PREPUBLICATION COPY NOTICE:

The EPA Assistant Administrator for the Office of Chemical Safety and Pollution Prevention 

(OCSPP) signed the following notice on May 29, 2013:

Endocrine Disruptor Screening Program; Final Policies and Procedures for 

Screening Safe Drinking Water Act Chemicals; Notice

[EPA-HQ-OPPT-2007-1080; FRL-9375-7]

This is a prepublication version of the document that EPA is submitting for publication in the 

Federal Register. While the Agency has taken steps to ensure the accuracy of this Internet 

version of the document, it is not the official version of the document for purposes of public 

comment. Please refer to the official version of the document that appears in the Federal 

Register , which will also be posted to the docket.

Once the official version publishes in the Federal Register, the public will also be able to access 

the on-line docket for this action at http://www.regulations.gov. You can then use EPA’s 

electronic docket and comment system at www.regulations.gov to view public comments, 

access the index listing of the contents of the docket, and to access those documents in the 

docket that are available electronically.

The docket number for this action is EPA-HQ-OPPT-2007-1080. For further information about 

the docket, please consult the ADDRESSES section in the front of the document.

EPA ICR No. 2488.01; Attachment B(2)
12T-1866

BILLING CODE 6560-50-P

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-1080; FRL-9375-7]

Endocrine Disruptor Screening Program; Final Policies and Procedures for 

Screening Safe Drinking Water Act Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

SUMMARY: This document describes EPA’s final policies and procedures for requiring 

Tier 1 screening under the Endocrine Disruptor Screening Program (EDSP) of chemicals

for which EPA may issue EDSP test orders pursuant to section 1457 of the Safe Drinking 

Water Act (SDWA) and section 408(p) of the Federal Food, Drug, and Cosmetic Act 

(FFDCA). Section 408(p) of the FFDCA directed EPA to develop a chemical screening 

program using appropriate validated test systems and other scientifically relevant 

information (OSRI) to determine whether certain chemicals may have hormonal effects. 

These final policies and procedures supplement the EDSP policies and procedures that 

were published in the Federal Register on April 15, 2009.

FOR FURTHER INFORMATION CONTACT: For technical information contact:

Mike Mattheisen, Chemical Information and Testing Branch (7405M), Office of 

Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-3077; email 

address: mattheisen.mike@epa.gov or Pat West, Office of Science Coordination and 

Policy (7203M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
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Washington, DC 20460-0001; telephone number: (202) 564-1656; email address: 

west.pat@epa.gov.

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South 

Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: 

TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you produce, manufacture, use, or import 

chemicals (including pesticide chemicals) that may be found in sources of drinking water; 

if you manufacture or import chemicals that degrade to chemicals found in sources of 

drinking water; or if you are, or may otherwise be, involved in the testing of chemicals 

for potential endocrine effects. The following list of North American Industrial Classification 

System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help 

readers determine whether this document applies to them. Potentially affected entities may 

include:

• Chemical manufacturers, importers, and processors (NAICS code 325), e.g., 

persons who manufacture, import, or process chemicals.

• Pesticide, fertilizer, and other agricultural chemical manufacturers, importers, 

and processors (NAICS code 3253), e.g., persons who manufacture, import, or process 

pesticide; fertilizer; or agricultural chemicals.

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

who conduct testing of chemicals for endocrine effects.
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To determine whether you or your business may be affected by this action, you 

should carefully examine the applicability provisions in Unit III.C., and examine FFDCA 

section 408(p). If you have any questions regarding the applicability of this action to a 

particular entity, consult either technical person listed under FOR FURTHER 

INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

The docket for this action, identified by docket identification (ID) number EPAHQ-OPPT-2007-1080, is available at http://www.regulations.gov or at the Office of 

Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection 

Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave., 

NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal holidays. The telephone number for the Public 

Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is 

(202) 566-0280. Please review the visitor instructions and additional information about 

the docket available at http://www.epa.gov/dockets.

II. Background 

A. What Action is the Agency Taking?

The Agency is publishing final policies and procedures for issuing EDSP test 

orders for chemicals pursuant to the Agency’s authority under SDWA section 1457 (i.e., 

“SDWA chemicals”). Section 1457 of the SDWA authorizes EPA to issue EDSP test 

orders to manufacturers and importers of chemicals that may be found in sources of 

drinking water and to which a substantial population may be exposed (42 USC 300j-17). 

SDWA chemicals encompass a wide variety of chemicals, including industrial and 
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pesticide chemicals, ingredients in pharmaceuticals and personal care products, and 

degradates. 

These SDWA/FFDCA policies and procedures supplement the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA)/FFDCA policies and procedures 

that were published in the Federal Register issue of April 15, 2009 (FIFRA/FFDCA 

policies and procedures) (Ref. 1). The FIFRA/FFDCA policies and procedures (Ref. 1) 

were developed primarily for the issuance of EDSP test orders on pesticide active and 

inert ingredients, which were the chemicals comprising the first EDSP chemical list (first 

list). Consequently, some of the FIFRA/FFDCA policies and procedures (Ref. 1) reflect 

issues uniquely associated with the pesticide market and the specific regulatory context 

under which EPA regulates pesticide chemicals. In this document, EPA describes the 

policies and procedures associated with the screening of SDWA chemicals, which 

include certain modifications to the FIFRA/FFDCA policies and procedures that are 

intended to address issues that are unique to SDWA chemicals, or to address the 

circumstances where other competing considerations for SDWA chemicals warrant a

modification of the FIFRA/FFDCA policies and procedures.

This document discusses the policy considerations for SDWA chemicals in the 

following areas: 

• Who would receive EDSP test orders for SDWA chemicals? Unit VI.A.

• How will recipients of EDSP test orders for SDWA chemicals be notified? Unit

VI.B.

• How will the public know who has received an EDSP test order for a SDWA 

chemical or who has supplied data? Unit VI.C.
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• How will the Agency minimize duplicative testing? Unit VI.D.

• What are the potential responses to EDSP test orders for SDWA chemicals?

Unit VI.E.

• How can an EDSP test order responses and data be submitted electronically?

Unit VI.F.

• How will EPA facilitate joint data development, cost sharing, and data 

compensation for SDWA chemicals? Unit VI.G.

• What procedures can EPA apply for handling Confidential Business Information 

(CBI) for SDWA chemicals? Unit VI.H.

• What is the process for contesting an EDSP test order or consequences for 

failure to respond or comply with an EDSP test order? Unit VI.I.

• What is the informal administrative review procedure? Unit VI.J.

• What are the adverse effects reporting requirements? Unit VI.K.

While the FIFRA/FFDCA policies and procedures (Ref. 1) remain relevant, 

SDWA chemical EDSP test order recipients are encouraged to refer to this document to 

fully understand all of the relevant policies and procedures. In addition, a new EDSP test 

order template for issuance of EDSP test orders under SDWA section 1457 and FFDCA 

section 408(p)(5) is available in the docket for this document (Ref. 2). 

EPA is publishing two related notices elsewhere in this Federal Register issue.

One announces the final second EDSP chemical list (second list), which includes both 

SDWA chemicals and pesticide active ingredients (PAIs). The other announces the 

submission to the Office of Management and Budget (OMB) of the final Information 
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Collection Request (ICR) Addendum that describes the estimated paperwork burden and 

costs associated with the second list. 

B. What are the Statutory Authorities for the Policies Discussed in this Document?

SDWA is the primary Federal law that ensures the quality of Americans’ drinking 

water. Under SDWA, EPA sets standards for drinking water and works closely with 

States, localities, and water suppliers to implement these standards. SDWA authorizes 

EPA to set national standards for drinking water to protect against both naturally

occurring and man-made contaminants that may be found in drinking water (42 U.S.C. 

300g-1).

Section 1457 of SDWA authorizes EPA to require testing, under FFDCA section 

408(p) (21 U.S.C. 346(a)(p)), of any chemical that may be found in sources of drinking 

water if the EPA Administrator determines that a substantial population may be exposed 

to such chemical (42 U.S.C. 300j-17). 

Section 408(p)(1) of FFDCA requires EPA “to develop a screening program, 

using appropriate validated test systems and other scientifically relevant information, to 

determine whether certain substances may have an effect in humans that is similar to an 

effect produced by a naturally occurring estrogen, or such other effects as [EPA] may 

designate” (21 U.S.C. 346a(p)(1)).

Section 408(p)(3) of FFDCA expressly requires that EPA “shall provide for the 

testing of all pesticide chemicals” (21 U.S.C. 346a(p)(3)). Section 201 of FFDCA defines 

“pesticide chemical” as “any substance that is a pesticide within the meaning of [FIFRA], 

including all active and pesticide inert ingredients of such pesticide” (21 U.S.C. 

231(q)(1)). 
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Section 408(p)(5)(A) of FFDCA provides that the EPA Administrator “shall issue 

an order to a registrant of a substance for which testing is required under [FFDCA section 

408(p)], or to a person who manufactures or imports a substance for which testing is 

required under [FFDCA section 408(p)], to conduct testing in accordance with the 

screening program ..., and submit information obtained from the testing to the 

Administrator, within a reasonable time period that the [Agency] determines is sufficient 

for the generation of the information” (21 U.S.C. 346a(p)(5)(A)). 

The statutes discussed in this unit provide EPA with the discretion to require 

testing of a pesticide chemical under FFDCA alone, or in any combination of the various 

authorities (e.g., FIFRA/FFDCA, SDWA/FFDCA, or FIFRA/SDWA/FFDCA).

Section 408(p)(5)(B) of FFDCA requires that, “to the extent practicable, the 

Administrator shall minimize duplicative testing of the same substance for the same 

endocrine effect, develop, as appropriate, procedures for fair and equitable sharing of test 

costs, and develop, as necessary, procedures for handling of confidential business 

information” (21 U.S.C. 346a (p)(5)(B)).

