Endocrine Disruptor Screening Program; Second List of Chemicals for Tier 1 Screening

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This document announces the second list of chemicals and substances for which EPA intends to issue test orders under the Endocrine Disruptor Screening Program (EDSP). EPA established the EDSP in response to section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA). This second list of chemicals expands the EDSP in an effort to include all pesticides, required by FFDCA, and adds priority drinking water chemicals into the program for screening as authorized by SDWA section 1457. Today's publication provides public notice of EPA's tentative decision-making in advance of the actual issuance of EDSP testing orders.

DATES:

In order for the Agency to consider information and/or comments that may be relevant to the inclusion or exclusion of chemicals contained on the second EDSP list, this information and/or comments should be received by EPA on or before December 17, 2010.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2009-0477, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2009-0477. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2009-0477. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov,, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov,, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: William Wooge, Office of Science Coordination and Policy, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-8476; e-mail address: wooge.william@epa.gov.

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you produce, manufacture, use, consume, work with, or import substances included on the second EDSP list. Potentially affected entities may include, but are not limited to:

• Chemical manufacturers, importers and processors (NAICS code 325), e.g., persons who manufacture, import or process chemical substances.
• Pesticide, fertilizer, and other agricultural chemical manufacturers (NAICS code 3253), e.g., persons who manufacture, import or process pesticide, fertilizer and agricultural chemicals.
• Scientific research and development services (NAICS code 5417), e.g., persons who conduct testing of chemical substances for endocrine effects.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Introduction

A. What action is the agency taking?

Today's document announces the second list of chemicals that the Agency intends to include in its EDSP. Through the issuance of orders, the Agency intends to require the submission of Tier 1 Screening data for these chemicals. Elsewhere in today's issue of the Federal Register, EPA also is announcing the policies and procedures expected to be followed for certain chemicals on this list. Information on EDSP and Tier 1 Screening data is available on the Agency's Web site at http://www.epa.gov/endo.

B. What is the agency's authority for taking this action?

EPA's authority for taking this action is based on several different Congressional actions, including FFDCA, the Safe Drinking Water Act (SDWA), and the House Appropriations Committee report for EPA's FY 2010 appropriations.

EPA developed the EDSP in 1998 to implement FFDCA section 408(p), which requires EPA to “develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as [EPA] may designate.” (21 U.S.C. 346a(p)). The statute generally requires EPA to “provide for the testing of all pesticide chemicals” and gives EPA discretionary authority to “provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such a substance.” (21 U.S.C. 346a(p)(3)). The statute also authorizes EPA to exempt a chemical upon a determination that “the substance is anticipated not to produce any effect in humans similar to an effect produced by a naturally occurring estrogen.” (21 U.S.C. 346a(p)(4)).

Section 1457 of SDWA provides that “in addition to the substances” referred to in FFDCA section 408(p)(3)(B), “the Administrator may provide for testing under the screening program authorized by section 408(p) of such Act, in accordance with the provisions of section 408(p) of such Act, 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.” (42 U.S.C. 300j-17). EPA used its authority under SDWA to identify a portion of the chemicals on the second EDSP list.

In addition, in Congress's House Appropriations Committee report for EPA's FY 2010 appropriations (H.R. 2996, H. Rept. 111-180) (Ref. 1), it directed EPA “to publish within 1 year of enactment a second list of no less than 100 chemicals for screening that includes drinking water contaminants, such as halogenated organic chemicals, dioxins, flame retardants (PBDEs, PCBs, PFCs), plastics (BPA), pharmaceuticals and personal care products, and issue 25 orders per year for the testing of these chemicals.”

III. Background

EPA developed EDSP in response to a Congressional mandate in FFDCA “to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as [EPA] may designate” (21 U.S.C. 346a(p)). As part of EDSP, EPA issues orders to collect certain test data on listed chemical substances. Unit II.B. describes the authority for listing a chemical. Test data requirements are derived from specific test assays, which are divided into two tiers. Tier I test assays are used to screen the chemicals for interaction with the estrogen (E), androgen (A) or thyroid (T) hormonal systems. Tier II test assays are intended to test for more specific chemical effects on the endocrine system, and are currently in the process of being developed and validated. Further information regarding EDSP and requirements for Tier I and Tier II can be found on the Agency's EDSP Web site, at http://www.epa.gov/endo/.

