June 9, 2015

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 collection 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 hormone systems using a battery of assays.3 Based on a Weight-ofEvidence (WoE) analysis of the Tier 1 battery results, substances 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 of 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 WoE5

determination for a chemical that some, or all, of the Tier 2 tests are required.

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 determine 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

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activities associated with Tier 1 under the EDSP. Instead, this ICR specifically addresses the 

information collection activities associated with Tier 2 of the EDSP. As such, this 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 from 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 an 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 the 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 for 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 information 

collection activity fulfills a direct statutory mandate and is needed in order to provide information that 

will allow the Agency to identify substances that have 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 naturally 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 Administrator to take action under available statutory authority to ensure 

protection 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 similar 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." FFDCA 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 the 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, "To 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. 346a (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 Administrator 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 "The only matter for resolution at the 

hearing shall be whether the registrant has failed to comply with an order under subparagraph (A) of this 

paragraph" [21 U.S.C. 346a (p)(5)(C)(ii)]. A decision by the Administrator after completion of a 

hearing is considered to be a final Agency action [21 U.S.C. 346a (p)(5)(C)(ii)]. The Administrator 

shall terminate a suspension issued with respect to a registrant if the Administrator determines that the 

registrant has complied fully with FFDCA 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 sanctions as 

are provided for under section 16 of TSCA [21 U.S.C. 346a (p)(5)(D)]. Such penalties and sanctions 

shall be assessed and imposed in the same manner as provided in TSCA 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 the 

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)].

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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 

408(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 pertaining 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 

with 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 treatment 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 connection 

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 interest), 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 Agency 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 after 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 

long 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 appropriate 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 registration 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 pesticide 

6 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.

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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 pesticide, 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 recipients 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 such 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 section 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 Agency 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 applicant 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 applies 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 the 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 bioactivity 

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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WoE8 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 substance 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 Agency 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 identifying 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 lifestages, and various taxa to further identify and characterize chemical-induced bioactivity with estrogen, 

androgen or thyroid hormone systems for risk assessment. 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 the 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 related to the issuance of the 

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

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

determinations related to 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 Agency is committed to preventing 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.

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

using validated test methods to identify and characterize the endocrine activity of pesticides, commercial 

chemicals, and environmental contaminants, specifically related to the estrogen, androgen, and thyroid 

hormone systems.

The Agency considered these goals in developing 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 Submission 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 recipients (Table 1) was decreased 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 

Bureau of Labor Statistics.

• The Agency burden hours were increased 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 costs associated with this ICR.

3(c) Consultations

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 Additional 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

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In addition to the solicitation of public comment on the draft ICR, EPA meets with stakeholders and 

presents regular updates at the Pesticide Program Dialogue Committee (PPDC) meetings.12

5 CFR 1320.8(d)(1) requires 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 whether 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 testing of all pesticide chemicals," unless the 

Agency 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 recipients 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 Agency's action may be challenged, it is imperative that all records, 

raw data, and specimens be available. Recognizing this, the recordkeeping requirements in 40 CFR part 

169 were authorized to exceed the PRA general guidelines when they were established. Those 

requirements are being adopted unchanged under 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 retention requirements do not apply.

3(f) Confidentiality

The policies 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 pesticide 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/.

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(Reference 1), and the EDSP Final Policies 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 existing 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 discussed 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 protections 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 Agency to obtain an affirmation from all persons seeking access to such information that 

they will not disclose the information to a foreign or multinational producer. FFDCA section 408(i) 

extends the protection available under FIFRA section 10 for data submitted in support 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 that 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 section 

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

No 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.

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4 The Respondents 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 respondents 

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 identify the recipients of Tier 2 test orders 

upon completion of the Tier 1 data reviews and WoE determinations on each chemical. As with all 

orders issued, to facilitate consortia formation, EPA will make a list of the order recipients for each 

chemical publicly available.

Grouping Respondents by Information Collection (IC) Activities: 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 that 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 assumes 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 Agency 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 respondents based on the Agency's efforts to date to identify 

potential Tier 2 test order 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 Agency 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 Agency will calculate 

the difference and submit 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 following 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 obligation.

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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 pesticide 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 orders, would be the subject of Tier 2 testing.

These numbers are used in calculating the burden and costs for the activities covered by this ICR, which 

are presented later in this document. The estimated total number of Tier 2 test order recipients is 100. 

