<NOTICE> 

<PREAMB> 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION AGENCY 

[EPA–HQ–OPPT–2007–1080; FRL–8848–9] 

Endocrine Disruptor Screening Program; Draft Policies and Procedures for 

Screening Safe Drinking Water Act Chemicals 

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Notice. 

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

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

substances for which EPA may issue testing 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). FFDCA section 408(p) directed EPA to develop a chemical 

screening program using appropriate validated test systems and other scientifically 

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

These draft policies and procedures are intended to supplement the existing EDSP 

policies and procedures that were published in the Federal Register on April 15, 2009 

(74 FR 17560); however, this document was drafted with the intent of explaining the 

policies and procedures relevant to EDSP Safe Drinking Water Act chemicals. 

DATES: Comments must be received on or before [insert date 60 days after date of 

publication in the Federal Register]. 

ADDRESSES: Submit your comments, identified by docket identification (ID) number 

EPA–HQ–OPPT–2007–1080, by one of the following methods: 

 • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line 

instructions for submitting comments. 
 2

 • Mail: Document Control Office (7407M), Office of Pollution Prevention and 

Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. 

 • Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 

6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number 

EPA–HQ–OPPT–2007–1080. The DCO is open from 8 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays. The telephone number for the DCO is (202) 564–8930. 

Such deliveries are only accepted during the DCO’s normal hours of operation, and 

special arrangements should be made for deliveries of boxed information. 

 Instructions: Direct your comments to docket ID number EPA–HQ–OPPT–

2007–1080. EPA's policy is that all comments received will be included in the docket 

without change and may be made available on-line at http://www.regulations.gov, 

including any personal information provided, unless the comment includes information 

claimed to be Confidential Business Information (CBI) or other information whose 

disclosure is restricted by statute. Do not submit information that you consider to be CBI 

or otherwise protected through regulations.gov or e-mail. The regulations.gov website is 

an “anonymous access” system, which means EPA will not know your identity or contact 

information unless you provide it in the body of your comment. If you send an e-mail 

comment directly to EPA without going through regulations.gov, your e-mail address 

will be automatically captured and included as part of the comment that is placed in the 

docket and made available on the Internet. If you submit an electronic comment, EPA 

recommends that you include your name and other contact information in the body of 

your comment and with any disk or CD-ROM you submit. If EPA cannot read your 
 3

comment due to technical difficulties and cannot contact you for clarification, EPA may 

not be able to consider your comment. Electronic files should avoid the use of special 

characters, any form of encryption, and be free of any defects or viruses. 

Docket: All documents in the docket are listed in the docket index available at 

http://www.regulations.gov. Although listed in the index, some information is not 

publicly available, e.g., CBI or other information whose disclosure is restricted by statute. 

Certain other material, such as copyrighted material, is not placed on the Internet and will 

be publicly available only in hard copy form. Publicly available docket materials are 

available either in the electronic docket at http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA 

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

Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 

4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of 

the EPA/DC Public Reading Room is (202) 566–1744, and the telephone number for the 

OPPT Docket is (202) 566–0280. Docket visitors are required to show photographic 

identification, pass through a metal detector, and sign the EPA visitor log. All visitor 

bags are processed through an X-ray machine and subject to search. Visitors will be 

provided an EPA/DC badge that must be visible at all times in the building and returned 

upon departure. 

FOR FURTHER INFORMATION CONTACT: For technical information contact: 

Susan Sharkey, Chemical Control Division, Office of Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

20460–0001; telephone number: (202) 564–8789; e-mail address: 
 4

sharkey.susan@epa.gov, or Bill Wooge, Office of Science Coordination and Policy, 

Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

20460–0001; telephone number: (202) 564–8476; e-mail address: 

wooge.william@epa.gov.

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

South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; e-mail 

address: TSCA-Hotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

 You may be potentially affected by this action if you manufacture or import 

chemical substances (including pesticide chemicals) that may be found in sources of 

drinking water; if you manufacture or import chemical substances that degrade to 

chemical substances found in sources of drinking water; or if you are, or may otherwise 

be, involved in the testing of chemical substances for potential endocrine effects. 

Potentially affected entities may include, but are not limited to: 

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

persons who manufacture, import or process chemical substances. 

 • Pesticide, fertilizer, and other agricultural chemical manufacturing (NAICS code 

3253), e.g., persons who manufacture, import or process pesticide, fertilizer and 

agricultural chemicals. 

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

who conduct testing of chemical substances for endocrine effects. 
 5

 This listing is not intended to be exhaustive, but rather provides a guide for 

readers regarding entities likely to be affected by this action. Other types of entities not 

listed in this unit could also be affected. The North American Industrial Classification 

System (NAICS) codes have been provided to assist you and others in determining 

whether this action might apply to certain entities. To determine whether you or your 

business may be affected by this action, you should carefully examine the applicability 

provisions in Unit III.C. of this document, and examine the Federal Food Drug and 

Cosmetic Act (FFDCA) section 408(p). If you have any questions regarding the 

applicability of this action to a particular entity, consult the technical person listed under 

FOR FURTHER INFORMATION CONTACT. 

