Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 56449 

docket and is made available in EPA’s 

E-Docket. 

You may submit public comments on 

a disk or CD ROM mailed to the OEI 

Docket mailing address. Files will be 

accepted in WordPerfect, Word, or PDF 

file format. Avoid the use of special 

characters and any form of encryption. 

If you provide public comments in 

writing, please submit one unbound 

original, with pages numbered 

consecutively, and three copies. For 

attachments, provide an index, number 

pages consecutively with the main text, 

and submit an unbound original and 

three copies. 

Dated: September 21, 2005. 

Peter W. Preuss, 

Director, National Center for Environmental 

Assessment. 

[FR Doc. 05–19253 Filed 9–26–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–7975–5] 

Proposed CERCLA Administrative 

Cost Recovery Settlement; Town of 

Tilton and Tilton/Northfield Fire 

Department, Old Pillsbury Mill 

Superfund Site, Tilton, NH 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of proposed settlement; 

request for public comment. 

SUMMARY: In accordance with section 

122(i) of the Comprehensive 

Environmental Response, 

Compensation, and Liability Act, as 

amended (‘‘CERCLA’’), 42 U.S.C. 

9622(i), notice is hereby given of a 

proposed administrative settlement for 

recovery of past costs concerning the 

Old Pillsbury Mill Superfund Site in 

Tilton, New Hampshire with the 

following settling parties: Town of 

Tilton and the Tilton/Northfield Fire 

Department. The settlement requires the 

settling parties to pay $378,706.00 to the 

Hazardous Substance Superfund. The 

settlement includes a covenant not to 

sue the settling parties pursuant to 

section 107(a) of CERCLA, 42 U.S.C. 

9606 and 9607(a). For thirty (30) days 

following the date of publication of this 

notice, the Agency will receive written 

comments relating to the settlement. 

The Agency will consider all comments 

received and may modify or withdraw 

its consent to the settlement if 

comments received disclose facts or 

considerations which indicate that the 

settlement is inappropriate, improper, 

or inadequate. 

The Agency’s response to any 

comments received will be available for 

public inspection at One Congress 

Street, Boston, MA 02214–2023 

(Telephone No. 617–918–1440). 

DATES: Comments must be submitted on 

or before October 27, 2005. 

ADDRESSES: Comments should be 

addressed to Audrey Zucker, 

Enforcement Counsel, U.S. 

Environmental Protection Agency, 

Region I, One Congress Street, Suite 

1100 (SES), Boston, Massachusetts 

02114–2023 (Telephone No. 617–918–

1778) and should refer to: In re: Old 

Pillsbury Mill Superfund Site, U.S. EPA 

Docket No. 01–2005–0016. 

FOR FURTHER INFORMATION CONTACT: A 

copy of the proposed settlement may be 

obtained from Audrey Zucker, U.S. 

Environmental Protection Agency, 

Region I, Office of Environmental 

Stewardship, One Congress Street, Suite 

1100 (SES), Boston, MA 02114–2023 

(Telephone No. 617–918–1778; E-mail 

zucker.audrey@epa.gov). 

Dated: September 12, 2005. 

Susan Studlien, 

Director, Office of Site Remediation & 

Restoration, Region 1. 

[FR Doc. 05–19262 Filed 9–26–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPPT–2004–0109 FRL–7716–9] 

Endocrine Disruptor Screening 

Program; Chemical Selection 

Approach for Initial Round of 

Screening 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice describes the 

approach EPA plans to use for selecting 

the first group of chemicals to be 

screened in the Agency’s Endocrine 

Disruptor Screening Program (EDSP). 

The Food Quality Protection Act of 1996 

(FQPA) amended the Federal Food, 

Drug, and Cosmetic Act (FFDCA) to 

direct 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 December 

2002, EPA sought comment on its 

approach for selecting the initial list of 

chemicals for which testing will be 

required under the EDSP. Following 

review and revision based on the public 

comments, EPA is now describing the 

approach that it intends to use for 

selecting the chemicals for the initial 

list. For this initial approach, as 

recommended by scientific advisory 

committees, EPA will select 50 to 100 

chemicals. The chemicals will be 

selected based on their relatively high 

potential for human exposure rather 

than using a combination of exposureand effects-related factors. The scope of 

this first group of chemicals to be tested 

includes pesticide active ingredients 

and High Production Volume (HPV) 

chemicals used as pesticide inerts. This 

will allow EPA to focus its initial 

screening efforts on a smaller and more 

manageable universe of chemicals that 

emphasizes the early attention to the 

pesticide chemicals that Congress 

specifically mandated EPA to test for 

possible endocrine effects. This notice 

does not identify the initial list of 

chemicals, nor does it 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. The initial 

chemical list and the details of the EDSP 

process that will apply to the initial 

chemical list will be addressed in 

subsequent notices published in the 

Federal Register. 

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Colby 

Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 554–1404; e-mail address: 

TSCA-Hotline@epa.gov. 

For technical information contact: 

Mary Belefski, Office of Science 

Coordination and Policy (7201M), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(202) 564–8461; e-mail address: 

belefski.mary@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

This action is directed to the public 

in general. This action may, however, be 

of interest if you produce, manufacture, 

use, consume, work with, or import 

pesticide chemicals, substances that 

may have an effect cumulative to an 

effect of a pesticide, or substances found 

in sources of drinking water. 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), and the 

Safe Drinking Water Act (SDWA), 42 

56450 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 

U.S.C. 300j–17. Since other entities may 

also be interested, the Agency has not 

attempted to describe all the specific 

entities that may be affected by this 

action. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

B. How Can I Get Copies of this 

Document and Other Related 

Information? 

1. Docket. EPA has established an 

official public docket for this action 

under docket identification (ID) number 

OPPT–2004–0109. The official public 

docket consists of the documents 

specifically referenced in this action, 

including EPA’s response to comments 

received and other information related 

to this action. In addition, documents 

are also in docket ID number OPPT–

2002–0066 for the proposed approach. 

Although a part of the official docket, 

the public docket does not include 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. The official public 

docket is the collection of materials that 

is available for public viewing at the 

EPA Docket Center, Rm. B102-Reading 

Room, EPA West, 1301 Constitution 

Ave., NW., Washington, DC. The EPA 

Docket Center is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The EPA 

Docket Center Reading Room telephone 

number is (202) 566–1744 and the 

telephone number for the OPPT Docket, 

which is located in EPA Docket Center, 

is (202) 566–0280. 

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. 

An electronic version of the public 

docket is available through EPA’s 

electronic public docket and comment 

system, EPA Dockets. You may use EPA 

Dockets at http://www.epa.gov/edocket/ 

to view public comments, to access the 

index listing of the contents of the 

official public docket, and to access 

those documents in the public docket 

that are available electronically. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B.1. Once in 

the system, select ‘‘search,’’ then key in 

the appropriate docket ID number. 

Certain types of information will not 

be placed in the EPA Dockets. 

Information claimed as CBI and other 

information whose disclosure is 

restricted by statute, which is not 

included in the official public docket, 

will not be available for public viewing 

in EPA’s electronic public docket. EPA’s 

policy is that copyrighted material will 

not be placed in EPA’s electronic public 

docket but will be available only in 

printed, paper form in the official public 

docket. To the extent feasible, publicly 

available docket materials will be made 

available in EPA’s electronic public 

docket. When a document is selected 

from the index list in EPA Dockets, the 

system will identify whether the 

document is available for viewing in 

EPA’s electronic public docket. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B.1. EPA 

intends to work towards providing 

electronic access to all of the publicly 

available docket materials through 

EPA’s electronic public docket. 

II. Introduction 

A. What Action is the Agency Taking? 

Following review of public comments 

received in response to the Federal 

Register notice of December 30, 2002 

(67 FR 79611) (FRL–7286–6), EPA is 

describing the approach it plans to use 

for selecting an initial group of 

chemicals to be screened in the 

Agency’s EDSP. This notice does not 

identify the initial list of chemicals, nor 

does it 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. The initial chemical 

list and the details of the EDSP process 

that will apply to the initial chemical 

list will be addressed in subsequent 

notices published in the Federal 

Register. 

EPA anticipates that it may modify its 

chemical selection approach for 

subsequent screening based on 

experience gained from the results of 

testing chemicals on the initial list, its 

needs to extend screening to additional 

categories of chemicals (e.g., nonpesticide substances) and additional 

pathways of exposure, 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 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 notice is to 

describe the approach that EPA plans to 

use to select this initial set of chemicals 

to undergo screening. EPA will use an 

approach based in part on the 

compartment-based priority-setting 

approach described in the Federal 

Register notices of December 28, 1998 

(63 FR 71542) (FRL–6052–9) and 

December 30, 2002. This approach 

focuses on human exposure-related 

factors rather than using a combination 

of exposure- and effects-related factors. 

However, in making selections for this 

exposure-based initial list, EPA does not 

plan to select substances it considers to 

be a low priority for early screening 

under the EDSP because they are 

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). Also, chemicals that are 

being used by EPA as ‘‘positive 

controls’’ to validate the screening 

assays will be excluded from its initial 

list. 

Although EPA’s general focus in this 

approach for the initial list is on 

pesticide active ingredients and inerts 

with relatively greater potential human 

exposure, EPA believes that the 

approach will also identify chemicals 

with high potential for exposure of 

humans from non-pesticide uses or 

chemicals with widespread 

environmental exposures to other 

organisms. EPA does not intend to 

develop an ordinal ranking of priorities 

of the chemicals within any list 

developed using this approach. 

The Agency will use the approach set 

forth in this notice to select the initial 

list of chemicals to test first under the 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 56451 

EDSP based primarily on exposure data. 

Therefore, this initial list of chemicals 

should not be construed as a list of 

known or likely endocrine disruptors 

nor characterized as such. Nothing in 

the approach for selecting the initial list 

would provide a basis to infer that any 

of the chemicals selected for the list 

interferes with or is suspected to 

interfere with the endocrine systems of 

humans or other species. 

In subsequent notices published in 

the Federal Register, EPA intends to 

issue the draft initial list of chemicals 

resulting from the implementation of 

this approach, and to describe the other 

aspects of the EDSP, including the 

procedures it will use to require the 

testing and the timeframe for the initial 

screening. EPA intends to provide time 

for review and comment on the draft 

initial list prior to the Agency’s 

imposition of actual screening of the 

initial chemicals. 

B. What is the Agency’s Authority for 

Taking this Action? 

Section 408(p) of FFDCA requires 

EPA ‘‘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 effect as [EPA] may 

designate.’’ (FFDCA 21 U.S.C. 346a(p)). 

The statute generally requires EPA to 

‘‘provide for the testing of all pesticide 

chemicals.’’ (FFDCA 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.’’ (FFDCA 

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.’’

(FFDCA section 201(q)(1) (21 U.S.C. 

231(q)(1))). 

III. Background 

A. EPA’s Endocrine Disruptor Screening 

Program (EDSP) 

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. 

EPA charged EDSTAC to advise the 

Agency regarding: 

1. Methods for chemical selection and 

setting priorities for screening. 

2. A set of available, validated 

screening assays for early application. 

3. Ways to identify new and existing 

screening assays and mechanisms for 

their validation. 

4. Processes and criteria for deciding 

when additional tests beyond screening 

would be needed and how to validate 

such tests. 

5. Processes for communicating to the 

public about EDSTAC’s agreements, 

recommendations, and information 

developed during priority setting, 

screening, and testing. 

In response to this charge, 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 

tiered approach for their program 

(referred to as the EDSP). The core 

elements of EDSP are: Priority setting, 

Tier 1 screening, and Tier 2 testing. Tier 

1 is envisioned as a battery of screening 

assays (referred to as ‘‘screening’’) that 

would identify substances that have the 

potential to interact with the estrogen, 

androgen, or thyroid hormone systems. 

The purpose of Tier 2 testing (referred 

to as ‘‘testing’’) is to determine whether 

the substance could, in fact, cause 

endocrine effects mediated by estrogen- 

, 

androgen-, or thyroid-related processes, 

and to establish the relationship 

between doses of an endocrine-active 

substance administered in the test and 

any effects observed. 