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 directs the recipient to provide an initial response within 90 days of receiving the order 

using EPA Form No. 6300-07, "EDSP Tier 2 Testing, Initial Response Form for Individual Order 

Recipients" (Attachment B). If the recipient joins a consortium, the consortium is expected to provide a 

response within 150 days of receiving the order using EPA Form No. 6300-07-C, "EDSP Tier 2 Testing,

Initial Response Form for Consortia/Task Forces" (Attachment C). EPA will include both forms in the 

Tier 2 test order packet. The order specifies 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 expected to engage in the following 

information collection related activities:

(1) Read instructions – Each recipient will read the order to understand what they must do to comply 

with the order, what deadlines are associated with those activities and the details of how and to 

whom to respond. The recipient may also read additional information about the EDSP, including 

applicable policies and procedures documents (References 1 and 2) that explain the Agency's 

rationale 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.

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(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 designated 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 tests 

identified 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 activities, 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 notified 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 

submission 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 submit 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. Order 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) clerical. 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

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Activity Managerial Duties Technical Duties Clerical Duties

(2) Identify timeframe for response

Identify and evaluate response 

options

Evaluate response options

Plan activities

Negotiate/establish consortium/ 

task force agreements

Participate in consortium/ task force 

discussions

(3) Determine response Recommend a response

Oversee employee activities Complete response form

Sign initial response forms Send to EPA

(4) Communicate with EPA Review of protocol (deviations) Arrange logistics for calls or 

Review Good Laboratory Practices meetings with EPA

(GLPs) or deviations

Identify and discuss other 

scientifically relevant information 

and related protocol and/or GLP 

deviations

(5) Plan/oversee employee and contract 

activities

Plan the data collection activities 

using the approved protocols

Secure contract lab services and 

approve statement of work (SOW)

Conduct the tests, using protocols 

and GLPs

Communicate with EPA, as 

appropriate

Maintain records and procedures 

during testing period in accordance 

with the GLPs

Assist in preparing files

(6) Review final report(s) Compile and review data

Prepare final data reports

(7) Approve final submission package Draft summary of the data for cover 

letter

Prepare final submission package

Review final submission package

(8) Approve/sign submission Send submission to EPA

(9) Prepare data for files Prepare 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 order 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 procedures, 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 product(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.

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4(c)(i) Tier 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 

response 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 Am Not Subject to the Test Order. Order recipients 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

(iii) 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 Pesticide 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 Claiming 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 ingredients).

(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.

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4(c)(iii) Extension Requests

If a recipient cannot comply with the time frames established in the order, they may seek additional time 

by submitting a written request for an extension to the Agency. The written request must 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 difficulties 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 Agency will respond to such requests in writing because time 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 

following 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 test 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 several 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 responses, 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 concentration-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. OCSPP Guideline 870.3800, Reproduction and Fertility Effects14

This 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 reproductive 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.

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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 post-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 individual documents included in the submission.

2. Individual Study or Test Result Documents. Unless otherwise specified by the Agency, 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 Agency. 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 date 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 compliance 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 registrants in their submissions. These templates are fillable electronic documents. Use of the 

templates improves the likelihood of a successful submission, 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/.

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In addition, Pesticide Registration (PR) Notice 11-3, entitled, Standard Format for Data Submitted 

under the FIFRA and Certain Provisions of the FFDCA, describes EPA's preferred method for 

organizing and formatting submittals 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-profile-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 

responses 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 Agency'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 will 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 Agency is expected to engage in the following activities related to the information 

collection activities under this ICR:

(1) Prepare instructions. EPA has developed and published policies and procedures, 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 Agency has made a WoE determination that some or all of the Tier 2 tests are required.

(3) Identify order recipients. The order recipients are manufacturers/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 individual 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.

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(7) Process Initial Responses. The Agency will receive the initial response form, document the 

response, track responses and determine next steps based on the responses. In general, the Agency 

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. Depending on the response, 

the Agency may also complete other tasks, e.g., document lead for a consortium, process a 

voluntary cancellation request, etc. The Agency will verify claims and review data cited or 

submitted and provide a written response to the order recipient that accepts or rejects their 

claim(s).

(8) Provide Assistance and Complete Follow-up, as needed. The Agency will respond to any 

questions the recipient may have regarding the Tier 2 test order in a timely manner, as well as 

process any requests for extensions or protocol variations.

