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Response-to-Comments on

the Endocrine Disruptor Screening Program’s

Draft Policies and Procedures for

Screening Safe Drinking Water Act Chemicals

(75 FR 70558; Nov. 17, 2010)

U.S. Environmental Protection Agency

Office of Chemical Safety and Pollution Prevention

February 1, 2013
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Table of Contents

Acronyms

Introduction

A. Response Option to Cease Manufacture

B. Persistence

a. Whether Policy Accounts for Chemical Persistence

b. Test Orders for Past Registrants, Manufacturers, and Importers

C. Catch-up Orders and Data Compensation

a. Length of Time to Issue SDWA/FFDCA Catch-Up Orders

b. Length of Time to Require Data Compensation

D. Orphan Chemicals

a. Value of Testing Orphan Chemicals

b. Strategies for Obtaining Data/Funding to Conduct EDSP Screening

E. Electronic Notification/Submission

a. Existing CDX Account Holders Preference

b. Mechanisms of Receipt

c. Electronic Submission of Data

F. Identification of Test Order Recipients

a. Reliance on IUR Data

b. Other Means of Identifying Potential Test Order Recipients

c. Publicizing Test Order Recipients
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G. Other Topics

a. Use of SDWA Authority

b. Cost Sharing

c. Minimizing Duplicative Testing

d. Confidential Business Information (CBI) 

e. Adverse Effects Reporting

f. Public Availability of Information

g. Basis for SDWA Chemical Selection 

h. EDSP List 2 Chemicals 

i. Other Scientifically Relevant Information (OSRI) 

j. Weight-of-Evidence

k. Communications 

l. Schedule 

m. Enforcement
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Acronyms

CBI Confidential Business Information

CDR Chemical Data Reporting

CDX Central Data Exchange

EDSP Endocrine Disruptor Screening Program

EPA US Environmental Protection Agency

FDA Food and Drug Administration

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FOIA Freedom of Information Act

GLP Good Laboratory Practices

IUR Inventory Update Reporting (now called CDR – Chemical Data Reporting)

OCSPP Office of Chemical Safety and Pollution Prevention, US EPA

OPP Office of Pesticide Programs, US EPA

OSRI Other Scientifically Relevant Information

PAI Pesticide Active Ingredient

SDWA Safe Drinking Water Act

TSA Trade Secret Act

TSCA Toxic Substances Control Act

WOE Weight of Evidence
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INTRODUCTION

This paper provides EPA’s responses to public comments received on a document describing 

EPA’s draft policies and procedures for requiring Tier 1 screening under the Endocrine Disruptor 

Screening Program (EDSP) of substances for which EPA may issue 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). These draft policies and procedures, published in the Federal 

Register on November 17, 2010 (75 FR 70558) (FRL– 8848–9), were intended to supplement 

the existing EDSP policies and procedures that were published in the Federal Register on April 

15, 2009 (74 FR 17560). The existing policies and procedures applied to screening pesticide 

active and inert ingredients and implemented authority under FFDCA and the Federal Fungicide, 

Insecticide, and Rodenticide Act (FIFRA). The draft document described certain modifications 

to those original policies and procedures intended to address issues that are unique to SDWA 

chemicals, or to address the circumstances where other competing considerations for SDWA 

chemicals warrant a modification of those earlier pesticide-oriented policies. Public comments 

were due on January 18, 2011. 

EPA published two other Federal Register documents related to Tier 1 EDSP screening on 

SDWA chemicals on the same day, one addressing the Information Collection Request (75 FR 

70568, Nov. 17, 2010) and one proposing the list of chemicals to which the draft policies and 

procedures would apply (75 FR 70248, Nov. 17, 2010). While there was substantial overlap in 

the comments received on all three documents, EPA specifically requested comment on five 

topics: 

1. Response Option to Cease Manufacture; 

2. Persistence; 

3. Catch-Up Orders and Data Compensation; 

4. Orphan Chemicals; and 

5. Electronic Notification.
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COMMENTS AND RESPONSES

A. Response Option to Cease Manufacture

Submitted Comments: Multiple commenters (the American Petroleum Institute (API), People for 

the Ethical Treatment of Animals (PETA), the American Chemical Association (ACC), Bayer 

CropScience LP, CropLife America (CLA), and the Chemical Producers and Distributors 

Association (CPDA)) agreed with EPA’s proposal to allow a List 2 order recipient to comply 

with a test order by ceasing all manufacturing of the listed chemical, and considered that option 

justified primarily because an order recipient who agrees to discontinue manufacture after 

receiving an EDSP order, like a former manufacturer, will receive no economic benefit from the 

sale of the chemical with which to defray the cost of testing. Commenters also noted that the 

language of the statute referred to manufacture and production in the present tense, and argued 

that the intent demonstrated by the plain language was not to apply testing requirements on the 

basis of past activities that were no longer continuing. 48.1, 50.1, 52.1, 55.1, 56.1, 57.1

EPA Response: EPA’s test order procedures will allow a List 2 SDWA order recipient to comply 

with a 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. 

