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 9 and 799 

[EPA-HQ-OPPT-2005-0033 ; FRL-7335-2] 

RI N 2070-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 acute toxicity, 

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 program is 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 allow the 

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 form in which it is exported, are 

subject to the export notification 

requirements of TSCA 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 of April 17, 

2006 . For purposes of judicial review, 

this final rule shall be promulgated at 1 

p.m. eastern daylight/standard time on 

March 30, 2006. 

ADDRESSES : Docket. EPA has 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, EPA Docket Center 

(EPA/DC), EPA West, Rm, B102,1301 

Constitution Ave., NW., Washington, 

DC. The Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays . The telephone number for the 

Public Reading Room is (202) 566-1744, 

and the telephone number for the OPPT 

Docket is (202) 566-0280 . 

TSCA section 4 submissions. For 

submission instructions, see Unit 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, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460-0001 ; telephone 

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

TSCA-HotlineCepa .gov. 

For technical 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 this Action Apply to 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 

CFR part 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 petroleum refineries . 

" Processors of one or more of the 17 

subject chemical substances (NAICS 

codes 325 and 324110), e.g ., chemical 

manufacturing and petroleum refineries . 

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 I Access 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. A frequently 

updated electronic version of 40 CFR 

part 9 and part 799 is available on ECFR Beta Site Two at http :// 

wwvv.gpoaccess.gov/ecfr. 

11 . Background 

A. What Action is the Agency Taking? 

EPA is 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 HPV chemicals, 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 HPV chemicals 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 to health 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 of such Following consideration of the public substance, depending upon what data manufacture, distribution in commerce, comments received by EPA on the 

are already available for that substance . processing, use, or disposal of such substance proposed test rule (Ref. 2) and updated 

In the proposal to this final rule, or mixture or of any combination of such production volume information (i .e ., published in the Federal Register of activities on health or the environment can 2002 IUR data), EPA is making the December 26, 2000, EPA proposed SIDS reasonably be determined or predicted, and following findings for the 17 chemical testing for 37 HPV chemicals (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 substance or mixture is or substantial human exposure to them; testing requirements for certain will be produced in substantial quantities, 

and (I) it enters or may existing data are insufficient to 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 EPA testing program known be significant or substantial human exposure necessary to develop such data . 

as the HPV Challenge Program (see Unit to such substance or mixture, 

II .C .), and updated production volume (ii) There are insufficient data and C. Why is EPA Taking this Action? 

data (i .e ., 2002 Inventory Update Rule experience upon which the effects of the On April 21, 1998, EPA initiated 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 of any combination of such knowledge about the most widespread this final rule (i .e ., the "proposed rule"), activities on health or the environment can 

chemicals in commerce. A major 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 of such substance or 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 EPA makes these findings for a with HPV chemicals 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 HPV chemicals as testing be conducted on that chemical HPV chemicals 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 HPV Challenge Program. potential hazards . an insuffici f d t d The volunt HPV Ch 11 

B. What is the Agency's Authority for and which are relevant to a officially launched in late 1998, was 

Taking this Action. determination that the manufacture, created to ensure that a baseline set of 

distribution in commerce, processing, data on approximately 2,800 HPV This final rule is being promulgated 

under TSCA use, or disposal of the chemical chemicals would be made available to section 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 those who 

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 under TSCA 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 program through data reported 

under the TSCA Inventory Update Rule 

(IUR) during 1990. 

EPA challenged U.S . manufacturers 

and importers of HPV chemicals 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 Program is 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 allow the Agency and others to from exposure to the 17 chemical make an informed, preliminary 
13710 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations 

judgment about the hazards of HPV includes agreements to sponsor a U.S . HPV Challenge Program or 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 through TSCA 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 allow the 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 from these 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, Program are posted to the Program and to assign a priority for further work, and any other interested parties on its website . It is at this time when all if necessary . The OECD HPV SIDS website (http ://www.epa.gov/chernrtk/ stakeholders-industry, environmental Program seeks 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 100 consortia 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) HPV Initiative . HPV chemicals 

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 HPV Challenge Program is 

further described in a Federal Register 

document which published on 

December 26, 2000 (Ref. 1) . 

2 . Certain international efforts. The 

voluntary HPV Challenge Program is 

designed to make maximum use 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) HPV chemicals 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 OECD as 

providing the minimum data set human and environmental risks as well required to make an informed as providing greater protection and 

preliminary judgment about the hazards knowledge to the public . By using the of a given HPV chemical . 

