EPA ICR No. 2488.01 June 3, 2013

Page 1 of 44 Supporting Statement for an Information Collection Request (ICR)



### 1. Identification of the Information Collection

1(a) Identification of the Information Collection:

1(a)(i) Title: ICR Addendum for the Second List of Chemicals; Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program

1(a)(ii) EPA ICR No.: 2 488.01

OMB Control No.: 2070

- [new]

Docket ID No.: EPA

– HQ

– OPPT

– 20 13

– 0275



### 1(b) Short Characterization/Abs tract

This is a n addendum to an existing ICR 1 that is currently approved under the Paperwork Reduction Act (PRA) 2 and that covers the first list of chemicals identified for Tier 1 screening under EPA's Endocrine Disruptor Screening Program (EDSP)

. The exis ting ICR is being amended to include the information collection activities associated with the screening of additional chemicals under Tier 1 of the EDSP (aka

“List 1 Chemicals ” ) . As directed by Congress in the House Appropriations Committee report for EPA 's Fiscal Year 2010 appropriations, 3 EPA has identified a second list of chemicals 4 to be screened under the EDSP that includes pesticide active ingredients (PAIs), pesticide inerts, and chemicals identified under the Safe Drinking Water Act (SDWA) 5

. This ICR addendum (which is being submitted under a different series than the existing ICR

– the new numbers are identified above ) covers the information collection activities and related burden associated with issuing orders, generating and collecting data for the second list of chemicals (aka "List 2 Chemicals"). List 2 consists of 109 identified chemicals, 41 of

which are PAIs and 68 are chemicals identified under SDWA

. The information collection activities otherwise remain the same as those described in the existing ICR, with only a few modifications that are necessary to address procedural differences that apply to SDWA chemicals.

The EDSP is established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 6
which requires EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determi ne 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 interac t with the estrogen, androgen, or thyroid hormone systems using a battery of assays. 7
Substances that have the potential to interact with the estrogen, androgen or thyroid systems may proceed to Tier 2 testing, which is designed to identify any adverse end ocrine

- related effects caused by the substance, and to establish a quantitative relationship between the dose and that endocrine effect.

1 Approved under OMB Control No. 2070

- 0176 (EPA ICR No. 2249)

. 2 44 U.S.C. 3501 et seq

. 3 See page 105, H.R. 2996, House Report 111

- 180

. 4 See Attachment G

- 2 for a list of the chemicals on the Second List of Chemicals to be Screened under EDSP Tier 1.

5 42 U.S.C. 300j

- 17

. See Attachment A( 2 ) to view the text of SDWA section 1457

6 21 U.S.C. 346a(p). See Attachment A(1) to view the text of F FDCA section 408(p).

7 Nothing in the identification of chemicals for Tier 1 screening under the EDSP provides a basis to infer that these chemicals are suspected to interfere with the endocrine systems of humans or other species, and it would be inappropr iate 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.EPA ICR No. 2488.01 June 3, 2013

Page 2 of 44 Additional information about the EDSP is available through the Agency 's Web site at http://www.epa.gov/endo

.

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

C hemicals as follows:

• For the PAIs and pesticide inerts on the second list, the information collection activities and applicabl e procedures a re identical to those described in the existing ICR and the EDSP Tier 1 policy and procedures issued in 2009 (Attachment B(1)) 8

. The order templates and response

forms have been modified to reflect the new electronic submission mechanism. This ICR addendum provides the related burden and costs estimates for th e se activities as they relate to the

PAIs and pesticide inerts on the second list; and

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

collectio n activities, and establishes a new order template and a new initial response form for SDWA chemicals, which are all based on the supplemental EDSP Tier 1 policies and procedures for SDWA chemicals (Attachment B ( 2 ) ). This ICR addendum also provides the rel ated burden

and costs estimates for the activities related to SDWA chemicals.

The EDSP policies and procedures document of 2009 describes the administrative policies and procedures that EPA generally intends to use in implementing the EDSP for initial scre ening, and serves as the general source for the information collection activities associated with the issuance of orders for Tier 1 screening under the EDSP. Although the policies and procedures contained in the 2009 document would clearly apply to the inf ormation collection activities for the PAIs and pesticide inerts on the second list, many of the existing policies and procedures reflect issues uniquely associated with the pesticide market and the specific regulatory context under which EPA regulates pes ticide chemicals. EPA therefore determined that some of the existing policies and procedures are generally not applicable

to non

- pesticide chemicals and/or there were competing considerations for SDWA chemicals that warranted a modification to those polici es and procedures with regard to SDWA chemicals. As such, EPA sought public comment via the Federal Register on a draft supplement to the 2009 document that addresses policies and procedures specifically for SDWA chemicals. After considering comments, EPA

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

While the requirements in the statutes and the individual Tier 1 orders are binding on EPA and the order recipients, the policies and procedures announced in both documents do not impose any binding requirements. The policies and procedures are not intended to be binding on either EPA or any outside parties, and EPA may depart from them where circumstances warrant, without prior notice. The Tier 1 order, however, is binding on the order recipient and non

- compliance with the provisions in the order will result in penalties as described in the order.

As an addendum, the focus of this document is on the modified activities and burdens related to the second list of chemicals. This addendum does not repeat verbatim descriptions in the existing ICR that remain applicable, yet unchanged. As such, this addendum should be viewed as a supplement to the existing ICR, in terms of adding to its contents, references and attachments.

As indicated previously, the cur rently approved ICR cover s the information collection activities

associated with the follow

- up activities and potential catch

- up orders related to the initial list of

8 74 FR 17560, April 15, 2009. http://www.gpo.gov/fdsys/pkg/FR

- 2009

- 04

- 15/pdf/E9

- 8706.pdf . See also Attachment B(1). Hereinafter referred to as the FIFRA/FFDCA policy and procedures.EPA ICR No. 2488.01 June 3, 2013

Page 3 of 44 chemicals identified for Tier 1 screening under the EDSP (aka “List 1 Chemicals”)

. The in itial list of

chemicals consists of 67 PAI s and pesticide inerts. EPA maintains a matrix with information on the status of the orders issued and responses received for those chemicals on the Agency 's Web site at http:/ /www.epa.gov/endo . On October 30 , 2012, EPA announced the submission of the renewal ICR for

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

estimates that were previously used in the draft ICR addendum issued in 2010. T his ICR addendum incorporates those updates to the base burden and costs estimates , as well as the revised presentation of

those estimates

.

T his ICR addendum is only intended to cover the information collection activities related to Tier 1 screening under the EDSP of List 2 Chemicals . EPA will prepare a separate ICR to address the information collection activities associated with Tier 2 testing. EPA will follow the notice and comment process prescribed by the PRA to seek public comment on any subsequent ICR or ICR addendum before submitting it to OMB for review and approval under the PRA.



### 2. Need For and Use of the Collection

2(a) Need/Authority for the Collection

The Agency 's authority for the information collection activities associated w ith the EDSP includes authorities under the FFDCA, SDWA, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). This information collection activity fulfills a direct statutory mandate and is needed in order to provide information that will allow the Agency to identify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems.

The EDSP was established in 1998 to carry out the mandate in section 408(p) of the F FDCA (see Attachment A), which directs EPA "to develop a screening program...to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the A dministrator may designate." If a substance is found to have such an effect, section 408(p)(6) directs the administrator to take action under available statutory authority to ensure protection of public health.

FFDCA section 408(p)(1) requires EPA "to dev elop a screening program, using appropriate validated test systems and other scientifically relevant information

, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other effects as [the EPA] may designate." [21 U.S.C. 346a(p)].

FFDCA section 408(p)(3) expressly requires that EPA "shall provide for the testing of all pesticide chemicals." FFDCA section 201 defines "pesticide chemical" as "any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and pesticide inert ingredients of such pesticide." [FFDCA section 201(q)(1), 21 U.S.C. 231(q)(1)]. The statute also provides EPA with discreti onary authority to "provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such a substance." [21 U.S.C. 346a(p)(3)].

FFDCA section 408(p)(5)(A) provides that the Administrator "shall issue an order to a registrant of a substance for which testing is required [under FFDCA section 408(p)], or to a person who manufactures

9 77 FR 65682, October 30, 2012. http://www.gpo.gov/fdsys/pkg/FR

- 2012

- 10

- 30/pdf/2012

- 26611.pdf

.EPA ICR No. 2488.01 June 3, 2013

Page 4 of 44 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 A gency determines is sufficient for the generation

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

FFDCA section 408(p)(5)(B) requires that, " [ t ] o the extent practicable, the Administrator shall minimize duplicative testing of the same substance for the sam e 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 wit h 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 o f the 30

– day period beginning on the date that the registrant receives the notice of intent to suspend, unless during that period, a person adversely affected by the notice requests a hearing or the Administrator determines that the registrant has complied fully with this paragraph." [21 U.S.C. 346a (p)(5)(C)]. Any hearing is required to be conducted in accordance with section 554 of the Administrative Procedures Act (APA). [5 U.S.C. 554]. FFDCA section 408(p) (5)(C)(ii) explicitly provides that " [t] he only matter for resolution at the hearing shall be whether the registrant has failed to comply with a n 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 t o 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. 3 46a (p)(5)(C)(iii)].

FFDCA section 408(p)(5)(D) provides that any person (other than a registrant) who fails to comply with an order issued under FFDCA section 408(p)(5) shall be liable for the same penalties and sanctions as are provided for under section 16 of TSCA. [21 U.S.C. 346a (p)(5)(D)]. Such penalties and sanctions shall be assessed and imposed in the same manner as provided in TSCA section 16. Under section 16 of TSCA, civil penalties of up to $ 37,500 per day may be assessed, after notice and an a dministrative 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 exempti on that is in effect. The provision identifies three options:

1. Issuance of a notice to the person holding a pesticide registration under FIFRA section 3(c)(2)(B) [ See 21 U.S.C. 346a (f)(1)(A) ].

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

3. Publication of a notice in the Federal Register requiring submission, by certain dates, of a commitment to generate the data "by one or more interested persons." [ See 21 U.S.C. 346a (f)(1)(C) ].

Before using the third option, EPA must demonstrat e why the data "could not be obtained" using either of the first two options. FFDCA section 408(f)(1) expressly provides that EPA may use these procedures to "require data or information pertaining to whether the pesticide chemical may have an effect in

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

effects." [21 U.S.C. 346a (f)(1)]. Finally, FFDCA section 408(f)( 2 ) provides that, in the event of failure to comply with a rule under TSCA section 4 or an orde r under FFDCA section 408(f)(1)(C), EPA may, after notice and opportunity for public comment, modify or revoke any tolerance or exemption to which

the data are relevant. [21 U.S.C. 346a (f)(2)]EPA ICR No. 2488.01 June 3, 2013

Page 5 of 44 In addition, FFDCA section 408(i) provides that "[d]ata and information that are or have been submitted to the Administrator under this section or FFDCA section 409 in support of a tolerance or an exemption from a tolerance shall be entitled to confidential treatment for reasons of business confidentiality and to exclusive use and data compensation to the same extent provided by section s 3 and 10 of [FIFRA]." [21

U

. S

. C

. 346a (i)].

FIFRA section 3(c)(1)(F) provides certain protections for people who submit data to EPA in connection with decisions under EPA's pest icide regulatory program. Specifically, FIFRA section 3(c)(1)(F) confers "exclusive use" or "data compensation" rights on certain persons ("original data submitters") who submit data (in which they have an ownership interest), in support of an application for registration, reregistration, or experimental use permit, or to maintain an existing registration. [7 U.S.C. 136a (c)(1)(F)].

Applicants who cite qualifying data previously submitted to the Agency by the original data submitter must certify that the or iginal 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 r ely 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

arbitratio n 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 registra nts 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 t he environment" (defined as "(1) any unreasonable risk to man or the environment, taking into account the economic, social, and

environmental cost s and benefits of the use of any pesticide, or (2) a human dietary risk from residues

that results from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the [FFDCA] ” ). [7 U.S.C. 136 (bb)].

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

- In notices " or "DCI notices") may jointly develop data and provides that "[a]ny registrant who agrees to share in the cost of producing the data shall be entitled to examine and rely upon such data in support of maintenance of such registration." The section establ ishes procedures to allow registrants who received DCI notices to use binding arbitration to resolve disputes about each person's fair share of the testing costs. [7 U.S.C. 136a (c)(2)(B)].

Further, FIFRA section 3(c)(1)(F) makes clear that data submitted under FIFRA section 3(c)(2)(B) are also "compensable" when cited in support of an application for a registration. In other words, a pesticide company that chooses to rely on such data rather than develop its own data must offer compensation to the original data submitter

– usually the data generator. Lastly, the Agency may suspend the registrationEPA ICR No. 2488.01 June 3, 2013

Page 6 of 44 of a pesticide if the registrant fails to take appropriate steps to provide data required under a DCI notice in a timely manner. [7 U.S.C. 136a (c)(1)(F)].

Finall y, 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 conta ining 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 Age ncy 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 docum entation that it bought the active ingredient from another registrant. [7 U.S.C. 136a (c)(2)(D)]

In addition, section 1457 of SDWA provides EPA with discretionary authority to require testing, under the FFDCA section 408(p) screening program, "of any other substances that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance." [42 U.S.C. 300j

– 17].