Submitted Comments: The San Francisco REACH Team (SFRT) requested that EPA’s test order 

procedures be revised to include a clear timeline for when the production must cease, and 

strongly believed that only manufacturers that completely cease all production activity within 6 

months of the response to the test order be eligible to use this option to comply. The commenter 

further recommended that EPA consider manufacturers’ annual revenue, chemical volume 

generated, location and years in business when determining whether a decision to cease 

manufacturing or importing chemicals is a satisfactory response to a test order. 49.1

EPA Response: EPA considers that all order recipients should have an opportunity to elect to 

cease manufacturing or importing a chemical as a satisfactory response to a test order. EPA 

agrees that requiring order recipients to provide a clear timeline for the cessation of production

as part of the explanation and documentation supporting their response is reasonable, and intends 

to include such a requirement. EPA, however, is concerned that varying production volumes and 

circumstances that are not comparable among companies, industry sectors, and types of 
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chemicals may justify varying cessation deadlines, that a uniform timeframe may not be 

appropriate under the circumstances, and that it does not have enough information at this time, in 

any case, to determine what an appropriate timeframe might be. Rather than specifying a single 

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

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

test order on a pesticide active ingredient. The Agency disagrees that a manufacturers’ annual 

revenue or other factors would be relevant in determining whether a decision to cease 

manufacturing is a satisfactory response. 

Submitted Comments: The American Water Works Association (AWWA) argued that a 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. 53.1

EPA Response: EPA generally interprets FFDCA section 408(p) as giving the Agency authority 

to issue orders to current registrants, manufacturers, and importers of a chemical. Under SDWA, 

EPA issues a test order based upon a finding that a chemical “may be found in sources of 

drinking water” and “that a substantial population may be exposed.” While the comments have 

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 proposed 

SDWA policy notice, a number of considerations weigh against requiring manufacturers who 

chose to cease manufacture of the chemical to nevertheless conduct EDSP testing. Specifically, 

if a 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 screening 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, since only those that will continue to 

derive an economic benefit from the continued manufacture (thereby continuing the associated

exposures) will bear the costs of testing. Further, as discussed below, 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 
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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

a. Whether Policy Accounts for Chemical Persistence

b. Test Orders for Past Registrants, Manufacturers, and Importers

Submitted Comments: Multiple commenters (API, PETA and the Physicians Committee for 

Responsible Medicine (PCRM), the ACC, Bayer CropScience, and CLA and the 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 is subject to differing interpretations. Commenters noted it was not clear how EPA 

would incorporate persistence in determining whether a chemical may be found in sources of 

drinking water and whether a substantial population is exposed, and asserted that those findings 

should be based on actual data concerning the presence of a chemical and a determination of 

what constitutes a substantial population. Commenters further noted that the persistence question 

is more relevant to the scope of EPA’s authority to limit testing to current manufacturers and 

providing an order compliance option of stopping manufacture of a chemical, and 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”). 

Assuming EPA did have the authority to issue EDSP orders to former manufacturers, some 

commenters observed it 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. Accordingly, commenters argued 

persistence should not be a factor and test orders should not issue to past registrants, 

manufacturers, or importers. Two commenters 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. 48.1, 49.1, 50.1, 52.1, 53.1, 55.1, 56.1, 57.1
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EPA Response: After carefully reviewing all comments, EPA has concluded that it should not 

factor a chemical’s persistence into EDSP policies and procedures at this time. Under SDWA, 

EPA issues a test order based upon a finding that a chemical “may be found in sources of 

drinking water” and “that a substantial population may be exposed.” 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 sections 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. Although past 

registrants, manufacturers, and importers are likely to have played a role in the presence of a 

persistent chemical in sources of drinking water, EPA acknowledges the practical, legal, and 

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

accordingly does not intend at this time to issue test orders to entities other than current 

registrants, manufacturers, and importers.

C. Catch-Up Orders and Data Compensation

a. Length of Time to Issue SDWA/FFDCA Catch-Up Orders

b. Length of Time to Require Data Compensation

Submitted Comments: The Methanol Institute (MI) argued that SDWA substances 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 substances are being subjected to the same testing requirements pursuant to the 

same legislative enactment. 47.1 

The San Francisco REACH Team asked that EPA continually update the catch-up orders 

(through public input process) without any timeline restriction of five years, arguing that for 

there to be an equitable sharing of costs, all past registrants, manufacturers, and importers that 

have contributed to current and ongoing chemical persistence in the environment must be 

included, and including a deadline for catch-up order issuance would severely limit the 

manufacturers targeted based on EPA’s workload and priorities. The commenter recommended 

that EPA keep the catch-up order issuance process open and target manufacturers of listed 

chemicals as they are identified. 49.1 
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The ACC agreed with EPA’s plan to issue catch up orders to require cost sharing by 

manufacturers and importers who enter the market after initial orders are issued and EDSP 

testing is complete, but believed that catch up orders should be issued for 10 years rather than 5 

years because of the significant expense of generating EDSP Tier 1 and Tier 2 data. 52.1

EPA Response: 

EPA noted in prior Federal Register notices on the EDSP program (75 FR 70558) that, unlike 

FIFRA, neither SDWA nor FFDCA enable EPA to readily identify manufacturers or importers of 

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

registrants, and EPA would bear a substantial burden if it were to issue SDWA catch-up orders 

on every chemical for 15 years following issuance of the first order(s) (or receipt of the data), 

simply based on the effort required to identify new manufacturers and importers. EPA also noted 

that data compensation requirements are also established in TSCA for data generated in response 

to section 4 test rules, and that reimbursement period ends ‘‘after an amount of time equal to that 

which had been required to develop data or after five years, whichever is later.’’ (40 CFR part 

790.) Nonetheless, 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 the same 15-year compensation period as for active and inert pesticide chemicals. 

