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### Supporting Statement for an Information Collection Request (ICR)

1. Identification of the Information Collection
1(a) Identification of the Information Collection:

1(a)(i) Title: Tier 1 Screen ing of Certain Chemicals U nder the Endocrine Disruptor Screening Program (EDSP).

1(a)(ii) EPA ICR No.: 2249.03 OMB Control No.: 2070-0176 Docket ID No.: EPA–HQ–OPPT–2011–0966


### 1(b) Short Characterization/Abstract

This is a renewal of an existing information co llection request (ICR) unde r the Paperwork Reduction Act (PRA), 1 covering the information collection activities as sociated with Tier 1 screening of chemicals under the EPA's Endocrine Disrupto r Screening Program (EDSP). Th e EDSP is established under section 408(p) of the Federal F ood, Drug, and Cosmetic Act (FFDCA), 2 which requires the EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have hormonal effects. The EDSP consists of a two-tiered approach to screen chem icals for potential endocrine disrupting effects. The purpose of Tier 1 screening is to id entify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems using a battery of assays. 3 Substances that have the potential to interact with estrogen, androgen or thyroid systems ma y proceed to Tier 2, which is designed to identify any adverse endocrine-related eff ects caused by the substance, and es tablish a quantitat ive relationship between the dose and that endocrine effect. Additional information about the EDSP is available through the agency's Web site at http://www.epa.gov/endo

.
This ICR addresses the information collection activitie s for the initial list of chemicals screened under Tier 1 of the EDSP, and covers the full range of in formation collection activities associated with the issuance of and response to Tier 1 EDSP orders issued by the EPA. The initial list was established in 2009, and consists of 67 pesticide active i ngredients (PAIs) a nd pesticide inerts. 4 As the renewal of an ongoing information collection activity approved under the PRA, this ICR addresses the paperwork burden associated with the continua tion of these activities over the ne xt three (3) years. As such, the paperwork burdens are adjusted to reflect the pl anned progression associated with the information collection activities covered by the ICR.

1 44 USC 3501 et seq

. 2 See Attachment A.
3 Nothing in the identification of chemicals for Tier 1 screenin g under the EDSP provides a basis to infer that these chemicals are suspected to interfere with the endocr ine systems of humans or other species, and it would be inappropriate to do so. As such, the list of chemicals identified for sc reening under Tier 1 of the EDSP should not be construed as a list of known or likely endocrine disruptors.
4 See Attachment G.October 25, 2012

Under the existing ICR, the EPA issued the Tier 1 ED SP orders to the identified pesticide registrant and inert manufacturers, and received the initial responses from those order recipients . However, as stated in the EDSP policies and procedures document (Attachment B), the EPA will continue to issue "catch-up" orders for a period of 15 years to companies who enter the marketplace after the issuance of the initial orders in 2010. An up to date matrix with informati on on the status of the orde rs issued and responses received for those chemicals is ava ilable on the agency's Web site at http://www.epa.gov/endo . To facilitate consortia forma tion, the EPA also makes a list of the order recipients for each chemical publicly available at the Web address above.

Although the information collection activities are not being changed by this ICR renewal, the burden estimates reflect the planned progre ssion of the collection activities asso ciated with the initial list of chemicals to be screened under the EDSP. At this stage of the program, the remaining ongoing information collection activi ties relate primarily to data submissi on, and to those activ ities associated with "catch-up" orders. In calculating the overall burden, the EPA assumes that all future "catch-up" order recipients will join existing data submitters , and will not elect to become independent data generators.
Finally, the EPA has also reviewed the cost estimates for the eleven assays, including the analytical chemistry costs, and adjusted the costs for inflation. As before, the total costs of the tests are used to calculate the paperwork burdens and costs for this ICR.



### 2. Need for and Use of the Collection
2(a) Need/Authority for the Collection

The agency's authority for the information collec tion activities associated with the EDSP includes authorities under the FFDCA, the Safe Drinking Wate r Act (SDWA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Toxic Subs tances Control Act (TSCA). This information collection activity fulfills a direct statutory mandate and is needed in order to provide information that will allow the agency to identify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems.

The EDSP was established in 1998 to carry out the mandate in sec tion 408(p) of the FFDCA (see Attachment A), which directs the EPA "to develop a screening program...to determine whether certain substances may have an effect in humans that is similar to an effe ct produced by a naturally occurring estrogen, or such other endocrine ef fect as the Administrator may desi gnate." If a subs tance is found to have an effect, section 408(p)(6) directs the administrator to take action under available statutory authority to ensure protection of public health. That is, the ultimate purpose of the EDSP is to provide information that will allow the agency to evaluate th e risks associated with the use of a chemical and take appropriate steps to mitigate any risks. The necessary information includes identifying any adverse effects that might result from the interaction of a s ubstance with the endocrine system and establishing a dose-response curve.

FFDCA section 408(p)(1) requires the EPA "to develop a screeni ng program, using appropriate validated test systems and other scientifically re levant information to de termine whether certain substances may have an effect in humans that is similar to an effe ct produced by a naturally occurring estrogen, or such other effects as [EPA ] may designate." [21 U.S.C. 346a(p)].

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FFDCA section 408(p)(3) expressly re quires that the EPA "shall provide for the testing of all pesticide chemicals." FFDCA section 201 defines "pesticide chemical" as "any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide , and Rodenticide Act (FIFRA), including all active and pesticide inert ingredients of such pesticide. " [FFDCA section 201(q)(1), 21 U.S.C. 231(q)(1)]. The statute also provides the EPA with discretionary authority to "p rovide for the testing of any other substance that may have an effect that is cumulati ve to an effect of a pe sticide chemical if the Administrator determines that a s ubstantial population may be exposed to such a substance." [21 U.S.C. 346a(p)(3)].

FFDCA section 408(p)(5)(A) pr ovides that the Administrator "shall i ssue an order to a registrant of a substance for which testing is required [under FFDCA section 408(p)], or to a person who manufactures or imports a substance for which testing is required [under FFDCA section 408(p)], to conduct testing in accordance with the screening program, and submit information obtained from the testing to the Administrator within a reasonable time period" that the agency determines is sufficient for the generation of the information."

FFDCA section 408(p)(5)(B) re quires that, "to the exte nt practicable, the Admi nistrator shall minimize duplicative testing of the same substance for the same endocrine effect, develop, as appropriate, procedures for fair and equitable sharing of test costs, and develop, as necessary, procedures for handling of confidential business inform ation..." [21 U.S.C. 346a (p)(5)(B)].

If a registrant fails to comply with an order issu ed under FFDCA section 408(p)(5 ), the Administrator is required to issue "a notice of intent to suspend the sale or distri bution of the substanc e by the registrant. Any suspension proposed under this paragraph sha ll become final at the end of the 30–day period beginning on the date that the regi strant receives the notice of inte nt to suspend, unless during that period, a person adversely affected by the notice request s a hearing or the Administrator determines that the registrant has complied fully with this paragr aph." [21 U.S.C. 346a (p)( 5)(C)]. Any hearing is required to be conducted in accordance with section 554 of the Administrative Procedures Act (APA). [5 U.S.C. 554]. FFDCA section 408(p) explicitly provides that "the only matter for resolution at the hearing shall be whether the registra nt has failed to comply with a test order under subparagraph (A) of this paragraph." [21 U.S.C. 346a (p)(5)(C)(ii)]. A decision by the Ad ministrator after completion of a hearing is considered to be a fina l agency action. [21 U.S.C. 346a (p )(5)(C)(ii)]. The Administrator shall terminate a suspension issued with respect to a registrant if the Administrator determines that the registrant has complied fully with FFDCA sec tion 408(p)(5). [21 U.S.C. 346a (p)(5)(C)(iii)].

FFDCA section 408(p)(5)(D) prov ides that any person (other than a re gistrant) who fails to comply with an order issued under FFDCA section 408(p)(5) shall be liable for the same penalties and sanctions as are provided for under section 16 of TSCA. [21 U.S.C. 346a (p)(5)(D)] . Such penalties and sanctions shall be assessed and imposed in the same manner as provided in TSCA sec tion 16. Under section 16 of TSCA, civil penalties of up to $25,000 per day may be assessed, after notice and an administrative hearing held on the record in accordance with section 554 of the APA. [15 U.S.C. 2615(a)(1)–(2)(A)].

FFDCA section 408(f) establishes pro cedures that the agency "shall use" to require data to support the continuation of a tolerance or exemption that is in effect. The provision identifies three options:

• Issuance of a notice to the pers on holding a pesticide registrati on under FIFRA section 3(c)(2)(B) [FFDCA section 408(f)(1)(A)].

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• Issuance of a rule under section 4 of TSCA [FFDCA section 408(f)(1)(B)].

• Publication of a notice in the Federal Register requiring submission, by certain dates, of a commitment to generate the data "by one or more interested persons." [FFDCA section 408(f)(1)(C)].

Before using the third option, however, the EPA must demonstrate why the data "could not be obtained" using either of the first two op tions. FFDCA section 408(f)(1) expres sly provides that the EPA may use these procedures to "require data or information pertaini ng to whether the pestic ide chemical may have an effect in humans that is sim ilar to an effect produced by a na turally occurring estrogen or other endocrine effects." Finally, FFDCA s ection 408(f)(1)(B) provides that, in the event of failure to comply with a rule under TSCA section 4 or an order under FFDCA s ection 408(f)(1)(C), the EPA may, after notice and opportunity for public comment, modify or revoke any tolerance or exemption to which the data are relevant.

In addition, FFDCA section 408(i) provides that "[ d]ata that are or have been submitted to the Administrator under this section or FFDCA section 409 in support of a tolerance or an exemption from a tolerance shall be entitled to confidential treatme nt for reasons of busines s confidentiality and to exclusive use and data compensation to the same extent provided by section 3 and section 10 of [FIFRA]."

FIFRA section 3(c)(1)(F) provides certain protections for people who submit data to the EPA in connection with decisions under the EPA's pesticid e regulatory program. Speci fically, FIFRA section 3(c)(1)(F) confers "exclusive use" or "data compensation" rights on certain persons (" original data submitters") who submit data (in which they have an ow nership interest), in support of an application for registration, reregistration, or e xperimental use permit, or to ma intain an existing registration.

Applicants who cite qualifying data previously submitte d to the agency by the original data submitter must certify that the original data submitter has grante d permission to the applicant to cite data or that the applicant has made an offer of compensation to the original data s ubmitter. In the case of "exclusive use" data, the applicant must obtain the permission of the original data submitter and certify to the agency that the applicant has obtained written author ization from the original data submitter. (Data are generally entitled to "exclusive use" for 10 years after the date of the initial registration of a pesticide product containing a new active ingredient.) If data ar e not subject to exclusive use but are compensable, an applicant may cite the data without the permissi on of the original data submitter, so long as the applicant offers to pay compensati on for the right to rely on the data. (Data are "compensable" for 15 years after the date on which the data were originally submitted.) If an appli cant and an original data submitter cannot agree on the appropriate amount of compensation, either may initiate binding arbitration to reach a determination. If an applicant fa ils to comply with either the statutory requirements or the provisions of a compensati on agreement or an arbitration deci sion, the application or registration is subject to denial or ca ncellation. [See also 7 U.S.C. 136a (c)(1)(F)(ii)–(iii)].

FIFRA section 3(c)(2)(B) provides that "...[i]f the Ad ministrator determines that additional data are required to maintain in effect an existing registrati on of a pesticide, the Administrator shall notify all existing registrants of the pesticide to which the determination relates and provide a list of such registrants to any interested pers on." [7 U.S.C. 136a(c)(2)(B)]. Con tinued registration of a pesticide requires that its use not result in "unreasonable adverse effects on the en vironment" [defined as "(1) any unreasonable risk to man or the environment, taking into account the economic, social, and

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Page 5 of 44 environmental cost and benefits of the use of any pe sticide, or (2) a human dietary risk from residues that results from a use of a pestic ide in or on any food inconsistent wi th the standard under section 408 of the [FFDCA]." [7 U.S.C. 136(bb)].

FIFRA section 3(c)(2)(B) contains a mechanism by wh ich recipients of notices of data requirements (referred to as "Data Call-In notic es" or "DCI notices") may jointly develop data and provides that "[a]ny registrant who offers to share in the cost of producing the data shall be entitled to examine and rely upon such data in support of ma intenance of such registration." Th e section establishes procedures to allow registrants who received DCI notices to use binding arbitrati on to resolve disputes about each person's fair share of the testing costs.

Further, FIFRA section 3(c)(1)(F) makes clear that data submitted under FIFRA section 3(c)(2)(B) are also "compensable" when cited in su pport of an application for a regist ration. In other words, a pesticide company that chooses to rely on such data rather than develop its own data must offer compensation to the original data submitter – usually the data genera tor. Lastly, the agency may suspend the registration of a pesticide if the registrant fails to take appropr iate steps to provide data required under a DCI notice in a timely manner.

Finally, FIFRA section 3(c)(2)(D) cont ains a provision, referred to as th e "formulator's exemption" that is intended to simplify and promote equity in th e implementation of the data compensation program under FIFRA section 3(c)(1)(F). This exemption reli eves an applicant of th e obligation to submit a study, or to cite and obtain pe rmission or offer to pay data compensa tion to cite the resu lts of a study if the study is relevant to the safety assessment of a registered product th at the applicant buys from another entity and uses to make the applicant's product. Congr ess' rationale for this ex emption is that the seller will recover any data generation costs through the purch ase price of its product. Thus, if a pesticide formulator applies to register a pr oduct containing an active ingredient that the formulator purchased from the basic manufacturer of the active ingredient, the formulator does not need to submit or cite and offer to pay compensation for any data specifically relevant to the purchased product. The agency has extended the principles of the formulator's ex emption to data require ments under FIFRA section 3(c)(2)(B). Consequently, if the fo rmulator received a DCI notice requi ring data on the active ingredient, the formulator could comply by providing documenta tion that it bought the active ingredient from another registrant.

In addition, section 1457 of SDWA provides the EPA with discretionary authority to require testing, under the FFDCA section 408(p) screening program, "of any other substances that may be found in sources of drinking water if the Ad ministrator determines that a s ubstantial population may be exposed to such substance." [42 U.S.C. 300j–17].


### 2(b) Use/Users of the Data

In general, the EPA intends to use the data coll ected under the EDSP, along w ith other information, to determine if the chemical may pose a risk to human health or the environment due to disruption of the endocrine system. 5 The determination that a chemical does or is not likely to ha ve the potential to interact with the endocrine system ( i.e. , disruption of the estrogen, a ndrogen, or thyroid hormone

5 To access an overview of the endocrine system go to http://www.epa.gov/endo/pubs/ edspoverview/primer.htm

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Page 6 of 44 systems) will be made on a weight-of-evidence basis taking into account data from the Tier 1 assays and/or other scientifically relevant information. The fact that a subs tance may interact with a hormone system, however, does not mean that when the substan ce is used, it will cause a dverse effects in humans or ecological systems.