B. What Should I Consider as I Prepare My Comments for EPA? 

 1. Submitting CBI. Do not submit this information to EPA through 

regulations.gov or e-mail. Clearly mark the part or all of the information that you claim 

to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the 

outside of the disk or CD-ROM as CBI and then identify electronically within the disk or 

CD-ROM the specific information that is claimed as CBI. In addition to one complete 

version of the comment that includes information claimed as CBI, a copy of the comment 

that does not contain the information claimed as CBI must be submitted for inclusion in 

the public docket. Information so marked will not be disclosed except in accordance with 

procedures set forth in 40 CFR part 2. 

 2. Tips for preparing your comments. When submitting comments, remember to: 

 i. Identify the document by docket ID number and other identifying information 

(subject heading, Federal Register date and page number). 
 6

 ii. Follow directions. The Agency may ask you to respond to specific questions or 

organize comments by referencing a Code of Federal Regulations (CFR) part or section 

number. 

 iii. Explain why you agree or disagree; suggest alternatives and substitute 

language for your requested changes. 

 iv. Describe any assumptions and provide any technical information and/or data 

that you used. 

 v. If you estimate potential costs or burdens, explain how you arrived at your 

estimate in sufficient detail to allow for it to be reproduced. 

 vi. Provide specific examples to illustrate your concerns and suggest alternatives. 

 vii. Explain your views as clearly as possible, avoiding the use of profanity or 

personal threats. 

 viii. Make sure to submit your comments by the comment period deadline 

identified. 

II. Background 

A. What Action is the Agency Taking? 

The Agency is proposing, and seeking public comment on, a number of draft 

policies and procedures for issuing EDSP test orders for substances based on the 

Agency’s authority under the Safe Drinking Water Act (SDWA) section 1457 (i.e., 

“SDWA chemicals”). SDWA authorizes EPA to issue EDSP test orders to manufacturers 

and importers of substances that may be found in sources of drinking water and to which 

a substantial population may be exposed (42 U.S.C. 300j-17). SDWA chemicals 
 7

encompass a wide variety of substances, including industrial and pesticide chemicals, 

ingredients in pharmaceuticals and personal care products, and degradates. 

These draft policies and procedures are intended to supplement the existing EDSP 

policies and procedures that were published in the Federal Register on April 15, 2009 

(74 FR 17560) (FRL–8399–9) (FIFRA/FFDCA policies and procedures) (Ref. 1). The 

policies discussed in the April 15, 2009, document were developed based primarily on 

considerations applicable to the issuance of EDSP test orders on pesticide active and inert 

ingredients, which were the chemicals comprising the first EDSP chemical list. It is 

important to note that chemicals on the first EDSP list may also fit the criteria to be 

considered a SDWA chemical and, therefore, these draft policies and procedures also 

may apply to those chemicals. Consequently, some of the existing policies and 

procedures reflect issues uniquely associated with the pesticide market and the specific 

regulatory context under which EPA regulates pesticide chemicals, i.e., FIFRA. In this 

document, EPA describes the policies and procedures associated with Tier 1 screening of 

SDWA chemicals, including certain modifications to those original 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 those earlier policies. 

This document discusses the policy considerations for SDWA chemicals and the 

procedural modifications and clarifications the Agency is considering for the following 

areas: 

 • Who would receive EDSP test orders on SDWA chemicals? [Unit V.A.] 

 • How will recipients of orders on SDWA chemicals be notified? [Unit V.B.] 
 8

 • How will the public know who has received a test order on a SDWA chemical 

or who has supplied the needed data? [Unit V.C.] 

 • How will the Agency minimize duplicative testing? [Unit V.D.] 

 • What are the potential responses to test orders on SDWA chemicals? [Unit 

V.E.] 

 • How can order responses and data be submitted electronically? [Unit V.F.] 

 • How will EPA facilitate joint data development and cost sharing for SDWA 

chemicals? [Unit V.G.] 

 • What procedures can EPA apply for handling CBI for SDWA chemicals? [Unit 

V.H.] 

 • What is the process for contesting a test order or consequences for failure to 

respond or comply with a test order? [Unit V.I.] 

 • What is the informal administrative review procedure? [Unit V.J.] 

 • What are the adverse effects reporting requirements? [Unit V.K.] 

The FIFRA/FFDCA policies and procedures remain relevant to recipients of 

FIFRA chemical test orders. SDWA chemical test order recipients should refer to this 

document and any subsequent revised document for policies and procedure guidelines. 

In addition, a new draft order template for issuance of orders under SDWA section 1457 

and FFDCA section 408(p)(5) is available in the docket for this Federal Register notice 

(Ref. 2). 

EPA has also published two related documents elsewhere in today’s Federal 

Register. One announces the second list of EDSP chemicals, which includes both 

SDWA chemicals and pesticide active ingredients (PAIs). Some of the listed chemicals 
 9

may be both SDWA chemicals and PAIs. The other requests public comment on a draft 

supplemental Information Collection Request (ICR), which describes the estimated 

paperwork burden and costs associated with the second list of EDSP chemicals. 

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 naturallyoccurring 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 substance that may be found in sources of drinking 

water, based on a determination that a substantial population may be exposed to such a 

substance. (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 
 10

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

pesticide inert ingredients of such pesticide.” (21 U.S.C. 231(q)(1)). 

