June 9 , 201 5



### 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 2 Data Collection for Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)

1(a)(ii) EPA ICR No.: 2479.01

OMB Control No.: 2070

- New

Docket ID No.: EPA

– HQ

– OPPT

– 2013

– 0171



### 1(b) Short Characterization/Abstract

This is a new information collec tion request (ICR) under the Paperwork Reduction Act (PRA)

, 1
covering the information collection activities associated with Tier 2 testing of chemicals under EPA ' s Endocrine Disruptor Screening Program (EDSP). The EDSP is established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 2 which requires EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information (OSRI) to determine whether certain substances may have hormonal effects.

The EDSP consists of a two

- tiered approach to screen chemicals for potential endocrine disrupting

effects. The purpose of Tier 1 screening is to identify substances that have potential bioactivity with estrogen, androgen, or thyroid horm one systems using a battery of assays. 3 Based on a Weight

- of

Evidence (WoE) analysis of the Tier 1 battery results

, su bstances that have potential bioactivity with estrogen, androgen or thyroid hormone systems will be considered for Tier 2 testing , which is designed to identify any adverse endocrine

- related effects caused by the substance, and to establish a quantitative relationship between the dose and that endocrine effect. 4 Tier 2 test order recipients will be identified

based on the results o f the Tier 1 screening of a given chemical. Tier 2 test orders will be issued to chemical manufacturers/importers and pesticide registrants for which the Agency has made a WoE 5

determination for a chemical that some, or all

, of the Tier 2 tests are requir ed.

To date, the Agency issued 779 orders requiring Tier 1 testing on the 67 pesticide chemicals that comprise List 1. Respondents supported 52 of the 67 chemicals. The agency is reviewing the data

submitted in response to the orders for each chemical to d etermine if Tier 2 testing is needed

.

A separate ICR addresses the information collection activities associated with Tier 1 screening orders (see OMB Control No. 2070

- 0176) , so this ICR does not address any of the information collection

1 44 U.S.C. 3501 et seq ., http://www.archives.gov/federal

- register/laws/paperwork

- reduction/

. 2 FFDCA sections 408(p), Estrogenic Substances Screening Program ; 408(i)

, Confidentiality and Use of Data.

—
. Available

at http://epw.senate.gov/FDA_001.pdf

. Paragraph 408(p) begins on page 84. Paragraph 408(i) begins on page 77.

3 Nothing in the identification of chemicals for Tier 1 screening or Tier 2 testing under the EDSP provides a basis to infer that these chemicals are suspected to interfere with the endocrine systems of humans or other species, and it would be inappropriate to do so.

4 Additional detail regarding EPA's EDSP is available via the Agency 's Web site at http://www.epa.gov/endo

. 5 U.S. EPA OCSPP, EDSP, Weight

- of

- Evidence: Evaluating Results of EDSP Tier 1 Screening to Identify the Need for Tier 2 Testing , September 14, 2011. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2010

- 0877

- 0021

Page 1 of 30June 9 , 201 5

activities associat ed with Tier 1 under the EDSP. Instead, this ICR specifically address es the

information collection activities associated with Tier 2 of the EDSP

. As such, th is ICR covers those

chemicals that were BOTH screened under Tier 1 of the EDSP and identified for testing under Tier 2 of the EDSP. The ICR covers the full range of information collection activities associated with Tier 2 of the EDSP, including the paperwork activities associated with the issuance of Tier 2 orders, initial responses fro m order recipients, paperwork activities associated with generating the data requested, and submitting the data to EPA pursuant to the order

.

EPA has no experience with this specific information collection and therefore, the exact proportion of

chemicals that will proceed to Tier 2 testing is unknown, but for the purpose of estimation under this

ICR the Agency will assume 50% of the chemicals on List 1 , or 26 chemicals will proceed to Tier 2 testing

. Similarly, in the absence of Tier 1 screening results to determine and inform which Tier 2 tests may be needed, it is not possible to make a n accurate estimate of which Tier 2 tests may be indicated in

the individual Tier 2 orders for each chemical . Thus, EPA will assume that each Tier 2 order could

include all four validated Tier 2 tests

.

Under the PRA, the ICR is intended to cover a three year period. Although the ICR activities may be described in an “annual” context, the activities may occur during th e three year period or longer. For presentation in this ICR and for the purposes of calculating burden, the activities are identified as annual, and then the total burden is averaged over the three year period.



### 2 Need For and Use of the Collection

2(a) Need/Authority for the Collection

The Agency ' s authority f or the information collection activities associated with the EDSP includes authorities under the FFDCA, the Safe Drinking Water Act ( SDWA ) , the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA)

. This i nformation 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 potential bioactivity with estrogen, androgen, or thyroid hormone systems.

The EDSP was established in 1998 to carry out the mandate in section 408(p) of the FFDCA, which

directs EPA " to develop a screening program

... to determine whether certain substances may have an effect in humans that is similar to an effect produced by a natu rally occurring estrogen, or such other endocrine effect as the Administrator may designate. " If a substance is found to have such an effect, section 408(p)(6) directs the A dministrator to take action under available statutory authority to ensure protecti on of public health.

FFDCA section 408(p)(1) requires EPA " to develop a screening program, using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may

have an effect in humans that is s imilar to an effect produced by a naturally occurring estrogen, or such

other effect as the Administrator may designate " [21 U.S.C. 346a(p)].

FFDCA section 408(p)(3) expressly requires that EPA " shall provide for the testing of all pesticide

chemicals. " F FDCA section 201 defines " pesticide chemical " as " any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and pesticide inert ingredients of such pesticide " [FFDCA section 201(q) (1), 21 U.S.C. 231(q)(1)]. The

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statute also provides EPA with discretionary authority to " provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator

determines that a substantial population may be exposed to such a substance " [21 U.S.C. 346a(p)(3)].

FFDCA section 408(p)(5)(A) provides that the Administrator " shall issue 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 described in paragraph (1) , and submit information obtained from the testing to t he Administrator

, within a reasonable time period that the Administrator determines is sufficient for the generation of the information " [ 21 U.S.C. 346a(p)(5)(A) ]

.

The statutes discussed in this subsection provide EPA with the discretion to require testing of a pesticide chemical under FFDCA alone, or in any combination of the various authorities ( e.g. , FIFRA/FFDCA, SDWA/FFDCA or FIFRA/SDWA/FFDCA).

FFDCA section 408(p)(5)(B) requires that, " T o the extent practicable, the Administrator 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 information " [21 U.S.C. 3 46a (p)(5)(B)].

If a registrant fails to comply with an order issued under FFDCA section 408(p)(5), the Administrator is required to issue " a notice of intent to suspend the sale or distribution of the substance by the registrant

. Any suspension proposed under this paragraph shall become final at the end of the 30

– day period beginning on the date that the registrant receives the notice of intent to suspend, unless during that period a person adversely affected by the notice requests a hearing or the Admini strator determines that the registrant has complied fully with this paragraph " [21 U.S.C. 346a (p)(5)(C) (i) ]. 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 " T he only matter for resolution at the hearing shall be whether the registrant has failed to comply with a n order under subparagraph (A) of this paragraph " [21 U.S.C. 346a (p)(5)(C)(ii)]

. A decision by the Administrator aft er completion of a hearing is considered to be a final A gency 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 section 408(p)(5) [21 U.S.C. 346a (p)(5)(C)(iii)].

FFDCA section 408(p)(5)(D) provides that any person (other than a registrant) who fails to comply with an order issued under FFDCA section 408(p)(5) shall be liable for the same penalties and sa nctions 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 section 16. Under section 16 of TSCA, civil penalties of up to $ 37,500 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 procedures that the Agency " shall use " to require data to support t he continuation of a tolerance or exemption [ from a tolerance ] that is in effect

. The provision identifies three options:

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

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

Page 3 of 3 0June 9 , 201 5

3. Publication of a notice in the Federal Register (FR) requiring submission, by certain dates, of a commitment to generate the data " by one or more interested persons " [FFDCA section

40 8(f)(1)(C)].

Before using the third option, EPA must demonstrate why the data " could not be obtained " using either of the first two options. FFDCA section 408(f)(1) expressly provides that EPA may use these procedures to " require data or information perta ining to whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other

endocrine effects. " Finally, FFDCA section 408(f)( 2 ) provides that, in the event of failure to comply

wit h a rule under TSCA section 4 (FFDCA section 408(f)(1)(B) or an order under FFDCA section 408(f)(1)(C), EPA may, after notice and opportunity for public comment, modify or revoke any tolerance or exemption [ from a tolerance ] to which the data are relevant.

