[Federal Register Volume 78, Number 115 (Friday, June 14, 2013)]
[Notices]
[Pages 35909-35922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-14228]


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ENVIRONMENTAL PROTECTION AGENCY

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


Endocrine Disruptor Screening Program; Final Policies and 
Procedures for Screening Safe Drinking Water Act Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This document describes EPA's final policies and procedures 
for requiring Tier 1 screening under the Endocrine Disruptor Screening 
Program (EDSP) of chemicals for which EPA may issue EDSP test orders 
pursuant to section 1457 of the Safe Drinking Water Act (SDWA) and 
section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA). 
Section 408(p) of the FFDCA directed EPA to develop a chemical 
screening program using appropriate validated test systems and other 
scientifically relevant information (OSRI) to determine whether certain 
chemicals may have hormonal effects. These final policies and 
procedures supplement the EDSP policies and procedures that were 
published in the Federal Register on April 15, 2009.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Mike Mattheisen, Chemical 
Information and Testing Branch (7405M), Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001; telephone number: (202) 564-3077; email 
address: [email protected] or Pat West, Office of Science 
Coordination and Policy (7203M), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001;

[[Page 35910]]

telephone number: (202) 564-1656; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be affected by this action if you produce, manufacture, 
use, or import chemicals (including pesticide chemicals) that may be 
found in sources of drinking water; if you manufacture or import 
chemicals that degrade to chemicals found in sources of drinking water; 
or if you are, or may otherwise be, involved in the testing of 
chemicals for potential endocrine effects. The following list of North 
American Industrial Classification System (NAICS) codes is not intended 
to be exhaustive, but rather provides a guide to help readers determine 
whether this document applies to them. Potentially affected entities 
may include:
     Chemical manufacturers, importers, and processors (NAICS 
code 325), e.g., persons who manufacture, import, or process chemicals.
     Pesticide, fertilizer, and other agricultural chemical 
manufacturers, importers, and processors (NAICS code 3253), e.g., 
persons who manufacture, import, or process pesticide; fertilizer; or 
agricultural chemicals.
     Scientific research and development services (NAICS code 
5417), e.g., persons who conduct testing of chemicals for endocrine 
effects.
    To determine whether you or your business may be affected by this 
action, you should carefully examine the applicability provisions in 
Unit III.C., and examine FFDCA section 408(p). If you have any 
questions regarding the applicability of this action to a particular 
entity, consult either technical person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPPT-2007-1080, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics 
Docket (OPPT Docket), Environmental Protection Agency Docket Center 
(EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., 
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the Public Reading Room is (202) 566-1744, and the telephone 
number for the OPPT Docket is (202) 566-0280. Please review the visitor 
instructions and additional information about the docket available at 
http://www.epa.gov/dockets.

II. Background

A. What action is the agency taking?

    The Agency is publishing final policies and procedures for issuing 
EDSP test orders for chemicals pursuant to the Agency's authority under 
SDWA section 1457 (i.e., ``SDWA chemicals''). Section 1457 of the SDWA 
authorizes EPA to issue EDSP test orders to manufacturers and importers 
of chemicals that may be found in sources of drinking water and to 
which a substantial population may be exposed (42 U.S.C. 300j-17). SDWA 
chemicals encompass a wide variety of chemicals, including industrial 
and pesticide chemicals, ingredients in pharmaceuticals and personal 
care products, and degradates.
    These SDWA/FFDCA policies and procedures supplement the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA)/FFDCA policies and 
procedures that were published in the Federal Register issue of April 
15, 2009 (FIFRA/FFDCA policies and procedures) (Ref. 1). The FIFRA/
FFDCA policies and procedures (Ref. 1) were developed primarily for the 
issuance of EDSP test orders on pesticide active and inert ingredients, 
which were the chemicals comprising the first EDSP chemical list (first 
list). Consequently, some of the FIFRA/FFDCA policies and procedures 
(Ref. 1) reflect issues uniquely associated with the pesticide market 
and the specific regulatory context under which EPA regulates pesticide 
chemicals. In this document, EPA describes the policies and procedures 
associated with the screening of SDWA chemicals, which include certain 
modifications to the FIFRA/FFDCA policies and procedures that are 
intended to address issues that are unique to SDWA chemicals, or to 
address the circumstances where other competing considerations for SDWA 
chemicals warrant a modification of the FIFRA/FFDCA policies and 
procedures.
    This document discusses the policy considerations for SDWA 
chemicals in the following areas:
     Who would receive EDSP test orders for SDWA chemicals? 
Unit VI.A.
     How will recipients of EDSP test orders for SDWA chemicals 
be notified? Unit VI.B.
     How will the public know who has received an EDSP test 
order for a SDWA chemical or who has supplied data? Unit VI.C.
     How will the agency minimize duplicative testing? Unit 
VI.D.
     What are the potential responses to EDSP test orders for 
SDWA chemicals? Unit VI.E.
     How can an EDSP test order responses and data be submitted 
electronically? Unit VI.F.
     How will EPA facilitate joint data development, cost 
sharing, and data compensation for SDWA chemicals? Unit VI.G.
     What procedures can EPA apply for handling Confidential 
Business Information (CBI) for SDWA chemicals? Unit VI.H.
     What is the process for contesting an EDSP test order or 
consequences for failure to respond or comply with an EDSP test order? 
Unit VI.I.
     What is the informal administrative review procedure? Unit 
VI.J.
     What are the adverse effects reporting requirements? Unit 
VI.K.
    While the FIFRA/FFDCA policies and procedures (Ref. 1) remain 
relevant, SDWA chemical EDSP test order recipients are encouraged to 
refer to this document to fully understand all of the relevant policies 
and procedures. In addition, a new EDSP test order template for 
issuance of EDSP test orders under SDWA section 1457 and FFDCA section 
408(p)(5) is available in the docket for this document (Ref. 2).
    EPA is publishing two related notices elsewhere in this Federal 
Register issue. One announces the final second EDSP chemical list 
(second list), which includes both SDWA chemicals and pesticide active 
ingredients (PAIs). The other announces the submission to the Office of 
Management and Budget (OMB) of the final Information Collection Request 
(ICR) Addendum that describes the estimated paperwork burden and costs 
associated with the second list.

B. What are the statutory authorities for the policies discussed in 
this document?

    SDWA is the primary Federal law that ensures the quality of 
Americans' drinking water. Under SDWA, EPA sets standards for drinking 
water and works closely with States, localities, and water suppliers to 
implement these standards. SDWA authorizes EPA to set national 
standards for drinking water to protect against both naturally 
occurring and man-made contaminants that may be found in drinking water 
(42 U.S.C. 300g-1).
    Section 1457 of SDWA authorizes EPA to require testing, under FFDCA

[[Page 35911]]

section 408(p) (21 U.S.C. 346(a)(p)), of any chemical that may be found 
in sources of drinking water if the EPA Administrator determines that a 
substantial population may be exposed to such chemical (42 U.S.C. 300j-
17).
    Section 408(p)(1) of FFDCA requires EPA ``to develop a screening 
program, using appropriate validated test systems and other 
scientifically relevant information, to determine whether certain 
substances may have an effect in humans that is similar to an effect 
produced by a naturally occurring estrogen, or such other effects as 
[EPA] may designate'' (21 U.S.C. 346a(p)(1)).
    Section 408(p)(3) of FFDCA expressly requires that EPA ``shall 
provide for the testing of all pesticide chemicals'' (21 U.S.C. 
346a(p)(3)). Section 201 of FFDCA defines ``pesticide chemical'' as 
``any substance that is a pesticide within the meaning of [FIFRA], 
including all active and pesticide inert ingredients of such 
pesticide'' (21 U.S.C. 231(q)(1)).
    Section 408(p)(5)(A) of FFDCA provides that the EPA Administrator 
``shall issue an order to a registrant of a substance for which testing 
is required under [FFDCA section 408(p)], or to a person who 
manufactures or imports a substance for which testing is required under 
[FFDCA section 408(p)], to conduct testing in accordance with the 
screening program . . ., and submit information obtained from the 
testing to the Administrator, within a reasonable time period that the 
[Agency] determines is sufficient for the generation of the 
information'' (21 U.S.C. 346a(p)(5)(A)).
    The statutes discussed in this unit provide EPA with the discretion 
to require testing of a pesticide chemical under FFDCA alone, or in any 
combination of the various authorities (e.g., FIFRA/FFDCA, SDWA/FFDCA, 
or FIFRA/SDWA/FFDCA).
    Section 408(p)(5)(B) of FFDCA requires that, ``to the extent 
practicable, the Administrator shall minimize duplicative testing of 
the same substance for the same endocrine effect, develop, as 
appropriate, procedures for fair and equitable sharing of test costs, 
and develop, as necessary, procedures for handling of confidential 
business information'' (21 U.S.C. 346a (p)(5)(B)).
    Section 408(p)(5)(D) of FFDCA provides that any person (other than 
a registrant) who fails to comply with a FFDCA section 408(p)(5) test 
order shall be liable for the same penalties and sanctions as are 
provided for under section 16 of the Toxic Substances Control Act 
(TSCA) (21 U.S.C. 346a (p)(5)(D)). Such penalties and sanctions shall 
be assessed and imposed in the same manner as provided in TSCA section 
16. Under TSCA section 16, civil penalties of up to $37,500 per day may 
be assessed, after notice and an administrative hearing held on the 
record in accordance with section 554 of the Administrative Procedure 
Act (APA) (15 U.S.C. 2615(a)(1)-(2)(A)).
    In addition, Congress's House Appropriations Committee Report (H. 
Rept.) for EPA's FY 2010 appropriations (Ref. 3), directed EPA ``to 
publish within 1 year of enactment a second list of no less than 100 
chemicals for screening that includes drinking water contaminants, such 
as halogenated organic chemicals, dioxins, flame retardants (PBDEs, 
PCBs, PFCs), plastics (BPA), pharmaceuticals and personal care 
products, and issue 25 orders per year for the testing of these 
chemicals.''