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

In general, EPA intends to use the data collected un der the EDSP, along with other information, to determine if the chemical may pose a risk to human health or the environment due to disruption of the endocrine system. 10 The determination that a chemical does or is not likely to have the potential to

interac t with the endocrine system ( i.e. , disruption of the estrogen, androgen, or thyroid hormone systems) will be made on a weight

- of

- evidence ( WoE ) (Reference 1) basis taking into account data from the Tier 1 screening assays and/or other scientifically releva nt information (OSRI) . The fact that a substance may interact with a hormone system, however, does not mean that when the substance is used, it will cause adverse effects in humans or ecological systems.

The ultimate purpose of the EDSP is to provide infor mation 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

s ubstance with the endocrine system and establishing a dose

- response curve.

More specifically, the data collected under Tier 1 screening will allow the Agency to evaluate the potential interaction of a chemical with the endocrine system.

The Agency intends to take a WoE approach to evaluate the available Tier 1 screening data for a particular chemical to determine its potential to interact with the endocrine system, and if so, whether additional data are needed. Chemicals that go through Tier 1 screening an d are found to have the potential to interact with the estrogen, androgen, or thyroid hormone systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on

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

.EPA ICR No. 2488.01 June 3, 2013

Page 7 of 44 the available data. Tier 2 t esting is designed to identify any adverse endocrine

- related effects caused by the substance, and establish a quantitative relationship between the dose and that endocrine effect for

risk assessment.

In addition to helping determine whether Tier 2 testing is necessary for a particular substance, the Tier 1 screening data may also be used to determine what kind of Tier 2 data are appropriate, and whether or not similar substances might share common mechanisms. Subsequently, Tier 1 screening data may be

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

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

most cost

- effective and least burdensome approach for complying with the statut ory 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

- rela ted effects, (b) identify the adverse endocrine

- related effects caused by the substance, and (c) establish a quantitative relationship between the dose and the adverse endocrine

related effect, EPA determined that it would be more efficient (and would use fewer animals) to conduct the less expensive and less complex Tier 1 screening to identify those substances that have the potential to interact with the estrogen, androgen and thyroid hormone systems.

The paperwork related requirements imposed on the respo ndents as part of Tier 1 screening under the EDSP allow EPA to ensure that the identified screening data will be developed, that the results will meet basic scientific standards, that unforeseen complications or issues can be promptly addressed, and that

t he 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 o r Pollution Prevention and Toxics (OPPT), the Office of Pesticide Programs (OPP), and the Office of Science Coordination and Policy (OSCP) will be responsible for EPA activities related to the issuance of the orders, receiving, processing and maintaining r ecords 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 wil l also include other EPA offices, e.g. , Office of Research and Development (ORD), Office of Water (OW),

etc.

As indicated previously, this ICR only applies to Tier 1 screening. A subsequent ICR will address Tier 2 testing. Tier 2 testing is discussed here only in the context of the use of the Tier 1 screening data

collected under this ICR.



### 3. Non

- Duplication, Consultation, and Other Collection Criteria

3(a) Non

- duplication

The information collected under this program is collected by no other federal agency or any other office within EPA. FFDCA specifically assigns this task to EPA. The EDSP is the only program in the United States mandated to validate assays and require testing of chemicals for their potential to disrupt the endocrine system. Prior to the en actment of FFDCA section 408(p) and initiation of the EDSP, there were no validated methods to screen or test chemicals for their potential to affect the endocrine system.EPA ICR No. 2488.01 June 3, 2013

Page 8 of 44 In addition, the Agency has a strong commitment to avoiding potential duplication in all of its testing programs, as well as in its implementation of the EDSP. EPA also actively promotes efficiency through its harmonized test guidelines and active participation in the rigorous scientific effort to identify data needs for risk assessments, develop testing protocols, and develop new methods for testing chemicals that minimize potential duplication, create greater efficiencies in testing, and minimize the use of animals in testing.

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

to make them less stre ssful, and replace the use of animals in tests where scientifically appropriate. EPA is using validated methods or assays to identify and characterize the endocrine activity of pesticides, commercial chemicals, and environmental contaminants, specifically in relation to estrogen, androgen, and thyroid hormones.

The Agency considered these goals in developing the procedures for the EDSP, both those procedures used within EPA and those that might be used by the respondents. For example, when a chemical is

man ufactured by several companies, the procedures encourage the companies to join together to develop and submit the requested data to EPA. In addition, order recipients and other interested stakeholders may cite existing or submit other scientifically releva nt data that they believe meet the screening requirements defined in the order. This is described in more detail in the policies and procedures document (See Attachment B ( 2 ) ).



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

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

- day public notice and comment period on the draft ICR. 11 EPA received comments from eight entities, and has prepared a response to comment document that can be found in Attachment H. Several c hanges were made to the ICR in response to public comments, ranging from language changes to increase overall understanding to specific changes in the burden activities and estimates. The substantive changes are highlighted in this section.

• Language in thi s ICR supporting statement (and across all documents related to this ICR) describing the use of EDSP Tier 1 screening data was changed to be consistent. Commenters

were concerned that the Agency had implied that EDSP Tier 1 screening data would be used to determine adverse effects. EDSP Tier 1 screening data are only used to determine if a chemical

has the potential to interact with the endocrine system.

• All costs and burdens were updated to reflect current labor rates, inflation costs, and to be consistent with the latest estimates provided in the ICR renewal.

• As suggested by commenters, EPA added a line

- item in its estimate to address potential burdens and costs associated with the submission of other scientifically relevant information (OSRI) that may be submitted to the Agency in order to fulfill all or part of an EDSP Tier 1 screening order.

• Previous references to relevant detailed discussions in the existing ICR have been supplemented with the inclusion of important detail so that it is no longer necessary to have both documents on hand when reviewing the activities or burden estimates.

11 75 FR 70568, November 17, 2010. http://www.gpo.gov/fdsys/pkg/FR

- 2010

- 11

- 17/pdf/2010

- 28815.pdf

.EPA ICR No. 2488.01 June 3, 2013

Page 9 of 44 • After considering the public comments received on the recent dra ft ICR renewal, EPA is increasing the burden hours associated with OSRI

. This increase is reflected in Table 6

- B.

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

No. 2249.02 and OMB Control No. 2070

- 0176 , with p ublic comments directed to Docket ID No.

EPA

- HQ

- OPPT

- 2007

- 1081 . That same docket was established for the initial ICR related to List 1 chemicals. Given the resulting confusion in finding documents in that docket, EPA has established a

new docket (EPA

- HQ

- OPPT

- 2013

- 0275)

, with a link to the old docket.



### 3(c) Consultations

EPA used an extensive public process in developing and implementing the EDSP. 12 Since the establishment of the EDSP in 1998, EPA has consulted with various stakeholders throughout its

deve lopment and implementation efforts, including: agrochemical and commodity chemical industries, environmental organizations, public health organizations, academia, animal welfare organizations, state governments and federal agencies, including consultation with the Department of Health and Human Services. A historical overview of the external consultations and public comment opportunities provided

since 1996 is available on EPA's Website. 13

In addition to the solicitation of public comment on the Agency 's dr aft ICR addendum in November 2010, the EDSP Draft Second List of Chemicals to be Screened (Reference 2 ), and the Draft Policies and Procedures for Screening SDWA Chemicals in the EDSP (Reference 3 ), EPA met with stakeholders and presents regular updates at the Pesticide Partners Dialogue Committee (PPDC) meetings. 14



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

The frequency of response is once per chemical, so a less frequent collection would equate to no collection. EDSP Tier 1 orders are expected to be issued once for each chemical. All recipients are required to provide an initial response that determines whether they will submit the annual report and final data, or if they are only participating in the consortium. Since the Agency is only asking for the

data to be generated and submitted once for each chemical, the majority of respondents will only provide one response per chemical, and at least 109 respondents (one for each chemical) will provide an additional two responses per chemical.

Once per chemical s ubstance is the statutory minimum under both FFDCA and the SDWA. FFDCA section 408(p)(3) specifically requires that EPA "shall provide for the testing of all pesticide chemicals,"

unless the Agency can determine that the chemical qualifies for the statutor y exemption

— i.e. , that it is not anticipated to interact with the endocrine system. Similarly, section 1457 of the SDWA authorizes testing upon a finding that a particular chemical "may be found in sources of drinking water if the

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

In addition, a recipient of an order for Tier 1 screening may provide an initial response that could justify delaying Tier 1 screening or, although expected to be rare for this group of chemi cals, allowing the

12 Additional information abo ut EPA's extensive public process is available on the agency's Website at http://www.epa.gov/endo/pubs/stakeholder/index.htm

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

. 14 The PPDC was established under the Federal Advisory Committee Act (FACA) to provide a forum for a diverse group of stakeholders to provide feedback to the pesticide program on various pesticide regulatory, policy and program implementation issues. For additional information about the PPDC, go to http://www.epa.gov/o ppfead1/cb/ppdc/

.EPA ICR No. 2488.01 June 3, 2013

Page 10 of 44 company to go directly to Tier 2 testing. The Agency will consider any such requests on a case

- by

- case or chemical

- by

- chemical basis and will provide an electronic and/or written response that will be made publicly available. In some cas es, 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 recipient s of an order for Tier 1 screening will provide an initial response and either generate the data or join a consortium to generate the data, while the submission of a progress report and the data will occur only once per chemical.



### 3(e) General PRA Guideline s

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

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

40 CFR 169.2(k) apply, w hich state that records containing research data relating to registered pesticides be retained for as long as the registration is valid and the producer remains in business. Registrations are valid until they are either voluntarily cancelled or withdrawn b y the registrant or until EPA has cause to suspend or cancel the registration. Since the average period of marketability of a pesticide ranges from 15 to 30 years, the PRA guidelines specifying that data other than health, medical or tax records not be

req uired 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 pesticid e registration related decisions under FIFRA and FFDCA.

However, when the data are being generated for a chemical that is not a pesticide or pesticide inert, those record retention requirements do not apply.



### 3(f) Confidentiality

The policies and procedures that EPA generally intends to apply under the EDSP are addressed in the original 2009 EDSP policies and procedures document and the recently finalized EDSP policies and procedures for SDWA Chemicals document. In general, most he alth and safety data submitted by registrants, manufacturers, and importers under FFDCA are considered to contain no Confidential Business Information (CBI). Although FFDCA section 408(p)(5)(B) requires that EPA develop, to the extent practicable and as ne cessary, procedures for the handling of confidential business information, it does not provide the authority for the Agency to either create new rights or to modify existing rights to confidentiality. Rather, EPA believes that this provision directs the Agency to create procedures that operate within the existing confines of FIFRA section 10, the Freedom of Information Act (FOIA), and the Trade Secrets Act (TSA).

As discussed in more detail in the 2009 policies and procedures document, when the data is su bmitted to support a tolerance or exemption from the requirement of a tolerance, FFDCA section 408(i) provides that much of the data submitted in response to an order issued under FFDCA section 408(p) would be subject to the protections in FIFRA section 10 . In addition, CBI submitted by pesticide registrants inEPA ICR No. 2488.01 June 3, 2013

Page 11 of 44 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. Ho wever covered, data subject to FIFRA section 10 would be provided certain protections that go beyond those authorized by FOIA. For example, FIFRA section 10(g) generally prohibits EPA from releasing information submitted by a registrant under FIFRA to a fo reign or multinational pesticide producer, and requires the Agency to obtain an affirmation from all persons seeking access to such information that they will not disclose the information to a foreign or multinational producer. FFDCA section 408(i)

extends the protection available under FIFRA section 10 for data submitted in support of a tolerance or tolerance exemption.

All other confidential business information submitted in response to an order issued under FFDCA section 408(p) ( i.e. , data not in support of a registration or tolerance/tolerance exemption) is only protected by the provisions of FOIA and TSA. FOIA requires agencies to make information available to the public upon request, except for information that is "specifically made confidential by oth er statutes" or data that are "trade secrets and commercial or financial information obtained from a person and is privileged or confidential." [5 U.S.C. 552]. Note that substantive criteria must be met to claim confidentiality of business information, as specified in 40 CFR 2.208.

As indicated in the 2009 policies and procedures document, EPA would consider that data submitted jointly with a registrant, or as part of a consortium in which pesticide registrants participate, to be data submitted in support o f 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 a nd TSA.

As discussed in the 2013 policies and procedures for SDWA chemicals document, SDWA has no provisions for handling CBI. With the exception of pesticide chemicals, data submitted in response to an EDSP order would only be subject to the protections u nder FOIA and TSA. The identities of chemicals

on the non

- confidential TSCA Inventory ( i.e. , the chemical identity of the chemical substance is publicly known) contained in health and safety data subject to TSCA may not be entitled to confidential

treatmen t

. [See 75 FR 3462 (January 21, 2010).] In addition, because the chemical identity is public for all SDWA chemicals on the second EDSP chemical list, EPA expects that there would be no need to

claim submitted information as confidential.

As indicated previ ously, 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 pr otection under FIFRA

section 10. However, if a non

- registrant chooses not to partner with a registrant, or the chemical is neither a pesticide active or inert ingredient, such data would only be subject to the protections available

under FOIA and the TSA.



