[Federal Register Volume 71, Number 51 (Thursday, March 16, 2006)]
[Rules and Regulations]
[Pages 13708-13735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2483]
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Part III
Environmental Protection Agency
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40 CFR Parts 9 and 799
Testing of Certain High Production Volume Chemicals; Final Rule
Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Rules
and Regulations
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 799
[EPA-HQ-OPPT-2005-0033; FRL-7335-2]
RIN 2070-AD16
Testing of Certain High Production Volume Chemicals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is promulgating a final rule under the Toxic Substances
Control Act (TSCA) that requires manufacturers (including importers)
and processors of 17 high production volume (HPV) chemicals to conduct
acute toxicity, repeat dose toxicity, developmental and reproductive
toxicity, genetic toxicity (gene mutations and chromosomal
aberrations), ecotoxicity (in fish, Daphnia, and algae), and
environmental fate (including 5 tests for physical chemical properties
and biodegradation) testing. EPA has determined that each of the 17
chemicals included in this final rule is produced in substantial
quantities and that there is or may be substantial human exposure to
each of them. Moreover, EPA has determined that there are insufficient
data to reasonably determine or predict the effects on health or the
environment of the manufacture, distribution in commerce, processing,
use, or disposal of the chemicals, or any combination of these
activities. EPA has concluded that this testing program is necessary
and appropriate for developing such data. Data developed under this
final rule will provide critical information about the environmental
fate and potential hazards of these chemicals which, when combined with
information about exposure and uses, will allow the Agency and others
to evaluate potential health and environmental risks and take
appropriate actions. Persons who export or intend to export any
chemical included in this final rule, regardless of the form in which
it is exported, are subject to the export notification requirements of
TSCA section 12(b).
DATES: This final rule is effective on April 17, 2006. The
incorporation by reference of certain publications listed in the rule
is approved by the Director of the Federal Register as of April 17,
2006. For purposes of judicial review, this final rule shall be
promulgated at 1 p.m. eastern daylight/standard time on March 30, 2006.
ADDRESSES: Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2005-0033. All documents
in the docket are listed on the regulations.gov web site. Although
listed in the index, some information is not publicly available, i.e.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically at http://www.regulations.gov or in hard copy at the OPPT Docket, EPA Docket
Center (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave., NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the OPPT Docket is (202) 566-0280.
TSCA section 4 submissions. For submission instructions, see Unit
IX. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: [email protected].
For technical information contact: Catherine Roman, Chemical
Control Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-4780; e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture
(defined by statute to include import) or process any of the chemical
substances that are listed in Table 2 in Sec. 799.5085(j) of the
regulatory text. Any use of the term ``manufacture'' in this final rule
will encompass ``import,'' unless otherwise stated. In addition, as
described in Unit VI., any person who exports or intends to export any
of the chemical substances in this final rule, regardless of the form
in which it is exported, is subject to the export notification
requirements in 40 CFR part 707, subpart D. Potentially affected
entities may include, but are not limited to:
Manufacturers (defined by statute to include importers) of
one or more of the 17 subject chemical substances (NAICS codes 325 and
324110), e.g., chemical manufacturing and petroleum refineries.
Processors of one or more of the 17 subject chemical
substances (NAICS codes 325 and 324110), e.g., chemical manufacturing
and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industry Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit V.E. and consult
Sec. 799.5085(b) of the regulatory text. If you have any questions
regarding the applicability of this action to a particular entity,
consult the technical person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using the online docket system, you may access this
Federal Register document electronically through the EPA Internet under
the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. A
frequently updated electronic version of 40 CFR part 9 and part 799 is
available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr.
II. Background
A. What Action is the Agency Taking?
EPA is promulgating a final test rule under TSCA section 4(a)(1)(B)
(15 U.S.C. 2603(a)(1)(B)) that requires manufacturers and processors of
17 chemical substances to conduct acute toxicity, repeat dose toxicity,
developmental and reproductive toxicity, genetic toxicity, ecotoxicity,
and environmental fate testing. The chemicals are HPV chemicals, i.e.,
chemicals with a production/import volume equal to or greater than 1
million pounds per year. A detailed discussion regarding efforts to
enhance the availability of screening level hazard and environmental
fate information about HPV chemicals can be found in a Federal Register
document which published on December 26, 2000 (Ref. 1).
The tests are screening level tests which in combination are known
as the
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Screening Information Data Set (SIDS) (see Unit II.D.). Some or all of
these tests are required for a particular chemical substance, depending
upon what data are already available for that substance.
In the proposal to this final rule, published in the Federal
Register of December 26, 2000, EPA proposed SIDS testing for 37 HPV
chemicals (Ref. 2). Numerous comments were received on the proposed
rule. In consideration of those comments, EPA changed some testing
requirements for certain chemicals as explained in Unit III. As a
result of recent commitments to a voluntary EPA testing program known
as the HPV Challenge Program (see Unit II.C.), and updated production
volume data (i.e., 2002 Inventory Update Rule (IUR) data) made
available after the publication of the proposal preceding this final
rule (i.e., the ``proposed rule''), EPA is requiring testing for 17 of
the 37 chemicals originally proposed for testing in 2000. EPA's
decision to not finalize testing requirements for the remaining 20
chemicals is described in Unit VII.
