October 25, 2012

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Supporting Statement for an Information Collection Request (ICR) 

1. Identification of the Information Collection 

1(a) Identification of the Information Collection: 

1(a)(i) Title: Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor 

Screening Program (EDSP). 

1(a)(ii) EPA ICR No.: 2249.03 

OMB Control No.: 2070-0176 

Docket ID No.: EPA–HQ–OPPT–2011–0966 

1(b) Short Characterization/Abstract 

This is a renewal of an existing information collection request (ICR) under the Paperwork Reduction 

Act (PRA),1 covering the information collection activities associated with Tier 1 screening of chemicals 

under the EPA's Endocrine Disruptor Screening Program (EDSP). The EDSP is established under 

section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA),2 which requires the EPA to 

develop a chemical screening program using appropriate validated test systems and other scientifically 

relevant information to determine whether certain substances may have hormonal effects. The EDSP 

consists of a two-tiered approach to screen 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.3 Substances that have the potential to 

interact with estrogen, androgen or thyroid systems may proceed to Tier 2, which 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. Additional information about the EDSP is available through 

the agency's Web site at http://www.epa.gov/endo. 

This ICR addresses the information collection activities for the initial list of chemicals screened under 

Tier 1 of the EDSP, and covers the full range of information collection activities associated with the 

issuance of and response to Tier 1 EDSP orders issued by the EPA. The initial list was established in 

2009, and consists of 67 pesticide active ingredients (PAIs) and pesticide inerts.4

 As the renewal of an 

ongoing information collection activity approved under the PRA, this ICR addresses the paperwork 

burden associated with the continuation of these activities over the next three (3) years. As such, the 

paperwork burdens are adjusted to reflect the planned progression associated with the information 

collection activities covered by the ICR. 

 

1

 44 USC 3501 et seq. 2

 See Attachment A. 

3

 Nothing in the identification of chemicals for Tier 1 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. 

4

See Attachment G. 
October 25, 2012

Under the existing ICR, the EPA issued the Tier 1 EDSP orders to the identified pesticide registrant and 

inert manufacturers, and received the initial responses from those order recipients. However, as stated in 

the EDSP policies and procedures document (Attachment B), the EPA will continue to issue "catch-up" 

orders for a period of 15 years to companies who enter the marketplace after the issuance of the initial 

orders in 2010. An up to date matrix with information on the status of the orders issued and responses 

received for those chemicals is available on the agency's Web site at http://www.epa.gov/endo. To 

facilitate consortia formation, the EPA also makes a list of the order recipients for each chemical 

publicly available at the Web address above. 

Although the information collection activities are not being changed by this ICR renewal, the burden 

estimates reflect the planned progression of the collection activities associated with the initial list of 

chemicals to be screened under the EDSP. At this stage of the program, the remaining ongoing 

information collection activities relate primarily to data submission, and to those activities associated 

with "catch-up" orders. In calculating the overall burden, the EPA assumes that all future "catch-up" 

order recipients will join existing data submitters, and will not elect to become independent data 

generators. 

Finally, the EPA has also reviewed the cost estimates for the eleven assays, including the analytical 

chemistry costs, and adjusted the costs for inflation. As before, the total costs of the tests are used to 

calculate the paperwork burdens and costs for this ICR. 

2. Need for and Use of the Collection 

2(a) Need/Authority for the Collection 

The agency's authority for the information collection activities associated with the EDSP includes 

authorities under the FFDCA, the Safe Drinking Water Act (SDWA), the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA). This information 

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

will allow the agency to identify substances that have the potential to interact with 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 the 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 an effect, section 408(p)(6) directs the administrator to take action under available statutory 

authority to ensure protection of public health. That is, the ultimate purpose of the EDSP is to provide 

information that will allow the agency to evaluate 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. 

FFDCA section 408(p)(1) requires the EPA "to develop a screening program, using appropriate 

validated test systems and other scientifically relevant information to determine whether certain 

substances may have an effect in humans that is similar to an effect produced by a naturally occurring 

estrogen, or such other effects as [EPA] may designate." [21 U.S.C. 346a(p)]. 

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October 25, 2012

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

chemicals." FFDCA section 201 defines "pesticide chemical" as "any substance that is a pesticide within 

the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including all active 

and pesticide inert ingredients of such pesticide." [FFDCA section 201(q)(1), 21 U.S.C. 231(q)(1)]. The 

statute also provides the EPA with discretionary authority to "provide for the testing of any other 

substance that may have an effect that is cumulative to an effect of a pesticide chemical if the 

Administrator determines that a substantial population may be exposed to such a substance." [21 U.S.C. 

346a(p)(3)]. 

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

substance for which testing is required [under FFDCA section 408(p)], or to a person who manufactures 

or imports a substance for which testing is required [under FFDCA section 408(p)], to conduct testing in 

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

Administrator within a reasonable time period" that the agency determines is sufficient for the 

generation of the information." 

FFDCA section 408(p)(5)(B) requires that, "to the extent practicable, the Administrator shall minimize 

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

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

handling of confidential business information..." [21 U.S.C. 346a (p)(5)(B)]. 

If a registrant fails to comply with an order issued under FFDCA section 408(p)(5), the Administrator is 

required to issue "a notice of intent to suspend the sale or distribution of the substance by the registrant. 

Any suspension proposed under this paragraph shall become final at the end of the 30–day period 

beginning on the date that the registrant receives the notice of intent to suspend, unless during that 

period, a person adversely affected by the notice requests a hearing or the Administrator determines that 

the registrant has complied fully with this paragraph." [21 U.S.C. 346a (p)(5)(C)]. Any hearing is 

required to be conducted in accordance with section 554 of the Administrative Procedures Act (APA). 

[5 U.S.C. 554]. FFDCA section 408(p) explicitly provides that "the only matter for resolution at the 

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

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

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

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

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

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

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

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

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

TSCA, civil penalties of up to $25,000 per day may be assessed, after notice and an administrative 

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

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

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

• Issuance of a notice to the person holding a pesticide registration under FIFRA section 3(c)(2)(B) 

[FFDCA section 408(f)(1)(A)]. 

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October 25, 2012

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

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

commitment to generate the data "by one or more interested persons." [FFDCA section 

408(f)(1)(C)]. 

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

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

these procedures to "require data or information pertaining to whether the pesticide chemical may have 

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

endocrine effects." Finally, FFDCA section 408(f)(1)(B) 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), the EPA may, after 

notice and opportunity for public comment, modify or revoke any tolerance or exemption to which the 

data are relevant. 

In addition, FFDCA section 408(i) provides that "[d]ata that are or have been submitted to the 

Administrator under this section or FFDCA section 409 in support of a tolerance or an exemption from a 

tolerance shall be entitled to confidential treatment for reasons of business confidentiality and to 

exclusive use and data compensation to the same extent provided by section 3 and section 10 of 

[FIFRA]." 

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

connection with decisions under the EPA's pesticide regulatory program. Specifically, FIFRA section 

3(c)(1)(F) confers "exclusive use" or "data compensation" rights on certain persons ("original data 

submitters") who submit data (in which they have an ownership interest), in support of an application for 

registration, reregistration, or experimental use permit, or to maintain an existing registration. 

Applicants who cite qualifying data previously submitted to the agency by the original data submitter 

must certify that the original data submitter has granted permission to the applicant to cite data or that 

the applicant has made an offer of compensation to the original data submitter. In the case of "exclusive 

use" data, the applicant must obtain the permission of the original data submitter and certify to the 

agency that the applicant has obtained written authorization from the original data submitter. (Data are 

generally entitled to "exclusive use" for 10 years after the date of the initial registration of a pesticide 

product containing a new active ingredient.) If data are not subject to exclusive use but are compensable, 

an applicant may cite the data without the permission of the original data submitter, so long as the 

applicant offers to pay compensation for the right to rely on the data. (Data are "compensable" for 15 

years after the date on which the data were originally submitted.) If an applicant and an original data 

submitter cannot agree on the appropriate amount of compensation, either may initiate binding 

arbitration to reach a determination. If an applicant fails to comply with either the statutory requirements 

or the provisions of a compensation agreement or an arbitration decision, the application or registration 

is subject to denial or cancellation. [See also 7 U.S.C. 136a (c)(1)(F)(ii)–(iii)]. 

FIFRA section 3(c)(2)(B) provides that "...[i]f the Administrator determines that additional data are 

required to maintain in effect an existing registration of a pesticide, the Administrator shall notify all 

existing registrants of the pesticide to which the determination relates and provide a list of such 

registrants to any interested person." [7 U.S.C. 136a(c)(2)(B)]. 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 

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October 25, 2012

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environmental cost 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 offers to share in the cost of producing the data shall be entitled to examine and 

rely upon such data in support of maintenance of such registration." The section establishes procedures 

to allow registrants who received DCI notices to use binding arbitration to resolve disputes about each 

person's fair share of the testing costs. 

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

also "compensable" when cited in support of an application for a registration. In other words, a pesticide 

company that chooses to rely on such data rather than develop its own data must offer compensation to 

the original data submitter – usually the data generator. Lastly, the agency may suspend the registration 

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

in a timely manner. 

Finally, FIFRA section 3(c)(2)(D) contains a provision, referred to as the "formulator's exemption" that 

is intended to simplify and promote equity in the implementation of the data compensation program 

under FIFRA section 3(c)(1)(F). This exemption relieves an applicant of the obligation to submit a 

study, or to cite and obtain permission or offer to pay data compensation to cite the results of a study if 

the study is relevant to the safety assessment of a registered product that the applicant buys from another 

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. 

