[Federal Register Volume 65, Number 248 (Tuesday, December 26, 2000)]
[Proposed Rules]
[Pages 81657-81685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32497]



[[Page 81657]]

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Part IV





Environmental Protection Agency





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40 CFR Part 799



Testing of Certain High Production Volume Chemicals; Data Collection 
and Development on High Production Volume (HPV) Chemicals; Proposed 
Rule and Notice

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / 
Proposed Rules

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42213A; FRL-6758-4]
RIN 2070-AD16


Testing of Certain High Production Volume Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing a test rule under section 4(a)(1)(B) of the 
Toxic Substances Control Act (TSCA) to require manufacturers (including 
importers) and processors of certain high production volume (HPV) 
chemical substances to conduct testing for 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 five tests for 
physical chemical properties and biodegradation). EPA has preliminarily 
determined that each of the 37 chemical substances included in this 
proposed rule is produced in substantial quantities and that there is 
substantial human exposure to each of them. Moreover, EPA believes 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 proposed 
testing program is needed and appropriate for developing such data. 
Data developed under this proposed rule will provide critical 
information about the environmental fate and potential hazards 
associated with 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 follow up 
action. Persons who export or intend to export any chemical substance 
included in the final rule based on this proposed rule would be subject 
to the export notification requirements in TSCA section 12(b)(1) and at 
40 CFR part 707, subpart D. EPA has also taken steps, as described in 
this document, to consider animal welfare and to provide instructions 
on ways to reduce or in some cases eliminate animal testing, while at 
the same time ensuring that the public health is protected.

DATES:  Comments, identified by docket control number OPPTS-42213A, 
must be received by EPA on or before April 25, 2001. If you want to 
request an opportunity to present oral comments, refer to Unit I.E. of 
the SUPPLEMENTARY INFORMATION. Your request must be in writing and must 
be received by EPA on or before January 25, 2001. Only if such a 
request is received, would EPA schedule a public meeting on this 
proposed rule, which would be announced in a subsequent document in the 
Federal Register and held in Washington, DC.

ADDRESSES:  Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify docket control 
number OPPTS-42213A in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  For general information contact: 
Barbara Cunningham, Acting Director, Environmental Assistance Division 
(7408), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone numbers: (202) 554-1404; e-mail address: [email protected].
    For technical information contact: Keith Cronin, Chemical Control 
Division (7405), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 260-8130; fax number: 
(202) 260-1096; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you manufacture (defined by 
statute to include import) or process any of the chemical substances 
that are listed in Sec. 799.5085(j) of the proposed regulatory text. 
Any use of the term ``manufacture'' in this document will encompass 
``import,'' unless otherwise stated. In addition, as described in Unit 
VI. , once the Agency issues a final rule, any person who exports, or 
intends to export, any of the chemical substances included in the final 
rule will be subject to the export notification requirements in 40 CFR 
part 707, subpart D. Potentially affected entities may include, but are 
not limited to:

     Table 1.--Entities Potentially Affected by the Proposed Testing
                              Requirements
------------------------------------------------------------------------
                                                         Examples of
         Type of entity              NAICS codes         potentially
                                                      affected entities
------------------------------------------------------------------------
Chemical Manufacturers           325, 32411          Persons who
 (including Importers)                                manufacture
                                                      (defined by
                                                      statute to include
                                                      import) one or
                                                      more of the
                                                      subject chemical
                                                      substances.
Processors                       325, 32411          Persons who process
                                                      one or more of the
                                                      subject chemical
                                                      substances.
------------------------------------------------------------------------

    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 Table 1 of this unit 
could also be affected. The North American Industrial 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 is affected by this action, you 
should carefully examine the applicability provisions in Unit V.E. 
entitled Would I be required to test under this rule? and consult the 
proposed regulatory test. 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.
    If you are an entity identified in Table 1 of this unit, you would 
only be subject to the testing requirements contained in this proposed 
rule if you manufacture or process any of the chemical substances that 
are listed in Sec. 799.5085(j) of the proposed regulatory text.

B. How Can I Get Additional Information, Including Copies of this 
Document or Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents from the EPA Internet 
Home Page at http://www.epa.gov/. To access this document, on the Home 
Page select

[[Page 81659]]

``Laws and Regulations,'' ``Regulations and Proposed Rules,'' and then 
look up the entry for this document under ``Federal Register--
Environmental Documents.'' You can also go directly to the Federal 
Register listings at http://www.epa.gov/fedrgstr/.
    You may also access additional information about the Chemical 
Right-to-Know Program at http://ww.epa.gov/chemrtk/ or about the TSCA 
testing program at http://www.epa.gov/opptintr/chemtest/. For your 
convenience, EPA may have also provided some non-EPA internet 
addresses. In doing so, the Agency has verified the accuracy of these 
addresses at the time of signature. However, since EPA is not 
responsible for these non-EPA sites, the Agency does not have any 
control over these addresses. A paper copy of any document referenced 
in this way has been included in the public version of the official 
record for this document as described in Unit I.B.2.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-42213A. The official 
record consists of the documents referenced in this action, any public 
comments received during an applicable comment period, and other 
information related to this action, including information claimed as 
Confidential Business Information (CBI). This official record includes 
the documents that are physically located in the docket, as well as the 
documents that are referenced in those documents. The public version of 
the official record does not include any information claimed as CBI. 
The public version of the official record, which includes printed, 
paper versions of any electronic comments submitted during an 
applicable comment period, is available for inspection in the TSCA 
Nonconfidential Information Center, Rm. NE B-607, 401 M St., SW., 
Washington, DC. The Center is open from noon to 4 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Center 
is (202) 260-7099.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPPTS-42213A in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Document Control Office 
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: OPPT Document 
Control Office (DCO), East Tower Rm. G-099, Waterside Mall, 401 M St., 
SW., Washington, DC. 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) 260-7093.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected] or mail your computer disk to the address 
identified above. Do not submit any information electronically that you 
consider to be CBI. Electronic comments must be submitted as an ASCII 
file avoiding the use of special characters and any form of encryption. 
Comments and data will also be accepted on standard computer disks in 
WordPerfect 6/7/8/9 or ASCII file format. All comments in electronic 
form must be identified by docket control number OPPTS-42213A. 
Electronic comments may also be filed online at many Federal Depository 
Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
consult the technical person listed under FOR FURTHER INFORMATION 
CONTACT.

E. Can I Request an Opportunity to Present Oral Comments to the Agency?

    You may submit a request for an opportunity to present oral 
comments. This request must be made in writing. If such a request is 
received on or before January 25, 2001, EPA will hold a public meeting 
on this proposed rule in Washington, DC. This written request must be 
submitted to the address provided in Unit I.C.1 and 2. If such a 
request is received, EPA will announce the scheduling of the public 
meeting in a subsequent document in the Federal Register. If a public 
meeting is announced, and if you are interested in attending or 
presenting oral and/or written comments at the public meeting, you 
should follow the instructions provided in the subsequent document 
announcing the public meeting.

F. What Should I Consider as I Prepare My Comments for EPA?

    EPA invites you to provide your views on the various options 
proposed, new approaches not yet considered, the potential impacts of 
the various options (including possible unintended consequences), and 
any data or information that you would like the Agency to consider 
during the development of the final rule. You may find the following 
suggestions helpful for preparing your comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the rule or collection 
activity.
    7. Make sure to submit your comments by the deadline listed under 
DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. Authority

    This document proposes a test rule under section 4(a)(1)(B) of 
TSCA, 15 U.S.C. 2603(a)(1)(B), that would require certain health and 
environmental tests for 37 chemical substances that are produced in 
substantial quantities, and that enter or may reasonably be anticipated 
to enter the environment in substantial quantities and/or to which 
there is or may be significant or substantial human exposure. The tests 
pertain to 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 (including five tests for physical chemical 
properties and biodegradation). Some or all of these

[[Page 81660]]

tests would be required for a particular chemical substance, depending 
upon what data are already available for that substance.
    Section 2(b)(1) of TSCA, 15 U.S.C. 2601(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 
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 must require by rule that testing be conducted on 
that chemical substance or mixture. The purpose of the testing would be 
to develop data about the substance or mixture's health and 
environmental effects where there is an insufficiency of data and 
experience, in order to support a determination that the manufacture, 
distribution in commerce, processing, use or disposal of the substance 
or mixture, or any combination of such activities, does or does not 
present an unreasonable risk of injury to health or the environment.
    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 
the chemical substance. 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 of any combination of such activities on health or the environment 
can reasonably be 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) in the 
Federal Register of May 14, 1993 (58 FR 28736) (Ref. 24 at 28738-
28739).
    In this proposed rule, EPA intends to use its broad TSCA section 4 
authority to obtain the data necessary to support the development of 
preliminary or ``screening level'' hazard and risk characterizations 
for certain HPV chemical substances (see Sec. 799.5085(j) of the 
proposed regulatory text for the list of chemicals). EPA has made 
preliminary findings for these chemicals under TSCA section 4(a)(1)(B) 
that: 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. Testing for additional HPV 
chemical substances (Ref. 1) will be proposed at a later date as the 
Agency learns more about these additional substances with respect to 
human exposure, release, and sufficiency of the data and experience 
available on the hazards of the substances.

III. Background

A. 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 reporting for EPA's Inventory Update Rule (IUR) (40 
CFR part 710), only 7% have a full set of publicly available 
internationally recognized basic health and environmental fate/effects 
screening test data (Ref. 2). Of the over 2,800 U.S. HPV chemicals 
based on 1990 data, 43% have no publicly available basic hazard data. 
For the remaining chemicals, limited amounts of the data are 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 right-to-
know about the hazards of chemicals that are found in their 
environment, their homes, their workplaces, and the products that they 
buy. It is EPA's intent to close this knowledge gap. EPA believes that 
for most of the HPV chemicals, insufficient data are readily available 
to reasonably determine or predict the effects on health or the 
environment from the manufacture (including importation), distribution 
in commerce, processing, use, or disposal of the chemicals, or any 
combination of these activities. EPA has concluded that a program to 
collect and, where needed, develop basic screening level toxicity data 
is necessary and appropriate to provide information in order to assess 
the potential hazards/risks that may be posed by exposure to HPV 
chemicals.
    On April 21, 1998, a national effort, known as the ``Chemical 
Right-To-Know'' (ChemRTK) Program, was announced in order to empower 
citizens with knowledge about the most widespread chemicals in 
commerce--chemicals that people may be exposed to in the places where 
they live, work, study, and play. EPA's ChemRTK Program is being 
designed in such a way as to make certain basic information about HPV 
chemicals available to the public.
    EPA plans to make available to the public the summarized data 
obtained on HPV chemicals. Additional information that EPA receives 
will also be shared with the public, other Federal agencies, and any 
other interested parties. 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. In addition, 
EPA and other parties agreed to work with other nations and 
international groups to ensure commensurate increases in the pace of 
complementary voluntary international data collection and development 
efforts on HPV chemicals.
    This ChemRTK Program is consistent with the U.S. policy as 
presented in the TSCA. Section 2(b)(1) of TSCA, 15 U.S.C. 2601(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

[[Page 81661]]

substances and mixtures on health and the environment and that the 
development of such data should be the responsibility of those who 
manufacture and those who process such chemical substances and 
mixtures.''

B. What Do We Currently Know About the Basic Health and Environmental 
Hazards of HPV Chemicals?

    The information relevant to understanding the basic health and 
environmental hazards of HPV chemicals is derived from a battery of 
tests agreed upon by the international community as appropriate for 
screening international HPV chemical substances for toxicity. Six basic 
testing endpoints have been adopted by the Organization for Economic 
Cooperation and Development (OECD) as the minimum required to screen 
international HPV chemical substances for toxicity (Ref. 4). The 
agreed-upon testing endpoints, known as the OECD's Screening 
Information Data Set (SIDS) include: Acute toxicity; repeat dose 
toxicity; developmental and reproductive toxicity; genetic toxicity 
(gene mutations and chromosomal aberrations); ecotoxicity (studies in 
fish, Daphnia, and algae); and 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). As conceived 
by the OECD, the ``SIDS battery'' of tests can be used by governments 
to conduct an initial assessment of the hazards and risks posed by HPV 
chemical substances and prioritize HPV chemicals to identify those in 
need of additional, more in-depth testing and assessment.
    A need for basic screening level data on HPV chemicals has been 
identified and supported by various data availability studies conducted 
by EPA and others. Toxic Ignorance, which was prepared by Environmental 
Defense (formerly the Environmental Defense Fund), raised a variety of 
concerns about the untested chemicals that are produced in and/or 
imported into the United States (Ref. 28). Environmental Defense found 
that baseline data on health effects were not publicly available for a 
selected set of 100 HPV chemicals.
    In April 1998, EPA completed a study entitled Chemical Hazard Data 
Availability Study: What Do We Really Know About the Safety of High 
Production Volume Chemicals? (Ref. 2) that evaluated the public 
availability of screening level health hazard data and environmental 
hazard/fate data on U.S. HPV chemicals. EPA's study found major gaps in 
the basic information on HPV chemicals that is readily available to EPA 
and to the public, and reinforced the need for governmental leadership 
on this issue. The study analyzed the availability of test data for 
2,863 HPV chemicals (defined as those non-polymeric organic substances 
produced in or imported into the United States in amounts equal to or 
greater than 1 million pounds per year based on 1990 reporting for 
EPA's IUR (40 CFR part 710). EPA searched for publicly available data 
on these chemicals and learned that most of them may never have been 
tested for any or most of the SIDS endpoints. The search strategy used 
a total of 11 publicly accessible data bases in its analysis. Details 
of the search strategy can be found in the report (Ref. 2). The major 
conclusions of EPA's study are described in Unit III.A.
    In June 1998, the American Chemistry Council (ACC, formerly the 
Chemical Manufacturers Association (CMA)) issued a report (Ref. 3) 
regarding public data availability for HPV chemicals based on a study 
conducted with 11 main data sources, including data sources other than 
those searched by EPA for its study. The ACC report, entitled Public 
Availability of SIDS-Related Testing Data for U.S. High Production 
Volume Chemicals (Ref. 3) reached conclusions similar to EPA, that is, 
that only limited toxicity and environmental fate data appear to exist 
in the public domain for many U.S. HPV substances. Details of the 
search strategy used can be found in the ACC report (Ref. 3).
    EPA recognizes that additional data may exist beyond those 
identified through either the EPA, ACC, or Environmental Defense 
studies. To the extent that additional relevant data are known to 
exist, EPA is particularly interested in receiving this information as 
part of the HPV Initiative (see Unit III.D.), including a full citation 
for publications and ``robust'' (i.e., detailed) summaries of pertinent 
published and unpublished studies. If relevant scientifically adequate 
existing data are submitted at any time before testing is initiated, 
including after the final rule is issued, the Agency will consider such 
data to determine if they satisfy the testing requirement and will take 
appropriate necessary action to ensure that unnecessary testing is no 
longer required. In addition, exemption procedures to be used are found 
at 40 CFR 790.80 and 790.82. Guidance on the preparation of robust 
summaries is available on EPA's ChemRTK website (Ref. 34).

