P

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81686 Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Notice s

ENVIRONMENTAL PROTECTION Agency, 1200 Pennsylvania Ave ., NW., verified the accuracy of these addresses

AGENCY Washington, DC 20460 ; telephone at the time of signature . However, since

[OPPTS-42213 ; AR-201 ; FRL-6754-6] number: (202) 554-1404; e-mail address: EPA is not responsible for these nonTSCAHotline@epa .gov. EPA sites, the Agency does not exercise

Data Collection and Development on

For technical information contact : any control over these addresses. A

High Production Volume (HPV) Barbara Leczynski, Existing Chemicals paper copy of any document referenced

Chemicals Branch, Chemical Control Division in this way has been included in th e

(7405), Office of Pollution Prevention public version of the official record for

AGENCY : Environmental Protection and Toxics, Environmental Protection this document as described in Unit

Agency (EPA). Agency, 1200 Pennsylvania Ave., NW., I.B .2 .

ACTION : Notice. Washington, DC 20460; telephone 2 . In person . The official record for

number: (202) 260-3945; fax number: this document, which includes the

SUMMARY : Although HPV chemicals are (202) 260-1096; e-mail address: public version, has been established

produced or imported in large quantities chem .rtk@epa .gov. under docket control number OPPTSin the United States, there is little or no

SUPPLEMENTARY INFORMATION :

42213 and administrative record

publicly available information regarding number AR-201. This official record

the potential hazards associated with I . General Information consists of the documents referenced in

most HPV chemicals. In order to obtain

A. Does this Document Apply to Me? this document, as well as any comments

such information, EPA has established a received, and other information related

data collection and development This document applies to the public to this document, including information

program for existing HPV chemicals. in general and, in particular, those claimed as Confidential Business

Through the HPV Initiative, which companies that manufacture (defined by Information (CBI) . This official record

includes the voluntary HPV Challenge statute to include import) industrial includes the documents that are

Program, certain international efforts, chemicals for which the aggregate U .S. physically located in the docket, as well

and potential rulemaking under the production/importation volumes meet as all documents that are referenced in

Toxic Substances Control Act (TSCA), or exceed 1 million pounds per year. those documents. The public version of

basic screening level hazard data Those chemicals that meet these criteria the official record does not include any

necessary to provide critical information are referred to as HPV chemicals . The information claimed as CBI. The public

about the environmental fate and HPV chemicals that are included in the version of the official record, which

potential hazards associated with HPV voluntary HPV Challenge Program are includes printed, paper versions of any

chemicals will be collected or, where listed in ChemHTKHPV Challenge electronic comments that may be

necessary, developed. A primary Program Chemical List (Ref. 1) . If you submitted, is available for inspection in

component of this HPV Initiative is the have any questions regarding the the TSCA Nonconfidential Information

voluntary HPV Challenge Program, applicability of this action to a Center, Northeast Mall, Rm . NE B-607,

which was created in cooperation with particular entity, consult the technical Waterside Mall, 401 M St., SW.,

industry, environmental groups, and person listed under FOR FURTHER Washington, DC. The Center is open to

other interested parties, and is designed INFORMATION CONTACT. the public from noon to 4 p .m., Monday

to assemble basic screening level test B. How Can I Get Additional through Friday, excluding legal

data on the potential hazards of HPV Information, Including Copies of this holidays. The telephone number of the

chemicals while avoiding unnecessary Document and Support Documents? Center is (202) 260-7099 .

or duplicative testing . Data needs which 1 . Electronically. You may obtain C. Can I Submit Comments Under the

remain unmet in the voluntary HPV copies of this document, and certain Voluntary HPV Challenge Program?

Challenge Program, may be addressed other related documents that might be Yes. Although this document does not

through the international efforts or available electronically, from the EPA establish a specific comment period, rulemaking

. Data collected and/or Internet Home Page at http :// you may submit comments at various developed under the HPV Initiative will www

.epa.gov/. To access this times throughout the voluntary HPV

provide critical basic information about document, on the Home Page select Challenge Program. This document

the environmental fate and potential "Laws and Regulations," "Regulations describes the various opportunities that

hazards associated with these chemicals and Proposed Rules," then look up the are available for you to submi t

which, when combined with entry for this document under the comments under the voluntary HPV information about exposure and uses, "

will allow the Agency and others to Documents Federal Register-Environmental Challenge Program. In addition, specific

." You can also go directly to information about the voluntary HPV evaluate and prioritize potential health the

Federal Register listings at http :// Challenge Program and th e and environmental effects and take www

.epa.gov/fedrgstr/. To access the opportunities for you to submi t

appropriate follow up action

. EPA has OPPTS Harmonized Guidelines comments is provided on the Agency's taken steps, as described in thi

s document, to consider animal welfare referenced in this document, go directly web site identified in Unit I .B.1 .

and to provide instructions on ways to to the guidelines at http ://www.epa .gov/ In general, you may submit comments

reduce or in some cases eliminate opptsfrs/home/guidelin .htm. under the voluntary HPV Challenge

animal testing, while at the same time You may also access additional Program via the following methods: The

ensuring that the public health is information about the Chemical Right- mail, in person, or electronically . To

protected. to-Know Program at http:// ensure proper receipt by EPA, please

www.epa .gov/chemrtk/ or about the identify the docket control number

FOR FURTHER INFORMATION CONTACT : For TSCA testing program at http :// OPPTS-42213 and the administrative

general information contact : Barbara www.epa .gov/opptintr/chemtest/ record number AR-201 in the subject

Cunningham, Acting Director, sct4main.htm. line on the first page of your response .

Environmental Assistance Division For your convenience, EPA has also In addition, Challenge Program sponsors

(7408), Office of Pollution Prevention provided some non-EPA internet should reference the unique seven-digit

and Toxics, Environmental Protection addresses. In doing so, the Agency has registration number they were assigned
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Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Notices 81687

when the Agency verified the not contain the information claimed as certain basic information about HPV

information presented in their original CBI must be submitted for inclusion in chemicals available to the public .

commitment letters. Sponsors who need the public version of the official record . EPA plans to make available to th e

to confirm their registration numbers Information not marked confidential public the summarized data obtained on

should call (202) 260-6199. will be included in the public version HPV chemicals. In addition, any

1 . By mail. Submit your comments to : of the official record without prior subsequent information that EPA

Carol Browner, Administrator, notice. If you have any questions about receives will be shared with the public,

Environmental Protection Agency, P.O . CBI or the procedures for claiming CBI, other Federal agencies, and any other

Box 1473, Merrifield, VA 22116, consult the technical person listed interested parties. As appropriate, this

Attention: Chemical Right-to-Know under FOR FURTHER INFORMATION information will be used to ensure a

Program. CONTACT. scientifically sound basis for risk

2 . In person or by courier. Deliver assessment/management actions. This

your comments to : OPPT Document II. Background initiative will serve to further the

Control Office (DCO) in East Tower Rm . A. Why is EPA Pursuing Hazard Agency's goal of identifying and

G-099, Waterside Mall, 401 M St., SW., Information on HPV Chemicals? controlling human and environmental

Washington, DC. The DCO is open from risks as well as providing greater

8 a .m. to 4 p .m., Monday through EPA found that, of those non- protection and knowledge to the public .

Friday, excluding legal holidays . The polymeric organic substances produced In addition, EPA and other parties

telephone number for the DCO is (202) or imported in amounts equal to or agreed to work with other nations and

260-7093 . greater than 1 million pounds per year international groups to ensure

3 . Electronically. Submit your based on 1990 reporting for EPA's commensurate increases in the pace of

comments electronically by e-mail to Inventory Update Rule (IUR) (40 CFR complementary voluntary international

oppt.ncic@epa.gov, hpv .crtk@epa .gov, part 710), only 7% have a full set of data collection and development efforts

and chem.rtk@epa.gov (please be sure to publicly available internationally on HPV chemicals .

send your e-mail to all three addresses) . recognized basic health and This ChemRTK initiative is consistent

(Note : To submit comments on a test environmental fate/effects screening test with the U.S. policy as presented in

plan, please go to http ://www.epa .gov/ data (Ref. 2). Of the over 2,800 HPV section 2(b)(1) of TSCA, 15 U .S.C.

chemrtk/viewsrch .htm.) Do not submit chemicals based on 1990 data, 43% 2601(b)(1), which states that it is the

any information electronically that you have no publicly available basic hazard policy of the United States tha t

consider to be CBI. Electronic comments data . For the remaining chemicals, "adequate data should be developed

must be submitted as an ASCII file limited amounts of the data are with respect to the effect of chemical

avoiding the use of special characters available . This lack of available hazard substances and mixtures on health and

and any form of encryption . Comments the environment and that the

will also be accepted on standard data compromises EPA's and others' development of such data should be the ability to determine whether these HPV

computer disks in WordPerfect 6.1/8 or chemicals pose potential risks to human responsibility of those who manufacture

ASCII file format, mailed or delivered to health or the environment, as well as and those who process such chemical

the address identified in Unit I.C. All the public's right-to-know about the substances and mixtures . "

comments in electronic form must be hazards of chemicals that are found in B. What do we Currently Know about

identified by docket control number their environment, their homes, their the Basic Health and Environmental

OPPTS-42213 and administrative workplaces, and the products that they Hazards of HPV Chemicals ?

record number AR-201 . Electronic buy. It is EPA's intent to close this

comments may also be filed online at knowledge EPA believes that for The information relevant to

many Federal Depository Libraries. gap. understanding the basic health and most of the HPV chemicals, insufficient environmental hazards of HPV

D. How Should I Handle CBI Comments data are readily available to reasonably chemicals is derived from a battery of

that I Want to Submit to the Agency? determine or predict the effects on tests agreed upon by the international