Subsequently, when used w ith the Tier 2 testing data 6 and other available information, 7 the Tier 1 screening data obtained through this information collection activity will be used by the EPA and others as part of the hazard characterizat ion of a chemical that is regu lated by FIFRA, FFDCA, TSCA and SDWA.

More specifically, the data coll ected under Tier 1 will allow the ag ency to evaluate the potential interaction of a chemical with the endocrine system . The EPA has extensive experience in using data from multiple sources to develop integrated assess ments of hazard, modes of action / mechanisms of toxicity, and overall potential for risk. EPA scientists will continue to use such experience to address the potential of chemicals to cause a dverse effects as a consequence of interaction with the endocrine system. In fact, the EPA has considered the potential interaction of a chemical with the endocrine system in making certain pesticide registration decisions . For example, the EPA considered data from prototypes of the assays included in the current EDSP Tier 1 screen, along with other existing data, in preparing the risk assessments of procymidone 8 and vinclozolin. 9

The agency intends to take a wei ght-of-evidence approach to evaluate the available Tier 1 data for a particular chemical to determine its potential to interact with the endocrine system, and if so, whether additional data are needed. Chemicals that go th rough Tier 1 screening an d are found to have the potential to interact with the estrogen, androgen, or thyroid hormone systems will proceed to the next stage of the EDSP where the EPA w ill determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testi ng is designed to identify any adve rse endocrine-related effects caused by the substance, and establish a qua ntitative relationship between the do se and that endocrine effect for risk assessment.

In addition to helping determine whether Tier 2 testing is necessary for a particul ar substance, the Tier 1 screening data may also be used to determine what kind of Tier 2 data are a ppropriate, and whether or not similar substances might share common mechanis ms. Subsequently, Tier 1 screening data may be used to qualitatively character ize the risk of pesticides.

The tiered approach for screening (T ier 1) and testing (Tier 2) that the EPA is using under the EDSP is the most cost-effective and least burdensome approach for complying with the statutory mandate to screen all pesticides in th e initial list of chemicals for endocrine disruptor effects. Instead of requiring that all pesticides undergo the tes ting that would be necessary to de termine (a) whether the substance causes adverse endocrine-related effect s, (b) identify the adverse endoc rine-related effects caused by the substance, and (c) establish a qua ntitative relationship between th e dose and the adverse endocrinerelated effect, the EPA determined that it would be more efficient (and would use fewer animals) to

6 The collection of Tier 2 data is not part of this information collection activity.
7 This refers to other information that is available to EPA at the time of its analysis, including information that is not cover ed by this ICR.
8 To access the procymidone decision, go to http://www.epa.gov/pesticides/reregistration/procymidone/

. 9 To access the vinclozolin decision, go to http://www.epa.gov/pesticides/r eregistration/vinclozolin/

.October 25, 2012

conduct the less expensive and less comp lex Tier 1 screening to identify those substances that have the potential to interact with the estrogen, androgen and thyroid hormone systems.

The paperwork related requirements imposed on the re spondents as part of Ti er 1 screening under the EDSP allow the EPA to ensure that the identified scr eening data will be developed, that the results will meet basic scientific standards, th at unforeseen complications or issu es can be promptly addressed, and that the screening is progressing on schedule so that the data will be available for consideration in time for anticipated regulatory decisions as required under FIFRA and FFDCA.

Within the Office of Chemical Safety and Pollu tion Prevention (OCSPP), the Office or Pollution Prevention and Toxics (OPPT), the Office of Pesticide Programs (OPP), and the Office of Science Coordination and Policy (OSCP) will be responsible fo r the EPA activities related to the issuance of the orders, receiving, processing and maintaining record s of responses to the or ders, as well as other administrative functions related to th e orders. The review of Tier 1 sc reening data received and resulting determinations related to the subject chemical will be based on a coordinated EPA effort that will also include other EPA offices, e.g. , Office of Research and Development (ORD), etc.

As indicated previously, this ICR onl y applies to Tier 1 screening for the initial list of EDSP chemicals. A subsequent ICR will address Tier 2 testing. Tier 2 is discussed here only in the context of the use of the Tier 1 data coll ected under this ICR.


### 3. Non-Duplication, Consultation , and Other Collection Criteria
3(a) Non-duplication

The information collected under this program is collect ed by no other federal agen cy or any other office within the EPA. FFDCA specifically assigns this task to the EPA. The EDSP is the only program in the United States mandated to validate assays and require testing of chemicals for th eir potential to disrupt the endocrine system. Prior to the enactment of FFDCA section 408(p) and initiation of EDSP, there were no validated methods to screen or test chemical s for their potential to aff ect the endocrine system.

In addition, the agency has a strong commitment to a voiding potential duplicati on in all of its testing programs, as well as in its implementation of the EDSP. The EPA also actively promotes efficiency through its harmonized test guidelines and active particip ation in the rigorous scien tific effort to identify data needs for risk assessments, develop testi ng protocols, and develop new methods for testing chemicals that minimize potential duplication, create greater efficien cies in testing, and minimize the use of animals in testing.

As a charter member of the Interagency Coordi nating Committee on the Validation of Alternative Methods (ICCVAM), the EPA is working in a manne r consistent with the interagency validation framework in the development and refinement of a ssays to reduce animal use, refine procedures involving animals to make them less stressful, and repl ace the use of animals in tests where scientifically appropriate. The EPA is using valida ted methods or assays to identi fy and characterize the endocrine activity of pesticides and inert ingredients specifical ly in relation to estrog en, androgen, and thyroid hormones.

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The agency considered these goals in developing the procedures for the ED SP, both those procedures used within the EPA and those that might be used by the respondents. For example, when a chemical is manufactured by several companies, the procedures en courage the companies to join together to develop and submit the requested data to the EPA. In addition, order recipients and other interested stakeholders may cite existing or submit other scientifically rele vant data that they believe meet the screening requirements defined in the order. This is describe d in more detail in the policies and procedures document (Attachment B).


### 3(b) Consultations

In addition to the notice and comment requirement, the EPA is required under 5 CFR 1320.8(d)(1) to consult with potential respondents and data users about specific aspects of an ICR before submitting it to OMB for review and approval, regardless of whethe r changes have or have not been made to the collection activity. The EPA identified eight entities based on previous intera ctions related to the existing ICR and consulted with them about the in formation collection activ ities and related burden estimates provided in the public revi ew draft for this ICR. The details of that consultation, including specific information about the entities, questions posed, and responses received, is provided in Attachment H of this document. The following is a summary of the consu ltation and the agency’s
response.
Publicly Available Data : Most respondents indicat ed that the submission of "other scientifically relevant information" (OSRI) was expensive and time consuming. It was stated that the agency was too strict in its review of the OS RI. Respondents stated that by not accepting OSRI, portions of the EDSP Tier 1 battery were duplicative.

Frequency of Collection : Most participants responde d that the frequency of th e data collection was fine given the fact that Tier 1 EDSP or ders would only be issued "once" per chemical (except in rare situations). One consultation partic ipant noted the lack of practical utility for the one-year progress report that is required of order recipients to be submitted to the EPA.

Clarity of Instructions : All respondents indicate d that instructions could be improved in terms of clarity. However, most respondents indicated that the forms that needed to be submitted were clear and easy to understand.

Electronic Reporting and Record Keeping : All respondents encouraged th e EPA to move to electronic reporting and record keeping as quickly as possible.

Burden and Costs : All respondents felt that the costs associ ated with the EDSP Tier 1 Battery were underestimated. Most respondents also felt that the EPA could do a better job explaining exactly how the ICR is calculated and where specific figures ar e "pulled" from. CropLife America stated that they felt the current cost estimate for the EDSP Tier 1 Batte ry is 15% lower than "rea l world" costs. CropLife America also indicated that the labor categories (curre ntly managerial, technical, and clerical) should be expanded to include legal a nd consultant categories.

EPA Response to Consultation Feedback : Because of the similarity in comments received during the consultation process and the public comment period and the general overlap of participants, please refer to the section 3(c) of this document.

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### 3(c) Public Notice Required Pr ior to ICR Submission to OMB

The EPA received four responses to the 60-day p ublic notice and comment period for the draft ICR renewal (77 FR 47640, August 9, 2012):

Commenter# (1) DCN (2) Commenter Name (3) Affiliate 1 EPA-HQ-OPPT2011-0966-0012 Bayer CropScience Endocrine Drive Team Bayer CropScience LP

2 EPA-HQ-OPPT2011-0966-0013 Clare Thorpe, Senior Director Human Health Policy CropLife America (CLA) and Endocrine Policy Forum (EPF) 3 EPA-HQ-OPPT2011-0966-0014 Scott Slaughter Center for Regulatory E ffectiveness (CRE) 4 EPA-HQ-OPPT2011-0966-0015 Patricia L. Bishop, Research Associate, Regulatory Testing Division and Kristie Sullivan, Director, Regulatory Testing Issues People for the Ethical Treatment of Animals (PETA) and Physicians Committee for Responsible Medicine (PCRM) Key: (1) This is the number that is used in this document to refer to this particular commenter. (2) This is the number that is used to identify this comment in the docket at http://www.regulations.gov

, (3) This is the name of the individual or entity that subm itted the comments, along with their affiliation, if provided.
A complete Response to Public Comments Document is in Attachment I, and is also in the docket at http://www.regulations.gov under Docket ID number EPA-HQ-OPPT-2011-0966.


### 3(d) Effects of Less Frequent Collection

Once per chemical substance is the statutory mini mum, because FFDCA sect ion 408(p)(3) specifically requires that the EPA "shall provide for the testing of all pesticide chemicals," unless the agency can determine that the chemical qualif ies for the statutory exemption— i.e. , that it is not anticipated to interact with the endocrine system.

In addition, a recipient of an order for Tier 1 screening may provide an initial response that could justify delaying Tier 1 screening or, although expected to be rare for the initi al group of chemicals, allowing the company to go directly to Tier 2. The agency will consider any such reque sts on a case-by-case or chemical-by-chemical basis and will provide a written response that will be made publicly available. In some cases, the agency's response to an individual reque ster may be applicable to all order recipients for that chemical or could otherwise provide insight to recipients of orders for other chemicals.

For purposes of this ICR, the agency assumes that a ll recipients of an order for Tier 1 screening will provide an initial response and either generate the data or join a cons ortium to generate the data, while the submission of a progress report and the data will occur only once per chemical. For the purposes of this ICR renewal, the agency assumes that the only additional new work will be that associated with the issuance of new "catch-up" orders.


### 3(e) General PRA Guidelines

The one general PRA guideline that is exceeded by this collection is the time period for retaining records. When data are generated to support a pes ticide registration under FIFR A, the EPA requirements in 40 CFR 169.2(k) apply, which stat e that records containing research data relating to registered

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pesticides be retained for as long as the registra tion is valid and the producer remains in business. Registrations are valid until they are either voluntari ly cancelled or withdrawn by the registrant or until the EPA has cause to suspend or cancel the registra tion. Since the average peri od of marketability of a pesticide ranges from 15 to 30 years, the PRA guidelin es specifying that data other than health, medical or tax records not be required to be retained for mo re than three years will be exceeded in this ICR.

In those regulatory cases where the agency's action ma y be challenged, it is imperative that all records, raw data, and specimens be available. Recognizing this, the recordkeeping requirements in 40 CFR part 169 were authorized to exceed the PRA general guidelines when they were established. Those requirements are being adopted unchanged under th e EDSP for these chemicals because the data submitted would be used to support pesticide regi stration related decisions under FIFRA and FFDCA.

It is important to note that the same record re tention requirements do not apply to non-pesticides.


### 3(f) Confidentiality

In general, most health and safety data submitte d by registrants, manufacturers, and importers under FFDCA are considered to contain no Confiden tial Business Information (CBI). Although FFDCA section 408(p)(5)(B) requires that the EPA devel op, to the extent practicable and as necessary, procedures for the handling of conf idential business information, it does not provide the authority for the agency to either create new rights or to modify existing rights to confidentiality. Rather, the EPA believes that this provision directs the agency to create procedures that operate within the existing confines of FIFRA section 10, the Freedom of Info rmation Act (FOIA), and the Trade Secrets Act.

As discussed in more detail in the policies and pr ocedures document (Attachment B), because the data would support a tolerance or exemption from the re quirement of a toleran ce, FFDCA section 408(i) provides that much of the data submitted in response to an order issued under FFDCA section 408(p) would be subject to the protec tions in FIFRA section 10. In a ddition, CBI submitted by pesticide registrants in response to an orde r issued under FFDCA section 408(p) w ould be considered as part of the registration process, and would therefore be considered to be data submitted in support of a registration. However covered, data subject to FIFRA section 10 would be provided certain protections that go beyond those authorized by FOIA. For exampl e, FIFRA section 10(g) generally prohibits the EPA from releasing information submitted by a registrant under FIFRA to a foreign or multinational pesticide producer, and requires the ag ency to obtain an affirmation from all persons seeking access to such information that they will not disclose the information to a foreign or multinational producer. FFDCA section 408(i) extends the protection availa ble under FIFRA section 10 for data submitted in support of a tolerance or tolerance exemption.

All other confidential bu siness information submitted in respons e to an order issued under FFDCA section 408(p) ( i.e. , data not in support of a registration or tolerance/tolerance exemption) is only protected by the provisio ns of FOIA and the Trade Secret Ac t. FOIA requires agencies to make information available to the public upon request, ex cept for information that is "specifically made confidential by other statutes" or da ta that are "trade secrets and co mmercial or financial information obtained from a person and is privileged or confidentia l." [5 U.S.C. 552]. Note that substantive criteria must be met to claim confidentiality of bus iness information, as specified in 40 CFR 2.208.

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As indicated in the policies and procedures document (Attachment B), the EPA w ould consider that data submitted jointly with a registrant, or as part of a cons ortium in which pesticide registrants participate, to be data submitted in support of a tolerance/tolerance exemption or registration, and therefore entitled to protection under FIFRA section 10. Howe ver, if a non-registrant chooses not to partner with a registrant, such data would only be subject to the protections available under FOIA and the Trade Secrets Act.


### 3(g) Sensitive Questions

No information of a sensitive or private nature is requested in conjunction with this information collection activity. Further, this information collec tion activity complies with the provisions of the Privacy Act of 1974 and OMB Circular A-108.


