54422 Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices 

examining the thyroid axis in both sexes 

provides the opportunity to detect 

potential gender differences in response 

to treatment at a relatively early life 

stage. 

b. Amphibian metamorphosis assay. 

The amphibian metamorphosis assay 

(AMA) is an in vivo screening assay 

intended to identify substances which 

interfere with the normal function of the 

HPT axis. The AMA represents a 

generalized vertebrate model based on 

the conserved structure and function of 

thyroid systems among species. The 

AMA is based on the principle that the 

dramatic morphological changes that 

occur during post-embryonic 

development are dependent upon the 

normal functioning of the HPT axis, and 

that interference with these processes 

leads to measurable effects. During 

tadpole metamorphosis, thyroid 

hormone (TH) influences virtually every 

tissue in the body initiating diverse 

morphological, physiological and 

biochemical changes that include cell 

proliferation, differentiation and death. 

The result is de novo organ formation, 

organ loss, and extensive tissue 

remodeling. Given the dependence of 

metamorphosis on TH and the strict 

biochemical control under which these 

processes occur, the transformations 

that occur can serve as endpoints 

representative of thyroid axis function. 

The primary endpoints in the AMA are 

the hindlimb length during the 

developmental stage and the thyroid 

histology. Each endpoint can be affected 

by chemicals that interact with the HPT 

axis. For example, antagonists of thyroid 

production, iodination and action have 

been shown to delay development and 

induce diagnostic lesions in the thyroid 

gland. Thyroid agonists (e.g., native 

thyroid hormone) will accelerate 

development. Additionally, unlike the 

mammalian assays that have been 

developed to detect interactions along 

the HPT axis, the AMA has the ability 

to detect chemicals that act on 

peripheral tissues. For example, 

inhibition of monodeiodinases that 

transform T4 to T3 can cause 

asynchronous development, detected by 

an inability to assign a developmental 

stage to a tadpole. Knowledge of this 

mechanism is important because 

development can be affected without 

concomitant effects on thyroid histology 

or circulating thyroid hormone 

concentrations. Although postembryonic development is different 

between mammals and most 

amphibians (i.e., metamorphosis), there 

is a high level of evolutionary 

conservation of the thyroid system and 

underlying molecular and cellular 

pathways among vertebrates. Hence, the 

AMA, particularly with the use of 

Anurans, is a general model for 

evaluating the interaction of chemicals 

with the HPT axis in the EDSP Tier 1 

screening battery. In addition, the 

results can be used to complement or 

corroborate results in the pubertal male 

and female assays (Table 2 of this unit). 

VI. Test Guidelines for EDSP Tier 1 

Screening Battery 

EPA is also announcing the 

availability of the test guidelines for 

conducting the assays included in the 

EDSP Tier 1 Screening Battery (Table 1 

in Unit V.A.). 

The Androgen Receptor Binding, 

Aromatase, Estrogen Receptor Binding 

(Rat Uterine Cytosol), Female Pubertal, 

Male Pubertal, and Steroidogenesis 

assays were developed and validated by 

the Agency. 

The Amphibian Metamorphosis, 

Estrogen Receptor Transcriptional 

Activation, Fish Short-term 

Reproduction, Hershberger and 

Uterotrophic assays were developed and 

validated using a collaborative process 

involving EPA’s Office of Science 

Coordination and Policy (OSCP), Office 

of Research and Development (ORD), 

and Office of Pesticide Programs (OPP) 

as well as OECD as previously outlined 

in a Federal Register notice of July 13, 

2007 (72 FR 38577) (FRL–8138–4). The 

process took into account the 

harmonized testing strategy for the 

screening and testing of potential 

endocrine disrupting chemicals and 

consequences of such a strategy on the 

development and validation of test 

guidelines involving regulatory systems 

for new and existing substances 

according to OECD’s Endocrine 

Disrupter Testing and Assessment 

(EDTA) Task Force in 1998. 

In both cases, the draft protocols (and 

all related materials) were made 

available as part of the independent 

peer review. The draft protocols were 

revised to reflect comments received 

during the peer review process, and 

have been incorporated into the OPPTS 

compendium of harmonized test 

guidelines, under Series 890–Endocrine 

Disruptor Screening Program Test 

Guidelines as follows: 

• 890.1100–Amphibian 

Metamorphosis (Frog) 

• 890.1150–Androgen Receptor 

Binding (Rat Prostate Cytosol) 

• 890.1200–Aromatase (Human 

Recombinant) 

• 890.1250–Estrogen Receptor 

Binding (Rat Uterine Cytosol) 

• 890.1300–Estrogen Receptor 

Transcriptional Activation (Human Cell 

Line — HeLa-9903) 

• 890.1350–Fish Short-term 

Reproduction 

• 890.1400–Hershberger (Rat) 

• 890.1450–Female Pubertal (Rat) 

• 890.1500–Male Pubertal (Rat) 

• 890.1550–Steroidogenesis (Human 

Cell Line — H295R) 

• 890.1600–Uterotrophic (Rat) 

For information on accessing these 

guidelines see Unit I.B.2. 

List of Subjects 

Environmental protection, Chemicals, 

Chemical testing, Endocrine disruptors, 

Pesticides, Test guideline. 

Dated: October 14, 2009. 

Stephen A. Owens, 

Assistant Administrator, Office of Prevention, 

Pesticides and Toxic Substances. 

[FR Doc. E9–25348 Filed 10–20–09; 8:45 am] 

BILLING CODE 6560–50–S 

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 


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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 email. 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 


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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) (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 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 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 


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to extend screening to additional 

categories of chemicals (e.g., nonpesticide 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 

Chemical Name CAS Number 

Pesticide Active Ingredient (x) or as 

Noted 

Order Issuance Time 

Frame 

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 ester 759–94–4 x November 2009 

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 


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TABLE 1-LIST OF CHEMICALS AND ORDER ISSUANCE DATES FOR TIER 1 SCREENING IN THE EDSP—Continued 

Chemical Name CAS Number 

Pesticide Active Ingredient (x) or as 

Noted 

Order Issuance Time 

Frame 

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, 2-(2-ethylhexyl)-3a,4,7,7atetrahydro113–48–4 x January 2010 

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-phenoxyphenoxy)ethoxy)- 95737–68–1 x January 2010 

Quintozene 82–68–8 x December 2009 


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TABLE 1-LIST OF CHEMICALS AND ORDER ISSUANCE DATES FOR TIER 1 SCREENING IN THE EDSP—Continued 

Chemical Name CAS Number 

Pesticide Active Ingredient (x) or as 

Noted 

Order Issuance Time 

Frame 

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 


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54428 Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices 

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 


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