Document ID: EPA-HQ-OPPT-2005-0033-0001
Agency: epa
Document Type: Rule
Title: Testing of Certain High Production Volume Chemicals
Posted Date: 2006-03-16T13:25:35Z

[Federal Register: March 16, 2006 (Volume 71, Number 51)]
[Rules and Regulations]               
[Page 13707-13735]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr06-12]                         

[[Page 13707]]

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Part III

Environmental Protection Agency

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40 CFR Parts 9 and 799

Testing of Certain High Production Volume Chemicals; Final Rule

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 799

[EPA-HQ-OPPT-2005-0033; FRL-7335-2]
RIN 2070-AD16

 
Testing of Certain High Production Volume Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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-HQ-OPPT-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-Hotline@epa.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 Sec.  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 
Sec.  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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr.

II. 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

[[Page 13709]]

Screening Information Data Set (SIDS) (see Unit II.D.). Some or all of 
these tests are required for a particular chemical substance, depending 
upon what data are already available for that substance.
    In the proposal to this final rule, published in the Federal 
Register of December 26, 2000, EPA proposed SIDS testing for 37 HPV 
chemicals (Ref. 2). Numerous comments were received on the proposed 
rule. In consideration of those comments, EPA changed some testing 
requirements for certain chemicals as explained in Unit III. As a 
result of recent commitments to a voluntary EPA testing program known 
as the HPV Challenge Program (see Unit II.C.), and updated production 
volume data (i.e., 2002 Inventory Update Rule (IUR) data) made 
available after the publication of the proposal preceding this final 
rule (i.e., the ``proposed rule''), EPA is requiring testing for 17 of 
the 37 chemicals originally proposed for testing in 2000. EPA's 
decision to not finalize testing requirements for the remaining 20 
chemicals is described in Unit VII.
    At a future date, EPA may propose testing for additional HPV 
chemicals as the Agency learns more about the chemicals with respect to 
human exposure, release, and sufficiency of the data and experience 
available on their potential hazards.

B. What is the Agency's Authority for Taking this Action?

    This final rule is being promulgated under TSCA section 4(a) (15 
U.S.C. 2603(a)), which directs EPA to require the development of data 
relevant to 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 manufacture, distribution in commerce, processing, 
use, or disposal of a chemical substance or mixture, or that any 
combination of such activities, may present an unreasonable risk of 
injury to health or the environment,
    (ii) There are insufficient data and experience upon which the 
effects of such manufacture, distribution in commerce, processing, 
use, or disposal of such substance or mixture or of any combination 
of such activities on health or the environment can reasonably be 
determined or predicted, and
    (iii) Testing of such substance or mixture with respect to such 
effects is necessary to develop such data; or
    (B)(i) a chemical substance or mixture is or will be produced in 
substantial quantities, and (I) it enters or may reasonably be 
anticipated to enter the environment in substantial quantities or 
(II) there is or may be significant or substantial human exposure to 
such substance or mixture,
    (ii) 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 of any combination 
of such activities on health or the environment can reasonably be 
determined or predicted, and(iii) Testing of such substance or 
mixture with respect to such effects is necessary to develop such 
data [.].

    If EPA makes these findings for a chemical substance or mixture, 
the Administrator shall require by rule that testing be conducted on 
that chemical substance or mixture. The purpose of the testing is to 
develop data about the substance's or mixture's health or environmental 
effects for which there is an insufficiency of data and experience, and 
which are relevant to a determination that the manufacture, 
distribution in commerce, processing, use, or disposal of the chemical 
substance or mixture, or any combination of such activities, does or 
does not present an unreasonable risk of 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 ``screening level'' determinations of the effects on 
health and the environment from exposure to the 17 chemical substances 
specified in Table 2 in Sec.  799.5085(j) of the regulatory text. 
Following consideration of the public comments received by EPA on the 
proposed test rule (Ref. 2) and updated production volume information 
(i.e., 2002 IUR data), EPA is making the following findings for the 17 
chemical substances under TSCA section 4(a)(1)(B): They are produced in 
substantial quantities; there is or may be substantial human exposure 
to them; existing data are insufficient to determine or predict their 
health and environmental effects; and testing is necessary to develop 
such data.

C. Why is EPA Taking this Action?

    On April 21, 1998, EPA initiated a national effort to empower 
citizens with knowledge about the most widespread chemicals in 
commerce. A major objective of this effort is to make certain basic 
information about the environmental fate and potential health and 
environmental hazards associated with HPV chemicals available to the 
public. Mechanisms to collect or, where necessary, develop needed data 
on U.S. HPV chemicals include the voluntary HPV Challenge Program, 
certain international efforts, and TSCA section 4 rules.
    1. Voluntary HPV Challenge Program. The voluntary HPV Challenge 
Program, officially launched in late 1998, was created to ensure that a 
baseline set of data on approximately 2,800 HPV chemicals would be made 
available to the public. HPV chemicals are manufactured or imported in 
amounts equal to or greater than 1 million 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 
human and environmental hazards, and will allow the Agency and others 
to make an informed, preliminary

[[Page 13710]]