At a future date, EPA may propose testing for additional HPV
chemicals as the Agency learns more about the chemicals with respect to
human exposure, release, and sufficiency of the data and experience
available on their potential hazards.
B. What is the Agency's Authority for Taking this Action?
This final rule is being promulgated under TSCA section 4(a) (15
U.S.C. 2603(a)), which directs EPA to require the development of data
relevant to assessing whether activities associated with chemical
substances and mixtures present an unreasonable risk of injury to
health or the environment, when appropriate findings are made.
Section 2(b)(1) of TSCA (15 U.S.C. 2603(b)(1)) states that it is
the policy of the United States that:
. . . adequate data should be developed with respect to the
effect of chemical substances and mixtures on health and the
environment and that the development of such data should be the
responsibility of those who manufacture [which is defined by statute
to include import] and those who process such chemical substances
and mixtures[.]
To implement this policy, TSCA section 4(a) mandates that EPA
require by rule that manufacturers and/or processors of chemical
substances and mixtures conduct testing if the Administrator finds
that:
(1)(A)(i) the manufacture, distribution in commerce, processing,
use, or disposal of a chemical substance or mixture, or that any
combination of such activities, may present an unreasonable risk of
injury to health or the environment,
(ii) There are insufficient data and experience upon which the
effects of such manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combination
of such activities on health or the environment can reasonably be
determined or predicted, and
(iii) Testing of such substance or mixture with respect to such
effects is necessary to develop such data; or
(B)(i) a chemical substance or mixture is or will be produced in
substantial quantities, and (I) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or
(II) there is or may be significant or substantial human exposure to
such substance or mixture,
(ii) There are insufficient data and experience upon which the
effects of the manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combination
of such activities on health or the environment can reasonably be
determined or predicted, and(iii) Testing of such substance or
mixture with respect to such effects is necessary to develop such
data [.].
If EPA makes these findings for a chemical substance or mixture,
the Administrator shall require by rule that testing be conducted on
that chemical substance or mixture. The purpose of the testing is to
develop data about the substance's or mixture's health or environmental
effects for which there is an insufficiency of data and experience, and
which are relevant to a determination that the manufacture,
distribution in commerce, processing, use, or disposal of the chemical
substance or mixture, or any combination of such activities, does or
does not present an unreasonable risk of injury to health or the
environment.
EPA need not limit the scope of testing required to the factual
basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) findings, as long as
EPA finds that there are insufficient data and experience upon which
the effects of the manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or any combination of
such activities on health or the environment can be reasonably
determined or predicted, and that testing is necessary to develop the
data. This approach is explained in more detail in EPA's statement of
policy for making findings under TSCA section 4(a)(1)(B) (frequently
described as the ``B'' policy) (Ref. 3, pp. 28738-28739).
In this final rule, EPA is using its broad TSCA section 4(a)
authority to obtain data necessary to support the development of
preliminary or ``screening level'' determinations of the effects on
health and the environment from exposure to the 17 chemical substances
specified in Table 2 in Sec. 799.5085(j) of the regulatory text.
Following consideration of the public comments received by EPA on the
proposed test rule (Ref. 2) and updated production volume information
(i.e., 2002 IUR data), EPA is making the following findings for the 17
chemical substances under TSCA section 4(a)(1)(B): They are produced in
substantial quantities; there is or may be substantial human exposure
to them; existing data are insufficient to determine or predict their
health and environmental effects; and testing is necessary to develop
such data.
C. Why is EPA Taking this Action?
On April 21, 1998, EPA initiated a national effort to empower
citizens with knowledge about the most widespread chemicals in
commerce. A major objective of this effort is to make certain basic
information about the environmental fate and potential health and
environmental hazards associated with HPV chemicals available to the
public. Mechanisms to collect or, where necessary, develop needed data
on U.S. HPV chemicals include the voluntary HPV Challenge Program,
certain international efforts, and TSCA section 4 rules.
1. Voluntary HPV Challenge Program. The voluntary HPV Challenge
Program, officially launched in late 1998, was created to ensure that a
baseline set of data on approximately 2,800 HPV chemicals would be made
available to the public. HPV chemicals are manufactured or imported in
amounts equal to or greater than 1 million pounds per year and were
identified for this program through data reported under the TSCA
Inventory Update Rule (IUR) during 1990.
EPA challenged U.S. manufacturers and importers of HPV chemicals to
voluntarily sponsor chemicals in the Program. Sponsorship entails
making screening-level health and environmental data available to the
public. Public availability of these data, a fundamental principle of
the Program, enables the public to know about the hazards associated
with chemicals in their environment. The data set sought by the HPV
Challenge Program is known as the Screening Information Data Set (SIDS)
that was developed by the Organization for Economic Cooperation and
Development (OECD). The SIDS provides an internationally agreed upon
set of test data for screening high production volume chemicals for
human and environmental hazards, and will allow the Agency and others
to make an informed, preliminary
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judgment about the hazards of HPV chemicals.
