

[Federal Register: June 18, 2007 (Volume 72, Number 116)]
[Notices]               
[Page 33486-33503]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jn07-55]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2004-0109; FRL-8129-3]

 
Draft List of Initial Pesticide Active Ingredients and Pesticide 
Inerts to be Considered for Screening under the Federal Food, Drug, and 
Cosmetic Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 408(p) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA) directs EPA to develop a chemical screening program using 
appropriate validated test systems and other scientifically relevant 
information to determine whether certain substances may have hormonal 
effects. In September 2005, EPA published its approach for selecting 
the initial list of chemicals for which testing will be required under 
the Endocrine Disruptor Screening Program (EDSP). This document 
presents the draft list of the first group of chemicals that will be 
screened in the Agency's EDSP. The draft list was produced using the 
approach described in the September 2005 notice, and includes chemicals 
that the Agency, in its discretion, has decided should be tested first, 
based upon exposure potential. This list should not be construed as a 
list of known or likely endocrine disruptors. Nothing in the approach 
for generating the initial list provides a basis to infer that by 
simply being on this list these chemicals are suspected to interfere 
with the endocrine systems of humans or other species, and it would be 
inappropriate to do so. The first group of chemicals identified for 
testing includes pesticide active ingredients and High Production 
Volume (HPV) chemicals used as pesticide inerts. After considering 
comments on this draft list of chemicals, EPA will issue a second 
Federal Register notice containing the final list of chemicals. This 
document does not describe other aspects of the EDSP such as the 
administrative procedures EPA will use to require testing, the 
validated tests and battery that will be included in the EDSP, or the 
timeframe for requiring the testing or receiving the data. These topics 
will be addressed in subsequent notices published in the Federal 
Register.

DATES: Comments must be received on or before September 17, 2007.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2004-0109, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID number EPA-HQ-OPPT-2004-0109. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2004-0109. 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

[[Page 33487]]

or viruses. For additional information about EPA's public docket, visit 
the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 

Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov web 
site to view the docket index or access available documents. Although 
listed in the index, some information is not publicly available, e.g., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available electronically at 
http://www.regulations.gov, or, if only available in hard copy, at the 

OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/
DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., 
Washington, DC. The EPA/DC Public Reading Room hours of operation are 
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal 
holidays. The telephone number of the EPA/DC Public Reading Room is 
(202) 566-1744, and the telephone number for the OPPT Docket is (202) 
566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: Linda Phillips, Office of Science 
Coordination and Policy (7203M), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-1264; e-mail address: phillips.linda@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. You may be 
potentially affected by this action if you produce, manufacture, use, 
consume, work with, or import pesticide chemicals. To determine whether 
you or your business may be affected by this action, you should 
carefully examine section 408(p) of FFDCA, 21 U.S.C. 346a(p). 
Potentially affected entities, using the North American Industrial 
Classification System (NAICS) codes to assist you and others in 
determining whether this action might apply to certain entities, may 
include, but are not limited to:
     Chemical manufacturers, importers and processors (NAICS 
code 325), e.g., persons who manufacture, import or process chemical 
substances.
     Pesticide, fertilizer, and other agricultural chemical 
manufacturers (NAICS code 3253), e.g., persons who manufacture, import 
or process pesticide, fertilizer and agricultural chemicals.
     Scientific research and development services (NAICS code 
5417), e.g., persons who conduct testing of chemical substances for 
endocrine effects.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. 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. What Should I Consider as I Prepare My Comments for EPA?

    1. Scope of comments sought. As discussed in more detail later in 
this document, the Agency has already sought and considered comments on 
the priority-setting approach before issuing the final approach in 2005 
(70 FR 56449, September 27, 2005), which was used to identify the 
initial group of chemicals presented today. As such, the Agency is not 
seeking comment on the particulars of the approach used. Since FFDCA 
requires that all pesticides be screened under the EDSP, any 
suggestions to add a chemical to the list should be based on the 
application of the Agency's approach and supported with additional 
information. Should you have more recent information that affects the 
Agency's application of the approach, e.g., chemical is no longer 
manufactured or sold in the United States as a pesticide or used as an 
inert in pesticides, please provide the supporting information and data 
with your comment.
    As indicated in the September 2005 Federal Register notice, any 
company subject to a testing requirement under Tier 1 may assert 
(supported by appropriate data) during the comment period for the draft 
list that the chemical is an endocrine disruptor and that the Tier 1 
EDSP screening is unnecessary. EPA does not intend to permit chemicals 
on this list to bypass Tier 1 screening and move directly to Tier 2 
testing without appropriate data to support such an action.
    2. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as 
CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed CBI. In addition to one complete 
version of the comment that includes information claimed as CBI, a copy 
of the comment that does not contain the information claimed as CBI 
must be submitted for inclusion in the public docket. Information so 
marked will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2.
    3. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at the estimate.
    vi. Provide specific examples to illustrate your concerns, and 
suggested alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Introduction

A. What Action is the Agency Taking?

    Based on the approach described in the Federal Register notice of 
September 27, 2005 (70 FR 56449) (FRL-7716-9), EPA is announcing the 
draft list of the first group of chemicals that will be screened in the 
Agency's Endocrine Disruptor Screening Program (EDSP).As required by 
FFDCA, all pesticides must eventually be screened under the EDSP, and 
this first group is simply a starting point.Because EPA developed this 
draft list of chemicals based upon exposure potential, it

[[Page 33488]]

should not be construed as a list of known or likely endocrine 
disruptors, and it would be inappropriate to do so. Nothing in the 
approach for generating the initial list provides a basis to infer that 
by simply being on this list these chemicals are suspected to interfere 
with the endocrine systems of humans or other species. The first group 
of chemicals to be tested consists of chemicals that section 408(p) 
requires be screened, i.e., pesticide active ingredients and chemicals 
used as pesticide inert ingredients that are also High Production 
Volume (HPV) chemicals. Following consideration of comments on this 
draft list of chemicals, EPA will issue a second Federal Register 
notice containing the final list of chemicals. This document does not 
describe other aspects of the EDSP such as the administrative 
procedures EPA will use to require testing, the validated tests and 
battery that will be included in the EDSP, or the timeframe for 
requiring the testing or receiving the data. These topics will be 
addressed in subsequent notices published in the Federal Register.
    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; implementation considerations flowing from a 
decision 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 (HTPS) or 
Quantitative Structure Activity Relationship (QSAR) models).
    EPA developed its 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.''
    The purpose of this document is to announce the draft initial list 
of chemicals to be screened in the Agency's EDSP. EPA used an approach 
based on the priority-setting approach described in the September 2005 
Federal Register notice. The approach focused on human exposure-related 
factors rather than using a combination of exposure- and effects-
related factors. The approach did not include a literature search for 
or consideration of any data on potential endocrine effects. It is 
therefore inappropriate to infer that by simply being on this list, 
these chemicals are suspected to interfere with the endocrine systems 
of humans or other species. As described in detail in the September 
2005 Federal Register notice, for the approach EPA:
     Focused chemical selection on the subset of chemicals for 
which testing is required (i.e., pesticide chemicals).
     Used exposure data as the basis for chemical selection.
     Deferred consideration of nominations from the public.
     Excluded mixtures.
     Excluded chemicals that are no longer produced or used in 
the U.S.
    The approach described in the September 2005 Federal Register 
notice further indicated that the following would be excluded from the 
initial list of chemicals for screening.
     Substances anticipated to have low potential to cause 
endocrine disruption (e.g., certain Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) List 4 inerts, most polymers with number 
average molecular weight greater than 1,000 daltons, strong mineral 
acids, and strong mineral bases).
     ``Positive control'' substances that are being used by EPA 
to validate screening assays proposed for the Tier 1 battery. See Unit 
IV.G. for more information.
    EPA's general focus in the approach for the initial list was on 
pesticide active ingredients and inerts with relatively greater 
potential for human exposure. The emphasis on human exposure does not 
necessarily mean that the list will not contain substances that may not 
also have potentially high levels of environmental exposure to 
ecological receptors. This Federal Register document presents the draft 
list of chemicals in alphabetical order. An ordinal ranking of 
chemicals selected using the approach was not created.

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

    Section 408(p) of FFDCA requires EPA to ``develop a screening 
program, using appropriate validated test systems and other 
scientifically relevant information, to determine whether certain 
substances may have an effect in humans that is similar to an effect 
produced by a naturally occurring estrogen, or such other endocrine 
effect as [EPA] may designate.'' (21 U.S.C. 346a(p)). The statute 
generally requires EPA to ``provide for the testing of all pesticide 
chemicals.'' (21 U.S.C. 346a(p)(3)). However, EPA is authorized to 
exempt a chemical, by order upon a determination that ``the substance 
is anticipated not to produce any effect in humans similar to an effect 
produced by a naturally occurring estrogen.'' (21 U.S.C. 346a(p)(4)). 
``Pesticide chemical'' is defined as ``any substance that is a 
pesticide within the meaning of the Federal Insecticide, Fungicide, and 
Rodenticide Act, including all active and inert ingredients of such 
pesticide.'' (21 U.S.C. 321(q)(1)).

III. Background

    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. The program set forth 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 (Ref. 1). Based on 
these recommendations, EPA developed a two-tiered approach, referred to 
as the EDSP. The purpose of the 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'')

[[Page 33489]]

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 described this approach in the Federal Register of 
September 2005. More information on EPA's priority setting approach for 
the EDSP is available at http://www.epa.gov/scipoly/oscpendo/prioritysetting
.

    EPA currently is implementing its EDSP in three major parts that 
are being developed in parallel and with substantial work on each well 
underway.
    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 the 
Administrator may designate. EPA is validating assays that are 
candidates for inclusion in the Tier 1 screening battery and Tier 2 
tests, and will select the appropriate screening assays for the Tier 1 
battery based on the validation data. 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 Tier 1 
screening battery is expected to complete peer review and be ready for 
use early in 2008. 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 in the Federal 
Register of September 2005, and this document today announces the draft 
initial list of chemicals to undergo Tier 1 screening. The Agency 
expects to finalize this initial list of chemicals early in 2008. More 
information on EPA's priority setting approach for the EDSP is 
available at http://www.epa.gov/scipoly/oscpendo/prioritysetting.

