subject to the Trade Secrets Act 18 U.S.C. § 1905
. The Freedom of Information Act (F OIA) requires agencies to make information available to the public upon request, except for information that is “specificall y made confidential b y other statutes” or data that are “trade secrets and commercial or financial information obtained from a perso n and is privileged or confidential” [5 U.S.C. §552]. Any information that you wish to have EPA protect as confidential business information should be clearl y identified as such. Note that substantive criteria must be met to support a claim confidentiality of business information, as specified in 40 CFR §2.208. 

### Section V . Submitting Data t o t he Agenc y V.A. Format for Submissions Note: The format for th i s orders is under development, but is expected to be similar in concept to the format used for the F IFRA/FFDCA orders. The following language is specific to those FIFRA/FFDCA orders and is retained as an example of the expected language for a SDWA/FFDCA order. EPA has developed standard data evaluation formats or templates for writing its data evaluati on records (DERs) of studies submitted under FIFRA and FFDCA to EPA that may be used to respond under this order

. These templates describe the layout and scope of information that should be contained within a study profile and can serve as guides for preparation of study documents. Use of the templates improves the likelihood of a successful submission, since the information necessary

for an efficient A gency

review is outlined. Additional details about these templates are available at: http://www.epa.gov/pesticides/regulating/studyprofile_templates/

. In addition, Pesticide Registration (PR) Notice 86

– 5, entitled Standard Format for Data Submitted Under the Federal Insecticid e, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) , describes EPA’s preferred method for organiz ing and formatting submittals of data supporting a pesticide registration ( http://www.epa.gov/PR_Notices/pr86

- 5.html).Page 13 of 16

The Agency

also encourages O rder recipients to submit completed study profiles and supporting data in an electronic format (PDF) whether submitting one or several studies 

### V.B. Transmittal Documents In order for EPA to effectively track the compliance of each order recipient, each submission in satisfaction of this O rder must be accompanied b y a transmittal document that includes the following information:

• Id entity of th e submitter.

• The date on which the submission package was prepared for transmittal to EPA.

• T he O rder number identified on page 1 of this Order

.

• A list of the individual documents included in the submission. 

### V.C. Submitting Individual Study or Test Result Documents Unless otherwise specified by the Agency , each submission must be in the form of individual documents or studies. Do n ot resubmit any documents that you previously submitted to EPA. Instead, as part of your Initial Response Form, please provide a citation or reference to the previously

submitted documents with sufficient information to allow the Agency to identify the previously

submitted document. Each stud y or document submitted to EPA must include the following: i. A title page i ncluding the following information:

• The O rder number identified on page 1 of this Order

.

• The title of the study , including identification of the substance(s) tested and the test name or data requirement addressed.

• The author(s) of the study

.

• The date the stud y was completed.

• If the stud y was performed in a laboratory, the name and address of the laboratory, project numbers or other identifying codes.

• If the stud y is a commentary on or supplement to another previously submitted study , full identi fication of the other study with which it should be associated in review.

• If the stud y is a reprint of a published document, all relevant facts of publication, such as the journal title, volume, issue, inclusive page numbers, and date of publication. ii . Upon submission to EPA, each document must be accompanied b y a signed and dated document containing the appropriate statement(s) regarding an y data confidentiality

.Page 14 of 16

iii. A statement of compliance or non

- compliance with respect to GLP standards as appl icable. iv. A complete and accurate English translation must be included for an y information that is not in English. 

### V.D. Mailing Instructions Your response to this Order and all related correspondence must be mailed or delivered to EPA using one of the following methods : Mail To: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), U.S. EPA , 1200 Pennsylvania Ave. NW, Washington, D.C. 20460 Deliver To: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, U.S. EPA, 1200 Pennsylvania Ave. NW, Washington, D.C. 20460

- 0001. [Deliveries are only accepted from 8:30 a.m. to 4 p.m., Monday through Friday , excluding legal holiday s.] 

