## Thursday, March 16, 2006



# Part III 

# Environmental Protection Agency 40 CFR Parts 9 and 799 

### Testing of Certain High Production Volume Chemicals; Final Rule

### p. 2

13708 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9and 799 [EPA-HQ-OPPT-2005-0033; FRL-7335-2] RIN2070-AD16 Testing of Certain High Production Volume Chemicals AGENCY: Environmental Protection Agency (EPA) . ACTION: Final rule. SUMMARY: EPA is promulgating a final rule under the Toxic Substances Control Act (TSCA) that requires manufacturers (including importers) and processors of 17 high production volume (HPV) chemicals to conduct acutetoxicity, repeat dose toxicity, developmental and reproductive toxicity, genetic toxicity (gene mutations and chromosomal aberrations), ecotoxicity (in fish, Daphnia, and algae), and environmental fate (including 5 tests for physical chemical properties and biodegradation) testing. EPA has determined that each of the 17 chemicals included in this final rule is produced in substantial quantities and that there is or may be substantial human exposure to each of them . Moreover, EPA has determined that there are insufficient data to reasonably determine or predict the effects on health or the environment of the manufacture, distribution in commerce, processing, use, or disposal of the chemicals, or any combination of these activities. EPA has concluded that this testing programis necessary and appropriate for developing such data. Data developed under this final rule will provide critical information about the environmental fate and potential hazards of these chemicals which, when combined with information about exposure and uses, will allowthe Agency and others to evaluate potential health and environmental risks and take appropriate actions. Persons who export or intend to export any chemical included in this final rule, regardless of the formin which it is exported, are subject to the export notification requirements ofTSCA section 12(b)

. DATES: This final rule is effective on April 17, 2006. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as ofApril 17, 2006. For purposes ofjudicial review, this final rule shall be promulgated at 1 p.m . eastern daylight/standard time on March 30, 2006. ADDRESSES: Docket . EPAhas established a docket for this action under docket identification (ID) number EPA-HQOPPT-2005-0033. All documents in the docket are listed on the regulations.gov web site. Although listed in the index, some information is not publicly available, i .e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form . Publicly available docket materials are available either electronically at http:// www .regulations.gov or in hard copy at the OPPT Docket, EPADocket Center (EPA/DC), EPAWest, Rm, B102,1301 ConstitutionAve., NW ., Washington, DC . The Public Reading Roomis open from8 :30a.m

. to 4:30p.m

., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number forthe OPPT Docket is (202) 566-0280

. TSCA section 4submissions. For submission instructions, seeUnit IX. of the SUPPLEMENTARY INFORMATION . FOR FURTHER INFORMATION CONTACT: For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200Pennsylvania Ave., NW ., Washington, DC 20460-0001 ; telephone number : (202) 554-1404; e-mail address: TSCA-HotlineCepa .gov. Fortechnical information contact: Catherine Roman, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW

., Washington, DC 20460- 0001 ; telephone number : (202) 564- 4780; e-mail address: roman. catherine@epa .gov. SUPPLEMENTARY INFORMATION: I . General Information A. Does thisAction Applyto Me? You may be potentially affected by this action if you manufacture (defined by statute to include import) or process any of the chemical substances that are listed in Table 2 in § 799 .5085(j) of the regulatory text. Any use of the term "manufacture" in this final rule will encompass "import," unless otherwise stated. In addition, as described in Unit VI ., any person who exports or intends to export any of the chemical substances in this final rule, regardless of the form in which it is exported, is subject to the export notification requirements in 40 CFRpart 707, subpart D . Potentially affected entities may include, but are not limited to: " Manufacturers (defined by statute to include importers) of one or more of the 17 subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleumrefineries. " Processors of one or more of the 17 subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleumrefineries. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industry Classification System(NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities . To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit V.E . and consult § 799

.5085(b) of the regulatory text . If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT. B. How Can IAccess Electronic Copies of this Document and Other Related Information? In addition to using the online docket system, you may access this Federal Register document electronically through the EPA Internet under the "Federal Register" listings at http:// www .epa.gov/fedrgstr. Afrequently updated electronic version of 40 CFR part 9 and part 799 is available on ECFRBeta Site Two at http:// wwvv.gpoaccess.gov/ecfr. 11. Background A. WhatAction is the Agency Taking? EPAis promulgating a final test rule under TSCA section 4(a)(1)(B) (15 U .S .C. 2603(a)(1)(B)) that requires manufacturers and processors of 17 chemical substances to conduct acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, genetic toxicity, ecotoxicity, and environmental fate testing

. The chemicals are HPVchemicals, i .e., chemicals with a production/import volume equal to or greater than 1 million pounds per year. A detailed discussion regarding efforts to enhance the availability of screening level hazard and environmental fate information about HPVchemicals can be found in a Federal Register document which published on December 26, 2000 (Ref. 1) . The tests are screening level tests which in combination are known as the

### p. 3 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations 13709 Screening Information Data Set (SIDS) an unreasonable risk of injury tohealth or the substances specified in Table 2 in (see Unit II .D.). Some or all of these tests environment, § 799.5085(j) of the regulatory text. are required for a particular chemical (ii) There are insufficient data and experience upon which the effects ofsuch Following consideration of the public substance, depending upon what data manufacture, distribution in commerce, comments received by EPA on the are already available forthat substance. processing, use, or disposal ofsuch substance proposed test rule (Ref. 2) and updated In the proposal to this final rule, or mixture or of anycombinationof such production volume information (i .e., published in the Federal Register of activities on health or the environment can 2002 IURdata), EPA is making the December 26, 2000, EPAproposed SIDS reasonably be determined or predicted, and following findings for the 17 chemical testing for 37 HPVchemicals (Ref. 2) . (iii) Testing of such substance or mixture substances under TSCA section Numerous comments were received on with respect to such effects is necessary to 4(a)(1)(B) : They are produced in the proposed rule. In consideration of develop such data; or substantial quantities; there is or may be those comments, EPA changed some (13)(i) a chemical substanceor mixture is or substantial human exposure to them ; testing requirements for certain will be produced in substantial quantities, existing data are insufficient to and(I) it enters or may reasonably be chemicals as explained in Unit III . As a anticipated to enter the environment in determine or predict their health and result of recent commitments to a substantial quantities or (I1) there is or may environmental effects; and testing is voluntary EPAtesting programknown be significant or substantial human exposure necessary to develop such data. as the HPV Challenge Program(see Unit to suchsubstance or mixture, II .C.), and updated production volume (ii) There are insufficient data and C . Why is EPA Taking thisAction? data (i .e., 2002 Inventory Update Rule experience upon which theeffects of the On April 21, 1998, EPAinitiated a (IUR) data) made available after the manufacture, distribution in commerce, national effort to empower citizens with publication of the proposal preceding or mixture~or ofanycombinationof such knowledge about the most widespread this final rule (i .e., the "proposed rule"), activities on health or the environment can chemicals in commerce. Amajor EPA is requiring testing for 17 of the 37 reasonably be determined or predicted, objective of this effort is to make certain chemicals originally proposed for and(iii) Testing ofsuchsubstanceor mixture basic information about the testing in 2000. EPA's decision to not with respect to such effects is necessary to environmental fate and potential health finalize testing requirements for the develop such data [.). and environmental hazards associated remaining 20 chemicals is described in If EPAmakes these findings for a with HPVchemicals available to the Unit VII . chemical substance or mixture, the public. Mechanisms to collect or, where At a future date, EPA may propose Administrator shall require by rule that necessary, develop needed data on U.S. testing for additional HPVchemicals as testing be conducted on that chemical HPVchemicals include the voluntary the Agency learns more about the substance or mixture. The purpose of HPV Challenge Program, certain chemicals with respect to human the testing is to develop data about the international efforts, and TSCA section exposure, release, and sufficiency of the substance's or mixture's health or 4 rules. data and experience available on their environmental effects for which there is 1 . Voluntary HPVChallenge Program . potential hazards. an insuffici f d t d The volunt HPV Ch 11 B. What is theAgency's Authorityfor and which are relevant to a officially launched in late 1998, was determination that the manufacture, created to ensure that a baseline set of Taking this Action. distribution in commerce, processing, data on approximately 2,800 HPV This final rule is being promulgated use, or disposal ofthe chemical chemicals would be made available to under TSCAsection 4(a) (15 U.S.C. substance or mixture, or any the public. HPV chemicals are 2603(a)), which directs EPA to require combination of such activities, does or manufactured or imported in amounts the development of data relevant to does not present an unreasonable risk of equal to or greater than 1 million assessing whether activities associated with chemical substances and mixtures present an unreasonable risk of injury to health or the environment, when appropriate findings are made. Section 2(b)(1) of TSCA (15 U .S.C. 2603(b)(1)) states that it is the policy of the United States that : adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data should be the responsibility of those who manufacture [which is defined by statute to include import] and thosewho process such chemical substances and mixtures[ .] To implement this policy, TSCA section 4(a) mandates that EPA require by rule that manufacturers and/or processors of chemical substances and mixtures conduct testing if the Administrator finds that : (1)(A)(i) the manufactiire, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or that anv combination of such activities, mav present ency o a a an experience, m'Y a enge Program,

injury to health or the environment . EPA need not limit the scope of testing required to the factual basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) findings, as long as EPA finds that there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or any combination of such activities on health or the environment can be reasonably determined or predicted, and that testing is necessary to develop the data. This approach is explained in more detail in EPA's statement of policy for making findings underTSCA section 4(a)(1)(B) (frequently described as the "B" policy) (Ref. 3, pp. 28738-28739) . In this final rule, EPA is using its broad TSCA section 4(a) authority to obtain data necessary to support the development of preliminary or pounds per year and were identified for this programthrough data reported under the TSCA Inventory Update Rule (IUR) during 1990. EPA challenged U.S. manufacturers and importers of HPVchemicals to voluntarily sponsor chemicals in the Program

. Sponsorship entails making screening-level health and environmental data available to the public. Public availability of these data, a fundamental principle of the Program, enables the public to know about the hazards associated with chemicals in their environment . The data set sought by the HPV Challenge Programis known as the Screening Information Data Set (SIDS) that was developed by the Organization for Economic Cooperation and Development (OECD) . The SIDS provides an internationally agreed upon set of test data for screening high production volume chemicals for screening level" determinations of the human and environmental hazards, and effects on health and the environment will allowthe Agency and others to fromexposure to the 17 chemical make an informed, preliminary

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ursday, March 16, 2006/Rules and Regulations judgment about the hazards of HPV includes agreements to sponsor a U.S. HPV Challenge Programor through chemicals. HPV chemical under either the OECD international efforts may be addressed As part of their commitment to the HPV SIDS Program(Ref. 5), including throughTSCA section 4 rulemaking, HPV Challenge Program, sponsors sponsorship by OECD member countries such as this final rule, where EPA submit data summaries of existing beyond the United States, or the determines that the statutory findings information along with a test plan that international HPV Initiative that is being can be made. This final rule is the first proposes a strategy to fill data gaps. organized by the International Council TSCA section 4 HPV SIDS rule, and Sponsors submit test plans for either of Chemical Associations (ICCA) (Ref. addresses the unmet data needs of 17 individual chemicals or for a category of 6) . chemicals. chemicals. A chemical category The OECD HPV SIDS Program Data collected and/or developed comprises a group of substances, includes information on the identity of under this final rule and the voluntary usually similar in chemical structure, each chemical, its uses, sources and HPV Challenge Program, when with a regular pattern of properties and extent of exposure; physical and combined with information about effects. Data for chemicals in the chemical properties; environmental fate; exposure and uses, will allowthe category can be used to estimate the and certain limited toxicity data for Agency and others to better assess the chemical properties and effects of other humans and the environment . The SIDS potential risk to health and the category members. is not intended to describe a chemical environment fromthese chemicals . EPA A 120-day comment period begins thoroughly, but rather is intended to intends to make the information when test plans and data summaries provide enough information to support collected under this final rule available submitted directly to the HPV Challenge an initial (or screening level) assessment to the public, other Federal agencies, Programare posted to the Program and to assign a priority for furtherwork, and any other interested parties on its website. It is at this time when all if necessary. The OECDHPVSIDS website (http://www .epa.gov/chernrtk/ stakeholders-industry, environmental Programseeks the development of test volchall .htm) and in the public docket protection groups, animal welfare data, if such data are not already for this final rule identified under groups, private citizens, etc.-can comment on the data summary and test plan submissions. EPA comments on all of the submissions as well . Comments are important because sponsors consider this feedback when revising their test plans and data summaries. All comments are posted to the Program website for public availability. Since the Program's inception in 1998, industry chemical manufacturers and importers have participated in the Challenge by sponsoring over 2,200 chemicals. More than 400 companies and 100consortia have sponsored chemicals directly in the Program while additional companies/consortia have sponsored chemicals indirectly in an international counterpart to the HPV challenge Program, the International Council of Chemical Associations (ICCA) HPVInitiative

. HPVchemicals that are not sponsored in the Program may be subject to a test rule under TSCA Section 4 because these chemicals lack needed testing. The voluntary HPVChallenge Programis further described in a Federal Register document which published on December 26, 2000 (Ref. 1) . 2. Certain international efforts. The voluntary HPVChallenge Programis designed to make maximumuse of scientifically adequate existing test data and to avoid unnecessary and duplicative testing of U .S. HPV chemicals. Therefore, EPA is continuing to participate in the voluntary international efforts, complementary to the voluntary PIPV Challenge Program, that are being coordinated by the OECD to secure basic hazard information on FIPV chemicals in use worldwide, including some of those on the U.S. (1990) HPVchemicals list (Ref. 4) . This available, related to six health and environmental effects endpoints for international HPV chemicals (see Unit II .D.). The SIDS data set has been internationally agreed upon by the 29 member countries of the OECDas providing the minimumdata set human and environmental risks as well required to make an informed as providing greater protection and preliminaryjudgment about the hazards knowledge to the public. By using the ofa given HPV chemical . The ICCA consists of representatives of chemical industry trade associations fromthe United States, Europe, Japan, Australia, Canada, Mexico, Brazil, New Zealand, and Argentina. The intended goal of the ICCAHPV Initiative was to complete screening-level hazard assessments on 1,000 "high priority" chemicals by the end of the year 2004. The progress of the ICCA HPV Initiative to date can be checked on ICCA's HPV Chemical Tracking Systemwebsite at http://www

.iccahpv.com/reports/ reportsmain.cfm

. Most of the chemicals on the ICCAworking list (Ref. 6) are also U.S. HPVchemicals. The ICCA testing/assessment work will be tied directly to that under the OECD HPV SIDS Programand to the U.S. voluntary HPV Challenge Programand any associated TSCA section 4 HPV SIDS rules. Any U.S. HPVchemicals that are handled under the OECD HPV SIDS Programor the ICCA HPV Initiative are considered by EPA to be "sponsored" and are not anticipated to be addressed in the voluntary HPV Challenge Programunless the international commitments are not met. Nor does EPA intend to evaluate these chemicals for possible TSCA section 4 HPV SIDS rulemaking unless the international commitments are not met . 3. TSCA rulemoking. U.S. data needs chemical substances for toxicity and which remain unmet in the voluntary produces information relevant to ADDRESSES

. As appropriate, this information will be used to ensure a scientifically sound basis for risk assessment/management actions. This effort will serve to further the Agency's goal of identifying and controllin

same approach to testing as that of the OECD Program, EPA is assuring that the data developed under this rule and the voluntary HPV Challenge Programwill be comparable to the data being developed in other countries, thereby enabling an international sharing of data and the prevention of unnecessary and duplicative testing

. See Refs. 1 and 2, pp. 81662-81664 for further information aboutthe voluntary HPVChallenge Program

and international efforts

. D . Whyis EPA Focusing on HPV Chemicals and SIDS Testing? EPA is focusing on HPV chemicals, which it defines as being manufactured in amounts equal to or greater that 1 million pounds, because although those chemicals cover only about 11%of the TSCA Inventory of chemical substances (see TSCA sections 8(a) and 8(b)), using Inventory information available in 1988 (Ref. 10, p. 32296), that small percentage of the Inventory accounts for 95%of total chemical production in the United States . EPA is focusing on Screening Information Data Set (SIDS) testing because it is comprised ofa battery of tests agreed upon by the international community through the OECD, ofwhich the United States is a member countrv, as appropriate for screening HPV

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understanding the basic health and existing chemicals and which is the environmental hazards and fate of HPV only trigger for entry into that program chemicals . The six basic testing should be determinative of the endpoints comprising this battery of threshold chosen for "substantial tests, known as the SIDS, have been production" under TSCA section adopted by the OECDas the minimum 4(a)(1)(B)(i) . See EPA's "B" policy (Ref. required to screen HPVchemical 3) . Among the reasons is that theTSCA substances for toxicity and section 4(a)(1)(B)(i) finding of environmental fate. The content of SIDS substantial production is not the sole was agreed upon at the 13th joint finding EPA must make to require Meeting of the OECDChemicals Group testing based onTSCAsection and Management Committee of the 4(a)(1)(B) . EPA must also find that there Special Programme on the Control of Chemicals (Refs. 7 and 8) . The United States believes these are the right tests for our domestic needs, i .e., screening U.S. HPVchemicals for health and environmental effects and environmental fate. SIDS testing evaluates the following six testing endpoints (Ref. 5) : " Acutetoxicity. " Repeat dose toxicity. " Developmental and reproductive toxicity. " Genetic toxicity (gene mutations and chromosomal aberrations) . " Ecotoxicity (studies in fish, Daphnia, and algae) . " Environmental fate (including physical/chemical properties (melting point, boiling point, vapor pressure, noctanol/water partition coefficient, and is substantial release, orsubstantial or significant human exposure under TSCAsections 4(a)(1)(B)(i)(I) and (II) . In addition, EPA mustfind that data are insufficient and testing is necessary under TSCA sections 4(a)(1)(B)(ii) and (iii). Accordingly, a finding that a chemical is produced in substantial quantities alone is not a sufficient basis to require testing underTSCAsection 4. In response to EPA's proposed "B" policy (Ref. 10), both the American Chemistry Council (ACC, formerly the Chemical Manufacturers Association (CMA)) and the Society of the Plastics Industry, Inc. commented that EPA's proposed production volume threshold of 1 million pounds is a reasonable interpretation of "substantial production" underTSCA (Refs. 11 and water solubility), photolysis, hydrolysis, the OECD's 2.2 million pound threshold transport/distribution, and would be preferable to achieve biodegradation) . consistency between EPA's activities While data on the six SIDS endpoints do under TSCA section 4 and the OECD not fully measure a chemical's toxicity, HPV SIDS Program . Although the they do provide a consistent minimum United States and OECDdiffer in their set of information that can be used to definition of an HPVchemical and what determine the relative hazards of chemicals and tojudge if additional testing or assessment is necessary. E. How Does EPA's HPVWork Relate to That of the OECD? As noted in Unit II .C.2., the OECD SIDS Programis complementary to the voluntary HPV Challenge Program . However, EPA's definition of an HPV chemical differs fromthat of the OECD . EPA defines an HPVchemical as having an annual production or importation volume of 1 million pounds or more. The OECD defines an HPVchemical as having an annual production volume of 2.2 million pounds (equivalent to 1 million kilograms (kg)) reported in any member country. The presence of a chemical on the OECD's list of HPVchemicals was and continues to be accepted by OECD member countries as providing a sufficient indicator of potential exposure to warrant testing at the SIDS level (Ref. 9) . EPA, however, does not believe that a production volurne threshold which is chosen for an international programon 12) . Additionally, they indicated that

should trigger basic screening tests of an HPVchemical, both the U.S. and OECD HPV Programs are alike in their information needs for an HPVchemical . Both the U.S. and OECD HPV Programs have identified the SIDS battery of tests as the basic screening tests needed to provide enough information to support a screening level assessment of the health and environmental effects of a chemical . F. Why is EPA Pursuing Hazard Information on HPVChemicals? EPA found that, of those nonpolymeric organic substances produced or imported in amounts equal to or greater than 1 million pounds per year based on 1990 IUR reporting, only 7% had a full set of publicly available and internationally recognized basic screening test data for health and environmental effects (Ref. 13) . Of the over 2,800 U.S. HPVchemicals based on 1990 IUR data, 43%had no publicly availahle basic hazard data. For the remaining chemicals, limited amounts of the data were available. This lack of available hazard data compromises 