    3. Procedures. EPA intends to commence Tier 1 screening of the 
first group of pesticide chemicals by issuing test orders under FFDCA 
section 408(p) to chemical companies identified as the manufacturer or 
processor of the identified chemicals, including the pesticide 
registrant. EPA is developing a draft implementation policy that will 
describe the procedures that EPA will use to issue orders, the 
procedures that order recipients would use to respond to the order, how 
data protection and compensation will be addressed in the test orders, 
and other related procedures or policies. In addition, EPA is 
developing 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). The Agency expects to seek public 
comment on the draft implementation policy and related documents late 
spring or early summer 2007, and after considering those comments, EPA 
expects to finalize the policy by the end of 2007.
    Based on the current timing for each of the three major parts of 
the EDSP, the Agency intends to initiate the EDSP Tier 1 screening for 
the first group of pesticide chemicals early in 2008, at which time the 
final Tier 1 screening battery and the final procedures will be 
available. This document deals only with the draft list of chemicals 
initially selected to go through screening in the Tier 1 assays. As 
indicated in Unit II.A, EPA intends to address the other aspects of the 
EDSP in subsequent notices published in the Federal Register.

IV. Development of the Initial List of Chemicals

    The following sections summarize the approach that was used to 
develop the draft initial list of chemicals, which is described in more 
detail in the September 2005 Federal Register notice. Again, it would 
be inappropriate to construe the draft initial list of chemicals as a 
list of known or likely endocrine disruptors. Nothing in the approach 
for generating the initial list provides a basis to infer that by 
simply being on this list, these chemicals are suspected to interfere 
with the endocrine systems of humans or other species.

A. Universe of Chemicals

    EPA indicated in the September 27, 2005 (70 FR 56449) (FRL-7716-9) 
Federal Register notice that the universe of chemicals to be considered 
would include: (1) Pesticide active ingredients and (2) high production 
volume (HPV) chemicals that are also pesticide inerts.
    1. Pesticide active ingredients. The Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) defines a pesticide active 
ingredient as a chemical contained in pesticide products that prevents, 
destroys, repels, or mitigates any pest, or is a plant regulator, 
defoliant, desiccant, or nitrogen stabilizer. (7 U.S.C. 136(2)(u)). The 
universe of pesticide active ingredients which are required to be 
screened for their potential to adversely affect the endocrine system 
corresponds to the active ingredients EPA has scheduled for review in 
its ``registration review'' program. (FIFRA requires EPA periodically 
to review the registration of all pesticide products, which the Office 
of Pesticide Programs (OPP) will implement through a program called 
``registration review.'' It should be noted that OPP may group similar 
active ingredients together, e.g., 2,4-D esters, salts, and amines, in 
``cases'' that are evaluated at the same time. The EDSP, however, will 
focus on screening individual active ingredients.) The registration 
review schedule identifies all pesticide active ingredients that are 
used in currently registered products and indicates when they will be 
addressed in EPA's periodic registration review program. The draft 
registration review schedule was posted on EPA's website in August 2005 
(Ref. 2). The draft schedule listed all registration review cases and 
pesticide active ingredients as of September 30, 2004. The draft 
schedule listed 666 registration review cases, comprising 1,056 active 
ingredients. Only those pesticide active ingredients that appear on 
this draft schedule were considered for generating the initial list of 
chemicals to undergo testing in the EDSP. The list is consistent with 
the final registration review schedule posted in October 2006. The 
principal difference between the draft and the final schedule is the 
inclusion of new active ingredients contained in newly registered 
pesticides as of September 30, 2005. The Agency does not expect any of 
the newly added active ingredients to be found in multiple exposure 
pathways. There are currently 678 registration review cases, comprising 
1,077 active ingredients. These numbers will change annually as 
registration review schedule updates are announced.
    2. High production volume pesticide inerts. HPV chemicals are those 
substances that are not pesticide active ingredients and that are 
produced or imported into the U.S. in amounts greater than or equal to 
one million pounds per year. The list of HPV chemicals is based on the 
non-confidential list of 2002 Toxic Substances Control Act (TSCA) 
Inventory Update Rule (IUR) chemicals (Ref. 3).
    Pesticide inert chemicals are defined as any ingredients in 
pesticide product formulations other than the active ingredient. (7 
U.S.C. 136(2)(m)). OPP maintains an inventory of pesticide inert 
chemicals that are categorized into the following four lists (Ref. 4):
     List 1--Inert Ingredients of Toxicological Concern. Any 
product

[[Page 33490]]

containing a List 1 ingredient must include the label statement:
    This product contains the toxic inert ingredient (name of 
inert).

     List 2--Potentially Toxic Inert Ingredients/High Priority 
for Testing Inerts. The substances on this list may be structurally 
similar to chemicals known to be toxic; some have data suggesting a 
concern.
     List 3--Inerts of Unknown Toxicity. Inert ingredients on 
this list have not yet been determined to be of known potential 
toxicological concern nor have they been determined to be of minimal 
concern. These substances will continue to be evaluated to determine if 
they merit reclassification to List 1, 2, or 4.
     List 4--Inerts of Minimal Concern. This list is subdivided 
into List 4A (minimal risk inert ingredients) and List 4B (inerts which 
have sufficient data to substantiate that they can be used safely in 
pesticide products).
    Table 1 presents the number of HPV and pesticide inert chemicals 
and the number of chemicals that are contained on both lists.

             Table 1.-HPV and Pesticide Inert Chemical Counts
------------------------------------------------------------------------
               Chemical List                     Number of Chemicals
------------------------------------------------------------------------
High Production Volume Chemicals\1\                                2,708
------------------------------------------------------------------------
Pesticide Inert Chemicals                                       2,775\2\
------------------------------------------------------------------------
Overlap of HPV/Pesticide Inert Chemicals                             643
------------------------------------------------------------------------
\1\Based on the 2002 TSCA IUR.
\2\The number of inert ingredients contained in one or more registered
  pesticide products as of April 27, 2007. Note that as new products and
  formulations are registered, and as other products are canceled or
  reformulated, the number of inert ingredients contained in one or more
  registered pesticide products can change.

    As shown in Table 1, there are a total of 643 chemicals that are 
both an HPV and pesticide inert chemical. This overlap was identified 
by matching Chemical Abstract Service (CAS) Registry numbers on each of 
the lists. Note that the list of pesticide inerts contains 109 
chemicals without corresponding CAS numbers. This list of 109 pesticide 
inert chemicals was reviewed to determine whether any overlap could be 
identified based on chemical name. Table 2 presents chemical matches 
that were identified based on name, and also includes the CAS number 
provided on the HPV list. These chemicals shown in Table 2 were 
included in the universe of HPV/pesticide inert overlap chemicals 
considered for EDSP screening as shown in Table 1 (Ref. 5).

     Table 2.--Additional Chemicals Included in the Universe of HPV/
                    Pesticide Inert Overlap Chemicals
------------------------------------------------------------------------
         HPV CAS Number                HPV Name           Inert Name
------------------------------------------------------------------------
67784901                          Fatty acids, coco,  Fatty acids, coco,
                                   reaction products   reaction products
                                   with 2- [(2-        with 2-[(2-
                                   aminoethyl)         aminoethyl)
                                   amino] ethanol      amino] ethanol,
                                                       alkylation
                                                       products with
                                                       methyl acrylate,
                                                       sodium salts
------------------------------------------------------------------------
68442091                          Naphthalenesulfoni  Naphthalenesulfoni
                                   c acid, sodium      c acid,
                                   salt,               isopropylisohexyl
                                   isopropylated       -, sodium salt
------------------------------------------------------------------------

B. Approach for Selecting the Initial List of Chemicals to Undergo 
Screening

    The following sections describe the approach that was used for 
selecting the initial list of chemicals to undergo screening, which is 
described in more detail in the September 2005 Federal Register notice. 
It is important to note that the approach did not include a literature 
search for or consideration of any data on potential endocrine effects. 
In fact, nothing in the approach for generating the initial list 
provides a basis to infer that by simply being on this list, these 
chemicals are suspected to interfere with the endocrine systems of 
humans or other species, and it would be inappropriate to make any such 
references.
    1. Pesticide active ingredients approach. EPA applied the approach 
outlined below and described in detail in the September 2005 Federal 
Register notice. EPA used several groups of data to identify pesticide 
active ingredients to include on the initial list of chemicals for 
screening. These data focus on the potential for human exposure by 
different pathways, including those resulting from:
    i. Consumption of food containing pesticide residues (i.e., food 
pathway);
    ii. Consumption of drinking water containing pesticide residues 
(i.e., water pathway);
    iii. Residential use of pesticide products (i.e., residential use 
pathway); and/or
    iv. Occupational contact with pesticide-treated surfaces (i.e., 
occupational exposure pathway).
    The data sources analyzed for each pathway are described in Unit 
IV.C. For each of the four pathways, EPA used the most current data 
available from each data source to identify active ingredients. As 
indicated in the September 2005 Federal Register notice, these data 
sources were selected to provide occurrence/usage data on a broad range 
of pesticide chemicals and across a wide geographical scope. Although 
the final selected data sources do have limitations, EPA believes that 
these data sources are suitable for identifying pesticide active 
ingredients likely to be among those having either potentially 
widespread or relatively higher levels of human exposure than would be 
expected for other active ingredients. These data sources were not used 
to create a definitive, scientifically rigorous list of pesticide 
chemicals to which the public is the most highly exposed. Nor did EPA 
create quantitative exposure estimates for this analysis using these 
databases.
    In accordance with the approach described in the September 
2005Federal Register notice, EPA considered pesticide active 
ingredients that indicated likely exposure via multiple pathways a 
higher priority for screening. Substances having potential exposure 
through all four pathways were considered the highest priority for 
inclusion on the draft list of chemicals for screening. Chemicals 
having potential exposure via three pathways were considered next 
highest in priority. For the purposes of further establishing 
priorities for pesticide active ingredients in three pathways, greater 
priority was given to chemicals