Section 408(p)(5)(D) of FFDCA provides that any person (other than a registrant) 

who fails to comply with a FFDCA section 408(p)(5) test order shall be liable for the 

same penalties and sanctions as are provided for under section 16 of the Toxic Substances 

Control Act (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 TSCA 

section 16, civil penalties of up to $37,500 per day may be assessed, after notice and an 

administrative hearing held on the record in accordance with section 554 of the 

Administrative Procedure Act (APA) (15 U.S.C. 2615(a)(1)-(2)(A)).
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In addition, Congress’s House Appropriations Committee Report (H. Rept.) for 

EPA's FY 2010 appropriations (Ref. 3), directed EPA “to publish within 1 year of 

enactment a second list of no less than 100 chemicals for screening that includes drinking 

water contaminants, such as halogenated organic chemicals, dioxins, flame retardants 

(PBDEs, PCBs, PFCs), plastics (BPA), pharmaceuticals and personal care products, and 

issue 25 orders per year for the testing of these chemicals.”

C. Does this Document Contain Binding Requirements?

While the requirements in the statutes and in any EDSP test orders ultimately 

issued under FFDCA section 408(p) are binding, the policies and procedures outlined in 

this document are not. The policies and procedures outlined in this document merely 

represent the general procedures and statutory interpretations on which EPA may rely to 

implement the existing goals of the statutory program. However, neither EPA nor any 

outside party is bound by any of the policies and procedures outlined in this document.

Accordingly, these policies and procedures may be modified at any time by EPA and the 

Agency may depart from these policies and procedures where circumstances warrant and 

without prior notice. 

III. Background on EDSP 

A. What is EDSP?

EPA developed EDSP in response to a Congressional mandate in FFDCA “to 

determine whether certain substances may have an effect in humans that is similar to an 

effect produced by naturally occurring estrogen, or such other endocrine effect as [EPA] 

may designate” (21 U.S.C. 346a(p)). As part of EDSP, EPA issues orders to collect 

certain test data on selected chemicals. In general, EPA intends to use the data collected 
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under EDSP, along with other information, to determine if a pesticide chemical, or other 

chemicals, may pose a risk to human health or the environment due to disruption of the 

endocrine system. The determination of whether a chemical has the potential to interact 

with the endocrine system will be made on a weight of evidence basis taking into account 

data from the Tier 1 assays and/or OSRI. Chemicals that go through Tier 1 screening and 

are found to have the potential to interact with the estrogen, androgen, or thyroid 

hormone systems will proceed to the next stage of EDSP where EPA will determine 

which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing 

is designed to identify any adverse endocrine-related effects caused by the chemical, and 

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

information regarding EDSP and requirements for Tier 1 and Tier 2 can be found on the 

Agency’s EDSP website (Ref. 4). EPA is aware of no issue specific to the chemicals in 

the second list that would warrant any modification to the existing testing scheme, and is 

not proposing to adopt any.

B. Why is EPA Publishing Additional Policies and Procedures for EDSP Tier 1 

Screening?

As stated in the FIFRA/FFDCA policies and procedures (Ref. 1), EPA intended to 

develop EDSP policies and procedures that could be used in subsequent data collection 

efforts, including those under SDWA, but indicated that EPA may make modifications as 

appropriate. The Agency now believes that modifications are needed to address issues 

that are specific to the larger universe of chemicals that are potentially subject to EDSP 

testing under SDWA. 

The FIFRA/FFDCA policies and procedures (Ref. 1) were originally developed 

for screening of pesticide chemicals and relied, in part, on a regulatory context that is 
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specific to pesticide chemicals. The presumptions applicable in that context are not 

necessarily applicable to this larger universe of chemicals. 

For example, much of the data that would be generated in response to an EDSP 

test order (particularly for pesticide active ingredients) would be entitled to the data 

compensation protections available under FIFRA (7 U.S.C. 136a(c)(1)(F)) and FFDCA 

(21 U.S.C. 346a(i)). Additionally, FIFRA section 10 prohibits EPA from releasing study 

data on pesticide chemicals unless the person seeking access to the information certifies 

that he is not an agent or employee of any multinational pesticide company (7 U.S.C. 

136h(g)). Because FFDCA section 408(p) did not authorize EPA to modify these FIFRA 

requirements, EPA needs to ensure that the policies and procedures adopted to implement 

FFDCA section 408(p) would operate in a manner that would be consistent with EPA’s 

existing FIFRA mandates. Moreover, EPA could rely on the existing FIFRA mechanisms 

to effectively minimize duplicative testing, and to promote cost-sharing. 

By contrast, these considerations are generally not applicable to the majority of 

chemicals that may be subject to EDSP screening under SDWA, such as chemicals used 

in pharmaceuticals and personal-care products, among others. 

In addition, the statutory authority for imposing testing of SDWA chemicals, the 

sources of SDWA chemicals, and EPA’s ability to identify manufacturers and importers, 

and other considerations unique to SDWA chemicals, create a need for policies and 

procedures specific to EDSP screening under SDWA/FFDCA authority. For example, 

some registered pesticide ingredients have additional uses that account for a much larger 

percentage of total manufacture and import. In such cases, the Agency seeks to be able to 
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identify, and issue orders to, all relevant manufacturers and importers in a manner that 

creates a fair and level playing field for complying with the order.

C. When Do These Policies and Procedures Apply?

EPA has the discretion to issue EDSP test orders under the authorities of SDWA 

section 1457 and FFDCA section 408(p) for all chemicals, including PAIs, for which the 

Agency can make the requisite factual findings. As described in this document, however, 

EPA generally intends to use SDWA authority to require EDSP testing of SDWA 

chemicals that are not PAIs and FIFRA authority to require EDSP testing of PAIs and 

pesticide inerts, even if the PAIs and inerts have non-pesticide uses. EPA may issue 

SDWA/FFDCA EDSP test orders for PAIs and inerts that have non-pesticide uses, 

except, when PAI registrants avoid EDSP testing by canceling their registrations and 

leaving the market. This approach will preserve familiar data compensation and 

confidentiality protections established in FIFRA sections 3(c)(1)(F) and 12, as well as 

FFDCA section 408(i), for pesticide registrants. 

IV. EDSP Policies and Procedures Considerations for SDWA Chemicals

The Agency used the following policies and procedures considerations to guide 

development of policies and procedures for issuing Tier 1 EDSP test orders on SDWA 

chemicals:

• A core part of EPA’s mission is to promote public understanding of the potential 

risks posed by chemicals in commerce.

• The basis for an order with respect to SDWA chemicals is that a chemical may 

be found in sources of drinking water and a determination that a substantial population 

may be exposed to such chemical. Thus, SDWA/FFDCA policies and procedures should 
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not be unnecessarily tied to the use of the chemical in any given market and should 

instead focus on obtaining data from companies that might be expected to contribute to a 

chemical’s presence in drinking water.

• For simplicity, policies and procedures for SDWA chemicals should be 

consistent with FIFRA/FFDCA policies and procedures (Ref. 1) unless there is a reason 

for modifying them (e.g., different statutory requirements), though for clarity EPA has 

written these SDWA/FFDCA policies and procedures as a complete, stand alone 

document.

• Procedures for EDSP testing of SDWA chemicals should strive to minimize 

duplicative testing and promote fair and equitable sharing of test costs, as described in 

FFDCA section 408(p)(5)(B).

• The Agency expects to issue SDWA/FFDCA EDSP test orders for pesticide 

inert ingredients that are listed for EDSP screening with a SDWA section 1457 finding; it 

has also been the Agency’s experience that pesticide inerts generally have a much larger 

market than solely as ingredients in pesticide formulations. For these reasons EPA 

believes it is reasonable and equitable to initially issue SDWA/FFDCA EDSP test orders 

on SDWA chemicals that are not PAIs.

• As noted previously, EPA intends to require EDSP testing pursuant to FIFRA 

and FFDCA for registrants of a pesticide chemical, even if the chemical has non-pesticide 

uses. If, however, recipients of such EDSP test orders fail to provide the required 

information by dropping out of the pesticide market to avoid EDSP testing, EPA may 

choose to reissue EDSP test orders under SDWA/FFDCA authority if the SDWA criteria 
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are met. EPA would then rely on the policies and procedures established in this 

document. 

V. Discussion of Final SDWA/FFDCA Policies and Procedures and Response to 

Comments

This document adopts the proposed SDWA/FFDCA policies and procedures

published in the Federal Register issue of November 17, 2010 (Ref. 5), with minor 

revisions. The Agency reviewed and considered all of the comments that were received 

on the proposed SDWA/FFDCA policies and procedures. All of the comments received 

are available in the docket for this document, and a response-to-comments document 

(Ref. 6) that summarizes and responds to all of the comments received on the proposed 

SDWA/FFDCA policies and procedures is also available in the same docket. The 

Agency specifically requested comments on five topics: Response option to cease 

manufacture; persistence; catch-up orders and data compensation; orphan chemicals; and 

electronic notification. The Agency’s consideration of such comments is described in 

this unit and the Agency’s response to comments document (Ref. 6).

A. Response Option to Cease Manufacture

EPA sought comment on whether a company could satisfy the EDSP test order 

simply by committing to stop manufacturing or importing a SDWA chemical, because, in 

ceasing to manufacture the chemical, the company thereby stops contributing to the 

presence of the chemical in the source of drinking water and reduces potential exposure. 