### 13711 EPA's and others' ability to determine whether these HPVchemicals pose potential risks to human health or the environment, as well as the public's ability to knowabout the hazards of chemicals that may be found in their environment, their homes, their workplaces, and the products they buy. G. What is the Role of this Final Rule and Any Future TSCA Section 4 HPV SIDS Rulemaking with Regard to the Voluntary HPV Challenge Program? As indicated in the December 26, 2000 Federal Register document (Ref. 1) describing the voluntary HPV Challenge Program, EPA intends to use rulemaking under TSCAwhere appropriate to help fill data gaps not addressed as part of the voluntary HPV Challenge Program or international efforts . EPA does not intend at this time to evaluate U.S. HPV chemicals that have been or are being handled through the OECD HPV SIDS Programor under a complementary programbeing coordinated by the ICCA (Ref. 6) for screening level testing under TSCA section 4 HPV SIDS rulemaking, although the Agency may revisit this question if commitments under those international programs are not met . See Unit III .G. of Ref. 1 for more information on these programs. EPA is evaluating the extent to which additional nonsponsored HPVchemicals meet the threshold criteria for rulemaking under TSCA section 4. H . How Will the Data Developed Under this Final Rule Be Used? The availability of hazard data on certain individual chemicals is fundamental to EPA's ability to accomplish its mission of environmental protection. Hazard data are used in risk assessment and risk management, and ultimately to inform the public and promote the pollution prevention ethic. Activities to ensure the availability of basic hazard information on HPV chemicals support EPA's objectives. EPAwill use the data obtained from this final rule to support development of preliminary hazard and risk assessments for the 17 HPVchemicals subject to this rule. The data will also be used by EPA to set priorities for further testing that may produce hazard information on these chemicals that may be needed by EPA, other Federal agencies, the public, industry, and others, to support adequate risk assessments. As appropriate, this information will be used to ensure a scientifically sound basis for risk characterizations and risk management actions. As such, this effort will serve to further the Agency's goal of identifying and controlling human

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and environmental risks as well as providing greater knowledge and protection to the public. In the past, EPAhas used data fromtest rules to support such activities as the development ofwater quality criteria, Toxic Release Inventory (TRI) listings, chemical advisories, and reduction of workplace exposures. Finally, because the SIDS data to be developed under this final rule will be comparable to the type of data agreed to as being appropriate and being developed by the OECD HPV SIDS Program, the development of these data will enable an international sharing of data . As conceived by the OECD, the SIDS battery of tests can be used by governments and others worldwide to conduct an initial assessment of the hazards and risks posed by HPV chemicals and prioritize HPV chemicals to identify those in need of additional, more in-depth testing and assessment, as well as those of lesser concern. Not only can the data generated fromthis and any future TSCA section 4 HPV SIDS test rules contribute to the international effort, but also international SIDS testing and assessments can be used to fill the data gaps identified as part of the voluntary HPV Challenge Program . Additional detailed information is available on the SIDS website (http://cs3-hq.oecd.org/ scripts/hpv) and EPA's voluntary HPV Challenge Programwebsite (http:// www .epa.gov/chemrtk/volchall .htm) . Data collected or developed for each sponsored chemical in the voluntary HPV Challenge Programare provided in the format of a "robust" (i .e., detailed) summary. A robust summary contains the technical information necessary to adequately describe an experiment or study and includes the objectives, methods, results, and conclusions of the full study report, which can either be an experiment or in some cases an estimation or prediction method. (See Ref. 14, also at http://rvtivw .epa .gov/ chemrtk/robsumgd.htm) . A robust summary provides sufficient information to allowa technically qualified person to make an independent assessment ofa given study without having to read the full study report, and thereby facilitates the evaluation of existing data and the identification of additional data needs. EPA suggests that existing data relevant to this final rule be submitted to the Agency in robust summary format and, for any data developed under this rule, that a robust summary of the final report for each specific test be submitted in addition to the final report itself (see § 799 .5085(i) of the regulatory text) . III . Response to Public Comments EPA received a number of comments in response to the proposal (Ref. 2) to this final rule. Asummary of those comments and EPA's response to each comment are presented in the document entitled Response to Public Comments (Ref. 40) . Both the comments and EPA's Response to Public Comments (Ref. 40) are available in the public docket under ADDRESSES. The comments on the proposed test rule (Ref. 2) were submitted by theAmerican Chemistry Council (ACC), American Petroleum Institute (API), Synthetic Organic Chemical Manufacturers Association (SOCMA), Center for Regulatory Effectiveness (CRE), Environmental Defense (ED), American Coke and Coal Chemicals Institute (ACCCI), Color Pigments Manufacturers Association, Inc. (CPMA), Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD), Merisol USALLC(Merisol), Ashland Distribution Company (Ashland), Dow

Chemical Company (Dow), ExxonMobil Chemical Company (EMCC), Lonza Group, Dyno Nobel, Inc. (Dyno Nobel), Sciences International Inc. (SIT), Institute of Makers of Explosives (IME), People for the Ethical Treatment of Animals (PETA), Physicians Committee for Responsible Medicine (PCRM), Doris Day Animal League WALL The Humane Society of the United States (HSUS), Alternative Research &Development Foundation (ARDF), American Anti-Vivisection Society (AAVS), New EnglandAntiVivisection Society (NEAVS), Silicones Environmental, Health and Safety Council (SEHSC), and numerous private citizens (Refs. 15-39) . After reviewand analysis of the submitted comments, EPA made the following changes to the regulatory text as proposed in response to those comments: 1 . The tests for melting point, boiling point and vapor pressure are not required for 1,3-propanediol, 2,2- bis[(nitrooxy)methyl]-, dinitrate (ester) (CAS No. 78-11-5), also known as pentaerythritol tetranitrate (PETN) . This change is further discussed in Unit VII .C.1 . and in the document entitled Response to Public Comments (Ref. 40) . 2 . The screening test for reproduction/ developmental toxicity is not required for 2,4-hexadienoic acid, (2E,4E)- (CAS No. 110-44-1), also known as sorbic acid. This change is further discussed in Unit VII .C.2. and in the document entitled Response to Public Comments (Ref. 40) . 3. The neutral red uptake basal cytotnxicity assay may be used to estimate the starting dose for the mammalian acute toxicity test. The test is included as a special condition in Table 3 in § 799.5085(j) of the regulatory text. This change is further discussed in Unit V.A.4. and in the document entitled Response to Public Comments (Ref. 40) . IV. Findings A. What is the Basisfor EPA's Final Rule to Test These Chemical Substances? As indicated in Unit II .B., in order to promulgate a rule under TSCAsection 4(a) requiring testing of chemical substances or mixtures, EPA must, among other things, make certain findings for those chemical substances or mixtures regarding either hazard (TSCA section 4(a)(1)(A)(i)) or production and either chemical release or human exposure (TSCA section 4(a)(1)(B)(i)) . EPA is requiring testing of the chemical substances included in this final rule based on its findings under TSCA section 4(a)(1)(B)(i) relating to "substantial production" and "substantial human exposure," as well as findings under TSCAsections 4(a)(1)(B)(ii) and (iii) relating to sufficient data and the need for testing. The chemical substances included in this final rule are listed in Table 2 in § 799 .5085(j) of the regulatory text along with their CAS numbers. "Substantial production" of a chemical substance or mixture under TSCA section 4(a)(1)(B)(i) is generally interpreted by EPAto be aggregate production (including import) volume equaling or exceeding 1 million pounds per year and exposure of 1,000workers or more on a routine or episodic basis to a chemical substance or mixture is considered to be "substantial exposure." See EPA's "B" policy (Ref. 3) for further discussion on how EPAgenerally makes decisions underTSCAsection 4(a)(1)(B)(i) . EPA finds that, under TSCA section 4(a)(1)(B)(i), each of the 17 chemical substances included in this final rule is produced in "substantial quantities" and there is or may be "substantial human exposure" to each chemical substance (Ref. 41) . In addition, under TSCA section 4(a)(1)(B)(ii), EPA finds that there are insufficient data and experience to reasonably determine or predict the effects of the manufacture, processing, or use of these chemical substances, or of any combination of such activities, on human health or the environment . EPA also finds that testing of the 17 chemical substances is necessary to develop such data (TSCA section 4(a)(1)(B)(iii)) (see Unit [V.E .).

### p. 7 Federal Register/Vol . 71, No . 51 /Thursday, March 16, 2006/Rules and Regulations EPA has not identified any factors to cause the Agency to use decisionmaking criteria other than the general thresholds described in the "B" policy with respect to the chemicals included in this final rule. B . Are These Chemical Substances Produced and/orlmported in Substantial Quantities? EPAfinds that each of the chemical substances included in this final rule is produced and/or imported in an amount equal to or greater than 1 million pounds per year based on information gathered pursuant to the 2002 IUR (40 CFRpart 710, subpart B) . The 2002 IUR is the most recently available compilation of TSCA section 8(a) Inventory Update Reporting data, and the IURdata have been compiled into a database called the TSCA Chemical Update System

. EPA also considered the fact that all of these chemicals were produced and/or imported above 1 million pounds annually based on the 1990, 1994, and 1998 IUR . EPA concludesthat the annual production volume of each chemical is "substantial" as that termis used with reference to production in TSCA section 4(a)(1)(B)(i) (Ref. 3) . C . Are a Substantial Number ofWorkers Exposed to These Chemicals? EPA finds that the manufacture, processing, and use of the chemical substances included in this action result or may result in exposure to a substantial number of workers. These chemical substances are used in a wide variety of industrial applications which result in potential exposures to workers, as described in the exposure support document for this final rule (Ref. 41) . EPAdefines human exposure as the contact with a chemical or agent at the visible exterior of a person (i .e., skin and openings into the body such as mouth and nostrils) (Ref. 42, p. 22891) . Worker exposure is the human exposure to a chemical or agent that occurs while a person is working. Worker exposure may have various causes, with chemical releases being a common cause of exposure. Chemical manufacturing and processing plants can release chemicals frompumps as fugitive emissions, from reactor and condenser vents as stack emissions, in the formof a vapor and/ or as a particulate. Diffusion and air currents may carry a chemical throughout the plant and workers may breathe air containing the chemical, resulting in exposures . Certain human activities such as manually transferring a chemical fromone container to another may also cause CXPOSLires. Each of the chemicals in this final rule was identified in the National Occupational Exposure Survey (NOES) as having a total worker exposure of 1,000workers or more (Ref. 41) . EPA concludes that an exposure of 1,000 workers or more to a chemical substance is or may be "substantial" as that term is used with reference to "human exposure" in TSCA section 4(a)(1)(B)(i) (Ref. 3) . D . Do Sufficient Data Existfor These Chemical Substances? As discussed in Unit II .D., data on SIDS testing endpoints, including acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, genetic toxicity (gene mutations and chromosomal aberrations), ecotoxicity (tests in fish, Daphnia, and algae), and environmental fate (five tests for physical/chemical properties (melting point, boiling point, vapor pressure, n-octanol/water partition coefficient, and water solubility) and biodegradation), are necessary in ascertainingthe health and environmental effects of the 17 chemicals in this final rule. EPA has determined that for the 17 chemicals for which testing is required under this final rule, there are either no data available on SIDS testing endpoints or, where there is some information, these data are insufficient (See Unit II .D. and II .E.). Therefore, existing data are insufficient to reasonably determine or predict the effects on human health that may result fromexposures to the chemical substances included in this final rule during the manufacturing, processing, or use of the subject chemical substances. EPA also sought existing information on the SIDS testing endpoints of chemical fate and ecotoxicity and found it to be insufficient . EPA undertook this evaluation because once the Administrator has madea finding under TSCAsection 4(a)(1), EPA may require any type of health or environmental effects testing necessary to address unanswered questions about the effects of a chemical (Ref. 2, p. 81660) . The finding for insufficient data is based on the results of searches for data on SIDS endpoints by EPA (Ref. 13) and ACC (Ref. 43), and EPA's reviewofstudies/ data identified by commenters in response to the proposal or identified by EPA after the publication of the proposal to this final rule. Thestudies and data submitted or identified subsequent to the proposal were found to be sufficient for some proposed tests of certain chemicals and those tests are not required for those chemicals in this final rule (See Unit VILC.) . Table 2 of 

### 13713 § 799.5085(j) of the regulatory text lists the SIDS endpoint tests for each of the remaining 17 chemicals for which no data are currently available to the Agency or, where some information is available, the data are not sufficient. In the proposal to this final rule, EPA encouraged the submission of existing data on SIDS testing endpoints which are relevant to characterizing the hazard of those chemicals for which testing was proposed. All such submitted information was carefully evaluated by EPA in the development of the final testing requirements in this rule. However, if persons required to test underthis final rule become aware of additional relevant scientifically adequate existing data (including structure-activity relationships (SAR) information or a scientifically defensible category approach) and submit this information to EPAat any time before testing is initiated, the Agency would consider such data to determine if they satisfy the testing requirement and would take appropriate necessary action to ensure that the testing in this rule is no longer required. In fact, they may submit such information as a requested modification to the testing requirements under 40 CFR790.55 at anytime as long as the request is made at least 60 days before the reporting deadline for the test in question. E. Is Testing Necessaryfor These Chemical Substances? As discussed in Unit IV.D., the lack of sufficient data for these 17 chemicals compromises EPA's and others' ability to determine whether each chemical poses an unreasonable risk to human health or the environment . EPA believes that conducting SIDS testing for the 17 subject chemical substances is necessary to provide data and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of the chemical substances or of any combination of such activities on health or the environment can reasonably be determined or predicted. EPA has determined that testing is necessary in order to obtain these relevant data. EPAwill use the data obtained from this final rule to support development of preliminary hazard assessments for these 17 HPVchemicals and to set priorities for obtaining exposure information and furthertesting that will produce more definitive hazard information where needed . Such additional information is needed by EPA, other Federal agencies, the public, industry, and others to ensure that adequate risk assessments can be conducted on these chemicals. EPAhas

### 13714 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations

used data fromtest rules to support such activities as the development of water quality criteria, TRI listings, chemical advisories, and input for actions resulting in reduction of workplace exposures . (See Unit II .C. thru II .G.). V . Final Rule A. What Testing is Being Required in this Action? EPA is requiring specific testing and reporting requirements for the chemical substances listed inTable 2 in § 799 .5085(j) of the regulatory text. The testing requirements for each chemical are denoted by alphanumeric symbols in Table 2 in § 799.5085(j) of the regulatory text. Table 3 in § 799 .5085(j) of the regulatory text provides the key to identify the tests denoted by the alphanumeric symbols and lists special conditions which might apply when conducting some of those tests. The test methods listed in Table 3 in § 799 .5085(j) of the regulatory text are grouped according to the endpoint that they address. The following endpoints and test standards are required under this final rule; also discussed in this Unit V .A. are the special conditions which EPAhas identified and is requiring for several of the required test standards. 1 . Physical/chemical properties. Melting Point: American Society for Testing andMaterials (ASTM) E 324 (capillary tube) (Ref. 44) . Boiling Point : ASTM E 1719 (ebulliometry) (Ref. 45) . Vapor Pressure

: ASTM

E 1782 (thermal analysis) (Ref. 46) . n-Octanol/Water Partition Coefficient :

Method A(40CFR 799.6755-shake flask) . Method B (ASTM E 1147-liquid chromatography) (Ref. 47) . Method C(40 CFR799.6756- generator column) . Water Solubility: Method A

: (ASTM

E 1148-shake flask) (Ref. 48) . flask) . Method B: (40 CFR 799.6784-shake Method C

: (40 CFR799.6784-column elution) . Method D

: (40CFR799.6786- generatorcolumn) . EPA proposed determining the melting point of all 17 chemicals in this final rule using the method ASTM E 324. Since the publication of the proposal to this final rule, ASTM has indicated on its website, http:// www .a stm .org/cgi-bin/So

ftCart.exe/ index.shtml?E+mystore, that ASTM E 324 has been withdrawn. To quote the ASTM rationale for the withdrawal of ASTM E 324: The standard utilizes old, well-developed technology; it is highly unlikely that any additional [changes] and/or modifications will ever be pursued by the E15 [committee] . The time and effort needed to maintain these documents detracts fromthe time available to developnew

standardswhich use modern technology (Ref. 49) . Note that withdrawal of the method by ASTM

means only that ASTM no longer continues to develop and improve the method. It does not mean that ASTM

no longer considers the method to be valid. ASTM still makes the method availablefor informational purposes and it can still be purchased fromASTM

at the address listed in § 799.5085(h) of the regulatory text. EPA concludes that ASTM's withdrawal of E 324 does not have negative implications on the validity of the method; therefore, EPA is still requiring, for those chemicals for which melting points determinations are needed, that melting points be determined according to the method ASTM

E 324. For the n-octanol/water partition coefficient and water solubility endpoints, EPA is requiring that certain "special conditions" be considered by test sponsors in determining the appropriate test method that would be used fromamong those included for these endpoints in Table 3 in § 799.5085(j) of the regulatory text. For the "n-octanol/water partition coefficient (log 10 basis)" endpoint, also known as log Kow, the test method required, if any, will be determined by the test substance's estimated log Ko,v. EPA provides three methods for measuring the substance's log K.-, but prior to selecting an appropriate method to use, if any, EPA is recommending that the log Ko, be quantitatively estimated by using the method described in the article entitled Atom/ Fragment Contribution Methodfor Estimating Octanol-Water Partition Coefficients (Ref. 50) . EPA is recommending that the Kow be estimated in recognition of the fact that, depending on the chemical substance's log Kow, one or more test methods can be expected to provide adequate information for determiningthe log Kow . In genera], EPAbelieves that the more hydrophobic a subject chemical is, the less well Method A (40CFR799.6755- shake flask) will work, and that Method B (ASTM

E 1147-liquid chromotography) and Method C(40 CFR 799 .6756-generator column) become more suitable, especially Method C . Whether the test sponsor chooses to quantitatively estimate the log Kow or not, EPArequires that the test sponsor provide with the final study report the underlying rationale for the test method selected to measure log Kow . The required test methods have been developed to meet a wide variety of needs and, as such, are silent on experimental conditions related to pH . Therefore, EPA highly recommends that all required log Kowtests be conducted at pH 7to ensure environmental relevance. The required test methods and estimated log K.wranges that determine which test method must be used for this endpoint for a given chemical are shown in Table 1 of this unit. The ranges of the estimated log Kows have been modified slightly since the proposal to eliminate the overlap of ranges stated in the proposal .

### Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations TABLE 1 .-TEST REQUIREMENTS FOR THE n-OCTANOL/WATER PARTITION COEFFICIENT ENDPOINT 

### 13715 Testing category --- Test requirements and references Special conditions Physical/chemical properties n-Octanol/water partition coefficient (log 10 basis) or n-Octanol/water partition coefficient or log K , : log Kow : Which method is required, if any, is determined by The appropriate log Ko,v test, if any, must be selected thetest substance's estimated log Kow as follows: from those listed in this column-see special con- log Kow<0: no testing required. ditions in the adjacent column. log Kow range 0-1 : Method A or B . Method A

: 40 CFR799

.6755 (shake flask) log Kow range >1-4: Method Aor B or C . Method B

: ASTME 1147 (liquid chromatography) log Ko,wrange >4-6: Method B or C . Method C

: 40 CFR799

.6756 (generator column) log ICo,v >6: Method C . Test sponsors are required to provide in the final study report the underlying rationale for the method selected. In order to ensure environmental relevance, EPA highly recommends that the selected study be conducted at pH 7. For the "water solubility" endpoint, thetest method, if any, will be determined by the test substance's estimated watersolubility. EPA recommends that water solubility be quantitatively estimated prior to initiating this study. One recommended method for estimating water solubility is described in the article entitled Improved Methodfor Estimating Water Solubility FromOctanol/Water Partition Coefficient (Ref. 51) . EPA requires that test sponsors provide in the final study report the underlying rationale for the test standard selected for this endpoint . The required test methods have been developed to meet a wide variety of needs and, as such, are silent on experimental conditions related to pH . Therefore, EPA highly recommends that all required water solubility tests be conducted at pH 7 to ensure environmental relevance. The estimated water solubility ranges that EPA proposed for use in selecting an appropriate test standard have been modified slightly since the proposal to eliminate overlaps. The estimated water solubility ranges that EPA is requiring in this final rule to select an appropriate test standard are shown in Table 2 of this unit. TABLE 2.-TEST REQUIREMENTS FOR THE WATER SOLUBILITY ENDPOINT Testing category Test requirements and references Special conditions Physical/chemical properties Watersolubility: Water solubility: The appropriate method to use, if any, to test for Which method is required, if any, is determined by water solubility must be selected from those listed the test substance's estimated water solubility. in this column-see special conditions in the adja- Test sponsors are required to provide in the final cent column. study report the underlying rationale for the methMethod A

: ASTME 1148 (shake flask) od selected. In order to ensure environmental relMethod B

: 40 CFR 799

.6784 (shake flask) evance, EPAhighly recommends that the selected Method C

: 40 CFR799

.6784 (column elution) study be conducted at pH 7. Method D

: 40 CFR 799

.6786 (generator column) >5,000 milligrams/liters (mg/L) : Method Aor B . >10mg/L-5,000 mg/L: Method A, B, C, or D . >0.001 mg/L-10mg/L: Method Cor D . 50 .001 mg/L: No testing required. 2. Environmental fate and pathways. Inherent Biodegradation: ASTM 1625 (semicontinuous activated sludge test) (Ref. 52) or ISO9888 (Zahn-Wellens Method) (Ref. 53) . Either method may be used, and no special conditions apply. 3 . Aquatictoxicity. Test Group 1 : Acute toxicity to fish (ASTM E 729) (Ref. 54) . Acute toxicity to Daphnia (ASTM E 729) (Ref. 54) . Toxicity to plants (algae) (ASTM E 1218) (Ref. 55) . Test Group 2

: Chronic toxicity to Daphnia (ASTM E 1193) (Ref. 56) . Toxicity to plants (algae) (ASTM E 1218) (Ref. 55) . For the "aquatic toxicity" endpoint, the OECD HPV SIDS Programrecognizes that, for certain chemicals, acute toxicity studies are of limited value in assessing the substances' aquatic toxicity. This issue arises with respect to chemicals with high log Kow values. In such cases, toxicity is unlikely to be observed over the duration of acute toxicity studies because of reduced uptake and the extended amount of time required for such substances to reach toxic concentrations in the test organism

. For such situations, the OECD HPV SIDS Programrecommends use of chronic toxicity testing in Daphnia in place of acute toxicity testing in fish and Daphnia. EPA is requiring that the aquatic toxicity testing requirement be determined based on the test substance's measured log K_ as determined by using the approach outlined in Unit V.A.1 ., in the discussion of "n-octanol/water partition coefficient," and in Table 3 in § 799 .5085(j) of the regulatory text. For test substances determined to have a log Kowof less than 4

.2, one or more of the following tests (described as "Test Group 1" in Table 3 in § 799 .5085(j) of the regulatory text) arerequired: Acute toxicity to fish (ASTM E 729), Acute toxicity to Daphnia (ASTM E 729), and Toxicity to plants (algae) (ASTM E 1218) . For test substances determined to have a log Kow

that is greater than or equal to 4

.2, one or both of the following tests (described as "Test Group 2" in Table 3 in § 799

.5085(j) of the regulatory text) are required: Chronic toxicity to Daphnia (ASTM

E 1193) and Toxicity to plants (algae) (ASTM E 1218)

. As outlined in Table 3 in § 799 .5085(j) of the regulatory text, depending on the testing required in Test Group 1, the Test Group 2chronic Daphnia test may substitute for either or both the acute

### p. 10

13716 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations fish toxicity test and the acute Daphnia test. EPArecognizes that in some circumstances, acute aquatic toxicity testing (Test Group 1) may be relevant for certain chemical substances having a log K .wequal to or greater than 4.2. Using SAR, a log Kow of 4 .2 corresponds with a fish bioconcentration factor (BCF) of about 1,000 (Refs. 57-59) . A chemical with a fish BCF value of 1,000 or more is characterized as having a tendency to accumulate in living organisms relative to the concentration of the chemical in the surrounding environment (Ref. 60) . Forthe purposes of this final rule, EPA's use of a log Kow equal to or greater than 4 .2 (which corresponds with a fish BCFvalue of 1,000) is consistent with the approach taken in the Agency's proposed (Ref. 61) and final (Ref. 62) Policy Statement under TSCA section 5 entitled Category for Persistent, Bioaccumulative, and Toxic New

Chemical Substances. EPA has also used a measured BCF that is equal to or greater than 1,000or, in the absence of a BCF, a log Kow value equal to or greater than 4 .3 to help define the potential of a new chemical substance to cause significant adverse environmental effects (Ref. 63) . EPAconsiders the difference between the log Kow of 4 .3 used with new

chemical substances (Ref. 63) and the log Kow value of 4.2 cited in this final TSCA section 4 test ruleto be negligible. Chemical substances that are dispersible in water (e.g., surfactants, detergents, aliphatic amines, and cationic dyes) may have log Kow values greater than 4.2 and may still be acutely toxic to aquatic organisms. To deal with such chemicals, EPA is recommending that test sponsors who wish to conduct Test Group 1 studies on chemicals with a log Kowgreater than or equal to 4.2 submit to EPA for approval a written request to conduct Test Group 1 studies 90days prior to conducting such studies . EPA solicited public comment on this approach as well as other alternative approaches in this area but did not receive comments on this matter. 4. Mammalian toxicity-acute. Acute Inhalation Toxicity (rat): Method A(40 CFR 799.9130) Acute Oral Toxicity (rat) : Method B (ASTM E 1163 or 40 CFR 799.9110(d)(1)(i)(A)) (Ref. 64) . For the "mammalian toxicity-acute" endpoint, EPA is requiring that certain "special conditions" he considered in determining the appropriate test method that would he used fromamong those included for this endpoint in Tahle 3 in § 799 .5085(j) of the regulatory text . The OECD HPV SIDS Programrecognizes that for most chemical substances, the oral route of administration will suffice for this endpoint. However, consistent with the approach taken under the voluntary HPV Challenge Program, EPA is requiring that for test substances that are gases at roomtemperature (25°C), the acute mammalian toxicity study be conducted using inhalation as the exposure route (described as MethodA (40 CFR 799.9130) in Table 3 in § 799 .5085(j) of the regulatory text) . For all other chemicals (i .e., those that are either liquids or solids at room temperature), EPAis requiringthat the mammalian acute toxicity testing be conducted via oral administration using an "Up/Down" test method (described as Method B (ASTM E 1163 or 40 CFR 799.9110(d)(1)(i)(A)) in Table 3 in § 799 .5085(j) of the regulatory text) . Consistent with the voluntary HPV Challenge Program, EPA is allowing the use of the neutral red uptake basal cytotoxicity assay to select the starting dose for the acute oral toxicity test as noted in Unit ITI . and discussed in the document Response to Public Comments (Ref. 40) . This test is included as a special condition in Table 3 in § 799

.5085(j) of the regulatory text . 5. Mammalian toxicity-genotoxicity. Gene Mutations: Bacterial Reverse Mutation Test (in vitro) : 40 CFR799.9510 Chromosomal Damage: In VitroMammalian ChromosomeAberration Test (40 CFR799

.9537), or Mammalian Bone MarrowChromosomal Aberration Test (in vivo in rodents: Mouse (preferred species), rat, or Chinese hamster) (40CFR 799 .9538), or Mammalian Erythrocyte Micronucleus Test (sampled in bone marrow) (in vivo in rodents: Mouse (preferred species), rat, or Chinese hamster) (40CFR 799.9539) . Persons required to conduct testing for chromosomal damage are encouraged to use in vitrogenetic toxicity testing (i .e., the Mammalian Chromosome Aberration Test) to generate the needed genetic toxicity screening data, unless known chemical properties preclude its use. These could include, for example, physical chemical properties or chemical class characteristics. A primary focus of both the voluntary HPV Challenge Program and this final rule is to implement this programin a manner consistent with the OECD HPV SIDS Programand as part of a targer international activity with global involvement . This approach provides the same degree of flexibility as that which currently exists under the OECD HPV SIDS testing program(Ref. 5) . Asubject person who uses one of the in vivo methods instead of the in vitro method to address a chromosomal damage test requirement must submit to EPA a rationale for conducting that alternate test in the final study report. EPA solicited comment on whether the Agency should instead require that a subject person wishing to use an alternate testing scheme submit to EPA a notice that includes the rationale for conducting the alternative tests prior to initiation of those studies. The comments received on this issue are addressed in Unit M .4. of the Response to Public Comments document (Ref. 40) . 6. Mammalian toxicity-repeated dose/reproduction/developmental

. Combined Repeated Dose Toxicity Study with theReproduction/Developmental Toxicity Screening Test : 40 CFR799.9365, or Reproduction/Developmental Toxicity ScreeningTest : 40CFR799.9355 and Repeated Dose 28-Day Oral Toxicity Study in Rodents: 40 CFR799.9305. For the "mammalian toxicityrepeated dose/reproduction/ developmental" endpoint, EPA recommends the use of the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (40CFR799 .9365) . EPA recognizes, however, that there may be reasons to test a particular chemical using both the reproduction/ developmental toxicity screening test (40CFR 799

.9355) and the repeated dose 28-day oral toxicity study in rodents (40CFR 799 .9305) instead of the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (40 CFR 799 .9365) . With regard to such cases, a subject person who uses the combination of the reproduction/ developmental toxicity screening test and the repeated dose 28-day oral toxicity study in rodents in place of the combined repeated dose toxicity study with reproduction/developmental toxicity screening test must submit to EPA a rationale for conducting these alternate tests in the final study reports. EPA solicited comment on whether the Agency should instead require that a subject person wishing to use an alternate testing scheme submit to EPA a notice that includes the rationale for conducting the alternative tests prior to initiation of those studies. The comments received on this issue are addressed in Unit M .4. of the Response to Public Comments document (Ref. 40) . In the proposal (Ref. 2) to this final rule, EPAstated that certain of the chemicals for which mammalian toxicity-repeated dose/reproduction/ developmental toxicity testing is required may be used solely as "closed system intermediates," and if that were the case, such chemicals may he eli ;ible

### p. 11 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations for a reduced testing battery which substitutes a developmental toxicity study for the SIDS requirement to address repeated dose, reproduction, and developmental toxicity. EPA requested persons who believe their chemical is used solely as a closed systemintermediate to submit appropriate information along with their comments which substantiate this belief. If EPA agreed that the chemical is used solely as a closed system intermediate it would address any developmental toxicity testing need in a subsequent rulemaking (Ref. 2, p . 81671) . In its comments on the proposal to this final rule, ExxonMobil (Ref. 26) claimed that methyl heptenone is a closed systemintermediate. EPA's response to ExxonMobil's claimis discussed in Unit K .5. of the Response to Public Comments document (Ref. 40) . B. When Will the Testing Imposed by this Final Rule Begin? Once this final rule is effective, which will be 30 days after its publication in the Federal Register, the required testing must be initiated at a time sufficient to allow the final report to be submitted by the deadline indicated in § 799.5085(i) of the regulatory text, i .e., 13 months after the effective date of the rule . C . How Must the Studies Required Under this Final Rule be Conducted? Persons required to comply with this final rule must conduct the necessary testing in accordance with the testing requirements listed in Tables 2 and 3 in § 799.5085(j) of the regulatory text, the reporting requirements described in § 799 .5085(i) of the regulatory text, and with 40 CFRPart 792-TSCA Good Laboratory Practice Standards (GLPS) . D . What Substances Will be Tested Under this Final Rule? With one exception, the "Class 1" chemical substances listed in Table 2 in § 799.5085(j) of the regulatory text (i .e., 12 of the 17 chemical substances included in this final rule) must be tested at a purity of at least 99% . The exception is 1,3- propanediol, 2,2- bisf(nitrooxy)methylj-, dinitrate (ester) (CAS No. 78-11-5), also known as pentaerythritol tetranitrate (PETN), which cannot be tested at 99% purity because of its explosive properties and must either he diluted in water or tested in a mixture with an appropriate stabilizing compound (e .g., D-lactose monohydrate is the stabilizer in PETN, NF which is a mixture that is 20%by weight PETN and 80%hy weight Dlac :tose monohydrate. PETN, NF is the formof PETN which was tested by NTP in several toxicity studies (Ref. 65)) . 

### 13717 EPA has specified in § 799.5085 (a) of production run, because of small the regulatory text that, if the test variations in feedstocks, manufacturing sponsor elects to test this chemical in a methods, or other production variables . mixture with a stabilizing compound (as Small variations in the feedstock or in opposed to dilution of the chemical in chemical production methods or water), then the stabilizer used must be conditions can account for the types of tested as a control . small variations in composition The termClass 1 chemical substance typically allowable within a given Class refers to a chemical substance having a 2 listing on the TSCA Inventory. By chemical composition that consists of a contrast, a "Class 1" designation single-chemical species (not including generally applies to a substance which impurities) that can be represented by a is an individual chemical whose only specific, completestructure diagram . In variables are its impurities. those instances in which thetest EPA believes that, for purposes of this sponsor(s) believes that a 99%level of final rule, thetesting of any purity is unattainable for a given representative formof a subject Class 2 chemical, the sponsor may request a substance would provide data necessary modification under the procedures to support the development of described in 40 CFR 790.55. preliminary or screening level hazard For the "Class 2" chemical substances and risk characterizations for the subject listed in Table 2 in § 799.5085(j) of the Class 2 substance. However, EPA regulatory text (i .e., 5 of the 17 chemical encourages theselection of substances included inthis final rule), representative forms of the test EPA is requiring that the substance to be substances that meet industry or tested be any representative formof the chemical substance. ThetermClass 2 chemical substance refers to a chemical substance having a composition that cannot be represented by a specific complete chemical diagram, because such a substancegenerally contains two or more different chemical species (not including impurities) . In providing a different approach for identifying the substance to be tested with regard to Class 2 substances, EPA recognizes two characteristicswhich further distinguish Class 2 fromClass 1 chemical substances. First, unlike for Class 1 substances, knowledge ofthe composition of commercial Class 2 substances can vary in quality and specificity fromsubstance to substance. The composition of the chemical species which comprise a Class 2 substance may be: " Well characterized in terms of molecular formula, structural diagrams, and compositional percentages ofall species present (for example, methyl phenol) ; " Less well-characterized, for example, characterized only by molecular formula, non-specific structural diagrams, and/or by incomplete or unknown compositional percentages of the species present (for example C,?-C,~, tert-alkyl amines) ; or " Poorly characterized because all that is known is the identity of only some of the chemical species present and their percentages of composition, or of only the feedstocks and method used to manufacture the substance (for example, nut shell liquor of cashew) . Second, the composition of some Class 2 substances may vary fromone manufacturer to another, or, for a single manufacturer, fromproduction run to consensus standards, where they exist. In accordance with TSCA GLPS at 40 CFRpart 792, the final study report must include test substance identification information, including name, CAS number, strength, purity, and composition, or other appropriate characteristics. (See 40 CFR 792.185) . In future TSCA section 4 test rules involving Class 2 substances, testing requirements relative to the number and specificity of the representative formof the substance may differ fromthe testing requirement in this final rule (i .e., testing of any representative form of the subject Class 2 substances)

