June 18, 2013

Page 1 of 31

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 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 the potential to interact with 

estrogen, androgen, or thyroid hormone systems using a battery of assays.3 Based on a Weight-ofEvidence analysis, substances that have the potential to interact 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 Weight-ofEvidence5 determination for a chemical that some, or all, of the Tier 2 tests are required.

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 

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 screened under Tier 1 of the EDSP and are now proceeding to testing under Tier 2 

 

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
June 18, 2013

Page 2 of 31

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. Under the PRA, the ICR is intended to cover a three 

year period. 

At this time, 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%, or 26 chemicals.6

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 the potential to interact 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 [EPA] 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 

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 

 

6 See Appendix for additional discussion.
June 18, 2013

Page 3 of 31

from the testing to the Administrator, within a reasonable time period that the [Agency] 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 $25,000 per day may be assessed, after notice and an administrative 

hearing held on the record in accordance with section 554 of the APA [15 U.S.C. 2615(a)(1)–(2)(A)].

FFDCA section 408(f) establishes procedures that the Agency "shall use" to require data to support the 

continuation of a tolerance or exemption that is in effect. The provision identifies three options: 

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)]. 

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 
June 18, 2013

Page 4 of 31

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 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 FFDCA 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]."

7

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 

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)]. 

 

7 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.
June 18, 2013

Page 5 of 31

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.8 The determination that a chemical does or is not likely to have the potential to 

interact with the endocrine system (i.e., estrogen, androgen, or thyroid hormone systems) will be made 

on a Weight-of-Evidence9

 basis taking into account all available data on the compound, including data 

from the Tier 1 screening assays and/or other scientifically relevant information. The fact that a 

 

8 To access an overview of the endocrine system go to http://www.epa.gov/endo/pubs/edspoverview/primer.htm. 9 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. 
June 18, 2013

Page 6 of 31

substance may interact 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 

interaction 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 interactions 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 other scientifically relevant information (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 assays to reduce animal use, refine procedures involving animals 

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

is using validated methods or assays to identify and characterize the endocrine activity of pesticides, 

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

and thyroid hormone systems. 
June 18, 2013

Page 7 of 31

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 screening requirements defined 

in the order. 

3(b) Public Notice Required Prior to ICR Submission to OMB

This document is being issued for public review and comment prior to submission to OMB for review 

and approval under the PRA. Prior to submission to OMB, EPA will amend this section of the ICR to 

reference that effort and delineate any revisions the Agency made after considering the comments 

received.

[Placeholder for revised ICR:

In response to the 60-day public notice and comment period EPA provided for the draft ICR as required 

under the PRA (## Federal Register [FR] #####-#####, [Date of FR Notice]), EPA received [##]

comments. [Insert summary of PRA issues raised by comments, and the EPA's response.]] 

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

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

presents regular updates at the Pesticide Partners 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. 

[Placeholder for outcome of consultation process.]

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 

 

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 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/. 
June 18, 2013

Page 8 of 31

Agency can determine that the chemical qualifies for the statutory exemption—i.e., that it is not 

anticipated to interact with the endocrine system.

For purposes of this ICR, the Agency assumes that all recipients of an 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 

not be 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 or pesticide inert, 

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)] 

(Reference 1), and the recently finalized 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 
June 18, 2013

Page 9 of 31

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. 

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). EPA will identify 

the recipients of Tier 2 test orders upon completion of the Tier 1 data reviews and Weight-of-Evidence 

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.
June 18, 2013

Page 10 of 31

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 responses 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.13 EPA assumes that there is only 

one "data doer" per chemical and that all "catch-up"14 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. 

Table 1 – Estimated Number of Potential Respondents/Responses

IC # IC Category Name

Estimated Number of 

Respondents

1. Total Tier 2 Test Order Recipients 210

– Tier 2 Test Order Recipients 150

– Catch-Up Orders 60

2. Total Tier 2 Data Generators/Submitters 26

– Tier 2 Data Generators/Submitters 26

– Catch-Up Orders 0

3. Total Tier 2 Consortium Participants 210

– Tier 2 Consortium Participants 150

– Catch-Up Orders 60

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. For the purpose of estimation in this ICR, the 

Agency assumes that 50% of the remaining 52 chemicals would be the subject of Tier 2 testing. 

 

13 See Appendix - Rationale for Expected number of Chemicals to be Tested, for additional detail. 14 "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.
June 18, 2013

Page 11 of 31

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 210. 

4(b) Respondent Activities

Respondents would receive an individual Tier 2 test order from EPA using the "FIFRA/FFDCA 408(p), 

EDSP Tier 2 Test Order Template" (Attachment A). The order directs the recipient to provide an initial 

response within 90 days of receiving the order using EPA Form No. ####-##, "EDSP Tier 2 Test Order 

Initial Response Form for Individuals" (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. ####-##-C, "EDSP Tier 2 Test Order 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. 

(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 
June 18, 2013

Page 12 of 31

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

(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
June 18, 2013

Page 13 of 31

Activity Managerial Duties Technical Duties Clerical Duties

(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 respond to the order. The specific 

information required with the individual initial response from each order recipient will vary based on the 

respondent's initial response – the options for which are described in the order, the applicable policies

and procedure documents, and are summarized in section 4(c)(i) of this ICR. Those recipients that 

generate data, either individually or as part of a consortium, are expected to provide a one-year progress 

report, and then submit the data 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 engage in additional 

activities associated with that response option. For example, a respondent could choose to reformulate 

the product. These response options involve established procedures, and additional activities that are 

already approved by OMB under existing ICRs. 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. 

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 Individuals, 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 B, FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order

Template.) 

(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) Claim Not to be Subject to the Test Order. Order recipients would choose this option to indicate 

that they believe they are not subject to the order because: 
June 18, 2013

Page 14 of 31

(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 Have or Intend to Voluntarily Cancel the Product Registration(s) or Reformulate the Product 

(only applicable to pesticide active ingredients). 

(6) I Claim a Formulators' Exemption (only applicable to pesticide active ingredients). 

(7) I Have or Am in the Process of Discontinuing the Manufacture/Importation of the Chemical 

(only applicable to pesticide inert ingredients).

(8) I Will Not Sell the Chemical for Use in Pesticide Products 

(only applicable to pesticide inert ingredients). 

(9) Request an exemption under FFDCA section 408(p)(4). 

(10) Other initial responses. 

a) Pre-enforcement challenges to the test order. 

b) Additional EDSP testing is unnecessary because the chemical is an endocrine disruptor or was 

used as a "positive control" in the EDSP Tier 2 validation effort.

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 specific due date will be identified in the order). The progress report should 

provide a brief description of the status of the respondent's planned activities for each test, and, if 

applicable, a description of any problems encountered or expected difficulties in meeting the schedule 

for complying with the order.

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, 
June 18, 2013

Page 15 of 31

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 five 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.TBD, Avian 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.TBD, 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 secondary sex characteristics, 

biochemical liver responses, thyroid function, and histopathology of several tissues.

3. OCSPP Guideline 870.3800, Reproduction and Fertility Effects15 

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 

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. OCSPP Guideline 890.TBD, Medaka Multi-Generation 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.

5. OCSPP Guideline 890.TBD, Mysid Two-Generation Toxicity Test 

This test guideline is designed to provide concentration-response information concerning the adverse 

effects of a test substance delivered via aqueous exposure on invertebrate reproduction, growth and 

development through two generations. 

 

15 Test guidelines 1) OECD TG 416 (Two-Generation Reproduction Toxicity Study), or 2) OECD TG 443 (Extended OneGeneration Reproductive Toxicity Study) are acceptable alternative tests.
June 18, 2013

Page 16 of 31

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 describe the layout and scope of information 

that should be contained within a study profile and can serve as guides for preparation of study 

documents. Use of the templates improves the likelihood of a successful submission, since the 

information necessary for an efficient Agency review is outlined. Additional details about these 

templates are available at: http://www.epa.gov/pesticides/regulating/studyprofile_templates/. 
June 18, 2013

Page 17 of 31

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://www.epa.gov/pesticides/regulating/registering/submissions/index.htm. 

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 coordinate the review of Tier 2 data received, posting of information on the Agency's 

Website, and the preparation of resulting 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 will 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 Weight-of-Evidence 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.
June 18, 2013

Page 18 of 31

(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. Orders will be mailed to each 

recipient using certified and return receipt mailing options offered by the U.S. Postal Service.

(7) Process Initial Responses. The Agency will receive the 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 consortia, 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 by 

OPP, OPPT and OSCP.

(12) Analyze Data. OCSPP and OW will implement the Agency's internal standard review procedures 

to review the results of the Tier 2 test data.