[[Page 33491]]

having potential exposure via the food pathway, followed by the 
occupational pathway (i.e., two of the three exposure pathways had to 
be food and occupational exposure to be included on the draft list of 
chemicals for screening). Specific details on EPA's approach for 
selecting pesticide active ingredients are presented in Unit VI. of the 
September 2005 Federal Register notice. In addition, a detailed summary 
of the analyses performed for each data source for pesticide active 
ingredients are available in the Docket (Ref. 6).
    2. High production volume pesticide inerts approach. EPA used a 
similar approach to identify HPV/pesticide inert chemicals to be 
included in the initial list for screening. In general, EPA had more 
extensive information available to assess potential exposure to 
pesticide active ingredients than to assess HPV/pesticide inert 
chemical exposure. In addition, more extensive information was 
available on pesticide active ingredient usage (including both 
agricultural and residential) than was available for HPV/pesticide 
inert chemicals (including both pesticidal and nonpesticidal uses of 
those same substances). For these reasons, the specific pathways and 
data sources EPA identified for selecting an initial set of HPV/
pesticide inert chemicals for endocrine disruptor screening differed 
somewhat from those for selecting pesticide active ingredients.
    For HPV/pesticide inert chemicals, EPA applied the approach 
outlined below and described in detail in the September 2005 Federal 
Register notice. EPA used several groups of data to identify HPV/
pesticide inert chemicals to include on the initial list of chemicals 
for screening. These data focus on indicators of potential human 
exposure using the following types of monitoring data:
    i. Human biological samples (i.e., human biological monitoring 
pathway);
    ii. Ecological tissues that have human food uses (e.g., fish 
tissues) (i.e., ecological biological pathway);
    iii. Drinking water (i.e., drinking water pathway); and/or
    iv. Indoor air (i.e., indoor air pathway).
    The data sources analyzed for each pathway are described in Unit 
IV.D. For each of these four pathways, EPA reviewed the most current 
existing data available from each data source to identify HPV/pesticide 
inert chemicals. As with pesticide active ingredients, these data 
sources were selected to provide occurrence data on a broad range of 
HPV/pesticide inert chemicals across a wide geographical scope. 
Although the final selected data sources do have limitations, EPA 
believes that these data sources are suitable for identifying HPV/
pesticide inert chemicals likely to be among those having either 
potentially widespread or higher levels of human exposure than would be 
expected for other HPV/pesticide inert chemicals. These data sources 
were not used to create a definitive, scientifically rigorous list of 
HPV/pesticide inert chemicals to which the public is the most highly 
exposed. Nor did EPA use these databases to create quantitative 
exposure estimates in this analysis.
    In accordance with the approach described in the September 2005 
Federal Register notice, EPA considered HPV/pesticide inert chemicals 
present in multiple pathways a higher priority for screening. 
Substances having potential exposure through all four pathways were 
considered the highest priority for inclusion on the draft list of 
chemicals for screening. Chemicals having potential exposure via three 
pathways were considered next highest in priority. For the purposes of 
further establishing priorities for HPV/pesticide inert chemicals in 
three pathways, greater priority was given to chemicals observed in 
human biological monitoring data (i.e., one of the three exposure 
pathways had to be human biological monitoring to be included on the 
draft list of chemicals for screening). Specific details on EPA's 
priority setting approach for selecting HPV/pesticide inert chemicals 
are presented in Unit VII. of the September 2005 Federal Register 
notice. In addition, a detailed summary of the analyses performed for 
each data source for high production volume pesticide inerts are 
available in the Docket (Ref. 7).

C. Pesticide Active Ingredients Data Sources

    The pesticide active ingredient data sources analyzed are briefly 
described below. Detailed data source summaries were prepared for each 
data source and are available in the Docket (Ref. 8). In addition, each 
of these data sources are described in the September 2005 Federal 
Register notice.
    1. Food pathway. Relevant data were extracted from the following 
data sources to determine the presence of pesticide active ingredients 
in food containing pesticide residues that may be consumed:
     Continuing Survey of Food Intake by Individuals (CSFII).
     U.S. Department of Agriculture's Pesticide Data Program 
(USDA PDP).
     U.S. Food and Drug Administration (FDA) Pesticide 
Monitoring Database.
    EPA used the most recent CSFII to develop a list of the top 20 
foods consumed in the U.S., in terms of the mean daily consumption by 
the general population. The list was derived using CSFII data in 
conjunction with recipe translations that appear in the revised Food 
Commodity Intake Database (FCID) (Ref. 9). The FCID can be reviewed at 
http://www.ars.usda.gov/Services/docs.htm?docid=14514. The list of top 

20 foods can be found in the September 2005 Federal Register notice. 
Having identified the top 20 raw agricultural foods, EPA identified the 
pesticide active ingredients detected on these foods using information 
collected by two Federal agency monitoring programs, the USDA PDP and 
the Surveillance Monitoring Program conducted by FDA's Center for Food 
Safety and Applied Nutrition. Additional information can be found at 
http://www.ams.usda.gov/science/pdp/index.htm Additional information on the FDA program appears at http://www.cfsan.fda.gov/~dms/.

dms/.

the top foods, as reported by the PDP or FDA Surveillance Monitoring 
Program sources, were considered for priority setting purposes.
    2. Water pathway. Relevant data were extracted from the following 
data sources to characterize the potential presence of pesticide active 
ingredients in drinking water:
     EPA Pesticides in Ground Water Database (PGWDB).
     EPA Chemical-Specific Monitoring Data.
     United States Geological Survey (USGS)/EPA Reservoir 
Monitoring Study.
     Environmental Monitoring and Assessment Program (EMAP).
     National Sediment Quality Database: 1980 to 1999 (or 
National Sediment Inventory (NSI)) Sediment Data.
     National Contaminant Occurrence Database (NCOD).
     National Stream Quality Accounting Network (NASQAN) 
Surface Water and Sediment Data.
     National Water Quality Assessment (NAWQA) Ground Water, 
Surface Water, and Sediment Data.
     USDA Pesticide Data Program (PDP) Water Data.
    i. EPA Pesticides in Ground Water Database (PGWDB). The PGWDB is a 
collection of ground water monitoring studies conducted by Federal, 
State and local governments; the pesticide industry; and private 
institutions between 1971-1991. The PGWDB contains pesticide data from 
monitoring

[[Page 33492]]

of untreated ground water. Further details can be found in ``EPA 
Pesticides in Ground Water Database, A Compilation of Monitoring 
Studies: 1971-1991 National Summary'' (Ref. 10).
    ii. EPA Chemical-Specific Monitoring Data. Pesticide registrants 
have conducted and submitted to the Agency targeted surface water and 
ground water monitoring studies for approximately 50 pesticide active 
ingredients. In implementing its approach for selecting the initial 
list of chemicals for screening, EPA reviewed these chemical-specific 
monitoring data sources to determine if they contain information for 
pesticide active ingredients for which data from other water monitoring 
data sources were not available.
    iii. United States Geological Survey (USGS)/EPA Reservoir 
Monitoring Study. The USGS/EPA Reservoir Monitoring study contains 
information for 178 different pesticides and degradation products in 
samples of raw water (at the intake point) and from finished drinking 
water (at the tap prior to entering the distribution system) collected 
in 1999 and 2000. Additional information on the USGS/EPA Reservoir 
Monitoring Study can be found in ``Pesticides in Select Water Supply 
Reservoirs and Finished Drinking Water, 1990-2000: Summary of Results 
from a Pilot Monitoring Program'' (Ref. 11).
    iv. Environmental Monitoring and Assessment Program (EMAP). EMAP is 
an EPA research initiative that collected sediment samples in 18 states 
at various times between 1990 and 1998. EMAP contains approximately 397 
individual data sets. Applicable EMAP sediment data sets identified and 
included in the analysis are described in the Data Manipulation Summary 
for Pesticide Active Ingredients (Ref. 6). Further details can be found 
at:http://www.epa.gov/emap/.

    v. National Sediment Inventory (NSI). EPA's Office of Science and 
Technology (OST) initiated the NSI to document the composition of 
sediment in rivers, lakes, oceans, and estuaries. The NSI includes data 
collected by a variety of Federal, State, regional, local, and other 
monitoring programs from 1980 through 1999. It includes over 4.6 
million analytical observations for over 50,000 monitoring stations 
across the country of sediment chemistry, tissue residues, and sediment 
toxicity data. EPA used both sediment and sub-sediment data from the 
NSI for the purpose of setting priorities for EDSP. Further details on 
the NSI database and the National Sediment Quality Survey, which the 
NSI was developed to support, can be found at:http://www.epa.gov/waterscience/cs/nsidbase.html
.

    vi. National Drinking Water Chemical Occurrence Database (NCOD). 
NCOD provides a library of water sample analytical data (or ``samples 
data'') that EPA uses for analysis, rulemaking, and rule evaluation. 
The drinking water sample data, collected at Public Water Systems, are 
for both regulated and unregulated contaminants. Further details can be 
found at:http://www.epa.gov/safewater/data/ncod/index.html.

    vii. National Stream Quality Accounting Network (NASQAN) Data. The 
NASQAN, a monitoring and data collection program conducted by the USGS, 
has focused on monitoring the water quality of four of the nation's 
largest river systems: the Mississippi, the Columbia, the Colorado, and 
the Rio Grande since 1995. A network of over 50 stations monitors the 
concentrations of a broad range of chemicals including pesticides, 
major ions, and trace elements. NASQAN contains data for over 70 
chemicals. EPA used both surface water and sediment data from the 
NASQAN for the purposes of setting priorities for EDSP. Further details 
can be found at:http://water.usgs.gov/nasqan/.

    viii. The National Water Quality Assessment Program (NAWQA). The 
NAWQA Program was designed to study 60 of the Nation's most important 
river basins and aquifer systems to provide both short-term information 
necessary for today's water-resource management decisions, and the 
long-term information needed for policy decisions. EPA used surface 
water, ground water, and sediment data from the NAWQA for the purposes 
of setting priorities for EDSP. Further details can be found at:http://water.usgs.gov/nawqa/
.

    ix. USDA Pesticide Data Program (PDP) Water Data. The USDA PDP was 
designed by USDA in 1991 to collect data on pesticide residues consumed 
in the U.S. PDP samples are collected as close as possible to the time 
of consumption. PDP has tested over 50 different commodities, including 
drinking water, for more than 290 pesticides. Further details can be 
found at:http://www.ams.usda.gov/science/pdp/index.htm.