Considering that one of the goals of health or the environment from the community as appropriate for screenin g

the HPV Initiative is to provide manufacture (including importation), international HPV chemical substances

information needed to meet the public's distribution in commerce, processing, for toxicity . Six basic testing endpoints

right-to-know about the hazards that use, or disposal of the chemicals, or any have been adopted by the Organization

may be posed by exposure to HPV combination of these activities. EPA has for Economic Cooperation and

chemicals, EPA encourages companies concluded that a program to collect and, Development (OECD) as the minimum

and other interested parties not to make where needed, develop basic screening required to screen international HPV

CBI claims in submitted comments. If level toxicity data is necessary and chemical substances for toxicity (Ref . 3).

you do choose to submit CBI in your appropriate to provide information in The agreed-upon testing endpoints,

comments, adhere to the following order to assess the potential hazards/ known as the OECD's "Screening

procedures . Do not submit any risks that may be posed by exposure to Information Data Set" (SIDS) include :

information electronically that you HPV chemicals . Acute toxicity; repeat dose toxicity ;

consider to be CBI. You may claim On April 21, 1998, a national developmental and reproductive

information that you submit to EPA in initiative, known as the "Chemical toxicity ; mutagenicity (gene mutation

response to this document as CBI by Right-To-Know" Program, was and chromosomal aberration/damage

marking any part or all of that announced in order to empower citizens assays) ; ecotoxicity (studies in fish,

information as CBI. Information so with knowledge about the most invertebrates, and algae) ; and

marked will not be disclosed except in widespread chemicals in commerce- environmental fate (including physical/

accordance with procedures set forth in chemicals that people may be exposed chemical properties [melting point ,

40 CFR part 2. In addition to one to in the places where they live, work, boiling point, vapor pressure, n-octanol/

complete version of the comment that study, and play. EPA's Chemical Right- water partition coefficient, and water

includes any information claimed as To-Know (ChemRTK) initiative is being solubility], photolysis, hydrolysis ,

CBI, a copy of the comment that does designed in such a way as to make transport/distribution, and
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81688 Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Notice s

biodegradation). As conceived by the HPV substances. Details of the search relevant information to the Agency that

OECD, the "SIDS battery" of tests can be strategy used can be found in the ACC indicates that certain endpoints need

used by governments to conduct an report (Ref. 5). not be tested. If EPA judges the available

initial assessment of the hazards and EPA recognizes that additional data data to be adequate, the data gap

risks posed by HPV chemical substances may exist beyond those identified identified in the HPV Initiative will be

and prioritize HPV chemicals to identify through either the EPA, ACC, or considered to be filled . To the extent those in need of additional, more in- Environmental Defense studies. To the that additional data relevant to the HPV

depth testing and assessment. extent that additional relevant data are chemicals are known to exist, EPA i s

A need for basic screening level data known to exist, EPA is particularly interested in receiving this information

on HPV chemicals has been identified interested in receiving this information under the voluntary HPV Challenge

and supported by various data as part of the HPV Initiative, including, Program, including a full citation for

availability studies conducted by EPA where possible, a full citation for publications and full copies o f

and others. Toxic Ignorance, which was publications and "robust" (i .e ., detailed) unpublished studies. Although the

prepared by Environmental Defense summaries of pertinent published and Agency encourages anyone with such

(formerly the Environmental Defense unpublished studies . Guidance on the information to submit it to EPA during

Fund), raised a variety of concerns preparation of robust summaries is the early stages of this initiative in order

about the untested chemicals that are available on EPA's ChemRTK web site to avoid any unnecessary testing, such

produced and/or imported into the (Ref. 6)

United States (Ref . In developing the testing submissions may be made at any time .. 4). Environmental requirements for chemicals contained in Commenters are also encouraged to

Defense found that baseline data on the HPV Initiative, EPA is utilizing prepare a robust summary (Ref. 6) for health effects were not publicly information and sources in EPA's study, each study to facilitate EPA's review of

available for a selected set of 100 HPV the Chemical Hazard Data Availability the full-study report or publication . It is chemicals. Study (Ref. 2), and ACC's report, i.e, important to note that EPA does not

In April 1998, EPA completed a study Public Availability of SIDS-Related intend to include any chemicals which entitled Chemical Hazard Data Testing Data for U.S. High Production

Availability Study are Generally Recognized as Safe : What Do We Really Volume Chemicals (Ref. 5), to determine (GRAS) for a particular use by the Food Know About the Safety of High

whether screening level data for and Drug Administration (FDA) in its Production Volume Chemicals

?

. (Ref. 2) characterizing the hazards of these HPV initial TSCA section 4 HPV SID S that evaluated the "public availability" chemicals are publicly available

. Under rulemaking for certain HPV chemicals . of health hazard data and environmental the voluntary HPV Challenge Program, However, such chemicals may be

hazard/fate data on HPV chemicals. EPA is utilizing the 120 day comment included in a future TSCA section 4

EPA's study found major gaps in the period for test plans to allow for further HPV SIDS rulemaking where SIDS data

basic information on HPV chemicals identification of existing data

. If no data needs remain unmet . that is readily available to EPA and to are available for a SIDS testin g

the public, and reinforced the need for endpoint, there cannot be sufficient data C. Why is EPA Focusing on HPV

governmental leadership on this issue . to characterize the potential hazards/ Chemicals ?

The study analyzed the availability of risks associated with the chemical. As It is generally accepted that chemicals test data for 2,863 HPV chemicals the Agency found in its study, having a high level of production have

(defined as those organic substances insufficient data are available to an increased potential for exposure in

produced in or imported into the United characterize many of the HPV chemicals comparison to low production volume

States in amounts equal to or greater with respect to the internationally chemicals

. The HPV focus of the HPV than 1 million pounds per year based on accepted SIDS testing endpoints, Initiative is derived from the experience

1990 reporting for EPA's JUR). EPA including acute toxicity, repeat dose gained over the past 15 years by EPA

searched for publicly available data on toxicity, developmental and and the OECD

. The OECD is an

these chemicals and learned that most reproductive toxicity, mutagenicity intergovernmental organizatio

n of them may never have been tested for (gene mutation and chromosomal consisting of 29 developed countries,

any or most of the SIDS endpoints. The aberration assays), ecotoxicity (tests in including the United States, wit

h search strategy used a total of 11 fish, Daphnia, and algae), and for advanced worldwide market economies

. publicly accessible databases in its environmental fate (including five tests The OECD is helping coordinate a

analysis . Details of the search strategy for physical chemical properties cooperative, international effort t

can be found in the report (Ref. 2) o . The [melting point, boiling point, vapor secure basic toxicity information on

major conclusions of EPA's study are pressure, n-octanol/water partition HPV chemicals in use worldwide

described in Unit II.A .

. coefficient, and water solubility], and The OECD, after consideri

In June 1998, the American Chemistry biodegradation) n

. As a result, EPA and g a variety

Council (ACC, formerly the Chemical others cannot reasonably determine or of priority setting approaches,

Manufacturers Association (CMA)) predict the human health and concluded in 1990 that consideration of

issued a report (Ref. 5) regarding public environmental effects resulting from HPV status provided a useful an d

data availability for HPV chemicals manufacture, processing, and use of effective organizing focus for a

based on a study conducted with 11 these chemical substances. voluntary testing and assessment effort

main data sources, including data EPA solicits comment concerning the to screen and thereby identify priorities

sources other than those searched by availability of SIDS data on the among international HPV chemicals .

EPA for its study. The ACC report, chemicals included in the HPV III. HPV Chemical Data Collection and entitled Public Availability of SIDS- Initiative and encourages industry and Development Initiative

Related Testing Data for U.S. High other interested parties to identify an d

Production Volume Chemicals (Ref. 5), provide any additional existing data A. What is the HPV Initiative?

reached conclusions similar to EPA, that which are relevant to the hazard Through the HPV Initiative, which

is, that only limited toxicity and characterization to avoid any includes the voluntary HPV Challenge

environmental fate testing data appear unnecessary or duplicative testing. Program, certain international efforts,

to exist in the public domain for many Furthermore, anyone may provide any and potential rulemaking under TSCA,
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Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Notices 81689

basic screening level hazard data B. Which Industrial Chemicals are Challenge Program Framework

necessary to provide critical information Covered in this HPV Initiative? Document, as quoted on the EP A

about the environmental fate and 1 . How were chemicals identified for Chemical Right-to-Know web site :

potential hazards associated with HPV inclusion in the HPV Initiative? The "Substances that sponsors verify are no

chemicals will be collected or, where industrial chemicals covered by the longer "HPV" and are not likely to

necessary, developed. These data, when HPV Initiative are those non-polymeric become HPV again will not require

combined with information about organic chemicals that are produced in, testing and will be removed from the

exposure and uses, will allow the or imported into, the United States in list . "

Agency and others to evaluate and amounts equal to, or greater than, 1 In accordance with the policy

prioritize potential health and million pounds per year according to announced in the guidance document

environmental effects and take the 1990 IUR. This list of HPV (Ref. 9), EPA has set the minimum

appropriate follow up . Created in chemicals can be viewed at EPA's criteria for identifying chemicals as no

cooperation with industry, ChemRTK web site (Ref. 1). longer HPV as a total annual aggregate

environmental groups, and other 2 . How will chemicals that are solely production

o pounds for the last two IUR reporting

interested parties, a primary component produced as closed system

of this initiative is the voluntary HPV intermediates be included in the HPV cycles documentation demonstrating

Challenge Program. To fill any data gaps Initiative? Chemicals which meet the that the current aggregate U .S.

not addressed as part of the voluntary requirements for "closed system production/importation volume of a

