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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, " Federal Register-Environmental Challenge Program . In addition, specific will allow the Agency and others to Documents ." 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 this 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, pleas e
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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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 greate r 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 ensur e 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 th e will also be accepted on standard data compromises EPA's and others' development of such data should be the ability to determine whether these HP V 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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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) . In developing the testing submissions may be made at any time

. United States (Ref. 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 are Generally Recognized as Safe Availability Study : 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, with 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
o can be found in the report (Ref. 2) . 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 n In June 1998, the American Chemistry biodegradation) . 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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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 productio n 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 d TSCA, which the Agency intends to use systems ." 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 th e 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

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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 Challeng e 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 tes t 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 know n 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 dat a 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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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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Program, including sponsorship by data do not exist or when existing data i . Testing of closed syste m 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 an d 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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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 shal l 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 fo r 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 that g ended, EPA can accept viable 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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• 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 an d 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)

. Volume Chemicals, published in July chemical names, proposes a "start year" 1997 (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/ EPA- reached for more information . 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 ( )' Boiling Point (OECD 103)

. www .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 Partitio n 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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• 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 o r • 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 fis h or Chinese hamster) (OECD 475), or the SIDS requirement to address repeated bioconcentration factor (BCF) o f 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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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 , includes testin on terrestrial organisms the OECD workgroup on existing EPA recommends that acute toxicit y 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 inhalation route could also be the OECD workgroup on existing OECD retained the element of considered ." 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 approac h 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 vitr o 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 . Following this HPV Challenge Program . 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 8169 7

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/o r

~ 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 Program ?

Y preamble of a final rule, are listed in 40 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 TSC A 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 th e 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 . OECD ._Acute Oral Toxicity Y 17, 1999) (http ://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