C. Why is EPA Focusing on HPV Chemicals?

    It is generally accepted that chemicals having a high level of 
production have an increased potential for exposure in comparison to 
low production volume chemicals. The focus on HPV chemicals is derived 
from the experience gained over the past 15 years by EPA and the OECD. 
The OECD is an intergovernmental organization consisting of 29 
developed countries, including the United States, with advanced 
worldwide market economies. The OECD is helping coordinate a 
cooperative, international effort to secure basic toxicity information 
on HPV chemicals in use worldwide.
    The OECD, after considering a variety of priority setting 
approaches, concluded in 1990 that consideration of HPV status provided 
a useful and effective organizing focus for a voluntary testing and 
assessment effort to screen and thereby identify priorities among 
international HPV chemicals.
    In the late 1980s, OECD initiated a voluntary program to ensure 
that basic information is available on international HPV chemicals. 
This program, which is a part of the OECD's program on existing 
chemicals, produced an internationally agreed upon set of basic SIDS 
screening tests and is working to develop complete SIDS data sets for 
all international HPV chemicals. The SIDS includes information on the 
identity of each chemical, 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) 
assessment and to assign a priority for further work. By 1990, the 
United States and 13 other OECD member countries established a 
voluntary international testing program to develop the basic data set 
for all international HPV chemicals. To date, the OECD has initiated or 
completed work on approximately 500 chemicals.
    The OECD threshold for high production volume chemicals is 2.2 
million pounds (equivalent to 1 million kilograms) reported in any 
member country. (Note that the OECD HPV threshold, like the U.S. HPV 
threshold, is not applied to polymers. However, the OECD threshold, 
unlike the U.S. HPV threshold, is applied to inorganics (Ref. 5)). The 
presence of a chemical on the OECD's list of HPV chemicals was and 
continues to be accepted (Ref. 5) by OECD member countries as providing 
a sufficient indicator of potential

[[Page 81662]]

exposure to warrant testing at the SIDS level.
    EPA 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. 24). 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).
    In response to EPA's proposed ``B'' policy (Ref. 23), both ACC 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 
(Ref. 6 and 7). Additionally, they indicated that the OECD 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.
    The 1 million pound threshold for production normally used by EPA 
under the ``B'' policy generally narrowed the universe of chemicals 
potentially subject to TSCA section 4(a)(1)(B) to 11% of the TSCA 
Inventory of chemical substances (see TSCA sections 8(a) and 8(b)), 
using Inventory information available in 1988 (Ref. 23 at 32296). 
However, that small percentage of the Inventory accounts for 95% of 
total chemical production in the United States. EPA believes it 
reasonable to use this information as a basis for making a finding of 
``substantial production'' for substances produced at or above that 
threshold. Furthermore, EPA equates ``substantial production'' with 
production in ``high volumes.''
    The United States committed to conducting SIDS testing and 
assessment on 25% of the international HPV chemicals as its 
contribution to the OECD HPV SIDS effort; other countries' commitments 
for conducting SIDS testing and assessment on international HPV 
chemicals vary in proportion to the size of the country's gross 
domestic product. Because most of the international HPV chemicals are 
also commercially available in the United States, EPA considers the 
OECD HPV SIDS program to be an integral part of domestic testing 
activities. EPA, in developing and implementing the OECD HPV SIDS 
program, worked jointly with industry and environmental groups in the 
United States and with governments and industry in other OECD member 
countries to achieve the common goal of developing this minimum level 
of testing for HPV chemicals. EPA continues to work with other parties 
(international organizations, environmental groups, unions, animal 
welfare groups, other Federal agencies, and others) to secure their 
interest and continued support for this effort.
    Nevertheless, because of the slow pace of the OECD's international 
efforts to generate the needed data (which would have potentially 
required over 30 years to complete), the OECD has recognized the need 
to accelerate its efforts in order to ensure the availability of the 
basic data needed to support screening level assessments of 
international HPV chemicals. EPA has also recognized the need to 
accelerate its efforts to develop SIDS data on US HPV chemicals to 
support domestic efforts on chemicals. The HPV Initiative, which is 
described in Unit III.D., reflects EPA's interest in collecting, 
developing and making publicly available these needed data.

D. Why is EPA Proposing to Take this Action?

    A major component of the Agency's ChemRTK activity is the HPV 
Initiative, which is a data collection and development program 
established by EPA for existing U.S. HPV chemicals. Under this 
Initiative, HPV chemicals are defined as non-polymeric organic 
chemicals manufactured (including imported) at or above 1 million 
pounds per year based on information submitted under the 1990 TSCA IUR. 
The strategy and overall approach that EPA is using to address data 
collection needs for U.S. HPV chemicals are discussed in a separate 
document entitled Data Collection and Development on High Production 
Volume (HPV) Chemicals that is published elsewhere in this issue of the 
Federal Register (Ref. 27).
     Through the HPV Initiative, which includes a voluntary component 
(the HPV Challenge Program), certain international efforts, and 
rulemaking under TSCA such as this proposed rule, basic screening level 
hazard data necessary to provide critical information about the 
environmental fate and potential hazards associated with HPV chemicals 
will be collected or, where necessary, developed. Data collected and/or 
developed under the HPV Initiative, when combined with information 
about exposure and uses, will allow the Agency and others to evaluate 
and prioritize potential health and environmental effects and take 
appropriate follow up action. The HPV Initiative will generally be 
carried out in a manner consistent with the OECD HPV SIDS program to 
ensure that the data and information generated can be contributed to 
the international effort and, conversely, that international SIDS 
testing and assessments can be used to fulfill the data gaps identified 
as part of the HPV Initiative. Additional detailed information is 
available on the SIDS website (http://www.oecd.org/ehs/sidsman.htm) and 
EPA's ChemRTK website (http://www.epa.gov/chemrtk).
    The following is a brief summary of this HPV Initiative. For 
additional background information related to the HPV Initiative, please 
refer to the document that is published elsewhere in this issue of the 
Federal Register (Ref. 27).
    1. Voluntary HPV Challenge Program. A primary component of this HPV 
Initiative is the voluntary HPV Challenge Program, which was created in 
cooperation with industry, environmental groups, and other interested 
parties, and is designed to assemble and make publicly available basic 
screening level data on the potential hazards of U.S. HPV chemicals 
while avoiding unnecessary or duplicative testing. The voluntary HPV 
Challenge Program is described in detail the document that is published 
elsewhere in this issue of the Federal Register (Ref. 27).
    As of November 9, 2000, EPA has received full or provisional 
commitments from 469 companies, individually or through 187 consortia 
to sponsor 2,155 chemicals under in the voluntary HPV Challenge 
Program. Continually updated information regarding the chemicals being 
sponsored under the voluntary HPV Challenge Program and the names of 
company sponsors and consortia can be found on EPA's ChemRTK website 
(http://www.epa.gov/chemrtk/sumresp.htm), and on the US HPV Chemical 
Tracking System (http://www.hpvchallenge.com).
    Under the voluntary HPV Challenge Program, alternatives to the 
testing proposed under this proposed rule are available. For example, 
under the OECD HPV SIDS program, some instances have been identified 
where, using chemical category approaches, less than a full set of SIDS 
tests for every chemical in the category has been judged sufficient for 
screening purposes. In addition, the OECD HPV SIDS

[[Page 81663]]

program allows some use of structure activity relationships (SAR) 
analysis for individual chemicals. These strategies have the potential 
to reduce the time required to complete the program, the number of 
tests actually conducted, and the number of test animals needed.
    While EPA is encouraging the use of scientifically appropriate 
categories of related chemicals and SAR under the voluntary component 
of the HPV Initiative, these approaches are not included in this 
proposed rule. However, EPA has not identified any possibilities that 
will allow inclusion of the category and SAR approach for any chemicals 
listed in this proposed rule. EPA believes that the incorporation of 
such elements in a test rule would require complex, time consuming, and 
resource intensive procedural steps, such as multi-phase rulemaking. 
EPA specifically solicits comments and suggestions on procedures that 
would allow inclusion of such approaches in HPV test rules. EPA 
solicits comments on simplified procedures which would allow inclusion 
of such approaches in TSCA section 4 HPV SIDS rulemaking.
    Although the Agency believes that none of the chemicals included in 
this proposed rule appear to be candidates for these approaches, 
persons who believe that a chemical under this proposed rule can be 
dealt with using a category or SAR approach are encouraged to submit 
appropriate information, along with their comments which substantiate 
this belief. If, based on submitted information and other information 
available to EPA, the Agency determines that a chemical meets the 
requirements for consideration under a category or SAR approach, and 
that practicable measures are available at the time to modify the 
testing requirement, EPA will take such measures as are necessary to 
avoid unnecessary testing. Modifications can also be applied for after 
the final rule issues under 40 CFR 790.55 up to 60 days before the 
specified reporting deadline. Category or SAR approaches which 
represent significant alterations in the scope of testing, however, 
would likely require multi-phase rulemaking involving publication of 
additional Federal Register document(s) soliciting comment on the 
proposed procedures to be used. Comment is specifically requested on 
simplified approaches which might allow for the efficient and effective 
handling of category and SAR approaches via rulemaking.
    a. Can I still participate in the voluntary HPV Challenge Program? 
Certainly. Although the participants in the voluntary HPV Challenge 
Program were asked to submit commitments by December 1, 1999, you can 
still volunteer through a viable commitment (as described in Unit 
III.D.1.b) to sponsor chemicals under the HPV Challenge Program. 
Sponsors who wish to use alternative approaches to those proposed for a 
chemical listed in a proposed TSCA section 4 HPV SIDS rulemaking should 
seriously consider sponsoring that chemical in this under the voluntary 
HPV Challenge Program prior to the close of the comment period for that 
rulemaking.
    b. How can I participate in the voluntary HPV Challenge? At this 
stage, persons who wish to sponsor a chemical through a viable 
commitment under the HPV Challenge Program must submit the following:
    i. Commitment letter;
    ii. Test plan, robust summaries of existing studies with full 
citations of published studies and full copies of unpublished studies; 
and
    iii. Robust summaries of any newly conducted studies, and full 
copies of these studies.
    Commitments must be consistent with the guidance available on the 
ChemRTK website. Full commitments must specify the names and the 
Chemical Abstract Service (CAS) numbers of the chemicals to be 
sponsored, the year in which sponsors will begin the assessment of each 
chemical, and the name and contact information for the technical person 
within the company who should be reached for more information. 
Commitment letters under the voluntary HPV Challenge Program must be 
submitted to the EPA Administrator according to the instructions on the 
ChemRTK website (Ref. 35).
    EPA encourages industry and other interested parties to identify 
and provide any additional existing data which are relevant to the 
hazard characterization to avoid any unnecessary or duplicative 
testing. Furthermore, anyone may provide any relevant information to 
the Agency that indicates that certain endpoints need not be tested. If 
EPA judges the available data to be adequate, the data gap identified 
in the HPV Initiative will be considered to be filled. To the extent 
that additional data relevant to the HPV chemicals are known to exist, 
EPA is interested in receiving this information under the voluntary HPV 
Challenge Program. In addition to submitting the full citation for 
published studies and full copies of any unpublished studies, 
Commenters under the HPV Challenge Program and/or a proposed TSCA 
section 4 HPV SIDS rule(s) who wish to submit any additional relevant 
studies, are encouraged to also prepare a robust summary (Ref. 34) for 
each study to facilitate making the information publicly available, as 
well as facilitate its review.
    EPA plans to include in a final TSCA section 4 HPV SIDS rulemaking 
any chemical that is listed in a proposed rule, unless a sponsor, in 
addition to agreeing to making a viable commitment under the voluntary 
HPV Challenge Program, provides the following additional information:
    i. Evidence that work is underway and proceeding in a timely 
manner;
    ii. Data required to complete the SIDS battery are developed within 
the time frame set by EPA in the proposed rule; and
    iii. Robust summaries, and full copies of all final study reports 
from new studies and existing data submitted to EPA in a timely manner.
    Viable commitments that involve SAR and categories and that are 
consistent with the guidance available on the website (Ref. 30 and 31) 
regarding SAR and categories under the voluntary component of the HPV 
Initiative can still be submitted to EPA, but submission as early as 
possible will best avoid unnecessary or duplicative testing. If a 
viable commitment is made and kept, and the information is deemed 
adequate, EPA would not include that chemical in a final TSCA section 4 
HPV SIDS rulemaking.
    Additional information on the voluntary HPV Challenge Program is 
available on the ChemRTK website.
    2. Certain international efforts. To fill any data gaps not 
addressed as part of the voluntary HPV Challenge Program, EPA is 
continuing to participate in the international efforts coordinated by 
the OECD to secure basic hazard information on HPV chemicals in use 
worldwide, including some of those on the U.S. HPV chemicals list. This 
includes agreements to sponsor a U.S. HPV chemical under either the 
OECD HPV SIDS Program, including sponsorship by OECD member countries 
beyond the United States, or the international HPV Initiative that is 
being organized by International Council of Chemical Associations 
(ICCA). The OECD HPV SIDS Program has already been described in Unit 
III.C. 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 ICCA HPV Initiative 
calls for the testing and screening-level assessment of 1,000 ``high 
priority'' chemicals by the end of the year 2004. Most of the chemicals 
on the ICCA working list (Ref. 8) are also U.S. HPV chemicals. The ICCA 
testing/assessment work will be tied directly to that under

[[Page 81664]]

the OECD HPV SIDS Program and to the U.S. HPV Initiative.
    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 intended 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.
    3. TSCA rulemaking. In establishing the HPV Initiative in 1998, the 
Agency indicated that data needs which remain unmet in the voluntary 
HPV Challenge Program or through international efforts may be addressed 
through TSCA rulemaking. This proposed rule is the first rulemaking 
associated with the HPV Initiative, and addresses the unmet data needs 
of the 37 chemicals that are included in this proposed rule.

E. What Information is being Collected on HPV Chemicals?

    In identifying the data needs for chemicals contained in the HPV 
Initiative, EPA is utilizing information and sources in EPA's study, 
the Chemical Hazard Data Availability Study (Ref. 2), and ACC's report, 
i.e, Public Availability of SIDS-Related Testing Data for U.S. High 
Production Volume Chemicals (Ref. 3), to determine whether screening 
level data for characterizing the hazards of these HPV chemicals are 
publicly available. If no data are available for a SIDS testing 
endpoint, there cannot be sufficient data to characterize the potential 
hazards and risks associated with the chemical. As the Agency found in 
its study, insufficient data are available to characterize the hazards 
and risks of many of the U.S. HPV chemicals with respect to the 
internationally accepted 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 for 
environmental fate (including five tests for physical chemical 
properties [melting point, boiling point, vapor pressure, n-octanol/
water partition coefficient, and water solubility], and 
biodegradation). As a result, EPA and others cannot reasonably 
determine or predict the human health and environmental effects 
resulting from manufacture, processing, and use of these chemical 
substances.
    The OECD HPV SIDS Program is part of the OECD overall program on 
existing chemicals, and 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 data set 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. To 
date, the OECD has initiated or completed work on approximately 500 HPV 
chemicals. 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 III.B.). The SIDS data set is regarded as the minimum data set 
required to make an informed preliminary judgment about the hazards of 
a given HPV chemical.
     EPA is implementing the HPV Initiative as part of its domestic 
industrial chemical screening efforts, in a manner that is consistent 
with OECD efforts. The information to be gathered under EPA's HPV 
Initiative comes from the same battery of tests agreed upon by the OECD 
member countries as being appropriate for screening international HPV 
chemicals for toxicity and environmental fate (Ref. 4). As conceived by 
the OECD, the SIDS data set can be used by governments and others 
worldwide to conduct an initial assessment of the hazards and risks 
posed by HPV chemical substances and to prioritize chemicals to 
identify those which are in need of additional, more in-depth testing 
and assessment, as well as those of lesser concern.
    This proposed test rule is intended to obtain needed SIDS testing 
for 37 of the approximately 2,800 chemicals (excluding polymers and 
inorganics) that are produced and/or imported at high volumes in the 
United States. EPA has chosen this group of 37 chemicals for its 
initial TSCA section 4 HPV SIDS rulemaking because of their high 
production and/or importation volumes and their potential for exposure 
to a substantial number of workers.
    In developing the list of candidates for this proposed test rule, 
EPA included only chemical substances which were reported on 1994 TSCA 
section 8(a) IUR as being manufactured (including imported) in the 
United States in amounts greater than or equal to one million pounds. 
In addition, each of the candidate chemical substances listed in this 
proposed rule was identified in the National Occupational Exposure 
Survey (NOES) as having a total potential exposure of greater than 
1,000 or more workers. A potential exposure of 1,000 or more workers to 
a chemical substance is a threshold for ``substantial human exposure'' 
under EPA's ``B'' Policy (Ref. 24).
    The data availability study conducted by EPA, discussed in Unit 
III.B., demonstrated that only a limited number of HPV chemicals have a 
full set of publicly available SIDS data. For chemicals for which some 
data are available on one or more SIDS endpoints, EPA is not requiring 
testing for those endpoints. However, no definitive determination has 
been made as to the adequacy of those data for an initial assessment of 
a chemical's hazards or risks to health or the environment. The Agency 
intends to promulgate additional test rules for any HPV chemicals for 
which SIDS testing is needed and for which a voluntary commitment to 
collect, develop, and make publically available the needed data has not 
been received.