(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 interactions 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

EPA is developing an electronic system for receiving submission in response to EDSP test orders. This 

will be a more advanced submission process for the pesticide chemical order recipients than currently 

exists, and for now, will apply solely to EDSP related submissions. The EDSP electronic reporting 

system will take advantage of the Agency's Central Data Exchange (CDX) to allow order recipients to 

respond to an order (e.g., to submit test data) via the Internet. See http://www.epa.gov/cdx for additional 
June 18, 2013

Page 19 of 31

information about CDX. Order recipients, if not already registered with CDX, will need to complete a 

simple registration process, thereby establishing a secure log-on to CDX. Specific requirements 

associated with these orders will be provided directly to the order recipients, and are expected to 

include: 

• Registration with CDX, resulting in the establishment of an electronic signature usable for 

electronically submitting test order responses;

• Access to a web-based response form, including the ability to attach PDF files; 

• Encrypted submission to EPA via CDX.

The systems will manage information related to the associated companies, requirement information, and 

information related to the responses. The systems will track the milestones associated with the drafting, 

concurrence, mail-out, 90-day response, submission receipts and reviews. Downstream process tracking

(e.g., time extensions and non-responsive companies) is part of the system design. The Agency will 

produce several reports to facilitate tracking, etc. For example, a 90-day company response status report 

is needed to determine whether companies have responded, and to identify their intentions. A status 

report by order across all chemicals, sorted by company is needed in order to present overall progress 

and allow management to directly identify delays. The status of each of the EDSP orders reported from 

these systems, which is currently posted to a public website, will continue for all existing and future 

orders issued under this program. 

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 an 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 
June 18, 2013

Page 20 of 31

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. 

For purposes of estimating the potential paperwork burden in this ICR, EPA assumed that the data 

would be submitted within 2 or 3 years of receiving 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. 
June 18, 2013

Page 21 of 31

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 2012 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. 

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 44.3% to the hourly rate, based on benefits for all private industry workers 

from June 2012 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 $54.34 $28.88 $17.23

Benefits Percentage of Total Labor2 Benefits % 42.0%

Loaded Hourly Rate (LHR) Wages + (Wages * Benefits %) $77.16 $41.01 $24.47

Overhead Percentage3 50%

Overhead Per Hour (OPH) LHR*Overhead % $38.58 $20.51 $12.24

Fully Loaded Hourly Rate LHR + OPH $115.74 $61.52 $36.71

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.

 

16 DOL, Bureau of Labor, September 11, 2012 Announcement of June 2012 Data

http://www.bls.gov/news.release/archives/ecec_09112012.htm
June 18, 2013

Page 22 of 31

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

$115.74; Technical = $61.52; and Clerical = $36.71. 

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 

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. 
June 18, 2013

Page 23 of 31

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 

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 will be required for each chemical, for the purposes of the ICR 

calculations, EPA is assuming that all five 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. 

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
June 18, 2013

Page 24 of 31

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 917 5,605 2,168 8,690

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: 1,160 6,653 2,332 10,145

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 = $115.74; Technical = $61.52; and 

Clerical = $36.71. 

Table 7 – Estimated Per Chemical Costs by Activity

Activity

Managerial Technical Clerical

$115.74 $61.52 $36.71 Total

1) Read instructions $1,389 $738 $0 $2,127

2) Plan activities 5,556 2,584 0 8,140

3) Submit an initial response to EPA 2,778 1,292 73 4,143

4) Read and discuss the protocol 4,167 8,920 0 13,087

5) Activities related to the submission of OSRI 5,787 26,331 2,570 34,688

6) Participate in Consortium 2,778 8,920 73 11,771

7) Generate the data 106,134 344,820 79,587 530,541

8) Submit Progress Report 579 1,230 257 2,066

9) Compile and review the final data for submission 4,167 11,750 441 16,358

10) Complete paperwork to assemble submission package 579 1,230 257 2,066

11) Submit final data to EPA 347 0 73 420

12) Maintain records 0 1,476 2,276 3,752

13) Delivery Costs 12

Total Cost: $134,261 $409,291 $85,607 $629,171

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 paper copy and a CD-ROM

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

delivery for the calculation to provide a conservative 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.
June 18, 2013

Page 25 of 31

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 42,840 hours and the estimated cost is $3,814,020. 

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. 

The total IC #2 estimated burden is 255,138 hours and the estimated cost is $15,677,740. 

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 35,910 hours and the estimated cost is $2,471,910. 
June 18, 2013

Page 26 of 31

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

210

24 $2,127 5,040 $446,670

2) Plan activities 90 8,140 18,900 1,709,400

3) Submit an initial response to EPA 47 4,143 9,870 870,030

12) Maintain records(g) 43 3,752 9,030 787,920

Subtotal: 204 $18,162 42,840 $3,814,020

IC #2 - Data Generators and Submitters

4) Read and discuss the protocol

26

181 $13,087 4,706 $340,262

5) Activities related to the submission of OSRI 548 34,688 14,248 901,888

7) Generate the data(h) 8,690 530,541 225,940 13,794,066

8) Submit Progress Report 32 2,066 832 53,716

9) Compile and review the final data for 

submission

239 16,358 6,214 425,308

10) Complete paperwork to assemble the 

submission package

32 2,066 832 53,716

11) Submit final data to EPA 5 420 130 10,920

12) Maintain records(g) 86 3,752 2,236 97,552

13) Delivery Costs 12 312

Subtotal: 9,813 $602,990 255,138 $15,677,740

IC #3 - Consortium Participants

6) Participate in Consortium 210 171 $11,771 35,910 $2,471,910

Subtotal: 171 $11,771 35,910 $2,471,910

Total: 10,188 $632,923 333,888 $21,963,670

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 (389 hours x 26 

chemicals = 10,114 hours). 
June 18, 2013

Page 27 of 31

Table 9 – Estimated Agency per Chemical Burden Hours

Activity(a) Managerial Technical Clerical Total

1) Prepare instructions 2 12 2 16

2) Identify chemicals to be tested 2 21 2 25

3) Identify recipients 2 16 0 18

4) Prepare the 408(p) order packages 0 4 10 14

5) Review and approve the orders 2 4 0 6

6) Issue the orders 0 0 6 6

7) Process initial responses(b) 1 4 1 6

8) Provide assistance and follow-up, as needed 0 36 0 36

9) Identify non-responders 0 0 1 1

10) Process data submissions 0 8 1 9

11) Analyze data(c) 0 200 0 200

12) Incorporate data into risk assessments(d) 0 40 0 40

13) Store data in retrievable system 0 4 8 12

Total Burden: 9 349 31 389

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 40 hours per test (40 x 5).

(d) Assumes 8 hours per test (8 x 5).

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 = $118.56; Technical = 

$76.92; and Clerical = $43.86. 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 the per 

chemical cost in Table 10 by the total number of chemicals ($29,274 x 26 chemicals = $761,124).

Table 10 – Estimated Agency Per Chemical Burden Hour Costs

Activity(a)

Managerial Technical Clerical

$118.56 $76.92 $43.86 Total $

1) Prepare instructions $237 $923 $88 $1,248

2) Identify chemicals to be tested 237 1,615 88 1,940

3) Identify recipients 237 1,231 0 1,468

4) Prepare the 408(p) order packages 0 308 439 747

5) Review and approve the orders 237 308 0 545

6) Issue the orders 0 0 263 263

7) Process initial responses(b) 119 308 44 471

8) Provide assistance and follow-up, as needed 0 2,769 0 2,769

9) Identify non-responders 0 0 44 44

10) Process data submissions 0 615 44 659

11) Analyze data 0 15,384 0 15,384

12) Incorporate data into risk assessments 0 3,077 0 3,077

13) Store data in retrievable system 0 308 351 659

Total Cost: $1,067 $26,846 $1,361 $29,274

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
June 18, 2013

Page 28 of 31

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

210

204 $18,162 42,840 $3,814,020 14,280 $1,271,340

Recording Keeping 43 3,752 9,030 787,920 3,010 262,640

Reporting 161 14,410 33,810 3,026,100 11,270 1,008,700

Non-Burden Costs 0 0 0 0 0 0

IC #2 - Data Generators/ Submitters

26

9,813 $602,990 255,138 $15,677,740 85,046 $5,225,913

Recording Keeping 86 3,752 2,236 97,552 745 32,517

Reporting 9,727 599,226 252,902 15,579,876 84,301 5,193,292

Non-Burden Costs 0 12 0 312 0 104

IC #3 - Consortium Participants

210

171 $11,771 35,910 $2,471,910 11,970 $823,970

Recording Keeping 171 11,771 35,910 2,471,910 11,970 823,970

Reporting 0 0 0 0 0 0

Non-Burden Costs 0 0 0 0 0 0

Total: 10,188 $632,923 333,888 $21,963,670 111,296 $7,321,223

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) Calculated by taking the totals from the tables in section 6(b) of this ICR, and dividing by 3. 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 111,296 hours (333,888 hours ÷ 3) and an estimated annualized cost of $7,321,223 

($21,963,670 ÷ 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 10,114 hours (389 x 26 chemicals) and a cost of $761,124 ($29,274 x 26 chemicals). These totals 

were divided by 3 to get an estimated annualized burden of 3,371 hours (10,114 ÷ 3) and an estimated 

annualized cost of $253,708 ($761,124 ÷ 3). 