HPV Challenge Program, EPA is intermediates" as described in an chemical was substantially less than 1

continuing to participate in the available guidance document (Ref. 7 and million pounds per year and was likely

international efforts coordinated by the Unit IV .B .1 .) on this topic, will be to remain so was required as described

OECD to secure basic hazard eligible for a reduced SIDS testing in the guidance document (Ref. 9). This

information on HPV chemicals in use battery . For further information you justification had to have been provided

worldwide, including some of those on should check EPA's ChemRTK web site for all U .S. producers and importers of

the HPV chemicals list. The voluntary (Ref. 7) to obtain a copy of this the chemical . Once it has bee n

document. EPA's guidance is based on established via specifi c Challenge Program and the section 3

.6 of the Screening Information

epecific requests

international efforts will be received before the end of the voluntary

supplemented by rulemaking under Data Set (SIDS) Manual which concerns HPV Challenge Program sign up period

"intermediates contained in closed that a chemical is "no longer HPV" an TSCA, which the Agency intends to use systems d

." The requirements for is not likely to become an HPV chemical

to collect or develop data on those HPV classification as a closed system again, EPA ould remove the chemical

chemical substances for which data intermediate must be met by all U .S . from the HPV Initiative .

needs remain unmet in the voluntary manufacturers (including importers) for 4 . How will EPA handle HPV

HPV Challenge Program, or as part of a chemical to be eligible for a reduce d

the international efforts.

chemicals that do not warrant any

level of testing. Under the voluntary further SIDS testing? As of November 9,

Although an important component of HPV Challenge Program, EPA asked that 2000, EPA has determined that for 44

the HPV Initiative is the potential for participants in that program observe HPV chemicals, SIDS level testing is not

TSCA rulemaking to address any data certain principles laid out in an October warranted . These chemicals ar e

needs identified that are not met by 14, 1999, letter (Ref. 8). One principle is identified on the Agency's web site at

either the voluntary HPV Challenge that participants shall not develop sub- http ://www.epa .gov/chemrtk/

Program or international efforts, the chronic or reproductive toxicity data for hpv_1990 .htm. EPA's preliminary

focus of this document is the voluntary the HPV chemicals that are solely closed review of these chemicals indicates that

HPV Challenge Program . The specific system intermediates as defined by the testing using the SIDS base set would

requirements for any associated TSCA OECD/SIDS guidelines, and that testing not further our understanding of the

section 4 HPV SIDS rulemaking will be of closed system intermediates shall be chemicals' properties . These chemicals

addressed in that rulemaking. deferred until 2003. are identified on the voluntary HPV

The voluntary HPV Challenge 3 . Are HPV Chemicals that are no Challenge Program Chemical List (Ref.

Program and any associated rulemaking, longer produced or imported included 1) with an indicator value of "1 ." EPA

will generally be carried out in a in this HPV Initiative? EPA previously has invited, and continues to invite,

manner consistent with the OECD HPV issued guidance for verifying that a industry and other interested parties to

SIDS Program to ensure that the data chemical is "no longer HPV" (based on identify additional chemicals that migh t

national aggregate production/ be appropriate for this designation . This

and information generated can be importation volume) and is not likely to identification process would take the

contributed to the international efforts become HPV in the future . This form of a review of the availabl e

and, conversely, that international SIDS guidance document can be found on the information which shows that, for a

testing and assessments can be used to Agency's ChemRTK web site (Ref. 9) . given chemical, conducting the SIDS

fulfill the data gaps identified as part of For EPA to conclude that a "no longer battery of tests would not be of value in

the voluntary HPV Challenge Program HPV" claim is valid, a chemical cannot furthering an understanding of the

or in related TSCA section 4 HPV SIDS be produced by any company or group chemical's properties including

rulemaking thus avoiding unnecessary of companies at a total aggregate physical/chemical, environmental fate,

or duplicative testing and its associated production volume of 1 million pounds environmental toxicity, and mammalian

costs. The elements of this strategy and per year or greater, and the chemical toxicity endpoints . Alternatively, for

the overall approach that EPA is using must be shown as not likely to become well-tested chemicals, companies ar e

to address data collection needs for HPV an HPV chemical in the future, based on encouraged to provide the information

chemicals are discussed in this business plans, past production in a "no test" test plan along with

document, along with the components patterns, and credible trends in the robust summaries of the existing data

of the voluntary HPV Challenge market. These conditions are intended which indicate that no testing is

Program . to satisfy the terms of the voluntary HPV required . In addition, as part of EPA's
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81690 Federal Register/Vol . 65, No. 248/Tuesday, December 26, 2000/Notices

efforts under the OECD HPV SIDS and levels of exposure, can be submitted Initiative and reporting requirements

Program, the Agency will be working under the HPV Initiative . The basic under TSCA section 8(e). In response to

with other OECD member countries to exposure information could be similar these concerns, and as part of the

identify chemicals for which adequate to that gathered as part of the OECD Agency's efforts to encourage the fullest

data may have been produced in the HPV SIDS Program. EPA encourages use of existing test data, EPA intends to

context of foreign regulatory or testing companies to provide exposure consider existing data submissions

regimes. information to help place the hazard under the voluntary HPV Challenge

C. What Information is Being Collected information into an appropriate context. Program in the manner described in an

on HPV Chemicals? Additional guidance may be made October 14, 1999, letter to program

available at EPA's ChemRTK web site or participants (herein after "the Octobe r

The OECD member countries reached through other means. In the interim, the 14, 1999, letter") (Ref. 8) . EPA's

consensus in 1990 on a set of basic voluntary HPV Challenge Program voluntary HPV Challenge Program

screening-level tests deemed needed for sponsors are encouraged to consult guidance document on literatur e

all international HPV chemicals . This Annex 5 of the SIDS Manual (Ref. 3) searches deals with part of this issue OECD understanding was captured in a which presents the exposure (Ref. 18). EPA believes that it is in the formal 1991 OECD decision (Ref. 10) information recommendations economic best interest of companies to

with which the United States concurred . developed by the Use and Exposure identify and make publicly available all

This decision resulted in the OECD HPV Information Project (UEIP) in the United relevant existing data in order to reduce

SIDS Program, which is part of the States. possible testing costs. To the extent that

OECD overall program on existing The OECD HPV SIDS Program data exist which address any SIDS

chemicals. The OECD HPV SIDS review includes the step of preparing an initial endpoints, the voluntary HPV Challenge

process includes information on the assessment of the SIDS data . Although Program is designed to ensure that

identity of each chemical, its uses, this step is not formally included as an sponsors identify and use such data to

sources and extent of exposure ; physical element in the voluntary HPV Challenge fill the related data gap(s) identified . In and chemical properties; environmental Program commitment, EPA encourages addition, EPA plans to post a n

fate ; and certain limited toxicity data for sponsors to prepare an initial announcement on its ChemRTK web

humans and the environment . The SIDS assessment using the OECD's procedure site for incoming test plans . Many of

data set is not intended to describe a for preparing a SIDS Initial Assessment these test plans will also be submitted

chemical thoroughly, but rather is Report (SIAR) that can be subsequently electronically by sponsors to the "US

intended to provide enough information reviewed through the OECD HPV SIDS HPV Chemical Tracking System" (Ref

.

to support an initial (or screening level) Program . The International Council of 19) .

assessment and to assign a priority for Chemical Associations' (ICCA) (Ref . 11) Studies that have been conducted as further work, if necessary. To date, the HPV Initiative, which complements the specified in appropriate OECD test

OECD has initiated or completed work OECD's HPV SIDS Program, has guidelines (as noted in the SIDS Manual

on over 350 HPV chemicals. The OECD committed to completing the full SIDS (Ref. 3) or comparable EPA test

HPV SIDS Program seeks the battery and preparing a SIAR . guidelines (such as the OPPTS

development of test data, if such data

D. What Role do Existing Data Play Guidelines (http://

are not already available, related to six

Under the HPV Initiative? y wxvti'•epa .gov/opptsfrs/home /

health and environmental effects guidelin.htm)), and appropriate Good

endpoints for international HPV The HPV Initiative is designed to Laboratory Practice Standards (GLPS)

chemicals (see Unit II.B .). The SIDS test make maximum use of scientifically (e .g ., see the TSCA GLPS at 40 CFR part

guidelines are regarded as the minimum adequate existing test data and to avoid 792) consistently generate data adequate

data set required to make an informed unnecessary, duplicative testing, to fulfill the HPV Initiative needs. Data preliminary judgment about the hazards thereby avoiding the excessive use of from studies that did not follow thes

e

of a given HPV chemical . animal testing. Opportunities to procedures, however, may not be

EPA is implementing the HPV comment on identified data gaps or adequate

.

