Document ID: EPA-HQ-OPP-2009-0634-0001
Agency: epa
Document Type: Notice
Title: Endocrine Disruptor Screening Program; Tier 1 Screening Order Issuing Announcement
Posted Date: 2009-10-21T04:00Z

[Federal Register: October 21, 2009 (Volume 74, Number 202)]
[Notices]               
[Page 54422-54428]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21oc09-129]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0634; FRL-8434-8]

 
Endocrine Disruptor Screening Program; Tier 1 Screening Order 
Issuing Announcement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This action announces the Agency's initiation of the Endocrine 
Disruptor Screening Program (EDSP) Tier 1 screening for the first group 
of 67 chemicals by issuing orders between October 29, 2009, and 
February 26, 2010, pursuant to the authority provided to EPA under 
section 408(p)(5) of the Federal Food, Drug, and Cosmetic Act (FFDCA). 
The EDSP Tier 1 screening data required to satisfy an order are due 
within 2 years of the date of issuance of the order. This action also 
provides information for pesticide registrants, manufacturers and 
importers of inert chemicals used in pesticide products, and the public 
on how to obtain details about the orders (such as the date of issuance 
and the recipients), the ``Pesticide Inert Ingredients Data Submitters 
and Suppliers List'' (PIIDSSL), and how interested persons other than 
recipients of test orders may submit other scientifically relevant 
information on the chemicals subject to the orders.

DATES:  Order recipients must respond according to the schedules 
contained in the order they receive. Persons other than order 
recipients who wish to submit other scientifically relevant information 
related to one of the chemical-specific orders should submit

[[Page 54423]]

that information within 90 days of the order issuance date.

ADDRESSES:  Persons other than order recipients should submit their 
information identified by docket identification (ID) number EPA-HQ-OPP-
2009-0634, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0634. 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 website 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 OPP Regulatory Public Docket in Rm. S-4400, 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) 305-5805.

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 20460-0001; telephone number: (703) 308-0048; fax 
number: (703) 308-8090; e-mail address: smith.jane-scott@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
use, or import pesticide/agricultural chemicals and other chemical 
substances; or if you are or may otherwise be involved in the testing 
of chemical substances for potential endocrine effects. 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 
manufacturing (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 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 EPA-HQ-OPP-2009-0634. 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. S-4400, 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) 305-5805.
    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

[[Page 54424]]

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) (FRL-6021-3), and solicited public 
comment on the program in the December 28, 1998 Federal Register notice 
(63 FR 71542) (FRL-6052-9). 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 hormone-related processes; and include non-pesticide chemicals, 
contaminants, and mixtures in addition to pesticides. Based on these 
recommendations, EPA developed a two-tiered 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 
dose-response relationship for any adverse effects that might result 
from the interactions identified through the Tier 1 assays. EDSTAC also 
recommended that EPA establish a priority-setting 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 25-27, 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/minutes2008-03-25.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 EPA-HQ-OPPT-2009-0634 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) (FRL-7716-
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) (FRL-8129-3). The public comments and Agency responses can be 
found in the associated docket EPA-HQ-OPPT-2004-0109. 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

[[Page 54425]]

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 Pre-screening 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) (FRL-8340-3), 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) (FRL-8399-9), (74 FR 17579) (FRL-8399-7), and 
(74 FR 17477) (FRL-8412-2)). 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 EPA-HQ-
OPPT-2007-1080).

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 1-List 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                                       71751-41-2  x                          January 2010
----------------------------------------------------------------------------------------------------------------
Acephate                                        30560-19-1  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Acetone                                            67-64-1  HPV/Inert                  February 2010
----------------------------------------------------------------------------------------------------------------
Atrazine                                         1912-24-9  x                          October 2009
----------------------------------------------------------------------------------------------------------------
Benfluralin                                      1861-40-1  x                          October 2009
----------------------------------------------------------------------------------------------------------------
Bifenthrin                                      82657-04-3  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Butyl benzyl phthalate                             85-68-7  HPV/Inert                  January 2010
----------------------------------------------------------------------------------------------------------------
Captan                                            133-06-2  x                          January 2010
----------------------------------------------------------------------------------------------------------------
Carbamothioic acid, dipropyl-, S-ethyl            759-94-4  x                          November 2009
 ester
----------------------------------------------------------------------------------------------------------------
Carbaryl                                           63-25-2  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Carbofuran                                       1563-66-2  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Chlorothalonil                                   1897-45-6  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Chlorpyrifos                                     2921-88-2  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Cyfluthrin                                      68359-37-5  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Cypermethrin                                    52315-07-8  x                          November 2009
----------------------------------------------------------------------------------------------------------------
2,4-D                                              94-75-7  x                          October 2009
----------------------------------------------------------------------------------------------------------------
DCPA (or chlorthal-dimethyl)                     1861-32-1  x                          October 2009
----------------------------------------------------------------------------------------------------------------
Diazinon                                          333-41-5  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Dibutyl phthalate                                  84-74-2  HPV/Inert                  January 2010
----------------------------------------------------------------------------------------------------------------
Dichlobenil                                      1194-65-6  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Dicofol                                           115-32-2  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Diethyl phthalate                                  84-66-2  HPV/Inert                  January 2010
----------------------------------------------------------------------------------------------------------------
Dimethoate                                         60-51-5  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Dimethyl phthalate                                131-11-3  HPV/Inert                  January 2010
----------------------------------------------------------------------------------------------------------------
Di-sec-octyl phthalate                            117-81-7  HPV/Inert                  January 2010
----------------------------------------------------------------------------------------------------------------
Disulfoton                                        298-04-4  x                          November 2009
----------------------------------------------------------------------------------------------------------------

