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Supporting Statement for an Information Collection Request (ICR)

1. Identification of the Information Collection

1(a) Identification of the Information Collection:

1(a)(i) Title: ICR Addendum for the Second List of Chemicals; Tier 1 Screening of 

Certain Chemicals Under the Endocrine Disruptor Screening Program

1(a)(ii) EPA ICR No.: 2488.01

OMB Control No.: 2070-[new]

Docket ID No.: EPA–HQ–OPPT–2013–0275

1(b) Short Characterization/Abstract

This is an addendum to an existing ICR1 that is currently approved under the Paperwork Reduction Act 

(PRA)2 and that covers the first list of chemicals identified for Tier 1 screening under EPA's Endocrine 

Disruptor Screening Program (EDSP). The existing ICR is being amended to include the information 

collection activities associated with the screening of additional chemicals under Tier 1 of the EDSP (aka 

“List 1 Chemicals”). As directed by Congress in the House Appropriations Committee report for EPA's 

Fiscal Year 2010 appropriations, 3 EPA has identified a second list of chemicals4 to be screened under 

the EDSP that includes pesticide active ingredients (PAIs), pesticide inerts, and chemicals identified 

under the Safe Drinking Water Act (SDWA)5. This ICR addendum (which is being submitted under a 

different series than the existing ICR – the new numbers are identified above) covers the information 

collection activities and related burden associated with issuing orders, generating and collecting data for 

the second list of chemicals (aka "List 2 Chemicals"). List 2 consists of 109 identified chemicals, 41 of 

which are PAIs and 68 are chemicals identified under SDWA. The information collection activities 

otherwise remain the same as those described in the existing ICR, with only a few modifications that are 

necessary to address procedural differences that apply to SDWA chemicals.

The EDSP is established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA),6

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 the estrogen, androgen, or thyroid hormone systems using a battery of assays.7

Substances that have the potential to interact with the estrogen, androgen or thyroid systems may 

proceed to 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. 

 1 Approved under OMB Control No. 2070-0176 (EPA ICR No. 2249). 2 44 U.S.C. 3501 et seq. 3 See page 105, H.R. 2996, House Report 111-180. 4 See Attachment G-2 for a list of the chemicals on the Second List of Chemicals to be Screened under EDSP Tier 1. 5 42 U.S.C. 300j-17. See Attachment A(2) to view the text of SDWA section 1457 6 21 U.S.C. 346a(p). See Attachment A(1) to view the text of FFDCA section 408(p). 7 Nothing in the identification of chemicals for Tier 1 screening 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. As 

such, the list of chemicals identified for screening under Tier 1 of the EDSP should not be construed as a list of known or 

likely endocrine disruptors.
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Additional information about the EDSP is available through the Agency's Web site at 

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

This ICR addendum addresses the information collection activities and related burdens for the List 2 

Chemicals as follows:

• For the PAIs and pesticide inerts on the second list, the information collection activities and 

applicable procedures are identical to those described in the existing ICR and the EDSP Tier 1 

policy and procedures issued in 2009 (Attachment B(1))8

. The order templates and response 

forms have been modified to reflect the new electronic submission mechanism. This ICR 

addendum provides the related burden and costs estimates for these activities as they relate to the 

PAIs and pesticide inerts on the second list; and 

• For the SDWA chemicals on the second list, this ICR addendum describes the information 

collection activities, and establishes a new order template and a new initial response form for 

SDWA chemicals, which are all based on the supplemental EDSP Tier 1 policies and procedures 

for SDWA chemicals (Attachment B(2)). This ICR addendum also provides the related burden 

and costs estimates for the activities related to SDWA chemicals.

The EDSP policies and procedures document of 2009 describes the administrative policies and 

procedures that EPA generally intends to use in implementing the EDSP for initial screening, and serves 

as the general source for the information collection activities associated with the issuance of orders for 

Tier 1 screening under the EDSP. Although the policies and procedures contained in the 2009 document 

would clearly apply to the information collection activities for the PAIs and pesticide inerts on the 

second list, many of the existing policies and procedures reflect issues uniquely associated with the 

pesticide market and the specific regulatory context under which EPA regulates pesticide chemicals. 

EPA therefore determined that some of the existing policies and procedures are generally not applicable 

to non-pesticide chemicals and/or there were competing considerations for SDWA chemicals that 

warranted a modification to those policies and procedures with regard to SDWA chemicals. As such, 

EPA sought public comment via the Federal Register on a draft supplement to the 2009 document that 

addresses policies and procedures specifically for SDWA chemicals. After considering comments, EPA 

finalized the document on May 29, 2013 (Attachment B(2)).

While the requirements in the statutes and the individual Tier 1 orders are binding on EPA and the order 

recipients, the policies and procedures announced in both documents do not impose any binding

requirements. The policies and procedures are not intended to be binding on either EPA or any outside 

parties, and EPA may depart from them where circumstances warrant, without prior notice. The Tier 1 

order, however, is binding on the order recipient and non-compliance with the provisions in the order 

will result in penalties as described in the order.

As an addendum, the focus of this document is on the modified activities and burdens related to the 

second list of chemicals. This addendum does not repeat verbatim descriptions in the existing ICR that 

remain applicable, yet unchanged. As such, this addendum should be viewed as a supplement to the 

existing ICR, in terms of adding to its contents, references and attachments. 

As indicated previously, the currently approved ICR covers the information collection activities 

associated with the follow-up activities and potential catch-up orders related to the initial list of 

 8 74 FR 17560, April 15, 2009. http://www.gpo.gov/fdsys/pkg/FR-2009-04-15/pdf/E9-8706.pdf. See also Attachment B(1). 

Hereinafter referred to as the FIFRA/FFDCA policy and procedures.
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chemicals identified for Tier 1 screening under the EDSP (aka “List 1 Chemicals”). The initial list of 

chemicals consists of 67 PAIs and pesticide inerts. EPA maintains a matrix with information on the 

status of the orders issued and responses received for those chemicals on the Agency's Web site at 

http://www.epa.gov/endo. On October 30, 2012, EPA announced the submission of the renewal ICR for 

the initial list of chemicals.9 That renewal contains several updates to the base burden and costs 

estimates that were previously used in the draft ICR addendum issued in 2010. This ICR addendum 

incorporates those updates to the base burden and costs estimates, as well as the revised presentation of 

those estimates.

This ICR addendum is only intended to cover the information collection activities related to Tier 1 

screening under the EDSP of List 2 Chemicals. EPA will prepare a separate ICR to address the 

information collection activities associated with Tier 2 testing. EPA will follow the notice and comment 

process prescribed by the PRA to seek public comment on any subsequent ICR or ICR addendum before 

submitting it to OMB for review and approval under the PRA.

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, 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 the estrogen, androgen, or thyroid hormone systems.

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

Attachment A), 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 effects as [the 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 

 9 77 FR 65682, October 30, 2012. http://www.gpo.gov/fdsys/pkg/FR-2012-10-30/pdf/2012-26611.pdf. 
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or imports a substance for which testing is required [under FFDCA section 408(p)], to conduct testing in 

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

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

of the information." [21 U.S.C. 246a (p)(5)(A)]

FFDCA section 408(p)(5)(B) requires that, "[t]o the extent practicable, the Administrator shall minimize 

duplicative testing of the same substance for the same endocrine effect, develop, as appropriate, 

procedures for fair and equitable sharing of test costs, and develop, as necessary, procedures for 

handling of confidential business information...." [21 U.S.C. 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)]. 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)(5)(C)(ii) explicitly provides that "[t]he only matter for resolution 

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

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

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

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

registrant has complied fully with FFDCA section 408(p)(5). [21 U.S.C. 346a (p)(5)(C)(iii)].

FFDCA section 408(p)(5)(D) provides that any person (other than a registrant) who fails to comply with 

an order issued under FFDCA section 408(p)(5) shall be liable for the same penalties and sanctions as 

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

shall be assessed and imposed in the same manner as provided in TSCA section 16. Under section 16 of 

TSCA, civil penalties of up to $37,500 per day may be assessed, after notice and an administrative 

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

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

continuation of a tolerance or exemption 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) 

[See 21 U.S.C. 346a (f)(1)(A)].

2. Issuance of a rule under section 4 of TSCA [See 21 U.S.C. 346a (f)(1)(B)].

3. Publication of a notice in the Federal Register requiring submission, by certain dates, of a 

commitment to generate the data "by one or more interested persons." [See 21 U.S.C. 346a 

(f)(1)(C)].

Before using the third option, EPA must demonstrate why the data "could not be obtained" using either 

of the first two options. FFDCA section 408(f)(1) expressly provides that EPA may use these procedures 

to "require data or information pertaining to whether the pesticide chemical may have an effect in 

humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine 

effects." [21 U.S.C. 346a (f)(1)]. Finally, FFDCA section 408(f)(2) provides that, in the event of failure 

to comply with a rule under TSCA section 4 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. [21 U.S.C. 346a (f)(2)]
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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 sections 3 and 10 of [FIFRA]." [21 

U.S.C. 346a (i)].

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. [7 U.S.C. 136a 

(c)(1)(F)].

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)]. 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 costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues 

that results from a use of a pesticide in or on any food inconsistent with the standard under section 408 

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

FIFRA section 3(c)(2)(B) 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 agrees 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. [7 U.S.C. 136a (c)(2)(B)].

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 
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of a pesticide if the registrant fails to take appropriate steps to provide data required under a DCI notice 

in a timely manner. [7 U.S.C. 136a (c)(1)(F)].

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 

entity 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. [7 U.S.C. 136a (c)(2)(D)]

In addition, section 1457 of SDWA provides EPA with discretionary authority to require testing, under 

the FFDCA section 408(p) screening program, "of any other substances that may be found in sources of 

drinking water if the 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.10 The determination that a chemical does or is not likely to have the potential to 

interact with the endocrine system (i.e., disruption of the estrogen, androgen, or thyroid hormone 

systems) will be made on a weight-of-evidence (WoE) (Reference 1) basis taking into account data from 

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

substance may interact with a hormone system, 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. 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.

More specifically, the data collected under Tier 1 screening will allow the Agency to evaluate the 

potential interaction of a chemical with the endocrine system. 

The Agency intends to take a WoE approach to evaluate the available Tier 1 screening data for a 

particular chemical to determine its potential to interact with the endocrine system, and if so, whether 

additional data are needed. Chemicals that go through Tier 1 screening and are found to have the 

potential to interact with the estrogen, androgen, or thyroid hormone systems will proceed to the next 

stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on 

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

In addition to helping determine whether Tier 2 testing is necessary for a particular substance, the Tier 1 

screening data may also be used to determine what kind of Tier 2 data are appropriate, and whether or 

not similar substances might share common mechanisms. Subsequently, Tier 1 screening data may be 

used to qualitatively characterize the risk of pesticides and SDWA chemicals.