Initiative as part of its domestic submit any available adequate data are As indicated in the October 14, 1999,

industrial chemical screening efforts, in being provided during the voluntary letter to the voluntary HPV Challeng

e

a manner that is consistent with OECD HPV Challenge Program, in response to Program participants, in analyzing the

efforts. The information to be gathered this document, and in response to any adequacy of existing data, EPA

under EPA's HPV Initiative comes from future proposed TSCA section 4 HPV encouraged participants to conduct a

the same battery of tests agreed upon by SIDS rulemaking. EPA will also post the thoughtful and qualitative analysis

the OECD member countries as being test plans submitted under the rather than using a rote checklist

appropriate for screening international voluntary Program to allow for a 120 approach . If EPA judges the available

HPV chemicals for toxicity and day review period before testing begins . data to be adequate, the data gap

environmental fate (Ref. 3) . As It is also EPA's intention for the identified in the HPV Initiative will be

conceived by the OECD, the SIDS data comment period in the associated TSCA considered to be filled . In addition,

set can be used by governments and section 4 HPV SIDS rulemaking to run participants in the voluntary HPV

others worldwide to conduct an initial for 120 days to allow for an equivalent Challenge Program may conclude that

assessment of the hazards and risks review to occur before the rulemaking certain endpoints need not be tested if,

posed by HPV chemical substances and requirements are finalized . If at any time given the totality of what is known

to prioritize chemicals to identify those the Agency receives adequate existing about a chemical, including human

which are in need of additional, more data that fulfill a specific data gap, EPA experience, there is sufficient existing

in-depth testing and assessment, as well will ensure that unnecessary testing is data that is consistent with the Agency's

as those of lesser concern . not conducted. guidance on determining the data

In addition to addressing the six basic During the continued development of adequacy . EPA has developed a

screening endpoints, basic exposure the HPV Initiative, EPA was encouraged guidance document on determining data

information including general and to consider the relationship between adequacy which is available on EPA's

occupational use patterns, and sources existing data submitted under the HPV ChemRTK web site (Ref . 12). This
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Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Notices 81691

guidance document is useful in consideration . Many test methods have best avoid unnecessary or duplicative

assessing whether a study design used begun the process of validation and testing .

in generating existing data is sufficient several have completed the steps F. How Will Data Collected on HPV to meet the needs of the HPV Initiative . leading to government-wide regulatory Chemicals be Used?

For example, summary information, acceptance . Within the SIDS battery o f

such as that taken from Material Safety tests, a number of in vitro genotoxicity The availability of hazard information

Data Sheets (MSDSs), is not considered tests, such as the Ames test for gene on individual chemicals is fundamental

adequate to meet the needs of the HPV mutations in bacteria, have received to EPA's ability to accomplish its

Initiative . Where relevant existing uniform acceptance among regulatory mission of environmental protectionstudies are identified, companies should agencies. risk assessment based on sound science,

provide information at the level of a In addition, as part of the voluntary risk management, safeguardin g

"robust summary" for each study (Ref. HPV Challenge Program, EPA asked children's health, transparency,

6). participants in that Program to observe expanding the public's right-to-know,

E. How are Animal Welfare Issues Being

certain principles laid out in the and promoting the pollution prevention

Considered in this Initiative? October 14, 1999, letter. In its letter, ethic. Activities to ensure th e

EPA also indicated that it is the availability of basic hazard information

EPA recognizes the concerns that intention of the Agency that the HPV on HPV chemicals are an integral part

have been expressed about test Initiative, including the voluntary HPV of meeting these objectives .

procedures that require the use of Challenge Program and any associated The approach to collection of

animals . EPA is making every effort to TSCA section 4 HPV SIDS rulemaking, information and conducting testing for

ensure that as the HPV Initiative is proceed in a manner consistent with identified needs on HPV chemicals is

implemented, unnecessary or these principles and concerns. One of essentially identical in scope and

duplicative testing is avoided and the the principles in the October 14, 1999, applicability to the OECD HPV SIDS

use of animals is minimized . As a letter to participants in the voluntary Program that has been internationally

general matter, EPA does not require HPV Challenge Program, is that agreed upon by the 29 OECD member

that tests on animals be conducted if an participants shall conduct a thoughtful, countries as providing the minimum

alternative scientifically validated qualitative analysis of existing data data set needed to screen HP V

method is found acceptable and before testing and that all animal testing chemicals and identify priorities for

practically available for use . Where on individual chemicals (as opposed to additional testing or assessment . While

testing must be conducted to develop testing of categories of chemicals) under the SIDS data set does not fully measure

adequate data, the Agency is committed the voluntary HPV Challenge Program a chemical's toxicity, it does provide a

to reducing the number of animals used or under an associated rule(s) be consistent minimum set of information

for testing, to replacing test methods deferred until November 2001 and that that can be used to assess the relative

requiring animals with alternative test testing of chemicals solely hazards and risks of chemicals and to

methods when acceptable alternative manufactured as closed system judge if additional testing or assessment

methods are available, and to refining intermediates be deferred until 2003 . is necessary or if a chemical may be

existing test methods to optimize animal Under the voluntary HPV Challenge considered of lesser concern . EPA and

use when there is no substitute for Program structure, alternatives to help others will use the data obtained from

animal testing . EPA believes that these further reduce animal testing are this program to support th e

reduction, replacement, and refinement available . For example, under the OECD development of preliminary risk

objectives are all important elements in HPV SIDS Program, some instances assessments for these HPV chemicals .

the overall consideration of alternative have been identified where, using Data in addition to those provided

testing methods. chemical category approaches, less than through the SIDS battery of tests may b e

The governmental and non- a full set of SIDS data for every chemical needed to provide sufficient

governmental scientific community is in the category has been judged understanding to adequately assess the

working to design, validate, and employ sufficient for screening purposes. In hazards and risks presented by some

new methods of toxicity testing that are addition, the OECD HPV SIDS Program HPV chemicals . The data obtained on

more accurate, less costly, and that allows some use of structure activity HPV chemicals under the HPV Initiative

reduce the need to use live animals. relationships (SAR) analysis for will be used to develop initial ris k

Over the years, significant research has individual chemicals. These strategies assessments that will allow EPA, other

been pursued to develop and validate have the potential to reduce the time Federal agencies, the public, industry,

non-animal test methods. United States required to complete the program, the and others to set priorities for further

scientists in academia, government, and number of tests actually conducted, and data collection/development and to

industry have participated in both the number of test animals needed . One identify chemicals of lesser concern .

domestic and international efforts to of the principles in the October 14, EPA has used data from previous data

develop alternative, non-animal tests . 1999, letter is that participants in the collection/development activities to

As part of the enterprise, the National voluntary HPV Challenge Program shall support a variety of EPA and other

Institute for Environmental Health maximize the use of scientifically Federal agency programs and actions

Science (NIEHS) established a Federal appropriate categories of related including the development of water

interagency committee, the Interagency chemicals and SAR . Those who wish to quality criteria, Toxics Release

Coordinating Committee on Validation use these alternative approaches should Inventory listings, chemical advisories,

of Alternative Methods (ICCVAM), to seriously consider handling the and reduction of workplace exposures

.

review the status and validation of chemical voluntarily, by submitting a

toxicological test methods including viable commitment as described in Unit G. Are There Other Voluntary Means to

those that are performed in vitro. EPA IV.C. A viable commitment involving Address the Data Needs for HPV

scientists have contributed significantly these alternate approaches can still be Chemicals ?

to this body of knowledge and are submitted during the regulatory phase Yes. These approaches include

continuing to play a vital role by of the HPV Initiative, but submission in agreements to sponsor a HPV chemical

developing test methods for the earlier phases of this initiative will under either the OECD HPV SIDS
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81692 Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Notice s

Program, including sponsorship by data do not exist or when existing data i . Testing of closed system

OECD member countries beyond the are not adequate . intermediates (as described in Unit

United States, or the international HPV The voluntary HPV Challenge III.B .2 .), which present less risk of

Initiative that is being organized by the Program will generally be carried out in exposure, shall be deferred until 2003 ;

ICCA. The OECD HPV SIDS Program a manner consistent with the OECD an d

has already been described in Unit II.B . HPV SIDS Program to ensure that the ii . Individual chemicals (i .e ., those

The ICCA consists of representatives of data and information generated can be HPV chemicals not proposed for testing

chemical industry trade associations contributed to the international effort in a category) that require further testing

from the Argentina, Australia, Brazil, and, conversely, that international SIDS on animals shall be deferred until

Canada, Europe, Japan, Mexico, New testing and assessments can be used to November 2001 .

Zealand, and United States. The ICCA fulfill the data gaps identified as part of The Agency also stated in the October

HPV Initiative calls for the testing and the HPV Initiative . (See also Refs. 1 and 14, 1999, letter that these revisions

screening-level assessment of 1,000 3) . Robust summaries of all of the data should not be construed to suggest that

"high priority" chemicals by the end of collected through the voluntary HPV delay or deferral is appropriate wit h

the year 2004. Most of the chemicals on Challenge Program will be made respect to testing of scientifically

the ICCA working list (Ref. 11) are also available by EPA to the public via the appropriate categories of related

HPV chemicals. The ICCA testing/ Internet in a timely manner, fulfilling chemicals.

assessment work will be tied directly to the Agency's commitment to the If adequate existing data ar e

that under the OECD HPV SIDS public's right-to-know about chemical submitted to EPA during the 120 day

Program. hazard information. The collected data test plan review period under the

Sponsorship under either the OECD will also be used to support efforts by voluntary HPV Challenge Program, or a t

HPV SIDS Program or the ICCA HPV EPA and others to evaluate an d prioritize potential HPV chemical risks . any other time before testing has begun ,

Initiative also includes the step of On October 9, 1998, the voluntary such that EPA can determine that

preparing the SIAR that provides a HPV Challenge Program was announced certain endpoints need not be tested,

screening level assessment of chemical as a major new effort to close a gap in EPA will consider the specific data gap

hazards and includes the reporting of the public's right-to-know about to be filled . As indicated previously, the

limited exposure information on each possible risks related to HPV chemicals, Agency strongly encourages participants

HPV chemical. While the submission of and any other interested parties to exposure information and the prompting companies to make mor e

informed and sensible decisions about maximize the use of existing and

preparation of the SIAR are not required chemical use . In this announcement, scientifically adequate data by

elements under the voluntary HPV EPA was joined by the American submitting such data in the early stages

Challenge Program, EPA encourages Petroleum Institute (API), ACC, and of the voluntary HPV Challenge Program

industry sponsors to include these Environmental Defense . The following so that the Program does not lead to the

elements in their submissions under the three elements comprise the voluntary unnecessary use of animals in tests, and

voluntary HPV Challenge Program. HPV Challenge Program: in order to minimize testing costs.

