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 person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket ID number EPAHQOPP20090634. 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 Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 3055805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. II. Introduction
A. What Action is the Agency Taking?
The Agency is initiating the EDSP Tier 1 screening for the first group of 67 chemicals by issuing test orders from October 29, 2009, through February 26, 2010. Details on the status of the orders will be provided on EPA's website at http://www.epa.gov/endo with information, including the order issuance date, the recipient(s) of the order, each order recipient's response and the order due date. EPA intends to update the list with subsequent publications and postings as appropriate. This public listing is provided to invite the public to identify additional entities who should receive the FFDCA section 408(p) test order. The commenters could either identify themselves or another person as additional candidates (with proper substantiation) for receipt of a FFDCA section 408(p) test order by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's Authority for Taking this Action?

FFDCA section 408(p)(1) 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
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similar to an effect produced by a naturally occurring estrogen, or such other effects as [EPA] may designate.'' (21 U.S.C. 346a(p)). Section 408(p)(3) specifically requires that the Administrator ``shall provide for the testing of all pesticide chemicals.'' (21 U.S.C. 346a(p)(3)).

Section 201 of FFDCA defines ``pesticide chemical'' as ``any substance that is a pesticide within the meaning of [FIFRA], including all active and inert ingredients of such pesticide.'' (21 U.S.C. 231(q)(1)).

Section 408(p)(5) of FFDCA provides that the Administrator shall issue an order to a registrant of a substance for which testing is required under this subsection, or to a person who manufactures or imports a substance for which testing is required under this subsection. The order shall require the recipient to conduct testing in accordance with the screening program, and to submit information obtained from the testing to the Administrator, within a reasonable time period that the Administrator determines is sufficient for the generation of the information.

Section 3(c)(2)(B) of FIFRA provides that registrants must submit additional data, upon notification that the Administrator has determined that additional data are required to maintain an existing pesticide registration. (7 U.S.C. 136a(c)(2)(B)). In light of the directive in section 408(p)(3) of FFDCA that EPA is to provide for the endocrine screening of all pesticide chemicals, EPA considers that such data have been statutorily determined to be necessary to maintain an existing pesticide registration.

III. Background

EPA developed the EDSP in response to the Congressional mandate in section 408(p) of FFDCA to ``develop a screening program. . .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 effects as [EPA] may designate'' (21 U.S.C. 346a(p)). When carrying out the program, the statute requires EPA to ``provide for the testing of all pesticide chemicals.'' The statute also provides EPA with 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.'' In addition, section 1457 of the Safe Drinking Water Act (SDWA) provides EPA with discretionary authority to provide for testing, under the FFDCA 408(p) screening program, ``of any other substances that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance.''

EPA initially set forth the EDSP in the August 11, 1998 Federal Register notice (63 FR 42852) (FRL60213), and solicited public comment on the program in the December 28, 1998 Federal Register notice (63 FR 71542) (FRL60529). The program initiated in these notices was based on the recommendations of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), which was chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C. App.2, section 9(c). The EDSTAC was comprised of members representing the commercial chemical and pesticides industries, Federal and State agencies, worker protection and labor organizations, environmental and public health groups, and research scientists.

EDSTAC recommended that EPA's program address both potential human and ecological effects; examine effects on estrogen, androgen, and thyroid hormonerelated processes; and include nonpesticide chemicals, contaminants, and mixtures in addition to pesticides. Based on these recommendations, EPA developed a twotiered assessment approach for these chemicals, referred to as the EDSP. The purpose of Tier 1 screening (referred to as ``screening'') is to identify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems using a battery of assays. The purpose of Tier 2 testing (referred to as ``testing'') is to identify and establish a doseresponse relationship for any adverse effects that might result from the interactions identified through the Tier 1 assays. EDSTAC also recommended that EPA establish a prioritysetting approach for choosing chemicals to undergo Tier 1 screening.

EPA implemented its EDSP in three major parts.