In addition, FFDCA section 408(i) provides that " [d]ata and information that are or have been submitted to the Administrator under this section or section 409 in support of a tolerance or an exemption from a

tolerance shall be entitled to confidential tre atment for reasons of business confidentiality and to exclusive use and data compensation to the same extent provided by section 3 and section 10 of [FIFRA]. " 6

FIFRA section 3(c)(1)(F) provides certain protections for people who submit data to EPA in conne ction

with decisions under EPA ' s pesticide regulatory program. Specifically, 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 ownership in terest), in support of an application for registration, reregistration, or experimental use permit, or to maintain an existing registration.

Applicants who cite qualifying data previously submitted to the A gency by the original data submitter must certify that the original data submitter has granted permission to the applicant to cite data or that the applicant has made an offer of compensation to the original data submitter. 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 authorization from the original data submitter

. (Data are generally entitled to " exclusive use " for 10 years a fter the date of the initial registration of a pesticide product containing a new active ingredient.) If data are not subject to exclusive use but are compensable, an applicant may cite the data without the permission of the original data submitter, so

lo ng as the applicant offers to pay compensation 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 applicant and an original data submitter cannot agree on the appropr iate amount of compensation, either may initiate binding arbitration to reach a determination. If an applicant fails to comply with either the statutory requirements or the provisions of a compensation agreement or an arbitration decision, the application or registration is subject to denial or cancellation. [See also 7 U.S.C. 136a (c)(1)(F)(ii)

– (iii)].

FIFRA section 3(c)(2)(B) provides that "

... [i]f the Administrator determines that additional data are required to maintain in effect an existing registratio n 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 person. " [7 U.S.C. 136a(c)(2)(B) (i) ]. Continued registration of a pestic ide

6 FFDCA sections 408(p), Estrogenic Substances Screening Program; 408(i), Confidentiality a nd Use of Data.

— . Available

at http://epw.senate.gov/FDA_001.pdf . Paragraph 408(p) begins on page 84. Paragraph 408(i) begins on page 77.

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requires that its use not result in " unreasonable adverse effects on the environment " (defined as " (1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental cost and benefits of the use of any pest icide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of

the FFDCA. " ) [7 U.S.C. 136(bb)].

FIFRA section 3(c)(2)(B) (ii) contains a mechanism by which recip ients of notices of data requirements (referred to as " Data Call

- In notices " 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 suc h data in support of maintenance of such registration. " The section establishes procedures to allow registrants who received DCI notices to use binding arbitration to resolve disputes about each

person ' s fair share of the testing costs.

Further, FIFRA sec tion 3(c)(1)(F) makes clear that data submitted under FIFRA section 3(c)(2)(B) are

also " compensable " when cited in support of an application for a registration. 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 generator. Lastly, the A gency may suspend the registration of a pesticide if the registrant fails to take appropriate steps to provide data required under a DCI notice

in a timely manner.

Finally, FIFRA section 3(c)(2)(D) contains a provision, referred to as the " formulator ' s exemption " that is intended to simplify and promote equity in the implementation of the data compensation program under FIFRA section 3(c)(1)(F). This exemption relieves an applicant of the obligation to submit a study, or to cite and obtain permission or offer to pay data compensation to cite the results of a study if the study is relevant to the safety assessment of a registered product that the a pplicant buys from another

person and uses to make the applicant ' s product. Congress ' rationale for this exemption is that the seller will recover any data generation costs through the purchase price of its product. Thus, if a pesticide formulator applie s to register a product 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 t he purchased product. The Agency has extended the principles of the formulator ' s exemption to data requirements under FIFRA section 3(c)(2)(B). Consequently, if the formulator received a DCI notice requiring data on the active ingredient, the formulator could comply by providing documentation that it bought the active ingredient from another registrant.

In addition, section 1457 of SDWA provides EPA with discretionary authority to provide for the testing, under the FFDCA section 408(p) screening program, " of any other substance that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed

to such substance. " [42 U.S.C. 300j

– 17].



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

In general, EPA intends to use the data collected under the EDSP, along with other information, to determine if the chemical may pose a risk to human health or the environment due to disruption of the endocrine system. 7 The determination that a chemical does or is not likely to have potential b ioactivity with the endocrine system ( i.e. , estrogen, androgen, or thyroid hormone systems) will be made on a

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

.

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W o E 8 basis taking into account all available data on the compound

, including data from the Tier 1 screening assays and/or OSRI

. The fact that a s ubstance is bioactive with a hormone system based on

Tier 1 screening , however, does not mean that when the substance is used, it will cause adverse effects in humans or ecological systems.

The ultimate purpose of the EDSP is to provide information that will allow the A gency to evaluate the risks associated with the use of a chemical and take appropriate steps to mitigate any risks of concern

. The necessary information includes data identify ing any adverse effects that might result from the bioactivity of a substance with the endocrine system and establishing a dose

- response curve.

More specifically, Tier 2 testing consists of a group of individual in vivo tests designed to include males

and females with an intact hypothalamic

- pituitary

- gonadal axis, multiple pathways of exposure and life

stages, and various taxa to further identify and characterize chemical

- induced bioactivity with estrogen, androgen or thyroid hormone systems for risk asses sment

. Tier 2 testing is designed to identify any

adverse endocrine

- related effects caused by the substance, and establish a quantitative relationship

between the dose and that endocrine effect for risk assessment to inform regulatory decisions

.

Within th e Office of Chemical Safety and Pollution 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 for EPA activities rela ted to the issuance of the

o rders, receiving, processing and maintaining records of responses to the o rders, as well as other

administrative functions related to the o rders. The review of Tier 2 testing data received and resulting

determinations related t o the subject chemical will be based on a coordinated EPA effort that may also include other EPA offices, e.g. , Office of Research and Development (ORD), Office of Water (OW).



### 3 Non

- Duplication, Consultation, and Other Collection Criteria

3(a) Non

- duplication

The information collected under this program is collected by no other federal agency or other office

within EPA . FFDCA specifically assigns this task to EPA

. The EDSP is the only program in the United States mandated to validate and require testing of chemicals for their potential to disrupt the endocrine

system.

In addition, the A gency is commit t e d to prevent ing duplication in its testing programs, including in its implementation of the EDSP. EPA also actively promotes efficiency through its harmonized test guidelines , the acceptance of OSRI and active participation in the rigorous scientific effort to identify data needs for risk assessments, develop testing protocols, and develop new methods for testing chemicals that minimize potential duplication, create greater efficiencies in testing, and minimize the use of animals in testing.

As a charter member of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), EPA is working in a manner consistent with the interagency validation framework in the development and refinement of tests to reduce animal use, refine procedures involving animals to

8 EPA OCSPP, EDSP, Weight

- of

- Evidence: Evaluating Results of EDSP Tier 1 Screening to Identify the Need for Tier 2 Testing , September 14, 2011. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2010

- 0877

- 0021 , or http://www.epa.gov/endo/pubs/edsp21_work_plan_summary%20_overview_final.pdf

.

Page 6 of 30June 9 , 201 5

make them less stressful, and replace the use of animals in tests where scientifically appropriate. EPA is

us ing vali dated test methods to identify and characterize the endocrine activity of pesticides, commercial chemicals, and environmental contaminants, specifically relat ed to the estrogen, androgen, and thyroid

hormone systems

.

The A gency considered these goals in de veloping the procedures for the EDSP, both those procedures

used within EPA, and those that might be used by the respondents. For example, when several companies manufacture a chemical , the procedures encourage the companies to collaborate to develop

and submit a single set of the requested data to EPA. In addition, order recipients and other interested

stakeholders may cite existing or submit OSRI that they believe meet the requirements defined in the

order

.



### 3(b) Public Notice Required Prior to ICR Submi ssion to OMB

On June 24, 2013 , EPA published a notice in the Federal Register to provide a 60

- day public notice and comment period on the draft ICR. 9 EPA received five sets of comments from a total of eight entities, and has prepared a response to comment document ( Attachment E)

. Several changes were made to the ICR in response to public comments. The substantive changes are highlighted in this section.

• The total number of test order r ecipients (Tabl e 1) was dec r eased from 210 to 100

.

• The burden hours and costs associated with the Mysid Two

- Generation Toxicity Test are no longer included under this ICR

.

• The labor rates and inflation costs were updated to reflect the latest data available from the

Bure au of Labor Statistics

.

• The Agency burden hours were increase d by 50% (Table 9).

As a result of these changes, there is a 25 % reduction in the overall industry burden hours, and a 20 % reduction in the industry cost s associated with this ICR.