IV. Development of the Second EDSP List

In developing the second EDSP list, EPA focused on a subset of chemicals and substances that have been listed as priorities within EPA's drinking water and pesticides programs. While the Agency has not included some chemicals or substances on the second EDSP list as explained in Unit IV.A., non-inclusion does not mean that these other chemicals or substances may not be subject to testing in the near term nor in the future. In addition, based on current information, the public should not presume that the listing of a chemical or substance indicates in any way that EPA currently suspects that such chemical or substance interferes with the endocrine systems of humans or other species simply because it has been listed for screening under the EDSP. At the present time, EPA believes that these chemicals or substances should be candidates, at least for screening purposes, under EDSP testing based only on their pesticide registration status and/or because such substances may occur in sources of drinking water to which a substantial population may be exposed.

A. Basis for Chemical Selection

The Agency considered chemicals contained on the Office of Water (OW) and Office of Pesticide Programs (OPP) priority lists for inclusion on the second EDSP list.

1. Initial compilation of OW candidate chemicals. The Agency identified candidate chemicals that are either contaminants regulated with a national primary drinking water regulation (NPDWR) (40 CFR part 141) (Ref. 2) or are unregulated contaminants that are listed on the third Contaminant Candidate List (CCL 3) (USEPA, 2009) (Ref. 3). EPA began with the 85 regulated drinking water contaminants with existing NPDWRs and the 116 unregulated contaminants listed on CCL 3 because these represent many of the priority contaminants for the drinking water program. Most of the regulated drinking water contaminants with NPDWRs were designated by Congress under the 1986 or the1996 SDWA amendments. Because Congress designated these contaminants for regulation due to concerns about occurrence in drinking water and adverse impacts on human health, EPA believes that each such substance meets the statutory testing criteria from SDWA section 1457. SDWA section 1412(b)(9) requires the Agency to periodically review the existing NPDWRs and revise them, if appropriate. Information about the potential for endocrine disruption will assist the Agency in updating human health assessments, which the Agency considers in its periodic review of NPDWRs to ensure that they are protective of human health.

SDWA section 1412(b)(1) requires the Agency to develop a list of unregulated contaminants that are known or anticipated to occur in public water systems (PWSs) and may require regulation under SDWA. The Agency is required to develop the CCL list every 5 years. In determining whether a substance may occur in drinking water, EPA considers not only public water system monitoring data, but also data on ambient concentrations in surface water and ground water, and releases to the environment (e.g., reporting data from the Toxics Release Inventory). The Agency believes that such data are sufficient to anticipate contaminants that may occur in public water systems and furthermore, also represent those substances that may be found in sources of drinking water and to which a substantial population may be exposed. In selecting contaminants for the CCL, SDWA section 1412(b)(1)(C) requires that the Agency “take into consideration, among other factors of public health concern, the effect of such contaminants upon subgroups that comprise a meaningful portion of the general population (such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations) that are identifiable as being at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population.” The protocol that EPA used to develop CCL 3 was reviewed by internal experts, as well as external experts such as the National Drinking Water Advisory Council and the Science Advisory Board (Ref. 3). The CCL 3 has undergone a rigorous listing and expert review process, including a public nomination and comment period, and therefore, represent an excellent source of potential drinking water candidates to consider for EDSP screening. The information about the potential for endocrine disruption will assist the Agency in evaluating the human health impacts of unregulated drinking water contaminants. In the CCL listing, EPA already has made the component of the SDWA section 1457 determination that such substances may occur in sources of drinking water. The final CCL 3 listing also represents EPA's determination that a substantial population may be exposed to such substance for the purposes of SDWA 1457.

In listing drinking water contaminants on the CCL 3, EPA closely evaluated the nature of the occurrence and prevalence information supporting each such CCL 3 listing. Evaluating occurrence, EPA considered and evaluated data based on occurrence in finished drinking water and ambient water, as well as based on total releases to the environment, pesticide application rates, and production volumes (73 FR 9628, February 21, 2008) (FRL-8529-7). In deciding whether to move a possible drinking water contaminant from the preliminary CCL 3 to the proposed CCL 3, EPA scored each such contaminant based on, among other attributes, its occurrence attributes (at 73 FR 9640-41, February 21, 2008). The occurrence attributes were weighted more heavily based on a hierarchy representing prevalence of the contaminant in the water environment or likely release to the water environment. The results of that scoring are described at 73 FR 9644, February 21, 2008. The administrative record supporting the CCL 3 ultimately published in 2009 includes contaminant-by-contaminant information sheets that document the occurrence data upon which EPA relied for the listing of CCL 3 contaminants. The basis for EPA's inclusion of the CCL 3 contaminants on its tentative testing list, therefore, also provides the basis for EPA's determination that a substantial population may be exposed to each such substance for the purposes of SDWA section 1457.