Alternatively, EPA sought comment on whether the company should be required to 

conduct the EDSP testing nevertheless, on the grounds that the company should not be 

able to evade responsibility for providing the data necessary to evaluate the existing 

water contamination to which their manufacturing activities had contributed. 
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Multiple commenters (the American Petroleum Institute (API), the American 

Chemistry Council (ACC), Bayer CropScience LP (BCS), Croplife America (CLA), and 

the Chemical Producers and Distributors Association (CPDA)) agreed with EPA’s 

proposal to allow a EDSP test order recipient for the second list to comply with an EDSP

test order by ceasing all manufacturing of the listed chemical, because former 

manufacturers will not receive any new income from the chemical to pay for the new 

EDSP testing requirement and language in the statute refers to manufacture and 

production in the present tense. The San Francisco REACH Team (SFRT) requested that 

EPA’s EDSP test order procedures be revised to include a clear timeline for when the 

production must cease.

EPA intends to allow a SDWA EDSP test order recipient for the second list to 

comply with the test order by ceasing all manufacturing, including manufacturing for 

export only, and importing of the listed chemical. EPA considers this approach to be 

consistent with the language of the statute and with the decision to accept pesticide 

cancellation as an acceptable response to an EDSP test order issued under FIFRA. EPA 

will require recipients to provide a timeline for the cessation of production as part of the 

explanation and documentation supporting the claim. Rather than specifying a single 

timeline, the Agency will take individual circumstances into account, essentially using 

the same procedure it applies to accepting pesticide cancellations as an acceptable 

response to an EDSP test order on a pesticide active ingredient. 

The American Water Works Association (AWWA) commented that an EDSP test 

order recipient should not be allowed to respond by ceasing manufacture, observing that 
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this would not absolve them from having contributed to the presence of the chemical in 

the environment, and that it might persist in the environment. 

While the comment has merit, EPA has decided that, in this instance, the equities 

weigh in favor of allowing companies to satisfy the order by entirely ceasing to 

manufacture the chemical. As discussed in the draft SDWA/FFDCA policies and 

procedures (Ref. 5), a number of considerations weigh against requiring manufacturers 

who choose to cease manufacture of the chemical to nevertheless conduct EDSP testing. 

Specifically, if an EDSP test order recipient stops manufacturing and importing a 

chemical, it will ultimately lead to less exposure to the chemical in sources of drinking 

water. (The decline will happen at different rates, depending on the chemical and whether 

the chemical is found in surface water or ground water.) Moreover, an order recipient 

who ceases to manufacture or import a chemical that is subject to EDSP testing will no 

longer receive any economic benefit from the sale of the chemical with which to defray 

the cost of testing. This approach will effectively focus the costs on those companies that 

can best bear the costs of testing. Further, as discussed in this unit, EPA has been unable 

to develop an effective mechanism for issuing EDSP test orders to past registrants, 

manufacturers, and importers given the practical, legal, and equitable difficulties of 

identifying and assessing the contributions of past participants. However, if EPA is 

unable to obtain information on most chemicals for which there is continued and ongoing 

significant exposures, EPA may revisit the issue.

B. Persistence

EPA sought comment on whether, and how, to factor chemical persistence into 

EDSP policies and procedures to account for the contribution associated with past 
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registrants, manufacturers and importers, to the presence of a chemical in a source of 

drinking water, given that the Agency’s policy has been to only issue orders to current 

registrants, manufacturers, and importers. 

Multiple commenters (API, People for the Ethical Treatment of Animals (PETA)

and the Physicians Committee for Responsible Medicine (PCRM), ACC, BCS, and CLA 

and the Endocrine Policy Forum (EPF)) indicated that EPA should not consider a 

chemical’s persistence in the environment when implementing EDSP, noting among 

other things that “persistence” does not appear in the language of the FFDCA and 

asserting that it is subject to differing interpretations. Commenters observed that the issue 

of persistence is most likely to arise only for chemicals that have not been manufactured 

and used by anyone for a significant period of time (i.e., “legacy chemicals”). Some 

commenters observed EPA would have to develop a legal and equitable process for 

identifying those chemicals along with all past manufacturers and importers, many of 

whom may not have manufactured or imported the chemical for decades. 

Two commenters (SFRT and AWWA) advocated that EPA should hold 

accountable all past registrants, manufacturers, and importers that have contributed to 

health and environmental impacts from past production activities, even if they are no 

longer actively manufacturing or importing a particular chemical, because chemicals 

persist in the environment, the consequences often become apparent decades after the 

cessation of exposure to a chemical, and companies should share the cost of generating 

data. 

Under SDWA, EPA issues an EDSP test order based upon a finding that a 

chemical “may be found in sources of drinking water” and “that a substantial population 
17

may be exposed.” While EPA believes that persistence can be defined (persistence is a 

factor in a variety of EPA’s water and toxics programs; e.g., 40 CFR 125.122, 141.24, 

711.6, 792.3, 795.70, 796.1050, 798.2250, and 799.5075), SDWA does not explicitly 

address how to factor in the possible presence of a chemical in a source of drinking water 

from past manufacturing and importing. And, although, EPA believes that the potential 

long term impacts of a persistent chemical in sources of drinking water is an important 

consideration, EPA has not been able to develop an effective mechanism for issuing 

EDSP test orders to past registrants, manufacturers, and importers given the practical, 

legal, and equitable difficulties of identifying and assessing the contributions of past 

participants. Accordingly, EPA does not intend at this time to issue test orders to entities 

other than current registrants, manufacturers, and importers. 

For more information on how EPA addresses commenters’ concerns about 

chemical persistence, see the comment response document for the second list of 

chemicals (Ref. 7).

C. Catch-up Orders and Data Compensation

EPA sought comment on “whether 5 years is the appropriate length of time that 

the Agency should continue to issue SDWA/FFDCA catch-up orders as a means to 

ensure equitable sharing of test costs.” (Five years is the length of time that data 

compensation is available for test rules issued under TSCA section 4. (See 40 CFR part 

791.))

The Methanol Institute argued that SDWA chemicals should be entitled to the 

same 15-year compensation period as pesticide chemicals, stating there was no logical 

reason to distinguish between SDWA chemicals and pesticide chemicals since both 
18

categories of chemicals are being subjected to the same testing requirements pursuant to 

the same legislative enactment. The SFRT and the ACC took similar positions. In 

addition, the 15-year compensation period applies to industrial chemicals used as inerts in 

pesticides as well. 

After carefully considering these comments and the equities involved, EPA has 

concluded that the most appropriate length of time to issue SDWA/FFDCA catch-up

orders is in fact the same 15-year compensation period as for active and inert pesticide 

chemicals because it will provide a consistent standard across the entire EDSP. Neither 

SDWA nor the FFDCA authorized EPA to identify manufacturers or importers of SDWA 

chemicals through mandatory registration provisions, such as those that apply to pesticide 

registrants. Furthermore, an inconsistency would develop if SDWA chemicals are not 

entitled to the same 15-year compensation period as the first list of chemicals, pesticides, 

particularly if they are mandates to the same testing requirements pursuant to the same 

legislative enactments. 

D. Orphan Chemicals

EPA sought comment on the mechanisms available for testing chemicals for 

which EDSP test orders do not generate the necessary data. 

AWWA asserted that water utilities are not manufacturers that can be required to 

test under FIFRA or TSCA, so disinfection byproducts and arsenic and other naturally 

occurring chemicals should be considered orphan chemicals and EPA should screen and 

test those chemicals itself. 

The BCS, PETA, and PCRM interpreted orphan chemicals as those chemicals no 

longer being produced or imported and reasoned that as environmental exposures to such 
19

chemicals would decrease over time, testing of such chemicals should not be required and 

resources to conduct testing should not be expended either by private parties or by the 

Agency without a documented rationale for why potentially harmful endocrine effects 

might be anticipated. 

Exposure to chemicals that are no longer being produced or imported may not 

decrease over time if the chemicals occur naturally or are persistent and bioaccumulative. 

However, exposure also will not increase from any continuing manmade contribution to 

environmental loading. As discussed in Unit V.A., EPA has not been able to develop an 

effective mechanism for issuing EDSP test orders to past registrants, manufacturers, and 

importers, and has, therefore, concluded not to issue test orders for chemicals that are no 

longer being manufactured or imported (see Unit V.B.). In addition, without reaching any 

conclusion with respect to whether water utilities can ever be manufacturers, EPA has not 

sought to require the testing of disinfection byproducts and arsenic or other naturally 

occurring chemicals as part of this second list of chemicals, but this issue warrants 

additional consideration.

E. Electronic Notification

EPA sought comment on whether companies that already have a Central Data 

Exchange (CDX) account with EPA would prefer to receive an EDSP notification 

electronically as opposed to notification by means of the U.S. Postal Service, either as a 

standard procedure or by request, and on mechanisms by which EPA could accurately 

document the receipt of orders through electronic reporting mechanisms.
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API commented that it generally supported electronic reporting but, for EDSP, 

recommended that electronic notification be optional, since there have been technical 

problems with electronic reporting in other EPA programs. 

Electronic reporting has become the standard mode of operation in business and 

government and provides overwhelming advantages over paper submissions. The OPPT’s 

premanufacture notice (PMN) and Chemical Data Reporting (CDR) rules (formerly 

known as the Inventory Update Reporting (IUR) rule) already require use of the Internet 

to electronically report. OPPT has also proposed additional electronic reporting 

requirements (Ref. 8). 

Electronic reporting requires use of EPA's CDX, the point of entry on the 

Environmental Information Exchange Network for environmental data submissions to the 

Agency. Currently, CDX has provided stakeholders with the ability to: 

1. Submit data through one centralized point of access and fill out a single 

electronic form which can be submitted instantaneously instead of mailing multiple paper 

forms.

2. Receive Agency confirmation when submissions are received.

3. Reduce costs associated with submitting and processing data submissions.

4. Pay fees through https://www.pay.gov.

5. Utilize publishing services to share information collected by EPA with other 

stakeholders.