    Pesticide active ingredients that were detected in monitoring 
samples from any of the water data sources described in this section 
were considered for priority setting purposes for the water exposure 
pathway.
    3. Residential use pathway. Human exposure to pesticides may occur 
as the result of use of pesticidal products in and around homes, 
schools, businesses, public areas, golf courses, and similar sites. 
Such use patterns, collectively referred to as ``residential use,'' 
include: Lawn and garden treatments, insect repellents, termite and 
other indoor insect control, fumigation products, products applied to 
pets for flea or tick control, household sanitizers and disinfectants, 
and many more.
    EPA obtained pesticide product labeling information from EPA's 
Labeling and Use Information System (LUIS). These data were used as the 
primary indicator of pesticides whose use involves potential human 
exposure by this pathway. Except for products approved only for limited 
exposure uses, such as rodenticides applied in tamper resistant bait 
boxes, all currently registered residential use pesticides were 
considered as having priority with respect to the residential use 
pathway. The data from the LUIS reports were cross referenced by the 
Agency with recent Reregistration Eligibility Decisions (REDs). If the 
RED had recommended cancellation of residential uses, the pesticide was 
considered to not have residential uses. In such an instance, the 
pesticide was not included in the residential use pathway.
    4. Occupational exposure pathway. Relevant data were extracted from 
the following data sources to identify the potential for post-
application exposure to pesticide active ingredients:
     Agricultural Reentry Task Force (ARTF) - Science Advisory 
Council on Exposure, Policy Number 003.1, Agricultural Transfer 
Coefficients.
     USDA's National Agriculture Statistics Services (NASS).
     California's Department of Pesticide Regulation (CDPR).
    EPA indicated in the approach published in the September 2005 
Federal Register notice that another source of pesticide use 
information is AgroTrak\TM\, a product of Doane Marketing Research. EPA 
did not need to rely on AgroTrak\TM\ data because sufficient data were 
available from the other publicly available data sources (i.e., NASS 
and CDPR).
    Using the ARTF data, EPA identified 14 work activities/crop 
categories (e.g., tree fruit crops) having the highest transfer 
coefficients. EPA then identified specific crops associated with the 
crop categories to use in conjunction with data available from the 
USDA's NASS and CDPR data to identify the pesticides used on those 
crops. More information on NASS pesticide use data can be found at 
http://www.pestmanagement.info/nass. More information on CDPR pesticide 

usage

[[Page 33493]]

data can be found at http://www.cdpr.ca.gov/docs/pur/purmain.htm. 

Pesticide active ingredients that were used on crops having the highest 
transfer coefficients were considered for priority setting purposes for 
the occupational exposure pathway.

D. High Production Volume Pesticide Inert Data Sources

    The HPV/pesticide inert chemical data sources analyzed are briefly 
described below. Detailed data source summaries were prepared for each 
data source and are available in the Docket (Ref. 8). In addition, each 
of these data sources are described in the September 2005 Federal 
Register notice.
    1. Human biomonitoring exposure pathway. Relevant data were 
extracted from the following data sources to determine the presence of 
HPV/pesticide inert chemicals in human tissues:
     National Health and Nutrition Examination Survey III 
(NHANES III) Priority Toxicant Reference Range Study for Volatile 
Organic Compounds.
     Centers for Disease Control and Prevention's National 
Reports on Human Exposure to Environmental Chemicals (NHANES 1999 to 
2002).
     National Human Adipose Tissue Survey (NHATS).
     Total Exposure Assessment Methodology (TEAM) Breath Study.
    i. National Health and Nutrition Examination Survey III (NHANES 
III) Priority Toxicant Reference Range Study for Volatile Organic 
Compounds. The Third NHANES (NHANES III) was conducted between 1988 and 
1994 on 33,994 people. Several studies (e.g., high blood pressure, 
immunization status, nutritional blood measures) were conducted under 
NHANES III. One study relevant to priority setting was the Priority 
Toxicant Reference Range Study, previously referenced as Ashley et al. 
(1994) (Ref. 12). This NHANES III article contains relevant human 
biomonitoring data for over 40 volatile organic compounds (VOCs).
    ii. Centers for Disease Control (CDC) and Prevention's National 
Reports on Human Exposure to Environmental Chemicals (NHANES 1999 to 
2002). The U.S. Department of Health and Human Services (HHS), CDC 
published three reports summarizing NHANES sampling data:
    a. First National Report on Human Exposure to Environmental 
Chemicals (issued in March 2001, Ref. 13).
    b. Second National Report on Human Exposure to Environmental 
Chemicals (issued in March 2003, Ref. 14).
    c. Third National Report on Human Exposure to Environmental 
Chemicals (issued in July 2005, Ref. 15).
Each year's report presents data from prior years, in addition to 
exposure data collected for current and additional chemicals studied. 
Overall, these reports provide data for 148 environmental chemicals for 
the survey years 1999 through 2002. These data were used for EDSP 
priority setting purposes.
    iii. National Human Adipose Tissue Survey (NHATS). NHATS collected 
and analyzed human adipose tissue specimens to monitor human exposure 
to potentially toxic chemicals. NHATS provides relevant human 
biomonitoring data for over 150 chemicals. Data are available for years 
1970 through 1987 in 14 journal articles and reports (Refs. 16-29). 
However, because a standard set of summarized data parameters has not 
been published, the NHATS data were previously compiled into a 
database. (See http://www.epa.gov/scipoly/oscpendo/prioritysetting/database.htm.
) In implementing its approach for selecting the initial 

list of chemicals for screening, EPA considered chemicals for which 
geometric means were calculated.
    iv. Total Exposure Assessment Methodology (TEAM) Breath Study. The 
TEAM study measured individual exposure through air, food, and water in 
urban populations in several U.S. cities. The TEAM Study reports the 
results of eight monitoring studies performed in five communities 
during different seasons of the year. Breath, personal air, outdoor 
air, and water samples were collected for 30 VOCs (Refs. 30-32).
    HPV/pesticide inert chemicals that were detected in monitoring 
samples from any of the human biomonitoring databases described in this 
section were considered for priority setting purposes for the human 
biomonitoring pathway.
    2. Ecological biomonitoring exposure pathway. Relevant data were 
extracted from the following data sources to determine the presence of 
HPV/pesticide inert chemicals in ecological tissues:
     National Sediment Inventory (NSI) Fish Tissue Data.
     National Fish Tissue Study (NFTS) Data.
     National Water Quality Assessment (NAWQA) Program Aquatic 
Animal Tissue Data.
    i. National Sediment Inventory (NSI) Fish Tissue Data (NSI Fish 
Tissue Data). This database is described in Unit IV.C.2.v. In 
implementing its approach for selecting the initial list of chemicals 
for screening, EPA considered the analytical results for fish tissue 
samples collected after 1989.
    ii. National Fish Tissue Study (NFTS) Data. EPA initiated this 4-
year study in 2000 to define the national background levels for 265 
chemicals in fish, establish a baseline to track the progress of 
pollution control activities, and identify areas where contaminant 
levels are high enough to warrant further investigation. More details 
can be found at: http://www.epa.gov/waterscience/fishstudy/results.htm.

    iii. National Water Quality Assessment (NAWQA) Program Aquatic 
Animal Tissue Data. This database, which also contains information on 
surface water and ground water monitoring studies, is described in Unit 
IV.C.2.viii. NAWQA has recently made aquatic organism tissue data 
available for a variety of species and tissues. EPA considered NAWQA 
tissue data for all species and tissue types for EDSP priority setting 
purposes.
    HPV/pesticide inert chemicals that were detected in monitoring 
samples from any of the ecological biomonitoring databases described in 
this section were considered for priority setting purposes for the 
ecological biomonitoring pathway.
    3. Drinking Water Data Exposure Pathway. Relevant data were 
extracted from the following data sources to determine the presence of 
HPV/pesticide inert chemicals in drinking water.
     National Contaminant Occurrence Database (NCOD).
     National Human Exposure Assessment Survey (NHEXAS) 
Drinking and Tap Water.
     TEAM Drinking Water Data.
     National Stream Quality Accounting Network (NASQAN) 
Surface Water and Sediment Data.
     National Water Quality Assessment (NAWQA) Ground Water, 
Surface Water, and Sediment Data.
    i. National Contaminant Occurrence Database (NCOD). This database 
is described in Unit IV.C.2.vi.
    ii. National Human Exposure Assessment Survey (NHEXAS) Drinking and 
Tap Water. EPA designed the NHEXAS program to evaluate comprehensive 
human exposure to multiple chemicals from multiple routes on both a 
community and regional scale, as well as its association with 
environmental concentrations and personal activities (Refs. 33-36, 45). 
Drinking water data and tap water from NHEXAS were used for priority 
setting purposes for this pathway.
    iii. TEAM Drinking Water Data. The TEAM study is described in Unit 
IV.D.1.iv.

[[Page 33494]]

    iv. National Stream Quality Accounting Network (NASQAN) Data. This 
database, which contains information on surface water monitoring 
studies, is described in Unit IV.C.2.vii.
    v. National Water Quality Assessment Program (NAWQA). This 
database, which contains information on surface water and ground water 
monitoring studies, is described in Unit IV.C.2.viii.
    HPV/pesticide inert chemicals that were detected in monitoring 
samples from any of the drinking water databases described in this 
section were considered for priority setting purposes for the drinking 
water exposure pathway.
    4. Indoor Air Exposure Pathway. Relevant data were extracted from 
the following data sources to determine the presence of HPV/pesticide 
inert chemicals in indoor air:
     EPA/Office of Research and Development (ORD) Journal 
Articles.
     NHEXAS - Indoor and Personal Air Data.
     TEAM Air Data.
    i. EPA/Office of Research and Development (ORD) Journal Articles. 
The following eight EPA/ORD-authored journal articles and reports 
provide indoor and personal air monitoring data: Brown et al. (1994), 
Daisey et al. (1994), Kelly et al. (1994), Immerman and Schaum (1990), 
Samfield (1992), Shah et al. (1988), Sheldon et al. (1992), and Shields 
et al. (1996) (Ref. 37-44). In implementing its approach for selecting 
the initial list of chemicals for screening, EPA excluded the Kelly et 
al. (1994) article, as this article only provides outdoor air data.
    ii. NHEXAS-Indoor and Personal Air Data. The NHEXAS program was 
designed to evaluate comprehensive human exposure via indoor and 
outdoor air to multiple chemicals on a community and regional scale. 
Samples were collected of both the indoor and outdoor air that people 
breathe. Preliminary results of Phase I of NHEXAS were reported in 15 
journal articles published in 1999. Four of these 15 journal articles 
provided information that is applicable to indoor air monitoring (Refs. 
33-36, 45). In implementing its approach for selecting the initial list 
of chemicals for screening, EPA considered both NHEXAS indoor and/or 
personal air samples for EDSP priority setting purposes.
    iii. TEAM Air Data. The TEAM study is described in Unit IV.D.1.iv. 
The ORD literature (see Unit IV.D.4.i.) includes all of the indoor air 
data collected in the TEAM study; therefore, EPA considered TEAM data 
in implementing its approach for selecting the initial list of 
chemicals along with the ORD data rather than as a separate source of 
information.
    HPV/pesticide inert chemicals that were detected in monitoring 
samples from any of the indoor air databases described in this section 
were considered for priority setting purposes for the indoor air 
exposure pathway.