judgment about the hazards of HPV chemicals.
    As part of their commitment to the HPV Challenge Program, sponsors 
submit data summaries of existing information along with a test plan 
that proposes a strategy to fill data gaps. Sponsors submit test plans 
for either individual chemicals or for a category of chemicals. A 
chemical category comprises a group of substances, usually similar in 
chemical structure, with a regular pattern of properties and effects. 
Data for chemicals in the category can be used to estimate the chemical 
properties and effects of other category members.
    A 120-day comment period begins when test plans and data summaries 
submitted directly to the HPV Challenge Program are posted to the 
Program website. It is at this time when all stakeholders--industry, 
environmental protection groups, animal welfare 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 HPV 
Challenge Program, that are being coordinated by the OECD to secure 
basic hazard information on HPV chemicals in use worldwide, including 
some of those on the U.S. (1990) HPV chemicals list (Ref. 4). This 
includes agreements to sponsor a U.S. HPV chemical under either the 
OECD HPV SIDS Program (Ref. 5), including sponsorship by OECD member 
countries beyond the United States, or the international HPV Initiative 
that is being organized by the International Council of Chemical 
Associations (ICCA) (Ref. 6).
    The OECD HPV SIDS Program includes information on the identity of 
each chemical, its uses, sources and extent of exposure; physical and 
chemical properties; environmental fate; and certain limited toxicity 
data for humans and the environment. The SIDS is not intended to 
describe a chemical thoroughly, but rather is intended to provide 
enough information to support an initial (or screening level) 
assessment and to assign a priority for further work, if necessary. The 
OECD HPV SIDS Program seeks the development of test data, if such data 
are not already 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 required to 
make an informed preliminary judgment about the hazards 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 rulemaking. U.S. data needs which remain unmet in the 
voluntary HPV Challenge Program or through international efforts may be 
addressed through TSCA section 4 rulemaking, such as this final rule, 
where EPA determines that the statutory findings can be made. This 
final rule is the first TSCA section 4 HPV SIDS rule, and addresses the 
unmet data needs of 17 chemicals.
    Data collected and/or developed under this final rule and the 
voluntary HPV Challenge Program, when combined with information about 
exposure and uses, will allow the Agency and others to better assess 
the potential risk to health and the environment from these chemicals. 
EPA intends to make the information collected under this final rule 
available to the public, other Federal agencies, and any other 
interested parties on its website (http://www.epa.gov/chemrtk/volchall.htm
) and in the public docket for this final rule identified 

under 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 controlling human and environmental risks as well as 
providing greater protection and knowledge to the public. By using the 
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 country, as appropriate for screening HPV chemical substances 
for toxicity and produces information relevant to

[[Page 13711]]

understanding the basic health and environmental hazards and fate of 
HPV chemicals. The six basic testing endpoints comprising this battery 
of tests, known as the SIDS, have been adopted by the OECD as the 
minimum required to screen HPV chemical substances for toxicity and 
environmental fate. The content of SIDS was agreed upon at the 13\th\ 
Joint Meeting of the OECD Chemicals Group and Management Committee of 
the 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, n-octanol/water 
partition coefficient, and water solubility), photolysis, hydrolysis, 
transport/distribution, and biodegradation).
While data on the six SIDS endpoints do not fully measure a chemical's 
toxicity, they do provide a consistent minimum set of information that 
can be used to 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 volume threshold 
which is chosen for an international program on existing chemicals and 
which is the only trigger for entry into that program should be 
determinative of the threshold chosen for ``substantial production'' 
under TSCA section 4(a)(1)(B)(i). See EPA's ``B'' policy (Ref. 3). 
Among the reasons is that the TSCA section 4(a)(1)(B)(i) finding of 
substantial production is not the sole finding EPA must make to require 
testing based on TSCA section 4(a)(1)(B). EPA must also find that there 
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 12). Additionally, they indicated that the 
OECD's 2.2 million pound threshold would be preferable to achieve 
consistency between EPA's activities under TSCA section 4 and the OECD 
HPV SIDS Program. Although the United States and OECD differ in their 
definition of an HPV chemical and what 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 non-polymeric 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 available basic 
hazard data. For the remaining chemicals, limited amounts of the data 
were available. This lack of available hazard data compromises 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

[[Page 13712]]

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://www.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 Sec.  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.(SII), Institute of Makers of Explosives (IME), 
People for the Ethical Treatment of Animals (PETA), Physicians 
Committee for Responsible Medicine (PCRM), Doris Day Animal League 
(DDAL), The Humane Society of the United States (HSUS), Alternative 
Research & Development Foundation (ARDF), American Anti-Vivisection 
Society (AAVS), New England Anti-Vivisection 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 cytotoxicity 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 Sec.  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 Sec.  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 IV.E.).

[[Page 13713]]

 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/or Imported 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 exposures.
    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 VII.C.). 
Table 2 of Sec.  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

[[Page 13714]]

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 Sec.  799.5085(j) of the 
regulatory text. The testing requirements for each chemical are denoted 
by alphanumeric symbols in Table 2 in Sec.  799.5085(j) of the 
regulatory text. Table 3 in Sec.  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 Sec.  
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).
     Method B: (40 CFR 799.6784--shake flask).
     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.astm.org/cgi-bin/SoftCart.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 Sec.  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 Sec.  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 
Kow. EPA provides three methods for measuring the 
substance's log Kow, but prior to selecting an appropriate 
method to use, if any, EPA is recommending that the log Kow 
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 general, 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 
Kow 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.

[[Page 13715]]

      Table 1.--Test Requirements for the n-Octanol/water Partition
                          Coefficient Endpoint
------------------------------------------------------------------------
                                   Test requirements
        Testing category            and references    Special conditions
------------------------------------------------------------------------
Physical/chemical properties      n-Octanol/water     n-Octanol/water
                                   partition           partition
                                   coefficient (log    coefficient or
                                   10 basis) or log    log Kow:
                                   Kow:               Which method is
                                  The appropriate      required, if any,
                                   log Kow test, if    is determined by
                                   any, must be        the test
                                   selected from       substance's
                                   those listed in     estimated log Kow
                                   this column--see    as follows:
                                   special            log Kow < 0: no
                                   conditions in the   testing required.
                                   adjacent column..  log Kow range 0-1:
                                  Method A: 40 CFR     Method A or B.
                                   799.6755 (shake    log Kow range >1-
                                   flask).             4: Method A or B
                                   Method B: ASTM E    or C.
                                   1147 (liquid       log Kow range >4-
                                   chromatography).    6: Method B or C.
                                   Method C: 40 CFR   log Kow >6: Method
                                   799.6756            C.
                                   (generator         Test sponsors are
                                   column).            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
------------------------------------------------------------------------
                                   Test requirements
        Testing category            and references    Special conditions
------------------------------------------------------------------------
Physical/chemical properties      Water solubility:   Water solubility:
                                  The appropriate     Which method is
                                   method to use, if   required, if any,
                                   any, to test for    is determined by
                                   water solubility    the test
                                   must be selected    substance's
                                   from those listed   estimated water
                                   in this column--    solubility. Test
                                   see special         sponsors are
                                   conditions in the   required to
                                   adjacent column..   provide in the
                                  Method A: ASTM E     final study
                                   1148 (shake         report the
                                   flask).             underlying
                                  Method B: 40 CFR     rationale for the
                                   799.6784 (shake     method selected.
                                   flask).             In order to
                                  Method C: 40 CFR     ensure
                                   799.6784 (column    environmental
                                   elution).           relevance, EPA
                                  Method D: 40 CFR     highly recommends
                                   799.6786            that the selected
                                   (generator          study be
                                   column).            conducted at pH
                                                       7.
                                                      >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.
                                                      < =0.001 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 Kow 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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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