The ICCA consists of representatives 

of chemical industry trade associations 

from the United States, Europe, Japan, 

Australia, Canada, Mexico, Brazil, New 

Zealand, and Argentina . The intended 

goal of the ICCA HPV 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 System website at 

http://www .iccahpv.com/reports/ 

reportsmain.cfm. Most of the chemicals 

on the ICCA working list (Ref. 6) are 

also U.S . HPV chemicals . The ICCA 

testing/assessment work will be tied 

directly to that under the OECD HPV 

SIDS Program and to the U.S . voluntary 

HPV Challenge Program and any 

associated TSCA section 4 HPV SIDS 

rules . Any U.S . HPV chemicals that are 

handled under the OECD HPV SIDS 

Program or the ICCA HPV Initiative are 

considered by EPA to be "sponsored" 

and are not anticipated to be addressed 

in the voluntary HPV Challenge 

Program unless 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 Program will 

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 

about the voluntary HPV Challenge 

Program and international efforts. 

D. Why is 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 of a battery of 

tests agreed upon by the international 

community through the OECD, of which 

the United States is a member countrv, 

as appropriate for screening HPV 
Federal Register/ Vol . 71, No. 51 /Thursday, March 16, 2006/Rules and Regulations 

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 OECD as the minimum 4(a)(1)(B)(i) . See EPA's "B" policy (Ref. 

required to screen HPV chemical 3) . Among the reasons is that the TSCA 

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 OECD Chemicals Group testing based on TSCA section 

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 . HPV chemicals for health and 

environmental effects and 

environmental fate . 

SIDS testing evaluates the following 

six testing endpoints (Ref. 5) : 

" Acute toxicity . 

" 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, or substantial or 

significant human exposure under 

TSCA sections 4(a)(1)(B)(i)(I) and (II) . In 

addition, EPA must find 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 under TSCA section 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" under TSCA (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 OECD differ in their 

set of information that can be used to definition of an HPV chemical and what 

determine the relative hazards of 

chemicals and to judge if additional 

testing or assessment is necessary . 

E. How Does EPA's HPV Work Relate to 

That of the OECD? 

As noted in Unit II .C.2 ., the OECD 

SIDS Program is complementary to the 

voluntary HPV Challenge Program . 

However, EPA's definition of an HPV 

chemical differs from that of the OECD. 

EPA defines an HPV chemical as having 

an annual production or importation 

volume of 1 million pounds or more. 

The OECD defines an HPV chemical 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 HPV chemicals 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 program on 

12). Additionally, they indicated that 

should trigger basic screening tests of an 

HPV chemical, both the U.S . and OECD 

HPV Programs are alike in their 

information needs for an HPV chemical . 

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 HPV Chemicals? 

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 . HPV chemicals 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 HPV chemicals pose 

potential risks to human health or the 

environment, as well as the public's 

ability to know about 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 TSCA where 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 

Program or under a complementary 

program being 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 HPV chemicals 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 . 

EPA will use the data obtained from 

this final rule to support development of 

preliminary hazard and risk assessments 

for the 17 HPV chemicals 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 
13712 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations 

and environmental risks as well as 

providing greater knowledge and 

protection to the public. In the past, 

EPA has used data from test rules to 

support such activities as the 

development of water 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 from this 

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 Program website (http :// 

www.epa.gov/chemrtk/volchall .htm). 

Data collected or developed for each 

sponsored chemical in the voluntary 

HPV Challenge Program are 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 allow a technically 

qualified person to make an 

independent assessment of a 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 . A summary 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 the American 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 USA LLC (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 England AntiVivisection Society (NEAVS), Silicones 

Environmental, Health and Safety 

Council (SEHSC), and numerous private 

citizens (Refs . 15-39) . 

After review and 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 Basis for EPA's Final 

Rule to Test These Chemical 

Substances? 

As indicated in Unit II .B ., in order to 

promulgate a rule under TSCA section 

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 TSCA sections 

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 EPA to be aggregate 

production (including import) volume 

equaling or exceeding 1 million pounds 

per year and exposure of 1,000 workers 

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 EPA generally makes 

decisions under TSCA section 

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? 

EPA finds 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 

CFR part 710, subpart B) . The 2002 IUR 

is the most recently available 

compilation of TSCA section 8(a) 

Inventory Update Reporting data, and 

the IUR data 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 

concludes that the annual production 

volume of each chemical is 

"substantial" as that term is used with 

reference to production in TSCA section 

4(a)(1)(B)(i) (Ref. 3) . 

C. Are a Substantial Number of Workers 

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). 