### 4. The Respondents and the Information Requested
4(a) Respondents

Respondents to this ICR consist of those individuals and companies that receive an order issued under FFDCA section 408(p) by the agency to collect Ti er 1 screening data under the EDSP. Under FFDCA section 408(p)(5)(A), the EPA "shall issue" orders "to a registrant of a substance fo r which testing is required... or to a person who manufactures or imports a substance for which testing is required" [emphasis added]. As such, the potential respondent universe as described in the existing ICR remains the same.

Identification of Order Recipients : The EPA generally identified the following categories of potential recipients of the Tier 1 orders:

• Pesticide Registrants - Entities who manufacture or import a pesticide active ingredient or inert ingredient and hold an active EPA registration for th at substance. In the pe sticide universe, there

are Technical Registrants (basic manufacturers) and End-Use Registrants (customers) . A Technical Registrant manufactures or imports the active ingred ient or inert ingredient that is, in most cases, used in the formulati on of other pesticide products. An End-Use Registrant manufactures or imports the end-use product that contains an active i ngredient or an inert ingredient that they ob tain from a technical registrant. Although the Technical Registrant can also be an End-Use Registrant , the agency's focus for purposes of the Tier 1 orders is on the Technical Registrant

.

• Manufacturers/Importer – Persons who manufacture or import a chemical substance but do NOT hold an EPA registration for that substance. For the most part, the chemical substances may be used as an inert ingredient in a pesticide, but also ha s other non-pesticidal uses.

The agency used the following North American I ndustrial Classification System (NAICS) codes to obtain publicly available informati on about potential responden ts that informed the estimates presented in this ICR:

• Chemical Manufacturers and Pr ocessors (NAICS code 325), e.g. , persons who manufacture, import or process chemical substances.

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• Pesticide, Fertilizer, and Other Agricultura l Chemical Manufacturi ng (NAICS code 3253), e.g. , persons who manufacture, import or process pesticid e, fertilizer and agricultural chemicals. This includes Producers and Formulators of Pestic ide Products (NAICS code 32532); Producers of Antifouling Paints (NAICS code 32551); Producers of Antimicrobial Pesticides (NAICS code 32561); and Producers of Nitrogen Stabilizers (NAICS code 32531).

• Scientific research and developm ent services (NAICS code 5417), e.g. , persons who conduct testing of chemical substances for endocrine e ffects. These entities will not receive orders, but their potential involvement in responding to paperwork activiti es did inform the estimates presented in this ICR.

As stated earlier, for a duration of 15 years after th e issuance of the initia l orders in 2010, the EPA intends to issue a "catch-up" order to any comp any who subsequently enters the marketplace to manufacture or import the substance that was the subj ect of an EDSP order. Specifically, in addition to the order recipients identified by the agency, the EPA may issue an order under FFDCA section 408(p)(5) to a manufacturer or im porter who enters the marketplace af ter the issuance of the initial orders, i.e. , when they begin to sell an inert ingredient following the submission of required EDSP data on the ingredient by manufacturers or importers who were in the marketplace when the initial orders were issued. The agency refers to these as "catch -up" orders. As with the initial order issued under FFDCA section 408(p), recipients of a "catch-up" order could fulfill the testing requirement either by submitting the results of a new study or by citing the data submitted by another person. In furtherance of the goal of "fair and equitable shar ing of test costs," the agency w ould accept citation of existing data only if the recipient either had th e original data submitter's permission, or the recipient had made an appropriate offer to pay compensation to the original data submitter that also determined how disputes would be resolved.

Grouping Respondents by Information Collection (IC) Activities : The agency has divided the two identified respondent groups into the following di stinct information coll ection (IC) categories:

• Order Recipients

. This category includes everyone that c ould receive an EDSP order for one or more of the chemicals on the initial list, but has not already received an EDSP order.

• Data Generators/Submitters

. This category includes one company for each chemical because the EPA expects companies to work together to pr ovide the required data so that they do not duplicate efforts.

• Consortium Participants

. This category includes the order reci pients that are not in the Data Generators/Submitters category. These companies w ill actively participate in consortia activities, and includes the recipien t of a subsequent "catch -up" order that is exp ected to join the ongoing activities.

Calculating the Number of Respondents : To date, the EPA has already issued the initial Tier 1 EDSP orders for the 67 chemicals, and thos e order recipients have already prov ided their initial responses. This is specifically reflected in the estimated numbe r of respondents for the di fferent IC categories.

In terms of estimating the potential number of order recipients for purposes of estimating the burden in this ICR, the EPA is assuming the potential issuan ce of up to 20 additional orders each year (15 involving pesticide active i ngredients and 5 involving pesticide inert ingredient s). Based on the agency's experience with "catch-up" orders to date, this appears to be a reas onable approach for estimating the

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number of potential catch-up orders. The EPA also assu mes that all "catch-up" or der recipients will join an existing data generator ( i.e. , a consortium).

In terms of estimating the potential number of data generators/submitters for purposes of estimating the burden in this ICR, the EPA assumed that ther e would be one for each of the 67 chemicals. The EDSP process is longer than three year s, the term of an ICR. All of the orders have been issued, with the exception of catch-up orders. Theref ore, for this ICR, the agency knows that Tier 1 data are being generated only once for each of th e 52 chemicals of the original 67. Of the 52 remaining chemicals, 22 are supported by a single respondent, while a group of respondents that have formed a consortia for 30 chemicals. The orders for the remaining 15 chemicals were satisfied through cancel lation in the case of (8) pesticides and withdrawn as a pesticidal inert for the 7 remaining (formerly) inert chemicals.

In terms of estimating the potential number of consortium participants for purposes of estimating the burden in this ICR, the EPA assumed that the recipients of a ca tch-up order would join the ongoing consortium. Based on the initial re sponses received already, there ar e 30 consortia currently underway that include a total of 213 participants.

Table 1 presents the estimated number of respondents for each IC category, which is used subsequently as a multiplier for the per response burden in order to calculate the total annual burdens.

Table 1 – Estimated Number of Potential Respondents

IC # IC Category Name Estimated Number of Respondents 1. Order Recipients 60 1(a). – Registrants 0 Catch-Up Orders 45 1(b). – Manufacturers/Importers 0 Catch-Up Orders 15 2. Data Generators/Submitters 52 2(a). – Registrants 50 Catch-Up Orders 0 2(b). – Manufacturers/Importers 2 Catch-Up Orders 0 3. Consortium Participants 273 3(a). – Registrants 207 Catch-Up Orders 45 3(b). – Manufacturers/Importers 6 Catch-Up Orders 15 Total Respondents 385 

### 4(b) Respondent Activities

Respondent activities vary based on the IC category and the res pondent group. Although identified under the applicable IC cate gory, the activities are numb ered sequentially to allo w for cross-referencing.

IC #1: Order Recipients:

In general, these respondents will receive individual orders that are prepared by the EPA using the order templates identified in Attachment C(1), entitled " FFDCA 408(p) Order Template for Pesticide Registrants (As of September 16, 2009) " or in Attachment C(2), entitled " FFDCA 408(p) Order

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Template for Pesticide Inert Ingr edients (As of September 16, 2009) ." The order will specify the data that must be submitted ( i.e. , based on the eleven Tier 1 assays as discussed later in this section), and outline the timeframes for responding to the order, in cluding providing an initial response, annual status reports, if applicable, and for submitti ng the data responsive to the order.

The order will direct the recipient to provide an initi al response within 90 days of receiving the order using the currently approved form iden tified as EPA Form No. 6300-05, entitled " FFDCA section 408(p) Order/FIFRA section (3)(c)(2)(B ) Data Call-In (DCI) - Initial Response Form for Individual Order Recipients ," in attachment D(1). The EPA will continue to include a copy of this form in the order packet sent to the recipient, a nd will continue to pr e-populate it with the basi c information about the recipient, the chemical covered, a nd the applicable test data sought.

Since the agency assumes that ther e is already an existing consortium, it is also assumed that the consortium has already provided an initial response using the currently approve d form identified as EPA Form No. 6300-05-C, entitled " FFDCA section 408(p) Order/FIFRA se ction (3)(c)(2)(B) Data Call-In (DCI) - Initial Response Form for Consortium/ Task Force ," in attachment D(2).

At this stage of the program, as discussed previously in section 4(a), those entities previously identified as respondents have already received the order, so the respondents for this IC category are now only those that will receive a catch-up order, i.e. , order recipients. Nevertheless, the activities for these respondents remain the same. Specifically, these res pondents will engage in the activities identified and described later in this sec tion as items (1) through (5).

IC #2: Data Generators/Submitters:

In general, the order recipients th at are included in this IC categor y are those respondents that have indicated an intention to generate and submit the da ta requested, either indivi dually or on behalf of a consortium. As such, these respondents will engage in the activities identified and described later in this section as items (4) through (9).

IC #3: Consortium Participants:

In general, the order recipients th at are included in this IC categor y are those respondents that will actively participate in consortia activities, and incl udes recipients of a subsequent "catch-up" order because they are expected to join the ongoing activities. These responde nts will be a participant in, but not fully responsible for, the activitie s identified and described later in this section as items (4) and (6), as well as maintain records related to their partic ipant and compliance with the order as described in item (9).

Overview of Covered Activities:

Each recipient of an order (aka re spondent) is expected to engage in the following information collection related activities:

(1) Read instructions – Each recipient will read the order to understand what they must do to comply with the order, what deadlines are associated with those activities and the details of how and who to respond to. Depending on the recipient's familiarity wi th the EDSP, the recipient may also read other information about the EDSP, such as the policies and procedures document (Attachment B) that

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explain the agency's rationale for the requirement s in the order and which describes the specific details of the policies and procedur es that the EPA generally intends to adopt for initial screening under the EDSP, including the statutory requirements asso ciated with and format of the orders issued under FFDCA section 408(p), as well as the EPA's pro cedures for fair and equ itable sharing of test costs and handling confidential data.

To illustrate what an order recipient might expect to receive in terms of an order under the EDSP, the agency has developed order templates for the tw o different kinds of poten tial order recipients:

• An Order Template for Pesticide Registrants, entitled " FFDCA 408(p) Order Template for Pesticide Registrants (As of September 16, 2009) ." Attachment C(1).

• An Order Template for Pesticide Inert Chemicals, entitled " FFDCA 408(p) Order Template for Pesticide Inert Ingredient s (As of September 16, 2009). " Attachment C(2).

Although the agency generally intends to use these te mplates, the individual orders will contain the necessary recipient specific deta ils and requirements for the subject chemical. As such, the final individual orders that a recipient might receive may vary from th ese templates, as well as from other orders issued for a chemical.

(2) Plan activities – After reading the Tier 1 order they rece ived, the recipient w ill plan the activities necessary to comply with the order base d on their intended res ponse to the order.

(3) Submit an initial response to the EPA – The Tier 1 orders will dire ct each recipient to provide an initial response to the EPA within 90 calendar days of issu ance of the order that indicates how they intend to comply with the order. The response options available to the recipient will vary depending on whether the subject chemical is a pesticide acti ve ingredient or pesticide inert chemical. The various response options available to a recipient, al ong with the related additiona l activities that they may engage in specific for that response option are described in section 4(c)(i) of this ICR.

To simplify completion of this initial respons e within the 90 days, the EPA has created an Initial Response Form for Individual Order Recipients [see Attachment D(1)]. The EPA intends to include this form in the order packet, pre-populated with the basic info rmation about the recipient, the chemical covered, and the applicable test data sought. The recipient will complete the form by checking the appropriate boxes to in dicate their intentions with rega rd to each assay listed in the order, and, if applicable, attach appropriate documentation to provi de a rationale and/or supporting documentation for their response. The response form allows for assay specific responses to provide maximum flexibility to the recipients who may wi sh to choose different response options for the individual assays identified in the order. An order recipient may elec t any of the response options for one or more of the assays in the order, and is not limited to electing a singl e response for all assays, nor are they required to elect di fferent options for each assay. For simplicity, however, the response form is structured so that recipi ents indicate their responses on an assay-by-assay basis – even if the response is the same for more than one of the assa ys. For example, the recipient may submit or cite existing data to address one or more assay, indicate that they will generate the data for one or more assay, and/or indicate that the intend to form or join a consortia to provide the data for one or more of the other assays identified in the order. OSRI may also be submitted for consideration in satisfying all of the assays in th e order, the initial response form includes a separate line item to indicate whether OSRI is being cited or submitted to address either (A) a particular assay ( i.e. , in

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Page 16 of 44 part 2.1.C. of the form), or (B) to satisfy the order as a whole ( i.e. , in part 2.2. of the form). The response option involving the submission of OSRI is described in section 4(c)(i) of this ICR.

If the recipient intends to form or join a consorti um (or task force) with other manufacturers of the chemical to provide the data for one or more of the assays identif ied in the order, each consortium participant or potential particip ant is expected to submit an Initial Response Form for Individual Order Recipients [Attachment D(1)] within 90 calendar days. Within 150 calendar days of issuance of the order, or as part of their initial response, the desi gnated lead for the consortium is expected to submit the Initial Response Form for Consortium /Task Force [Attachment D(2) ] to provide the primary contact for the task force or consortium, the list of participan ts, and an indication of the task force or consortium's planned response for each assay, along with documenta tion of its formation (such as a copy of the jo int agreement or a written statement by all the parties th at 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 th e mechanism to resolve the terms.

In the context of this renewal ICR, the respondents in the IC category for or der recipients are only expected to submit an individual response form, because the EPA is assuming that the recipients of catch-up orders will join an ongoi ng consortium, rather than form a new one or generate data.

(4) Read and discuss the protocol – The order recipients will need to read the protocols for the assays identified in the order and may have questions or may need to modify one or more of the protocols for the subject chemical. An order recipient wishi ng to deviate from any of the protocols identified in the order, may do so only after consultation w ith the EPA. Such requests should be submitted to the EPA with a clear rationale and explanation of the deviation. All protocol variations will be reviewed by the EPA and a response will be sent to the specific order recipient in a timely fashion. These procedures are consistent with current EPA practices regarding pestic ide test guidelines and the data requirements in 40 CFR parts 158 and 161. Although this activity is expected to be primarily performed by the data generating entity , other participants in a consortium may also participate in these discussions.

If the order recipient chooses to submit or cite ex isting data, including other scientifically relevant information, this discussion would be focused on wh ether the data provided or cited follows an accepted scientific methodology or protocol, includi ng but not limited to those presented in the EPA's harmonized test guideline compendium. 10 Such recipients will be expected to provide a cogent and complete rationale for why they believe th e information is sufficient to satisfy part or all of the order. The EPA's decisions about whether the information satisf ies part or all of the Tier 1 order will be based on the weight-o f-evidence from all relevant info rmation available to the agency.