D. Orphan Chemicals

a. Value of Testing Orphan Chemicals 

b. Strategies for Obtaining Data/Funding to Conduct EDSP Screening

Submitted Comments: The Agency requested comment on the value of EDSP testing on orphan 

chemicals (described as “those for which test orders do not generate the necessary data”) and the 

strategy EPA should use to obtain EDSP data on orphan chemicals. EPA particularly expressed 

interest in strategies for obtaining the data or sources of funding to conduct EDSP screening. One 

commenter suggested that water treatment facilities cannot be required to test under FIFRA or 

TSCA, so disinfection byproducts and arsenic and other naturally-occurring chemicals should be 

considered orphans, and EPA should screen and test those chemicals itself. Some commenters 

(including the American Petroleum Institute, PETA, the AWWA, and Bayer CropScience) 

interpreted orphan chemicals as those chemicals no longer being produced or imported, and 
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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. They further argued that test orders could be 

issued only to current manufacturers or importers, and no orders could thus issue on orphan 

chemicals no longer in commerce. 48.1, 50.1, 53.1, 55.1.

EPA Response: EPA has concluded that it would not be useful or practical to issue test orders for 

chemicals that are no longer being manufactured or imported. For chemicals that are not 

persistent, there is a declining risk of exposure. Even for chemicals that are persistent, the risk of 

exposure would still be declining and certainly not increasing. In addition, EPA has not resolved 

the many and various practical and legal implementation issues involved in such an approach, 

e.g., determining to whom orders should be issued based on past manufacture and importation, as 

well as determining equitable cost sharing for past production. 

E. Electronic Notification/Submission

a. Existing CDX Account Holders Preference

b. Mechanisms of Receipt

c. Electronic Submission of Data

Submitted Comments: The American Petroleum Institute commented that it generally supported 

electronic reporting for submissions to government agencies, because its members favor 

reporting electronically when the option is offered and “quality electronic reporting systems have 

high value for both reporters and the receiving government agencies.” For the EDSP, however, 

API recommend that EPA provide companies only with the option of receiving the notification 

electronically, rather than as a standard procedure, because “reporting through CDX [EPA’s 

central data exchange] for submissions under the TRI [Toxics Release Inventory] have not been 

without difficulties” due to “company firewall and Java settings ... creating problems with 

submissions.” 48.1. 

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

government and provides overwhelming advantages over paper submissions. OPPT’s premanufacture notice (PMN) and chemical data reporting (CDR) rules already require electronic 
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reporting by the Internet, and OPPT has also already proposed requiring electronic reporting for 

a number of other rules as well (see, 74 FR 22707, Apr. 17, 2012). EPA's central data exchange 

(CDX) is the point of entry on the Environmental Information Exchange Network (Exchange 

Network) for environmental data submissions to the Agency. CDX works with both EPA 

program offices looking for a way to better manage incoming data and stakeholders looking for a 

way to reduce time and money spent to meet EPA reporting requirements. CDX provides 

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) submit data in a variety of formats, including Webs Forms, XML, binary, or flat-file, 

4) utilize Public Key Infrastructure (PKI) and encryption security protocols to ensure a 

secure data exchange environment, 

5) receive support for authentication, authorization, and digital signature, 

6) exchange data with target systems using web services, 

7) reduce costs associated with submitting and processing data submissions, 

8) utilize CDX’s web services to implement machine-to-machine data exchanges, data 

transformations, and validations, 

9) pay fees automatically through Pay.gov, and 

10) utilize publishing services to share information collected by EPA with other stakeholders. 

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

provides overwhelming advantages over paper submissions. OPPT’s pre-manufacture notice 

(PMN) and chemical data reporting (CDR) rules already require electronic reporting by the 

Internet, and OPPT has also already proposed requiring electronic reporting for a number of 

other rules as well (see, 74 FR 22707, Apr. 17, 2012).In an effort to streamline the reporting 

process, reduce the administrative costs, and maintain consistency with current proposed 

regulations to require electronic reporting of information submissions and recordkeeping (see, 74 

FR 22707, Apr. 17, 2012), EPA will require test order information to be submitted electronically. 

EPA will continue (at least for this next group of chemicals) to issue test orders by U.S. Postal 

Service. 
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F. Identification of Test Order Recipients

a. Reliance on IUR Data

b. Other Means of Identifying Potential Test Order Recipients

c. Publicizing Test Order Recipients

Submitted Comments: Comments were received from the SFRT the ACC, the AWWA, and API. 