EPA defines 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 

from pumps as fugitive emissions, from 

reactor and condenser vents as stack 

emissions, in the form of 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 from one 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 

1,000 workers 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 Exist for 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 ascertaining the 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 from exposures 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 made a finding under 

TSCA section 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 review of studies/ 

data identified by commenters in 

response to the proposal or identified by 

EPA after the publication of the 

proposal to this final rule . The studies 

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 

under this 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 EPA at 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 CFR 790 .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 Necessary for 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. 

EPA will use the data obtained from 

this final rule to support development of 

preliminary hazard assessments for 

these 17 HPV chemicals and to set 

priorities for obtaining exposure 

information and further testing 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. EPA has 
13714 Federal Register/Vol . 71, No. 51/Thursday, March 16, 2006/Rules and Regulations 

used data from test 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 in Table 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 EPA has identified and is 

requiring for several of the required test 

standards . 1 . Physical/chemical properties . 

Melting Point: American Society for Testing 

and Materials (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 (40 CFR 799 .6755-shake 

flask) . Method B (ASTM E 1147-liquid 

chromatography) (Ref. 47) . 

Method C (40 CFR 799.6756-

generator column). 

Water Solubility : 

Method A: (ASTM E 1148-shake 

flask) (Ref. 48). 

flask) . 

Method B : (40 CFR 799.6784-shake 

Method C: (40 CFR 799.6784-column 

elution) . 

Method D: (40 CFR 799.6786-

generator column). 

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 from the time available to 

develop new standards which 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 available for informational 

purposes and it can still be purchased 

from ASTM 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 from among 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 Method for 

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 determining the log Kow. 

In genera], EPA believes that the more 

hydrophobic a subject chemical is, the 

less well Method A (40 CFR 799.6755-

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, EPA requires 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 Kow tests be conducted 

at pH 7 to ensure environmental 

relevance . The required test methods 

and estimated log K.w ranges 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 the test 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 CFR 799.6755 (shake flask) log Kow range >1-4 : Method A or B or C. 

Method B: ASTM E 1147 (liquid chromatography) log Ko,w range >4-6 : Method B or C. 

Method C: 40 CFR 799.6756 (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, 

the test method, if any, will be 

determined by the test substance's 

estimated water solubility. 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 Method for Estimating Water 

Solubility From Octanol/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 Water solubility : 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: ASTM E 1148 (shake flask) od selected . In order to ensure environmental relMethod B: 40 CFR 799.6784 (shake flask) evance, EPA highly recommends that the selected 

Method C: 40 CFR 799.6784 (column elution) study be conducted at pH 7. 

Method D: 40 CFR 799.6786 (generator column) >5,000 milligrams/liters (mg/L) : Method A or B. 

>10 mg/L-5,000 mg/L: Method A, B, C, or D. 

>0 .001 mg/L-10 mg/L : Method C or D. 

50.001 mg/L : No testing required . 

2 . Environmental fate and pathways . 

Inherent Biodegradation : ASTM 1625 

(semicontinuous activated sludge test) (Ref. 

52) or 

ISO 9888 (Zahn-Wellens Method) (Ref. 53). 

Either method may be used, and no 

special conditions apply. 

3. Aquatic toxicity. 

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 Program recognizes 

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 Program recommends 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 

Kow of 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) are required : 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 2 chronic 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 . 

EPA recognizes that in some 

circumstances, acute aquatic toxicity 

testing (Test Group 1) may be relevant 

for certain chemical substances having a 

log K.w equal 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). For the purposes 

of this final rule, EPA's use of a log Kow 

equal to or greater than 4.2 (which 

corresponds with a fish BCF value 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 1,000 or, 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). EPA considers 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 

rule to 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 Kow greater than or equal to 4.2 

submit to EPA for approval a written 

request to conduct Test Group 1 studies 

90 days 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 from among those 

included for this endpoint in Tahle 3 in 

§ 799.5085(j) of the regulatory text . The 

OECD HPV SIDS Program recognizes 

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 room temperature (25°C), 

the acute mammalian toxicity study be 

conducted using inhalation as the 

exposure route (described as Method A 

(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), EPA is requiring that 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 

CFR 799.9510 

Chromosomal Damage: 

In Vitro Mammalian Chromosome Aberration 

Test (40 CFR 799.9537), or Mammalian Bone 

Marrow Chromosomal Aberration Test (in 

vivo in rodents: Mouse (preferred species), 

rat, or Chinese hamster) (40 CFR 799.9538), 

or 

Mammalian Erythrocyte Micronucleus Test 

(sampled in bone marrow) (in vivo in 

rodents: Mouse (preferred species), rat, or 

Chinese hamster) (40 CFR 799.9539) . 