6(e) Burden Statement for this ICR

The annual public burden for this information collection activity is estimated to range between 204 and 

9,813 hours, depending on the respondent category and activities, with an estimated cost between 

$18,162 and $602,990. The total annual burden is estimated to be 111,296 hours, with an annual cost of 

 

18 See activity 13 in Table 8. 
June 18, 2013 

Page 29 of 31 

$7,321,233. 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. 

Submit any comments online at http://www.regulations.gov, following the online instructions for 

viewing documents and submitting comments. Please include the Docket ID No. 

EPA-HQ-OPPT-2013-0171, and EPA ICR number (2479.01) in any correspondence. EPA is 

particularly interested in comments regarding the Agency's burden estimates and any suggested methods 

for minimizing respondent burden, including the use of automated collection techniques. If commenting 

on the burden or costs estimates, please provide sufficient detail to allow for the proper consideration of 

your comment. 

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). 

2. EDSP, Final Policies and Procedures for Screening Safe Drinking Water Act (SDWA) 

Chemicals; (78 FR 35909-35922, June 14, 2013). 

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. 

A. FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template. 

B. EDSP Tier 2 Testing, Initial Response Form for Individual Order Recipients (EPA Form No. 

####-##) (Draft, June 2013). 

C. EDSP Tier 2 Testing, Initial Response Form for Consortia/Task Forces (EPA Form No. 

####-##-C) (Draft, June 2013). 

D. Calculations for Paperwork Burden and Costs for Data Generation Activities 

(June 18, 2013). 
June 18, 2013

Page 30 of 31

Appendix - Rationale for Expected Number of Chemicals to be Tested

Estimate of Number of Tier 2 Tests for List 1 Chemicals

It is not possible to derive a realistic estimate of the number of EDSP Tier 2 tests that may be needed 

given that the results of Tier 1 screening have not been fully reviewed and integrated with other 

scientifically relevant information (OSRI) (e.g., Part 158) in a Weight-of-Evidence analysis. 

Nonetheless, EPA has years of experience in review of reproductive toxicity studies and published or 

publically available scientific peer-reviewed studies that are required to support pesticide registration. 

Based on this experience and knowledge, the Agency believes that not all chemicals act in the same 

way, produce the same apical toxicities or affect all possible apical endpoints. Furthermore, of the 

potential endocrine or non-endocrine toxicities produced by a chemical, not all of the observed apical 

endpoints would be the most critical and sensitive effects used in risk assessment, which is the ultimate 

basis for EDSP Tier 2 testing. Thus, despite the absence of Tier 1 screening results, EPA believes it can 

make a reasonable high-end estimate for determining the number of Tier 2 tests using the results of 

toxicity test guideline studies as the primary source of information, and published and publically 

available scientific peer-reviewed studies as a secondary or supportive source of information. 

Reproductive toxicity is used for this estimation exercise because of the large database of reproductive 

studies for pesticide active ingredients that EPA has acquired and evaluated over the years. Hence, the 

primary sources of information to support the estimation are EPA reproductive toxicity test guideline 

studies. Notably, test guideline studies typically only measure apical endpoints and do not discern 

mechanisms of reproductive toxicity, which may be the result of endocrine or non-endocrine effects. In 

this regard, a reproductive toxicity study is not designed to capture all the types of apical effects that 

may involve the estrogen, androgen, or thyroid hormonal pathways. Nonetheless, examination of the 

toxicity database of pesticide active ingredients indicated that an apical reproductive endpoint was 

affected by a chemical on EDSP List 1 approximately 22% of the time in rats and 43% of the time in 

birds. Thus, a high-end estimate of the EDSP List 1 chemicals could be candidates for Tier 2 testing as 

follows: 

50% x 52 List 1 chemicals x 5 test guideline studies = approximately 130 Tier 2 tests19

In support of the primary source of information and high-end estimate of the EDSP Tier 2 tests, a 

secondary source of information was considered based on published and publically available scientific 

peer-reviewed studies. A publically available database20 of approximately 870 studies through 

October 2011 with chemicals that apparently have the potential to affect the endocrine system was 

examined by cross-checking the EDSP List 1 chemicals with the public list. Perusal of the publically 

available list indicated about 50% of List 1 chemicals were included and involved at least one in vivo

toxicity study that appeared to represent most of the species associated with Tier 2 testing. EPA 

acknowledges that the reproductive toxicity studies on the publically available list were used only in 

support of estimating EDSP Tier 2 tests and not for regulatory decision making, especially since they 

 

19 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. For the purpose of estimation in this ICR, the Agency 

assumes that 50% of the remaining 52 chemicals would be the subject of Tier 2 testing.

20 http://www.endocrinedisruption.com/endocrine.TEDXList.overview.php 
June 18, 2013

Page 31 of 31

have not been examined for quality of scientific and technical information in accord with Agency 

standards. In this regard, the Agency feels the results of these studies are worthy of providing secondary 

or supportive information to defend the high-end estimate of the EDSP Tier 2 tests that may be needed 

for List 1 chemicals.

Estimate of which Tier 2 Tests for List 1 Chemicals

In the absence of Tier 1 screening results to determine and inform which Tier 2 tests may be needed, it is 

not possible to make a realistic estimate of which Tier 2 tests may be indicated. Thus, EPA will assume 

that all validated Tier 2 tests are needed.

FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 1 of 16

Note: This template was developed by EPA to provide guidance to EPA staff and managers who will 

be preparing the Tier 2 test orders that will be issued under the Endocrine Disruptor Screening 

Program (EDSP), as well as for the recipients of the orders. This template is not a rule or 

regulation, nor does it create or confer legal rights or impose any legally binding requirements on 

EPA or any party. In preparing a final order, EPA may depart from the guidance presented in 

this template where circumstances warrant and without prior notice. Orders will be generated 

individually for each chemical and each order recipient. EPA will insert the information in blue 

type and brackets when the order is generated.

As of June 18, 2013 

FIRST CLASS MAIL – RETURN RECEIPT®

Summary Information About this Order and the Order Recipient

Order/DCI #: ................................................[Insert sequential number as assigned by the system.]

Chemical Common Name: ..........................[Insert chemical name.]

Chemical #: ...................................................[Insert number assigned to identify the chemical named.]

Date Issued:...................................................[Insert date of signature. This serves as the issuance date.]

Due Date for Initial Response: ....................[Insert date, calculated as 90 calendar days from issuance 

plus 10 calendar days for final processing and mailing 

(i.e., total 100 calendar days from issuance).]

Due Date for Consortia Documentation: ...[Insert date, calculated as 150 calendar days from issuance 

plus 10 calendar days for final processing and mailing 

(i.e., total 160 calendar days from issuance).]

Due Date for Progress Report:....................[Insert date, calculated as 12 months from issuance.]

Due Date for Required Tier 2 Studies: .......[Insert date, calculated as 24 to 48 months from issuance or 

Not Required as applicable.]

☐ 1. Avian Two-Generation Toxicity Test

[Insert date, calculated as 24 months from issuance or Not Required as applicable].

☐ 2. Larval Amphibian Growth and Development Test

[Insert date, calculated as 24 months from issuance or Not Required as applicable].

☐ 3. Reproduction and Fertility Effects1

[Insert date, calculated as 24 to 48 months from issuance or Not Required as applicable].

☐ 4. Medaka Multi-Generation Test

[Insert date, calculated as 24 months from issuance or Not Required as applicable].

☐ 5. Mysid Two-Generation Toxicity Test

[Insert date, calculated as 24 months from issuance or Not Required as applicable].

Company Name: [Insert name.]

Company #(s): [Insert number assigned to identify the company in the system.]

Company Address: [Insert address where order will be directed.]

Company Contact Person: [Insert the name of the contact person.]

 

1 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.

Attachment A
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 2 of 16

EPA Contact: [Insert name of the Chemical Review Manager (first name, last name).]

EPA Contact Phone Number: [Insert Area Code, Phone No.]

EPA Contact E-Mail Address: [Insert Chemical Review Manager E-Mail (first name, last name).]

Dear Sir or Madam:

This order requires you and 1) other registrants of pesticide products containing the chemical; and 

2) other manufacturers and importers of the chemical named above to submit certain data or otherwise 

respond as noted herein to the U. S. Environmental Protection Agency (EPA, the agency). This chemical 

is identified as a pesticide chemical. Pursuant to sections 408(p)(3) and (5) of the Federal Food, Drug 

and Cosmetic Act (FFDCA), which mandates that all pesticide chemicals be tested under the Endocrine 

Disruptor Screening Program (EDSP), these data are necessary, to maintain the continued registration of 

your product(s) containing the listed pesticide active ingredient(s) (PAIs); or, for pesticide inert 

ingredients, necessary to maintain your product on EPA's list of approved inerts. [21 U.S.C. 346a(p)(3), 

(5)]. 

As a pesticide registrant, if you do not respond to this order, or if you fail to otherwise comply with its 

requirements, then the registration of product(s) subject to this order will be subject to suspension, 

pursuant to FFDCA section 408(p)(5)(C)(i) and section 3(c)(2)(B)(iv) of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA). As manufacturers and importers of the chemical, if you do not 

respond to this order, or if you fail to otherwise comply with its requirements, you will be subject to 

fines in accordance with section 16 of the Toxic Substances Control Act (TSCA) [15 U.S.C. 2601]. 