### 3 (g) Sensitive Questions

No information of a sensitive or private nature is requested in conjunction with this information collection activity. Further, this information collection activity complies with the provisions of the Privacy Act of 1974 and OMB Ci rcular A

- 108.EPA ICR No. 2488.01 June 3, 2013

Page 12 of 44 

### 4. The Respondents and the Information Requested

4(a) Respondents

Respondents to the information collection activities covered by this ICR consist of those individuals and companies that receive an order issued under FFDCA section 408(p) by t he Agency to collect Tier 1 screening data under the EDSP. Under FFDCA section 408(p)(5)(A), EPA "shall issue" orders "to a registrant of a substance for which testing is required... or to a person who manufactures or imports a substance for which testing is required" [emphasis added]. As such, the potential respondent universe remains the same as that described in the existing ICR. There are, however, a few differences described

in this section that reflect the inclusion of SDWA chemicals.

Identification of O rder Recipients : The respondents under this ICR consist of order recipients, which can be grouped into three categories:

• Pesticide Registrants

- Entities who manufacture or import a pesticide active ingredient or inert ingredient and hold an active EPA r egistration 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 Reg istrant can also be an End

- Use Registrant , the A gency'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 sub stance. For the most part, the chemical substances may be used as an inert ingredient in a pesticide, but also has other non

- pesticidal uses.

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

the chemical substance found in Sources of Drinking Water

.

• For both PAIs /Inerts and SDWA chemicals, EPA may issue a "catch

- up" order to a company who either is identified or enters the marketplace after the initial issuance of orders. The recipient

of a catch

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

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

As was done for the initial list of chemicals, EPA will complete the final identification of the specific individual recipients for the Tier 1 order for each chemical at the time that the orders are being prepared for final issuance. To facilitate consortia formation, EPA will make a list of the order recipients for each chemical publicly available.

Grouping Respondents by Information Coll ection (IC) Activities : For purposes of this ICR addendum,

the Agency has divided the respondent groups into the following distinct "IC" or information collection categories:

Order Recipients . This category includes everyone that could receive an order fo r one or more of the

chemicals on the second list.EPA ICR No. 2488.01 June 3, 2013

Page 13 of 44 Data Generators/Submitters . This category includes one respondent for each chemical on the second list. As before, EPA is assuming that companies will work together to provide the required data and

will n ot duplicate efforts by conducting separately the required assays.

Consortium Participants . This category includes all of the order recipients, including those that are not in the data generators/submitters category. In addition, the Agency is assuming tha t the data generators/submitters will also incur burdens and costs associated with general participation in the

consortium.

Calculating the Number of Respondents : To identify the potential number of order recipients for purposes of estimating the burden i n this ICR, the Agency used internal data sources. Specifically, for

PAIs and pesticide inerts on the second list, the Agency used the Office of Pesticide Programs Information Network (OPPIN), which is an internal OPP database for query, input and tracking of pesticide products, ingredients, studies, regulatory decisions and other information about registered products to identify registrants and manufacturers/importers. For the SDWA chemicals, the Agency used data from the TSCA Inventory Update Reporting (I UR) rule database or, in cases where there were no IUR reporters, the Toxics Release Inventory (TRI) database to identify manufacturers and importers of the SDWA chemicals on the second list. In addition, as appropriate, the Agency may also use other

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

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

should have received an order but for whatever reason were mi ssed or are new to the market. Once identified, the Agency will determine whether to issue a "catch

- up" order to those entities. For purposes of this addendum, we assume that the majority of the catch

- up orders will involve the pesticide registrants, and h ave allocated this number accordingly.

Table 1

- B 15 presents the estimated number of responses based on the Agency 's efforts to date to identify potential order recipients, and assumptions regarding the anticipated response from each respondent in

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

chemical and that all "catch

- up" order recipients will join an already formed consortium.

The Agency has made every effort to provide a conservative estimate, b ut should the final number of recipients be greater once the orders are all prepared and issued for the year, the Agency will calculate the difference and submit an Information Correction Worksheet (ICW) to OMB to have the total annual burden adjusted as a ppropriate.

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

addition of "

- B" to indicate that the table is associated with the ICR addendum. After the ICR addendum is approved, the ICRs may be combined and this approach will be used to combine the tables.EPA ICR No. 2488.01 June 3, 2013

Page 14 of 44 Table 1

- B

– Estimated Number of Potential Respondents/Responses

IC # IC Category Name Estimated Number of Respondents

1. Order Recipients 1000
1(a).

– Registrants 125

– Catch

- Up Orders 60 1(b).

– Manufacturers/Importers 770

– Catch

- Up Orders 45

2. Data Generators/Submitters 109 2(a).

– Registrants 41

– Catch

- Up Orders 0 2(b).

– Manufacturers/Importers 68

– Catch

- Up Orders 0

3. Consortium Participants 1000 3(a).

– Registrants 125

– Catch

- Up Orders 60
3(b).

– Manufacturers/Importers 770

– Catch

- Up Orders 45 Total Respons es 2,109

These numbers are used in calculating the burden and costs for the activities covered by this ICR addendum, which are presented later in this ICR addendum. In general, the estimated total number of order recipients is 1000 (Initial recipients = 125 + 770, plus 105 catch

- up order recipients). This represents the universe of respondents. These respondents, as indicated in their initial response, are assumed to either be a Data Generator/Submitter or a Consortium Participant. The second list consists of

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



### 4(b) Respondent Activities

Individual respondent activities vary based on the IC category and the respondent group. Following a summary of the general activities by res pondent group, this discussion will provided a more detailed

overview of the activities.

Pesticide s : For registrants of the PAIs on the second list, the information collection activities are identical to those described in the 2009 policies and procedures document and the existing ICR. In general, these respondents will receive individual orders that are prepared by EPA using the revised order template in Attachment C(1) , entitled " F IFIRA/F FDCA 408(p) Order Template for Pesticide Active Ingredients (PAIs) " ( As of April 15, 2013). EPA has also made similar revisions to the order template used for pesticide inert ingredients

– see Attachment C(2). See Attachment I for a list and full description of the changes that were made to the templates currently approve d under the existing ICR.

As with List 1 Orders, the orders prepared using these templates will provide the recipients with the same options for responding as those discussed in the template order and covered by the existing ICR, including the submission o f other scientifically relevant information (OSRI) that the recipient believes should be considered by EPA as responsive to the order. See also Attachment E, which provides a diagram of the overall process for EDSP orders, including the various response op tions available for pesticides.

The order will direct the recipient to provide an initial response within 90 days of receiving the order by submitting their response to the order and all related correspondence electronically to EPA using the following met hods : 1) Send s ubmissions electronically to EPA via CDX, and 2) Access the EDSPEPA ICR No. 2488.01 June 3, 2013

Page 15 of 44 electronics reporting tool and instructions on the EPA EDSP internet homepage at http://www.epa.gov/endo and follow the appropriate links to CDX. T he currently approved form identified in the existing ICR as EPA Form No. 6300

- 05, entitled " FFDCA §408(p) Order/FIFRA §(3)(c)(2)(B) Data Call

- In (DCI)

- Initial Response Form for Individual Order Recipients ," has been revised in a few minor ways as identified in Attachment I. EPA intends to include a copy of this form (see Attachment D(1)) in the order packet as a reminder of the options available to the order recipient. The online response form will be consistent with this form, with available information pre

- populated for the respondent.

If the recipient joins a consortium, the consortium will be expected to provide an initial response within 150 days of receiving the order by submitting their response to the ord er and all related correspondence electronically to EPA using the following methods : 1) Send s ubmissions electronically to EPA via CDX,

and 2) Access the EDSP electronics reporting tool and instructions on EPA EDSP internet homepage at http://www.epa.gov/endo and follow the appropriate links to CDX. The currently approved form identified in the existing ICR as EPA Form No. 6300

- 05

- C, entitled " FFDCA §408(p) Order/FIFRA §(3)(c)(2)(B) Data Call

- In (DCI)

- Initial Respons e Form for Consortium/ Task Force " has been revised in a few minor ways as identified in Attachment I. EPA intends to include a copy of this form (see Attachment D(2)) in the order packet as a reminder of the options available to the order recipient. The

o nline response form will be consistent with this form, with available information pre

- populated for the respondent.

SDWA Chemicals : As indicated previously, EPA determined that some of the existing policies and procedures are generally not applicable to non

- pesticide chemicals and that there are competing considerations for SDWA chemicals warranting a modification to the procedures with regard to SDWA chemicals. The modifications are specifically described in a supplement to the 2009 policies and procedur es document (Attachment B (2) ).

In general, these recipients will receive individual orders that are prepared by EPA using the new order template in Attachment C ( 3 ) , entitled " SDWA/ FFDCA §408(p) Order Template for SDWA § 1457

Chemicals " ( as of April 15 , 2013 ). The new order template for SDWA chemicals is similar to the existing order templates except that it reflects the policies and procedures for SDWA chemicals. As such, the order specifies the options provided for recipients to follow in responding to the order, including the submission of other scientifically relevant information (OSRI) that the recipient believes should be considered by EPA as responsive to the order. A major difference in these response options and those covered in the existing ICR, is t he elimination or modification of options that are not applicable to SDWA chemicals.

The order still directs the recipient to provide an initial response within 90 days of receiving the order by submitting their response to the order and all related corres pondence electronically to EPA using the following methods : 1) Send s ubmissions electronically to EPA via CDX, and 2) Access the EDSP electronics reporting tool and instructions on the E PA EDSP internet homepage at

htt p://www.epa.gov/endo and follow the appropriate links to CDX. A new initial response form for use by individuals that received an order for a SDWA chemical is provided in Attachment D (3) , entitled

" FFDCA §408(p) Order for SDWA §1457 Chemicals

- Initial Res ponse Form for Individual Order Recipients " (EPA Form No. 6300

- 06 ). EPA will include this form in the order packet sent to the se recipient s as a draft of the response options available to the order recipient

. See also Attachment E.

If the recipient joins a consortium, the consortium will be expected to provide an initial response within 150 days of receiving the order by submitting their response to the order and all related correspondenceEPA ICR No. 2488.01 June 3, 2013

Page 16 of 44 electronically to EPA using the following methods : 1) Send s ubmissio ns electronically to EPA via CDX,

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

at http://www.epa.gov/endo and follow the appropriate links to CDX. A new initial response form for use by the consortium formed for a SDWA chemical is provided in Attachment D(4), entitled

“ SDWA/ FFDCA §408(p) Order for SDWA § 1457 Chemicals

– Initial Response Form for Consortium " (EPA Form No. 6300

- 06

- C )

, which will also be included in the initial order packet they receive

.

In both cases, the order will specify the same eleven Tier 1 screening assays, and outline the same timeframes for responding to the order, including providing one year progress reports. The order s may

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

issued. The order s will also provide instructions for electronic submission in response to orders that were not previously available.

Overview of Covered Acti vities : Each recipient of an order is expected to engage in the following

information collection related activities:

(1) Read instructions

– Each recipient will read the order to understand what they must do to comply with the order, what deadlines are associated with those activities and the details of how and to whom to respond. The recipient may also read other information about the EDSP, including the applicable policies and procedures document that explains the Agency 's rational for the requirements in the order, and which describes the specific details of the policies that EPA generally intends to adopt in implementing for the EDSP.

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

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

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

drafted , the individual orders will contain the necessary recipient details and requirements for the subject chemical. As such, the final individual orders that a recipient might receive may vary from these templates, a s well as vary from order to order , and recipient to recipient

.

(2) Plan activities

– The recipient will plan the activities necessary to comply with the order based on their intended response to the order.

(3) Submit an initial response to EPA

– Each order recipient will be directed to provide an individual initial response to EPA that indicates how they intend to comply with the order. In addition, each consortium participant is expected to submit the initial individual response, and then the designated lead for the consortium is also expected to submit an initial consortium response that indicates what the consortium intends to submit. As indicated previously, the response options available to the recipient will vary depending on whether the s ubject chemical is a PAI /pesticide inert or a SDWA chemical, but generally the initial response will involve the following activities. The various response options available to a recipient, along with related activities they may engage in that are specific to that response option, are described in section 4(c)(i) of this ICR.

(3)(a) Individuals submit an initial response to EPA

– The orders will direct each recipient to provide an individual initial response to EPA within 90 calendar days of issuance of the order that indicates how they intend to comply with the order. As indicated previously, the response options available to the recipient will vary depending on whether the subject chemical is a PAI or SDWA chemical. To simplify completion of this initial r esponse within the 90 days, the recipient will receive the appropriate draft initial response form which EPA will include inEPA ICR No. 2488.01 June 3, 2013

Page 17 of 44 the order packet they receive as a sample of the options available to the order recipient , the chemical covered, and the applicable test data sought. The Agency has an existing sample individual response form for PAIs and developed a new form sample for recipients of orders

under SDWA:

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

Form No. 6300

- 05 . See Attachment D(1).

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

form identified as EPA Form No. 6300

- 06. See Attachment D(3)

.

Each order recipient will complete the form electronically by checking the appropriate boxes to indicate their intentions with regard to each assay listed in the order, and, if applicable, attach appropriate documentation to provide a rationale and/or supporting documentation for their response. The response is assay specific to provide max imum 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 elec ting a single response for all assays.