Any HPV chemicals that are handled 1 . Fixed timetable and fixed list of 2 . Continuous public access to

under the OECD HPV SIDS Program or chemicals. Information gathering for the program status and results. The public

the ICCA HPV Initiative are considered chemicals in the voluntary HPV will be able to follow the status and

by EPA to be "sponsored" and are not Challenge Program will begin in 2000, progress of the chemicals in the

intended to be addressed in either the with voluntary participants indicating voluntary HPV Challenge Program over

voluntary HPV Challenge Program or in commitments to provide the needed time . This will be done by making

any associated TSCA section 4 HPV data for specific HPV chemicals. After information publicly available on the

SIDS rulemaking unless the relevant existing data have been Internet . EPA and other parties have

international commitments are not met. identified, and EPA has judged their committed to help the public sta y

adequacy, participants will analyze the informed about progress in th e

IV. Voluntary HPV Challenge Program status of existing data fulfilling the SIDS voluntary HPV Challenge Program, with

A. What is the Voluntary HPV Challenge data set and prepare a test plan which an emphasis on the status of data

Program? identifies needed testing based on this collection and testing efforts . EPA will

analysis. The test plans that are have responsibility for making the data

As a part of the Chemical Right-to- submitted by the voluntary participants available in ways which are useful to

Know initiative that was announced in will be posted for 120 days before any diverse stakeholders .

April, 1998, EPA, in partnership with testing is initiated, providing an 3 . International sharing of testing

industry and environmental groups, opportunity for interested parties to responsibility. A significant increase in

announced a voluntary chemical data review and provide comments on the the pace of information gathering and

collection effort called the HPV test plans, including technical testing by chemical manufacturers in

Challenge Program. This program comments regarding alterations to the other countries is needed . To encourage

challenges industry to make publicly proposed test plans. EPA will also this, EPA and other parties agreed to

available a complete set of baseline review the test plans during the 120 day work with other nations an d

health and environmental effects data period, and will judge the adequacy of international groups to assur e

(i .e ., the SIDS data set) on HPV any existing data submitted with the test commensurate increases in the rate of

chemicals. Under the voluntary HPV plan . In addition, as indicated in the these efforts on HPV chemicals .

Challenge Program, data are to be October 14, 1999, letter, because B. What are the Goals and Principles for collected for each chemical on EPA's validated non-animal tests for some the Voluntary HPV Challenge Program? list of 1990 U.S. HPV chemicals. For the SIDS endpoints may be available soon ,

voluntary HPV Challenge Program, participants in the voluntary HPV 1 . HPV Challenge, Program goals, The

production volumes were derived from Challenge Program shall make the original goals established for the

reporting under the 1990 IUR (Ref. 2). following revisions to the sequence of voluntary HPV Challenge Program are as

Testing will be necessary only when testing: follows:
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Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Notices 81693

i . Ensure full public availability of • Procedures for Removing Chemicals vitro genetic toxicity testing to generate

screening level data on HPV chemicals. that are No Longer HPV and are not any needed genetic toxicity screening

ii. Determine the adequacy of existing Likely to Become HPV Again from the data, unless known chemical properties

published and unpublished data to HPV List (Ref. 9). preclude its use.

maximize its use for HPV chemicals in 2 . HPV Challenge Program principles.

In addition, as indicated in Unit

order to avoid repeat testing . EPA supplemented these goals in the IV .A., the letter states that individua l

iii. Conduct needed testing to ensure October 14, 1999, letter to the chemicals (i .e ., those HPV chemicals not

the availability of screening level data companies participating in the proposed for testing in a category) that

on HPV chemicals . voluntary HPV Challenge Program (Ref. require further testing on animals shall

EPA intends to make available to the 11), by asking the participants to be deferred until November 2001 . The

public all the summarized data obtained observe several principles as they October 14, 1999, letter also indicates

on HPV chemicals . In addition, any proceed with the program. These that testing of chemicals which are

subsequent information that EPA principles, which were developed after determined to meet the requirements of

receives on HPV chemicals would be consultation with the organizations closed system intermediates shall be

shared with the public, other Federal involved in developing the framework deferred until 2003, and tha t

agencies, and any other interested for the program, are intended to address participants shall not develop subsubparties. concerns raised by certain animal chronic or reproductive toxicity data for

The voluntary HPV Challenge advocacy organizations who wish to the HPV chemicals that are solely closed

Program is designed to make maximum ensure that the HPV Initiative not lea d

use of scientifically adequate existing to the excessive use of animals in tests system intermediates, as defined by

test data and to avoid unnecessary, and that attention is paid to existing OECD/SIDS Guidelines .

duplicative testing, thereby avoiding the information and alternative testing As indicated in Unit IV .A., and

excessive use of animal testing . EPA methods that do not require animals as discussed in more detail in Unit IV.C.2 .,

encourages industry in general and test subjects . A copy of the October 14, the letter indicates that participating

other interested parties to identify and 1999, letter is available on the companies shall allow 120 days

provide any additional adequate ChemRTK web site (Ref. 8) and the between the posting of test plans and

existing data about these HPV chemicals public version of the official record for the implementation of any testing plans.

that are relevant to the hazard this document. As indicated in the C. What Does Participation in the

characterization. If at any time, the letter, animal experiments should not be Voluntary HPV Challenge Program

Agency receives adequate existing data performed if another validated Specifically Involve ?

that fulfill a specific data gap, EPA will method-not involving the use of

ensure that unnecessary testing is not animals-is reasonably and practically The voluntary HPV Challenge

conducted . available for use. Program contained two phases during

The Agency will provide additional The October 14, 1999, letter to which sponsors made commitments .

opportunities in the voluntary HPV participants in the voluntary HPV The first phase ended on March 15,

Challenge Program to minimize the Challenge Program, indicates that 1999, and the second commitment

participant's burden where there is a participants shall maximize the use of phase ended on December 1, 1999 . EPA

need to develop new test data . These existing and scientifically adequate data is not currently planning to include in

opportunities will include : to minimize further testing. EPA also a TSCA section-4 HPV SIDS rulemakin g

• Providing guidance for the use of stated that participants, in analyzing the any chemicals which were sponsored

SAR. adequacy of existing data, shall conduct during these first two phases . EPA,

• Encouraging the maximum use of a thoughtful and qualitative analysis however, intends to issue proposed

category approaches to handle groups of rather than use a rote checklist TSCA section 4 HPV SIDS rulemaking

HPV chemicals with similar structures approach . The letter also indicated that to address unmet data needs for a

or functionalities. participants may conclude that there are portion of those chemicals which were

• Identifying those HPV chemicals sufficient data, given the totality of what not sponsored during these phases

.

that do not need further screening level is known about a chemical, including Although the commitment phase of the

testing because additional testing will human experience, that certain voluntary HPV Challenge Program has

not enhance understanding of the endpoints need not be tested, and tha g ended, EPA can accept viable t

potential health or environmental participants shall maximize the use of commitments to sponsor additional

hazards/risks. SAR analysis and scientifically chemicals, even though the chemica l

• Allowing reduced data sets for appropriate category approaches where may have been included in a proposed

closed system intermediates. feasible to address the data needs under

• Allowing parties to identify and the voluntary HPV Challenge Progran~ . rule. Such commitments must be

substantiate that certain chemicals are The letter further suggests that consistent with the "viabl e

"no longer HPV ." participants reviewing the adequacy of commitment" guidance available on th

e Guidance documents have been existing data for GRAS chemicals EPA's ChemRTK web site (Ref . 15). EPA

developed for: should specifically consider whether does not intend to include a chemical

• The Use of Structure Activity the information available makes it covered by a viable commitment in a

Relationships (SAR) in the High unnecessary to proceed with further final TSCA section 4 HPV SIDS

Production Volume Chemicals testing involving animals. rulemaking, if, during the regulatory

Challenge Program (Ref. 13). As discussed in Unit IV.H ., the letter phase of the Program, the sponsor, i n

• Development of Chemical Categories states that participants in the voluntary addition to agreeing to meeting all of the

in the HPV Challenge Program (Ref. 14). HPV Challenge Program shall not commitments that would have bee n

• Determining the Adequacy of conduct any terrestrial toxicity testing, necessary under the voluntary phase of

Existing Data (Ref. 12). and should generally not develop any the Program, provides the followin g

• Guidance for Testing Closed System new dermal toxicity data . In the letter additional information :

Intermediates for the HPV Challenge and as discussed in Unit IV .F.5 ., EPA • Evidence that work is underway and

Program (Ref. 7) . also encourages participants to use in proceeding in a timely manner.
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81694 Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Notice s

• Data required to complete the SIDS Agency anticipates that test plans will HPV Challenge Program . EPA

battery are developed within the time be submitted electronically to the "US anticipates that most, if not all, of the

frame set by EPA in the proposed rule . HPV Chemical Tracking System" (Ref. provisional commitments received thus

• Robust summaries and full copies of 19) . To ensure adequate public notice far will be upgraded to ful l

all study reports from new studies and about the proposed test plan, a principle commitments upon the Agency's receipt

existing data are submitted to EPA in a in the October 14, 1999, letter is that of the needed additional information .

timely manner. sponsors shall allow 120 days between Continually updated informatio n

Viable commitments can include the posting of a test plan and the regarding the chemicals being

categories and SAR consistent with the implementation of any testing plans . sponsored under the voluntary HPV available guidance (Refs. 13 and 14). If EPA will post specific reference as to Challenge Program and the names o f

a viable commitment is made and the public availability of the submitted company sponsors and consortia can be

fulfilled, and the information is deemed test plan and robust summary found on EPA's ChemRTK web site

adequate, EPA would not include that information on the ChemRTK web site . (http://www.epa.gov/chemrtk/ chemical in a multi-chemical HPV 3 . A "Robust Summary. "A "robust sumresp .htm), and on the "US HPV TSCA rulemaking for SIDS testing. summary" prepared in a standardized Chemical Tracking System" (Ref. 19). The following are expected to be electronic format for each existing and

provided by those wishing to participate new study . These summaries will be F. What Specific Testing Endpoints are

as viable commitment sponsors in the submitted to EPA and will be posted on Called for in the Voluntary HPV

voluntary HPV Challenge Program: the Agency's ChemRTK web site to Challenge Program ?