In addition, the order recipient is expected to comply with th e agency's good laboratory practice (GLP) standards described in 40 CFR part 160, whic h require entities to fo llow certain practices when conducting studies, and, with the submission of data to the EPA, to provide a GLP compliance statement indicating: a) that th e data were generated using GLPs; or b) describe in detail "all differences" between the GLPs and the practices us ed; or c) confirm that you did not sponsor or

10 http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm

.October 25, 2012

conduct the study and do not therefore know whethe r the study was conducted in accordance with the GLPs.

(5) Generate the data – As indicated by the initial response, some recipients will conduct the research or administer the tests to generate the data requested in the order. For purposes of this renewal ICR, however, recipients of the catch-up order are not exp ected to engage in such activities because they are expected to join with whoever has already committed to do this.

For the purposes of calculating paperwork burden hours and costs in this ICR, the EPA assumed that the data generation will be perfor med by a contract laboratory at th e request of an individual order recipient or a consortium. The agency has no information upon which to estimate how many recipients might use a contract la boratory and how many might genera te the data in house. Assuming that data will always be generate d by a contract laboratory is consis tent with the assumption used in other ICRs that involve data ge neration. In addition, as indicate d by industry, many companies now outsource toxicology testing becaus e it is less expensive than main taining that function in-house (Reference 8, p. 5.). Nevertheless, only those act ivities imposed by the information collection request are attributable to this I CR. For example, the time and cost s for the contract laboratory staff to travel to meet with the c ontracting company is not an acti vity imposed by the information collection request and is therefore not attributable to the ICR. Nor are any cost s or burden related to mistakes made by the contract laboratory, such as failure to properly follow an applicable protocol, which then requires the contract laboratory to redo the study.

(6) Report progress, compile and review the data – Unless the EPA has notified a recipient in writing that the requirements of the order have been satisfied, the order recipient will be expected to submit a progress report to the EPA within 12 months after the issuance of the order. The progress report should provide a brief description of the status of the planned activities for each assay, and, if applicable, a description of any problems encount ered or expected difficulties in meeting the schedule for complying with the order. Compiling a nd reviewing the data can include such activities such as Data Entry Spreadsheet Templates (DES Ts). DESTs for the EDSP Tier 1 Battery can be found at http://www.epa.gov/endo/pubs/toresources/seps.htm#dests

. (7) Complete paperwork to asse mble the submission package – Those order recipien ts that generate the data or serve as the consortium lead will be ex pected to compile the data results from having performed the applicable assay(s), review the da ta for completeness and compliance with GLPs, and assemble the submission package in accordance with the instructions provid ed in the order. In general, these are the same submission procedures as those that are currently used for submitting other data in support of a pestic ide registration, with only a few m odifications – such as the mailing address.

(8) Submit final data to the EPA – The final data package is then submitted to the EPA following the specific instructions provided in the order, which will also specify the due date for final compliance with the order's request for data. Although the order sp ecifies a final due date for submission of all of the data specified in the order, an order recipient may either submit th e data for each individual assay as it is completed, or submit the data from all of th e assays at one time. The order recipient may also submit the data before the due date specified in the order.

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(9) Maintain records – Recipients will be asked to maintain a record of their initial response for three (3) years. Recipients who submit data in support of a pesticide registration will also be asked to maintain records of that da ta pursuant to 40 CFR 169.2(k), i.e. , containing research data relating to a registered pesticide for as long as the registration is valid and the producer remains in business.

Distribution of Activities by Labor Categories:

For purposes of estimating the poten tial respondent paperwork burden an d costs associated with these activities, the agency identified three separate la bor categories: 1) managerial; 2) technical; and 3) clerical. Each activity identifi ed above may involve one or more labor or duty category. In Table 2, the agency identifies the assumed recipient activities divided betw een the three labor categories.

Table 2 – Expected Respondent Activities by Labor Categories Activity Managerial Duties Technical Duties Clerical Duties (1) Read the EPA's policies and procedures document Read the EPA's policies and procedures document Review the EDSP order Review the EDSP order (2) Identify timeframe for response Identify and evaluate response options Evaluate response options Plan activities Negotiate/establish consortium/ task force agreements Participate in consortium/ task force discussions (3) Determine response Recommend a response Oversee employee activities Complete response form Sign initial response forms Send to the EPA (4) Communicate with the EPA Review of protocol (deviations) Arrange logistics for calls or meetings with the EPA Review GLPs (deviations) Identify and discuss other scientifically relevant information and related protocol &/or GLP deviations (5) Plan/oversee employee and contract activities Plan the data collection activities using the approved protocols Secure contract lab services and approve statement of work (SOW) Conduct the tests, using protocols and GLPs Communicate with the EPA, as appropriate Maintain records and procedures during testing period in accordance with the GLPs Assist in preparing files

(6) Review final report(s) Compile and review data Prepare final data reports (7) Approve final submission package Draft summary of the data for cover letter Prepare final submission package Review final submission package (8) Approve/sign submission Send submission to the EPA (9) Prepare data for files Prepare final file folders Maintain records 

### 4(c) Information Requested

This section of the ICR renewal desc ribes the information that an order recipient is exp ected to provide the agency. The order will identify the Tier 1 da ta being requested and will provide the specific instructions for complying with the order. In general, all order recipi ents are expected to provide an

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individual initial response that identifies how the recipient intends to respond to the order. The specific information required to be provided with the indi vidual initial response from each order recipient will vary based on the respondent's initial response – th e options for which are described in the order, the applicable procedure documents, and are summarized in section 4(c)(i) of this ICR. Those recipients that generate data, either individually or as part of a consortium, are expected to provide a 1-year progress report, and then submit the data to the EPA.

For purposes of this ICR, it is important to note that many of the initial re sponse options adopted for EDSP already exist within the pesticide program, e.g. , for Data Call-Ins under FIFRA 3(c)(2)(B). In providing the option as described in more detail in the policies a nd procedures document (Attachment B), the agency adopted the existing procedures un changed for use under the EDSP. Under those existing procedures, a registrant may engage in additional activitie s associated with that response option. For example, a respondent/registrant could choose to reformulate the product or seek a formulator's exemption. Both of these initia l response options involve estab lished procedures, and additional activities that are already approved by OMB under se parate existing ICRs. The agency believes that any additional use of those existing procedures relate d to the EDSP do not impact the estimated burden covered by those other existing ICRs. As such, this ICR does not duplicate the burden associated with the response options that involve existing procedures that are already covered by another ICR.

4(c)(i) Order Recipient's Response Options

The recipient of an order will have several potential re sponse options, as specified within the order itself. The recipient uses the Initial Response Form for Individual Order Recipients [see Attachment D(1)] to indicate which option they intend to use to respond to the data reque st for each assay. The response is assay specific to provide maximu m flexibility to the recipients who may wish to choose different response options for the individual as says identified in the order. An order recipient may elect any of these options for one or more of the assays in the order, and is not limited to electing a single response for all assays, nor are they required to elect differe nt options for each assay. The order recipient would complete the form by checking the a ppropriate boxes to indicate their intentions with regard to each assay listed in the order, and, if applicable, attach appropriate doc umentation to provide a rationale and/or supporting documentation for their response.

The following provides a brief overview of the availa ble response options for or ders involving pesticide active ingredients and pesticide inert ingredients (see also Attachment E, which provides an overview of the response options in a workflow format).

(1) I Will Generate New Data . The recipient would choose this opti on to indicate that they agree to individually generate new data fo r each test specified to meet the requirements of the order.

In the case of data pertaining to an inert ingredient for which ther e is no tolerance or exemption, the recipient may identify a "cooperatin g registrant/agent" for the EPA ( e.g. , to whom the EPA could send a DCI notice under FIFRA section 3(c)(2)(B) or identify on the recipien t list). The cooperating registrant/agent would then become jointly responsible for generating and submitting the data. This is different from a consortium, which is discussed later.

(2) I Am Citing or Submitting Existing Data . The recipient would choose th is option to submit or cite existing data (including other relevant scientific information) that they believe can be used to satisfy

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part or all of the Tier 1 order. Existing data may be of several types. An example may be an in vitro assay for transcriptional activation that is conducted with a different cell line and by a different protocol. But more generally, existing data may be "other scientifically rele vant information." Other scientifically relevant information can include data from studies other than the EDSP Tier 1 assays,
e.g. , studies conducted to satisfy a 40 CFR part 158 or part 161 data requirement, data from other studies conducted to address an id entified issue, or data from studies found in the scientific literature. In addition to the Tier 1 order recipient, anyone can subm it other scientific ally relevant information. To allow the EPA to review the submi ssion of other scientifica lly relevant information in a timely fashion, the submitter of the informati on should consider providing a scientifically sound rationale that explains how the s ubmitted or cited data provides th e information needed to satisfy part or all of the Tier 1 orde r and/or otherwise inform the agency's Tier 1 determination.

When citing something that was previously submitted, the agency needs a copy of the title page along with the identification number of the study c ited (MRID number), and, if the study has been reviewed by the agency, the agency's classification of the study. The agency specifically asks that a study that has previously been submitted to the EPA NOT be resubmitted in its entirety.

If the individual citing a study is no t the original data submitter, th at individual may need to submit an offer to pay compensation to the original da ta submitter. Consequently, such individuals are encouraged to simultaneously include an offer to pay [in accordance with 40 CFR 152.93] [which includes an offer to resolve any dispute over the reci pients' shares of the test costs by submitting the dispute to a neutral third party wi th authority to bind the parties ( e.g. , through binding ar bitration or through a state or federal court action)], unless the individual ha s received confirmation from the EPA that no such compensation is necessary.

The EPA will review any existing study submitted or cited in response to the order to determine whether the study is of sufficient qua lity and can be used to satisfy the order. The agency intends to notify submitters in writing of its determinati on, as well as make the determination publicly available.

(3) I Will Enter (or Offer to Enter) Into an Agreem ent to Form a Consortium to Generate the Data . The recipient would choose this option to indicate that they are forming a task force or consortium to comply with the order. In such cases, each particip ant or potential participan t is expected to submit

an Initial Response Form for Individual Order Recipients within 90 calendar days. Within 150 calendar days of issuance of the order, or as part of their initial response, the designated lead for the consortium is expected to submit the Initial Response Form for Consortium /Task Force [ see Attachment D(2)] to provide the primary contact for the task force or consortium, the list of participants, and an indication of the task for ce or consortium's planned response for each assay, along with documentation of its formation (such as a copy of the joint agreement or a written statement by all the parties that an agreement exis ts). 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.

Alternatively, an order recipient may provide the EPA with documentation that they made a judicially enforceable offer to enter into an agreement to develop data jointly with one or more recipients of the order and that th ey offered to pay a reasonable shar e of the test costs (or developed a process for resolving disputes with regard to th e appropriate share of test costs). If the required

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Page 21 of 44 data are not generated by the person(s) to whom th e offer is made, all parties, including those that have made offers to pay or otherwise joined the consortium, would be res ponsible for generating and submitting the data.

Although catch-up order recipients are most likely to select this option, these respondents are generally expected to join a consortium that has already been formed, or otherwise join with an individual who has already committed to generate the data.

(4) Claim Not to be Subject to the Test Order . The recipient would choose th is option to indicate that they are not subject to the order because:

(i) In the case of a Tier 1 order involving a pest icide active ingredient, the recipient is not a pesticide registrant, or

ical, or

by (ii ) In the case of a Tier 1 order involving a pe sticide inert ingredient, the recipient does not currently manufacture or import the chem (ii i) In the case of a "catch-up" order, the recipien t obtains the chemical solely from persons who are either (1) an original data submitter; (2) a person who has complied with an EDSP order offering compensation; or (3) a person who is otherwise an approved source for the pesticide inert ingredient.

The recipient's initial response would include an explanation a nd documentation supporting their claim to allow the EPA to evaluate the claim. If th e EPA cannot verify the claim, the recipient is still subject to the order and the d eadline(s) for responding remain.

(5) I Intend to Voluntarily Cancel or Reformulate the Product Registration . This option is only available for pesticide registrants. Regist rants may request voluntary cancella tion of their product's pesticide registration pursuant to FIFRA sect ion 6(f). Doing so would initiate the existing procedures for a voluntary cancellation. Under those procedures, the registrant ma y either adopt the standard procedures for sale or use of existing stocks of their pesticide, or may propose an alternative procedure. Alternatively, in the ca se of an inert ingredient, a regi strant of an end-use product may submit an application to amend the formulation of its product by removing the ingredient that is the subject of the Tier 1 order. This is all accomp lished through the submission of an application to amend the registration following the established pr ocedures. In general, the EPA's policy does not include the issuance of orders under FFDCA section 408(p) to re gistrants of end-use products.

(6) I Claim a Formulators' Exemption . A pesticide registrant who receiv es an order to test a chemical who purchases the chemical from another recipien t who has agreed to gene rate the data may be eligible for a formulators' exemption, but exercise of this option may depe nd on the authority under which the order is issued. If the EPA were to re ly solely on FIFRA 3(c)(2)(B), the option would not be available for orders to test an inert ingredient since manufactu rers and importers would not be subject to a FIFRA order. Such a claim would in itiate the existing procedures for formulators' exemption. The EPA will confirm claims of eligibility. A formulators' exemption would become invalid if the supplier of the chemical were not to submit the data either individually or jointly with other recipients.

(7) I H ave or Am in the Process of Discontinui ng the Manufacture/Impor tation of the Chemical . This option is only available for pesticid e inert ingredients. The recipient of an order for a pesticide inertOctober 25, 2012

ingredient ( i.e. , manufacturer/importer) would choose this opti on to indicate that they have already or are in the process of discon tinuing the manufacture or import of the chemical. The recipient's initial response would include an explanation and documentation supporting their claim. The EPA intends to verify such a claim. If the EPA confir ms the claim, the Initial Response Form is the only response required to satisfy the or der. If, however, the EPA determines that the claim is false, the recipient must comply with the order.

(8) I Will Not Sell the Chemical for Use in Pesticide Products . This option is only available for pesticide inert ingredients. The recipient of an order for a pesticide inert ingredient ( i.e. , manufacturer/ importer) would choose this option to indicate that they do not curren tly or agree to no longer sell their chemical for use in the pesticide market. To elect this option, th e order recipient would indicate, as part of its initial response, that they commit to discontinue, on or before a date six months after the issuance of the Ti er 1 order, all sale and distributi on of the chemical to any person who the recipient knows, or reason ably should know, intends to use the chemical in the formulation of a pesticide product. The order reci pient would also indicate that it will include in all contracts for sale or distribution of the materi al a provision that contractually pr ohibits the purchaser from using the substance in the formulation of a pesticide pr oduct. As part of its initial response, the order recipient would be asked to provide a copy of the contract provision and a certification to include this contractual provision in any contracts entere d into on or after a date six months after the issuance of the Tier 1 order.