The tiered approach for screening (Tier 1) and testing (Tier 2) that EPA is using under the EDSP is the 

most cost-effective and least burdensome approach for complying with the statutory mandate to screen 

all pesticides in the initial list of chemicals for endocrine disruptor effects. Instead of requiring that all 

pesticides undergo the testing that would be necessary to determine (a) whether the substance causes 

adverse endocrine-related effects, (b) identify the adverse endocrine-related effects caused by the 

substance, and (c) establish a quantitative relationship between the dose and the adverse endocrinerelated effect, EPA determined that it would be more efficient (and would use fewer animals) to conduct 

the less expensive and less complex Tier 1 screening to identify those substances that have the potential 

to interact with the estrogen, androgen and thyroid hormone systems.

The paperwork related requirements imposed on the respondents as part of Tier 1 screening under the 

EDSP allow EPA to ensure that the identified screening data will be developed, that the results will meet 

basic scientific standards, that unforeseen complications or issues can be promptly addressed, and that 

the screening is progressing on schedule so that the data will be available for consideration in time for 

anticipated regulatory decisions as required under FIFRA and FFDCA.

Within the Office of Chemical Safety and 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 1 screening data received and resulting 

determinations related to the subject chemical will be based on a coordinated EPA effort that will also 

include other EPA offices, e.g., Office of Research and Development (ORD), Office of Water (OW), 

etc.

As indicated previously, this ICR only applies to Tier 1 screening. A subsequent ICR will address Tier 2 

testing. Tier 2 testing is discussed here only in the context of the use of the Tier 1 screening data 

collected under this ICR.

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 any other office 

within EPA. FFDCA specifically assigns this task to EPA. The EDSP is the only program in the United 

States mandated to validate assays and require testing of chemicals for their potential to disrupt the 

endocrine system. Prior to the enactment of FFDCA section 408(p) and initiation of the EDSP, there 

were no validated methods to screen or test chemicals for their potential to affect the endocrine system.
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In addition, the Agency has a strong commitment to avoiding potential duplication in all of its testing 

programs, as well as in its implementation of the EDSP. EPA also actively promotes efficiency through 

its harmonized test guidelines 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 in relation to estrogen, androgen, 

and thyroid hormones.

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 a chemical is 

manufactured by several companies, the procedures encourage the companies to join together to develop 

and submit the requested data to EPA. In addition, order recipients and other interested stakeholders 

may cite existing or submit other scientifically relevant data that they believe meet the screening 

requirements defined in the order. This is described in more detail in the policies and procedures 

document (See Attachment B(2)). 

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

On November 17, 2010, EPA published a notice in the Federal Register to provide a 60-day public 

notice and comment period on the draft ICR.11 EPA received comments from eight entities, and has 

prepared a response to comment document that can be found in Attachment H. Several changes were 

made to the ICR in response to public comments, ranging from language changes to increase overall 

understanding to specific changes in the burden activities and estimates. The substantive changes are 

highlighted in this section.

• Language in this ICR supporting statement (and across all documents related to this ICR) 

describing the use of EDSP Tier 1 screening data was changed to be consistent. Commenters 

were concerned that the Agency had implied that EDSP Tier 1 screening data would be used to 

determine adverse effects. EDSP Tier 1 screening data are only used to determine if a chemical 

has the potential to interact with the endocrine system.

• All costs and burdens were updated to reflect current labor rates, inflation costs, and to be 

consistent with the latest estimates provided in the ICR renewal. 

• As suggested by commenters, EPA added a line-item in its estimate to address potential burdens 

and costs associated with the submission of other scientifically relevant information (OSRI) that 

may be submitted to the Agency in order to fulfill all or part of an EDSP Tier 1 screening order. 

• Previous references to relevant detailed discussions in the existing ICR have been supplemented 

with the inclusion of important detail so that it is no longer necessary to have both documents on 

hand when reviewing the activities or burden estimates.

 11 75 FR 70568, November 17, 2010. http://www.gpo.gov/fdsys/pkg/FR-2010-11-17/pdf/2010-28815.pdf .
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• After considering the public comments received on the recent draft ICR renewal, EPA is 

increasing the burden hours associated with OSRI. This increase is reflected in Table 6-B.

Please note that when comments were sought in 2010, the draft ICR was identified under EPA ICR 

No. 2249.02 and OMB Control No. 2070-0176, with public comments directed to Docket ID No. 

EPA-HQ-OPPT-2007-1081. That same docket was established for the initial ICR related to List 1 

chemicals. Given the resulting confusion in finding documents in that docket, EPA has established a 

new docket (EPA-HQ-OPPT-2013-0275), with a link to the old docket. 

3(c) Consultations

EPA used an extensive public process in developing and implementing the EDSP.12 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.13

In addition to the solicitation of public comment on the Agency's draft ICR addendum in November 

2010, the EDSP Draft Second List of Chemicals to be Screened (Reference 2), and the Draft Policies 

and Procedures for Screening SDWA Chemicals in the EDSP (Reference 3), EPA met with stakeholders 

and presents regular updates at the Pesticide Partners Dialogue Committee (PPDC) meetings.14

3(d) Effects of Less Frequent Collection

The frequency of response is once per chemical, so a less frequent collection would equate to no 

collection. EDSP Tier 1 orders are expected to be issued once for each chemical. All recipients are 

required to provide an initial response that determines whether they will submit the annual report and 

final data, or if they are only participating in the consortium. Since the Agency is only asking for the 

data to be generated and submitted once for each chemical, the majority of respondents will only 

provide one response per chemical, and at least 109 respondents (one for each chemical) will provide an 

additional two responses per chemical. 

Once per chemical substance is the statutory minimum under both FFDCA and the SDWA. FFDCA 

section 408(p)(3) specifically requires that EPA "shall provide for the testing of all pesticide chemicals," 

unless the Agency can determine that the chemical qualifies for the statutory exemption—i.e., that it is 

not anticipated to interact with the endocrine system. Similarly, section 1457 of the SDWA authorizes 

testing upon a finding that a particular chemical "may be found in sources of drinking water if the 

Administrator determines that a substantial population may be exposed to such substance."

In addition, a recipient of an order for Tier 1 screening may provide an initial response that could justify 

delaying Tier 1 screening or, although expected to be rare for this group of chemicals, allowing the 

 12 Additional information about EPA's extensive public process is available on the agency's Website at 

http://www.epa.gov/endo/pubs/stakeholder/index.htm. 13 http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/index.htm. 14 The PPDC was established under the Federal Advisory Committee Act (FACA) to provide a forum for a diverse group of 

stakeholders to provide feedback to the pesticide program on various pesticide regulatory, policy and program 

implementation issues. For additional information about the PPDC, go to http://www.epa.gov/oppfead1/cb/ppdc/.
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company to go directly to Tier 2 testing. The Agency will consider any such requests on a case-by-case 

or chemical-by-chemical basis and will provide an electronic and/or written response that will be made 

publicly available. In some cases, the Agency's response to an individual requester may be applicable to 

all order recipients for that chemical or could otherwise provide insight to recipients of orders for other 

chemicals.

For purposes of this ICR, the Agency assumes that all recipients of an order for Tier 1 screening 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, EPA 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 2009 EDSP policies and procedures document and the recently finalized EDSP policies and 

procedures for SDWA Chemicals document. 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, to the 

extent practicable and 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 is 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 
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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 in the 2009 policies and procedures document, 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, 

such data would only be subject to the protections available under FOIA and TSA.

As discussed in the 2013 policies and procedures for SDWA chemicals document, SDWA has no 

provisions for handling CBI. With the exception of pesticide chemicals, data submitted in response to an 

EDSP order would only be subject to the protections under FOIA and TSA. The identities of chemicals 

on the non-confidential TSCA Inventory (i.e., the chemical identity of the chemical substance is publicly 

known) contained in health and safety data subject to TSCA may not be entitled to confidential 

treatment. [See 75 FR 3462 (January 21, 2010).] In addition, because the chemical identity is public for 

all SDWA chemicals on the second EDSP chemical list, EPA expects that there would be no need to 

claim submitted information as confidential.

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 

section10. 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.
EPA ICR No. 2488.01 June 3, 2013

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4. The Respondents and the Information Requested

4(a) Respondents

Respondents to the information collection activities covered by this ICR consist of those individuals and 

companies that receive an order issued under FFDCA section 408(p) by the Agency to collect Tier 1 

screening data under the EDSP. Under FFDCA section 408(p)(5)(A), EPA "shall issue" orders "to a 

registrant of a substance for which testing is required...or to a person who manufactures or imports

a substance for which testing is required" [emphasis added]. As such, the potential respondent universe 

remains the same as that described in the existing ICR. There are, however, a few differences described 

in this section that reflect the inclusion of SDWA chemicals.

Identification of Order Recipients: The respondents under this ICR consist of order recipients, which 

can be grouped into three categories:

• Pesticide Registrants - Entities who manufacture or import a pesticide active ingredient or inert 

ingredient and hold an active EPA registration for that substance. In the pesticide universe, there 

are Technical Registrants (basic manufacturers) and End-Use Registrants (customers). A 

Technical Registrant manufactures or imports the active ingredient or inert ingredient that is, in 

most cases, used in the formulation of other pesticide products. An End-Use Registrant

manufactures or imports the end-use product that contains an active ingredient or an inert 

ingredient that they obtain from a technical registrant. Although the Technical Registrant can 

also be an End-Use Registrant, the Agency's focus for purposes of the Tier 1 orders is on the 

Technical Registrant.

• Manufacturers/Importer – Persons who manufacture or import a chemical substance but do NOT

hold an EPA registration for that substance. For the most part, the chemical substances may be 

used as an inert ingredient in a pesticide, but also has other non-pesticidal uses. 

• For the SDWA chemicals, order recipients will be identified manufacturers and importers of 

the chemical substance found in Sources of Drinking Water. 

• For both PAIs/Inerts and SDWA chemicals, EPA may issue a "catch-up" order to a company 

who either is identified or enters the marketplace after the initial issuance of orders. The recipient 

of a catch-up order may be a pesticide registrant or a manufacturer/importer, depending on 

whether the chemical is a PAI/Inert or a SDWA chemical. 

As was done for the initial list of chemicals, EPA will complete the final identification of the specific 

individual recipients for the Tier 1 order for each chemical at the time that the orders are being prepared 

for final issuance. 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 this ICR addendum, 

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 an order for one or more of the 

chemicals on the second list. 
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Data Generators/Submitters. This category includes one respondent for each chemical on the second 

list. As before, EPA is assuming that companies will work together to provide the required data and 

will not duplicate efforts by conducting separately the required assays.

Consortium Participants. This category includes all of the 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.

Calculating the Number of Respondents: To identify the potential number of order recipients for 

purposes of estimating the burden in this ICR, the Agency used internal data sources. Specifically, for 

PAIs and pesticide inerts on the second list, the Agency used the Office of Pesticide Programs 

Information Network (OPPIN), which is an internal OPP database for query, input and tracking of 

pesticide products, ingredients, studies, regulatory decisions and other information about registered 

products to identify registrants and manufacturers/importers. For the SDWA chemicals, the Agency used 

data from the TSCA Inventory Update Reporting (IUR) rule database or, in cases where there were no 

IUR reporters, the Toxics Release Inventory (TRI) database to identify manufacturers and importers of 

the SDWA chemicals on the second list. In addition, as appropriate, the Agency may also use other 

sources, including public sources, to identify manufacturers/importers that should receive an order.