(3)(b) Consortium submit an initial response to EPA

– If the recipient intends to form or join a consortium (or task force) with other order recipients to submit the data for a subject chemical, each consortium partic ipant is expected to submit an initial individual response within 90 calendar days, and then the designated lead for the consortium is also expected to submit within 150 calendar days of issuance of the order a separate consortium initial

response that ind icates what the consortium intends to submit. To facilitate the completion of the consortium's response, EPA has prepared a form for the consortium to use in providing an

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

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

version of EPA Form No. 6300

- 05

- C . See Attachment D(2).

• Consortium involving a SDWA c hemical order will be directed to use the new initial response form identified as EPA Form No. 6300

- 06

- C . See Attachment D( 4 ).

In addition to indicating the consortium's intentions with regard to each assay listed in the order by checking the appropriate boxes, and, if applicable, attaching appropriate documentation, the consortium initial response form id entifies the primary contact for the consortium, the list of participants, and documentation of its formation (such as a copy of the joint agreement or an electronic and/or written statement by all the parties that an agreement exists). The joint agreement to produce the data need not specify all of the terms of the final arrangement between the parties or the mechanism to resolve the terms.

(3)(c) Submit OSRI as the initial response

– As indicated in the policies and procedures documents, OSRI may also be submitted to fulfill part or all of the order. The initial response forms include a separate line item to indicate if OSRI is being cited or submitted to address either (A) a particular assay, or (B) to satisfy the order as a whole. If the order recipient chooses to submit or cite existing data, including other scientifically relevant information, the order directs the recipient to include an explanation of whether the data provided or cited follows an accepted scientific methodology or protocol, including but not limited to those presented inEPA ICR No. 2488.01 June 3, 2013

Page 18 of 44 EPA's harmonized test guideline compendium. 16 The order also directs recipients to provide a cogent and complete rationale for why they believe the information is sufficient to satisfy part

or all of the order. EPA's d ecisions about whether the information satisfies part or all of the Tier 1 order will be based on the weight

- of

- evidence from all relevant information available to

the Agency

.

In addition, the order recipient must comply with the Agency 's good laboratory p ractice (GLP) standards described in 40 CFR part 160 and part 792 , which require entities to follow certain practices when conducting studies, and, with the submission of data to EPA, to provide a GLP compliance statement indicating: a) that the data were generated using GLPs; or b) describe in detail "all differences" between the GLPs and the practices used; or c) confirm that you did not sponsor or conduct the study and do not therefore know whether the study was

conducted in accordance with the GLPs.

(4 ) Read and discuss the protocol

– The order recipients will read the protocols for the assays identified in the order and may have questions or may need to modify one or more of the protocols for the subject chemical. The recipient may deviate from a proto cols identified in the order only after consultation with EPA. Such requests should be submitted to EPA with a clear rationale and explanation of the deviation. All protocol variations will be reviewed by EPA and a response will be sent to the specific ord er recipient in a timely fashion. These procedures are consistent with current EPA practices regarding pesticide test guidelines and the data requirements in 40 CFR parts 158 and 161, as well as with test guidelines followed for other chemical testing prog rams. Although this activity is expected to be primarily performed by the data generating entity, other participants in a consortium may also participate in these discussions.

If the order recipient chooses to submit or cite existing data, including other scientifically relevant information, this discussion would be focused on whether the data provided or cited follows an accepted scientific methodology or protocol, including but not limited to those presented in EPA's harmonized test guideline compendium.

(5) Generate the data

– As indicated by the initial response, some recipients will conduct the research or administer the tests to generate the data requested in the order. Although conducting the tests may involve many activities, it is important to note that only those activities that are attributable to the paperwork aspects and are imposed by the information collection itself are attributable to this ICR. For example, the travel time and costs for identifying a contract laboratory or to have laboratory staff travel to meet with company officials, are not activities imposed by the information collection activities and are therefore not attributable to the ICR. Nor are any costs or burden related to mistakes made by the laboratory, such as failure to prope rly follow an applicable protocol, which then requires the laboratory to redo the screening assay.

In addition, the data generator is expected to comply with applicable GLP standards, such as those described in 40 CFR part 160 for pesticides, which require entities to follow certain practices when conducting studies. With the submission of data to EPA, the data generator is expected to provide a GLP compliance statement indicating: a) that the data were generated using GLPs; or b) describe in

detail "all d ifferences" between the GLPs and the practices used; or c) confirm that you did not sponsor or conduct the study and do not therefore know whether the study was conducted in

accordance with the GLPs.

16 http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htmEPA ICR No. 2488.01 June 3, 2013

Page 19 of 44 For the purposes of calculating paperwork burden hours a nd costs in this ICR, EPA assumed that the data generation will not be directly performed by the order recipient. Instead, EPA assumes that data generation will be performed by a contract laboratory at the request of the order recipient or a

consortium. Th e Agency has no information to estimate how many recipients might use a contract laboratory and how many might generate the data in house. Assuming that data will always be generated by a contract laboratory is consistent with the assumption used in other ICRs that involve data generation. One of the commenters on the original ICR provided evidence to support this assumption, commenting that many companies now outsource toxicology testing because it is less expensive than maintaining that function in

- house.

(6) Report progress, compile and review the data

– Unless EPA has notified a recipient in writing that the requirements of the order have been satisfied, the order recipient is expected to submit a progress report to EPA within 12 months after the issuanc e of the order. The progress report should provide a brief description of the status of the planned activities for each assay, and, if applicable, a description of any problems encountered or expected difficulties in meeting the schedule for complying with the

order.

(7) Complete paperwork to assemble the submission package

– Those order recipients that generate the data or serve as the consortium lead will be expected to compile the data results from performing the assay(s), review the data for completene ss and compliance with GLPs, and then assemble the submission package in accordance with the instructions provided in the order. In general, for PAIs these are the same submission procedures as those that are currently used for submitting other data in

sup port of a pesticide registration, with only a few modifications

– such as the mailing address

.

For SDWA chemicals, EPA is developing an electronic online submission option using the Agency 's Central Data Exchange (CDX). The Agency expects the net resultin g burden for using the electronic option to be no more burdensome than the paper process. Initial users of CDX will be required to register before using the system, which will involve some additional burden. Although most, if not

all

, of the manufacturers/ importers that receive an EDSP order for a SDWA chemical are likely to be registered with CDX already, EPA has not attempted to off

- set the reporting burden at this time. To the extent that an electronic reporting process can create efficiencies not readil y available in a paper system, the reporting burden might actually be less than estimated in this ICR addendum. In the event that orders are issued prior to the completion of the electronic option, the submission procedures will be the same as those used f or PAIs. See Attachment J for mock

- up screenshots of the new electronic system.

(8) Submit final data to EPA

– The final data package is then submitted to EPA following the specific instructions provided in the order, which will also specify the due date f or final compliance with the order's request for data. Although the order specifies a final due date for submission of all of the data specified in the order, an order recipient may submit either the data for each individual assay as it is completed, or th e data from all of the assays at one time. The order recipient may also submit the data before the due date specified in the order.

(9) Maintain records

– All order recipients will be asked to maintain a record of their initial response for three (3) years. order recipients who submit data in support of a pesticide registration will also be asked to maintain records of that data pursuant to 40 CFR 169.2(k ), which specifies that records containing research data relating to a registered pesticide be kept for as long as the registration is valid and the producer remains in business.EPA ICR No. 2488.01 June 3, 2013

Page 2 0 of 44 Distribution of Activities by Labor Categories:

For purposes of estimating t he potential respondent paperwork burden and costs associated with these activities, the Agency identified three separate labor categories: 1) managerial; 2) technical; and 3) clerical. Each activity identified previously may involve one or more labor or duty category. In Table 2 of the existing ICR, the Agency identifies the assumed recipient activities divided between the three labor categories, which is duplicated here for completeness.

Table 2

– Expected Order Recipient Activities by Labor Categories

A ctivity Managerial Duties Technical Duties Clerical Duties (1) Read the EPA's policies and procedures document Read the EPA's policies and procedures document

Review the EDSP order Review the EDSP order (2) Identify timeframe for response Identify and evaluate response options Evaluate response options

Plan activities Negotiate/establish consortium/ task force agreements Participate in consortium/ task force

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

deviations (5) Plan/oversee employee and contract

activities Plan the data collection activities using the approved protocols

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

and GLPs
Communicate with EPA, as appropriate Maintain records and procedures during testing period in accordance

with the GLPs Assist in preparing files

(6) Review final report(s) Compile and review data Prepare final data reports (7) Approve final submission package Draft summary of the data for cover

letter Prepare final submission package

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

Maintain records



### 4(c) Information Requested

This section of the ICR addendum describes the information that an order recipient is expected to provide the Agency . The order will identify the Tier 1 assay data being requested and will provide the specific instructions for complying with the order. All order recipients are expected to provide an individual initial response that identifies how the recipient intends to respond to the order. The specific information required with the individual initial response from each order recipient will vary based on the respondent's initial response

– the options for which are described in the order

. T he applicable policies and procedure documents, and are summarized in section 4(c)(i) of this ICR. Those recipients thatEPA ICR No. 2488.01 June 3, 2013

Page 21 of 44 generate data, either individually or as part of a consortium, are expected to provide a 1 year progress report, and then submit the data to EPA.

It is important to note that many of the initial response options adopted for the EDSP already exist within the pesticide program, e.g. , for Data Call

- Ins und er FIFRA 3(c)(2)(B). In providing the option as described in more detail in the 2009 policies and procedures document, the Agency adopted the existing procedures unchanged for use under the EDSP. Under those existing procedures, a pesticide registrant

may engage in additional activities associated with that response option. For example, a respondent/registrant could choose to reformulate the product or seek a formulator's exemption. Both of these initial response options involve established procedures, and additional activities that are already approved by OMB under separate existing ICRs. The Agency believes that any additional use of those existing procedures related to the EDSP do not impact the estimated burden covered by those other existing ICRs. As su ch, this ICR does not duplicate the burden associated with the response options that involve existing procedures that are already covered by another ICR.

4(c)(i) Order Recipients' Response Options

The recipient of an order will have several potential respo nse options as specified within the order itself

, as well as indicated on the response forms. As indicated previously, the order recipient will use the Initial Response Form s for Individual Order Recipients to indicate which option they intend to use to

re spond 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 appro priate boxes to indicate their intentions with regard to each assay listed in the order, and, if applicable, attach appropriate documentation to provide a rationale and/or supporting documentation for their response.

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

PAIs /pesticide inert ingredients and SDWA chemicals, which are described in the policies and procedure documents and the orders themselves. See also Attachment E for an overview of the process

for iss uing and responding to EDSP Tier 1 orders.

(1) I Will Generate New Data . The recipient would choose this option to indicate that they agree to individually generate new data for each test specified to meet the requirements of the order.

(2) I Am Citing or Submitting Existing Data . The recipient would choose this option to submit or cite existing data (including OSRI) that they believe can be used to satisfy part or all of the Tier 1 order. To allow EPA to review the submission of OSRI in a timely fashion, t he submitter of the information should consider providing a scientifically sound rationale that explains how the submitted or cited data provides the information needed to satisfy part or all of the Tier 1 order

and/or otherwise inform the Agency 's Tier 1 determination. EPA will review any existing study submitted or cited in response to the order to determine whether the study is relevant and of sufficient quality to satisfy the order. The Agency intends to notify submitters in writing of its

determination , as well as make the determination publicly available.

When citing something that was previously submitted, the Agency needs a copy of the title page along with the identification number of the study cited (MRID number), and, if the study has beenEPA ICR No. 2488.01 June 3, 2013

Page 22 of 44 reviewe d by the Agency , the Agency 's classification of the study. The Agency specifically asks that a study that has previously been submitted to EPA NOT be resubmitted in its entirety.

If the individual citing a study for a pesticide chemical (active or inert) i s 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] [w hich includes an offer to resolve any dispute over the recipients' shares of the test costs by submitting the dispute to a neutral third party with authority to bind the parties ( e.g. , through binding arbitration or through a state or federal court action) ], unless the individual has received confirmation from EPA that no such compensation is necessary.

(3) I Will Enter (or Offer to Enter) Into an Agreement to Form a Consortium to Generate the Data. The recipient would choose this option to indicate that th ey are forming a task force or consortium to comply with the order. In such cases, each participating or potential participant is expected to submit

an Initial Response Form for Individual Order Recipients within 90 calendar days. Within 150 calendar days of issuance of the order, or as part of their initial response, the designated lead for the consortium is expected to submit the Initial Response Form for Consortium/Task Force to provide the primary contact for the task force or consortium, the list of pa rticipants, and an indication of the task force or consortium's planned response for each assay, along with documentation of its formation (such as a copy of the joint agreement or an electronic and/or written statement by all the parties that an agreement exists). The joint agreement to produce the data need not specify all of the terms of the final arrangement between the parties or the mechanism to resolve the terms.

Alternatively, an order recipient may provide EPA with documentation that they made a ju dicially 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 appro priate share of test costs). If the required data are not generated by the person(s) to whom the offer is made, all parties, including those that have made offers to pay or otherwise joined the consortium, would be responsible for generating and submitting

the data.