Introduction

This order is issued pursuant to sections 408(p)(3) and (5) of FFDCA [21 U.S.C. 346a(p)(3) and (5)] and 

section 3(c)(2)(B) of FIFRA [7 U.S.C. 136a(c)(2)(B)] and/or based on an EPA determination under 

section 1457 of the Safe Drinking Water Act [42 U.S.C. 300j-17]. FFDCA section 201(q)(1) 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 inert ingredients of such pesticide" 

[21 U.S.C. 231(q)(1)]. 

To facilitate the formation of consortia to develop the data required by this order, and to the extent that 

the information is not protected as confidential business information (CBI), we have provided each order

recipient with a list of the other recipients of an order for this chemical. (See Enclosure A). The EPA 

intends to announce the issuance of this order and the availability of a list of all order recipients for this 

chemical in the Federal Register. The list of order recipients for this chemical will be publicly available 

on the agency's Web site, along with the status of the orders, including recipients' responses. The EPA 

intends to update this information with subsequent publication(s) and posting(s) as appropriate. You are 

encouraged to join a consortium and you may check on the status of responses from the other order

recipients for this chemical on the Web site. 

The information collection requirements described in this document have been approved by the Office 

of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. 

The Information Collection Request (ICR) document prepared by the EPA is identified under EPA ICR 

No. 2279.01, and OMB Control No: 2070-New. The public reporting burden for this collection of 

information is estimated to range between 204 and 9,813 hours, depending on the respondent category 

and activities, with an estimated cost between $18,162 and $602,990. 
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 3 of 16

Section I. The Authority for this Order

FFDCA section 408(p)(1) requires the 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 effects as [EPA] may designate" [21 U.S.C. 346a(p)]. Section 408(p)(3) 

specifically requires that the EPA "shall provide for the testing of all pesticide chemicals." 

[21 U.S.C. 346a(p)(3)]. 

Section 201 of the FFDCA defines "pesticide chemical" as "any substance that is a pesticide within the 

meaning of [FIFRA], including all active and inert ingredients of such pesticide." [21 U.S.C. 231(q)(1).] 

Section 408(p)(5) of the FFDCA provides that the Administrator shall issue an order to a registrant of a 

substance for which testing is required under this subsection, or to a person who manufactures or 

imports a substance for which testing is required under this subsection, to conduct testing in accordance 

with the screening program, and submit information obtained from the testing to the Administrator, 

within a reasonable time period that the Administrator determines is sufficient for the generation of the 

information. 

Section 3(c)(2)(B) of the FIFRA provides that registrants must submit additional data, upon notification 

that the Administrator has determined that additional data are required to maintain an existing pesticide 

registration. [7 U.S.C. 136a(c)(2)(B).] In light of the directive in section 408(p)(3) that the EPA is to 

provide for the endocrine screening of all pesticide chemicals, the EPA considers that such data have 

been statutorily determined to be necessary to maintain an existing pesticide registration. 

Section II. Why You are Receiving this Order

You are receiving this order because you have previously received and fulfilled a Tier 1 screening order

and for which, based on those data, the agency determined Tier 2 testing is required as such, pursuant to 

section 408(p)(3) of the FFDCA, you are subject to this order. 

Section III. Data Required by this Order

This order identifies the Tier 2 testing required to be conducted for the chemical named on the first page 

of this order. The 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 identifying any adverse effects that might result from the 

interaction of a substance with the endocrine system and establishing a dose-response curve. 

Specifically, the purpose of Tier 2 testing, which 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 

interactions with estrogen, androgen and thyroid hormones 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. The fact that a substance is identified for Tier 2 testing does not mean that when the substance 

is used, it will cause adverse effects in humans or ecological systems. 
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 4 of 16

III.A. Data Required – The Tier 2 Tests

The following is a list of Tier 2 tests that of which some or all maybe required for submission to the 

agency in response to this order (see page 1): 

1. OCSPP Guideline 890.TBD, Avian 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.TBD, 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 secondary sex characteristics, 

biochemical liver responses, thyroid function, and histopathology of several tissues.

3. OCSPP Guideline 870.3800, Reproduction and Fertility Effects2

 

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 

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. OCSPP Guideline 890.TBD, Medaka Multi-Generation 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. 

5. OCSPP Guideline 890.TBD, Mysid Two-Generation Toxicity Test 

This test guideline is designed to provide concentration-response information concerning the adverse 

effects of a test substance delivered via aqueous exposure on invertebrate reproduction, growth and 

development through two generations. 

III.B. Conducting the Tests – Tier 2 Testing Protocols 

Pursuant to section 408(p)(1) of the FFDCA, testing conducted for the EDSP must be based on 

"validated test systems and other scientifically relevant information." [21 U.S.C. 346a (p)(1).] "Other 

scientifically relevant information" (OSRI) is information demonstrating whether substances has/does 

not have an effect on the functioning of the endocrine system. Other scientifically relevant information 

may either be functionally equivalent to information obtained e.g., for pesticide registration, —or may 

include data that provide information on a potential consequence or effect that could be due to effects on 

the estrogen, androgen or thyroid systems. See also the discussion in Section IV. of this order. 

 

2 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
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 5 of 16 

The tests identified in Section III.A. of this order must be conducted using the test protocols that have 

been validated and made available for use by the order recipients that are completing the tests to 

generate new data to respond to this order. Four of the five applicable testing protocols are being peer 

reviewed by the Science Advisory Panel (SAP) in 2013. When available, the final protocols will be on 

the agency's Web site in the 2013 at: http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm, or, 

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

If you choose to generate the data to respond to this order, you may not deviate from an approved testing 

protocol unless you first consult with the agency and obtain agency approval of any deviation. If you 

wish to use a protocol that differs from those attached to this order, you must submit a detailed 

description of the proposed protocol (including a precise description of any deviations from the protocol 

identified in this order) and your reason(s) for wishing to use it. Because section 408(p)(1) of the 

FFDCA requires that the screening be conducted with validated tests, in order for the EPA to approve 

the use of your proposed protocol, you must demonstrate that the protocol has been scientifically 

validated or the deviation is such that the final study is nonetheless properly considered to have been 

scientifically validated. If the agency rejects your protocol you will be notified in writing. Moreover, 

you should be aware that rejection of a proposed protocol will not be a basis for extending the deadline 

for submission of data. 

If you choose to cite or submit existing data, including other OSRI, you must indicate whether the 

information provided follows an accepted scientific methodology or protocol, including but not limited 

to those presented in the EPA's harmonized test guideline compendium,3

 and provide a cogent and 

complete rationale for why you believe the information is sufficient to satisfy part or all of this order. 

The EPA's decisions about whether the information satisfies part or all of the Tier 2 order will be based 

on all relevant information available to the agency. See the instructions for submitting your response, 

which appear in Section IV. of this order. 

You must also adhere to the good laboratory practice (GLP) standards described in 40 CFR part 160 and 

40 CFR part 792, which require you to follow certain practices when conducting studies, and when you 

submit data to the EPA you must provide a GLP compliance statement indicating a) that the data were 

generated using GLPs; b) describe in detail "all differences" between the GLPs and the practices used; 

or c) confirm that you did not sponsor or conduct the study and do not therefore know whether the study 

was conducted in accordance with the GLPs. 

III.C. Generating the Data – Applicable Timeframes 

You are required to submit the data or otherwise satisfy the data requirements specified in this order and 

submit the data to the EPA on the dates indicated on first page of this order. The agency set this due date 

after considering the amount of time one might reasonably expect is needed to complete each test, 

including the planning activities before beginning the test, actual performance of the test, analyzing test 

results, and completing the final study report for that test (see Table 1). The EPA also included several 

months for overall planning, and several months after the last test is completed to allow ample time for 

the order recipients to prepare the final report for submission to the EPA. 

 

3 http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm, or, http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 6 of 16

Table 1 – Estimated Timeframes for Completing the Individual Tests and Reports

OCSPP Guideline # OCSPP Guideline Test Timeframes (months)

890.TBD Avian Two-Generation Toxicity Test 24

890.TBD Larval Amphibian Growth and Development Test 24

870.3800 Reproduction and Fertility Effects1 24 to 48

890.TBD Medaka Multi-Generation Test 24

890.TBD Mysid Two-Generation Toxicity Test 24 1

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.

There is no set sequence for completing these tests, and the due date for submitting the final report to the 

EPA provides you with ample flexibility for order recipients to join forces and complete this battery 

within the timeframe provided. Order recipients may also submit data before the due date. 

Section IV. Responding to the Order

You must respond to this order within the timeframes established pursuant to Section IV.A. of this 

order, and the specific applicable dates as identified on the first page of this order. If you do not respond 

to this order, or if you fail to otherwise comply with its requirements, then the registration of the 

product(s) subject to this order will be subject to suspension pursuant to FFDCA section 408 (p)(5)(C)(i) 

and FIFRA section 3(c)(2)(B)(iv). 