1. Assay validation. Under FFDCA section 408(p), EPA is required to use ``appropriate validated test systems and other scientifically relevant information'' to determine whether substances may have estrogenic effects in humans or other endocrine effects as EPA may designate. Validation is defined as the process by which the reliability and relevance of test methods are evaluated for the purpose of supporting a specific use. The EDSP Tier 1 screening assays were peer reviewed by independent experts and by the FIFRA Scientific Advisory Panel (SAP) during a public meeting on March 2527, 2008. Details on the validation and peer review process for the assays as well as the peer review reports can be found on EPA's website at http:/ /www.epa.gov/scipoly/oscpendo/pubs/assayvalidation/index.htm. The FIFRA SAP report is available at http://www.epa.gov/scipoly/sap/meetings/ 2008/march/minutes20080325.pdf. Elsewhere in this issue of the Federal Register, EPA is issuing the final Tier 1 battery composed of the validated assays. The Tier 1 battery protocols can be found in the corresponding docket EPAHQOPPT20090634 or the website at http:// www.epa.gov/oppts (select ``Test Methods & Guidelines''). EPA is also in the process of developing and validating Tier 2 tests. The status of each assay can be viewed on the EDSP website in the Assay Status table: http://www.epa.gov/scipoly/oscpendo/pubs/assayvalidation/status.htm.

2. Priority setting. EPA described its priority setting approach for the first group of pesticide chemicals to be tested under the EDSP in the Federal Register of September 27, 2005 (70 FR 56449) (FRL7716 9), and proposed the draft list of initial chemicals for review and public comment in the Federal Register notice of June 18, 2007 (72 FR 33486) (FRL81293). The public comments and Agency responses can be found in the associated docket EPAHQOPPT20040109. In April 2009, EPA published in the Federal Register its final list of the first group of chemicals to be screened under EDSP. The first group of 67 chemicals identified for screening includes pesticide active ingredients and high production volume (HPV) chemicals used as pesticide inert ingredients (also known as other ingredients). This list should not be construed as a list of known or likely endocrine disruptors. More information on EPA's priority setting approach for selection of the first group of chemicals for the EDSP is available at http://www.epa.gov/scipoly/ oscpendo/prioritysetting.

The first group of chemicals to be screened consists of chemicals that section 408(p) of FFDCA requires be screened, i.e., pesticide active ingredients and chemicals used as pesticide inert ingredients (also known as other ingredients). EPA anticipates that it may, in the future, modify its approach to selecting chemicals for screening. Information and factors that EPA may consider in selecting chemicals could include: Public input; the results of testing chemicals on the initial list; management considerations to increase the integration of screening with other regulatory activities within the Agency; implementation considerations flowing from a decision
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to extend screening to additional categories of chemicals (e.g., non pesticide chemical substances); and the availability of new priority setting tools (e.g., High Throughput Prescreening or Quantitative Structure Activity Relationships models). More information on EPA's priority setting approach is available at http://www.epa.gov/scipoly/ oscpendo/pubs/prioritysetting.

3. Procedures. EPA published a document in the Federal Register of December 13, 2007 (72 FR 70842) (FRL83403), that describes the proposed procedures that EPA would use to issue orders, the proposed procedures that order recipients would use to respond to the order, how data protection and compensation would be addressed in the test orders, and other related proposed procedures or policies. In addition, EPA developed a draft template for the test order and a draft information collection request (ICR) to obtain the necessary clearances under the Paperwork Reduction Act (PRA). On April 15, 2009, the Agency published the final policies and procedures and related documents in the Federal Register ((74 FR 17560) (FRL83999), (74 FR 17579) (FRL83997), and (74 FR 17477) (FRL84122)). EPA generally intends to adopt these procedures for initial screening of chemicals under the EDSP, including the statutory requirements associated with and format of the test orders, as well as EPA's procedures for fair and equitable sharing of test costs and handling of confidential data (docket number EPAHQ OPPT20071080).