In an effort to streamline the reporting process, reduce the administrative costs, 

and maintain consistency with other electronic reporting of information submissions and 

recordkeeping (Ref. 8), EPA will require EDSP test order information to be submitted 
21

electronically. EPA will continue to issue EDSP test orders by U.S. Postal Service for the 

second list of chemicals.

F. Identification of EDSP Test Order Recipients

Though EPA did not specifically request comment on the identification of EDSP 

test order recipients, some comments were received. 

API agreed with EPA that the CDR rule is the appropriate source for identifying 

current chemical manufacturers and importers, but recommended that EPA only use the 

Toxics Release Inventory (TRI) as a last resort, because TRI was less specific. AWWA

commented that EPA should clarify what entities the EDSP test orders apply to by 

defining all terms describing potentially affected entities. The ACC commented that EPA 

should pay close attention to manufacturing and other activities that contribute to the 

occurrence of chemicals in drinking water to which a substantial population may be 

exposed, with an emphasis on the equitable sharing of the cost of testing. 

EPA believes it is “important to identify and issue orders to all significant 

manufacturers and importers of a listed chemical” and the Agency intends to rely on the 

CDR rule, which periodically requires manufacturers and importers to report chemical 

production information to EPA for chemicals manufactured (including imported) in 

amounts of 25,000 lb or more at a single site. EPA considers the CDR rule to be a reliable 

means of identifying manufacturers and importers of non-pesticide, industrial chemicals 

and believes that the CDR rule generally accounts for most of such chemicals in 

commerce. EPA intends to use other, publicly available databases, such as, but not 

limited to, TRI, to identify possible EDSP test order recipients. EPA disagrees that the 

TRI data are imprecise. TRI data are reported annually and reporters must indicate if they 
22

manufacture, including import, a listed chemical as well as more specific information on 

the manufacture of the chemical. EPA is aware that any given database, including CDR 

and TRI, is imperfect and has limitations. On the whole, however, EPA believes that 

CDR and TRI constitute comprehensive and generally reliable databases. Moreover, no 

commenter disagreed with EPA’s assessment or submitted any information to rebut 

EPA’s conclusions. 

In addition, EPA believes that relying on these databases effectively addresses the 

AWWA request that EPA clarify the entities that will be subject to EDSP test orders, and 

for a definition of all terms describing potentially affected entities. The rules that 

establish the reporting requirements for these databases (40 CFR parts 372 and 711) 

already include definitions of all of the necessary terms and should be already familiar to 

the regulated community. Nonetheless, EPA asked for, and continues to be interested in 

learning about, any other credible source or method that may be used to identify EDSP 

test order recipients. In the final analysis, the objective is to identify responsible 

manufacturers and importers of relevant chemicals, and not to apportion responsibility. 

EDSP test order recipients may combine in consortia to conduct the required testing on 

whatever basis they find most suitable. 

SFRT asked that EPA “incorporate a system which takes into account the location 

of chemical manufacturers and potential disproportionate burden on neighboring 

communities, in addition to production volume, when issuing test orders” in order to 

“account for the unequal geographic distribution of manufacturing locations of these 

chemicals and the potential impact of neighboring communities from a chemical’s 

presence in the drinking water among other sources.” SFRT also recommended that, in 
23

order to “avoid disproportionate burdens and promote equitable responsibility among 

manufacturers,” EPA issue EDSP test order to “all manufacturers of listed chemicals... 

with the exception of manufacturers using small quantities of the listed chemical 

(reported in grams instead of lbs.) for research and development purposes only.”

EPA believes it is “important to identify and issue orders to all significant 

manufacturers and importers of a listed chemical.” The Agency intends to rely on the 

CDR rule, as well as TRI, both of which periodically require manufacturers and 

importers to report chemical production information to EPA for chemicals manufactured 

(including imported) in amounts of 25,000 lb or more at a single site. EPA considers the 

CDR rule to be the most reliable means of identifying “significant” manufacturers and 

importers of non-pesticide, industrial chemicals and believes that the CDR rule generally 

accounts for most of such chemicals in commerce. It is unclear what the commenter 

intends by requesting that EPA require self-disclosure in this context, as the only vehicle 

for requirements relating to EDSP testing in this context will be the EDSP test orders, and 

EPA can only issue the orders to those manufacturers it can identify. Nonetheless, EPA is 

interested in finding other existing sources for reliably identifying EDSP test order 

recipients and will consider issuing EDSP test orders to other significant manufacturers 

and importers that are identified. EPA, however, does not intend to issue test orders to 

companies that only manufacture and/or import a chemical in small amounts for research 

and development or in amounts more appropriately measured in grams rather than 

thousands of pounds. Issuing EDSP test orders based on the geographic distribution of 

manufacturing locations and potential impact of chemicals on neighboring communities 

is, at least, not an express part of the basic requirement that EPA identify and issue EDSP 
24

test orders to chemical manufacturers and importers and would add another complex and 

potentially burdensome requirement to the issuance of EDSP test orders that appears 

unnecessary and unlikely to achieve the primary goal of the program: To obtain the 

necessary data to evaluate the endocrine potential of pesticide chemicals and drinking 

water contaminants. 

G. Other Topics

1. Cost sharing. ACC, CLA, EPF, and CPDA stated that EPA had developed a 

workable data compensation and cost sharing plan and agreed with EPA’s decision to 

issue catch-up orders to require cost sharing by manufacturers and importers who enter 

the market after initial orders are issued (but suggested that such orders be issued for 10

instead of 5 years), but recommended that EPA develop new procedures in the form of 

explicit, legally enforceable compensation rights to ensure fair and equitable sharing of 

test costs. 

Section 408(p) of FFDCA only authorizes EPA to create procedures that operate 

within the confines of existing statutory authority and to develop procedures to facilitate 

joint data generation. EPA, however, is authorized to determine what actions comply 

with a FFDCA section 408(p) test order and intends to use this discretion to create strong 

incentives for companies to jointly volunteer to develop EDSP test data under the 

circumstances enumerated in Unit VI.G.

2. Minimizing duplicative testing. PETA and the PRCM commented that EPA 

should mandate, and create incentives to form testing consortia. 

EPA does not have the authority to compel EDSP test order recipients to join 

testing consortia to minimize testing, but may develop procedures to facilitate joint data 
25

generation. In particular, EPA has the discretion to determine what constitutes 

compliance with an EDSP test order and can exercise that discretion to allow cost sharing 

and the joint electronic submission of data by EDSP test order recipients, in appropriate 

circumstances, to reduce costs and duplicative testing. EPA intends to continue to list 

other manufacturers and contact information in each EDSP test order as well as providing

such information on the Agency’s EDSP website. 

3. CBI. SFRT commented that EPA should strictly disallow CBI claims. The 

ACC, CLA, and EPF commented that FFDCA authorized, and EPA should provide, 

EDSP-specific CBI protection, which was critical to protect industry’s legitimate 

intellectual property interests. 

FFDCA does not authorize EPA to either create new rights or to modify existing 

rights to confidentiality. Rather, FFDCA only directs EPA to apply the confidentiality 

provisions in existing statutory authorities: FIFRA, the Freedom of Information Act 

(FOIA), and the Trade Secret Act (TSA), as applicable. SDWA, in particular, only 

authorizes EPA to apply CBI protection under the TSA. Data submitted to EPA in 

response to an order issued under SDWA/FFDCA for non-pesticide chemicals, for 

example, would only have the protections provided under FOIA and TSA. 

4. Adverse effects reporting. ACC commented that EPA has not, but should, give 

clear guidance on the significance of positive Tier 1 test results for TSCA section 8(e) 

and FIFRA section 6(a)(2) reporting purposes. 

EPA made a considered decision not to reinterpret the existing requirements for 

Tier 1 data, nor to otherwise take steps to amend the existing requirements. Rather, EPA 

referenced the existing regulatory provisions of 40 CFR part 159 and existing 
26

interpretations of TSCA section 8(e). In general, EPA does not believe that data from a 

single Tier 1 assay that provides some evidence that a chemical may have the potential to 

interact with the endocrine system necessarily meets the standard for information that 

must be reported in accordance with FIFRA section 6(a)(2) or TSCA section 8(e) in all 

cases. In addition, EPA believes that it has not yet accumulated adequate experience with 

the Tier 1 results to be able to provide general guidance as to the significance of positive 

results from Tier 1 assays for purposes of the reporting requirements under FIFRA 

section 6(a)(2) or TSCA section 8(e). Under existing procedures, the determination to 

report is to be made by the company in the first instance, on a case-by-case basis, taking 

into account all circumstances, and EPA is not aware of any reason to change that with 

respect to EDSP data. Accordingly, to the extent that Tier 1 information meets the 

standards laid out in EPA’s regulations (40 CFR part 159), or falls within the categories 

described in EPA’s past statements regarding TSCA section 8(e) (Ref. 9), that 

information should continue to be reported, consistent with those requirements.

Any information previously submitted to EPA under FIFRA section 6(a)(2), 

TSCA section 8(c), or TSCA section 8(e) need not be resubmitted to EPA in response to 

an EDSP test order, because EPA would already have the data. 

5. Public availability of information. SFRT commented that the EDSP test data on 

SDWA chemicals should be made publicly available on EPA’s website. 

EPA intends to make all non-confidential EDSP data publicly available on the 

Agency’s EDSP website. However, TSA and FOIA may apply and provide some 

protections against disclosure and it may not be possible to publicly post all available 

data. Nonetheless, EPA expects that confidential data will be limited, and health and 
27

safety data for chemicals on the non-confidential TSCA Chemical Substance Inventory

(TSCA Inventory) of existing chemicals, which all of the SDWA chemicals are, may not 

be entitled to confidential treatment.