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

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

sources of drinking water if the 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, the 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.5

 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 

 

5

 To access an overview of the endocrine system go to http://www.epa.gov/endo/pubs/edspoverview/primer.htm. 
October 25, 2012

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systems) will be made on a weight-of-evidence basis taking into account data from the Tier 1 assays 

and/or other scientifically relevant information. The fact that a 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. 

Subsequently, when used with the Tier 2 testing data6 and other available information,7 the Tier 1 

screening data obtained through this information collection activity will be used by the EPA and others 

as part of the hazard characterization of a chemical that is regulated by FIFRA, FFDCA, TSCA and 

SDWA. 

More specifically, the data collected under Tier 1 will allow the agency to evaluate the potential 

interaction of a chemical with the endocrine system. The EPA has extensive experience in using data 

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

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

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

system. In fact, the EPA has considered the potential interaction of a chemical with the endocrine system 

in making certain pesticide registration decisions. For example, the EPA considered data from 

prototypes of the assays included in the current EDSP Tier 1 screen, along with other existing data, in 

preparing the risk assessments of procymidone8

 and vinclozolin.9

The agency intends to take a weight-of-evidence approach to evaluate the available Tier 1 data for a 

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

additional data are needed. Chemicals that go 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 the EPA will determine which, if any, of the Tier 2 tests are necessary based 

on the available data. Tier 2 testing is designed to 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. 

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

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

screen all pesticides in 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, the EPA determined that it would be more efficient (and would use fewer animals) to 

 

6

 The collection of Tier 2 data is not part of this information collection activity. 

7

 This refers to other information that is available to EPA at the time of its analysis, including information that is not covered 

by this ICR. 

8

 To access the procymidone decision, go to http://www.epa.gov/pesticides/reregistration/procymidone/. 9

 To access the vinclozolin decision, go to http://www.epa.gov/pesticides/reregistration/vinclozolin/. 
October 25, 2012

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 the 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 the 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), etc. 

As indicated previously, this ICR only applies to Tier 1 screening for the initial list of EDSP chemicals. 

A subsequent ICR will address Tier 2 testing. Tier 2 is discussed here only in the context of the use of 

the Tier 1 data 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 the EPA. FFDCA specifically assigns this task to the EPA. The EDSP is the only program in the 

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

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

were no validated methods to screen or test chemicals for their potential to affect the endocrine system. 

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. The 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), the 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. The EPA is using validated methods or assays to identify and characterize the endocrine 

activity of pesticides and inert ingredients specifically in relation to estrogen, androgen, and thyroid 

hormones. 

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The agency considered these goals in developing the procedures for the EDSP, both those procedures 

used within the EPA and those that might be used by the respondents. For example, when a chemical is 

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

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

may cite existing or submit other scientifically 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 (Attachment B). 

3(b) Consultations 

In addition to the notice and comment requirement, the EPA is required under 5 CFR 1320.8(d)(1) to 

consult with potential respondents and data users about specific aspects of an ICR before submitting it to 

OMB for review and approval, regardless of whether changes have or have not been made to the 

collection activity. The EPA identified eight entities based on previous interactions related to the 

existing ICR and consulted with them about the information collection activities and related burden 

estimates provided in the public review draft for this ICR. The details of that consultation, including 

specific information about the entities, questions posed, and responses received, is provided in 

Attachment H of this document. The following is a summary of the consultation and the agency’s 

response. 

Publicly Available Data: Most respondents indicated that the submission of "other scientifically 

relevant information" (OSRI) was expensive and time consuming. It was stated that the agency was too 

strict in its review of the OSRI. Respondents stated that by not accepting OSRI, portions of the EDSP 

Tier 1 battery were duplicative. 

Frequency of Collection: Most participants responded that the frequency of the data collection was fine 

given the fact that Tier 1 EDSP orders would only be issued "once" per chemical (except in rare 

situations). One consultation participant noted the lack of practical utility for the one-year progress 

report that is required of order recipients to be submitted to the EPA. 

Clarity of Instructions: All respondents indicated that instructions could be improved in terms of 

clarity. However, most respondents indicated that the forms that needed to be submitted were clear and 

easy to understand. 

Electronic Reporting and Record Keeping: All respondents encouraged the EPA to move to electronic 

reporting and record keeping as quickly as possible. 

Burden and Costs: All respondents felt that the costs associated with the EDSP Tier 1 Battery were 

underestimated. Most respondents also felt that the EPA could do a better job explaining exactly how 

the ICR is calculated and where specific figures are "pulled" from. CropLife America stated that they 

felt the current cost estimate for the EDSP Tier 1 Battery is 15% lower than "real world" costs. CropLife 

America also indicated that the labor categories (currently managerial, technical, and clerical) should be 

expanded to include legal and consultant categories. 

EPA Response to Consultation Feedback: Because of the similarity in comments received during the 

consultation process and the public comment period and the general overlap of participants, please refer 

to the section 3(c) of this document. 

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

The EPA received four responses to the 60-day public notice and comment period for the draft ICR 

renewal (77 FR 47640, August 9, 2012): 

Commenter#(1) DCN(2) Commenter Name(3) Affiliate 

1 EPA-HQ-OPPT2011-0966-0012 Bayer CropScience Endocrine Drive 

Team 

Bayer CropScience LP 

2 EPA-HQ-OPPT2011-0966-0013 Clare Thorpe, Senior Director Human 

Health Policy 

CropLife America (CLA) and Endocrine 

Policy Forum (EPF) 

3 EPA-HQ-OPPT2011-0966-0014 Scott Slaughter Center for Regulatory Effectiveness 

(CRE) 

4 EPA-HQ-OPPT2011-0966-0015 Patricia L. Bishop, Research 

Associate, Regulatory Testing 

Division and Kristie Sullivan, 

Director, Regulatory Testing Issues 

People for the Ethical Treatment of 

Animals (PETA) and Physicians 

Committee for Responsible Medicine 

(PCRM) 

Key: 

(1) This is the number that is used in this document to refer to this particular commenter. 

(2) This is the number that is used to identify this comment in the docket at http://www.regulations.gov, 

(3) This is the name of the individual or entity that submitted the comments, along with their affiliation, if provided. 

A complete Response to Public Comments Document is in Attachment I, and is also in the docket at 

http://www.regulations.gov under Docket ID number EPA-HQ-OPPT-2011-0966. 

3(d) Effects of Less Frequent Collection 

Once per chemical substance is the statutory minimum, because FFDCA section 408(p)(3) specifically 

requires that the EPA "shall provide for the testing of all pesticide chemicals," unless the agency can 

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

interact with the endocrine system. 

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

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

company to go directly to Tier 2. The agency will consider any such requests on a case-by-case or 

chemical-by-chemical basis and will provide a written response that will be made publicly available. In 

some cases, the agency's response to an individual 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. For the purposes of 

this ICR renewal, the agency assumes that the only additional new work will be that associated with the 

issuance of new "catch-up" orders. 

3(e) General PRA Guidelines 

The one general PRA guideline that is exceeded by this collection is the time period for retaining 

records. When data are generated to support a pesticide registration under FIFRA, the EPA requirements 

in 40 CFR 169.2(k) apply, which state that records containing research data relating to registered 

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October 25, 2012

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 

the 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. 

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

3(f) Confidentiality 

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 the 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, the EPA 

believes that this provision directs the agency to create procedures that operate within the existing 

confines of FIFRA section 10, the Freedom of Information Act (FOIA), and the Trade Secrets Act. 

As discussed in more detail in the policies and procedures document (Attachment B), because the data 

would support a tolerance or exemption from the requirement of a tolerance, FFDCA section 408(i) 

provides that much of the data submitted in response to an order issued under FFDCA section 408(p) 

would be subject to the protections in FIFRA section 10. In addition, CBI submitted by pesticide 

registrants in response to an order issued under FFDCA section 408(p) would be considered as part of 

the registration process, and would therefore be considered to be data submitted in support of a 

registration. However covered, data subject to FIFRA section 10 would be provided certain protections 

that go beyond those authorized by FOIA. For example, FIFRA section 10(g) generally prohibits the 

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 the Trade Secret Act. FOIA requires agencies to make 

information available to the public upon request, except for information that is "specifically made 

confidential by other statutes" or data that are "trade secrets and commercial or financial information 

obtained from a person and is privileged or confidential." [5 U.S.C. 552]. Note that substantive criteria 

must be met to claim confidentiality of business information, as specified in 40 CFR 2.208. 

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October 25, 2012

As indicated in the policies and procedures document (Attachment B), the 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 the Trade Secrets Act. 

3(g) Sensitive Questions 

No information of a sensitive or private nature is requested in conjunction with this information 

collection activity. Further, this information collection activity complies with the provisions of the 

Privacy Act of 1974 and OMB Circular A-108. 

4. The Respondents and the Information Requested 

4(a) Respondents 

Respondents to 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), the 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 as described in the existing ICR remains 

the same. 

Identification of Order Recipients: The EPA generally identified the following categories of potential 

recipients of the Tier 1 orders: 

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

ingredient and hold an active EPA registration for 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. 

The agency used the following North American Industrial Classification System (NAICS) codes to 

obtain publicly available information about potential respondents that informed the estimates presented 

in this ICR: 

• Chemical Manufacturers and Processors (NAICS code 325), e.g., persons who manufacture, 

import or process chemical substances. 

Page 11 of 44 
October 25, 2012

• Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing (NAICS code 3253), e.g., 

persons who manufacture, import or process pesticide, fertilizer and agricultural chemicals. This 

includes Producers and Formulators of Pesticide Products (NAICS code 32532); Producers of 

Antifouling Paints (NAICS code 32551); Producers of Antimicrobial Pesticides (NAICS code 

32561); and Producers of Nitrogen Stabilizers (NAICS code 32531). 