The ACC commented that “EPA’s goal should be to assure equitable resolution of who should 

either conduct the testing or contribute to the cost of testing,” and referred EPA to the 

comparable Toxic Substances Control Act (TSCA) test rule program as a model and 

recommended that EPA “give due consideration to what manufacturing, importing, or other 

activities contribute to the occurrence of chemicals in drinking water to which a substantial 

population may be exposed.” The AWWA commented that EPA clarify to what entities the 

EDSP test orders apply by defining all terms describing potentially affected entities. The API 

agreed with EPA that the Inventory Update Reporting (IUR) rule, now the Chemical Data 

Reporting (CDR) rule, is “the appropriate source for identifying current manufacturers and 

importers of chemical substance.” API recommended that EPA avoid using the Toxic Release 

Inventory (TRI), however, except as a last resort, because the TRI includes “processors and 

users” in addition to manufacturers and importers, or use only “the specific TRI data fields that 

indicate whether a company manufactured and/or imported the chemical.” 48.1, 52.1, 53.1, 

The SFRT asked EPA to “incorporate a system which takes into account the location of chemical 

manufacturers and potential disproportionate burden on neighboring communities, in addition to 

volume, when issuing test orders,” because select communities and populations are also at 

increased risk of exposure and are more vulnerable to poor health outcomes as a result of 

contaminated air and water from chemical manufacturing plants and waste sites located in their 

communities.” The SFRT also recommended that, in order to “avoid disproportionate burdens 

and promote equitable responsibility among manufacturers,” “all manufacturers of listed 

chemicals be targeted for test order issuance with the exception of manufacturers using small 

quantities of the listed chemical,” and that, on general right-to-know principles and “in order to 

further strengthen the identification of manufacturers under the ‘shared responsibility model,’ 
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EPA ”require that manufacturers producing a listed chemical to self identify themselves and the 

quantity of production and impose ‘legal penalties’ for those who fail to self disclose.” 49.1. 

EPA Response: As described in the proposed policies and procedures for SDWA chemicals, 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 primarily on the Chemical Data 

Reporting (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 pounds or more at a single site. EPA considers the CDR rule to be the most 

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. 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 

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 test order 

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

that are identified. EPA, however, does not generally intend at this time 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 (e.g., as impurities, contaminants, or byproducts, which are not expected to be released 

into the environment in significant amounts). Issuing orders based on the geographic distribution 

of manufacturing locations and potential impact of chemicals on neighboring communities 

would add another complex and burdensome requirement to the issuance of EDSP test orders 

that appears unlikely to achieve the primary goal of the program: obtaining the data necessary to 

evaluate the endocrine potential of pesticide chemicals and drinking water contaminants. 
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G. Other Topics

a. Use of SDWA Authority

Submitted Comments: Comments were received from AI, SFRT, PETA, the Physicians 

Committee for Responsible Medicine, ACC, CLA, EPF, CPDA, and the AWWA about the use 

of SDWA to issue EDSP test orders. The American Petroleum Institute commented that 

“Congress limited EPA’s authority to require EDSP screening pursuant to the SDWA when it 

stated that EPA may provide for EDSP testing ‘of any other substance that may be found in 

sources of drinking water if the Administrator determines that a substantial population may be 

exposed to such substance’” and “the only way for EPA to ensure it acts within the authority 

granted by Congress is for the Agency to define the phrases ‘may be found in sources of drinking 

water’ and ‘that a substantial population may be exposed.’” The ACC, CLA, EPF, and the CPDA 

submitted similar statements. The ACC added that EPA should focus on chemicals in “water that 

people actually will drink,” that chemicals on the chemical candidate list (CCL) are not 

necessarily found in drinking water sources to which a substantial population may be exposed, 

and that EPA should rely instead on EPA’s “own accepted regulatory provisions for identifying 

regulated and unregulated contaminants that may pose risks in source waters based on actual 

data,” such as “the extensive database of monitoring data that is recorded and reported to [EPA ] 

by the nations’ thousands of public water systems.” CLA, EPF, and the CPDA contributed 

coordinated comments. PETA and the PCRM commented that EPA should define several key 

terms and phrases “in order to focus the program on those chemicals with the greatest chance of 

causing harm” to minimize animal testing. The SFRT commented that, since the SDWA’s CCL 

is “developed” periodically and the chemicals on the CCL “represent widespread human 

exposure through public water systems,” the latter should be “automatically ‘flagged’ for Tier 1 

EDSP screening.” The AWWA commented that existing regulatory mechanisms should be used 

to protect water and understand endocrine disrupting compounds. 48.1, 49.1, 50.1, 52.1, 53.1, 

56.1, 57.1. 

EPA Response: For EPA’s response to comments about the use of SDWA authority, see 

Comment Code 1060 within the Final Comment Response Document for the Second Endocrine 

Disruptor Screening Program List (Categorized Public Comments).
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b. Cost Sharing

Submitted Comments: The ACC, CLA EPF and the CPDA commented that EPA should use 

Congressionally-granted authority under section 408(p) of FFDCA to develop, to the extent 

practicable, new procedures to ensure fair and equitable sharing of test costs in the form of 

explicit, legally enforceable compensation rights, rather than to “create procedures that operate 

within the confines of existing statutory authorities.” They complimented EPA, however, “for 

developing a workable data compensation and cost sharing plan that utilizes EPA’s FFDCA 

order authority to determine compliance.” They 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 and EDSP testing has been completed,” but suggested that such orders be 

issued for ten, rather than five, years. 52.1, 56.1, 57.1. 