To comply with this order, you are expected to engage in the following activities:

1) Read this order. 

2) Determine and plan activities necessary to respond to the order. 

3) Submit the completed EDSP Tier 2 Testing, Initial Response Form for Individual Order 

Recipients to the EPA, identifying the response option you intend to use. See Section IV.B. of 

this order. 

4) If you decide to generate the data, read and, if applicable, discuss the protocols. See Section 

III.B. of this order. 

5) Submit a Progress Report. See Section VI. of this order. 

6) Generate the data.

7) Compile and review the data for submission. See Section V. of this order. 

8) Complete paperwork to assemble the submission package. See Section V. of this order. 

9) Submit Final Report/Data to the EPA. See Section V. of this order. 

10) Maintain records. See Section VII. of this order. 

IV.A. Schedule for Responding to the Order 

Your schedule for responding may vary based on the response options discussed in more detail in the 

next section of this order. Please note that in calculating the due date for the initial response, the agency

has included an additional 10 calendar days to account for processing the final order package for 

delivery to the post office. Your basic schedule is summarized on the first page of this order and is based 

on the timeframes identified in Table 2, below: 
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 7 of 16

Table 2 – Basis for Establishing the Due Dates in this Order

Timeframes for Due Dates What is Due

Within 90 calendar days of the order's issuance 

(plus 10 calendar days for processing)

Individual recipient's initial response 

Within 150 calendar days of the order's issuance 

(plus 10 calendar days for processing)

Consortia documentation and consortia's 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 the EPA

In general, the agency will not consider any requests for extending the deadlines for the initial response 

or progress report. However, the agency will consider extending the final report due date when the 

circumstances warrant it. If you cannot submit the final report to the agency in the time frame required 

by this order, you may seek additional time to meet the requirement. To do so, you must submit a 

request for an extension to the agency using the electronic system identified in Unit V. of this order. You 

will receive an acknowledgement or notice from the system to confirm the Agency’s receipt of your 

electronic request. Your request must occur 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 this order on a step-by-step basis. In your description, you must explain any 

technical or laboratory difficulties and provide related documentation from the laboratory performing 

the testing. While the EPA is considering your request, the original deadline remains. The agency will 

respond to your request in via the electronic system. If the EPA does not grant your request, the original 

deadline remains. Generally, extensions should be requested only in cases of extraordinary testing 

problems beyond the expectation or control of the registrant, manufacturer, or importer. Extensions will 

not be considered if the request for extension is not made in a timely fashion or in accordance with the 

instructions provided in this order. In no event shall an extension request be considered if it is submitted 

at or after the lapse of the applicable deadline. 

IV.B. Options for Responding to the Order 

You have several options for responding to this order. To report your commitment to act in response to 

this order, you must submit an initial response to the EPA within 90 days of the issuance of this order. 

Please complete the EDSP Tier 2 Testing, Initial Response Form for Individual Order Recipients

(Enclosure B), which the EPA has pre-populated with basic information about this order, the chemical 

and your contact information. Follow the mailing instructions in Section V.D. of this order to submit this 

form to the EPA by the due date for the initial response that is indicated on the first page of this order. 

You have several potential response actions from which to choose, each response option involves 

specific procedures that you must follow if you choose that response option: 

Option 1: Generate Data 

If you choose to individually generate new data for each test specified in this order, you must comply 

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

Good Laboratory Practices (GLP) set out in FIFRA in 40 CFR part 160. The tests must be conducted 

according to protocol requirements identified in Section III.B. of this order. In submitting the data, you 

must follow the procedures described in Section V. of this order. 
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 8 of 16

Option 2: Submit or Cite Existing Data

If you choose to submit or cite an existing study in response to this order (including data previously 

submitted to the agency and/or OSRI), your initial response must include either the data or a reference to 

the data for each test that is required, along with a rationale that explains how the study you cited or 

submitted satisfies part or all of this order. Existing studies are studies that predate issuance of this 

order. In order to be accepted as satisfaction of the requirements imposed in this order, the agency

expects that any such hazard-related data would be of high quality and achieves the objective of Tier 2 

testing to provide reasonable assurance that a chemical does or does not result in adverse endocrine 

related effects. The EPA's decisions about whether the data cited or submitted satisfies part or all of the 

Tier 2 Test order will be based on an evaluation of all relevant information available to the agency. 

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

methodology or protocol, including but not limited to those presented in the EPA's harmonized test 

guideline compendium.4

 Deviations from the protocols validated for the Tier 2 tests, must be identified, 

along with an explanation for the deviations, including an explanation as to why, notwithstanding the 

deviations, the protocol used should still be considered as providing an accepted scientific methodology 

or protocol, and any other information you think the agency should consider in deciding whether to 

accept the data in satisfaction of this order. 

If the EPA has previously reviewed a protocol for a study you are submitting or citing, you must identify 

any action taken by the agency on the protocol and must indicate the manner in which all agency 

comments, concerns or issues were addressed in the final protocol and study. 

If you choose to cite a study that has been previously submitted to the EPA, that study must have been 

previously classified by the EPA as acceptable (i.e., the study was not rejected by the agency for any 

reason related to completeness or quality) or it must be a study which has not yet been reviewed by the 

agency. With respect to any studies for which you wish to select this option you must provide the EPA

with a copy of the title page along with the identification number of the study you are citing (Master 

Record Identification [MRID] number), and, if the study has been reviewed by the agency, you must 

provide the agency's classification of the study. Do not resubmit a study that has previously been 

submitted to the EPA for another purpose. 

The EPA will review any existing study submitted or cited in response to this order to determine 

whether the study is acceptable and whether the study satisfies the requirements of this order. The 

agency will notify you in writing of its determination. If the agency determines that the study is 

acceptable, the EDSP Tier 2 Testing, Initial Response Form for Individual Order Recipients is the only 

response you are required to complete to satisfy this order and the EPA will notify you in writing that 

the order is satisfied. If, however, the EPA determines that the study is not acceptable, you must still 

satisfy the requirements of this order. You should be aware that if the agency determines that the study 

is not acceptable, the agency will require you to comply with this order, normally without an extension 

of the required due date for submission of the data. The agency may determine at any time that a study is 

not valid and needs to be repeated. 

If you are citing a study of which you are not the original data submitter, you may need to submit an 

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

include an offer to pay [in accordance with 40 CFR 152.93] [which includes an offer to resolve any 

 

4 http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm, or, http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 9 of 16

dispute over the recipients' shares of the test costs by submitting the dispute to a neutral third party with 

authority to bind the parties (e.g., through binding arbitration or through a state or federal court action)], 

unless you have received confirmation from the EPA that no such compensation is necessary. 

Option 3: Form a Consortium/Task Force or Offer to Join a Consortium/Task Force 

If you choose to form a task force or consortium to share in the cost of producing the required data, all 

participants of the task force or consortium must submit their own EDSP Tier 2 Testing, Initial Response 

Form for Individual Order Recipients providing the name of the party who will be submitting the data 

on your behalf. 

The designated lead for the task force or consortium must complete the EDSP Tier 2 Testing, Initial 

Response Form for Consortia/Task Forces (Enclosure C) to provide the primary contact for the task 

force or consortium, the list of participants, and an indication of the task force or consortium's planned 

response for each test, along with documentation of its formation (such as a copy of the joint agreement 

or a written statement by all the parties that an agreement exists). The joint agreement to produce the 

data need not specify all of the terms of the final arrangement between the parties or the mechanism to 

resolve the terms. The designated lead for the task force or consortium must follow the mailing 

instructions in Section V.D. of this order to submit EDSP Tier 2 Testing, Initial Response Form for 

Consortia/Task Forces and accompanying information to the EPA by the due date for the consortia 

response that is indicated on the first page of this order. 

Once the task force or consortium submits the data and the EPA has completed its initial review to 

accept the data in satisfaction of this order, the EPA will provide written notification to the contact for 

the task force or consortium that this order has been satisfied, which in turn will close out the orders for 

each of the participants in the consortium/task force. 

If you are unable to join a task force or consortium, you must provide the EPA with documentary 

evidence that you made a reasonable offer to join or share in the testing costs. Such evidence may be: 

(1) your letter offering to join in an agreement, or (2) your letter that contains a legally binding offer to 

join in an agreement and provide a reasonable share of the test costs, and that includes a reasonable 

process for resolving any disputes of the appropriate share of the test costs.

If the task force or consortium fails to submit the data or meet the requirements of the order in a timely 

and adequate manner, you will normally be subject to penalties of up to $25,000 per day, unless you 

commit to submit, and do submit, the required data by the dates specified in this order. In such cases, the 

agency will generally not grant time extensions for the submission of data. Thus, if you agree to jointly 

submit the data, each order recipient is still subject to penalties of up to $25,000 per day, unless some 

party with whom you are in agreement makes a commitment to generate the data and submits the data in 

accordance with the deadlines and all other requirements set forth in this order. 