In addition, based on EDSTAC’s 

recommendations, EPA proposed in the 

December 28, 1998 Federal Register 

notice an approach to establish the 

priority of chemicals for Tier 1 

screening. The approach reflected the 

concern that the quantity and quality of 

exposure and effects information would 

be uneven across chemicals. EPA 

wanted to ensure that data-rich and 

data-poor chemicals were not directly 

compared in the priority-setting process 

because data-poor chemicals might tend 

to be ranked low under such an 

approach. Thus, EPA proposed to 

develop categories of information 

relating to the production, release, 

exposure, and hazard of chemicals and 

to group the chemicals according to the 

available data. This approach was 

termed a ‘‘compartment-based 

approach.’’ The compartment-based 

approach was based on exposure- and 

effects-related compartments even 

though it was recognized that effects or 

toxicity data relevant to endocrine 

disruption would be extremely limited 

for the majority of chemicals. To partly 

compensate for the lack of relevant 

toxicity data, EPA proposed to conduct 

a HTPS study addressing all chemicals 

with a production volume in excess of 

10,000 pounds per year, excluding 

pesticide active ingredients. EPA 

developed the Endocrine Disruptor 

Priority Setting Database (EDPSD) to 

assist in assigning chemicals to 

compartments and setting priorities. 

More information on the EDPSD is 

available at http://www.epa.gov/scipoly/ 

oscpendo/prioritysetting. 

EPA currently is implementing its 

EDSP in three major parts. The Agency 

is: 

1. Developing and validating the 

screening level assays, selecting the 

appropriate screening assays for the 

screening battery based on the 

validation data, and developing and 

validating Tier 2 tests. 

2. Finalizing the priority-setting 

chemical selection approach to be 

applied to select an initial list of 

chemicals to go through screening. 

3. Developing the procedures the 

Agency will use to require screening. 

This notice deals only with finalizing 

the priority-setting chemical selection 

approach to be applied to select an 

initial list of chemicals to go through 

screening. As indicated, EPA intends to 

address the other aspects of the EDSP in 

subsequent notices published in the 

Federal Register. 

B. Science Advisory Board/FIFRA 

Scientific Advisory Panel Review 

EPA asked its Science Advisory Board 

(SAB) and the FIFRA Scientific 

Advisory Panel (SAP), independent 

scientific review committees of nonEPA scientists, to review jointly the 

Agency’s proposed EDSP. The Agency’s 

charge to the SAB/SAP Subcommittee 

was broad and complex consisting of 18 

questions in four broad areas: 

1. Scope of the program. 

2. Priority setting. 

3. HTPS. 

4. Screening and testing. 

The SAB/SAP Subcommittee met on 

March 30–April 1, 1999. Its report was 

published the following July (Ref. 2). In 

general, the SAB/SAP Subcommittee 

56452 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 

agreed with the program that EPA had 

developed for conducting endocrine 

disruptor screening. The following are 

recommendations from the SAB/SAP 

Subcommittee with respect to the scope 

of the program and setting of priorities 

for screening. 

In the December 28, 1998 Federal 

Register notice, EPA explained that it 

was considering 87,000 substances as 

potential candidates for testing under 

EDSP. The SAP/SAB Subcommittee 

expressed some reservations about the 

ambitious scope of the universe of 

chemicals that EPA envisioned as 

potentially being included in the 

program. The SAP/SAB Subcommittee 

felt that developing massive amounts of 

screening data on a large universe of 

chemicals would not necessarily 

expedite the development of the 

appropriate underpinning that the 

Agency needs before it proceeds with 

the screening of the large universe of 

chemicals that it anticipates will be 

included in EDSP. The SAB/SAP 

Subcommittee also expressed concern 

that it did not see a provision for midcourse correction or optimization of the 

program. Thus, the SAB/SAP 

Subcommittee recommended that the 

EPA start by applying EDSP to 50 to 100 

compounds and submit the data to 

independent review to consider 

eliminating methods that do not work, 

and also evaluate how to optimize the 

program. 

The SAB/SAP Subcommittee also 

recommended against including 

mixtures in the initial set of chemicals 

to be tested. The SAB/SAP 

Subcommittee thought that the question 

of testing mixtures should be deferred 

until single-compound methods had 

been successfully demonstrated. 

The SAB/SAP Subcommittee also 

found that the compartment-based 

approach to priority setting was 

supportable when ranking is based on 

both effect and exposure data. It 

suggested that the greatest weight 

should be given to chemicals for which 

there are data that indicate actual 

human or environmental exposure and 

effects. Lower weight should be given to 

chemicals for which the data are 

indicative of probable exposure (in food 

or drinking water) or probable effects 

(from animal studies). The lowest 

weight and priority should be given to 

chemicals for which the data are 

indicative of possible exposure (based 

on release or production volume) or 

possible effects (from in vitro or HTPS 

assays). The SAB/SAP Subcommittee 

expressed concern that the lack of 

effects data on the universe of chemicals 

currently in commercial use would lead 

to a database that only identifies known 

problem chemicals that are already well 

studied. To overcome this obstacle, the 

SAB/SAP Subcommittee encouraged the 

development of new techniques 

including QSAR and molecular 

modeling to help identify the bioavailable, potentially active compounds 

for further testing in EDSP. The SAB/ 

SAP Subcommittee supported the 

concept of nominations by citizens, but 

recommended that the process needed 

further definition. 

Finally, the SAB/SAP Subcommittee 

agreed with EPA’s assessment that the 

HTPS system, which EPA subjected to 

a demonstration project, was not ready 

for use but that the concept was still 

valuable. The SAB/SAP Subcommittee 

encouraged EPA to be open to other 

types of assays for HTPS including 

receptor binding, gene chip and 

microarrays, and computer modeling. 

The SAB/SAP Subcommittee also gave 

some guidance regarding further 

development and employment of HTPS, 

including the need for standardization 

and validation of any system to be used 

in priority setting. 

C. Public Comments on Priority Setting 

In addition to comments provided by 

the SAB/SAP Subcommittee, comments 

were also provided by the public on 

priority setting in response to EPA’s 

EDSP Proposed Statement of Policy 

notice published in the December 28, 

1998 Federal Register, at two public 

meetings held on the Endocrine 

Disruptor Priority Setting Database 

(EDPSD), and from the request for 

comment on the proposed approach in 

the December 30, 2002 Federal Register 

notice. The January 20, 1999 meeting 

was published in the Federal Register of 

December 28, 1998 (63 FR 71568) (FRL–

6052–8) and the June 5–6, 2000 meeting 

was published in the Federal Register of 

May 19, 2000 (65 FR 31900) (FRL–6559–

9). All of these comments were helpful 

to the Agency in developing the 

approach presented in this notice for 

selecting the initial list of chemicals to 

be screened in EDSP. 

IV. Summary of Comments Received on 

EPA’s Proposed Approach to Selecting 

the Initial Set of Chemicals 

After reviewing all of the comments 

received, EPA has decided to make 

some changes to the proposed approach. 

The priority-setting issues raised in the 

most recent comments on the proposed 

approach are addressed in the Comment 

Response Document for Endocrine 

Disruptor Chemical Selection/Priority 

Setting (Ref. 3), which can be found in 

the public docket. This unit addresses 

the major comments that caused EPA to 

revise its proposed approach. 

A. Use of Effects Data for Chemical 

Selection 

In the proposed chemical selection 

approach in the December 30, 2002 

Federal Register notice, EPA stated that, 

prior to publishing the draft initial list 

of chemicals for screening, the Agency 

intended to review the available effects 

information for those candidate 

chemicals identified using the exposurebased approach, in order to identify any 

chemical for which the effects 

information either clearly indicates an 

endocrine-mediated effect/perturbation 

or clearly indicates low potential to 

cause endocrine disruption. Such 

chemicals would then be excluded from 

the initial list. Most commenters urged 

EPA to utilize existing effects data to the 

greatest extent that is scientifically 

justifiable, and emphasized that an 

exposure-based approach should only 

be used, if at all, for the initial list. 

Following review of the comments 

and further evaluation of the proposed 

approach, EPA has decided for the 

initial list to limit its review of effects 

data and primarily select chemical 

candidates based on exposure. With two 

exceptions where EPA believes that it 

has sufficient information of an 

appropriate quality, EPA generally 

believes that it lacks sufficient 

information and experience to 

determine whether a chemical should 

be designated as a ‘‘potential endocrine 

disruptor.’’ As a general matter, EPA 

will therefore not exclude chemicals 

from the initial list based on a finding 

of the chemical’s endocrine disruption 

potential. 

Generally, with respect to using 

additional existing effects data, given 

the current state of scientific 

understanding of endocrine system 

effects and the types of testing currently 

available for most pesticide chemicals, 

EPA has decided for this initial list that 

it would be impractical to establish 

criteria for judging whether a chemical 

should be designated as a ‘‘potential 

endocrine disruptor’’ and removed from 

the initial group for screening. Although 

a relatively broad range of toxicity data 

are available for pesticide active 

ingredients regulated under FIFRA, in 

most cases EPA has not yet established 

how the available data might be 

confidently used to predict the 

endocrine disruption potentials of these 

chemicals. This may be due to the nonspecific nature of an effect or effects 

observed, questions related to whether 

the mode of action in producing a given 

effect or effects is or are endocrine 

system-mediated in whole or in part, or 

the lack of relevant data to make a 

judgement altogether. When the draft 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 56453 

initial list is published, any company 

subject to a testing requirement may 

request, during the comment period, a 

waiver (supported by appropriate data) 

on the grounds that the chemical is an 

endocrine disruptor and that EDSP 

screening is unnecessary. 

EPA has identified two exceptions. 

First, chemicals that are being used by 

EPA as ‘‘positive controls’’ to validate 

the screening assays will be excluded 

from its initial list. Inclusion of these 

chemicals in the initial list would be to 

require companies to generate 

duplicative data unnecessarily. These 

chemicals were selected because they 

were expected to elicit positive 

responses in the assays proposed to 

identify estrogen-, androgen-, and/or 

thyroid-system disruptors. Second, EPA 

does not plan to select substances it 

anticipates as having low potential to 

cause endocrine disruption (e.g., certain 

FIFRA List 4 inerts, most polymers with 

number average molecular weight 

greater than 1,000 daltons, strong 

mineral acids, and strong mineral 

bases), and considers these substances 

to be a low priority for early screening 

under the EDSP. High molecular weight 

substances are unlikely to reach 

molecular receptors or other target 

tissue; highly reactive chemicals will 

destroy tissue at the point of entry 

leading to toxicity other than through 

the endocrine system. 

B. Appropriateness of the Proposed 

Data Sources 

Many comments received on the 

appropriateness of the data sources 

identified in the December 30, 2002 

Federal Register notice questioned the 

relevance and quality of the proposed 

data sources. Specific issues raised in 

these comments included: The inability 

to analyze and fully understand the data 

in some data sources because the raw 

data underlying the summary data are 

not accessible; several databases are 

very dated and may not be relevant to 

potential exposures today; several 

databases may not be relevant to or 

extrapolated to the U.S. population as a 

whole; some databases/data sources 

used biased sampling rather than 

random or probability design; although 

the data do indicate exposure, they do 

not fully characterize exposure in terms 

of time, duration, and level of exposure; 

and that the EPA review of the 

databases should comply with the 

Agency’s policies provided in its 

December 2002 information quality 

guidelines (Ref. 4). 

In accordance with EPA’s information 

quality guidelines, EPA has reviewed 

the data sources described in this 

chemical selection approach for the 

initial round of screening in the EDSP. 

Following review of the proposed 

databases (Ref. 5), EPA made the 

determination to exclude the Heidelberg 

College’s Monitoring Data at this time 

because it has limited public 

availability, at best, and because 

comparable data are available from two 

other sources that are publicly available. 

For the remainder of the data sources, 

EPA believes that the data sources are 

appropriate and relevant for the 

intended application and that the 

quality and transparency of the 

information is sufficient for the 

intended use. The most current versions 

of the databases will be used and 

evaluated when developing the initial 

list. 

EPA acknowledges that many of the 

proposed data sources may be limited in 

their usefulness for certain applications 

but believes, nonetheless, that the data 

sources are of appropriate quality for 

their intended use and purpose for a 

number of reasons. First, the most 

current versions of the databases will be 

used and evaluated when developing 

the initial list. In addition, the 

limitations of an individual data set can 

be overcome, to some extent, by 

consideration of multiple sets of data 

and multiple databases. EPA thinks that, 

when considered collectively, the 

databases discussed in Units VI. and 

VII. are not as vulnerable to criticism as 

a particular individual data set. Finally, 

EPA generally determines the quality of 

data sources based on the Agency’s 

intended use of the data. For the initial 

list, EPA will select 50 to 100 pesticide 

active ingredients and HPV chemicals 

used as pesticide inerts to which the 

public may be more highly exposed. 