[[Page 13716]]

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 Kow 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'' be considered in determining the 
appropriate test method that would be used from among those included 
for this endpoint in Table 3 in Sec.  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[deg]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 Sec.  
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 
Sec.  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 III. and discussed in the 
document Response to Public Comments (Ref. 40). This test is included 
as a special condition in Table 3 in Sec.  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 
larger 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 toxicity--repeated 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 be eligible

[[Page 13717]]

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 Sec.  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 Sec.  799.5085(j) of the regulatory text, the 
reporting requirements described in Sec.  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 Sec.  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-
bis[(nitrooxy)methyl]-, 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 be 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% by weight D-
lactose monohydrate. PETN, NF is the form of PETN which was tested by 
NTP in several toxicity studies (Ref. 65)). EPA has specified in Sec.  
799.5085 (a) of the regulatory text that, if the test sponsor elects to 
test this chemical in a mixture with a stabilizing compound (as opposed 
to dilution of the chemical in water), then the stabilizer used must be 
tested as a control.
    The term Class 1 chemical substance refers to a chemical substance 
having a chemical composition that consists of a single-chemical 
species (not including impurities) that can be represented by a 
specific, complete structure diagram. In those instances in which the 
test sponsor(s) believes that a 99% level of purity is unattainable for 
a given chemical, the sponsor may request a modification under the 
procedures described in 40 CFR 790.55.
    For the ``Class 2'' chemical substances listed in Table 2 in Sec.  
799.5085(j) of the regulatory text (i.e., 5 of the 17 chemical 
substances included in this final rule), EPA is requiring that the 
substance to be 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 C12-C14 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 production run, because of small variations in 
feedstocks, manufacturing methods, or other production variables. Small 
variations in the feedstock or in chemical production methods or 
conditions can account for the types of small variations in composition 
typically allowable within a given Class 2 listing on the TSCA 
Inventory. By contrast, a ``Class 1'' designation generally applies to 
a substance which is an individual chemical whose only variables are 
its impurities.
    EPA believes that, for purposes of this final rule, the testing of 
any representative form of a subject Class 2 substance would provide 
data necessary to support the development of preliminary or screening 
level hazard and risk characterizations for the subject Class 2 
substance. However, EPA encourages the selection of representative 
forms of the test substances that meet industry or 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 Sec.  
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

[[Page 13718]]

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 Sec.  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    Tier 2 (Persons not initially
                comply)                        required to comply)
------------------------------------------------------------------------
Persons who manufacture (as defined at   A. Persons who manufacture (as
 TSCA section 3(7)), or intend to         defined at TSCA section 3(7))
 manufacture, a test rule substance,      or intend to manufacture a
 and who are not listed under Tier 2      test rule substance 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
                                          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 lbs.) 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 to submit a letter of intent 
to conduct testing? You may apply for an exemption if you believe that 
the 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 Sec.  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 burdensome. 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 Sec.  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., Sec.  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 Sec.  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 Sec.  799.5085(c)(8) of 
the regulatory text.

[[Page 13719]]

    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 Sec.  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 be fewer manufacturers (even as byproducts, impurities, etc.) 
than processors (Ref. 68, p. 31789). EPA also believes that testing 
costs have traditionally been passed by 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 non-isolated 
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 Sec.  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 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 Sec.  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 I 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

[[Page 13720]]

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-1-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, bis(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 http://www.epa.gov/chemrtk/viewsrch.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-sulfo-2-
naphthalenyl]azo]phenyl]amino]-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 n-octanol/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 n-octanol/water partition 
coefficient and water solubility, as well as environmental fate, 
toxicity to algae, and screening level reproduction/developmental 
toxicity.
    2. Reproduction/developmental toxicity screening test of sorbic 
acid. As discussed in Unit K.3. of the Response

[[Page 13721]]

to Public Comments document (Ref. 40), EPA reviewed four studies on 
sorbic acid (2,4-hexadienoic acid, (2E,4E)-) (CAS No. 110-44-1) which 
ADC (Ref. 24) thought might satisfy the testing proposed to be 
conducted according to 40 CFR 799.9355 to obtain screening level data 
on the reproductive and developmental toxicity of sorbic acid. EPA 
determined that the studies provided sufficient information on this 
endpoint(s) at this time for sorbic acid (Ref. 74). Therefore, EPA is 
not requiring the reproduction/developmental toxicity screening test of 
sorbic acid in this final rule. EPA is still requiring the testing of 
sorbic acid for aquatic toxicity and the determination 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 Sec.  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 by soliciting the involvement of the 
Agency under the reimbursement regulations at 40 CFR part 791. Given 
this consistent experience with previous test rules, EPA does not 
believe that there will be any administrative, negotiation, or any 
other costs associated with seeking reimbursement from Tier 2 
companies.
    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 compares the annual revenues from 
the sale of a chemical to the annualized testing costs for that 
chemical and expresses the testing costs as a percent of revenues 
generated from each 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 which price data were not available. The ``critical price'' is the 
price per pound below which there would be an impact of 1.0% or 
greater. The production volume for this chemical falls between 10 
million to 50 million pounds. Assuming a production volume at the 
midpoint of that range equal to 30 million pounds per year and 
annualized testing costs of $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 $2.62 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 Agency, 1200 Pennsylvania

[[Page 13722]]

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-HQ-OPPT-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. Journal of the American Pharmaceutical Association. 44:619-621. 
1955.
    Environmental Defense (ED) (formerly Environmental Defense Fund, 
Inc.) Toxic Ignorance. 1997.
    EPA 1983. Ethyltoluenes, Trimethylbenzenes, and the C9 
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/chemrtk/categuid.htm
.