Section 408(p)(5)(A) of FFDCA provides that the Administrator “shall issue an 

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

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

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

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

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

generation of the information. Based on the statutes discussed in this subsection, EPA has 

the discretion to require testing of a pesticide chemical under FFDCA solely, 

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 may be assessed, after notice and an administrative hearing 
 11

held on the record in accordance with section 554 of the Administrative Procedure Act 

(APA). (15 U.S.C. 2615(a)(1)–(2)(A)). 

C. Does this Document Contain Binding Requirements?

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

under FFDCA section 408(p) are binding, the policies outlined in this notice are not. The 

policies outlined in this notice merely represent the general procedures and statutory 

interpretations on which EPA may rely to implement the existing goals of the statutory 

program. 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 the EDSP 

A. What is the EDSP? 

EPA developed the 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 effects as [EPA] may designate” 

(21 U.S.C. 346a(p)). As part of the EDSP, EPA issues orders to collect certain test data 

on selected chemical substances. In general, EPA intends to use the data collected under 

the EDSP, along with other information, to determine if a pesticide chemical, or other 

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

endocrine system. The determination that a chemical does or is not likely to have 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 other scientifically relevant 

information. Chemicals that go through Tier 1 screening and are found to have the 
 12

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 substance, and establish a quantitative 

relationship between the dose and that endocrine effect. Further information regarding the 

EDSP and requirements for Tier 1 and Tier 2 can be found on the Agency’s EDSP 

website, at http://www.epa.gov/endo/. (Ref. 3) EPA is aware of no issue specific to the 

chemicals in the second list of screening that would warrant any modification to the 

existing testing scheme, and is not proposing to adopt any. 

B. Why is EPA Publishing a Second EDSP Policies and Procedures Used to Require the 

Submission of Test Data? 

As stated in the April 15, 2009, document (Ref. 1), EPA generally developed 

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 believes that some significant modifications are needed because 

the existing policies were designed to address screening of pesticide chemicals which are 

regulated under FIFRA, a statute that does not apply to non-pesticides. 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); 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 
 13

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 

needed to ensure that the procedures adopted to implement section 408(p) would operate 

in a manner that would be compatible with EPA’s implementation of the existing FIFRA 

mandates. Moreover, the fact that a long-standing FIFRA mechanism was already 

effectively minimizing duplicative testing and promoting cost sharing among order 

recipients meant that EPA could rely on the existing mechanisms as a uniquely relevant 

model for screening of pesticides under the EDSP. By contrast, the SDWA chemicals 

that may be subject to EDSP screening include pesticide chemicals, industrial (nonpesticide) chemicals, as well as ingredients in pharmaceuticals and personal care 

products, among others. 

EPA has also drafted these new policies and procedures to address issues specific 

to SDWA chemicals beyond those associated with the applicability of FIFRA. The 

rationale and statutory authority for listing 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 

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. In addition, many of 

the companies likely to receive SDWA/FFDCA test orders may be unfamiliar with the 

initial policies and procedures because those companies are not associated with the 
 14

pesticide market, were unaffected by that earlier proposal, and consequently had no 

interest in commenting. EPA also believes it would be inappropriate to publish this 

document in a manner identifying only the changes to the existing policies and 

procedures because the procedures are inherently complex and would require numerous 

cross referencing by parties unfamiliar with the referenced regulation. 

C. When do these Policies and Procedures Apply? 

These policies and procedures apply to all SDWA chemicals listed for screening 

under the EDSP. EPA has the discretion to issue EDSP test orders under the authorities 

of SDWA section 1457 and FFDCA section 408(p) for all SDWA chemicals, including 

PAIs. As described in this document, EPA generally intends to use SDWA authority (1) 

to require testing of SDWA chemicals that are not PAIs, and (2) to require testing of 

SDWA chemicals that are also PAIs if the initial FIFRA/FFDCA orders to technical 

registrants did not generate the required data. Note that, in the event that FIFRA/FFDCA 

order recipients exercise the option to exit the pesticide market and the Agency 

subsequently sends such recipients a SDWA/FFDCA order, the recipient would be 

required to submit data or otherwise respond to the SDWA/FFDCA test order, even if 

they previously responded to an earlier FIFRA/FFDCA order. 

For a variety of reasons, EPA generally intends to issue FIFRA/FFDCA orders to 

manufacturers and registrants of PAIs. For such order recipients, the policies discussed 

in the April 15, 2009, document would be applicable, rather than the policies discussed in 

this document. EPA believes that this will minimize administrative burdens and 

ultimately be less confusing to order recipients. Burdens and confusion should be 

reduced because many of the policies for these chemicals were driven by existing 
 15

statutory requirements applicable to the test order recipients for these chemicals, such as 

the requirements for data compensation and confidentiality established by FIFRA 

sections 3(c)(1)(F) and 12, as well as FFDCA section 408(i). These requirements would 

remain applicable, whether or not the test orders are issued for SDWA chemicals, and 

EPA lacks the authority to modify them. Thus, EPA believes that continuing to issue 

FIFRA/FFDCA orders to the manufacturers and registrants of these chemicals would 

generally be appropriate, to avoid any confusion, and to simplify Agency policies, even 

though EPA has determined that these chemicals meet the standards laid out in SDWA 

section 1457. 