EPA will use these data sources to help 

select just the first round of chemicals 

to be screened and does not intend to 

use these sources to create a definitive, 

scientifically rigorous list of chemicals 

with a high potential for exposure, nor 

to develop quantitative exposure 

estimates in this analysis. The 

chemicals identified under this 

approach belong to the group of 

chemicals that are required to be tested 

under FFDCA section 408(p)(3)(A)—

pesticide chemicals. Because Congress 

specifically required that these 

chemicals be tested, the impact of EPA’s 

assessments in this case is quite 

limited—merely determining the timing 

of the testing, rather than whether the 

testing is to be conducted. 

Consequently, EPA believes the 

proposed data sources are of sufficient 

quality for their intended use. 

C. Synchronization of the Endocrine 

Disruptor Screening Program’s 

Components 

In response to comments and 

consistent with its intent to have the 

initial list drafted and finalized when 

the screening assays are available for 

testing, EPA plans on publishing the 

draft initial chemical list well in 

advance of when an appropriate 

screening test battery is ready for use. 

This interval is intended to allow 

adequate time for EPA to solicit and 

consider public comments on the draft 

list without delaying the initial round of 

testing. 

V. EPA’s Approach to Selecting the 

Initial Set of Chemicals to Undergo 

Screening 

On the basis of EPA’s experience to 

date and comments received, EPA is 

setting forth its approach for selecting 

the first group of chemicals to be 

screened in the EDSP. Based on the 

SAB/SAP Subcommittee 

recommendations and public 

comments, EPA will select and screen 

approximately 50 to 100 chemicals 

drawn from pesticide active ingredients 

and pesticide inerts with relatively large 

overall production volumes considering 

both pesticide and non-pesticide uses 

(HPV/Inert chemicals) to help the 

Agency further refine the EDSP. EPA 

will list the chemicals alphabetically, or 

numerically by CAS number, to avoid 

the appearance of a specific ranking of 

the chemicals selected for initial 

screening. 

As recommended by the SAP/SAB 

Subcommittee, the Agency intends to 

conduct a review of the data received 

from the screening to evaluate whether 

the program could be improved or 

optimized, and if so, how. In addition 

to Agency scientists, the review of the 

initial list screening results will be 

evaluated by an expert panel such as 

one under the SAP/SAB Subcommittee. 

Evaluation of the screening results for 

the initial 50 to 100 chemicals will add 

substantially to our understanding of 

the performance of the Tier I test 

battery. Thus, the evaluation 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 optimization of 

the assays to improve performance. The 

evaluation may also identify 

interpretive issues such as a 

determination that a specific assay may 

not be needed because another assay in 

the screening battery adequately 

measures the same effect. Other 

information from the review process 

56454 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 

may help identify potential issues or 

areas for improvement, such as whether 

there is sufficient laboratory capacity or 

problems with correctly performing the 

tests, 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. 

EPA will use an approach based in 

part on the compartment-based prioritysetting approach described in the 

December 28, 1998 Federal Register 

notice that provided details about the 

EDSP and that the SAB/SAP 

Subcommittee commented on in 1999. 

As explained in Unit IV.A., the 

approach focuses primarily on 

exposure-related factors rather than 

using a combination of exposure- and 

effects-related factors. Although EPA 

will use many of the exposure data sets 

previously identified for use in the 

EDPSD in this approach, EPA 

anticipates not directly using the EDPSD 

itself at this time in light of the narrower 

scope and focus of this initial list. EPA 

anticipates that it will modify its 

chemical selection approach for 

subsequent screening lists based on 

experience gained from the results of 

testing chemicals on the initial list, the 

feasibility of incorporating different 

categories of chemicals (e.g., nonpesticide substances), and the 

availability of new priority-setting tools 

(e.g., HTPS and QSAR models). 

EPA will use several groups of data to 

identify pesticide active ingredients to 

include on the initial list of chemicals 

for screening. These data focus on 

human exposure by different pathways: 

1. As a consequence of consuming 

food containing pesticide residues. 

2. As a consequence of consuming 

drinking water containing pesticide 

residues. 

3. As a consequence of residential use 

of pesticide products. 

4. Through occupational contact with 

pesticide-treated surfaces. 

For each of the four pathways, EPA 

will use the most current data available 

from each data source to identify active 

ingredients. To ensure, to the extent 

possible, that all pesticide chemicals are 

addressed using this approach based on 

comparable exposure potential, EPA is 

most interested in identifying and 

selecting data sources which 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 is confident that these 

data sources can be used to identify 

pesticide active ingredients likely to be 

among those having either potentially 

widespread or higher levels of human 

exposure than would be expected for 

other active ingredients. EPA does not 

plan to use these data sources to create 

a definitive, scientifically rigorous list of 

pesticide chemicals to which the public 

is the most highly exposed. Nor is EPA 

proposing to use these databases to 

create quantitative exposure estimates 

in this analysis. 

EPA is giving higher priority to 

chemicals likely to have human 

exposure via multiple pathways, with 

the highest priority being given to 

substances having potential exposure 

through all four pathways, followed by 

those having potential exposure via 

three pathways, etc. for inclusion on the 

list for initial screening. Details on 

EPA’s approach for selecting pesticide 

active ingredients are presented in Unit 

VI. 

EPA will use a similar approach to 

identify HPV/Inert chemicals to be 

included in the initial list for screening 

in the screening battery. However, EPA 

generally has more extensive 

information available to assess potential 

exposure to pesticide active ingredients 

via food, water, occupational, and 

residential exposure pathways than is 

available to assess exposure to HPV/ 

Inert chemicals. In addition, EPA 

generally has more extensive 

information available on usage 

(including both agricultural and 

residential) of active ingredients than is 

available for HPV/Inert chemicals 

(including both pesticidal and nonpesticidal uses of those same 

substances). For these reasons, the 

specific pathways and data sources EPA 

has identified for selecting an initial set 

of HPV/Inert chemicals for endocrine 

disruptor screening differ somewhat 

from those for selecting pesticide active 

ingredients. 

For HPV/Inert chemicals, EPA will 

focus on several indicators of the 

potential for human exposure, including 

production volume, specific pathways 

of exposure, and presence in human 

tissues. First, EPA will use the most 

current databases available to identify 

chemicals that are both pesticide inerts 

and HPV (defined as chemicals that are 

manufactured or imported into the 

United States for all uses in amounts 

equal to or greater than one million 

pounds per year) chemicals. This first 

step will focus initial screening of 

pesticide inerts on chemicals with 

higher potential human exposure on the 

basis of large amounts produced or 

imported each year in the United States. 

Second, EPA will review the most 

current existing data available for its use 

to identify HPV/Inert chemicals that 

have been found to be present in: 

Human biological samples, ecological 

tissues that have human food uses (i.e., 

fish tissues), drinking water, and/or 

indoor air. Using this approach, an 

HPV/Inert chemical appearing in 

monitoring data from one or more of 

these media, would be a higher priority 

for testing than an HPV/Inert chemical 

that does not appear in monitoring data 

from any of the media. Details on EPA’s 

priority-setting approach for selecting 

HPV/Inert chemicals are presented in 

Unit VII. 

While EPA’s general focus in this 

approach is on pesticide active 

ingredients and HPV/Inert chemicals 

with relatively greater potential human 

exposure, this does not necessarily 

mean that the list developed using this 

approach will not contain substances 

which also have potentially high levels 

of environmental exposure to ecological 

receptors. As explained in Units VI. and 

VII., EPA believes that the approach to 

select an initial list of pesticide active 

ingredients and HPV/Inert chemicals for 

screening, while focused on human 

exposure, will also capture many 

chemicals to which other organisms 

have potential for widespread 

environmental exposures. In addition, 

because the screening battery will likely 

include assays involving different 

species (e.g., amphibians and fish) 

whose results are relevant to both 

humans and wildlife, EPA will capture 

information relevant to ecological 

protection. 

The approach is consistent with the 

proposed approach and many of the 

comments received on the December 30, 

2002 Federal Register notice. For its 

approach EPA is: 

1. Focusing chemical selection for this 

initial list on the subset of chemicals for 

which testing is required (i.e., pesticide 

chemicals). 

2. Using exposure data as the primary 

basis for chemical selection rather than 

using HTPS, QSARs, or other hazard 

data in conjunction with exposure data. 

3. Excluding substances for the initial 

list anticipated to have low potential to 

cause endocrine disruption (e.g., certain 

FIFRA List 4 inerts, most polymers with 

number average molecular weight 

greater than 1,000 daltons, strong 

mineral acids, and strong mineral 

bases). 

4. Deferring consideration of 

nominations from the public. 

5. Not including mixtures for the 

initial list. 

6. Excluding chemicals that are no 

longer produced or used in the United 

States. 

7. Excluding ‘‘positive control’’

chemicals used for the validation of the 

screening assays. 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 56455 

EPA will issue an additional Federal 

Register notice setting forth the draft 

initial list of chemicals it proposes for 

screening. EPA expects that low-priority 

designations will initially be made on a 

case-by-case basis. Therefore, the 

Federal Register notice in which EPA 

will publish for public comment the 

draft initial list of chemicals for 

screening will clearly identify any 

chemical, which was identified having 

priority for testing through the 

application of the exposure-based 

criteria, but was excluded because it is 

considered to be a low priority for one 

of the reasons listed in this unit. That 

Federal Register notice will explain the 

rationale underlying any decisions 

made for selection of chemicals in the 

draft initial list. The draft initial list of 

chemicals is expected to be published to 

allow sufficient time for review and 

comment prior to actual testing. After 

considering comment on the draft list of 

chemicals, EPA will issue the initial list 

of chemicals for which screening will be 

required. 

VI. Approach for Selecting Pesticide 

Active Ingredients 

As proposed, EPA will use several 

criteria to identify pesticide active 

ingredients for the initial round of the 

screening. These criteria would focus on 

human exposure by different pathways: 

As a consequence of consuming food 

containing pesticide residues, drinking 

water containing pesticide residues, and 

residential use of pesticide products; 

and through occupational contact with 

pesticide-treated surfaces. For each of 

the four pathways, EPA will review the 

most current existing databases 

available to identify active ingredients 

generally expected to be among those 

having either widespread or high levels 

of human exposure. 

While EPA’s general focus is on 

pesticide active ingredients with 

relatively greater potential human 

exposure, this focus does not 

necessarily mean that the list of active 

ingredients will not contain substances 

which also have potentially high levels 

of environmental exposure to ecological 

receptors. Many of the pesticide active 

ingredients having greater potential for 

human exposure will also have greater 

potential for exposure to wildlife. For 

example, one pathway of human 

exposure, drinking water, is also a 

pathway through which aquatic life and 

many terrestrial species are exposed. 

Most of the databases that EPA will 

consider in evaluating active ingredients 

for exposure through drinking water 

contain monitoring data collected on 

raw surface water (i.e., before the water 

enters a public water system). Thus, 

these monitoring data show the levels of 

pesticide residues that fish, amphibians, 

and other aquatic species will 

encounter. Similarly, when data show 

higher and more widely distributed 

levels of pesticide residues in food, EPA 

thinks that such residues generally tend 

to reflect greater usage and/or 

persistence of the pesticide on crops 

and thus, greater environmental loads. 

Accordingly, EPA believes that the 

approach to evaluate pesticide active 

ingredients, while focused on human 

exposure, will also capture many active 

ingredients with widespread 

environmental exposures. 

A. Food Pathway 

Every person eats food and a 

significant portion of food contains 

some amount of pesticide residues, 

although usually at very low levels. 

Therefore, pesticide residues in food 

have the potential to cause widespread 

human exposure. Pesticides have 

different use patterns and have different 

physical and chemical properties that 

affect how they move in the 

environment and how quickly they 

break down. As a result, there are often 

significant differences among pesticides 

in the proportion of food containing 

residues and in the levels of such 

residues. People also consume different 

amounts of different foods. All of these 

factors mean that people ingest greater 

quantities of some pesticide active 

ingredients than others. 

To evaluate the interplay of these 

different variables, EPA will identify the 

pesticide active ingredients which are 

found most frequently as residues on 

the top 20 foods that people consume. 