6. OSRI and Weight-of-Evidence (WoE). ACC, CLA, EPF, and CPDA 

commented that EPA’s offer to accept OSRI in lieu of EDSP test data was justified, but 

that EPA had not clearly articulated a basis for evaluating OSRI. ACC, CLA, EPF, and 

CPDA also commented that EPA needed to develop meaningful WoE guidelines for 

assessing voluminous Tier 1 EDSP data to determine whether a chemical interacts with 

the endocrine system and publish peer reviewed guidance for conducting WoE 

evaluations. 

EPA issued guidance on OSRI for Tier 1 test orders in 2009 (Ref. 10) and on

WoE approach evaluating Tier 1 screening results in 2011 (Ref. 11).

7. Communications: Consistent use of language and definitions. API, ACC, CLA, 

and EPF commented that, given the sensitivity of the issue of endocrine disruption, EPA 

should be careful to use clear and accurate definitions for all important EDSP terms and 

to communicate clearly, accurately, and consistently to the public and within the Agency 

in order to avoid confusion and misunderstanding. 

EPA generally agrees with these comments and has made every effort to be as 

clear, concise, and unambiguous as possible. EPA has, for example, generally adhered to 

widely accepted definitions, such as the World Health Organization’s (WHO) definition 

of “endocrine disruptor” as “an exogenous substance or mixture that alters function(s) of 

the endocrine system and consequently causes adverse health effects in an intact 

organism” (Ref. 12). EPA has also repeatedly cautioned that the public should not 
28

presume that the listing of a chemical or substance indicates in any way that EPA 

currently suspects that such chemical or substance interferes with the endocrine systems 

of humans or other species. EPA plans on maintaining these communications in future 

EDSP documents. See also EPA’s response to comments documents (Refs. 7 and 13).

8. Schedule. API, SFRT, ACC, BCS, CLA, EPF, and CPDA commented that EPA 

should not issue EDSP orders for the second list of chemicals or for Tier 2 testing until 

the data from the first list had been evaluated and the Tier 1 assays had been examined in 

light of those data.

The Agency intends to complete review of the Tier 1 data from the EDSP test 

orders issued for the first list of EDSP chemicals before issuing Tier 1 test orders for the 

second list of EDSP chemicals. EPA intends to continue to rely on the available validated 

methods and to follow the recommendations in the 1999 report from the joint meeting of 

the Agency’s Science Advisory Board (SAB) and FIFRA Scientific Advisory Panel 

(SAP) (Ref. 14). The steps for this process are described in the EDSP Comprehensive 

Management Plan issued in 2012 (Ref. 15). With these recommendations, the Agency 

improves the validating screening and testing methods to develop complete information 

on chemicals being tested. In continuing with this process of developing efficiency, the 

Agency does not intend to release any finalized EDSP Tier 1 WoE decisions until the 

EDSP Tier 2 protocols are available. 

9. Enforcement. SFRT commented that EPA should enact a system of graduated 

penalties for noncompliance with testing requirements based on the length of delay in 

complying with requirements. 
29

EPA agrees that graduated penalties are generally appropriate, and has generally

exercised its discretion consistent with that policy. For non-pesticides, failure to comply 

with an EDSP order carries the same civil and criminal penalties set out in TSCA section 

16, under which each new day of continued noncompliance is another violation, so 

graduated penalties based on the length of delay are already built into the law. For 

pesticide chemicals, the FFDCA imposes more specific requirements with respect to the 

penalty for non-compliance, although they are generally consistent with the concept that 

penalties should be tied to the period of non-compliance. FFDCA section 408(p)(5)(C) 

requires the suspension of the pesticide registration for the period of non-compliance, and 

specifies that the suspension shall be terminated upon a determination that the registrant 

is no longer out of compliance. 

10. Other comments. EPA also received comments on topics that do not address 

aspects of the policies and procedures for issuing EDSP test orders, e.g., the use of 

SDWA authority to issue orders, the basis of SDWA chemical selection, and the second 

list of chemicals. The comments related to SDWA and the second list of chemicals are 

addressed in EPA’s response to comments document prepared for the second list of 

chemicals (Ref. 7).

VI. Final Procedures for EDSP Tier 1 Screening Pursuant to SDWA

For purposes of discussing the EDSP policies and procedures in this document, 

SDWA chemicals can be described as either currently registered PAIs (SDWA PAIs) or 

“Other SDWA Chemicals” (including inert ingredients in currently registered pesticide 

products). EPA generally intends to issue FIFRA/FFDCA orders to manufacturers and 

registrants of PAIs, but would retain the discretion to issue an SDWA/FFDCA test order 
30

to any chemical that meets the statutory criteria in SDWA section 1457. Consequently, 

for any pesticide chemical that also has non-pesticidal uses, in the event that no 

FIFRA/FFDCA test order recipient generates the required data because all order 

recipients opt out of the pesticide market, EPA may decide to issue EDSP testing orders 

based on the SDWA authority in order to obtain the data. In such instances, the policies 

and procedures outlined in this document would be applicable. 

By contrast, for SDWA chemicals that are not PAIs, (i.e., “Other SDWA 

Chemicals”), EPA generally intends to rely on SDWA section 1457 and/or FFDCA 

section 408(p)(5) to issue EDSP test orders. The Other SDWA Chemicals are very 

similar to the non-food use inert ingredients discussed in the FIFRA/FFDCA policies and 

procedures (Ref. 1), and the similarities are reflected in the policies that EPA has adopted 

in this document. Unit VI. describes the policies and procedures that relate to EDSP test 

orders issued under SDWA/FFDCA authority.

A. Who Would Receive EDSP Test Orders on SDWA Chemicals?

EPA believes it is important to identify and issue orders to all significant 

manufacturers and importers of a listed chemical. Under FFDCA section 408(p)(5)(A), 

EPA “shall issue” EDSP test 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...” (21 U.S.C. 346(a)(p)(5)(A). The process EPA generally intends to use to 

issue EDSP test orders for SDWA chemicals depends on whether the chemical is a 

SDWA PAI or an Other SDWA Chemical. A chart depicting the process for issuing 

EDSP test orders on SDWA chemicals is included in the docket (Ref. 16).
31

As noted, the Agency generally intends to issue orders under FIFRA/FFDCA for 

SDWA PAIs, and to rely on the FIFRA/FFDCA policies and procedures (Ref. 1). As 

described in that document, EPA intends to use internal databases -- principally the 

Office of Pesticide Program’s Information Network (OPPIN) -- to identify technical 

registrants with a current pesticide registration containing a SDWA chemical as the active 

ingredient, and anticipates issuing a FIFRA/FFDCA test order to all identified technical 

registrants. 

For Other SDWA Chemicals, EPA generally intends to rely on information 

reported to the Agency under the TSCA CDR rule (Ref. 17) and TRI to identify the initial 

SDWA/FFDCA test order recipients. The CDR rule and TRI require manufacturers and 

importers of certain chemicals included on the TSCA Inventory to report site and 

manufacturing information for chemicals manufactured (including imported) in amounts 

of 25,000 lb. or more at a single site, or, for TRI, other lower thresholds as specified. The 

Agency believes that this information is an appropriate source for identifying EDSP test 

order recipients. It has been EPA’s experience that relying on companies that have 

reported to the CDR is the most reliable mechanism for identifying manufacturers and 

importers of (non-pesticide) industrial chemicals. Such manufacturers and importers are 

required, by regulation, to report under the CDR rule. Companies that report under the 

CDR rule generally account for most of a chemical in commerce (therefore, in many 

instances, these companies can be expected to account for most of a chemical when it is 

found in drinking water), which is the basis for listing a chemical under SDWA authority 

(see Unit II.B.). As relatively large manufacturers and importers, EPA also believes that 

companies reporting under CDR comprise the majority of the volume associated with the 
32

chemical; these companies are more likely to be able to afford the cost of EDSP testing 

than companies manufacturing volumes below the CDR reporting threshold. EPA 

believes that, in general, these manufacturers are analogous to the technical registrants, 

who received orders in the first round of EDSP screening. Finally, using the CDR 

information to identify order recipients will facilitate joint data development, as reporters 

for these chemicals are generally publicly known and not numerous.

If there are no companies reporting in response to the CDR rule for a given 

chemical, EPA intends to use other publicly available databases, such as the TRI, to 

identify other major EDSP test order recipients. For Other SDWA Chemicals that are 

regulated or tracked by another agency (e.g., pharmaceuticals by the Food and Drug 

Administration), EPA may also consult with that agency as appropriate to identify main 

manufacturers and importers. In addition to using CDR, TRI, and other Federal agency 

databases, EPA also generally intends to issue orders to manufacturers and importers who 

are subsequently identified as such. The Agency will follow up on any new information 

it receives to this effect and issue orders accordingly. EPA, however, does not generally

intend at this time to issue orders to companies that manufacture or import a chemical for 

research and development purposes only, or who otherwise manufacture or import 

quantities of a chemical that are more appropriately measured in grams (e.g., as 

impurities, contaminants, or byproducts, which are not expected to be released into the 

environment in significant amounts). 

The Agency intends to issue catch-up orders to manufacturers or importers who 

begin to manufacture or import an EDSP SDWA chemical within 15 years of the 

issuance of a SDWA/FFDCA test order. The EDSP SDWA chemical catch-up order 
33

process will be similar to the catch-up order process described in the FIFRA/FFDCA 

policies and procedures (Ref. 1), except that EPA generally expects that the source of 

information for identifying such manufacturers will primarily come from the public, 

because there is no industrial chemical registration process comparable to the pesticide 

registration process that would provide a mechanism for EPA to independently identify 

such entities. A recipient of such catch-up orders would have the same options for 

compliance as an initial order recipient: independently generate the data or participate in 

the cost sharing by making a good faith offer to participate, if it wishes to rely on data 

developed or submitted by another recipient or consortium to satisfy its EDSP test order 

obligation.