EPA Response: EPA disagrees with the commenters’ interpretation of FFDCA section 408(p). 

As stated in EPA’s November 2010 Federal Register notice, FFDCA section 408(p) only 

establishes a qualified direction that EPA minimize duplicative testing to the extent practicable. 

At most, FFDCA section 408(p) directs EPA to create procedures that operate within the 

confines of existing statutory authority and authorizes EPA to develop procedures to facilitate 

joint data generation. Accordingly, EPA developed procedures based on its discretion to 

determine what actions comply with a FFDCA section 408(p) test order that create strong 

incentives for companies to voluntarily jointly develop test data. As the commenters’ 

acknowledge, the current scheme establishes “a workable data compensation and cost sharing 

plan,” and EPA intends to continue to rely on it for this second list of chemicals. 

c. Minimizing Duplicative Testing

Submitted Comments: PETA and PCRM commented that EPA’s approach for encouraging test 

order recipients to form testing consortia in order to reduce costs and duplicative testing is 

inadequate and that EPA should mandate testing consortia unless there is a compelling reason 

not to form a consortium. PETA and PCRM also recommended that EPA facilitate the joint 

development of test data by listing other manufacturers and contact information in each test order 

and by providing incentives for joining consortia by providing disincentives for multiple 
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submissions and expediting review of consortia submissions. PETA also commented that, 

inasmuch as the EPA’s proposed policies and procedures for active pesticide ingredients and 

minimizing duplicative testing had not changed, it repeated its comments on the original policies 

and procedures. 50.1. 

EPA Response: EPA lacks the authority to compel test order recipients to join testing consortia to 

minimize duplicative testing; however, EPA has taken several steps to minimize duplicative 

testing. Specifically, as discussed in the preceding response, EPA has developed procedures to 

facilitate joint data generation. In addition, EPA intends to continue its practice of listing other 

manufacturers and contact information in each test order, as recommended by PETA and PCRM, 

as well as publishing such information on the EDSP Website. EPA also accepts existing data 

(i.e., OSRI) in satisfaction of the test order, provided it is equivalent to the required assays. 

d. Confidential Business Information

Submitted Comments: The San Francisco REACH Team commented in favor of further 

increasing public transparency by generally disallowing CBI claims in accordance with EPA’s 

decision to strictly review confidential business information (CBI) claims (see, 

http://www.epa.gov/oppt/existingchemicals/pubs/transparency.html). The ACC, CLA, and EPF, 

commented that, in the FFDCA, Congress authorized, and EPA should provide, EDSP specific 

CBI protection, because protecting CBI from disclosure to competitors is critical to protect 

industry’s legitimate intellectual property interests. They also commented that everything exempt 

from disclosure under FOIA should be deemed eligible for CBI protection if the CBI claim can 

be substantiated against well-established criteria, and that it is important to protect information 

that may not be particularly sensitive alone if it may reveal CBI when combined with other 

information. 49.1, 52.1, 56.1.

EPA Response: EPA acknowledges the support for its efforts to increase public transparency in 

its chemical programs by strictly reviewing, and generally disallowing, CBI claims. Among 

other things, EPA has challenged the chemical industry to voluntarily declassify unwarranted 

CBI claims and issued new guidance outlining the Agency’s plans to deny CBI claims. Where 

EPA determines that the information is not eligible for CBI treatment, the Agency is taking 
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various actions to make the information publically available. EPA disagrees with the comment 

that the FFDCA authorizes specific EDSP CBI protections. 

As previously explained in the November 2010 Federal Register notice, he FFDCA does not 

authorize EPA to either create new rights or to modify existing rights to confidentiality. Rather, 

the FFDCA only directs EPA to apply the confidentiality provisions of the Federal Insecticide, 

Fungicide and Rodenticide Act (FIFRA), the Freedom of Information Act (FOIA), and the Trade 

Secret Act (TSA), as applicable. The Safe Drinking Water Act (SDWA), in particular, only 

authorizes EPA to apply the confidential business information (CBI) protection in the TSA. Thus 

data submitted to EPA in response to an order issued under SDWA/FFDCA would only have the 

protections provided under FOIA and the TSA, except for data on pesticide chemical substances, 

which would be entitled to the CBI and data compensation provisions in FIFRA and FFDCA 

408(i). (EPA intends to continue to rely on its existing FOIA regulations, which currently 

establish “well-established criteria” to be used in substantiating claims of confidentiality, and 

allow submitters to demonstrate that the information needs to be protected because it may reveal 

CBI when combined with other information...”) 

e. Adverse Effects Reporting

Submitted Comments: The ACC commented that EPA has not, but should, give clear guidance on 

the significance of positive test results for TSCA section 8(e) and FIFRA section 6(a)(2) 

reporting purposes. 52.1. 