First, EPA will use the most recent 

Continuing Survey of Food Intake by 

Individuals (CSFII) to determine the 

mean amount of each raw agricultural 

commodity consumed in the general 

population. The CSFII is a database 

derived from a survey performed by the 

U.S. Department of Agriculture (USDA) 

in 1994–1996 and supplemented with 

additional survey responses collected in 

1998. USDA collected food diary 

information from over 20,000 

individuals who were interviewed on 2 

non-consecutive days, generally spaced 

3 to 10 days apart. After appropriate 

statistical weighting, the survey, in the 

aggregate, is representative of the U.S. 

population in terms of age, gender, 

major ethnic groups, and socioeconomic status. Moreover, sampling 

was representative of different days of 

the week, seasons of the year, and parts 

of the country. Extensive quality control 

procedures assured that the data 

collected in the survey were accurate 

and reliable. More information on 

USDA’s food surveys and the CSFII 

(1994–1996) is available at http:// 

www.barc.usda.gov/bhnrc/foodsurvey. 

Using standard, scientifically peerreviewed recipes, EPA has converted 

the reported food consumption for each 

CSFII survey respondent into the 

constituent raw agricultural 

commodities. For example, if a person 

reported eating six ounces of beef stew, 

EPA estimated the amount of beef, 

carrot, potato, and each other raw 

agricultural commodity used in making 

that quantity of beef stew. EPA made 

similar conversions for each of the 

different finished foods reported in the 

CSFII—from apple pie to yogurt. EPA 

then estimated the total amount of each 

of the various raw agricultural 

commodities eaten over the course of 

the day, for example summing the 

amount of apple consumed from 

drinking cider and eating apple sauce. 

The results of these recipe translations 

appears in the revised Food Commodity 

Intake Database (FCID) (Ref. 6). 

Information on the FCID can be 

reviewed at http://www.barc.usda.gov/

bhnrc/foodsurvey/fcid.html. This 

individual food consumption database 

provides the basis for identifying the top 

20 foods consumed, in terms of mean 

daily consumption for the general 

population. Table 1 of this unit presents 

these raw agricultural commodities. 

TABLE 1.—TOP TWENTY FOODS

Foods accounting for the largest quantity of 

food intake by individuals (arranged alphabetically) 

1 ............. Apple 

2 ............. Banana 

3 ............. Beef 

4 ............. Carrot 

5 ............. Chicken 

6 ............. Corn, field 

7 ............. Corn, sweet 

8 ............. Egg 

9 ............. Grape 

10 ........... Lettuce 

11 ........... Milk 

12 ........... Onion 

13 ........... Orange 

14 ........... Pork 

15 ........... Potato 

16 ........... Rice 

17 ........... Soybean, oil 

18 ........... Sugar 

19 ........... Tomato 

20 ........... Wheat 

Having identified the top 20 raw 

agricultural foods, EPA will characterize 

the pesticide residue levels on these 

foods using information collected by 

two Federal Agency monitoring 

programs, the USDA Pesticide Data 

Program (PDP) and the Surveillance 

56456 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 

Monitoring Program conducted by 

FDA’s Center for Food Safety and 

Applied Nutrition. PDP has been 

collecting pesticide residue data since 

1991. PDP is designed to provide a 

nationally representative database on 

the distribution of pesticide residues in 

food as close as possible to the actual 

time of consumption as practical. Using 

analytical methods that have been 

standardized and validated, and 

following strict quality control 

procedures, USDA has focused on foods 

highly consumed by children 

throughout the year. Over the years of 

operation, PDP has collected data on 

over 290 different pesticides and 50 

different commodities. Additional 

information can be found at http:// 

www.ams.usda.gov/science/pdp/ 

index.htm. The FDA Surveillance 

Monitoring Program is designed 

primarily for enforcement of pesticide 

tolerances on imported foods and 

domestic foods shipped in interstate 

commerce. Domestic samples are 

collected as close as possible to the 

point that the food enters the 

distribution system. FDA samples 

imported food at the port of entry into 

the United States. Additional 

information on the FDA program 

appears at http://www.cfsan.fda.gov/ 

~dms/pesrpts.html. 

Because of the differences in how 

samples are collected and handled, EPA 

will rely on the PDP database when both 

sources cover the same pesticides and 

commodities. The FDA Surveillance 

Monitoring Program data covers 

different pesticides and commodities in 

different years from the PDP monitoring 

(e.g., in 1999, FDA used analytical 

methods capable of detecting 366 

different active ingredients). Therefore, 

in making its weight-of-the-evidence 

judgement, EPA will consider the FDA 

information as a supplement to the 

information from the PDP database. 

EPA will review the two residue 

monitoring databases to identify the 

pesticide active ingredients which 

appear on the largest proportion of the 

samples, focusing on the 20 foods which 

make up the largest part of the U.S. diet. 

EPA will then review all of the 

information to make a judgment about 

whether the pesticide is likely to have 

relatively more widespread or higher 

levels of human exposure by the food 

pathway than other pesticides. This 

judgement involves consideration of 

such factors as the number of foods on 

which the residue is detected, the 

quantity of the diet represented by the 

food, and the overall number of 

detections and the frequency of 

detection. 

EPA recognizes that this approach 

would be more likely to give higher 

priority to the pesticides which are the 

subject of routine monitoring in either 

PDP or FDA’s Surveillance Monitoring 

Program. Both programs rely primarily 

on ‘‘multi-residue methods’’ that are 

capable of detecting many different 

chemical substances using a single 

analytical procedure. Active ingredients 

which require specialized analytical 

methodology may not be looked for and 

thus would be unlikely to be included 

for consideration in the food pathway. 

This limitation particularly applies to 

newer pesticide active ingredients. 

Notwithstanding these limitations, EPA 

believes the approach described is a 

practicable approach for identifying 

pesticide active ingredients with 

widespread or high levels of exposure. 

B. Water Pathway 

Portions of the general population 

may be exposed to pesticide residues in 

sources of drinking water. Although 

monitoring data indicate that most 

pesticide active ingredients are rarely 

detected, analytical surveys in virtually 

every region of the country have 

detected a number of active ingredients 

in ground and surface water used as 

sources of drinking water. Monitoring 

also indicates that, even when found in 

water, residue levels vary significantly 

both seasonally and regionally for a 

single pesticide, as well as across 

pesticides. Particularly for surface 

water, residues tend to occur in pulses 

that can last days to weeks to months, 

depending on the type of water body 

and the pesticide. Almost every person 

consumes some water every day, either 

in prepared foods or beverages (e.g., 

coffee, tea, or reconstituted juice) or 

simply by drinking water; therefore, 

water may be a significant source of 

exposure. 

To assess relative exposure to 

different pesticides in water, EPA will 

examine a number of different databases 

that contain the results of programs to 

monitor surface and ground water for 

the presence of pesticide residues. The 

different media covered by these 

databases include, finished drinking 

water, ambient water, finished ground 

water, fish tissue, and sediment, all of 

which reflect the presence of a 

substance in water sources. The 

presence of a substance in these media 

establishes the potential for exposure 

via drinking water. All sources of 

drinking water exposure will be 

considered of equal priority. 

As with the residue data for the food 

pathway, EPA will compile the 

information from the various databases 

concerning the detection of different 

pesticides in water. After compiling the 

information, EPA will examine the 

results to identify pesticides for which 

there appears to be greater potential for 

widespread human exposure, based on 

factors such as the number of samples 

and the geographic distribution of the 

detections. The presence of a single or 

only a few detections of a pesticide in 

a limited geographic area typically 

would not be a sufficient basis for 

concluding that the pesticide should be 

identified as potentially having either 

widespread or high levels of exposure 

by the water pathway. 

These databases, which contain data 

collected by Federal and State agencies, 

academicians, pesticide companies, and 

others, are summarized in this unit: 

1. EPA Pesticides in Ground Water 

Database. The Pesticides in Ground 

Water Database (PGWDB) was created to 

provide a more complete picture of 

ground water monitoring for pesticides 

in the United States. It 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 compiles, in tabular 

format, data from monitoring of 

untreated ground water and contains 

data only from studies in which 

pesticides were included as analytes. 

Some data limitations include: Age of 

the data; differences in the design of 

studies; lack of historical pesticide use 

or hydrological information; and lack of 

information on well use, sampling 

practices, and laboratory procedures. 

Further details can be found in EPA 

Pesticides in Ground Water Database, A 

Compilation of Monitoring Studies: 

1971–1991 National Summary (Ref. 7). 

2. 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. The Agency 

decides whether to require monitoring 

of untreated or ambient surface or 

ground water for a pesticide based on 

the environmental fate characteristics 

(persistence and mobility) of the 

pesticide; the current or proposed use 

patterns for the pesticide; and other 

information that would indicate 

potentially significant levels of the 

pesticide that could be present in water. 

The design of monitoring studies takes 

into consideration application rate, 

crops, and the location of potentially 

more vulnerable use sites. These studies 

are performed under Good Laboratory 

Practice regulations, and contain 

internal quality assurance procedures. 

When submitted, the monitoring data 

undergo primary and secondary review 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 56457 

by Agency scientists. In implementing 

its approach for selecting the initial list 

of chemicals for screening, EPA will 

review these chemical-specific 

monitoring data sources to determine if 

they contain information for pesticide 

active ingredients without data from 

other water monitoring data sources. 

3. United States Geological Survey/ 

EPA Reservoir Monitoring Study. The 

United States Geological Survey 

(USGS)/EPA Reservoir Monitoring 

Study was a pilot monitoring program 

initiated by the USGS and EPA to 

provide information on pesticide 

concentrations in drinking water and to 

assist in the implementation of FQPA. 

Drinking-water utilities that withdrew 

water from reservoirs were sampled in 

1999 and 2000. Water samples were 

collected from raw water (at the intake 

point) and from finished drinking water 

(at the tap prior to entering the 

distribution system). At some sites, 

samples were also collected at the 

reservoir outflow. Sampling frequencies 

were designed to measure long-term 

mean and short-term peak 

concentrations of pesticides in drinking 

water. The analytical methods used for 

analyzing the pesticides in the water 

samples included 178 different 

pesticides and degradation products. 

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. 8). 

4. Environmental Monitoring and 

Assessment Program. Environmental 

Monitoring and Assessment Program 

(EMAP) is an EPA research initiative 

designed to support the development of 

tools necessary to monitor and assess 

the status and trends of national 

ecological resources. Research is 

conducted on various ecosystems (e.g., 

estuaries, forests, rangelands, and lakes). 

Sediment samples were collected in 18 

states at various times between 1990 

and 1998. This data source provides 

information about the contaminants 

present in sediment/soil that humans 

and wildlife may contact. EMAP 

includes relevant data for over 170 

chemicals and three separate data sets 

for estuary sediments. In addition, six 

additional estuary data sets are now 

available that will also be considered. 

Extensive field and laboratory quality 

assurance/quality control (QA/QC) 

procedures were performed during the 

collection and analysis of the samples. 

Further details can be found at http:// 

www.epa.gov/emap. 

5. National Sediment Inventory. The 

Water Resources Development Act 

(WRDA) of 1992 directed EPA, in 

consultation with the National Oceanic 

and Atmospheric Administration 

(NOAA) and the U.S. Army Corps of 

Engineers (USACE), to conduct a 

national survey of data regarding the 

quality of sediments in the United 

States. To comply with the WRDA 

mandate, EPA’s Office of Science and 

Technology initiated the National 

Sediment Inventory (NSI). The NSI is a 

database that documents the 

composition of sediment in rivers, lakes, 

oceans, and estuaries. The NSI tissue 

residues studies (primarily fish) help 

assess sediment quality and can be used 

to assess potential exposure of humans 

to these chemicals through the 

consumption of fish. Also, sediment 

chemistry data are evaluated for 

theoretical bioaccumulation potential. 

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. 

NSI’s minimum data requirements 

include monitoring program 

identification, sampling date, latitude 

and longitude coordinates, and 

measured units. EPA retains additional 

data such as QA/QC information, if 

available, but did not require that 

information for a data set to be included 

in NSI. Additional limitations of the 

compiled data include the mixture of 

data sets derived using different 

sampling strategies, incomplete 

sampling coverage, and the age and 

quality of the data. Because the data 

analyzed in the NSI report were 

collected over a relatively long period of 

time, conditions may have changed 

since the sediment was sampled. 