Although catch

- up order recipients are most likely to select this option, these respondents are generally expected to join a consortium that has already been formed, or otherwise join with an individual who has already committed to generate the data.

(4) Claim Not to be Subject to the Test Order . The recipient would choose this option to indicate that they are not subject to the order because:

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

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

the chemical ; or

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

chemical ; or

(i v ) In the case of a "catch

- up" order, this option wou ld be essentially the same as the option discussed in the original policies and procedures for manufacturers of inert ingredients. EPAEPA ICR No. 2488.01 June 3, 2013

Page 23 of 44 has not identified any issues unique to SDWA chemicals that would warrant a change in policy on this point.

The recipie nt's initial response would include an explanation and documentation supporting their claim to allow EPA to evaluate the claim. If EPA cannot verify the claim, the recipient is still subject to the order and the deadline(s) for responding remain.

(5) I Int end to Voluntarily Cancel or Reformulate the Product Registration (only applicable to pesticide chemicals, not to SDWA chemicals) . A pesticide registrant may request voluntary cancellation of their product's pesticide registration pursuant to FIFRA section 6(f). Doing so would initiate the existing procedures for a voluntary cancellation. Cancellation procedures are addressed in a separate ICR that is already approved by OMB.

(6) I Claim a Formulators' Exemption (only applicable to pesticide chemicals [act ives and inerts]) . A pesticide registrant receiving an order to test a chemical, and who purchases the chemical from another recipient who has agreed to generate the data may be eligible for a formulators' exemption.

Such a claim would initiate the existin g procedures for formulators' exemption. EPA will confirm claims of eligibility. A formulators' exemption would become invalid if the supplier of the chemical were not to submit the data either individually or jointly with other recipients.

(7) I Have or A m in the Process of Discontinuing the Manufacture/Importation of the Chemical. The recipient of an order for a pesticide inert ingredient or a SDWA chemical ( i.e.

, manufacturer/importer) would choose this option to indicate that they have already or are in the process of discontinuing the manufacture or import of the chemical. The recipient's initial response would include an explanation and documentation supporting their claim. EPA intends to verify such a claim. If EPA confirms the claim, the initial resp onse form is the only response required to satisfy the order. If, however, EPA determines that the claim is false, the recipient must comply with the

order.

(8) Request an exemption under FFDCA section 408(p)(4). FFDCA section 408(p)(4) provides that "the Administrator may, by order, exempt from the requirements of this section a biologic substance or other substance if the Administrator determines that the substance is anticipated not to produce any

effect in hum ans 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

- chemi cal basis in response to individual submissions or requests for such consideration. In order for the Agency to make the necessary statutory finding to issue the exemption, the request would need to provide any

hazard

- related information or any other scient ifically relevant information that the recipient believes would allow EPA to determine that the chemical is not anticipated "...to produce any effect in humans similar to an effect produced by a naturally occurring estrogen."

(9) Other initial responses. The re 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 EP A may

review

, objections to the issuance of an order or to specific provisions in the order. For EPA to be able to respond to the objections in a timely manner, the recipient would need to state withEPA ICR No. 2488.01 June 3, 2013

Page 24 of 44 particularity the scope and basis of the objection, prov iding 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 choos es to ask EPA to reconsider some or all of the testing specified in the Tier 1 order, EPA would review the request, along with the appropriate information supporting the claim that additional EDSP screening of the chemical is unnecessary because the chemic al has been shown to interact with the endocrine system or was used as a "positive control" in the EDSP validation effort, on a case

by

- case basis. Based on the information currently available, EPA generally expects that if the chemical was used by EPA as a ''positive control'' to validate one or more of the Tier 1 screening assays, only the data submitted related to those assays for which the chemical was used to complete the testing as part of the validation effort would be sufficient to satisfy the Tier 1 order.

4(c)(ii) Progress Report

Unless EPA has notified the order recipient in writing that the requirements of the order have been satisfied, the order recipient must submit a progress report to EPA within 12 months of the issuance of the order (the spe cific 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 difficult ies in meeting the schedule for complying

with the order.

4(c)(iii) Extension Requests

If a recipient cannot comply with the time frame established in the order (see section 5(d) of this ICR), they may seek additional time by submitting a request via the C DX system for an extension to the Agency . The request must be submitted before the applicable deadline and include: (1) a detailed description of the expected difficulty and (2) a proposed schedule including alternative dates for meeting the requirements of the order. If the delay is based on technical or laboratory difficulties, recipients are expected to explain any technical or laboratory difficulties and provide documentation from the laboratory performing the testing.

While EPA is considering any such request, the original deadlines in the order remain unchanged. The Agency will respond to such requests in writing because time extensions can only be granted in writing

. If EPA does not grant the request, the original deadline remains. Normally, time ext ensions can be requested only in cases of extraordinary testing problems beyond the expectation or control of the registrant, manufacturer, or importer. Time extensions will not be considered if the request for extension is not made in a timely fashion; in no event shall a time extension request be considered if it is submitted at or after the lapse of the subject deadline.

4(c)(iv) Data Generation

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

is i ntended to identify chemicals that have the potential to interact with the estrogen, androgen, or thyroid hormone systems through any of several recognized modes of action. The following is a list and brief description of each of the assays that are part o f the final EDSP Tier 1 battery:EPA ICR No. 2488.01 June 3, 2013

Page 25 of 44 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 rec eptors to either mimic the action of the natural hormone or block access of the hormone to the site and thus block hormone controlled activity.

3. Aromatase (Human Recombinant)

– Aromatase is an enzyme complex responsible for estrogen biosynthesis that conver ts androgens into estrogens, estradiol, and estrone. The aromatase in vitro assay focuses on this portion of the steroidogenic pathway to detect substances that inhibit aromatase activity.

4. Estrogen Receptor Binding

– The estrogen receptor (ER) is involved in female maturation and reproductive function. The ER Binding assay measures the ability of a chemical to bind to the
estrogen receptor.
5. Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa

- 9903))

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

Activation is a cell

- based assay that measures the ability of a chemical to bind to the ER and activate transcription resulting in the synthesis of the enzyme luciferase.

6. Fish Short

- term Reproduction

– The Fish Short

- term Reproduction assay screens for disturbances in the hypothalamic

- pituitary

- gonadal (HPG) axis including (anti

- ) estrogenic, (anti

- ) androgenic, aromatase inhibition, and steroid modulating effects. The assay examines abnor malities 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 (R at)

– The Hershberger assay is designed to detect androgenic and anti

- androgenic effects. In this in vivo assay, the weight of several androgen

- dependent tissues, including accessory sex glands, are measured in castrated or immature male rats.

8. Female Puber tal (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. M ale 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 we ll 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 adrenocorti cal 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 vi vo assay, uterine weight changes are measured in ovariectomised or immature

female rats.

For purposes of estimating the potential burden for the Tier 1 screening information collection activities covered by the ICR, the Agency is assuming that each Tier 1 order will include all of the above listed assays. By assuming that each order will include all of these assays, the ICR provides coverage for those cases where the order may not include all of the assays.EPA ICR No. 2488.01 June 3, 2013

Page 26 of 44 4(c)(v) Data Submission

The order itself will spec ify the data submission content and format that the recipient should use. In general, the content and format of the data submission package for transmittal to EPA should be consistent with the following existing standards, which are expected to be incorpor ated into the

individual orders:

1. Format for Data Submission. As part of a cooperative project, EPA and the Canadian Pest Management Regulatory Agency (PMRA) developed standard data evaluation formats, or templates. The templates have been in use by these a gencies since 2002 for writing their data evaluation records (DERs) of studies submitted under FIFRA and FFDCA to EPA and the Canadian data codes (DACOs). The DER that the agencies prepare contains a study profile documenting basic study

information such a s materials, methods, results, applicant's conclusions and the evaluator's conclusions. The agencies encourage recipients to include study profiles based on these templates, which describe the layout and scope of information that should be contained within a study profile and can serve as guides for preparation of study documents. Use of the templates improves the likelihood of a successful submission, since the information necessary for an efficient agency review

is outlined.

The study profiles templates are available at: http://www.epa.gov/pesticides/regulating/studyprofile_templates/ . The Agency encourages order recipients to submit completed study profiles and supporting dat a in an electronic format (PDF) whether submitting one or several studies. For more information about electronic submissions, go to http://epa.gov/endo/pubs/toresources/index.htm . In addition, as discussed previously, EPA is developing an online electronic submission option using CDX.

2. Transmittal Document. Each submission in satisfaction of a Tier 1 order must be accompanied by a transmittal document that includes the following information:

(1) Identity of the submitter.

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

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

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

3. Individual Study or Test Result Documents. Unless otherwise specified by the Agency , each submission is expected to be in the form of individual documents or studies. Previously submitted documents should not be resubmitted unless specifically requested by the Agency . Instead, previously submitted documents should be cited with adequate information to identify the previously submitted document. Each study or document should normally include the following:

(1) A title page including the following information:

(i) The title of the study, including identification of the substance(s) tested and the test name or data requirement addressed.

(ii) The author(s) of the study.EPA ICR No. 2488.01 June 3, 2013

Page 27 of 44 (iii) The date the study was completed.

(iv) If the study was performed in a laboratory, the na me 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.

(v i) If the study is a reprint of a published document, all relevant facts of publication, such as the journal title, volume, issue, inclusive page numbers, and date of publication.

(2) Upon submission to EPA, each document must be accompanied by a signed a nd 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 responsibili ties associated with the EDSP under FFDCA section 408(p) have been assigned to EPA's OCSPP. 17 Within OCSPP, OPP will be primarily responsible for the administrative functions involving PAIs and Pesticide Inerts

, i.e. , related to the issuance of the orders, receiving, processing and maintaining records of responses to the orders, as well as other administrative functions related to the orders. OCSPP's OPPT will be primarily responsible for the administrative functions involving SDWA chemicals, including the i ssuance 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 informa tion on

the Agency 's Website, and the preparation of resulting determinations related to the subject chemical. Data received by EPA will first be reviewed for completeness and then routed to an agency team of scientists and analysts for technical review. A lthough the technical review teams will consist mostly of staff from the offices in OCSPP, it will also include staff from other EPA offices, e.g. , OW, ORD, and other EPA offices as appropriate.

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

information collection activities under this ICR addendum:

(1) Prepare instructions. As indicated previously and in the existing ICR, EPA has prepared instructions in terms of the two policies and procedures documents, an d the order templates that provide guidance and instructions for order recipients so that they understand how to respond to the order, what data are to be submitted, when and how.

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

Page 28 of 44 (2) Identify chemicals to be screened. In addition to identify the chemical s covered by the existing ICR, EPA has identified a second list of chemicals to be screened under the EDSP. This ICR addendum assumes that all of the chemicals on the second list will be the subject of a Tier 1 order issued under FFDCA §408(p).

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

identified on the second list of chemicals to be screened under the EDSP. See the discussion on respondents in section 4(a) of this ICR addendum.

In addition, t o facilitate the formation of consortia to develop the data requested in an order, and to the extent that the information is not protected as CBI, EPA will provide each order recipient with a list of the other recipients of the order for the subject chemic al. The list of order recipients will also be maintained up to date on the Agency 's EDSP website, along with the status of the order (including recipients' responses).

This ICR also assumes that other entities that should receive an order might be identifi ed after the first set of orders is issued, either by EPA or by someone else. In those cases, EPA intends to issue

"catch

- up" orders as appropriate.

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

in sect ion 4(b) of this ICR addendum) to prepare individual orders for each chemical and order recipient. The order will identify all of the non

- CBI protected recipients so that the recipients may more easily identify the potential participants to include in a co nsortium, and it will indicate how many recipients could not be listed. Those companies protected as CBI will not be listed, but will still receive an order and will have an opportunity to designate an agent for purposes of the List of order Recipients. As indicated previously, EPA intends to maintain an up to date list of order recipients on the Agency 's EDSP website.

Along with preparation of the orders, EPA will prepare the pre

- populated initial response form for each order recipient. The Agency intends to accomplish this through a semi

- automated process using the same database that will track the orders, initial responses, and data submissions. This system is discussed in more detail in section 5(b) of thi s ICR. In using this approach, EPA is maximizing the available resources and efficiencies related to the administrative components of Tier 1 screening under the EDSP.

(5) Review and Approve Orders. The EDSP Tier 1 orders will be reviewed and approved by a senior agency official(s) for completeness before they are issued.

(6) Issue the Orders. The appropriate authorized OCSPP senior official will sign each order, which will then be processed for issuance as appropriate. Orders will then be mailed to each recipient using certified and return receipt mailing options offered by the U.S. Postal Service.

(7) Process Initial Responses. The Agency will receive the initial response form, document the response, track responses and determine next steps based on the responses. In general, the Agency

will review the re sponse 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, pr ocess a voluntary cancellation request or request for reformulation, etc. The Agency will verify claims and reviewEPA ICR No. 2488.01 June 3, 2013

Page 29 of 44 data cited or submitted and provide an electronic response to the order recipient that accepts or rejects their claim(s).