    EPA 1999c. OPPT. The Use of Structure-Activity Relationships (SAR) 
in the High Production Volume Chemicals Challenge Program. August 26, 
1999. Available online at: http://www.epa.gov/chemrtk/sarfinl1.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://www.epa.gov/chemrtk/ceoltr2.htm.

    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) (FRL-7192-7).
    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/c15210tc.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://www.epa.gov/chemrtk/hpvstatr.htm.

    FDRL 1975. Food and Drug Research Labs. Teratologic evaluation of 
FDA 73-4 (potassium sorbate: Sorbistat) in mice and rats. Prepared 
under DHEW

[[Page 13723]]

Contract No: FDA 223-74-2176. NTIS No. PB-245520. Waverly, NY. 1975.
    Hawley's Condensed Chemical Dictionary. 14\th\ Edition. Revised by 
Richard J. Lewis, Sr. Publisher: John Wiley & Sons, Inc. 2002.
    Larsen, J., Schultz, T.W., Rasmussen, L., Hooftman, R., and Pauli, 
W. Progress in an ecotoxicological standard protocol with protozoa: 
Results from a pilot ring test with Tetrahymena pyriformis. 
Chemosphere. 35(5): 1023-1041. 1997.
    LeBlanc, G.A. Interspecies relationships in acute toxicity of 
chemicals to aquatic organisms. Environmental Toxicology and Chemistry. 
3: 47-60. 1984.
    National Institute of Environmental Health Sciences (NIEHS) 1997. 
Validation and Regulatory Acceptance of Toxicological Test Methods: A 
Report of the ad hoc Interagency Coordinating Committee on the 
Validation of Alternative Methods. NIH Publication No: 97-3981. 1997. 
Available online at: http://iccvam.niehs.nih.gov/docs/guidelines/validate.pdf
.

    NIEHS 2001a. Report of the International Workshop on In Vitro 
Methods for Assessing Acute Systemic Toxicity. NIH Publication No. 01-
4499. August 2001. Available online at: http://www.epa.gov/chemrtk/nih/2001a.pdf
.

    NIEHS 2001b. Guidance Document on Using In Vitro Data to Estimate 
In Vivo Starting Doses for Acute Toxicity. NIH Publication No. 01-4500. 
August 2001.
    NIEHS 2003a. Test Method Protocol for Solubility Determination, in 
vitro Cytotoxicity Validation Study--Phase III. National Toxicology 
Program (NTP) Interagency Center for the Evaluation of Alternative 
Toxicological Methods (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/phIIIprot/3t3phIII.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/nhkphIII.pdf
.

    National Institute for Occupational Safety and Health (NIOSH) 
1983a. NOES. Estimated numbers of employees potentially exposed to 
pentaerythritol tetranitrate by occupation within 2-digit Standard 
Industrial Classification (SIC). 1981-1983. Available online at: http://www.cdc.gov/noes/noes4/83538sco.html
.

    NIOSH 1983b. NOES. Estimated number of employees potentially 
exposed to light oil by occupation within 2-digit Standard Industrial 
Classification (SIC). 1981-1983. Available online at: http://www.cdc.gov/noes/noes4/x2973sco.html
.

    NIOSH 1983c. NOES. Estimated number of employees potentially 
exposed to 1-chlorododecane by occupation within 2-digit Standard 
Industrial Classification (SIC). 1981-1983. Available online at: http://www.cdc.gov/noes/noes4/x2609sco.html
.

    NIOSH 1988. National occupational exposure survey analysis of 
management interview responses. Vol. III. Pedersen DH, Sieber WK, eds. 
Cincinnati, OH: U.S. Department of Health and Human Services, Centers 
for Disease Control, National Institute for Occupational Safety and 
Health, DHHS (NIOSH) Publication No. 89-103. March 1988. Available 
online at: http://www.cdc.gov/niosh/89-103.html.

    OECD 2001a. Guidance Document on Acute Oral Toxicity Testing. OECD 
Series on Testing and Assessment No. 24. June, 2001.
    OECD 2001b. Acute Oral Toxicity--Fixed Dose Procedure. OECD Test 
Guideline 420. Adopted December 17, 2001.
    OECD 2001c. Acute Oral Toxicity--Acute Toxic Class Method. OECD 
Test Guideline 423. Adopted December 17, 2001.
    OECD 2001d. Acute Oral Toxicity-Up-and-Down Procedure. OECD Test 
Guideline 425. Adopted December 17, 2001. Available online at: http://www.oecd.org/document
 /23/0,2340, en--2649--34379--1948503-- 1--1-- 1--

1,00.html.
    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 1\st\ 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.
    United Nations. Report of the United Nations Conference on 
Environment and Development (UNCED), Agenda 21, Chapter 19, Programme 
Area C--Information 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) (FRL-6758-4).
    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/hpvchmlt.htm
.

    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--1--1,00.html.
    6. International Council of Chemical Associations (ICCA). ICCA HPV 
Working List. Chemicals. August 2003.
    7. OECD Secretariat. Summary Record of the 13\th\ 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-Recommendation on the Co-Operative Investigation 
and Risk Reduction of Existing Chemicals--C(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 Public

[[Page 13724]]

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 Chemicals? April 1998. Available online at: 
http://www.epa.gov/chemrtk/hazchem.htm.