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. 

6. National Drinking Water Chemical 

Occurrence Database. EPA developed 

the National Drinking Water Chemical 

Occurrence Database (NCOD) to satisfy 

the statutory requirements set forth by 

Congress in the 1996 amendments to 

SDWA to maintain a national drinking 

water contaminant occurrence database 

using occurrence data for both regulated 

and unregulated contaminants in public 

water systems. NCOD provides a library 

of water sample analytical data (or 

‘‘samples data’’) that EPA is currently 

using and has used in the past for 

analysis, rulemaking, and rule 

evaluation. The drinking water sample 

data, collected at public water systems, 

are for both regulated and unregulated 

contaminants. The data have been 

extensively checked for data quality and 

analyzed for national 

representativeness. 

Currently, NCOD provides links to the 

unregulated contaminant monitoring 

data (UCMR), which are being collected 

and added to NCOD, as well as to static 

data sets that have been used in 

published regulatory analyses. These 

latter (static) data sets have been 

extensively quality-checked, and their 

corresponding reports provide full 

descriptions (meta data) of the data. 

Further details can be found at http:// 

www.epa.gov/safewater/data/ncod.html. 

7. National Stream Quality 

Accounting Network Data. The National 

Stream Quality Accounting Network 

(NASQAN), a monitoring and data 

collection program conducted by the 

USGS, is designed to characterize raw 

surface water and sediment in large subbasins of rivers, determine regional 

source areas for chemicals, and assess 

the effects of human influences on 

observed concentrations and amounts of 

chemicals. Since 1995, NASQAN 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. A 

network of 40 stations monitors the 

concentrations of a broad range of 

chemicals including pesticides, major 

ions, and trace elements. NASQAN 

contains relevant data for over 70 

chemicals. NASQAN samplers collect 

quality control samples to evaluate the 

quality of sampling data. However, the 

data in NASQAN do not characterize 

ambient water quality throughout the 

United States, only for four river basins 

and sub-basins. Further details can be 

found at http://water.usgs.gov/nasqan. 

EPA will use the most current 

NASQAN data available. Following a 

brief review of current NASQAN data, 

EPA determined that no sediment data 

exists and only surface water data were 

available for pesticide active 

ingredients. NASQAN data may be 

updated prior to selecting the initial list 

of chemicals for screening and it is 

possible that sediment data may be 

made available and used for pesticide 

active ingredients for screening. 

8. National Water Quality Assessment 

Program. Congress appropriated funds 

in 1986 for the USGS to design and 

implement a program to address 

questions related to status and long-term 

trends in raw surface and ground water 

quality at national, regional, and local 

scales. The USGS began a pilot program 

in seven project areas to develop and 

56458 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 

refine a plan for the National Water 

Quality Assessment (NAWQA) Program. 

In 1991, the USGS began full 

implementation of the program. The 

NAWQA Program builds upon an 

existing base of water-quality studies of 

the USGS, as well as those of other 

Federal, State, and local agencies. The 

NAWQA Program was designed to study 

60 of the Nation’s most important river 

basins and aquifer systems, which are 

referred to as study units. A national 

map of these study units shows that 

they are distributed throughout the 

Nation and cover a diversity of 

hydrogeologic settings. More than twothirds of the Nation’s freshwater use 

occurs within the study units and more 

than two-thirds of the people served by 

public water-supply systems live within 

their boundaries. The 60 study units 

have been divided into groups of 20 

study units each, and their intensive 

data collection phases have been 

staggered to allow efficient and effective 

use of resources. The first 20 studies 

began in 1991, the second group began 

in 1994, and the third group began 

study in 1997. Due to funding 

constraints, only 14 of the original first 

group of 20 study units began a second 

cycle of study in the year 2000. The 

cycle is intended to continue into the 

future with a total of 52 study units to 

provide both short-term information 

necessary for today’s water-resource 

management decisions, and the longterm information needed for policy 

decisions. Further details can be found 

at http://water.usgs.gov/nawqa. 

9. USDA Pesticide Data Program 

Water Data. The Pesticide Data Program 

(PDP) was designed by USDA in 1991 to 

collect data on pesticide residues 

consumed in the United States. PDP 

samples are collected as close as 

possible to the time of consumption, 

and are also designed to provide better 

pesticide residue data for the foods most 

consumed by children. PDP is a FederalState partnership with program 

operations carried out with the support 

of 10 States that collectively represent 

50% of the U.S. population. Samples are 

collected using a statistically reliable, 

random sampling protocol, and the 

number of samples collected is 

apportioned according to State 

population or commodity production 

figures. PDP has tested over 50 different 

commodities, including drinking water, 

for more than 290 pesticides. 

EPA recognizes that most of the 

monitoring databases just described 

report results from samples of ambient 

or untreated water, rather than treated 

drinking water prepared by a drinking 

water facility for its customers. To the 

extent that treatment methodologies 

(such as flocculation, softening, 

filtration, chlorination, sedimentation, 

etc.) either remove or transform the 

pesticide residue in the source water, 

residues found in the untreated water 

may not represent exposure of the 

public consuming the finished water. 

EPA has considered the impacts of 

various treatment methodologies on 

different classes of pesticides found in 

untreated water and concluded that 

while conventional water treatment 

processes (such as coagulation/ 

flocculation, sedimentation, and 

filtration) can reduce or remove some 

pesticides, there may be little or no 

effect on the removal of other pesticides 

(Ref. 9). Thus, the Agency regards the 

results of monitoring untreated or 

ambient water as a plausible and 

appropriate indicator of potential 

human exposure. 

Other factors affect the interpretation 

of water monitoring data. These data 

sources represent compilations of data 

to support a variety of regulatory and 

surveillance programs. Monitoring is 

most likely to detect the presence of 

pesticide residues in water if it is 

conducted in an area where the 

pesticide has been used, and samples 

are collected at a time when residues are 

likely to occur. Moreover, the analysis 

must employ methods sensitive enough 

to detect any residue. Often, however, 

monitoring reports lack sufficient 

information to evaluate how well the 

above conditions were met. 

Consequently, evaluation of water 

monitoring data requires considerable 

judgment. See the discussion of 

considerations affecting the evaluation 

of water monitoring data in Estimating 

the Drinking Water Component of a 

Dietary Exposure Assessment (Ref. 10) 

and the EPA Background Paper for the 

FIFRA Scientific Advisory Panel 

Meeting on Monitoring Strategies for 

Pesticides in Surface-Derived Drinking 

Water (Ref. 11). 

The limitations of an individual data 

set can be overcome, to some extent, by 

consideration of multiple sets of data 

and multiple databases. EPA thinks that, 

when considered collectively, the 

databases discussed in Unit VI.B. are 

not as vulnerable to criticism as a single 

data set. Generally, all of these 

databases include studies with high 

levels of quality control, and together 

they provide wide temporal and spatial 

coverage for a large number of 

pesticides. Thus, the Agency believes 

the databases in Unit VI.B. would 

provide a reliable basis for drawing 

conclusions about the relative potential 

of different active ingredients to leach 

into ground water or run off into surface 

water in different parts of the country. 

In light of these considerations, EPA 

will review the databases described to 

identify those active ingredients which 

appear relatively more frequently and/or 

in more geographical areas than other 

pesticides. Because the scope of 

monitoring varies from pesticide to 

pesticide, EPA will use a weight-of-theevidence approach to assess the 

frequency and geographic distribution 

of pesticide residues in water. 

EPA’s reliance on these databases 

would necessarily have some 

limitations. For example, most 

monitoring looks only for the ‘‘parent’’

compound (i.e., the pesticide active 

ingredient), rather than for 

environmental degradation products or 

compounds formed by chemical 

reactions during the treatment of raw 

water sources in a drinking water 

facility. Further, like food residue 

monitoring programs, monitoring efforts 

rely on multi-residue methods that may 

not detect certain compounds or classes 

of compounds. Notwithstanding these 

limitations, EPA believes that the 

approach described is a practicable 

approach for identifying pesticide active 

ingredients generally expected to be 

among those having either widespread 

or high levels of human exposure. 

C. 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 repellants, 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 will use pesticide product 

labeling information as the primary 

indicator of pesticides whose use 

involves potential human exposure by 

this pathway. EPA will review its 

databases and identify those active 

ingredients approved for residential use. 

Aside from products approved only for 

limited exposure uses, such as 

rodenticides applied in tamper resistant 

bait boxes, all currently registered 

residential use pesticides will be 

identified as having higher priority with 

respect to the residential use pathway. 

EPA may also consider the number of 

residential uses for which each 

pesticide active ingredient is approved 

in selecting the initial list of chemicals 

for screening. 

The Agency recognizes that 

registration of a pesticide for residential 

use does not necessarily mean that it 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 56459 

1The transfer coefficient is calculated by dividing 

the amount of residue found on workers, expressed 

as milligrams (mg), by the amount of dislodgeable 

residue found on the crop foliage, expressed as mg 

per square centimeter (cm2), and dividing this value 

by the length of time spent in the activity, 

expressed in hours (hr). The resulting coefficient for 

each activity is expressed as cm2/hr and 

quantitatively reflects the extent to which the 

activity involves contact with pesticide-treated 

surfaces in a manner that dislodges the residues 

present on the surface. 

2Acre-treatments are measured as the number of 

times an acre of crop may have been treated with 

a pesticide. For example, if two acres were each 

treated one time in a season, that would represent 

two acre-treatments. If a single acre were treated 

two times in a season, that would also represent 

two acre-treatments. 

would be widely used or that its use 

would entail significant levels of human 

exposure. EPA, however, generally lacks 

information to compare the extent of 

application of different active 

ingredients for residential uses. 

Moreover, EPA does not have a basis for 

distinguishing among various 

residential use patterns on the basis of 

those which consistently have potential 

for higher levels of human exposure. 

Thus, EPA does not regard its basis for 

selecting priority chemicals for this 

pathway as being as effective in setting 

priorities among active ingredients as 

the criteria used for the other pathways. 

Nonetheless, residential use pesticides 

involve potential exposures to the 

general population, and the Agency 

believes it is appropriate to consider 

giving priority to some of these 

products. 

D. Occupational Exposure Pathways 

Occupational exposure can occur 

either as a person mixes, loads, or 

applies a pesticide product (i.e., during 

pesticide use), or as a person, during 

some other occupational activity, comes 

in direct, repeated contact with 

pesticide residues present on previously 

treated surfaces (i.e., post-application 

exposure). Although numerically 

smaller than the populations exposed to 

pesticides through food, drinking water, 

and residential use, individuals 

receiving occupational exposures 

generally experience significantly 

higher levels of exposure than the larger 

groups encounter by the other 

pathways. Based on available data and 

current agricultural practices, the 

number of workers exposed through 

post-application is greater than the 

number of workers exposed through 

mixing, loading, and applying 

pesticides. As a result, EPA will focus 

on post-application exposures. 

Many factors affect the postapplication exposure of agricultural 

workers, most notably the type of work 

activity and the level of residue present 

on pesticide-treated surfaces. As will be 

discussed in more detail in this unit, 

different activities involve differing 

levels of contact with pesticide-treated 

surfaces and therefore can lead to 

different levels of exposure. Exposure 

levels also depend on the amount of 

residue available on a treated surface. 

This, in turn, depends on the amount of 

pesticide initially applied, how quickly 

the material degrades or is taken up by 

the plant, and how soon after 

application the worker contacts the 

treated surface. Pesticides show a large 

range of variation in application rates, 

application timing, and environmental 

fate characteristics with the result that 

there are significant differences in the 

levels of dislodgeable residues on 

treated surfaces encountered by 

workers. 

In identifying active ingredients for 

priority consideration by this pathway, 

EPA will rank pesticides on the basis of 

their potential for post-application 

exposure to agricultural workers. This 

group includes farmers and farm 

workers who reenter pesticide-treated 

fields and orchards to care for or harvest 

the crop. These agriculture transfer 

coefficients developed by the 

Agricultural Reentry Task Force (ARTF) 

clearly indicate that certain work 

activities in particular crops lead to 

higher levels of exposure than other 

post-application work activities (Ref. 

12). For example, harvesting fruit in 

orchards or pruning vines in a grape 

vineyard requires extensive contact with 

plant foliage that is likely to contain 

pesticide residues. When the worker 

touches the foliage, a certain amount of 

the residue transfers to the worker’s skin 

or clothing. The greater the contact is, 

the higher the residue transferred, and 

the higher the ensuing exposure. 