• Scientific research and development services (NAICS code 5417), e.g., persons who conduct 

testing of chemical substances for endocrine effects. These entities will not receive orders, but 

their potential involvement in responding to paperwork activities did inform the estimates 

presented in this ICR. 

As stated earlier, for a duration of 15 years after the issuance of the initial orders in 2010, the EPA 

intends to issue a "catch-up" order to any company who subsequently enters the marketplace to 

manufacture or import the substance that was the subject of an EDSP order. Specifically, in addition to 

the order recipients identified by the agency, the EPA may issue an order under FFDCA section 

408(p)(5) to a manufacturer or importer who enters the marketplace after the issuance of the initial 

orders, i.e., when they begin to sell an inert ingredient following the submission of required EDSP data 

on the ingredient by manufacturers or importers who were in the marketplace when the initial orders 

were issued. The agency refers to these as "catch-up" orders. As with the initial order issued under 

FFDCA section 408(p), recipients of a "catch-up" order could fulfill the testing requirement either by 

submitting the results of a new study or by citing the data submitted by another person. In furtherance of 

the goal of "fair and equitable sharing of test costs," the agency would accept citation of existing data 

only if the recipient either had the original data submitter's permission, or the recipient had made an 

appropriate offer to pay compensation to the original data submitter that also determined how disputes 

would be resolved. 

Grouping Respondents by Information Collection (IC) Activities: The agency has divided the two 

identified respondent groups into the following distinct information collection (IC) categories: 

• Order Recipients. This category includes everyone that could receive an EDSP order for one or 

more of the chemicals on the initial list, but has not already received an EDSP order. 

• Data Generators/Submitters. This category includes one company for each chemical because the 

EPA expects companies to work together to provide the required data so that they do not 

duplicate efforts. 

• Consortium Participants. This category includes the order recipients that are not in the Data 

Generators/Submitters category. These companies will actively participate in consortia activities, 

and includes the recipient of a subsequent "catch-up" order that is expected to join the ongoing 

activities. 

Calculating the Number of Respondents: To date, the EPA has already issued the initial Tier 1 EDSP 

orders for the 67 chemicals, and those order recipients have already provided their initial responses. This 

is specifically reflected in the estimated number of respondents for the different IC categories. 

In terms of estimating the potential number of order recipients for purposes of estimating the burden in 

this ICR, the EPA is assuming the potential issuance of up to 20 additional orders each year (15 

involving pesticide active ingredients and 5 involving pesticide inert ingredients). Based on the agency's 

experience with "catch-up" orders to date, this appears to be a reasonable approach for estimating the 

Page 12 of 44 
October 25, 2012

number of potential catch-up orders. The EPA also assumes that all "catch-up" order recipients will join 

an existing data generator (i.e., a consortium). 

In terms of estimating the potential number of data generators/submitters for purposes of estimating 

the burden in this ICR, the EPA assumed that there would be one for each of the 67 chemicals. The 

EDSP process is longer than three years, the term of an ICR. All of the orders have been issued, with the 

exception of catch-up orders. Therefore, for this ICR, the agency knows that Tier 1 data are being 

generated only once for each of the 52 chemicals of the original 67. Of the 52 remaining chemicals, 22 

are supported by a single respondent, while a group of respondents that have formed a consortia for 30 

chemicals. The orders for the remaining 15 chemicals were satisfied through cancellation in the case of 

(8) pesticides and withdrawn as a pesticidal inert for the 7 remaining (formerly) inert chemicals. 

In terms of estimating the potential number of consortium participants for purposes of estimating the 

burden in this ICR, the EPA assumed that the recipients of a catch-up order would join the ongoing 

consortium. Based on the initial responses received already, there are 30 consortia currently underway 

that include a total of 213 participants. 

Table 1 presents the estimated number of respondents for each IC category, which is used subsequently 

as a multiplier for the per response burden in order to calculate the total annual burdens. 

Table 1 – Estimated Number of Potential Respondents 

IC # IC Category Name 

Estimated Number of 

Respondents 

1. Order Recipients 60 

1(a). – Registrants 0 

Catch-Up Orders 45 

1(b). – Manufacturers/Importers 0 

Catch-Up Orders 15 

2. Data Generators/Submitters 52 

2(a). – Registrants 50 

Catch-Up Orders 0 

2(b). – Manufacturers/Importers 2 

Catch-Up Orders 0 

3. Consortium Participants 273 

3(a). – Registrants 207 

Catch-Up Orders 45 

3(b). – Manufacturers/Importers 6 

Catch-Up Orders 15 

Total Respondents 385 

4(b) Respondent Activities 

Respondent activities vary based on the IC category and the respondent group. Although identified 

under the applicable IC category, the activities are numbered sequentially to allow for cross-referencing. 

IC #1: Order Recipients:

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

templates identified in Attachment C(1), entitled "FFDCA 408(p) Order Template for Pesticide 

Registrants (As of September 16, 2009)" or in Attachment C(2), entitled "FFDCA 408(p) Order 

Page 13 of 44 
October 25, 2012

Template for Pesticide Inert Ingredients (As of September 16, 2009)." The order will specify the data 

that must be submitted (i.e., based on the eleven Tier 1 assays as discussed later in this section), and 

outline the timeframes for responding to the order, including providing an initial response, annual status 

reports, if applicable, and for submitting the data responsive to the order. 

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

using the currently approved form identified as EPA Form No. 6300-05, entitled "FFDCA section 

408(p) Order/FIFRA section (3)(c)(2)(B) Data Call-In (DCI) - Initial Response Form for Individual 

Order Recipients," in attachment D(1). The EPA will continue to include a copy of this form in the order 

packet sent to the recipient, and will continue to pre-populate it with the basic information about the 

recipient, the chemical covered, and the applicable test data sought. 

Since the agency assumes that there is already an existing consortium, it is also assumed that the 

consortium has already provided an initial response using the currently approved form identified as EPA 

Form No. 6300-05-C, entitled "FFDCA section 408(p) Order/FIFRA section (3)(c)(2)(B) Data Call-In 

(DCI) - Initial Response Form for Consortium/ Task Force," in attachment D(2). 

At this stage of the program, as discussed previously in section 4(a), those entities previously identified 

as respondents have already received the order, so the respondents for this IC category are now only 

those that will receive a catch-up order, i.e., order recipients. Nevertheless, the activities for these 

respondents remain the same. Specifically, these respondents will engage in the activities identified and 

described later in this section as items (1) through (5). 

IC #2: Data Generators/Submitters:

In general, the order recipients that are included in this IC category are those respondents that have 

indicated an intention to generate and submit the data requested, either individually or on behalf of a 

consortium. As such, these respondents will engage in the activities identified and described later in this 

section as items (4) through (9). 

IC #3: Consortium Participants:

In general, the order recipients that are included in this IC category are those respondents that will 

actively participate in consortia activities, and includes recipients of a subsequent "catch-up" order 

because they are expected to join the ongoing activities. These respondents will be a participant in, but 

not fully responsible for, the activities identified and described later in this section as items (4) and (6), 

as well as maintain records related to their participant and compliance with the order as described in 

item (9). 

Overview of Covered Activities:

Each recipient of an order (aka respondent) is expected to engage in the following information collection 

related activities: 

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

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

respond to. Depending on the recipient's familiarity with the EDSP, the recipient may also read other 

information about the EDSP, such as the policies and procedures document (Attachment B) that 

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October 25, 2012

explain the agency's rationale for the requirements in the order and which describes the specific 

details of the policies and procedures that the EPA generally intends to adopt for initial screening 

under the EDSP, including the statutory requirements associated with and format of the orders issued 

under FFDCA section 408(p), as well as the EPA's procedures for fair and equitable sharing of test 

costs and handling confidential data. 

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

the agency has developed order templates for the two different kinds of potential order recipients: 

• An Order Template for Pesticide Registrants, entitled "FFDCA 408(p) Order Template for 

Pesticide Registrants (As of September 16, 2009)." Attachment C(1). 

• An Order Template for Pesticide Inert Chemicals, entitled "FFDCA 408(p) Order Template for 

Pesticide Inert Ingredients (As of September 16, 2009)." Attachment C(2). 

Although the agency generally intends to use these templates, the individual orders will contain the 

necessary recipient specific 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 from other 

orders issued for a chemical. 

(2) Plan activities – After reading the Tier 1 order they received, 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 the EPA – The Tier 1 orders will direct each recipient to provide an 

initial response to the EPA within 90 calendar days of issuance of the order that indicates how they 

intend to comply with the order. The response options available to the recipient will vary depending 

on whether the subject chemical is a pesticide active ingredient or pesticide inert chemical. The 

various response options available to a recipient, along with the related additional activities that they 

may engage in specific for that response option are described in section 4(c)(i) of this ICR. 

To simplify completion of this initial response within the 90 days, the EPA has created an Initial 

Response Form for Individual Order Recipients [see Attachment D(1)]. The EPA intends to include 

this form in the order packet, pre-populated with the basic information about the recipient, the 

chemical covered, and the applicable test data sought. The recipient will 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 response form allows for assay specific responses 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 the response 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. For simplicity, however, the response 

form is structured so that recipients indicate their responses on an assay-by-assay basis – even if the 

response is the same for more than one of the assays. For example, the recipient may submit or cite 

existing data to address one or more assay, indicate that they will generate the data for one or more 

assay, and/or indicate that the intend to form or join a consortia to provide the data for one or more 

of the other assays identified in the order. OSRI may also be submitted for consideration in 

satisfying all of the assays in the order, the initial response form includes a separate line item to 

indicate whether OSRI is being cited or submitted to address either (A) a particular assay (i.e., in 

Page 15 of 44 
October 25, 2012

Page 16 of 44 

part 2.1.C. of the form), or (B) to satisfy the order as a whole (i.e., in part 2.2. of the form). The 

response option involving the submission of OSRI is described in section 4(c)(i) of this ICR. 