E. Integration of Pathway Priorities for Pesticide Active Ingredients

    The Agency analyzed the data sources for each pathway to produce 
four candidate lists of chemicals for potential screening using the 
endocrine disruptor screening battery. A number of pesticide active 
ingredients were identified for more than one pathway, and some 
chemicals appeared only in a single pathway. Table 3 presents the 
number of unique pesticide active ingredients included on each list.

  Table 3.--Number of Pesticide Active Ingredients on Each Pathway List
------------------------------------------------------------------------
                                             Number of Unique Pesticide
             Exposure Pathway                    Active Ingredients
------------------------------------------------------------------------
Overall Pesticides Combined List                                  690\1\
------------------------------------------------------------------------
Food Pathway                                                          92
------------------------------------------------------------------------
Water Pathway                                                        130
------------------------------------------------------------------------
Residential Use Pathway                                           381\2\
------------------------------------------------------------------------
Occupational Exposure Pathway                                        564
------------------------------------------------------------------------
\1\One active ingredient was excluded because its registration was
  recently canceled; three active ingredients were excluded because they
  only have import tolerances (i.e., there are no domestic registrations
  for these active ingredients).
\2\Three hundred and eighty-one active ingredients were identified with
  residential uses based on the output of the LUIS report. These data
  were used to generate the list of active ingredients listed in Table
  5. EPA performed a quality assurance review of the 64 chemicals
  presented in Table 5 to verify residential use.

    Table 4 presents the number of pesticide active ingredients 
according to the number and types of pathways in which they were 
observed.

Table 4.--Number of Pesticide Active Ingredients According to the Number
                 of Pathways in which they were Observed
------------------------------------------------------------------------
                                             Number of Pesticide Active
         Number (Type) of Pathways                   Ingredients
------------------------------------------------------------------------
4 (Food, Water, Residential, Occupational)                            28
------------------------------------------------------------------------
3 (Food, Water, Occupational)                                         19
------------------------------------------------------------------------

[[Page 33495]]


3 (Food, Water, Residential)                                           0
------------------------------------------------------------------------
3 (Food, Residential, Occupational)                                   17
------------------------------------------------------------------------
3 (Water, Residential, Occupational)                                  33
------------------------------------------------------------------------
2 (Food, Water)                                                        1
------------------------------------------------------------------------
2 (Food, Residential)                                                  1
------------------------------------------------------------------------
2 (Food, Occupational)                                                22
------------------------------------------------------------------------
2 (Water, Residential)                                                 3
------------------------------------------------------------------------
2 (Water, Occupational)                                               40
------------------------------------------------------------------------
2 (Residential, Occupational)                                        175
------------------------------------------------------------------------
1 (Food)                                                               4
------------------------------------------------------------------------
1 (Water)                                                              6
------------------------------------------------------------------------
1 (Residential)                                                      111
------------------------------------------------------------------------
1 (Occupational)                                                     230
------------------------------------------------------------------------
Total                                                                690
------------------------------------------------------------------------

    Because there were a large number of chemicals from which to 
select, it was necessary to establish priorities within the pathways. 
EPA gave priority to those pesticide active ingredients that appeared 
in four exposure pathways, followed by those that appeared in three 
pathways. Further, for pesticide active ingredients appearing in three 
pathways, EPA gave priority to those where the food pathway was 
represented because of the potential for widespread exposure to the 
general population, followed by those where the occupational exposure 
pathway was represented due to the potential for workers to be highly 
exposed.
    Table 5 presents the draft initial list of 64 pesticide active 
ingredients to undergo screening in the Tier 1 assays under the EDSP, 
along with an indication of the pathways in which they appeared. 
Because this list of pesticide active ingredients was selected on the 
basis of exposure potential only, it should not be construed as a list 
of known or likely endocrine disruptors.

                                     Table 5.--Pesticide Active Ingredients
----------------------------------------------------------------------------------------------------------------
                                                   Total
          Chemical Name             CAS Number    Pathways       Food        Water     Residential  Occupational
----------------------------------------------------------------------------------------------------------------
     Chemicals in 4 Pathways

2,4-D                                    94757            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Atrazine                               1912249            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Benfluralin                            1861401            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Bifenthrin                            82657043            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Captan                                  133062            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Carbamothioic acid, dipropyl-, S-       759944            4            x            x            x             x
 ethyl ester
----------------------------------------------------------------------------------------------------------------
Carbaryl                                 63252            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Chlorothalonil                         1897456            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Chlorpyrifos                           2921882            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Dichlobenil                            1194656            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Disulfoton                              298044            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Fenvalerate                           51630581            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Glyphosate                             1071836            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Imidacloprid                         138261413            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Malathion                               121755            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------

[[Page 33496]]


Metalaxyl                             57837191            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Methiocarb                             2032657            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Metolachlor                           51218452            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Metribuzin                            21087649            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Myclobutanil                          88671890            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Norflurazon                           27314132            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Permethrin                            52645531            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Propiconazole                         60207901            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Propyzamide                           23950585            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Quintozene                               82688            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Simazine                                122349            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Triadimefon                           43121433            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------
Trifluralin                            1582098            4            x            x            x             x
----------------------------------------------------------------------------------------------------------------

     Chemicals in 3 Pathways


4,7-Methano-1H-isoindole-1,3(2H)-       113484            3            x                         x             x
 dione, 2-(2-ethylhexyl)-
 3a,4,7,7a-tetrahydro-
----------------------------------------------------------------------------------------------------------------
Abamectin                             71751412            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Acephate                              30560191            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Aldicarb                                116063            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Allethrin                               584792            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Azinphos-Methyl                          86500            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Carbofuran                             1563662            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Cyfluthrin                            68359375            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Cypermethrin                          52315078            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
DCPA (or chlorthal-dimethyl)           1861321            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Diazinon                                333415            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Dichlorvos                               62737            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Dicofol                                 115322            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Dimethoate                               60515            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Endosulfan                              115297            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Esfenvalerate                         66230044            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Ethoprop                              13194484            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Fenbutatin oxide                      13356086            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Flutolanil                            66332965            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Folpet                                  133073            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Gardona (cis-isomer)                  22248799            3            x                         x             x
----------------------------------------------------------------------------------------------------------------

[[Page 33497]]


Iprodione                             36734197            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Linuron                                 330552            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Methamidophos                         10265926            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Methidathion                            950378            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Methomyl                              16752775            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Methyl parathion                        298000            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
o-Phenylphenol                           90437            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Oxamyl                                23135220            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Phosmet                                 732116            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Piperonyl butoxide                       51036            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Propachlor                             1918167            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Propargite                             2312358            3            x            x                          x
----------------------------------------------------------------------------------------------------------------
Pyridine, 2-(1-methyl-2-(4-           95737681            3            x                         x             x
 phenoxyphenoxy) ethoxy)-
----------------------------------------------------------------------------------------------------------------
Resmethrin                            10453868            3            x                         x             x
----------------------------------------------------------------------------------------------------------------
Tebuconazole                         107534963            3            x                         x             x
    Total = 64 Pesticide Active
     Ingredients)................
----------------------------------------------------------------------------------------------------------------

F. Integration of Pathway Priorities for High Production Volume/
Pesticide Inerts

    The Agency analyzed the data sources for each HPV/pesticide inert 
exposure pathway to produce four candidate lists of chemicals for 
potential screening using the endocrine disruptor screening battery. A 
number of HPV/pesticide inerts were identified for more than one 
pathway, and some chemicals appeared only in a single pathway. Table 6 
presents the number of unique high production volume pesticide inerts 
included on each list.

   Table 6.--Number of High Production Volume Pesticide Inerts on Each
                              Pathway List
------------------------------------------------------------------------
                                             Number of Unique HPV/Inert
             Exposure Pathway                         Chemicals
------------------------------------------------------------------------
Overall Combined List                                                 62
------------------------------------------------------------------------
Human Biological Monitoring Exposure                                  14
 Pathway
------------------------------------------------------------------------
Ecological Biological Monitoring Exposure                             17
 Pathway
------------------------------------------------------------------------
Chemicals in Drinking Water Exposure                                  19
 Pathway
------------------------------------------------------------------------
Indoor Air Monitoring Exposure Pathway                                48
------------------------------------------------------------------------

    Table 7 presents the number of HPV/pesticide inert chemicals 
according to the number and types of pathways in which they were 
observed.