EPA will review the ARTF’s transfer 

coefficient studies to identify those 

work activities and crops which have 

the highest potential for postapplication exposure. The ARTF is a 

consortium of pesticide companies that 

formed a joint venture to develop data 

for use in EPA assessments of worker 

risk. The ARTF conducted a series of 

carefully controlled studies that 

measured the amount of pesticide 

residue present on workers’ clothing 

after a specific period of time working 

in a crop with known amounts of 

pesticide residue on the crop foliage. 

The ARTF set of data is very extensive, 

covering over 100 different crops—

essentially all crops, including 

greenhouses and ornamental crops, in 

which workers might come into contact 

with pesticide-treated leaf surfaces. The 

studies permit the calculation of a 

standardized ‘‘transfer coefficient’’ for 

the crop and activity.1 Activities having 

higher transfer coefficients should result 

in higher levels of worker exposure, all 

other factors being equal. 

EPA will identify those work 

activities and specific crops and crop 

categories (e.g., tree fruit crops) having 

approximately the dozen highest 

transfer coefficients to identify the 

pesticides having the highest levels of 

use on those crops. EPA will then 

identify specific crops associated with 

the highest transfer coefficients to 

obtain information from the data 

sources described in this unit. 

Specifically, EPA will estimate the total 

number of acre treatments for each 

pesticide on all of the top crops and 

then array the pesticides on the basis of 

the highest totals.2 The Agency will 

obtain information about the number of 

acre-treatments for each pesticide from 

a variety of public and private data 

sources including USDA’s National 

Agriculture Statistics Service (NASS) 

and California’s Department of Pesticide 

Regulation (CDPR). 

The USDA’s NASS has, for more than 

10 years, conducted annual surveys of 

pesticide use in a large number of crops, 

surveying thousands of agricultural 

producers in any given year. NASS 

conducts their use survey every year for 

a set of row crops. NASS also surveys 

pesticide usage on other crops, 

alternating every year between a group 

of fruit and nut crops and a group of 

vegetable crops (i.e., selected fruits/nuts 

were surveyed in 1997, 1999, 2001; 

selected vegetables were surveyed in 

1996, 1998, and 2000). NASS surveys 

States representing a majority of 

national production for a crop and 

reports a number of statistics for 

insecticide, fungicide, and herbicide use 

including: Percent crop treated, 

application rate, numbers of 

applications, acreage grown. Using these 

data, EPA can estimate the average acretreatments for the pesticides used on 

crops with the highest transfer 

coefficients. More information on NASS 

pesticide use data can be found at 

http://www.pestmanagement.info/nass. 

The State of California has reported 

annually on all agricultural pesticide 

usage in the State for almost 10 years. 

This data collection effort is managed by 

CDPR, and includes an extensive array 

of treatment information on crops 

including timing, location, area, and 

rate. These data allow EPA to calculate 

average pounds of pesticides applied for 

crops grown in California. In cases 

where crops with high transfer 

coefficients are grown in California, but 

not reported by NASS, CDPR data 

would be extremely useful. For those 

56460 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 

crops reported by both CDPR and NASS, 

data from both sources would serve to 

validate estimates. More information on 

CDPR pesticide usage data can be found 

at http://www.cdpr.ca.gov/docs/pur/ 

purmain.htm. 

EPA’s third major source of pesticide 

use information is AgroTrakTM, a 

product of Doane Marketing Research, 

Inc. (referred to here simply as Doane). 

Doane maintains a proprietary national 

database of agricultural pesticide use 

summarizing data from surveys of 

thousands of agricultural producers 

across a wide range of row and specialty 

crops. Doane has conducted an annual 

survey for more than 15 years, and 

among the statistics they publish for a 

given crop/chemical combination are 

acres grown, acres treated, and acretreatments. Although the database is 

proprietary, these data represent an 

important source of data, and can be 

compared to NASS and CDPR data to 

fill data gaps, or serve as another point 

of validation. Doane’s survey can be 

particularly useful because their 

national survey covers fruits and 

vegetables producers every year. More 

information on Doane can be found at 

http://www.doanemr.com/rowspecialty-turf/index.html. 

Basing its priorities for this pathway 

on the number of acre-treatments of 

crops with worker activities having high 

transfer coefficients should identify 

pesticides that have potential for 

relatively higher worker exposure. The 

combined criteria of crops with high 

transfer coefficients and pesticides used 

on such crops should identify those 

active ingredients with potential for 

high worker exposures. The use of the 

additional criterion of total acretreatments should identify pesticides 

with the widest use, and thus the 

potential for exposures for the largest 

number of workers. 

The criteria, however, would not 

account for any of the characteristics 

specific to the use of a particular 

pesticide on a crop that could decrease 

or increase the potential for exposure, 

such as application rate, application 

timing, and environmental fate 

characteristics. Consequently, the 

priority listing may not completely 

reflect where the highest postapplication exposures exist. 

Nevertheless, EPA believes that the 

approach described is a practicable 

approach for identifying those pesticide 

active ingredients with the potential for 

either widespread or high levels of 

exposure to post-application workers. 

E. Integration of Pathway Priorities for 

Pesticide Active Ingredients 

This unit addresses how EPA will 

integrate the information developed on 

priorities through the analysis of the 

four exposure pathways discussed Units 

VI.A. through VI.D. As its first step, the 

Agency will apply the criteria for each 

pathway to produce four lists of 

candidate chemicals for potential 

screening in the endocrine disruptor 

screening battery. EPA expects that a 

number of pesticide active ingredients 

will be identified for more than one 

pathway, and that some chemicals will 

appear only on the list for a single 

pathway. In choosing which active 

ingredients it will recommend for 

screening, EPA will give higher priority 

to chemicals that appear on multiple 

lists, with the substances appearing on 

four lists receiving the highest priority, 

followed by the group of chemicals 

appearing on three lists, followed by 

chemicals on only two lists. To the 

extent necessary to establish priorities 

within these four groups, EPA will give 

greater priority to chemicals which 

appear on the list for the food pathway 

(which generally involves the most 

widespread exposure of the four 

pathways), followed by the list for the 

occupational pathway (which generally 

involves the highest per capita levels of 

exposure of the different pathways). 

EPA will review the candidate list to 

exclude the chemicals which are being 

used as ‘‘positive controls’’ to validate 

the screening assays. Also, in making 

selections for this exposure-based initial 

list, EPA does not plan to select 

substances it anticipates as having low 

potential to cause endocrine disruption 

(e.g., certain FIFRA List 4 inerts, most 

polymers with number average 

molecular weight greater than 1,000 

daltons, strong mineral acids, and strong 

mineral bases), and considers these 

substances to be a low priority for early 

screening under the EDSP. EPA will 

also exclude any chemicals that are no 

longer used or produced in the United 

States. 

VII. Approach for Selecting High 

Production Volume Pesticide Inerts 

EPA will use several sets of criteria 

for identifying High Production Volume 

Pesticide Inerts (HPV/Inerts) that will be 

given priority for screening in the 

screening battery. In general, the Agency 

is using an approach for HPV/Inerts that 

is similar to that used for pesticide 

active ingredients. EPA will focus on 

several indicators of the potential for 

human exposure including production 

volume, specific pathways of exposure, 

and presence in human biological 

samples. While EPA’s general focus is 

on HPV/Inerts with relatively greater 

potential human exposure, this focus 

does not necessarily mean that the list 

of chemicals produced will contain no 

substances which have potentially high 

levels of environmental exposure to 

ecological receptors. Many of the HPV/ 

Inerts having greater potential for 

human exposure will also have greater 

potential for exposure to wildlife. For 

example, the databases to be reviewed 

for ecological biological monitoring data 

will directly identify certain chemicals 

to which aquatic organisms have been 

exposed (see Unit VII.B.). Similarly, 

several of the monitoring databases that 

will be reviewed for the drinking water 

pathway contain monitoring data 

collected on raw surface water (i.e., 

before the water enters a public water 

system) (see Unit VII.C.). Thus, these 

surface water monitoring data will show 

the levels of chemical to which fish, 

amphibians, and other aquatic species 

are exposed. Accordingly, EPA believes 

that the approach to evaluate HPV/ 

Inerts, while focused on human 

exposure, will also capture HPV/Inerts 

with potentially widespread 

environmental exposures. 

EPA generally has more extensive 

information available to assess potential 

exposure to pesticide active ingredients 

via food, water, occupational and 

residential exposure pathways than is 

available to assess exposure to HPV/ 

Inerts. In addition, EPA generally has 

more extensive information available on 

usage (including both agricultural and 

residential) of active ingredients than is 

available for HPV/Inerts (including both 

pesticidal and non-pesticidal uses of 

those same substances). For these 

reasons, the specific data sources and 

pathways EPA has identified for 

selecting an initial set of HPV/Inerts for 

endocrine disruptor screening differs 

somewhat from those for selecting 

pesticide active ingredients. 

First, EPA will review existing 

databases to identify chemicals that are 

both pesticide inerts and HPV 

chemicals. HPV chemicals are those 

chemicals manufactured or imported 

into the United States in amounts equal 

to or greater than one million pounds 

per year. The HPV chemicals are 

identified through information collected 

under the Toxic Substances Control 

Act’s (TSCA) Inventory Update Rule 

(IUR). IUR provides for periodic 

updating of production volume and 

other information pertaining to selected 

Inventory chemicals currently in 

commerce. Second, EPA will review 

existing databases to identify HPV/ 

Inerts that are present in four types of 

environmental media or monitoring 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 56461 

data: Human biological samples, 

ecological tissues that have human food 

uses (i.e., fish tissues), drinking water, 

and indoor air. Third, EPA will 

prioritize these chemicals based on the 

number of monitoring data types in 

which the chemicals have been 

detected. Thus, HPV/Inerts appearing in 

four types of monitoring data would be 

given higher priority than those 

appearing in only one type of 

monitoring data. To the extent it 

becomes necessary to establish priorities 

within these four types of monitoring 

data, EPA will give higher priority to 

those HPV/Inerts that appear in human 

biological monitoring data, followed by 

drinking water/indoor air monitoring 

data (weighted equally), followed by 

ecological biological data relevant to 

human exposure. 

A. High Production Volume/Inerts in 

Human Biological Monitoring Data 

EPA will review the following data 

sources to determine which HPV/Inerts 

have been detected in human biological 

samples and to identify HPV/Inerts for 

which there appears to be widespread 

human exposure, based on factors such 

as the number of samples and number 

of detections. The presence of a single 

or only a few detections of a HPV/Inert 

chemical typically would not be a 

sufficient basis for concluding that the 

chemical should be identified as having 

significant exposure. 

1. Third National Health and 

Nutrition Examination Survey. The 

Third National Health and Nutrition 

Examination Survey (NHANES III) was 

conducted between 1988 and 1994 on 

33,994 people. The survey was designed 

to obtain nationally representative 

information on the health and 

nutritional status of the U.S. population 

through interviews and direct physical 

examinations. Several studies (e.g., high 

blood pressure, immunization status, 

nutritional blood measures, etc.) were 

conducted under NHANES III. One 

study relevant to this priority-setting 

exercise is the Priority Toxicant 

Reference Range Study, previously 

referenced as Ashley et al (1994) (Ref. 

13). This NHANES III article contains 

relevant human biomonitoring data for 

over 40 volatile organic compounds 

(VOCs). Standard QA/QC procedures 

such as sample duplicates and blanks 

were used in the NHANES III Study. 

The study participants in the special 

study are not statistically representative 

of the U.S. population. 

2. National Report on Human 

Exposure to Environmental Chemicals. 

The National Report on Human 

Exposure for 2001 (Ref. 14) was a U.S. 

Department of Health and Human 

Services (HHS), Centers for Disease 

Control and Prevention (CDC) report 

that provided exposure information 

about people participating in an ongoing 

national survey of the general U.S. 

population—the NHANES. This report 

provides information on concentrations 

of 27 environmental chemicals 

measured in blood and/or urine in the 

U.S. population. The most current 2003 

Report (Ref. 15) presents exposure data 

for 116 chemicals (including the 27 

chemicals presented in the 2001 Report) 

during NHANES 1999 and 2000. VOCs 

are not included in the 2003 Report. 