To the extent permitted by confidentiality requirements, the agency has provided a list of the other 

pesticide registrants, manufacturers and/or importers that have received an EDSP order for this 

chemical. (Enclosure A). This list is intended to help order recipients identify other companies with 

whom they could form agreements to develop data jointly, or otherwise collaborate on a response to 

satisfy the requirements in this order. 
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 10 of 16

Option 4: Claim Not Subject to the Order

You may claim that you are not subject to this order if you do not manufacture or import the chemical 

and/or you are not a pesticide registrant of the chemical identified on the first page of this order or you 

believe the order was otherwise sent to you in error. An explanation of the basis for the claim, along 

with appropriate information to substantiate that claim, must accompany your initial response so that the 

EPA can evaluate the claim. The agency intends to make a determination and respond to your request in 

writing within 90 days of receipt. If the EPA cannot verify your claim, the original requirements and 

deadlines in this order remain. If your claim is verified, the EPA will consider your response to be 

satisfaction of the order and will close out this order. 

Option 5: Voluntarily Cancel the Pesticide Registration(s) or Reformulate the Product 

In place of submitting the data required in this order, you may request the voluntary cancellation of your 

product(s) containing the pesticide active ingredient(s) that is the subject of this order. If you wish to 

voluntarily cancel your product, you must submit a request for voluntary cancellation under FIFRA 

section 6(f). You must submit your request within 90 days of the issuance of this order using the 

agency's existing procedures for a voluntary cancellation (see 40 CFR 152.99). 

In response to your request to voluntary cancel your product(s) registrations, the EPA will initiate the 

standard process for voluntary cancellation, which includes publication of a Federal Register notice 

announcing the proposed voluntary cancellation, as required by FIFRA section 6(f). The agency has 

standard provisions for sale or use of existing stocks of a pesticide, but you may propose an alternative. 

If you propose alternative provisions for sale or use of existing stocks, the EPA will review your 

proposal and respond in writing, prior to publication of the FIFRA section 6(f) notice. 

If you choose this option and cancel your registrations, the EDSP Tier 2 Testing, Initial Response Form 

for Individual Order Recipients is the only response you are required to complete to satisfy this order. 

When the product's pesticide registration(s) is cancelled, the agency will notify you in writing that you 

have satisfied the order. 

Alternatively, in place of submitting the data required in this order, you may submit an application to 

amend the pesticide formulation of your registered product by removing as an ingredient of your product 

the chemical that is the subject of this order. Submitting such an application will initiate the existing 

procedures for reformulation. If you choose this option, the EDSP Tier 2 Testing, Initial Response Form 

for Individual Order Recipients is the only response required to satisfy the order as long as you complete 

the procedures and reformulate your product(s). When you product's formulation has been changed, the 

agency will notify you in writing that you have satisfied the order 

Option 6: Claim a Formulators' Exemption

If you are a pesticide product registrant who purchases the chemical from another order recipient for the 

chemical identified on the first page of this order, and that order recipient has agreed to generate the 

data, you may be eligible for a formulator's exemption. The EPA will confirm claims of eligibility. A 

response asserting the formulator's exemption would no longer be considered an appropriate response to 

an order if the supplier of the chemical fails to comply with the order (i.e., it fails to submit the data 

either individually or jointly with other recipients, or it fails to comply with the terms of a compensation 

agreement or the binding decision of a neutral third party regarding the terms of compensation). If the 

EPA confirms your eligibility for this option, the EDSP Tier 2 Testing, Initial Response Form for 
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 11 of 16

Individual Order Recipients is the only response you are required to complete to satisfy this order. If, 

however, the EPA determines that you are not eligible, you must comply with the order and the original 

deadline remains. 

Option 7: Discontinue the Manufacture or Import of the Chemical

If you have already, or otherwise are in the process of discontinuing the manufacture or import of this 

chemical, you may satisfy the order by submitting documentation to this effect with your EDSP Tier 2 

Testing, Initial Response Form for Individual Order Recipients. If the EPA cannot verify your claim, the 

original requirements and deadlines in this order remain. If your claim is verified, the EPA will consider 

your response to be satisfaction of the order and will close out this order. 

Option 8: Stop Sales in the Pesticide Market

You may commit not to sell the chemical for use in the pesticide market. As part of your initial 

response, you must document your commitment that on or before a date six months after the issuance of 

the test order, all sale and distribution of the pesticide inert ingredient that is the subject of this order to 

any person who you know, or reasonably should know, intends to use the substance in the formulation 

of a pesticide product. In addition, you must certify that you will include in all contracts for sale or 

distribution of the material, a provision that contractually prohibits the purchaser of your chemical from 

using the substance in the formulation of a pesticide product. As part of your initial response, you must 

provide a copy of the contract provision and your commitment to include this contractual provision in 

any contracts entered into on or after a date six months after the issuance of this order. If you choose this 

option, the EDSP Tier 2 Testing, Initial Response Form for Individual Order Recipients, with supporting 

information, is the only response you are required to complete under this order. 

If you do not fulfill the commitments made in your initial response, you will be subject to enforcement 

action for failing to comply with the FFDCA section 408(p) order, in accordance with section 

408(p)(5)(D). Having failed to perform the actions necessary for this response option, you will be 

obliged to immediately comply with the order—i.e., to provide the data, within the time frame that had 

originally been required by the order. In addition, you may be subject to potential penalties, pursuant to 

18 U.S.C. 1001, for willfully making any false or misleading statements to the federal government. 

Option 9: Recipient requests an exemption under FFDCA section 408(p)(4)

You may request an exemption FFDCA section 408(p)(4) provides that "the Administrator may, by 

order, exempt from the requirements of this section a biologic substance or other substance if the 

Administrator determines that the substance is anticipated not to produce any effect in humans similar to 

an effect produced by a naturally occurring estrogen." In order for the agency to make the necessary 

statutory finding to issue the exemption, the request would need to provide any hazard-related 

information that you believe would allow the EPA to determine that your chemical is anticipated to not 

be an endocrine disruptor (i.e., is not anticipated "to produce any effect in humans similar to an effect 

produced by a naturally occurring estrogen").

Under this option, you may satisfy the order by submitting documentation to this effect with your EDSP 

Tier 2 Testing, Initial Response Form for Individual Order Recipients. If the EPA cannot verify your 

claim, the original requirements and deadlines in this order remain. If your claim is verified, the EPA 

will consider your response to be satisfaction of the order and will close out this order. 
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 12 of 16

Option 10. Other Initial Response

As part of your initial response, you may also ask the EPA to reconsider some or all of the testing 

specified in this order if: 

a) Pre-enforcement challenges to a test order. A recipient may wish to challenge the test order. 

(For additional information, see section IV.C below.) 

b) Additional EDSP testing is unnecessary because the chemical is an endocrine disruptor or was 

used as a "positive control" in the validation of the Tier 2 tests. Order recipients may choose to 

ask EPA to reconsider some or all of the testing specified in the order. EPA would review the 

request, along with the appropriate information supporting the claim that additional EDSP testing 

of the chemical is unnecessary because the chemical is an endocrine disruptor or was used as a 

"positive control" in the validation of the EDSP Tier 2 tests, on a case-by-case basis. Based on 

the information currently available, EPA generally expects that if the chemical was used by EPA 

as a ''positive control'' to validate one or more of the Tier 2 tests, only the data submitted related 

to those assays for which the chemical was used to complete the testing as part of the validation 

would be sufficient to satisfy the order. 

IV.C. Procedures for Challenging this Order 

If you wish to challenge the validity of any of the provisions of this order, including the requirement to 

conduct any test or use the specific test protocols required by this order, you must submit to the agency a 

detailed explanation of the basis for your challenge that provides sufficient information for the agency to 

evaluate the issue. The agency intends to respond to your request in writing within 90 days of receipt. 

While the EPA is considering your submission, the original deadline remains. If the EPA does not grant 

your request, the original deadline remains. If your claim is verified, the EPA will consider your 

response to be satisfaction of the order and will close out this order. 

IV.D. Procedures for Cost Sharing 

Cost sharing is the process by which two or more recipients of an EDSP order contribute to the 

generation of data (or the compensation for existing data). Contributions may be in cash or in kind and 

apportionment of costs is subject to negotiation between the participants. The EPA encourages all 

recipients of an order for a particular substance to jointly submit data and share data generation costs. 

All other parties who are also subject to this order are listed in Enclosure A, unless that information is 

protected as CBI, and will be made publicly available on the agency's Web site. 

The EPA has not established specific coordination procedures by which you must collectively generate 

data. You may therefore determine the procedures that are best suited to your individual circumstances, 

and the most acceptable approach to identifying and sharing test costs. 

If you are aware of another manufacturer of the chemical listed on the first page of this order who is not 

listed on Enclosure A, and you provide the EPA with this information, and the EPA intends to send that 

manufacturer an order for this chemical within 90 days of your notification. 
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 13 of 16

IV.E. Procedures for Data Protection 

If (a) a tolerance or exemption has been established for your chemical, (b) an application for a tolerance 

or exemption is pending; or (c) you have partnered with pesticide registrants (either technical or enduse), or otherwise joined a consortium with a pesticide registrant, the EPA considers such data to be 

subject to the requirements of FIFRA section 10. All other confidential business information submitted 

in response to a 408(p) order (i.e., data not in support of a registration or tolerance/tolerance exemption) 

is subject to the Trade Secrets Act [18 U.S.C. 1905]. 