(9) Address Non-responders. Once identified, OCSPP will determine appropriate action (i.e., whether 

to initiate cancellation procedures refer the case to 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 Agency 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 characterize 

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) Store Data in Retrievable System. The Agency will index and store the data the Agency's 

electronic document repository.

5(b) Collection Methodology and Management

The Agency intends to issue the Tier 2 orders electronically using email. Receipt of information from 

the order recipient will be in an electronic format using compact discs as the transport medium. The 

submission of information from 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. These are some of the steps the Agency is 

taking as it transitions to a web-based electronic submission process. For detailed up-to-date information 

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

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5(c) Small Entity Flexibility

In developing the policies and procedure documents, the Agency 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 happens 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 

broad range of assistance to small businesses. An extension in time may help a small business because 

other manufacturers who received an order for that 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 and effort involved in making a reasonable offer.

5(d) Collection Schedule

There is no periodic 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 issuance

(+ 10 calendar days for processing)

Consortia's documentation and initial response

Within 12 months from order's issuance A progress report describing the status of an order recipient's 

compliance with the order

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 response, the Agency has included an additional 10 calendar 

days to build in extra time for the Agency to process the final order package after signature, i.e., to add 

all the due dates that will be calculated from the signature date, and for physical delivery of the package 

to the U.S. Post Office for mailing. In general, the Agency does not expect to consider requests for 

extending the deadlines for the initial response. However, the Agency will consider extending the final 

report due date when the circumstances warrant it as described in the applicable policies and procedures 

document.

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Although one of the tests15 may require 4 years for completion, for purposes of estimating the potential 

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 Agency assumed 3-year duration 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 provide information to or for 

a federal 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: review 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 the existing ways of complying with any 

previously applicable instructions and requirements to now comply with new requirements; and, train 

personnel. The Agency is also required to estimate the paperwork costs, which include both the costs 

associated with the paperwork burden hours, and any additional costs not tied to a burden hour, but 

incurred under the PRA nonetheless (e.g., the cost for mailing the forms to EPA).

In this section of the ICR, the Agency 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 2013 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 Chemical Manufacturing 

http://www.bls.gov/oes/current/naics4_325300.htm. Within that sector, the wage data are provided by 

Standard Occupational Classification (SOC). The SOC 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 experience. For more information on SOC and what is included in each SOC, see 

http://www.bls.gov/oes/current/oes_stru.htm. The SOCs used for the following labor types are listed 

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

15 OCSPP Guideline 870.3800, Reproduction and Fertility Effects

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Table 4 – Respondent Standard Occupational Classifications 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 43.2% to the hourly rate, based on benefits for all private industry workers 

from June 2014 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 Rate1 Wages $57.76 $32.46 $18.18

Benefits Percentage of Total Labor2 Benefits % 43.2%

Loaded Hourly Rate (LHR) Wages + (Wages * Benefits %) $82.74 $46.50 $26.04

Overhead Percentage3 50%

Overhead Per Hour (OPH) LHR*Overhead % $41.37 $23.25 $13.02

Fully Loaded Hourly Rate LHR + OPH $124.11 $69.75 $39.06

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, pp. 2-34. The loading for indirect 

costs used in this ICR (i.e., 50%) is within the range of 20-70% of the load labor rate (wage + benefits) suggested in this EPA guidance.

For this ICR, the Agency therefore uses the following labor rates for the respondents: Managerial = 

$124.11; Technical = $69.75; and Clerical = $39.06.

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 Agency then used two basic approaches to calculate the potential burden and costs for 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 activity, 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 

paperwork 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 reasonable estimate of the burden 

16 DOL, Bureau of Labor, September 10, 2014 Announcement of June 2014 Data, Employer Costs for Employee 

Compensation – June 2014, http://www.bls.gov/news.release/archives/ecec_09102014.pdf

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June 9, 2015

associated with the paperwork component of data generation, which may vary based on the 

complexity of the test performed. This appears to be a reasonable and fair alternative to simply 

setting a single estimate for data generation 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 Agency has adopted this established methodology for estimating the 

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

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

Agency starts with the cost of the test, typically the market price for the test as identified by 

laboratories that offer testing services. The Agency 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 calculate 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 Agency 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 few 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 estimates 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) Paperwork burden is disaggregated by labor category as follows:

a. Managerial (20%)

b. Technical (65%)

c. Clerical (15%)

(4) Labor rates are fully loaded, meaning that they include the estimated costs of wages, 

overhead, and benefits paid to an employee. See section 6(a)(i) of this ICR.