Chemicals and their metabolites were 

measured in blood, urine, and blood 

serum samples from selected NHANES 

participants. These chemicals include 

metals, organophosphate pesticide 

metabolites, phthalate metabolites, and 

cotinine, a marker of exposure to 

tobacco smoke. This report will be 

updated with additional biomonitoring 

data for these same or different 

chemicals on an annual basis. 

3. National Human Adipose Tissue 

Survey. The EPA’s Office of Pollution 

Prevention and Toxics (OPPT) operated 

the National Human Monitoring 

Program (NHMP) until the early 1990s. 

The NHMP’s primary activity was 

conducting a National Human Adipose 

Tissue Survey (NHATS), which 

analyzed human adipose tissue 

specimens to monitor human exposure 

to potentially toxic chemicals. A 

nationwide network of pathologists and 

medical examiners from 47 standard 

metropolitan statistical areas (SMSAs) 

collected tissue specimens from 

cadavers and surgical patients that were 

then analyzed for certain chemicals. 

Throughout the 1970s and early 1980s, 

the chemical residues of primary 

interest were organochlorine pesticides 

and polychlorinated biphenyls (PCBs). 

In 1982, VOCs and semivolatile organic 

compounds (SVOCs) were included in 

the survey. NHATS contains relevant 

human biomonitoring data for over 150 

chemicals. Quality control samples, 

such as method and equipment blank 

samples, control samples, and spike 

samples, were collected to evaluate the 

quality of sampling data. Data are 

available for years 1970 through 1987 in 

13 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 by 

EPA, and this database was 

incorporated into the EDPSD (version 

2). (See http://www.epa.gov/scipoly/ 

oscpendo/prioritysetting/database.htm) 

In implementing its approach for 

selecting the initial list of chemicals for 

screening, EPA will consider chemicals 

contained in the database compiled for 

EDPSD and include those chemicals for 

which geometric means were calculated 

for EDSP priority-setting purposes. 

4. Total Exposure Assessment 

Methodology Study. The Total Exposure 

Assessment Methodology (TEAM) Study 

was designed to develop methods to 

measure individual total exposure 

(exposure through air, food, and water) 

and resulting body burden of toxic and 

carcinogenic chemicals, and to apply 

these methods within a probabilitybased sampling framework to estimate 

the exposures and body burdens of 

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). 

Established methods were used to 

collect and analyze TEAM Study data. 

Quality control and quality assurance 

samples collected and analyzed include 

reagent blanks, field blanks, duplicate 

samples, and spiked samples. Data were 

reported for water using units of 

measure different than those used for air 

and breath samples. Environmental and 

biological data are generally 

lognormally distributed; thus, the data’s 

central tendency is generally best 

represented using a geometric mean. 

Geometric means are provided for all 

compounds that were measured in 50% 

or more of the samples. For most of the 

compounds that were measured in less 

than 50% of the samples, a minimum 

quantifiable limit that can be used for 

ranking the data was provided. 

B. High Production Volume/Inerts in 

Ecological Biological Monitoring Data 

Relevant to Human Exposure 

EPA will review the following data 

sources to determine which HPV/Inerts 

have been detected in non-human 

tissues potentially relevant to human 

ingestion exposure and to identify HPV/ 

Inerts for which there appears to be 

widespread human exposure, based on 

factors such as the number of samples 

and number of detections. The presence 

of a single or only a few detections of 

a HPV/Inert chemical typically would 

not be a sufficient basis for concluding 

that the chemical should be identified 

as having significant exposure. 

1. National Sediment Inventory Fish 

Tissue Data (NSI Fish Tissue Data). This 

database is described in Unit VI.B.5. In 

implementing its approach for selecting 

the initial list of chemicals for 

screening, EPA will consider fish 

species tissues for samples collected 

56462 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 

after 1989 in NSI for EDSP prioritysetting purposes. 

2. National Fish Tissue Study. EPA is 

conducting a screening-level study to 

estimate the national distribution of 

selected persistent, bioaccumulative and 

toxic chemical residues in fish tissue 

from lakes and reservoirs of the 

continental United States. This 4-year 

study, which was initiated in 2000, will 

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. 

The National Fish Tissue Study is the 

first survey of fish tissue to be based on 

a random sampling design. This 

sampling design will allow EPA to 

develop national estimates of the mean 

levels of persistent, bioaccumulative, 

and toxic chemicals in fish tissue. It will 

also provide data on the largest set of 

persistent, bioaccumulative and toxic 

chemicals ever studied in fish. More 

details can be found at http:// 

www.epa.gov/waterscience/fishstudy/ 

results.htm. 

3. National Water Quality Assessment 

Program Aquatic Animal Tissue Data. 

This database, which also contains 

information on surface water and 

ground water monitoring studies, is 

described in Unit VI.B.8. The National 

Water Quality Assessment (NAWQA) 

has recently made aquatic organism 

tissue data available for a variety of 

species and tissues. EPA will consider 

NAWQA tissue data for all species and 

tissue types for the ecological biological 

monitoring exposure pathway. 

C. High Production Volume/Inerts in 

Drinking Water Monitoring Data 

EPA will review the following data 

sources to determine which HPV/Inerts 

have been detected in drinking water 

and in potential sources of drinking 

water and identify HPV/Inerts for which 

there appears to be widespread human 

exposure, based on factors such as the 

number of samples and number of 

detections. The presence of a single or 

only a few detections of a HPV/Inert 

chemical typically would not be a 

sufficient basis for concluding that the 

chemical should be identified as having 

significant exposure. 

1. National Contaminant Occurrence 

Data Base (NCOD Database). This 

database is described in Unit VI.B.6. 

2. National Human Exposure 

Assessment Survey. EPA designed the 

National Human Exposure Assessment 

Survey (NHEXAS) program to address 

some of the limitations of singlechemical and single-media exposure 

route studies. The purpose of NHEXAS 

is 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. 

EPA completed Phase 1 field sample 

collection and laboratory analyses of 

NHEXAS in 1998. EPA used established 

methods to collect and analyze 

NHEXAS data. Quality control and 

quality assurance samples collected and 

analyzed include reagent blanks, field 

blanks, duplicate samples, and spiked 

samples. Samples were split and 

analyzed in multiple laboratories; when 

appropriate audit samples were 

available, they were also analyzed. Data 

are reported for different media using 

different units of measure and different 

measures of central tendency. For 

example, arsenic concentrations are 

reported in micrograms per kilogram 

(μg/Kg) for beverages and food and in 

micrograms per liter (μg/L) for water. 

Sometimes the central tendency value is 

reported as an arithmetic mean, 

sometimes as a median, and sometimes 

as a 90th percentile. (Refs. 33–36). 

3. Total Exposure Assessment 

Methodology Water Data (TEAM Water 

Data). This study is described in Unit 

VII.A.4. 

4. National Stream Quality 

Accounting Network (NASQAN) Data. 

This database, which contains 

information on surface water monitoring 

studies, is described in Unit VI.B.7. 

5. National Water Quality Assessment 

Program (NAWQA). This database, 

which contains information on surface 

water and ground water monitoring 

studies, is described in Unit VI.B.8. 

D. High Production Volume/Inerts in 

Indoor Air Monitoring Data 

EPA will review the following data 

sources to determine which HPV/Inerts 

have been detected in residential indoor 

air and to identify HPV/Inerts for which 

there appears to be widespread human 

exposure, based on factors such as the 

number of samples and number of 

detections. The presence of a single or 

only a few detections of a HPV/Inert 

typically would not be a sufficient basis 

for concluding that the chemical should 

be identified as having significant 

exposure. 

1. Office of Research and 

Development published literature. The 

following eight EPA/Office of Research 

and Development (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) (Refs. 37–44). In 

implementing its approach for selecting 

the initial list of chemicals for 

screening, EPA will exclude the Kelly et 

al. (1994) article, as this article only 

provides outdoor air data. 

2. National Human Exposure 

Assessment Survey. The National 

Human Exposure Assessment Survey 

(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. 34–36, 44). In 

implementing its approach for selecting 

the initial list of chemicals for 

screening, EPA will consider both 

NHEXAS indoor and/or personal air 

samples for EDSP priority-setting 

purposes. 

3. Total Exposure Assessment 

Methodology Study. The Total Exposure 

Assessment Methodology (TEAM) Study 

is described in Unit VII.A.4. The ORD 

literature (see Unit VII.D.1.) includes all 

of the indoor air data collected in the 

TEAM Study; therefore, EPA will 

consider TEAM Study 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. 

E. Integration of Pathway Priorities for 

High Production Volume/Inerts 

This unit addresses how EPA will 

integrate the information developed on 

priorities through the analysis of the 

four types of exposure monitoring data 

discussed in Units VII.A. through VII.D. 

(human biological data, ecological 

biological data relevant to human 

exposure, drinking water data, and 

indoor air data). As its first step, the 

Agency will produce four lists of 

candidate chemicals, one for each type 

of monitoring data, for potential 

screening in the endocrine disruptor 

screening battery. EPA expects that a 

number of chemicals will be identified 

in more than one type of monitoring 

data and that some chemicals will 

appear only in a single type of 

monitoring data. In choosing which 

HPV/Inerts to propose for the initial 

screening list, EPA will give higher 

priority to chemicals that appear in 

multiple types of monitoring data, with 

the HPV/Inerts appearing in four types 

receiving the highest priority, three 

types the next highest priority, etc. To 

the extent it becomes necessary to 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 56463 

establish priorities within these four 

types of monitoring data, EPA will give 

greater priority to HPV/Inerts which 

appear in human biological monitoring 

data, followed by drinking water/indoor 

air monitoring data (weighted equally), 

followed by ecological biological 

monitoring data relevant to human 

exposure. EPA will also exclude any 

chemicals that are no longer produced 

or used in the United States. 

EPA will review the candidate list to 

exclude the chemicals which are being 

used as ‘‘positive controls’’ to validate 

the screening assays. Also, in making 

selections for this exposure-based initial 

list, EPA does not plan to select 

substances it anticipates as having low 

potential to cause endocrine disruption 

(e.g., certain FIFRA List 4 inerts, most 

polymers with number average 

molecular weight greater than 1,000 

daltons, strong mineral acids, and strong 

mineral bases), and considers these 

substances to be a low priority for early 

screening under the EDSP. 

VIII. Integration of the Pesticide Active 

Ingredients and High Production 

Volume/Inerts Lists 

EPA will use similar but somewhat 

different sets of criteria for identifying 

pesticide active ingredients and HPV/ 

Inerts that should be given priority 

consideration for inclusion in the initial 

round of screening. 

EPA will generate four lists of 

candidate pesticide active ingredients 

(one for each exposure pathway) and 

four lists of candidate HPV/Inerts (one 

for each type of exposure monitoring 

data). Because EPA generally has more 

extensive exposure information for 

pesticide active ingredients than for 

HPV/Inerts, the Agency does not think 

it would be appropriate to integrate the 

eight lists. Instead, EPA will separately 

select pesticide active ingredients and 

HPV/Inerts giving higher priority to 

pesticide active ingredients and HPV/ 

Inerts that appear in multiple lists of 

exposure pathways and exposure 

monitoring data types, respectively. 

Thus, the selected pesticide active 

ingredients may be those that appear in 

three or more pathways whereas the 

selected HPV/Inerts may be those that 

appear in one or more pathways. 

Finally, EPA will review the lists for 

chemical class representation (e.g., as a 

tie breaker). EPA’s intent is to select a 

total of 50 to 100 chemicals to initiate 

the screening program, but will not treat 

that overall target as a rigid quota. In 

addition, EPA may sponsor Tier 1 

screening of some of the positive control 

chemicals used for validation of the 

assays, and other chemicals, to provide 

data for comparison purposes and to test 

the performance of the battery. This 

would be in addition to the 50 to 100 

chemicals selected using the approach 

described in this notice. 

IX. References 

The following is a list of the 

documents that are specifically 

referenced in this notice. These 

references are available in the docket for 

this notice as described in Unit 1.B.1., 

under docket ID number OPPT–2004–

0109. In addition, some documents 

referenced are only available in docket 

ID number OPPT–2002–0066, which is 

the docket used for the proposed 

approach. These dockets are linked in 

EDOCKET, 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. (See 

Unit I.B.1. for information on how to 

access these dockets). 

1. EPA. Endocrine Disruptor 

Screening and Testing Advisory 

Committee Final Report. August 1998. 