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

    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 Manufacturers (ETAD). 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.
    23. Merisol USA LLC (Merisol). 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 (Ashland). 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.
    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.
    33. Doris Day Animal League (DDAL). 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.
    34. The Humane Society of the United States (HSUS). 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.
    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 Non-Substantive 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 Testing 
Data for U.S. High Production Volume Chemicals. June 12, 1998.
    44. American Society for Testing and Materials International (ASTM 
International). Standard Test Method for

[[Page 13725]]

Relative Initial and Final Melting Points and the Melting Range of 
Organic Chemicals. ASTM. E 324. 1999.
    45. ASTM International. Standard Test Method for Vapor Pressure of 
Liquids by Ebulliometry. ASTM. E 1719. 1997.
    46. ASTM International. Standard Test Method for Determining Vapor 
Pressure by Thermal Analysis. ASTM. E 1782. 2003.
    47. ASTM International. Standard Test Method for Partition 
Coefficient (N-Octanol/Water) Estimation by Liquid 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 
Quality--Evaluation of Ultimate Aerobic Biodegradability of Organic 
Compounds in Aqueous Medium--Static Test (Zahn-Wellens 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 octanol/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 fish bioconcentration on n-octanol/water partition 
coefficient. SAR and QSAR in Environmental Research. 1:29-39. 1993.
    59. Meylan, W.M., Howard, P.H., Boethling, R.S., Aronson, D., 
Printup, H., and Gouchie, S. Improved method of estimating 
bioconcentration/bioaccumulation factor from octanol/water partition 
coefficient. Environmental Toxicology and Chemistry. 18(4): 664-672. 
1999.
    60. Smrchek, J.C. and Zeeman, M.G. Assessing Risks to Ecological 
Systems 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) (FRL-5771-6).
    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.
    71. EPA. EPA Census of TSCA Testing Laboratories. Prepared by EPAB, 
EETD, OPPT. Washington, DC. October 10, 1996.
    72. EPA. Notices of export under section 12(b). Federal Register 
(45 FR 82850, December 16, 1980).
    73. EPA. Review of comments on proposed determination of physical/
chemical properties for PETN. Memorandum from Dr. Robert Boethling, 
EAB, EETD, OPPT, to Greg Schweer, CITB. August 20, 2004.
    74. EPA. Request for assistance in 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, 2005.
    76. Small Business Administration, Office of Size Standards. Small 
Business Size Standards matched to North American Industry 
Classification System (NAICS). Available online at: http://www.sba.gov/size/sizetable2002.htm
.

XI. 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

[[Page 13726]]

estimated to be $1.44 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 
processors of a subject chemical would be required to comply with the 
requirements of the rule only if they are directed to do so by EPA as 
described in Sec.  799.5085(c)(5) and (c)(6) of the regulatory text. 
EPA would only require such entities to test if no person in Tier 1 has 
submitted a letter of intent to test, 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 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) export notification requirements (included in the total 
and annualized cost estimates) that would be triggered by the rule are 
expected to have a negligible impact on exporters. The TSCA section 
12(b) export notification requirements under the final rule would be 
required for the first export to a particular country of a chemical 
subject to the rule. The Agency's estimated total costs of testing 
(including both laboratory and administrative costs), annualized 
testing cost, price impacts, and public reporting burden hours for this 
final rule are presented in the economic assessment.
    Under a least cost scenario, 12 out of the 16 chemicals for which 
price data were available (75%) would have a price impact at less than 
the 1% level. Similarly, 12 out of the 16 chemicals (75%) would be 
impacted at less than 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 a percentage of annual revenue, are very small 
for most chemicals. There are, however, some chemicals for which the 
price impact is expected to exceed 1% of the revenue from that 
chemical. The potential for adverse economic impact is expected to be 
higher for these chemicals. In these cases, companies may choose to use 
revenue sources other than the profits from the individual chemicals 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 2070-0033 (EPA ICR No. 1139). The 
information collection activities related to export notification under 
TSCA section 12(b)(1) are already approved under OMB control number 
2070-0030 (EPA 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.

[[Page 13727]]

    As defined by the PRA and 5 CFR 1320.3(b), ``burden`` means the 
total time, effort, or financial resources expended by persons to 
generate, maintain, retain, or disclose or provide 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

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 
5 U.S.C. 601 et seq., after considering the potential economic impacts 
of this final rule on small entities, the Agency hereby certifies that 
this final rule will not have a significant adverse economic impact on 
a substantial number of small entities. The Agency's determination is 
based on the small entity impact analysis prepared as part of the 
economic analysis for this final rule (Ref. 75), which is summarized in 
Unit XI.A., and a copy of which is available in the docket for this 
final rule. The following is a brief summary of the factual basis for 
this certification.
    Under the RFA, small entities include small businesses, small 
organizations, and small governmental jurisdictions. For purposes of 
assessing the impacts of this final rule on small entities, small 
entity is defined in accordance with the RFA as:
    1. A small business as defined by the Small Business 
Administration's (SBA) regulations at 13 CFR 121.201.
    2. A small governmental jurisdiction that is a government of a 
city, county, town, school district, or special district with a 
population of less than 50,000.
    3. A small organization that is any not-for-profit enterprise which 
is independently owned and operated and is not dominant in its field.
    Based on the industry profile for this rule that EPA prepared as 
part of the Economic Analysis prepared for this final rule, EPA has 
determined that this rule is not expected to impact any small not-for-
profit organizations or small governmental jurisdictions. As such, the 
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 to determine whether a 
business entity is eligible for government programs and preferences 
reserved for small businesses (13 CFR 121.101), ``seek to ensure that a 
concern that meets a specific size standard is not dominant in its 
field of operation.'' (13 CFR 121.102(b)). See section 632(a)(1) of the 
Small Business Act. Industrial sectors are identified by a NAICS code. 
In most cases, SBA has specified an employee size standard (100; 500; 
750; 1,000; or 1,500 employees) or, in some cases, a sales-based, or 
other industry-specific indicator below which an entity in that 
particular NAICS code would be considered small (Ref. 76). The SBA 
employee size standards that apply to the companies that are 
potentially impacted (Ref. 75) by this final rule range from 500 to 
1,500 employees.
    Sales and employment data were obtained for the 52 UCEs that 
manufacture the 17 chemicals subject to this final rule to identify 
those UCEs that qualify for ``small business'' status, where data were 
available. Based on the SBA size standards for the NAICS codes that 
applied to those UCEs, 23 of the 52 UCEs (44%) were identified as 
small. The significance of this final rule's impact on these small 
businesses was analyzed by examining the number of small entities that 
experienced different levels of costs as a percentage of their sales. 
In such an analysis, small businesses are placed in the following 
categories on the basis of cost-to-sales ratios: less than 1.0%, 1.0% 
but less than 3.0%, and 3.0% or greater. Of the 23 companies that 
qualified for small business status according to the SBA 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(b) 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