C. Does this document contain binding requirements?

    While the requirements in the statutes and in any EDSP test orders 
ultimately issued under FFDCA section 408(p) are binding, the policies 
and procedures outlined in this document are not. The policies and 
procedures outlined in this document merely represent the general 
procedures and statutory interpretations on which EPA may rely to 
implement the existing goals of the statutory program. However, neither 
EPA nor any outside party is bound by any of the policies and 
procedures outlined in this document. Accordingly, these policies and 
procedures may be modified at any time by EPA and the Agency may depart 
from these policies and procedures where circumstances warrant and 
without prior notice.

III. Background on EDSP

A. What is EDSP?

    EPA developed EDSP in response to a Congressional mandate in FFDCA 
``to determine whether certain substances may have an effect in humans 
that is similar to an effect produced by naturally occurring estrogen, 
or such other endocrine effect as [EPA] may designate'' (21 U.S.C. 
346a(p)). As part of EDSP, EPA issues orders to collect certain test 
data on selected chemicals. In general, EPA intends to use the data 
collected under EDSP, along with other information, to determine if a 
pesticide chemical, or other chemicals, may pose a risk to human health 
or the environment due to disruption of the endocrine system. The 
determination of whether a chemical has the potential to interact with 
the endocrine system will be made on a weight of evidence basis taking 
into account data from the Tier 1 assays and/or OSRI. Chemicals that go 
through Tier 1 screening and are found to have the potential to 
interact with the estrogen, androgen, or thyroid hormone systems will 
proceed to the next stage of EDSP where EPA will determine which, if 
any, of the Tier 2 tests are necessary based on the available data. 
Tier 2 testing is designed to identify any adverse endocrine-related 
effects caused by the chemical, and establish a quantitative 
relationship between the dose and that endocrine effect. Further 
information regarding EDSP and requirements for Tier 1 and Tier 2 can 
be found on the Agency's EDSP Web site (Ref. 4). EPA is aware of no 
issue specific to the chemicals in the second list that would warrant 
any modification to the existing testing scheme, and is not proposing 
to adopt any.

B. Why is EPA publishing additional policies and procedures for EDSP 
Tier 1 screening?

    As stated in the FIFRA/FFDCA policies and procedures (Ref. 1), EPA 
intended to develop EDSP policies and procedures that could be used in 
subsequent data collection efforts, including those under SDWA, but 
indicated that EPA may make modifications as appropriate. The Agency 
now believes that modifications are needed to address issues that are 
specific to the larger universe of chemicals that are potentially 
subject to EDSP testing under SDWA.
    The FIFRA/FFDCA policies and procedures (Ref. 1) were originally 
developed for screening of pesticide chemicals and relied, in part, on 
a regulatory context that is specific to pesticide chemicals. The 
presumptions applicable in that context are not necessarily applicable 
to this larger universe of chemicals.
    For example, much of the data that would be generated in response 
to an EDSP test order (particularly for pesticide active ingredients) 
would be entitled to the data compensation protections available under 
FIFRA (7 U.S.C. 136a(c)(1)(F)) and FFDCA (21 U.S.C. 346a(i)). 
Additionally, FIFRA section 10 prohibits EPA from releasing study data 
on pesticide chemicals unless the person seeking access to the 
information certifies that he is not an agent or employee of any 
multinational pesticide company (7 U.S.C. 136h(g)). Because FFDCA 
section 408(p) did not authorize EPA to modify these FIFRA 
requirements, EPA needs to ensure that the policies and procedures 
adopted to implement FFDCA section 408(p) would operate in a manner 
that would be consistent with EPA's existing FIFRA mandates. Moreover, 
EPA could rely on the existing FIFRA mechanisms to

[[Page 35912]]

effectively minimize duplicative testing, and to promote cost-sharing.
    By contrast, these considerations are generally not applicable to 
the majority of chemicals that may be subject to EDSP screening under 
SDWA, such as chemicals used in pharmaceuticals and personal-care 
products, among others.
    In addition, the statutory authority for imposing testing of SDWA 
chemicals, the sources of SDWA chemicals, and EPA's ability to identify 
manufacturers and importers, and other considerations unique to SDWA 
chemicals, create a need for policies and procedures specific to EDSP 
screening under SDWA/FFDCA authority. For example, some registered 
pesticide ingredients have additional uses that account for a much 
larger percentage of total manufacture and import. In such cases, the 
Agency seeks to be able to identify, and issue orders to, all relevant 
manufacturers and importers in a manner that creates a fair and level 
playing field for complying with the order.

C. When do these policies and procedures apply?

    EPA has the discretion to issue EDSP test orders under the 
authorities of SDWA section 1457 and FFDCA section 408(p) for all 
chemicals, including PAIs, for which the Agency can make the requisite 
factual findings. As described in this document, however, EPA generally 
intends to use SDWA authority to require EDSP testing of SDWA chemicals 
that are not PAIs and FIFRA authority to require EDSP testing of PAIs 
and pesticide inerts, even if the PAIs and inerts have non-pesticide 
uses. EPA may issue SDWA/FFDCA EDSP test orders for PAIs and inerts 
that have non-pesticide uses, except, when PAI registrants avoid EDSP 
testing by canceling their registrations and leaving the market. This 
approach will preserve familiar data compensation and confidentiality 
protections established in FIFRA sections 3(c)(1)(F) and 12, as well as 
FFDCA section 408(i), for pesticide registrants.

IV. EDSP Policies and Procedures Considerations for SDWA Chemicals

    The Agency used the following policies and procedures 
considerations to guide development of policies and procedures for 
issuing Tier 1 EDSP test orders on SDWA chemicals:
     A core part of EPA's mission is to promote public 
understanding of the potential risks posed by chemicals in commerce.
     The basis for an order with respect to SDWA chemicals is 
that a chemical may be found in sources of drinking water and a 
determination that a substantial population may be exposed to such 
chemical. Thus, SDWA/FFDCA policies and procedures should not be 
unnecessarily tied to the use of the chemical in any given market and 
should instead focus on obtaining data from companies that might be 
expected to contribute to a chemical's presence in drinking water.
     For simplicity, policies and procedures for SDWA chemicals 
should be consistent with FIFRA/FFDCA policies and procedures (Ref. 1) 
unless there is a reason for modifying them (e.g., different statutory 
requirements), though for clarity EPA has written these SDWA/FFDCA 
policies and procedures as a complete, stand alone document.
     Procedures for EDSP testing of SDWA chemicals should 
strive to minimize duplicative testing and promote fair and equitable 
sharing of test costs, as described in FFDCA section 408(p)(5)(B).
     The Agency expects to issue SDWA/FFDCA EDSP test orders 
for pesticide inert ingredients that are listed for EDSP screening with 
a SDWA section 1457 finding; it has also been the Agency's experience 
that pesticide inerts generally have a much larger market than solely 
as ingredients in pesticide formulations. For these reasons EPA 
believes it is reasonable and equitable to initially issue SDWA/FFDCA 
EDSP test orders on SDWA chemicals that are not PAIs.
     As noted previously, EPA intends to require EDSP testing 
pursuant to FIFRA and FFDCA for registrants of a pesticide chemical, 
even if the chemical has non-pesticide uses. If, however, recipients of 
such EDSP test orders fail to provide the required information by 
dropping out of the pesticide market to avoid EDSP testing, EPA may 
choose to reissue EDSP test orders under SDWA/FFDCA authority if the 
SDWA criteria are met. EPA would then rely on the policies and 
procedures established in this document.

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

    This document adopts the proposed SDWA/FFDCA policies and 
procedures published in the Federal Register issue of November 17, 2010 
(Ref. 5), with minor revisions. The Agency reviewed and considered all 
of the comments that were received on the proposed SDWA/FFDCA policies 
and procedures. All of the comments received are available in the 
docket for this document, and a response-to-comments document (Ref. 6) 
that summarizes and responds to all of the comments received on the 
proposed SDWA/FFDCA policies and procedures is also available in the 
same docket. The Agency specifically requested comments on five topics: 
Response option to cease manufacture; persistence; catch-up orders and 
data compensation; orphan chemicals; and electronic notification. The 
Agency's consideration of such comments is described in this unit and 
the Agency's response to comments document (Ref. 6).

