- 1

- 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 P ollution Prevention

February 1, 201 3- 2

- 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 Recipient s- 3

- 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 Scient ifically Relevant Information (OSRI) j. Weight

- of

- Evidence
k. Communications
l. Schedule

m. Enforcement- 4

- Acronyms

CBI Confidential Business Information

CDR Chemical Data Reporting

CDX Central Data Exchange

EDSP Endocrine Disruptor Screening Program

EPA US En vironmental 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 Rep orting (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 Drinkin g Water Act

TSA Trade Secret Act

TSCA Toxic Substances Control Act

WOE Weight of Evidence- 5

- I NTRODUCTION
This paper provides EPA’s responses to public comments received on a document describing EPA’s draft policies and procedures for requiring Tier 1 sc reening 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 dr aft 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 1756 0). 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 modificatio ns 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 po licies. 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.- 6

- C OMMENTS AND R ESPONSES

A. Response Option to Cease Manufacture
Submitted Comments : Multiple commenters (the Amer ican 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 pro posal 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 L ist 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 d ecision 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 whe n 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- 7

- 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 time frame 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 Work s 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 persis t 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 findi ng that a chemical “may be found in sources of drinking water” and “that a substantial population may be exposed.” While the comment s have merit, EPA has decided that in this instance the equities weigh in favor of allowing companies to satisfy the order b y 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. Specifica lly, 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 chemi cal 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 difficul ties of identifying and assessing the- 8

- 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 Poli cy 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. Commente rs 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 con cerning 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 provi ding 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- 9

- 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 likel y 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 i ntend 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 bo th 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 i ncluding 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
chem icals as they are identified. 49.1- 10

- 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, ne ither 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 c atch

- 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 es tablished 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.) Nonet heless, 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 or ders 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 sugge sted 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 co mmenters (including the American Petroleum Institute, PETA, the AWWA, and Bayer CropScience) interpreted orphan chemicals as those chemicals no longer being produced or imported, and- 11

- 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 anticipate d. 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 usefu l 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 d eclining 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 importatio n, 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 comme nted 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 exch ange] 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 o peration 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- 12

- reporting by the Internet, and OPPT has also already pro posed 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 abi lity 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 ad vantages 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, an d maintain consistency with current proposed regulations to require electronic reporting of information submissions and recordke eping ( 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

.- 13

- F. Identification of Test Order Reci pients

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 as sure 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 t o 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 chemic al 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 manufac turing 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, ’- 14

- 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 proce dures 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 re quires 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 identifyin g 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

c ontext, 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 manufactu re 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 e nvironment 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 tes t 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.- 15

- G. Other Topics

a. Use of SDWA Authority

Submitted Comments : Co mments 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 authorit y 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 suc h 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, a nd 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 substa ntial 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 databas e 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 o rder 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 t hrough 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)

.- 16

- 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 te st 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 a nd 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 a nd 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 Fed eral 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 s tatutory 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
incen tives for companies to volunt arily 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 testi ng 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 ince ntives for joining consortia by providing disincentives for multiple- 17

- 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
minimizin g 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 ha s 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 require d 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 C BI 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 subst antiated 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, E PA 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- 18

- various actions to make the information publically available. EPA disagrees with the comment
th at 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 onl y 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 us ed 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 comment ed 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 re quirements 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 TSC A 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 ab le to provide- 19

- 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 t o 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 standa rds 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 wo uld 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
“’d ata 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 c ommented 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, alth ough 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 da ta 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 cl aim 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 Respons e : 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
Endocri ne 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 Commen ts : 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 c ommented 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 crit eria 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 th e 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 noti ce (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 dat a 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 res ponse 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 n otice.- 22

- 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 generat e 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 conduct ing 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 Respons e : 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 Registe r 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 communicat ions 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 st atutory 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
d etermination ‘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 d isruptor’ 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 a nd 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 d isruption,’” 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” an d “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 com munications 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 deter mine 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 m anagement 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 re production 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 CropSc ience 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 rep orts, [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 in clude 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 chem icals 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 b y 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, accu racy 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

p hase 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 “req uire 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 un necessary 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 th e 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 Boar d’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 t he 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

scre ening 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

exe rcised 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 vio lation, 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 dete rmination that the registrant is no longer out of compliance.- 27

- References

Appendix A: Commenter Reference List by FDMSID Number