F. What Role do Existing Data Play Under the HPV Initiative?

    The HPV Initiative, including this rulemaking, is designed to make 
maximum use of scientifically adequate existing test data and to avoid 
unnecessary, duplicative testing, thereby avoiding the excessive use of 
animal testing. If at any time, including after this rule is finalized, 
the Agency receives adequate existing data that fulfill a specific data 
gap, EPA will ensure that unnecessary testing is not required.
    During the continued development of the HPV Initiative, EPA was 
encouraged to consider the relationship between existing data submitted 
under the HPV Initiative and reporting requirements under TSCA section 
8(e). In response to these concerns, and as part of the Agency's 
efforts to ensure the fullest use of existing test data, EPA intends to 
consider existing data submissions in the manner described in an 
October 14, 1999, letter to the voluntary HPV Challenge Program 
participants (herein after ``the October 14, 1999, letter'') (Ref. 29). 
EPA's guidance document on literature searches, which deals with part 
of this issue, is available on the Agency's ChemRTK website (Ref. 36). 
EPA believes that it is in the economic best interest of companies to 
identify and make publicly available all relevant existing data in 
order to reduce possible testing costs.
    Studies that have been conducted as specified in appropriate OECD 
test guidelines (as noted in the SIDS Manual (Ref. 4) or comparable EPA 
test guidelines (such as the OPPTS Harmonized Guidelines available at 
http://www.epa.gov/opptsfrs/home/guidelin.htm), and appropriate Good 
Laboratory Practice Standards (GLPS)

[[Page 81665]]

like those for TSCA (40 CFR part 792) consistently generate data 
adequate to fulfill the HPV Initiative needs. Data from studies that 
did not follow these procedures, however, may not be adequate.
    As stated in the October 14, 1999, letter to the voluntary HPV 
Challenge Program participants, in analyzing the adequacy of existing 
data, participants shall conduct a thoughtful and qualitative analysis 
rather than using a rote checklist approach (Ref. 29). The same 
principle applies to persons evaluating existing data in connection 
with this rulemaking. If EPA judges the available data to be adequate, 
the data gap identified in the HPV Initiative will be considered to be 
filled. EPA has developed a guidance document on determining data 
adequacy which is available on EPA's ChemRTK website (Ref. 37).
    EPA solicits comment concerning the availability of SIDS data on 
the chemicals included in the HPV Initiative and encourages industry 
and other interested parties to identify and provide any additional 
existing data which are relevant to hazard characterization to avoid 
any unnecessary or duplicative testing. Anyone may provide any relevant 
information to the Agency that indicates that certain endpoints need 
not be tested. If EPA judges the available data to be adequate, the 
data gap identified in the HPV Initiative will be considered to be 
filled. To the extent that additional data relevant to the HPV 
chemicals are known to exist, EPA is interested in receiving this 
information, including a full citation for publications and full copies 
of unpublished studies. Although the Agency encourages anyone with such 
information to submit it to EPA during the early stages of this 
Initiative in order to avoid any unnecessary testing, such submissions 
may be made at any time to allow EPA to take appropriate action. 
Commenters are also encouraged to prepare a robust summary (Ref. 34) 
for each study to facilitate EPA's review of the full study report or 
publication. It is important to note that EPA does not intend to 
include any chemicals which are Generally Recognized as Safe (GRAS) for 
a particular use by the Food and Drug Administration (FDA) in this 
initial TSCA section 4 HPV SIDS rulemaking. However, such chemicals may 
be included in a future TSCA section 4 HPV SIDS rulemaking where SIDS 
data needs remain unmet.

G. How Would the Data Developed Under this Test Rule be Used?

    The availability of hazard information on individual chemicals is 
fundamental to EPA's ability to accomplish its mission of environmental 
protection--risk assessment, risk management, safeguarding children's 
health, expanding the public's right-to-know, and promoting the 
pollution prevention ethic. Activities to ensure the availability of 
basic hazard information on HPV chemicals are an integral part of 
meeting these objectives.
     The testing proposed is essentially identical in scope and 
applicability to that which has been internationally agreed upon by the 
OECD as providing the minimum needed to screen HPV chemicals and 
identify priorities for additional testing or assessment. While the 
SIDS data set does not fully measure a chemical's toxicity, it does 
provide a consistent minimum set of information that can be used to 
determine the relative hazards and risks of chemicals and to judge if 
additional testing or assessment is necessary. Thus, EPA will use the 
data obtained from this proposed test rule to support development of 
preliminary hazard and risk assessments for these HPV chemicals. 
Furthermore, the data obtained under this testing program will be used 
to set priorities for further testing that will produce hazard 
information on these chemicals which is needed by EPA , other Federal 
agencies, the public, industry, and others, to support adequate risk 
assessments. EPA has used data from test rules to support such 
activities as the development of water quality criteria, Toxic Release 
Inventory listings, chemical advisories, and reduction of workplace 
exposures.

H. What is the Role of this Proposed Rule with Regard to the HPV 
Initiative?

    To fill data gaps not addressed as part of the voluntary HPV 
Challenge Program or international efforts, EPA indicated in the 
document that is published elsewhere in this issue of the Federal 
Register (Ref. 27) that it would supplement the voluntary HPV Challenge 
Program and international efforts with rulemaking under TSCA. 
Specifically, EPA intends to use its authority under section 4 of TSCA 
to propose the testing of those chemicals listed at http:/www.epa.gov/chemrtk/hpvchmtl.htm which have an indicator value of ``0,'' which 
identifies a chemical as a candidate for sponsorship under the 
voluntary HPV Challenge Program and a sponsorship status value of 
``N,'' i.e., not sponsored. EPA intends to issue additional test rules 
as needed to cover chemicals with unmet data needs or if voluntary HPV 
Challenge Program commitments are not met. 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. 8) will not 
be listed in any of these follow-up TSCA section 4 HPV SIDS rulemaking, 
unless commitments under those international programs are not met (see 
Unit. IV.G. of the document that is published elsewhere in this issue 
of the Federal Register (Ref. 27) for more information on these 
programs). In addition, as indicated in Unit IV.B.2. of the document 
that is published elsewhere in this issue of the Federal Register (Ref. 
27), chemicals identified as GRAS for a particular use by FDA are only 
intended to be included in a future TSCA section 4 HPV SIDS rulemaking 
if SIDS data needs remain unmet.
    As indicated in the October 14, 1999, letter to the participants in 
the voluntary HPV Challenge Program (Ref. 29), and restated in the 
document that is published elsewhere in this issue of the Federal 
Register (Ref. 27), EPA intends for the TSCA section 4 HPV SIDS 
rulemaking to proceed in a manner that is consistent with the 
principles outlined in the letter for the participants in the voluntary 
program. As such, EPA has incorporated the criteria established under 
the voluntary HPV Challenge Program into this rulemaking to the extent 
possible, and has also considered improvements based on experiences 
with implementing that Program.
     Potential endpoints for testing under test rules. As with 
the voluntary HPV Challenge Program, the test data needs that are 
addressed in this proposed rule pertain to physical/chemical 
properties, acute toxicity; repeat dose toxicity; developmental and 
reproductive toxicity; genetic toxicity, ecotoxicity; and environmental 
fate. Testing for some or all of these endpoints would be required for 
a particular chemical substance where such data are not already 
available for that substance. The specific testing, reporting, and 
recordkeeping requirements contained in this proposed rule are 
described for each chemical substance in the proposed regulatory text.
     Potential timetable for testing under test rules. EPA 
stated in the October 14, 1999, letter to the participants in the 
voluntary HPV Challenge Program (Ref. 29), that testing of closed 
system intermediates shall be deferred until 2003; and that testing of 
individual chemicals (i.e., those HPV chemicals not proposed for 
testing in a category) that require further testing on animals shall

[[Page 81666]]

be deferred until November 2001. EPA will use these time frames in the 
effective dates of TSCA section 4 HPV SIDS rulemakings as well.
     Existing data submissions during the rulemaking phase. As 
indicated in Unit III.B., if relevant scientifically adequate existing 
data are submitted to EPA during the comment period for this proposed 
rule, EPA does not intend to include that HPV chemical in the final 
rule. If relevant scientifically adequate existing data are submitted 
to EPA after the final rule is issued, or at any other time before 
testing is initiated, the Agency will consider such data to satisfy the 
testing requirement and will take any necessary action to ensure that 
unnecessary testing is not required.
     Treatment of testing endpoints under HPV SIDS test rules. 
EPA proposes that testing under this proposed rule be consistent with 
the voluntary HPV Challenge Program's treatment of the following 
endpoints:
    --Acute aquatic toxicity studies would not always be needed under 
the TSCA section 4 HPV SIDS rulemaking associated with this Initiative 
(See Unit V.A.3.).
    --Dermal toxicity or terrestrial toxicity testing would not be 
included in TSCA section 4 HPV SIDS rulemaking associated with this 
Initiative (See Unit III.I. and Unit V.A.).
    --The LD50 test (OECD 401) would not be needed for 
mammalian acute toxicity testing under the TSCA section 4 HPV SIDS 
rulemaking associated with this Initiative (See Unit V.A.4.).
    --EPA will encourage persons subject to the TSCA section 4 HPV SIDS 
rulemaking to use in vitro testing unless there are chemical properties 
(including chemical class considerations) or other aspects which may 
call its use into question (see Unit V.A.5.).
    --EPA will consider combining some of the mammalian toxicity 
protocols under TSCA section 4 HPV SIDS rulemaking associated with this 
Initiative (See Unit V.A.6.).
    If necessary for a particular chemical and/or endpoint, any 
variations are described in detail in this proposed rule.

I. How are Animal Welfare Issues being Considered in the HPV 
Initiative?

    EPA recognizes the concerns that have been expressed about the use 
of test procedures that require the use of animals. As discussed in 
Unit II.E. of the document that is published elsewhere in this issue of 
the Federal Register (Ref. 27), EPA is making every effort to ensure 
that as the HPV Initiative is implemented, unnecessary or duplicative 
testing is avoided and the use of animals is minimized. As a general 
matter, EPA does not require that tests on animals be conducted if an 
alternative scientifically validated method is found acceptable and 
practically available for use. Where testing must be conducted to 
develop adequate data, the Agency is committed to reducing the number 
of animals used for testing, to replacing test methods requiring 
animals with alternative test methods when acceptable alternative 
methods are available, and to refining existing test methods to 
optimize animal use when there is no substitute for animal testing. EPA 
believes that these reduction, replacement, and refinement objectives 
are all important elements in the overall consideration of alternative 
testing methods.
    The governmental and non-governmental scientific community is 
working to design, validate, and employ new methods of toxicity testing 
that are more accurate, less costly, and that reduce the need to use 
live animals. Over the years, significant research has been pursued to 
develop and validate non-animal test methods. U.S. scientists in 
academia, government, and industry have participated in both domestic 
and international efforts to develop alternative, non-animal tests. As 
part of the enterprise, the National Institute of Environmental Health 
Sciences (NIEHS) established a Federal Interagency Committee, the 
Interagency Coordinating Committee on Validation of Alternative Methods 
(ICCVAM), to review the status and validation of toxicological test 
methods including those that are performed in vitro. EPA scientists 
have contributed significantly to this body of knowledge and are 
continuing to play a vital role by developing test methods for 
consideration. Many test methods have begun the process of validation 
and several have completed the steps leading to government-wide 
regulatory acceptance. Within the SIDS battery of tests, certain in 
vitro genotoxicity tests, such as the Ames test for gene mutations in 
bacteria, have received uniform acceptance among regulatory agencies.
    In addition, as part of the voluntary HPV Challenge Program, EPA 
asked participants in that program to observe certain principles laid 
out in the October 14, 1999, letter, in which the Agency also indicated 
its intention that related TSCA rulemaking proceed in a manner 
consistent with the principles (Ref. 29). This letter is available in 
the public version of the official record for this rulemaking, as well 
as on EPA's ChemRTK website. In the letter, EPA requested that 
participants conduct a thoughtful, qualitative analysis of existing 
data before testing. EPA also asked that all animal testing on 
individual chemicals (as opposed to testing of categories of chemicals) 
under the voluntary HPV Challenge Program, or under an associated 
rule(s), not be initiated earlier than November 2001, and that testing 
of chemicals solely manufactured as closed system intermediates not 
begin earlier than 2003. This proposed rule reflects many of the 
principles presented in the referenced voluntary HPV Challenge Program 
letter. Certain components of these principles, however, are not 
pertinent to this proposed rule. For example, this proposed rule does 
not require any dermal toxicity testing or any terrestrial toxicity 
testing.
    Furthermore, a primary focus of the HPV Initiative, including the 
voluntary HPV Challenge Program and associated TSCA section 4 HPV SIDS 
rulemaking is to implement these efforts as contributors to a larger 
international activity with global involvement and in a manner 
consistent with meeting the needs of the OECD HPV SIDS program and to 
further the goals under Programme Area (c) of Agenda 21, Chapter 19 of 
the United Nations Conference on Environment and Development (UNCED) 
concerning information exchange on toxic chemicals and chemical risks. 
EPA solicits comment on the potential approaches that may be used to 
incorporate the principles contained in the October 14, 1999, letter in 
the context of TSCA section 4 HPV SIDS rulemakings (Ref. 29).

IV. EPA Findings

A. What is the Basis for EPA's Proposal to Test These Chemical 
Substances?

    As indicated in Unit II., in order to develop a rulemaking under 
TSCA section 4(a) requiring the testing of chemical substances or 
mixtures, EPA must make certain findings regarding either risk (TSCA 
section 4(a)(1)(A)(i)); or production and either chemical release or 
human exposure (TSCA section 4(a)(1)(B)(i)), with regard to those 
chemicals. EPA is proposing to require testing of the chemical 
substances included in this proposed test rule based on its preliminary 
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).
    In EPA's ``B'' policy (see Unit II.), ``substantial production'' of 
a chemical substance or mixture is generally interpreted to be 
aggregate production

[[Page 81667]]

(including import) volume equaling or exceeding 1 million pounds per 
year of that chemical substance or mixture. (Ref. 24 at 28747). For 
workers, the ``B'' policy threshold for ``substantial human exposure'' 
is the exposure of 1,000 workers annually to that chemical substance or 
mixture. (Ref. 24) See EPA's ``B'' policy for further discussion on how 
EPA makes decisions under TSCA section 4(a)(1)(B)(i). For the reasons 
set out in the ``B'' policy, EPA believes that the thresholds included 
in the ``B'' policy are appropriate for use in this proposed rule. 
(Ref. 24)
    EPA has found preliminarily that, under TSCA section 4(a)(1)(B)(i), 
each of the 37 chemical substances included in this proposed rule is 
produced in ``substantial'' quantities (see Unit IV.B.) and that there 
is or may be ``substantial human exposure'' to each chemical substance 
(see Unit IV.C.). In addition, under TSCA section 4(a)(1)(B)(ii), EPA 
believes 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 (see Unit IV.D.). In particular, EPA 
has preliminarily determined that there are insufficient data on these 
chemicals. EPA has also found preliminarily that testing the 37 
chemical substances identified in this Federal Register document is 
necessary to develop such data (TSCA section 4(a)(1)(B)(iii)) (see Unit 
IV.E.). EPA has not identified any ``additional factors'' as discussed 
in the ``B'' policy (Ref. 24 at 28746) to cause the Agency to use 
decisionmaking criteria other than those described in the policy.
    The chemical substances included in this proposed test rule are 
listed in Sec. 799.5085(j) of the proposed regulatory text along with 
their CAS numbers.

B. Are These Chemical Substances Produced and/or Imported in 
Substantial Quantities?

    Each of the chemical substances included in this proposal is 
produced and/or imported in an amount equal to or greater than one 
million pounds per year (Ref. 9), based on information gathered 
pursuant to the 1998 TSCA section 8(a) IUR (40 CFR part 710) which is 
the most recently available compilation of TSCA Inventory data, and 
which is contained in 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 and 1994 
IUR. EPA believes that these annual production and/or importation 
volumes are ``substantial'' as that term is used with reference to 
production in TSCA section 4(a)(1)(B)(i). (See also Ref. 24 at 28746).