IV. EDSP Policy Considerations for SDWA Chemicals 

The Agency used the following policy considerations to guide development of 

procedures for issuing EDSP Tier 1 screening 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 substance may 

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

may be exposed to such substance. Thus, SDWA procedures should 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, procedures for SDWA chemicals should be consistent with 

existing EDSP procedures unless there is a reason for modifying them (e.g., different 
 16

statutory requirements), though for the sake of clarity EPA has written these draft 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 

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

 • The Agency expects to issue SDWA/FFDCA 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 orders on all 

SDWA chemicals that are not PAIs.

 • EPA intends, where appropriate, to rely on FIFRA and FFDCA when issuing 

orders to technical registrants of a pesticide chemical. If, however, recipients of such test 

orders fail to provide the required information, EPA may choose to reissue test orders 

under SDWA/FFDCA authority based on the SDWA criteria. EPA would then rely on the 

policies and procedures established in this document. 

V. Proposed Procedures for Requiring Testing under the EDSP Pursuant to SDWA 

For purposes of discussing the EDSP procedures in this document, SDWA 

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

SDWA Chemicals (including currently registered pesticide inert ingredients). As 

previously noted, EPA generally intends to issue FIFRA/FFDCA orders to manufacturers 

and registrants of PAIs. EPA would retain, however, the discretion to issue an 

SDWA/FFDCA order to any substance that meets the statutory criteria in SDWA section 
 17

1457. Consequently, in the event that no FIFRA/FFDCA test order recipient generates 

the required data, either because all registrations containing the PAI or inert ingredient 

has been cancelled, or because all manufacturers decide to “opt out” of the pesticide 

market, EPA may determine to issue testing orders based on the SDWA authority in 

order to obtain the data. In such instances, the policies outlined in this document would 

be applicable. 

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

Chemicals”), EPA may determine to issue test orders relying on both SDWA section 

1457 and FFDCA section 408(p)(5). For readers associated with the pesticide 

community, EPA notes that in several respects, the Other SDWA Chemicals are similar 

to the non-food use inert ingredients discussed in EPA’s April 15, 2009 policies; the 

similarities are reflected in the policies that EPA is proposing in this document. 

Subsections A-K of this unit 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? 

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 for issuing 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 test 

orders on SDWA chemicals is included in the docket (Ref. 4). 

As noted for SDWA PAIs, the Agency is not proposing to modify the FIFRA 

policies and procedures. Readers potentially affected by FIFRA/FFDCA test orders 
 18

should review the April 15, 2009, document. 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 intends to issue SDWA/FFDCA test orders 

following the polices and procedures proposed in this document. Generally, EPA intends 

to rely primarily on information reported to the Agency under the TSCA Inventory 

Update Reporting (IUR) Rule (Ref. 5) to identify the initial SDWA/FFDCA test order 

recipients. The IUR Rule requires manufacturers and importers of certain chemical 

substances 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. The Agency believes that the IUR information is an appropriate source for 

identifying test order recipients for four primary reasons: 

(1) It has been EPA’s experience that relying on companies that have reported to 

the IUR 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 IUR rule. 

(2) Companies that report under the IUR Rule generally account for most of a 

chemical in commerce; therefore 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 IUR comprise the majority of the 
 19

volume associated with the chemical; these companies are more likely to be able to afford 

the cost of EDSP testing than companies manufacturing volumes below the IUR 

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. 

(3) Using the IUR information to identify order recipients will facilitate joint data 

development as reporters for these chemicals are generally publicly known and not 

numerous. 

(4) EPA anticipates that initially sending orders on Other SDWA Chemicals to all 

potential manufacturers and importers may lead to unnecessary administrative costs to 

the regulated industry and EPA. EPA’s experience in the first round of EDSP screening 

identified that, to date, for the nine inert pesticide chemicals, only 10 of the 524 orders 

issued have resulted in an initial response of entering a consortia or otherwise providing 

the data. The remaining 514 responses have been either no response, returned to the 

Agency as undeliverable, or a response indicating not subject to the order, discontinued 

manufacture or import, or will not sell for a pesticide use. Should EPA send a 

SDWA/FFDCA order to these recipients as a follow-up, the Agency anticipates that the 

115 responses of “will not sell for a pesticide use” are manufacturers or importers which 

would need to provide data under the SDWA/FFDCA order. (Ref. 6) A de minimis

exemption for very low volume producers is discussed later in this subsection. 

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

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

Release Inventory (TRI), to identify possible test order recipients. For Other SDWA 

Chemicals that are also regulated or tracked by another agency (e.g., pharmaceuticals by 
 20

the Food and Drug Administration), EPA may also consult with that agency as 

appropriate to identify main manufacturers and importers. EPA is interested in finding 

other sources of information for reliably identifying test order recipients and requests 

comment on other means of identifying potential test order recipients. 