1 . A simple commitment letter. The ensure public access to detailed Definitive test guidance can be found

letter lists those HPV chemicals, synopses of the studies for the SIDS in the third edition of the Screening including those included in categories, endpoints. Guidance on the content/ Information Data Set Manual of the

for which SIDS data will be supplied by format of a "robust" summary can be

OECD Programme on the Co-operative the company(s). The letter identifies found on the ChemRTK web site (Ref. Investigation of High Production chemicals by CAS numbers and 6)

chemical names, proposes a "start year" 1997

. Volume Chemicals, published in July

(Ref. 3) . The SIDS basic screening- for evaluation of each chemical, and D. How Will the, Test Data Collected

identifies a technical contact (including Under the Voluntary HPV Challenge level endpoints are listed in section 2. 2

name and phone number) with whom Program be Managed? of the SIDS Manual (Ref. 3) . Because

EPA can consult. Full commitments Most information associated with the terrestrial toxicity testing will normally

under the voluntary HPV Challenge voluntary HPV Challenge Program will be considered to belong to the OECD

Program must specify the names and be submitted electronically in order to post-SIDS tier, terrestrial toxicity testing

CAS numbers of the chemicals to be better allow both efficient analysis of (including avian toxicity) is not

sponsored, the year test plans will be the data by EPA and real-time public included in the voluntary HPV

submitted, and the name and other access to the collected data . Many Challenge Program. The actual OECD

contact data for the technical person submissions will be made electronically test guideline for each of the SIDS tests

within the company who should be via the Internet. EPA intends to post the can be found at http ://www.oecd.org/

reached for more information EPA- . information on the Internet immediately ehs/guide/index .htm . The BPACommitment letters under the voluntary following a simple quality control check recommended screening level tests

HPV Challenge Program were due to the to ensure the information is complete (with their OECD test guideline

Agency Y and in a form that can be uploaded on Challenge Program are as follows

: posted the voluntary HPV Challenge the web, and will note that it has not

1, physical/chemical property tests: Program commitment letters on its been critically reviewed for adequacy by • Meltin Point OECD 102)

web site (http .

:// EPA. The web posting will be updated • g ( )'

www Boiling Point (OECD 103)..epa .gov/chemrtk/smrestbl .htm). following the Agency's review of the . Vapor Pressure (OECD 104) . EPA anticipates that many companies information . EPA will provide the • n-Octanol/Water Partition

will also submit their commitments public with more complete and detailed Coefficient Method (OECD 107 or OECD

electronically to a third-party Internet information via its web site (http :// 117),

database, the "US HPV Chemical www .epa.gov/chemrtk/elecsubm.htm) • Water Solubility (OECD 105 and Tracking System" (Ref. 19), the initial about EPA's approach to data OECD 112, if applicable)

. development of which was supported management as the voluntary HPV 2 . Environmental fate tests: by the ACC. For more information on Challenge Program progresses . • Photo degradation (determined via

making commitments to the voluntary estimation, see guidance document on

HPV Challenge Program, consult the E. How Many HPV Chemicals Have

data adequac y

2 . Test plans. Test plans submitted Voluntary HPV Challenge Program? site (Ref. 12) .

• Hydrolysis-Stability in Water (OECD electronically at a pace that is specified As of November 9, 2000, EPA has 111 )

in the commitment letter. The test plans received full or provisional • Transport/Distribution (determined

and accompanying robust summaries commitments from 469 companies, via modeling, see guidance document

will be submitted in the year indicated, individually or as part of 187 consortia on data adequacy at EPA's ChemRTK

will identify existing adequate test data (see Unit 11I.G.) to sponsor 2,155 web site (Ref. 12) .

on the SIDS endpoints, and will propose chemicals under the voluntary HPV • Biodegradation (OECD 301 or OECD

the tests deemed necessary to complete Challenge Program . A provisional 302).

the SIDS testing requirements . For those commitment is one that is lacking one 3 . Ecotoxicity tests:

chemicals for which the sponsor or more of the specific elements ( e .g ., •Acute Toxicity to Fish (OECD 203).

determines that existing test data are name and phone number of a technical • Acute Toxicity to Daphnia (OECD

inadequate, needed tests included in the contact) required for a commitment to 202) .

test plan will be conducted in be considered a "full" commitment to • Toxicity to Plants (Algae) (OECD

accordance with OECD guidelines. The sponsor a chemical under the voluntary 201).
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Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Notices 81695

• Chronic Toxicity to Daphnia, when program in a manner consistent with the existing OECD procedures . A principle

appropriate (OECD 211) . OECD HPV SIDS Program and as part of in the October 14, 1999, letter t o

4 . Mammalian toxicity-acute : a larger international activity with participants in the voluntary HP V

• Acute Oral Toxicity Test (rat)(OECD global involvement . This approach Challenge Program is that participants

425). provides the same degree of flexibility shall not develop sub-chronic or

• Acute Inhalation Toxicity Test as that which currently exists under the reproductive toxicity data for the HPV

(OECD 403) . OECD HPV SIDS Program (Ref. 2). chemicals that are solely closed system For the "Mammalian Toxicity- 6 . Mammalian toxicity-repeated intermediates as defined by the OECD /

Acute" endpoint, certain "Special dose/reproductive/developmental: SIDS guidelines. Actual initiation of

Conditions" in the form of a chemical • Combined Repeated Dose Toxicity testing for chemicals that are solely

substance's physical/chemical Study with the Reproduction/ closed system intermediates would be

properties or physical state should be Developmental Toxicity Screening Test deferred until 2003, if adequate existing

considered in determining the (OECD 422) [or use these two tests: data are not otherwise available .

appropriate test method that would be Reproduction/Developmental Toxicity

used from among those included for this Screening Test (OECD 421) and G . Are Acute Aquatic Toxicity Studies

endpoint. The OECD HPV SIDS Program Repeated Dose 28-Day Oral Toxicity Always Needed Under the Voluntary

recognizes that for most chemical Screen (OECD 407)] . HPV Challenge Program ?

substances, the oral route of For "Mammalian Toxicity-Repeated No, acute aquatic toxicity studies are

administration will suffice for this Dose/Reproductive/Developmental," not always needed under the voluntary

endpoint. Under the voluntary HPV EPA recommends the use of the HPV Challenge Program. For

Challenge Program, for test substances Combined Repeated Dose Toxicity "Ecotoxicity Tests," the OECD HPV

that are gases at room temperature Study with the Reproduction/ SIDS Program recognizes that, for

(25°C), the acute mammalian toxicity Developmental Toxicity Screening Test certain HPV chemicals, acute toxicity

study should be conducted using (OECD 422) . EPA recognizes, however, studies are of limited value in assessing

inhalation as the exposure method . In that there may be reasons to test a the substances' aquatic toxicity . This

the case of a potentially explosive test particular chemical using both the issue arises when considering chemicals

substance, care should be taken to avoid Reproduction/Developmental Toxicity with higher n-octanol/water partition

the generation of explosive Screening Test (OECD 421) test coefficients (log Ko,v or log P) values. In

concentrations. For all other chemicals guideline and the Repeated Dose 28-Day such cases, toxicity is less likely to be

(i.e ., those that are either liquids or Oral Toxicity Screen (OECD 407) test observed over the duration of acute

solids at room temperature), acute guideline instead of the OECD 422 test toxicity studies because of the reduced

toxicity testing should be conducted via guideline . With regard to such cases, uptake and the extended amount of time

oral administration . Dermal toxicity test sponsors are asked to submit to EPA required for such substances to reach

testing is not included in the voluntary the rationale for conducting these toxic concentrations in the tes t

HPV Challenge Program . alternative tests as part of the test plan . organism. For such situations, the OECD

5 . Mammalian toxicity-genotoxicity: Certain of the chemicals for which HPV SIDS Program recommends use of

i . Gene mutations. Mammalian Toxicity-Repeated Dose/ chronic toxicity testing in Daphni a

• Bacterial Reverse Mutation Test : Reproductive/Developmental data are (OECD 211) in place of acute toxicity

(OECD 471) [or use the In Vitro needed may be used solely as "closed testing in fish (OECD 203) and Daphnia

Mammalian Cell Mutation Test (OECD system intermediates," as described in (OECD 202). For the purposes of the

476)] . the EPA guidance document developed voluntary HPV Challenge Program, EP A

ii. Chromosomal damage . for the voluntary HPV Challenge recommends that the need for longer

• In Vitro Mammalian Chromosomal Program (Ref. 7). As described in this term tests be judged based on log K_

Aberration Test (OECD 473) [or use guidance document, such chemicals and other factors . In general, EPA either the In Vivo Mammalian Bone may be eligible for a reduced testing believes that for chemicals determined

Marrow Chromosomal Aberration Test battery which substitutes a to have a log K„w equal to or greater than

(rodents: mouse (preferred species), rat, developmental toxicity study for the 4.2 (which corresponds to a fish

or Chinese hamster) (OECD 475), or the SIDS requirement to address repeated bioconcentration factor (BCF) of