. For example, EPAmay require testing of more than one representative formof a Class 2substance or may specify the representative formto be tested and/or may specify equivalence data that must be submitted by exemption applicants. (See 40 CFR790

.82) . E . AmI Required to Test Under this Final Rule? 1 . Am Isubject to this final rule? You are subject to this final rule and may be required to test ifyou manufacture (which is defined by statute to include import) or process, or intend to manufacture or process, one or more chemical substances listed in Table 2 in § 799.5085(j) of the regulatory text during the time period discussed in Unit V.E.2. However, ifyou do not know or cannot reasonably ascertain that you manufacture or process a listed test rule substance (based on all information in your possession or control, as well as all information that a reasonable person similarly situated might be expected to possess, control, or know, or could obtain without an unreasonable burden), you are not

### p. 12

13718 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations subject to the rule for that listed substance. 2. When will my manufacture or processing (or my intent to do so) cause me to be subject to this final rule? You are subject to this final rule ifyou manufacture or process, or intend to manufacture or process, a substance listed in Table 2 in § 799.5085(j) of the regulatory text at any time fromthe effective date of the final test rule to the end of the test cost reimbursement period. The termreimbursement period is defined at 40 CFR 791 .3(h) and may vary in length for each substance to be tested under a final TSCAsection 4(a) test rule, depending on what testing is required and when testing is completed. (See Unit V.E.4.). 3. Will I be required to test if I am subject to the rule? It depends on the nature ofyour activities. All persons who are subject to this TSCAsection 4(a) test rule, which, unless otherwise noted in the regulatory text, incorporates EPA's generic procedures applicable to TSCA section 4(a) test rules (containedwithin 40 CFR part 790), fall into one of two groups, designated here as Tier 1 and Tier 2. Persons in Tier 1 (those who must initially comply with the rule) must either: " Submit to EPA letters of intent to conduct testing, conduct this testing, and submit the test data to EPA or " Applyto and obtain fromEPA exemptions fromtesting. Persons in Tier 2 (those who do not have to initially comply with the rule) need not take any action unless they are notified by EPA that they are required to do so, as described in Unit V.E.3.d. Note that persons in Tier 1 who obtain exemptions and persons in Tier 2 are nonetheless subject to providing reimbursement to persons who actually conduct the testing, as described in Unit V.E .4. a. Who is in Tier 1 and Tier 2? All persons subject to this final rule are considered to be in Tier 1 unless they fall within Tier 2. Table 3 of this unit describes who is in Tier 1 and Tier 2. TABLE 3.-PERSONS SUBJECT TO THE RULE: PERSONS IN TIER 1 ANDTIER 2 Tier 1 (Persons initially required to comply) Tier 2 (Persons not initially required to comply) Persons who manufacture (as defined at TSCA section 3(7)), A . Persons who manufacture (as defined at TSCA section 3(7)) or intend to or intend to manufacture, a test rule substance, and who are manufacture a test rule substance solely as one or more of the following: not listed under Tier 2 -As a byproduct (asdefined at 40 CFR791 .3(c)) ; -As an impurity (as defined at 40 CFR790 .3) ; -As a naturally occurring chemical substance (as defined at 40 CFR 710 .4(b)) ; -As a non-isolated intermediate (as defined at 40 CFR704 .3); -As a component of a Class 2 substance (as described at 40 CFR 720 .45(a)(1)(i)) ; -In amounts of less than 500 kg (1,100 Ibs.) annually (as described at 40 CFR790

.42(a)(4)) ; or -In small quantities solely for research and development (R & D) (as described at 40 CFR790 .42(a)(5)) . B . Persons who process (as defined at TSCA section 3(10)) or intend to process a test rule substance (see 40 CFR 790 .42(a)(2)) .

b. When is it appropriate for a person required to comply with the rule to applyfor an exemption rather than submit a letter of intent to conduct testing? You may apply for an exemption ifyou believe that the to required testing will be performed by another person (or a consortiumof persons formed under TSCA section 4(b)(3)(A)) . You can find procedures relating to exemptions in 40 CFR 790 .80 through 790

.99, and § 799

.5085(c)(2), (c)(5), and (c)(9) of the regulatory text. In this final rule, EPAwill not require the submission of equivalence data (i .e., data demonstrating that your substance is equivalent to the substance actually being tested) as a condition for approval of your exemption. Therefore, 40 CFR 790.82(e)(1) and 40 CFR790 .85 do not apply to this final rule. c. What will happen if I submit an exemption application? EPA believes that requiring the collection of duplicative data is unnecessarily hurdensome. As a result, if EPAreceives a letter of intent to test fromanother source or has received (or expects to receive) thetest data that are required underthis final rule, the Agency would conditionally approve your exemption application under40 CFR790 .87. TheAgency would terminate a conditional exemption if a problem occurs with the initiation, conduct, or completion of the required testing, or with the submission of the required data to EPA. EPA may then require you to submit a letter of intent to test or an exemption application. See 40 CFR 790.93 and § 799.5085(c)(8) of the regulatory text. In addition, the Agency would terminate a conditional exemption if no letter of intent to test has been received by persons required to comply with the rule. See, e.g., § 799 .5085(c)(6) of the regulatory text . (Note that the provisions at 40 CFR 790 .48(b) have been incorporated into the regulatory text of this rule, thus persons subject to this rule are not required to comply with 40 CFR790.48 itself (see § 799.5085(c)(4), (c)(5), (c)(6), (c)(7), and (d)(3)) Persons who obtain exemptions or receive themautomatically will nonetheless be subject to providing reimbursement to persons who actually conduct the testing, as described in Unit V.E.4. d. What are my obligations if I am in Tier 2? Ifyou are in Tier 2, you are subject to the rule and you are responsible for providing reimbursement to persons in Tier 1, as described in Unit V.E.4. You are considered to have an automatic conditional exemption. You do not need to submit a letter of intent to test or an exemption application unless you are notified by EPA that you are required to do so. If a problemoccurs with the initiation, conduct, or completion of the required testing, or the submission of the required data to EPA, the Agency may require you to submit a letter of intent to test or an exemption application. See 40CFR 790.93 and 5799 .5085(c)(8) of the regulatory text.

### p. 13 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations In addition, you will need to submit a letter of intent to test or an exemption application if: " No manufacturer in Tier 1 has notified EPA of its intent to conduct testing. " EPA has published a Federal Register document directing persons in Tier 2 to submit to EPA letters of intent to conduct testing or exemption applications. (See § 799.5085(c)(4) and (c)(5) of the regulatory text.) The Agency would conditionally approve an exemption application under 40 CFR 790.87, if EPA has received a letter of intent to test or has received (or expects to receive) thetest data required under this final rule. e. Subdivision of Tier 2entities. If the Agency needs testing frompersons in Tier 2, EPAmay propose to subdivide thegroup of subject persons in Tier 2 into Tier 2A (Tier 2 manufacturers, i .e., those who manufacture, or intend to manufacture a test rule substance solely as one or more of the following: A byproduct; an impurity; a naturally occurring substance; a non-isolated intermediate; a component of a Class 2 substance; in amounts less than 1,100 lbs. annually; or in small quantities solely for R& D) and Tier 2B (all processors, i .e ., those who process, or intend to process, a test rule substance (in any form) . The terms "process" and "processor" are defined by TSCA section 3(10) and 3(11) respectively) . The Agency may propose to seek testing fromTier 2A manufacturers before proceeding to Tier 2B processors. EPAsolicited comment on the subdivision of Tier 2entities in another recent proposed TSCA section 4 test rule pertaining to dermal absorption rate testing (Ref. 55, pp. 31081-31082) . Although commenters did not favor the subdivision of Tier 2 entities as a general matter, EPA decided to implement the approach in the final rule (Ref. 67, pp. 22417, 22426, and 22437-22438) . TheAgency indicated that subdividing Tier 2 up front in test rules may facilitate compliance by requiring Tier 2 manufacturers, when required to comply, to submit letters of intent to test or exemption applications before processors are called upon to do so. The Agency's expectation was that it maygenerally be less administratively complex for manufacturers to conduct the testing (including coordinating efforts to determine who will actually conduct testing) than for processors to do so. This is because there may generally he fewer manufacturers (even as byproducts, impurities, etr, .) than processors (Ref. 68, p. 31789) . EPAalso believes that testing costs have traditionally been passed hy manufacturers along to processors, enabling themto share in the costs of testing (Ref. 69, p. 20654), and has not received evidence to the contrary. Although the subdivision ofTier 2 entities was not included in the proposal to this final rule, and is thus not being implemented inthis final rule, such an approach could be proposed, if needed, to facilitate compliance with the rule. f. How did EPA decide who would be in Tier 1 and Tier 2 and who would be excludedfromthe rule? Under 40 CFR 790.2, EPA may establish procedures applying to specific test rules that differ fromthe generic procedures governing TSCA section 4 test rules in 40 CFR part 790. For the purposes of this final rule, EPA is setting forth certain requirements that differ fromthose under 40 CFR part 790. In this final rule, EPAhas reconfigured the tiers in 40 CFR790 .42 . In addition to processors, manufacturers of less than 500kg (1,100 lbs.) per year ("small-volume manufacturers"), and manufacturers of small quantities for research and development ("R &D manufacturers"), EPAhas added the following persons to Tier 2 : Byproduct manufacturers; impurity manufacturers; manufacturers of naturally occurring substances; manufacturers of nonisolated intermediates; and manufacturers of components of Class 2 substances. For further discussion on this point, see Unit F. of the Response to Public Comments document (Ref. 40) . TSCA section 4(b)(3)(B) requires all manufacturers and processors of a chemical substance to test that chemical substance if EPAhas made findings for that chemical substance, and therefore issued a TSCA section4(a) test rule requiring testing. However, practicality must be a factor in determining whois subject to a particular test rule. Thus, persons whodo not know or cannot reasonably ascertain that they are manufacturing or processing any of the substances subject to this final rule, e.g., manufacturers or processors of a substance as a trace contaminant who are not aware of these activities, are not subject to the rule. (See Unit V .E.1 . and § 799 .5085(b)(2) of the regulatory text .) 4. How

do the reimbursement procedures work? In the past, persons subject to test rules have independently worked out among themselves their respective financial contributions to those persons who have actually conducted the testing. However, if persons are unable to agree privately on reimbursement, they may take advantage of EPA's reimbursement procedures at 40 CFRpart 791, promulgated under the authority of 

### 13719 TSCA section 4(c) . These procedures include: " The opportunity for a hearing with the American Arbitration Association. " Publication by EPA of a Federal Register document concerning the request for a hearing. " The appointment of a hearing officer to propose an orderfor fair and equitable reimbursement . The hearing officer may base his or her proposed order on the production volume formula set out at 40 CFR 791 .48, but is not obligated to do so. Under this final rule, amounts manufactured as impurities will be included in production volume (40 CFR 791 .48(b)), subject to the discretion of thehearing officer (40CFR 791 .40(a)) . The hearing officer's proposed order may become the Agency's final order, which is reviewable in Federal court (40 CFR791 .60) . F. What are the Reporting Requirements Under this Final Rule? A final report must be submitted for each test for each chemical 13 months after the effective date of the final rule, i .e., by the deadline indicated in § 799.5085(i) of the regulatory text. EPA requests that a robust summary of each final test report be prepared and submitted with each final report. The term"robust summary" is used to describe the technical information necessary to adequately describe an experiment or study and includes the objectives, methods, results, and conclusions of the full study report, which can either be an experiment or in some cases an estimation or prediction method. "Draft Guidance on Developing Robust Summaries" (Ref. 14) is available on the website of the voluntary HPV Challenge Program, http:// www .epa.gov/chemrtk/robsumgd.htm, and in the public docket for this final rule. EPA is not requiring the submission of interimprogress reports for the testing required in this final rule. For the short-termstudies required by this final rule, interimprogress reports would likely yield little useful information. Furthermore, by not requiring interimprogress reports for these short-termstudies, the overall burden of the rule will be somewhat reduced. G. What Would 1 Need to Do If I Cannot Complete the Testing? Acompany that submits a letter of intent to test under this final rule and that subsequently anticipates difficulties in completing the testing by the deadline may submit a request to the Agency to modify the test schedule, pursuant to 40 CFR 790.55. EPA will

### p. 14

13720 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations determine whether modification of the test schedule is appropriate, and may first seek public comment on the modification. H . Will There Be Sufficient Test Facilities and Personnel to Undertake the Testing in this Final Rule? Various surveys of the availability of test facilities and personnel to handle the additional demand for testing services created by TSCA section 4(a) test rules indicate that available test facilities and personnel will adequately accommodate the testing specified in this final rule (Refs. 70 and 71) . For further discussion on this point, see UnitJ. of the Response to Public Comments document (Ref. 40) . I . Might EPA Seek Further Testing of the Chemicals in this Final Rule? If EPA determines that it needs additional data regarding any of the chemical substances included in this final rule, the Agency might seek further health and/or environmental effects testing for those chemical substances. Should theAgency decide to seek such additional testing, EPAwould initiate a separate action under TSCA section 4 for that purpose. VI . Export Notification Any person whoexports, or who intends to export, one of the chemical substances contained in this final rule in any form(e.g., as components of Class 2 substances, byproducts, impurities, etc.) is subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFRpart 707, subpart D

. This approach is consistent with the Agency's approach when the export notification regulations were originally promulgated in 1980 (Ref. 72) . Export notification is generally not required forarticles, as provided by 40 CFR707.60(b) . Section 12(b) of TSCA states, in part, that any person who exports or intends to export to a foreign country a chemical substance or mixture for which the submission of data is required under section 4 must notify the EPAAdministrator of such export or intent to export . The Administrator in turn will notify the government of the importing country of EPA's regulatory action with respect to the substance. VII . Decision Not to Pursue Rulemaking EPAhas decided to withdraw20 chemicals included in the proposal for this final rule for the reasons presented in Unit VII .A. and B. A. Voluntary Commitments to the HPV Challenge Program Since the publication of the proposed rule (Ref. 2), commitments have been made to sponsor 13 of the 37 chemicals originally proposed for testing. "Viable" commitments have been made for 11 chemicals through the voluntary HPV Challenge Programand 2 chemicals are now sponsored through the ICCA HPV Initiative (Ref. 6) . Any U.S. HPV chemicals that are handled under the ICCA HPV Initiative are considered by EPA to be "sponsored" and are not anticipated to be addressed in either the voluntary HPV Challenge Programor in any TSCAsection 4 HPV SIDS rulemaking unless the international commitments are not met . These 13 chemicals are: " 1,2,3-Propanetriol,trinitrate (CAS No. 55-63-0) . " Methanesulfonic acid (CAS No. 75- 75-2) . " Phenol, 2-(1,1-dimethylethyl)- (CAS No. 88-18-6) . " Phenol, 2-ethyl- (CAS No. 90-00-6) . " 1-Naphthalenol (CAS No. 90-15-3) . " Benzenesulfonic acid (CAS No. 98- 11-3) . " Phenol, 2,4-dimethyl- (CAS No. 105-67-9) . " 2-Propen-l-ol (CAS No. 107-18-6) . " Phenol, 2,4,6-tris(1,1- dimethylethyl)- (CAS No. 732-26-3) . " Benzensulfonic acid, hydroxy- (CAS No. 1333-39-7) . " Benzenesulfonamide, N-butyl- (CAS No. 3622-84-2) . " Quaternary ammonium compounds, benzylbis(hydrogenated tallowalkyl)methyl, salts with bentonite (CAS No. 68153-30-0) . " Quaternary ammonium compounds, his(hydrogenated tallow alkyl)dimethyl, salts with bentonite (CAS No. 68953-58-2) . EPAbelieves that these voluntary commitments will result in the generation of data necessary to support development of preliminary or screening level hazard and risk determinations for these chemicals. Therefore, testing of these chemicals under TSCA section 4 is not necessary at the present time. EPA is not including these chemicals in the final rule, and testing of these chemicals under this final rule is not required. Specific information on sponsorship, test plans, and other pertinent information may be obtained by visiting EPA's voluntary HPV Challenge Programwebsite at http://wcv~v.epa.gov/cherrirtk/ viecvsrch .htm

. This approach is not intended to set a precedent for howEPA will address this issue in future HPV SIDS test rules. B. TSCA Section 4(a)(1)(B)(i) Finding Not Made In developing the finding of substantial production for this final rule, EPAdetermined that, based on 2002 IURdata, seven chemicals that had been included in the proposed rule are no longer produced or imported in amounts equal to or greater than 1 million pounds per year. Because the 2002 IURdata show manufacture (including import) below the 1 million pounds per year threshold which EPA generally relies upon as "substantial production" under TSCA section 4(a)(1)(B)(i), the following seven chemicals are not included in the final rule: " Thiourea (CAS No. 62-56-6) . " 1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester (CAS. No. 84- 69-5) . " Acetonitrile, hydroxy- (CAS No. 107-16-4) . " Methanone, (2-hydroxy-4- methoxyphenyl)phenyl- (CAS No. 131- 57-7) . " 2-Naphthalenesulfonic acid, 6-[(2,4- diaminophenyl)azo)-3-[[4-[[4-[[7-[(2,4-diaminophenyl)azo)-1-hydroxy-3-sulfo2-naphthalenyl]azo]phenyl]amino1-3- sulfophenyl)azo)-4-hydroxy-, trisodium salt (CAS No. 6473-13-8) . " Methanesulfonic acid, hydroxy-, monosodiumsalt (CAS No. 870-72-4) . " Octadecanoic acid, 2- (hydroxymethyl)-2-[[(1- oxooctadecyl)oxy)methyl)-1,3- propanediyl ester (CAS No. 28188-24- 1) . C . TSCA Section 4(a)(1)(B)(ii) Finding Not Made 1 . Melting point, boiling point and vapor pressure ofPETN . As discussed in Unit K.2. of the Response to Public Comments document (Ref. 40), EPA reviewed data submitted by SII (Ref. 28) on the physical/chemical properties of PETN (CAS No. 78-11-5)

. EPA believes those data are sufficient for melting point, boiling point and vapor pressure, but that data are still needed on the noctanol/water partition coefficient and water solubility (Ref. 73) . Therefore, EPA is not finalizing the proposed testing to determine the melting point, boiling point and vapor pressure of PETN in this final rule, but EPA is still requiring the testing of PETN for noctanol/water partition coefficient and water solubility, as well as environmental fate, toxicity to algae, and screening level reproduction/ developmental toxicity. 2. Reproduction/developmentol toxicity screening test of sorbic ocid. As discussed in Unit K.3. of the Response