   Table 7.--Number of HPV/Pesticide Inert Chemicals According to the
             Number of Pathways in which they were Observed
------------------------------------------------------------------------
                                              Number of HPV/ Pesticide
         Number (Type) of Pathways                 Inert Chemicals
------------------------------------------------------------------------
4 (Human, Eco, Water, Air)                                             8
------------------------------------------------------------------------
3 (Human, Eco, Water)                                                  1
------------------------------------------------------------------------
3 (Human, Eco, Air)                                                    0
------------------------------------------------------------------------
3 (Human, Water, Air)                                                  0
------------------------------------------------------------------------
3 (Eco, Water, Air)                                                    3
------------------------------------------------------------------------
2 (Human, Eco)                                                         0
------------------------------------------------------------------------
2 (Human, Water)                                                       1
------------------------------------------------------------------------

[[Page 33498]]


2 (Human, Air)                                                         2
------------------------------------------------------------------------
2 (Eco, Water)                                                         0
------------------------------------------------------------------------
2 (Eco, Air)                                                           0
------------------------------------------------------------------------
2 (Water, Air)                                                         1
------------------------------------------------------------------------
1 (Human)                                                              2
------------------------------------------------------------------------
1 (Eco)                                                                5
------------------------------------------------------------------------
1 (Water)                                                              5
------------------------------------------------------------------------
1 (Air)                                                               34
------------------------------------------------------------------------

    Because there were a large number of chemicals from which to 
select, it was necessary to establish priorities within the pathways. 
In choosing which HPV/pesticide inert chemicals to propose for the 
initial screening list, EPA gave highest priority to chemicals that 
appeared in four exposure pathways, followed by chemicals that appeared 
in three pathways. For those chemicals that appeared in three pathways, 
EPA gave highest priority to those chemicals appearing in human 
biological monitoring exposure data.
    Table 8 presents the draft initial list of nine HPV/pesticide inert 
chemicals to undergo screening in the EDSP. Because this list of HPV/
pesticide inert chemicals was selected on the basis of exposure 
potential only, it should not be construed as a list of known or likely 
endocrine disruptors.

                                Table 8.--High Production Volume Pesticide Inerts
----------------------------------------------------------------------------------------------------------------
                                                    Total
           Chemical Name             CAS Number    Pathways      Human         Eco         Water         Air
----------------------------------------------------------------------------------------------------------------
      Chemicals in 4 Pathways

Acetone                                   67641            4            x            x            x            x
----------------------------------------------------------------------------------------------------------------
Butyl benzyl phthalate                    85687            4            x            x            x            x
----------------------------------------------------------------------------------------------------------------
Dibutyl phthalate                         84742            4            x            x            x            x
----------------------------------------------------------------------------------------------------------------
Diethyl phthalate                         84662            4            x            x            x            x
----------------------------------------------------------------------------------------------------------------
Dimethyl phthalate                       131113            4            x            x            x            x
----------------------------------------------------------------------------------------------------------------
Di-sec-octyl phthalate                   117817            4            x            x            x            x
----------------------------------------------------------------------------------------------------------------
Methyl ethyl ketone                       78933            4            x            x            x            x
----------------------------------------------------------------------------------------------------------------
Toluene                                  108883            4            x            x            x            x
----------------------------------------------------------------------------------------------------------------

      Chemical in 3 Pathways

Isophorone                                78591            3            x            x            x  ...........
----------------------------------------------------------------------------------------------------------------

G. Chemical Substances Deferred from Screening

    EPA previously indicated that the following types of chemical 
substances may be deferred from the initial list of chemicals to 
undergo screening:
     Certain FIFRA List 4 pesticide inerts (i.e., List 4 inerts 
are described as ``Inerts of minimal concern'').
     Most polymers with number average molecular weight greater 
than 1,000 daltons.
     Strong mineral acids and bases.
     Chemicals that are being used as a ``positive controls'' 
to validate the screening assays.
    EPA has examined the 73 chemicals identified by the selection 
process in light of the criteria for deferral. None of the chemicals 
selected for initial screening using the approach described in 
thisFederal Register notice were categorized as List 4 inerts, high 
molecular weight polymers, or strong mineral acids or bases. Several 
have been used as ``positive controls'' in the validation of individual 
assays by the EDSP. However, none of the chemicals identified as EDSP 
``positive controls'' on the draft chemical lists were used in a full 
battery of Tier 1 screening assays. As a result, none of the chemicals 
qualify as ``positive controls'' for Tier 1 screening, as a whole. Use 
of these chemicals in the validation of individual assays by the EDSP 
does not mean that these chemicals should be characterized as endocrine 
disruptors at this time. EPA intends to use the results of the battery 
of Tier 1 assays on this initial list to make a ``weight of the 
evidence'' determination about a chemical's potential to interact with 
the endocrine system. Excluding ``positive controls'' used in 
individual assays from the list of chemicals for initial Tier 1 
screening would mean that EPA would not have data for the remainder of 
the assays in the Tier 1 battery and would not be able to evaluate 
these chemicals' potential interaction with the endocrine system in the 
same manner as for all other chemicals, and would not be able to 
properly evaluate whether these chemicals should proceed to Tier 2 
testing. Thus, these chemicals were retained on the list of 73 
chemicals for initial screening.

H. Bypassing Tier 1 Screening

    As indicated in the September 2005 Federal Register notice, any 
company subject to a testing requirement under Tier 1 may assert 
(supported by appropriate data) during the comment period for the draft 
list that the chemical

[[Page 33499]]

is an endocrine disruptor and that the Tier 1 EDSP screening is 
unnecessary. EPA does not intend to permit chemicals on this list to 
bypass Tier 1 screening and move directly to Tier 2 testing without 
appropriate data to support such an action.

I. Integration of the Pesticide Active Ingredients and High Production 
Volume/Inerts Lists

    Table 9 presents an alphabetized draft list of the 73 pesticide 
active ingredients and HPV/pesticide inert chemicals for screening in 
the EDSP. Because this list of chemicals was selected on the basis of 
exposure potential only, it should neither be construed as a list of 
known or likely endocrine disruptors nor characterized as such.

                        Table 9.--Draft List of Chemicals for Tier 1 Screening in the EDSP
----------------------------------------------------------------------------------------------------------------
                                                                             Pesticide Active
                     Chemical Name                           CAS Number         Ingredient         HPV/Inert
----------------------------------------------------------------------------------------------------------------
2,4-D                                                                94757                  x  .................
----------------------------------------------------------------------------------------------------------------
4,7-Methano-1H-isoindole-1,3(2H)-dione, 2-(2-                       113484                  x  .................
 ethylhexyl)-3a,4,7,7a-tetrahydro-
----------------------------------------------------------------------------------------------------------------
Abamectin                                                         71751412                  x  .................
----------------------------------------------------------------------------------------------------------------
Acephate                                                          30560191                  x  .................
----------------------------------------------------------------------------------------------------------------
Acetone                                                              67641                                     x
----------------------------------------------------------------------------------------------------------------
Aldicarb                                                            116063                  x  .................
----------------------------------------------------------------------------------------------------------------
Allethrin                                                           584792                  x  .................
----------------------------------------------------------------------------------------------------------------
Atrazine                                                           1912249                  x  .................
----------------------------------------------------------------------------------------------------------------
Azinphos-Methyl                                                      86500                  x  .................
----------------------------------------------------------------------------------------------------------------
Benfluralin                                                        1861401                  x  .................
----------------------------------------------------------------------------------------------------------------
Bifenthrin                                                        82657043                  x  .................
----------------------------------------------------------------------------------------------------------------
Butyl benzyl phthalate                                               85687                                     x
----------------------------------------------------------------------------------------------------------------
Captan                                                              133062                  x  .................
----------------------------------------------------------------------------------------------------------------
Carbamothioic acid, dipropyl-, S-ethyl ester                        759944                  x  .................
----------------------------------------------------------------------------------------------------------------
Carbaryl                                                             63252                  x  .................
----------------------------------------------------------------------------------------------------------------
Carbofuran                                                         1563662                  x  .................
----------------------------------------------------------------------------------------------------------------
Chlorothalonil                                                     1897456                  x  .................
----------------------------------------------------------------------------------------------------------------
Chlorpyrifos                                                       2921882                  x  .................
----------------------------------------------------------------------------------------------------------------
Cyfluthrin                                                        68359375                  x  .................
----------------------------------------------------------------------------------------------------------------
Cypermethrin                                                      52315078                  x  .................
----------------------------------------------------------------------------------------------------------------
DCPA (or chlorthal-dimethyl)                                       1861321                  x  .................
----------------------------------------------------------------------------------------------------------------
Diazinon                                                            333415                  x  .................
----------------------------------------------------------------------------------------------------------------
Dibutyl phthalate                                                    84742                                     x
----------------------------------------------------------------------------------------------------------------
Dichlobenil                                                        1194656                  x  .................
----------------------------------------------------------------------------------------------------------------
Dichlorvos                                                           62737                  x  .................
----------------------------------------------------------------------------------------------------------------
Dicofol                                                             115322                  x  .................
----------------------------------------------------------------------------------------------------------------
Diethyl phthalate                                                    84662                                     x
----------------------------------------------------------------------------------------------------------------
Dimethoate                                                           60515                  x  .................
----------------------------------------------------------------------------------------------------------------
Dimethyl phthalate                                                  131113                                     x
----------------------------------------------------------------------------------------------------------------
Di-sec-octyl phthalate                                              117817                                     x
----------------------------------------------------------------------------------------------------------------
Disulfoton                                                          298044                  x  .................
----------------------------------------------------------------------------------------------------------------

[[Page 33500]]