A. Response Option To Cease Manufacture

    EPA sought comment on whether a company could satisfy the EDSP test 
order simply by committing to stop manufacturing or importing a SDWA 
chemical, because, in ceasing to manufacture the chemical, the company 
thereby stops contributing to the presence of the chemical in the 
source of drinking water and reduces potential exposure. Alternatively, 
EPA sought comment on whether the company should be required to conduct 
the EDSP testing nevertheless, on the grounds that the company should 
not be able to evade responsibility for providing the data necessary to 
evaluate the existing water contamination to which their manufacturing 
activities had contributed.
    Multiple commenters (the American Petroleum Institute (API), the 
American Chemistry Council (ACC), Bayer CropScience LP (BCS), Croplife 
America (CLA), and the Chemical Producers and Distributors Association 
(CPDA)) agreed with EPA's proposal to allow a EDSP test order recipient 
for the second list to comply with an EDSP test order by ceasing all 
manufacturing of the listed chemical, because former manufacturers will 
not receive any new income from the chemical to pay for the new EDSP 
testing requirement and language in the statute refers to manufacture 
and production in the present tense. The San Francisco REACH Team 
(SFRT) requested that EPA's EDSP test order procedures be revised to 
include a clear timeline for when the production must cease.
    EPA intends to allow a SDWA EDSP test order recipient for the 
second list to comply with the test order by ceasing all manufacturing, 
including manufacturing for export only, and importing of the listed 
chemical. EPA considers this approach to be consistent with the 
language of the statute and with the decision to accept pesticide 
cancellation as an acceptable response to an EDSP test order issued 
under FIFRA. EPA will require recipients to provide a timeline for the 
cessation of production as part of the explanation

[[Page 35913]]

and documentation supporting the claim. Rather than specifying a single 
timeline, the Agency will take individual circumstances into account, 
essentially using the same procedure it applies to accepting pesticide 
cancellations as an acceptable response to an EDSP test order on a 
pesticide active ingredient.
    The American Water Works Association (AWWA) commented that an EDSP 
test order recipient should not be allowed to respond by ceasing 
manufacture, observing that this would not absolve them from having 
contributed to the presence of the chemical in the environment, and 
that it might persist in the environment.
    While the comment has merit, EPA has decided that, in this 
instance, the equities weigh in favor of allowing companies to satisfy 
the order by entirely ceasing to manufacture the chemical. As discussed 
in the draft SDWA/FFDCA policies and procedures (Ref. 5), a number of 
considerations weigh against requiring manufacturers who choose to 
cease manufacture of the chemical to nevertheless conduct EDSP testing. 
Specifically, if an EDSP test order recipient stops manufacturing and 
importing a chemical, it will ultimately lead to less exposure to the 
chemical in sources of drinking water. (The decline will happen at 
different rates, depending on the chemical and whether the chemical is 
found in surface water or ground water.) Moreover, an order recipient 
who ceases to manufacture or import a chemical that is subject to EDSP 
testing will no longer receive any economic benefit from the sale of 
the chemical with which to defray the cost of testing. This approach 
will effectively focus the costs on those companies that can best bear 
the costs of testing. Further, as discussed in this unit, EPA has been 
unable to develop an effective mechanism for issuing EDSP test orders 
to past registrants, manufacturers, and importers given the practical, 
legal, and equitable difficulties of identifying and assessing the 
contributions of past participants. However, if EPA is unable to obtain 
information on most chemicals for which there is continued and ongoing 
significant exposures, EPA may revisit the issue.

B. Persistence

    EPA sought comment on whether, and how, to factor chemical 
persistence into EDSP policies and procedures to account for the 
contribution associated with past registrants, manufacturers and 
importers, to the presence of a chemical in a source of drinking water, 
given that the Agency's policy has been to only issue orders to current 
registrants, manufacturers, and importers.
    Multiple commenters (API, People for the Ethical Treatment of 
Animals (PETA) and the Physicians Committee for Responsible Medicine 
(PCRM), ACC, BCS, and CLA and the Endocrine Policy Forum (EPF)) 
indicated that EPA should not consider a chemical's persistence in the 
environment when implementing EDSP, noting among other things that 
``persistence'' does not appear in the language of the FFDCA and 
asserting that it is subject to differing interpretations. Commenters 
observed that the issue of persistence is most likely to arise only for 
chemicals that have not been manufactured and used by anyone for a 
significant period of time (i.e., ``legacy chemicals''). Some 
commenters observed EPA would have to develop a legal and equitable 
process for identifying those chemicals along with all past 
manufacturers and importers, many of whom may not have manufactured or 
imported the chemical for decades.
    Two commenters (SFRT and AWWA) advocated that EPA should hold 
accountable all past registrants, manufacturers, and importers that 
have contributed to health and environmental impacts from past 
production activities, even if they are no longer actively 
manufacturing or importing a particular chemical, because chemicals 
persist in the environment, the consequences often become apparent 
decades after the cessation of exposure to a chemical, and companies 
should share the cost of generating data.
    Under SDWA, EPA issues an EDSP test order based upon a finding that 
a chemical ``may be found in sources of drinking water'' and ``that a 
substantial population may be exposed.'' While EPA believes that 
persistence can be defined (persistence is a factor in a variety of 
EPA's water and toxics programs; e.g., 40 CFR 125.122, 141.24, 711.6, 
792.3, 795.70, 796.1050, 798.2250, and 799.5075), SDWA does not 
explicitly address how to factor in the possible presence of a chemical 
in a source of drinking water from past manufacturing and importing. 
And, although, EPA believes that the potential long term impacts of a 
persistent chemical in sources of drinking water is an important 
consideration, EPA has not been able to develop an effective mechanism 
for issuing EDSP test orders to past registrants, manufacturers, and 
importers given the practical, legal, and equitable difficulties of 
identifying and assessing the contributions of past participants. 
Accordingly, EPA does not intend at this time to issue test orders to 
entities other than current registrants, manufacturers, and importers.
    For more information on how EPA addresses commenters' concerns 
about chemical persistence, see the comment response document for the 
second list of chemicals (Ref. 7).

C. Catch-Up Orders and Data Compensation

    EPA sought comment on ``whether 5 years is the appropriate length 
of time that the Agency should continue to issue SDWA/FFDCA catch-up 
orders as a means to ensure equitable sharing of test costs.'' (Five 
years is the length of time that data compensation is available for 
test rules issued under TSCA section 4. (See 40 CFR part 791.))
    The Methanol Institute argued that SDWA chemicals should be 
entitled to the same 15-year compensation period as pesticide 
chemicals, stating there was no logical reason to distinguish between 
SDWA chemicals and pesticide chemicals since both categories of 
chemicals are being subjected to the same testing requirements pursuant 
to the same legislative enactment. The SFRT and the ACC took similar 
positions. In addition, the 15-year compensation period applies to 
industrial chemicals used as inerts in pesticides as well.
    After carefully considering these comments and the equities 
involved, EPA has concluded that the most appropriate length of time to 
issue SDWA/FFDCA catch-up orders is in fact the same 15-year 
compensation period as for active and inert pesticide chemicals because 
it will provide a consistent standard across the entire EDSP. Neither 
SDWA nor the FFDCA authorized EPA to identify manufacturers or 
importers of SDWA chemicals through mandatory registration provisions, 
such as those that apply to pesticide registrants. Furthermore, an 
inconsistency would develop if SDWA chemicals are not entitled to the 
same 15-year compensation period as the first list of chemicals, 
pesticides, particularly if they are mandates to the same testing 
requirements pursuant to the same legislative enactments.

D. Orphan Chemicals

    EPA sought comment on the mechanisms available for testing 
chemicals for which EDSP test orders do not generate the necessary 
data.
    AWWA asserted that water utilities are not manufacturers that can 
be required to test under FIFRA or TSCA, so disinfection byproducts and 
arsenic and other naturally occurring chemicals should be considered 
orphan chemicals

[[Page 35914]]

and EPA should screen and test those chemicals itself.
    The BCS, PETA, and PCRM interpreted orphan chemicals as those 
chemicals no longer being produced or imported and reasoned that as 
environmental exposures to such chemicals would decrease over time, 
testing of such chemicals should not be required and resources to 
conduct testing should not be expended either by private parties or by 
the Agency without a documented rationale for why potentially harmful 
endocrine effects might be anticipated.
    Exposure to chemicals that are no longer being produced or imported 
may not decrease over time if the chemicals occur naturally or are 
persistent and bioaccumulative. However, exposure also will not 
increase from any continuing manmade contribution to environmental 
loading. As discussed in Unit V.A., EPA has not been able to develop an 
effective mechanism for issuing EDSP test orders to past registrants, 
manufacturers, and importers, and has, therefore, concluded not to 
issue test orders for chemicals that are no longer being manufactured 
or imported (see Unit V.B.). In addition, without reaching any 
conclusion with respect to whether water utilities can ever be 
manufacturers, EPA has not sought to require the testing of 
disinfection byproducts and arsenic or other naturally occurring 
chemicals as part of this second list of chemicals, but this issue 
warrants additional consideration.

E. Electronic Notification

    EPA sought comment on whether companies that already have a Central 
Data Exchange (CDX) account with EPA would prefer to receive an EDSP 
notification electronically as opposed to notification by means of the 
U.S. Postal Service, either as a standard procedure or by request, and 
on mechanisms by which EPA could accurately document the receipt of 
orders through electronic reporting mechanisms.
    API commented that it generally supported electronic reporting but, 
for EDSP, recommended that electronic notification be optional, since 
there have been technical problems with electronic reporting in other 
EPA programs.
    Electronic reporting has become the standard mode of operation in 
business and government and provides overwhelming advantages over paper 
submissions. The OPPT's premanufacture notice (PMN) and Chemical Data 
Reporting (CDR) rules (formerly known as the Inventory Update Reporting 
(IUR) rule) already require use of the Internet to electronically 
report. OPPT has also proposed additional electronic reporting 
requirements (Ref. 8).
    Electronic reporting requires use of EPA's CDX, the point of entry 
on the Environmental Information Exchange Network for environmental 
data submissions to the Agency. Currently, CDX has provided 
stakeholders with the ability to:
    1. Submit data through one centralized point of access and fill out 
a single electronic form which can be submitted instantaneously instead 
of mailing multiple paper forms.
    2. Receive Agency confirmation when submissions are received.
    3. Reduce costs associated with submitting and processing data 
submissions.
    4. Pay fees through https://www.pay.gov.
    5. Utilize publishing services to share information collected by 
EPA with other stakeholders.
    In an effort to streamline the reporting process, reduce the 
administrative costs, and maintain consistency with other electronic 
reporting of information submissions and recordkeeping (Ref. 8), EPA 
will require EDSP test order information to be submitted 
electronically. EPA will continue to issue EDSP test orders by U.S. 
Postal Service for the second list of chemicals.