### 3(c) Consultat ions

EPA used an extensive public process in developing and implementing the EDSP. 10 Since the

establishment of the EDSP in 1998, EPA has consulted with various stakeholders throughout its development and implementation efforts, including: agrochemical and commodity chemical industries, environmental organizations, public health organizations, academia, animal welfare organizations, state

governments and federal agencies, including consultation with the Department of Health and Human

Services. A historical overview of the external consultations and public comment opportunities provided since 1996 is available on EPA ' s Website. 11

9 78 FR 37803 June 24, 2013. http://www.gpo.gov/fdsys/pkg/FR

- 2013

- 06

- 24/pdf/2013

- 15035.pdf

10 Ad ditional information about EPA ' s public process is available on the Agency' s Website at http://www.epa.gov/endo/pubs/stakeholder/index.htm

. 11 http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/index.htm

Page 7 of 30June 9 , 201 5

In addition to the solicitation of public comment on th e draft ICR, EPA meets with stakeholders and presents regular up dates at the Pesticide Program Dialogue Committee (PPDC) meetings. 12

5 CFR 1320.8(d)(1) require s EPA 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 whe ther changes have or have not been made to the collection activity

.



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

Once per chemical substance is the statutory minimum under FFDCA

. FFDCA section 408(p)(3) specifically requires that EPA " shall provide for the t esting of all pesticide chemicals, " unless the

A gency can determine that the chemical qualifies for the statutory exemption

— i.e. , that it is not anticipated be bioactive with the endocrine system.

For purposes of this ICR, the Agency assumes that all recip ients of a Tier 2 test order will provide an initial response and either generate the data or join a consortium to generate the data, while the submission of a progress report and the data will occur only once per chemical.



### 3(e) General PRA Guidelines

The one general PRA guideline that is exceeded by this collection is the time period for retaining records as it relates to pesticides.

When data are generated to support a pesticide registration under FIFRA, the requirements in

40 CFR 169.2(k) apply, which state that records containing research data relating to registered pesticides be retained for as long as the registration is valid and the producer remains in business. Registrations are valid until they are either voluntarily cancelled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration

. Since the average period of marketability of a pesticide ranges from 15 to 30 years, the PRA guidelines specifying that data other than health, medical or tax records

are not required to be retained for more than three years will be exceeded in this ICR.

In those regulatory cases where the A gency ' s action may be challenged, it is imperative that all records, raw data, and specimens be available

. Recogniz ing 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 the EDSP for these chemicals because the data

submitted would be used to support pesticide registration related decisions under FIFRA and FFDCA.

However, when the data are being generated for a chemical that is not a pesticide active or pesticide

inert ingredient , those record reten tion requirements do not apply.



### 3(

f) Confidentiality

The polic ies and procedures that EPA generally intends to apply under the EDSP are addressed in the original EDSP Policies and Procedures for Initial Screening [74 FR 17560

- 17579 (April 15, 2009)]

12 The PPDC was established under the Federal Advisory Committee Act (FACA) to provide a forum for a diverse group of stakeholders to provide feedback to the p esticide program on various pesticide regulatory, policy and program implementation issues. For additional information about the PPDC, go to http://www.epa.gov/oppfead1/cb/ppdc/

.

Page 8 of 30June 9 , 201 5

( Reference 1 )

, and the EDSP Final Polici es and Procedures for Screening SDWA Chemicals [78 FR 35909

- 35922 (June 14, 2013)] ( Reference 2 )

. In general, most health and safety data submitted by registrants, manufacturers, and importers under FFDCA are considered to contain no Confidential

Business Information (CBI). Although FFDCA section 408(p)(5)(B) requires that EPA develop, as necessary, procedures for the handling of confidential business information, it does not provide the authority for the Agency to either create new rights or to modify ex isting rights to confidentiality. Rather, EPA believes that this provision directs the Agency to create procedures that operate within the existing confines of FIFRA section 10, the Freedom of Information Act (FOIA), and the Trade Secrets Act (TSA).

As di scussed in more detail in the 2009 policies and procedures document, when the data are submitted to support a tolerance or exemption from the requirement of a tolerance, 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 protections in FIFRA section 10. In addition, CBI submitted by pesticide registrants in

response to an order issued under FFDCA section 408(p) would 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 pr otections that go beyond those authorized by FOIA. For example, FIFRA section 10(g) generally prohibits EPA from releasing information submitted by a registrant under FIFRA to a foreign or multinational pesticide producer, and requires the A gency to obtai n 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 available under FIFRA section 10 for data submitted in sup port of a tolerance or tolerance exemption.

All other confidential business information submitted in response 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 provisions of FOIA and TSA. FOIA requires agencies to make information available to the public upon request, except for information that is " specifically made confidential by other statutes "

or data that are " trade secrets and commercial or financial information obtained from a person and is privileged or confidential. " [5 U.S.C. 552]. Note that substantive criteria must be met to claim confidentiality of business information, as specified in 40 CFR 2.208.

As indicated previously, EPA would consider t hat data submitted jointly with a registrant, or as part of a consortium 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 sectio n 10. However, if a non

- registrant chooses not to partner with a registrant, or the chemical is neither a pesticide active or inert ingredient

, such data would only be subject to the protections available under

FOIA and the TSA.



### 3(g) Sensitive Questions

N o information of a sensitive or private nature is requested in conjunction with this information collection activity

. Further, this information collection activity complies with the provisions of the Privacy Act of 1974 and OMB Circular A

- 108.

Page 9 of 30June 9 , 201 5



### 4 The Respo ndents and the Information Requested

4(a) Respondents

Respondents to the information collection activities covered by this ICR consist of those individuals and companies who receive a Tier 2 test order in accordance with FFDCA section 408(p). The responde nts that will be identified for Tier 2 testing will be a subset of those Tier 1 order recipients that have conducted Tier 1 screening to satisfy those orders. EPA will identif y the recipients of Tier 2 test orders upon completion of the Tier 1 data reviews and W o E determinations on each chemical

. As with all orders issued, to fa cilitate consortia formation, EPA will make a list of the order recipients for each chemical publicly available.

Grouping Respondents by Information Collection (IC) Ac tivities : For purposes of the information collection activities covered by this ICR , the Agency has divided the respondent groups into the following distinct " IC " or information collection categories:

Order Recipients

. This category includes everyone tha t could receive a Tier 2 test order for one or

more of the chemicals.

Data Generators/Submitters

. This category includes one respondent for each chemical on which

Tier 2 test orders are issued

. EPA assum es that order recipients will work collaboratively to provide

the data , avoiding duplication of efforts

.

Consortium Participants

. This category includes all of the Tier 2 test order recipients, including those that are not in the data generators/submitters category. In addition, the A gency is assuming that the data generators/submitters will also incur burdens and costs associated with general participation in the consortium.

Table 1 presents the estimated number of respon dent s based on the A gency ' s efforts to date to identify potential Tier 2 test orde r recipients, and assumptions regarding the anticipated response from each respondent in terms of data generation or consortium participation. EPA assumes that there is only one

" data doer " per chemical and that all " catch

- up " 13 order recipients will join an already formed

consortium.

The A gency has made every effort to provide a reasonable estimate, but should the final number of recipients be greater once the orders are all prepared and issued for the year, the A gency will calculate

the difference and sub mit an Information Correction Worksheet (ICW) to OMB to have the total annual burden adjusted as appropriate.

13 "Catch

- up" orders are those orders issued to a registrant, manufacturer or importer of a chemical who either is identified or enters the market, after the issuance of initial EDSP test order(s) for that chemical. The Agency may issue "catch

- up" orders for up to 15 years followi ng issuance of the initial EDSP test order(s) for a given chemical. Recipients of catch

- up orders are expected to participate in the cost sharing if it relies on data developed or submitted by another recipient or consortium to satisfy its test order oblig ation.

Page 10 of 30June 9 , 201 5

Table 1

– Estimated Number of Potential Respondents/Responses

IC # IC Category Name Estimated Number of Respondents

1. Total Tier 2 Test Order Recipients 100

– Tier 2 Test Order Recipients 95

– Catch

- Up Orders 5

2

. Total Tier 2 Data Generators/Submitters 26

– Tier 2 Data Generators/Submitters 26

– Catch

- Up Orders 0

3. Total Tier 2 Consortium Participants 100

– Tier 2 Consortium Participants 95

– Catch

- Up Orders 5

The original EDSP ICR (EPA ICR No.: 2249.01, OMB Control No: 2070

- 0176 ) contemplated the

issuance of Tier 1 screening orders to registrants, manufactures and importers of 67 chemicals; comprised of 58 pesticide active ingredients (PAIs) and 9 pesticide inert ingredients

. Since 2009, when

the first Tier 1 orders were issued, order recipients have generated Tier 1 screening data (and/or submitted existing studies) for 52 (including 2 inerts) of the 67 chemicals

. Fifteen of the original 67 chemicals were withdrawn from the pesticide market or voluntarily cancelled their pestic ide registration

. For the purpose of this ICR, the Agency estimates that 50% of the remaining 52 chemicals

, for which screening data have been submitted to satisfy the Tier 1 order s , would be the subject of Tier 2 testing.

