FR Doc E7-11711

[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