In addition to using IUR, TRI, and other federal Agency data, EPA intends to 

issue orders to manufacturers and importers who are subsequently identified as such. In 

the interest of equity and shared test cost burden, EPA believes it is important to identify 

and issue orders to all significant manufacturers and importers of a listed chemical; the 

Agency will follow up on any new information it receives to this effect and issue orders 

accordingly. Of particular interest to the Agency are companies whose production or 

import of a listed chemical fluctuates year-by-year or who can otherwise be considered 

current manufacturers or importers even though they did not report under the most recent 

IUR. Information submitted that identifies potential test order recipients not listed on the 

most recent IUR should pertain to those companies who manufacturer or import the 

chemical in relevant quantities. That is, EPA does not intend to issue orders to companies 

who 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 (as opposed to thousands of pounds). The rationale for this de 

minimis exemption is also based on the authority for listing an Other SDWA Chemical 

for EDSP screening (see Unit II.B.). 

The Agency is also considering issuing catch-up orders for manufacturers or 

importers who are identified as beginning manufacture or import within five years of the 

issuance of the SDWA/FFDCA test order. The catch-up order process would be similar 
 21

to the catch-up order process described in the April 15, 2009, document, except EPA 

intends to rely on the public to identify such manufacturers. A recipient of such catch-up 

orders would be expected to participate in the cost sharing if it relies on data developed or 

submitted by another recipient or consortia to satisfy its test order obligation. 

If, after going through this process, all test order recipients have ceased to 

manufacture a SDWA chemical and the Agency has not received the required data, the 

SDWA chemical would be considered an “orphan.” The Agency seeks comment on the 

value of EDSP testing on orphan chemicals and the strategy EPA should use to obtain 

EDSP data on orphan chemicals. 

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

Order recipients would receive a test order in one of two ways: By registered 

mail or electronically, once a process has been established. In addition to the test order, 

EPA will send each recipient a packet that contains the instructions, background 

materials, and forms needed to comply with the order or will provide directions as to the 

location of such materials. 

EPA is moving toward electronic exchange of information in many of its 

programs. For instance, reporting for the IUR Rule is anticipated to be fully electronic 

sometime in 2011. The Agency seeks comment as to whether companies who already 

have a Central Data Exchange (CDX) (Ref. 7) account would prefer to receive the 

notification electronically, either as a standard procedure or upon request. EPA requests 

that commenters include some discussion of the mechanisms by which EPA can ensure 

that accurate records documenting that the individual has received the order, as well as 
 22

the date of receipt of the test order, can be obtained through the use of electronic 

reporting mechanisms. 

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

Who Has Supplied Data? 

EPA intends to publish the list of all test order recipients on the Agency's public 

website, https://www.epa.gov/endo. EPA invites the submission of information (with 

proper substantiation) identifying additional entities -- including entities who 

manufacture for 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 

order. 

D. How Will the Agency Minimize Duplicative Testing? 

The Agency also intends to post the status of the test orders, including recipients' 

responses, on the EPA website so that both order recipients and the public can determine 

the status of responses. EPA is making 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 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 existing policies and procedures 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 substantial populations may 

be exposed. Exiting any given market (e.g., the pesticide market) is not sufficient if the 
 23

SDWA chemical is manufactured or imported for other uses because the chemical may 

still be found in sources of drinking water. Accordingly, if sufficient data on a SDWA 

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

order recipients exit the market or otherwise indicate that they are not providing data), a 

subsequent SDWA/FFDCA order may be issued. 

Order recipients provide their initial responses on an “Initial Response Form for 

Individual Order Recipients.” (Ref. 8) Response options that EPA anticipates including 

in SDWA/FFDCA test orders are as follows: 

Option 1: Recipient indicates that it intends to generate data. The test order 

recipient may decide to generate new data for each test specified in the order, and would 

then comply with the procedures prescribed in the test order. In general, this option 

would be identical to the option discussed in the original policies and procedures. EPA is 

not proposing to make any changes for SDWA chemicals. Data generated and submitted 

would need to comply with Good Laboratory Practices (GLP). Good Practices have 

been set out both in FIFRA for pesticides in 40 CFR part 160 and for TSCA chemicals in 

40 CFR part 792. Test order recipients would need to follow appropriate GLPs, protocol 

requirements identified in the order, and procedures described in test order for submitting 

the data. 

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

scientifically relevant information (OSRI). The recipient would choose this option to 

indicate that it is submitting or citing existing data (including citing 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 either the data or a reference to 
 24

the data for each assay specified in the order. In submitting or citing existing data, the 

order recipient or other party should follow, as appropriate, relevant format guidelines 

described in the 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 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 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 (see 

http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm) (Ref. 9), 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 

other scientifically relevant information) to determine whether the information is 

acceptable (i.e., 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 order will be based on the weight-of-evidence from all 

relevant information available. The Agency would notify the recipient in writing of its 

determination. 
 25

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

initial response received from an order recipient can be used to satisfy the Tier 1 order, 

which will be based on the weight-of-evidence from all relevant information available to 

the Agency, the 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 order, although it may satisfy part of 

the order, the recipient would still need to satisfy the remainder of the order. 

As indicated previously, EPA intends to use a weight-of-evidence basis, taking 

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

identify any adverse endocrine-related effects caused by the substance, and establish a 

quantitative relationship between the dose and that endocrine effect. 