If, at the end of this process, all EDSP test order recipients have ceased to 

manufacture a SDWA chemical without submitting the required data, the Agency 

generally intends to treat the SDWA chemical as an “orphan.”

B. How Will Recipients of Orders on SDWA Chemicals Be Notified?

Order recipients will receive an EDSP test order in one of two ways: By

registered mail or electronically. In addition to the EDSP test order, EPA will send each 

recipient a packet that contains the instructions, background materials, and sample forms 

needed to comply electronically with the EDSP test order via CDX or will provide 

directions as to the location of such materials in an electronic format.

C. How Will the Public Know Who Has Received a Test Order on a SDWA Chemical or 

Who Has Supplied Data?

EPA intends to provide the list of all EDSP test order recipients on the Agency's 

EDSP website (Ref. 4). EPA invites the submission of information (with proper 

substantiation) identifying additional entities -- including entities who manufacture for 
34

export only -- who should have received a test order. Commenters could either identify 

themselves or another person as additional candidates for the receipt of an EDSP test

order.

D. How Will the Agency Minimize Duplicative Testing?

As described in greater detail in this unit, EPA generally intends to continue to 

rely on its existing procedures to minimize duplicative EDSP testing for SDWA 

chemicals, including continuing to allow companies to voluntarily develop data jointly, 

and, as described in Unit VI.G., continuing to apply the policies that facilitate joint data 

development, as well as to accept OSRI in satisfaction of the order. 

In addition, the Agency intends to provide the status of the EDSP test orders, 

including recipients' responses, on the Agency’s EDSP website so that both order 

recipients and the public can determine the status of responses (see for example Ref. 18).

EPA will make such information available to enable test order recipients to identify and 

join other order recipients to develop the data in response to the order, thereby helping to 

achieve EPA's goals of minimizing duplicative testing and promoting fair and equitable 

sharing of EDSP test costs. 

E. What are the Potential Responses to Test Orders on SDWA Chemicals?

The options for responding to a SDWA/FFDCA test order are similar to those 

established in the FIFRA/FFDCA policies and procedures (Ref. 1), except that the option 

of exiting the pesticide market will not be available. The basis for a SDWA/FFDCA 

order is that a chemical may be found in sources of drinking water to which a substantial 

population may be exposed. Exiting any given market (e.g., the pesticide market) is not 

sufficient if the SDWA chemical is manufactured or imported for other uses because the 
35

chemical may still be found in sources of drinking water. If sufficient data on a SDWA 

chemical that is a pesticide is not generated in response to a FIFRA/FFDCA order (e.g., 

all FIFRA/FFDCA order recipients exit the pesticide market), EPA may issue a follow-up

SDWA/FFDCA order for such chemicals if they have non-pesticide uses.

EDSP test order recipients provide their initial responses electronically 

referencing the options on a sample Initial Response Form for Individual Order 

Recipients (Initial Response Form) (Ref. 19). Response options that EPA anticipates 

including in SDWA/FFDCA test orders are as follows:

Option 1: Recipient indicates that it intends to generate data. If the EDSP test 

order recipient decides to generate new data for each test specified in the order, the 

recipient would then comply with the procedures prescribed in the EDSP test order. In 

general, this option would be identical to the option discussed in the FIFRA/FFDCA 

policies and procedures (Ref. 1). EPA has not identified any changes that would be 

necessary to accommodate SDWA chemicals. Data generated and submitted would need 

to comply with the existing requirements for Good Laboratory Practices (GLP), as 

applicable. GLPs have been set out both in FIFRA for pesticides in 40 CFR part 160 and 

for TSCA chemicals in 40 CFR part 792. EDSP test order recipients would need to 

follow any appropriate GLPs, protocol requirements identified in the EDSP test order, 

and procedures described in EDSP test orders for submitting the data.

Option 2: Recipient indicates that it is submitting or citing existing data or OSRI.

The recipient would choose this option to indicate that it is submitting or citing existing 

data (including data previously submitted to the Agency) that it believes is relevant to one 

or more of the requests in the test order. The recipient’s initial response would include 
36

either the data or a reference to the data for each assay specified in the order. In 

submitting or citing existing data, the order recipient should follow, as appropriate, 

relevant format guidelines described in the EDSP test order and provide an explanation of 

the relevance of the data to the order, including, where appropriate, a cogent and 

complete rationale for why it believes the information is or is not sufficient to satisfy part 

or all of the Tier 1 test order.

Data compensation procedures may apply to data previously submitted to the 

Agency. If the data cited or submitted are from a study that was not conducted exactly as 

specified in the protocols referenced in the EDSP test order or in accordance with 

accepted scientific methodology or protocol, including but not limited to those presented 

in EPA’s harmonized test guideline compendium (Ref. 20), the recipient would also 

identify the deviations from the applicable protocol(s), along with an explanation for the 

deviations, including an explanation as to why, notwithstanding the deviations, the 

protocol used for developing the cited or submitted data should still be considered as 

providing an accepted scientific methodology or protocol, and any other information 

relevant to a decision to accept the data as satisfaction of the order.

EPA would review any existing relevant information submitted or cited (including 

OSRI) to determine whether the information is acceptable (e.g., the study was not 

rejected by the Agency for any reason related to completeness or quality) and satisfies the 

order. Decisions about whether the information satisfies part or all of the Tier 1 test order 

will be based on WoE from all relevant information available. The Agency would notify 

the recipient of its determination.
37

If the Agency determines that the information cited or submitted as part of the 

initial response received from an order recipient satisfies the Tier 1 test order the 

electronic Initial Response Form is the only response required.

If, however, EPA determines that the information cited or submitted as part of the 

initial response is insufficient to satisfy the Tier 1 test order, in whole or in part, the 

recipient would still need to satisfy any order requirements EPA had determined had not 

been met. EPA intends to use a WoE approach as described in the EDSP WoE guidance 

document (Ref. 11) which takes into account data from the Tier 1 assays and any other 

scientifically relevant information available, to determine whether the chemical has the 

potential to interact with the endocrine system. Chemicals that go through Tier 1 

screening and are found to have the potential to interact with the estrogen, androgen, or 

thyroid hormone systems will proceed to the next stage of the EDSP where EPA will 

determine which, if any, of the Tier 2 tests are necessary. 

Option 3: Recipient indicates that it intends to enter (or offer to enter) into an 

agreement to form a consortium to provide the data. The recipient may choose to join or 

form a consortium to share the cost of producing the required data. All participants of the 

consortium must submit their own electronic Initial Response Form for Individual Order 

Recipients, providing the name of the party who will be submitting the data on the 

recipient’s behalf.

Under this option, the designated lead for the consortium would complete their

Initial Responses electronically (Consortium Response Form) (Ref. 21) for the 

consortium to provide the primary contact for the consortium, the list of participants, and 

an indication of the consortium’s planned response for each assay, along with 
38

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

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

data would not need to specify all of the terms of the final arrangement between the 

parties or the mechanism to resolve the terms. The designated lead for the consortium 

would be responsible for submitting the consortium’s initial response and accompanying 

information to EPA by the due date for the consortium’s response, consistent with any 

mailing instructions indicated in the EDSP test order.

Once the consortium submits the data electronically and EPA has completed its 

initial review, EPA would notify the contact of the consortium indicating whether the 

order has been satisfied. If satisfied, such an action would satisfy EDSP test order 

obligations for each of the consortium participants.

If the consortium fails to submit the data or meet the requirements of the order in 

a timely and adequate manner, each recipient would be subject to penalties of up to 

$37,500 per day, unless the recipient were to commit to submit, and then did submit, the 

required data by the dates originally specified in the order. The Agency has typically 

granted very few, if any, time extensions for the submission of EDSP data. 

The Agency intends to provide to every EDSP test order recipient a list of the 

other manufacturers and/or importers (to the extent permitted by confidentiality 

requirements) that have also received an EDSP order for the specified SDWA chemical. 

This list would be intended to help order recipients identify other companies with whom 

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

response to satisfy the requirements in the order. If the identity of a company subject to 

the SDWA/FFDCA test order is claimed as CBI, EPA intends to offer the company an 
39

opportunity to identify an agent who would act on their behalf in all matters relating to 

the EDSP program. For any company that chooses to designate an agent, the Agency 

intends to make the name of the agent (instead of the company) public by including it on 

the list of recipients of SDWA/FFDCA test orders. This name use would be similar to the 

process used for FIFRA/FFDCA test orders and presented in the FIFRA/FFDCA policies 

and procedures (Ref. 1). If the identity of a company subject to the EDSP test order is 

claimed as CBI, and yet the company does not name an agent, that company’s ability to 

obtain data compensation from other parties (or rely on compensable data submitted by 

other parties) would likely be affected. EPA intends to make available the list of EDSP 

test order recipients on the Agency’s EDSP website (Ref. 4). EPA intends to update the 

list with subsequent publication(s) and posting(s) as appropriate. For example, the 

Agency intends to post the status of the EDSP test orders, including the recipient’s 

response, on the Agency’s EDSP website so that both EDSP test order recipients and the 

public can check on the status of responses to the EDSP test orders. This public listing is 

intended to also facilitate the formation of consortia to develop data jointly since 

recipients would know all other entities required to generate the same data.