EPA Response: EPA has 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 C.F.R. part 159 and existing interpretations of 

section 8(e). 

In general, EPA does not believe that data from a single Tier one 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. However, EPA is not prepared to conclude that such 

information could never be reportable. Since publication of the EDSP policies, EPA believes that 

it has not yet accumulated adequate experience with the Tier 1 results to be able to provide 
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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 of whether 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, or falls within the categories 

described in EPA’s past statements regarding TSCA section 8(e), that information should 

continue to be reported, consistent with those requirements. 

However, EPA does not believe that it would typically be necessary to submit any early or 

preliminary test results that might otherwise be required to be reported within the time frames 

required under FIFRA § 6(a)(2) or TSCA § 8(e) prior to the submission of the final, completed 

study . Rather, the appropriate reporting period for otherwise reportable Tier 1 data would be the 

time frames laid out in the Order or any applicable time extension. In addition, 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.

f. Public Availability of Information 

Submitted Comments: The SFRT commented that, since only FIFRA chemicals are subject to 

“’data compensation protections,’” SDWA chemicals test data should be made publicly available 

and recommended that the data be made available on EPA’s Website. The SFRT also noted that, 

“[as] the law stands, chemical manufacturing companies are able to claim that some, if not all, of 

their chemicals test data submitted under TSCA should be protected as confidential business 

information (CBI)” and recommended that the public have access to “all available information 

about chemicals in commerce.” The SFRT also commented that it was not clear how EPA 

intended to enforce reporting on active ingredients in pesticides. 49.1. 

EPA Response: EPA intends to make all non-confidential EDSP data publicly available in the 

EDSP docket and on EPA’s EDSP Website. However, although FIFRA and TSCA data 

protection and compensation provisions may not apply to SDWA chemicals, TSA and FOIA 

may apply and provide some protections, as noted in EPA’s November 2010 Federal Register 
- 20 -

notice. Thus, it may not be possible to publicly post all available data. Nonetheless, EPA expects 

that confidential data will be limited. The identities of chemicals on the non-confidential 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. See 75 FR 

3462 (January 21, 2010). 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.

g. Basis for SDWA Chemical Selection

Submitted Comments: PETA and PCRM commented that EPA should “focus on chemicals for 

which there is a clear regulatory need,” such as “those chemicals for which appropriate 

mitigation: (1) is not currently being carried out (i.e., removal of POPs from drinking water by 

filtration); and (2) is feasible,” and not those chemicals that are no longer being imported or 

manufactured and are not persistent, because “mitigation is not possible by restricting use” and 

“the regulatory ‘need’ for testing is unjustifiable.” 50.1. 

EPA Response: For EPA’s response to comments about the basis for SDWA chemical selection, 

see the Final Comment Response Document for the Second Endocrine Disruptor Screening 

Program List (Categorized Public Comments) and the Federal Register notice (entitled 

Endocrine Disruptor Screening Program: Final Second List of Chemicals and Substances for Tier 

1 Screening) discussing the SDWA chemical selection that are being published simultaneously 

with this Federal Register notice. 

h. EDSP List 2 Chemicals

Submitted Comments: Comments were received from the Army Institute of Public Health (AIPH) 

and Bayer CropScience LP. The AIPH was specifically concerned with the chemical RDX and 

commented that, to its knowledge, there is “very limited evidence that RDX has been found in 

drinking water” and that there is “evidence suggesting that the primary mode of action for RDX 

toxicity is not mediated through the endocrine system” or “information that suggests RDX 
- 21 -

causes effects consistent with disruption of the endocrine system.” The AIPH asked that EPA 

remove RDX from the second list of chemicals to be tested in the EDSP, because it is a “primary 

explosive” in use since World War II, of significant importance to the military, and “vital” to 

national security. 

Bayer CropScience LP commented that, given that the focus of the second list of chemicals to be 

tested under the EDSP is “the potential presence of a chemical in drinking water and potential 

substantial exposure to the human population,” pesticides that do not fulfill both criteria should 

be removed from the list (in particular, three named Bayer CropScience “substances”) or, “at a 

minimum, any test orders for pesticides should be among the last group issued from List 2 in 

deference to the ongoing burden already shouldered by the pesticide industry.” 

EPA Response: For EPA’s response to comments about EDSP List 2 chemicals, see the Final 

Comment Response Document for the Second Endocrine Disruptor Screening Program List 

(Categorized Public Comments) and the Federal Register notice (entitled Endocrine Disruptor 

Screening Program: Final Second List of Chemicals and Substances for Tier 1 Screening) 

discussing the SDWA chemical selection that are being published simultaneously with this 

Federal Register notice.

i. Other Scientifically Relevant Information (OSRI)

Submitted Comments: Comments were received from the ACC, CLA, EPF, and the CPDA. All 

four commented that EPA’s offer to accept OSRI in lieu of test data was justified given that 

many of the “chemicals for EDSP screening are data rich chemicals for which relevant testing 

data exist,” but that EPA had not “clearly articulated its basis for evaluating the OSRI 

submissions and has not clearly outlined its policy goals concerning OSRI.” 52.1, 56.1, 57.1. 