C. Are a Substantial Number of Workers Exposed to These Chemicals?

    EPA finds that the manufacture, processing, and uses 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 proposed rule (Ref. 10).
    EPA defines chemical exposure as the contact of a chemical with a 
person's outer boundary (for example, the skin or lungs) (Ref. 11). 
Worker exposure is the chemical exposure that occurs while a person is 
working. Exposure to workers may have various causes. Chemical releases 
are a common cause of exposure. For example, a chemical manufacturing 
plant can release a chemical from pumps as fugitive emissions, from 
reactor and condenser vents as stack emissions, and/or as a 
particulate. Diffusion and air currents may carry a chemical through 
the air in the plant. Plant workers breathe air containing this 
chemical, resulting in exposures. Human activity such as manually 
transferring a chemical from one container to another may cause 
exposures.
    For each of the chemicals in this proposed rule, estimates for the 
number of exposed workers were identified in the National Occupational 
Exposure Survey (NOES). The NOES was a nationwide data gathering 
project conducted by the National Institute for Occupational Safety and 
Health (NIOSH), which was designed to develop national estimates for 
the number of workers potentially exposed to various chemical, physical 
and biological agents and describe the distribution of these potential 
exposures. Begun in 1980 and completed in 1983, the survey involved a 
walk-through investigation by trained surveyors of 4,490 facilities in 
523 different types of industries. Surveyors recorded potential 
exposures when a chemical agent was likely to enter or contact the 
worker's body for a minimum duration. These potential exposures could 
be observed or inferred. Information from these representative 
facilities was extrapolated to generate national estimates of 
potentially exposed workers for more than 10,000 different chemicals 
(Ref. 12). The NOES survey is the most recent and comprehensive source 
of this kind of information.
    Each of the chemicals in this proposed rule was identified in the 
NOES as having a total potential worker exposure of greater than 1,000 
workers (Ref. 10). EPA believes that an exposure of over 1,000 workers 
to a chemical substance is ``substantial'' as that term is used with 
reference to ``human exposure'' in section 4(a)(1)(B)(i) of TSCA. EPA 
believes, based on experience gained through case-by-case analysis of 
existing chemicals, that an exposure of 1,000 workers or more to a 
chemical substance is a reasonable interpretation of the phrase 
``substantial human exposure'' in TSCA section 4(a)(1)(B)(i). See 58 FR 
28736, 28746.

D. Do Sufficient Data Exist for These Chemical Substances?

    In developing the testing requirements for chemicals contained in 
this proposed rule, EPA utilized information and sources in EPA's 
study, the Chemical Hazard Data Availability Study (Ref. 2), and in 
ACC's study, the Public Availability of SIDS-Related Testing Data for 
U.S. High Production Volume Chemicals (Ref. 3), to determine whether 
screening level data for characterizing the risks of these HPV 
chemicals are available. Section 799.5085(j) of the proposed regulatory 
text lists each chemical and the tests for which no data are currently 
available to the Agency. If no data are available for a SIDS testing 
endpoint, there cannot be sufficient data to characterize the risk 
associated with exposure to the chemical. The Agency preliminarily 
finds that for the 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 for environmental fate 
(including five tests for physical chemical properties [melting point, 
boiling point, vapor pressure, n-octanol/water partition coefficient, 
and water solubility], and biodegradation), there are insufficient data 
and experience to reasonably determine or predict the human health and 
environmental effects resulting from manufacture, processing, and use 
of the chemical substances included in this proposal.
     EPA solicits comment concerning the availability of SIDS data on 
these substances and encourages industry and others to identify and 
provide any additional existing test data which are relevant to the 
proposed testing. If EPA judges such data to be sufficient, 
corresponding testing will not be

[[Page 81668]]

included in the final rule. To the extent that additional data relevant 
to the testing proposed in this rulemaking are known to exist, EPA 
strongly encourages the submission of this information as comments to 
the proposed rule, including full citations for publications and full 
copies of unpublished studies. Commenters are also encouraged to 
prepare a robust summary (Ref. 34) for each such study to facilitate 
EPA's review of the full study report or publication. EPA has not 
included any chemicals in this proposal which are GRAS for a particular 
use by the FDA. As indicated in Unit III.F., such chemicals may be 
included in a future TSCA section 4 HPV SIDS rulemaking where SIDS data 
needs remain unmet.

E. Is Testing Necessary for These Chemical Substances?

     Of the nearly 3,000 chemicals that the U.S. manufactures at more 
than 1 million pounds per year, EPA's study concluded that 43% of them 
have no SIDS data. For the remaining chemicals, generally limited 
amounts of the data appear to be available (see Unit III.A. and Ref. 
2). The lack of available data compromises EPA's and others' ability to 
determine whether these chemicals pose unreasonable risks to human 
health or the environment, as well as the public's right to know about 
the hazards of chemicals that are found in their environment, their 
homes, their workplaces, and the products that they buy. It is EPA's 
intent to close this knowledge gap. EPA will use the data obtained from 
this proposed rule to support development of preliminary hazard and 
risk assessments for these HPV chemicals and to set priorities for 
further testing that will produce more definitive hazard information 
where needed on such chemicals. Such additional information is needed 
by EPA, other Federal agencies, the public, industry, and others to 
ensure that adequate hazard and risk assessments can be conducted on 
these chemicals. EPA has used data from test rules to support such 
activities as the development of water quality criteria, Toxic Release 
Inventory listings, chemical advisories, and input for actions 
resulting in reduction of workplace exposures.
    EPA believes that conducting the needed SIDS testing identified for 
the 37 subject chemicals will provide data relevant to a determination 
of whether the manufacture, processing, and use of the chemical 
substances does or does not present an unreasonable risk of injury to 
human health and the environment.

V. Proposed Rule

A. What Testing is being Proposed in this Action?

    EPA is proposing specific testing and reporting requirements for 
the chemical substances specified in Sec. 799.5085(j) of the proposed 
regulatory text.
    All of the proposed testing requirements are listed in Table 2 in 
Sec. 799.5085(j) of the proposed regulatory text and consist of a 
series of test methods covering many of the endpoints in the OECD HPV 
SIDS testing battery. Most of the proposed testing requirements for a 
particular endpoint are specified in one test standard, although in the 
case of certain endpoints, any of one or more listed methods could be 
used. The following endpoints and proposed test standards would be 
required under this proposed rule. For several of the proposed test 
standards, EPA has identified and is proposing certain ``Special 
Conditions'' as discussed below in this unit. Because terrestrial 
toxicity testing will normally be considered to belong at the OECD 
post-SIDS tier, EPA is not proposing any terrestrial toxicity testing 
(including avian toxicity) in this rulemaking.
    1. Physical/Chemical Properties.
        Melting Point: American Society for Testing and Materials 
(ASTM) E 324 (capillary tube)
        Boiling Point: ASTM E 1719 (ebulliometry)
        Vapor Pressure: ASTM E 1782 (thermal analysis)
        n-Octanol/Water Partition Coefficient: Method A (40 CFR 
799.6755--shake flask)
            Method B (ASTM E 1147--liquid chromatography)
            Method C (40 CFR 799.6756--generator column)
      Water Solubility: Method A: (ASTM E 1148--shake flask)
            Method B: (40 CFR 799.6784--shake flask)
            Method C: (40 CFR 799.6784--column elution)
            Method D: (40 CFR 799.6786--generator column)
    For the n-Octanol/Water Partition Coefficient and Water Solubility 
endpoints, EPA is proposing that certain ``Special Conditions'' in the 
form of the chemical substance's physical/chemical properties or 
physical state (acute only) be considered by test sponsors in 
determining the appropriate test method that would be used from among 
those included for these endpoints in Table 2 in Sec. 799.5085(j) of 
the proposed regulatory text.
    For the ``n-Octanol/Water Partition Coefficient'' endpoint, the 
test method, if any, would be determined by the test substance's 
estimated n-octanol/water partition coefficient (log 10 basis; ``log 
Kow''). EPA proposes three methods for measuring the 
substance's n-Octanol/Water Partition Coefficient. The method that 
would be required would be based on the test substance's estimated log 
Kow. Prior to determining the appropriate standard to use, 
if any, to measure the n-octanol/water partition coefficient, EPA is 
recommending that the log Kow be quantitatively estimated. 
EPA suggests that the method described in Atom/Fragment Contribution 
Method for Estimating Octanol-Water Partition Coefficients (Ref. 13) be 
used in making such an estimation. EPA is proposing that test sponsors 
be required to submit with the final study report the underlying 
rationale for the test standard selected for this endpoint. EPA is 
proposing this approach 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 (799.6755--shake flask) 
will work and Method B (ASTM E 1147) and Method C (799.6756--generator 
column) become more suitable, especially Method C. The proposed test 
methodologies 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 n-Octanol/Water 
Partition Coefficient tests be conducted at pH 7 to ensure 
environmental relevance. The proposed test standards and log 
Kow ranges that would determine which tests must be 
conducted for this endpoint are shown below:

[[Page 81669]]



 
------------------------------------------------------------------------
                                Test requirements
      Testing category           and references      Special conditions
------------------------------------------------------------------------
Physical/Chemical Properties  n-Octanol/Water       n-Octanol/Water
                               Partition             Partition
                               Coefficient:          Coefficient:
                              The appropriate n-    Which method is
                               Octanol/Water         required, if any,
                               Partition             would be determined
                               Coefficient test,     by the test
                               if any, would be      substance's
                               selected from those   estimated n-octanol/
                               listed below--see     water partition
                               Special Conditions    coefficient (log 10
                               in the adjacent       basis). Test
                               column..              sponsors would be
                              Method A: 40 CFR       required to submit
                               799.6755 (shake       in the final study
                               flask).               report the
                              Method B: ASTM E       underlying
                               1147 (liquid          rationale for the
                               chromatography).      method selected. In
                              Method C: 40 CFR       order to ensure
                               799.6756 (generator   environmental
                               column).              relevance, EPA is
                                                     recommending that
                                                     the selected study
                                                     be conducted at pH
                                                     7.
                                                    log Kow <0: no
                                                     testing required.
                                                    log Kow range 0--1:
                                                     Method A or B.
                                                    log Kow range 1-4:
                                                     Method A or B or C.
                                                    log Kow range 4--6:
                                                     Method B or C.
                                                    log Kow>6: Method C.
------------------------------------------------------------------------

    For ``Water Solubility,'' the test method, if any among the four 
proposed, would 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 Improved Method for 
Estimating Water Solubility From Octanol/Water Partition Coefficient 
(Ref. 14). EPA is also proposing that test sponsors be required to 
submit in the final study report the underlying rationale for the test 
standard selected for this endpoint. The proposed test methodologies 
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 is proposing for use in selecting an appropriate 
proposed test standard are shown below:

 
------------------------------------------------------------------------
                                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      would be determined
                               Water Solubility      by the test
                               would be selected     substance's
                               from those listed     estimated water
                               below--see Special    solubility. Test
                               Conditions in the     sponsors would be
                               adjacent column .     required to submit
                              Method A: ASTM E       with the final
                               1148 (shake flask).   study report the
                              Method B: 40 CFR       underlying
                               799.6784 (shake       rationale for the
                               flask).               method selected. In
                              Method C: 40 CFR       order to ensure
                               799.6784 (column      environmental
                               elution).             relevance, EPA
                                                     recommends that the
                                                     selected study be
                                                     conducted at pH 7.
                              Method D: 40 CFR      >5,000 milligram/
                               799.6786 (generator   Liter (mg/L):
                               column)               Method A or B.
                                                    <5,000 mg/L but > 10
                                                     mg/L: Method A, B,
                                                     C, or D.
                                                    <10 mg/L but > 0.001
                                                     mg/L: Method C or
                                                     D.
                                                    <0.001 mg/L: No
                                                     testing required.
------------------------------------------------------------------------

      
    2. Environmental Fate and Pathways.
      Inherent Biodegradation: ASTM 1625-94 (Semicontinuous Activated 
Sludge Test) or International Standards Organization (ISO) 9888 (Zahn-
Wellens Method)
    3. Aquatic Toxicity.
        Test Group 1: Acute toxicity to fish (ASTM E 729)
          Acute toxicity to Daphnia (ASTM E 729)Toxicity to plants 
(algae) (ASTM E 1218)
        Test Group 2: Chronic toxicity to Daphnia (ASTM E 1193)
          Toxicity to plants (algae) (ASTM E 1218)
    For ``Aquatic Toxicity,'' the OECD HPV SIDS test battery recognizes 
that for certain chemicals acute toxicity studies are of limited value 
in assessing the substances' aquatic toxicity. This issue arises when 
considering 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 battery 
recommends use of chronic toxicity testing in Daphnia in place of acute 
toxicity testing in fish and Daphnia. EPA is proposing that the testing 
requirement be determined based on the test substance's log 
Kow as determined by using the approach outlined in Unit 
V.A.1. ``n-Octanol/Water Coefficient'' and in Table 2 in 
Sec. 799.5085(j) of the proposed 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 2 in 
Sec. 799.5085(j) of the proposed regulatory text) are proposed: 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 2 in Sec. 799.5085(j) of the proposed regulatory text) are 
proposed: Chronic toxicity to Daphnia (ASTM E 1193) and Toxicity to 
plants (algae) (ASTM E 1218). As outlined in Table 2 in 
Sec. 799.5085(j) of the proposed regulatory text, depending on the 
testing proposed in Test Group 1, the Test Group 2 chronic Daphnia test 
may substitute for either or both the acute fish toxicity test and the 
acute Daphnia test.
    EPA recognizes that in some circumstances, acute aquatic toxicity 
testing (Test Group 1) may be relevant

[[Page 81670]]

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. 15, 16, 
and 17). 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. 18). For the purposes of this proposed rulemaking, 
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 Persistent, Bioaccumulative and 
Toxic (PBT) Policy Statement under section 5 of TSCA (63 FR 53417, 
October 5, 1998) (FRL-5771-6) Policy Statement under TSCA section 5 
entitled Category for Persistent, Bioaccumulative, and Toxic New 
Chemical Substances (64 FR 60194, November 4, 1999) (FRL-6097-7)] (Ref. 
25). EPA has also used a measured BCF that is ``equal to or greater 
than 1,000x or, in the absence of bioconcentration data, a log P [same 
as 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 (Significant New Use Rules; General 
Provisions For New Chemical Follow-Up under sections 5 and 26(c) of 
TSCA (54 FR 31307, July 27, 1989; see also 40 CFR 721.3) (Ref. 26). EPA 
considers the difference between the log Kow of 4.3 cited in 
the 1989 Federal Register document and the log Kow value of 
4.2 cited in this proposed 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. One approach for dealing with such 
chemicals would be to allow test sponsors who wish to conduct Test 
Group 1 studies on chemicals with a log Kow greater than or 
equal to 4.2 to submit to EPA for approval a written request to conduct 
these Test Group 1 studies. The written request would have to include 
the rationale for conducting these Test Group 1 studies and be approved 
by the Agency prior to (e.g., 90 days before) initiating these Test 
Group 1 studies. EPA is soliciting public comment on this approach as 
well as other alternative approaches in this area.
    4. Mammalian Toxicity--Acute.
      Acute Inhalation Toxicity (rat): Method A (40 CFR 799.9130)
      Acute Oral Toxicity (rat): Method B (ASTM E 1163-98 or 40 CFR 
799.9110(d)(1)(i)(A))
    For the ``Mammalian Toxicity--Acute'' endpoint, EPA is proposing 
that certain ``Special Conditions'' in the form of the chemical 
substance's physical/chemical properties or physical state be 
considered in determining the appropriate test method that would be 
used from among those included for this endpoint in Table 2 in 
Sec. 799.5085(j) of the proposed 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 
proposing 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 2 in Sec. 799.5085(j) of the proposed regulatory 
text). In the case of a potentially explosive test substance, care must 
be taken to avoid the generation of explosive concentrations. For all 
other chemicals (i.e., those that are either liquids or solids at room 
temperature), EPA is proposing that the acute toxicity testing be 
conducted via oral administration using an ``Up/Down'' test method 
(described as Method B (ASTM E 1163-98 or 40 CFR 799.9110(d)(1)(i)(A)) 
in Table 2 in Sec. 799.5085(j) of the proposed regulatory text). Dermal 
toxicity testing is not required in this rulemaking, and the Agency 
does not intend to include any dermal toxicity testing in any TSCA 
section 4 HPV SIDS rulemakings.
    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 use either the In Vivo Mammalian Bone Marrow Chromosomal 
Aberration Test (rodents: mouse (preferred species), rat, or Chinese 
hamster): 40 CFR 799.9538, or the In Vivo Mammalian Erythrocyte 
Micronucleus Test (sampled in bone marrow) (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 (Mammalian 
Chromosome Aberration Test) to generate 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 proposed 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 
proposed approach provides the same degree of flexibility as that which 
currently exists under the OECD HPV SIDS testing program (Ref. 4). A 
subject person who uses one of the in vivo methods instead of the in 
vitro method to address this end-point must submit to EPA a rationale 
for conducting that alternate test in the final study report. EPA 
solicits 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 planned initiation of those studies. Comments should 
include suggestions for efficient procedures for such a notification 
process.
    6. Mammalian Toxicity--Repeated Dose/Reproduction/Developmental.
        Combined Repeated Dose Toxicity Study with the Reproduction/
Developmental Toxicity Screening Test: 40 CFR 799.9365
        Reproduction/Developmental Toxicity Screening Test: 40 CFR 
799.9355
        Repeated Dose 28-Day Oral Toxicity Study: 40 CFR 799.9305
    For ``Mammalian Toxicity--Repeated Dose/Reproduction/
Developmental,'' 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 (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 place of the Combined Repeated Dose 
Toxicity Study with Reproduction/Developmental Toxicity Screen must 
submit to EPA a rationale for conducting these alternate tests in the 
final study reports. EPA solicits comment on whether the Agency should 
instead require that a subject person