(9) Request an exemption unde r FFDCA section 408(p)(4) . FFDCA section 408(p)(4 ) provides that "the Administrator may, by order, exempt from the require ments of this section a biologic substance or other substance if the Administrator determines th at the substance is antic ipated not to produce any effect in humans similar to an effect pr oduced by a naturally occurring estrogen."

If an order recipient believes th at this showing can be made fo r its chemical, the agency would consider requests to issue such an exemption or der on a case-by-case or chemical-by-chemical basis in response to individual submissi ons or requests for such considera tion. In order for the agency to make the necessary statutory findi ng to issue the exemption, the reque st would need to provide any hazard-related information that th e recipient believes would allow the EPA to determine that the chemical is anticipated to not be an endocrine disruptor, i.e. , is not anticipated "to produce any effect in humans similar to an effect produ ced by a naturally occurring estrogen."

(10 ) Other initial responses . There are two other response options available to all order recipients.

a) P re-enforcement challenges to the Tier 1 Order . If a recipient wishes to challenge the Tier 1 order, the order will describe the informal process by which a recipient may raise, and the EPA may review, objections to the issuance of an order or to specific provisions in the order. For the EPA to be able to respond to the objections in a timely manner, the recipient would need to state with particularity the scope and basis of the obj ection, providing sufficient detail to allow the agency to evaluate the objection. b) A dditional EDSP screening is unnecessary becaus e the chemical is an endocrine disruptor or was used as a "positive control" in the EDSP validation effort . If an order recipient chooses to ask the EPA to reconsider some or all of the test ing specified in the Tier 1 order, the EPA would review the request, along with the appropriate information suppor ting the claim that additional EDSP screening of the chemical is unnecessary becau se the chemical is an endocrine disruptor or

Page 22 of 44October 25, 2012

Page 23 of 44 was used as a "positive control" in the EDSP validation effort, on a case-by-case basis. Based on the information currently available, the EPA gene rally expects that if the chemical was used by the EPA as a ''positive control'' to validate one or more of the screening assays, only the data submitted related to those assays for which the chem ical was used to complete the testing as part of the validation effort would be suffi cient to satisfy the Tier 1 order.

4(c)(ii) Progress Report

Unless the EPA has notified the order recipient in writi ng that the requirements of the order have been satisfied, the order recipient must submit a progress re port to the EPA within 12 months of the issuance of the order (the specific due date will be identified in the order). The progress report should provide a brief description of the status of the respondent's planned activities for each assay, and, if applicable, a description of any problems encounter ed or expected difficulties in m eeting the schedule for complying with the order.

4(c)(iii) Extension Requests

If a recipient cannot comply with the time frame establ ished in the order (see sec tion 5(d) of this ICR), they may seek additional time by submitting a written request for an extension to the agency. The written request must be submitted before the applicab le deadline and include: (1) a detailed description of the expected difficulty and (2) a proposed sche dule including alternativ e dates for meeting the requirements of the order. If the delay is based on technical or laboratory difficulties, recipients are expected to explain any technical or laborator y difficulties and provide documentation from the laboratory performing the testing.

While the EPA is considering any such request, the original deadlines in th e order remain unchanged. The agency will respond to such requests in writing because time extensions can only be granted in writing. If the EPA does not grant th e request, the original deadline re mains. Normally, time extensions can be requested only in cases of extraordinary testing problems beyond the expectation or control of the registrant, manufacturer, or importer. Time extensions will not be considered if the request for extension is not made in a timely fashion; in no event shall a time extension request be considered if it is submitted at or after the lapse of the subject deadline.

4(c)(iv) Data Generation

The Tier 1 order will request specific data from a battery of assays. The Tier 1 screening battery is intended to identify chemicals affecting the estroge n, androgen, or thyroid hormone systems through any of several recognized modes of action. The following is a list and brief descripti on of each of the assays that are part of the final Tier 1 battery:

1. Am phibian Metamorphosis (Frog) - The Amphibian Metamorphosis assay involves the use of tadpoles to determine if chemicals affect the hypothalamic-pituitary-thyroid (HPT) axis during metamorphosis and consequently re sult in developmental effects.

2. Androgen Receptor Binding (Rat Prostate) - The androgen receptor (AR) is involved in the development of male sexual char acteristics. The AR Binding assay identifies chemicals that affect the endocrine system by binding to hormone receptors to either mimic the action of theOctober 25, 2012

Page 24 of 44 natural hormone or block access of the hormone to the site and thus block hormone controlled activity.

3. Aromatase (Human Recombinant) - Aromatase is an enzyme complex responsible for estrogen biosynthesis that converts andr ogens into estrogens, estradiol, and estrone. The Aromatase in vitro assay focuses on this portion of the steroi dogenic pathway to detect substances that inhibit aromatase activity.

4. Estrogen Receptor Binding - The estrogen receptor (ER) is involved in female maturation and reproductive function. The ER Binding assay measures the ability of a chem ical to bind to the estrogen receptor.

enic, ines

, ale rats. 5. Estrogen Receptor Transcriptional Ac tivation (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 ab ility of a chemical to bind to the ER and activate transcription resulting in the synthesis of the enzyme luciferase.

6. Fish Short-term Reproduction - The Fish Short-term Re production assay screens for disturbances in the hypothalamic -pituitary-gonadal (HPG ) axis including (anti-) ¬estrog (anti-) androgenic, aromatase i nhibition, and steroid modulating effects. The assay exam abnormalities associated with survival, reproduc tive behavior, secondary sex characteristics, histopathology, and fecundity ( i.e. , number of spawns, number of eggs/spawn, fertility, and development of offspring) of fish exposed to test chemicals.

7. Hershberger (Rat) - The Hershberger assay is designed to detect androgenic and antiandrogenic effects. In this in vivo assay, the weight of severa l androgen-dependent tissues including accessory sex glands , are measured in castrated or immature m

8. Female Pubertal (Rat) - The Pubertal Female assay involves the use of rats to screen for estrogenic and thyroid activity in females dur ing sexual maturation. This assay examines abnormalities associated with sex organs and pub erty markers, as well as thyroid tissue.

9. Male Pubertal (Rat) - The Pubertal Male assay involves the use of rats to screen for androgenic, anti-androgenic, and thyroid activity in males during sexual maturation. This assay examines abnormalities associated with sex organs and pub erty markers, as well as thyroid tissue.

10

. Steroidogenesis (Hum an Cell Line – H295R) - The Steroidogenesis in vitro assay detects interference with the bod y's production of male and female steroid sex hormones. This assay is a cell-based assay using the H295R human adreno cortical carcinoma cell line which can detect inducers of enzymes responsible for steroid synt hesis as well as chemicals that inhibit it.

11

. 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.

For purposes of estimating the potential burden for the Tier 1 screening informa tion collection activities covered by the ICR, the agency is assuming that each Tier 1 order will include all of the above listedOctober 25, 2012

Page 25 of 44 assays. By assuming that each order will include all of these assays, the ICR provides coverage for those cases where the order may not include all of the assays.

4(c)(v) Data Submission

The order itself will specify the data submission cont ent and format that the recipient should use. For pesticide active ingredients and pesticide inert ingred ients the content and format is based on that used currently for other pesticide data submissions. Si nce the initial chemicals involve pesticides and pesticide inerts, the EPA believes that doing this helps to minimize the pot ential burden because the order recipients are likely to be familiar with the ex isting requirements. As such, the content and format of the data submission package for transmittal to the EPA should be consistent with the following existing standards:

1. Format for Data Submission . As part of a cooperative projec t, the EPA and the Canadian Pest Management Regulatory agency (PMRA) developed st andard data evaluation formats, or templates. The templates have been in use by the agencies since 2002 for writing their data evaluation records (DERs) of studies submitted under FIFRA and FFDC A to the EPA and the Canadian data codes (DACOs). The DER that the agencies prepare contains a study profile documenting basic study information such as materials, methods, results, applicant's conclusi ons and the evaluator's conclusions. The agencies encourage recipients to include study profiles based on these templates, which describe the layout and scope of information that should be contained within a study profile and can serve as guides for preparation of st udy documents. Use of the templates improves the likelihood of a successful submission, since the inform ation necessary for an efficient agency review is outlined. Additional details about these templates are available at: http://www.epa.gov/pesticides/re gulating/studyprofile_templates/

. Pesticide Registration (PR) Notice 86-5, entitled "Standard Format for Data Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA)," describes the requirements for organizing and formatting submittals of data supporting a pesticide registration ( http://www.epa.gov/PR_Notices/pr86-5.html ). The agency has begun the process of updating the gui dance in PR Notice 86-5 to further clarify the data submission process for pesticide related submissions and will provide the public with an opportunity to comment on the propose d revisions to PR Notice 86-5 c onsistent with the procedures described in PR Notice 2003-3, entitled "Procedur al Guidance for EPA's Office of Pesticide Programs Procedures Concerning the Development, Modification, and Implementation of Policy Guidance Documents" ( http://www.epa.gov/PR_Notices/pr2003-3.pdf ).

In addition, the agency encourages order reci pients to submit completed study profiles and supporting data in an electronic format (PDF) whet her submitting one or several studies. For more information about electronic submissions, go to http://www.epa.gov/pesticides/regula ting/registering/submissions/index.htm

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2. T ransmittal Document . Each submission in satisfaction of a Tier 1 order must be accompanied by a transmittal document that includes the following information:

(1) Identity of the submitter

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. (2 ) The date on which the submission package was prepared for transmittal to the EPAOctober 25, 2012

Page 26 of 44 (3 ) Identification of the Tier 1 order associated with the submission ( e.g. , the number assigned to the orde r).

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ssed. (4) A list of the individual docume nts included in the submission

3. I ndividual Study or Te st Result Documents. Unless otherwise specified by the agency, each submission must be in the form of individual do cuments or studies. Previously submitted documents should not be resubmitted unless specifically reques ted by the agency. Instead, previously submitted documents should be cited with adequate informati on to identify the previously submitted document. Each study or document should include the following:

(1) A title page including the following information: (i) The title of the study, including identification of the substan ce(s) tested and the test name or data requirement addre (ii ) The author(s) of the study. (i ii) The date the study was completed. (iv ) If the study was performed in a laboratory, the name and address of the laboratory, project numbers or other identifying codes. (v) I f the study is a commentary on or supplem ent to another previously submitted study, full identification of the other study with wh ich it should be asso ciated in review. (vi) I f the study is a reprint of a published documen t, all relevant facts of publication, such as the journal title, volume, issue, inclusiv e page numbers, and date of publication. (2) Upon submission to the EPA, each document must be accompanied by a signed and dated document containing the appropriate statement(s) regarding any data confidentiality claims as described in the Tier 1 order. (3) A statement of compliance or non-comp liance with respect to GLP standards, e.g. , such as those required by 40 CFR 160.12, if applicable. (4) A complete and accurate English translation mu st be included for any information that is not in English.


### 5. Agency Activities, Collection Me thodology, and Information Management
5(a) Agency Activities

The functions and responsibilities associated wi th the EDSP under FFDCA section 408(p) have been assigned to the EPA's OCSPP. 11 Within OCSPP, OPP will be primarily responsible for the administrative functions related to the issuance of the orders, r eceiving, processing and maintaining records of responses to the orders , as well as other administrative functions related to the orders.

OCSPP's OSCP will coordinate the review of Tier 1 screening data received, posting of information on the agency's Website, and the preparation of resulti ng determinations related to the subject chemical. Data received by the EPA will first be reviewed for co mpleteness and then routed to an agency team of scientists and analysts for technical review. Although the technical review team s will consist mostly of staff from the offices in OCSPP, it will also include staff from othe r EPA offices, as appropriate.

11 Prior to April 22, 2010, this office was known as the Offi ce of Prevention, Pesticides and Toxic Substances (OPPTS).October 25, 2012

In general, the agency is expected to engage in th e following general activities related to the information collection activities unde r this ICR renewal:

(1) P repare instructions. Prepare procedural steps, guid ance and instructions for or der recipients so that they understand what data are to be submitte d, when and how. The policies and procedures document (Attachment B) describes the policies a nd procedures that the EPA intends to use to implement the data collection component of th e EDSP. Although that docu ment is non-binding, the agency will incorporate specific in structions into each order, so th at each order recipient receives detailed instructions on what they must do to comply with the order.

(2) Identify chemicals to be screened. The list of th e chemicals covered by this ICR is provided in Attachment G. For purposes of this renewal ICR, since all of the remaining 52 chemicals on the final list have been the subject of a Tier 1 order issued under FFDCA s ection 408(p), the agency assumes that they could also be the subject of a catch-up order.

(3) I dentify order recipients. As indi cated previously, the EP A has already issued Tier 1 orders to those identified for the remaining 52 chemicals as desc ribed in the existing I CR. As such, this ICR renewal involves potential recipients of catch-up or ders. Recipients of catch-up orders will only be identified if a new registration application is re ceived by the agency for one of the chemicals on the initial list, or if a company is otherwise identifie d. See the discussion on res pondents in section 4(a) of this ICR renewal.

To facilitate the formation of consortia to develop th e data requested in an order, and to the extent that the information is not protected as confiden tial business information, the EPA will provide each order recipient with a list of the other recipients of the order for the subject chemical. The list of order recipients is maintained up to date on the agency's EDSP Web site, along with the status of the order (including recipients' responses receiv ed by the EPA). These reports can be accessed at http://www.epa.gov/endo/pubs/toresources/index.htm

. (4) Prepare the EDSP Tier 1 Orders . The EPA intends to use the appropriate order template (as discussed in section 4(b) of th is ICR) to prepare individual orders for each chemical and order recipient. The order will identify all of the non-CBI protected recipients so that the recipients may more easily identify the potential participants to include in a c onsortium, and it will indicate how many recipients could not be listed. Those companie s protected as CBI will not be listed, but will still receive an order and will have an opportunity to designate an agent for purposes of the list of order recipients. As indicated previously, the EPA in tends to maintain an up to date list of order recipients on the agency's EDSP Web site.

Along with preparation of the orders, the EPA w ill prepare the pre-populate d Initial Response Form for each order recipient. The agen cy intends to accomplish this through a semi-automated process using the same database that will track the orde rs, initial responses, and data submissions. This system is discussed in more detail in section 5(b) of this ICR. In using this approach, the EPA is maximizing the available resources and efficiencies related to the administrative components of Tier 1 screening under the EDSP.

(5) Review and Approve Orders . The EDSP Tier 1 orders will be reviewed and approved by a senior agency official(s) for completeness before they are issued.