As before, the Agency assumes that additional order recipients may be identified subsequently that 

should have received an order but for whatever reason were missed or are new to the market. Once 

identified, the Agency will determine whether to issue a "catch-up" order to those entities. For purposes 

of this addendum, we assume that the majority of the catch-up orders will involve the pesticide 

registrants, and have allocated this number accordingly.

Table 1-B15 presents the estimated number of responses based on the Agency's efforts to date to identify 

potential order recipients, and assumptions regarding the anticipated response from each respondent in 

terms of data generation or consortium participation. EPA assumes that there is only one "data doer" per 

chemical and that all "catch-up" order recipients will join an already formed consortium. 

The Agency has made every effort to provide a conservative 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.

 15 Since this is an ICR addendum, the table is numbered in the same manner as that used in the existing ICR, with the 

addition of "-B" to indicate that the table is associated with the ICR addendum. After the ICR addendum is approved, the 

ICRs may be combined and this approach will be used to combine the tables.
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Table 1-B – Estimated Number of Potential Respondents/Responses

IC # IC Category Name Estimated Number of Respondents

1. Order Recipients 1000

1(a). – Registrants 125

– Catch-Up Orders 60

1(b). – Manufacturers/Importers 770

– Catch-Up Orders 45

2. Data Generators/Submitters 109

2(a). – Registrants 41

– Catch-Up Orders 0

2(b). – Manufacturers/Importers 68

– Catch-Up Orders 0

3. Consortium Participants 1000

3(a). – Registrants 125

– Catch-Up Orders 60

3(b). – Manufacturers/Importers 770

– Catch-Up Orders 45

Total Responses 2,109

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

addendum, which are presented later in this ICR addendum. In general, the estimated total number of 

order recipients is 1000 (Initial recipients = 125 + 770, plus 105 catch-up order recipients). This 

represents the universe of respondents. These respondents, as indicated in their initial response, are 

assumed to either be a Data Generator/Submitter or a Consortium Participant. The second list consists of 

109 chemicals, 41 of which are pesticide active ingredients (PAIs) and 68 are SDWA chemicals.

4(b) Respondent Activities

Individual respondent activities vary based on the IC category and the respondent group. Following a 

summary of the general activities by respondent group, this discussion will provided a more detailed 

overview of the activities.

Pesticides: For registrants of the PAIs on the second list, the information collection activities are 

identical to those described in the 2009 policies and procedures document and the existing ICR. In 

general, these respondents will receive individual orders that are prepared by EPA using the revised 

order template in Attachment C(1), entitled "FIFIRA/FFDCA 408(p) Order Template for Pesticide 

Active Ingredients (PAIs)" (As of April 15, 2013). EPA has also made similar revisions to the order 

template used for pesticide inert ingredients – see Attachment C(2). See Attachment I for a list and full 

description of the changes that were made to the templates currently approved under the existing ICR.

As with List 1 Orders, the orders prepared using these templates will provide the recipients with the 

same options for responding as those discussed in the template order and covered by the existing ICR, 

including the submission of other scientifically relevant information (OSRI) that the recipient believes 

should be considered by EPA as responsive to the order. See also Attachment E, which provides a 

diagram of the overall process for EDSP orders, including the various response options available for 

pesticides. 

The order will direct the recipient to provide an initial response within 90 days of receiving the order by 

submitting their response to the order and all related correspondence electronically to EPA using the 

following methods: 1) Send submissions electronically to EPA via CDX, and 2) Access the EDSP 
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electronics reporting tool and instructions on the EPA EDSP internet homepage at 

http://www.epa.gov/endo and follow the appropriate links to CDX. The currently approved form 

identified in the existing ICR as EPA Form No. 6300-05, entitled "FFDCA §408(p) Order/FIFRA 

§(3)(c)(2)(B) Data Call-In (DCI) - Initial Response Form for Individual Order Recipients," has been 

revised in a few minor ways as identified in Attachment I. EPA intends to include a copy of this form 

(see Attachment D(1)) in the order packet as a reminder of the options available to the order recipient. 

The online response form will be consistent with this form, with available information pre-populated for 

the respondent.

If the recipient joins a consortium, the consortium will be expected to provide an initial response within 

150 days of receiving the order by submitting their response to the order and all related correspondence 

electronically to EPA using the following methods: 1) Send submissions electronically to EPA via CDX, 

and 2) Access the EDSP electronics reporting tool and instructions on EPA EDSP internet homepage at 

http://www.epa.gov/endo and follow the appropriate links to CDX. The currently approved form 

identified in the existing ICR as EPA Form No. 6300-05-C, entitled "FFDCA §408(p) Order/FIFRA 

§(3)(c)(2)(B) Data Call-In (DCI) - Initial Response Form for Consortium/ Task Force" has been revised 

in a few minor ways as identified in Attachment I. EPA intends to include a copy of this form (see 

Attachment D(2)) in the order packet as a reminder of the options available to the order recipient. The 

online response form will be consistent with this form, with available information pre-populated for the 

respondent.

SDWA Chemicals: As indicated previously, EPA determined that some of the existing policies and 

procedures are generally not applicable to non-pesticide chemicals and that there are competing 

considerations for SDWA chemicals warranting a modification to the procedures with regard to SDWA 

chemicals. The modifications are specifically described in a supplement to the 2009 policies and 

procedures document (Attachment B(2)).

In general, these recipients will receive individual orders that are prepared by EPA using the new order 

template in Attachment C(3), entitled "SDWA/FFDCA §408(p) Order Template for SDWA §1457 

Chemicals" (as of April 15, 2013). The new order template for SDWA chemicals is similar to the 

existing order templates except that it reflects the policies and procedures for SDWA chemicals. As 

such, the order specifies the options provided for recipients to follow in responding to the order, 

including the submission of other scientifically relevant information (OSRI) that the recipient believes 

should be considered by EPA as responsive to the order. A major difference in these response options 

and those covered in the existing ICR, is the elimination or modification of options that are not 

applicable to SDWA chemicals.

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

submitting their response to the order and all related correspondence electronically to EPA using the 

following methods: 1) Send submissions electronically to EPA via CDX, and 2) Access the EDSP 

electronics reporting tool and instructions on the EPA EDSP internet homepage at 

http://www.epa.gov/endo and follow the appropriate links to CDX. A new initial response form for use 

by individuals that received an order for a SDWA chemical is provided in Attachment D(3), entitled 

"FFDCA §408(p) Order for SDWA §1457 Chemicals - Initial Response Form for Individual Order 

Recipients" (EPA Form No. 6300-06). EPA will include this form in the order packet sent to these 

recipients as a draft of the response options available to the order recipient. See also Attachment E.

If the recipient joins a consortium, the consortium will be expected to provide an initial response within 

150 days of receiving the order by submitting their response to the order and all related correspondence 
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electronically to EPA using the following methods: 1) Send submissions electronically to EPA via CDX, 

and 2) Access the EDSP electronics reporting tool and instructions on the EPA EDSP internet homepage 

at http://www.epa.gov/endo and follow the appropriate links to CDX. A new initial response form for 

use by the consortium formed for a SDWA chemical is provided in Attachment D(4), entitled 

“SDWA/FFDCA §408(p) Order for SDWA §1457 Chemicals – Initial Response Form for Consortium" 

(EPA Form No. 6300-06-C), which will also be included in the initial order packet they receive.

In both cases, the order will specify the same eleven Tier 1 screening assays, and outline the same 

timeframes for responding to the order, including providing one year progress reports. The orders may 

provide different contact information within the Agency depending on the chemical for which it is 

issued. The orders will also provide instructions for electronic submission in response to orders that 

were not previously available. 

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 other information about the EDSP, including the 

applicable policies and procedures document that explains the Agency's rational for the requirements 

in the order, and which describes the specific details of the policies that EPA generally intends to 

adopt in implementing for the EDSP.

To illustrate what an order recipient might expect to receive in terms of an order under the EDSP, 

the Agency has developed order templates for the three different kinds of potential order recipients, 

which are all presented in Attachment C. Although the Agency intends to use these templates as 

drafted, the individual orders will contain the necessary recipient details and requirements for the 

subject chemical. As such, the final individual orders that a recipient might receive may vary from 

these templates, as well as vary from order to order, and recipient to recipient.

(2) Plan activities – The recipient will plan the activities necessary to comply with the order based on 

their intended response to the order.

(3) Submit an initial response to EPA – Each order recipient will be directed to provide an individual 

initial response to EPA that indicates how they intend to comply with the order. In addition, each 

consortium participant is expected to submit the initial individual response, and then the designated 

lead for the consortium is also expected to submit an initial consortium response that indicates what 

the consortium intends to submit. As indicated previously, the response options available to the 

recipient will vary depending on whether the subject chemical is a PAI/pesticide inert or a SDWA 

chemical, but generally the initial response will involve the following activities. The various 

response options available to a recipient, along with related activities they may engage in that are 

specific to that response option, are described in section 4(c)(i) of this ICR.

(3)(a) Individuals submit an initial response to EPA – The orders will direct each recipient to 

provide an individual initial response to EPA within 90 calendar days of issuance of the order 

that indicates how they intend to comply with the order. As indicated previously, the response 

options available to the recipient will vary depending on whether the subject chemical is a 

PAI or SDWA chemical. To simplify completion of this initial response within the 90 days, 

the recipient will receive the appropriate draft initial response form which EPA will include in 
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the order packet they receive as a sample of the options available to the order recipient, the 

chemical covered, and the applicable test data sought. The Agency has an existing sample 

individual response form for PAIs and developed a new form sample for recipients of orders 

under SDWA:

• Recipients of FIFRA/FFDCA orders will be directed to use the revised version of EPA 

Form No. 6300-05. See Attachment D(1). 

• Recipients of SDWA chemical orders will be directed to use the new initial response 

form identified as EPA Form No. 6300-06. See Attachment D(3).

Each order recipient will complete the form electronically by checking the appropriate boxes 

to indicate their intentions with regard to each assay listed in the order, and, if applicable, 

attach appropriate documentation to provide a rationale and/or supporting documentation for 

their response. The response is assay specific to provide maximum flexibility to the recipients 

who may wish to choose different response options for the individual assays identified in the 

order. An order recipient may elect any of these options for one or more of the assays in the 

order, and is not limited to electing a single response for all assays.

(3)(b) Consortium submit an initial response to EPA – If the recipient intends to form or join a 

consortium (or task force) with other order recipients to submit the data for a subject 

chemical, each consortium participant is expected to submit an initial individual response 

within 90 calendar days, and then the designated lead for the consortium is also expected to 

submit within 150 calendar days of issuance of the order a separate consortium initial 

response that indicates what the consortium intends to submit. To facilitate the completion of 

the consortium's response, EPA has prepared a form for the consortium to use in providing an 

initial response, and will include a copy of this form in the order packet:

• Consortium involving a FIFRA/FFDCA order will be directed to use the revised 

version of EPA Form No. 6300-05-C. See Attachment D(2). 

• Consortium involving a SDWA chemical order will be directed to use the new initial 

response form identified as EPA Form No. 6300-06-C. See Attachment D(4).