Persons required to conduct testing 

for chromosomal damage are 

encouraged to use in vitro genetic 

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 

program in a manner consistent with the 

OECD HPV SIDS Program and 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) . A subject 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 the Reproduction/Developmental 

Toxicity Screening Test : 40 CFR 799.9365, or 

Reproduction/Developmental Toxicity 

Screening Test : 40 CFR 799.9355 and 

Repeated Dose 28-Day Oral Toxicity Study 

in Rodents: 40 CFR 799.9305 . 

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 (40 CFR 799.9365) . EPA 

recognizes, however, that there may be 

reasons to test a particular chemical 

using both the reproduction/ 

developmental toxicity screening test 

(40 CFR 799.9355) and the repeated 

dose 28-day oral toxicity study in 

rodents (40 CFR 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, EPA stated 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 
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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 

system intermediate 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 system intermediate . EPA's 

response to ExxonMobil's claim is 

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 CFR Part 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 

form of 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 term Class 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, complete structure diagram . In variables are its impurities . 

those instances in which the test EPA believes that, for purposes of this 

sponsor(s) believes that a 99% level of final rule, the testing of any 

purity is unattainable for a given representative form of 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 the selection of 

substances included in this final rule), representative forms of the test 

EPA is requiring that the substance to be substances that meet industry or 

tested be any representative form of the 

chemical substance . The term Class 2 

chemical substance refers to a chemical 

substance having a composition that 

cannot be represented by a specific 

complete chemical diagram, because 

such a substance generally 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 characteristics which 

further distinguish Class 2 from Class 1 

chemical substances . First, unlike for 

Class 1 substances, knowledge of the 

composition of commercial Class 2 

substances can vary in quality and 

specificity from substance 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 of all 

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 from one 

manufacturer to another, or, for a single 

manufacturer, from production run to 

consensus standards, where they exist. 

In accordance with TSCA GLPS at 40 

CFR part 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 form of 

the substance may differ from the 

testing requirement in this final rule 

(i .e ., testing of any representative form 

of the subject Class 2 substances) . For 

example, EPA may require testing of 

more than one representative form of a 

Class 2 substance or may specify the 

representative form to be tested and/or 

may specify equivalence data that must 

be submitted by exemption applicants . 

(See 40 CFR 790.82) . 

E. Am I Required to Test Under this 

Final Rule? 

1 . Am I subject to this final rule? You 

are subject to this final rule and may be 

required to test if you 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, if you 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 
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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 if you 

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 from the 

effective date of the final test rule to the 

end of the test cost reimbursement 

period . 

The term reimbursement period is 

defined at 40 CFR 791 .3(h) and may 

vary in length for each substance to be 

tested under a final TSCA section 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 of your activities . All persons 

who are subject to this TSCA section 

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 (contained within 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 

" Apply to and obtain from EPA 

exemptions from testing . 

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 AND TIER 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 (as defined at 40 CFR 791 .3(c)) ; 

-As an impurity (as defined at 40 CFR 790.3); 

-As a naturally occurring chemical substance (as defined at 40 CFR 

710.4(b)) ; 

-As a non-isolated intermediate (as defined at 40 CFR 704.3); 

-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 

CFR 790.42(a)(4)) ; or 

-In small quantities solely for research and development (R & D) (as described at 40 CFR 790.42(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 

apply for an exemption rather than 

submit a letter of intent to conduct 

testing? You may apply for an 

exemption if you believe that the 

to 

required testing will be performed by 

another person (or a consortium of 

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, EPA will 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 CFR 790.85 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 EPA receives 

a letter of intent to test from another 

source or has received (or expects to 

receive) the test data that are required 

under this final rule, the Agency would 

conditionally approve your exemption 

application under 40 CFR 790.87. 

The Agency 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 CFR 790 .48 

itself (see § 799 .5085(c)(4), (c)(5), (c)(6), 

(c)(7), and (d)(3)) 

Persons who obtain exemptions or 

receive them automatically 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? If you 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 problem occurs 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 40 CFR 790.93 and 

5 799.5085(c)(8) of the regulatory text . 
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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) the test 

data required under this final rule. 

e. Subdivision of Tier 2 entities . If the 

Agency needs testing from persons in 

Tier 2, EPA may propose to subdivide 

the group 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 

from Tier 2A manufacturers before 

proceeding to Tier 2B processors. 

EPA solicited comment on the 

subdivision of Tier 2 entities 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) . The Agency 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 

may generally 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) . EPA also 

believes that testing costs have 

traditionally been passed hy 

manufacturers along to processors, 

enabling them to share in the costs of 

testing (Ref. 69, p . 20654), and has not 

received evidence to the contrary . 