[[Page 13728]]

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, or 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
----------------------------------------------------------------------------------------------------------------
                                          Title of Voluntary       TSCA Guideline/CFR
Voluntary Consensus Standard No./Year     Consensus Standard            Citation           OECD Test Method No.
----------------------------------------------------------------------------------------------------------------
ASTM E 324 (1999)                      Standard Test Method                              .......................
                                        for Relative Initial
                                        and Final Melting
                                        Points and the Melting
                                        Range of Organic
                                        Chemicals
----------------------------------------------------------------------------------------------------------------

[[Page 13729]]

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     799.6755, 799.6756       .......................
                                        for Partition
                                        Coefficient (N-Octanol/
                                        Water) Estimation by
                                        Liquid Chromatography
----------------------------------------------------------------------------------------------------------------
ASTM. E1148 (2002)                      Standard Test Method    799.6784, 799.6786       .......................
                                        for Measurements of
                                        Aqueous Solubility
----------------------------------------------------------------------------------------------------------------
ASTM E 1163 (2002)                     Standard Test Method     799.9130 (if gas at      425
                                        for Estimating Acute     room temp.).
                                        Oral Toxicity in Rats
----------------------------------------------------------------------------------------------------------------
ASTM E 1193 (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)                        Water Quality--                                   .......................
                                        Evaluation of Ultimate
                                        Aerobic
                                        Biodegradability of
                                        Organic 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 CH-1211 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 guidelines 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 low-income 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.

XII. 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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 9--[AMENDED]

0
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. 241,

[[Page 13730]]

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 Sec.  9.1, the table is amended by adding an entry for Sec.  
799.5085 in numerical order under the indicated heading to read as 
follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                   40 CFR citation                      OMB control No.
------------------------------------------------------------------------
                                * * * * *

------------------------------------------------------------------------
    Identification of Specific Chemical Substance and Mixture Testing
                              Requirements
------------------------------------------------------------------------
                                * * * * *
799.5085.............................................          2070-0033
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 799--[AMENDED]

0
3. The authority citation for part 799 continues to read as follows:

    Authority: 15 U.S.C. 2603, 2611, 2625.

0
4. By adding Sec.  799.5085 to subpart D to read as follows:

Sec.  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.

   Table 1.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
                                          Persons not initially required
  Persons initially required to comply     to comply with this section
       with this section (Tier 1)                    (Tier 2)
------------------------------------------------------------------------
Persons not otherwise specified in       A. Persons who manufacture (as
 column 2 of this table that              defined at TSCA section 3(7))
 manufacture (as defined at TSCA          or intend to manufacture a
 section 3(7)) or intend to manufacture   chemical substance included in
 a chemical substance included in this    this section solely as one or
 section.                                 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 lbs.) 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)).
------------------------------------------------------------------------

    (ii) Table 1 of paragraph (c)(1)(i) of this section expands the 
list of persons specified in Sec.  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 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

[[Page 13731]]

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 in Sec.  Sec.  790.93 and 790.97 of 
this chapter, EPA may initiate termination proceedings for all testing 
exemptions with respect to that chemical substance and may notify 
persons in Tier 1 and Tier 2 that they are required to submit letters 
of intent to test or exemption applications within a specified period 
of time.
    (9) If you are required to comply with this section, but your 
manufacturing or processing of a chemical substance listed in Table 2 
in paragraph (j) of this section begins after the applicable compliance 
date referred to in paragraphs (c)(2), (c)(5), or (c)(8) of this 
section, you must either submit a letter of intent to test or apply to 
EPA for an exemption. The letter of intent to test or the exemption 
application must be received by EPA no later than the day you begin 
manufacturing or processing.
    (d) What must I do to comply with this section? (1) To comply with 
this 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 or exemption 
applications, the conduct of testing, and the submission of data; Part 
792--Good Laboratory Practice 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 Sec.  790.45; 
paragraph (a)(2) and paragraph (b) of Sec.  Sec.  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 
amounts of a chemical substance produced as an impurity.
    (g) Who must comply with the export notification requirements? Any 
person who exports, or intends to export, a chemical substance listed 
in Table 2 in paragraph (j) of this section is subject to part 707, 
subpart D, of this chapter.
    (h) How must I conduct my testing? (1) The tests that are required 
for each chemical substance are indicated in Table 2 in paragraph (j) 
of this section. The test methods that must be followed are provided in 
Table 3 in paragraph (j) of this section. You must proceed in 
accordance with these test methods as required according to Table 3 in 
paragraph (j) of this section, or as appropriate if more than one 
alternative is allowed according to Table 3 in paragraph (j) of this 
section. Included in Table 3 in paragraph (j) of this section are the 
following 11 methods which are incorporated by reference:
    (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, Macroinvertebrates, and Amphibians, ASTM E 729-
96. (Reapproved 2002)
    (iv) Standard Test Method for Measurements of Aqueous Solubility, 
ASTM E 1148-02.
    (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.

[[Page 13732]]