In addition to indicating the consortium's intentions with regard to each assay listed in the 

order by checking the appropriate boxes, and, if applicable, attaching appropriate 

documentation, the consortium initial response form identifies the primary contact for the 

consortium, the list of participants, and documentation of its formation (such as a copy of the 

joint agreement or an electronic and/or 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.

(3)(c) Submit OSRI as the initial response – As indicated in the policies and procedures documents, 

OSRI may also be submitted to fulfill part or all of the order. The initial response forms 

include a separate line item to indicate if OSRI is being cited or submitted to address either 

(A) a particular assay, or (B) to satisfy the order as a whole. If the order recipient chooses to 

submit or cite existing data, including other scientifically relevant information, the order 

directs the recipient to include an explanation of whether the data provided or cited follows an 

accepted scientific methodology or protocol, including but not limited to those presented in 
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EPA's harmonized test guideline compendium.16 The order also directs recipients to provide a 

cogent and complete rationale for why they believe the information is sufficient to satisfy part 

or all of the order. EPA's decisions about whether the information satisfies part or all of the 

Tier 1 order will be based on the weight-of-evidence from all relevant information available to 

the Agency.

In addition, the order recipient must comply with the Agency's good laboratory practice 

(GLP) standards described in 40 CFR part 160 and part 792, which require entities to follow 

certain practices when conducting studies, and, with the submission of data to EPA, to provide 

a GLP compliance statement indicating: a) that the data were generated using GLPs; or b) 

describe in detail "all differences" between the GLPs and the practices used; or c) confirm that 

you did not sponsor or conduct the study and do not therefore know whether the study was 

conducted in accordance with the GLPs.

(4) Read and discuss the protocol – The order recipients will read the protocols for the assays identified 

in the order and may have questions or may need to modify one or more of the protocols for the 

subject chemical. The recipient may deviate from a protocols identified in the order only after 

consultation with EPA. Such requests should be submitted to EPA with a clear rationale and 

explanation of the deviation. All protocol variations will be reviewed by EPA and a response will be 

sent to the specific order recipient in a timely fashion. These procedures are consistent with current 

EPA practices regarding pesticide test guidelines and the data requirements in 40 CFR parts 158 and 

161, as well as with test guidelines followed for other chemical testing programs. Although this 

activity is expected to be primarily performed by the data generating entity, other participants in a 

consortium may also participate in these discussions.

If the order recipient chooses to submit or cite existing data, including other scientifically relevant 

information, this discussion would be focused on whether the data provided or cited follows an 

accepted scientific methodology or protocol, including but not limited to those presented in EPA's 

harmonized test guideline compendium.

(5) Generate the data – As indicated by the initial response, some recipients will conduct the research or 

administer the tests to generate the data requested in the order. 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. 

For example, the travel time and costs for identifying a contract laboratory or to have laboratory staff 

travel to meet with company officials, are not activities imposed by the information collection 

activities and are therefore not attributable to the ICR. Nor are any costs or burden related to 

mistakes made by the laboratory, such as failure to properly follow an applicable protocol, which 

then requires the laboratory to redo the screening assay.

In addition, the data generator is expected to comply with applicable GLP standards, such as those 

described in 40 CFR part 160 for pesticides, which require entities to follow certain practices when 

conducting studies. With the submission of data to EPA, the data generator is expected to provide a 

GLP compliance statement indicating: a) that the data were generated using GLPs; or b) describe in 

detail "all differences" between the GLPs and the practices used; or c) confirm that you did not 

sponsor or conduct the study and do not therefore know whether the study was conducted in 

accordance with the GLPs.

 16 http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm
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For the purposes of calculating paperwork burden hours and costs in this ICR, EPA assumed that the 

data generation will not be directly performed by the order recipient. Instead, EPA assumes that data 

generation will be performed by a contract laboratory at the request of the order recipient or a 

consortium. The Agency has no information to estimate how many recipients might use a contract 

laboratory and how many might generate the data in house. Assuming that data will always be 

generated by a contract laboratory is consistent with the assumption used in other ICRs that involve 

data generation. One of the commenters on the original ICR provided evidence to support this 

assumption, commenting that many companies now outsource toxicology testing because it is less 

expensive than maintaining that function in-house.

(6) Report progress, compile and review the data – Unless EPA has notified a recipient in writing that 

the requirements of the 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. The progress report should provide a 

brief description of the status of the planned activities for each assay, and, if applicable, a description 

of any problems encountered or expected difficulties in meeting the schedule for complying with the 

order. 

(7) Complete paperwork to assemble the submission package – Those order recipients that generate the 

data or serve as the consortium lead will be expected to compile the data results from performing the 

assay(s), review the data for completeness and compliance with GLPs, and then assemble the 

submission package in accordance with the instructions provided in the order. In general, for PAIs 

these are the same submission procedures as those that are currently used for submitting other data in 

support of a pesticide registration, with only a few modifications – such as the mailing address. 

For SDWA chemicals, EPA is developing an electronic online submission option using the Agency's 

Central Data Exchange (CDX). The Agency expects the net resulting burden for using the electronic 

option to be no more burdensome than the paper process. Initial users of CDX will be required to 

register before using the system, which will involve some additional burden. Although most, if not 

all, of the manufacturers/importers that receive an EDSP order for a SDWA chemical are likely to be 

registered with CDX already, EPA has not attempted to off-set the reporting burden at this time. To 

the extent that an electronic reporting process can create efficiencies not readily available in a paper 

system, the reporting burden might actually be less than estimated in this ICR addendum. In the 

event that orders are issued prior to the completion of the electronic option, the submission 

procedures will be the same as those used for PAIs. See Attachment J for mock-up screenshots of the 

new electronic system.

(8) Submit final data to EPA – The final data package is then submitted to EPA following the specific 

instructions provided in the order, which will also specify the due date for final compliance with the 

order's request for data. Although the order specifies a final due date for submission of all of the data 

specified in the order, an order recipient may submit either the data for each individual assay as it is 

completed, or the data from all of the assays at one time. 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. 
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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. In Table 

2 of the existing ICR, the Agency identifies the assumed recipient activities divided between the three 

labor categories, which is duplicated here for completeness.

Table 2 – Expected Order Recipient Activities by Labor Categories

Activity Managerial Duties Technical Duties Clerical Duties

(1) Read the EPA's policies and 

procedures document 

Read the EPA's policies and 

procedures document 

Review the EDSP order Review the EDSP order 

(2) Identify timeframe for response 

Identify and evaluate response 

options 

Evaluate response options 

Plan activities 

Negotiate/establish consortium/ 

task force agreements 

Participate in consortium/ task force 

discussions 

(3) Determine response Recommend a response 

Oversee employee activities Complete response form 

Sign initial response forms Send to EPA 

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

Review GLPs (deviations) meetings with EPA

Identify and discuss other 

scientifically relevant information 

and related protocol and/or GLP 

deviations 

(5) Plan/oversee employee and contract 

activities 

Plan the data collection activities 

using the approved protocols 

Secure contract lab services and 

approve statement of work (SOW) 

Conduct the tests, using protocols 

and GLPs 

Communicate with EPA, as 

appropriate 

Maintain records and procedures 

during testing period in accordance 

with the GLPs 

Assist in preparing files 

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

Prepare final data reports 

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

letter 

Prepare final submission package 

Review final submission package 

(8) Approve/sign submission Send submission to EPA 

(9) Prepare data for files Prepare final file folders 

Maintain records

4(c) Information Requested

This section of the ICR addendum describes the information that an order recipient is expected to 

provide the Agency. The order will identify the Tier 1 assay data being requested 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 
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generate data, either individually or as part of a consortium, are expected to provide a 1 year progress 

report, and then submit the data to EPA.

It is important to note that many of the initial response options adopted for the EDSP already exist 

within the pesticide program, e.g., for Data Call-Ins under FIFRA 3(c)(2)(B). In providing the option as 

described in more detail in the 2009 policies and procedures document, the Agency adopted the existing 

procedures unchanged for use under the EDSP. Under those existing procedures, a pesticide registrant 

may engage in additional activities associated with that response option. For example, a 

respondent/registrant could choose to reformulate the product or seek a formulator's exemption. Both of 

these initial response options involve established procedures, and additional activities that are already 

approved by OMB under separate 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) Order Recipients' Response Options

The recipient of an order will have several potential response options as specified within the order itself, 

as well as indicated on the response forms. As indicated previously, the order recipient will use the 

Initial Response Forms for Individual Order Recipients to indicate which option they intend to use to 

respond to the data request for each assay. The response is assay specific to provide maximum flexibility 

to the recipients who may wish to choose different response options for the individual assays identified 

in the order. An order recipient may elect any of these options for one or more of the assays in the order, 

and is not limited to electing a single response for all assays, nor are they required to elect different 

options for each assay. The order recipient would complete the form by checking the appropriate boxes 

to indicate their intentions with regard to each assay listed in the order, and, if applicable, attach 

appropriate documentation to provide a rationale and/or supporting documentation for their response.

The following provides a brief overview of the available response options for orders involving 

PAIs/pesticide inert ingredients and SDWA chemicals, which are described in the policies and 

procedure documents and the orders themselves. See also Attachment E for an overview of the process 

for issuing and responding to EDSP Tier 1 orders.

(1) I Will Generate New Data. The recipient would choose this option to indicate that they agree to 

individually generate new data for each test specified to meet the requirements of the order.

(2) I Am Citing or Submitting Existing Data. The recipient would choose this option to submit or cite 

existing data (including OSRI) that they believe can be used to satisfy part or all of the Tier 1 order. 

To allow EPA to review the submission of OSRI in a timely fashion, the submitter of the 

information should consider providing a scientifically sound rationale that explains how the 

submitted or cited data provides the information needed to satisfy part or all of the Tier 1 order 

and/or otherwise inform the Agency's Tier 1 determination. EPA will review any existing study 

submitted or cited in response to the order to determine whether the study is relevant and of 

sufficient quality to satisfy the order. The Agency intends to notify submitters in writing of its 

determination, as well as make the determination publicly available.

When citing something that was previously submitted, the Agency needs a copy of the title page 

along with the identification number of the study cited (MRID number), and, if the study has been 
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reviewed by the Agency, the Agency's classification of the study. The Agency specifically asks 

that a study that has previously been submitted to EPA NOT be resubmitted in its entirety.

If the individual citing a study for a pesticide chemical (active or inert) is not the original data 

submitter, that individual may need to submit an offer to pay compensation to the original data 

submitter. Consequently, such individuals are encouraged to simultaneously include an offer to pay 

[in accordance with 40 CFR 152.93] [which includes an offer to resolve any dispute over the 

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 

the individual has received confirmation from EPA that no such compensation is necessary.

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

recipient would choose this option to indicate that they are forming a task force or consortium to 

comply with the order. In such cases, each participating or potential participant is expected to submit 

an Initial Response Form for Individual Order Recipients within 90 calendar days. Within 150 

calendar days of issuance of the order, or as part of their initial response, the designated lead for the 

consortium is expected to submit the Initial Response Form for Consortium/Task Force 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 assay, along with documentation of its 

formation (such as a copy of the joint agreement or an electronic and/or 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.