### Section V I . Submit a Progress Report Unless EPA has notified yo u in writing that the requirements of this Order have been satisfied, you must submit a progress report to EPA 12 months after the issuance of th is O rder (the specific due date for you is identified on page 1 of this Order)

. Your progress report sh ould provide a brief descrip tion of the status of your planned activities for each assay , and, if applicable, a description of an y problems encountered or expected difficulties in meeting the schedule for complying with the O rder. Please include the transmittal document described in Se ction V. B of this Order

. 

### Section V I I . Recordkeeping Requirements You must re tain copies of the generation of the data and other information documenting yo ur compliance with this Order

. T his includes all test reports submitted to the Agency , all underlying raw data, and interpretations and evaluations thereof. These records shall be retained as long as the chemical is produced and the producer is in business, and be made available to EPA or its agent for inspection. 

### Section VI I I . Consequences o f Failure t o Comply w ith t his Order Failure to compl y with any of the requirements in this O rder renders you liable for the penalties and sanctions. Each day that the violation continues constitutes a separate violation. Any person who knowingl y or willf ull y violates this O rder shall (either in addition to or in lieu of) be subject to a fine per day of violation , or to imprisonment for not more than one ye ar, or both. [21 U.S.C. §346a(p)(5)(D), citing 15 U.S.C. §2615] Before such penalties are assessed, you will be entitled to an administrative hearing held on the record in accordance with section 554 of the Administrative Procedures Act (APA). 15 U.S.C. §2615(a)(1)

- (2)(A). Before issuing a final penalty order, EPA must provide notice of its intention to assess the penalty , including a draft of the final penalt y order, and provide you withPage 15 of 16

the opportunity

to request a hearing within 15 days of the date the notice has been received. 15 U.S.C. §2615(a)(2)(A). See also, 40 C.F.R. §§ 22.13

- 22.14. If a hearing is requested, the only matters for resolution at the hearing shall be the following: (1) whether you have failed to comply with an O rder issued under FFDCA section 408(p)(5)(A), (2) the circumstances of the violation; (3) the extent and gravity of the violation(s); (4) your ability to pay ; (5) the effect on your ability to continue to do business; (6) any history of prior violations; and (7) the degree of culpability [15 U.S.C. § 2615(a)(2)(B)]. In this hearing, you may

not raise an y challenge t o the validity of this O rder , or any

test required by this O rder

. 

### Section I X . Ad ditional Information Additional information and details about the EDSP may be found on the Agency ’s Web site at http://www.epa.gov/ endo

. If you have an y questions about the requirements and procedures established in this Order, please contact one of the following EPA pe ople :

Susan Sharkey Environmental Protection Agency 1200 Pennsylvania Ave., NW, Washington, DC 20460

– 0001 telephone number: (202) 564

–4775 ; fax number: (202) 564

– 8789 e - mail address: ssharkey .susan@epa.gov William Wooge Environmental Protection Agency 1200 Pennsylvania Ave., NW, Washington, DC 20460

– 0001 telephone number: ( 202 ) 564
- 8476 ; fax number: ( 202 ) 5 64
- 8482 e - mail address: wooge. w illiam@epa.gov 

### Section X. Conclusion Under the authority in FFDCA section 408(p) [ 21 U.S.C. 346a(p) ] , the United States Environmental Protection Agency hereb y issues this Order to take effect on the date of m y signature

. Date: _____________________ Signature: ________________________________________

Jim Willis, Director Chemical Control Division Office of Pollution Prevention and Toxics U.S. Environmental Protection Agency EnclosuresPage 16 of 16

Enclosure A

– List o f EDSP Order Recipients for this Chemical Enclosure B

– The Initial Response Form for Individual Responders Enclosure C

– The Initial Response Form for Consortium Enclosure D

– Optional Questio nnaire : Level of Effort for Recipients of Tier 1 Screening Ord ers