Endosulfan                                                          115297                  x  .................
----------------------------------------------------------------------------------------------------------------
Esfenvalerate                                                     66230044                  x  .................
----------------------------------------------------------------------------------------------------------------
Ethoprop                                                          13194484                  x  .................
----------------------------------------------------------------------------------------------------------------
Fenbutatin oxide                                                  13356086                  x  .................
----------------------------------------------------------------------------------------------------------------
Fenvalerate                                                       51630581                  x  .................
----------------------------------------------------------------------------------------------------------------
Flutolanil                                                        66332965                  x  .................
----------------------------------------------------------------------------------------------------------------
Folpet                                                              133073                  x  .................
----------------------------------------------------------------------------------------------------------------
Gardona (cis-isomer)                                              22248799                  x  .................
----------------------------------------------------------------------------------------------------------------
Glyphosate                                                         1071836                  x  .................
----------------------------------------------------------------------------------------------------------------
Imidacloprid                                                     138261413                  x  .................
----------------------------------------------------------------------------------------------------------------
Iprodione                                                         36734197                  x  .................
----------------------------------------------------------------------------------------------------------------
Isophorone                                                           78591                                     x
----------------------------------------------------------------------------------------------------------------
Linuron                                                             330552                  x  .................
----------------------------------------------------------------------------------------------------------------
Malathion                                                           121755                  x  .................
----------------------------------------------------------------------------------------------------------------
Metalaxyl                                                         57837191                  x  .................
----------------------------------------------------------------------------------------------------------------
Methamidophos                                                     10265926                  x  .................
----------------------------------------------------------------------------------------------------------------
Methidathion                                                        950378                  x  .................
----------------------------------------------------------------------------------------------------------------
Methiocarb                                                         2032657                  x  .................
----------------------------------------------------------------------------------------------------------------
Methomyl                                                          16752775                  x  .................
----------------------------------------------------------------------------------------------------------------
Methyl ethyl ketone                                                  78933                                     x
----------------------------------------------------------------------------------------------------------------
Methyl parathion                                                    298000                  x  .................
----------------------------------------------------------------------------------------------------------------
Metolachlor                                                       51218452                  x  .................
----------------------------------------------------------------------------------------------------------------
Metribuzin                                                        21087649                  x  .................
----------------------------------------------------------------------------------------------------------------
Myclobutanil                                                      88671890                  x  .................
----------------------------------------------------------------------------------------------------------------
Norflurazon                                                       27314132                  x  .................
----------------------------------------------------------------------------------------------------------------
o-Phenylphenol                                                       90437                  x  .................
----------------------------------------------------------------------------------------------------------------
Oxamyl                                                            23135220                  x  .................
----------------------------------------------------------------------------------------------------------------
Permethrin                                                        52645531                  x  .................
----------------------------------------------------------------------------------------------------------------
Phosmet                                                             732116                  x  .................
----------------------------------------------------------------------------------------------------------------
Piperonyl butoxide                                                   51036                  x  .................
----------------------------------------------------------------------------------------------------------------
Propachlor                                                         1918167                  x  .................
----------------------------------------------------------------------------------------------------------------
Propargite                                                         2312358                  x  .................
----------------------------------------------------------------------------------------------------------------
Propiconazole                                                     60207901                  x  .................
----------------------------------------------------------------------------------------------------------------
Propyzamide                                                       23950585                  x  .................
----------------------------------------------------------------------------------------------------------------
Pyridine, 2-(1-methyl-2-(4-phenoxyphenoxy)ethoxy)-                95737681                  x  .................
----------------------------------------------------------------------------------------------------------------
Quintozene                                                           82688                  x  .................
----------------------------------------------------------------------------------------------------------------

[[Page 33501]]


Resmethrin                                                        10453868                  x  .................
----------------------------------------------------------------------------------------------------------------
Simazine                                                            122349                  x  .................
----------------------------------------------------------------------------------------------------------------
Tebuconazole                                                     107534963                  x  .................
----------------------------------------------------------------------------------------------------------------
Toluene                                                             108883                                     x
----------------------------------------------------------------------------------------------------------------
Triadimefon                                                       43121433                  x  .................
----------------------------------------------------------------------------------------------------------------
Trifluralin                                                        1582098                  x  .................
----------------------------------------------------------------------------------------------------------------

V. Other Related Future Actions

    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; implementation considerations flowing from a 
decision 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 (HTPS) or 
Quantitative Structure Activity Relationship (QSAR) models).
    As discussed in Unit III., EPA also expects to address other 
aspects of the EDSP such as the information collection request, the 
administrative procedures EPA will use to require testing, the 
validated tests and battery that will be included in the EDSP, and the 
timeframe for requiring the testing and receiving the data in 
subsequent notices published in the Federal Register.
    The Agency intends to conduct a review of the data received from 
Tier 1 screening both to evaluate individual chemicals and to evaluate 
whether the EDSP could be improved or optimized, and if so, how. In 
addition to its own scientists, the Agency will ask an independent 
expert panel, such as one under the Scientific Advisory Panel (SAP)/
Scientific Advisory Board (SAB) to review the results from the Tier 1 
screening of the initial group of chemicals. The review may identify 
methodological issues encountered when this larger set of chemicals are 
tested by laboratories not involved in the assay validation effort that 
may lead to further refinements in the protocols for the Tier 1 assays 
to improve their performance for a wider range of chemicals. The 
evaluation may also identify interpretive issues, such as a 
determination that two assays in the screening battery adequately 
measures the same effect. Other information from the review process may 
help identify potential issues or areas for improvement, such as 
whether there is sufficient laboratory capacity or difficulties 
performing tests in strict adherence with the validated protocols, 
whether there are issues with the industry's ability to test the 
identified chemicals, or whether there are any procedural changes that 
would improve the overall program.

VI. References

    The following is a list of the documents that are specifically 
referenced in this document. These references are available in the 
docket as identified under ADDRESSES, which is the same docket that was 
used for the final chemical selection approach described in the 
September 2005Federal Register notice. In addition, some documents 
referenced are only available in docket ID number EPA-HQ-OPPT-2002-
0066, which is the docket used for the proposed chemical selection 
approach described in the Federal Register notice of December 30, 2002 
(67 FR 79611) (FRL-7286-6). These dockets are cross referenced, but to 
simplify identifying the specific documents that can be found only in 
docket ID number OPPT-2002-0066, those references include the 
appropriate document ID number.
    1. U.S. EPA. Endocrine Disruptor Screening and Testing Advisory 
Committee Final Report. August 1998. Available at: http://www.epa.gov/scipoly/oscpendo/edspoverview/finalrpt.htm.
 (Ref. 2, Docket ID number 

OPPT-2002-0066)
    2. U.S. EPA. Registration Review Draft Schedule. (Docket ID number 
EPA-HQ-OPPT-2004-0109-0010). August 2005.
    3. U.S. EPA. Non-confidential List of 2002 Toxic Substances Control 
Act (TSCA) Inventory Update Rule (IUR) Chemicals. http://www.epa.gov/oppt/iur/tools/data/2002-vol.htm.
 2002.

    4. U.S. EPA. Inert (other) Pesticide Ingredients in Pesticide 
Products - Categorized List of Inert (other) Pesticide Ingredients. 
http://www.epa.gov/opprd001/inerts/lists.html.

    5. ERG. High Production Volume Pesticide Inert Overlap Chemicals. 
EPA Contract EP-W-05-014, Work Assignment 1-09. Eastern Research Group, 
Inc. April 2007. (Docket ID number EPA-HQ-OPPT-2004-0109-0011)
    6. U.S. EPA. Data Manipulation Summary for Pesticide Active 
Ingredients. EPA Contract EP-W-05-014, Work Assignment 3-03. Eastern 
Research Group, Inc. May 2007. (Docket ID number EPA-HQ-OPPT-2004-0109-
0012)
    7. U.S. EPA. Data Manipulation Summary for High Production Volume 
Pesticide Inerts. EPA Contract EP-W-05-014, Work Assignment 3-03. 
Eastern Research Group, Inc. May 2007. (Docket ID number EPA-HQ-OPPT-
2004-0109-0013)
    8. U.S. EPA. Compilation of Data Source Summaries Prepared for High 
Production Volume (HPV) and Pesticide Inert Chemicals and Pesticide 
Active Ingredients Data Sources. EPA Contract 68-W-02-024, Task Order 
69. Eastern Research Group, Inc. June 2005. (Docket ID number 
EPA-HQ-OPPT-2004-0109-0005)
    9. U.S. Department of Agriculture. Food Commodity Intake Database 
(FCID). July 2000. Available at: http://www.ars.usda.gov/Services/docs.htm?docid=14514
.

    10. U.S. EPA. EPA Pesticides in Ground Water Database, A 
Compilation of Monitoring Studies: 1971-1991 National Summary, EPA 734-
12-92-001. September 1992. (Ref. 4, Docket ID number EPA-HQ-OPPT-2002-
0066)
    11. U.S. Geological Survey. Pesticides in Select Water Supply 
Reservoirs and Finished Drinking Water, 1999-2000:

[[Page 33502]]

Summary of Results from a Pilot Monitoring Program. 2001. USGS Open 
File Report 01-456. (Ref. 5, Docket ID number EPA-HQ-OPPT-2002-0066)
    12. Ashley, David L.; Bonin, Michael A.; Cardinall, Frederick L.; 
McCraw, Joan M.; and Wootan, Joe V. Blood Concentrations of Volatile 
Organic Compounds (VOCs) in a Nonoccupationally Exposed U.S. Population 
and in Groups with Suspected Exposure. Clinical Chemistry (1994) 40: 
1401-1404. (Ref. 10, Docket ID number EPA-HQ-OPPT-2002-0066)
    13. U.S. Centers for Disease Control and Prevention. National 
Report on Human Exposure to Environmental Chemicals. March 2001. (Ref. 
11, Docket ID number EPA-HQ-OPPT-2002-0066)
    14. U.S. Department of Health and Human Services Centers for 
Disease Control and Prevention. Second National Report on Human 
Exposure to Environmental Chemicals. January 2003. (Docket ID number 
EPA-HQ-OPPT-2004-0109-0007)
     15. U.S. Department of Health and Human Services Centers for 
Disease Control and Prevention. Third National Report on Human Exposure 
to Environmental Chemicals. July 2005 http://www.cdc.gov/exposurereport/pdf/thirdreport.pdf.
 (Docket ID number EPA-HQ-OPPT-2004-