These numbers are used in calcu lating the burden and costs for the activities covered by this ICR, which are presented later in this document

. T he estimated total number of Tier 2 test order recipients is 10 0

.



### 4(b) Respondent Activities

Respondents would receive an individual Tier 2 test order from EPA using either " FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template for Pesticide Active Ingredients " (Attachment A (1) ) or

" FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template for Pesticide Inert Ingredients " (Attachment A(2))

. The order direct s the recipient to provide an initial response within 90 days of receiving the order using EPA Form No. 6300

- 07

, " EDSP Tier 2 Test ing, Initial Response Form for Individual Order Recipients " (Attachment B). If the recipient joins a consortium, the c onsortium is expected to provide a response within 150 days of receiving the order using EPA Form No. 6300

- 07

- C

, " EDSP Tier 2 Test ing, Initial Response Form for Consorti a /Task Force s " (Attachment C). EPA will include both forms in the

Tier 2 test order packet

. The order specif ies the required Tier 2 tests , and outlines the timeframes for fulfilling the Tier 2 testing and response to the order, including providing one

- year progress reports.

Overview of Covered Activities : Each recipient of an order is e xpected 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 d etails of how and to whom to respond. The recipient may also read additional information about the EDSP, including applicable policies and p rocedures document s ( References 1 and 2 ) that explain the A gency's

rational e for the requirements in the order and the specific details of the policies that EPA generally intends to adopt in implementing for the EDSP.

(2) Plan activities

– The recipient will plan the activities necessary to comply with the Tier 2 test order

based on their intended response to the order.

Page 11 of 30June 9 , 201 5

(3) Submit an initial response to EPA

– Each Tier 2 test order recipient is directed to provide an individual initial response to EPA that indicates how they intend to comply with the order. In addition, the design ated lead for the consortium is expected to submit a consortium response that

indicates how the consortium intends to comply with the order

.

(4) Read and discuss the protocol

– The Tier 2 test order recipients will read the protocols for the test s identifi ed in the order.

(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 Tier 2 test order. Although conducting the tests may involve many activi ties, it is important to note that only those activities that are attributable to the paperwork aspects and are imposed by the information collection itself are attributable to this

ICR.

(6) Report progress, compile and review the data

– Unless EPA has not ified a recipient in writing that the requirements of the Tier 2 test order have been satisfied, the order recipient is expected to submit a progress report to EPA within 12 months after the issuance of the order.

(7) Complete paperwork to assemble the submission package

– Those Tier 2 test order recipients that generate the data or serve as the consortium lead will be expected to compile the data results from performing the test(s), review the data for completeness and compliance, and assemble the

submi ssion package in accordance with the instructions provided in the order.

(8) Submit final data to EPA

– The final data package is then submitted to EPA following the specific instructions provided in the Tier 2 test order. The order recipient may also sub mit the data before the due date specified in the order.

(9) Maintain records

– All order recipients will be asked to maintain a record of their initial response for three (3) years. O rder recipients who submit data in support of a pesticide registration will also be asked to maintain records of that data pursuant to 40 CFR 169.2(k), which specifies that records containing research data relating to a registered pesticide be kept 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 potential respondent paperwork burden and costs associated with these activities, the Agency identified three separate labor categories: 1) managerial; 2) technical; and 3) cl erical

. Each activity identified previously may involve one or more labor or duty category. Table 2 (below), delineates the assumed recipient activities divided between the three labor categories.

Table 2

– Expected Tier 2 Test Order Recipient Activities by Labor Categories

Activity Managerial Duties Technical Duties Clerical Duties (1) Read EPA's policies and procedures

document Read EPA's policies and procedures

document

Review the EDSP Tier 2 test order Review the EDSP Tier 2 test order

Page 12 of 30June 9 , 201 5

Activity Managerial Duties Technical Duties Clerical Duties (2) Identify timeframe for response Identify and evaluate response options Evaluate response options

Plan activities Negotiate/establish co nsortium/ task force agreements Participate in con sortium/ task force

discussions (3) Determine response Recommend a response Oversee employee activities Complete response form Sign initial response forms Send to EPA (4) Communicate with EPA Review of protocol (deviations) Arrange logistics for calls or meetings with EPA Review Good Laboratory Practices ( GLPs ) or deviations Identify and discuss other scientifically relevant information

and related protocol and /or GLP

deviations (5) Plan/oversee e mployee and contract

activities Plan the data collection activiti es using the approved protocols

Secure contract lab services and approve statement of work (SOW) Conduct the tests, using protocols

and GLPs

Communicate with EPA, as appropriate Maintain records and procedures during testing per iod in accordance

with the GLPs Assist in preparing files

(6) Review final report(s) Compile and review data Prepare final data reports (7) A pprove final submission package Draft summa ry of the data for cover

letter P repare final submission package

Review final submission package (8) Approve/sign submission Send submission to EPA (9) Prepare data for files Pr epare final file folders

Maintain records



### 4(c) Information Requested

This section of the ICR describes the information that an order recipient is expected to provide the Agency. The Tier 2 test order will identify the specific tests required and will provide the specific instructions for complying with the order. All orde r recipients are expected to provide an individual initial response that identifies how the recipient intends to satisfy the order. The specific information required will vary based on the respondent's initial response and which Tier 2 tests are required. Those recipients that generate data, either individually or as part of a consortium, are expected to provide a

one

- year progress report, and then submit the Tier 2 test results to EPA.

The Agency generally intends to rely on the existing policies and pro cedures, including the existing response options. Under those existing procedures, an order recipient may choose a response option other than conducting the Tier 2 testing/submitting OSRI. For example, a respondent could choose to reformulate their produ ct(s). These response options involve established procedures, and activities that are already approved by OMB under existing ICRs or they are substantially less burdensome. The Agency believes that any additional use of those existing procedures related 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.

Page 13 of 30June 9 , 201 5

4(c)(i) Tie r 2 Test Order Recipients ' Response Options

The recipient of a Tier 2 test order will have several response options from which to choose , as specified

within the order itself. As indicated previously, the order recipient will use Attachment B, EDSP Tier 2 Test Order Initial Response Form for Individual Order Recipients

, to indicate which option they intend to use to respond to the data request for each test

.

Brief summaries of the available response options follow below. (Additional detail regarding the

r esponse options may be found in Attachment A(1)

, FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template for Pesticide Active Ingredients , and Attachment A(2), FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template for Pesticide Inert Ingredients .)

(1) I Will Generate New Data

.

(2) I Am Citing or Submitting Existing Data

.

(3) I Will Enter (or Offer to Enter) Into an Agreement to Form a Consortium to Provide the Data

.

(4) I A m Not Subject to the Test Order

. O rder recipient s would choose this option to indicate that they believe they are not subject to the order because:

(i) In the case of a pesticide active ingredient , the recipient is not a pesticide registrant, or (ii) In the case of a pesticide inert ingredient , the recipient does not currently manufacture or import the chemical, or (i ii ) In the case of a "catch

- up" order, the recipient obtains the chemical solely from persons who are either (1) the original data submitter; (2) a person who has complied with a test order by offering compensation; or (3) a person who is otherwise an approved source for that inert.

(5) I Intend to Voluntarily Cancel the P esticide Registration(s) (only applicable to pesticide active ingredients)

.

( 6 ) I Intend to Reformulate the Product (s) to Exclude this Chemical from the Formulation (only applicable to pesticide active ingredients).

( 7 ) I Am Claim ing a Formulators ' Exemption (only applicable to pesticide active ingredients )

.

( 8 ) I Have / Am in the Process of Discontinuing the Manufacture/Import of the Chemical (only applicable to pesticide inert ingredient s)

.

( 9 ) I Do Not and Will Not Sell the Chemical for Use in Pesticide Products (only applicable to pesticide inert ingredients )

.