2. Initial compilation of OPP candidate chemicals. The Agency identified candidate chemicals from OPP based on pesticides that were scheduled for Registration Review during fiscal years 2007 and 2008. This selection is part of the Agency's intent to efficiently expedite the testing of pesticides by conducting the testing in parallel or as part of the OPP Registration Review program.

3. Streamlining the second EDSP list. Consolidating the lists of OW and OPP chemicals resulted in over 200 chemicals. A listing of these chemicals is available in the docket for this notice (Ref. 4). The Agency streamlined this initial second EDSP list by excluding any chemical that fell into one or more of the following categories:

i. Biological agent and naturally occurring chemicals (e.g., microbials, microbial toxins, inorganics, radionuclides).

ii. Chemicals for which the manufacturer, importer or registrant cannot be clearly identified (e.g., disinfection byproducts or DBPs, microbes, microbial toxins, degradate compounds with more than one possible source).

iii. Chemicals already included on the first EDSP list because these chemicals have already received an EDSP order. Note however that if no one agreed to provide data in response to that order, additional orders may be issued under a SDWA determination.

iv. Chemicals that are hormones with confirmed endocrine effects.

v. Chemicals not likely to be biologically active or which are incompatible with testing assays for various reasons due to one or more of their physiochemical properties (e.g., gases, strongly acidic or basic, solubility, vapor pressure molecular weight).

vi. Pesticides that are scheduled for registration review after FY 2008.

Although these chemicals have been excluded from the second EDSP list for one or more of these reasons, it is important to note that these exclusions do not imply that the Agency has no interest in the potential for endocrine disruption activity for these chemicals. In some instances, the Agency recognizes that information on endocrine effects is already available (e.g., for the hormones) or the Agency is currently collecting information (e.g., through the first EDSP list). In other cases, the Agency simply realizes that at this time there is some difficulty with collecting the information about endocrine effects through the EDSP (i.e., because of the Agency's inability to identify a manufacturer, importer, or registrant or because the contaminant is incompatible with the testing assays). In addition, EPA recognizes that some of the naturally occurring chemicals also have anthropogenic sources and should be considered for the EDSP. In no way should it be inferred that removal from this initial second EDSP list signifies that a chemical does not have the potential to be placed on a future EDSP chemical list. The Agency intends to reexamine currently excluded chemicals for future EDSP chemical lists.

EPA is interested in receiving information from the public that may help the Agency resolve the difficulties with the currently excluded chemicals so that the Agency will be able to consider adding them to future EDSP chemical lists.

B. Second EDSP List of Chemicals

There are approximately 134 chemicals on the second ESDP list (see Table 1). This list includes a large number of pesticides, two perfluorocarbon compounds (PFCs), and three pharmaceuticals (erythromycin, nitroglycerin, and quinoline). This list also consists of an array of other chemicals, ranging from those used for industrial manufacturing processes, as plasticizers, or in the production of pharmaceutical and personal care products (PPCPs).

EPA is interested in receiving information and/or comment that may inform the exclusion or inclusion of chemicals on the second EDSP list. The Agency does not plan to respond formally to information or comments that may be submitted on this document, but will add such information to the notice docket as public record. EPA will consider such information and/or comment before finalizing the second EDSP list and publishing the Schedule for Issuance of Orders along with the second EDSP list. In addition, please note that by relying on the CCL 3 as part of this effort, the Agency does not intend to re-open CCL 3 for public comment or any of the individual lists used to create the second list of EDSP chemicals and does not intend to respond to any such comments so submitted.

V. References

The following is a list of the documents that are specifically referenced in this document. These references are available in the docket number identified under General Information (Section I.B).

1. U.S. Congress. House Report 111-180. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111congreports&docid=f:hr180.111.pdf.

2. USEPA. 2009. National Primary Drinking Water Regulations. May 2009. EPA 816-F-09-004. Available at: http://www.epa.gov/safewater/consumer/pdf/mcl.pdf.

3. USEPA. 2009. Drinking Water Contaminant Candidate List 3—Final Notice. Federal Register. Vol, 74. No 194. p. 51850. October 8, 2009.

4. Initial Compilation of Chemicals and Substances Considered for the Second Endocrine Disruptor Screening Program List.

List of Subjects

• Environmental protection
• Chemicals
• Drinking water
• Endocrine disruptors
• Pesticides