EPA Response: For EPA’s response to comments about other scientifically relevant information, 

see the Response-to-Comments and Federal Register notice on the EDSP SDWA chemicals 

Information Collection Request (ICR) that are being published simultaneously with this Federal 

Register notice.
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j. Weight-of-Evidence

Submitted Comments: Comments were received from the ACC, CLA, EPF, and the CPDA. All 

four commented that it was “critical that EPA develop meaningful weight of evidence (WoE) 

guidelines,” because “Tier 1 of the EDSP will generate large amounts of data that must be 

assessed to determine whether a substance interacts with the endocrine system and whether those 

data trigger further Tier 2 testing,” and that EPA should “publish a thorough [peer reviewed] 

guidance document for conducting WoE evaluations of the Tier 1 Endocrine Screening Battery 

that includes a clear delineation of guiding principles, clear criteria for evaluating studies, and a 

methodology for weighting evidence and reaching conclusions.” 52.1, 56.1, 57.1. 

EPA Response: For EPA’s response to comments about weight-of-evidence (WoE), see the 

Response-to-Comments and the Federal Register notice on the EDSP SDWA chemicals 

Information Collection Request (ICR) that are being published simultaneously with this Federal 

Register notice.

k. Communications

Submitted Comments: Comments were received from API, ACC, CLA and the EPF. API 

commented that it was important that EPA “use consistent descriptions of ‘endocrine disruptor’ 

and the purpose of Tier 1 and Tier 2 and that communications across the Agency should be 

consistent with the descriptions adopted in its EDSP Policy,” that “the results from the entire 

battery of tests required in the Tier 1 screening and Tier 2 testing stages (or their equivalents) are 

necessary to make the statutory determination of whether a particular substance ‘may have an 

effect in humans that is similar to an effect produced by a naturally occurring [hormone],’” and 

that “a positive result in the Tier 1 screening assays would not be adequate to make the 

determination ‘whether a substance may have an effect in humans that is similar to an effect 

produced by a naturally occurring [hormone].’" CLA and EPF commented that EPA should 

“consistently communicate across the Agency that the definition of ‘endocrine disruptor’ 

includes adverse effect,” and encouraged EPA to “harmonize with the World Health 

Organization's definition of an endocrine disruptor," because “broader definitions only serve to 

unnecessarily alarm the public and perpetuate the waste of animals and resources extensively 

evaluating compounds that do not pose any real risk.” According to CLA and the EPF, EPA's 
- 23 -

description of endocrine disruption has the two important implications that “a mere interaction 

with the endocrine system is not ‘endocrine disruption,’” because “most substances have the 

potential to interact with the endocrine system,” and that “substances that have an adverse impact 

on the endocrine system as a secondary response to some other type of toxicity (e.g., 

hepatotoxicity) are not endocrine disruptors,” because “their toxicity is not by a primary mode of 

action on the endocrine system.” Accordingly, CLA and the EPF “strongly encourage[d] EPA to 

communicate its EDSP definition concerning endocrine disruption throughout the Agency” and 

“encourage[d] all EPA Offices and programs to follow the Agency's policies in defining 

‘endocrine disruption’ and ensuring the appropriate use and understanding of information 

generated in the Tier I EDSP.” 

The ACC urged EPA “to maintain its efforts to accurately inform the public concerning the 

EDSP and to take steps to improve communications by all Agency offices and programs,” 

because, although EPA had generally “clearly and accurately communicated important aspects of 

its EDSP to the public,” EPA communications across EPA offices and programs occasionally 

had not. In particular, the ACC believed that “EPA’s description of the EDSP in the Draft Phase 

2 Policies and Procedures is clear and accurate, and should be consistently used by all EPA 

offices and programs,” because EPA “clearly describes the EDSP as a two-tiered program in 

which the ultimate goal is not to simply generate Tier 1 data” or “to merely determine whether a 

substance may interact with the endocrine system” (Tier 1), but rather “to determine whether 

substances cause adverse effects through an endocrine mechanism” (Tier 2). According to the 

ACC, “the mere interaction of a substance with the endocrine system may be of no practical 

concern and certainly may not be the basis for Agency risk management action,” because “a 

mere interaction with the endocrine system is not “’endocrine disruption’;” rather, “’endocrine 

disruptors’ are substances that adversely affect organ systems by interacting with the endocrine 

system.” Thus, the definition of endocrine disruption should include “both the direct interaction 

with the endocrine system and adverse effects.” Accordingly, the ACC commented that EPA 

“must continue to communicate accurate and complete information about the substances on the 

EDSP Phase 2 list” and “should clarify that the current lack of endocrine mechanistic 

information for any particular substance does not mean that the substance poses significant risks 

to human health, even at environmentally relevant levels of exposure.” Finally, the ACC 

recommended that EPA include references and links to such relevant Agency hazard and risk 
- 24 -

information data sources as Drinking Water Standards and Health Advisories, the Integrated 

Risk Information System (IRIS), and e-ChemPortal when it publishes the final, second list of 

chemicals to be tested in the EDSP, because, “for many if not all of the EDSP Phase 2 

substances, the Agency already has data and information on relevant apical tests that are used for 

risk assessment purposes, including tests for reproduction and developmental toxicity (potential 

effects which can be mediated by endocrine pathways).” 48.1, 52.1, 56.11. 