As part of their commitment to the HPV Challenge Program, sponsors
submit data summaries of existing information along with a test plan
that proposes a strategy to fill data gaps. Sponsors submit test plans
for either individual chemicals or for a category of chemicals. A
chemical category comprises a group of substances, usually similar in
chemical structure, with a regular pattern of properties and effects.
Data for chemicals in the category can be used to estimate the chemical
properties and effects of other category members.
A 120-day comment period begins when test plans and data summaries
submitted directly to the HPV Challenge Program are posted to the
Program website. It is at this time when all stakeholders--industry,
environmental protection groups, animal welfare groups, private
citizens, etc.--can comment on the data summary and test plan
submissions. EPA comments on all of the submissions as well. Comments
are important because sponsors consider this feedback when revising
their test plans and data summaries. All comments are posted to the
Program website for public availability.
Since the Program's inception in 1998, industry chemical
manufacturers and importers have participated in the Challenge by
sponsoring over 2,200 chemicals. More than 400 companies and 100
consortia have sponsored chemicals directly in the Program while
additional companies/consortia have sponsored chemicals indirectly in
an international counterpart to the HPV challenge Program, the
International Council of Chemical Associations (ICCA) HPV Initiative.
HPV chemicals that are not sponsored in the Program may be subject to a
test rule under TSCA Section 4 because these chemicals lack needed
testing. The voluntary HPV Challenge Program is further described in a
Federal Register document which published on December 26, 2000 (Ref.
1).
2. Certain international efforts. The voluntary HPV Challenge
Program is designed to make maximum use of scientifically adequate
existing test data and to avoid unnecessary and duplicative testing of
U.S. HPV chemicals. Therefore, EPA is continuing to participate in the
voluntary international efforts, complementary to the voluntary HPV
Challenge Program, that are being coordinated by the OECD to secure
basic hazard information on HPV chemicals in use worldwide, including
some of those on the U.S. (1990) HPV chemicals list (Ref. 4). This
includes agreements to sponsor a U.S. HPV chemical under either the
OECD HPV SIDS Program (Ref. 5), including sponsorship by OECD member
countries beyond the United States, or the international HPV Initiative
that is being organized by the International Council of Chemical
Associations (ICCA) (Ref. 6).
The OECD HPV SIDS Program includes information on the identity of
each chemical, its uses, sources and extent of exposure; physical and
chemical properties; environmental fate; and certain limited toxicity
data for humans and the environment. The SIDS is not intended to
describe a chemical thoroughly, but rather is intended to provide
enough information to support an initial (or screening level)
assessment and to assign a priority for further work, if necessary. The
OECD HPV SIDS Program seeks the development of test data, if such data
are not already available, related to six health and environmental
effects endpoints for international HPV chemicals (see Unit II.D.). The
SIDS data set has been internationally agreed upon by the 29 member
countries of the OECD as providing the minimum data set required to
make an informed preliminary judgment about the hazards of a given HPV
chemical.
The ICCA consists of representatives of chemical industry trade
associations from the United States, Europe, Japan, Australia, Canada,
Mexico, Brazil, New Zealand, and Argentina. The intended goal of the
ICCA HPV Initiative was to complete screening-level hazard assessments
on 1,000 ``high priority'' chemicals by the end of the year 2004. The
progress of the ICCA HPV Initiative to date can be checked on ICCA's
HPV Chemical Tracking System website at http://www.iccahpv.com/reports/reportsmain.cfm. Most of the chemicals on the ICCA working list (Ref.
6) are also U.S. HPV chemicals. The ICCA testing/assessment work will
be tied directly to that under the OECD HPV SIDS Program and to the
U.S. voluntary HPV Challenge Program and any associated TSCA section 4
HPV SIDS rules. Any U.S. HPV chemicals that are handled under the OECD
HPV SIDS Program or the ICCA HPV Initiative are considered by EPA to be
``sponsored'' and are not anticipated to be addressed in the voluntary
HPV Challenge Program unless the international commitments are not met.
Nor does EPA intend to evaluate these chemicals for possible TSCA
section 4 HPV SIDS rulemaking unless the international commitments are
not met.
3. TSCA rulemaking. U.S. data needs which remain unmet in the
voluntary HPV Challenge Program or through international efforts may be
addressed through TSCA section 4 rulemaking, such as this final rule,
where EPA determines that the statutory findings can be made. This
final rule is the first TSCA section 4 HPV SIDS rule, and addresses the
unmet data needs of 17 chemicals.
Data collected and/or developed under this final rule and the
voluntary HPV Challenge Program, when combined with information about
exposure and uses, will allow the Agency and others to better assess
the potential risk to health and the environment from these chemicals.
EPA intends to make the information collected under this final rule
available to the public, other Federal agencies, and any other
interested parties on its website (http://www.epa.gov/chemrtk/volchall.htm) and in the public docket for this final rule identified
under ADDRESSES. As appropriate, this information will be used to
ensure a scientifically sound basis for risk assessment/management
actions. This effort will serve to further the Agency's goal of
identifying and controlling human and environmental risks as well as
providing greater protection and knowledge to the public. By using the
same approach to testing as that of the OECD Program, EPA is assuring
that the data developed under this rule and the voluntary HPV Challenge
Program will be comparable to the data being developed in other
countries, thereby enabling an international sharing of data and the
prevention of unnecessary and duplicative testing. See Refs. 1 and 2,
pp. 81662-81664 for further information about the voluntary HPV
Challenge Program and international efforts.
D. Why is EPA Focusing on HPV Chemicals and SIDS Testing?
EPA is focusing on HPV chemicals, which it defines as being
manufactured in amounts equal to or greater that 1 million pounds,
because although those chemicals cover only about 11% of the TSCA
Inventory of chemical substances (see TSCA sections 8(a) and 8(b)),
using Inventory information available in 1988 (Ref. 10, p. 32296), that
small percentage of the Inventory accounts for 95% of total chemical
production in the United States.
EPA is focusing on Screening Information Data Set (SIDS) testing
because it is comprised of a battery of tests agreed upon by the
international community through the OECD, of which the United States is
a member country, as appropriate for screening HPV chemical substances
for toxicity and produces information relevant to
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understanding the basic health and environmental hazards and fate of
HPV chemicals. The six basic testing endpoints comprising this battery
of tests, known as the SIDS, have been adopted by the OECD as the
minimum required to screen HPV chemical substances for toxicity and
environmental fate. The content of SIDS was agreed upon at the 13\th\
Joint Meeting of the OECD Chemicals Group and Management Committee of
the Special Programme on the Control of Chemicals (Refs. 7 and 8). The
United States believes these are the right tests for our domestic
needs, i.e., screening U.S. HPV chemicals for health and environmental
effects and environmental fate.
SIDS testing evaluates the following six testing endpoints (Ref.
5):
Acute toxicity.
Repeat dose toxicity.
Developmental and reproductive toxicity.
Genetic toxicity (gene mutations and chromosomal
aberrations).
Ecotoxicity (studies in fish, Daphnia, and algae).
Environmental fate (including physical/chemical properties
(melting point, boiling point, vapor pressure, n-octanol/water
partition coefficient, and water solubility), photolysis, hydrolysis,
transport/distribution, and biodegradation).
While data on the six SIDS endpoints do not fully measure a chemical's
toxicity, they do provide a consistent minimum set of information that
can be used to determine the relative hazards of chemicals and to judge
if additional testing or assessment is necessary.
E. How Does EPA's HPV Work Relate to That of the OECD?
As noted in Unit II.C.2., the OECD SIDS Program is complementary to
the voluntary HPV Challenge Program. However, EPA's definition of an
HPV chemical differs from that of the OECD. EPA defines an HPV chemical
as having an annual production or importation volume of 1 million
pounds or more. The OECD defines an HPV chemical as having an annual
production volume of 2.2 million pounds (equivalent to 1 million
kilograms (kg)) reported in any member country.
The presence of a chemical on the OECD's list of HPV chemicals was
and continues to be accepted by OECD member countries as providing a
sufficient indicator of potential exposure to warrant testing at the
SIDS level (Ref. 9).
EPA, however, does not believe that a production volume threshold
which is chosen for an international program on existing chemicals and
which is the only trigger for entry into that program should be
determinative of the threshold chosen for ``substantial production''
under TSCA section 4(a)(1)(B)(i). See EPA's ``B'' policy (Ref. 3).
Among the reasons is that the TSCA section 4(a)(1)(B)(i) finding of
substantial production is not the sole finding EPA must make to require
testing based on TSCA section 4(a)(1)(B). EPA must also find that there
is substantial release, or substantial or significant human exposure
under TSCA sections 4(a)(1)(B)(i)(I) and (II). In addition, EPA must
find that data are insufficient and testing is necessary under TSCA
sections 4(a)(1)(B)(ii) and (iii). Accordingly, a finding that a
chemical is produced in substantial quantities alone is not a
sufficient basis to require testing under TSCA section 4.
In response to EPA's proposed ``B'' policy (Ref. 10), both the
American Chemistry Council (ACC, formerly the Chemical Manufacturers
Association (CMA)) and the Society of the Plastics Industry, Inc.
commented that EPA's proposed production volume threshold of 1 million
pounds is a reasonable interpretation of ``substantial production''
under TSCA (Refs. 11 and 12). Additionally, they indicated that the
OECD's 2.2 million pound threshold would be preferable to achieve
consistency between EPA's activities under TSCA section 4 and the OECD
HPV SIDS Program. Although the United States and OECD differ in their
definition of an HPV chemical and what should trigger basic screening
tests of an HPV chemical, both the U.S. and OECD HPV Programs are alike
in their information needs for an HPV chemical. Both the U.S. and OECD
HPV Programs have identified the SIDS battery of tests as the basic
screening tests needed to provide enough information to support a
screening level assessment of the health and environmental effects of a
chemical.
F. Why is EPA Pursuing Hazard Information on HPV Chemicals?
EPA found that, of those non-polymeric organic substances produced
or imported in amounts equal to or greater than 1 million pounds per
year based on 1990 IUR reporting, only 7% had a full set of publicly
available and internationally recognized basic screening test data for
health and environmental effects (Ref. 13). Of the over 2,800 U.S. HPV
chemicals based on 1990 IUR data, 43% had no publicly available basic
hazard data. For the remaining chemicals, limited amounts of the data
were available. This lack of available hazard data compromises EPA's
and others' ability to determine whether these HPV chemicals pose
potential risks to human health or the environment, as well as the
public's ability to know about the hazards of chemicals that may be
found in their environment, their homes, their workplaces, and the
products they buy.
G. What is the Role of this Final Rule and Any Future TSCA Section 4
HPV SIDS Rulemaking with Regard to the Voluntary HPV Challenge Program?
As indicated in the December 26, 2000 Federal Register document
(Ref. 1) describing the voluntary HPV Challenge Program, EPA intends to
use rulemaking under TSCA where appropriate to help fill data gaps not
addressed as part of the voluntary HPV Challenge Program or
international efforts. EPA does not intend at this time to evaluate
U.S. HPV chemicals that have been or are being handled through the OECD
HPV SIDS Program or under a complementary program being coordinated by
the ICCA (Ref. 6) for screening level testing under TSCA section 4 HPV
SIDS rulemaking, although the Agency may revisit this question if
commitments under those international programs are not met. See Unit
III.G. of Ref. 1 for more information on these programs. EPA is
evaluating the extent to which additional nonsponsored HPV chemicals
meet the threshold criteria for rulemaking under TSCA section 4.
H. How Will the Data Developed Under this Final Rule Be Used?
The availability of hazard data on certain individual chemicals is
fundamental to EPA's ability to accomplish its mission of environmental
protection. Hazard data are used in risk assessment and risk
management, and ultimately to inform the public and promote the
pollution prevention ethic. Activities to ensure the availability of
basic hazard information on HPV chemicals support EPA's objectives.
EPA will use the data obtained from this final rule to support
development of preliminary hazard and risk assessments for the 17 HPV
chemicals subject to this rule. The data will also be used by EPA to
set priorities for further testing that may produce hazard information
on these chemicals that may be needed by EPA, other Federal agencies,
the public, industry, and others, to support adequate risk assessments.
As appropriate, this information will be used to ensure a
scientifically sound basis for risk characterizations and risk
management actions. As such, this effort will serve to further the
Agency's goal of identifying and controlling human
[[Page 13712]]
and environmental risks as well as providing greater knowledge and
protection to the public. In the past, EPA has used data from test
rules to support such activities as the development of water quality
criteria, Toxic Release Inventory (TRI) listings, chemical advisories,
and reduction of workplace exposures.
Finally, because the SIDS data to be developed under this final
rule will be comparable to the type of data agreed to as being
appropriate and being developed by the OECD HPV SIDS Program, the
development of these data will enable an international sharing of data.
As conceived by the OECD, the SIDS battery of tests can be used by
governments and others worldwide to conduct an initial assessment of
the hazards and risks posed by HPV chemicals and prioritize HPV
chemicals to identify those in need of additional, more in-depth
testing and assessment, as well as those of lesser concern. Not only
can the data generated from this and any future TSCA section 4 HPV SIDS
test rules contribute to the international effort, but also
international SIDS testing and assessments can be used to fill the data
gaps identified as part of the voluntary HPV Challenge Program.
Additional detailed information is available on the SIDS website
(http://cs3-hq.oecd.org/scripts/hpv) and EPA's voluntary HPV Challenge
Program website (http://www.epa.gov/chemrtk/volchall.htm).
Data collected or developed for each sponsored chemical in the
voluntary HPV Challenge Program are provided in the format of a
``robust'' (i.e., detailed) summary. A robust summary contains the
technical information necessary to adequately describe an experiment or
study and includes the objectives, methods, results, and conclusions of
the full study report, which can either be an experiment or in some
cases an estimation or prediction method. (See Ref. 14, also at http://www.epa.gov/chemrtk/robsumgd.htm). A robust summary provides sufficient
information to allow a technically qualified person to make an
independent assessment of a given study without having to read the full
study report, and thereby facilitates the evaluation of existing data
and the identification of additional data needs. EPA suggests that
existing data relevant to this final rule be submitted to the Agency in
robust summary format and, for any data developed under this rule, that
a robust summary of the final report for each specific test be
submitted in addition to the final report itself (see Sec. 799.5085(i)
of the regulatory text).
III. Response to Public Comments
EPA received a number of comments in response to the proposal (Ref.
2) to this final rule. A summary of those comments and EPA's response
to each comment are presented in the document entitled Response to
Public Comments (Ref. 40). Both the comments and EPA's Response to
Public Comments (Ref. 40) are available in the public docket under
ADDRESSES. The comments on the proposed test rule (Ref. 2) were
submitted by the American Chemistry Council (ACC), American Petroleum
Institute (API), Synthetic Organic Chemical Manufacturers Association
(SOCMA), Center for Regulatory Effectiveness (CRE), Environmental
Defense (ED), American Coke and Coal Chemicals Institute (ACCCI), Color
Pigments Manufacturers Association, Inc. (CPMA), Ecological and
Toxicological Association of Dyes and Organic Pigments Manufacturers
(ETAD), Merisol USA LLC (Merisol), Ashland Distribution Company
(Ashland), Dow Chemical Company (Dow), ExxonMobil Chemical Company
(EMCC), Lonza Group, Dyno Nobel, Inc. (Dyno Nobel), Sciences
International Inc.(SII), Institute of Makers of Explosives (IME),
People for the Ethical Treatment of Animals (PETA), Physicians
Committee for Responsible Medicine (PCRM), Doris Day Animal League
(DDAL), The Humane Society of the United States (HSUS), Alternative
Research & Development Foundation (ARDF), American Anti-Vivisection
Society (AAVS), New England Anti-Vivisection Society (NEAVS), Silicones
Environmental, Health and Safety Council (SEHSC), and numerous private
citizens (Refs. 15-39).
After review and analysis of the submitted comments, EPA made the
following changes to the regulatory text as proposed in response to
those comments:
1. The tests for melting point, boiling point and vapor pressure
are not required for 1,3-propanediol, 2,2-bis[(nitrooxy)methyl]-,
dinitrate (ester) (CAS No. 78-11-5), also known as pentaerythritol
tetranitrate (PETN). This change is further discussed in Unit VII.C.1.
and in the document entitled Response to Public Comments (Ref. 40).
2. The screening test for reproduction/developmental toxicity is
not required for 2,4-hexadienoic acid, (2E,4E)- (CAS No. 110-44-1),
also known as sorbic acid. This change is further discussed in Unit
VII.C.2. and in the document entitled Response to Public Comments (Ref.
40).
3. The neutral red uptake basal cytotoxicity assay may be used to
estimate the starting dose for the mammalian acute toxicity test. The
test is included as a special condition in Table 3 in Sec. 799.5085(j)
of the regulatory text. This change is further discussed in Unit V.A.4.
and in the document entitled Response to Public Comments (Ref. 40).
IV. Findings
A. What is the Basis for EPA's Final Rule to Test These Chemical
Substances?
As indicated in Unit II.B., in order to promulgate a rule under
TSCA section 4(a) requiring testing of chemical substances or mixtures,
EPA must, among other things, make certain findings for those chemical
substances or mixtures regarding either hazard (TSCA section
4(a)(1)(A)(i)) or production and either chemical release or human
exposure (TSCA section 4(a)(1)(B)(i)). EPA is requiring testing of the
chemical substances included in this final rule based on its findings
under TSCA section 4(a)(1)(B)(i) relating to ``substantial production''
and ``substantial human exposure,'' as well as findings under TSCA
sections 4(a)(1)(B)(ii) and (iii) relating to sufficient data and the
need for testing. The chemical substances included in this final rule
are listed in Table 2 in Sec. 799.5085(j) of the regulatory text along
with their CAS numbers.
``Substantial production'' of a chemical substance or mixture under
TSCA section 4(a)(1)(B)(i) is generally interpreted by EPA to be
aggregate production (including import) volume equaling or exceeding 1
million pounds per year and exposure of 1,000 workers or more on a
routine or episodic basis to a chemical substance or mixture is
considered to be ``substantial exposure.'' See EPA's ``B'' policy (Ref.
3) for further discussion on how EPA generally makes decisions under
TSCA section 4(a)(1)(B)(i).
EPA finds that, under TSCA section 4(a)(1)(B)(i), each of the 17
chemical substances included in this final rule is produced in
``substantial quantities'' and there is or may be ``substantial human
exposure'' to each chemical substance (Ref. 41). In addition, under
TSCA section 4(a)(1)(B)(ii), EPA finds that there are insufficient data
and experience to reasonably determine or predict the effects of the
manufacture, processing, or use of these chemical substances, or of any
combination of such activities, on human health or the environment. EPA
also finds that testing of the 17 chemical substances is necessary to
develop such data (TSCA section 4(a)(1)(B)(iii)) (see Unit IV.E.).
[[Page 13713]]
EPA has not identified any factors to cause the Agency to use
decisionmaking criteria other than the general thresholds described in
the ``B'' policy with respect to the chemicals included in this final
rule.
B. Are These Chemical Substances Produced and/or Imported in
Substantial Quantities?
EPA finds that each of the chemical substances included in this
final rule is produced and/or imported in an amount equal to or greater
than 1 million pounds per year based on information gathered pursuant
to the 2002 IUR (40 CFR part 710, subpart B). The 2002 IUR is the most
recently available compilation of TSCA section 8(a) Inventory Update
Reporting data, and the IUR data have been compiled into a database
called the TSCA Chemical Update System. EPA also considered the fact
that all of these chemicals were produced and/or imported above 1
million pounds annually based on the 1990, 1994, and 1998 IUR. EPA
concludes that the annual production volume of each chemical is
``substantial'' as that term is used with reference to production in
TSCA section 4(a)(1)(B)(i) (Ref. 3).
C. Are a Substantial Number of Workers Exposed to These Chemicals?
EPA finds that the manufacture, processing, and use of the chemical
substances included in this action result or may result in exposure to
a substantial number of workers. These chemical substances are used in
a wide variety of industrial applications which result in potential
exposures to workers, as described in the exposure support document for
this final rule (Ref. 41).
EPA defines human exposure as the contact with a chemical or agent
at the visible exterior of a person (i.e., skin and openings into the
body such as mouth and nostrils) (Ref. 42, p. 22891). Worker exposure
is the human exposure to a chemical or agent that occurs while a person
is working. Worker exposure may have various causes, with chemical
releases being a common cause of exposure. Chemical manufacturing and
processing plants can release chemicals from pumps as fugitive
emissions, from reactor and condenser vents as stack emissions, in the
form of a vapor and/or as a particulate. Diffusion and air currents may
carry a chemical throughout the plant and workers may breathe air
containing the chemical, resulting in exposures. Certain human
activities such as manually transferring a chemical from one container
to another may also cause exposures.
Each of the chemicals in this final rule was identified in the
National Occupational Exposure Survey (NOES) as having a total worker
exposure of 1,000 workers or more (Ref. 41). EPA concludes that an
exposure of 1,000 workers or more to a chemical substance is or may be
``substantial'' as that term is used with reference to ``human
exposure'' in TSCA section 4(a)(1)(B)(i) (Ref. 3).
D. Do Sufficient Data Exist for These Chemical Substances?
As discussed in Unit II.D., data on SIDS testing endpoints,
including acute toxicity, repeat dose toxicity, developmental and
reproductive toxicity, genetic toxicity (gene mutations and chromosomal
aberrations), ecotoxicity (tests in fish, Daphnia, and algae), and
environmental fate (five tests for physical/chemical properties
(melting point, boiling point, vapor pressure, n-octanol/water
partition coefficient, and water solubility) and biodegradation), are
necessary in ascertaining the health and environmental effects of the
17 chemicals in this final rule. EPA has determined that for the 17
chemicals for which testing is required under this final rule, there
are either no data available on SIDS testing endpoints or, where there
is some information, these data are insufficient (See Unit II.D. and
II.E.). Therefore, existing data are insufficient to reasonably
determine or predict the effects on human health that may result from
exposures to the chemical substances included in this final rule during
the manufacturing, processing, or use of the subject chemical
substances. EPA also sought existing information on the SIDS testing
endpoints of chemical fate and ecotoxicity and found it to be
insufficient. EPA undertook this evaluation because once the
Administrator has made a finding under TSCA section 4(a)(1), EPA may
require any type of health or environmental effects testing necessary
to address unanswered questions about the effects of a chemical (Ref.
2, p. 81660). The finding for insufficient data is based on the results
of searches for data on SIDS endpoints by EPA (Ref. 13) and ACC (Ref.
43), and EPA's review of studies/data identified by commenters in
response to the proposal or identified by EPA after the publication of
the proposal to this final rule. The studies and data submitted or
identified subsequent to the proposal were found to be sufficient for
some proposed tests of certain chemicals and those tests are not
required for those chemicals in this final rule (See Unit VII.C.).
Table 2 of Sec. 799.5085(j) of the regulatory text lists the SIDS
endpoint tests for each of the remaining 17 chemicals for which no data
are currently available to the Agency or, where some information is
available, the data are not sufficient.
In the proposal to this final rule, EPA encouraged the submission
of existing data on SIDS testing endpoints which are relevant to
characterizing the hazard of those chemicals for which testing was
proposed. All such submitted information was carefully evaluated by EPA
in the development of the final testing requirements in this rule.
However, if persons required to test under this final rule become aware
of additional relevant scientifically adequate existing data (including
structure-activity relationships (SAR) information or a scientifically
defensible category approach) and submit this information to EPA at any
time before testing is initiated, the Agency would consider such data
to determine if they satisfy the testing requirement and would take
appropriate necessary action to ensure that the testing in this rule is
no longer required. In fact, they may submit such information as a
requested modification to the testing requirements under 40 CFR 790.55
at anytime as long as the request is made at least 60 days before the
reporting deadline for the test in question.
E. Is Testing Necessary for These Chemical Substances?
As discussed in Unit IV.D., the lack of sufficient data for these
17 chemicals compromises EPA's and others' ability to determine whether
each chemical poses an unreasonable risk to human health or the
environment. EPA believes that conducting SIDS testing for the 17
subject chemical substances is necessary to provide data and experience
upon which the effects of the manufacture, distribution in commerce,
processing, use, or disposal of the chemical substances or of any
combination of such activities on health or the environment can
reasonably be determined or predicted. EPA has determined that testing
is necessary in order to obtain these relevant data.