IV. Order Issuance Schedule

The Agency intends to initiate the EDSP Tier 1 screening for the first group of 67 chemicals by issuing test orders listed in the following table.
Table 1List of Chemicals and Order Issuance Dates for Tier 1 Screening in the EDSP Pesticide Active Chemical Name CAS Number Ingredient (x) or as Order Issuance Time Frame Noted Abamectin 71751412 x January 2010 Acephate 30560191 x November 2009 Acetone 67641 HPV/Inert February 2010 Atrazine 1912249 x October 2009 Benfluralin 1861401 x October 2009 Bifenthrin 82657043 x November 2009 Butyl benzyl phthalate 85687 HPV/Inert January 2010 Captan 133062 x January 2010 Carbamothioic acid, dipropyl, Sethyl 759944 x November 2009 ester
Carbaryl 63252 x November 2009 Carbofuran 1563662 x November 2009 Chlorothalonil 1897456 x December 2009 Chlorpyrifos 2921882 x November 2009 Cyfluthrin 68359375 x November 2009 Cypermethrin 52315078 x November 2009 2,4D 94757 x October 2009 DCPA (or chlorthaldimethyl) 1861321 x October 2009 Diazinon 333415 x November 2009 Dibutyl phthalate 84742 HPV/Inert January 2010 Dichlobenil 1194656 x December 2009 Dicofol 115322 x December 2009 Diethyl phthalate 84662 HPV/Inert January 2010 Dimethoate 60515 x November 2009 Dimethyl phthalate 131113 HPV/Inert January 2010 Disecoctyl phthalate 117817 HPV/Inert January 2010 Disulfoton 298044 x November 2009 [[Page 54426]]
Endosulfan 115297 x December 2009 Esfenvalerate 66230044 x November 2009 Ethoprop 13194484 x November 2009 Fenbutatin oxide 13356086 x October 2009 Flutolanil 66332965 x December 2009 Folpet 133073 x January 2010 Gardona (cisisomer) 22248799 x November 2009 Glyphosate 1071836 x January 2010 Imidacloprid 138261413 x January 2010 Iprodione 36734197 x January 2010 Isophorone 78591 HPV/Inert January 2010 Linuron 330552 x December 2009 Malathion 121755 x November 2009 Metalaxyl 57837191 X December 2009 Methamidophos 10265926 X November 2009 4,7Methano1Hisoindole1,3(2H)dione, 113484 x January 2010 2(2ethylhexyl)3a,4,7,7atetrahydro
Methidathion 950378 x November 2009 Methomyl 16752775 x November 2009 Methyl ethyl ketone 78933 HPV/Inert January 2010 Methyl parathion 298000 x November 2009 Metolachlor 51218452 x December 2009 Metribuzin 21087649 x December 2009 Myclobutanil 88671890 X December 2009 Norflurazon 27314132 X October 2009 oPhenylphenol 90437 x January 2010 Oxamyl 23135220 x November 2009 Permethrin 52645531 x November 2009 Phosmet 732116 x November 2009 Piperonyl butoxide 51036 x November 2009 Propachlor 1918167 x December 2009 Propargite 2312358 x October 2009 Propiconazole 60207901 x December 2009 Propyzamide 23950585 x January 2010 Pyridine, 2(1methyl2(4 95737681 x January 2010 phenoxyphenoxy)ethoxy)
Quintozene 82688 x December 2009 [[Page 54427]]
Resmethrin 10453868 x November 2009 Simazine 122349 x December 2009 Tebuconazole 107534963 x December 2009 Toluene 108883 HPV/Inert February 2010 Triadimefon 43121433 x December 2009 Trifluralin 1582098 x January 2010

Details on the status of the orders will be provided on EPA's website at http://www.epa.gov/endo with information, including the order issuance date, the recipient(s) of the order, the order recipient's response to the order, and the order due date.
V. Submission of Other Scientifically Relevant Information by Interested Parties