Although the subdivision of Tier 2 

entities was not included in the 

proposal to this final rule, and is thus 

not being implemented in this 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 

excluded from the rule? Under 40 CFR 

790.2, EPA may establish procedures 

applying to specific test rules that differ 

from the 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 from those under 40 CFR part 

790. 

In this final rule, EPA has 

reconfigured the tiers in 40 CFR 790.42. 

In addition to processors, manufacturers 

of less than 500 kg (1,100 lbs.) per year 

("small-volume manufacturers"), and 

manufacturers of small quantities for 

research and development ("R & D 

manufacturers"), EPA has 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 EPA has made findings for 

that chemical substance, and therefore 

issued a TSCA section 4(a) test rule 

requiring testing. However, practicality 

must be a factor in determining who is 

subject to a particular test rule . Thus, 

persons who do 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 CFR part 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 order for 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 

the hearing officer (40 CFR 791 .40(a)) . 

The hearing officer's proposed order 

may become the Agency's final order, 

which is reviewable in Federal court (40 

CFR 791 .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 interim progress reports 

for the testing required in this final rule. 

For the short-term studies required by 

this final rule, interim progress reports 

would likely yield little useful 

information . Furthermore, by not 

requiring interim progress reports for 

these short-term studies, the overall 

burden of the rule will be somewhat 

reduced. 

G. What Would 1 Need to Do If I Cannot 

Complete the Testing? 

A company 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 
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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 

Unit J . 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 the Agency decide to seek such 

additional testing, EPA would initiate a 

separate action under TSCA section 4 

for that purpose . 

VI. Export Notification 

Any person who exports, 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 CFR part 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 for articles, as provided by 40 

CFR 707.60(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 

EPA Administrator 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 

EPA has decided to withdraw 20 

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 Program and 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 Program or in 

any TSCA section 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 

tallow alkyl)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). 

EPA believes 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 Program website at 

h ttp : //wcv~v . epa.gov/ch errirtk/ 

viecvsrch .htm. This approach is not 

intended to set a precedent for how EPA 

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, EPA determined that, based on 

2002 IUR data, 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 IUR data 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-, 

monosodium salt (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 of PETN. 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 from Tier 2 companies, at the midpoint of that range equal to 30 

developmental toxicity of sorbic 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 from the 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 of sorbic acid for expresses the testing costs as a percent 

aquatic toxicity and the determination of revenues generated from each 

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 Rule for 

High Production Volume Chemicals 

(Ref. 75), a copy of which 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 

of a 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 . EPA would 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, under 40 CFR 

790.93, a problem occurs 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 

from Tier 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 . 

EPA estimates 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 for the 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 for this final 

rule are presented in the economic 

impact analysis (Ref . 75). 

Price data were available for 16 of the 

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, 

EPA believes 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 below 1 .0% of the revenue for 

these chemicals . For these chemicals, 

companies may choose to use revenue 

sources other than profits from the 

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 from testing, 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, DC 20460-0001 

(Attention : TSCA Section 4) . 

2. In person or by courier. Deliver 

your submission to : OPPT Document 

Control Office (DCO), EPA East Bldg., 

Rm . 6428, 1201 Constitution Ave., NW., 

Washington, DC. (Attention : TSCA 

Section 4) . The DCO is open from 8 a.m. 

to 4 p.m ., Monday through Friday, 

excluding legal holidays . The telephone 

number for the DCO is (202) 564-8930. 

Such deliveries are only accepted 

during the DCO's normal hours of 

operation. 

X. Materials in the Docket 

As indicated under ADDRESSES at the 

beginning of this document, an official 

docket was established for this 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 

EPA has 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 EPA has 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 review as 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 of the 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 metabolism of 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). 

EPA 1986. 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). 

EPA 1994. 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/ch emrtk/categuid .h tm. 

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 from Susan 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/ceol tr2 . 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 

Act Test Guidelines ; Final Rule. Federal 

Register (65 FR 78746, December 15, 

2000) (FRL-6551-2). 

EPA 2002a. Agency Information 

Collection Activities ; OMB Responses . 

Federal Register (67 FR 39712, June 10, 

2002) (FRL-7225-8). 

EPA 2002b. 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. Review of comments on 

biodegradation testing of a proposed test 

rule chemical (PETN) . Memorandum 

from Dr. Robert Boethling, Exposure 

Assessment Branch (EAB), EETD to Paul 

Campanella, Chemical Information and 

Testing Branch (CITB), Chemical 

Control Division (CCD) . February 26, 

2003. 