EPA is not currently able to provide definitive examples of the specific 

circumstances in which a chemical would be able to go directly to Tier 2 testing; 

however, if an order recipient chooses to make such a request, EPA will consider it, along 

with any justification provided. In general, it may in some cases be possible to determine 

that a particular chemical has the potential to interact with the endocrine system and 

therefore could proceed to Tier 2 even if Tier 1 data are limited. However, if only some 

of the Tier 1 data are available, there may not be sufficient information to determine that 
 26

some of the Tier 2 data are not necessary. These determinations will be made in a weightof-evidence judgment on a case-by-case basis and made publicly available for 

consideration by others with the same or similar circumstances. 

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 form a 

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

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

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

recipient’s behalf. 

The designated lead for the consortium would need to complete the “Initial 

Response Form for 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 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 need to follow the mailing instructions on the order to submit the 

consortium’s initial response and accompanying information to EPA by the due date for 

the consortium’s response, which would be indicated in the test order. 

Once the consortium submits the data and EPA has completed its initial review, 

EPA would provide written notification to the contact of the consortium indicating 

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

obligations for each of the consortium participants. 
 27

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, unless it were 

to commit to submit, and then did submit, the required data by the dates specified in the 

order. The Agency would generally not grant time extensions for the submission of data. 

The Agency intends to provide to every 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 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 April 15, 2009, document. If the identity 

of a company subject to the 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 

generally intends to publish the list of order recipients in the Federal Register and post it 

on the Agency’s website. 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 

test orders, including the recipient’s response, on the Agency website so that both order 
 28

recipients and the public can check on the status of responses to the 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 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 testing, or because it believes the order 

was otherwise erroneously sent. An explanation of the basis for the claim, along with 

appropriate information to substantiate the claim, would accompany the Initial Response. 

The Agency intends to evaluate the claim and respond to any request in writing within 90 

days of receipt. If EPA was unable to verify the claim, the original requirements and 

deadlines in the order would be expected to remain. If EPA could verify the claim, such 

a response would satisfy the order and no further response would be necessary. This 

option would be similar to the option discussed in the original policies and procedures for 

manufacturers of inert ingredients. EPA is not proposing to make any changes for 

SDWA chemicals. 

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 previously, 

manufacture would also include manufacture for the purposes of export only. The 

recipient’s “Initial Response Form” would need to include an explanation and 

documentation supporting its claim, which EPA could verify. If EPA verifies the claim, 

the initial response is all that would be required to satisfy the order. If EPA could not 

verify the claim, the recipient’s obligation to comply with the test order would remain. 
 29

Unlike the existing policies and procedures, which enable a manufacturer or 

importer of a pesticide chemical 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 necessarily address the 

chemical’s potential presence in “sources of drinking water to which a 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 testing specified in the order if: 

6a. The recipient can demonstrate (supported by appropriate data) that the 

chemical is an endocrine disruptor and that additional EDSP Tier 1 screening is 

unnecessary. 

6b. 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”). 

6c. The chemical was used by EPA as a ‘‘positive control’’ to validate one or 

more of the screening assays. EPA generally expects that if the chemical was used by 

EPA as a “positive control” to validate one or more of the screening assays, only the data 
 30

submitted related to those assays for which the chemical was used to complete the testing 

as part of the validation effort would be sufficient to satisfy the Tier 1 Order. 

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

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

requirements and deadlines in the order would remain. If EPA could verify the claim, 

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

be required. 

F. How can Order Responses and Data be Submitted Electronically? 

 EPA is developing a new 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 under development for other TSCA 

reporting, including TSCA Section 8 IUR. The order electronic reporting system will 

take advantage of the Agency’s CDX to allow order recipients to respond to an order and 

to submit test data via the Internet. See www.epa.gov/cdx for additional information 

about CDX. (Ref. 7) Recipients, if not already registered with CDX, will need to 

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

Specific requirements associated with these orders will be provided directly to the order 

recipients, and are expected to include: 

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

usable for electronically submitting test order responses; 

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

• Encrypted submission to EPA via CDX. 
 31

Each test order would contain specific, updated information regarding the most 

current process to use to respond to the order. If the CDX registration process and/or 

web-based response form are not fully established at the time of your response, EPA 

intends to provide an alternate methodology in each order which may be one or more of 

the following: 

• Fillable-PDF response form available from the Agency’s website, which can be 

completed, printed, signed, and mailed or delivered to EPA with attachments included as 

PDF files on a CD; 

• Form provided along with the order which can be completed, signed, and mailed 

or delivered to EPA with attachments included as PDF files on a CD. 

Specific instructions for mailing or delivering the response package to the Agency would 

be provided on the Order Response Form. 

G. How Will EPA Facilitate Joint Data Development and Cost Sharing for SDWA 

Chemicals? 

As described in the existing policies and procedures (74 FR 17560), the Agency 

has concluded that FFDCA section 408(p)(5) does not provide the authority to create 

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 
 32

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. 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 I 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: 

• 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 
 33

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 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 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 
 34

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 April 15, 2009, document, 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, the 

Freedom of Information Act (FOIA), and the Trade Secret Act (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 possible 

exception of data for pesticide food-use inert chemicals. Registrants of a food use inert 

ingredient that is also identified as a SDWA chemical should expect to receive 

SDWA/FFDCA test orders; however, all CBI and data compensation provisions 

established in FIFRA would still apply. Test order recipients with a current registration 

for the food-use inert, or a pesticide with a food tolerance or exemption, should consult 

the April 15, 2009, document for a more detailed explanation of the FIFRA provisions 

that apply. 