[[Page 81671]]

wishing to use an alternate testing scheme submit to EPA a notice that 
includes the rationale for conducting the alternative tests prior to 
planned initiation of those studies. Comments should include 
suggestions for efficient procedures for such a notification process.
    Certain of the chemicals for which Mammalian Toxicity--Repeated 
Dose/Reproduction/ Developmental testing is proposed may be used solely 
as ``closed system intermediates,'' as described in the EPA guidance 
document developed for the voluntary HPV Challenge Program (Ref. 32). 
As described in that guidance, such chemicals may be eligible for a 
reduced testing battery which substitutes a developmental toxicity 
study for the SIDS requirement to address repeated dose (e.g., 
subchronic), reproductive, and developmental toxicity. In other words, 
since only the developmental toxicity study would be conducted for 
those chemicals that qualify for a reduced testing battery, repeated 
dose (e.g., subchronic) and reproductive studies would not be 
conducted. At the present time, EPA does not have sufficient 
information to know with any degree of certainty which if any of the 
chemicals that are listed in the proposed regulatory text are solely 
closed system intermediates as defined by OECD/SIDS guidelines. Persons 
who believe that a chemical fully satisfies the terms outlined in the 
guidance document are encouraged to submit appropriate information 
along with their comments which substantiate this belief. If, based on 
submitted information and other information available to EPA, the 
Agency believes that a chemical is considered likely to meet the 
requirements for use solely as a closed system intermediate, EPA will 
address any developmental toxicity testing need in a subsequent 
rulemaking. In those cases in which the Agency can determine that 
chemicals are solely closed system intermediates, it plans to handle 
them in accordance with the existing OECD procedures. EPA intends that 
actual initiation of testing of closed system intermediates be deferred 
until 2003.

B. When Would any Testing Imposed by this Rulemaking Begin?

    The testing requirements contained in this proposed rule are not 
effective until and unless the Agency issues a subsequent final rule. 
Based on the effective date of the final rule, which is typically 30 
days after the publication of a final rule in the Federal Register, the 
test sponsor may plan the initiation of any required testing as 
appropriate to submit the required final report by the deadline 
indicated as the number of months after the effective date that would 
be shown in Sec. 799.5085(j) of the proposed regulatory text. As 
indicated previously, in establishing the time frame for testing under 
this rulemaking, the Agency will consider the time frames used under 
the voluntary HPV Challenge Program. Specifically, any testing of 
closed system intermediates (as described in Unit III.I.) will be 
deferred until 2003; and any testing of individual chemicals (i.e., 
those HPV chemicals not proposed for testing in a category) that 
require further testing on animals will be deferred until November 
2001.

C. How Would the Studies Proposed Under this Test Rule be Conducted?

    Persons required to comply with the final rule would have to 
conduct the necessary testing in accordance with those testing and 
reporting requirements, and with the TSCA GLPS (40 CFR part 792).

D. What Substances Would be Tested Under this Rule?

    EPA is proposing two distinct approaches for identifying the 
specific substances that would be tested under this proposed rule, the 
application of which would depend on whether the substance is 
considered to be a ``Class 1'' or a ``Class 2'' chemical substance. 
First introduced when EPA compiled the TSCA Chemical Substance 
Inventory, 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. By contrast, the term Class 2 
chemical substance refers to a chemical substance having a composition 
that cannot be represented by a specific, complete chemical structure 
diagram, because such a substance generally contains two or more 
different chemical species (not including impurities). Table 2 in 
Sec. 799.5085(j) of the proposed regulatory text identifies the listed 
substances as either Class 1 or Class 2 substances.
    EPA is proposing that, for the Class 1 chemical substances that are 
listed in the proposed rule, the test substance have a purity of 99% or 
greater. EPA has generally applied this standard of purity to the 
testing of Class 1 chemical substances in the past under TSCA section 
4(a) testing actions, except for substances where it has been shown 
that such purity is unattainable. EPA is soliciting comment on whether 
a purity level of 99% or greater cannot be attained for any of the 
Class 1 substances listed in this proposed rule. For the Class 2 
chemical substances that are listed in the proposed rule, EPA is 
proposing that the test substance be any representative form of the 
chemical substance, to be defined by the test sponsor(s).
    In proposing a different approach for identifying the substance to 
be tested with regard to Class 2 substances, EPA recognizes two 
characteristics which further distinguish Class 1 from Class 2 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 formulae, 
structural diagrams, and compositional percentages of all species 
present (for example, methyl phenol);
     Less well-characterized, for example, characterized only 
by molecular formulae, non-specific structural diagrams, and/or by 
incomplete or unknown compositional percentages of the species present 
(for example, C12-C14 tert-akyl 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 of 
manufacture used to manufacture the substance (for example, nut shell 
liquor of cashew).
    Secondly, 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. A 
``Class 2'' designation most frequently represents a group of 
substances comprising substances that have similar combinations of 
different chemical species and/or that were prepared from similar 
feedstocks using similar production methods. By contrast, Class 1 
substances generally represent a much narrower group of substances for 
which the only variables are their impurities.
    EPA believes that, for purposes of this proposed rule which would 
require basic screening-level testing, the testing of any 
representative form of a subject Class 2 substance would be relevant to 
a determination of whether the chemical substance would or would not 
present an unreasonable risk to human health or the environment. 
However, EPA would encourage the selection of representative forms of 
test substances

[[Page 81672]]

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.
    As an alternative to requiring the testing of a representative form 
of a Class 2 substance designated by a person subject to the final 
rule, EPA is considering whether the Agency should specify the 
particular form of each substance that must be tested, and, if so, what 
criteria EPA should use to identify the particular representative form 
that would be tested. EPA might specify, for example, a form of a 
substance that meets an industry or consensus specification, if one 
exists, or the form with the highest production volume, which could 
potentially be identified via information reported under a TSCA section 
8(a) rule, or by other means.
    Under both of the approaches described in this unit, manufacturers 
and processors of each chemical substance listed in the rule would be 
jointly responsible for the testing of a representative form of each 
Class 2 substance.
    EPA is also considering whether, for some or all Class 2 
substances, more than one form of a substance should be tested. 
Regardless of which of the above approaches for testing Class 2 
substances is ultimately chosen (i.e., persons subject to the rule 
choosing vs. EPA choosing the forms(s) of the Class 2 substances to be 
tested), EPA is considering requiring that persons applying for an 
exemption provide data to EPA that would allow the Agency to determine 
whether:
    1. The form of the Class 2 substance with respect to which an 
exemption application is being submitted is equivalent to the form of a 
test substance for which data required under the rule have been or will 
be submitted; and
    2. The submission of the required test data concerning a particular 
form of a Class 2 substance would be duplicative of data that have been 
or will be submitted to EPA in accordance with the test rule.
    To facilitate EPA's review of exemption applications under this 
alternative, the Agency would require the submission of certain 
chemical substance-identifying data, including characteristics and 
properties of the exemption applicant's substance, such as boiling 
point, melting point, chemical analysis, additives (if any), and 
spectral data information.
    EPA solicits comment on the proposed alternative approaches to the 
testing of Class 2 substances included in this proposed rule. 
Additionally, EPA solicits comment on whether the proposed approach for 
testing Class 1 substances in the proposed rule, i.e., that Class 1 
test substances have a purity of 99% or greater, should be applied to 
any Class 2 substances in the proposed rule. Similarly, EPA solicits 
comment on whether the proposed or alternative approaches for the 
testing of Class 2 substances should be applied to any Class 1 
substances.

E. Would I Be Required to Test Under this Rule?

    Under TSCA section 4(a)(1)(B)(ii), EPA has made preliminary 
findings that there are insufficient data and experience to reasonably 
determine or predict health and environmental effects resulting from 
the manufacture, processing, or use of the chemical substances listed 
in this rulemaking. As a result, under TSCA section 4(b)(3)(B), 
manufacturers and processors of these substances would be subject to 
the rule with regard to those listed chemicals which they manufacture 
or process.
    1. Would I be subject to this rule? You would be subject to this 
rule and may be required to test if you manufacture or process, or 
intend to manufacture or process, one or more chemical substances 
listed in this proposed rule during the time period discussed in Unit 
V.E.2 , entitled When would my manufacture or processing (or my intent 
to do so) cause me to be subject to this rule? However, if you do not 
know or cannot reasonably ascertain that you manufacture or process a 
listed test 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 unreasonable burden), you would not be subject to the 
rule.
    2. When would my manufacture or processing (or my intent to do so) 
cause me to be subject to this rule? You would be subject to this rule 
if you manufacture or process, or intend to manufacture or process, a 
substance listed in the rule at any time from the effective date of the 
final test rule to the end of the test data 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. , entitled How do the 
reimbursement procedures work?
    3. Would I be required to test if I were subject to the rule? It 
depends on the nature of your activities. All persons who would be 
subject to this TSCA section 4(a) test rule, which incorporates EPA's 
generic procedures applicable to TSCA section 4(a) test rules 
(contained within 40 CFR part 790), would fall into one of two groups, 
designated here as Tier 1 and Tier 2. Persons in Tier 1 (those who 
would have to initially comply with the final 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 would not have to initially comply 
with the final 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 , 
entitled What would my obligations be if I were in Tier 2? Note that 
persons in Tier 1 who obtain exemptions and persons in Tier 2 would 
nonetheless be subject to providing reimbursement to persons who 
actually conduct the testing, as described in Unit V.E.4. , entitled 
How do the reimbursement procedures work?
    a.Who would be in Tier 1 and Tier 2? All persons subject to this 
rule would be considered to be in Tier 1 unless they fall within Tier 
2. The following table describes who is in Tier 1 and Tier 2.

   Table 2.--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   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
                                          substance (as defined at 40
                                          CFR 710.4(b));

[[Page 81673]]

 
                                         --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
                                          (as described at 40 CFR
                                          790.42(a)(5))
                                         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 would it be appropriate for a person in Tier 1 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)) in Tier 1. 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)(7) of the proposed regulatory 
text. In this rule, EPA would not require 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. 
See Sec. 799.5085(j) of the proposed regulatory text for a description 
of the substances that would be tested under this proposed rule.
    c. What would happen if I were in Tier 1 and I submitted an 
exemption application? EPA believes that requiring the collection of 
duplicative data is unnecessarily burdensome. As a result, if EPA has 
received a letter of intent to test from another source or has received 
(or expects to receive) the test data that would be required under this 
rule, the Agency would conditionally approve your exemption application 
under 40 CFR 790.87. The Agency would terminate conditional exemptions 
if a problem occurs with the initiation, conduct, or completion of the 
required testing, or the submission of the required data to EPA. EPA 
may then require you to submit a notice of intent to test or an 
exemption application. See 40 CFR 790.93 and Sec. 799.5085(c)(6) of the 
proposed regulatory text. Note that persons in Tier 1 who obtain 
exemptions and persons in Tier 2 would nonetheless be subject to 
providing reimbursement to persons who do actually conduct the testing, 
as described in Unit V.E.4., entitled How do the reimbursement 
procedures work?
    d. What would my obligations be if I were in Tier 2? If you are in 
Tier 2, you would be subject to the rule and you would be 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 would not need to take any action 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 notice of intent to test or an 
exemption application. See 40 CFR 790.93 and Sec. 799.5085(c)(6) of the 
proposed regulatory text.
    In addition, you would need to submit a notice of intent to test or 
an exemption application if:
     No manufacturer in Tier 1 has notified EPA of its intent 
to conduct testing; and
     EPA has published a document in the Federal Register 
directing all persons in Tier 2 to submit to EPA letters of intent to 
conduct testing or exemption applications. See 40 CFR 790.48(b) and 
Sec. 799.5085(c)(4) and (c)(5) of the proposed 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 
rule.
    e. 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 
proposed rule, EPA is proposing to set forth certain requirements that 
differ from those under 40 CFR part 790.
    Under 40 CFR part 790, in TSCA section 4(a) test rules EPA 
traditionally has treated the persons specified below as being in Tier 
2. (These rules are found at 40 CFR part 799, subparts B and D.):
     Processors (40 CFR 790.42(a)(2));
     Manufacturers of less than 500 kg (1,100 lbs) per year 
(``small-volume manufacturers'') (40 CFR 790.42(a)(4)); and
     Manufacturers of small quantities for research and 
development (``R&D manufacturers'') (40 CFR 790.42(a)(5)).
    EPA has historically placed processors in Tier 2 because the Agency 
``expected that, in most cases, testing will be performed by the 
manufacturers and that part of the cost of testing will be passed on to 
processors through the pricing mechanism, thereby enabling them to 
share in the costs of testing'' (50 FR 20652, 20654, May 17, 1985). In 
addition, ``[t]here are so many processors that it would be difficult 
to include them all in the technical decisions about the tests and in 
the financial decisions about how to allocate the costs'' (48 FR 31786, 
31789, July 11, 1983).
     EPA has historically placed small-volume manufacturers and R&D 
manufacturers in Tier 2 because this type of manufacturing ``normally 
represents a small percentage of the overall production volume [and] 
test sponsors are not expected to expend the administrative resources 
to recover the small proportional amounts of the testing costs from 
these manufacturers'' (55 FR 18881, May 7, 1990).
    In this proposed test rule, EPA has reconfigured these tiers. 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. The Agency took 
administrative burden and complexity into account in determining who 
was to be in Tier 1 in this proposed rule. EPA believes that those 
persons in Tier 1 who would conduct testing under this proposed rule, 
when finalized, would generally be large chemical manufacturers who, in 
the experience of the Agency, have traditionally conducted testing or 
participated in

[[Page 81674]]

testing consortia under previous TSCA section 4(a) test rules.
    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 a substance would not be subject to the 
proposed rule. See Unit V.E.1. and Sec. 799.5085(b)(2) of the proposed 
regulatory text.
    Under 40 CFR 790.42(a)(4), certain small-quantity manufacturers 
(i.e., those who manufacture less than 500 kg (1,100 lb) of the test 
rule chemical annually) do not initially need to submit letters of 
intent to test or exemption applications under a test rule unless EPA 
specifically requires them to do so. EPA established this provision 
because such small-quantity manufacturing normally represents a small 
percentage of the overall production volume, so that test sponsors are 
not expected to expend the administrative resources necessary to seek 
reimbursement of the associated small proportional amounts of the 
testing costs from these small-quantity manufacturers. As a result, EPA 
determined that the reason for requiring an exemption application to be 
filed did not exist for these manufacturers (55 FR 18881, at 18881, May 
7, 1990).
    During interagency review, it was suggested that EPA consider 
increasing the small-quantity amount in this proposed rule in order to 
eliminate the need for certain persons subject to the rule to initially 
submit a letter of intent to test or an exemption application. As a 
result this group of persons would be shifted to Tier 2. As with the 
existing tiering system, these persons would still be subject to 
reimbursement requirements and could potentially be required to conduct 
testing (for example, if Tier 1 entities do not submit letters of 
intent to test).
    EPA is interested in receiving comment on whether the 1,100 lb (500 
kg) small-quantity threshold in this proposed rule should be raised 
(e.g., to 5,000, 10,000, or 25,000 lbs) in order to shift certain 
small-quantity manufacturers from Tier 1 to Tier 2. These persons would 
represent a small percentage of the overall production volume of a 
chemical in the test rule such that test sponsors would not be expected 
to expend the administrative resources necessary to seek reimbursement 
from these manufacturers. EPA is particularly interested in comments on 
the appropriate annual production amount at which test sponsors would 
not be expected to seek reimbursement such that the reason for 
requiring an exemption application to be filed by these manufacturers 
would not exist. Please provide a rationale and supporting information 
for any alternative threshold(s) suggested.
    EPA is also soliciting comment on who should be included in Tier 1 
and Tier 2. The Agency may define these categories differently in 
response to comments received. EPA is also soliciting comment on who 
should not be subject to the rule. The latter persons are described in 
Unit V.E.1. and Sec. 799.5085(b)(2) of the proposed 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 document in the Federal Register concerning the 
request for a hearing; and 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 proposed rule, amounts manufactured as impurities would 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 Proposed Under this Test Rule?