Alternatively, an order recipient may provide EPA with documentation that they made a judicially 

enforceable offer to enter into an agreement to develop data jointly with one or more recipients of 

the order and that they offered to pay a reasonable share of the test costs (or developed a process for 

resolving disputes with regard to the appropriate share of test costs). If the required data are not 

generated by the person(s) to whom the offer is made, all parties, including those that have made 

offers to pay or otherwise joined the consortium, would be responsible for generating and submitting

the data.

Although catch-up order recipients are most likely to select this option, these respondents are 

generally expected to join a consortium that has already been formed, or otherwise join with an 

individual who has already committed to generate the data.

(4) Claim Not to be Subject to the Test Order. The recipient would choose this option to indicate that 

they are not subject to the order because:

(i) In the case of a PAI, the recipient is not a pesticide registrant;or

(ii) In the case pesticide inert ingredients, the recipient does not currently manufacture or import 

the chemical; or

(iii) In the case of a SDWA chemical, the recipient does not currently manufacture or import the 

chemical; or

(iv) In the case of a "catch-up" order, this option would be essentially the same as the option 

discussed in the original policies and procedures for manufacturers of inert ingredients. EPA 
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has not identified any issues unique to SDWA chemicals that would warrant a change in policy 

on this point. 

The recipient's initial response would include an explanation and documentation supporting their 

claim to allow EPA to evaluate the claim. If EPA cannot verify the claim, the recipient is still subject 

to the order and the deadline(s) for responding remain.

(5) I Intend to Voluntarily Cancel or Reformulate the Product Registration (only applicable to pesticide 

chemicals, not to SDWA chemicals). A pesticide registrant may request voluntary cancellation of 

their product's pesticide registration pursuant to FIFRA section 6(f). Doing so would initiate the 

existing procedures for a voluntary cancellation. Cancellation procedures are addressed in a separate 

ICR that is already approved by OMB. 

(6) I Claim a Formulators' Exemption (only applicable to pesticide chemicals [actives and inerts]). A 

pesticide registrant receiving an order to test a chemical, and who purchases the chemical from 

another recipient who has agreed to generate the data may be eligible for a formulators' exemption. 

Such a claim would initiate the existing procedures for formulators' exemption. EPA will confirm 

claims of eligibility. A formulators' exemption would become invalid if the supplier of the chemical 

were not to submit the data either individually or jointly with other recipients.

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

recipient of an order for a pesticide inert ingredient or a SDWA chemical (i.e., 

manufacturer/importer) would choose this option to indicate that they have already or are in the 

process of discontinuing the manufacture or import of the chemical. The recipient's initial response 

would include an explanation and documentation supporting their claim. EPA intends to verify such 

a claim. If EPA confirms the claim, the initial response form is the only response required to satisfy 

the order. If, however, EPA determines that the claim is false, the recipient must comply with the 

order.

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

If an order recipient believes that this showing can be made for its chemical, the Agency would 

consider requests to issue such an exemption order on a case-by-case or chemical-by-chemical basis 

in response to individual submissions or requests for such consideration. 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 or any other scientifically relevant information that the recipient believes 

would allow EPA to determine that the chemical is not anticipated "...to produce any effect in 

humans similar to an effect produced by a naturally occurring estrogen."

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

a) Pre-enforcement challenges to the Tier 1 Order. If a recipient wishes to challenge the Tier 1 

order, the order will describe the informal process by which a recipient may raise, and EPA may 

review, objections to the issuance of an order or to specific provisions in the order. For EPA to 

be able to respond to the objections in a timely manner, the recipient would need to state with 
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particularity the scope and basis of the objection, providing sufficient detail to allow the Agency

to evaluate the objection.

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

was used as a "positive control" in the EDSP validation effort. If an order recipient chooses to 

ask EPA to reconsider some or all of the testing specified in the Tier 1 order, EPA would review 

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

screening of the chemical is unnecessary because the chemical has been shown to interact with 

the endocrine system or was used as a "positive control" in the EDSP validation effort, on a caseby-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 1 screening 

assays, only the data submitted related to those assays for which the chemical was used to 

complete the testing as part of the validation effort would be sufficient to satisfy the Tier 1 order.

4(c)(ii) Progress Report

Unless EPA has notified the 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 assay, 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 frame established in the order (see section 5(d) of this ICR), 

they may seek additional time by submitting a request via the CDX system for an extension to the 

Agency. The 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 deadlines 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. Normally, time extensions can be 

requested only in cases of extraordinary testing problems beyond the expectation or control of the 

registrant, manufacturer, or importer. Time extensions will not be considered if the request for extension 

is not made in a timely fashion; in no event shall a time extension request be considered if it is submitted 

at or after the lapse of the subject deadline.

4(c)(iv) Data Generation

The Tier 1 order will request specific data from a battery of eleven assays. The Tier 1 screening battery 

is intended to identify chemicals that have the potential to interact with the estrogen, androgen, or 

thyroid hormone systems through any of several recognized modes of action. The following is a list and 

brief description of each of the assays that are part of the final EDSP Tier 1 battery:
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1. Amphibian Metamorphosis (Frog) – The Amphibian Metamorphosis assay involves the use of 

tadpoles to determine if chemicals affect the hypothalamic-pituitary-thyroid (HPT) axis during 

metamorphosis and consequently result in developmental effects.

2. Androgen Receptor Binding (Rat Prostate) – The androgen receptor (AR) is involved in the 

development of male sexual characteristics. The AR Binding assay identifies chemicals that affect 

the endocrine system by binding to hormone receptors to either mimic the action of the natural 

hormone or block access of the hormone to the site and thus block hormone controlled activity.

3. Aromatase (Human Recombinant) – Aromatase is an enzyme complex responsible for estrogen 

biosynthesis that converts androgens into estrogens, estradiol, and estrone. The aromatase in vitro 

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

activity.

4. Estrogen Receptor Binding – The estrogen receptor (ER) is involved in female maturation and 

reproductive function. The ER Binding assay measures the ability of a chemical to bind to the 

estrogen receptor.

5. Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa-9903)) – The estrogen 

receptor (ER) is involved in female maturation and reproductive function. The ER Transcriptional 

Activation is a cell-based assay that measures the ability of a chemical to bind to the ER and activate 

transcription resulting in the synthesis of the enzyme luciferase.

6. Fish Short-term Reproduction – The Fish Short-term Reproduction assay screens for disturbances in 

the hypothalamic-pituitary-gonadal (HPG) axis including (anti-) estrogenic, (anti-) androgenic, 

aromatase inhibition, and steroid modulating effects. The assay examines abnormalities associated 

with survival, reproductive behavior, secondary sex characteristics, histopathology, and fecundity 

(i.e., number of spawns, number of eggs/spawn, fertility, and development of offspring) of fish 

exposed to test chemicals.

7. Hershberger (Rat) – The Hershberger assay is designed to detect androgenic and anti-androgenic 

effects. In this in vivo assay, the weight of several androgen-dependent tissues, including accessory 

sex glands, are measured in castrated or immature male rats.

8. Female Pubertal (Rat) – The Pubertal Female assay involves the use of rats to screen for estrogenic 

and thyroid activity in females during sexual maturation. This assay examines abnormalities 

associated with sex organs and puberty markers, as well as thyroid tissue.

9. Male Pubertal (Rat) – The Pubertal Male assay involves the use of rats to screen for androgenic, 

anti-androgenic, and thyroid activity in males during sexual maturation. This assay examines 

abnormalities associated with sex organs and puberty markers, as well as thyroid tissue.

10. Steroidogenesis (Human Cell Line – H295R) – The Steroidogenesis in vitro assay detects 

interference with the body's production of male and female steroid sex hormones. This assay is a 

cell-based assay using the H295R human adrenocortical carcinoma cell line which can detect 

inducers of enzymes responsible for steroid synthesis as well as chemicals that inhibit it.

11. Uterotrophic (Rat) – The Uterotrophic assay involves the use of female rats to screen for estrogenic 

effects. In this in vivo assay, uterine weight changes are measured in ovariectomised or immature 

female rats.

For purposes of estimating the potential burden for the Tier 1 screening information collection activities 

covered by the ICR, the Agency is assuming that each Tier 1 order will include all of the above listed 

assays. By assuming that each order will include all of these assays, the ICR provides coverage for those 

cases where the order may not include all of the assays.
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4(c)(v) Data Submission

The order itself will specify the data submission content and format that the recipient should use. In 

general, the content and format of the data submission package for transmittal to EPA should be 

consistent with the following existing standards, which are expected to be incorporated into the 

individual orders:

1. Format for Data Submission. As part of a cooperative project, EPA and the Canadian Pest 

Management Regulatory Agency (PMRA) developed standard data evaluation formats, or templates. 

The templates have been in use by these agencies since 2002 for writing their data evaluation records 

(DERs) of studies submitted under FIFRA and FFDCA to EPA and the Canadian data codes 

(DACOs). The DER that the agencies prepare contains a study profile documenting basic study 

information such as materials, methods, results, applicant's conclusions and the evaluator's 

conclusions. The agencies encourage recipients to include study profiles based on these templates, 

which describe the layout and scope of information that should be contained within a study profile 

and can serve as guides for preparation of study documents. Use of the templates improves the 

likelihood of a successful submission, since the information necessary for an efficient agency review 

is outlined. 

The study profiles templates are available at: 

http://www.epa.gov/pesticides/regulating/studyprofile_templates/. The Agency encourages order 

recipients to submit completed study profiles and supporting data in an electronic format (PDF) 

whether submitting one or several studies. For more information about electronic submissions, go to 

http://epa.gov/endo/pubs/toresources/index.htm. In addition, as discussed previously, EPA is 

developing an online electronic submission option using CDX.

2. Transmittal Document. Each submission in satisfaction of a Tier 1 order must be accompanied by a 

transmittal document that includes the following information: 

(1) Identity of the submitter.

(2) The date on which the submission package was prepared for transmittal to EPA. 

(3) Identification of the Tier 1 order associated with the submission (e.g., the number assigned to 

the order). 

(4) A list of the individual documents included in the submission. 

3. 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. 

(ii) The author(s) of the study. 
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(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 1 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.

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 OCSPP.17 Within OCSPP, OPP will be primarily responsible for the administrative 

functions involving PAIs and Pesticide Inerts, 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's OPPT will be primarily responsible for the administrative functions 

involving SDWA chemicals, including 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's OSCP will coordinate the review of Tier 1 screening 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 general activities related to the 

information collection activities under this ICR addendum:

(1) Prepare instructions. As indicated previously and in the existing ICR, EPA has prepared 

instructions in terms of the two policies and procedures documents, and the order templates that 

provide guidance and instructions for order recipients so that they understand how to respond to 

the order, what data are to be submitted, when and how. 

 17 Prior to April 22, 2010, this office was known as the Office of Prevention, Pesticides and Toxic Substances (OPPTS).
EPA ICR No. 2488.01 June 3, 2013

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(2) Identify chemicals to be screened. In addition to identify the chemicals covered by the existing 

ICR, EPA has identified a second list of chemicals to be screened under the EDSP. This ICR 

addendum assumes that all of the chemicals on the second list will be the subject of a Tier 1 order 

issued under FFDCA §408(p).