Option 4: Recipient claims that it is not subject to the EDSP test order. Under 

this option, a recipient would claim that it is not subject to the order because it does not 

manufacture or import the chemical identified for EDSP testing, or because it believes the 

order was otherwise erroneously sent. This option would be essentially the same as the 

option discussed in the original policies and procedures for manufacturers of inert 

ingredients. EPA has not identified any issues unique to SDWA chemicals that would 

warrant a change in policy on this point. An explanation of the basis for the claim, along 
40

with appropriate information to allow the Agency to substantiate the claim, would 

accompany the Initial Response. The Agency intends to evaluate the claim and respond to 

any request within 90 days of receipt. If EPA were unable to verify the claim, the original 

requirements and deadlines in the order would be expected to remain. If EPA were able 

to verify the claim, such a response would satisfy the order and no further response would 

be necessary.

Option 5: Recipient intends to discontinue the manufacture or import of the 

chemical. Under this option, the recipient would indicate it has or is in the process of 

discontinuing all manufacture and import of the chemical. As noted in Unit V.A., in order 

to take advantage of this option, a recipient would need to also cease manufacture of the 

chemical, including for the purposes of export. In addition, the recipient would be 

required to provide an electronic initial response via CDX that includes a verifiable

explanation and documentation supporting its claim. If EPA verifies the claim, the 

electronic Initial Response Form is all that would be required to satisfy the EDSP test 

order. If EPA could not verify the claim, the recipient’s obligation to comply with the 

EDSP test order would remain.

Unlike the FIFRA/FFDCA policies and procedures (Ref. 1), which enable a 

manufacturer or importer of a pesticide inert ingredient to comply with the 

FIFRA/FFDCA test order by discontinuing the sale of the chemical into the pesticide 

market, SDWA/FFDCA test orders cannot be satisfied in this manner. A chemical 

manufacturer or importer that receives a SDWA/FFDCA test order would need to cease 

all manufacture and import of that chemical. Simply exiting the pesticide market would 

not address the chemical’s potential presence in “sources of drinking water to which a 
41

substantial population may be exposed” and it would therefore be inappropriate to allow 

companies to satisfy a test order with such a response. 

Option 6: Recipient responds according to one of three other response options. 

As part of the Initial Response, a recipient may also ask EPA to reconsider some or all of 

the EDSP testing specified in the order if:

a. The recipient can demonstrate (supported by appropriate data) that the chemical 

is an endocrine disruptor and that additional EDSP Tier 1 screening is unnecessary. 

b. The recipient can demonstrate (supported by appropriate data) that the chemical 

meets the standard for an exemption under FFDCA section 408(p)(4) (i.e., “that the 

substance is not anticipated to produce any effect in humans similar to an effect produced 

by a naturally occurring estrogen”).

c. The chemical was used by EPA as a ‘‘positive control’’ to validate one or more 

of the screening assays. In the last data collection, chemicals used by EPA as a “positive 

control” to validate one or more of the screening assays were only required to submit the 

assays for which the chemical did not serve as a positive control (e.g., if the chemical 

served as a positive control in the validation of two assays, the EDSP test order recipient 

would not be required to generate additional data for those two assays). EPA generally 

expects that it would continue this policy. 

For more information on the response options discussed in this unit, see the 

FIFRA/FFDCA policies and procedures (Ref. 1).

The Agency intends to make a determination on any claim and respond to the 

recipient within 90 days of receipt. If EPA cannot verify the claim, the original 

requirements and deadlines in the order would remain. If EPA were to verify the claim, 
42

EPA would consider the response to fully satisfy the order and no further response would 

be required.

F. How to Submit Order Responses and Data Electronically?

EPA has developed an electronic submission system for data submitted in 

response to SDWA/FFDCA test orders following the general process established for 

TSCA Section 5 Premanufacture Notices and for other TSCA reporting, including TSCA 

Section 8 CDR. The EDSP order electronic reporting system will allow order recipients 

to use the Agency’s CDX to respond to an order and to submit test data via the Internet. 

See http://www.epa.gov/cdx for additional information about CDX (Ref. 22). If not 

already registered with CDX, recipients will need to complete a simple registration 

process in order to use this system for electronic submissions of EDSP test order data,

thereby establishing a secure log-on to CDX. Specific requirements associated with these 

EDSP test orders will be provided directly to the order recipients, and are expected to 

include:

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

usable for electronically submitting EDSP test order responses.

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

• Encrypted submission to EPA via CDX.

Each EDSP test order would contain specific, updated information regarding the 

most current process to use to respond to the EDSP test order. 

G. How Will EPA Facilitate Joint Data Development and Cost Sharing for SDWA 

Chemicals?

As described in the FIFRA/FFDCA policies and procedures (Ref. 1), the Agency 

believes that FFDCA section 408(p)(5) does not provide the authority to create 
43

requirements for joint data development, including a requirement to use binding 

arbitration to resolve disputes, as does FIFRA section 3. In EPA’s view, FFDCA section 

408(p)(5)(B) merely establishes a qualified direction that the Agency ‘‘[t]o the extent 

practicable ... minimize duplicative testing ....’’ This, standing alone, does not create new 

authority to compel companies to use arbitration to resolve disputes arising from an effort 

to develop data jointly, nor does it even authorize EPA to impose a requirement for joint 

data development. Rather, EPA believes that this provision directs the Agency to create 

procedures that operate within the confines of existing statutory authorities. While 

FFDCA section 408(p) does not allow EPA to impose requirements identical to those 

authorized by FIFRA section 3, EPA has the authority under FFDCA section 408(p) to 

develop Agency procedures that would facilitate joint data generation and electronic 

submission. Specifically, the Agency has discretion to determine what actions constitute 

compliance with a FFDCA section 408(p) test order, and EPA intends to apply this 

discretion in a manner that creates strong incentives for companies to voluntarily develop 

data jointly. Section 408(p) of FFDCA confers adequate discretion for EPA to consider 

whether a recipient has fulfilled its obligation to provide data when the recipient 

individually or jointly submits results from the required studies, or when EPA judges that 

it would be equitable to allow the recipient to rely on, or cite, results of studies submitted 

by another person. 

At the same time, however, each recipient of an order under FFDCA section 

408(p) has a separate obligation to satisfy the Tier 1 test order that it received. EPA 

thinks that FFDCA section 408(p) confers adequate discretion to consider that a recipient 

has fulfilled its obligation to provide data when:
44

• The recipient individually or jointly submits results from the required assays.

• EPA judges that it would be equitable to allow the recipient to rely on, or cite, 

results of studies submitted by another person.

The determination of whether it would be equitable to allow citation to another 

recipient’s data will be necessarily based on a case-by-case review of the specifics of the 

individual circumstances. However, the Agency believes that it would generally be 

equitable to allow a recipient of a FFDCA section 408(p) test order to rely on the results 

of studies submitted by another person where:

• The data generator has given permission to the recipient to cite the results, or

• Within a reasonable period after receiving the FFDCA section 408(p) test order, 

the recipient has made an offer to commence negotiations regarding the amount and 

terms of paying a reasonable share of the cost of testing; has included 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); 

and, if arbitration is requested, participates in the arbitration proceeding and complies 

with the terms of any arbitration award.

The Agency believes this approach to minimizing duplicative EDSP testing, 

which parallels that used under FIFRA section 3(c)(2)(B), provides all recipients of 

FFDCA section 408(p) test orders adequate incentives to develop data jointly. In the first 

instance, where the data generator had granted permission for another party to cite its 

data, the equities are clear, and EPA has no reason for refusing to allow it. In the second 

instance, where the data generator received an offer to commence negotiations regarding 

the amount and terms of compensation and to go to a neutral decisionmaker with 
45

authority to bind the parties failing successful negotiations, EPA believes that the 

company has demonstrated a good faith effort to develop data jointly, and consequently 

would typically consider that the order recipient had complied with the order. Based on 

EPA’s experience under FIFRA, there would be little or no reason for a data generator to 

decline such an offer. Moreover, if EPA did not adopt such an approach, the end result 

would effectively confer the sort of ‘‘exclusive use’’ property rights established under 

FIFRA section 3(c)(1)(F), on a broad category of data, and EPA does not believe that 

FFDCA section 408(p)(5) creates such rights, or provides EPA with the authority to 

create such rights. These conditions would also apply to recipients of any ‘‘catch-up’’ 

FFDCA § 408(p) orders, who enter the market after the data have been submitted.

H. What Procedures Can EPA Apply for Handling CBI for SDWA Chemicals?

As stated in the FIFRA/FFDCA policies and procedures (Ref. 1), FFDCA does 

not authorize EPA to either create new rights or to modify existing rights to 

confidentiality, but directs the Agency to create procedures that operate within the 

existing confines of FIFRA, FOIA, and TSA. SDWA has no provisions that authorize

EPA to extend protections for handling CBI beyond those established by TSA. Thus data 

submitted in response to SDWA/FFDCA orders would only be subject to the protections 

under FOIA and TSA, with the notable exception of data generated on pesticide 

chemicals. Manufacturers of a food use inert ingredient that is also identified as a SDWA 

chemical should generally expect to receive SDWA/FFDCA test orders; however, all CBI 

and data compensation provisions established in FIFRA would still apply. In addition, 

under certain circumstances, data generated on non-food use inert ingredients may be 

entitled to FIFRA CBI and data compensation protections. Test order recipients for the 
46

food use-inert, or a pesticide with a food tolerance or exemption, should consult the 

FIFRA/FFDCA policies and procedures (Ref. 1) for a more detailed explanation of the 

FIFRA provisions that apply.

The identities of chemicals on the non-confidential portion TSCA Inventory (i.e., 

the chemical identity of the chemical substance is publicly known), contained in health 

and safety data subject to TSCA may not be entitled to confidential treatment (Ref. 23).

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. EPA also believes that it would be particularly difficult to 

substantiate such a claim, given that the information would already be publicly available.

As described in Unit V.E. under Option 3, when the identity of a company subject 

to the SDWA/FFDCA test order is claimed as CBI, EPA intends to offer the company an 

opportunity to identify an agent who would act on their behalf in all matters relating to 

EDSP. For any company that chooses to designate an agent, the Agency intends to make 

the name of the agent (instead of the company) public by including it on the list of 

recipients of SDWA/FFDCA test orders. 