If the recipient intends to form or join a consortium (or task force) with other manufacturers of the 

chemical to provide the data for one or more of the assays identified in the order, each consortium 

participant or potential participant is expected to submit an Initial Response Form for Individual 

Order Recipients [Attachment D(1)] within 90 calendar days. Within 150 calendar days of issuance 

of the order, or as part of their initial response, the designated lead for the consortium is expected to 

submit the Initial Response Form for Consortium /Task Force [Attachment D(2)] to provide the 

primary contact for the task force or consortium, the list of 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 a written statement by all the parties that an agreement 

exists). The joint agreement to produce the data need not specify all of the terms of the final 

arrangement between the parties or the mechanism to resolve the terms. 

In the context of this renewal ICR, the respondents in the IC category for order recipients are only 

expected to submit an individual response form, because the EPA is assuming that the recipients of 

catch-up orders will join an ongoing consortium, rather than form a new one or generate data. 

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

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

for the subject chemical. An order recipient wishing to deviate from any of the protocols identified 

in the order, may do so only after consultation with the EPA. Such requests should be submitted to 

the EPA with a clear rationale and explanation of the deviation. All protocol variations will be 

reviewed by the EPA and a response will be sent to the specific order recipient in a timely fashion. 

These procedures are consistent with current EPA practices regarding pesticide test guidelines and 

the data requirements in 40 CFR parts 158 and 161. Although this activity is expected to be 

primarily performed by the data generating entity, other participants in a consortium may also 

participate in these discussions. 

If the order recipient chooses to submit or cite 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 the 

EPA's harmonized test guideline compendium.10 Such recipients will be expected to provide a 

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

of the order. The 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 is expected to comply with the agency's good laboratory practice 

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

when conducting studies, and, with the submission of data to the 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 

 

10 http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm. 
October 25, 2012

conduct the study and do not therefore know whether the study was conducted in accordance with 

the GLPs. 

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

administer the tests to generate the data requested in the order. For purposes of this renewal ICR, 

however, recipients of the catch-up order are not expected to engage in such activities because they 

are expected to join with whoever has already committed to do this. 

For the purposes of calculating paperwork burden hours and costs in this ICR, the EPA assumed that 

the data generation will be performed by a contract laboratory at the request of an individual order 

recipient or a consortium. The agency has no information upon which to estimate how many 

recipients might use a contract 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. In addition, as indicated by industry, many companies now 

outsource toxicology testing because it is less expensive than maintaining that function in-house 

(Reference 8, p. 5.). Nevertheless, only those activities imposed by the information collection 

request are attributable to this ICR. For example, the time and costs for the contract laboratory staff 

to travel to meet with the contracting company is not an activity imposed by the information 

collection request and is therefore not attributable to the ICR. Nor are any costs or burden related to 

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

which then requires the contract laboratory to redo the study. 

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

that the requirements of the order have been satisfied, the order recipient will be expected to submit 

a progress report to the EPA within 12 months after the issuance of the order. The progress report 

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

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

schedule for complying with the order. Compiling and reviewing the data can include such activities 

such as Data Entry Spreadsheet Templates (DESTs). DESTs for the EDSP Tier 1 Battery can be 

found at http://www.epa.gov/endo/pubs/toresources/seps.htm#dests. 

(7) Complete paperwork to 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 having 

performed the applicable assay(s), review the data for completeness and compliance with GLPs, and 

assemble the submission package in accordance with the instructions provided in the order. In 

general, these are the same submission procedures as those that are currently used for submitting 

other data in support of a pesticide registration, with only a few modifications – such as the mailing 

address. 

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

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

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

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

as it is completed, or submit 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. 

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(9) Maintain records – Recipients will be asked to maintain a record of their initial response for three 

(3) years. Recipients who submit data in support of a pesticide registration will also be asked to 

maintain records of that data pursuant to 40 CFR 169.2(k), i.e., containing research data relating to a 

registered pesticide for as long as the registration is valid and the producer remains in business. 

Distribution of Activities by Labor Categories:

For purposes of estimating the 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 above may involve one or more labor or duty category. In Table 2, 

the agency identifies the assumed recipient activities divided between the three labor categories. 

Table 2 – Expected Respondent Activities by Labor Categories 

Activity Managerial Duties Technical Duties Clerical Duties 

(1) Read the EPA's policies and 

procedures document 

Read the EPA's policies and 

procedures document 

Review the EDSP order Review the EDSP order 

(2) Identify timeframe for response 

Identify and evaluate response options Evaluate response options 

Plan activities 

Negotiate/establish consortium/ task 

force agreements 

Participate in consortium/ task force 

discussions 

(3) Determine response Recommend a response 

Oversee employee activities Complete response form 

Sign initial response forms Send to the EPA 

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

Review GLPs (deviations) meetings with the EPA 

Identify and discuss other 

scientifically relevant information and 

related protocol &/or GLP deviations 

(5) Plan/oversee employee and contract 

activities 

Plan the data collection activities 

using the approved protocols 

Secure contract lab services and 

approve statement of work (SOW) 

Conduct the tests, using protocols and 

GLPs 

Communicate with the EPA, as 

appropriate 

Maintain records and procedures 

during testing period in accordance 

with the GLPs 

Assist in preparing files 

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

Prepare final data reports 

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

letter 

Prepare final submission 

package 

Review final submission package 

(8) Approve/sign submission Send submission to the EPA 

(9) Prepare data for files Prepare final file folders 

Maintain records 

4(c) Information Requested 

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

the agency. The order will identify the Tier 1 data being requested and will provide the specific 

instructions for complying with the order. In general, all order recipients are expected to provide an 

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individual initial response that identifies how the recipient intends to respond to the order. The specific 

information required to be provided with the 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 procedure documents, and are summarized in section 4(c)(i) of this ICR. Those recipients that 

generate data, either individually or as part of a consortium, are expected to provide a 1-year progress 

report, and then submit the data to the EPA. 

For purposes of this ICR, it is important to note that many of the initial response options adopted for 

EDSP already exist within the pesticide program, e.g., for Data Call-Ins under FIFRA 3(c)(2)(B). In 

providing the option as described in more detail in the policies and procedures document (Attachment 

B), the agency adopted the existing procedures unchanged for use under the EDSP. Under those existing 

procedures, a 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 Recipient's Response Options 

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

The recipient uses the Initial Response Form for Individual Order Recipients [see Attachment D(1)] to 

indicate which option they intend to use to respond to the data 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 pesticide 

active ingredients and pesticide inert ingredients (see also Attachment E, which provides an overview of 

the response options in a workflow format). 

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

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

In the case of data pertaining to an inert ingredient for which there is no tolerance or exemption, the 

recipient may identify a "cooperating registrant/agent" for the EPA (e.g., to whom the EPA could 

send a DCI notice under FIFRA section 3(c)(2)(B) or identify on the recipient list). The cooperating 

registrant/agent would then become jointly responsible for generating and submitting the data. This 

is different from a consortium, which is discussed later. 

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

existing data (including other relevant scientific information) that they believe can be used to satisfy 

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October 25, 2012

part or all of the Tier 1 order. Existing data may be of several types. An example may be an in vitro

assay for transcriptional activation that is conducted with a different cell line and by a different 

protocol. But more generally, existing data may be "other scientifically relevant information." Other 

scientifically relevant information can include data from studies other than the EDSP Tier 1 assays, 

e.g., studies conducted to satisfy a 40 CFR part 158 or part 161 data requirement, data from other 

studies conducted to address an identified issue, or data from studies found in the scientific 

literature. In addition to the Tier 1 order recipient, anyone can submit other scientifically relevant 

information. To allow the EPA to review the submission of other scientifically relevant information 

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. 

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 

reviewed by the agency, the agency's classification of the study. The agency specifically asks that a 

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

If the individual citing a study is 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 the 

EPA that no such compensation is necessary. 

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

whether the study is of sufficient quality and can be used to satisfy the order. The agency intends to 

notify submitters in writing of its determination, as well as make the determination publicly 

available. 

(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 participant 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 [see 

Attachment D(2)] to provide the primary contact for the task force or consortium, the list of 

participants, and an indication of the task force or consortium's planned response for each assay, 

along with documentation of its formation (such as a copy of the joint agreement or a written 

statement by all the parties that an agreement 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 the EPA with documentation that they made a 

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

recipients of the order and that 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 

Page 20 of 44 
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Page 21 of 44 

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 Tier 1 order involving a pesticide active ingredient, the recipient is not a

pesticide registrant, or 

ical, or 

by 

(ii) In the case of a Tier 1 order involving a pesticide inert ingredient, the recipient does not 

currently manufacture or import the chem

(iii) In the case of a "catch-up" order, the recipient obtains the chemical solely from persons who 

are either (1) an original data submitter; (2) a person who has complied with an EDSP order 

offering compensation; or (3) a person who is otherwise an approved source for the pesticide 

inert ingredient. 

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

claim to allow the EPA to evaluate the claim. If the 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. This option is only available 

for pesticide registrants. Registrants 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. Under those procedures, the registrant may either adopt the standard 

procedures for sale or use of existing stocks of their pesticide, or may propose an alternative 

procedure. Alternatively, in the case of an inert ingredient, a registrant of an end-use product may 

submit an application to amend the formulation of its product by removing the ingredient that is the 

subject of the Tier 1 order. This is all accomplished through the submission of an application to 

amend the registration following the established procedures. In general, the EPA's policy does not 

include the issuance of orders under FFDCA section 408(p) to registrants of end-use products. 