    You would be required to submit a final report for a specific test 
by the deadline indicated as the number of months after the effective 
date of the final rule, which would be shown in Sec. 799.5085(j) of the 
proposed regulatory text.

G. What Would I Need to do If I Cannot Complete the Testing Required by 
the Final Rule?

    A company who submits a letter of intent to test under the final 
rule and who subsequently anticipates difficulties in completing the 
testing by the deadline set forth in the final rule may submit a 
modification request to the Agency, pursuant to 40 CFR 790.55. EPA will 
determine whether modification of the test schedule is appropriate, and 
may first seek public comment on the modification.

H. Would There be Sufficient Test Facilities and Personnel To Undertake 
the Testing Proposed Under this Test Rule?

    Yes. In 1996, EPA conducted a study of TSCA testing laboratories to 
evaluate the expected capacity of these laboratories to conduct various 
tests through the year 2000 (Ref. 19). The results suggest that 
laboratory capacity is expected to expand at a rate such that the 
testing that would be required by this proposed rule should be readily 
accommodated by testing laboratories (Ref. 9).

I. Might EPA Seek Further Testing of the Chemicals in this Proposed 
Test Rule?

    If EPA determines that it needs additional data regarding any of 
the chemical substances included in this proposed rule, the Agency 
might seek further health and/or environmental effects testing for 
these chemical substances. Should the Agency decide to seek such 
additional testing, EPA would initiate a separate action for this 
purpose.

VI. Export Notification

    Any person who exports, or intends to export, one of the chemical 
substances contained in this proposed rule in any form will be subject 
to the export notification requirements in TSCA section 12(b)(1) and at 
40 CFR part 707, subpart D, but only after the final rule is issued and 
only if the chemical is contained in the final rule. However, export 
notification would generally not be required for articles, as provided 
by 40 CFR 707.60(b).

VII. Public Comment

    As discussed in Unit III.D, EPA is interested in comments regarding 
specific procedures for incorporating the use of categories and SAR 
into this proposed rule.
    Comments which identify existing data that may meet the 
requirements of studies under this proposed rule should include the 
data with the submission of comments to EPA. Data submitted to

[[Page 81675]]

EPA to meet the requirements of testing under this proposed rule must 
be in the form of full copies of unpublished studies or full citations 
of published studies, and may be accompanied by a robust summary (Ref. 
34). To the extent that studies required under this proposed rule are 
currently available, and the data are judged sufficient by EPA, testing 
for the endpoint/chemical combination will not be required in the final 
rule based on this proposed rule.
    EPA solicits public comment on the test methods proposed in this, 
the approach discussed in Unit V.E. entitled Would I be required to 
test under this rule?, and the analysis detailing the burdens and costs 
for the regulatory impacts resulting from this rule.
    In addition, EPA solicits comment on the proposed and alternative 
approaches to the testing of Class 2 substances, whether the proposed 
approach for testing Class 1 substances (i.e., that each Class 1 
substance be tested at a purity of 99% or more) should be applied to 
any Class 2 substances, and whether the proposed or alternative 
approaches for the testing of Class 2 substances (i.e. that a 
representative sample of each Class 2 substance be tested) should be 
applied to any Class 1 substances.

VIII. Documents in the Official Record

    The official record for this proposed rule has been established 
under docket control number OPPTS-42213A, and the public version of the 
official record is available for inspection as specified in Unit I.B.2. 
The following is a listing of the documents that have already been 
placed in the official record for this proposed rule, including those 
specifically referenced in this document. For your convenience, EPA may 
have also provided some non-EPA internet addresses to allow you to 
access the electronic version of the referenced document. In doing so, 
the Agency has verified the accuracy of these addresses at the time of 
signature. However, since EPA is not responsible for these non-EPA 
sites, the Agency does not have any control over these web addresses. A 
paper copy of any document referenced in this way has been included in 
the public version of the official record for this document as 
described in Unit I.B.2.
    1. EPA, OPPT. ChemRTK, HPV Challenge Program Chemical List. (This 
list is updated periodically, and is available electronically at http://www.epa.gov/chemrtk/hpvchmlt.htm).
    2. EPA, OPPT. Chemical Hazard Data Availability Study: What Do We 
Really Know About the Safety of High Production Volume Chemicals? 
(April 1998) (An electronic copy of this document is available on the 
EPA website at http://www.epa.gov/opptintr/chemtest/hazchem.htm).
    3. ACC (formerly CMA). Public Availability of SIDS-Related Testing 
Data for U.S. High Production Volume Chemicals (June 12, 1998). Copies 
of ACC's report can be obtained by writing to ACC at 1300 Wilson Blvd., 
Arlington, VA 22209 or by calling ACC at (703) 741--226.
    4. OECD Secretariat. SIDS Manual. Third Ed. Screening Information 
Data Set Manual of the OECD Programme on the Co-Operative Investigation 
of High Production Volume Chemicals. Paris, France (July 1997). 
Electronic copies of this Manual can be obtained from OECD at http://www.oecd.org/ehs/sidsman.htm, or by accessing EPA's ChemRTK website at 
http://www.epa.gov/chemrtk/sidsappb.htm.
    5. OECD. Decision-Recommendation on the Co-Operative Investigation 
and Risk Reduction of Existing Chemicals--C(90)163/FINAL (January 31, 
1991).
    6. ACC. 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).
    7. 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 TSCA Public Docket Office, EPA (September 17, 
1991).
    8. ICCA. ICCA HPV Working List 22-040-1999; Chemicals Common to 2 
or more of the Regions: Canada, European Union (EU), Japan, and USA 
(1999). (Electronic copies of this list can be obtained from the ICCA 
website at http://www.icca-chem.org/hpv).
    9. EPA, OPPT. Economic Impact Analysis of a Section 4 Test Rule for 
High Production Volume Chemicals (December 2000).
    10. EPA. Comparison of 1990 High Production Volume (HPV) Chemicals 
with National Occupational Exposure Survey (NOES) Database (November 
13, 1998).
    11. EPA. Guidelines for Exposure Assessment, Federal Register (57 
FR 28888, May 29, 1992).
    12. Seta, J.A. et al., National Exposure Survey Field Guidelines. 
Cincinnati Ohio: National Institute for Occupational Safety and Health. 
DHHS (NIOSH) Publication No. 88-106 (1988).
    13. Meylan WM, and Howard PH. Atom/Fragment Contribution for 
Estimating Octanol-Water Partition Coefficients. Journal of 
Pharmaceutical Sciences. Vol.84, No.1 (January 1995).
    14. Meylan WM, Howard PH, and Boethling, RS. Improved Method for 
Estimating Water Solubility From Octanol/Water Partition Coefficient. 
Environmental Toxicology and Chemistry. Vol. 15, No.2, pp. 1006-106 
(1996).
    15. Veith GD 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).
    16. Bintein S, DeVillers J, and Karcher W. Nonlinear dependence of 
fish bioconcentration on n-octanol/water partition coefficient. SAR and 
QSAR in Environmental Research, Vol.1, pp. 29-39 (1993).
    17. Meylan WM, Howard PH, Boethling RS, Aronson D, Printup H, and 
Gouchie S. Improved method of estimating bioconcentration/
bioaccumulation factor from octanol/water partition coefficient. 
Environmental Toxicology and Chemistry, Vol.18, No.4, pp 664-672) 
(1999).
    18. Smrchek JC and Zeeman MG. 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).
    19. EPA. EPA Census of TSCA Laboratories, Washington, DC (October 
10, 1996).
    20. EPA. Treatment of 12(b) Export Notification Unit Costs for 
Section 4 Test Rule Analyses, OPPT/EETD/EPAB, Washington, DC (April 1, 
1999).
    21. EPA. Economic Analysis in Support of the TSCA 12(b) Information 
Collection Request, OPPT/EETD/EPAB, Washington, DC (October 30, 1998).
    22. EPA. April 1999 Agenda of Regulatory and Deregulatory Actions; 
Semiannual regulatory agenda. Chemical Right-to-Know, sequence #3424 
(64 FR 21898, April 26, 1999) (FRL-6238-9).
    23. EPA. TSCA section 4(a)(1)(B) Proposed Statement of Policy (56 
FR 32297, July 15, 1991).
    24. EPA. TSCA section 4(a)(1)(B) Final Statement of Policy (58 FR 
28736, May 14, 1993).
    25. EPA. Document containing EPA's Policy Statement under TSCA 
section 5 entitled Category for Persistent, Bioaccumulative, and Toxic 
New Chemical Substances (64 FR 60194, November 4, 1999) (FRL-6097-7). 
(An electronic copy is available at http://www.epa.gov/opptintr/newchems/pbtpolcy.htm).
    26. EPA. Significant New Use Rules; General Provisions for New 
Chemical Followup under sections 5 and 26(c) of TSCA (54 FR 31307, July 
27, 1989).

[[Page 81676]]

    27. Document describing the HPV Initiative, entitled Data 
Collection/development on High Production Volume (HPV) Chemicals; 
Notice, which is published elsewhere in this issue of the Federal 
Register (FRL-6754-6). (An electronic copy of this document is 
available on the EPA website at http://www.epa.gov/fedrgstr/).
    28. Environmental Defense (formerly EDF). Toxic Ignorance. New 
York, New York (Summer 1997). Copies of Toxic Ignorance can be obtained 
by accessing Environmental Defense's website (http://www.environmentaldefense.org/Reports/ToxicIgnorance) or by calling 1-
800-684-3322.
    29. EPA, 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) (An electronic copy of this document is available on the EPA 
website at http://www.epa.gov/chemrtk/ceoltr2.htm).
    30. EPA, OPPT. The Use of Structure-Activity Relationships (SAR) in 
the High Production Volume Chemicals Challenge Program (August 26, 
1999). (An electronic copy of this document is available on the EPA 
website at http://www.epa.gov/chemrtk/sarfinl1.htm).
    31. EPA, OPPT. Development of Chemical Categories in the HPV 
Challenge Program (Draft) (August 25, 1999). (An electronic copy of 
this document is available on the EPA website at http://www.epa.gov/chemrtk/categuid.htm).
    32. EPA, OPPT. Guidance for Testing Closed System Intermediates for 
the HPV Challenge Program (Draft) (March 17, 1999). (An electronic copy 
of this document is available on the EPA website at http://www.epa.gov/chemrtk/closed9.htm).
    33. EPA, OPPT. Procedures for Removing Chemicals that are No longer 
HPV and Not Likely to Become HPV Again from the HPV List (Draft) (March 
17, 1999). (An electronic copy of this document is available on the EPA 
website at http://www.epa.gov/chemrtk/nolohpv8.htm).
    34. EPA, OPPT. Draft Guidance on Developing Robust Summaries 
(October 27, 1999). (An electronic copy of this document is available 
on the EPA website at http://www.epa.gov/chemrtk/robsumgd.htm).
    35. EPA, OPPT. ChemRTK HPV Challenge Program Making Commitments 
(June 29, 2000). (An electronic copy of this document is available on 
the EPA website at http://www.epa.gov/chemrtk/makecom.htm).
    36. EPA, OPPT. Draft Guidance on Searching for Chemical Information 
and Data (August 1999). (An electronic copy of this document is 
available on the EPA website at http://www.epa.gov/chemrtk/srchguid.htm).
    37. EPA, OPPT. Determining the Adequacy of Existing Data (February 
10, 1999). (An electronic copy of this document is available on the EPA 
website at http://www.epa.gov/chemrtk/datadfin.htm).
    38. SBA. Office of Advocacy-Statistics-Major Industry, Firms, 
Establishment, Employment, Payroll and Receipts, 1995. Information from 
the Small Business Administration on the Internet (http://www.sba.gov/advo/stats/us-ind95.html. Downloaded on December 10, 1998).

IX. Regulatory Assessment Requirements

A. Executive Order 12866

    Under E.O. 12866, entitled Regulatory Planning and Review (58 FR 
51735, October 4, 1993), the Office of Management and Budget (OMB) has 
designated this proposed rule a ``significant regulatory action'' 
subject to review by OMB under E.O. 12866, 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 E.O. EPA therefore submitted this proposed rulemaking to OMB for 
review under E.O. 12866, and any comments or changes made during that 
review have been documented in the public version of the official 
record for this rulemaking.
    In addition, EPA has prepared an economic assessment entitled 
Economic Impact Analysis for the Proposed Section 4 Test Rule for High 
Production Volume Chemicals (Ref. 9), a copy of which has been placed 
in the public version of the official record for this rulemaking. This 
economic assessment evaluates the potential for significant economic 
impacts as a result of the testing that would be required by this 
proposal. The analysis covers 49 chemicals, 12 more than identified in 
the proposal, therefore, the costs presented here are expected to be an 
overestimate. The total social cost of providing test data on the 49 
chemicals that were evaluated in this economic analysis is estimated to 
be $13 million (Ref. 9).
    While legally subject to this test rule, 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 proposed regulatory text. EPA 
would only require processors to test if no person in Tier 1 has 
submitted a notice 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 assumes that, for each chemical in this 
proposed 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. Because processors would 
not need to comply with the proposed rule initially, the economic 
assessment does not address processors.
    To evaluate the potential for an adverse economic impact of testing 
on manufacturers of the chemical substances in this proposed 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 49 chemicals evaluated in the economic analysis to 
be $ 1.5 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 final 
rule are expected to have a negligible impact on exporters. The 
estimated cost of the TSCA section 12(b) export notification 
requirements, which, under the final rule, would be required for the 
first export to a particular country of a chemical subject to the rule, 
is estimated to be $83.38 for the first time that an exporter must 
comply with TSCA section 12(b) export notification requirements, and 
$19.08 for each subsequent export notification submitted by that 
exporter (Refs. 9, 20, and 21). The Agency's estimated total costs of 
testing (including both

[[Page 81677]]

laboratory and administrative costs) annualized testing cost, price 
impacts, and public reporting burden hours for this proposed rule are 
presented in the economic assessment.
    Under a least cost scenario, 28 out of the 45 chemicals for which 
price data were available (62%) would have a price impact at less than 
the 1% level. Similarly, 28 out of the 45 chemicals (58%) would be 
impacted at less than the 1% level under an average cost scenario. 
Thus, the potential for adverse economic impact due to the proposed 
test rule is low for at least 58% of the chemicals in this proposed 
rule. Approximately 17 (19) chemicals (38% (42%)) of the 45 chemicals 
for which price data are available would have a price impact at a level 
greater than or equal to 1% under the least (average) cost scenario.
    The Agency computed ``critical prices'' for all 49 chemicals, 
including the 37 chemicals included in this proposed TSCA section 4 HPV 
SIDS rule. Using chemical specific volume and test cost data, the 
critical price per pound that would result in a 1% impact on the annual 
revenue of the chemical was estimated. The critical prices are 
particularly informative for the 4 chemicals for which price data are 
unavailable because they represent the minimum price that is required 
to support testing at the 1% level.
    Of the 4 chemicals for which price data were unavailable, an 
approximate price range could be inferred for 2 chemicals based on the 
knowledge of the nature of these chemicals. Based on the critical 
prices and basic information on their nature or use, it is expected 
that neither of these chemicals is likely to be impacted at greater 
than the 1% level. For the remaining 2 chemicals without price 
information, it is unclear whether they will be impacted at greater 
than the 1% level.
    EPA believes, on the basis of these calculations, that the proposed 
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. Therefore, the Agency also compared the costs of 
compliance to company sales for small businesses.

B. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 
5 U.S.C. 601(b) et seq., the Agency hereby certifies that this 
rulemaking, if promulgated as proposed, will not have a significant 
economic impact on a substantial number of small entities. The factual 
basis for the Agency's determination is presented in the small entity 
impact analysis prepared as part of the economic analysis for this rule 
(Ref. 9), and is briefly summarized here.
    Two factors are examined in EPA's small entity impact analysis 
(Ref. 9) in order to characterize the potential small entity impacts of 
this rule:
    1. The size of the adverse impact (measured as the ratio of the 
cost to sales or revenue), and
    2. The total number of small entities that experience the adverse 
impact.
    Section 601(3) of the 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 Small Business 
Administration (SBA) establishes small business size standards (13 CFR 
121.201). For this rulemaking, 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. In 
analyzing potential impacts, the RFA recognizes that it may be 
appropriate at times to use an alternate definition of small business. 
As such, section 601(3) of the RFA provides that an agency may 
establish a different definition of small business after consultation 
with the SBA Office of Advocacy and after notice and an opportunity for 
public comment. Even though the Agency has used the default SBA 
definition of small business to conduct its analysis of potential small 
entity impacts for this proposed rule, EPA does not believe that the 
SBA size standards are generally the best size standards to use in 
assessing potential small entity impacts with regard to TSCA section 
4(a) test rules.
    The SBA size standard is generally based on the number of employees 
an entity in a particular industrial sector may have. For example, in 
the chemical manufacturing industrial sector (i.e., SIC 28 and SIC 29), 
approximately 98% of the firms would be classified as small businesses 
under the default SBA definition. The SBA size standard for 75% of this 
industry sector is 500 employees, and the size standard for 23% of this 
industry sector is 750, 1,000, or 1,500 employees. As a result, when 
assessing the potential impacts of test rules on chemical 
manufacturers, EPA believes that a standard based on total annual sales 
may provide a more appropriate means to judge the ability of a chemical 
manufacturing firm to support chemical testing without significant 
costs or burdens.
    EPA is currently determining what level of annual sales would 
provide the most appropriate size cutoff with regard to various 
segments of the chemical industry usually impacted by TSCA section 4(a) 
test rules, but has not yet reached a determination. As stated above, 
therefore, the factual basis for the RFA determination for this 
proposed rule is based on an analysis using the default SBA size 
standards. Although EPA is not currently proposing to establish an 
alternate definition for use in the analysis conducted for this 
proposed rule, the analysis for this proposed rule also presents the 
results of calculations using a standard based on total annual sales 
(40 CFR 704.3). EPA is interested in receiving comments on whether the 
Agency should consider establishing an alternate definition for small 
business to use in the small entity impact analyses for future TSCA 
section 4(a) test rules, and what size cutoff may be appropriate.
    The SBA has developed 6 digit NAICS code-specific size standards 
based on employment thresholds. These size standards range from 500 to 
1,500 employees for the various 6 digit NAICS codes that are 
potentially impacted (Ref. 9). For a conservative estimate of the 
number of small businesses affected by the HPV rule, the Agency chose 
an employment threshold of less than employees 1,500 for all businesses 
regardless of the NAIC-specific threshold to determine small business 
status.
    For each manufacturer of the 49 chemicals in the economic analysis, 
the parent company (ultimate corporate entity, or UCE) was identified 
and sales and employment data were obtained for companies where data 
was available. The search determined that there were 103 affected UCEs. 
Sales and employment data could be found for 102 of these UCEs (99%).
    Parent company sales data were collected to identify companies that 
qualified for ``small business'' status.

[[Page 81678]]

 Based on the SBA size standard applied, 35 companies were identified 
as small. Employment data were unavailable for 1 company. A separate 
analysis, contained in the economic assessment prepared for this 
proposed rule, was conducted for these companies to determine the 
potential economic impact of this proposed rule.
    The significance of this proposed HPV rule's impact on small 
businesses was analyzed by examining the number of small entities that 
experienced different levels of costs as a percentage of their sales. 
Small businesses were placed in the following categories on the basis 
of cost-to sales ratios: less than 1%, greater than 1%, greater than 
3%. This analysis was conducted under both the least and the average 
cost scenarios.
    Of the 35 companies that qualified for small business status per 
the SBA size standards, only 1 had cost-to-sales ratios of greater than 
1% under least and average cost scenarios. None were impacted at 
greater than the 3% level. Given these results, there does not appear 
to be a significant impact on a substantial number of small entities as 
a result of this proposed rule.
    As stated earlier in this unit, employment data were unavailable 
for 1 of the identified 103 companies (1%). While data on their company 
level sales were also unavailable, the volumes of the chemicals 
included in this proposed rule that it produced could be identified 
from the 1994 IUR database. Combining secondary data on chemical prices 
with production volume data, the sales value of these chemicals could 
be estimated for this company. In addition, the minimum critical sales 
level that would be needed to avoid an impact at the 1% and the 3% 
levels was calculated. These critical sales were then compared to the 
sales estimated using the method described in this unit. Using these 
estimates, EPA concluded that this company is not impacted at greater 
than 1% of sales in the least or average cost scenarios
    The estimated cost of the TSCA section 12(b)(1) export 
notification, which, as a result of the final rule, would be required 
for the first export to a particular country of a chemical subject to 
the rule, is estimated to be $83.38 for the first time that an exporter 
must comply with TSCA section 12(b)(1) export notification 
requirements, and $19.08 for each subsequent export notification 
submitted by that exporter (Refs. 9, 20, and 21). EPA has concluded 
that the costs of TSCA section 12(b)(1) export notification would have 
a negligible impact on exporters of the chemicals in the final rule, 
regardless of the size of the exporter.
    Therefore, the Agency certifies that this proposed rule, if 
finalized, would not have a significant economic impact on small 
entities. Information relating to this determination has been included 
in the public version of the official record for this proposed rule. 
This information will also be provided to the SBA Chief Counsel for 
Advocacy upon request. Any comments regarding the impacts that this 
action may impose on small entities, or regarding whether the Agency 
should consider establishing an alternate definition of small business 
to be used for analytical purposes for future test rules and what size 
cutoff may be appropriate, should be submitted to the Agency in the 
manner specified under ADDRESSES.

C. Paperwork Reduction Act

    Pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., 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, after appearing in the preamble of the final 
rule, are listed in 40 CFR part 9, and included on the related 
collection instrument. The information collection activities related to 
chemical testing under TSCA section 4(a) have already been approved 
under OMB control number 2070-0033 (EPA ICR No.1139), and 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 action does not contain any new 
information collection activities requiring additional OMB review and 
approval.
    Although the information collection activities contained in this 
proposed rule have already been approved by OMB, the total burden hours 
currently approved for the information collection activities related to 
chemical testing may not reflect the estimated burden hours 
specifically related to the activities contained in this proposed rule 
because the total number of chemicals included in this proposed rule 
exceeds the total number of chemicals estimated in the ICR. As 
described in the information collection instrument for chemical testing 
(EPA ICR No. 1139), the Agency's total burden estimate specifically 
accounts for the potential issuance of approximately three average test 
rules per year, each assumed to involve five chemicals and three 
sponsors. With an estimated burden of approximately 263 hours for each 
study, the Agency estimated an average burden of 14,444 hours per test 
sponsor . When a final rule based on this proposed rule is issued, EPA 
will verify that the approved burden hours contained in the ICR are 
sufficient to cover the estimated burden for the final rule. If not, 
EPA will request that the total approved burden hour for the ICR be 
increased accordingly.
    The standard chemical testing program involves the submission of 
letters of intent to test (or exemption applications), study plans, 
administering the tests, progress reports, and test results. For this 
proposed rule, EPA estimates that the information collection activities 
related to chemical testing for all chemicals in this proposal 
(representing the submission of letters of intent or exemption 
applications, administering the tests, and submitting the final 
reports--the study plan is represented by this proposed rule and 
progress reports are not required by this proposed rule because testing 
will be completed within 1 year) would result in an annual public 
reporting burden of approximately 12,942 hours per sponsor, assuming 
seven chemicals per sponsor.
    The annual public reporting burden related to export notification 
is estimated to be 0.5-1.5 burden hours for each chemical/country 
combination (Ref. 9). 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. As such, EPA does not expect to need to 
request an increase in the total burden hours approved by OMB for 
export notifications.
    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; train personnel to 
be able to respond to a collection of information; search data sources; 
complete and review the collection of

[[Page 81679]]

information; and transmit or otherwise disclose the information.
    Comments are requested on the Agency's need for this information, 
the accuracy of the provided burden estimates, and any suggested 
methods for minimizing respondent burden, including through the use of 
automated collection techniques. Send comments to EPA as part of your 
overall comments on this proposed action in the manner specified under 
ADDRESSES. In the final rule, the Agency will address any comments 
received regarding the information collection requirements contained in 
this proposal.

D. Unfunded Mandates Reform Act and Executive Orders 13084 and 13132

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA), Public Law 104-4, EPA has determined that this rulemaking 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 the private sector in any 1 year. It is estimated that 
the total aggregate costs of this proposed rule, which are summarized 
in Unit XI.A. , would be $13 million. The total annualized costs of 
this proposed rule are estimated to be $1.5 million. In addition, EPA 
has determined that this proposed rule does not significantly or 
uniquely affect small governments. Accordingly, this proposed rule is 
not subject to the requirements of sections 202, 203, 204, and 205 of 
UMRA.
    Under E.O. 13084, entitled Consultation and Coordination with 
Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA has 
determined that this proposed rule would not significantly or uniquely 
affect the communities of Indian tribal governments. This determination 
is based on the Agency's experience over the years which indicates 
that, as a practical matter, the burden of chemical testing under TSCA 
section 4(a) rules has traditionally fallen on large, private sector 
manufacturers rather than on tribal governments. Accordingly, the 
requirements of section 3(b) of E.O. 13084 do not apply to this 
proposed rule. Nor will this action have a substantial direct effect on 
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 E.O. 13132, entitled 
Federalism (64 FR 43255, August 10, 1999).
    In the history of the TSCA section 4(a) testing program, the Agency 
has never received a letter of intent to test or an exemption 
application from a State, local, or tribal government. EPA is 
requesting comment on whether any State, local, or tribal government is 
engaged in the manufacture or processing of these HPV chemicals such 
that they might be subject to the requirements of this proposed rule. 
On the basis of these comments, EPA may determine that it is 
appropriate to consult with representatives of potentially affected 
State, local, or tribal governments prior to promulgating the final 
rule.

E. Executive Order 12898

    This proposed rule does not involve special considerations of 
environmental-justice issues pursuant to E.O. 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).

F. Executive Order 13045

    E.O. 13045, entitled Protection of Children from Environmental 
Health Risks and Safety Risks (62 FR 19885, April 23, 1997), does not 
apply to this proposed rule, because it is not designated as an 
``economically significant'' regulatory actions as defined under E.O. 
12866, and it does not establish an environmental standard that is 
intended to mitigate environmental health or safety risks that EPA has 
reason to believe may have a disproportionate effect on children. EPA 
interprets E.O. 13045 as applying only to those regulatory actions that 
establish an environmental standard intended to mitigate health or 
safety risks, such that the analysis required under section 5-501 of 
the Order has the potential to influence the regulation.
    Although this proposed rule is not subject to this E.O., the 
information obtained by the testing proposed in this rule will be used 
to inform the Agency's decision making process regarding chemicals to 
which children may be disproportionately disposed. This information 
will also assist the Agency and others in evaluating these chemical 
substances for potential health or safety risk concerns, and will serve 
to further the Agency's goal of identifying and controlling human and 
environmental risks as well as provide greater protection and knowledge 
to the public.
    In addition, in a separate Federal Register document (64 FR 46673, 
August 26, 1999), EPA announced the initiation of a stakeholder 
involvement process to involve stakeholders in the design and 
development of a voluntary program to test commercial chemicals to 
which children may have a high likelihood of exposure. The purpose of 
the voluntary testing program is to obtain toxicity data needed to 
assess the potential risks resulting from childhood exposure to certain 
commercial chemicals.

G. National Technology Transfer and Advancement Act

    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.
    If the Agency has made findings under TSCA section 4(a), EPA is 
required by TSCA section 4(b) to include specific standards for the 
development of data in test rules. For some of the testing that would 
be required by this rule, EPA is proposing the use of voluntary 
consensus standards issued by the ASTM and ISO which evaluate the same 
type of toxicity as the TSCA and OECD test guidelines, where 
applicable. Copies of the ASTM and ISO standards referenced in this 
proposed rule have been placed in the public version of the official 
record for this rulemaking. In the final rule, EPA intends to seek 
approval from the Director of the Federal Register for the 
incorporation by reference of the ASTM and ISO standards used in the 
final rule in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
    EPA is not aware of any potentially applicable voluntary consensus 
standards which evaluate partition coefficient (n-octanol/water) 
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, 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 proposed rule are

[[Page 81680]]

based. The Agency invites comment on the potential use of voluntary 
consensus standards in this rulemaking, and, specifically, invites the 
public to identify potentially applicable consensus standard(s) and to 
explain why such standard(s) should be used here.

H. Executive Order 12630

    EPA has complied with E.O. 12630, entitled Governmental Actions and 
Interference with Constitutionally Protected Property Rights (53 FR 
8859, March 15, 1988), by examining the takings implications of this 
rule in accordance with the Attorney General's Supplemental Guidelines 
for the Evaluation of Risk and Avoidance of Unanticipated Takings 
issued under the E.O.

I. Executive Order 12988

    In issuing this proposed rule, EPA has taken the necessary steps to 
eliminate drafting errors and ambiguity, minimize potential litigation, 
and provide a clear legal standard for affected conduct, as required by 
section 3 of E.O. 12988, entitled Civil Justice Reform (61 FR 4729, 
February 7, 1996).

List of Subjects in 40 CFR Part 799

     Environmental protection, Chemicals, Hazardous substances, 
Laboratories, Reporting and recordkeeping requirements.


    Dated: December 14, 2000.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

    Therefore, it is proposed that 40 CFR chapter I, subchapter R, be 
amended as follows:

PART 799--[AMENDED]

    1. The authority citation for part 799 would continue to read as 
follows:

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


    2. By adding Sec. 799.5085 to subpart D of part 799 that would read 
as follows:


Sec. 799.5085  Testing of certain High Production Volume (HPV) 
chemicals.

    (a) What substances will be tested under this section? Table 2 in 
Sec. 799.5085(j) identifies the chemical substances that must be tested 
under this section. For the chemical substances identified as ``Class 
1'' substances in Table 2, the purity of each substance must be 99% or 
greater, unless otherwise specified in this section. For the chemical 
substances identified as ``Class 2'' substances, a representative form 
of each substance must be tested.
    (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 799.5085(j) at any time from 
the effective date of the final rule 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 
Sec. 799.5085(j) 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 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: 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.

   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       Persons that 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
                                          kilograms (kg) (1,100 lbs)
                                          annually (as described at 40
                                          CFR 790.42(a)(4)); or
                                         --For research and development
                                          (as described at 40 CFR
                                          790.42(a)(5)).
                                         Persons that 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 expands the list of persons specified in 40 CFR 
790.42(a)(2), (a)(4) and (a)(5), 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)(4) and (c)(5) of this section.
    (2) If you are in Tier 1 with respect to a chemical substance 
listed in Table 2 in Sec. 799.5085(j), you will be required to comply 
with this section with regard to that chemical substance, as described 
in paragraph (d) of this section, no later than 30 days after the 
effective date of the final rule. Sections 790.45(a) and 790.80(b)(1) 
of this chapter do not apply to this section.
    (3) If you are in Tier 2 with respect to a chemical substance 
listed in Table 2 in Sec. 799.5085(j), 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)(6) 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 Sec. 799.5085(j) within 30 days 
after the effective date of the final rule, EPA will publish a Federal 
Register document that will specify the test and the chemical substance 
for which no letter of intent has been submitted.