4(c)(ii) Progress Report

Unless EPA has notified the Tier 2 test order recipient in writing that the requirements of the order have been satisfied, the order recipient must submit a progress report to EPA within 12 months of the

issuance of the order. The progress report should provide a brief description of the status of the respondent ' s planned activities for each test , and, if applicable, a description of any problems encountered or expected difficulties in meeting the schedule for complying with the order.

Page 14 of 30June 9 , 201 5

4(c)(iii) Extension Requests

If a recipient cannot comply wi th the time frame s established in the order, they may seek additional time by submitting a written request for an extension to the A gency. The written request m ust be submitted before the applicable deadline and include: (1) a detailed description of the expected difficulty

, and (2) a proposed schedule including alternative 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 laboratory difficul ties and provide documentation from the laboratory performing the testing.

While EPA is considering any such request, the original Tier 2 test due dates specified in the order remain unchanged. The A gency will respond to such requests in writing because t ime extensions can only be granted in writing. If EPA does not grant the request, the original deadline remains. Generally

, 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 2 test order will specify which of the four tests are required , and when they are due . The

follow ing is a list and brief description of each of the EDSP Tier 2 tests :

1. OCSPP Guideline 890. 2100

, Japanese Quail Two

- Generation Toxicity Test This test guideline is designed to provide concentration

- response information concerning the adverse

effects of a t est substance delivered via dietary exposures on avian reproductive and thyroid function, including gonadal function, mating behavior, secondary sex characteristics, reproductive output, fertility, hatchability, biochemical responses, histopathology of sev eral tissues, and growth and development relevant to all life stages of the first and second generations.

2. OCSPP Guideline 890.2200, Medaka Extended One

- Generation Reproduction Test This test guideline is designed to provide concentration

- response information concerning the adverse effects from aqueous exposures of a test substance in fish on the integrity and performance of male and female reproductive systems, including fecundity, fertility, secondary sex characteristics, biochemical liver respons es, histopathology of several tissues and growth and development that are relevant to all life stages, and subsequent generations.

3. OCSPP Guideline 890. 2300 , Larval Amphibian Growth and Development Test This test guideline is designed to provide concentrat ion

- response information concerning the adverse effects from aqueous exposures of a test substance in amphibians on larval development and metamorphosis, and juvenile growth and development, including thyroid, gonad and liver

.

4. O CS PP Guideline 870.3800, Rep roduction and Fertility Effects 14

Th is test guideline is designed to provide dose

- response information to assess the potential for adverse effects from oral exposure of a test substance in rodents on the integrity and performance of male and female reprodu ctive systems, including gonadal function, the estrous cycle, mating

14 Test guidelines 1) OECD TG 416 ( Two

- Generation Reproduction Toxicity Study) , or 2) OECD TG 443 ( Extended One

- Generation Reproductive Toxicity Study ) are acceptable alternative tests.

Page 15 of 30June 9 , 201 5

behavior, conception, gestation, parturition, lactation, weaning, and growth and development that are relevant to adults and offspring of the first and second generations in utero and pos t

- partum.

4(c)(v) Data Submission

The Tier 2 test order itself will specify the data submission content and format that the recipient should

use. In general, EPA expects that the content and format of the data submission package for transmittal

to EPA will be consistent with the following existing standards:

1. Transmittal Document

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

(1) Identity of the submitter. (2) The date on which the submission package was prepared for transmittal to EPA. (3) Identification of the Tier 2 order number/or consortium number (as appropriate) associated with the submission ( e.g. , the number assigned to the order). (4) A list of the indivi dual documents included in the submission.

2. Individual Study or Test Result Documents. Unless otherwise specified by the A gency, each

submission is expected to be in the form of individual documents or studies. Previously submitted

documents should not be resubmitted unless specifically requested by the A gency. Instead, previously submitted documents should be cited with adequate information to identify the previously

submitted document. Each study or document should normally include the following:

(1) A title page including the following information: (i) The title of the study, including identification of the substance(s) tested and the test name or data requirement addressed and the Tier 2 test order or consortium number

. (ii) The author(s) of the study

. (iii) 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) If the study is a commentary on or supplement to another previously submitted study, full identification of the other study with which it should be associated in review. (vi) If the study is a reprint of a published document, all relevant facts of publication, such as the journal title, volume, issue, inclusive page numbers, and da te of publication. (2) Upon submission to 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 2 order. (3) A statement of complianc e or non

- compliance 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 must be included for any information that is not in English.

3. Format for Data Submission.

EPA will develop standard data evaluation formats

, referred to as Study Profile Templates (SPTs) , to
assist registrant s in their submissions

. These templates are fillable electronic documents. Use of the templates improves the likelihood of a successful subm ission , since the information necessary for an

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

.

Page 16 of 30June 9 , 201 5

In addition, Pesticide Registration (PR) Notice 11

- 3, entitled

, Standard Format for Data Submitted

u nder the FIFRA and Certain Provisions of the FFDCA , describes EPA's preferred method for organizing and formatting submi ttals of data supporting a pesticide registration ( http://www.epa.gov/pesticides/PR_Notices/pr2011

- 3.pdf ).

The Agency also encourages order recipients to submit completed study profiles and supporting data in an electronic format. For more information, go to the electronic data submissions Web site at http://www2.epa.gov/pesticide

- registration/study

- profil e

- templates

.



### 5 Agency Activities, Collection Methodology, and Information Management

5(a) Agency Activities

The functions and responsibilities associated with the EDSP under FFDCA section 408(p) have been assigned to EPA ' s Office of Chemical Safety and Pollution Prevention (OCSPP)

. Within OCSPP, OPP will be primarily responsible for the administrative functions involving PAIs and pesticide inert ingredients

, i.e. , related to the issuance of the orders, receiving, processing and maintaining records of

re sponses to the orders, as well as other administrative functions related to the orders.

OCSPP will provide the status and updates on all the Tier 2 orders, coordinate the release of documents

related to the Tier 2 data received, post information on the A ge ncy ' s Website, and the determinations related to the subject chemical. Data received by EPA will first be reviewed for completeness and then

routed to an Agency team of scientists and analysts for technical review

. Although the technical review

teams wil l consist mostly of staff from the offices in OCSPP, it may also include staff from other EPA offices, e.g. , OW, ORD, and other EPA offices as appropriate.

In general, the A gency is expected to engage in the following activities related to the information

collection activities under this ICR:

(1) Prepare instructions

. EPA has developed and p ublish ed policies and procedur es , order templates

and standard forms to provide guidance and instructions for Tier 2 test order recipients.

(2) Identify chemicals to be tested

. Chemicals for which Tier 1 screening has been completed, and for

which the A gency has made a WoE determination that some or all of the Tier 2 tests are required.

(3) Identify order recipients. The order recipients are man ufacturers/importers and pesticide registrants of chemicals that have been identified for Tier 2 testing.

(4) Prepare the EDSP Tier 2 Test Orders. EPA intends to use the appropriate order template (as discussed in section 4(b) of this ICR) to prepare indi vidual Tier 2 test orders for each chemical and order recipient.

(5) Review and Approve Orders. The EDSP Tier 2 test orders will be reviewed and approved by a

senior Agency official(s) for completeness before they are issued.

(6) Issue the Tier 2 Test Orders. The appropriate authorized OCSPP senior official will sign each order, which will then be processed for issuance as appropriate.

Page 17 of 30June 9 , 201 5

(7) Process Initial Responses. The A gency will receive the initial response form, document the response, track respon ses and determine next steps based on the responses. In general, the A gency will review the response to determine if it is complete and whether it satisfies the request in the

Tier 2 test order, if so, the response will be documented accordingly. Dependi ng on the response,

the A gency may also complete other tasks, e.g. , document lead for a consorti um , process a voluntary cancellation request, etc. The A gency 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 A gency will respond to any questions the recipient may have regarding the Tier 2 test order in a timely manner, as well as

process any request s 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 EPA ' s Office of Enforcement and Compliance

Assurance [ OECA ] for enforcement, etc.).

(10) Issue " Catch

- up " Orders. EPA may issue a "catch

- up" Tier 2 test order to a company who either is identified, or enters the marketplace after the initial issuance of orders

.

(11) Process Data Submissions. The A gency will process submissions of data generated under the

Tier 2 test order, including review of the data submission for completeness, document receipt, track the data, data reviews and decisions

. As indicated previously, this will be coordinated

between OPP, OPPT and OSCP.

(12) Analyze Data. OCSPP will utilize the Agency ' s internal standard review procedures to review the

results of the Tier 2 test data. This review may include other offices ( i.e. OW) as appropriate.