(6) I Claim a Formulators' Exemption. A pesticide registrant who receives an order to test a chemical 

who purchases the chemical from another recipient who has agreed to generate the data may be 

eligible for a formulators' exemption, but exercise of this option may depend on the authority under 

which the order is issued. If the EPA were to rely solely on FIFRA 3(c)(2)(B), the option would not 

be available for orders to test an inert ingredient since manufacturers and importers would not be 

subject to a FIFRA order. Such a claim would initiate the existing procedures for formulators' 

exemption. The EPA will confirm claims of eligibility. A formulators' exemption would become 

invalid if the supplier of the chemical were not to submit the data either individually or jointly with 

other recipients. 

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

option is only available for pesticide inert ingredients. The recipient of an order for a pesticide inert 
October 25, 2012

ingredient (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. The EPA 

intends to verify such a claim. If the EPA confirms the claim, the Initial Response Form is the only 

response required to satisfy the order. If, however, the EPA determines that the claim is false, the 

recipient must comply with the order. 

(8) I Will Not Sell the Chemical for Use in Pesticide Products. This option is only available for pesticide 

inert ingredients. The recipient of an order for a pesticide inert ingredient (i.e., manufacturer/ 

importer) would choose this option to indicate that they do not currently or agree to no longer sell 

their chemical for use in the pesticide market. To elect this option, the order recipient would 

indicate, as part of its initial response, that they commit to discontinue, on or before a date six 

months after the issuance of the Tier 1 order, all sale and distribution of the chemical to any person 

who the recipient knows, or reasonably should know, intends to use the chemical in the formulation 

of a pesticide product. The order recipient would also indicate that it will include in all contracts for 

sale or distribution of the material a provision that contractually prohibits the purchaser from using 

the substance in the formulation of a pesticide product. As part of its initial response, the order 

recipient would be asked to provide a copy of the contract provision and a certification to include 

this contractual provision in any contracts entered into on or after a date six months after the 

issuance of the Tier 1 order. 

(9) 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 that the recipient believes would allow the EPA to determine that the 

chemical is anticipated to not be an endocrine disruptor, i.e., is not anticipated "to produce any effect 

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

(10) 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 the EPA 

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

EPA to be able to respond to the objections in a timely manner, the recipient would need to state 

with particularity the scope and basis of the 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 the EPA to reconsider some or all of the testing specified in the Tier 1 order, the 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 is an endocrine disruptor or 

Page 22 of 44 
October 25, 2012

Page 23 of 44 

was used as a "positive control" in the EDSP validation effort, on a case-by-case basis. Based on 

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

the EPA as a ''positive control'' to validate one or more of the screening assays, only the data 

submitted related to those assays for which the 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 the 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 the EPA within 12 months of the issuance 

of the order (the specific due date will be identified in the order). The progress report should provide a 

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

description of any problems 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 written request for an extension to the agency. The 

written request must be submitted before the applicable deadline and include: (1) a detailed description 

of the expected difficulty and (2) a proposed schedule including alternative dates for meeting the 

requirements of the order. If the delay is based on technical or laboratory difficulties, recipients are 

expected to explain any technical or laboratory difficulties and provide documentation from the 

laboratory performing the testing. 

While the 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 the 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 assays. The Tier 1 screening battery is 

intended to identify chemicals affecting 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 Tier 1 battery: 

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 
October 25, 2012

Page 24 of 44 

natural hormone or block access of the hormone to the site and thus block hormone controlled 

activity. 

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

biosynthesis that converts 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. 

enic, 

ines 

, 

ale rats. 

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-) ¬estrog

(anti-) androgenic, aromatase inhibition, and steroid modulating effects. The assay exam

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

including accessory sex glands, are measured in castrated or immature m

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

estrogenic and thyroid activity in females 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 
October 25, 2012

Page 25 of 44 

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

cases where the order may not include all of the assays. 

4(c)(v) Data Submission 

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

pesticide active ingredients and pesticide inert ingredients the content and format is based on that used 

currently for other pesticide data submissions. Since the initial chemicals involve pesticides and 

pesticide inerts, the EPA believes that doing this helps to minimize the potential burden because the 

order recipients are likely to be familiar with the existing requirements. As such, the content and format 

of the data submission package for transmittal to the EPA should be consistent with the following 

existing standards: 

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

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

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

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

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

information such as materials, methods, results, applicant's 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. Additional details about these templates are available at: 

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

Pesticide Registration (PR) Notice 86-5, entitled "Standard Format for Data Submitted Under the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal 

Food, Drug, and Cosmetic Act (FFDCA)," describes the requirements for organizing and formatting 

submittals of data supporting a pesticide registration (http://www.epa.gov/PR_Notices/pr86-5.html). 

The agency has begun the process of updating the guidance in PR Notice 86-5 to further clarify the 

data submission process for pesticide related submissions and will provide the public with an 

opportunity to comment on the proposed revisions to PR Notice 86-5 consistent with the procedures 

described in PR Notice 2003-3, entitled "Procedural Guidance for EPA's Office of Pesticide 

Programs Procedures Concerning the Development, Modification, and Implementation of Policy 

Guidance Documents" (http://www.epa.gov/PR_Notices/pr2003-3.pdf). 

In addition, the agency encourages order 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://www.epa.gov/pesticides/regulating/registering/submissions/index.htm. 

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 the EPA. 
October 25, 2012

Page 26 of 44 

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

the order). 

. 

ssed. 

 

(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 must 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 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 addre

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

(iii) The date the study was completed. 

(iv) If the study was performed in a laboratory, the name and address of the laboratory, 

project numbers or other identifying codes. 

(v) If the study is a commentary on or supplement to another previously submitted study, 

full identification of the other study with which it should be associated in review. 

(vi) If the study is a reprint of a published document, all relevant facts of publication, such 

as the journal title, volume, issue, inclusive page numbers, and date of publication. 

(2) Upon submission to the EPA, each document must be accompanied by a signed and dated 

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

as described in the Tier 1 order. 

(3) A statement of compliance or non-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 the EPA's OCSPP.11 Within OCSPP, OPP will be primarily responsible for the 

administrative functions 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 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 the 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, as appropriate. 

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

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

collection activities under this ICR renewal: 

(1) Prepare instructions. Prepare procedural steps, guidance and instructions for order recipients so that 

they understand what data are to be submitted, when and how. The policies and procedures 

document (Attachment B) describes the policies and procedures that the EPA intends to use to 

implement the data collection component of the EDSP. Although that document is non-binding, the 

agency will incorporate specific instructions into each order, so that each order recipient receives 

detailed instructions on what they must do to comply with the order. 

(2) Identify chemicals to be screened. The list of the chemicals covered by this ICR is provided in 

Attachment G. For purposes of this renewal ICR, since all of the remaining 52 chemicals on the 

final list have been the subject of a Tier 1 order issued under FFDCA section 408(p), the agency 

assumes that they could also be the subject of a catch-up order. 

(3) Identify order recipients. As indicated previously, the EPA has already issued Tier 1 orders to those 

identified for the remaining 52 chemicals as described in the existing ICR. As such, this ICR 

renewal involves potential recipients of catch-up orders. Recipients of catch-up orders will only be 

identified if a new registration application is received by the agency for one of the chemicals on the 

initial list, or if a company is otherwise identified. See the discussion on respondents in section 4(a) 

of this ICR renewal. 

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 confidential business information, the EPA will provide each 

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

order recipients is maintained up to date on the agency's EDSP Web site, along with the status of 

the order (including recipients' responses received by the EPA). These reports can be accessed at 

http://www.epa.gov/endo/pubs/toresources/index.htm. 

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

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

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

more easily identify the potential participants to include in a 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, the EPA intends to maintain an up to date list of order 

recipients on the agency's EDSP Web site. 

Along with preparation of the orders, the EPA 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, the EPA is 

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

Tier 1 screening under the EDSP. 

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

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

Page 27 of 44 
October 25, 2012

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

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

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

(7) Process Initial Responses. The agency will receive the 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 data 

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

claim(s). 

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

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

requests for extensions or protocol variations. 

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

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

Compliance Assurance (OECA) for enforcement, etc.). 

(10) Issue "Catch-up" Orders. The EPA may issue a so called "catch-up" order to a manufacturer or 

importer who begins to sell a pesticide ingredient (active or inert) 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, and determining the close out of the order. As indicated previously, this will be coordinated 

by OPP, OPPT and OSCP. Although each order will need to be addressed individually, the agency 

may determine that the satisfaction of the order for a particular chemical by one order recipient can 

be used to determine that all of the orders for that chemical are also satisfied. However, satisfaction 

of an order by one order recipient, may not affect the need for the other order recipients to comply 

at all. For more information, see the policies and procedures document (Attachment B). 

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

the data. For example, what do the data tell us about the chemical's potential to interact with E, A, 

and/or T? 

In general, the agency intends to take a weight-of-evidence approach to evaluate the available data 

for a particular chemical to determine whether the potential endocrine disrupting effects associated 

with the use of the chemical can be ascertained with the data available, or whether additional data 

are needed. For more background information on the weight-of-evidence approach, please go to 

http://www.regulations.gov, specifically under docket EPA-HQ-OPPT-2010-0877. 

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

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

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

Page 28 of 44 
October 25, 2012

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

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

endocrine system. For example, do we know enough to determine whether or not we should take 

any regulatory action to prevent or mitigate the exposures that might lead to the interaction 

identified? Should the chemical be considered for Tier 2 testing? 

In addition, chemicals that go 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 the EPA will determine which, if any, of the Tier 2 tests are necessary based on the 

available data. Tier 2 testing is designed to identify any adverse endocrine-related effects caused by 

the substance, and establish a quantitative relationship between the dose and that endocrine effect. 

(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 will be stored in OPPIN. This system is discussed in 

more detail in section 5(b) of this ICR. 