Page 27 of 44October 25, 2012

(6) Issue the Orders . The appropriate authorized OCSPP senior official will sign each order, which will then be processed for issuance as appropriate. Orders will then be mailed to each recipient using certified and return receipt mailing options offered by the U.S. Postal Service.

(7) Process Initial Responses . The agency will receive the In itial Response Form, document the response, track responses and determine next step s based on the responses. In general, the agency will review the response to determ ine if it is complete and whethe r it satisfies the request in the Tier 1 order, if so, the response will be doc umented accordingly. Depending on the response, the agency may also complete other tasks, e.g. , document lead for a consortia, process a voluntary cancellation request or request for reformulation, etc. The agency will verify claims and review data cited or submitted and provide a written response to the order recipient that accepts or rejects their claim(s).

(8) Provide Assistance and Complete Follow-up, as needed . The agency will respond to any questions the recipient may have regarding the Tier 1 order in a timely manner, as well as process any requests for extensions or protocol variations.

(9) Address Non-responders . Once identified, OCSPP will determine appropriate action ( i.e. , whether to initiate cancellation procedures, refer the case to the EPA's Office of Enforcement and Compliance Assurance (OECA) for enforcement, etc.).

(10 ) Issue "Catch-up" Orders . The EPA may issue a so called "cat ch-up" order to a manufacturer or importer who begins to sell a pesticide ingredient (active or inert) foll owing the submission of required EDSP data on the ingredient by manufacture rs or importers who were in the marketplace when the initial orders were issued.

(11 ) Process Data Submissions . The agency will process submissions of data generated under the Tier 1 order, including initial review of the data submission for comp leteness, initial log-in to document receipt, and determining the close out of the order. As indicated prev iously, this will be coordinated by OPP, OPPT and OSCP. Although each order will need to be addres sed individually, the agency may determine that the satisfaction of the order fo r a particular chemical by one order recipient can be used to determine that all of the orders for th at chemical are also sati sfied. However, satisfaction of an order by one order recipient, may not affect the need for the other order recipients to comply at all. For more information, see the polic ies and procedures document (Attachment B).

(12 ) Analyze Data . OCSPP will implement the agency's internal standard review procedures to review the data. For example, what do the data tell us about the chemical's potential to interact with E, A, and/or T?

In general, the agency intends to take a weight-o f-evidence approach to evaluate the available data for a particular chemical to dete rmine whether the potential endocri ne disrupting eff ects associated with the use of the chemical can be ascertained wi th the data available, or whether additional data are needed. For more background information on the weight-of-evidence approach, please go to http://www.regulations.gov , specifically under docket EPA-HQ-OPPT-2010-0877.

(13) Incorporate/Use the Data . The agency will incorporate the data into a risk assessment and make a regulatory decision as necessary a nd appropriate. The EPA has extens ive experience in using data from multiple sources to develop integrated asse ssments of hazard, modes of action / mechanisms

Page 28 of 44October 25, 2012

of toxicity, and overall potential for risk. EPA scientists will con tinue to use such experience to address the potential of chemicals to cause adverse effects as a cons equence of interaction with the endocrine system. For example, do we know enough to determine whether or not we should take any regulatory action to prevent or mitigate the exposures that might lead to the interaction identified? Should the chemical be considered for Tier 2 testing?

In addition, chemicals that go th rough Tier 1 screening and are found to have the potential to interact with the estrogen, androgen, or thyroid ho rmone systems will proceed to the next stage of the EDSP where the EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to iden tify any adverse endocrine-related effects caused by the substance, and establish a quantitative relation ship between the dose and that endocrine effect.

(14) Store Data in Retrievable System . The agency will index and store th e data in the agency's files. For pesticide active and inert ingredient s, the data will be stored in O PPIN. This system is discussed in more detail in section 5(b) of this ICR.


### 5(b) Collection Methodology and Management

For each of the chemicals identified for Tier 1 screeni ng as part of the EDSP, the specific data requested, the testing necessary to generate th at data, along with the validated pr otocols to conduct the tests, the time frame for completing the testing, and the date by which the requested data must be submitted to the agency will be established in the Tier 1 order. As indicated previously, the agen cy intends to utilize the systems and procedures already esta blished and in use for Data-Call-In activities under FIFRA to collect and manage the data submitted in response to the Tier 1 order. For example, as with other pesticide data related submissions, the EPA will maintain a record of each study submitted in the agency's Pesticide Document Management System (PDMS), and public access to the PDMS bibliography may be made through the National Pes ticides Information Retrieval System (N PIRS). NPIRS supports searches of the PDMS database by chemical, subject, submission date, laboratory, guideline number, and document type. The public, after satisfyi ng any applicable requirements ( e.g. , FIFRA section 10) may request copies of non-confidentia l studies through FOIA.

In addition, OPP's Information Technology and Res ource Management Division (ITRMD) has enhanced the agency's tracking database (PRISM) to provide the necessary information to accomplish the Tier 1 goal. PRISM was used for issuance and tracking of EDSP orders related to the initial list of chemicals.

To meet the goals of the EDSP, the system allows for the creation of orders for each chemical. For pesticide active ingredients, the system will mana ge information associated with the company, product or pesticide active ingred ients, requirement information, and info rmation related to the responses. For inert ingredients, the system manages the associ ated companies only, since these companies may not have any registered products. In addition, the sy stem allows for the submission of studies through registrant consortiums, in addition to individuals. This will ensure that the companies who received orders are given credit for the submissions when the consortium is identified as the study owner. For every inert there is a subsection for its Battery, results and comments. The system will track the milestones associated with the drafting, concurren ce, mail-out, 90-day respons e, submission receipts, and reviews. Also, the system mana ges response extensions and identi fies all non-respons ive companies.

Page 29 of 44October 25, 2012

In addition to tracking the previously mentioned elem ents related to each specific order, the agency will track the following: submission type, submission date, submission co mment, review sent and completed dates, requirement status and requi rement status comment. These elemen ts are needed in order to track the responses submitted by each company, the submitte d studies, study reviews, study status and requirement status.

The agency will produce several reports to facilitate tracking, etc. For example, a 90-day company response status report is needed to determine wh ether companies have responded, and to identify their intentions. An option to display on ly overdue responses will be includ ed. It should include all chemicals and be sorted by company (and product if applic able). A status report by requirement across all chemicals, sorted by company is needed in order to present overall progress and allow management to directly identify delays.


### 5(c) Small Entity Flexibility

In developing the policies and procedures document (A ttachment B), the agency considered alternatives for small businesses to the extent practical within the mandate in FFDCA. For example, as described in more detail in that document, the EPA does not intend to issue Tier 1 orders to registrants of end-use products or formulators, primarily because most sm all entities potentially impacted under the EDSP are end-use product registrants or formulators and are not basic manufacturers or regi strants. As such, small businesses are not expected to be responsible for supplying endocrine data on a chemical they use in their end-use product or formulation.

In addition, the procedures are intended to minimize potential dup licative testing, and emphasize collaborative efforts to generate the requested data. If there is a small business that happens to manufacture one of the chemicals and therefore receives a Tier 1 te st order, the small business may minimize potential burden by joining a consortium or task force, which may relieve the small business of direct responsibility for generating or submitti ng the data. The EPA has further facilitated this collaborative approach by including the list of order re cipients for a particular chemical in the original order package that the entity will receive. Participants in a consortium are free to negotiate the terms of the agreement, including the level of participation expected from each member. Typically, that level of participation, which may be based on time or mone y, is based on the entity's market share for that chemical.

The EPA can accommodate requests for extensions of time from small businesses, and provide other assistance, as needed. In fact, OPP has established sm all business liaisons that are available to provide a broad range of assistance to small businesses. An extension in time may help a small business because other manufacturers who received an order for that sa me chemical may submit the data sooner. Since an entity may demonstrate that they made a reasonable offer to contribute toward s the costs for generating that data, a small entity in this case would only be re sponsible for their fair share of the costs, and the time an effort involved in making a reasonable offer.


### 5(d) Collection Schedule

There is no periodic schedule for the collections unde r this ICR. This information collection activity only involves a one-time, three step collection acti vity per chemical. The order will identify the applicable due dates for the collections under the orde r, which will be calculated based on the date the

Page 30 of 44October 25, 2012

order is issued. In general, the basic schedule th e EPA intends to use in the order is based on the timeframes identified in Table 3.

Table 3 – General Basis for Establishing the Due Dates in the Order Timeframes for Due Dates What is Due Within 90 calendar days of the order's issuance (+ 10 calendar days for processing) Individual Recipient's Initial Response

Within 150 calendar days of the order's issuance (+ 10 calendar days for processing) Consortia's Documentation and Initial Response

Within 12 months from order's issuance A Progress Report describing the status of an order Recipient's compliance with the order. 24 months from order's issuance Final Study Report and submission of the data to the EPA
In calculating the due date for the Initial Response, the agency has included an additional 10 calendar days to build in extra time for the agency to process the final order package after signature, i.e. , to add all the due dates that will be calcu lated from the signature date, and for physical delivery of the package to the Post Office for mailing.

In general, the agency does not expect to consider requests for extending the deadlines for the Initial Response. However, the agency will consider extending the final report due date when the circumstances warrant it. The agency's policy regardi ng time extensions is pres ented in the policies and procedures document (Attachment B).

The timing of the activities covered by this ICR is not specific enough to accurately divide them by year. For purposes of estimating the potential paperwork burde n in this ICR, the EPA therefore assumed that the data would be submitted within 2 or 3 years of receiving the Tier 1 order, i.e. , within the 3 year approval period for this ICR. To cal culate an annual burden, the agen cy assumed a 3 year duration of equal annual effort.


### 6. Estimating the Burden and Cost of the Collection

The PRA requires the EPA to estimate the "paperwork burden" i.e. , the total time, effort, or financial resources expended by persons to generate, maintain, reta in, or disclose or provide information to or for a federal agency. Under the PRA, "burden" means th e "time, effort, or financial resources expended by persons to generate, maintain, or provide information to or for a Federal agency." This can include the resources to: review instructions; develop, acquire, install, and use t echnology and systems; search data sources; collect, review, validate, an d verify information/data; process and maintain information/data; disclose and transmit/submit information/data; change/adjust the existing ways of complying with any previously applicable in structions and requirements to now comp ly with new requirements; and, train personnel. The agency is also required to estimate the paperwork costs, which include both the costs associated with the paperwork burden hours, and any additional costs not tied to a burden hour, but incurred under the PRA nonetheless ( e.g. , the cost for mailing the forms to the EPA).

In this section of the ICR, the agency discusses the methodology and a ssumptions used to calculate the potential paperwork burden and costs for both respondents and the EPA.

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### 6(a) Methodology for Estimating Respondent Burden and Cost

6(a)(i) Method Used to Calculate the Loaded Labor Rates

Average wage data for the relevant sectors of respondents are available in the May 2011 National Industry-Specific Occupational Employment and Wage Estimates from the Bureau of Labor Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm

. We used the NAICS codes to obtain the estimated loaded labor rates used in this ICR, i.e. , NAICS 325300, Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing http://www.bls.gov/oes/current/naics4_325300.htm . Within that sector, the wage data are provided by Standard Occupational Classification (SOC). The SOC sy stem is used by Federal statistical agencies to classify workers into occupationa l categories for the purpose of coll ecting, calculating, or disseminating data. Each broad occupation incl udes detailed occupation(s) based on similar job duties, skills, education, or experience. For more information on SOC and what is included in each SOC, see http://www.bls.gov/oes/current/oes_stru.htm . The SOCs used for the fo llowing labor types are listed below in Table 4 and apply to a ll of the sectors identified above.

Table 4 – Respondent SOCs Used in this ICR Labor Category SOC # Standard Occupational Classification Management 11-0000 Management Occupations
Technical 19-0000 Life, Physical, and Social Science Occupations
Clerical 43-0000 Office and Admini strative Support Occupations

For purposes of calculating a loaded labor rate, we us ed the mean average hourly wage rate and assumed that benefits are 29.6% of total labor cost, based on benefits for all private industry workers from http://www.bls.gov/schedul e/archives/ecec_nr.htm. 12 We then multiply the loaded wage by 50% to get overhead costs. Overhead costs are added to the load ed wage rate to get the fully loaded wage rate.

Table 5 – Respondent Loaded La bor Rates Used in this ICR Labor Category Formula Used Managerial Technical Clerical Unloaded Hourly Rate 1 Wages $57.42 $28.32 $17.02 Benefits Percentage of Total Labor 2 Benefits% 29.6% 29.6% 29.6%
Loaded Hourly Rate (LHR) Wages $81.56 $40.23 $24.18 1-Benefits% Overhead Percentage 3 50% 50% 50% Overhead Per Hour (OPH) LHR*Overhead% $40.78 $20.12 $12.09 Fully Loaded Hourly Rate LHR + OPH $122.34 $60.35 $36.27
1. Data Source: http://www.bls.gov/oes/current/naics4_325300.htm 2. Fringe benefits/wage per hour. 3. U.S. EPA, EPA Air Pollution Control Cost Manual, Sixth Edition , EPA-452-02-001, January 2002, pp. 2-34. The loading for indirect costs used in this ICR ( i.e. , 50%) is within the range of 20-70% of the load labor rate (wage + benefits) suggested in this EPA guidance.

12 DOL, Bureau of Labor, September 11, 2012 Announcement of June 2012 Data http://www.bls.gov/news.relea se/archives/ecec_09112012.htmOctober 25, 2012

Page 33 of 44 For this ICR, the agency therefore uses th e following labor rates for the respondents: Managerial = $122.34, Technical = $60.35; and Clerical = $36.27.

6(a)(ii) Method Used to Calculate the Burden and Costs

The specific activities used for estimating the potential burden and costs are identif ied in section 4(b) of this ICR. Paperwork burden hours and costs are subdivi ded into the managerial, technical, and clerical duty labor categories, which are also described in more detail in section 4(b) of this ICR.

The agency then used two basic appr oaches to calculate the potential burden and costs for this ICR: 1) For the data generation activities, the EPA calcula ted the paperwork burden as a percentage of the testing costs; and 2) For the rest of the paperwor k activities, the EPA estimated the average amount of time required to complete the specific activity, consid ering estimates provided in other approved ICRs involving the same activity, feedback from stakeholde rs, and the EPA's overall experience with such activities.

1. Me thod Used to Calculate the Burden and Costs for Data Generation . The EPA calculated the paperwork burden for the data generation activities as a percentage of the testing costs. This percentbased estimate of paperwork associated with conducting a test was ini tially established in consultation with OMB in the 1980's in an effort to provide a reasonable estimate of the burden associated with the paperwork component of data generation, which may vary based on the complexity of the test performed. This appears to be a reasonable and fair alternative to simply setting a single estimate for data generation burde n or perhaps using some set criteria like high, medium or low burden, neither of which may fairly reflect potential differences in burden. For purposes of this ICR, the agency has adopted this established methodology for estimating the paperwork burden for data generation, which is explained further in this section of the ICR.