F. Identification of EDSP Test Order Recipients

    Though EPA did not specifically request comment on the 
identification of EDSP test order recipients, some comments were 
received.
    API agreed with EPA that the CDR rule is the appropriate source for 
identifying current chemical manufacturers and importers, but 
recommended that EPA only use the Toxics Release Inventory (TRI) as a 
last resort, because TRI was less specific. AWWA commented that EPA 
should clarify what entities the EDSP test orders apply to by defining 
all terms describing potentially affected entities. The ACC commented 
that EPA should pay close attention to manufacturing and other 
activities that contribute to the occurrence of chemicals in drinking 
water to which a substantial population may be exposed, with an 
emphasis on the equitable sharing of the cost of testing.
    EPA believes it is ``important to identify and issue orders to all 
significant manufacturers and importers of a listed chemical'' and the 
Agency intends to rely on the CDR rule, which periodically requires 
manufacturers and importers to report chemical production information 
to EPA for chemicals manufactured (including imported) in amounts of 
25,000 lb or more at a single site. EPA considers the CDR rule to be a 
reliable means of identifying manufacturers and importers of non-
pesticide, industrial chemicals and believes that the CDR rule 
generally accounts for most of such chemicals in commerce. EPA intends 
to use other, publicly available databases, such as, but not limited 
to, TRI, to identify possible EDSP test order recipients. EPA disagrees 
that the TRI data are imprecise. TRI data are reported annually and 
reporters must indicate if they manufacture, including import, a listed 
chemical as well as more specific information on the manufacture of the 
chemical. EPA is aware that any given database, including CDR and TRI, 
is imperfect and has limitations. On the whole, however, EPA believes 
that CDR and TRI constitute comprehensive and generally reliable 
databases. Moreover, no commenter disagreed with EPA's assessment or 
submitted any information to rebut EPA's conclusions.
    In addition, EPA believes that relying on these databases 
effectively addresses the AWWA request that EPA clarify the entities 
that will be subject to EDSP test orders, and for a definition of all 
terms describing potentially affected entities. The rules that 
establish the reporting requirements for these databases (40 CFR parts 
372 and 711) already include definitions of all of the necessary terms 
and should be already familiar to the regulated community. Nonetheless, 
EPA asked for, and continues to be interested in learning about, any 
other credible source or method that may be used to identify EDSP test 
order recipients. In the final analysis, the objective is to identify 
responsible manufacturers and importers of relevant chemicals, and not 
to apportion responsibility. EDSP test order recipients may combine in 
consortia to conduct the required testing on whatever basis they find 
most suitable.
    SFRT asked that EPA ``incorporate a system which takes into account 
the location of chemical manufacturers and potential disproportionate 
burden on neighboring communities, in addition to production volume, 
when issuing test orders'' in order to ``account for the unequal 
geographic distribution of manufacturing locations of these chemicals 
and the potential impact of neighboring communities from a chemical's 
presence in the drinking water among other sources.'' SFRT also 
recommended that, in order to ``avoid disproportionate burdens and 
promote equitable responsibility among manufacturers,'' EPA issue EDSP 
test

[[Page 35915]]

order to ``all manufacturers of listed chemicals . . . with the 
exception of manufacturers using small quantities of the listed 
chemical (reported in grams instead of lbs.) for research and 
development purposes only.''
    EPA believes it is ``important to identify and issue orders to all 
significant manufacturers and importers of a listed chemical.'' The 
Agency intends to rely on the CDR rule, as well as TRI, both of which 
periodically require manufacturers and importers to report chemical 
production information to EPA for chemicals manufactured (including 
imported) in amounts of 25,000 lb or more at a single site. EPA 
considers the CDR rule to be the most reliable means of identifying 
``significant'' manufacturers and importers of non-pesticide, 
industrial chemicals and believes that the CDR rule generally accounts 
for most of such chemicals in commerce. It is unclear what the 
commenter intends by requesting that EPA require self-disclosure in 
this context, as the only vehicle for requirements relating to EDSP 
testing in this context will be the EDSP test orders, and EPA can only 
issue the orders to those manufacturers it can identify. Nonetheless, 
EPA is interested in finding other existing sources for reliably 
identifying EDSP test order recipients and will consider issuing EDSP 
test orders to other significant manufacturers and importers that are 
identified. EPA, however, does not intend to issue test orders to 
companies that only manufacture and/or import a chemical in small 
amounts for research and development or in amounts more appropriately 
measured in grams rather than thousands of pounds. Issuing EDSP test 
orders based on the geographic distribution of manufacturing locations 
and potential impact of chemicals on neighboring communities is, at 
least, not an express part of the basic requirement that EPA identify 
and issue EDSP test orders to chemical manufacturers and importers and 
would add another complex and potentially burdensome requirement to the 
issuance of EDSP test orders that appears unnecessary and unlikely to 
achieve the primary goal of the program: To obtain the necessary data 
to evaluate the endocrine potential of pesticide chemicals and drinking 
water contaminants.

G. Other Topics

    1. Cost sharing. ACC, CLA, EPF, and CPDA stated that EPA had 
developed a workable data compensation and cost sharing plan and agreed 
with EPA's decision to issue catch-up orders to require cost sharing by 
manufacturers and importers who enter the market after initial orders 
are issued (but suggested that such orders be issued for 10 instead of 
5 years), but recommended that EPA develop new procedures in the form 
of explicit, legally enforceable compensation rights to ensure fair and 
equitable sharing of test costs.
    Section 408(p) of FFDCA only authorizes EPA to create procedures 
that operate within the confines of existing statutory authority and to 
develop procedures to facilitate joint data generation. EPA, however, 
is authorized to determine what actions comply with a FFDCA section 
408(p) test order and intends to use this discretion to create strong 
incentives for companies to jointly volunteer to develop EDSP test data 
under the circumstances enumerated in Unit VI.G.
    2. Minimizing duplicative testing. PETA and the PRCM commented that 
EPA should mandate, and create incentives to form testing consortia.
    EPA does not have the authority to compel EDSP test order 
recipients to join testing consortia to minimize testing, but may 
develop procedures to facilitate joint data generation. In particular, 
EPA has the discretion to determine what constitutes compliance with an 
EDSP test order and can exercise that discretion to allow cost sharing 
and the joint electronic submission of data by EDSP test order 
recipients, in appropriate circumstances, to reduce costs and 
duplicative testing. EPA intends to continue to list other 
manufacturers and contact information in each EDSP test order as well 
as providing such information on the Agency's EDSP Web site.
    3. CBI. SFRT commented that EPA should strictly disallow CBI 
claims. The ACC, CLA, and EPF commented that FFDCA authorized, and EPA 
should provide, EDSP-specific CBI protection, which was critical to 
protect industry's legitimate intellectual property interests.
    FFDCA does not authorize EPA to either create new rights or to 
modify existing rights to confidentiality. Rather, FFDCA only directs 
EPA to apply the confidentiality provisions in existing statutory 
authorities: FIFRA, the Freedom of Information Act (FOIA), and the 
Trade Secret Act (TSA), as applicable. SDWA, in particular, only 
authorizes EPA to apply CBI protection under the TSA. Data submitted to 
EPA in response to an order issued under SDWA/FFDCA for non-pesticide 
chemicals, for example, would only have the protections provided under 
FOIA and TSA.
    4. Adverse effects reporting. ACC commented that EPA has not, but 
should, give clear guidance on the significance of positive Tier 1 test 
results for TSCA section 8(e) and FIFRA section 6(a)(2) reporting 
purposes.
    EPA made a considered decision not to reinterpret the existing 
requirements for Tier 1 data, nor to otherwise take steps to amend the 
existing requirements. Rather, EPA referenced the existing regulatory 
provisions of 40 CFR part 159 and existing interpretations of TSCA 
section 8(e). In general, EPA does not believe that data from a single 
Tier 1 assay that provides some evidence that a chemical may have the 
potential to interact with the endocrine system necessarily meets the 
standard for information that must be reported in accordance with FIFRA 
section 6(a)(2) or TSCA section 8(e) in all cases. In addition, EPA 
believes that it has not yet accumulated adequate experience with the 
Tier 1 results to be able to provide general guidance as to the 
significance of positive results from Tier 1 assays for purposes of the 
reporting requirements under FIFRA section 6(a)(2) or TSCA section 
8(e). Under existing procedures, the determination to report is to be 
made by the company in the first instance, on a case-by-case basis, 
taking into account all circumstances, and EPA is not aware of any 
reason to change that with respect to EDSP data. Accordingly, to the 
extent that Tier 1 information meets the standards laid out in EPA's 
regulations (40 CFR part 159), or falls within the categories described 
in EPA's past statements regarding TSCA section 8(e) (Ref. 9), that 
information should continue to be reported, consistent with those 
requirements.
    Any information previously submitted to EPA under FIFRA section 
6(a)(2), TSCA section 8(c), or TSCA section 8(e) need not be 
resubmitted to EPA in response to an EDSP test order, because EPA would 
already have the data.
    5. Public availability of information. SFRT commented that the EDSP 
test data on SDWA chemicals should be made publicly available on EPA's 
Web site.
    EPA intends to make all non-confidential EDSP data publicly 
available on the Agency's EDSP Web site. However, TSA and FOIA may 
apply and provide some protections against disclosure and it may not be 
possible to publicly post all available data. Nonetheless, EPA expects 
that confidential data will be limited, and health and safety data for 
chemicals on the non-confidential TSCA Chemical Substance Inventory 
(TSCA Inventory)