5(b) Collection Methodology and Management 

For each of the chemicals identified for Tier 1 screening as part of the EDSP, the specific data requested, 

the testing necessary to generate that data, along with the validated protocols to conduct the tests, the 

time frame for completing the testing, and the date by which the requested data must be submitted to the 

agency will be established in the Tier 1 order. As indicated previously, the 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. For example, as with other pesticide data 

related submissions, the EPA will maintain a record of each study submitted in the agency's Pesticide 

Document Management System (PDMS), and public access to the PDMS bibliography may be made 

through the National Pesticides Information Retrieval System (NPIRS). NPIRS supports searches of the 

PDMS database by chemical, subject, submission date, laboratory, guideline number, and document 

type. The public, after satisfying any applicable requirements (e.g., FIFRA section 10) may request 

copies of non-confidential studies through FOIA. 

In addition, OPP's Information Technology and Resource Management Division (ITRMD) has enhanced 

the agency's tracking database (PRISM) to provide the necessary information to accomplish the Tier 1 

goal. PRISM was used for issuance and tracking of EDSP orders related to the initial list of chemicals. 

To meet the goals of the EDSP, the system allows for the creation of orders for each chemical. For 

pesticide active ingredients, the system will manage information associated with the company, product 

or pesticide active ingredients, requirement information, and information related to the responses. For 

inert ingredients, the system manages the associated companies only, since these companies may not 

have any registered products. In addition, the system allows for the submission of studies through 

registrant consortiums, in addition to individuals. This will ensure that the companies who received 

orders are given credit for the submissions when the consortium is identified as the study owner. For 

every inert there is a subsection for its Battery, results and comments. The system will track the 

milestones associated with the drafting, concurrence, mail-out, 90-day response, submission receipts, 

and reviews. Also, the system manages response extensions and identifies all non-responsive companies. 

Page 29 of 44 
October 25, 2012

In addition to tracking the previously mentioned elements related to each specific order, the agency will 

track the following: submission type, submission date, submission comment, review sent and completed 

dates, requirement status and requirement status comment. These elements are needed in order to track 

the responses submitted by each company, the submitted studies, study reviews, study status and 

requirement status. 

The agency will produce several reports to facilitate tracking, etc. For example, a 90-day company 

response status report is needed to determine whether companies have responded, and to identify their 

intentions. An option to display only overdue responses will be included. It should include all chemicals 

and be sorted by company (and product if applicable). A status report by requirement across all 

chemicals, sorted by company is needed in order to present overall progress and allow management to 

directly identify delays. 

5(c) Small Entity Flexibility 

In developing the policies and procedures document (Attachment B), the agency considered alternatives 

for small businesses to the extent practical within the mandate in FFDCA. For example, as described in 

more detail in that document, the EPA does not intend to issue Tier 1 orders to registrants of end-use 

products or formulators, primarily because most small entities potentially impacted under the EDSP are 

end-use product registrants or formulators and are not basic manufacturers or registrants. As such, small 

businesses are not expected to be responsible for supplying endocrine data on a chemical they use in 

their end-use product or formulation. 

In addition, the procedures are intended to minimize potential 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 test order, the small business may 

minimize potential burden by joining a consortium or task force, which may relieve the small business 

of direct responsibility for generating or submitting the data. The 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. 

The EPA can 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, which will be calculated based on the date the 

Page 30 of 44 
October 25, 2012

order is issued. In general, the basic schedule the EPA intends to use in the order is based on the 

timeframes identified in Table 3. 

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

Timeframes for Due Dates What is Due 

Within 90 calendar days of the order's issuance 

(+ 10 calendar days for processing) 

Individual Recipient's Initial Response 

Within 150 calendar days of the order's issuance 

(+ 10 calendar days for processing) 

Consortia's Documentation and Initial Response 

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

compliance with the order. 

24 months from order's issuance Final Study Report and submission of the data to the EPA 

In calculating the due date for the Initial Response, the agency has included an additional 10 calendar 

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

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

to the Post Office for mailing. 

In general, the agency does not expect to consider requests for extending the deadlines for the Initial 

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

circumstances warrant it. The agency's policy regarding time extensions is presented in the policies and 

procedures document (Attachment B). 

The timing of the activities covered by this ICR is not specific enough to accurately divide them by year. 

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

the data would be submitted within 2 or 3 years of receiving the Tier 1 order, i.e., within the 3 year 

approval period for this ICR. To calculate an annual burden, the agency assumed a 3 year duration of 

equal annual effort. 

6. Estimating the Burden and Cost of the Collection 

The PRA requires the EPA to estimate the "paperwork burden" i.e., the total time, effort, or financial 

resources expended by persons to generate, maintain, retain, or disclose or provide information to or for 

a federal agency. Under the PRA, "burden" means the "time, effort, or financial resources expended by 

persons to generate, maintain, or provide information to or for a Federal agency." This can include the 

resources to: review instructions; develop, acquire, install, and use technology and systems; search data 

sources; collect, review, validate, and verify information/data; process and maintain information/data; 

disclose and transmit/submit information/data; change/adjust the existing ways of complying with any 

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

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

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

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

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

potential paperwork burden and costs for both respondents and the EPA. 

Page 31 of 44 
October 25, 2012

Page 32 of 44 

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 SOCs Used in this ICR 

Labor Category SOC # Standard Occupational Classification 

Management 11-0000 Management Occupations 

Technical 19-0000 Life, Physical, and Social Science Occupations 

Clerical 43-0000 Office and Administrative Support Occupations 

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

that benefits are 29.6% of total labor cost, based on benefits for all private industry workers from 

http://www.bls.gov/schedule/archives/ecec_nr.htm.12 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. 

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 Labor 2 Benefits% 29.6% 29.6% 29.6% 

Loaded Hourly Rate (LHR) Wages $81.56 $40.23 $24.18 1-Benefits% 

Overhead Percentage3 50% 50% 50% 

Overhead Per Hour (OPH) LHR*Overhead% $40.78 $20.12 $12.09 

Fully Loaded Hourly Rate LHR + OPH $122.34 $60.35 $36.27 

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

2. Fringe benefits/wage per hour. 

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

The loading for indirect costs used in this ICR (i.e., 50%) is within the range of 20-70% of the load labor rate (wage + benefits) 

suggested in this EPA guidance. 

 

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

http://www.bls.gov/news.release/archives/ecec_09112012.htm 
October 25, 2012

Page 33 of 44 

For this ICR, the agency therefore uses the following labor rates for the respondents: 

Managerial = $122.34, Technical = $60.35; and Clerical = $36.27. 

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

The specific activities used for estimating the potential burden and costs are 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, the EPA calculated the paperwork burden as a percentage of the 

testing costs; and 2) For the rest of the paperwork activities, the 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 the EPA's overall experience with such 

activities. 

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

paperwork burden for the data generation activities as a percentage of the testing costs. This percentbased estimate of paperwork associated with conducting a test was 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 2 assays that were based 

on estimates provided by the EPA scientist overseeing the validation effort for those 2 assays. Since 

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

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

the agency used the Cost Estimate Survey of commercial laboratories and other information 

provided by industry representatives (References 8 and 9). The EPA 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 Endocrine Disruptor Screening," which estimated the costs for the 

eleven assays to be $572,913.13 As indicated in Attachment F, the estimate provided by the EPA is 

slightly higher at $637,184. 

Based on the existing methodologies, the EPA used 35% of the estimated total test cost to calculate 

the total potential cost for the 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 

 

13 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. 
October 25, 2012

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 section 6(b) of this ICR. 

Figure 1 – Method for Calculating Paperwork Burden from Test Costs 

Divide 35% cost into: 

20% for Managerial 

65% for Technical 

15% for Clerical 

Divide each by 

Loaded Labor 

rate for that 

Category 

Identify 35% 

of the Test 

Cost 

Burden 

Hours by 

Category

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, the 

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 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. 

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. 

Page 34 of 44 
October 25, 2012

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 

The estimated per chemical burden for each of the paperwork activities described in section 4(b) of 

this ICR, disaggregated by the labor category listed in Table 4, are presented in Table 6. 

Table 6 – Estimated Per Chemical Burden Hours for the Activities 

Activity(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 the EPA(b) 24 21 2 47 

4) Read and discuss the protocol 36 145 0 181 

---> Activities related to the submission of OSRI(c) 40 201 37 278 

5) Participate in Consortium 24 145 2 171 

6) Generate the data(d) 397 2,612 1,003 4,012 

7) Submit Progress Report 5 20 7 32 

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

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

10) Submit final data to the EPA 3 0 2 5 

11) Maintain records 0 24 62 86 

Total Burden: 630 3,433 1,134 5,197 

(a) Activities described in 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) Hours required for OSRI Submission from CLA/EPF Report (Reference 9). 

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

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

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

labor categories, with the costs for generating the data coming from Attachment F to the existing ICR. 

The following loaded labor rates were used to calculate these costs: 

Managerial = $122.34; Technical = $60.35; and Clerical = $36.27. 

Table 7 – Estimated Per Chemical Costs by Activity 

Activity (a)

Managerial Technical Clerical 

$122.34 $60.35 $36.27 Total 

1) Read instructions $1,468 $724 $0 $2,192 

2) Plan activities 5,872 2,535 0 8,407 

3) Submit an initial response to the EPA(b) 2,936 1,267 73 4,276 

4) Read and discuss the protocol 4,404 8,751 0 13,155 

---> Activities related to the submission of OSRI(c) 4,894 12,130 1,342 18,366 

5) Participate in Consortium 2,936 8,751 73 11,760 

6) Generate the data(d) 48,569 157,634 36,379 242,582 

7) Submit Progress Report 612 1,207 254 2,073 

8) Compile and review the final data for submission 4,404 11,527 435 16,366 

9) Complete paperwork to assemble submission package 612 1,207 254 2,073 

10) Submit final data to the EPA 367 0 73 440 

11) Maintain records 0 1,448 2,249 3,697 

12) Delivery costs $10.55 

Total Cost: $77,074 $207,181 $41,132 $325,398 

Page 35 of 44 
October 25, 2012

Page 36 of 44 

(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 9). 