    (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 CH-
1211 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_federal_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 chemical 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
----------------------------------------------------------------------------------------------------------------
                                                                                     Required tests/(See Table 3
                 CAS No.                          Chemical name            Class           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-                   1  A4, A5, B, C6, F2
                                           bis[(nitrooxy)methyl]-,
                                           dinitrate (ester)
----------------------------------------------------------------------------------------------------------------
84-65-1                                   9,10-Anthracenedione                    1  A, F2
----------------------------------------------------------------------------------------------------------------
108-19-0                                  Imidodicarbonic diamide                 1  A, B, C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
110-44-1                                  2,4-Hexadienoic acid,                   1  A, C4
                                           (2E,4E)-
----------------------------------------------------------------------------------------------------------------
112-52-7                                  Dodecane, 1-chloro                      1  A, B, C3, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
118-82-1                                  Phenol, 4,4'-                           1  A, B, D, E1, E2, F2
                                           methylenebis[2,6-bis(1,1-
                                           dimethylethyl)]-
----------------------------------------------------------------------------------------------------------------
149-44-0                                  Methanesulfinic acid,                   1  A, B, C1, E2, F1
                                           hydroxy-, monosodium salt
----------------------------------------------------------------------------------------------------------------
409-02-9                                  Heptenone, methyl-                      2  A, B, C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
594-42-3                                  Methanesulfenyl chloride,               1  A, B, C1, E1, E2, F2
                                           trichloro-
----------------------------------------------------------------------------------------------------------------
624-83-9                                  Methane, isocyanato-                    1  A, C1
----------------------------------------------------------------------------------------------------------------
1324-76-1                                 Benzenesulfonic acid, [[4-              2  A, B, C1, D, E1, E2, F1
                                           [[4-(phenylamino)phenyl][4-
                                           (phenylimino)-2,5-
                                           cyclohexadien-1-
                                           ylidene]methyl]phenyl]amino
                                           ]-
----------------------------------------------------------------------------------------------------------------
2941-64-2                                 Carbonochloridothioic acid,             1  A, B, C1, E2, F1
                                           S-ethyl ester
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
68611-64-3                                Urea, reaction products with            2  A, B, C1, D, E1, E2, F1
                                           formaldehyde
----------------------------------------------------------------------------------------------------------------

[[Page 13733]]

       Table 3--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2 of This Paragraph
----------------------------------------------------------------------------------------------------------------
                                                                 Test requirements and
           Testing category                  Test symbol               references           Special conditions
----------------------------------------------------------------------------------------------------------------
Physical/chemical properties           A                        1. Melting Point: ASTM   n-Octanol/water
                                                                 E 324 (capillary tube)   Partition Coefficient
                                                                2. Boiling Point: ASTM    or log Kow:
                                                                 E 1719 (ebulliometry).  Which method is
                                                                3. Vapor Pressure: ASTM   required, if any, is
                                                                 E 1782 (thermal          determined by the test
                                                                 analysis).               substance's
                                                                4. n-Octanol/Water        estimated\1\ log Kow
                                                                 Partition Coefficient    as follows:
                                                                 (log 10 basis) or log   log Kow < 0: no testing
                                                                 Kow: (See special        required.
                                                                 conditions for the log  log Kow range 0-1:
                                                                 Kow test requirement     Method A or B.
                                                                 and select the          log Kow range >1-4:
                                                                 appropriate method to    Method A or B or C.
                                                                 use, if any, from       log Kow range >4-6:
                                                                 those listed in this     Method B or C.
                                                                 column.).               log Kow >6: Method C.
                                                                 Method A: 40 CFR        Test sponsors are
                                                                 799.6755 (shake flask).  required to provide in
                                                                 Method B: ASTM E 1147    the final study report
                                                                 (liquid                  the underlying
                                                                 chromatography).         rationale for the
                                                                 Method C: 40 CFR         method selected. In
                                                                 799.6756 (generator      order to ensure
                                                                 column).                 environmental
                                                                5. Water Solubility:      relevance, EPA highly
                                                                 (See special             recommends that the
                                                                 conditions for the       selected study be
                                                                 water solubility test    conducted at pH 7.
                                                                 requirement and select  Water Solubility:
                                                                 the appropriate method  Which method is
                                                                 to use, if any, from     required, if any, is
                                                                 those listed in this     determined by the test
                                                                 column.).                substance's
                                                                 Method A: ASTM E 1148    estimated\2\ water
                                                                 (shake flask).           solubility. Test
                                                                 Method B: 40 CFR         sponsors are required
                                                                 799.6784 (shake flask).  to provide in the
                                                                 Method C: 40 CFR         final study report the
                                                                 799.6784 (column         underlying rationale
                                                                 elution).                for the method
                                                                 Method D: 40 CFR         selected. In order to
                                                                 799.6786 (generator      ensure environmental
                                                                 column).                 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--      B                        For B, choose either of  None
 Inherent biodegradation                                         the methods listed in
                                                                 this column:
                                                                1. ASTM 1625
                                                                 (semicontinuous
                                                                 activated sludge test)
                                                                 OR.
                                                                2. ISO 9888 (Zahn-
                                                                 Wellens method).
----------------------------------------------------------------------------------------------------------------
Aquatic toxicity                       C1                       For C1, Test Group 1 or  The following are the
                                                                 Test Group 2 listed in   special conditions for
                                                                 this column must be      C1, C2, C3, C4, C5,
                                                                 used to fulfill the      and C7 testing; there
                                                                 testing requirements--   are no special
                                                                 See special              conditions for C6.
                                                                 conditions.              If log Kow < 4.2: Test
                                                                Test Group 1 for C1:...   Group 1 is required
                                                                1. Acute Toxicity to     If log Kow >= 4.2: Test
                                                                 Fish: ASTM E 729.        Group 2 is required
                                                                2. Acute Toxicity to     Which test group is
                                                                 Daphnia: ASTM E 729.     required is determined
                                                                3. Toxicity to Plants     by the test
                                                                 (Algae): ASTM E 1218.    substance's measured
                                                                Test Group 2 for C1:...   log Kow as obtained
                                                                1. Chronic Toxicity to    under A\3\.
                                                                 Daphnia: ASTM E 1193.
                                                                2. Toxicity to Plants
                                                                 (Algae): ASTM E 1218.
                                      --------------------------------------------------
                                       C2                       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 1 for C2:...
                                                                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.
                                      --------------------------------------------------

[[Page 13734]]