[[Page 35916]]

of existing chemicals, which all of the SDWA chemicals are, may not be 
entitled to confidential treatment.
    6. OSRI and Weight-of-Evidence (WoE). ACC, CLA, EPF, and CPDA 
commented that EPA's offer to accept OSRI in lieu of EDSP test data was 
justified, but that EPA had not clearly articulated a basis for 
evaluating OSRI. ACC, CLA, EPF, and CPDA also commented that EPA needed 
to develop meaningful WoE guidelines for assessing voluminous Tier 1 
EDSP data to determine whether a chemical interacts with the endocrine 
system and publish peer reviewed guidance for conducting WoE 
evaluations.
    EPA issued guidance on OSRI for Tier 1 test orders in 2009 (Ref. 
10) and on WoE approach evaluating Tier 1 screening results in 2011 
(Ref. 11).
    7. Communications: Consistent use of language and definitions. API, 
ACC, CLA, and EPF commented that, given the sensitivity of the issue of 
endocrine disruption, EPA should be careful to use clear and accurate 
definitions for all important EDSP terms and to communicate clearly, 
accurately, and consistently to the public and within the Agency in 
order to avoid confusion and misunderstanding.
    EPA generally agrees with these comments and has made every effort 
to be as clear, concise, and unambiguous as possible. EPA has, for 
example, generally adhered to widely accepted definitions, such as the 
World Health Organization's (WHO) definition of ``endocrine disruptor'' 
as ``an exogenous substance or mixture that alters function(s) of the 
endocrine system and consequently causes adverse health effects in an 
intact organism'' (Ref. 12). EPA has also repeatedly cautioned that the 
public should not presume that the listing of a chemical or substance 
indicates in any way that EPA currently suspects that such chemical or 
substance interferes with the endocrine systems of humans or other 
species. EPA plans on maintaining these communications in future EDSP 
documents. See also EPA's response to comments documents (Refs. 7 and 
13).
    8. Schedule. API, SFRT, ACC, BCS, CLA, EPF, and CPDA commented that 
EPA should not issue EDSP orders for the second list of chemicals or 
for Tier 2 testing until the data from the first list had been 
evaluated and the Tier 1 assays had been examined in light of those 
data.
    The Agency intends to complete review of the Tier 1 data from the 
EDSP test orders issued for the first list of EDSP chemicals before 
issuing Tier 1 test orders for the second list of EDSP chemicals. EPA 
intends to continue to rely on the available validated methods and to 
follow the recommendations in the 1999 report from the joint meeting of 
the Agency's Science Advisory Board (SAB) and FIFRA Scientific Advisory 
Panel (SAP) (Ref. 14). The steps for this process are described in the 
EDSP Comprehensive Management Plan issued in 2012 (Ref. 15). With these 
recommendations, the Agency improves the validating screening and 
testing methods to develop complete information on chemicals being 
tested. In continuing with this process of developing efficiency, the 
Agency does not intend to release any finalized EDSP Tier 1 WoE 
decisions until the EDSP Tier 2 protocols are available.
    9. Enforcement. SFRT commented that EPA should enact a system of 
graduated penalties for noncompliance with testing requirements based 
on the length of delay in complying with requirements.
    EPA agrees that graduated penalties are generally appropriate, and 
has generally exercised its discretion consistent with that policy. For 
non-pesticides, failure to comply with an EDSP order carries the same 
civil and criminal penalties set out in TSCA section 16, under which 
each new day of continued noncompliance is another violation, so 
graduated penalties based on the length of delay are already built into 
the law. For pesticide chemicals, the FFDCA imposes more specific 
requirements with respect to the penalty for non-compliance, although 
they are generally consistent with the concept that penalties should be 
tied to the period of non-compliance. FFDCA section 408(p)(5)(C) 
requires the suspension of the pesticide registration for the period of 
non-compliance, and specifies that the suspension shall be terminated 
upon a determination that the registrant is no longer out of 
compliance.
    10. Other comments. EPA also received comments on topics that do 
not address aspects of the policies and procedures for issuing EDSP 
test orders, e.g., the use of SDWA authority to issue orders, the basis 
of SDWA chemical selection, and the second list of chemicals. The 
comments related to SDWA and the second list of chemicals are addressed 
in EPA's response to comments document prepared for the second list of 
chemicals (Ref. 7).

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

    For purposes of discussing the EDSP policies and procedures in this 
document, SDWA chemicals can be described as either currently 
registered PAIs (SDWA PAIs) or ``Other SDWA Chemicals'' (including 
inert ingredients in currently registered pesticide products). EPA 
generally intends to issue FIFRA/FFDCA orders to manufacturers and 
registrants of PAIs, but would retain the discretion to issue an SDWA/
FFDCA test order to any chemical that meets the statutory criteria in 
SDWA section 1457. Consequently, for any pesticide chemical that also 
has non-pesticidal uses, in the event that no FIFRA/FFDCA test order 
recipient generates the required data because all order recipients opt 
out of the pesticide market, EPA may decide to issue EDSP testing 
orders based on the SDWA authority in order to obtain the data. In such 
instances, the policies and procedures outlined in this document would 
be applicable.
    By contrast, for SDWA chemicals that are not PAIs, (i.e., ``Other 
SDWA Chemicals''), EPA generally intends to rely on SDWA section 1457 
and/or FFDCA section 408(p)(5) to issue EDSP test orders. The Other 
SDWA Chemicals are very similar to the non-food use inert ingredients 
discussed in the FIFRA/FFDCA policies and procedures (Ref. 1), and the 
similarities are reflected in the policies that EPA has adopted in this 
document. Unit VI. describes the policies and procedures that relate to 
EDSP test orders issued under SDWA/FFDCA authority.

A. Who would receive EDSP test orders on SDWA chemicals?

    EPA believes it is important to identify and issue orders to all 
significant manufacturers and importers of a listed chemical. Under 
FFDCA section 408(p)(5)(A), EPA ``shall issue'' EDSP test orders ``to a 
registrant of a substance for which testing is required . . . or to a 
person who manufactures or imports a substance for which testing is 
required . . .'' (21 U.S.C. 346(a)(p)(5)(A). The process EPA generally 
intends to use to issue EDSP test orders for SDWA chemicals depends on 
whether the chemical is a SDWA PAI or an Other SDWA Chemical. A chart 
depicting the process for issuing EDSP test orders on SDWA chemicals is 
included in the docket (Ref. 16).
    As noted, the Agency generally intends to issue orders under FIFRA/
FFDCA for SDWA PAIs, and to rely on the FIFRA/FFDCA policies and 
procedures (Ref. 1). As described in that document, EPA intends to use 
internal databases--principally the Office of Pesticide Program's 
Information Network (OPPIN)--to identify technical registrants with a 
current pesticide registration containing a SDWA

[[Page 35917]]

chemical as the active ingredient, and anticipates issuing a FIFRA/
FFDCA test order to all identified technical registrants.
    For Other SDWA Chemicals, EPA generally intends to rely on 
information reported to the Agency under the TSCA CDR rule (Ref. 17) 
and TRI to identify the initial SDWA/FFDCA test order recipients. The 
CDR rule and TRI require manufacturers and importers of certain 
chemicals included on the TSCA Inventory to report site and 
manufacturing information for chemicals manufactured (including 
imported) in amounts of 25,000 lb. or more at a single site, or, for 
TRI, other lower thresholds as specified. The Agency believes that this 
information is an appropriate source for identifying EDSP test order 
recipients. It has been EPA's experience that relying on companies that 
have reported to the CDR is the most reliable mechanism for identifying 
manufacturers and importers of (non-pesticide) industrial chemicals. 
Such manufacturers and importers are required, by regulation, to report 
under the CDR rule. Companies that report under the CDR rule generally 
account for most of a chemical in commerce (therefore, in many 
instances, these companies can be expected to account for most of a 
chemical when it is found in drinking water), which is the basis for 
listing a chemical under SDWA authority (see Unit II.B.). As relatively 
large manufacturers and importers, EPA also believes that companies 
reporting under CDR comprise the majority of the volume associated with 
the chemical; these companies are more likely to be able to afford the 
cost of EDSP testing than companies manufacturing volumes below the CDR 
reporting threshold. EPA believes that, in general, these manufacturers 
are analogous to the technical registrants, who received orders in the 
first round of EDSP screening. Finally, using the CDR information to 
identify order recipients will facilitate joint data development, as 
reporters for these chemicals are generally publicly known and not 
numerous.
    If there are no companies reporting in response to the CDR rule for 
a given chemical, EPA intends to use other publicly available 
databases, such as the TRI, to identify other major EDSP test order 
recipients. For Other SDWA Chemicals that are regulated or tracked by 
another agency (e.g., pharmaceuticals by the Food and Drug 
Administration), EPA may also consult with that agency as appropriate 
to identify main manufacturers and importers. In addition to using CDR, 
TRI, and other Federal agency databases, EPA also generally intends to 
issue orders to manufacturers and importers who are subsequently 
identified as such. The Agency will follow up on any new information it 
receives to this effect and issue orders accordingly. EPA, however, 
does not generally intend at this time to issue orders to companies 
that manufacture or import a chemical for research and development 
purposes only, or who otherwise manufacture or import quantities of a 
chemical that are more appropriately measured in grams (e.g., as 
impurities, contaminants, or byproducts, which are not expected to be 
released into the environment in significant amounts).
    The Agency intends to issue catch-up orders to manufacturers or 
importers who begin to manufacture or import an EDSP SDWA chemical 
within 15 years of the issuance of a SDWA/FFDCA test order. The EDSP 
SDWA chemical catch-up order process will be similar to the catch-up 
order process described in the FIFRA/FFDCA policies and procedures 
(Ref. 1), except that EPA generally expects that the source of 
information for identifying such manufacturers will primarily come from 
the public, because there is no industrial chemical registration 
process comparable to the pesticide registration process that would 
provide a mechanism for EPA to independently identify such entities. A 
recipient of such catch-up orders would have the same options for 
compliance as an initial order recipient: independently generate the 
data or participate in the cost sharing by making a good faith offer to 
participate, if it wishes to rely on data developed or submitted by 
another recipient or consortium to satisfy its EDSP test order 
obligation.
    If, at the end of this process, all EDSP test order recipients have 
ceased to manufacture a SDWA chemical without submitting the required 
data, the Agency generally intends to treat the SDWA chemical as an 
``orphan.''