EPA 2004a. HPV Challenge Program 

Disclaimer on posted robust summaries 

and test plans. May 13, 2004. (For 

example, see http ://www.epa .gov/ 

chemrtk/quatcatg/c1521Otc.htm) . 

EPA 2004b. IUR Data on methyl 

heptenone. E-mail message from Lynne 

Blake-Hedges, EPAB, EETD to Catherine 

Roman, EPA. July 8, 2004. 

EPA 2004c. IUR Data on PETN . E-mail 

message from Lynne Blake-Hedges, 

EPAB, EETD to Catherine Roman, EPA. 

July 22, 2004. 

EPA 2004d. Memorandum from Larry 

Newsome, High Production Volume 

Chemicals Branch (HPVCB), Risk 

Assessment Division (RAD) to Greg 

Schweer, CITB, CCD. August 5, 2004. 

EPA 2004e. Memorandum from 

Katherine Anitole, Existing Chemicals 

Assessment Branch (ECAB), RAD to 

Greg Schweer, CITB, CCD. August 13, 

2004. 

EPA 2004f. 1-Chlorododecane. E-mail 

from Lynne Blake-Hedges, EPAB, EETD 

to Catherine Roman, EPA. August 25, 

2004 . 

EPA 2004g. TETRATOX test . 

Memorandum from Donald 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 .go v/ch em rtk/h p vsta tr . h t rn . 

FDRL 1975 . Food end Drug Research 

Labs. Teratologic evaluation of FDA 73-

4 (potassium sorbate: 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 from a pilot ring within 2-digit Standard Industrial 

test with 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/ 

of Toxicological Test Methods: A Report x2609sco .html. 

of the ad hoc Interagency Coordinating NIOSH 1988 . National occupational 

Committee on the Validation of exposure survey analysis of Alternative Methods. NIH Publication management interview responses . 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 Vitro Data to Estimate In Vivo Acute Oral Toxicity Testing. OECD 

Starting Doses for Acute Toxicity . NIH Series on Testing and 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. OECD Test 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. OECD Test 

(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 of Alternative 

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. OECD Test 

Guideline 425. Adopted December 17, 

2001

www, 

. Available online at : http :// 

oecd. org/d ocum en t/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. 

Sodium Formaldehyde Bisulfite 

Manufacturers Association (SFBMA) . 

Comments on Hydroxymethanesulfonic 

acid, monosodium salt 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 

and sorbates . Food Additives 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 

Testing of 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 

Program Chemical List . This list is 

updated periodically, and is available 

online at : http://www.epa.gov/oppt/ 

chemrtk/h pvchml t .h tm . 

5 . OECD Secretariat. Manual for the 

Investigation of HPV Chemicals. 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 . OECD Secretariat . Proposal for 

Further Work on the Investigation of 

High Production Volume Chemicals . 

OECD Chemicals 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 

of the 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 Do We 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 for Testing of 

Certain High Production Volume 

Chemicals submitted to the TSCA 

Public Docket Office, EPA. April 25, 

2001. 

16. American Petroleum Institute 

(API) . Comments on EPA's Proposed 

Test Rule for Testing of Certain High 

Production Volume Chemicals 

submitted to the TSCA Public 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 

TSCA Public 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 for Testing 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 submitted to 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 the TSCA 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 for Testing 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 England Anti-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 

of Certain 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 TSCA Testing 

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. Review of comments on 

Test Method for Determining Vapor bioaccumulation factor from octanol/ proposed determination of physical/ 

Pressure by Thermal Analysis . ASTM. E water partition coefficient . chemical properties for PETN. 

1782. 2003 . Environmental Toxicology and Memorandum from Dr. 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 from Diane 

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 of Pharmaceutical 

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 

from octanot/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 

from Chemicals, pp. 24-90. In . P. 

Callow (ed .), Handbook of 

Environmental Risk Assessment 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 under sections 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 

HPV Challenge Program . Prepared by 

EPAB, EETD, OPPT. Washington, DC. 

October 14, 1999. 

reviewing four studies for TSCA section 

4 test rule . Memorandum from Maria 

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 : 

h ttp ://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 review under Executive 

Order 12866 and any changes made 

based on OMB recommendations 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 

Rule for High Production Volume 

Chemicals (Ref. 75), a copy of which 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 problem occurs 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, for each 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. Because Tier 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 to the rule is low 

for at least 75% of the chemicals in the 

rule. Approximately 4 chemicals (25%) 

of the 16 chemicals for which 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 . 

The Agency computed a "critical 

price" for the chemical without price 

data . This price is the maximum price 

per pound, at which the ratio of testing 

costs to annual revenue would be 1% . 