To calculate the burden associated with the paperw ork activities involved in conducting the tests, the agency starts with the cost of the test, typically the market pri ce for the test as identified by laboratories that offer testing serv ices. The agency used estimated co sts for 2 assays that were based on estimates provided by the EPA scientist overseei ng the validation effort for those 2 assays. Since the EPA is funding the assay validation effort, we believe that these estimates are reasonable surrogates for actual market prices at this time and for the purposes of this ICR. For the other assays, the agency used the Cost Estimate Survey of commercial laboratories and other information provided by industry representatives (References 8 and 9). The EPA be lieves that these estimates are still valid as adjusted for infla tion. Our basis for being comfortable with these cost estimates is a peer-reviewed article that appeared in Toxicological Sciences entitled, "Application of an Integrated Testing Strategy to the U.S. EPA Endocrine Disruptor Screening," wh ich estimated the costs for the eleven assays to be $572,913. 13 As indicated in Attachment F, the estimate provided by the EPA is slightly higher at $637,184.

Based on the existing methodologies, the EPA used 35% of the estimated total test cost to calculate the total potential cost for the pape rwork activities related to data ge neration. The 35% of test cost is disaggregated by labor category, an d then burden hours are extrapolated by using the loaded labor

13 The total in the article of $544,397 was in 2010 dollars, wh ich were adjusted for 2012 using the inflation calculator at http://www.bls.gov/data/inflation_calculator.htm

.October 25, 2012

rates. To disaggregate by labor category, the ag ency considered the estimated distribution of paperwork activity across the labor category re presented and the existing methodology assumption that paperwork activities for data generation mostly involve the technical staff to perform the tests, with a few activities related to management and clerical.

See Figure 1 for an illustrated outline of the agen cy burden calculation process for data generation. The results from using this method are presented in section 6(b) of this ICR.

Figure 1 – Method for Calculating Pa perwork Burden from Test Costs

Divide 35% cost into: 20% for Managerial 65% for Technical 15% for Clerical Divide each by Loaded Labor rate for that Category Identify 35%

of the Test Cost Burden Hours by Cate g or y

This approach assumes and incorporates the following: (1) Recipients generate all of the data as specified in the Tier 1 order. (2) All data generation is perfor med by an independ ent laboratory. (3) Paperwork burden is disaggregated by labor category as follows: a. Managerial (20%) b. Technical (65%) c. Clerical (15%) 4) Labor rates are fully loaded, meaning that they include the estimated costs of wages, overhead, and benefits paid to an employee. See section 6(a)(i) of this ICR.

2. Me thod Used to Calculate the Burden and Costs for Other Activities . For the other activities, the EPA estimated the burden hours by considering the act ivities themselves and the expected amount of time that the activity involves on average. These es timates consider the agency's experience with similar data collection ac tivities and direct experience in cond ucting the assays for validation. The costs are calculated using the loaded labor rates for the labor categories that are identified in section 6(a)(i) of this ICR.

As indicated previously, almost all of the response options provided to recipients of Tier 1 orders are the same as those afforded to pesticide registrant s in response to DCIs. Although other ICRs already address the paperwork burden associ ated with the activitie s involved in those options, the agency has provided a general estimate for the burden associ ated with providing the s upporting materials related to the various options based on its general experience with the pesticide program. At this time, it is not possible to estimate how many respondents may choose which option.

Regardless of the response option that recipients of Tier 1 orders choose, the agency has assumed that the data will be generated for each chemical with all manufacturers participating in a consortium or task force, and with only one order recipien t engaged in actually generating and submitting the data. This means that all of the potential recipien ts of orders will experience a base set of burden associated with the initial receipt, response activ ities and subsequent burde n related to consortium participation, and that one recipient for each of the chemicals will experience the burden associated with generating the data, submitting a one-time progress report and eventually submitting the data. The results of this method are presen ted in section 6(b) of this ICR.

Page 34 of 44October 25, 2012



### 6(b) Estimating Respondent Burden and Cost

This section explains how the agen cy calculated the estimated respondent burden and costs for this ICR.

6(b)(i) Estimated Burden and Costs

The estimated per chemical burden for each of the paperwork activitie s described in section 4(b) of this ICR, disaggregated by the labor category listed in Tabl e 4, are presented in Table 6.

Table 6 – Estimated Per Chemical Burden Hours for the Activities Activity (a) Managerial Technical Clerical Total 1) Re ad instructions 12 12 0 24 2) Plan activities 48 42 0 90 3) Submit an initial response to the EPA (b) 24 21 2 47 4) Read and discuss the protocol 36 145 0 181 ---> Activities related to the submission of OSRI (c) 40 201 37 278 5) Participate in Consortium 24 145 2 171 6) Generate the data (d) 397 2,612 1,003 4,012 7) Submit Progress Report 5 20 7 32 8) Compile and review the final data for submission 36 191 12 239 9) Complete paperwork to assemble submission package 5 20 7 32 10 ) Submit final data to the EPA 3 0 2 5 11 ) Maintain records 0 24 62 86 Total Burden: 630 3,433 1,134 5,197 (a) Activities described in mo re detail in section 4(b) of this ICR, whic h are disaggregated base d on labor category. (b) This estimate includes an estimated burden to pr ovide additional material with the response. (c) Hours required for OSRI Submissi on from CLA/EPF Report (Reference 9). (d) Burden estimate is a percentage of the total test cost, which is calculated in Attachment F.
The estimated per chemical cost for each of the pape rwork activities is presented in Table 7. The burden costs are calculated by multiplying the burden hours in Table 6 by the loaded labor rate for the different labor categories, with the costs fo r generating the data coming from A ttachment F to the existing ICR. The following loaded labor rates were used to calculate these costs: Managerial = $122.34; Technical = $60.35; and Clerical = $36.27.

Table 7 – Estimated Per Chemical Costs by Activity

Activity (a) Managerial Technical Clerical Total $122.34 $60.35 $36.27 1) Read instructions $1,468 $724 $0 $2,192 2) P lan activities 5,872 2,535 0 8,407 3) S ubmit an initial response to the EPA (b) 2,936 1,267 73 4,276 4) Read and discuss the protocol 4,404 8,751 0 13,155 ---> Activities related to the submission of OSRI (c) 4,894 12,130 1,342 18,366 5) Participate in Consortium 2,936 8,751 73 11,760 6) Generate the data (d) 48,569 157,634 36,379 242,582 7) Submit Progress Report 612 1,207 254 2,073 8) Compile and review the final data for submission 4,404 11,527 435 16,366 9) Complete paperwork to assemble submission package 612 1,207 254 2,073 10 ) Submit final data to the EPA 367 0 73 440 11 ) Maintain records 0 1,448 2,249 3,697 12 ) Delivery costs $10.55 Total Cost: $77,074 $207,181 $41,132 $325,398

Page 35 of 44October 25, 2012

Page 36 of 44 (a) Activities described in mo re detail in section 4(b) of this ICR, whic h are disaggregated base d on labor category. (b) This estimate includes an estimated burden to provide any additional burden requested for an option. (c) Hours required for OSRI Submissi on from CLA/EPF Report (Reference 9). (d) Burden cost estimate is a percentage of the total test cost, which is calculated in Attachment F.
In addition to the burden costs, the costs of delivering the data to the agency are added to arrive at the total estimated per respondent cost . Delivery costs were calculated us ing the agency's experience with data submissions for pesticide deliveries, which assumes the delivery of a paper copy and a CD-Rom using special delivery. Although not required, nor used by everyone, the agency is using special delivery for the calculation to provide a conservative estima te that would account for expected variations in delivery costs. Based on the 2-day delivery rate for a large envelope up to 2 lb s. in weight, the U.S. Postal Service rate is $10.55 from the west coast to the east coast (Reference 7).

6(b)(ii) Estimating Burden and Costs by IC Category

As discussed earlier, all respondents are not expected to engage in the same basic act ivities, their activities will be based on their ini tial response to the order. For the purposes of this ICR renewal, the estimated burden and costs for the two respondent gr oups are divided into dis tinct "IC" categories as presented in Table 1. Using the estimated number of respondents in Table 1 and the estimated per chemical burden and costs from Tables 6 and 7 fo r the various activities, the estimated respondent burden and costs for the different IC categor ies is presented in the following tables.

IC #1: Order Recipients

For this IC category, the agency a ssumed that all respondents are expect ed to engage in the activities identified in Table 6 and 7 as activ ities 1-3, and 11, which are all associ ated with receipt of the order and submission of the required initial response.

Table 8 – IC #1: Estimated Burden and Costs for Order Recipients – Registrants of Pesticide Active Ingredients

Activity (a) Total # Responses (b) Per Response Total Burden (hrs) (c) Cost ($) (d) Burden (hrs.) (e) Costs ($) (f) 1) R ead instructions

45 24 $2,192 1,080 $98,640 2) P lan activities 90 8,407 4,050 378,315 3) S ubmit an initial response to the EPA 47 4,276 2,115 192,420 11) Maintain records (g) 43 3,697 1,935 166,365 Total: 204 $18,572 9,180 $835,740 Key: (a) Activities are de scribed in more detail in section 4(b) of this ICR. (b) From Table 1, catch-up orders. (c) See Activity listing in Table 6. (d) See Activity listing in Table 7. (e) Total = (b) x (c) (f) Total = (b) x (d) (g) Maintaining records of the initial response is estim ated to be 1⁄2 of the totals in Tables 6 and 7.October 25, 2012

Page 37 of 44 Table 9 – IC #1: Estimated Burden and Costs for Order Recipients – Manufacturers and Importers of Pesticide Inert Ingredients

Activity (a) Total # Responses (b) Per Response Total Burden (hrs) (c) Cost ($) (d) Burden (hrs.) (e) Costs ($) (f) 1) Read instructions

15 24 $2,192 360 $32,880 2) Plan activities 90 8,407 1,350 126,105 3) Submit an initial response to the EPA 47 4,276 705 64,140 11) Maintain records (g) 43 3,697 645 55,455 Total: 204 $18,572 3,060 $278,580 Key: (a) Activities are de scribed in more detail in section 4(b) of this ICR. (b) From Table 1, catch-up orders. (c) See Activity listing in Table 6. (d) See Activity listing in Table 7. (e) Total = (b) x (c) (f) Total = (b) x (d) (g) Maintaining records of the initial response is estim ated to be 1⁄2 of the totals in Tables 6 and 7.

The total IC #1 burden and costs is therefore a total of 12,240 hours (9,18 0 hrs + 3,060 hrs) and $1,114,320 ($835,740 + $278,580).

IC #2: Data Generators/Submitters:

This IC category of respondents is intended to capture the additiona l burden and costs expected for a subset of the order recipients who are generating and submitting the requested data to the agency. As discussed previously, the EPA assumes that for e ach chemical, the data will be submitted only once, either by an individual order reci pient or a consortium. For this IC category, the agency assumes that these respondents will engage in the activities identified in Table 6 and 7 as activities 4 and 6 through 12, which are all associated with generating and submitting the data. Pl ease note that participation in a consortium is addressed in the next group of ICs.

Table 10 – IC #2: Estimated Burden and Costs for Data Generators and Submitters – Registrants of Pesticide Active Ingredients

Activity (a) Total # Responses (b) Per Response Total Burden (hrs) (c) Cost ($) (d) Burden (hrs.) (e) Costs ($) (f) 4) Read and discuss the protocol

50 181 $13,155 9,050 $657,750 6) Generate the data (h) 4,012 242,582 200,600 12,129,100 7) Submit Progress Report 32 2,073 1,600 103,650 8) Compile and review the final data for submission 239 16,366 11,950 818,300 9) Complete paperwork to assemble the submission package 32 2,073 1,600 103,650

10) Submit final data to the EPA 5 440 250 22,000 11) Maintain records (g) 43 3,697 2,150 184,850 12) Delivery Costs 11 528 Total: 4,544 $280,397 227,200 $14,019,828 Key: (a) Activities are de scribed in more detail in section 4(b) of this ICR. (b) From Table 1, incl udes catch-up orders. (c) See Activity listing in Table 6. (d) See Activity listing in Table 7. (e) Total = (b) x (c)October 25, 2012

Page 38 of 44 (f) Total = (b) x (d) (g) Maintaining records of the initial Response is estim ated to be 1⁄2 of the totals in Tables 6 and 7. (h) Burden cost estimate is a percentage of the total test cost, which is calculated in Attachment F.

Table 11 – IC #2: Estimated Additional Burden and Costs for Data Generators and Submitters – Manufacturers and Importers of Pesticide Inert Ingredients

Activity (a) Total # Responses (b) Per Response Total Burden (hrs) (c) Cost ($) (d) Burden (hrs.) (e) Costs ($) (f) 4) Read and discuss the protocol

2 181 $13,155 362 $26,310 6) Generate the data (h) 4,012 242,582 8,024 485,164 7) Submit Progress Report 32 2,073 64 4,146 8) Compile and review the final data for submission 239 16,366 478 32,732 9) Complete paperwork to assemble the submission package 32 2,073 64 4,146

10) Submit final data to the EPA 5 440 10 880 11) Maintain records (g) 43 3,697 86 7,394 12) Delivery Costs 11 21 Total: 4,544 $280,397 9,088 $560,793 Key: (a) Activities are de scribed in more detail in section 4(b) of this ICR. (b) From Table 1, incl udes catch-up orders. (c) See Activity listing in Table 6. (d) See Activity listing in Table 7. (e) Total = (b) x (c) (f) Total = (b) x (d) (g) Maintaining records of the initial Response is estim ated to be 1⁄2 of the totals in Tables 6 and 7. (h) Burden cost estimate is a percentage of the total test cost, which is calculated in Attachment F.

The total IC #2 burden and costs is therefore a total of 236,288 hours ( 227,200 hours + 9,088 hours) and $14,580,621 ($14,019,828 + $560,793).

IC #3: Consortium Participants

This IC category is intended to cap ture the additional burden and costs ex pected for a subset of the order recipients who are participating in a consortium. As discussed previ ously, the EPA assumes that when there are more than one order recipients for a partic ular chemical, the recipients will join forces to generate and submit the data in response to the orde r. If the order recipient is not the lead, they are assumed to be participants in that effort. For this IC category, the agency assumes that these respondents will also engage in the activities identified in Tabl es 6 and 7 as activity 5, which is associated with participating in a consortium.