Available at: http://www.epa.gov/ 

scipoly/oscpendo/edspoverview/ 

finalrpt.htm. Document ID number 

OPPT–2002–0066–0003. 

2. EPA, Science Advisory Board. 

Review of EPA’s Proposed 

Environmental Endocrine Disruptor 

Screening Program. July 1999. EPA–

SAB–EC–99–013. Available at: http:// 

www.epa.gov/science1/pdf/ec13.pdf. 

Document ID number OPPT–2002–

0066–0002. 

3. EPA. Comment Response 

Document for Endocrine Disruptor 

Chemical Selection/Priority Setting. 

November 2004. 

4. EPA. Guidelines for Ensuring and 

Maximizing the Quality, Objectivity, 

Utility, and Integrity of Information 

Disseminated by the Environmental 

Protection Agency. October 2002. EPA/ 

260R-02-008. Available at: http:// 

www.epa.gov/quality/ 

informationguidelines. 

5. EPA. Compilation of Data Source 

Summaries Prepared for High 

Production Volume (HPV) and Pesticide 

Inert Chemicals and Pesticide Active 

Ingredients Data Sources. EPA Contract 

68W02024, Task Order #69. Eastern 

Research Group, Inc. June 2005. 

6. USDA. Food Commodity Intake 

Database (FCID). July 2000. Available at: 

http://www.barc.usda.gov/bhnrc/ 

foodsurvey/fcid.html. 

7. EPA. EPA Pesticides in Ground 

Water Database, A Compilation of 

Monitoring Studies: 1971–1991 National 

Summary, EPA 734–12–92–001. 

September 1992. Document ID number 

OPPT–2002–0066–0005. 

8. USGS. Pesticides in Select Water 

Supply Reservoirs and Finished 

Drinking Water, 1999–2000: Summary 

of Results from a Pilot Monitoring 

Program. 2001. USGS Open File Report 

01–456. Document ID number OPPT–

2002–0066–0006. 

9. EPA. The Incorporation of Water 

Treatment Effects on Pesticide Removal 

and Transformation in Food Quality 

Protection Act Drinking Water 

Assessments. October 25, 2001. 

Available at: http://www.epa.gov/ 

pesticides/trac/science/ 

water_treatment.pdf. Document ID 

number OPPT–2002–0066–0007. 

10. EPA. Estimating the Drinking 

Water Component of a Dietary Exposure 

Assessment. Revised November 2, 1999. 

Available at: http://www.epa.gov/ 

fedrgstr/EPA-PEST/1999/November/ 

Day-10/6044.pdf. Document ID number 

OPPT–2002–0066–0008. 

11. EPA. EPA Background Paper for 

the FIFRA Scientific Advisory Panel 

Meeting on Monitoring Strategies for 

Pesticides in Surface–Derived Drinking 

Water. June 2000. Available at: http:// 

www.epa.gov/scipoly/sap/2000/june/ 

drinkingwatersurvey.pdf. Document ID 

number OPPT–2002–0066–0009. 

12. EPA. Science Advisory Council on 

Exposure, Policy Number 003.1, 

Agricultural Transfer Coefficients. 

Document ID number OPPT–2002–

0066–0010. 

13. 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. Document ID 

number OPPT–2002–0066–0011. 

14. HHS, CDC. National Report on 

Human Exposure to Environmental 

Chemicals. March 2001. Document ID 

number OPPT–2002–0066–0012. 

15. HHS, CDC. Second National 

Report on Human Exposure to 

Environmental Chemicals. January 

2003. Available at: http://www.cdc.gov/ 

exposurereport/2nd/pdf/secondner.pdf. 

16. EPA. Chlorinated Dioxins and 

Furans in the General U.S. Population: 

NHATS FY87 Results—Executive 

Summary. EPA–560/5–91–003. May 

1991. Document ID number OPPT–

2002–0066–0013. 

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, 

56464 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 

1990. Document ID number OPPT–

2002–0066–0014. 

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. Document ID number 

OPPT–2002–0066–0015. 

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. Document 

ID number OPPT–2002–0066–0016. 

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. Document ID number OPPT–

2002–0066–0017. 

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. Document ID number OPPT–

2002–0066–0018. 

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. 

Document ID number OPPT–2002–

0066–0019. 

23. Orban, John E.; Stanley, John S.; 

Schwemberger, John G.; and Remmers, 

Janet C. Dioxins and Dibenzofurans in 

Adipose Tissue of the General US 

Population and Selected 

Subpopulations. American Journal of 

Public Health. 1994 84: 439–445. 

Document ID number OPPT–2002–

0066–0020. 

24. EPA. Semivolatile Organic 

Compounds in the General U.S. 

Population: NHATS FY86 Results—

Volume I. EPA–747–R–94–001. July 

1994. Document ID number OPPT–

2002–0066–0021. 

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. Document ID number 

OPPT–2002–0066–0022. 

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. 

Document ID number OPPT–2002–

0066–0023. 

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. Document ID number OPPT–

2002–0066–0024. 

28. Stanley, John S. Broad Scan 

Analysis of Human Adipose Tissue: 

Volume IV—Polychlorinated Dibenzo-pDioxins (PCDDs) and Polychlorinated 

Dibenzofurans (PCDFs): Final Report. 

EPA–560/5–86–038 (NTIS PB87–

177234). December 1986. Document ID 

number OPPT–2002–0066–0025. 

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. 

Document ID number OPPT–2002–

0066–0026. 

30. 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. Document ID 

number OPPT–2002–0066–0027. 

31. 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. Document ID 

number OPPT–2002–0066–0028. 

32. Wallace, Lance. Project Summary: 

The Total Exposure Assessment 

Methodology (TEAM) Study. EPA/600/ 

S6–87/002. September 1987. Document 

ID number OPPT–2002–0066–0029. 

33. Thomas, Kent W.; Pelizzari, Edo 

D.; and Berry, Maurice R. Populationbased dietary intakes and tap water 

concentrations for selected elements in 

EPA Region V National Human 

Exposure Assessment Survey 

(NHEXAS).Journal of Exposure and 

Environmental Epidemiology. 1999. 9: 

402–413. Document ID number OPPT–

2002–0066–0030. 

34. Clayton, C.A.; Pellizzari, 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. 

Document ID number OPPT–2002–

0066–0031. 

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. 

Document ID number OPPT–2002–

0066–0032. 

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. 

Document ID number OPPT–2002–

0066–0033. 

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: 123–134. Document 

ID number OPPT–2002–0066–0034. 

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. Document ID number 

OPPT–2002–0066–0035. 

39. Kelly, Thomas J.; Mukund, R.; 

Spicer, Chester W.; and Pollack, Albert 

J. Concentrations and Transformations 

of Hazardous Air Pollutants. 

Environmental Science and Technology. 

1994. 28: 378A–387A. Document ID 

number OPPT–2002–0066–0036. 

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. 

Document ID number OPPT–2002–

0066–0037. 

41. Samfield, Max M. Indoor Air 

Quality Data Base for Organic 

Compounds. EPA–600–R–92–025 (NTIS 

PB92–158468). February 1992. 

Document ID number OPPT–2002–

0066–0038. 

42. Shah, Jitendra J. and Singh, 

Hanwant B. Distribution of Volatile 

Organic Chemicals in Outdoor and 

Indoor Air. A National VOCs Data Base. 

Environmental Science and Technology. 

1988. 22: 1381–1388. Document ID 

number OPPT–2002–0066–0039. 

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. Document ID number 

OPPT–2002–0066–0040. 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 56465 

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. 

Document ID number OPPT–2002–

0066–0041. 

45. Gordon, Sydney M.; Callahan, 

Patrick J.; Nishioka, Marcia G.; 

Brinkman, Marielle C.; O’Rourke, Mary 

Kay; Lebowitz, Michael D.; and 

Moschandreas, Demetrios. 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: 456–470. 

Document ID number OPPT–2002–

0066–0042. 

X. Statutory and Executive Order 

Reviews 

This notice describes the approach 

that EPA intends to use to identify the 

first 50 to 100 chemicals to be screened 

under the EDSP. It represents a 

statement of Agency policy in this 

respect, but does not impose any 

requirements. As a policy statement 

related to a new program and the 

potential for novel policy issues to arise 

during this initial implementation of the 

statutory mandate in section 408(p) of 

FFDCA, the Office of Management and 

Budget (OMB) has designated this 

notice as ‘‘significant’’ under section 3(f) 

of Executive Order 12866, entitled 

Regulatory Planning and Review (58 FR 

51735, October 4, 1993). The Agency 

therefore submitted this notice to OMB 

for review under this Executive order, 

and any changes made in response to 

recommendations or comments received 

from OMB during that review have been 

documented in the public docket as 

required by the Executive order. 

Since this notice is not a regulation 

and does not otherwise impose any 

requirements, it does not qualify as an 

economically significant action under 

section 3(f)(1) of Executive Order 12866. 

As such, this action is not subject to 

Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997), or 

Executive Order 13211, entitled Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). Nor does this notice contain 

any information collection requirements 

that require review and approval by 

OMB pursuant to the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501 et seq.). 

Since this type of action does not 

require any proposal, no action is 

needed under the Regulatory Flexibility 

Act (RFA) (5 U.S.C. 601 et seq.), and 

since this action does not involve any 

technical standards, section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (NTTAA), 

Public Law 104–113, section 12(d) (15 

U.S.C. 272 note), does not apply. 

For the same reason, this action will 

not have substantial direct effects on 

State or tribal governments, on the 

relationship between the Federal 

Government and States or Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and States or Indian tribes. 

As a result, this action does not require 

any action under Executive Order 

13132, entitled Federalism (64 FR 

43255, August 10, 1999), or under 

Executive Order 13175, entitled 

Consultation and Coordination with 

Indian Tribal Governments (65 FR 

67249, November 6, 2000). Nor does it 

impose any enforceable duty or contain 

any unfunded mandate or otherwise 

require any action under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

Nor does this action require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

In addition, although not a final 

action that requires action under the 

Congressional Review Act, 5 U.S.C. 801 

et seq., which generally provides that 

before a final action may take effect, the 

issuing Agency must submit a report to 

each House of the Congress and the 

Comptroller General of the United 

States, EPA has submitted a courtesy 

copy of this notice to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to its publication in the 

Federal Register. 

List of Subjects 

Environmental protection, Chemicals, 

Endocrine disruptors, Pesticides and 

pests. 

Dated: August 8, 2005. 

Susan B. Hazen, 

Acting Assistant Administrator, Office of 

Prevention, Pesticides and Toxic Substances. 

[FR Doc. 05–19260 Filed 9–26–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–7975–3] 

New Hampshire Sanitation Device 

Standard; Notice of Determination 

This Notice of Determination is for all 

New Hampshire coastal waters. 

On July 8, 2005 notice was published 

that the State of New Hampshire had 

petitioned the Regional Administrator, 

Environmental Protection Agency, to 

determine that adequate facilities for the 

safe and sanitary removal and treatment 

of sewage from all vessels are 

reasonably available for all coastal 

waters of New Hampshire. The petition 

was filed pursuant to section 312(f)(3) of 

Public Law 92–500, as amended by 

Public laws 95–217 and 100–4, for the 

purpose of declaring these waters a ‘‘No 

Discharge Area’’ (NDA). 

Section 312(f)(3) states: After the 

effective date of the initial standards 

and regulations promulgated under this 

section, if any State determines that the 

protection and enhancement of the 

quality of some or all of the waters 

within such States require greater 

environmental protection, such State 

may completely prohibit the discharge 

from all vessels of any sewage, whether 

treated or not, into such waters, except 

that no such prohibition shall apply 

until the Administrator determines that 

adequate facilities for the safe and 

sanitary removal and treatment of 

sewage from all vessels are reasonably 

available for such water to which such 

prohibition would apply. 

The information submitted to me by 

the State of New Hampshire certified 

that there are six disposal facilities 

available to service vessels operating in 

the coastal waters of New Hampshire. A 

list of the facilities, phone numbers, 

locations, and hours of operation is 

appended at the end of the 

determination. 

Based on the examination of the 

petition and its supporting information, 

which included site visits by EPA New 

England staff, I have determined that 

adequate facilities for the safe and 

sanitary removal and treatment of 

sewage from all vessels are reasonably 

available for the area covered under this 

determination. 

The area covered under this 

determination is: