[Federal Register Volume 65, Number 248 (Tuesday, December 26, 2000)]
[Proposed Rules]
[Pages 81658-81685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32497]
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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
[[Page 81658]]
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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
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Examples of
Type of entity NAICS codes potentially
affected entities
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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