(13) Incorporate/ Use the Data. The Tier 2 testing consists of a group of individual in vivo tests designed to include males and females with an intact hypothalamic

- pituitary

- gonadal axis, multiple pathways of exposure and life

- stages, and various taxa to further identify and characteri ze chemical

- induced bioactivity with estrogen, androgen and thyroid hormones for risk assessment

. EPA has extensive experience in using data from multiple sources to develop integrated risk

assessments to inform regulatory decisions on chemicals

.

(14) Sto re Data in Retrievable System. The A gency will index and store the data the A gency ' s electronic document repository.



### 5(b) Collection Methodology and Management

The Agency intends to issue the Tier 2 or ders electronically using email. Receipt of informati on from the order recipient will be in an electronic format using compact discs as the transport medium. The

submission of information f rom order recipients is based on the eXtensible Markup Language (XML)

format which facilitates the uploading of metadata to EPA internal electronic tracking and reporting

systems. Information submitted to EPA in the XML format improves data quality and provides efficiencies for processing

, storage, tracking, and reporting. Th ese are some of the steps the Agency is taking as it transitions to a web

- based electronic submission process. For d etailed up

- to

- date information on the submission process visit our website at www.epa.gov/endo

.

Page 18 of 30June 9 , 201 5



### 5(c) Small Entity Flexibility

In developing the policies and procedure documents, the A gency considered alternatives for small

businesses to the extent permitted within the mandate in FFDCA. For example, the procedures are intended to minimize potential duplicative testing, and emphasize collaborative efforts to generate the requested data. If there is a small business that happen s to manufacture one of the chemicals and

therefore receives a Tier 2 test 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 submitting the data. EPA has further facilitated this collaborative approach by including the list of order recipients 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 money, is based on the entity ' s market share for that chemical.

EPA can also accommodate requests for extensions of time from small businesses, and provide other assistance, as needed. In fact, OPP has established small business liaisons that are available to provide a

b road range of assistance to small businesses. An extension in time may help a small business because other manufacturers who received an order for that same chemical may submit the data sooner

. Since an entity may demonstrate that they made a reasonable offer to contribute towards the costs for generating that data, a small entity in this case would only be responsible for their fair share of the costs, and the

time an d effort involved in making a reasonable offer.



### 5(d) Collection Schedule

There is no per iodic schedule for the collections under this ICR. This information collection activity only involves a one

- time, three step collection activity per chemical. The order will identify the applicable due dates for the collections under the order

. In general, the basic schedule 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 Tier 2 Test 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 issua nce (+ 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

Within 24 to 48 months from order ' s issuance Final study report and submission of the data to EPA

In calculating the due date for the initial respo nse, the A gency has included an additional 10 calendar days to build in extra time for the A gency to process the final order package after signature, i.e. , to add all the due dates that will be calculated from the signature date, and for physical delivery of the package

to the U

. S

. Post Office for mailing. In general, the A gency does not expect to consider requests for extending the deadlines for the initial response. However, the A gency will consider extending the final report due date when the circumstances warrant it as described in the applicable policies and procedures

document.

Page 19 of 30June 9 , 201 5

Although one of the tests 15 may require 4 years for completion, f or purposes of estimating the potenti al paperwork burden in this ICR, EPA assumed that the study data would be submitted within 2 or 3 years

of issuance of the Tier 2 test order, i.e. , within the 3 year approval period for this ICR. To calculate an annual burden, the A gency assumed 3

- year du ration of equal annual effort.



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

The PRA requires EPA to estimate the " paperwork burden " i.e. , the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or p rovide information to or for

a f ederal agency. Under the PRA, " burden " means the " 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: re view instructions; develop, acquire, install, and use technology and systems; search data sources; collect, review, validate, and verify information/data; process and maintain information/data; disclose and transmit/submit information/data; change/adjust t he existing ways of complying with any previously applicable instructions and requirements to now comply with new requirements; and, train personnel. The A gency 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 EPA).

In this section of the ICR, the A gency discusses the methodology and assumptions used to calculate the potential paperwork burden and costs for respondents, which are presented based on the information

collection or " IC " groups discussed previously.



### 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 201 3 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

.

EPA used the NAICS codes to obtain the estimated loaded labor rates used in this ICR, i.e. , NAICS 325300, Pesticide, Fertilizer, and Other Agricultural Che mical 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 system is used by federal statistical agencies to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating

data. Each broad occupation includes detailed occupation(s) based on similar job duties, skills, education, or expe rience. 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 following labor types are listed

below in Table 4 and apply to all of the sectors identified above.

15 O CS PP Guideline 870.3800, Reproduction and Fertility Effects

Page 20 of 30June 9 , 201 5

Table 4

– Respondent S tandard O ccupational C lassification s 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 Administrative Support Occupations

For purposes of calculating a loaded labor rate, EPA used the mean average hourly wage rate and

assumed that benefits add 4 3. 2 % to the hourly rate , ba sed on benefits for all private industry workers

from June 201 4 data from the U.S. Bureau of Labor Statistics

. 16 EPA then multiplied the loaded wage by 50% to obtain overhead costs. Overhead costs are added to the loaded wage rate to get the fully

loaded wage rate.

Table 5

– Respondent Loaded Labor Rates Used in this ICR

Labor Category Formula Used Managerial Technical Clerical Unloaded Hourly Rate 1 W ages $ 57.76 $ 32.46 $ 18.18 Benefits Percentage of Total Labor 2 Benefits % 43. 2 % Loaded Hourly Rate (LHR) Wages + (Wages * Benefits %) $ 82. 74 $ 46. 50 $ 26.0 4 Overhead Percentage 3 50% Overhead Per Hour (OPH) LHR*Overhead % $ 41.3 7 $ 23.2 5 $ 13.0 2
Fully Loaded Hourly Rate LHR + OPH $ 12 4

. 11 $ 69.75 $ 39.0 6
Key:

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, p p. 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.

For this ICR, the A gency therefore uses the following labor rates for the respondents: Managerial =
$ 12 4

. 11 ; Technical = $ 69. 75 ; and Clerical = $ 39.0 6

.

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

The specific activities used for estimating the potential burden and costs are identified in section 4(b) of

this ICR. Paperwork burden hours and costs are subdivided into the managerial, technical, and clerical duty labor categories, which are also described in more detail in section 4(b) of this ICR.

The A gency then used two basic approaches to calculate the potential burden and costs f or this ICR: 1) For the data generation activities, EPA calculated the paperwork burden as a percentage of the testing costs; and 2) For the rest of the paperwork activities, EPA estimated the average amount of time required to complete the specific activ ity, considering estimates provided in other approved ICRs involving the same activity, feedback from stakeholders, and EPA ' s overall experience with such

activities.

1. Method Used to Calculate the Burden and Costs for Data Generation

. EPA calculated the

pa perwork burden for the data generation activities as a percentage of the testing costs. This

percent

- based estimate of paperwork associated with conducting a test was initially established in

consultation with OMB in the 1980 ' s in an effort to provide a r easonable estimate of the burden

16 DOL, Bureau of Labor, September 10, 2014 Announcement of June 2014 Data, Employe r Costs for Employee Compensation

– June 2014

, http://www.bls.gov/news.release/archives/ecec_091020 14.pdf

Page 21 of 30June 9 , 201 5

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 ge neration burden 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 A gency has adopted this established methodology for estimating the

paper work burden for data generation, which is explained further in this section of the ICR.

To calculate the burden associated with the paperwork activities involved in conducting the tests, the

A gency starts with the cost of the test, typically the market pri ce for the test as identified by laboratories that offer testing services. The A gency used estimated costs for the tests based on EPA experience

. Since EPA is funding the test validation effort, we believe that these estimates are reasonable surrogates for actual market prices at this time and for the purposes of this ICR

. Attachment D provides the detailed calculations.

EPA used 35% of the estimated total test cost to calcula te the total potential cost for the paperwork activities related to data generation. The 35% of test cost is disaggregated by labor category, and then burden hours are extrapolated by using the loaded labor rates. To disaggregate by labor category, the A gency considered the estimated distribution of paperwork activity across the labor category represented and the existing methodology assumption that paperwork activities for data generation mostly involve the technical staff to perform the tests, with a fe w activities related to management and clerical.

See Figure 1 for an illustrated outline of the Agency burden calculation process for data generation

. The results from using this method are presented in Attachment D and were used in the burden and

cost es timates provided in section 6(b) of this ICR.

Figure 1

– Method for Calculating Paperwork Burden from Test Costs

This approach assumes and incorporates the following:

(1) Recipients generate all of the data as specified in the Tier 2 order. (2) All data generation is performed by an independent laboratory. (3) Paperw ork 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 se ction 6(a)(i) of this ICR.