### p. 15 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations 13721 to Public Comments document (Ref. 40), involvement of the Agency under the which price data were not available. EPA reviewed four studies on sorbic reimbursement regulations at 40 CFR The "critical price" is the price per acid (2,4-hexadienoic acid, (2E,4E)-) part 791 . Given this consistent pound below which there would be an (CAS No. 110-44-1) which ADC (Ref. experience with previous test rules, EPA impact of 1 .0%or greater. The 24) thought might satisfy the testing does not believe that there will be any production volume for this chemical proposed to be conducted according to administrative, negotiation, or any other falls between 10 million to 50 million 40 CFR 799.9355 to obtain screening costs associated with seeking pounds . Assuming a production volume level data on the reproductive and reimbursement fromTier 2 companies, at the midpoint of that range equal to 30 developmental toxicity ofsorbic acid. To evaluate the potential for an million pounds per year and annualized EPA determined that the studies adverse economic impact of testing on testing costs of $33,585, the critical provided sufficient information on this manufacturers of the chemical price is $0.11 per pound. Below that endpoint(s) at this time for sorbic acid substances in this final rule, EPA price, the testing costs would represent (Ref. 74) . Therefore, EPA is not employed a screening approach that more than 1 .0%of the revenues from requiring the reproduction/ compares the annual revenues fromthe the chemical . The average price for the developmental toxicity screening test of sale of a chemical to the annualized sorbic acid in this final rule. EPA is still testing costs for that chemical and requiring the testing ofsorbic acid for expresses the testing costs as a percent aquatic toxicity and the determination of revenues generated fromeach of melting point, boiling point, vapor pressure, n-octanol/water partition coefficient, and water solubility. VIII . Economic Impacts EPA has prepared an economic assessment entitled Economic Analysis for the Final Section 4 Test Rulefor High Production Volume Chemicals (Ref. 75), a copy ofwhich has been placed in the public docket. This economic assessment evaluates the potential for significant economic impacts as a result of the testing that would be required by this final rule. The total social cost of this final rule is estimated to be $4.08 million, using a social discount rate of 3%over a 3-year period (Ref. 75) . While legally subject to this final rule, Tier 2 manufacturers and all processors ofa subject chemical would only be required to comply with the requirements of the rule if they are directed to do so by EPA as described in § 799.5085(c)(5) and (c)(8) of the regulatory text. EPAwould require Tier 2 manufacturers or processors to test only if no Tier 1 manufacturer has submitted a letter of its intent to conduct testing, or if, under40 CFR 790 .93, a problemoccurs with the initiation, conduct, or completion of the required testing, or the submission of the required data to EPA. Because EPA has identified at least one manufacturer in Tier 1 for each subject chemical, the Agency expects that, for each chemical in this final rule, at least one such person will submit a letter of intent to conduct the required testing and that person will conduct such testing and will submit the test data to EPA . EPA believes that there will not be any costs to Tier 2 manufacturers or processors for conducting the testing required by the final rule because EPA is not aware of any circumstances in which Tier 1 entities have sought reimbursement fromTier 2 entities either through private agreements or hy soliciting the chemical . Annualized testing costs divide testing expenditures into an equivalent, constant yearly expenditure over a longer period of time. To calculate the percent price impact, testing costs (including laboratory and administrative expenditures) are annualized over 15 years (the expected life of a chemical) using a 7%discount rate. Annualized testing costs are then divided by the estimated annual revenue of the chemical to derive the cost-to-sales ratio. EPAestimates the cost to industry of testing the 17 chemicals evaluated in the economic analysis to be $4.03 million with an average cost of $237,000 per chemical (Ref. 75) . In addition, the TSCA section 12(b) export notification, that is required only forthe first export by a particular exporter to a particular country of each chemical subject to the rule, is estimated to average $67.35 (Ref. 75) . The Agency's estimated total costs of testing (including both laboratory and administrative costs), annualized testing costs, price impacts, and public reporting burden hours forthis final rule are presented in the economic impact analysis (Ref. 75) . Price data were available for 16 ofthe 17 chemicals, with an average price of $2.62 per pound for those 16 chemicals. The price impact of the test costs is a function of the chemical's price per pound and the production volume. For 12 of the chemicals (75%) for which price data were available, the price impact is less than 1 .0% . With a price impact of less than 1 .0%, EPA concludes that for these chemicals the potential for adverse economic impacts is low . For 4 of the 16 chemicals (25%) with price data, the price impact is in excess of 1 .0% . For chemicals where the profit margins are low, the costs of testing may use a significant part of the profits generated by the chemical . The Agency computed "critical prices" for the remaining chemical for 16 chemicals with actual price data available is $2.62 per pound. Thus, the critical price is substantially below this average. Only 2 of the 16 chemicals with price data were estimated to have prices below$0.11 per pound. While it cannot be shown conclusively that the price impacts will be less than or greater than 1 .0%of the sales for this chemical, the Agency believes that adverse impacts are unlikely. On the basis of these calculations, EPAbelieves that the required chemical testing presents a low potential for adverse economic impact for the majority of the chemicals subject to the rule. Because the subject chemical substances have relatively large production volumes, the annualized costs of testing, expressed as a percentage of annual revenues, are very small for most chemicals. There are, however, four chemicals for which it cannot be shown that the price impact will be below1 .0%of the revenue for these chemicals. For these chemicals, companies may choose to use revenue sources other than profits fromthe individual chemicals to pay for testing. To account for this, the Agency also compared the costs of compliance to company sales data. These calculations were made as part of the Agency's small entity impact analysis (Ref. 75), conducted in accordance with the requirements of the RFA, as amended by the Small Business Regulatory Enforcement Fairness Act . These results are presented in Unit XI .C. IX . Submissions to EPA You may make submissions such as letters of intent to test, applications for exemption fromtesting, study plans, applications for modification, and final study reports through the mail or in person. To ensure proper receipt by EPA, it is imperative that you direct such submissions to the attention of "TSCA Section 4.- 1 . By mail . Mail your submission to: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agencv, 1200 Pennsylvania

### 13722 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations

Ave., NW

., Washington, DC20460-0001 (Attention: TSCA Section 4) . 2 . In person or by courier. Deliver your submission to: OPPT Document Control Office (DCO), EPAEast Bldg., Rm . 6428, 1201 Constitution Ave., NW ., Washington, DC

. (Attention: TSCA Section 4) . The DCOis open from8a.m . to 4 p.m

., Monday through Friday, excluding legal holidays. The telephone number for the DCOis (202) 564-8930 . Such deliveries are only accepted during the DCO's normal hours of operation. X. Materials in the Docket As indicated under ADDRESSES at the beginning of this document, an official docket was established forthis final rule under docket ID number EPA-HQOPPT-2005-0033. The docket includes information considered by EPA in developing this final rule, such as the documents specifically referenced in this action, any public comments received, and other information related to this action. In addition, interested parties should consult documents that are referenced in the documents that EPAhas placed in the public docket, regardless of whether these referenced documents are physically located in the public docket . For assistance in locating documents that are referenced in documents that EPAhas placed in the public docket, but that are not physically located in the docket, please consult the technical contact listed under FOR FURTHER INFORMATION CONTACT. The public docket is available for reviewas specified under ADDRESSES. A. Supporting Documentation The items listed in this Unit X.A., although supporting documentation for this final rule, are not referenced in this preamble, but they are available in the public docket for this final rule: Anon. Final report on the safety assessment of sorbic acid and potassium sorbate. Journal ofthe American College of Toxicology. 7(6) : 837-880

. 1988. Buell, D.A., Blaustein, M .B., and Lynch, J .R. An Assessment of the National Occupational Exposure Survey. Prepared by Temple, Barker & Sloane, Inc. and Exxon Corp. Undated. Demaree, G

.E., et al . Preliminary studies on the effect of feeding sorbic acid upon growth, reproduction and cellular metabolismof albino rats. Journnl of the American Pharmaceutical Associotion. 44:619-621 . 1955. Environmental Defense (ED) (formerly Environmental Defense Fund, Inc.) Toxic Ignorance. 1997. EPA 1983. Ethyl toluenes, Trimethylbenzenes, and the C, Aromatic Hydrocarbon Fraction; Proposed Test Rule. Federal Register (48 FR 23088, May 23, 1983) . EPA 1985a. Identification of Specific Chemical Substance and Mixture Testing Requirements; Ethyltoluenes, Trimethylbenzenes, and the C9 Aromatic Hydrocarbon Fraction. Federal Register (50 FR 20662, May 17, 1985) . EPA 1985b. Toxic Substances; Biphenyl ; Final Test Rule

. Federal Register (50 FR 37182, September 12, 1985)

. EPA1986. Methylcyclopentane and Commercial Hexane; Proposed Test Rule . Federal Register (51 FR 17854, May 15, 1986) . EPA 1988. Commercial Hexane and Methylcyclopentane; Final Test Rule. Federal Register (53 FR 3382, February 5, 1988) . EPA 1990. Testing Consent Agreements and Test Rules; Final Rule. Federal Register (55 FR 18881, May 7, 1990) . EPA1994. Office of Water Chemicals, Final Test Rule; Clarification. Federal Register (59 FR 45629, September 2, 1994) . EPA 1996. Announcement of the availability of draft test guidelines and solicitation of public comment. Federal Register (61 FR 31522, June 20, 1996) (FRL-5367-7) . EPA 1998. Announcement of the availability of the final harmonized test guidelines. Federal Register (63 FR 41845, August 5, 1998) (FRL-5740-1) . EPA 1999a. OPPT. Determining the Adequacy of Existing Data. February 10, 1999. Available online at: http:// www .epa.gov/chemrtk/datadfin.htm . EPA 1999b. OPPT. Development of Chemical Categories in the HPV Challenge Program(Draft) . August 25, 1999. Available online at: http:// www . epa.gov/chemrtk/categuid.htm . EPA 1999c. OPPT. The Use of Structure-Activity Relationships (SAR) in the High Production Volume Chemicals Challenge Program . August 26, 1999. Available online at: http:// www .epa.gov/chemrtk/sarfinll .htm . EPA 1999d. Office of Prevention, Pesticides, and Toxic Substances (OPPTS) . Letter fromSusan H . Wayland, Deputy Assistant Administrator, to participants in the voluntary HPV Challenge Program

. October 14, 1999. Available online at: http://~vww .epa.gov/ chem rtk/ceoltr2.h tm

. EPA 2000a. OPPT. Economic Impact of a Section 4 Test Rule for High Production Volume Chemicals. Prepared by the Economic Policy and Analysis Branch (EPAB), Economics, Exposure, and Technology Division (EETD), OPPT. December 2000 . EPA 2000b. Toxic Substance Control

ActTest Guidelines; Final Rule. Federal Register (65 FR 78746, December 15, 2000) (FRL-6551-2) . EPA2002a. Agency Information Collection Activities; OMB Responses. Federal Register (67 FR 39712, June 10, 2002) (FRL-7225-8) . EPA2002b. Notification of Chemical Exports-TSCA Section 12(b) : Request for Comment on Renewal of Information Collection Activities. Federal Register (67 FR 53792, August 19, 2002) (FRL7192-7) . EPA 2002c. Revised final health effects test guidelines; acute toxicity testing-Background and acute oral toxicity; Notice of availability. Federal Register (67 FR 77064, December 16, 2002) (FRL-7282-3)

. EPA 2003. Reviewof comments on biodegradation testing of a proposed test rule chemical (PETN) . Memorandum fromDr. Robert Boethling, Exposure Assessment Branch (EAB), EETDto Paul Campanella, Chemical Information and Testing Branch (CITB), Chemical Control Division (CCD) . February 26, 2003. EPA2004a. HPVChallenge Program Disclaimer on posted robust summaries and test plans. May 13, 2004. (For example, see http://www .epa .gov/ chemrtk/quatcatg/c1521Otc.htm) . EPA2004b. IURData on methyl heptenone

. E-mail message from Lynne Blake-Hedges, EPAB, EETDto Catherine Roman, EPA

. July 8, 2004. EPA2004c. IURData on PETN. E-mail message fromLynne Blake-Hedges, EPAB, EETD to Catherine Roman, EPA . July 22, 2004. EPA 2004d. MemorandumfromLarry Newsome, High Production Volume Chemicals Branch (HPVCB), Risk Assessment Division (RAD) to Greg Schweer, CITB, CCD . August 5, 2004. EPA 2004e. Memorandumfrom Katherine Anitole, Existing Chemicals Assessment Branch (ECAB), RADto Greg Schweer, CITB, CCD . August 13, 2004. EPA2004f. 1-Chlorododecane. E-mail fromLynne Blake-Hedges, EPAB, EETD to Catherine Roman, EPA . August 25, 2004. EPA2004g. TETRATOX test. MemorandumfromDonald Rodier, RAD, to Greg Schweer, CITB, CCD . November 1, 2004. EPA 2004h. OPPT. Status and Future Directions of the High Production Volume Challenge Program . December 1, 2004. Available online at: http:// wvvw .epc7.gov/chem

rtk/hpvstatr. htrn . FDRL 1975. Food end Drug Research Labs. Teratologic evaluation of FDA 73- 4 (potassiumsorbate: Sorbistat) in rnice and rats. Prepared under DHEW

### Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations

Contract No: FDA 223-74-2176. NTIS potentially exposed to pentaerythritol No. PB-245520

. Waverly, NY. 1975. tetranitrate by occupation within 2-digit Hawley's Condensed Chemical Standard Industrial Classification (SIC) . Dictionary. 14th Edition. Revised by 1981-1983. Available online at : http :// Richard J. Lewis, Sr. Publisher: John www .cdc.gov/noes/noes4/ Wiley &Sons, Inc. 2002. 83538sco.html. Larsen, J., Schultz, T.W ., Rasmussen, NIOSH 1983b. NOES. Estimated L., Hooftman, R., and Pauli, W . Progress number of employees potentially in an ecotoxicological standard protocol exposed to light oil by occupation with protozoa: Results froma pilot ring within 2-digit Standard Industrial testwith Tetrahymena pyriformis. Classification (SIC) . 1981-1983. Chemosphere. 35(5) : 1023-1041 . 1997. Available online at : http://www .cdc.gov/ LeBlanc, G

.A. Interspecies noes/noes4/x2973sco.html. relationships in acute toxicity of NIOSH 1983c. NOES. Estimated chemicals to aquatic organisms. number of employees potentially Environmental Toxicology and exposed to 1-chlorododecane by Chemistry

. 3: 47-60

. 1984. occupation within 2-digit Standard National Institute of Environmental Industrial Classification (SIC) . 1981- Health Sciences (NIEHS) 1997. 1983. Available online at: http:// Validation and Regulatory Acceptance i,,,i,vT,v.cdc.gov/noes/noes4/ ofToxicological Test Methods: A Report x2609sco.html. of the ad hoc Interagency Coordinating NIOSH1988. National occupational Committee on the Validation of exposure survey analysis of Alternative Methods. NIHPublication management interviewresponses. Vol . No: 97-3981. 1997. Available online at : III . Pedersen DH, Sieber WK, eds. http://iccvam

.niehs.nih .gov/docs/ Cincinnati, OH : U .S. Department of guide]ines/validate.pdf . Health and Human Services, Centers for NIEHS 2001a. Report of the Disease Control, National Institute for International Workshop on In Vitro Occupational Safety and Health, DHHS Methods for Assessing Acute Systemic Toxicity. NIH Publication No. 01-4499. (NIOSH) Publication No. 89-103. March August 2001 . Available online at: http:// 1988' Available online at: lhttp:// www .epa .gov/chemrtk/nih/2001a.pdf . ~'w

.cdc.gov/rniosh/89-103.htm1. NIEHS 2001b. Guidance Document on OECD 2001a. Guidance Document on Using In VitroData to Estimate In Vivo Acute Oral Toxicity Testing. OECD Starting Doses for Acute Toxicity. NIH Series on Testingand Assessment No. Publication No. 01-4500. August 2001 . 24. June, 2001 . ~ OECD 2001b. Acute Oral Toxicityfor NIEHS 2003a. Test Method Protocol 5 Fixed Dose Procedure. OECDTest Solubility Determination, in vitro Cytotoxicity Validation Study-Phase Guideline 420. Adopted December 17, III . National Toxicology Program(NTP) 2001 . Interagency Center for the Evaluation of ,"' OECD 2001c. Acute Oral ToxicityAlternative Toxicological Methods Acute Toxic Class Method. OECDTest (NICEATM) . September 24, 2003. NIEHS 2003b. Test Method Protocol for the BALB/c 3T3 Neutral Red Uptake Cytotoxicity Test, a Test for Basal Cytotoxicity for an in vitro Validation Study-Phase III . National Toxicology Program(NTP) Interagency Center for the Evaluation ofAlternative Toxicological Methods (NICEATM) . November 4, 2003. Available online at: http://iccvam.niehs.nih.gov/methods/ invidocs/phlllprot/3t3ph11I .pdf . NIEHS 2003c. Test Method Protocol for the NHK Neutral Red Uptake Cytotoxicity Test, a Test for Basal Cytotoxicity for an in vitro Validation Study-Phase III . National Toxicology Program(NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) . November 4, 2003. Available online at: http ://iccvam.niehs.nih.gov/methods/ invidocs/phIIIprot/nhkphlIl .pdf. National Institute for Occupational Safety and Health (NIOSH) 1983a. NOES. Estimated numbers of employees Guideline 423. Adopted December 17, 2001 . OECD 2001d. Acute Oral Toxicity-Upand-Down Procedure. OECDTest Guideline 425

. Adopted December 17, 2001 . Available online at: http:// www, oecd. org/d

ocum ent/23/0,2340, en_2649_34379_1948503_1_1_ 1_1,OO.htm1. Schultz, T.W

. TETRATOX: Tetrahymena pyriformis population growth impairment endpoint-a surrogate for fish lethality. Toxicology Methods. 7: 289-309 . 1997. Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) . Opinion concerning The 15t Update of the Inventory of Ingredients Employed in Cosmetic Products . Section II . Perfume and Aromatic Raw Materials. October 24, 2000. SodiumFormaldehyde Bisulfite Manufacturers Association (SFBMA) . Comments on Hydroxymethanesulfonic acid, monosodiumsalt submitted to the EPA . July 17, 2003. 