 For chemicals on the non-confidential TSCA Inventory (i.e., the chemical 

identity of the chemical substance is publicly known), health and safety data may not be 

claimed as CBI when it is submitted to EPA. Because the chemical identity is public for 

all SDWA chemicals on the second EDSP chemical list, EPA expects that there would be 
 35

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 

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. 

I. What is the Process for Contesting a Test Order or Consequences for Failure to 

Respond or Comply with a Test Order? 

Section 408(p) of FFDCA [21 U.S.C. § 34a] does not explicitly address the 

process for contesting a test order. EPA’s interpretation is that a test order is final agency 

action subject to review by all order recipients, including non-registrants. (EPA believes 

this is an appropriate conclusion because the provisions in FFDCA section 408(p)(5)(A) 

describing “Collection of Information” for a test order does not distinguish between 

FIFRA registrants and other test order recipients.) 

If anyone potentially subject to an order wishes to challenge the validity of the 

factual predicate for issuance of the Order, specifically the EPA determination that the 

chemical or substance for which testing is required by the order is a “substance that may 

occur in sources of drinking water” and/or that “a substantial population may be exposed 

to such substance,” that person would only be able to do so under SDWA section 1448 
 36

[42 U.S.C. 300j-7(a)] by filing a petition for review in the United States Court of Appeals 

for the circuit in which the recipient resides or transacts business within 45 days of the 

date of the SDWA determination, plus 14 days provided under 40 CFR 23.7. EPA 

interprets the date of the determination to be the date that EPA publishes the finalized 

EDSP list along with the Schedule for Issuance of Orders. 

If the order recipient wishes to challenge the validity of any other the provisions 

of the order, including the requirement to conduct any test or use the specific test 

protocols required by the order, it must submit to the Agency a detailed explanation of 

the basis for its challenge that provides sufficient information for the Agency to evaluate 

the issue. While EPA is considering the submission, the original deadline would remain. 

The Agency intends to respond to a request in writing within 90 days of receipt. If EPA 

does not grant the recipient’s request, the original deadline remains. 

FFDCA does specify procedures available to non-registrants who fail to comply 

with a test order (see FFDCA section 408(p)(5)(D)). Non-registrants who fail to comply 

with a test order shall be liable for the same penalties and sanctions as are provided for 

under TSCA section 16. [15 U.S.C. § 2615(a)(1),(2)(A)]. Section 16 provides that after 

notice and an administrative hearing held on the record in accordance with APA section 

554, civil penalties may be assessed. Additionally, for EDSP test orders issued under the 

authorities of FIFRA/FFDCA or SDWA/FFDCA, the enforcement response described in 

the FIFRA policies and procedures apply (Ref. 1).

J. What is the Informal Administrative Review Procedure? 

As described in the April 15, 2009, document, EPA generally intends to include a 

provision in test orders issued under FFDCA section 408(p) by which recipients could 
 37

raise any questions or challenges concerning the issuance of the order. 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. The filing of a 

challenge or objection does not extend the test order timeline, and EPA recommends that 

order recipients who respond with a challenge do so in a timely manner, and with 

adequate detail. EPA would review the objections and respond in writing. The Agency 

understands the appropriateness of responding to such objections with sufficient time for 

an aggrieved order recipient to comply with the orders, or to pursue judicial review. 

K. What are the Adverse Effects Reporting Requirements? 

Adverse effects reporting requirements for pesticide chemicals in registered 

products are established in FIFRA section 6(a)(2) and can be found in the existing 

policies and procedures (74 FR 17560). 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)). 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 substance if the information may lead to a 

conclusion that the chemical substance 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 
 38

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 test order recipient believes 

that it is responsive to the test order, need not be resubmitted to satisfy the FFDCA 

section 408(p) test orders. The test order recipient need only cite the previously submitted 

information in lieu of re-submission. 

VI. Request for Comment 

A. Response Option to Cease Manufacture 

 EPA seeks comment on the option for test order recipients of a SDWA/ FFDCA 

order to comply with the order by ceasing to manufacture or import the chemical. Under 

SDWA, EPA issues a test order based upon a finding that a chemical “may be found in 

sources of drinking water” and “that a substantial population may be exposed.” The 

chemical’s current presence in sources of drinking water and the corresponding potential 

for public exposure is not altered by the fact that a particular company may subsequently 

choose to no longer manufacture or import the chemical in response to the order. The 

potential for continued exposure to the chemical exists despite any potential decrease that 

might be caused by the exit of one or more test order recipients. Moreover, given that 

past actions contributed to the source of the current exposure, the company should remain 

responsible for generating the data to allow the Agency to characterize the significance of 

that exposure. On the other hand, if test order recipient stops manufacturing and 

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

water. (The decline will happen at different rates, depending on the chemical and 
 39

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 

screening will no longer receive any economic benefit from the sale of the chemical with 

which to defray the cost of testing. Finally, requiring a company to provide EDSP data 

on a chemical, even if it ceases manufacture and import of the chemical, removes a major 

incentive for companies to stop producing chemicals for which test orders are issued. 