2. Method Used to Calculate the Burden and Costs for Other Activities

. For the other activities, EPA estimated the burden hours by considering the activities themselves and the expected amount of time that the activity involves on average. These estimates consider the A gency ' s experience with similar Identify

35% o f the

Test Cost Divide 35% cost into:

20% for Managerial

65% for Technical

15% for Clerical Divide each by

Loaded Labor

rate for that Category B urden Hours by Category

Page 22 of 30June 9 , 201 5

data collection activities

, including those for the EDSP List 1 chemicals

. The costs are calculated using the loaded labor rates for the labor categories that are identified in section 6(a)(i) of this ICR.

Although not all Tier 2 tests may be required for each chemical, for the purposes of the ICR calculations, EPA is assuming that all four tests will be performed. Further, t he A gency assum es that the data will be generated for each chemical with all manufacturers participating in a consortium or task force, and with only one order recipient engaged in actually generating and submitting the

data

. This means that all of the potential recipients of orders will experience a base se t of burden associated with the initial receipt, response activities and subsequent burden related to consortium participation, and that one recipient for each of the chemicals will experience the burden associated with generating the data, submitting a on e

- time progress report and eventually submitting the data

. The results of this method are presented in section 6(b) of this ICR.



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

This section explains how the A gency calculated the estimated respondent burden and costs for this ICR.

6(b)(i) Estimated Burden and Costs

- per Chemical

The estima ted per chemical burden for each of the paperwork activities described in section 4(b) of this ICR, disaggregated by the labor category listed in Table 4, are presented in Table 6.

Table 6

– Estimated Per Chemical Burden Hours for the Activities

Activity Managerial Technical Clerical Tot al 1) Read instructions 12 12 0 24 2) Plan activities 48 42 0 90 3) Submit an initial response to EPA 24 21 2 47 4) Read and discuss the protocol 36 145 0 181 5) Activities related to the submission of OSRI 50 428 70 548 6) Participate in Consortium 24 145 2 171 7) Generate the data 771 4,459 1,838 7,068 8) Submit Progress Report 5 20 7 32 9) Compile and review the final data for submission 36 191 12 239 10) Complete paperwork to assemble submission package 5 20 7 32 11) Submit final data to EPA 3 0 2 5 12) Maintain records 0 24 62 86

Total Per Chemical Burden: 1,014 5,507 2,002 8,523

The estimated per chemical cost for each of the paperwork 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 for generating the data coming from Attachment D

. The following

loaded labor rates were used to calculate these costs: Managerial = $12 4.11 ; Technical = $69. 75 ; and

Clerical = $39.0 6

.

Page 23 of 30June 9 , 201 5

Table 7

– Estimated Per Chemical Costs by Activity

Activity Managerial Technical Clerical

Total $ 12 4

. 11 $ 69. 75 $ 39.0 6 1) Read instructions $ 1,48 9 $ 83 7 $ 0 $ 2,32 6 2) Plan activities 5,957 2,930 0 8,8 87 3) Submit an initial response to EPA 2,97 9 1 ,465 78 4,522 4) Read and discuss the protocol 4,468 10,1 14 0 14,5 82 5) Activities related to the submission of OSRI 6, 206 29,8 53 2,73 4 3 8,793 6) Participate in Consortium 2,979 10,114 78 13,171 7) Generate the data 95,689 311,015 71,792 478,496 8) Submit Progress Report 621 1,395 273 2,289 9) Compile and review the final data for submission 4,468 13,322 469 18,259 10) Complete paperwork to assemble submission package 621 1,395 273 2,289 11) Submit final data to EPA 372 0 78 450 12) Maintain records 0 1,674 2,422 4,096 13) Delivery Costs 12

Total Cost: $ 125,849 $ 384,114 $ 78,197 $ 588,172

In addition to the burden costs, the costs of delivering the data to the A gency are added to arrive at the total estimated per respondent cost. Delivery costs were estimated using the A gency ' s experience with data submissions for pesticide deliveries, which assumes the delivery of a C D

- ROM using special delivery. Although not required, nor used by everyone, the A gency is using special delivery for the calculation to provide a conservative est imate that would account for expected variations in delivery

costs. Based on the 2

- day delivery rate for a large envelope up to 2 lbs. in weight, the U

. S

. Postal
Service rate is $ 1 2 from the west coast to the east coast.

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

As discussed earlier, all respondents are not expected to engage in the same basic activities, their activities will be based on their initial response to the order. For the purposes of this ICR, the estimated

burden and costs for the respondent groups are divided into distinct " 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 for the various activities, the estimated respon dent burden and costs for the different IC categories is presented in this section of the ICR.

IC #1: Tier 2 Test Order Recipients

For this IC category, the A gency assumed that all respondents are expected to engage in the activities

identified in Tables 6 and 7 as activities 1

- 3, and 1 2 , which are all associated with receipt of the order and submission of the required initial response.

The total IC # 1 estimated burden is 20,400 hours and the estimated cost is $ 1, 778

, 300

.

IC #2: Data Generators/Submitters

This IC category of respondents is intended to capture the additional burden and costs expected for a subset of the order recipients who are generating and submitting the requested data to the A gency

. As discussed previously, EPA assumes that for each ch emical, the data will be submitted only once, either by an individual order recipient or a consortium. For this IC category, the Agency assumes that these respondents will also engage in the activities identified in Table 6 and 7 as activities 4 , 5 and 7 through

1 3 , which are all associated with generating and submitting the data.

Page 24 of 30June 9 , 201 5

The total IC #2 estimated burden is 211,848 hours and the estimated cost is $ 1 4,487,668

.

IC #3: Consortium Participants

This IC category is intended to capture the additional burden and costs expected for a subset of the order recipients who are participating in a consortium. As discussed previously EPA assumes that when there are more than one order recipients for a parti cular chemical, the recipients will join forces to generate and submit the data in response to the order. 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 resp ondents will engage in the activities identified in Tables 6 and 7 as activity 6 , which is associated with participating in a

consortium.

The total IC #3 estimated burden is 17,100 hours and the estimated cost is $ 1, 317

, 100

.

Page 25 of 30June 9 , 201 5

Table 8

- Estimated Burden and Costs by Information Collection ( IC )

Activity (a) Total # Responses (b) Per Response Total

Burden (Hours) (c) Cost ($) (d) Burden (Hours) (e) Cost ($) (f)

IC #1

- Order Recipients 1) Read instructions

100 24 $ 2,326 2,400 $ 232,600 2) Plan activities 90 8,887 9,000 888,700 3) Submit an initial response to EPA 47 4,522 4,700 452,200 12) Maintain records (g) 43 2,048 4,300 204,800

Subtotal: 204 $ 17,783 20,400 $ 1, 778,300

IC #2

- Data Generators and Submitters 4) Read and discuss the protocol

2 6 181 $ 14,582 4,706 $ 379,132 5) Activities related to the submission of OSRI 548 38,793 14,248 1,008,618 7) Generate the data (h) 7,068 478,496 183,768 12,440,896 8) Submit Progress Report 32 2,289 832 59,514 9) Compile and review the final data for

submission 239 18,259 6,214 474,734

10) Complete paperwork to assemble the submission package 32 2,289 832 59,514

11) Submit final data to EPA 5 450 130 11,700 12) Maintain records (g) 43 2,048 1,118 53,248 13) Delivery Costs 12 312

Subtotal: 8,148 $ 557,218 211,848 $ 14,487,668

IC #3

- Consortium Participants 6) Participate in Consortium 100 171 $ 13,171 17,100 $ 1,317,100

Subtotal: 171 $ 13,171 17,100 $ 1,317,100

Total: 8,523 $ 588,172 249,348 $ 17,583,068
Key: (a) Activities are described in more detail in section 4(b) of this ICR. (b) From Table 1, includes 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 estimated 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 D

.



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

For the Agency activities, EPA estimated the burde n hours by considering the activities themselves and the expected amount of time that the activity may involve on average. These estimates consider the

A gency ' s experience with similar data collection activities. The estimated per chemical/respondent

bur den hours for the Agency are presented in Table 9

. To calculate the total potential A gency burden over the three years, EPA has multiplied this burden by the total number of chemicals ( 442 hours x 26

chemicals = 11,492 hours).