(3) Identify order recipients. EPA has identified the potential recipients of the orders for the chemicals 

identified on the second list of chemicals to be screened under the EDSP. See the discussion on 

respondents in section 4(a) of this ICR addendum.

In addition, to facilitate the formation of consortia to develop the data requested in an order, and to 

the extent that the information is not protected as CBI, EPA will provide each order recipient with 

a list of the other recipients of the order for the subject chemical. The list of order recipients will 

also be maintained up to date on the Agency's EDSP website, along with the status of the order 

(including recipients' responses).

This ICR also assumes that other entities that should receive an order might be identified after the 

first set of orders is issued, either by EPA or by someone else. In those cases, EPA intends to issue 

"catch-up" orders as appropriate.

(4) Prepare the EDSP Tier 1 Orders. EPA intends to use the appropriate order template (as discussed 

in section 4(b) of this ICR addendum) to prepare individual orders for each chemical and order 

recipient. The order will identify all of the non-CBI protected recipients so that the recipients may 

more easily identify the potential participants to include in a consortium, and it will indicate how 

many recipients could not be listed. Those companies protected as CBI will not be listed, but will 

still receive an order and will have an opportunity to designate an agent for purposes of the List of 

order Recipients. As indicated previously, EPA intends to maintain an up to date list of order 

recipients on the Agency's EDSP website.

Along with preparation of the orders, EPA will prepare the pre-populated initial response form for 

each order recipient. The Agency intends to accomplish this through a semi-automated process 

using the same database that will track the orders, initial responses, and data submissions. This 

system is discussed in more detail in section 5(b) of this ICR. In using this approach, EPA is 

maximizing the available resources and efficiencies related to the administrative components of 

Tier 1 screening under the EDSP.

(5) Review and Approve Orders. The EDSP Tier 1 orders will be reviewed and approved by a senior 

agency official(s) for completeness before they are issued.

(6) Issue the Orders. The appropriate authorized OCSPP senior official will sign each order, which 

will then be processed for issuance as appropriate. Orders will then be mailed to each recipient 

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

(7) Process Initial Responses. The Agency will receive the 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 1 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 or request for reformulation, etc. The Agency will verify claims and review 
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data cited or submitted and provide an electronic response to the order recipient that accepts or 

rejects their claim(s).

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

the recipient may have regarding the Tier 1 order in a timely manner, as well as process any 

requests for extensions or protocol variations.

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

to initiate cancellation procedures, refer the case to EPA's Office of Enforcement and Compliance 

Assurance (OECA) for enforcement, etc.).

(10) Issue "Catch-up" Orders. EPA may issue a "catch-up" order to a manufacturer or importer who 

begins to sell an inert ingredient following the submission of required EDSP data on the ingredient 

by manufacturers or importers who were in the marketplace when the initial orders were issued.

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

1 order, including initial review of the data submission for completeness, initial log-in to 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 1 screening data. For example, what do the data tell us about the 

chemical's potential to interact with the estrogen, androgen or thyroid hormonal pathways? In 

general, the Agency intends to conduct a WoE analysis on the results of Tier 1 screening in 

combination with all other OSRI to determine the need for Tier 2 testing. For more information on 

the WoE approach for Tier 1 screening, please go to http://www.regulations.gov, specifically 

under docket EPA-HQ-OPPT-2010-0877.

(13) Incorporate/ Use the Data. The Agency will incorporate the data into a risk assessment and make a 

regulatory decision as necessary and appropriate. EPA has extensive experience in using data from 

multiple sources to develop integrated assessments of hazard, modes of action / mechanisms of 

toxicity, and overall potential for risk. EPA scientists will continue to use such experience, 

together with insights from the validation process for Tier 1 screening assays, to address the 

potential of chemicals to cause adverse effects as a consequence of interaction with the endocrine 

system. 

In addition, chemicals that go through Tier 1 screening and are found to have the potential to 

interact with the estrogen, androgen, or thyroid hormone systems will be considered for Tier 2 

testing. The purpose of Tier 2 testing is to identify and establish a dose-response relationship for 

any adverse effects for hazard and risk assessment.

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

For pesticide active and inert ingredients, the data and related documents are stored in an 

electronic document repository that OPP employs. For SDWA chemicals, the data will be stored in 

a similar computer system managed by OPPT. These systems are discussed in more detail in 

section 5(b) of this ICR.
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5(b) Collection Methodology and Management

For each of the chemicals identified for Tier 1 screening as part of the EDSP, the Tier 1 order will 

establish the specific data requested, the testing necessary to generate that data, the expected duration of 

the testing and report preparation, and the date by which the requested data must be submitted to the 

Agency. As indicated previously, the Agency intends to utilize the systems and procedures already 

established and in use for Data Call-In activities under FIFRA to collect and manage the data submitted 

in response to the Tier 1 order, and is developing an electronic online submission options that involves 

the use of CDX to submit responses to the EDSP Tier 1 orders. See Attachment J for screenshots of the 

new electronic system.

As discussed previously, EPA is also developing a new electronic submission system for data submitted 

in response to SDWA/FFDCA and FIFRA/FFDCA test orders for the second list of chemicals following 

the general process established for electronic reporting under TSCA. 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 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 information about CDX. (Reference 4). 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; and

• Encrypted submission to EPA via CDX.

Each test order will contain specific information regarding the process the recipient can use to respond 

to the order.

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 

like 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 practical 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 1 order, the small business may minimize potential burden by joining a 
EPA ICR No. 2488.01 June 3, 2013

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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 

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 of the existing ICR, which is duplicated 

here:

Table 3 – General Basis for Establishing the Due Dates in the Order 

Timeframes for Due Dates What is Due

Within 90 calendar days of the order's issuance 

(+ 10 calendar days for processing)

Individual Recipient's Initial Response 

Within 150 calendar days of the order's issuance 

(+ 10 calendar days for processing)

Consortia's Documentation and Initial Response 

Within 12 months from order's issuance A Progress Report describing the status of an order recipient's 

compliance with the order. 

24 months from order's issuance Final Study Report and submission of the data to 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 1 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 burden associated with the information collection activities.

Burden is defined at 5 CFR 1320.03(b). The Agency is required to estimate both the hour burden and 
EPA ICR No. 2488.01 June 3, 2013

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the cost burden. The cost burden includes both the costs associated with the paperwork burden hours, 

and any additional costs not tied to a burden hour, but incurred under the PRA nonetheless (e.g., the cost 

for mailing the forms to EPA). 

In this section of the ICR, the Agency discusses the methodology and assumptions used to calculate the 

potential paperwork burden and costs for respondents, which are presented based on the information 

collection or "IC" groups discussed previously.

6(a) Methodology for Estimating Respondent Burden and Cost

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

Average wage data for the relevant sectors of respondents are available in the May 2011 National 

Industry-Specific Occupational Employment and Wage Estimates from the Bureau of Labor Statistics 

(BLS) at http://www.bls.gov/oes/current/oes_nat.htm.

We used the NAICS codes to obtain the estimated loaded labor rates used in this ICR, i.e., NAICS 

325300, Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing 

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

Standard Occupational Classification (SOC). The SOC 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, we used the mean average hourly wage rate and assumed 

that benefits add 44.1% to the hourly rate, based on benefits for all private industry workers from 

http://www.bls.gov/schedule/archives/ecec_nr.htm.

18 We then multiply the loaded wage by 50% to get 

overhead costs. Overhead costs are added to the loaded wage rate to get the fully loaded wage rate.

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

http://www.bls.gov/news.release/archives/ecec_09112012.htm
EPA ICR No. 2488.01 June 3, 2013

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Table 5 – Respondent Loaded Labor Rates Used in this ICR

Labor Category Formula Used Managerial Technical Clerical

Unloaded Hourly Rate1 Wages $57.42 $28.32 $17.02

Benefits Percentage of Total Labor2 Benefits% 44.1% 44.1% 44.1%

Benefits per hour Wages*Benefits% $25.32 $12.49 $7.51

Loaded Hourly Rate (LHR) Wages + Benefits per hour $82.74 $40.81 $24.53

Overhead Percentage3 50% 50% 50%

Overhead Per Hour (OPH) LHR*Overhead% $41.37 $20.41 $12.27

Fully Loaded Hourly Rate LHR + OPH $124.11 $61.22 $36.80

Key:

1. Data Source: http://www.bls.gov/oes/current/naics4_325300.htm

2. Fringe benefits/wage per hour.

3. U.S. EPA, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pp. 2-34. The loading for indirect 

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

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

$124.11, Technical = $61.22; and Clerical = $36.80.

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 percentbased 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 two assays that were 

based on estimates provided by EPA scientist overseeing the validation effort for those two assays. 

Since EPA is funding the assay validation effort, we believe that these estimates are reasonable 

surrogates for actual market prices at this time and for the purposes of this ICR. For the other assays, 

the Agency used the cost estimate survey of commercial laboratories and other information provided 

by industry representatives. EPA believes that these estimates are still valid as adjusted for inflation. 

Our basis for being comfortable with these cost estimates is a peer reviewed article that appeared in 

Toxicological Sciences entitled "Application of an Integrated Testing Strategy to the U.S. EPA 
EPA ICR No. 2488.01 June 3, 2013

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Endocrine Disruptor Screening," which estimated the costs for the eleven assays to be $572,913.19

As indicated in Attachment F, the estimate provided by EPA is slightly higher at $637,184.

Based on the existing methodologies, 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 F and were used in the burden and 

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

Figure 1 – Method for Calculating Paperwork Burden from Test Costs

This approach assumes and incorporates the following:

(1) Recipients generate all of the data as specified in the Tier 1 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 initial list of chemicals, and direct experience 

in conducting the assays for validation. The costs are calculated using the loaded labor rates for the 

labor categories that are identified in section 6(a)(i) of this ICR.

As indicated previously, almost all of the response options provided to recipients of Tier 1 orders are 

the same as those afforded to pesticide registrants in response to DCIs. Although other ICRs already 

address the paperwork burden associated with the activities involved in those options, the Agency

has provided a general estimate for the burden associated with providing the supporting materials 

related to the various options based on its general experience with the pesticide program. At this 

time, it is not possible to estimate how many respondents may choose which option.

 19 The total in the article of $544,397 was in 2010 dollars, which were adjusted for 2012 using the inflation calculator at 

http://www.bls.gov/data/inflation_calculator.htm.

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
EPA ICR No. 2488.01 June 3, 2013

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Regardless of the response option that recipients of Tier 1 orders choose, the Agency has assumed 

that the data will be generated for each chemical with all manufacturers participating in a consortium 

or task force, and with only one order 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-B. 

Table 6-B – Estimated Per Chemical Burden Hours for the Activities

Activity(a) 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(b) 24 21 2 47

4) Read and discuss the protocol 36 145 0 181

---> Activities related to the submission of OSRI(c) 50 428 70 548

5) Participate in Consortium 24 145 2 171

6) Generate the data(d) 361 2,376 912 3,649

7) Submit Progress Report 5 20 7 32

8) Compile and review the final data for submission 36 191 12 239

9) Complete paperwork to assemble submission package 5 20 7 32

10) Submit final data to EPA 3 0 2 5

11) Maintain records 0 24 62 86

Total Per Chemical Burden: 604 3,424 1,076 5,104

Key:

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category.

