Document ID: EPA-HQ-OPPT-2007-1080-0040
Agency: epa
Document Type: Notice
Title: Endocrine Disruptor Screening Program: Draft Policies and Procedures for Screening Safe Drinking Water Act Chemicals
Posted Date: 2010-11-17T05:00Z

[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Notices]
[Pages 70558-70568]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28812]

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Part IV

Environmental Protection Agency

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Endocrine Disruptor Screening Program; Draft Policies and Procedures 
for Screening Safe Drinking Water Act Chemicals, Second List of 
Chemicals for Tier 1 Screening, Agency Information Collection 
Activities; Proposed Collection; Comment Request; Addendum for the 
Second List of Chemicals; Tier 1 Screening of Certain Chemicals; 
Notices

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

[[Page 70558]]

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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.

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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

[[Page 70559]]

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 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 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 
(non-pesticide) 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

[[Page 70561]]

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 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

[[Page 70562]]

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 (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 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-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 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

[[Page 70563]]

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 weight-of-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

[[Page 70564]]

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 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.
    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

[[Page 70565]]

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

[[Page 70566]]

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 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 [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

[[Page 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 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 
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.

[[Page 70568]]

    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