Page 26 of 30June 9 , 201 5

Table 9

– Estimated Agency P e r Chemical Burden Hours

Activity (a) Managerial Technical Clerical Total 1) Prepare instructions 3 18 3 24 2) Identify chemicals to be tested 3 32 3 38 3) Identify recipients 3 24 0 27 4) Prepare the 408(p) order packages 0 6 15 21 5) Review and approve the orders 3 6 0 9 6) Issue the orders 0 0 9 9 7) Process initial responses (b) 2 6 2 10 8) Provide assistance and follow

- up, as needed 0 54 0 54 9) Identify non

- responders 0 0 2 2 10) Process data submissions 0 12 2 14 11) Analyze data (c) 0 240 0 240 12) Incorporate data into risk assessments (d) 0 48 0 48 13) Store data in retrievable system 0 6 12 18

Total Burden: 14 452 48 524
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. (c) Assumes 60 hours per test ( 60 x 4 ). (d) Assumes 12 hours per test ( 12 x 4 ).

The costs are calculated using the U.S. Department of Labor, Bureau of Labor Statistics data 17 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 calculate these costs: Managerial = $ 121.91 ; Technical =
$ 80.48 ; and Clerical = $ 45.35

. The estimated burden hour costs for the A gency are presented i n Table

9

. To calculate the total potential A gency costs over the three years, EPA has multiplied theper

chemical cost in Table 10 by the total number of chemicals ($ 40,263 x 26 chemicals = $ 1,046,838 ).

Table 1 0

– Estimated Agency Per Chemical Burden Hour Costs

Activity (a) Managerial Technical Clerical

Total $ $ 121.91 $ 80.48 $ 45.3 5 1) Prepare instructions $ 36 6 $ 1,44 9 $ 136 $ 1,951 2) Identify chemicals to be tested 36 6 2,57 5 136 3,07 7 3) Identify recipients 36 6 1,932 0 2,298 4) Prepare the 408(p) order packages 0 48 3 680 1,16 3 5) Review and approve the orders 36 6 48 3 0 84 9 6) Issue the orders 0 0 408 408 7) Process initial responses (b) 244 48 3 91 81 8 8) Provide assistance and follow

- up, as needed 0 4,34 6 0 4,34 6 9) Identify non

- responders 0 0 91 91 10) Process d ata s ubmissions 0 96 6 91 1,05 7 11) Analyze data 0 19,315 0 19,315 12) Incorporate data into risk assessments 0 3,863 0 3,863 13) Store data in retrievable system 0 48 3 544 1,02 7

Total Cost: $ 1,70 8 $ 36,378 $ 2,177 $ 40,263
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.

17 http://www.bls.gov/oes/current/naics4_999100.htm

Page 27 of 30June 9 , 201 5



### 6(d) Total Burden Hours and Costs for the ICR (Bottomline) , including
Annualized Totals

The estimated total burden and costs for the information collection activities associated with EDSP Tier 2 testing of the first list of chemicals are presented in Table 1 1

.

Table 1 1

– Annualized Estimated Total Respondent Burden and Costs for A ll Activities

Respondent Category (a) Total # Responses

(b) Per Response (c) Total (d) Annualized Total ( ÷ 3) (e)

Burden (Hours) Cost ($) Burden (Hours) Costs ($) Burden (Hours) Costs ($)

IC #1

- Order Recipients

100 204 $ 17,783 20,400 $ 1, 778,300 6,800 $ 5 92,767 Recording Keeping 43 2,048 4,300 204,800 1,433 68,267
Reporting 161 15,735 16,100 1,573,500 5,367 524,500

Non

- Burden Costs 0 0 0 0 0 0

IC #2

- Data Generators/ Submitters

26 8,148 $ 557,218 211,848 $ 14,487,668 70,616 $ 4,829,223 Recording Keeping 43 2,048 1, 118 53,248 373 17,749
Reporting 8,105 555,158 210,730 14,434,108 70,243 4,811,369

Non

- Burden Costs 0 12 0 312 0 104

IC #3

- Consortium Participants

100 171 $ 13,1 71 17,100 $ 1, 317,100 5,700 $ 439,033 Recording Keeping 171 13, 171 1 7,100 1, 317

, 100 5,700 439,033
Reporting 0 0 0 0 0 0

Non

- Burden Costs 0 0 0 0 0 0

Total: 8,523 $ 588,172 249,348 $ 17,583,068 83,116 $ 5,861,023
Key: (a) Grouped by respondents and according to IC category as presented in section 6(b) of this ICR. (b) From Table 1, includes catch

- up orders. (c) See the totals from the tables in section 6(b) of this ICR

. Numbers are rounded. (d) Total = (b) x (c) (e) Calculated by dividing the previous total by 3 ( y ears).

The t otal potential respondent burden and cost calculated in this ICR involves activities that cannot be accurately divided by or assigned to occur in a particular year. The Agency has calculated the total

burden and assumes a 3

- year duration of equal effort to calculate an annual burden and costs fo r this

ICR. As such, the total respondent burden and costs for this ICR is divided by 3 to get an estimated

annual ized burden of 83,116 hours ( 249,348 hours ÷ 3) and an estimated annualized cost of $ 5,861,023 ($ 17,583,068 ÷ 3). Included in the estimated annual cost are non

- burden hours costs associated with delivery of $ 1 04 ($ 312 ÷ 3). 18

To calculate the total potential Agency burden and cost over the three years, EPA multiplied the per

chemical burden and cost in Tables 9 and 1 0 by the total number of che micals for a total A gency burden

of 1 3,364 hours ( 512 x 26 chemicals) and a cost of $ 1,046,838 ($ 40,263 x 26 chemicals). These totals

were d ivided by 3 to get an estimated annualized burden of 4,455 hours ( 13,364 ÷ 3) and an estimated

annualized cost of $ 348,946 ($ 1,046,838 ÷ 3).



### 6( e

) Burden Statement for this ICR

The annual public burden for this information collection activity is estimated to range between 204 and 8,148 hours, depending on the respondent category and activities, with an estimated cost be tween $ 1 7,783 and $ 557,218

. The total annual burden is estimated to be 83,116 hours, with a n annual cost of

18 See activity 1 3 in Table 8

.

Page 28 of 30June 9 , 201 5

$ 5,861,023

. 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 o f information unless it displays a current and valid

OMB control number. The OMB control numbers for EPA ' 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.

EPA has established a docket for this ICR under docket ID No. EPA

– HQ

– OPPT

– 2013

– 0171

, which is available electronically at http://www.reg ulations.gov

. A hard copy of the docket materials are also available for public viewing at the OPPT Docket, which is located in EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. EPA /DC Public Reading

Roo m hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of 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 EPA 's visitor log. All visitor bags are processed through an X

- ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.



### 7. List of References

The following is a list of the documents that are referenced in this document

. To access these references

go to http://www.regulations.gov/search/Regs/home.html#docketDetail?R=EPA

- HQ

- OPPT

- 2013

- 0171

.

1. EDSP; Policies and Procedures for Initial Screening ; ( 74 FR 17560

- 17579

, April 15, 2009) https://www.federalregister.gov/articles/2009/04/15/E9

- 8706/endocrine

- disruptor

- screening

program

- policies

- and

- procedures

- for

- initial

- screening

. 2. EDSP, Final Policies and Procedures for Screening Safe Drinking Water Act (SDWA) Chemicals; ( 78 FR 35909

- 35922

, June 14

, 2013) https://www.federalregister.gov/articles/2013/06/14/2013

- 14228/endocrine

- disruptor

- screening

program

- final

- policies

- and

- procedures

- for

- screening

- safe

- drinking

.



### 8

. Attachments to This Document

The following is a list of the attachments specific to this document

. They can be found in the docket for this ICR and are accessible electronically through http://www.regulations.g ov , under Docket ID

Number: EPA

- HQ

- OPPT

- 2013

– 0171

.

Attachment A (1)

– FIFRA/ FFDCA 408(p), EDSP Tier 2 Test Order Template for Pesticide Active Ingredients

. Attachment A(2 )

– FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template for Pesticide Inert Ingredients

. Attachment B

– EDSP Tier 2 Test ing, Initial Response Form for Individua l Order Recipients ( EPA Form No. 6300

- 07 ) ( Draft, June 201 5 ).

Attachment C

– EDSP Tier 2 Test ing, Initial Response Form for Consorti a /Task Force s (EPA Form No. 6300

- 07

- C) ( Draft, June 201 5 ).

Attachment D

– Calculations for Paperwork Burden and Costs for Data Generation Activities ( October 21, 2014 ).

Page 29 of 30June 9 , 201 5

Attachment E

– Response to Public Comments on the Public Review Draft of the Information

Collection Request (ICR) entitled: " Tier 2 Testing of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP) ."

Page 30 of 30