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

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

total estimated per respondent cost. Delivery costs were calculated 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 from the west coast to the east coast (Reference 7). 

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

As discussed earlier, all respondents are not expected to engage in the same basic activities, their 

activities will be based on their initial response to the order. For the purposes of this ICR renewal, the 

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

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

chemical burden and costs from Tables 6 and 7 for the various activities, the estimated respondent 

burden and costs for the different IC categories is presented in the following tables. 

IC #1: Order Recipients

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

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

submission of the required initial response. 

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

Active Ingredients

Activity(a)

Total # 

Responses(b)

Per Response Total 

Burden 

(hrs)(c) Cost ($)(d)

Burden 

(hrs.)(e) Costs ($)(f)

1) Read instructions 

45 

24 $2,192 1,080 $98,640 

2) Plan activities 90 8,407 4,050 378,315 

3) Submit an initial response to the EPA 47 4,276 2,115 192,420 

11) Maintain records(g) 43 3,697 1,935 166,365 

Total: 204 $18,572 9,180 $835,740 

Key:

(a) Activities are described in more detail in section 4(b) of this ICR. 

(b) From Table 1, catch-up orders. 

(c) See Activity listing in Table 6. 

(d) See Activity listing in Table 7. 

(e) Total = (b) x (c) 

(f) Total = (b) x (d) 

(g) Maintaining records of the initial response is estimated to be 1⁄2 of the totals in Tables 6 and 7. 
October 25, 2012

Page 37 of 44 

Table 9 – IC #1: Estimated Burden and Costs for Order Recipients – Manufacturers and 

Importers of Pesticide Inert Ingredients

Activity(a)

Total # 

Responses (b)

Per Response Total 

Burden 

(hrs)(c) Cost ($)(d)

Burden 

(hrs.)(e) Costs ($)(f)

1) Read instructions 

15 

24 $2,192 360 $32,880 

2) Plan activities 90 8,407 1,350 126,105 

3) Submit an initial response to the EPA 47 4,276 705 64,140 

11) Maintain records(g) 43 3,697 645 55,455 

Total: 204 $18,572 3,060 $278,580 

Key:

(a) Activities are described in more detail in section 4(b) of this ICR. 

(b) From Table 1, catch-up orders. 

(c) See Activity listing in Table 6. 

(d) See Activity listing in Table 7. 

(e) Total = (b) x (c) 

(f) Total = (b) x (d) 

(g) Maintaining records of the initial response is estimated to be 1⁄2 of the totals in Tables 6 and 7. 

The total IC #1 burden and costs is therefore a total of 12,240 hours (9,180 hrs + 3,060 hrs) and 

$1,114,320 ($835,740 + $278,580). 

IC #2: Data Generators/Submitters:

This IC category of respondents is intended to capture the 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, the 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 engage in the activities identified in Table 6 and 7 as activities 4 and 6 through 

12, which are all associated with generating and submitting the data. Please note that participation in a 

consortium is addressed in the next group of ICs. 

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

of Pesticide Active Ingredients

Activity(a)

Total # 

Responses(b)

Per Response Total 

Burden

(hrs)(c) Cost ($)(d)

Burden

(hrs.)(e) Costs ($)(f)

4) Read and discuss the protocol 

50 

181 $13,155 9,050 $657,750 

6) Generate the data(h) 4,012 242,582 200,600 12,129,100 

7) Submit Progress Report 32 2,073 1,600 103,650 

8) Compile and review the final data for submission 239 16,366 11,950 818,300 

9) Complete paperwork to assemble the submission 

package 

32 2,073 1,600 103,650 

10) Submit final data to the EPA 5 440 250 22,000 

11) Maintain records (g) 43 3,697 2,150 184,850 

12) Delivery Costs 11 528 

Total: 4,544 $280,397 227,200 $14,019,828 

Key:

(a) Activities are described in more detail in section 4(b) of this ICR. 

(b) From Table 1, includes catch-up orders. 

(c) See Activity listing in Table 6. 

(d) See Activity listing in Table 7. 

(e) Total = (b) x (c) 
October 25, 2012

Page 38 of 44 

(f) Total = (b) x (d) 

(g) Maintaining records of the initial Response is estimated to be 1⁄2 of the totals in Tables 6 and 7. 

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

Table 11 – IC #2: Estimated Additional Burden and Costs for Data Generators and Submitters – 

Manufacturers and Importers of Pesticide Inert Ingredients

Activity(a)

Total # 

Responses(b)

Per Response Total 

Burden

(hrs)(c) Cost ($)(d)

Burden

(hrs.)(e) Costs ($)(f)

4) Read and discuss the protocol 

2 

181 $13,155 362 $26,310 

6) Generate the data(h) 4,012 242,582 8,024 485,164 

7) Submit Progress Report 32 2,073 64 4,146 

8) Compile and review the final data for submission 239 16,366 478 32,732 

9) Complete paperwork to assemble the submission 

package 

32 2,073 64 4,146 

10) Submit final data to the EPA 5 440 10 880 

11) Maintain records (g) 43 3,697 86 7,394 

12) Delivery Costs 11 21 

Total: 4,544 $280,397 9,088 $560,793 

Key:

(a) Activities are described in more detail in section 4(b) of this ICR. 

(b) From Table 1, includes catch-up orders. 

(c) See Activity listing in Table 6. 

(d) See Activity listing in Table 7. 

(e) Total = (b) x (c) 

(f) Total = (b) x (d) 

(g) Maintaining records of the initial Response is estimated to be 1⁄2 of the totals in Tables 6 and 7. 

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

The total IC #2 burden and costs is therefore a total of 236,288 hours (227,200 hours + 9,088 hours) and 

$14,580,621 ($14,019,828 + $560,793). 

IC #3: Consortium Participants

This IC category is intended to capture the additional burden and costs expected for a subset of the order 

recipients who are participating in a consortium. As discussed previously, the 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 also engage in the activities identified in Tables 6 and 7 as activity 5, which is associated with 

participating in a consortium. 

Again, the EPA has issued all orders for the 67 chemicals on the initial list of chemicals and is assuming 

that there will be no more new data generators or submitters (i.e., no new consortium) for this IC 

category. However, the EPA is making the assumption that 60 "catch-up" order recipients (45 pesticide 

active ingredients and 15 pesticide inert ingredients over a 3 year period) will join an existing 

consortium to generate data. 
October 25, 2012

Page 39 of 44 

Table 12 – IC #3: Estimated Additional Burden and Costs for Consortium Participants – 

Registrants of Pesticide Active Ingredients

Activity(a)

Total # 

Responses(b)

Per Response Total 

Burden 

(hrs)(c) Cost ($)(d)

Burden 

(hrs.)(e) Costs ($)(f)

5) Participate in Consortium 252 171 $11,760 43,092 $2,963,520 

Total: 171 $11,760 43,092 $2,963,520 

Key:

(a) Activities are described in more detail in section 4(b) of this ICR. 

(b) From Table 1, includes catch-up orders. 

(c) See Activity listing in Table 6. 

(d) See Activity listing in Table 7. 

(e) Total = (b) x (c) 

(f) Total = (b) x (d) 

Table 13 – IC #3: Estimated Additional Burden and Costs for Consortium Participants – 

Manufacturers and Importers of Pesticide Inert Ingredients

Activity(a)

Total # 

Responses (b)

Per Response Total 

Burden 

(hrs)(c) Cost ($)(d)

Burden 

(hrs.)(e) Costs ($)(f)

5) Participate in Consortium 21 171 $11,760 3,591 $246,960 

Total: 171 $11,760 3,591 $246,960 

Key:

(a) Activities are described in more detail in section 4(b) of this ICR. 

(b) From Table 1, includes catch-up orders. 

(c) See Activity listing in Table 6. 

(d) See Activity listing in Table 7. 

(e) Total = (b) x (c) 

(f) Total = (b) x (d) 

The total IC #3 burden and costs is therefore a total of 46,683 hours (43,092 hrs + 3,591 hrs) and 

$3,210,480 ($2,963,520 + $246,960). 

6(c) Estimating Agency Burden and Cost 

For the agency activities, the 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, the EPA has multiplied this burden by the total number of chemicals (667 hours x 

52 chemicals = 35,204 hours). 
October 25, 2012

Page 40 of 44 

Table 14 – Estimated Agency per Chemical Burden Hours 

Activity(a) Managerial Technical Clerical Total 

1) Prepare instructions 2 12 2 16 

2) Identify chemicals to be screened 2 21 2 25 

3) Identify recipients 2 16 0 18 

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

5) Review and approve the orders 2 4 0 6 

6) Issue the orders 0 0 6 6 

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

8) Provide assistance and 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 

(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 data14 and the 

methods identified in section 6(a)(i) of this ICR based on the NAICS 999100, Federal Executive Branch. 

The resulting loaded labor rates were used to calculate these costs: Managerial = $118.62; Technical = 

$76.74; and Clerical = $43.43. The estimated burden hour costs for the agency are presented in Table 

15. To calculate the total potential agency costs over the three years, the EPA has multiplied the per 

chemical cost in Table 14 by the total number of chemicals ($51,297 x 52 chemicals = $2,667,444). 