EPA Response: For EPA’s response to comments about the consistent use of language and 

definitions, see the Response-to-Comments and the Federal Register notice on the EDSP SDWA 

chemicals Information Collection Request (ICR) that are being published simultaneously with 

this Federal Register notice.

l. Schedule

Submitted Comments: Comments were submitted by the API, SFRT, ACC, Bayer CropScience 

LP, CLA, EPF, and the CPDA. 48.1, 49.1, 52.1, 55.1, 56.1, 57.1. 

The API commented that it “believes it is inappropriate for EPA to issue test orders for the 

second list of substances ... before [EPA] has reviewed the results of the screening battery being 

applied.” Bayer urged EPA to refrain from listing pesticides, or any chemical, for screening or 

from issuing new test orders until EPA “has had an opportunity to properly evaluate the 

usefulness of the Tier 1 battery assays,” noting that “there are still a number of pending issues 

with the EDSP implementation under the first list of chemicals,” such as guidance for OSRI 

[other scientifically relevant information], resolution of errors within the 890 Series Test 

Guidelines, SEPs for the 890 Series reports, [and] an appropriately detailed weight of evidence 

approach.” 

The SFRT requested that EPA develop a “more precise timeline for the test order issuance and 

reporting activities resulting from the Federal Register,” “revise the Federal Register to include 

timelines for issuance of test orders as well as deadlines for manufacturers to respond to the test 

orders, by February 18, 2011,” “adopt a tiered approach for issuing test orders to all 

manufacturers of chemicals on the finalized second list of chemicals for Tier 1 screening ... 

based on the volume produced and other relevant factors ... and revise the Federal Register to 
- 25 -

describe this approach,” “start issuing test orders to the high volume manufacturers identified 

through the TSCA-IUR reporting program, by July 2011,” and “complete issuing test orders to 

all manufacturers of listed chemicals, by December 2011.” 

The ACC, CLA, EPF, and the CPDA commented that EPA had “wisely adopted a phased 

approach for implementing its EDSP,” and urged EPA to “abide by its current plan to issue new 

orders after it receives the results of Phase 1 screening, assesses those results and, if necessary, 

modifies its Tier 1 battery and policies and procedures.” According to the ACC, “concerns 

remain as to the usefulness, accuracy and repeatability of some of the individual assays,” so “the 

Tier 1 battery and individual assay protocols will likely need to be modified” and “EPA will 

learn of battery, assay and compliance problems only after it assesses the results of the first 

phase of screening.” The ACC added that, “while the House Appropriations Committee report 

directs EPA to list potential drinking water contaminants and to issue orders for those 

substances, it is not a statutory requirement,” and neither FFDCA nor SDWA “require EPA to 

list or order the testing of potential drinking water contaminants.” According to the ACC, 

“premature issuance of Phase 2 EDSP test orders could result in unnecessary screening, and 

unnecessary use of assays and protocols that may be unable to determine with adequate scientific 

certainty whether a substance interacts with the endocrine system,” “requiring new EDSP testing 

before EPA has an opportunity to learn of and correct problems with its existing assays and 

battery would likely result in unnecessary testing costs and the unnecessary use of laboratory 

animals,” “assays may need to be repeated and new assays may need to be included in the 

screening battery,” and “a phased approach would also give EPA time to accelerate the 

determination of the relevance, reliability, sensitivity and specificity of available high throughput 

and high-content endocrine screening techniques” as an alternative. 

EPA Response: The Agency intends to complete review of the Tier 1 data from the test orders 

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

EDSP chemicals. In addition, the Agency intends to continue to rely on the best available 

validated methods for test order issuance and follow the Science Advisory Board’s (SAB) 

recommendations to “convene a panel of independent scientists to review all the screening data 

for 50-100 compounds, with an eye towards raising the process and eliminating those methods 
- 26 -

that don’t work.” (U.S. EPA Report, Joint Subcommittee of the Science Advisory Board and 

Scientific Advisory Panel, Review of the EPA’s Proposed Environmental Endocrine Disruptor 

Screening Program, July 1999.) In an effort to maintain a standard of efficiency, EPA’s current 

plan is to delay the issuance of future test orders, including those for the second list of chemicals,

until after the Scientific Advisory Panel (SAP) has completed its review of scientific issues being 

considered by the Agency concerning the development of the Agency’s endocrine disruptor 

screening and testing program. 

m.Enforcement

Submitted Comments: The SFRT suggested that, in addition to making the testing requests and 

the companies that have fulfilled the testing requests public and generally disallowing CBI 

claims for Tier 1 chemicals, EPA should enact a system of graduated penalties for 

noncompliance with testing requirements based on the length of delay in complying with 

requirements. 49.1. 

EPA Response: 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 that 

section, each new day of continued noncompliance is another violation, so graduated penalties 

based on the length of delay is 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. 
- 27 -

References

Appendix A: Commenter Reference List by FDMSID Number