(8) Provide Assistance and Complete Follow

- up, as needed. The Agency will respond to any questions the recipient may have regarding the Tier 1 order in a timely manner, as well as process any requests for extensions or protocol variations.

(9) Address Non

- responders. Once identified, OCSPP will determine appropriate action ( i.e. , whether to initiate cancellation procedures

, refer the case to EPA's Office of Enforcement and Compliance Assurance (OECA) for enforcement, etc.).

(10) Issue "Catch

- up" Orders. EPA may issue a "catch

- up" order to a manufacturer or importer who begins to sell an inert ingredient following the submission of required EDSP data on the ingredient by manufacturers or importers who were in the marketplace when the initial orders were issued.

(11) Proc ess Data Submissions. The Agency will process submissions of data generated under the Tier 1 order, including initial review of the data submission for completeness, initial log

- in to document receipt, track the data, data reviews and decisions. As indicat ed previously, this will be coordinated by OPP, OPPT and OSCP.

(12) Analyze Data. OCSPP and OW will implement the Agency 's internal standard review procedures to review the results of the Tier 1 screening data. For example, what do the data tell us about the chemical's potential to interact with the estrogen, androgen or thyroid hormonal pathways? In general, the Agency intends to conduct a Wo E analysis on the results of Tier 1 screening in

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

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

under docket EPA

- HQ

- OPPT

- 2010

- 0877.

(13) Incorporate/ Us e the Data. The Agency will incorporate the data into a risk assessment and make a regulatory decision as necessary and appropriate. EPA has extensive experience in using data from multiple sources to develop integrated assessments of hazard, modes of acti on / mechanisms of toxicity, and overall potential for risk. EPA scientists will continue to use such experience, together with insights from the validation process for Tier 1 screening assays, to address the potential of chemicals to cause adverse effects as a consequence of interaction with the endocrine
system.

In addition, chemicals that go through Tier 1 screening and are found to have the potential to interact with the estrogen, androgen, or thyroid hormone systems will be considered for Tier 2

testi ng. The purpose of Tier 2 testing is to identify and establish a dose

- response relationship for any adverse effects for hazard and risk assessment.

(14) Store Data in Retrievable System. The Agency will index and store the data in the Agency 's files. For p esticide active and inert ingredients, the data and related documents are stored in an electronic document repository that OPP employs. For SDWA chemicals, the data will be stored in a similar computer system managed by OPPT. These systems are discussed in more detail in section 5(b) of this ICR.EPA ICR No. 2488.01 June 3, 2013

Page 30 of 44 

### 5(b) Collection Methodology and Management

For each of the chemicals identified for Tier 1 screening as part of the EDSP, the Tier 1 order will establish the specific data requested, the testing necessary to genera te that data, the expected duration of the testing and report preparation, and the date by which the requested data must be submitted to the Agency . As indicated previously, the Agency intends to utilize the systems and procedures already

established and i n use for Data Call

- In activities under FIFRA to collect and manage the data submitted in response to the Tier 1 order, and is developing an electronic online submission options that involves the use of CDX to submit responses to the EDSP Tier 1 orders. Se e Attachment J for screenshots of the new electronic system.

As discussed previously, EPA is also developing a new electronic submission system for data submitted in response to SDWA/FFDCA and FIFRA/FFDCA test orders for the second list of chemicals follow ing the general process established for electronic reporting under TSCA. This will be a more advanced submission process for the pesticide chemical order recipients than currently exists, and for now, will apply solely to EDSP related submissions. The EDSP electronic reporting system will take advantage of

the Agency 's CDX to allow order recipients to respond to an order ( e.g. to submit test data) via the

Internet. See http://www.epa.gov/cdx for additional information ab out CDX. (Reference 4 ). Recipients, if not already registered with CDX, will need to complete a simple registration process, thereby establishing a secure log

- on to CDX. Specific requirements associated with these orders will be provided directly to the or der recipients, and are expected to include:

• Registration with CDX, resulting in the establishment of an electronic signature usable for electronically submitting test order responses;

• Access to a web

- based response form, including the ability to attach PD F files; and

• Encrypted submission to EPA via CDX.

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

to the order.

The systems will manage information related to the associated companies, requirement in formation, and information related to the responses. The systems will track the milestones associated with the drafting, concurrence, mail

- out, 90

- day response, submission receipts and reviews. Downstream process tracking

like time extensions and non

- respo nsive companies is part of the system design. The Agency will produce several reports to facilitate tracking, etc. For example, a 90

- day company response status report is needed to determine whether companies have responded, and to identify their intention s. A status report by order across all chemicals, sorted by company is needed in order to present overall progress and allow management to directly identify delays. The status of each of the EDSP orders reported from these systems which is currently posted to a public website will continue for all existing and future orders issued under this program.



### 5(c) Small Entity Flexibility

In developing the policies and procedure documents, the Agency considered alternatives for small businesses to the extent practic al within the mandate in FFDCA. For example, the procedures are intended to minimize potential duplicative testing, and emphasize collaborative efforts to generate the requested data. If there is a small business that happens to manufacture one of the chem icals and therefore receives a Tier 1 order, the small business may minimize potential burden by joining aEPA ICR No. 2488.01 June 3, 2013

Page 31 of 44 consortium or task force, which may relieve the small business of direct responsibility for generating or submitting the data. EPA has further facili tated 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 l evel of participation expected from each member. Typically, that level of participation, which may be based on time or money, is based on the entity's market share for that chemical.

EPA can also accommodate requests for extensions of time from small busin esses, 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 w ho 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 th eir fair share of the costs, and the time an effort involved in making a reasonable offer.



### 5(d) Collection Schedule

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

- time, three step collection activity per chemical. The order will identify the applicable due dates for the collections under the order. In general, the basic schedule EPA intends to use in the order is based on the timeframes identified in Table 3 of the existing ICR, wh ich is duplicated

here:

Table 3

– General Basis for Establishing the Due Dates in the Order

Timeframes for Due Dates What is Due Within 90 calendar days of the order's issuance (+ 10 calendar days for processing) Individual Recipient's Initial Response

Within 150 calendar days of the order's issuance (+ 10 calendar days for processing) Consortia's Documentation and Initial Response

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

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

In calculating the due date for the initial response, the Agency has included an additional 10 calendar days to build in extra time for the Agency to process the final order package after signature, i.e. , to add all the due dates that will be calculated from the signature date, and for physical delivery of the package to the U.S. Post Office for mailing. In general, the Agency does not expect to con sider requests for extending the deadlines for the initial response. However, the Agency will consider extending the final report due date when the circumstances warrant it as described in the applicable policies and procedures

document.

For purposes of e stimating the potential paperwork burden in this ICR, EPA assumed that the data would be submitted within 2 or 3 years of receiving the Tier 1 order, i.e. , within the 3 year approval period for this ICR. To calculate an annual burden, the Agency assumed 3 year duration of equal annual

effort.



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

The PRA requires EPA to estimate the burden associated with the information collection activities

. Burden is defined at 5 CFR 1320.03(b)

. The Agency is re quired to estimate both the hour burden andEPA ICR No. 2488.01 June 3, 2013

Page 32 of 44 the cost burden. The cost burden include s both the costs associated with the paperwork burden hours, and any additional costs not tied to a burden hour, but incurred under the PRA nonetheless ( e.g. , the cost

for mailing the forms to EPA).

In this section of the ICR, the Agency discusses the methodology and assumptions used to calculate the potential paperwork burden and costs for respondents, which are presented based on the information collection or "IC" groups discussed previously.



### 6(a) Methodology for Estimating Respondent Burden and Cost

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

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

- Specific Occ upational 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 use d 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 p rovided by Standard Occupational Classification (SOC). The SOC system is used by federal statistical agencies to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating data. Each broad occupation includes detailed occupation(s) based on similar job duties, skills, education, or experience. For more information on SOC and what is included in each SOC, see http://www.bls.gov/oes/current/oes_stru.htm

. The SOCs used for the following labor types are listed below in Table 4 and apply to all of the sectors identified above.

Table 4

– Respondent Standard Occupational Classifications Used in this ICR
Labor Category SOC # Standard Occupational Classification

Management 11

- 0000 Management Occupations

Technical 19

- 0000 Life, Physical, and Social Science Occupations

Clerical 43

- 0000 Office and Administrative Support Occupations

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

that benefits add 44.1 % to the hourly rate, based on benefits for all private industry workers from http://www.bls.gov/schedule/archives/ecec_nr.htm

. 18 We then multiply the loaded wage by 50% to get overhead costs. Overhead costs are added to the loaded wage rate to get the fully loaded wage rate.

18 DOL, Bureau of Labor, September 11, 2012 Announcement of June 2012 Data http://www.bls.gov/news.release/archives/ecec_09112012.htmEPA ICR No. 2488.01 June 3, 2013

Page 33 of 44 Table 5

– Respondent Loaded Labor Rates Used in this ICR
Labor Category Formula Used Managerial Technical Clerical Unloaded Hourly Rate 1 Wages $57.42 $28.32 $17.02 Benefits Percentage of Total Labor 2 Benefits% 44.1 % 44.1 % 44.1 % Benefits per hour W ages * Benefits% $ 25.32 $ 12.49 $ 7.51 Loaded Hourly Rate (LHR) Wages + Ben e fits per hour $82.74 $40.81 $24.53 Overhead Percentage 3 50% 50% 50% Overhead Per Hour (OPH) LHR*Overhead% $4 1.37 $20. 41 $12. 27 Fully Loaded Hourly Rate LHR + OPH $12 4.11 $6 1.22 $36. 80
Key:

1. Data Source: http://www.bls.gov/oes/current/naics4_325300.htm 2. Fringe benefits/wage per hour. 3. U.S. EPA, EPA Air Pollution Control Cost Manual , Sixth Edition, EPA

- 452

- 02

- 001, January 2002, pp. 2

- 34. The loading for indirect costs used in this ICR ( i.e. , 50%) is within the range of 20

- 70% of the load labor rate (wage + benefits) suggested in this EPA guidance.

For this ICR, the Agency therefore uses the following labor rates for the respondents: Manager ial = $12 4

. 11 , Technical = $6 1

. 22 ; and Clerical = $36. 80

.

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

The specific activities used for estimating the potential burden and costs are identified in section 4(b) of this ICR. Paperwork burden hours a nd costs are subdivided into the managerial, technical, and clerical duty labor categories, which are also described in more detail in section 4(b) of this ICR.

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

1. Method Used to Calculate the Burden and Costs for Data Generation . EPA calculated the paperwork burden for the data generation activities as a percentage of the testing costs. This percent

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

consultation with OMB in the 1980's in an effort to provide a reasonable estimate of the burden associated with the paperwork component of data generation, which may vary based on the complexity of the test performed. This appears to be a reasonable and fair alternative to simply setting a single estimate for data generation burden or perhaps using some set criteria like high, medium or low burden, neither of which may fairly reflect potential differences in burden. For purposes of this ICR, the Agency has adopted this established methodology for estimating the paperwork burden for data generation, which is explained further in this section of the ICR.

To calculate the burden associated with the paperwork activities involved in conducting the tests, the Agency starts with the cost of the test, typi cally the market price for the test as identified by laboratories that offer testing services. The Agency used estimated costs for two assays that were based on estimates provided by EPA scientist overseeing the validation effort for those two assays.

Sinc e 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 lab oratories and other information provided by industry representatives. EPA believes that these estimates are still valid as adjusted for inflation. Our basis for being comfortable with these cost estimates is a peer reviewed article that appeared in

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

Page 34 of 44 Endocrine Disruptor Screening," which estimated the costs for the eleven assays to be $572,913. 19
As indicated in Attachment F, the estimate provided by EPA is slightly higher at $637,184.

Based on the existing methodologies, EPA used 35% of the estimated total test cost to calculate the total potential cost for the paperwork activities related to data generation. The 35% of test cost is disaggregated by labor category, a nd then burden hours are extrapolated by using the loaded labor rates. To disaggregate by labor category, the Agency considered the estimated distribution of paperwork activity across the labor category represented and the existing methodology assumption

t hat 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 genera tion. The results from using this method are presented in Attachment F and were used in the burden and cost estimates provided in section 6(b) of this ICR.

Figure 1

– Method for Calculating Paperwork Burden from Test Costs

This approach assumes and incorporates the following:

(1) Recipients generate all of the data as specified in the Tier 1 order. (2) All data generation is performed by an independent laboratory. (3) Paperwork burden is d isaggregated by labor category as follows:

a. Managerial (20%)

b. Technical (65%)

c. Clerical (15%) (4) Labor rates are fully loaded, meaning that they include the estimated costs of wages, overhead, and benefits paid to an employee. See section 6(a)(i) of this ICR.

2. Method Used to Calculate the Burden and Costs for Other Activities . For the other activities, EPA estimated the burden hours by considering the activities themselves and the expected amount of time that the activity involves on average. These es timates consider the Agency 's experience with similar data collection activities, including those for the EDSP initial list of chemicals, and direct experience in conducting the assays for validation. The costs are calculated using the loaded labor rates f or 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. Alt hough 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 base d on its general experience with the pesticide program. At this time, it is not possible to estimate how many respondents may choose which option.