I. What is the Process for Contesting a Test Order or Consequences for Failure to 

Respond or Comply with a Test Order?

EPA generally intends to rely on the existing interpretations and policies relating 

to pre-enforcement challenges to and enforcement of a test order. Order recipients are 

encouraged to consult the FIFRA/FFDCA policies and procedures (Ref. 1) for further 

details on these policies. 
47

J. What is the Informal Administrative Review Procedure?

EPA generally intends to continue to include the informal administrative review 

provisions in SDWA/FFDCA test orders by which recipients could raise any questions or 

challenges concerning the issuance of the order, that were included in the orders issued 

for the first list of chemicals. As explained in the FIFRA/FFDCA policies and procedures

(Ref. 1), because the mere filing of the objection (or indeed, the filing of a judicial 

challenge) would not extend the deadline for submission of the studies, in order for this 

process to be completed in a timely fashion, EPA expects order recipients who file a 

challenge to present their objections with sufficient specificity and detail to allow the 

Agency to effectively evaluate the issue(s) presented. EPA would review the issues 

presented and respond within a reasonable amount of time. The Agency understands that

it will need to respond to such objections within sufficient time for the order recipient to 

comply with the orders, or to pursue judicial review. 

K. What are the Adverse Effects Reporting Requirements?

EPA is not modifying any of its existing reporting requirements or any of the 

policies with respect to how the adverse effects reporting requirements relate to EDSP 

data. 

Adverse effects reporting requirements for pesticide chemicals in registered 

products are established in FIFRA section 6(a)(2) and can be found in the 

FIFRA/FFDCA policies and procedures (Ref. 1). In addition to requirements under 

FIFRA, TSCA section 8(c) allows EPA to request that companies record, retain and/or 

report “allegation of significant adverse reactions” to a chemical substance or mixture 

that the company produces, imports, processes or distributes (15 U.S.C. 2607(c)). 
48

Additional information can be found in 40 CFR part 717. Chemical substance is defined 

in TSCA (15 U.S.C. 2602(2)).

Under TSCA section 8(e), U.S. chemical manufacturers, importers, processors, 

and distributors are required to notify EPA within 30 days of new unpublished 

information regarding their chemical if the information may lead to a conclusion that the 

chemical poses substantial risk to human health or the environment (15 U.S.C. 2607(e)). 

“Substantial risk” information is information that offers reasonable support for a 

conclusion that the subject chemical substance or mixture poses a substantial risk of 

injury to health or the environment. The information need not, and typically does not, 

establish conclusively that a substantial risk exists.

Any information that has been previously submitted under FIFRA section 6(a)(2), 

TSCA section 8(c), or TSCA section 8(e), to the extent the EDSP test order recipient 

believes that it is responsive to the EDSP test order, need not be resubmitted to satisfy the 

FFDCA section 408(p) test orders. The EDSP test order recipient need only cite the 

previously submitted information in lieu of resubmission.

VII. Statutory and Executive Order Reviews

A. Regulatory Planning and Review

Under Executive Order 12866, entitled “Regulatory Planning and Review” (58 

FR 51735, October 4, 1993), this policy statement is not considered to be a “significant 

guidance document” under the terms of the Executive Order because this policy 

statement does not raise novel legacy or policy issues arising out of legal mandates, the 

President’s priorities, or the principles set forth in the Executive Order. As indicated in 
49

this unit, this policy statement only makes a few modifications that are necessary to 

address procedural differences that apply to SDWA chemicals. 

B. Paperwork Reduction Act (PRA) 

The information collection requirements described in this document have been 

submitted to OMB for review under PRA, 44 U.S.C. 3501 et seq. Elsewhere in this 

Federal Register issue is a separate document prepared by EPA that announces the 

availability of the ICR document entitled “Agency Information Collection Activities: 

Submission to OMB for Review and Approval; Comment Request; (Addendum)”

(identified by EPA ICR No. 2249.02 and OMB Control Number 2070-0176). The docket 

ID number for this ICR submission is EPA-HQ-OPPT-2007-1081. An Agency may not 

concur or sponsor, and a person is not required to respond to a collection of information 

unless it displays a currently valid OMB control number. The OMB control numbers are 

displayed either by publication in the Federal Register or by other appropriate means, 

such as on the related collection instrument or form, if applicable. The display of OMB 

control numbers in certain EPA regulations is consolidated in 40 CFR part 9. As a new 

ICR, the Agency does not yet have an OMB control number for this information 

collection activity. Once assigned, EPA will announce the OMB control number for this 

information collection in the Federal Register, and will add it to any related collection 

instruments or forms used. Burden is defined in 5 CFR 1320.3(b). 

VIII. References

As indicated under ADDRESSES, a docket has been established for this notice 

under docket ID number EPA-HQ-OPPT-2007-1080. The following is a listing of the 

documents that are specifically referenced in this action. The docket includes these 
50

documents and other information considered by EPA, including documents that are 

referenced within the documents that are included in the docket, even if the referenced 

document is not physically located in the docket. For assistance in locating these other 

documents, please consult the technical person listed under FOR FURTHER 

INFORMATION CONTACT.

1. EPA. Endocrine Disruptor Screening Program; Policies and Procedures for 

Initial Screening; Notice. Federal Register (74 FR 17560, April 15, 2009) (FRL-8399-

9).

2. EPA. Order Template: “FFDCA §408(p) Order Template for SDWA §1457

Chemicals”. April 15, 2013. Available in Attachment C(3) to the ICR in Docket ID 

Number EPA-HQ-OPPT-2013-0275.

3. U.S. Congress. House Resolution 2996, H. Rept. 111-180.

4. EPA. Endocrine Disruptor Screening Program website at 

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

5. EPA. Endocrine Disruptor Screening Program; Draft Policies and Procedures 

for Screening Safe Drinking Water Act Chemicals; Notice. Federal Register (75 FR 

70558, November 17, 2010) (FRL-8848-9). 

6. EPA. Response-to-Comments Document for the Notice on the Endocrine 

Disruptor Screening Program’s Draft Policies and Procedures for Screening Safe 

Drinking Water Act Chemicals that published in the Federal Register on November 17, 

2010 at 75 FR 70558 . March 7, 2013.

7. EPA. Comment Response Document for the Second List of Chemicals and 

Substances for Tier 1 Screening under the Endocrine Disruptor Screening Program 
51

(Categorized Public Comments). February 1, 2013. Available in Docket ID Number

EPA-HQ-OPPT-2009-0477.

8. EPA. Electronic Reporting Under the Toxic Substances Control Act; Proposed 

rule. Federal Register (77 FR 22707, April 17, 2012) (FRL-9337-5).

9. EPA. TSCA section 8(e); Notification of Substantial Risk; Policy Clarification 

and Reporting Guidance. Federal Register (68 FR 33129, June 3, 2003) (FRL-7287-4).

10. EPA. EPA’s Approach for Considering Other Scientifically Relevant 

Information (OSRI) under the Endocrine Disruptor Screening Program (EDSP). March 

26, 2009. Document ID Number EPA-HQ-OPPT-2007-1080-0032.

11. EPA. Weight-of-Evidence: Evaluating Results of EDSP Tier 1 Screening to 

Identify the Need for Tier 2 Testing. September 14, 2011. Document ID Number EPAHQ-OPPT-2010-0877-0021.

12. EPA. Universe of Chemicals and General Validation Principles. November 

2012. Available at 

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

paper_11_12.pdf.

13. EPA. Response to Comments on the Public Review Draft of the Information 

Collection Request (ICR) entitled “Addendum for the Second List of Chemicals; Tier 1

Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program 

(EDSP). Available in Docket ID Number EPA-HQ-OPPT-2013-0275.

14. EPA. SAB. Review of the EPA’s Proposed Environmental Endocrine 

Disruptor Screening Program; Review of the Endocrine Disruptor Screening Program by 

a Joint Subcommittee of the Science Advisory Board and Scientific Advisory Panel. July 
52

1999. EPA publication number EPA-SAB-EC-99-013. Available at 

http://www.epa.gov/endo/pubs/sab_sap_report.pdf.

15. EPA. U.S. Environmental Protection Agency Endocrine Disruptor Screening 

Program Comprehensive Management Plan. June 2012. Available at 

http://www.epa.gov/endo/pubs/EDSP-comprehensive-management-plan.pdf.

16. EPA. At a Glance: Issuing EDSP Second List Orders. (March 28, 2013).

17. EPA. Chemical Data Reporting website at http://www.epa.gov/oppt/cdr.

18. EPA. Status of EDSP Orders/DCIs as of Wednesday, January 2, 2013. 

19. EPA. Sample Form: “FFDCA §408(p) Order for SDWA §1457 Chemicals --

Initial Response Form for Individual Order Recipients” (EPA Form No. 6300-06). March 

27, 2013. Available in Attachment D(3) to the ICR in Docket ID Number EPA-HQOPPT-2013-0275.

20. EPA. OCSPP Harmonized Test Guidelines website at 

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

21. EPA. Sample Form: “FFDCA §408(p) Order for SDWA §1457 Chemicals -

Initial Response Form for Consortium” (EPA Form No. 6300-06-C). March 27, 2013.

Available in Attachment D(4) to the ICR in Docket ID Number EPA-HQ-OPPT-2013-

0275.

22. EPA. Central Data Exchange website at http://www.epa.gov/cdx.

23. EPA. Claims of Confidentiality of Certain Chemical Identities Submitted 

under Section 8(e) of the Toxic Substances Control Act; Notice. Federal Register (75 

FR 3462, January 21, 2010) (FRL-8807-9).