In Vivo Mammalian Erythrocyte dose, reproductive, and developmental approximately 1,000), the following

Micronucleus Test (sampled in bone toxicity . At the present time, EPA does tests should be conducted : Chronic

marrow) (rodents: mouse (preferred not have sufficient information to know Toxicity to Daphnia study (in place of

species), rat, or Chinese hamster) (OECD with any degree of certainty which if the acute toxicity tests in fish and

474)] . any of the chemicals that are included Daphnia) and Toxicity to Plants (Algae ;

Persons who conduct testing for in the voluntary HPV Challenge OECD 201) . For chemicals determined

chromosomal damage are encouraged to Program are solely closed system to have a log K„w less than 4 .2, EPA

use in vitro genetic toxicity testing intermediates as defined by the OECD/ believes that Acute Toxicity to Fish,

(Mammalian Chromosomal Aberration SIDS guidelines. Persons who believe Acute Toxicity to Daphnia and Toxicity

Test) to generate needed genetic toxicity that a chemical fully satisfies the terms to Plants (Algae) testing should be

screening data, unless known chemical outlined in the guidance document are conducted . EPA recognizes that in some

properties preclude its use . These could encouraged to submit appropriate circumstances, however, acute aquatic

include, for example, physical information which substantiates this toxicity testing may be relevant for

properties or chemical class belief. If, based on submitted certain chemical substances having high

characteristics. With regard to such information and other information log K„w values . For example, chemical

cases, test sponsors are asked to submit available to EPA, the Agency believes substances that are dispersible in water

to EPA the rationale for conducting one that a chemical substance is considered (e .g ., surfactants, detergents, aliphatic

of these alternative tests (OECD 474 or likely to meet the requirements for use amines, and cationic dyes) may have

OECD 475) as part of the test plan. A solely as a closed system intermediate, high log Kow values and yet may still

primary focus of the voluntary HPV EPA will handle that chemical be acutely toxic to aquatic organisms.

Challenge Program is to implement this substance in accordance with the Sponsors under the voluntary HPV
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81696 Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Notice s

Challenge Program are encouraged to I. Are Acute LD5() Tests Always Needed agree to modify the SIDS battery

consider these factors in developing test for Mammalian Acute Toxicity Testing requirements for acute toxicity. As

plans. Thus, a sponsor who believes that Under the Voluntary HPV Challenge indicated in Unit IV .H., dermal toxicity

acute aquatic testing is appropriate for Program? testing is not included in the voluntary

an HPV chemical with a high log K_ No, acute LD50tests are not always HPV Challenge Program.

should provide in its submitted test needed for mammalian acute toxicity Recognizing that exposur e

plan the rationale for conducting such testing under the voluntary HPV information need not be collected/

testing. Public comments on test plans Challenge Program . In fact, as was submitted under the voluntary HPV

relating to this issue will be considered discussed in the proposal (Ref. 16) Challenge Program, and the contingent

on a chemical by chemical basis. which was submitted by the United nature of the need for acute toxicit y

The OECD HPV SIDS Program States to the February 1999, meeting of testing by a second route of exposure

y , includes testin on terrestrial organisms the OECD workgroup on existing EPA recommends that acute toxicit g chemicals, EPA recommends the use of testing conducted under the voluntary

if "significant exposure is expected in the "Up and Down Procedure" (OECD HPV Challenge Program be limited to a

the terrestrial environment." Under the 425) in the voluntary HPV Challenge single route of exposure . Decisions

voluntary HPV Challenge Program, program for those chemicals in need of regarding the need for acute toxicity

exposure information need not be acute toxicity testing . This particular testing by a second route would be need

collected/submitted on each HPV to be considered for HPV chemicals

chemical as is done under the OECD test greatly reduces the number of test which enter the OECD HPV SID S animals required and provides a point

HPV SIDS Program . In addition, OECD estimate of the lethal dose that is program .

is limiting the collection of exposure adequate for screening assessments on J. Are Both In Vitro and In Vivo

information to that obtained from the industrial chemicals . The OECD's Joint Genotoxicity Tests Needed Under the

sponsor country/countries; in the past, Meeting, at its 29th Session in June Voluntary HPV Challenge Program?

each OECD member country was 1999, agreed with the general approach Sponsors are encouraged to use in

expected to provide this exposure to use alternative methods for acute oral vitro testing unless there are chemical information . In recognition of the toxicity testing on industrial chemicals properties (including chemical class

changing role of exposure information and "specifically encourages this for considerations) or other aspects which

in the OECD HPV SIDS process, EPA work under the OECD's Existing may call its use into question. EPA has raised the issue of changing the OECD's Chemicals [(i .e ., SIDS)] Program" (Ref. recommended certain in vitro protocols,

approach to terrestrial toxicity testing at 17)• and, as appropriate and to the extent

the 8th Meeting of the OECD's As this topic is discussed in section possible, will review test plans

workgroup on existing chemicals 3 .4 of the OECD HPV SIDS Manual, "All submitted by sponsors of HPV

(October 25-28, 1999, Paris). EPA substances, except gases and vapors, chemicals to promote use of such

proposed that the OECD move should be tested by the oral route . .

. protocols. Participants in the voluntary

consideration of the need for terrestrial Gases should be tested by the HPV Challenge Program are encouraged

toxicity testing to a subsequent step in inhalation route alone" (Ref . 3). The to use in vitro genetic toxicity testing to

its process (known as "post-SIDS" SIDS Manual also notes that "dependent generate any needed genetic toxicity

testing). This proposal was accepted in upon the physical-chemical properties . screening data, unless known chemical

part by the OECD. Avian toxicity testing ' • and the most important route of properties preclude its use.

was moved to the post-SIDS tier but the human exposure, the dermal or the In February 1999, at the meeting of

OECD retained the element of considered inhalation route could also be the OECD workgroup on existing

." EPA raised a question chemicals, EPA made a proposal (Ref.

considering the need for soil toxicity regarding this guidance for 16) for the use of the male rats from the

testing (earthworms and plants) based consideration by the OECD at the combined repeated dose/reproductive/

on the potential for terrestrial exposure. October 1999, meeting of the OECD's developmental toxicity screen (OECD For the purposes of the voluntary HPV workgroup on existing chemicals . As 422) for the purpose of running the

Challenge Program, EPA is not asking originally presented, the United States mammalian erythrocyte micronucleus

sponsors to include consideration of soil proposed to delete the reference to test (OECD 474) . This would reduce the toxicity testing . This aspect, however, dermal testing in the SIDS data set; number of animals needed, and, if the

will need to be considered for HPV however, comments indicated that this protocol can be successfully developed,

chemicals which enter the OECD HPV would not be accepted by other would also increase the amount of

SIDS Program. countries. The United States modified information which would be received

H. Are Dermal Toxicity or Terrestrial its proposal, based on comments from from this single study. Initial

other countries, to indicate that acute consideration of this approach Toxicity Testing Required Under the

testing need be done by one route of suggested that while this strategy might Voluntary HPV Challenge Program? exposure only, such that, where be acceptable with mice, the use of this

No. Another principle in the October appropriate, dermal testing could be approach with rats (the species typically

14, 1999, letter, is that participants in done as an alternative to oral testing, used in SIDS testing) appeared t o

the voluntary HPV Challenge Program This revision also failed to gain the present technical issues . Because there

shall not conduct any terrestrial toxicity needed support . The basis for rejection seemed to be technical problems with

testing and generally should not of the revised proposal was that oral this modification of the in vitro

develop any new dermal toxicity data. testing is necessary to satisfy hazard micronucleus protocol, EPA initiated a

See also Unit IV.F. Dermal toxicity classification requirements and that if review of its approach to this SIDS

dermal exposure (or inhalation endpoint under the voluntary HPV

testing is not included in the voluntary exposure) was an issue, countries Challenge Program HPV Challenge Program . Following this

. should still consider the need for testing review, EPA has decided to remove its

by an additional route at the SIDS level . preference for the use of the in vivo

Thus, the OECD workgroup did not chromosomal effects test and to accept
p. 12

Federal Register/Vol. 65, No. 248/Tuesday, December 26, 2000/Notices 81697

either in vitro or in vivo studies, as is In cases for which adequate data are Regulatory Planning and Review (58 FR

allowed under the OECD procedure for available for the repeat dose endpoint, 51735, October 4, 1993), because OMB

this endpoint. Sponsors are encouraged but not for reproductive and/or determined that this document ma y

to use in vitro testing unless there are developmental toxicity, EPA result in a "significant regulatory

chemical properties (including chemical recommends that the combined action" subject to review by OMB . Any

class considerations) or other aspects reproductive and developmental comments or changes made during that

which may call its use into question. toxicity guideline (OECD 421) be used review have been documented in the

K. Can Some of the Mammalian Toxicity in lieu of separate testing for public version of the official record .

Protocols Included in the Voluntary reproductive toxicity (OECD 415) and/or

~ developmental toxicity (OECD 414) B. Does the Agency Have Approval for

HPV Challenge Program be Combined?

unless there is information indicating this Information Collection Activity?