(b) This estimate includes an estimated burden to provide additional material with the response. 

(c) Based on hours required for OSRI Submission from CLA/EPF Report (Reference 5)

(d) Burden estimate is a percentage of the total test cost, which is calculated in Attachment F.

The estimated per chemical cost for each of the paperwork activities is presented in Table 7-B. The 

burden costs are calculated by multiplying the burden hours in Table 6-B by the loaded labor rate for the 

different labor categories, with the costs for generating the data coming from Attachment F. The 

following loaded labor rates were used to calculate these costs: Managerial = $124.11; Technical = 

$61.22; and Clerical = $36.80.

Table 7-B – Estimated Per Chemical Costs by Activity

Activity(a)

Managerial Technical Clerical

$124.11 $61.22 $36.80 Total

1) Read instructions $1,489 $735 $0 $2,224

2) Plan activities 5,957 2,571 0 8,528

3) Submit an initial response to EPA(b) 2,979 1,286 74 4,339

4) Read and discuss the protocol 4,468 8,877 0 13,345

---> Activities related to the submission of OSRI(c) 6,206 26,202 2,576 34,984
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Activity(a)

Managerial Technical Clerical

$124.11 $61.22 $36.80 Total

5) Participate in Consortium 2,979 8,877 74 11,930

6) Generate the data(d) 44,804 145,459 33,562 223,825

7) Submit Progress Report 621 1,224 258 2,103

8) Compile and review the final data for submission 4,468 11,693 442 16,603

9) Complete paperwork to assemble submission package 621 1,224 258 2,103

10) Submit final data to EPA 372 0 74 446

11) Maintain records 0 1,469 2,282 3,751

12) Delivery Costs 11

Total Cost: $74,964 $209,617 $39,600 $324,192

Key:

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category.

(b) This estimate includes an estimated burden to provide any additional burden requested for an option.

(c) Hours required for OSRI Submission from CLA/EPF Report (Reference 5)

(d) Burden cost estimate is a percentage of the total test cost, which is calculated in Attachment F.

In addition to the burden costs, the costs of delivering the data to the Agency are added to arrive at the 

total estimated per respondent cost. Delivery costs were calculated 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 $10.55 (rounded to $11) from the west coast to the east coast (Reference 6).

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 addendum, the 

estimated burden and costs for the two respondent groups are divided into distinct "IC" categories as 

presented in Table 1-B. Using the estimated number of respondents in Table 1-B and the estimated per 

chemical burden and costs from Tables 6-B and 7-B 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: Order Recipients

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

identified in Tables 6-B and 7-B as activities 1-3, and 11, which are all associated with receipt of the 

order and submission of the required initial response.

Table 8-B – IC #1(a): Estimated Burden and Costs for Order Recipients – Registrants of Pesticide 

Active Ingredients

Activity(a)

Total # 

Responses(b)

Per Response Total

Burden 

(hours)(c) Cost ($)(d)

Burden 

(hours)(e) Cost ($)(f)

1) Read instructions

185

24 $2,224 4,440 $411,440

2) Plan activities 90 8,528 16,650 1,577,680

3) Submit an initial response to EPA 47 4,339 8,695 802,715

11) Maintain records(g) 43 3,751 7,955 693,935

Total: 204 $18,842 37,740 $3,485,770
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Activity(a)

Total # 

Responses(b)

Per Response Total

Burden 

(hours)(c) Cost ($)(d)

Burden 

(hours)(e) Cost ($)(f)

Key:

(a) Activities are described in more detail in section 4(b) of this ICR.

(b) From Table 1-B, includes catch-up orders.

(c) From Table 6-B.

(d) From Table 7-B.

(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-B and 7-B.

Table 9-B – IC #1(b): Estimated Burden and Costs for Order Recipients – Manufacturers and 

Importers of SDWA Chemicals

Activity(a)

Total # 

Responses(b)

Per Response Total

Burden 

(hours)(c) Cost ($)(d)

Burden 

(hours)(e) Cost ($)(f)

1) Read instructions

815

24 $2,224 19,560 $1,812,560

2) Plan activities 90 8,528 73,350 6,950,320

3) Submit an initial response to EPA 47 4,339 38,305 3,536,285

11) Maintain records(g) 43 3,751 35,045 3,057,065

Total: 204 $18,842 166,260 $15,356,230

Key:

(a) Activities are described in more detail in section 4(b) of this ICR.

(b) From Table 1-B, includes catch-up orders.

(c) From Table 6-B.

(d) From Table 7-B.

(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-B and 7-B.

The total IC #1 estimated burden is 204,000 hours (37,740 hours + 166,260 hours) and the estimated 

cost is $18,842,000 ($3,485,770 + $15,356,230).

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-B and 7-B as activities 4 and 6 

through 12, which are all associated with generating and submitting the data. Please note that 

participation in a consortium is addressed in the next IC group.
EPA ICR No. 2488.01 June 3, 2013

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Table 10-B – IC #2(a): Estimated Burden and Costs for Data Generators and Submitters –

Registrants of Pesticide Active Ingredients

Activity(a)

Total # 

Responses(b)

Per Response Total

Burden 

(hours)(c)

Cost 

($)(d)

Burden 

(hours)(e) Cost ($)(f)

4) Read and discuss the protocol

41

181 $13,345 7,421 $547,145

---> Activities related to the submission of OSRI 548 34,984 22,468 1,434,344

6) Generate the data(h) 3,649 223,825 149,609 9,176,825

7) Submit Progress Report 32 2,103 1,312 86,223

8) Compile and review the final data for submission 239 16,603 9,799 680,723

9) Complete paperwork to assemble the submission 

package

32 2,103 1,312 86,223

10) Submit final data to EPA 5 446 205 18,286

11) Maintain records(g) 43 3,751 1,763 153,791

12) Delivery Costs 11 451

Total: 4,729 $297,171 193,889 $12,184,011

Key:

(a) Activities are described in more detail in section 4(b) of this ICR. 

(b) From Table 1-B, includes catch-up orders.

(c) From Table 6-B.

(d) From Table 7-B.

(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-B and 7-B. 

(h) Burden cost estimate is a percentage of the total test cost, which is calculated in Attachment F.

Table 11-B – IC #2(b): Estimated Additional Burden and Costs for Data Generators and 

Submitters – Manufacturers and Importers of SDWA Chemicals

Activity(a)

Total # 

Responses(b)

Per Response Total

Burden 

(hours)(c)

Cost 

($)(d)

Burden 

(hours)(e) Cost ($)(f)

4) Read and discuss the protocol 

68

181 $13,145 12,308 $907,460

---> Activities related to the submission of OSRI 548 34,984 37,264 2,378,912

6) Generate the data(h) 3,649 223,825 248,132 15,220,100

7) Submit Progress Report 32 2,103 2,176 143,004

8) Compile and review the final data for submission 239 16,603 16,252 1,129,004

9) Complete paperwork to assemble the submission 

package

32 2,103 2,176 143,004

10) Submit final data to EPA 5 446 340 30,328

11) Maintain records(g) 43 3,751 2,924 255,068

12) Delivery Costs 11 748

Total: 4,729 $297,171 321,572 $20,207,628

Key:

(a) Activities are described in more detail in section 4(b) of this ICR. 

(b) From Table 1-B, includes catch-up orders.

(c) From Table 6-B.

(d) From Table 7-B.

(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-B and 7-B. 

(h) Burden cost estimate is a percentage of the total test cost, which is calculated in Attachment F.

The total IC #2 estimated burden is 515,461 hours (193,889 hours + 321,572 hours) and the estimated 

cost is $32,391,639 ($12,184,011 + $20,207,628).
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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-B and 7-B as activity 5, which is associated with participating in a 

consortium.

Table 12-B – IC #3(a): Estimated Additional Burden and Costs for Consortium Participants –

Registrants of Pesticide Active Ingredients

Activity(a)

Total # 

Responses(b)

Per Response Total

Burden 

(hours)(c) Cost ($)(d)

Burden 

(hours)(e) Cost ($)(f)

5) Participate in Consortium 185 171 $11,930 31,635 $2,207,050

Total: 171 $11,930 31,635 $2,207,050

Key:

(a) Activities are described in more detail in section 4(b) of this ICR. 

(b) From Table 1-B, includes catch-up orders.

(c) From Table 6-B.

(d) From Table 7-B.

(e) Total = (b) x (c)

(f) Total = (b) x (d)

Table 13-B – IC #3(b): Estimated Additional Burden and Costs for Consortium Participants –

Manufacturers and Importers of SDWA Chemicals

Activity(a)

Total # 

Responses(b)

Per Response Total

Burden 

(hours)(c) Cost ($)(d)

Burden 

(hours)(e) Costs ($)(f)

5) Participate in Consortium 815 171 $11,930 139,365 $9,722,950

Total: 171 $11,930 139,365 $9,722,950

Key:

(a) Activities are described in more detail in section 4(b) of this ICR. 

(b) From Table 1-B, includes catch-up orders.

(c) From Table 6-B.

(d) From Table 7-B.

(e) Total = (b) x (c)

(f) Total = (b) x (d)

The total IC #3 estimated burden is 171,000 hours (31,635 hours + 139,365 hours) and the estimated 

costs is $11,930,000 ($2,207,050 + $9,722,950).

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 14. To calculate the total potential agency burden 

over the three years, EPA has multiplied this burden by the total number of chemicals (677 hours x 109 

chemicals = 73,793 hours).
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Table 14 – Estimated Agency per Chemical Burden Hours

Activity(a) Managerial Technical Clerical Total

1) Prepare instructions 2 12 2 16

2) Identify chemicals to be screened 2 21 2 25

3) Identify recipients 2 16 0 18

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

5) Review and approve the orders 2 4 0 6

6) Issue the orders 0 0 6 6

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

8) Provide assistance and 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) 0 440 0 440

12) Incorporate data into risk assessments(d) 0 88 0 88

13) Store data in retrievable system 0 4 8 12

Total Burden: 9 637 31 677

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 hrs per assay (40 x 11).

(d) Assumes 8 hrs per assay (8 x 11).

The costs are calculated using the U.S. Department of Labor, Bureau of Labor Statistics data20 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 = $120.33; Technical = 

$77.85; and Clerical = $44.06. The estimated burden hour costs for the Agency are presented in Table 

15-B. To calculate the total potential agency costs over the three years, EPA has multiplied the per 

chemical cost in Table 15-B by the total number of chemicals ($52,039 x 109 chemicals = $5,672,251).

Table 15-B – Estimated Agency Per Chemical Burden Hour Costs

Activity(a)

Managerial Technical Clerical

$120.33 $77.85 $44.06 Total $

1) Prepare instructions $241 $934 $88 $1,263

2) Identify chemicals to be screened 241 1,635 88 1,964

3) Identify recipients 241 1,246 0 1,487

4) Prepare the 408(p) order packages 0 311 441 752

5) Review and approve the orders 241 311 0 552

6) Issue the orders 0 0 264 264

7) Process initial responses(b) 120 311 44 475

8) Provide assistance and follow-up, as needed 0 2,803 0 2,803

9) Identify non-responders 0 0 44 44

10) Process Data Submissions 0 623 44 667

11) Analyze data 0 34,254 0 34,254

12) Incorporate data into risk assessments 0 6,851 0 6,851

13) Store data in retrievable system 0 311 352 663

Total Cost: $1,084 $49,590 $1,365 $52,039

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.