Table 15 – Estimated Agency Per Chemical Burden Hour Costs 

Activity(a)

Managerial Technical Clerical 

$118.62 $76.74 $43.43 Total 

1) Prepare instructions $237 $921 $87 $1,245 

2) Identify chemicals to be screened 237 1,612 87 1,936 

3) Identify recipients 237 1,228 0 1,465 

4) Prepare the 408(p) order packages 0 307 434 741 

5) Review and approve the orders 237 307 0 544 

6) Issue the orders 0 0 261 261 

7) Process initial responses(b) 119 307 43 469 

8) Provide assistance and follow-up, as needed 0 2,763 0 2,763 

9) Identify non-responders 0 0 43 43 

10) Process Data Submissions 0 614 43 657 

11) Analyze data 0 33,766 0 33,766 

12) Incorporate data into risk assessments 0 6,753 0 6,753 

13) Store data in retrievable system 0 307 347 654 

Total Cost: $1,067 $48,885 $1,345 $51,297 

Key: 

(a) Activities described in more detail in section 5(a) of this ICR. 

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

 

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

Page 41 of 44 

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 renewal 

of the ICR for the initial list of chemicals to be screened under the EDSP is presented in Table 16. 

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

Respondent Category(a)

Total # 

Responses(b)

Per Response(c) Total(d)

Burden 

(hrs) Cost ($) 

Burden 

(hrs) Costs ($) 

Registrants of PAIs 

IC #1(a) - Order Recipients 45 204 $18,572 9,180 $835,740 

IC #2(a) - Data Generators/Submitters 50 4,544 $280,397 227,200 $14,019,828 

IC #3(a) - Consortium Participants 252 171 $11,760 43,092 $2,963,520 

Subtotal for Pesticide Active Ingredients: 270,472 $17,819,088 

Manufacturers/Importers of Pesticide Inert Ingredients 

IC #1(b) - Order Recipients 15 204 $18,572 3,060 $278,580 

IC #2(b) - Data Generators/Submitters 2 4,544 $280,397 9,088 $560,793 

IC #3(b) - Consortium Participants 21 171 $11,760 3,591 $246,960 

Subtotal for Pesticide Inert Ingredients: 15,739 $1,086,333 

Total:(e) 385 9,838 $621,458 295,211 $18,905,421 

Key:

(a) Grouped by respondents and according to IC category as presented in section 6(b) of this renewal ICR. 

(b) From Table 1, includes catch-up orders. 

(c) See totals from Tables in section 6(b) of this renewal ICR. 

(d) Total = (b) x (c) 

(e) Calculated by adding the column. 

The total potential respondent burden and cost calculated in this renewal ICR involves activities that 

cannot be divided by year. The agency has calculated the total burden and assumed a 3-year duration of 

equal effort to calculate the annual burden and cost for this ICR. As such, the total respondent burden 

and costs for this ICR (as presented in Table 14) is simply divided by 3 to get an estimated annualized 

burden of 98,403 hours (295,211 hours ÷ 3) and an estimated annualized cost of $6,301,807 

($18,905,421 ÷ 3). 

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

Respondent Category(a) Total # 

Responses(b)

Per Response(c) Total(d)

Burden (hrs) Cost ($) Burden (hrs) Costs ($) 

Registrants of PAIs 

IC #1(a) - Order Recipients 

45 

68 $6,191 3,060 $278,580 

Recording Keeping 54 4,958 2,415 223,125 

Reporting 14 1,232 645 55,455 

Non-Burden Costs 0 0 0 0 

IC #2(a) - Data Generators/Submitters 

50 

1,515 $93,466 75,733 $4,673,276 

Recording Keeping 1,500 92,230 75,017 4,611,483 

Reporting 14 1,232 717 61,617 

Non-Burden Costs 0 3.52 0 175.83 

IC #3(a) - Consortium Participants 

252 

57 $3,920 14,364 $987,840 

Recording Keeping 57 3,920 14,364 987,840 

Reporting 0 0 0 0 

Non-Burden Costs 0 0 0 0 

Subtotal for Pesticide Active Ingredients: 93,157 $5,939,696 
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Page 42 of 44 

Respondent Category(a) Total # 

Responses(b)

Per Response(c) Total(d)

Burden (hrs) Cost ($) Burden (hrs) Costs ($) 

Manufacturers/Importers of Pesticide Inert Ingredients 

IC #1(b) - Order Recipients 

15 

68 $6,191 1,020 $92,860 

Recording Keeping 54 4,958 805 74,375 

Reporting 14 1,232 215 18,485 

Non-Burden Costs 0 0 0 0 

IC #2(b) - Data Generators/Submitters 

2 

1,515 $93,466 3,029 $186,931 

Recording Keeping 1,500 92,230 3,001 184,459 

Reporting 14 1,232 29 2,465 

Non-Burden Costs 0 3.52 0 7.03 

IC #3(b) - Consortium Participants 

21 

57 $3,920 1,197 $82,320 

Recording Keeping 57 3,920 1,197 82,320 

Reporting 0 0 0 0 

Non-Burden Costs 0 0 0 0 

Subtotal for Pesticide Inert Ingredients: 5,246 $362,111 

Total:(e) 385 3,279 $207,152 98,403 $6,301,807 

Key:

(a) Grouped by respondents and according to IC category as presented in section 6(b) of this renewal ICR. 

(b) From Table 1, 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), and dividing by 3. Numbers are 

rounded. 

(d) Total = (b) x (c) 

(e) Calculated by adding the column. 

To calculate the total potential agency burden and cost over the three years, the EPA has multiplied 

the per chemical burden and cost in Tables 13 and 14 by the total number of chemicals for a total agency 

burden of 35,204 hours (677 x 52 chemicals) and a cost of $2,667,444 ($51,297 x 52 chemicals). 

Divided by 3 to get an estimated annualized burden of 11,735 hours (35,204 ÷ 3) and an estimated 

annualized cost of $889,148 ($2,667,444 ÷ 3). 

6(e) Reasons for Changes in Burden Estimates 

This request represents a decrease of the annualized burden by 63,012 hours from that currently in 

the OMB inventory (from 161,415 hours to 98,403 hours). This change is an adjustment in burden 

estimates due to the planned progression of the collection activities associated with the initial list of 

chemicals to be screened under the EDSP. This change is an adjustment. 

6(f) Burden Statement for this ICR 

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

4,919 hours, depending on the respondent category, with an estimated cost between $18,572 and 

$310,729. Burden is defined in 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person 

is not required to respond to a collection of information unless it displays a current and valid OMB 

control number. The OMB control numbers for the 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. 

The EPA has established a docket for this ICR under docket ID No. EPA-HQ-OPPT-2011-0966, which 

is available electronically at http://www.regulations.gov. A hard copy of the docket materials are also 
October 25, 2012

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. 

7. List of References 

The following is a list of the documents that are specifically referenced in this document, along with 

information about where to access the documents: 

1. Endocrine Disruptor Screening Program; Notice (63 FR 42852, August 11, 1998) 

http://www.epa.gov/scipoly/oscpendo/pubs/081198frnotice.pdf. 

2. Endocrine Disruptor Screening Program; Proposed Statement of Policy; Notice (63 FR 71541, 

December 28, 1998) http://www.epa.gov/scipoly/oscpendo/pubs/122898frnotice.pdf. 

3. Draft List of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for 

Screening under the Federal Food, Drug, and Cosmetic Act; Notice (72 FR 33486, June 18, 

2007) http://www.epa.gov/scipoly/oscpendo/pubs/draft_list_frn_061807.pdf. 

4. Final List of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for 

Screening under the Federal Food, Drug, and Cosmetic Act; Notice (74 FR 17579, April 15, 

2009) http://www.epa.gov/fedrgstr/EPA-PEST/2009/April/Day-15/p8709.pdf. 

5. Endocrine Disruptor Screening Program (EDSP); Draft Policies and Procedures Document; 

Request for Comment; Notice (72 FR 70842, December 13, 2007) 

http://www.epa.gov/scipoly/oscpendo/pubs/draft_policies_frn.pdf. 

6. Endocrine Disruptor Screening Program (EDSP); Policies and Procedures for Initial Screening; 

Notice (74 FR 17560, April 15, 2009) (see Attachment B to this ICR) 

http://www.epa.gov/fedrgstr/EPA-PEST/2009/April/Day-15/p8706.pdf. 

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

8. EPA Report "Laboratory Testing of Chemicals for Endocrine Disruption Potential - Analysis of 

Market Factors" (October 14, 2009). 

9. Crop Life America, EDSP Tier 1 Screening; Preliminary Burden Report dated November 2010 

submitted by Crop Life America's Endocrine Policy Forum. 

8. Attachments 

All of the attachments listed below can be found in the docket for this ICR (unless otherwise noted); and 

are accessible electronically through http://www.regulations.gov, under Docket ID Number: 

EPA-HQ-OPPT-2011-0966. 

Attachment Description 

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

Page 43 of 44 
October 25, 2012

Page 44 of 44 

Attachment Description 

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

B Endocrine Disruptor Screening Program (EDSP); Policies and Procedures for Initial 

Screening; Notice (74 FR 17560, April 15, 2009) 

http://www.gpo.gov/fdsys/pkg/FR-2009-04-15/pdf/E9-8706.pdf

C (1) FFDCA 408(p) Order Template for Pesticide Registrants (As of September 16, 2009). 

(2) FFDCA 408(p) Order Template for Pesticide Inert Ingredients (As of September 16, 

2009). 

D (1) Initial Response Form for Individual Order Recipients (As of April 3, 2009). 

(2) Initial Response Form for Consortium/Task Force (As of April 3, 2009). 

E Overall Process for EDSP Orders (April 3, 2009). 

F Calculations for Paperwork Burden and Costs for Data Generation Activities (July 30, 

2012). 

G Final List of Chemicals for Initial Tier 1 Screening in the EDSP (April 3, 2009). 

H Compendium of Consultation Responses 

I Response to Public Comments Document