The critical price is informative because 

it represents the minimum price that 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 from the 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 chemicals with price data were 

estimated to have prices below $.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 . 

EPA believes, on the basis of these 

calculations, that the testing of the 

chemicals presents a low potential 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 for which the 

by the rule are expected to have a price impact is expected to exceed 1% 

negligible impact on exporters . The of the revenue from that chemical . The 

TSCA section 12(b) export notification potential for adverse economic impact is 

requirements under the final rule would expected to be higher for 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 

from the 

to pay for testing . 

B. Paperwork Reduction Act 

The information collection 

requirements contained in TSCA section 

4 test 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 20 70-

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 ICR No. 0795). This final rule does 

not contain any new or amended 

requirements that would require 

additional review and/or approval by 

OMB. 

The standard chemical testing 

program involves 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 : 

review instructions; 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 

review the 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 OMB control number. 

The OMB control 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 CFR satisfies 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 OMB approval, 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" 

under section 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 Flexibility Act 

For purposes of assessing the impacts of range from 500 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 . A small 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. A small 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. A small 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 RFA establishes as 

the default definition of "small 

business" the definition used in section 

3 of the Small Business Act, 15 U.S .C . 

632, under which the SBA establishes 

small business size standards for each 

industry sector . (13 CFR 121 .201). For 

this final rule, EPA has analyzed the 

potential small business impacts using 

the size standards established under this 

default definition . The SBA size 

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, SBA has 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 

ratio that 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 the test 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 Reform Act 

Pursuant to Title II of the Unfunded 

Mandates Reform Act 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, EPA has 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 205 of 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 

federalism implications" 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 

federalism implications . 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 13132 does 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 between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in the Executive order. As 

indicated in this unit, EPA has no 

information to indicate that any tribal 

government manufactures or processes 

the chemical substances covered by this 

action . Thus, Executive Order 13175 

does not apply to this final rule . 

Although Executive Order 13175 was 

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 

Significantly Affect 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, the Agency has concluded that 

this final rule is not likely to have 

adverse energy effects. 

I. National Technology Transfer and 

Advancement Act 

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 EPA to 

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 NTTAA directs 

EPA to 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 . EPA identified 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 

4 of 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- OECD Test 

. tion Method No. 

ASTM E 729 (2002) Standard Guide for Conducting Acute Toxicity Tests on Test Materials 

with Fishes, Macroinvertebrates, and Amphibians 

ASTM E 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 

ASTM E 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 

ASTM E 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) 

ASTM E 1719 (1997) Standard Test Method for Vapor Pressure of Liquids by Ebulliometry 

ASTM E 1782 (2003) Standard Test Method for Determining Vapor Pressure by Thermal Analysis 

ISO 9888 (1999) I Water Quality-Evaluation of Ultimate Aerobic Biodegradability of Organic I 

Compounds in Aqueous Medium-Static Test (Zahn-Wellens Method), 

Second Edition 

Copies of the ASTM 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 EPA Docket location 

described in ADDRESSES. You may 

obtain copies of the ASTM standards 

from the American Society for Testing 

and Materials, 100 Bar Harbor Dr., West 

Conshohocken, PA 19428-2959, and a 

copy of the ISO standard from the 

International Organization for 

Standardization, Case Postale, 56 CH1211 Geneve 20 Switzerland. EPA 

received the required approval from the 

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 . 

EPA is 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 

Environmental Justice in 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 EPA and 

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 of Subjects 

40 CFR 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 Assistant Administrator, Office of 

Prevention, Pesticides and Toxic Substances . 

ri Therefore, 40 CFR chapter I is 

amended as follows : 

PART 9-[AMENDED] 

ti 1 . The authority citation 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 as follows : 

§ 9.1 OMB approvals 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 

for certain 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). 

PETN cannot be tested at 99% purity 

because of its explosive properties . It 

must be diluted in water or tested as a 

stabilized mixture with an appropriate 

stabilizer (e .g ., D-lactose monohydrate is 

the stabilizer in PETN, NF which is a 

mixture of 20% by weight PETN and 

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 

form of each chemical substance must 

be tested. The representative form 

selected for a given Class 2 chemical 

substance should meet industry or 

consensus standards where they exist . 

(b) Am I subject 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 from April 

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) If you 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) If I 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) . If you 

are subject to this section, you must 

determine if you fall within Tier 1 or 

Tier 2, based on Table 1 of this 

paragraph. 