Again, the EPA has issued all orders for the 67 chemicals on the initial list of chemicals and is assuming that there will be no more new data generators or submitters ( i.e. , no new consortium) for this IC category. However, the EPA is making the assumption th at 60 "catch-up" order re cipients (45 pesticide active ingredients and 15 pesticide inert ingredie nts over a 3 year period) will join an existing consortium to generate data.October 25, 2012

Page 39 of 44 Table 12 – IC #3: Estimated Additional Burden and Costs for Consortium Participants – Registrants of Pesticid e Active Ingredients

Activity (a) Total # Responses (b) Per Response Total Burden (hrs) (c) Cost ($) (d) Burden (hrs.) (e) Costs ($) (f) 5) Participate in Consortium 252 171 $11,760 43,092 $2,963,520 Total: 171 $11,760 43,092 $2,963,520 Key: (a) Activities are de scribed in more detail in section 4(b) of this ICR. (b) From Table 1, incl udes catch-up orders. (c) See Activity listing in Table 6. (d) See Activity listing in Table 7. (e) Total = (b) x (c) (f) Total = (b) x (d)

Table 13 – IC #3: Estimated Additional Burden and Costs for Consortium Participants – Manufacturers and Importers of Pesticide Inert Ingredients

Activity (a) Total # Responses (b) Per Response Total Burden (hrs) (c) Cost ($) (d) Burden (hrs.) (e) Costs ($) (f) 5) Participate in Consortium 21 171 $11,760 3,591 $246,960 Total: 171 $11,760 3,591 $246,960 Key: (a) Activities are de scribed in more detail in section 4(b) of this ICR. (b) From Table 1, incl udes catch-up orders. (c) See Activity listing in Table 6. (d) See Activity listing in Table 7. (e) Total = (b) x (c) (f) Total = (b) x (d)

The total IC #3 burden and costs is therefore a total of 46,683 hours (43,0 92 hrs + 3,591 hrs) and $3,210,480 ($2,963,520 + $246,960).


### 6(c) Estimating Agency Burden and Cost

For the agency activities, the EP A estimated the burden hours by consid ering the activities themselves and the expected amount of time that the activity ma y involve on average. These estimates consider the agency's experience with simila r data collection activ ities. The estimated per chemical/respondent burden hours for the agency are presented in Table 14. To calculate the total potential agency burden over the three years, the EPA has multiplied this burden by the total number of chemicals (667 hours x 52 chemicals = 35,204 hours).October 25, 2012

Page 40 of 44 Table 14 – Estimated Agency per Chemical Burden Hours Activity (a) Managerial Technical Clerical Total 1) Prepare instructions 2 12 2 16 2) Identify chemicals to be screened 2 21 2 25 3) Identify recipients 2 16 0 18 4) Prepare the 408(p) order packages 0 4 10 14 5) Review and approve the orders 2 4 0 6 6) Issue the orders 0 0 6 6 7) Process initial responses (b) 1 4 1 6 8) Provide assistance and fo llow-up, as needed 0 36 0 36 9) Identify non-responders 0 0 1 1 10) Process Data Submissions 0 8 1 9 11) Analyze data (c) 0 440 0 440 12) Incorporate data into risk assessments (d) 0 88 0 88 13) Store data in retrievable system 0 4 8 12 Total Burden: 9 637 31 677 (a) Activities described in more detail in section 5(a) of this ICR. (b) This estimate includes an estimated burden to provide any additional burden requested for an option. (c) Assumes 40 hrs per assay (40 x 11). (d) Assumes 8 hrs per assay (8 x 11).
The costs are calculated using the U.S. Departme nt of Labor, Bureau of Labor Statistics data 14 and the methods identified in section 6(a) (i) of this ICR based on the NAICS 999100, Federal Executive Branch. The resulting loaded labor rates were used to calc ulate these costs: Manage rial = $118.62; Technical = $76.74; and Clerical = $43.43. The estimated burden hour costs for the agency are presented in Table 15. To calculate the total potential agency costs ov er the three years, the EPA has multiplied the per chemical cost in Table 14 by the total num ber of chemicals ($51,297 x 52 chemicals = $2,667,444).

Table 15 – Estimated Agency Per Chemical Burden Hour Costs

Activity (a) Managerial Technical Clerical Total $118.62 $76.74 $43.43 1) Prepare instructions $237 $921 $87 $1,245 2) Identify chemicals to be screened 237 1,612 87 1,936 3) Identify recipients 237 1,228 0 1,465 4) Prepare the 408(p) order packages 0 307 434 741 5) Review and approve the orders 237 307 0 544 6) Issue the orders 0 0 261 261 7) Process initial responses (b) 119 307 43 469 8) Provide assistance and follow-up, as needed 0 2,763 0 2,763 9) Identify non-responders 0 0 43 43 10) Process Data Submissions 0 614 43 657 11) Analyze data 0 33,766 0 33,766 12) Incorporate data into risk assessments 0 6,753 0 6,753 13) Store data in retrievable system 0 307 347 654 Total Cost: $1,067 $48,885 $1,345 $51,297 Key: (a) Activities described in more detail in section 5(a) of this ICR. (b) This estimate includes an estimated burden to provide any additional burden requested for an option.

14 http://www.bls.gov/oes/current/naics4_999100.htmOctober 25, 2012

Page 41 of 44 

### 6(d) Total Burden Hours and Co sts for the ICR (Bottomline)

The total estimated burden and costs for the information collection activities associated with the renewal of the ICR for the initial list of chemicals to be screened under the EDSP is presented in Table 16.

Table 16 – Estimated TOTAL Respondent Burden and Costs for ALL Activities

Respondent Category (a) Total # Responses (b) Per Response (c) Total (d)
Burden

(hrs) Cost ($) Burden (hrs) Costs ($) Registrants of PAIs IC #1(a) - Order Recipients 45 204 $18,572 9,180 $835,740 IC #2(a) - Data Generators/Submitters 50 4,544 $280,397 227,200 $14,019,828 IC #3(a) - Consortium Participants 252 171 $11,760 43,092 $2,963,520 Subtotal for Pesticide Active Ingredients: 270,472 $17,819,088 Manufacturers/Importers of Pesticide Inert Ingredients IC #1(b) - Order Recipients 15 204 $18,572 3,060 $278,580 IC #2(b) - Data Generators/Submitters 2 4,544 $280,397 9,088 $560,793 IC #3(b) - Consortium Participants 21 171 $11,760 3,591 $246,960 Subtotal for Pesticide Inert Ingredients: 15,739 $1,086,333 Total: (e ) 385 9,838 $621,458 295,211 $18,905,421 Key: (a) Grouped by respondents and according to IC category as presented in section 6(b) of this renewal ICR. (b) From Table 1, incl udes catch-up orders. (c) See totals from Tables in section 6(b) of this renewal ICR. (d) Total = (b) x (c) (e) Calculated by adding the column.

The total potential respondent burden and cost calculated in this renewal ICR involves activities that cannot be divided by year. The agency has calculated the total burden and assume d a 3-year duration of equal effort to calculate the annual burden and cost for this ICR. As such, the total respondent burden and costs for this ICR (as presente d in Table 14) is simply divided by 3 to get an estimated annualized burden of 98,403 hours (295,211 hours ÷ 3) and an estim ated annualized cost of $6,301,807 ($18,905,421 ÷ 3).

Table 17 – Annualized Estimated Total Responde nt Burden and Costs for ALL Activities

Respondent Category (a) Total # Responses (b) Per Response (c) Total (d)

Burden (hrs) Cost ($) Burden (hrs) Costs ($)
Registrants of PAIs IC #1(a) - Order Recipients

45 68 $6,191 3,060 $278,580 Recording Keeping 54 4,958 2,415 223,125 Reporting 14 1,232 645 55,455 Non-Burden Costs 0 0 0 0 IC #2(a) - Data Generators/Submitters

50 1,515 $93,466 75,733 $4,673,276 Recording Keeping 1,500 92,230 75,017 4,611,483 Reporting 14 1,232 717 61,617 Non-Burden Costs 0 3.52 0 175.83 IC #3(a) - Consortium Participants

252 57 $3,920 14,364 $987,840 Recording Keeping 57 3,920 14,364 987,840 Reporting 0 0 0 0 Non-Burden Costs 0 0 0 0 Subtotal for Pesticide Active Ingredients: 93,157 $5,939,696October 25, 2012

Page 42 of 44 Respondent Category (a) Total # Responses (b) Per Response (c) Total (d)

Burden (hrs) Cost ($) Burden (hrs) Costs ($)
Manufacturers/Importers of Pesticide Inert Ingredients IC #1(b) - Order Recipients

15 68 $6,191 1,020 $92,860 Recording Keeping 54 4,958 805 74,375 Reporting 14 1,232 215 18,485 Non-Burden Costs 0 0 0 0 IC #2(b) - Data Generators/Submitters

2 1,515 $93,466 3,029 $186,931 Recording Keeping 1,500 92,230 3,001 184,459 Reporting 14 1,232 29 2,465 Non-Burden Costs 0 3.52 0 7.03 IC #3(b) - Consortium Participants

21 57 $3,920 1,197 $82,320 Recording Keeping 57 3,920 1,197 82,320 Reporting 0 0 0 0 Non-Burden Costs 0 0 0 0 Subtotal for Pesticide Inert Ingredients: 5,246 $362,111 Total: (e) 385 3,279 $207,152 98,403 $6,301,807 Key: (a) Grouped by respondents and according to IC category as presented in section 6(b) of this renewal ICR. (b) From Table 1, incl udes catch-up orders. (c) Calculated by taking the totals from the Tables in section 6(b) of this renewal ICR (see al so Table 16), and dividing by 3. Numbers are rounded. (d) Total = (b) x (c) (e) Calculated by adding the column.

To calculate the total potential agency burden and cost over the three years, the EPA has multiplied the per chemical burden and cost in Tables 13 and 14 by the total number of chemicals for a total agency burden of 35,204 hours (677 x 52 chemicals) and a cost of $2,667,444 ($51,297 x 52 chemicals). Divided by 3 to get an estimated annualized burden of 11,735 hours (35,204 ÷ 3) and an estimated annualized cost of $889,148 ($2,667,444 ÷ 3).


### 6(e) Reasons for Changes in Burden Estimates

This request represents a decrease of the annualized burden by 63,012 hours from that currently in the OMB inventory (from 161,415 hours to 98,403 hours). This change is an adjustment in burden estimates due to the planned progression of the collection activities associated w ith the initial list of chemicals to be screened under the ED SP. This change is an adjustment.


### 6(f) Burden Statement for this ICR

The annual public burden for this information collect ion activity is estimated to range between 204 and 4,919 hours, depending on the responde nt category, with an estim ated cost between $18,572 and $310,729. Burden is defined in 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to respond to a collection of info rmation unless it displays a current and valid OMB control number. The OMB control numbers for the EP A's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

The EPA has established a docket for this ICR under docket ID No. EPA-HQ-OPPT-2011-0966, which is available electronically at http://www.regulations.gov . A hard copy of the docket materials are alsoOctober 25, 2012

available for public viewing at the OPPT Docket, whic h is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave ., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visito r log. All visitor bags are processed through an X-ray mach ine and subject to search. Visito rs will be provided an EPA/DC badge that must be visible at all times in the building and re turned upon departure.



### 7. List of References

The following is a list of the documents that are sp ecifically referenced in this document, along with information about where to access the documents:

1. Endocrine Disruptor Screening Program; Notice (63 FR 42852, August 11, 1998) http://www.epa.gov/scipoly/oscp endo/pubs/081198frnotice.pdf

. 2. Endocrine Disruptor Screening Program; Propos ed Statement of Policy; Notice (63 FR 71541, December 28, 1998) http://www.epa.gov/scipoly/oscp endo/pubs/122898frnotice.pdf

. 3. Draft List of Initial Pesticide Active Ingredie nts and Pesticide Inerts to be Considered for Screening under the Federal Food, Drug, and Cosmetic Act; Notice (72 FR 33486, June 18, 2007) http://www.epa.gov/scipoly/ oscpendo/pubs/draft_list_frn_061807.pdf

. 4. Final List of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for Screening under the Federal Food, Drug, and Cosmetic Act; Notice (74 FR 17579, April 15, 2009) http://www.epa.gov/fedrgstr/EPA-PEST/2009/April/Day-15/p8709.pdf

. 5. Endocrine Disruptor Screening Program (EDSP) ; Draft Policies and Procedures Document; Request for Comment; Notice (72 FR 70842, December 13, 2007) http://www.epa.gov/scipoly/oscp endo/pubs/draft_policies_frn.pdf

. 6. Endocrine Disruptor Screening Program (EDSP); Po licies and Procedures for Initial Screening; Notice (74 FR 17560, April 15, 2009) (see Attachment B to this ICR) http://www.epa.gov/fedrgstr/E PA-PEST/2009/April/Day-15/p8706.pdf

. 7. U.S. Postal Service, Online Ra te Calculator, as of May 7, 2012. http://postcalc.usps.gov/

. 8. EPA Report "Laboratory Testing of Chemicals for Endocrine Disruption Potential - Analysis of Market Factors" (October 14, 2009).

9. Crop Life America, EDSP Tier 1 Screening; Preliminary Burden Report dated November 2010 submitted by Crop Life America's Endocrine Policy Forum.


### 8. Attachments

All of the attachments listed below can be found in the docket for this ICR (unless otherwise noted); and are accessible elec tronically through http://www.regulations.gov , under Docket ID Number: EPA-HQ-OPPT-2011-0966.

Attachment Description A FFDCA sections 408(p) , 408(i). Available at http://epw.senate.gov/FDA_001.pdf

.

Page 43 of 44October 25, 2012

Page 44 of 44 Attachment Description Paragraph 408(p) begins on page 84. Paragraph 408(i) begins on page 77. B Endocrine Disruptor Screening Program (E DSP); Policies and Procedures for Initial Screening; Notice (74 FR 17560, April 15, 2009) http://www.gpo.gov/fdsys/pkg/FR-2009-04-15/pdf/E9-8706.pdf C (1 ) FFDCA 408(p) Order Template for Pesticid e Registrants (As of September 16, 2009). (2 ) FFDCA 408(p) Order Template for Pesticid e Inert Ingredients (As of September 16, 2009). D (1 ) Initial Response Form for Individual Or der Recipients (As of April 3, 2009). (2 ) Initial Response Form for Consortiu m/Task Force (As of April 3, 2009). E Overall Process for EDSP Orders (April 3, 2009). F Calculations for Paperwork Burden and Co sts for Data Generati on Activities (July 30, 2012). G Final List of Chemicals for Initial Ti er 1 Screening in the EDSP (April 3, 2009). H Compendium of C onsultation Responses I Response to Public Comments Document