### 13723 United Nations. Report of the United Nations Conference on Environment and Development (UNCED), Agenda 21, Chapter 19, Programme Area CInformation Exchange on Toxic Chemicals and Chemical Risks. 1992. Walker, R

., Toxicology of sorbic acid andsorbates. FoodAdditives and Contaminants

. 7(5) : 671-676 . 1990. B. References The items listed in Unit X.B. are referenced in this preamble and are available in the public docket for this final rule: 1 . EPA . Data Collection and Development on High Production Volume (HPV) Chemicals. Federal Register (65 FR 81686, December 26, 2000) (FRL-6754-6)

. 2 . EPA . Proposed test rule for the Testingof Certain High Production Volume Chemicals

. Federal Register (65 FR 81658, December 26, 2000) (FRL6758-4) . 3 . EPA . TSCA section 4(a)(1)(B) Final Statement of Policy. Federal Register (58 FR 28736, May 14, 1993) . 4. EPA, OPPT. HPV Challenge ProgramChemical List. This list is updated periodically, and is available online at: http://www .epa.gov/oppt/ chemrtk/hpvchmlt.h tm . 5. OECDSecretariat. Manual for the Investigation of HPVChemicals. OECD Programme on the Co-Operative Investigation of High Production Volume Chemicals. Paris, France. December 2003. Available online at : http://www

.oecd.org/document/7/ 0,2340,en 2649 34379-1947463_1_ 1_2_1,OO.htm1. 6. International Council of Chemical Associations (ICCA) . ICCA HPV Working List. Chemicals. August 2003. 7. OECD Secretariat. Summary Record of the 13th Joint Meeting of the OECD Chemicals Group and Management Committee of the Special Programme on the Control of Chemicals, November 8- 10, 1989. ENV/CHEM/CM/89.2. February 1990. 8. OECDSecretariat . Proposal for Further Work on the Investigation of High Production Volume Chemicals. OECDChemicals Group and Management Committee of the Special Programme on the Control of Chemicals. ENV/CHEM/CM/89.14. October 1989. 9. OECD

. Decision -Recomtnendation on the Co-Operative Investigation and Risk Reduction of Existing ChemicalsC(90)163/FINAL. January 31, 1991 . 10. EPA. TSCA section 4(a)(1)(B) Proposed Statement of Policy. Federal Register (56 FR 32294, June 15, 1991) . 11 . ACC . Comments on EPA's TSCA section 4(a)(1)(B) Proposed Statement of Policy submitted to the TSCA Puhlic

### 13724 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations

Docket Office, EPA. September 17, 1991 . 12. Epoxy Resin Systems Task Group ofthe Society of the Plastics Industry, Inc. Comments on EPA's TSCA section 4(a)(1)(B) Proposed Statement of Policy submitted to the TSCA Public Docket Office, EPA

. September 17, 1991 . 13. EPA, Office of Pollution Prevention and Toxics (OPPT) . Chemical Hazard Data Availability Study: What DoWe Really Know About the Safety of High Production Volume (Ashland) . Comments on EPA's Chemicals? April 1998. Available online Proposed Test Rule for Testin2 of at: http ://www

.epa .gov/chernrtk/ hazchem

.htm . 14. EPA, OPPT. Draft Guidance on Developing Robust Summaries. October, 22, 1999. Available online at: http:// www .epa.gov/chemrtk/robsumgd.h tm . 15. ACC

. Comments on EPA's Proposed Test Rule forTesting of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA . April 25, 2001 . 16. American PetroleumInstitute (API) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted tothe TSCAPublic Docket Office, EPA. April 20, 2001 . 17. Synthetic Organic Chemical Manufacturers Association (SOCMA) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA . April 25, 2001 . 18. Center for Regulatory Effectiveness (CRE) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA . April 25, 2001 . 19. Environmental Defense (ED) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCAPublic Docket Office, EPA. April 25, 2001 . 20. American Coke and Coal Chemicals Institute (ACCCI) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA . April 25, 2001 . 21 . Color Pigments Manufacturers Association, Inc. (CPMA) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA . April 23, 2001 . 22. Ecological and Toxicological Association of Dyes and Organic Pigments Manufaaturers (ETAD) . Comments on EPA's Proposed Test Rule 33. Doris Day Animal League (DDAL) . for Testing of Certain High Production Comments on EPA's Proposed Test Rule Volume Chemicals submitted to the for Testing of Certain High Production TSCA Public Docket Office, EPA. April Volume Chemicals submitted to the 25, 2001 . TSCA Public Docket Office, EPA. April 23. Merisol USA LLC (Merisol) . 25, 2001 . Comments on EPA's Proposed Test Rule 34. The Humane Society of the United for Testing of Certain High Production States (HSUS) . Comments on EPA's Volume Chemicals submitted to the Proposed Test Rule forTesting of TSCA Public Docket Office, EPA. April Certain High Production Volume 25, 2001 . Chemicals submitted to the TSCA

Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA . April 25, 2001 . 25. Dow

Chemical Company (Dow). Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submittedto the TSCA Public Docket Office, EPA . April 24, 2001 . 26. ExxonMobil Chemical Company (EMCC) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to theTSCA Public Docket Office, EPA. April 23, 2001 . 27. Lonza Group. Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA . April 25, 2001 . 28. Sciences International Inc. (SII) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA . April 24, 2001 . 29. Dyno Nobel, Inc., (Dyno Nobel) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA . April 25, 2001 . 30. Institute of Makers of Explosives (IME) . Comments on EPA's Proposed Test Rule forTesting of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA. April 25, 2001 . 31 . People for the Ethical Treatment of Animals (PETA) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA. April 25, 2001 . 32. Physicians Committee for Responsible Medicine (PCRM) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to thE TSCA Public Docket Office, EPA . April 25. 2001 . 24. Ashland Distribution Company Public Docket Office, EPA. April 25, 2001 . 35. Alternative Research & Development Foundation (ARDF)_ Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA . April 24, 2001 . 36. American Anti-Vivisection Society (AAVS) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA. April 24, 2001 . 37. New

EnglandAnti-Vivisection Society (NEAVS) . Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA. April 19, 2001 . 38. Silicones Environmental, Health and Safety Council (SEHSC) . Comments on EPA's Proposed Test Rule for Testing ofCertain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA . April 25, 2001 . 39. EPA, OPPT. Compilation of NonSubstantive Comments Submitted by Private Citizens in Response to EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA. April 25, 2001 . 40. EPA

. Response to Public Comments. Prepared by CITB, OPPT. May 31, 2005. 41 . EPA

. Comparison of 1990 High Production Volume (HPV) Chemicals with National Occupational Exposure Survey (NOES) Database. November 13, 1998. 42. EPA. Guidelines for Exposure Assessment. Federal Register (57 FR 28888, May 29, 1992) . 43. American Chemistry Council (ACC) (formerly Chemical Manufacturers Association) . Public Availability of SIDS-Related 'resting Data for U.S. Eligh Production Volume Chemicals. June 12, 1998. 44. American Society for'i'esting and Materials International (ASTM International) . Standard Test Method for

### p. 19 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations 13725 Relative Initial and Final Melting Points fish bioconcentration on n-octanol/ 71 . EPA. EPA Census of TSCATesting and the Melting Range of Organic water partition coefficient. SAR and Laboratories. Prepared by EPAB, EETD, Chemicals. ASTM

. E 324. 1999. QSAR in Environmental Research. 1 :29- OPPT. Washington, DC . October 10, 45. ASTM

International . Standard 39. 1993. 1996. Test Method for Vapor Pressure of 59. Meylan, W .M ., Howard, P.H., 72. EPA. Notices of export under Liquids by Ebulliometry. ASTM . E 1719. Boethling, R.S., Aronson, D., Printup, section 12(b) . Federal Register (45 FR 1997. H ., and Gouchie, S. Improved method of 82850, December 16, 1980) . 46 . ASTM

International . Standard estimating bioconcentration/ 73. EPA. Reviewof comments on Test Method for Determining Vapor bioaccumulation factor fromoctanol/ proposed determination of physical/ Pressure by Thermal Analysis. ASTM . E water partition coefficient. chemical properties for PETN . 1782. 2003. Environmental Toxicology and Memorandum fromDr. Robert 47. ASTM

International . Standard Chemistry. 18(4) : 664-672. 1999. Boethling, EAB, EETD, OPPT, to Greg Test Method for Partition Coefficient (N- 60. Smrchek, J.C. and Zeeman, M .G . Schweer, CITB. August 20, 2004. Octanol/Water) Estimation by Liquid Assessing Risks to Ecological Systems 74. EPA. Request for assistance in Chromatography. ASTM . E 1147. 1997. 48. ASTM

International . Standard Test Method for Measurements of Aqueous Solubility. ASTM . E 1148. 2002. 49. ASTM

International . Question about ASTM

E 324 . E-mail fromDiane Rehiel, ASTM, to Greg Schweer, CITB, CCD, OPPT, EPA

. September 15, 2004. 50. Meylan, W

.M . and Howard, P.H. Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients. Journal ofPharmaceutical Sciences. 84(1) :83-92. 1995. 51 . Meylan, W

.M ., Howard, P.H., and Boethling, R.S. Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient. Environmental Toxicology and Chemistry. 15(2) :100-106. 1996. 52. ASTM

International . Standard Test Method for Determining Biodegradability of Organic Chemicals in Semi-Continuous Activated Sludge (SCAS) . ASTM

. E 1625. 2001 . 53. International Organization for Standardization (ISO) . Water QualityEvaluation of Ultimate Aerobic Biodegradability of Organic Compounds in Aqueous Medium-Static Test (ZahnWellens Method) . Second Edition. ISO 9888. 1999. 54. ASTM

International . Standard Guide for Conducting Acute Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and Amphibians. ASTM . E 729. 2002. 55. ASTM

International . Standard Guide for Conducting Static Toxicity Tests with Microalgae . ASTM . E 1218. 2004. 56. ASTM

International . Standard Guide for Conducting Daphnia Magna Life-Cycle Toxicity Tests. ASTM . E 1193. 2004. 57. Veith, G

.D. and Kosian, P. Estimating bioconcentration potential fromoctanot/water partition coefficients, in Physical Behavior of PCB's in the Great Lakes (MacKay, Paterson, Eisenreich, and Simmons, eds.), Ann Arbor Science, Ann Arbor, MI . 1982. 58. Bintein, S

., DeVillers, J ., and Karcher, W

. Nonlinear dependence of fromChemicals, pp. 24-90 . In. P. Callow(ed .), Handbook of Environmental RiskAssessment and Management. Blackwell Science Ltd. Oxford, UK. 1998. 61 . EPA

. Proposed Category for Persistent, Bioaccumulative and Toxic Chemical Substances. Federal Register (63 FR 53417, October 5, 1998) (FRL5771-6) . 62. EPA

. Policy Statement-Category for Persistent, Bioaccumulative, and Toxic New

Chemical Substances. Federal Register (64 FR 60194, November 4, 1999) (FRL-6097-7) . 63. EPA. Significant New Use Rules; General Provisions For New Chemical Follow-Up undersections 5 and 26(c) of TSCA. Federal Register (54 FR 31307, July 27, 1989) . 64. ASTM

International . Standard Test Method for Estimating Acute Oral Toxicity in Rats. ASTM . E 1163. 2002. 65. U.S. Department of Health and Human Services . National Institutes of Health . NTP

. Toxicology and carcinogenesis studies of pentaerythritol tetranitrate (CAS No. 78-11-5) with 80%D-lactose monohydrate (PETN, NF) in F344/N rats and B6C3F1 mice (feed studies), Technical Report Series No. 365. August 1989. 66. EPA

. In Vitro Dermal Absorption Rate Testing of Certain Chemicals of Interest to Occupational Safety and Health Administration; Proposed Rule. Federal Register (64 FR 31074, June 9, 1999) (FRL-5760-3) . 67. EPA

. In Vitro Dermal Absorption Rate Testing of Certain Chemicals of Interest to the Occupational Safety and Health Administration; Final Rule. Federal Register (69 FR 22402, April 26, 2004) (FRL-7312-2) . 68. EPA. Toxic Substances Control Act ; Data Reimbursement. Federal Register (48 FR 31785, July 11, 1983) . 69. EPA

. Toxic Substances; Test Rule Development and Exemption Procedures. Federal Register (50 FR 20652, May 17, 1985) . 70. EPA. Laboratory Capacity and the HPVChallenge Program . Prepared by EPAB, EETD, OPPT. Washington, DC . October 14, 1999. reviewing four studies for TSCAsection 4 test rule. Memorandum fromMaria Szilagyi, RAD, OPPT to Donald Rodier, High Production Volume Chemical Branch (HPVCB), RAD. October 5, 2004. 75. EPA. Economic Analysis for the Final Section 4 Test Rule for High Production Volume Chemicals. Prepared by EPAB, EETD, OPPT. February 18

;2-005- '-1J- Z,Y .:' -~- v",,_. 76. Small Business Administration, Office of Size Standards. Small Business Size Standards matched to North American Industry Classification System(NAICS) . Available online at : http ://www

.sba.gov/size/ sizetab1e2002.htm

. X1. Statutory and Executive Order Reviews A. Executive Order 12866 Under Executive Order 12866, entitled Regulatory Planning and Review(58 FR 51735, October 4, 1993), it has been determined that this rule is a "significant regulatory action" because this action may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in section 3 (f)(4) of the Executive Order. Accordingly, this final rule was submitted to the Office of Management and Budget (OMB) for reviewunder Executive Order 12866 and any changes made based on OMBrecommendations have been documented in the public docket for this rulemaking as required by section 6(a)(3)(E) of the Executive Order. In addition, EPA has prepared an economic assessment entitled Economic Analysis for the Final Section 4 Test Rulefor High Production Volume Chemicals (Ref. 75), a copy ofwhich has been placed in the public docket for this rulemaking. This economic assessment evaluates the economic impacts of the testing that would be required by this final rule. The total social cost of providing the test data on the 17 chemicals that were evaluated in this economic analysis is estimated to be $4.08 million (Ref. 75) . The annualized social costs of the final rule are

### p. 20

13726 Federal Register/Vol . 71, No. 51 /Thursday, March 16, 2006/ Rules and Regulations estimated to be $1 .44 million, using a to the rule. The Agency's estimated total other than the profits social discount rate of 3%over a 3-year costs of testing (including both individual chemicals period (Ref. 75) . laboratory and administrative costs), While legally subject to this final rule, annualized testing cost, price impacts, Tier 2 manufacturers and processors of and public reporting burden hours for a subject chemical would be required to this final rule are presented in the comply with the requirements of the economic assessment. rule only if they are directed to do so Under a least cost scenario, 12 out of by EPA as described in § 799.5085(c)(5) the 16 chemicals for which price data and (c)(6) of the regulatory text. EPA were available (75%) would have a would only require such entities to test price impact at less than the 1%level . if no person in Tier 1 has submitted a Similarly, 12 out of the 16 chemicals letter of intent to test, or if under 40 CFR (75%) would be impacted at less than 790 .93, a problemoccurs with the initiation, conduct, or completion of the required testing, or the submission of the required data to EPA . Because EPA has identified at least one manufacturer in Tier 1 for each subject chemical, the Agency assumes that, foreach chemical in this final rule, at least one such person will submit a letter of intent to test and that person will conduct such testing and will submit the test data to EPA . BecauseTier 2 manufacturers and processors do not need to comply with the rule initially, the economic assessment does not address these entities . To evaluate the potential for an adverse economic impact of testing on manufacturers of the chemical substances in this final rule, EPA employed a screening approach that estimated the impact of testing requirements as a percentage of each chemical's sale price. This measure compares annual revenues from the sale of a chemical to the annualized testing costs for that chemical to assess the percentage of testing costs that can be accommodated by the revenue generated by that chemical . Annualized testing costs divide testing expenditures into an equivalent, constant yearly expenditure over a longer period of time. To calculate the percent price impact, testing costs (including laboratory and administrative expenditures) are annualized over 15 years using a 7% discount rate. Annualized testing costs are then divided by the estimated annual revenue of the chemical to derive the cost-to-sales ratio. EPA estimates the total annualized compliance cost of testing for the 17 chemicals evaluated in the economic analysis to be $0.44 million under the average cost scenario. In addition, the TSCA section 12(b) the 1 %level under an average cost scenario. Thus, the potential for adverse economic impact due tothe rule is low for at least 75%of the chemicals in the rule. Approximately 4 chemicals (25%) of the 16 chemicals forwhich price data are available would have a price impact at a level greater than or equal to 1% under the least and average cost scenario. TheAgency computed a "critical price" for the chemical withoutprice data. This price is the maximumprice per pound, at which the ratio of testing costs to annual revenuewould be 1% . The critical price is informative because it represents the minimum pricethat is required to support testing at the one percent level . The production volume for isocyanatomethane (CAS No. 624- 83-9) ranges from 10 million to 50 million pounds. With an annualized testing cost estimated at $33,585, the critical price is $0.11 per pound. Below that price, the testing costs would represent more than 1 .0%of the revenues fromthe chemical . The average price for the 16 chemicals with actual price data available is $2.67 per pound. Thus, the critical price is substantially below this average. Only 2 of the 16 chemicalswith price data were estimated to have prices below $.11 per pound. While it cannot be shown conclusively that theprice impacts will be less than or greater than 1 .0%of the sales for this chemical, the Agency believes that adverse impacts are unlikely. EPA believes, on the basis of these calculations, that the testing of the chemicals presents a lowpotential for adverse economic impact for the majority of chemicals. Because the subject chemical substances have relatively large production volumes, the annualized costs of testing, expressed as export notification requirements a percentage of annual revenue, are very (included in the total and annualized small for most chemicals. There are, cost estimates) that would be triggered however, some chemicals forwhich the by the rule are expected to have a price impact is expected to exceed 1% negligible impact on exporters. The of the revenue fromthat chemical . The TSCA section 12(b) export notification potential for adverse economic impact is requirements under the final rule would expected to be higherfor these he required for the first export to a chemicals. In these cases, companies particular country of a chemical subject may choose to use revenue sources fromthe to pay for testing. B. Paperwork Reduction Act The information collection requirements contained in TSCA section 4test rules have already been approved by OMB under the provisions of the Paperwork Reduction Act (PRA), 44 U .S.C. 3501 et seq., and have been assigned OMB control number 2070- 0033 (EPA ICR No. 1139) . The information collection activities related to export notification under TSCA section 12(b)(1) are already approved under OMB control number 2070-0030 (EPA ICRNo. 0795) . This final rule does not contain any new or amended requirements that would require additional reviewand/or approval by OMB . The standard chemical testing programinvolves the submission of letters of intent to test (or exemption applications), study plans, progress reports, and test results. EPA estimates that the information collection activities related to chemical testing for all chemicals in this final rule (representing the submission of letters of intent or exemption applications, study plans, and the final reports; progress reports are not required by this final rule because testing will be completed within about 1 year) would result in an annual public reporting burden of 1,179 hours per chemical or a total of 20,039 hours for the17 chemicals (Ref. 75) . The annual public reporting burden related to export notification is estimated to be 0.5 to 1 .5 burden hours for each chemical/country combination (Ref. 75) . In estimating the total burden hours approved for the information collection activities related to export notification, the Agency has included sufficient burden hours to accommodate any export notifications that may be required by the Agency's issuance of final chemical test rules (Ref. 75) . For each manufacturer of the 17 chemicals identified in the economic analysis, the parent company (ultimate corporate entity, or UCE) was also identified. The economic analysis identified a total of 52 UCEs that EPA believes would be the likely respondents to the final rule. The public reporting burden for this collection of information is estimated to be 20,039 hours total . Dividing 20,039 hours by 52 UCEs, results in a per respondent estimated burden of 304 hours. This burden estimate includes time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