[[Page 54426]]

Endosulfan                                        115-29-7  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Esfenvalerate                                   66230-04-4  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Ethoprop                                        13194-48-4  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Fenbutatin oxide                                13356-08-6  x                          October 2009
----------------------------------------------------------------------------------------------------------------
Flutolanil                                      66332-96-5  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Folpet                                            133-07-3  x                          January 2010
----------------------------------------------------------------------------------------------------------------
Gardona (cis-isomer)                            22248-79-9  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Glyphosate                                       1071-83-6  x                          January 2010
----------------------------------------------------------------------------------------------------------------
Imidacloprid                                   138261-41-3  x                          January 2010
----------------------------------------------------------------------------------------------------------------
Iprodione                                       36734-19-7  x                          January 2010
----------------------------------------------------------------------------------------------------------------
Isophorone                                         78-59-1  HPV/Inert                  January 2010
----------------------------------------------------------------------------------------------------------------
Linuron                                           330-55-2  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Malathion                                         121-75-5  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Metalaxyl                                       57837-19-1  X                          December 2009
----------------------------------------------------------------------------------------------------------------
Methamidophos                                   10265-92-6  X                          November 2009
----------------------------------------------------------------------------------------------------------------
4,7-Methano-1H-isoindole-1,3(2H)-dione,           113-48-4  x                          January 2010
 2-(2-ethylhexyl)-3a,4,7,7a-tetrahydro-
----------------------------------------------------------------------------------------------------------------
Methidathion                                      950-37-8  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Methomyl                                        16752-77-5  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Methyl ethyl ketone                                78-93-3  HPV/Inert                  January 2010
----------------------------------------------------------------------------------------------------------------
Methyl parathion                                  298-00-0  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Metolachlor                                     51218-45-2  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Metribuzin                                      21087-64-9  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Myclobutanil                                    88671-89-0  X                          December 2009
----------------------------------------------------------------------------------------------------------------
Norflurazon                                     27314-13-2  X                          October 2009
----------------------------------------------------------------------------------------------------------------
o-Phenylphenol                                     90-43-7  x                          January 2010
----------------------------------------------------------------------------------------------------------------
Oxamyl                                          23135-22-0  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Permethrin                                      52645-53-1  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Phosmet                                           732-11-6  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Piperonyl butoxide                                 51-03-6  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Propachlor                                       1918-16-7  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Propargite                                       2312-35-8  x                          October 2009
----------------------------------------------------------------------------------------------------------------
Propiconazole                                   60207-90-1  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Propyzamide                                     23950-58-5  x                          January 2010
----------------------------------------------------------------------------------------------------------------
Pyridine, 2-(1-methyl-2-(4-                     95737-68-1  x                          January 2010
 phenoxyphenoxy)ethoxy)-
----------------------------------------------------------------------------------------------------------------
Quintozene                                         82-68-8  x                          December 2009
----------------------------------------------------------------------------------------------------------------

[[Page 54427]]

Resmethrin                                      10453-86-8  x                          November 2009
----------------------------------------------------------------------------------------------------------------
Simazine                                          122-34-9  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Tebuconazole                                   107534-96-3  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Toluene                                           108-88-3  HPV/Inert                  February 2010
----------------------------------------------------------------------------------------------------------------
Triadimefon                                     43121-43-3  x                          December 2009
----------------------------------------------------------------------------------------------------------------
Trifluralin                                      1582-09-8  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 assays--that 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 EPA-HQ-
OPPT-2007-1080-0032). 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 case-by-case 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:
     The submitter's contact information.
     The name of the program (i.e., Endocrine Disruptor 
Screening Program (EDSP).
     The name of the chemical to which the information applies.
     The citation of the study and/or a copy of the study, if 
possible.
     The order number(s) to which the information applies.
     A rationale that explains how the cited or submitted 
study(ies) satisfies all or some portion of the Tier 1 order.
In order for this information to be given timely consideration, the 
information should be submitted on the same time frame as the response 
to orders, i.e. this information should be submitted as a comment to 
the docket for this action (EPA-HQ-OPP-2009-0634) within 90 days of the 
issuance date of the orders for a given chemical. The details about the 
dates of issuance of the orders can be found at www.epa.gov/endo.

VI. Pesticide Inert Ingredients Data Submitters and Suppliers List

    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

[[Page 54428]]

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. E9-25352 Filed 10-20-09; 8:45 am]

BILLING CODE 6560-50-S