2. 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 Agency's experience with similar 

Identify 

35% of 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

Burden 

Hours by 

Category

Page 22 of 30
June 9, 2015

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, the Agency assumes

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 set 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 one-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 Agency calculated the estimated respondent burden and costs for this ICR.

6(b)(i) Estimated Burden and Costs - per Chemical

The estimated 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 Total

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 = $124.11; Technical = $69.75; and 

Clerical = $39.06.

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June 9, 2015

Table 7 – Estimated Per Chemical Costs by Activity

Activity

Managerial Technical Clerical

$124.11 $69.75 $39.06 Total

1) Read instructions $1,489 $837 $0 $2,326

2) Plan activities 5,957 2,930 0 8,887

3) Submit an initial response to EPA 2,979 1,465 78 4,522

4) Read and discuss the protocol 4,468 10,114 0 14,582

5) Activities related to the submission of OSRI 6,206 29,853 2,734 38,793

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 Agency are added to arrive at the 

total estimated per respondent cost. Delivery costs were estimated using the Agency's experience with 

data submissions for pesticide deliveries, which assumes the delivery of a CD-ROM using special 

delivery. Although not required, nor used by everyone, the Agency is using special delivery for the 

calculation to provide a conservative estimate 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 $12 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 respondent 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 Agency assumed that all respondents are expected to engage in the activities 

identified in Tables 6 and 7 as activities 1-3, and 12, 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 Agency. As 

discussed previously, EPA assumes that for each chemical, 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 

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

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June 9, 2015

The total IC #2 estimated burden is 211,848 hours and the estimated cost is $14,487,668.

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 particular 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 respondents 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 30
June 9, 2015

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

26

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 burden hours by considering the activities themselves and 

the expected amount of time that the activity may involve on average. These estimates consider the 

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

burden hours for the Agency are presented in Table 9. To calculate the total potential Agency 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 30
June 9, 2015

Table 9 – Estimated Agency Per 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 data17 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 Agency are presented in Table 

9. To calculate the total potential Agency 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 10 – Estimated Agency Per Chemical Burden Hour Costs

Activity(a)

Managerial Technical Clerical

$121.91 $80.48 $45.35 Total $

1) Prepare instructions $366 $1,449 $136 $1,951

2) Identify chemicals to be tested 366 2,575 136 3,077

3) Identify recipients 366 1,932 0 2,298

4) Prepare the 408(p) order packages 0 483 680 1,163

5) Review and approve the orders 366 483 0 849

6) Issue the orders 0 0 408 408

7) Process initial responses(b) 244 483 91 818

8) Provide assistance and follow-up, as needed 0 4,346 0 4,346

9) Identify non-responders 0 0 91 91

10) Process data submissions 0 966 91 1,057

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 0 483 544 1,027

Total Cost: $1,708 $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

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June 9, 2015

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 11.

Table 11 – Annualized Estimated Total Respondent Burden and Costs for All 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 $592,767

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 $13,171 17,100 $1,317,100 5,700 $439,033

Recording Keeping 171 13,171 17,100 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 (years).

The total 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 for this 

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

annualized 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 $104 ($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 10 by the total number of chemicals for a total Agency burden 

of 13,364 hours (512 x 26 chemicals) and a cost of $1,046,838 ($40,263 x 26 chemicals). These totals 

were divided 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 between 

$17,783 and $557,218. The total annual burden is estimated to be 83,116 hours, with an annual cost of 

18 See activity 13 in Table 8.

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June 9, 2015

$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 of 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.regulations.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 

Room 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-screeningprogram-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-screeningprogram-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.gov, 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 Testing, Initial Response Form for Individual Order Recipients 

(EPA Form No. 6300-07) (Draft, June 2015).

Attachment C – EDSP Tier 2 Testing, Initial Response Form for Consortia/Task Forces

(EPA Form No. 6300-07-C) (Draft, June 2015).

Attachment D – Calculations for Paperwork Burden and Costs for Data Generation Activities 

(October 21, 2014).

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June 9, 2015

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)."

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