The Agency published the final policies and procedures and related documents in the Federal Register of April 15, 2009 ((74 FR 17560), (74 FR 17579), and (74 FR 17477)); as part of those documents, EPA discussed its policies relating to the submission of other scientifically relevant information in satisfaction of a test order. As explained at greater length in those documents, if recipients of the FFDCA section 408(p) test orders choose to cite or submit existing data, (i.e., other scientifically relevant information (OSRI)), along with a rationale that explains how the cited or submitted study satisfies the Tier 1 test order in lieu of developing new data, EPA will determine whether the information can be used to satisfy part or all of the Tier 1 order and/or otherwise inform the Tier 1 determination. Existing data may include data that has already been generated using the assay(s) specified in the order, or other scientifically relevant information. Other scientifically relevant information is information that informs the determination as to whether the substance may have an effect that is similar to an effect produced by a substance that interacts with the estrogen, androgen, and/or thyroid hormonal systems (e.g., information that identifies substances as having the potential to interact with the estrogen, androgen, and/or thyroid system(s); information demonstrating whether substances have an effect on the functioning of the endocrine system). Other
scientifically relevant information may either be functionally equivalent to information obtained from the Tier 1 assaysthat is, data from assays that perform the same function as EDSP Tier 1 assays or may include data that provide information on a potential consequence or effect that could be due to effects on the estrogen, androgen or thyroid systems. Some other scientifically relevant information may be sufficient to satisfy part or all of the Tier 1 order and/or otherwise inform the Tier 1 determination.

The Agency has written a paper entitled ``EPA's Approach for Considering Other Scientifically Relevant Information (OSRI) under the EDSP'' (see www.regulations.gov and search for docket number EPAHQ OPPT200710800032). This paper was developed to provide guidance to EPA staff and managers who will review the responses to Tier 1 test orders issued under the EDSP, and may also be of interest to parties considering whether to submit OSRI to EPA. This paper is intended only to provide general guidance and is not binding on either EPA or any outside parties. Anyone, including members of the general public, may provide OSRI, and the Agency will assess the information for appropriateness on a casebycase basis to determine whether the information can be used to satisfy part or all of the Tier 1 order and/ or otherwise inform the Tier 1 determination.

Persons other than those receiving testing orders who would like to submit OSRI on chemicals subject to test orders should include the following information:

Currently, EPA maintains a list of all data on pesticide active ingredients that supports registration of products containing the active ingredient, along with contact information for the submitters (i.e., owners) of the data, known as the ``Data Submitters List.'' The Agency published the final policies and procedures and related documents in the Federal Register on April 15, 2009 ((74 FR 17560), (74 FR 17579), and (74 FR 17477)) describing EPA's intention to establish a Pesticide Inert Ingredients Data Submitters & Suppliers List (PIIDSSL) which is similar to the ``Data Submitters List.'' The purpose of the PIIDSSL is to identify any entity who has submitted compensable data on a pesticide inert ingredient in response to a test order issued under section 408(p) of FFDCA. Pursuant to FIFRA section 3(c)(1)(F), when a applicant's product contains a pesticide inert ingredient on the PIIDSSL, EPA intends to require the applicant to identify the source of the pesticide inert ingredient. If the applicant's source does not appear on the PIIDSSL, EPA intends to require the applicant either to switch to a source on the PIIDSSL; offer to pay compensation to the original data submitter(s) on the PIIDSSL; or generate
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their own data to support their application.
The PIIDSSL can be found on EPA's website at www.EPA.gov/ DataSubmittersList or a link to it can be found at www.epa.gov/endo. List of Subjects

Environmental protection, Chemicals, Endocrine disruptors, Pesticides.

Dated: October 14, 2009.
Stephen A. Owens,
Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.
[FR Doc. E925352 Filed 102009; 8:45 am]
BILLING CODE 656050S

FOR FURTHER INFORMATION CONTACT

Jane Scott Smith, Pesticide Re- evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3080048; fax number: (703) 3088090; email address: smith.janescott@epa.gov.