The Freedom of Information Act (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]. Any information that you wish to have the EPA protect as CBI should be 

clearly identified as such. Note that substantive criteria must be met to support a claim for CBI, as 

specified in 40 CFR 2.208. 

Section V. Procedures for Submitting Data to the Agency

You must submit all correspondence related to this order to EPA electronically using the EPA's Central 

Data Exchange (CDX), the point of entry for electronic environmental submissions to the agency, 

including your initial response, the initial response from the consortium, progress reports, the final 

report, supporting data, and other related information. 

V.A. Format for Submissions 

The EPA will develop standard data evaluation formats, referred to as Study Profile Templates (SPTs), 

to assist registrants in their submissions. These templates describe the layout and scope of information 

that should be contained within a study profile and can serve as guides for preparation of study 

documents. Use of the templates improves the likelihood of a successful submission, since the 

information necessary for an efficient agency review is outlined and the submissions of these templates 

should be in a format that can be manipulated (i.e., Microsoft Word and Excel, or similar formats). 

Additional details about these templates are available at: 

http://www.epa.gov/pesticides/regulating/studyprofile_templates/. 

In addition, Pesticide Registration (PR) Notice 2011-3, entitled, Standard Format for Data Submitted 

Under FIFRA and Certain Provisions of FFDCA,

5 describes the EPA's preferred method for organizing 

and formatting submittals of data supporting a pesticide registration. 

The agency requires order recipients to submit completed study profiles, supporting data, and all related 

correspondence request electronically using CDX, the point of entry on the Environmental Information 

Exchange Network (Exchange Network) for environmental submissions to the agency.

V.B. Transmittal Documents 

In order for the EPA to effectively track the compliance of each order recipient, each submission in 

satisfaction of an order issued under FFDCA section 408(p) must be accompanied by a transmittal 

document that includes the following information:

 

5 http://www.epa.gov/PR_Notices/pr2011-3.pdf
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 14 of 16

• Identity of the submitter.

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

• The order number identified on the first page of this order. 

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

V.C. Submitting Individual Study or Test Result Documents

Unless otherwise specified by the agency, each submission must be in the form of individual documents 

or studies. Do not resubmit any documents that you previously submitted to the EPA. Instead, in your 

EDSP Tier 2 Testing, Initial Response Form for Individual Order Recipients that you submit via CDX, 

please provide a citation or reference to the previously submitted documents with sufficient information 

to allow the agency to identify the previously submitted document. 

Each study or document submitted to the EPA must include the following:

i. A title page including the following information:

• The order number identified on the first page of this order. 

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

data requirement addressed.

• The author(s) of the study. 

• The date the study was completed.

• If the study was performed in a laboratory, the name and address of the laboratory, project 

numbers or other identifying codes. 

• 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. 

• 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. 

ii. Upon submission to the EPA, each document must be accompanied by a signed and dated 

document containing the appropriate statement(s) regarding any data confidentiality claims as 

described in PR-Notice 86-5. 

iii. A statement of compliance or non-compliance with respect to GLP standards as required in 

40 CFR part 160, as applicable. 

iv. A complete and accurate English translation must be included for any information that is not in 

English. 

V.D. Transmittal Instructions

All correspondence related to this order must be transmitted to EPA electronically using CDX. In order 

to use CDX, you must register with CDX. CDX registration enables EPA to authenticate user identities 

and verify user authorizations. To register in CDX, the CDX registrant (also referred to as “Electronic 

Signature Holder” or “Public/Private Key Holder”) would agree to the Terms and Conditions, provide 

information about the user and organization, select a user name and password, and follow the procedures 

outlined in the guidance document for CDX online available at: 

http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf. 

To access the EDSP electronic reporting tool in CDX and related instructions, go to the EPA EDSP 

Internet homepage at http://www.epa.gov/endo and follow the appropriate links, or go directly to CDX 

at https://cdx.epa.gov/. 
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 15 of 16

For additional instructions on submitting your information electronically or on paper, please see our 

instructions at: http://www.epa.gov/endo/pubs/toresources/index.htm#submit. 

Section VI. Submit a Progress Report

Unless the EPA has notified you in writing that the requirements of this order have been satisfied, you 

must submit a progress report to the EPA 12 months after the issuance of this order (the specific due 

date for you is identified on the first page of this order). Your progress report should provide a brief 

description of the status of your 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. 

Please include the transmittal document described in Section V.B. of this order. 

Section VII. Recordkeeping Requirements

You must retain copies of the generation of the data and other information documenting your 

compliance with this order. This includes all test reports submitted to the agency in support of a 

registration or in support of a tolerance petition, all underlying raw data, and interpretations and 

evaluations thereof. Consistent with 40 CFR 169.2(k), this includes all test reports submitted to the 

agency in support of a registration or in support of a tolerance petition, all underlying raw data, and 

interpretations and evaluations thereof. Under FIFRA section 8, all producers of pesticides, devices, or 

active ingredients used in producing pesticides subject to FIFRA, including pesticides produced 

pursuant to an experimental use permit and pesticides, devices, and pesticide active ingredients 

produced for export, are required to maintain certain records. As such, any recipients who are pesticide 

registrants or who otherwise submit their data in support of a pesticide registration will be held to the 

recordkeeping standards in 40 CFR part 169. These records shall be retained as long as the registration is 

valid and the producer is in business, and made available to the EPA or its agent for inspection. 

Section VIII. Consequences of Failure to Comply with this Order

FFDCA section 408(p)(5)(C)(i) requires the EPA to issue to any pesticide registrant that fails to comply 

with an order issued under section 408(p) "a notice of intent to suspend the sale or distribution of the 

substance by the registrant." The proposed suspension "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" with the order issued under section 408(p). 

[21 U.S.C. 346a(p)(5)(C)(i).] If a hearing is requested, the only matter for resolution at the hearing shall 

be whether the registrant has failed to comply with an order issued under section 408(p)(5)(A). 

[21 U.S.C. 346a(p)(5)(C)(ii).] 

Any suspension issued under FFDCA section 408(p)(5)(C)(ii), shall be terminated only upon the 

Administrator's determination that the registrant has complied fully with the terms of this order. 

[21 U.S.C. 346a(p)(5)(C)(iii).] 

Failure of chemical manufacturers and importers to comply with any of the requirements in this order 

renders you liable for the penalties and sanctions of up to $25,000 per violation. Each day that the 

violation continues constitutes a separate violation. Any person who knowingly or willfully violates this 

order shall (either in addition to or in lieu of) be subject to a fine of not more than $25,000 per day of 

violation, or to imprisonment for not more than one year, or both. [21 U.S.C. 346a(p)(5)(D), citing 

15 U.S.C. 2615.] 
FIFRA/FFDCA 408(p), EDSP Tier 2 Test Order Template

Draft, June 18, 2013 Page 16 of 16

Before such penalties are assessed, you will be entitled to an administrative hearing held on the record in 

accordance with section 554 of the Administrative Procedures Act (APA). 

[15 U.S.C. 2615(a)(1)-(2)(A).] Before issuing a final penalty order, the EPA must provide notice of its 

intention to assess the penalty, including a draft of the final penalty order, and provide you with the 

opportunity to request a hearing within 15 days of the date the notice has been received. 

[15 U.S.C. 2615(a)(2)(A). See also, 40 CFR §22.13-22.14.] 

If a hearing is requested, the only matters for resolution at the hearing shall be the following: 

(1) whether you have failed to comply with an order issued under FFDCA section 408(p)(5)(A), (2) the 

circumstances of the violation; (3) the extent and gravity of the violation(s); (4) your ability to pay; 

(5) the effect on your ability to continue to do business; (6) any history of prior violations; and (7) the 

degree of culpability [15 U.S.C. 2615(a)(2)(B)]. In this hearing, you may not raise any challenge to the 

validity of this order, or any test required by this order. 

Section IX. Additional Information 

Additional information and details about the EDSP may be found on the agency's Web site at 

http://www.epa.gov/endo. 

If you have any questions about the requirements and procedures established in this order, please 

contact:

TBD

TBD Office Symbol, Mail Code TBD

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave., NW 

Washington, DC 20460–0001 

Telephone number: (000) 000–0TBD; fax number: (000) 000–0TBD

e-mail address: tbd@epa.gov 

Section X. Conclusion 

Under the authority in FFDCA section 408(p) [21 U.S.C. 346a(p)], and FIFRA section 3(c)(2)(B) 

[7 U.S.C. 136a(c)(2)(B)], the U.S. Environmental Protection Agency hereby issues this order to take 

effect on the date of my signature.

Signature: ________________________________________ __________________ 

TBD, Title Date

TBD Division, TBD Program

Office of Chemical Safety and Pollution Prevention 

U.S. Environmental Protection Agency 

Enclosures

Enclosure A – List of EDSP order recipients for this chemical 

Enclosure B – EDSP Tier 2 Testing, Initial Response Form for Individual Order Recipients, EPA Form 

No. ####-## 

Enclosure C – EDSP Tier 2 Testing, Initial Response Form for Consortia/Task Forces, EPA Form No. 