### p. 21 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations 13727 As defined by the PRA and 5 CFR following is a brief summary of the particular NAICS code would be 1320.3(b), "burden" means the total factual basis for this certification. considered small (Ref. 76) . The SBA time, effort, or financial resources Under the RFA, small entities include employee size standards that apply to expended by persons to generate, small businesses, small organizations, the companies that are potentially maintain, retain, or disclose or provide and small governmental jurisdictions. impacted (Ref. 75) by this final rule information to or for a Federal agency. This includes the time needed to: reviewinstructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and reviewthe collection of information; and transmit or otherwise disclose the information. Under the PRA, an agency may not conduct or sponsor, and a person is not required to respond to, an information collection request unless it displays a currently valid OMBcontrol number. The OMBcontrol numbers for EPA's regulations are listed in 40 CFR part 9 and included on the related collection instrument. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this final rule. This listing of the OMB control numbers and their subsequent codification in the CFRsatisfies the display requirements of the PRA and OMB's implementing regulations at 5 CFR part 1320. This ICR was previously subject to public notice and comment prior to OMBapproval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is "good cause" undersection 553(b)(1)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(1)(B), to amend this table without further notice and comment . C . Regulatory FlexibilityAct For purposes of assessing the impacts of range from500 to 1,500 employees. this final rule on small entities, small Sales and employment data were entity is defined in accordance with the obtained for the 52 UCEs that RFA as: manufacture the 17 chemicals subject to 1. Asmall business as defined by the this final rule to identify those UCEs Small Business Administration's (SBA) that qualify for "small business" status, regulations at 13 CFR 121 .201 . where data were available. Based on the 2. Asmall governmental jurisdiction SBA size standards for the NAICS codes that is a government of a city, county, that applied to those UCEs, 23 of the 52 town, school district, or special district UCEs (44%) were identified as small . with a population of less than 50,000. The significance of this final rule's 3. Asmall organization that is any impact on these small businesses was not-for-profit enterprise which is analyzed by examining the number of independently owned and operated and small entities that experienced different is not dominant in its field. levels of costs as a percentage of their Based on the industry profile for this sales. In such an analysis, small rule that EPA prepared as part of the businesses are placed in the following Economic Analysis prepared for this categories on the basis of cost-to-sales final rule, EPA has determined that this ratios: less than 1 .0%, 1 .0%but less rule is not expected to impact any small than 3.0%, and 3.0%or greater. Of the not-for-profit organizations or small 23 companies that qualified for small governmental jurisdictions . As such, the business status according to the SBA Agency evaluated small businesses as the small entities potentially impacted by this final rule. Three factors are examined in EPA's small entity assessment (Ref. 75) in order to characterize the potential small entity impacts of this final rule: " The size of the adverse impact (measured as the ratio of the cost to sales or revenue) . " The total number of small entities that experience the adverse impact. " The percentage of the total number of small entities that experience the adverse impact . Section 601(3) of RFAestablishes as the default definition of "small business" the definition used in section 3of the Small Business Act, 15 U .S.C. 632, under which the SBA establishes small business size standards foreach industry sector. (13 CFR 121 .201) . For this final rule, EPAhas analyzed the potential small business impacts using the size standards established under this default definition . The SBAsize standards, which are primarily intended Pursuant to section 605(b) of the to determine whether a business entity Regulatory Flexibility Act (RFA), 5 is eligible for government programs and U.S.C. 601 et seq., after considering the preferences reserved for small potential economic impacts of this final businesses (13 CFR 121 .101), "seek to rule on small entities, the Agency ensure that a concern that meets a hereby certifies that this final rule will specific size standard is not dominant in not have a significant adverse economic its field of operation." (13 CFR impact on a substantial number of small 121 .102(b)) . See section 632(a)(1) of the entities. The Agency's determination is Small Business Act. Industrial sectors based on the small entity impact are identified by a NAICS code. In most analysis prepared as part of the cases, SBAhas specified an employee economic analysis for this final rule size standard (100; 500 ; 750 ; 1,000 ; or (ReE 75), which is summarized in Unit 1,500 employees) or, in some cases, a XC .A., and a copy of which is available sales-based, or other industry-specific in the docket for this final rule. The indicator below which an entity in that size standards, none had a cost-to-sales ratiothat exceeded 1 .0% . Given these results, EPA concludes that there is not a significant economic impact on these small entities as a result of this final rule. There were an additional two UCEs for which the NAICS code, sales, and employment data were not available. Because of this, EPA could not determine whether they are small businesses or assess the potential impacts of thetest rule on them . However, it is very unlikely that both of these UCEs are small entities. Moreover, given the Agency's analysis for the identified small businesses, which concluded that there is not a significant economic impact on any of them, EPA believes it is reasonable to conclude that even if these two UCEs are small entities, they will not experience a significant economic impact . Consequently, EPA concludes that there will not be a significant economic impact on a substantial number of small entities as a result of the testing imposed in this final rule. The estimated costs of the TSCA section 12(b) export notification, which, as a result of this final rule, would be required for the first export to a particular country of a chemical subject to the rule, is estimated to be $67.35 for the first time that an exporter must comply with TSCA section 12(h) export notification requirements, and $21 .81 for each subsequent export notification submitted by that exporter to an additional country (Ref. 75) . EPA has concluded that the costs of TSCA section 12(b) export notification would

### p. 22

13728 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations have a negligible impact on exporters of the chemicals in this final rule, regardless of the size of the exporter. Therefore, the Agency certifies that this final rule will not have a significant adverse economic impact on a substantial number of small entities. D . Unfunded Mandates ReformAct Pursuant to Title II of the Unfunded Mandates ReformAct of 1995 (UMRA) (Public Law

104-4), EPA has determined that this regulatory action does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or for the private sector in any 1 year . The analysis of the costs associated with this action are described in Unit VIII . In addition, since EPA does not have any information to indicate that any State, local, or tribal government manufactures or processes the chemicals covered by this action such that this final rule would apply directly to State, local, or tribal governments, EPAhas determined that this final rule does not significantly or uniquely affect small governments. Accordingly, this final rule is not subject to the requirements of sections 202, 203, 204, and 205of UMRA. E . Executive Order 13132 Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure "meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications." "Policies that have federalismimplications" is defined in the Executive order to include regulations that have "substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government ." This final rule does not have federalismimplications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This final rule establishes testing and recordkeeping requirements that apply to manufacturers (including importers) and processors of certain chemicals. Because EPA has no information to indicate that any State or local government manufactures or processes the chemical substances covered by this action, this rule does not apply directly to States and localities and will not affect State and local governments. Thus, Executive Order 13132does not apply to this final rule. F . Executive Order 13175 Under Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), this final rule does not have tribal implications because it will not have substantial direct effects on tribal governments, on the relationship betweenthe Federal Government and the Indian tribes, or on the distribution of powerand responsibilities between the Federal Government and Indian tribes, as specified in theExecutive order. As indicated in this unit, EPAhas no information to indicate that any tribal government manufactures or processes the chemical substances coveredby this action. Thus, Executive Order 13175 does not apply to this final rule. Although Executive Order 13175was not yet in effect when EPA developed the proposed rule, its predecessor, Executive Order 13084, was and EPA's conclusions under Executive Order 13175 are consistent with EPA's considerations under Executive Order 13084 . G . Executive Order 13045 This final rule does not require special consideration pursuant to the terms of Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because it is not likely to have an annual effect on the economy of $100 million or more and it does not have a potential effect or impact on children. This final rule establishes testing and recordkeeping requirements that apply to manufacturers (including importers) and processors of certain chemicals, and will result in the production of information that will assist the Agency and others in determining whether the chemical substances in this final rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks. H . Executive Order 13211 This final rule is not a "significant energy action" as defined in Executive Order 13211, entitled Actions Concerning Regulations That SignificantlyAffect Energy Supply, Distribution, OF Use (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. As such, theAgency has concluded that this final rule is not likely to have adverse energy effects. I. National Technology Transfer and AdvancementAct As noted in the proposed rule, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U

.S.C 272 note) directs EPAto use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical . Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies . The NTTAAdirects EPAto provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. Because this final rule involves technical standards, the Agency conducted a search to identify potentially applicable voluntary consensus standards. EPAidentified 11 applicable voluntary consensus standards (Refs. 44-48, 52-56, and 64), listed in Table 4 of this unit, and is allowing their use in this final rule . Of the 11 voluntary consensus standards, 3 of those issued by ASTM evaluate the same type of toxicity as TSCA and OECD test guidelines, as shown in Table 4of this unit . TABLE 4

.-APPLICABLE VOLUNTARY CONSENSUS STANDARDS Voluntary Consensus Standard Title of Voluntary Consensus Standard TSCA Guideline/CFR Cita- OECD Test No./Year tion Method No. ASTM E 324 (1999) Standard Test Method for Relative Initial and Final Melting Points and the 1 Melting Range of Organic Chemicals

### p. 23 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations

TABLE 4.-APPLICABLE VOLUNTARY CONSENSUS STANDARDS-Continued 

### 13729

Voluntary Consensus Standard

No/Year Title of Voluntary Consensus Standard TSCA Guideline/CFR Cita- OECDTest

. tion Method No. ASTME 729 (2002) Standard Guide for Conducting Acute Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and Amphibians ASTME 1147 (1997) Standard Test Method for Partition Coefficient (N-Octanol/Water) Esti- 799 .6755, mation by Liquid Chromatography 799 .6756 ASTM . E1148 (2002) Standard Test Method for Measurements of Aqueous Solubility 799.6784, 799 .6786 ASTME 1163 (2002) Standard Test Method for Estimating Acute Oral Toxicity in Rats 799 .9130 (if 425 gas at room temp.) . ASTM E 1 193 (2004) Standard Guide for Conducting Daphnia Magna Life-Cycle Toxicity Tests ASTME 1218 (2004) Standard Guide for Conducting Static Toxicity Tests with Microalgae ASTM E 1625 (2001) Standard Test Method for Determining Biodegradability of Organic Chemicals in Semi-Continuous Activated Sludge (SCAS) ASTME 1719 (1997) Standard Test Method for Vapor Pressure of Liquids by Ebulliometry ASTME 1782 (2003) Standard Test Method for Determining Vapor Pressure by Thermal Analysis ISO9888 (1999) Water Quality-Evaluation of Ultimate Aerobic Biodegradability of Organic I I Compounds in Aqueous Medium-Static Test (Zahn-Wellens Method), Second Edition Copies of theASTM and ISO standards referenced in this final rule have been placed in the public version of the official record for this final rule and are available to read, but not to copy, at the EPADocket location described in ADDRESSES. You may obtain copies of theASTM standards fromthe American Society for Testing and Materials, 100Bar Harbor Dr ., West Conshohocken, PA 19428-2959, and a copy of the ISOstandard fromthe International Organization for Standardization, Case Postale, 56 CH1211 Geneve 20 Switzerland. EPA received the required approval fromthe Director of the Federal Register for the incorporation by reference of the ASTM and ISO standards used in this final rule in accordance with 5 U.S.C . 552(a) and 1 CFR part 51 . EPAis not aware of any potentially applicable n-octanol/water partition coefficient (generator column), water solubility (column elution and generator column), acute inhalation toxicity, bacterial reverse mutations, in vivo mammalian bone marrow chromosomal aberrations, combined repeated dose with reproductive/developmental toxicity screen, repeated dose 28-day oral toxicity screen, or the reproductive developmental toxicity screen which could be considered in lieu of the TSCA ~uidelines published in 40 CFR 799.6756, 799

.6784, 799.6786, 799 .9130, 799

.9510, 799

.9538, 799

.9365, 799

.9305, and 799

.9355, respectively, upon which the test standards in this final rule are based. J. Executive Order 12898 Pursuant to Executive Order 12898, entitled Federal Actions to Address EnvironmentalJusticein Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994), the Agency has considered environmental justice-related issues with regard to the potential impacts of this action on the environmental and health conditions in minority and lowincome populations. The Agency believes that the information collected under this final rule will assist EPAand others in determining the hazards and risks associated with the chemicals covered by the rule. Although not directly impacting environmental justice-related concerns, this information will better enable the Agency to protect human health and the environment

. X11. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a "major rule" as defined by 5 U.S.C. 804(2) . List ofSubjects 40CFR Part 9 Environmental protection, Reporting and recordkeeping requirements. 40 CFR Part 799 Environmental protection, Chemicals, Hazardous substances, Incorporation by reference, Laboratories, Reporting and recordkeeping requirements. Dated: March 1, 2006. Susan B. Hazen, Acting AssistantAdministrator, Office of Prevention, Pesticides and Toxic Substances. ri Therefore, 40 CFRchapterI is amended as follows: PART 9-[AMENDED] ti 1 . The authoritycitation for part 9 continues to read as follows: Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S .C. 2001, 2003, 2005, 2006, 2601-2671, 21 U.S.C

. 331j, 346a, 348; 31 U.S.C : 9701 ; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361 ; E.O

. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U .S.C. 2-11,

### p. 24

13730 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k,7401-7671q,7542,9601-9657, 11023, 11048. 0 2. In § 9.1, the table is amended by adding an entry for § 799.5085 in numerical order under the indicated heading to read asfollows: § 9 .1 OMBapprovals under the Paperwork Reduction Act.

. . 40 CFR citation OMB control No.

Identification of Specific Chemical Substance and ments Mixture Testing Require799.5085 .. ..... ..... ...... ....

PART 799-[AMENDED] 2070-0033 §799.5085 Chemical testing requirements forcertain high production volume chemicals. (a) What substances will be tested under this section? Table 2 in paragraph (j) of this section identifies the chemical substances that must be tested under this section. For the chemical substances identified as "Class 1" substances in Table 2 in paragraph (j) of this section, the purity of each chemical substance must be 99%or greater, except for 1,3-propanediol, 2,2- bis[(nitrooxy)methyl)-, dinitrate (ester) (CAS No. 78-11-5), also known as pentaerythritol tetranitrate (PETN) . PETNcannot be tested at 99%purity because of its explosive properties. It must be diluted inwater or tested as a stabilized mixturewith an appropriate stabilizer (e.g., D-lactose monohydrate is thestabilizer in PETN, NF which is a mixture of 20%by weight PETNand 80%by weight D-lactose monohydrate) . The stabilizer used must be tested as a control . For the chemical substances identified as "Class 2" substances in Table 2 in paragraph (j), a representative formof each chemical substance must be tested. The representative form selected for a given Class 2 chemical substanceshould meet industry or consensus standards where they exist. (b) Am Isubject to this section? (1) If you manufacture (including import) or intend to manufacture, or process or intend to process, any chemical substance listed in Table 2 in paragraph (j) of this section at any time fromApril 17, 2006 to the end of the test data reimbursement period as defined in 40 CFR 791 .3(h), you are subject to this section with respect to that chemical substance. (2) Ifyou do not know or cannot reasonably ascertain that you manufacture or process a chemical substance listed in Table 2 in paragraph (j) of this section during the time period described in paragraph (b)(1) of this section (based on all information in your possession or control, as well as all information that a reasonable person similarly situated might be expected to possess, control, or know, or could obtain without an unreasonable burden), you are not subject to this section with respect to that chemical substance. (c) IfI am

subject to this section, when must I comply with it? (1)(i) Persons subject to this section are divided into two groups, as set forth in Table 1 of this paragraph: Tier 1 (persons initially required to comply) and Tier 2 (persons not initially required to comply)

. Ifyou are subject to this section, you must determine ifyou fall within Tier 1 or Tier 2, based on Table 1 of this paragraph. N 3 . The authority citation forpart 799 continues to read as follows: Authority: 15 U

.S.C. 2603, 2611, 2625. 0 4 . By adding § 799

.5085 to subpart D to read as follows: TABLE 1 .-PERSONS SUBJECT TO THE RULE: PERSONS IN Persons initially required to comply with this section (Tier 1) Persons not otherwise specified in column 2 of this table that manufacture (as defined at TSCA section 3(7)) or intend to manufacture a chemical substance included in this section.