 20 http://www.bls.gov/oes/current/naics4_999100.htm
EPA ICR No. 2488.01 June 3, 2013

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6(d) Total Burden Hours and Costs for the ICR (Bottomline)

The total estimated burden and costs for the information collection activities associated with the second 

list of chemicals to be screened under the EDSP are presented in Table 16-B.

Table 16-B – Estimated TOTAL Burden and Costs for Respondents

Respondent Category(a)

Total # 

Responses(b)

Per Response(c) Total(d)

Burden 

(hours) Cost ($)

Burden 

(hours) Cost ($)

Registrants of PAIs

IC #1(a) - Order Recipients 185 204 $18,842 37,740 $3,485,770

IC #2(a) - Data Generators/Submitters 41 4,729 297,171 193,889 12,184,011

IC #3(a) - Consortium Participants 185 171 $11,930 31,635 2,207,050

Subtotal for Pesticide Active Ingredients: 263,264 $17,876,831

Manufacturers/Importers of SDWA Chemicals

IC #1(b) - Order Recipients 815 204 $18,842 166,260 $15,356,230

IC #2(b) - Data Generators/Submitters 68 4,729 297,171 321,572 20,207,628

IC #3(b) - Consortium Participants 815 171 $11,930 139,365 9,722,950

Subtotal for SDWA Chemicals: 627,197 $45,286,808

Total:(e) 890,461 $63,163,639

Key:

(a) Grouped by respondents and according to IC category as presented in section 6(b) of this ICR addendum. 

(b) From Table 1-B, includes catch-up orders.

(c) See totals from Tables in section 6(b) of this ICR addendum. 

(d) Total = (b) x (c)

(e) calculated by adding the columns.

Table 17-B – Annualized Estimated Total Respondent Burden and Costs for ALL Activities

Respondent Category(a)

Total # 

Responses(b)

Per Response(c) Total(d)

Burden 

(Hours) Cost ($)

Burden 

(Hours) Costs ($)

Registrants of Pesticide Active Ingredients

IC #1(a) - Order Recipients

185

68 $6,281 12,580 $1,161,923

Reporting 54 5,030 9,928 930,612

Recordkeeping 14 1,250 2,652 231,312

Non-Burden Costs 0 0 0 0

IC #2(a) - Data Generators/Submitters

41

1,576 $99,057 64,630 $4,061,337

Reporting 1,562 97,803 64,042 4,009,923

Recordkeeping 14 1,250 588 51,264

Non-Burden Costs 0 4 0 150

IC #3(a) - Consortium Participants

185

57 $3,977 10,545 $735,683

Reporting (3rd Party Disclosure) 57 3,977 10,545 735,683

Recordkeeping 0 0 0 0

Non-Burden Costs 0 0 0 0

Subtotal for Pesticide Active Ingredients: 87,755 $5,958,944

Manufacturers and Importers of SDWA Chemicals

IC #1(b) - Order Recipients

815

68 $6,281 55,420 $5,118,743

Reporting 54 5,030 43,738 4,099,722

Recordkeeping 14 1,250 11,682 1,019,022

Non-Burden Costs

IC #2(b) - Data Generators/Submitters

68

1,576 $99,057 107,191 $6,735,876

Reporting 1,562 97,803 106,216 6,650,604

Recordkeeping 14 1,250 975 85,023

Non-Burden Costs 4 249
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Respondent Category(a)

Total # 

Responses(b)

Per Response(c) Total(d)

Burden 

(Hours) Cost ($)

Burden 

(Hours) Costs ($)

IC #3(b) - Consortium Participants

815

57 $3,977 46,455 $3,240,983

Reporting (3rd Party Disclosure) 57 3,977 46,455 3,240,983

Recordkeeping 0 0 0 0

Non-Burden Costs 0 0 0 0

Subtotal for SDWA Chemicals: 209,066 $15,095,603

Total:(e) 3,403 $218,629 296,820 $21,054,546

Key:

(a) Grouped by respondents and according to IC category as presented in section 6(b) of this ICR addendum.

(b) From Table 1-B, includes catch-up orders.

(c) Calculated by taking the totals from the tables in section 6(b) of this renewal ICR (see also Table 16-B), and dividing by 3. Numbers are 

rounded.

(d) Total = (b) x (c)

(e) Calculated by adding the columns.

The total potential respondent burden and cost calculated in this ICR addendum involves activities that 

cannot be accurately divided by or assigned to occur in a particular year. As was done for the existing 

ICR, 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 (as presented in Table 16-B) is divided by 3 to get an estimated annualized burden of 296,820 hours 

(890,461 hours ÷ 3) and an estimated annualized cost of $21,054,546 ($63,163,639 ÷ 3). Included in the 

estimated annual cost are non-burden hours costs associated with delivery of $400 ($1,199 ÷ 3).21

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

chemical burden and cost in Tables 14 and 15-B by the total number of chemicals for a total agency 

burden of 73,793 hours (677 x 109 chemicals) and a cost of $5,672,251 ($52,039 x 109 chemicals). 

Divided by 3 to get an estimated annualized burden of 24,598 hours (73,793 ÷ 3) and an estimated 

annualized cost of $1,890,750 ($5,672,251 ÷ 3).

6(e) Changes to Currently Approved ICRs

This request represents an annual burden increase of 296,820 hours from that currently in the OMB 

inventory. This change reflects a program change resulting from the identification of the second list of 

chemicals to be screened under the EDSP. 

6(f) Burden Statement for this ICR

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

4,729 hours, depending on the respondent category and activities, with an estimated cost between 

$18,842 and $297,171. The total annual burden is estimated to be 296,820 hours, with an annual cost of 

$21,054,546. 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.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, 

and any suggested methods for minimizing respondent burden, including the use of automated collection 

 21 See activity 12 in Tables 10-B and 11-B.
EPA ICR No. 2488.01 June 3, 2013

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techniques, EPA has established a docket for this ICR under Docket ID No. EPA-HQ-OPPT-2013-0275, 

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 the EPA Docket Center 

(EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC 

Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 

Federal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566–1744, and 

the telephone number for the OPPT Docket is (202) 566–0280. Docket visitors are required to show 

photographic identification, pass through a metal detector, and sign the EPA 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.

Please note that when comments were sought in 2010, the draft ICR was identified under EPA ICR No. 

2249.02 and OMB Control No. 2070-0176. Public comments were also directed to Docket ID No. EPAHQ-OPPT-2007-1081, which had been established for the initial ICR related to List 1 chemicals. Given 

the resulting confusion in finding documents in that docket, EPA has established a new docket, which is 

linked to the old docket. Copies of this ICR and the related documents are available in the new docket.

Submit any additional comments to EPA 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-2013-0275, and the EPA ICR number (2488.01) 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.

Comments can also be sent to the Office of Information and Regulatory Affairs (OIRA) at OMB via 

email to oira_submission@omb.eop.gov. Please address your comments to the OMB Desk Officer for 

EPA, and include the EPA Docket ID Number EPA-HQ-OPPT-2013-0275 and OMB Control Number 

2070-NEW in any correspondence.

7. List of References

The following is a list of the documents that are specifically referenced in this Addendum Document. 

To access these references go to 

http://www.regulations.gov/search/Regs/home.html#docketDetail?R=EPA-HQ-OPPT-2007-1081. 

1. 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.

2. EPA. Endocrine Disruptor Screening Program (EDSP); Draft Second List of Chemicals to be 

Screened; Notice. Federal Register (75 FR 70248, November 17, 2010). 

http://www.gpo.gov/fdsys/pkg/FR-2010-11-17/pdf/2010-28818.pdf. 

3. EPA. Endocrine Disruptor Screening Program (EDSP); Draft Policies and Procedures for 

Screening Safe Drinking Water Act (SDWA) Chemicals in the EDSP; Request for Comment; 

Notice (72 FR 70842, November 17, 2010). 

http://www.epa.gov/scipoly/oscpendo/pubs/draft_policies_frn.pdf.

4. Central Data Exchange (CDX) http://www.epa.gov/cdx/. 
EPA ICR No. 2488.01 June 3, 2013

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5. Crop Life America, EDSP Tier 1 Screening; Preliminary Burden Report dated November 2010 

submitted by Crop Life America's Endocrine Policy Forum.

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2007-1081-0037.

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

7. EPA Report "Laboratory Testing of Chemicals for Endocrine Disruption Potential - Analysis of 

Market Factors" (October 14, 2009). Available in the docket.

8. Attachments to This Addendum

The following is a list of the attachments to this addendum. The ICR addendum and the attachments 

listed below, can be found in the docket for this ICR and are accessible electronically through 

http://www.regulations.gov, under Docket ID No.: EPA-HQ-OPPT-2013-0275 and under Docket ID 

No.: EPA-HQ-OPPT-2007-1081 for the existing ICR materials.

Attachment Description

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

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

B (1) EDSP; Policies and Procedures for Initial Screening (April 15, 2009). 

http://www.gpo.gov/fdsys/pkg/FR-2009-04-15/pdf/E9-8706.pdf. 

(2) EDSP; Policies and Procedures for Screening Safe Drinking Water Act (SDWA) 

Chemicals (May 29, 2013) [Prepublication Copy].

C (1) FIFRA/FFDCA §408(p) Order Template for Pesticide Active Ingredients (As of 

April 15, 2013). 

(2) FIFRA/FFDCA §408(p) Order Template for Pesticide Inert Ingredients (As of April 

15, 2013).

(3) SDWA/FFDCA §408(p) Order Template for SDWA §1457 Chemicals (As of April 

15, 2013).

D (1) EPA Form 6300-05: FFDCA §408(p) Order/FIFRA §(3)(c)(2)(B) Data Call-In (DCI) 

- Initial Response Form for Individual Order Recipients (As of March 27,2013).

(2) EPA Form 6300-05-C: FFDCA §408(p) Order/FIFRA §(3)(c)(2)(B) Data Call-In

(DCI) - Initial Response Form for Consortium/Task Force (As of March 27, 2013).

(3) EPA Form No. 6300-06: FFDCA §408(p) Order/SDWA §1457 - Initial Response 

Form for Individual Order Recipients (March 27, 2013).

(4) EPA Form No. 6300-06-C: FFDCA §408(p) Order/SDWA §1457 - Initial Response 

Form for Consortium (EPA Form No. 6300-06-C) (March 27, 2013).

E Process for Issuing & Responding to EDSP Tier 1 Orders (April 4, 2013). 

F Calculations for Paperwork Burden and Costs for Data Generation Activities (July 30, 

2012).

G Final Second List of Chemicals for Tier 1 Screening in the EDSP (March 29, 2013).

H ICR Final Comment Response Document for the Second List of Chemicals for Tier 1 

Screening (March 26, 2013).

I Specific Changes Made to the Forms & Order Templates for EDSP/FIFRA Orders (May 

29, 2013)

J EDSP Mock-up Screenshots (April 3, 2013).