Consequently, EPA seeks comment on whether it is generally inappropriate to allow 

companies to comply with an order by agreeing to cease manufacture or import of a 

SDWA chemical. 

B. Persistence 

 EPA seeks comment on whether and how to factor a chemical’s persistence in 

the environment into EDSP policies and procedures. As discussed previously, the 

Agency generally intends FFDCA section 408(p) as giving the Agency authority to issue 

orders to current registrants, manufacturers, and importers of a chemical. For persistent 

chemicals, past registrants, manufacturers, and importers (as well as processors and 

users) are likely to have contributed to current and ongoing contamination. EPA requests 

comment on the ways in which this could be taken into account. For example, one option 

would be for EPA to issue orders to such manufacturers, to ensure that they share in the 

costs of generating the data. Another option would be for EPA to issue orders to such 

parties only where the chemical is no longer manufactured or imported in the United 

States. 

C. Catch-up Orders and Data Compensation 
 40

EPA seeks 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. Under FIFRA, new pesticide registrants who did not 

generate data on an EDSP pesticide chemical are required to pay data compensation to 

the registrant who sponsored the testing. Test data are compensable for a 15 year period 

(7 U.S.C. 136a(c)(1)(F)(ii)-(iii)). For this reason, EPA stated in the existing policies and 

procedures that it intends to issue catch-up orders for 15 years after the initial data were 

submitted. Requirements in FIFRA ensure that any new manufacturer of a pesticide 

chemical registers with the EPA, thus enabling EPA to identify test order recipients and 

issue orders accordingly. Neither SDWA nor FFDCA enable EPA to identify 

manufacturers or importers of SDWA chemicals so readily, and EPA would bear a 

substantial burden if it were to issue SDWA catch-up orders on every chemical for 15 

years following issuance of the first order(s) (or receipt of the data), simply based on the 

effort required to identify new manufacturers and importers. Data compensation 

requirements are also established in TSCA for data generated in response to section 4 test 

rules. The reimbursement period for TSCA test data ends “after an amount of time equal 

to that which had been required to develop data or after five years, whichever is later.” 

(40 CFR part 790). The Agency seeks comment in regards to the appropriate amount of 

time to require data compensation for EDSP data generated in response to 

SDWA/FFDCA orders. This data will be made public after the EPA has received it, and 

data compensation measures exist solely to maintain fair and equitable sharing of test 

costs. EPA also notes that a five-year window for issuing catch-up orders would include 

the next IUR collection. 
 41

D. Orphan Chemicals 

 As stated in Unit V.A. the Agency seeks comment on the value of testing orphan 

chemicals (those for which test orders do not generate the necessary data). EPA is 

interested in strategies for obtaining the data or sources of funding to conduct EDSP 

screening. 

E. Electronic Notification

 As stated in Unit V.B. The Agency seeks comment as to whether companies who 

already have a Central Data Exchange (CDX) account would prefer to receive the 

notification electronically, either as a standard procedure or upon request. EPA requests 

that commenters include some discussion of the mechanisms by which EPA can ensure 

that accurate records documenting that the individual has received the order, as well as 

the date of receipt of the test order, can be obtained through the use of electronic 

reporting mechanisms. 

VII. References 

1. EPA. Endocrine Disruptor Screening Program; Polices and Procedures for 

Initial Screening: Notice. Federal Register (74 FR 17560, April 15, 2009) (FRL–8399–

9). 

2. EPA. FFDCA section 408(p) Order Template for Manufacturers/Importers of 

SDWA Chemicals. Draft. September 22, 2010. 

3. EPA. OCSPP. Endocrine Disruptor Screening Program. Available online at 

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

4. EPA. OCSPP. Process for Issuing EDSP Second List Test Orders. September 

20, 2010. 
 42

5. EPA. OCSPP. Inventory Update Reporting (IUR). Available online at 

http://www.epa.gov/iur. 

6. EPA. Status of EDSP Orders/DCIs as of Thursday, September 16, 2010 (Next 

update September 23, 2010). Updated tables available online at 

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

7. EPA. Central Data Exchange. Available online at http://www.epa.gov/cdx. 

8. EPA. [DRAFT] FFDCA section 408(p) Order for SDWA Chemicals - Initial 

Response Form for Individual Order Recipients (EPA Form No. tba). September 20, 

2010. 

9. EPA. Harmonized Test Guidelines. Available online at 

http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm. 
 43

List of Subjects 

 Environmental protection, Chemicals, Endocrine disruptors, Pesticides and pests, 

Safe drinking water, Reporting and recordkeeping. 

Dated: September 28, 2010. 

Stephen A. Owens, 

Assistant Administrator, Office of Chemical Safety and Pollution Prevention. 

<FRDOC> [FR Doc. 2010–28812 Filed 11–16–10; 8:45 am] 

<BILCOD>BILLING CODE 6560–50–P 

[FR Doc. 2010-28812 Filed 11/16/2010 at 8:45 am; Publication Date: 11/17/2010]