70558 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 

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 January 18, 2011. 

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. 

• 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 Web site 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 

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: 

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. 

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 


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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). 

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 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.] 

• 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 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 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 


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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 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 

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 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 Web 

site, 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 nonpesticides. 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 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 


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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 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 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 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 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 nonfood 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 


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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 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 (nonpesticide) 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 

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 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-byyear 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 

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 


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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 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 Web site, 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 Web 

site 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 

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 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 weightof-evidence from all relevant 

information available. The Agency 

would notify the recipient in writing of 

its determination. 

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 


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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 some of 

the Tier 2 data are not necessary. These 

determinations will be made in a 

weight-of-evidence judgment on a caseby-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. 

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 Web site. 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 Web site so 

that both order 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. 

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 


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was used by EPA as a ‘‘positive control’’ 

to validate one or more of the screening 

assays, only the data submitted related 

to those assays for which the chemical 

was used to complete the testing as part 

of the validation effort would be 

sufficient to satisfy the Tier 1 Order. 

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 http://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. 

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 Web site, 

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 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 

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 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 


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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 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 nonregistrants. (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 [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 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 poses a substantial risk of 

injury to health or the environment. The 

information need not, and typically 


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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 70567 

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 resubmission. 

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 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 

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. 

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. 

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. 


emcdonald on DSK2BSOYB1PROD with NOTICES2
70568 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 

9. EPA. Harmonized Test Guidelines. 

Available online at http://www.epa.gov/ 

ocspp/pubs/frs/home/guidelin.htm. 

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. 

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

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2007–1081; FRL–8849–3] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Addendum for the 

Second List of Chemicals; Tier 1 

Screening of Certain Chemicals Under 

the Endocrine Disruptor Screening 

Program (EDSP); EPA ICR No. 2249.02, 

OMB Control No. 2070–0176 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), this document 

announces that EPA is planning to 

submit a request an addendum to an 

existing approved Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB). This 

addendum simply covers the burden for 

a new list of chemicals to receive and 

respond to EDSP Orders. The activities 

articulated in the original ICR are not 

changing. This ICR addendum, entitled 

‘‘Addendum for the Second List of 

Chemicals; Tier 1 Screening of Certain 

Chemicals Under the Endocrine 

Disruptor Screening Program (EDSP)’’ 

and identified by EPA ICR No. 2249.02 

and OMB Control No. 2070–0106. 

Before submitting the ICR to OMB for 

review and approval, EPA is soliciting 

comments on specific aspects of the 

proposed information collection. 

DATES: Comments must be received on 

or before January 18, 2011. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2007–1081, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• 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, Rm. 

6428, 1201 Constitution Ave., NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2007–1081. 

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– 

2007–1081. 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 email. The regulations.gov Web site 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 

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, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically 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: 

William Wooge, (7201M), Office of 

Science Coordination and Policy 

(OSCP), Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–8476; fax number: 

(202) 564–8482; e-mail address: 

wooge.william@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. What should I consider when I 

prepare my comments for EPA? 

A. Considerations Under the Paperwork 

Reduction Act (PRA) 

Pursuant to section 3506(c)(2)(A) of 

PRA, EPA specifically solicits 

comments and information to enable it 

to: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the Agency, including 

whether the information will have 

practical utility. 

2. Evaluate the accuracy of the 

Agency’s estimates of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used. 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected. 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology, e.g., permitting 

electronic submission of responses. In 

particular, EPA is requesting comments 

from very small businesses (those that 

employ less than 25) on examples of 

specific additional efforts that EPA 

could make to reduce the paperwork 


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