19 The total in the article of $544,397 was in 2010 dollars, whic h were adjusted for 2012 using the inflation calculator at http://www.bls.gov/data/inflation_calculator.htm

. Identify 35%

of the Test

Cos t Divide 35% cost into: 20% for Managerial

65% for Technical

15% for Clerical Divide each by

Loaded Labor

rate for that Category Burden Hours by CategoryEPA ICR No. 2488.01 June 3, 2013

Page 35 of 44 Regardless of the response option that recipients of Tier 1 orders choose, the Agency has assumed

that the da ta 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 w ill 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 t he data, submitting a one

- time progress report and eventually submitting the data. The results of this method are presented in section 6(b) of this ICR.



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

This section explains how the Agency calculated the estimat ed respondent burden and costs for this ICR.

6(b)(i) Estimated Burden and Costs

- per Chemical

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

- B.

Table 6

- B

– Estimated Per Chemical Burden Hours for the Activities
Activity (a) Managerial Technical Clerical Total 1) Read instructions 12 12 0 24 2) Plan activities 48 42 0 90 3) Submit an initial response to EPA (b) 24 21 2 47 4) Read and discuss the protocol 36 145 0 181

--- > Activities related to the submission of OSRI (c) 50 428 70 548 5) Participate in Consortium 24 145 2 171 6) Generate the data (d) 361 2, 376 912 3,649 7) Submit Progress Report 5 20 7 32 8) Compile and review the final data for submission 36 191 12 239 9) Complete paperwork to assemble submission package 5 20 7 32 10) Submit final data to EPA 3 0 2 5 11) Maintain records 0 24 62 86

Total Per Chemical Burden: 6 04 3, 424 1, 076 5, 104
Key: (a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category. (b) This estimate includes an estimated burden to provide additional material with the response. (c) Based on hours required for OSRI Submission from CLA/EPF Report (Reference 5 ) (d) Burden estimate is a percentage of the total test cost, which is calculated in Attachment F.

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

- B. The

burden costs are calculated by multiplying the burden hours in Table 6

- B by the loaded labor rate for the different labor categories, with the costs for generating the data coming from Attachment F. The following loaded labor rates were used to calculate these costs: Managerial = $1 2 4

. 11 ; Technical = $6 1.22 ; and Clerical = $36. 80

.

Table 7

- B

– Estimated Per Chemical Costs by Activity

Activity (a) Managerial Technical Clerical

Total $12 4

. 11 $6 1

. 22 $36. 80 1) Read instructions $1,4 89 $7 35 $0 $2, 224 2) Plan activities 5, 957 2,5 71 0 8, 528 3) Submit an initial response to EPA (b) 2,9 79 1,2 86 7 4 4, 339 4) Read and discuss the protocol 4,4 68 8, 877 0 13, 345

--- > Activities related to the submission of OSRI (c) 6, 206 2 6

, 202 2,5 76 3 4, 984EPA ICR No. 2488.01 June 3, 2013

Page 36 of 44 Activity (a) Managerial Technical Clerical

Total $12 4

. 11 $6 1

. 22 $36. 80 5) Participate in Consortium 2,9 79 8, 877 7 4 11, 930 6) Generate the data (d) 4 4

, 804 1 45

, 459 3 3

, 562 2 23
, 825 7) Submit Progress Report 6 21 1,2 24 25 8 2, 103 8) Compile and review the final data for submission 4,4 68 11, 693 4 42 16, 603 9) Complete paperwork to assemble submission package 6 21 1,2 24 25 8 2, 103 10) Submit final data to EPA 37 2 0 74 44 6 11) Maintain records 0 1,4 69 2,2 82 3, 751 12) Delivery Costs 11

Total Cost: $7 4
, 964 $2 09
, 617 $ 39
, 600 $3 24
, 192
Key: (a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category. (b) This estimate includes an estimated burden to provide any additional burden requested for an option. (c) Hours required for OSRI Submission from CLA/EPF Report (Reference 5 ) (d) Burden cost estimate is a percentage of the total test cost, which is calculated in Attachment F.

In addition to the burden costs, the costs of delivering the data to the Agency are added to arrive at the total estimated per respondent cost. Delivery costs were calculated using the Agency 's experience with data submissions for pesticide deliveries, which assumes the delivery of a paper copy and a CD

- Rom using special delivery. Although not required, nor used by everyone, the Agency is using special delivery for the calculation to provide a conservative estimate that would account for expected variations in delivery costs. Based on the 2

- day delivery rate for a large envelope up to 2 lbs. in weight, the U.S. Postal Service rate is $10.55 (rounded to $11) from the west coast to the east coast (Reference 6 ).

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

As discussed earlier, all respondents are not expected to engage in the same basic activities, their activities will be based on their initial response to the order. For the purposes of th is ICR addendum, the estimated burden and costs for the two respondent groups are divided into distinct "IC" categories as presented in Table 1

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

- B and the estimated per

chemical burden and costs from T ables 6

- B and 7

- B for the various activities, the estimated respondent burden and costs for the different IC categories is presented in this section of the ICR.

IC #1: Order Recipients

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

identified in Tables 6

- B and 7

- B as activities 1

- 3, and 11, which are all associated with receipt of the order and submission of the required initial response.

Table 8

- B

– IC #1(a): Estimated Burden and Costs for Order Rec ipients

– Registrants of Pesticide Active Ingredients

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

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

1) Read instructions

185 24 $2, 224 4,440 $4 11,440 2) Plan activities 90 8, 528 16,650 1,5 77,680 3) Submit an initial response to EPA 47 4, 339 8,695 802,715 11) Maintain records (g) 43 3, 751 7,955 6 93,935

Total: 204 $18, 842 37,740 $3,4 85,770EPA ICR No. 2488.01 June 3, 2013

Page 37 of 44 Activity (a) Total # Responses (b) Per Response Total

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

Key: (a) Activities are described in more detail in section 4(b) of this ICR. (b) From Table 1

- B, includes catch

- up orders. (c) From Table 6

- B. (d) From Table 7

- B. (e) Total = (b) x (c) (f) Total = (b) x (d) (g) Maintaining records of the initial response is estimated to be 1⁄2 of the totals in Tables 6

- B and 7

- B.

Table 9

- B

– IC #1(b): Estimated Burden and Costs for Order Recipients

– Manufacturers and Importers of SDWA Chemicals

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

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

1) Read instructions

815 24 $2, 224 19,560 $1, 812,560 2) Plan activities 90 8, 528 73,350 6, 950,320 3) Submit an initial response to EPA 47 4, 339 38,305 3, 536,285 11) Maintain records (g) 43 3, 751 35,045 3,0 57,065

Total: 204 $18, 842 166,260 $15, 356,230
Key: (a) Activities are described in more detail in section 4(b) of this ICR. (b) From Table 1

- B, includes catch

- up orders. (c) From Table 6

- B. (d) From Table 7

- B. (e) Total = (b) x (c) (f) Total = (b) x (d) (g) Maintaining records of the initial response is estimated to be 1⁄2 of the totals in Tables 6

- B and 7

- B.

The total IC #1 estimated burden is 204,000 hours (37,740 hours + 166,260 hours) and the estimated cost is $18, 842 ,000 ($3,4 85

, 770 + $15, 356

, 230 ).

IC #2: Data Generators/Submitters

This IC category of respondents is intended to capture the additional burden and costs expected for a subset of the order recipients who are generating and submitting the requested data to the Agency . As discussed previously, EPA assumes that for each chem ical, the data will be submitted only once, either by an individual order recipient or a consortium. For this IC category, the Agency assumes that these respondents will also engage in the activities identified in Table 6

- B and 7

- B as activities 4 and 6

th rough 12, which are all associated with generating and submitting the data. Please note that participation in a consortium is addressed in the next IC group.EPA ICR No. 2488.01 June 3, 2013

Page 38 of 44 Table 10

- B

– IC #2(a): Estimated Burden and Costs for Data Generators and Submitters

– Registrant s of Pesticide Active Ingredients

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

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

4) Read and discuss the protocol

41 181 $ 13,345 7,421 $ 547,145

--- > Activities related to the submission of OSRI 548 34, 984 22,468 1,4 34,344 6) Generate the data (h) 3,649 2 23

, 825 1 49,609 9,176,825 7) Submit Progress Report 32 2,103 1,312 86,223 8) Compile and review the final data for submission 239 16,603 9,799 680,723 9) Complete paperwork to assemble the submission package 32 2,103 1,312 86,223

10) Submit final data to EPA 5 446 205 18,286 11) Maintain records (g) 43 3,751 1,763 153,791 12) Delivery Costs 11 451

Total: 4,729 $ 297,171 193,889 $ 12,184,011
Key: (a) Activities are described in more detail in section 4(b) of this ICR. (b) From Table 1

- B, includes catch

- up orders. (c) From Table 6

- B. (d) From Table 7

- B. (e) Total = (b) x (c) (f) Total = (b) x (d) (g) Maintaining records of the initial Respons e is estimated to be 1⁄2 of the totals in Tables 6

- B and 7

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

Table 11

- B

– IC #2(b): Estimated Additional Burden and Costs for Data Generators and

Submitters

– Manufacturers and Importers of SDWA Chemicals

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

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

4) Read and discuss the protocol

68 181 $13,1 45 12,308 $ 907,460

--- > Activities related to the submission of OSRI 548 34, 984 37,264 2,3 78,912 6) Generate the data (h) 3,649 223,825 248,132 1 5,220,100 7) Submit Progress Report 32 2,103 2,176 14 3,004 8) Compile and review the final data for submission 239 16, 603 16,252 1,1 29,004 9) Complete paperwork to assemble the submission package 32 2, 103 2,176 14 3,004

10) Submit final data to EPA 5 44 6 340 30,328 11) Maintain records (g) 43 3, 751 2,924 25 5,068 12) Delivery Costs 11 748

Total: 4,729 $ 297,171 3 21,572 $2 0,207,628
Key: (a) Activities are described in more detail in section 4(b) of this ICR. (b) From Table 1

- B, includes catch

- up orders. (c) From Table 6

- B. (d) From Table 7

- B. (e) Total = (b) x (c) (f) Total = (b) x (d) (g) Maintaining records of the initial Response is estimated to be 1⁄2 of the totals in Tables 6

- B and 7

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

The total IC #2 estimated burden is 5 15 ,461 hours ( 193,889 hours + 321,572 hours) and the estimated cost is $3 2

, 391

, 639 ($1 2

, 184

, 011 + $2 0

, 207

, 628 ).EPA ICR No. 2488.01 June 3, 2013

Page 39 of 44 IC #3: Consortium Participants

This IC category is intended to capture the additional burden and costs expected for a subset of the order recipients who are participating in a consortium. As discussed previously, EPA assumes that when there are more than one order recipients for a particular chemical, the recipients will join forces to generate and submit the data in response to the order. If the order recipient is not the lead, they are assumed to be participants in that effort. For this IC category, the Agency assumes that these respondents will engage

in the activities identified in Tables 6

- B and 7

- B as activity 5, which is associated with participa ting in a

consortium.

Table 12

- B

– IC #3(a): Estimated Additional Burden and Costs for Consortium Participants

– Registrants of Pesticide Active Ingredients

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

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

5) Participate in Consortium 185 171 $11, 930 31,635 $2, 207

, 050

Total: 171 $11, 930 31,635 $2, 207,050
Key: (a) Activities are described in more detail in section 4(b) of this ICR. (b) From Table 1

- B, includes catch

- up orders. (c) From Table 6

- B. (d) From Table 7

- B. (e) Total = (b) x (c) (f) Total = (b) x (d)

Table 13

- B

– IC #3(b): Estimated Additional Burden and Costs for Consortium Participants

– Manufacturers and Importers of SDWA Chemicals

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

Burden (hours) (c) Cost ($) (d) Burden (hours) (e) Costs ($) (f)

5) Participate in Consortium 815 171 $11, 930 139,365 $9, 722,950

Total: 171 $11, 930 139,365 $9, 722,950
Key: (a) Activities are described in more detail in section 4(b) of this ICR. (b) From Table 1

- B, includes catch

- up orders. (c) From Table 6

- B. (d) From Table 7

- B. (e) Total = (b) x (c) (f) Total = (b) x (d)

The total IC #3 estimated burden is 171,000 hours (31,635 hours + 139,365 hours) and the estimated costs is $11, 930 ,000 ($2, 207

, 050 + $9, 722

, 950 ).



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

For the Agency activities, EPA estimated the burden hours by considering the activities themselves and the expecte d 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 t he total potential agency burden over the three years, EPA has multiplied this burden by the total number of chemicals (677 hours x 109 chemicals = 73,793 hours).EPA ICR No. 2488.01 June 3, 2013

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
Key: (a) Activities described in more detail in section 5(a) of this ICR. (b) This estimate includes an estimated burden to provide any additional burden requested for an option. (c) Assumes 40 hrs per assay (40 x 11). (d) Assumes 8 hrs per assay (8 x 11).

The costs are calculated using the U.S. Department of Labor, Bureau of Labor Statistics data 20 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 = $1 20

. 33 ; Technical = $7 7

. 85 ; and Clerical = $4 4

. 06 . The estim ated burden hour costs for the Agency are presented in Table

15

- B. To calculate the total potential agency costs over the three years, EPA has multiplied the per

chemical cost in Table 15

- B by the total number of chemicals ($5 2

, 039 x 109 chemicals = $5, 672

, 251 ).