N 3. The authority citation for part 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 AND TIER 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 CFR 791.3(c)) ; 

-As an impurity (as defined at 40 CFR 790.3); 

-As a naturally occurring substance (as defined at 40 CFR 710.4(b)) ; 

-As a non-isolated intermediate (as defined at 40 CFR 704.3) ; 

-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 CFR 

790.42(a)(4)) ; or 

-For R & D (as described at 40 CFR 790.42(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 CFR 790.42(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 

from testing . 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) If you 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 from testing . The letter 

of intent to test or the exemption 

application must be received by EPA no 

later than 30 days 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, EPA will 

notify all manufacturers and processors 

of those chemical substances of this fact 

by certified letter or by publishing a 

Federal Register document specifying 

the test(s) for which 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 problem occurs 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 

time (h) How must I conduct my testing? . 

(9) If you are (1) The tests that are required for each required to comply with 

this section, but your manufacturing chemical substance are indicated in or 

processing Table 2 in paragraph (j) of this section . 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 to test 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 from EPA an exemption from 

testing . 

(2) For each test with respect to which 

you submit 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 790 of 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 

Melting Range 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, Macro invertebrates, 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) If I 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-Cycle Toxicity 

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, 

ISO 9888-99. 
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 CFR part 51 . You may 

obtain copies of the ASTM guidelines 

from the American Society for Testing 

and Materials, 100 Bar Harbor Dr., West 

Conshohocken, PA 19428-2959, and a 

copy of the ISO guideline from the 

International Organization for 

Standardization, Case Postale, 56 CH1211 Geneve 20 Switzerland. You may 

inspect each test method at the EPA 

Docket Center, EPA West, 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. A final 

report for each specific test for each 

subject chemical substance must be 

received by EPA by May 17, 2007, 

unless an extension is granted in writing 

pursuant to 40 CFR 790.55 . A robust 

summary of the final report for each 

specific test should be submitted in 

addition to and at the same time as the 

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 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 of specific 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 AND TESTING 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-dimethyl ethyl)]- 1 A, B, D, E1, E2, F2 

149-44-0 Methanesulfinic acid, hydroxy-, monosodium salt 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: ASTM E 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 CFR 799.6755 (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, from those listed in this column .) 

Method A: ASTM E 1148 (shake flask) 

Method B: 40 CFR 799.6784 (shake flask) 

Method C: 40 CFR 799.6784 (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 A or B. 

log Ko , range >1-4 : Method A or 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. 

Water Solubility. 

Which method is required, if any, is determined by the test substance's estimated2 

water solubility . 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 A or B. 

>10 mg/L -5,000 mg/L: Method A, B, C, or 

D. 

> 0.001 mg/L-10 mg/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. ISO 9888 (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 for C1: 

1 . Acute Toxicity to Fish : ASTM E 729 

2. Acute Toxicity to Daphnia: ASTM E 729 

3. Toxicity to Plants (Algae): ASTM E 1218 

Test Group 2 for Cl : 

1 . Chronic Toxicity to Daphnia: ASTM E 1193 

2. Toxicity to Plants (Algae): ASTM E 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: ASTM E 729 

2. Toxicity to Plants (Algae): ASTM E 1218 

Test Group 2 for 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 under A3 . 
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 TO THE TEST REQUIREMENTS DENOTED BY ALPHANUMERIC SYMBOLS IN TABLE 2 OF THIS PARAGRAPHContinued 

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 Marrow Chromosomal 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 CFR 799.9538 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 CFR 799.9539 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 CFR 799.9365 OR Study with the Reproduction/Developmental Reproduction/Developmental Toxicity Screen- mental Toxicity Screening Test (40 CFR ing Test : 40 CFR 799.9355 AND 799.9365) . However, there may be valid 

Repeated Dose 28-Day Oral Toxicity Study reasons to test a particular chemical using in rodents: 40 CFR 799.9305 both 40 CFR 799.9355 and 40 CFR 

799.9305 to fill Mammalian Toxicity-Repeated Dose/Reproduction/Developmental 

data needs. A subject 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 CFR 799.9355 

F_3 .% Repeated Dose 28-Day Oral Toxicity Study 

in rodents: 40 CFR 799.9305 

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,w is 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, from 8:30 a.m . to 4:30 p.m ., Monday through Friday, excluding legal holidays . 

2 EPA 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 From Oc- 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, from 8:30 a.m. to 4:30 p.m ., Monday through Friday, excluding legal holidays . 

3 Chemical substances that are dispersible in water may have log Kow values 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 for conducting Test Group 1 studies. 

4 The OECD 425 Up/Down Procedure, revised by OECD in 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 8:30 a.m . to 4:30 p.m., Monday through Friday, ex- cluding legal holidays . 

5 The 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, from 8:30 a.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