0109-0014)
    16. U.S. EPA. Chlorinated Dioxins and Furans in the General U.S. 
Population: NHATS FY87 Results - Executive Summary. EPA-560/5-91-003. 
May 1991. (Ref. 12, Docket ID number EPA-HQ-OPPT-2002-0066)
    17. Cramer, Paul H.; Stanley, John S.; Bauer, Karin; Ayling, Randy 
E.; Thornburg, Kelly R.; and Schwemberger, John. Brominated Dioxins and 
Furans in Human Adipose Tissue: Final Report. EPA-560/5-90-005 (NTIS 
PB91-103507). April 11, 1990. (Ref. 13, Docket ID number EPA-HQ-OPPT-
2002-0066)
    18. Cramer, Paul H.; Stanley, John S.; and Thornburg, Kelly R. Mass 
Spectral Confirmation of Chlorinated and Brominated Diphenylethers in 
Human Adipose Tissues: Final Report. EPA-560/5-90-012 (NTIS PB91-
159699). June 15, 1990. (Ref. 14, Docket ID number EPA-HQ-OPPT-2002-
0066)
    19. Mack, Gregory A. and Mohadjer, Leyla. Baseline Estimates and 
Time Trends for Beta-benzene hexachloride, Hexachlorobenzene, and 
Polychlorinated Biphenyls in Human Adipose Tissue 1970-1983. EPA-560/5-
85-025. September 30, 1985. (Ref. 15, Docket ID number EPA-HQ-OPPT-
2002-0066)
    20. Onstot, J.D.; Ayling, R.E.; and Stanley, J.S. Characterization 
of HRGC/MS Unidentified Peaks from the Analysis of Human Adipose 
Tissue: Volume I - Technical Approach. EPA-560/5-87-002A (NTIS PB88-
100367). May 1987. (Ref. 16, Docket ID number EPA-HQ-OPPT-2002-0066)
    21. Onstot, J.D.; Ayling, R.E.; and Stanley, J.S. Characterization 
of HRGC/MS Unidentified Peaks from the Analysis of Human Adipose 
Tissue: Volume II - Appendices. EPA-560/5-87-002B (NTIS PB88-100375). 
May 1987. (Ref. 17, Docket ID number EPA-HQ-OPPT-2002-0066)
    22. Onstot, J.D. and Stanley, J.S. Identification of SARA Compounds 
in Adipose Tissue. EPA-260/5-89-003 (NTIS PB90-132564). August 1989. 
(Ref. 18, Docket ID number EPA-HQ-OPPT-2002-0066)
    23. Orban, John E.; Stanley, John S.; Schwemberger, John G.; and 
Remmers, Janet C. Dioxins and Dibenzofurans in Adipose Tissue of the 
General U.S. Population and Selected Subpopulations. American Journal 
of Public Health. (1994) 84: 439-445. (Ref. 19, Docket ID number EPA-
HQ-OPPT-2002-0066)
    24. U.S. EPA. Semivolatile Organic Compounds in the General U.S. 
Population: NHATS FY86 Results - Volume I. EPA-747-R-94-001. July 1994. 
(Ref. 20, Docket ID number EPA-HQ-OPPT-2002-0066)
    25. Stanley, John S. Broad Scan Analysis of the FY82 National Human 
Adipose Tissue Survey Specimens: Volume I - Executive Summary. EPA-560/
5-86-035 (NTIS PB87-177218). December 1986. (Ref. 21, Docket ID number 
EPA-HQ-OPPT-2002-0066)
    26. Stanley, John S. Broad Scan Analysis of the FY82 National Human 
Adipose Tissue Survey Specimens: Volume II - Volatile Organic 
Compounds. EPA-560/5-86-036 (NTIS PB87-177226). December 1986. (Ref. 
22, Docket ID number EPA-HQ-OPPT-2002-0066)
    27. Stanley, John S. Broad Scan Analysis of Human Adipose Tissue: 
Volume III - Semivolatile Organic Compounds: Final Report. EPA-560/5-
86-037 (NTIS PB87-180519). December 1986. (Ref. 23, Docket ID number 
EPA-HQ-OPPT-2002-0066)
    28. Stanley, John S. Broad Scan Analysis of Human Adipose Tissue: 
Volume IV - Polychlorinated Dibenzo-p-Dioxins (PCDDs) and 
Polychlorinated Dibenzofurans (PCDFs): Final Report. EPA-560/5-86-038 
(NTIS PB87-177234). December 1986. (Ref. 24, Docket ID number EPA-HQ-
OPPT-2002-0066)
    29. Stanley, John S. and Stockton, Rodney A. Broad Scan Analysis of 
the FY82 National Human Adipose Tissue Survey Specimens: Volume V - 
Trace Elements. EPA-560/5-86-039 (NTIS PB87-180527). December 1986. 
(Ref. 25, Docket ID number EPA-HQ-OPPT-2002-0066)
    30. U.S. EPA. The Total Exposure Assessment Methodology (TEAM) 
Study: Elizabeth and Bayonne, New Jersey, Devils Lake, North Dakota, 
and Greensboro, North Carolina: Volume II. Part 2. EPA-600/6-87/002b 
(NTIS PB88-100078). June 1987. (Ref. 26, Docket ID number EPA-HQ-OPPT-
2002-0066)
    31. U.S. EPA. The Total Exposure Assessment Methodology (TEAM) 
Study: Selected Communities in Northern and Southern California: Volume 
III. EPA-600/6-87/002c (NTIS PB88-100086). June 1987. (Ref. 27, Docket 
ID number EPA-HQ-OPPT-2002-0066)
    32. Wallace, Lance. Project Summary: The Total Exposure Assessment 
Methodology (TEAM) Study. EPA/600/S6-87/002. September 1987. (Ref. 28, 
Docket ID number EPA-HQ-OPPT-2002-0066)
    33. Thomas, Kent W.; Pelizzari, Edo D.; and Berry, Maurice R. 
Population-based dietary intakes and tap water concentrations for 
selected elements in EPA Region V National Human Exposure Assessment 
Survey (NHEXAS). Journal of Exposure Analysis and Environmental 
Epidemiology. (1999) 9: 402-413. (Ref. 29, Docket ID number EPA-HQ-
OPPT-2002-0066)
    34. Clayton, C.A.; Pelizzari, E.D.; Whitmore, R.W.; Perritt, R.L.; 
and J.J. Quackenboss. National Human Exposure Assessment Survey 
(NHEXAS): distributions and associations of lead, arsenic and volatile 
organic compounds in EPA Region 5. Journal of Exposure and 
Environmental Epidemiology. (1999) 9: 381-392. (Ref. 30, Docket ID 
number EPA-HQ-OPPT-2002-0066)
    35. O'Rourke, Mary Kay; Van de Water, Peter K.; Jin, Shan; Rogan, 
Seumas P.; Weiss, Aaron D.; Gordon, Sydney M.; Moschandreas, Demetrios 
M.; and Lebowitz, Michael D. Evaluations of primary metals from NHEXAS 
Arizona: distributions and preliminary exposures. Journal of Exposure 
Analysis and Environmental Epidemiology. (1999) 9: 435-445. (Ref. 31, 
Docket ID number EPA-HQ-OPPT-2002-0066)
    36. Robertson, Gary L.; Lebowitz, Michael D.; O'Rourke, Mary Kay; 
Gordon, Sydney; and Moschandreas, Demetrios. The National Human 
Exposure Assessment Survey (NHEXAS) study in Arizona - introduction and 
preliminary results. Journal of Exposure Analysis and Environmental 
Epidemiology. (1999) 9: 427-434. (Ref.

[[Page 33503]]

32, Docket ID number EPA-HQ-OPPT-2002-0066)
    37. Brown, S.K.; Sim, M.R.; Abramson, M.J.; and Gray, C.N. 
Concentrations of Volatile Organic Compounds in Indoor Air - A Review. 
Indoor Air. (1994) 4: 123-124. (Ref. 33, Docket ID number EPA-HQ-OPPT-
2002-0066)
    38. Daisey, J.M.; Hodgson, A.T.; Fisk, W.J.; Mendell, M.J.; and 
Brinke, J. Ten. Volatile Organic Compounds In Twelve California Office 
Buildings: Classes, Concentrations and Sources. Atmospheric 
Environment. (1994) 28: 3557-3562. (Ref. 34, Docket ID number EPA-HQ-
OPPT-2002-0066)
    39. Kelly, Thomas J.; Mukund, R.; Spicer, Chester W.; and Pollack, 
Albert J. Concentrations and Transformations of Hazardous Air 
Pollutants. Environ. Sci. Technol. (1994) 28: 378A-387A. (Ref. 35, 
Docket ID number EPA-HQ-OPPT-2002-0066)
    40. Immerman, Frederick W. and Schaum, John L. Final Report of the 
Nonoccupational Pesticide Exposure Study (NOPES). EPA/600/3-90/003 
(NTIS PB90-152224). January 1990. (Ref. 36, Docket ID number EPA-HQ-
OPPT-2002-0066)
    41. Samfield, Max M. Indoor Air Quality Data Base for Organic 
Compounds. EPA-600-R-92-025 (NTIS PB92-158468). February 1992. (Ref. 
37, Docket ID number EPA-HQ-OPPT-2002-0066)
    42. Shah, Jitendra J. and Singh, Hanwant B. Distribution of 
Volatile Organic Chemicals in Outdoor and Indoor Air. A National VOCs 
Data Base. Environ. Sci. Technol. (1988) 22: 1381-1388. (Ref. 38, 
Docket ID number EPA-HQ-OPPT-2002-0066)
    43. Sheldon, L.; Clayton, A.; Jones, B.; Keever, J.; Perritt, R.; 
Smith, D.; Whitaker, D.; and Whitmore, R. Indoor Pollutant 
Concentrations and Exposures: Final Report. California Air Resources 
Board, Contract A833-156. January 1992. (Ref. 39, Docket ID number EPA-
HQ-OPPT-2002-0066)
    44. Shields, Helen C.; Fleischer, Daniel M.; and Weschler, Charles 
J. Comparisons among VOCs Measured in Three Types of U.S. Commercial 
Buildings with Different Occupant Densities. Indoor Air. (1996) 6: 2-
17. (Ref. 40, Docket ID number EPA-HQ-OPPT-2002-0066)
    45. Gordon, Sydney M.; Callahan, Patrick J.; Nishioka, Marcia G.; 
Brinkman, Marielle C.; O'Rourke, Mary Kay; Lebowitz, Michael D.; and 
Moschandreas, Demetrios J. Residential Environmental Measurements in 
the National Human Exposure Assessment Survey (NHEXAS) Pilot Study in 
Arizona: Preliminary Results for Pesticides and VOCs. Journal of 
Exposure Analysis and Environmental Epidemiology. (1999) 9: 546-470. 
(Ref. 41, Docket ID number EPA-HQ-OPPT-2002-0066)

List of Subjects

    Environmental protection, Chemicals, Endocrine disruptors, 
Pesticides.


    Dated: May 24, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.

[FR Doc. E7-11711 Filed 6-15-07; 8:45 am]

BILLING CODE 6560-50-S