[[Page 81681]]

 Section 790.48(b)(2) of this chapter does not apply to this section.
    (5) If you are in Tier 2 with respect to a chemical substance 
listed in Table 2 in Sec. 799.5085(j), and if you manufacture or 
process this chemical as of the effective date of the final rule, or 
within 30 days after publication of the Federal Register document 
described in paragraph (c)(4) of this section, you must do the 
following: For each test on that chemical specified in the Federal 
Register document described in paragraph (c)(4) of this section, either 
notify EPA by letter of your intent to test or submit to EPA an 
exemption application. You must comply within 30 days after the date of 
publication of the Federal Register document described in paragraph 
(c)(4) of this section. Sections 790.48(b)(3), and 790.80(a)(2) and 
(b)(1) of this chapter do not apply to this section.
    (6) 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 Sec. 799.5085(j), 
under the procedures in 40 CFR 790.93 and 790.97 EPA will terminate all 
testing exemptions with respect to that 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. Notification will be given by certified letter or by 
publication in the Federal Register.
    (7) If you are required to comply with this section, but your 
manufacture or processing of a chemical substance listed in Table 2 in 
Sec. 799.5085(j) begins after the applicable compliance date referred 
to in paragraphs (c)(2), (c)(5) or (c)(6) of this section, you must 
comply by submitting a letter of intent to test or an exemption 
application as of the day you begin manufacture or processing. Sections 
790.45(d)(1) and (d)(2), and 790.80(b)(2) and (b)(3) of this chapter do 
not apply to this section.
    (d) What must I do to comply with this section? (1) To comply with 
this section you must either:
    (i) submit to EPA a letter of intent to test, conduct the testing 
specified in Table 2 in Sec. 799.5085(j), and submit the test data to 
EPA; or
    (ii) apply to and obtain from EPA an exemption from testing.
    (2) 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.
    (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 one day after the date by which you are required to comply with 
this section. Sections 790.45(e) and (f) of this chapter do not apply 
to 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 Sec. 799.5085(j) is subject to part 707, subpart D, of 
this chapter.
    (h) What test standards must I follow? Follow the guidelines and 
other test methods described in Table 2 in Sec. 799.5085(j).
    (i) Reporting requirements. A final report for a specific test must 
be submitted by the deadline indicated in Table 2 in Sec. 799.5085(j).
    (j) Designation of specific chemical substances and applicable 
testing requirements. The substances identified by name and the 
Chemical Abstract Service (CAS) number in Table 2 of this section must 
be tested in accordance with the designated testing requirements, the 
requirements described in Part 792--Good Laboratory Practice Standards 
of this chapter, and any additional requirements and limitations 
specified in the following Table 2:

                        Table 2--Chemical Substances and Applicable Testing Requirements
----------------------------------------------------------------------------------------------------------------
                                                                                              Deadline for final
                                                                                                report (Months
             CAS No.                 Chemical name      Chemical class      Required tests      from effective
                                                                               (See Key)         date of final
                                                                                                     rule)
----------------------------------------------------------------------------------------------------------------
55-63-0                           1,2,3-               1                  A, C6, E2, F2.      13
                                   Propanetriol,
                                   trinitrate
62-56-6                           Thiourea            1                   A.                  13
74-95-3                           Methane, dibromo-   1                   A, C1, E2, F2.      13
75-36-5                           Acetyl chloride     1                   A, B, C2, E2, F1.   13
75-75-2                           Methanesulfonic     1                   A, C1, E1, E2, F1.  13
                                   acid
78-11-5                           1,3-Propanediol,    1                   A, B, C6, F2.       13
                                   2,2-
                                   bis[(nitrooxy)met
                                   hyl]-, dinitrate
                                   (ester)
84-65-1                           9,10-               1                   A, F2.              13
                                   Anthracenedione
84-69-5                           1,2-                1                   A, E2, F2           13
                                   Benzenedicarboxyl
                                   ic acid, bis(2-
                                   methylpropyl)
                                   ester
88-18-6                           Phenol, 2-(1,1-     1                   A, C2, D, E1, E2,   13
                                   dimethylethyl)-                         F1.
90-00-6                           Phenol, 2-ethyl-    1                   A, B, C1, E2, F2.   13
90-15-3                           1-Naphthalenol      1                   A, C5, F2           13
98-11-3                           Benzenesulfonic     1                   A, C3, E2, F1.      13
                                   acid
105-67-9                          Phenol, 2,4-        1                   A, C6, E2, F2.      13
                                   dimethyl-
107-16-4                          Acetonitrile,       1                   A, B, C1, E2, F2.   13
                                   hydroxy-
107-18-6                          2-Propen-1-ol       1                   A, C6, E2.          13
108-19-0                          Imidodicarbonic     1                   A, B, C1, D, E1,    13
                                   diamide                                 E2, F1.
110-44-1                          2,4-Hexadienoic     1                   A, C4, F2.          13
                                   acid, (E,E)-
112-52-7                          Dodecane, 1-chloro- 1                   A, B, C3, D, E1,    13
                                                                           E2, F1
118-82-1                          Phenol, 4,4'-       1                   A, B, D, E1, E2,    13
                                   methylenebis[2,6-                       F2.
                                   bis(1,1-
                                   dimethylethyl)-

[[Page 81682]]

 
131-57-7                          Methanone, (2-      1                   A, C1, D, E2, F2.   13
                                   hydroxy-4-
                                   methoxyphenyl)phe
                                   nyl-
149-44-0                          Methanesulfinic     1                   A, B, C1, E2, F1.   13
                                   acid, hydroxy-,
                                   monosodium salt
409-02-9                          Heptenone, methyl-  2                   A, B, C1, D, E1,    13
                                                                           E2, F1.
594-42-3                          Methanesulfenyl     1                   A, B, C1, E1, E2,   13
                                   chloride,                               F2.
                                   trichloro-
624-83-9                          Methane,            1                   A, C1.              13
                                   isocyanato-
732-26-3                          Phenol, 2,4,6-      1                   A, C2, E1, E2, F1.  13
                                   tris(1,1-
                                   dimethylethyl)-
870-72-4                          Methanesulfonic     1                   A, B, C1, E1, E2,   13
                                   acid, hydroxy-,                         F1.
                                   monosodium salt
1324-76-1                         Benzenesulfonic     2                   A, B, C1, D, E1,    13
                                   acid, [[4-[[4-                          E2, F1.
                                   (phenylamino)phen
                                   yl][4-
                                   (phenylimino)-2,5-
                                   cyclohexadien-1-
                                   ylidene]methyl]ph
                                   enyl]amino]-
1333-39-7                         Benzenesulfonic     2                   A, B, C1, E1, E2,   13
                                   acid, hydroxy-                          F1.
2941-64-2                         Carbonochloridothi  1                   A, B, C1, E2, F1.   13
                                   oic acid, S-ethyl
                                   ester
3622-84-2                         Benzenesulfonamide  1                   A, B, C1, E1, E2,   13
                                   , N-butyl-                              F2.
6473-13-8                         2-                  1                   A, B, C1, D, E1,    13
                                   Naphthalenesulfon                       E2, F1.
                                   ic 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
8005-02-5                         C.I. Solvent Black  2                   A, B, C1, D, E2,    13
                                   7                                       F1.
28188-24-1                        Octadecanoic acid,  1                   A, B, C1, D, E1,    13
                                   2-(hydroxymethyl)-                      E2, F1.
                                   2-[[(1-
                                   oxooctadecyl)oxy]
                                   methyl]-1,3-
                                   propanediyl ester
65996-78-3                        Light oil, coal,    2                   A, B, C1, D, E1,    13
                                   coke-oven                               E2, F1.
68153-30-0                        Quaternary          2                   A, B, C1, D, E1,    13
                                   ammonium                                E2, F1.
                                   compounds,
                                   benzylbis(hydroge
                                   nated tallow
                                   alkyl)methyl,
                                   salts with
                                   bentonite
68611-64-3                        Urea, reaction      2                   A, B, C1, D, E1,     13
                                   products with                           E2, F1.
                                   formaldehyde
68953-58-2                        Quaternary          2                   A, B, C1, D, E1,    13
                                   ammonium                                E2, F1.
                                   compounds,
                                   bis(hydrogenated
                                   tallow
                                   alkyl)dimethyl,
                                   salts with
                                   bentonite
----------------------------------------------------------------------------------------------------------------


 Key to the Test Requirements for the chemicals listed in Table 2 and specified by alphanumeric symbols (e.g., A
                                                     or C5)
----------------------------------------------------------------------------------------------------------------
                                                              Test requirements and
         Testing category                Test symbol              references\1\            Special conditions
----------------------------------------------------------------------------------------------------------------
Physical/Chemical Properties        A                      1. Melting Point: ASTM E    n-Octanol/Water Partition
                                                            324 (capillary tube)        Coefficient:
                                                           2. Boiling Point: ASTM E    Which method is required,
                                                            1719 (ebulliometry)         if any, is determined by
                                                                                        the test substance's
                                                                                        estimated\2\ n-octanol/
                                                                                        water partition
                                                                                        coefficient (log 10
                                                                                        basis). Test sponsors
                                                                                        are required to provide
                                                                                        in the final study
                                                                                        report the underlying
                                                                                        rationale for the method
                                                                                        selected. In order to
                                                                                        ensure environmental
                                                                                        relevance, EPA highly
                                                                                        recommends that the
                                                                                        selected study be
                                                                                        conducted at pH 7.
                                                           3. Vapor Pressure: ASTM E
                                                            1782 (thermal analysis)
                                                           4. n-Octanol/Water          log Kow <0: no testing
                                                            Partition Coefficient:      required.
                                                            (See Special Conditions    log Kow range 0-1: Method
                                                            for the n-Octanol/Water     A or B.
                                                            Partition Coefficient      log Kow range 1-4: Method
                                                            test requirement and        A or B or C.
                                                            select the appropriate     log Kow range 4-6: Method
                                                            method to use, if any,      B or C.
                                                            from those listed below.)  log Kow >6: Method C.
                                                               Method A: 40 CFR
                                                            799.6755 (shake flask).
                                                               Method B: ASTM E 1147
                                                            (liquid chromatography).
                                                               Method C: 40 CFR
                                                            799.6756 (generator
                                                            column).

[[Page 81683]]

 
                                                           5. Water Solubility: (See   Water Solubility:
                                                            Special Conditions for     Which method is required,
                                                            the Water Solubility test   if any, is determined by
                                                            requirement and select      the test substance's
                                                            the appropriate method to   estimated\3\ water
                                                            use, if any, from those     solubility. Test
                                                            listed below.)              sponsors are required to
                                                               Method A: ASTM E 1148    provide in the final
                                                            (shake flask).              study report the
                                                               Method B: 40 CFR         underlying rationale for
                                                            799.6784 (shake flask).     the method selected. In
                                                               Method C: 40 CFR         order to ensure
                                                            799.6784 (column elution).  environmental relevance,
                                                               Method D: 40 CFR         EPA highly recommends
                                                            799.6786 (generator         that the selected study
                                                            column).                    be conducted at pH 7.
                                                                                       >5,000 mg/L: Method A or
                                                                                        B.
                                                                                       < 5,000 mg/L but > 10 mg/
                                                                                        L: Method A, B, C, or D.
                                                                                       <10 mg/L but > 0.001 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 following methods:
                                                             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 below must     Special Conditions for
                                                            be used to fulfill the      C1, C2, C3, C4, C5, and
                                                            testing requirements--See   C7 testing; there are no
                                                            Special Conditions.         Special Conditions for
                                                           Test Group 1 for C1:......   C6.
                                                             1. Acute Toxicity To        log Kow <4.2: Test
                                                            Fish: ASTM E 729.           Group 1 is required
                                                             2. Acute Toxicity To        log Kow 
                                                            Daphnia: ASTM E 729.        4.2: Test Group 2 is
                                                             3. Toxicity To Plants      required
                                                            (Algae): ASTM E 1218.      Which test group is
                                                           Test Group 2 for C1:......   required is determined
                                                             1. Chronic Toxicity To     by the test substance's
                                                            Daphnia: ASTM E 1193.       log Kow as obtained
                                                             2. Toxicity To Plants      under A.
                                                            (Algae): ASTM E 1218.
                                   ---------------------------------------------------
                                    C2                     For C2, Test Group 1 or
                                                            Test Group 2 below 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.
                                   ---------------------------------------------------
                                    C3                     For C3, Test Group 1 or
                                                            Test Group 2 below 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.
                                   ---------------------------------------------------

[[Page 81684]]

 
                                    C4                     For C4, Test Group 1 or
                                                            Test Group 2 below 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 below 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 for  Which testing method is
                                                            this test requirement and   required is determined
                                                            select the required         by the test substance's
                                                            method to use from those    physical state at room
                                                            listed below.               temperature (25oC). For
                                                           Method A: Acute Inhalation   those test substances
                                                            Toxicity (rat): 40 CFR      that are gases at room
                                                            799.9130.                   temperature, Method A is
                                                           Method B: EITHER:.........   required; otherwise, use
                                                             1. Acute (Up/Down) Oral    of either of the two
                                                            Toxicity (rat): ASTM E      methods listed under
                                                            1163.                       Method B is required.
                                                                 OR..................  In Method B, 40 CFR
                                                             2. Acute (Up/Down) Oral    799.9110(d)(1)(i)(A)
                                                            Toxicity (rat): 40 CFR      refers to the OECD 425
                                                            799.9110(d)(1)(i)(A).       Up/Down test
                                                                                        methodology.
                                                                                       NOTE: In the case of a
                                                                                        potentially explosive
                                                                                        test substance, care
                                                                                        must be taken to avoid
                                                                                        the generation of
                                                                                        explosive
                                                                                        concentrations.
----------------------------------------------------------------------------------------------------------------
Mammalian Toxicity--Genotoxicity    E1                     Bacterial Reverse Mutation  None
                                                            Test (in vitro): 40 CFR
                                                            799.9510
                                   -----------------------------------------------------------------------------
                                    E2                     Conduct any one of the      Persons required to
                                                            following three tests for   conduct testing for
                                                            chromosomal damage:         chromosomal damage are
                                                           In vitro Mammalian           encouraged to use the in
                                                            Chromosome Aberration       vitro Mammalian
                                                            Test: (40 CFR 799.9537 ).   Chromosome Aberration
                                                                 OR..................   Test to generate the
                                                           In vivo Mammalian Bone       needed data unless known
                                                            Marrow Chromosomal          chemical properties
                                                            Aberration Test (rodents:   (e.g., physical/chemical
                                                            Mouse (preferred            properties, chemical
                                                            species), rat, or Chinese   class characteristics)
                                                            hamster): 40 CFR 799.9538.  preclude its use. A
                                                                 OR..................   subject person who uses
                                                           In vivo Mammalian            one of the in vivo
                                                            Erythrocyte Micronucleus    methods instead of the
                                                            Test [sampled in bone       in vitro method to
                                                            marrow] (rodents: Mouse     address this end-point
                                                            (preferred species), rat,   must submit to EPA a
                                                            or Chinese hamster): 40     rationale for conducting
                                                            CFR 799.9539.               that alternate test in
                                                                                        the final study report.
----------------------------------------------------------------------------------------------------------------

[[Page 81685]]

 
Mammalian Toxicity--Repeated Dose/  F1                     Combined Repeated Dose      EPA recommends use of the
 Reproduction/Developmental                                 Toxicity Study with the     Combined Repeated Dose
                                                            Reproduction/               Toxicity Study with the
                                                            Developmental Toxicity      Reproduction/
                                                            Screening Test: (40 CFR     Developmental Toxicity
                                                            799.9365)                   Screening Test. However,
                                                                 OR..................   EPA does recognize that
                                                           Reproduction/Developmental   there may be valid
                                                            Toxicity Screening Test:    reasons to test a
                                                            (40 CFR 799.9355)           particular chemical
                                                            (Identified as F2 below).   using both F2 and F3 to
                                                                 AND.................   fill Mammalian Toxicity
                                                           Repeated Dose 28-Day Oral    Repeated Dose/
                                                            Toxicity Study in           Reproduction/
                                                            rodents: 40 CFR 799.9305)   Developmental data
                                                            (Identified as F3 below).   needs. A subject person
                                                                                        who uses the combination
                                                                                        of F2 and F3 in place of
                                                                                        the Combined Repeated
                                                                                        Dose Toxicity Study with
                                                                                        the Reproduction/
                                                                                        Developmental Toxicity
                                                                                        Screening Test must
                                                                                        submit to EPA a
                                                                                        rationale for conducting
                                                                                        these alternate tests in
                                                                                        the final study reports.
                                   ---------------------------------------------------
                                    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\ Copies of the ASTM and ISO standards referenced in this proposed rule have been placed in the public version
  of the official record for this rulemaking. For the final rule, EPA intends to seek approval from the Director
  of the Federal Register for the incorporation by reference of the ASTM and ISO standards used in the final
  rule in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
\2\ 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 Atom/Fragment
  Contribution Method for Estimating Octanol-Water Partition Coefficients (Ref. 1).
\3\ 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 Improved
  Method for Estimating Water Solubility From Octanol/Water Partition Coefficient (Ref. 2).

    (k) Effective date. (1) The effective date of this section is 
[insert effective date of the final rule.]
    (2) The guidelines and other test methods cited in this section are 
referenced as they exist on the effective date of this section. You can 
apply for a modification under 40 CFR 790.55.
[FR Doc. 00-32497 Filed 12-22-00]
BILLING CODE 6560-50-S