Table 15

- B

– Estimated Agency Per Chemical Burden Hour Costs

Activity (a) Managerial Technical Clerical Total $ $1 20

. 33 $7 7

. 85 $4 4

. 06 1) Prepare instructions $2 41 $9 34 $ 88 $1,2 63 2) Identify chemicals to be screened 2 41 1,6 35 8 8 1,9 64 3) Identify recipients 2 41 1,2 46 0 1,4 87 4) Prepare the 408(p) order packages 0 3 11 4 41 7 52 5) Review and approve the orders 2 41 3 11 0 5 52 6) Issue the orders 0 0 26 4 26 4 7) Process initial responses (b) 1 20 3 11 4 4 4 75 8) Provide assistance and follow

- up, as needed 0 2, 803 0 2, 803 9) Identify non

- responders 0 0 4 4 4 4 10) Process Data Submissions 0 6 23 4 4 6 67 11) Analyze data 0 3 4,254 0 3 4,254 12) Incorporate data into risk assessments 0 6, 851 0 6, 851 13) Store data in retrievable system 0 3 11 3 52 6 63

Total Cost: $1,0 84 $4 9,590 $1,3 65 $5 2,039
Key: (a) Activities described in more detail in section 5(a) of this ICR. (b) This estimate includes an estimated burden to provide any additional burden requested for an option.

20 http://www.bls.gov/oes/current/naics4_999100.htmEPA ICR No. 2488.01 June 3, 2013

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 second list of chemicals to be screened under the EDSP are presented in Table 16

- B.

Table 16

- B

– Estimated TOTAL Burden and Costs for Respondents

Respondent Category (a ) Total # Responses (b) Per Response (c) Total (d)

Burden (hours) Cost ($) Burden (hours) Cost ($) Registrants of PAIs IC #1(a)

- Order Recipients 185 204 $ 18,842 37,740 $ 3,485,770 IC #2(a)

- Data Generators/Submitters 41 4

, 729 297,171 193,889 12,184,011 IC #3(a)

- Consortium Participants 185 171 $ 11,930 31,635 2,207,050 Subtotal for Pesticide Active Ingredients: 263,264 $ 17,876,831 Manufacturers/Importers of SDWA Chemicals IC #1(b)

- Order Recipients 815 204 $ 18,842 166,260 $ 15,356,230

IC #2(b)

- Data Generators/Submitters 68 4,729 297,171 3 21

, 572 20,207,628 IC #3(b)

- Consortium Participants 815 171 $ 11,930 139,365 9,722,950 Subtotal for SDWA Chemicals: 627,197 $ 45,286,808

Total: (e) 890,461 $ 63,163,639
Key: (a) Grouped by respondents and according to IC category as presented in section 6(b) of this ICR addendum. (b) From Table 1

- B, includes catch

- up orders. (c) See totals from Tables in section 6(b) of this ICR addendum. (d) Total = (b) x (c) (e) calculated by adding the columns.

Table 17

- B

– Annualized Estimated Total Respondent Burden and Costs for ALL Activities

Respondent Category (a) Total # Responses (b) Per Response (c) Total (d)

Burden (Hours) Cost ($) Burden (Hours) Costs ($) Registrants of Pesticide Active Ingredients IC #1(a)

- Order Recipients

185 68 $6,281 12,580 $1,161,923 Reporting 54 5,030 9,928 930,612

Re cordkeeping 14 1,250 2,652 231,312

Non

- Burden Costs 0 0 0 0 IC #2(a)

- Data Generators/Submitters

41 1,576 $99,057 64,630 $4,061,337 Reporting 1,562 97,803 64,042 4,009,923

Re cordkeeping 14 1,250 588 51,264

Non

- Burden Costs 0 4 0 150 IC #3(a)

- Consortium Participants

185 57 $3,9 77 10,545 $735,683 Reporting (3 rd Party Disclosure) 57 3,977 10,545 735,683

Re cordkeeping 0 0 0 0

Non

- Burden Costs 0 0 0 0 Subtotal for Pesticide Active Ingredients: 87,755 $ 5,958,944 Manufacturers and Importers of SDWA Chemicals IC #1(b)

- Order Recipients

815 68 $ 6,281 55,420 $ 5,118,743 Reporting 54 5,030 43,738 4,099,722

Re cordkeeping 14 1,250 11,682 1,019,022

Non

- Burden Costs IC #2(b)

- Data Generators/Submitters

68 1,576 $ 99,057 107,191 $ 6,735,876 Reporting 1,562 97,803 106,216 6,650,604

Re cordkeeping 14 1,250 975 85,023

Non

- Burden Costs 4 249EPA ICR No. 2488.01 June 3, 2013

Page 42 of 44 Respondent Category (a) Total # Responses (b) Per Response (c) Total (d)

Burden (Hours) Cost ($) Burden (Hours) Costs ($) IC #3(b)

- Consortium Participants

815 57 $ 3,977 46,455 $ 3,240,983 Reporting (3 rd Party Disclosure) 57 3,977 46,455 3,240,983

Re cordkeeping 0 0 0 0

Non

- Burden Costs 0 0 0 0 Subtotal for SDWA Chemicals: 209,066 $15,095,603

Total: (e ) 3,403 $218,629 296,820 $21,054,546
Key: (a) Grouped by respondents and according to IC category as presented in section 6(b) of this ICR addendum. (b) From Table 1

- B, includes catch

- up orders. (c) Calculated by taking the totals from the tables in section 6(b) of this renewal ICR (see also Table 16

- B), and dividing by 3. Numbers are

rounded. (d) Total = (b) x (c) (e) Calculated by adding the columns.

The total potential respondent burden and cost calculated in this ICR addendum involves activities that cannot be accurately divided by or assigned to occur in a particular year. As was done for the existing ICR, the Agency has calculated the total burden and assumes a 3

- year duration of equal effort to calculate an annual burden and costs for this ICR. As such, the total respondent burden and costs for this ICR (as presented in Table 16

- B) is divided by 3 to get an estimated annualized burden of 296,820 ho urs ( 890,461 hours ÷ 3) and an estimated annualized cost of $21, 054,546 ($6 3,163,639 ÷ 3). Included in the

estimated annual cost are non

- burden hours costs associated with delivery of $400 ($1,199 ÷ 3). 21

To calculate the total potential agency burden and c ost over the three years EPA multiplied the per

chemical burden and cost in Tables 14 and 15

- B by the total number of chemicals for a total agency burden of 73,793 hours (677 x 109 chemicals) and a cost of $5, 672

, 251 ($5 2

, 039 x 109 chemicals). Divided by 3 to get an estimated annualized burden of 24,598 hours (7 3

, 793 ÷ 3) and an estimated annualized cost of $1,8 90

, 750 ($5, 672

, 251 ÷ 3).



### 6(e) Changes to Currently Approved ICRs

This request represents an annual burden increase of 296,820 hours from that curren tly in the OMB inventory. This change reflects a program change resulting from the identification of the second list of

chemicals to be screened under the EDSP.



### 6(f) Burden Statement for this ICR

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

4

, 729 hours, depending on the respondent category and activities, with an estimated cost between $1 8

, 842 and $ 297,171 . The total annual burden is estimated to be 296,820 hours, with an annual cost of $21, 054

, 546 . Burden is defined in 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a current and valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection

21 See activity 12 in Tables 10

- B and 11

- B.EPA ICR No. 2488.01 June 3, 2013

Page 43 of 44 techniques, EPA has established a docket for this ICR under D ocket ID No. EPA

- HQ

- OPPT

- 2013

- 0275

, which is available electronically at http://www.regulations.gov . A hard copy of the docket materials are also available for public viewing at the OPPT Docket, which is loc ated 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 v isitor bags are processed through an X

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

Please note that when comments were sought in 2010, the draft ICR was identified under EPA ICR No.

2249.02 and OMB Control No. 2070

- 0176. Public comments were also directed to Docket ID No. EPA

HQ

- OPPT

- 2007

- 1081 , which had been established for the initial ICR related to List 1 chemicals. Given the resulting confusio n in finding documents in that docket, EPA has established a new docket, which is

linked to the old docket. Copies of th is ICR and the related documents are available in th e new docket.

Submit any additional comments to EPA online at http://www.regulations.gov , following the online instructions for viewing documents and submitting comments. Please include the Docket ID No.

EPA

- HQ

- OPPT

- 20 13

- 0275 , and the EPA ICR number (2 488 .0 1 ) in any correspondence. EPA is particula rly interested in comments regarding the Agency 's burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques. If commenting on the burden or costs estimates, please provide sufficient d etail to allow for the proper consideration of
your comment.

Comments can also be sent to the Office of Information and Regulatory Affairs (OIRA) at OMB via

e mail to oira_submission@omb.eop.gov . Please address your comments to the OMB Desk Officer for EPA, and include the EPA Docket ID Number EPA

- HQ

- OPPT

- 2013

- 0275 and OMB Control Number

2070

- NEW in any correspondence.



### 7. List of References

The following is a list of the documents that are specif ically referenced in this Addendum Document

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

- HQ

- O PPT

- 2007

- 1081

.

1. EPA OCSPP, EDSP, Weight

- of

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

- HQ

- OPPT

- 2010

- 0877

- 0021

.
2. EPA. Endocrine Disruptor Screening Program (EDSP); Draft Second List of Chemicals to be Screened; Notice. Federal Register (75 FR 70248, November 17, 2010). http://www.gpo.gov/fdsys/pkg/FR

- 2010

- 11

- 17/pdf/2010

- 28818.pdf

.
3. EPA. Endocrine Disruptor Screening Program (EDSP); Draft Policies and Procedures for Screening Safe Drinking Water Act (SDWA) Chemicals in the EDSP; Request for Comment; Notice (72 FR 70842, November 17, 2010)

. http://www.epa.gov/scipoly/oscpendo/pubs/draft_policies_frn.pdf

.
4. Central Data Excha nge ( CDX ) http://www.epa.gov/cdx/

.EPA ICR No. 2488.01 June 3, 2013

Page 44 of 44 5. Crop Life America

, EDSP Tier 1 Screening; Preliminary Burden Report dated November 2010 submitted by Crop Life America ' s Endocrine Policy Forum. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2007

- 1081

- 0037

.

6. U.S. Postal Service, Online Rate Calculator, as of May 7, 2012. http://postcalc.usps.g ov/

.

7. E PA R eport " Laboratory Testing of Chemicals for Endocrine Disruption Potential

- Analysis of

Market Factors " (October 14, 2009)

. Available in the docket.



### 8. Attachments to This Addendum

The following is a list of the attachments to this addendum. The ICR addendum and the attachments listed below, can be found in the docket for this ICR and are accessible electronically through http://www.regulations.gov

, under Docket ID No.: EPA

- HQ

- OPPT

- 20 13

- 0275 and under Docket ID

N o. : EPA

- HQ

- OPPT

- 2007

- 1081 for the existing ICR materials

.

Attachment Description

A FFDCA sections 408(p), 408(i). Available at http://epw.senate.gov/FDA_001.pdf

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

B (1) EDSP ; Policies and Pro cedures for Initial Screening (April 15, 2009)

. http://www.gpo.gov/fdsys/pkg/FR

- 2009

- 04

- 15/pdf/E9

- 8706.pdf

. (2) EDSP; Policies and Procedures for Screening Safe Drinkin g Water Act (SDWA)

Chemicals ( May 29, 2013 ) [Prepublication Copy]

. C ( 1 ) FIFRA/ FFDCA § 408(p) Order Template for Pesticide Active Ingredients (As of April 15, 2013 )

. ( 2 ) FIFRA/ FFDCA § 408(p) Order Template for Pesticide Inert Ingredients ( As of April 15, 2013). ( 3 ) SDWA/ FFDCA § 408(p) Order Template for SDWA § 1457 Chemicals ( As of April 15, 2013 )

. D (1) EPA Form 6300

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

- In (DCI)

- Initial Response Form for Individual Order Recipients ( As of March 27,2013). (2) EPA Form 6300

- 05

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

- In (DCI)

- Initial Response Form for Consortium/Task Force (As of March 27 , 2013). ( 3 ) EPA Form No. 6 300

- 06 : FFDCA §408(p) Order / SDWA § 1457

- Initial Response

Form f or Individual Order Recipients (March 27

, 2013 ). ( 4 ) EPA Form No. 6300

- 06

- C: FFDCA §408(p) Order / SDWA § 1457

- Initial Response Form for Consortium (EPA Form No. 6300

- 06

- C ) ( March 27, 2013 ).

E Process for Issuing & Responding to EDSP Tier 1 Orders (April 4 , 20 13 ).

F Calculations for Paperwork Burden and Costs for Data Generation Activities (July 30, 2012).

G Final Second List of Chemicals for Tier 1 Screening in the EDSP ( March 29 , 2013 ).

H ICR Final Comment Response Document for the Second List of Chemicals for Tier 1 Screening (March 26, 2013).

I Specific Changes Made to the Forms & Order Templates for EDSP/FIFRA Orders (May 29, 2013)

J EDSP Mock

- up Screenshots (April 3, 2013).