For the purposes of the voluntary that separate testing may be advisable . Yes. Pursuant to the Paperwork

HPV Challenge Program, EPA strongly This point was raised by the United Reduction Act (PRA), 44 U .S.C. 3501 et

recommends the use of the combined States at the February 1999 meeting of seq., an agency may not conduct or

protocol for repeat dose, reproductive, the OECD's Working Party on Existing sponsor, and a person is not required to

and developmental toxicity (OECD 422) Chemicals and further discussions will respond to, an information collection

for chemicals where data are needed for be pursued in that forum. request unless it displays a currently

these endpoints (see Unit IV .F.6 .) . This

L. How do the Rulemaking valid OMB control number. In general,

particular test guideline was initially Efforts Relate the OMB control numbers for EPA's

developed by the United States in the to the Voluntary HPV Challenge regulations, after appearing in the

late 1980's and early 1990's for use in Y preamble of a final rule, are listed in 40 Program ?

the OECD HPV SIDS Program. This In the October 14, 1999, letter to CFR part 9, and included on the related

screening test guideline provides participants in the voluntary HPV collection instrument . The information

limited information on systemic toxicity Challenge Program, EPA stated that it collection activities related to chemical

following repeated exposure over a was the intention of the Agency that the testing under TSCA section 4(a), which

limited time period. In addition, it TSCA section 4 HPV SIDS rulemaking includes activities related to chemical

provides initial information on proceed in a manner that is consistent testing under a consent order, a

developmental and reproductive with the principles and concerns voluntary program, or a TSCA

toxicity. The United States has been and outlined in the letter for the participants rulemaking, have already been approved

remains one of its strongest supporters in the voluntary program . As such, EPA under OMB control number 2070-0033

within the OECD and strongly would incorporate in the TSCA section (EPA ICR No .1139) . This action does not

recommends its use . Historically, EPA 4 HPV SIDS rulemaking the criteria contain any new information collection

has relied on this combined protocol for established under the voluntary HPV activities requiring additional OMB

HPV chemicals needing this type of Challenge Program to the extent review and approval .

testing under the OECD HPV SIDS possible in the context of a rulemaking, As described in this document, the

effort. and would also consider improvements voluntary HPV Challenge Program

EPA also recognizes that the OECD based on experiences with involves the submission of a

HPV SIDS Program allows for other implementing that program . The commitment letter, study or testing

approaches that can be used to meet the specific requirements of any associated plans, and a final report . In general, the

repeat dose, reproductive and TSCA section 4 HPV SIDS rulemaking average annual per chemical burden

developmental toxicity endpoint needs will be addressed in future proposed estimate approved under OMB Control

covered by the combined protocol . EPA rulemaking . number 2070-0033 is about 488 hours

can also envision circumstances where per response, including time fo r

other such approaches might make V . Administrative Requirements preparing letter of intent and study

sense. These can include, for example, As indicated previously, this action plans, conducting laboratory testing,

situations concerning existing data describes the HPV Initiative, focusing submitting progress reports (if

wherein only certain of these endpoints on the Agency's strategy and overall applicable), and preparing final reports

require testing or in cases where there approach to addressing data collection on each study . For recordkeeping, the

is a particular need identified by a needs for HPV chemicals, along with the average burden is estimated to be 330

sponsor (e.g ., high-exposure potential) components of the voluntary HPV hours per recordkeeper . As defined by

such that a different testing approach is Challenge Program . Although the the PRA and 5 CFR 1320 .3(b), "burden"

indicated. In these cases, voluntary HPV Agency has indicated that the HPV means the total time, effort, or financial

Challenge Program sponsors are asked Initiative may also involve rulemaking resources expended by persons t o

to provide the rationale for conducting under TSCA, any TSCA rulemaking generate, maintain, retain, or disclose or

such testing in their submitted test associated with the HPV Initiative will provide information to or for a Federal

plans. EPA, as appropriate and to the be addressed in that rulemaking, rather agency . This includes the time needed

extent possible, plans to follow up with than in this document. Since this action to: Review instructions; develop,

sponsors who propose in their test plans is not a regulatory action and does not acquire, install, and utilize technology

to use approaches other than OECD 422 impose any requirements, the regulatory and systems for the purposes o f

to ensure that their decision to do so is assessment requirements that apply collecting, validating, and verifying

an informed one . when an agency imposes requirements information, processing an d

In those cases for which adequate data do not apply to this action . maintaining information, and disclosing

are available for reproductive and and providing information ; adjust the

developmental toxicity but not for A . Was this Action Reviewed by the existing ways to comply with any

repeat dose toxicity, EPA recommends Office of Management and Budget? previously applicable instructions and

that the 28-day repeated dose toxicity Yes. The Agency submitted this requirements ; train personnel to be able

test (OECD 407) be used by sponsors to action to the Office of Management and to respond to a collection o f

meet the repeat dose data need for the Budget (OMB) for review under information ; search data sources;

voluntary HPV Challenge Program. Executive Order 12866, entitled complete and review the collection of
p. 13

81698 Federal Register/Vol. 65, No . 248/Tuesday, December 26, 2000/Notice s

information ; and transmit or otherwise OECD at http ://www.oecd.org/ehs/ 12. EPA, OPPT. Determining the

disclose the information . sidsman.htm (non-EPA site) . Adequacy of Existing Data (May 17,

VI. Materials in the Public Docket 4 . Environmental Defense. Toxic 2000) (http ://www.epa .gov/chemrtk/

Ignorance. New York, New York, datadfin.htm).

As indicated in Unit I.B.2 ., the official (Summer 1997). Copies of "Toxic 13. EPA, OPPT. The Use of Structurerecord for this document has been Ignorance" can be obtained by accessing Activity Relationships (SAR) in the

established under docket control ED's web site (non-EPA site) at http :// High Production Volume Chemicals

number OPPTS-42213 and the www.edf.org/pubs/reports/toxic Challenge Program (August 26, 1999)

administrative record number AR-201 . ignorance/ or by calling 1-800-684- (http://www.epa .gov/chemrtk /

The following is a listing of documents 3322 . sarfinli.htm).

that are specifically referenced in this 5 . ACC. Public Availability of SIDS- 14. EPA. OPPT. Development of

document and which have already been Related Testing Data for U .S. High Chemical Categories in the HPV

placed in the public version of the Production Volume Chemicals (June 12, Challenge Program (Draft, August 25,

official record for this action. For your 1998). Copies of ACC's report can be 1999) (http ://www.epa.gov/chemrtk/

convenience, EPA has also provided obtained by writing to ACC at 1300 categuid .htm).

some non-EPA internet addresses to Wilson Blvd ., Arlington, VA 22209 or 15 . EPA, OPPT. ChemRTK HPV

allow you to access the electronic by calling ACC at (703) 741-5226 . Challenge Program Making

version of the referenced document . In 6. EPA, OPPT. Draft Guidance on Commitments (June 29, 2000) (http ://

doing so, the Agency has verified the Developing Robust Summaries (October www•epa .gov/chemrtk/makecom .htm).

accuracy of these addresses at the time 22, 1999) (http ://www.epa .gov/chemrtk/ 16. EPA. Proposal Made at the

of signature . However, since EPA is not robsumgd .htm). Organization for Economic Cooperation

responsible for these non-EPA sites, the 7 . EPA, OPPT. Guidance for Testing and Development (OECD) Working

Agency does not exercise any control Closed System Intermediates for the Party Meeting on Existing Chemicals

over these addresses. A paper copy of HPV Challenge Program (Draft, March (February 1999) .

any document referenced in this way 17 Y 17, 1999) (http . OECD ._Acute Oral Toxicity ://www.epa.gov/chemrtk/

has been included in the public version closedg .htm). Testing: Data Needs and Animal Welfare

of the official record for this document 8. EPA, Office of Prevention, Considerations Agreement Reached by

as described in Unit I.B.2 . Pesticides and Toxic Substances the 29th Joint Meeting of the Chemicals

Committee

1 . EPA, Office of Pollution Prevention (OPPTS) . Letter from Susan H

. Wayland, and the Working Party on

and Toxics (OPPT). ChemRTK HPV Deputy Assistant Administrator, to Chemicals (ENV/JM/HCL/RD(99)6 ; June

Challenge Program Chemical List. (May participants in the voluntary High 1999)'

1999) (This list is updated periodically Production Volume Challenge Program 18• EPA, OPPT . Draft Guidance on

and is available electronically at http :/ (October 14, 1999) (http://www.epa

.gov/ Searching for Chemical Information and

/www.epa.gov/chemrtk/hpvchmlt .htm). chemrtk/ceoltr2 .htm)

. Data (April 1999, rev. May 1999) (http :/

2 . EPA, OPPT. Chemical Hazard Data 9. EPA, OPPT. Procedures for /~v~v~v•epa

.gov/chemrtk/srchguid .htm).

Availability Study : What Do We Really Removing Chemicals that are No longer 19

. ACC. U.S. HPV Chemical Tracking

Know About the Safety of High HPV and Not Likely to Become HPV System

. Non-EPA site : http ://

Production Volume Chemicals? (April Again from the HPV List (Draft, March ~^~"~"'hpvchallenge

.com.

1998) (http://www.epa.gov/opptintr/ 17, 1999) (http ://www.epa .gov/chemrtk/ List of Subjects

chemtest/hazchem.htm) . nolohpt8.htm). Environmental protection, Hazardous

3 . OECD Secretariat . SIDS Manual . 10. OECD. Decision-Recommendation chemicals, Reporting an d

Third Ed. Screening Information Data of the Council on the Cooperative recordkeeping.

Set Manual of the OECD Programme on Investigation and Risk Reduction of Dated: December 14, 2000 .

the Co-Operative Investigation of High Existing Chemicals (January 31, 1991) .

Production Volume Chemicals. Paris, 11. ICCA. ICCA HPV Working List Susan H. Wayland ,

France; July 1997 . Copies this Manual (July 1, 2000). Copies of this List can be ActingAssistontAdministratorfor

can be obtained by accessing EPA's web obtained by accessing ICCA's web site

Prevention, Pesticides and Toxic Substances.

site at http ://www.epa .gov/chemrtk/ (non-EPA site): http://www.icca- [FR Doc. 00-32498 Filed 12-22-00 ; 8 :45am]

sidsappb.htm, as well as directly from chem .Orglhpv . BILLING CODE 6560-50-S