B. How will recipients of orders on SDWA chemicals be notified?

    Order recipients will receive an EDSP test order in one of two 
ways: By registered mail or electronically. In addition to the EDSP 
test order, EPA will send each recipient a packet that contains the 
instructions, background materials, and sample forms needed to comply 
electronically with the EDSP test order via CDX or will provide 
directions as to the location of such materials in an electronic 
format.

C. How will the public know who has received a test order on a SDWA 
chemical or who has supplied data?

    EPA intends to provide the list of all EDSP test order recipients 
on the Agency's EDSP Web site (Ref. 4). 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 EDSP test order.

D. How will the Agency minimize duplicative testing?

    As described in greater detail in this unit, EPA generally intends 
to continue to rely on its existing procedures to minimize duplicative 
EDSP testing for SDWA chemicals, including continuing to allow 
companies to voluntarily develop data jointly, and, as described in 
Unit VI.G., continuing to apply the policies that facilitate joint data 
development, as well as to accept OSRI in satisfaction of the order.
    In addition, the Agency intends to provide the status of the EDSP 
test orders, including recipients' responses, on the Agency's EDSP Web 
site so that both order recipients and the public can determine the 
status of responses (see for example Ref. 18). EPA will make such 
information available to enable test order recipients to identify and 
join other order recipients to develop the data in response to the 
order, thereby helping to achieve EPA's goals of minimizing duplicative 
testing and promoting fair and equitable sharing of EDSP test costs.

E. What are the potential responses to test orders on SDWA chemicals?

    The options for responding to a SDWA/FFDCA test order are similar 
to those established in the FIFRA/FFDCA policies and procedures (Ref. 
1), except that the option of exiting the pesticide market will not be 
available. The basis for a SDWA/FFDCA order is that a chemical may be 
found in sources of drinking water to which a substantial population 
may be exposed. Exiting any given market (e.g., the pesticide market) 
is not sufficient if the SDWA chemical is manufactured or imported for 
other uses because the chemical may still be found in sources of 
drinking water. If sufficient data on a SDWA chemical that is a 
pesticide is not generated in response to a FIFRA/FFDCA order (e.g., 
all FIFRA/FFDCA order recipients exit the pesticide market), EPA may 
issue a follow-up SDWA/FFDCA order for such

[[Page 35918]]

chemicals if they have non-pesticide uses.
    EDSP test order recipients provide their initial responses 
electronically referencing the options on a sample Initial Response 
Form for Individual Order Recipients (Initial Response Form) (Ref. 19). 
Response options that EPA anticipates including in SDWA/FFDCA test 
orders are as follows:
    Option 1: Recipient indicates that it intends to generate data. If 
the EDSP test order recipient decides to generate new data for each 
test specified in the order, the recipient would then comply with the 
procedures prescribed in the EDSP test order. In general, this option 
would be identical to the option discussed in the FIFRA/FFDCA policies 
and procedures (Ref. 1). EPA has not identified any changes that would 
be necessary to accommodate SDWA chemicals. Data generated and 
submitted would need to comply with the existing requirements for Good 
Laboratory Practices (GLP), as applicable. GLPs have been set out both 
in FIFRA for pesticides in 40 CFR part 160 and for TSCA chemicals in 40 
CFR part 792. EDSP test order recipients would need to follow any 
appropriate GLPs, protocol requirements identified in the EDSP test 
order, and procedures described in EDSP test orders for submitting the 
data.
    Option 2: Recipient indicates that it is submitting or citing 
existing data or OSRI. The recipient would choose this option to 
indicate that it is submitting or citing existing data (including data 
previously submitted to the Agency) that it believes is relevant to one 
or more of the requests in the test order. The recipient's initial 
response would include either the data or a reference to the data for 
each assay specified in the order. In submitting or citing existing 
data, the order recipient should follow, as appropriate, relevant 
format guidelines described in the EDSP test order and provide an 
explanation of the relevance of the data to the order, including, where 
appropriate, a cogent and complete rationale for why it believes the 
information is or is not sufficient to satisfy part or all of the Tier 
1 test order.
    Data compensation procedures may apply to data previously submitted 
to the Agency. If the data cited or submitted are from a study that was 
not conducted exactly as specified in the protocols referenced in the 
EDSP test order or in accordance with accepted scientific methodology 
or protocol, including but not limited to those presented in EPA's 
harmonized test guideline compendium (Ref. 20), the recipient would 
also identify the deviations from the applicable protocol(s), along 
with an explanation for the deviations, including an explanation as to 
why, notwithstanding the deviations, the protocol used for developing 
the cited or submitted data should still be considered as providing an 
accepted scientific methodology or protocol, and any other information 
relevant to a decision to accept the data as satisfaction of the order.
    EPA would review any existing relevant information submitted or 
cited (including OSRI) to determine whether the information is 
acceptable (e.g., the study was not rejected by the Agency for any 
reason related to completeness or quality) and satisfies the order. 
Decisions about whether the information satisfies part or all of the 
Tier 1 test order will be based on WoE from all relevant information 
available. The Agency would notify the recipient of its determination.
    If the Agency determines that the information cited or submitted as 
part of the initial response received from an order recipient satisfies 
the Tier 1 test order the electronic Initial Response Form is the only 
response required.
    If, however, EPA determines that the information cited or submitted 
as part of the initial response is insufficient to satisfy the Tier 1 
test order, in whole or in part, the recipient would still need to 
satisfy any order requirements EPA had determined had not been met. EPA 
intends to use a WoE approach as described in the EDSP WoE guidance 
document (Ref. 11) which takes into account data from the Tier 1 assays 
and any other scientifically relevant information available, to 
determine whether the chemical has the potential to interact with the 
endocrine system. Chemicals that go through Tier 1 screening and are 
found to have the potential to interact with the estrogen, androgen, or 
thyroid hormone systems will proceed to the next stage of the EDSP 
where EPA will determine which, if any, of the Tier 2 tests are 
necessary.
    Option 3: Recipient indicates that it intends to enter (or offer to 
enter) into an agreement to form a consortium to provide the data. The 
recipient may choose to join or form a consortium to share the cost of 
producing the required data. All participants of the consortium must 
submit their own electronic Initial Response Form for Individual Order 
Recipients, providing the name of the party who will be submitting the 
data on the recipient's behalf.
    Under this option, the designated lead for the consortium would 
complete their Initial Responses electronically (Consortium Response 
Form) (Ref. 21) for the consortium to provide the primary contact for 
the consortium, the list of participants, and an indication of the 
consortium's planned response for each assay, along with documentation 
of its formation (such as a copy of the joint agreement or a written 
statement by all the parties that an agreement exists). The joint 
agreement to produce the data would not need to specify all of the 
terms of the final arrangement between the parties or the mechanism to 
resolve the terms. The designated lead for the consortium would be 
responsible for submitting the consortium's initial response and 
accompanying information to EPA by the due date for the consortium's 
response, consistent with any mailing instructions indicated in the 
EDSP test order.
    Once the consortium submits the data electronically and EPA has 
completed its initial review, EPA would notify the contact of the 
consortium indicating whether the order has been satisfied. If 
satisfied, such an action would satisfy EDSP test order obligations for 
each of the consortium participants.
    If the consortium fails to submit the data or meet the requirements 
of the order in a timely and adequate manner, each recipient would be 
subject to penalties of up to $37,500 per day, unless the recipient 
were to commit to submit, and then did submit, the required data by the 
dates originally specified in the order. The Agency has typically 
granted very few, if any, time extensions for the submission of EDSP 
data.
    The Agency intends to provide to every EDSP test order recipient a 
list of the other manufacturers and/or importers (to the extent 
permitted by confidentiality requirements) that have also received an 
EDSP order for the specified SDWA chemical. This list would be intended 
to help order recipients identify other companies with whom they could 
form agreements to develop data jointly, or otherwise collaborate on a 
response to satisfy the requirements in the order. If the identity of a 
company subject to the SDWA/FFDCA test order is claimed as CBI, EPA 
intends to offer the company an opportunity to identify an agent who 
would act on their behalf in all matters relating to the EDSP program. 
For any company that chooses to designate an agent, the Agency intends 
to make the name of the agent (instead of the company) public by 
including it on the list of recipients of SDWA/FFDCA test orders. This 
name use would be similar to the process used for FIFRA/FFDCA test 
orders and presented in the FIFRA/FFDCA policies and procedures (Ref. 
1). If the identity of a company subject to the EDSP test order is 
claimed as CBI,

[[Page 35919]]

and yet the company does not name an agent, that company's ability to 
obtain data compensation from other parties (or rely on compensable 
data submitted by other parties) would likely be affected. EPA intends 
to make available the list of EDSP test order recipients on the 
Agency's EDSP Web site (Ref. 4). EPA intends to update the list with 
subsequent publication(s) and posting(s) as appropriate. For example, 
the Agency intends to post the status of the EDSP test orders, 
including the recipient's response, on the Agency's EDSP Web site so 
that both EDSP test order recipients and the public can check on the 
status of responses to the EDSP test orders. This public listing is 
intended to also facilitate the formation of consortia to develop data 
jointly since recipients would know all other entities required to 
generate the same data.
    Option 4: Recipient claims that it is not subject to the EDSP test 
order. Under this option, a recipient would claim that it is not 
subject to the order because it does not manufacture or import the 
chemical identified for EDSP testing, or because it believes the order 
was otherwise erroneously sent. This option would be essentially the 
same as the option discussed in the original policies and procedures 
for manufacturers of inert ingredients. EPA has not identified any 
issues unique to SDWA chemicals that would warrant a change in policy 
on this point. An explanation of the basis for the claim, along with 
appropriate information to allow the Agency to substantiate the claim, 
would accompany the Initial Response. The Agency intends to evaluate 
the claim and respond to any request within 90 days of receipt. If EPA 
were unable to verify the claim, the original requirements and 
deadlines in the order would be expected to remain. If EPA were able to 
verify the claim, such a response would satisfy the order and no 
further response would be necessary.
    Option 5: Recipient intends to discontinue the manufacture or 
import of the chemical. Under this option, the recipient would indicate 
it has or is in the process of discontinuing all manufacture and import 
of the chemical. As noted in Unit V.A., in order to take advantage of 
this option, a recipient would need to also cease manufacture of the 
chemical, including for the purposes of export. In addition, the 
recipient would be required to provide an electronic initial response 
via CDX that includes a verifiable explanation and documentation 
supporting its claim. If EPA verifies the claim, the electronic Initial 
Response Form is all that would be required to satisfy the EDSP test 
order. If EPA could not verify the claim, the recipient's obligation to 
comply with the EDSP test order would remain.
    Unlike the FIFRA/FFDCA policies and procedures (Ref. 1), which 
enable a manufacturer or importer of a pesticide inert ingredient to 
comply with the FIFRA/FFDCA test order by discontinuing the sale of the 
chemical into the pesticide market, SDWA/FFDCA test orders cannot be 
satisfied in this manner. A chemical manufacturer or importer that 
receives a SDWA/FFDCA test order would need to cease all manufacture 
and import of that chemical. Simply exiting the pesticide market would 
not address the chemical's potential presence in ``sources of drinking 
water to which a substantial population may be exposed'' and it would 
therefore be inappropriate to allow companies to satisfy a test order 
with such a response.
    Option 6: Recipient responds according to one of three other 
response options. As part of the Initial Response, a recipient may also 
ask EPA to reconsider some or all of the EDSP testing specified in the 
order if:
    a. The recipient can demonstrate (supported by appropriate data) 
that the chemical is an endocrine disruptor and that additional EDSP 
Tier 1 screening is unnecessary.
    b. The recipient can demonstrate (supported by appropriate data) 
that the chemical meets the standard for an exemption under FFDCA 
section 408(p)(4) (i.e., ``that the substance is not anticipated to 
produce any effect in humans similar to an effect produced by a 
naturally occurring estrogen'').
    c. The chemical was used by EPA as a ``positive control'' to 
validate one or more of the screening assays. In the last data 
collection, chemicals used by EPA as a ``positive control'' to validate 
one or more of the screening assays were only required to submit the 
assays for which the chemical did not serve as a positive control 
(e.g., if the chemical served as a positive control in the validation 
of two assays, the EDSP test order recipient would not be required to 
generate additional data for those two assays). EPA generally expects 
that it would continue this policy.
    For more information on the response options discussed in this 
unit, see the FIFRA/FFDCA policies and procedures (Ref. 1).
    The Agency intends to make a determination on any claim and respond 
to the recipient within 90 days of receipt. If EPA cannot verify the 
claim, the original requirements and deadlines in the order would 
remain. If EPA were to verify the claim, EPA would consider the 
response to fully satisfy the order and no further response would be 
required.

F. How to submit order responses and data electronically?

    EPA has developed an electronic submission system for data 
submitted in response to SDWA/FFDCA test orders following the general 
process established for TSCA Section 5 Premanufacture Notices and for 
other TSCA reporting, including TSCA Section 8 CDR. The EDSP order 
electronic reporting system will allow order recipients to use the 
Agency's CDX to respond to an order and to submit test data via the 
Internet. See http://www.epa.gov/cdx for additional information about 
CDX (Ref. 22). If not already registered with CDX, recipients will need 
to complete a simple registration process in order to use this system 
for electronic submissions of EDSP test order data, thereby 
establishing a secure log-on to CDX. Specific requirements associated 
with these EDSP test orders will be provided directly to the order 
recipients, and are expected to include:
     Registration with CDX, resulting in the establishment of 
an electronic signature usable for electronically submitting EDSP test 
order responses.
     Access to a web-based response form, including the ability 
to attach PDF files.
     Encrypted submission to EPA via CDX.
    Each EDSP test order would contain specific, updated information 
regarding the most current process to use to respond to the EDSP test 
order.

G. How will EPA facilitate joint data development and cost sharing for 
SDWA chemicals?

    As described in the FIFRA/FFDCA policies and procedures (Ref. 1), 
the Agency believes that FFDCA section 408(p)(5) does not provide the 
authority to create 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

[[Page 35920]]

statutory authorities. While FFDCA section 408(p) does not allow EPA to 
impose requirements identical to those authorized by FIFRA section 3, 
EPA has the authority under FFDCA section 408(p) to develop Agency 
procedures that would facilitate joint data generation and electronic 
submission. Specifically, the Agency has discretion to determine what 
actions constitute compliance with a FFDCA section 408(p) test order, 
and EPA intends to apply this discretion in a manner that creates 
strong incentives for companies to voluntarily develop data jointly. 
Section 408(p) of FFDCA confers adequate discretion for EPA to consider 
whether a recipient has fulfilled its obligation to provide data when 
the recipient individually or jointly submits results from the required 
studies, or when EPA judges that it would be equitable to allow the 
recipient to rely on, or cite, results of studies submitted by another 
person.
    At the same time, however, each recipient of an order under FFDCA 
section 408(p) has a separate obligation to satisfy the Tier 1 test 
order that it received. EPA thinks that FFDCA section 408(p) confers 
adequate discretion to consider that a recipient has fulfilled its 
obligation to provide data when:
     The recipient individually or jointly submits results from 
the required assays.
     EPA judges that it would be equitable to allow the 
recipient to rely on, or cite, results of studies submitted by another 
person.
    The determination of whether it would be equitable to allow 
citation to another recipient's data will be necessarily based on a 
case-by-case review of the specifics of the individual circumstances. 
However, the Agency believes that it would generally be equitable to 
allow a recipient of a FFDCA section 408(p) test order to rely on the 
results of studies submitted by another person where:
     The data generator has given permission to the recipient 
to cite the results, or
     Within a reasonable period after receiving the FFDCA 
section 408(p) test order, the recipient has made an offer to commence 
negotiations regarding the amount and terms of paying a reasonable 
share of the cost of testing; has included an offer to resolve any 
dispute over the recipients' shares of the test costs by submitting the 
dispute to a neutral third party with authority to bind the parties 
(e.g., through binding arbitration); and, if arbitration is requested, 
participates in the arbitration proceeding and complies with the terms 
of any arbitration award.
    The Agency believes this approach to minimizing duplicative EDSP 
testing, which parallels that used under FIFRA section 3(c)(2)(B), 
provides all recipients of FFDCA section 408(p) test orders adequate 
incentives to develop data jointly. In the first instance, where the 
data generator had granted permission for another party to cite its 
data, the equities are clear, and EPA has no reason for refusing to 
allow it. In the second instance, where the data generator received an 
offer to commence negotiations regarding the amount and terms of 
compensation and to go to a neutral decisionmaker with authority to 
bind the parties failing successful negotiations, EPA believes that the 
company has demonstrated a good faith effort to develop data jointly, 
and consequently would typically consider that the order recipient had 
complied with the order. Based on EPA's experience under FIFRA, there 
would be little or no reason for a data generator to decline such an 
offer. Moreover, if EPA did not adopt such an approach, the end result 
would effectively confer the sort of ``exclusive use'' property rights 
established under FIFRA section 3(c)(1)(F), on a broad category of 
data, and EPA does not believe that FFDCA section 408(p)(5) creates 
such rights, or provides EPA with the authority to create such rights. 
These conditions would also apply to recipients of any ``catch-up'' 
FFDCA Sec.  408(p) orders, who enter the market after the data have 
been submitted.

H. What procedures can EPA apply for handling CBI for SDWA chemicals?

    As stated in the FIFRA/FFDCA policies and procedures (Ref. 1), 
FFDCA does not authorize EPA to either create new rights or to modify 
existing rights to confidentiality, but directs the Agency to create 
procedures that operate within the existing confines of FIFRA, FOIA, 
and TSA. SDWA has no provisions that authorize EPA to extend 
protections for handling CBI beyond those established by TSA. Thus data 
submitted in response to SDWA/FFDCA orders would only be subject to the 
protections under FOIA and TSA, with the notable exception of data 
generated on pesticide chemicals. Manufacturers of a food use inert 
ingredient that is also identified as a SDWA chemical should generally 
expect to receive SDWA/FFDCA test orders; however, all CBI and data 
compensation provisions established in FIFRA would still apply. In 
addition, under certain circumstances, data generated on non-food use 
inert ingredients may be entitled to FIFRA CBI and data compensation 
protections. Test order recipients for the food use-inert, or a 
pesticide with a food tolerance or exemption, should consult the FIFRA/
FFDCA policies and procedures (Ref. 1) for a more detailed explanation 
of the FIFRA provisions that apply.
    The identities of chemicals on the non-confidential portion TSCA 
Inventory (i.e., the chemical identity of the chemical substance is 
publicly known), contained in health and safety data subject to TSCA 
may not be entitled to confidential treatment (Ref. 23). In addition, 
because the chemical identity is public for all SDWA chemicals on the 
second EDSP chemical list, EPA expects that there would be no need to 
claim submitted information as confidential. EPA also believes that it 
would be particularly difficult to substantiate such a claim, given 
that the information would already be publicly available.
    As described in Unit V.E. under Option 3, when the identity of a 
company subject to the SDWA/FFDCA test order is claimed as CBI, EPA 
intends to offer the company an opportunity to identify an agent who 
would act on their behalf in all matters relating to EDSP. For any 
company that chooses to designate an agent, the Agency intends to make 
the name of the agent (instead of the company) public by including it 
on the list of recipients of SDWA/FFDCA test orders.

I. What is the process for contesting a test order or consequences for 
failure to respond or comply with a test order?

    EPA generally intends to rely on the existing interpretations and 
policies relating to pre-enforcement challenges to and enforcement of a 
test order. Order recipients are encouraged to consult the FIFRA/FFDCA 
policies and procedures (Ref. 1) for further details on these policies.

J. What is the informal administrative review procedure?

    EPA generally intends to continue to include the informal 
administrative review provisions in SDWA/FFDCA test orders by which 
recipients could raise any questions or challenges concerning the 
issuance of the order, that were included in the orders issued for the 
first list of chemicals. As explained in the FIFRA/FFDCA policies and 
procedures (Ref. 1), because the mere filing of the objection (or 
indeed, the filing of a judicial challenge) would not extend the 
deadline for submission of the studies, in order for this process to be 
completed in a timely fashion, EPA expects order recipients who file a

[[Page 35921]]

challenge to present their objections with sufficient specificity and 
detail to allow the Agency to effectively evaluate the issue(s) 
presented. EPA would review the issues presented and respond within a 
reasonable amount of time. The Agency understands that it will need to 
respond to such objections within sufficient time for the order 
recipient to comply with the orders, or to pursue judicial review.

K. What are the adverse effects reporting requirements?

    EPA is not modifying any of its existing reporting requirements or 
any of the policies with respect to how the adverse effects reporting 
requirements relate to EDSP data.
    Adverse effects reporting requirements for pesticide chemicals in 
registered products are established in FIFRA section 6(a)(2) and can be 
found in the FIFRA/FFDCA policies and procedures (Ref. 1). In addition 
to requirements under FIFRA, TSCA section 8(c) allows EPA to request 
that companies record, retain and/or report ``allegation of significant 
adverse reactions'' to a chemical substance or mixture that the company 
produces, imports, processes or distributes (15 U.S.C. 2607(c)). 
Additional information can be found in 40 CFR part 717. Chemical 
substance is defined in TSCA (15 U.S.C. 2602(2)).
    Under TSCA section 8(e), U.S. chemical manufacturers, importers, 
processors, and distributors are required to notify EPA within 30 days 
of new unpublished information regarding their chemical if the 
information may lead to a conclusion that the chemical poses 
substantial risk to human health or the environment (15 U.S.C. 
2607(e)). ``Substantial risk'' information is information that offers 
reasonable support for a conclusion that the subject chemical substance 
or mixture poses a substantial risk of injury to health or the 
environment. The information need not, and typically does not, 
establish conclusively that a substantial risk exists.
    Any information that has been previously submitted under FIFRA 
section 6(a)(2), TSCA section 8(c), or TSCA section 8(e), to the extent 
the EDSP test order recipient believes that it is responsive to the 
EDSP test order, need not be resubmitted to satisfy the FFDCA section 
408(p) test orders. The EDSP test order recipient need only cite the 
previously submitted information in lieu of resubmission.

VII. Statutory and Executive Order Reviews

A. Regulatory Planning and Review

    Under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993), this policy statement is not 
considered to be a ``significant guidance document'' under the terms of 
the Executive Order because this policy statement does not raise novel 
legacy or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order. As 
indicated in this unit, this policy statement only makes a few 
modifications that are necessary to address procedural differences that 
apply to SDWA chemicals.

B. Paperwork Reduction Act (PRA)

    The information collection requirements described in this document 
have been submitted to OMB for review under PRA, 44 U.S.C. 3501 et seq. 
Elsewhere in this Federal Register issue is a separate document 
prepared by EPA that announces the availability of the ICR document. 
The docket ID number for this ICR submission is EPA-HQ-OPPT-2013-0275. 
An Agency may not concur or sponsor, and a person is not required to 
respond to a collection of information unless it displays a currently 
valid OMB control number. The OMB control numbers are displayed either 
by publication in the Federal Register or by other appropriate means, 
such as on the related collection instrument or form, if applicable. 
The display of OMB control numbers in certain EPA regulations is 
consolidated in 40 CFR part 9. As a new ICR, the Agency does not yet 
have an OMB control number for this information collection activity. 
Once assigned, EPA will announce the OMB control number for this 
information collection in the Federal Register, and will add it to any 
related collection instruments or forms used. Burden is defined in 5 
CFR 1320.3(b).

VIII. References

    As indicated under ADDRESSES, a docket has been established for 
this notice under docket ID number EPA-HQ-OPPT-2007-1080. The following 
is a listing of the documents that are specifically referenced in this 
action. The docket includes these documents and other information 
considered by EPA, including documents that are referenced within the 
documents that are included in the docket, even if the referenced 
document is not physically located in the docket. For assistance in 
locating these other documents, please consult the technical person 
listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Endocrine Disruptor Screening Program; Policies and 
Procedures for Initial Screening; Notice. Federal Register (74 FR 
17560, April 15, 2009) (FRL-8399-9).
2. EPA. Order Template: ``FFDCA Sec.  408(p) Order Template for SDWA 
Sec.  1457 Chemicals.'' April 15, 2013. Available in Attachment C(3) 
to the ICR in Docket ID Number EPA-HQ-OPPT-2013-0275.
3. U.S. Congress. House Resolution 2996, H. Rept. 111-180.
4. EPA. Endocrine Disruptor Screening Program Web site at http://www.epa.gov/endo.
5. EPA. Endocrine Disruptor Screening Program; Draft Policies and 
Procedures for Screening Safe Drinking Water Act Chemicals; Notice. 
Federal Register (75 FR 70558, November 17, 2010) (FRL-8848-9).
6. EPA. Response-to-Comments Document for the Notice on the 
Endocrine Disruptor Screening Program's Draft Policies and 
Procedures for Screening Safe Drinking Water Act Chemicals that 
published in the Federal Register on November 17, 2010 at 75 FR 
70558. March 7, 2013.
7. EPA. Comment Response Document for the Second List of Chemicals 
and Substances for Tier 1 Screening under the Endocrine Disruptor 
Screening Program (Categorized Public Comments). February 1, 2013. 
Available in Docket ID Number EPA-HQ-OPPT-2009-0477.
8. EPA. Electronic Reporting Under the Toxic Substances Control Act; 
Proposed rule. Federal Register (77 FR 22707, April 17, 2012) (FRL-
9337-5).
9. EPA. TSCA section 8(e); Notification of Substantial Risk; Policy 
Clarification and Reporting Guidance. Federal Register (68 FR 33129, 
June 3, 2003) (FRL-7287-4).
10. EPA. EPA's Approach for Considering Other Scientifically 
Relevant Information (OSRI) under the Endocrine Disruptor Screening 
Program (EDSP). March 26, 2009. Document ID Number EPA-HQ-OPPT-2007-
1080-0032.
11. EPA. Weight-of-Evidence: Evaluating Results of EDSP Tier 1 
Screening to Identify the Need for Tier 2 Testing. September 14, 
2011. Document ID Number EPA-HQ-OPPT-2010-0877-0021.
12. EPA. Universe of Chemicals and General Validation Principles. 
November 2012. Available at http://www.epa.gov/endo/pubs/edsp_chemical_universe_and_general_validations_white_paper_11_12.pdf.
13. EPA. Response to Comments on the Public Review Draft of the 
Information Collection Request (ICR) entitled ``Addendum for the 
Second List of Chemicals; Tier 1 Screening of Certain Chemicals 
Under the Endocrine Disruptor Screening Program (EDSP).'' Available 
in Docket ID Number EPA-HQ-OPPT-2013-0275.
14. EPA. SAB. Review of the EPA's Proposed

[[Page 35922]]

Environmental Endocrine Disruptor Screening Program; Review of the 
Endocrine Disruptor Screening Program by a Joint Subcommittee of the 
Science Advisory Board and Scientific Advisory Panel. July 1999. EPA 
publication number EPA-SAB-EC-99-013. Available at http://www.epa.gov/endo/pubs/sab_sap_report.pdf.
15. EPA. U.S. Environmental Protection Agency Endocrine Disruptor 
Screening Program Comprehensive Management Plan. June 2012. 
Available at http://www.epa.gov/endo/pubs/EDSP-comprehensive-management-plan.pdf.
16. EPA. At a Glance: Issuing EDSP Second List Orders. (March 28, 
2013).
17. EPA. Chemical Data Reporting Web site at http://www.epa.gov/oppt/cdr.
18. EPA. Status of EDSP Orders/DCIs as of Wednesday, January 2, 
2013.
19. EPA. Sample Form: ``FFDCA Sec.  408(p) Order for SDWA Sec.  1457 
Chemicals--Initial Response Form for Individual Order Recipients'' 
(EPA Form No. 6300-06). March 27, 2013. Available in Attachment D(3) 
to the ICR in Docket ID Number EPA-HQ-OPPT-2013-0275.
20. EPA. OCSPP Harmonized Test Guidelines Web site at http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm.
21. EPA. Sample Form: ``FFDCA Sec.  408(p) Order for SDWA Sec.  1457 
Chemicals--Initial Response Form for Consortium'' (EPA Form No. 
6300-06-C). March 27, 2013. Available in Attachment D(4) to the ICR 
in Docket ID Number EPA-HQ-OPPT-2013-0275.
22. EPA. Central Data Exchange Web site at http://www.epa.gov/cdx.
23. EPA. Claims of Confidentiality of Certain Chemical Identities 
Submitted under Section 8(e) of the Toxic Substances Control Act; 
Notice. Federal Register (75 FR 3462, January 21, 2010) (FRL-8807-
9).

List of Subjects

    Environmental protection, Chemicals, Endocrine disruptors, 
Pesticides and pests, Safe drinking water, Reporting and recordkeeping.

    Dated: May 29, 2013.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2013-14228 Filed 6-13-13; 8:45 am]
BILLING CODE 6560-50-P