####-##-C 
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

Endocrine Disruptor Screening Program (EDSP)

FFDCA §408(p) Order/FIFRA §(3)(c)(2)(B) Data Call-In (DCI)

OMB Control No.

2070-TBD

EDSP Tier 2 Testing, Initial Response Form for Individual Order Recipients

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1 hour per response. Send 

comments regarding the burden estimate to: Director, Collection Strategies Division (2822T), U.S. Environmental Protection Agency, Washington, DC 

20460. Do not send the completed form to this address – follow the submission instructions in the order/DCI and Part 4 below. 

Part 1 Recipient Information (from the order/DCI and completed by the EPA):

1.1. Order/DCI Info: 

A. Order/DCI #: B. Date Issued: C. Initial Response Due: 

1.2. Company Name: 1.3. Address:

1.4. Contact Person: 

1.5. Chemical Info: 

A. Chemical #: B. Chemical Name: C. Company Number(s): 

Part 2 Recipient’s Initial Response: (Please refer to the order/DCI for more information about response options, as well as detailed 

instructions on how to comply with the order/DCI.)

2.1. I will generate new data or am citing/submitting existing data.

For each required test, check the appropriate box in the following table and follow the order/DCI 

instructions to attach the data and/or required documentation.

A. I will generate new data. 

B. I am citing/submitting existing data and/or other scientifically relevant information. 

C. I am entering (or offering to enter) into an agreement to form a Consortium/Task Force to respond to the order/DCI. 

The Consortium/Task Force must provide a separate initial response within 150 calendar days from issuance of the order/DCI. 

(See Tier 2 Testing, Initial Response Form for Consortium/Task Force at http://www.epa.gov/endo/.)

Required Test A B C 

Required Documentation 

is Attached

OCSPP Guideline 890.TBD, Avian Two-Generation Toxicity 

OCSPP Guideline 890.TBD, Larval Amphibian Growth and Development 

OCSPP Guideline 870.3800, Reproduction and Fertility Effects 

OCSPP Guideline 890.TBD, Medaka Multi-Generation 

OCSPP Guideline 890.TBD, Mysid Two-Generation Toxicity 

2.2. I claim not to be subject to the order/DCI.

These Response Options Apply Only to Registered Pesticides:

2.3. I have or intend to voluntarily cancel the SURGXFWregistration(s) or reformulate the product.

2.4. I claim a formulator's exemption.

These Response Options Apply Only to Pesticide Inert Ingredients (aka, Inerts):

2.5. I have or am in the process of discontinuing the manufacture/importation of this chemical.

2.6. I do not and will not sell my chemical for use as an inert ingredient to the pesticide market.

Other Initial Responses

2.7. I have requested an exemption under FFDCA section 408(p)(4).

2.8. Pre-enforcement challenge to the test order

2.9. Additional EDSP testing is unnecessary because the chemical is an endocrine disruptor or was 

used as a "positive control" in the EDSP validation effort. 

Part 3 3.1. Certification: I certify that the statements made on this form and all attachments are true, accurate and complete. 

I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.

3.2. Company’s Authorized Representative 3.3. Date

Signature: 

Name & Title: 3.4. Telephone Number

Email Address: 

Part 4 Your response to this order and all related correspondence must be submitted electronically to the EPA using the following 

methods: 

• Responses must be submitted electronically to EPA via CDX. 

• Access the EDSP electronic reporting tool and instruction on the EPA EDSP Internet homepage at http://www.epa.gov/endo and 

follow the appropriate links to CDX.

EPA Form No. ####-## (Draft, June 2013)

Attachment B Draft
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

Endocrine Disruptor Screening Program (EDSP)

FFDCA §408(p) Order/FIFRA §(3)(c)(2)(B) Data Call-In (DCI)

OMB Control No.

2070-TBD

EDSP Tier 2 Testing, Initial Response Form for Consortium/Task Forces

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1 hour per response. Send 

comments regarding the burden estimate to: Director, Collection Strategies Division (2822T), U.S. Environmental Protection Agency, Washington, DC 

20460. Do not send the completed form to this address – follow the submission instructions in the order/DCI and Part 5 below.

Part 1 Primary Contact Information (i.e., the Administrator of the Consortium/Task Force):

1.1. Chemical Info:

A. Chemical #: B. Chemical Name:

1.2. Company/Consortium/

Task Force Name

1.3. Address:

1.4. Contact Person:

Part 2 Consortium/Task Force’s Initial Response: (Please refer to the order/DCI for more information about response options, as 

well as detailed instructions on how to comply with the order/DCI.)

2.1. For each assay, check the appropriate box to indicate the Consortium/Task Force’s initial response in the 

following table and follow the order/DCI instructions to attach the data and/or required documentation. 

A. The Consortium/Task Force will generate new data. 

B. The Consortium/Task Force is citing/submitting existing data and/or other scientifically relevant information. 

Required Test A B 

Required Documentation

is Attached

OCSPP Guideline 890.TBD, Avian Two-Generation Toxicity

OCSPP Guideline 890.TBD, Larval Amphibian Growth and Development

OCSPP Guideline 870.3800, Reproduction and Fertility Effects

OCSPP Guideline 890.TBD, Medaka Multi-Generation

OCSPP Guideline 890.TBD, Mysid Two-Generation Toxicity

2.1. The Consortium/Task Force is citing and/or submitting other scientifically relevant 

information that it believes can be used to satisfy the entire order/DCI.

Part 3 Consortium/Task Force Participants: (Please list all participants, including recipient information from the order.)

3.1. Order/DCI #: 3.2. Company Name(s): 3.3. Company Number(s): 3.4. Contact Name/Phone No.:

EDSP - 

EDSP - 

EDSP - 

EDSP - 

EDSP - 

EDSP - 

EDSP - 

See attached continuation sheet identifying additional participants in the Consortium/Task Force.

See attached copy of the Consortium/Task Force agreement.

Part 4 4.1. Certification: I certify that the statements made on this form and all attachments are true, accurate and complete. 

I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.

4.2. Consortium/Task Force’s Authorized Representative 4.3. Date

Signature:

Name & Title: 4.4. Telephone Number

Email Address:

Part 5 Your response to this order and all related correspondence must be submitted electronically to the EPA using the following 

methods: 

• Responses must be submitted electronically to EPA via CDX. 

• Access the EDSP electronic reporting tool and instruction on the EPA EDSP Internet homepage at http://www.epa.gov/endo and 

follow the appropriate links to CDX.

EPA Form No. ####-##-C (Draft, June 2013)

Attachment C Draft
 ICR for Tier 2 Data Collection for Certain Chemicals Under the EDSP (EPA 

Test

2011 Test 

Cost ($)a

2013 Adjusted

Test Cost ($)b

Paperwork 

Cost ($)c

Management 

Cost ($)d

Technical 

Cost ($)e

Clerical 

Cost ($)f

Management 

(Hours)g

Tec

(H

Avian Two-Generation Toxicity Test $ 336,200 $ 347,909 $ 121,768 $ 24,354 $ 18,265 79,149 $ 210 

Larval Amphibian Growth and Development Test 258,920 267,937 93,778 18,756 60,956 14,067 162 

Reproduction and Fertility Effects 378,479 391,660 137,081 27,416 89,103 20,562 237 

Medaka Multi-Generation Test 319,320 330,441 115,654 23,131 75,175 17,348 200 

Mysid Two-Generation Toxicity Test 171,800 177,783 62,224 12,445 40,446 9,334 108 

Total 1,464,719 $ $ 1,515,730 $ 530,505 $ 106,102 $ 344,829 $ 79,576 917 

35%

20%

65%

15%

$ 115.74

$ 

j Total burden hours is used in Table 6 of this ICR for estimating the burden & costs related to data generation paperwork activities.

Note: Except for the labor rates, numbers have been rounded to the nearest whole digit.As of -XQH, 2013 

Calculations for Paperwork Burden and Costs for Data Generation Activities

i Based on total estimated clerical costs (f) divided by the loaded labor rate for clerical staff.h Based on total estimated technical costs (e) divided by the loaded labor rate for technical staff.g Based on total estimated managerial costs (d) divided by the loaded labor rate for managers.f Calculated as 15% of (c), which is 35% of the total estimated test costs.e Calculated as 65% of (c), which is 35% of the total estimated test costs.d Calculated as 20% of (c), which is 35% of the total estimated test costs.c Based on 35% of the total estimated test costs.

Estimated Costs in Dollars Estim

a Estimated costs are based on average costs provided by OPP and OPPT.b The estimated costs for these assays were adjusted using an inflation factor to convert 2011$ to 2013$ (approximately 3.48% increase). Specifically, the estimated cost in (a) 

online inflation calculator provided by US Department of Labor, Bureau of Labor and Statistics at: http://www.bls.gov/data/inflation_calculator.htm. 

Attachment D