                                       C3                       For C3, 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 C3:...
                                                                1. Acute Toxicity to
                                                                 Fish: ASTM E 729.
                                                                2. Toxicity to Plants
                                                                 (Algae): ASTM E 1218.
                                                                Test Group 2 for C3:...
                                                                1. Chronic Toxicity to
                                                                 Daphnia: ASTM E 1193.
                                                                2. Toxicity to Plants
                                                                 (Algae): ASTM E 1218.
                                      --------------------------------------------------
                                       C4                       For C4, 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 C4:...
                                                                1. Acute Toxicity to
                                                                 Fish: ASTM E 729.
                                                                2. Acute Toxicity to
                                                                 Daphnia: ASTM E 729.
                                                                Test Group 2 for C4:...
                                                                1. Chronic Toxicity to
                                                                 Daphnia: ASTM E 1193.
                                      --------------------------------------------------
                                       C5                       For C5, Test Group 1 or
                                                                 Test Group 2 below
                                                                 must be used to
                                                                 fulfill the testing
                                                                 requirements--See
                                                                 special conditions.
                                                                Test Group 1 for C5:...
                                                                1. Acute Toxicity to
                                                                 Daphnia: ASTM E 729.
                                                                Test Group 2 for C5:...
                                                                1. Chronic Toxicity to
                                                                 Daphnia: ASTM E 1193.
                                      --------------------------------------------------
                                       C6                       Toxicity to Plants
                                                                 (Algae): ASTM E 1218
                                      --------------------------------------------------
                                       C7                       For C7, Test Group 1 or  .......................
                                                                 Test Group 2 of this
                                                                 column must be used to
                                                                 fulfill the testing
                                                                 requirements--See
                                                                 special conditions.
                                                                Test Group 1 for C7:...
                                                                1. Acute Toxicity to
                                                                 Fish: ASTM E 729.
                                                                Test Group 2 for C7:...
                                                                1. Chronic Toxicity to
                                                                 Daphnia: ASTM E 1193.
----------------------------------------------------------------------------------------------------------------
Mammalian toxicity--Acute              D                        See special conditions   Which testing method is
                                                                 for this test            required is determined
                                                                 requirement and select   by the test
                                                                 the method that must     substance's physical
                                                                 be used from those       state at room
                                                                 listed in this column.   temperature
                                                                Method A: Acute           (25[deg]C). For those
                                                                 Inhalation Toxicity      test substances that
                                                                 (rat): 40 CFR 799.9130.  are gases at room
                                                                Method B: EITHER:......   temperature, Method A
                                                                1. Acute (Up/Down) Oral   is required;
                                                                 Toxicity (rat): ASTM E   otherwise, use either
                                                                 1163 OR.                 of the two methods
                                                                 2. Acute (Up/Down)       listed under Method B.
                                                                 Oral Toxicity (rat):    In Method B, 40 CFR
                                                                 40 CFR                   799.9110(d)(1)(i)(A)
                                                                 799.9110(d)(1)(i)(A).    refers to the OECD 425
                                                                                          Up/Down Procedure\4\.
                                                                                         Estimating starting
                                                                                          dose for Method B:
                                                                                          Data from the neutral
                                                                                          red uptake basal
                                                                                          cytotoxicity assay\5\
                                                                                          using normal human
                                                                                          keratinocytes or mouse
                                                                                          BALB/c 3T3 cells may
                                                                                          be used to estimate
                                                                                          the starting dose.
----------------------------------------------------------------------------------------------------------------
Mammalian toxicity--Genotoxicity       E1                       Bacterial Reverse        None
                                                                 Mutation Test (in
                                                                 vitro): 40 CFR
                                                                 799.9510
                                      --------------------------------------------------------------------------

[[Page 13735]]

                                       E2                       Conduct any one of the   Persons required to
                                                                 following three tests    conduct testing for
                                                                 for chromosomal          chromosomal damage are
                                                                 damage:                  encouraged to use the
                                                                In vitro Mammalian        in vitro Mammalian
                                                                 Chromosome Aberration    Chromosome Aberration
                                                                 Test: 40 CFR 799.9537    Test (40 CFR 799.9537)
                                                                 OR.                      to generate the needed
                                                                Mammalian Bone Marrow     data unless known
                                                                 Chromosomal Aberration   chemical properties
                                                                 Test (in vivo in         (e.g., physical/
                                                                 rodents: mouse           chemical properties,
                                                                 (preferred species),     chemical class
                                                                 rat, or Chinese          characteristics)
                                                                 hamster): 40 CFR         preclude its use. A
                                                                 799.9538 OR.             subject person who
                                                                Mammalian Erythrocyte     uses one of the in
                                                                 Micronucleus Test        vivo methods instead
                                                                 [sampled in bone         of the in vitro method
                                                                 marrow] (in vivo in      to address a
                                                                 rodents: Mouse           chromosomal damage
                                                                 (preferred species),     test requirement must
                                                                 rat, or Chinese          submit to EPA a
                                                                 hamster): 40 CFR         rationale for
                                                                 799.9539.                conducting that
                                                                                          alternate test in the
                                                                                          final study report.
                                      --------------------------------------------------------------------------
 Mammalian toxicity--Repeated dose/    F1                       Combined Repeated Dose   Where F1 is required,
 reproduction/ developmental                                     Toxicity Study with      EPA recommends use of
                                                                 the Reproduction/        the Combined Repeated
                                                                 Developmental Toxicity   Dose Toxicity Study
                                                                 Screening Test: 40 CFR   with the Reproduction/
                                                                 799.9365 OR              Developmental Toxicity
                                                                Reproduction/             Screening Test (40 CFR
                                                                 Developmental Toxicity   799.9365). However,
                                                                 Screening Test: 40 CFR   there may be valid
                                                                 799.9355 AND.            reasons to test a
                                                                Repeated Dose 28-Day      particular chemical
                                                                 Oral Toxicity Study in   using both 40 CFR
                                                                 rodents: 40 CFR          799.9355 and 40 CFR
                                                                 799.9305.                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
                                      --------------------------------------------------
                                       F3                       Repeated Dose 28-Day
                                                                 Oral Toxicity Study in
                                                                 rodents: 40 CFR
                                                                 799.9305
----------------------------------------------------------------------------------------------------------------
\1\ EPA recommends, but does not require, that log Kow be quantitatively estimated prior to initiating this
  study. One method, among many similar methods, for estimating log Kow 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 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.
\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 Octanol/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 organisms. 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, excluding 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-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.

    (k) Effective date. This section is effective on April 17, 2006.
[FR Doc. 06-2483 Filed 3-15-06; 8:45 am]

BILLING CODE 6560-50-S