(ii) Table 1 of paragraph (c)(1)(i) of this section expands the list of persons specified in § 790 .42(a)(2), (a)(4), and (a)(5) of this chapter, who, while legally subject to this section, must comply with the requirements of this section only if directed to do so by EPA under the circumstances set forth in paragraphs (c)(5) and (c)(8) of this section. (2) If you are in Tier 1 with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, you TIER 1 ANDTIER 2 Persons not initially required to comply with this section (Tier 2) A . Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a chemical substance included in this section solely as one or more of the following: -As a byproduct (as defined at 40 CFR791.3(c)) ; -As an impurity (as defined at 40 CFR790 .3); -As a naturally occurring substance (as defined at 40 CFR 710 .4(b)) ; -As a non-isolated intermediate (asdefined at 40 CFR704 .3) ; -As a component of a Class 2substance (as described at 40 CFR720 .45(a)(1)(i)) ; -In amounts of less than 500 kg (1,100 Ibs.) annually (as described at 40 CFR 790 .42(a)(4)) ; or -For R&D(as described at 40 CFR790 .42(a)(5)) . B. Persons who process (as defined at TSCA section 3(10)) or intend to process a chemical substance included in this section (see 40 CFR790 .42(a)(2)) . must, for each test required under this section for that chemical substance, either submit to EPA a letter of intent to test or apply to EPA for an exemption fromtesting. The letter of intent to test or the exemption application must be received by EPA no later than May 15, 2006. (3) If you are in Tier 2 with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, you are considered to have an automatic conditional exemption and you will be required to comply with this section with regard to that chemical substance only if directed to do so by EPA under paragraphs (c)(5) or (c)(8) of this section. (4) If no person in Tier 1 has notified EPA of its intent to conduct one or more of the tests required by this section on any chemical substance listed in Table 2 in paragraph (j) of this section by May 15, 2006, EPA will publish a Federal Register document that will specify the test(s) and the chemical substance(s) for which no letter of intent has been

### p. 25 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations submitted, and notify manufacturers and processors in Tier 2 of their obligation to submit a letter of intent to test or to apply for an exemption from testing. (5) Ifyou are in Tier 2 with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, and if you manufacture or process this chemical substance as of April 17, 2006, or within 30 days after publication of the Federal Register document described in paragraph (c)(4) of this section, you must, for each test specified for that chemical substance in the document described in paragraph (c)(4) of this section, either submit to EPA a letter of intent to test or apply to EPA for an exemption fromtesting. The letter of intent to test or the exemption application must be received by EPA no later than 30days after publication of the document described in paragraph (c)(4) of this section. (6) If no manufacturer or processor has notified EPA of its intent to conduct one or more of the tests required by this section for any of the chemical substances listed in Table 2 in paragraph (j) of this section within 30 days after the publication of the Federal Register document described in paragraph (c)(4) of this section, EPAwill notifyall manufacturers and processors of those chemical substances of this fact by certified letter or by publishing a Federal Register document specifying the test(s) forwhich no letter of intent has been submitted. This letter or Federal Register document will additionally notify all manufacturers and processors that all exemption applications concerning the test(s) have been denied, and will give the manufacturers and processors of the chemical substance(s) an opportunity to take corrective action. (7) If no manufacturer or processor has notified EPA of its intent to conduct one or more of the tests required by this section for any of the chemical substances listed in Table 2 in paragraph (j) of this section within 30 days after receipt of the certified letter or publication of the Federal Register document described in paragraph (c)(6) of this section, all manufacturers and processors subject to this section with respect to that chemical substance who are not already in violation of this section will be in violation of this section. (8) If a problemoccurs with the initiation, conduct, or completion of the required testing or the submission of the required data with respect to a chemical substance listed in Table 2 in paragraph (j) of this section, under the procedures 

### 13731 EPA may initiate termination (g) Who must comply with the export proceedings for all testing exemptions notification requirements? Any person with respect to that chemical substance who exports, or intends to export, a and may notify persons in Tier 1 and chemical substance listed in Table 2 in Tier 2 that they are required to submit paragraph (j) of this section is subject to letters of intent to test or exemption part 707, subpart D, of this chapter. applications within a specified period of (h) How must I conduct my testing? time. (1) The tests that are required for each (9) Ifyou are required to comply with chemical substance are indicated in this section, but your manufacturing or Table 2 in paragraph (j) of this section. processing of a chemical substance listed in Table 2 in paragraph (j) of this The test methods that must be followed section begins after the applicable are provided in Table 3 in paragraph (j) compliance date referred to in of this section. You must proceed in paragraphs (c)(2), (c)(5), or (c)(8) of this accordance with these test methods as section, you must either submit a letter required according to Table 3 in of intent to test or apply to EPA for an paragraph (j) of this section, or as exemption. The letter of intent totest or appropriate if more than one alternative the exemption application must be is allowed according to Table 3 in received by EPA no later than the day paragraph (j) of this section. Included in you begin manufacturing or processing. Table 3 in paragraph (j) of this section (d) What must I do to comply with are the following 11 methods which are this section? (1) To comply with this incorporated by reference: section you must either submit to EPA a letter of intent to test, or apply to and obtain fromEPA an exemption from testing. (2) For each test with respect to which yousubmit to EPA a letter of intent to test, you must conduct the testing specified in paragraph (h) of this section and submit the test data to EPA. (3) You must also comply with the procedures governing test rule requirements in part 790of this chapter, as modified by this section, including the submission of letters of intent to test (i) Standard Test Method for Relative Initial and Final Melting Points and the MeltingRange of Organic Chemicals, ASTM

E 324-99. (ii) Standard Test Method for Partition Coefficient (N-Octanol/Water) Estimation by Liquid Chromatography, ASTM E 1147-92. (Reapproved 1997) (iii) Standard Guide for Conducting Acute Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and Amphibians, ASTM E 729-96. (Reapproved 2002) or exemption applications, the conduct (iv) Standard Test Method for of testing, and the submission of data; Measurements of Aqueous Solubility, Part 792-Good Laboratory Practice ASTM E 1148-02

. Standards of this chapter; and this section. The following provisions of 40 CFR part 790 do not apply to this section: Paragraphs (a), (d), (e), and (f) of § 790 .45; paragraph (a)(2) and paragraph (b) of §§ 790 .80 ; 790 .82(e)(1) ; 790 .85; and 790

.48. (e) IfI do not comply with this section, when will I be considered in violation of it? You will be considered in violation of this section as of 1 day after the date by which you are required to comply with this section. (f) How are EPA's data reimbursement procedures affected for purposes of this section? If persons subject to this section are unable to agree on the amount or method of reimbursement for test data development for one or more chemical substances included in this section, any person may request a hearing as described in 40 CFR part 791 . In the determination of fair reimbursement shares under this section, if the hearing officer chooses to use a formula based on production volume, the total production volume amount will include aniounts of a chemical substance in § § 790

.93 and 790.97 of this chapter, produced as an impurity. (v) Standard Test Method for Estimating Acute Oral Toxicity in Rats, ASTM

E 1163-98. (Reapproved 2002) (vi) Standard Guide for Conducting Daphnia Magna Life-CycleToxicity Tests, ASTM

E 1193-97. (Reapproved 2004) (vii) Standard Guide for Conducting Static Toxicity Tests with Microalgae, ASTM

E 1218-04

. (viii) Standard Test Method for Determining Biodegradability of Organic Chemicals in Semi-Continuous Activated Sludge (SCAS), ASTM E 1625-94

. (Reapproved 2001) (ix) Standard Test Method for Vapor Pressure of Liquids by Ebulliometry, ASTM E 1719-97. (x) Standard Test Method for Determining Vapor Pressure by Thermal Analysis, ASTM

E 1782-03. (xi) Water Quality-Evaluation of Ultimate Aerobic Biodegradability of Organic Compounds in Aqueous Medium-Static Test (Zahn-Wellens Method), Second Edition, June 1, 1999, ISO9888-99

.

### p. 26

13732 Federal Register/Vol . 71, No. 51 /Thursday, March 16, 2006/Rules and Regulations (2) The Director of the Federal Register approved this incorporation by reference in accordance with 5 U .S .C. 552(a) and 1 CFRpart 51 . You may obtain copies of the ASTM guidelines fromthe American Society for Testing and Materials, 100Bar Harbor Dr ., West Conshohocken, PA 19428-2959, and a copy of the ISOguideline fromthe International Organization for Standardization, Case Postale, 56 CH1211 Geneve 20 Switzerland . You may inspect each test method at the EPA Docket Center, EPAWest, Rm . B102, 1301 Constitution Ave ., NW ., Washington, DC or at the National Archives and Records Administration (NARA) . For information on the availability of this material at NARA, call (202) 741-6030, or go to: http :// www .archives.gov/federal register/ code-of federa] regulations/ ibr locations.html. (i) Reporting requirements. Afinal report for each specific test for each subject chemical substancemust be received by EPAby May 17, 2007, unless an extension is granted in writing pursuant to 40 CFR790 .55. Arobust summary of the final report for each specific test should be submitted in addition to andat the same time as the final report . The term"robust summary" is used to describe the technical information necessaryto adequately describe an experiment or study and includes the objectives, methods, results, and conclusions ofthe full study report which can be either an experiment or in some cases an estimation or prediction method. Guidance for the compilation of robust summaries is described in a document entitled Draft Guidance on Developing Robust Summaries which is available at: http://www

.epa.gov/chemrtk/ robsumgd.htm

. (j) Designation ofspecific chernical substances and testing requirements. The chemical substances identified by chemical name, Chemical Abstract Service Number (CAS No.), and class in Table 2 of this paragraph must be tested in accordance with the requirements designated in Tables 2 and 3 of this paragraph, and the requirements described in 40 CFR Part 792-Good Laboratory Practice Standards: TABLE 2

.-CHEMICAL SUBSTANCES ANDTESTING REQUIREMENTS CAS No. Chemical name Class Required tests/(See Table 3 of this section) 74-95-3 Methane, dibromo- 1 A, C1, E2, F2 75-36-5 Acetyl chloride 1 A, B, C2, E2, F1 78-11-5 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester) 1 A4, A5, B, C6, F2 84-65-1 9,10-Anthracenedione 1 A, F2 108-19-U Imidodicarbonic diamide 1 A, B, C1, D, E1, E2, F1 110-44-1 2,4-Hexadienoic acid, (2E,4E)- 1 A, C4 112-52-7 Dodecane, 1-chloro 1 A, B, C3, D, E1, E2, F1 118-82-1 Phenol, 4,4'-methylenebis[2,6-bis(1,1-dimethylethyl)]- 1 A, B, D, E1, E2, F2 149-44-0 Methanesulfinic acid, hydroxy-, monosodiumsalt 1 A, B, C1, E2, F1 409-02-9 Heptenone, methyl- 2 A, B, C1, D, E1, E2, F1 594-42-3 Methanesulfenyl chloride, trichloro- 1 A, B, C1, E1, E2, F2 624-83-9 Methane, isocyanato- i A, C1 1324-76-1 Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5- cyclohexadien-1-ylidene]methyl]phenyl]amino]- 2 A, B, C1, D, E1, E2, F1 2941-64-2 Carbonochloridothioic acid, S-ethyl ester 1 A, B, C1, E2, F1 8005-02-5 C .I . Solvent Black 7 2 A, B, C1, D, E2, F1 65996-78-3 Light oil (coal), coke-oven 2 A, B, C1, D, E1, E2, F1 68611~4-3 Urea, reaction products with formaldehyde 2 A, B, C1, D, E1, E2, F1

### p. 27

TABLE 3-KEY



### Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations TO THE TEST REQUIREMENTS Testing category Physical/chemical properties A Test symbol DENOTED 

### 13733 BY ALPHANUMERIC SYMBOLS IN TABLE 2 OF THIS PARAGRAPH Test requirements and references 1 . Melting Point: ASTM E 324 (capillary tube) 2 . Boiling Point: ASTME 1719 (ebulliometry) 3 . Vapor Pressure: ASTM E 1782 (thermal analysis) 4 . n-Octanol/Water Partition Coefficient (log 10 basis) or log Kow : (See special conditions for the log Ko,V test requirement and select the appropriate method to use, if any, from those listed in this column.) Method A

: 40 CFR799

.6755 (shake flask) Method B

: ASTM E 1147 (liquid chromatography) Method C

: 40 CFR 799.6756 (generator column) 5 . Water Solubility

. (See special conditions for the water solubility test requirement and select the appropriate method to use, if any, fromthose listed in this column.) Method A

: ASTME 1148 (shake flask) Method B

: 40 CFR 799.6784 (shake flask) Method C

: 40 CFR799

.6784 (column elution) Method D

: 40 CFR 799

.6786 (generator column) Special conditions n-Octanol/water Partition Coefficient or log Kow : Which method is required, if any, is determined by the test substance's estimated' log Kow, as follows: log Kow<0: no testing required. log Kow

range 0-1 : Method Aor B . log Ko , range >1-4: Method Aor B or C . log Kow, range >4-6: Method B or C . log Ka, >6: Method C. Test sponsors are required to provide in the final study report the underlying rationale for the method selected. In order to ensure environmental relevance, EPA highly recommends that the selected study be conducted at pH 7. WaterSolubility

. Which method is required, if any, is determined by the test substance's estimated2 watersolubility. Test sponsors are required to provide in the final study report the underlying rationale for the method selected. In order to ensure environmental relevance, EPA highly recommends that the selected study be conducted at pH 7 . >5,000 mg/L: Method Aor B . >10 mg/L -5,000 mg/L: Method A, B, C, or D . > 0.001 mg/L-10mg/L: Method C or D . <_0 .001 mg/L: No testing required. Environmental fate and pathways-Inherent biodegradation Aquatic toxicity B

C1

C2 For B, choose either of the methods listed in this column: 1 . ASTM 1625 (semicontinuous activated sludge test) OR 2 . ISO9888 (Zahn-Wellens method) For C1, Test Group 1 or Test Group 2 listed in this column must be used to fulfill the testing requirements-See special conditions. Test Group 1 forC1 : 1 . Acute Toxicity to Fish: ASTME 729 2 . Acute Toxicity to Daphnia: ASTME 729 3 . Toxicity to Plants (Algae): ASTM E 1218 Test Group 2for Cl : 1 . Chronic Toxicity to Daphnia: ASTME 1193 2. Toxicity to Plants (Algae) : ASTME 1218 For C2, Test Group 1 or Test Group 2 listed in this column must be used to fulfill the testing requirements-See special conditions. Test Group I for C,1

. 1 . Acute Toxicity to Daphnia: ASTME 729 2. Toxicity to Plants (Algae) : ASTME 1218 Test Group2for C2

: 1 . Chronic Toxicity to Daphnia: ASTM E 1193 2 . Toxicity to Plants (Algae) : ASTM E 1218 None

The following are the special conditions for C1, C2, C3, C4, C5, and C7 testing ; there are no special conditions for C6 . If log Kow<4.2: Test Group 1 is required If log Kow>_ 4

.2: Test Group 2 is required Which test group is required is determined by the test substance's measured log Ko , as obtained underA3.

### p. 28

13734 Federal Register/Vol . 71, No . 51/Thursday, March 16, 2006/Rules and Regulations TABLE 3-KEY TO THE TEST REQUIREMENTS DENOTED BY ALPHANUMERIC SYMBOLS IN TABLE 2 OF THIS PARAGRAPHContinued Testing category Special conditions

Mammalian toxicity-Acute

Mammalian toxicityGenotoxicity Which testing method is required is determined by the test substance's physical state at room temperature (25°C)

. For those test substances that are gases at room temperature, Method A is required; otherwise, use either of the two methods listed under Method B . In Method B, 40 CFR 799 .9110(d)(1)(i)(A) refers to the OECD 425 Up/Down Procedure4. Estimating starting dose for Method B : Data from the neutral red uptake basal cytotoxicity assays using normal human keratinocytes or mouse BALB/c 3T3 cells may be used to estimate the starting dose. Bacterial Reverse Mutation Test (in vitro) : 40 CFR 799.9510

### p. 29 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations 13735 TABLE 3-KEY TOTHE TEST REQUIREMENTS DENOTED BY ALPHANUMERIC SYMBOLS IN TABLE 2 OF THIS PARAGRAPH

### Continued Testing category Test symbol Test requirements and references Special conditions E2 Conduct any one of the following three tests Persons required to conduct testing for chrofor chromosomal damage: mosomal damage are encouraged to use In vitro Mammalian Chromosome Aberration the in vitro Mammalian Chromosome AberTest: 40 CFR 799

.9537 OR ration Test (40 CFR 799 .9537) to generate Mammalian Bone MarrowChromosomal Ab- the needed data unless known chemical erration Test (in vivo in rodents: mouse properties (e.g., physical/chemical prop- (preferred species), rat, or Chinese ham- erties, chemical class characteristics) prester) : 40 CFR799

.9538 OR clude its use . A subject person who uses Mammalian Erythrocyte Micronucleus Test one of the in vivo methods instead of the in [sampled in bone marrow] (in vivo in ro- vitro method to address a chromosomal dents: Mouse (preferred species), rat, or damage test requirement must submit to Chinese hamster) : 40 CFR799 .9539 EPA a rationale for conducting that alternate test in the final study report. Oammalian toxicity-Re- F1 Combined Repeated Dose Toxicity Study Where F1 is required, EPA recommends use pealed dose/ with the Reproduction/Developmental Tox- of the Combined Repeated Dose Toxicity reproduction/ develop- icity Screening Test: 40 CFR799 .9365 OR Study with the Reproduction/Developmental Reproduction/Developmental Toxicity Screen- mental Toxicity Screening Test (40 CFR ing Test : 40 CFR 799.9355AND 799.9365) . However, there may be valid Repeated Dose 28-Day Oral Toxicity Study reasons to test a particular chemical using in rodents: 40 CFR799.9305 both 40 CFR 799 .9355 and 40 CFR 799 .9305 to fill Mammalian Toxicity-Repeated Dose/Reproduction/Developmental data needs. Asubject person who uses the combination of 40 CFR 799 .9355 and 40 CFR 799.9305 in place of 40 CFR 799.9365 must submit to EPA a rationale for conducting these alternate tests in the final study reports. Where F2 or F3 is required, no rationale for conducting the required test need be provided in the final study report. F2 Reproduction/Developmental Toxicity Screening Test: 40 CFR799.9355 F_3 .% Repeated Dose 28-Day Oral Toxicity Study in rodents: 40 CFR799.9305 I EPA recommends, but does not require, that log Ko , be quantitatively estimated prior to initiating this study . One method, among many simi- lar methods, for estimating log Ko,wis described in the article entitled Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients) by W

.M . Meylan and P.H. Howard in the Journal of Pharmaceutical Sciences. 84(1) :83-92. January 1992. This reference is avail- able under docket ID number EPA-HQ-0PPT-2005-0033 at the EPA Docket Center, Rm . B102, 1301 Constitution Ave., NW ., Washington, DC, from8 :30a.m . to 4:30 p.m

., Monday through Friday, excluding legal holidays. 2EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating this study. One method, among many similar methods, for estimating water solubility is described in the article entitled Improved Method for Estimating Water Solubility FromOc- tanol/Water Partition Coefficient by W .M . Meylan, P.H. Howard, and R .S . Boethling in Environmental Toxicology and Chemistry . 15(2) :100-106. 1996. This reference is available under docket ID number EPA-HQ-OPPT-2005-0033 at the EPA Docket Center, Rm . B102, 1301 Constitution Ave., NW

., Washington, DC, from8 :30a.m . to 4:30 p.m

., Monday through Friday, excluding legal holidays. 3Chemical substances that are dispersible in water may have log Kowvalues greater than 4 .2 and may still be acutely toxic to aquatic orga- nisms. EPA recommends, but does not require, that test sponsors who wish to conduct Test Group 1 studies on such chemicals to submit to EPA for approval a written request to conduct Test Group 1 studies 90 days prior to conducting such studies. The written request should include the rationale forconducting Test Group 1 studies . 4The OECD 425 Up/Down Procedure, revised by OECDin December 2001, is available under docket ID number EPA-HQ-OPPT-2005-0033 at the EPA Docket Center, Rm . B102, 1301 Constitution Ave., NW ., Washington, DC, from 8 :30a.m . to 4 :30 p.m ., Monday through Friday, ex- cluding legal holidays. 5The neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the mammalian toxicity-acute endpoint, is available under docket ID number EPA-HO,0PPT-2005-0033 at the EPA Docket Center, Rm . B102, 1301 Constitution Ave., NW ., Wash- ington, DC, from8

:30a.m . to 4:30 p.m., Monday through Friday, excluding legal holidays. (k) Effective date. This section is effective on April 17, 2006. [FR Doc. 06-2483 Filed 3-15-0618:45 am] BILLING CODE 6560-50 .S