EPA will use the data obtained from this final rule to support
development of preliminary hazard assessments for these 17 HPV
chemicals and to set priorities for obtaining exposure information and
further testing that will produce more definitive hazard information
where needed. Such additional information is needed by EPA, other
Federal agencies, the public, industry, and others to ensure that
adequate risk assessments can be conducted on these chemicals. EPA has
[[Page 13714]]
used data from test rules to support such activities as the development
of water quality criteria, TRI listings, chemical advisories, and input
for actions resulting in reduction of workplace exposures. (See Unit
II.C. thru II.G.).
V. Final Rule
A. What Testing is Being Required in this Action?
EPA is requiring specific testing and reporting requirements for
the chemical substances listed in Table 2 in Sec. 799.5085(j) of the
regulatory text. The testing requirements for each chemical are denoted
by alphanumeric symbols in Table 2 in Sec. 799.5085(j) of the
regulatory text. Table 3 in Sec. 799.5085(j) of the regulatory text
provides the key to identify the tests denoted by the alphanumeric
symbols and lists special conditions which might apply when conducting
some of those tests. The test methods listed in Table 3 in Sec.
799.5085(j) of the regulatory text are grouped according to the
endpoint that they address. The following endpoints and test standards
are required under this final rule; also discussed in this Unit V.A.
are the special conditions which EPA has identified and is requiring
for several of the required test standards.
1. Physical/chemical properties.
Melting Point: American Society for Testing and Materials (ASTM) E
324 (capillary tube) (Ref. 44).
Boiling Point: ASTM E 1719 (ebulliometry) (Ref. 45).
Vapor Pressure: ASTM E 1782 (thermal analysis) (Ref. 46).
n-Octanol/Water Partition Coefficient:
Method A (40 CFR 799.6755--shake flask).
Method B (ASTM E 1147--liquid chromatography) (Ref. 47).
Method C (40 CFR 799.6756--generator column).
Water Solubility:
Method A: (ASTM E 1148--shake flask) (Ref. 48).
Method B: (40 CFR 799.6784--shake flask).
Method C: (40 CFR 799.6784--column elution).
Method D: (40 CFR 799.6786--generator column).
EPA proposed determining the melting point of all 17 chemicals in
this final rule using the method ASTM E 324. Since the publication of
the proposal to this final rule, ASTM has indicated on its website,
http://www.astm.org/cgi-bin/SoftCart.exe/index.shtml?E+mystore, that
ASTM E 324 has been withdrawn. To quote the ASTM rationale for the
withdrawal of ASTM E 324:
The standard utilizes old, well-developed technology; it is
highly unlikely that any additional [changes] and/or modifications
will ever be pursued by the E15 [committee]. The time and effort
needed to maintain these documents detracts from the time available
to develop new standards which use modern technology (Ref. 49).
Note that withdrawal of the method by ASTM means only that ASTM no
longer continues to develop and improve the method. It does not mean
that ASTM no longer considers the method to be valid. ASTM still makes
the method available for informational purposes and it can still be
purchased from ASTM at the address listed in Sec. 799.5085(h) of the
regulatory text. EPA concludes that ASTM's withdrawal of E 324 does not
have negative implications on the validity of the method; therefore,
EPA is still requiring, for those chemicals for which melting points
determinations are needed, that melting points be determined according
to the method ASTM E 324.
For the n-octanol/water partition coefficient and water solubility
endpoints, EPA is requiring that certain ``special conditions'' be
considered by test sponsors in determining the appropriate test method
that would be used from among those included for these endpoints in
Table 3 in Sec. 799.5085(j) of the regulatory text.
For the ``n-octanol/water partition coefficient (log 10 basis)''
endpoint, also known as log Kow, the test method required,
if any, will be determined by the test substance's estimated log
Kow. EPA provides three methods for measuring the
substance's log Kow, but prior to selecting an appropriate
method to use, if any, EPA is recommending that the log Kow
be quantitatively estimated by using the method described in the
article entitled Atom/Fragment Contribution Method for Estimating
Octanol-Water Partition Coefficients (Ref. 50). EPA is recommending
that the Kow be estimated in recognition of the fact that,
depending on the chemical substance's log Kow, one or more
test methods can be expected to provide adequate information for
determining the log Kow. In general, EPA believes that the
more hydrophobic a subject chemical is, the less well Method A (40 CFR
799.6755--shake flask) will work, and that Method B (ASTM E 1147--
liquid chromotography) and Method C (40 CFR 799.6756--generator column)
become more suitable, especially Method C. Whether the test sponsor
chooses to quantitatively estimate the log Kow or not, EPA
requires that the test sponsor provide with the final study report the
underlying rationale for the test method selected to measure log
Kow. The required test methods have been developed to meet a
wide variety of needs and, as such, are silent on experimental
conditions related to pH. Therefore, EPA highly recommends that all
required log Kow tests be conducted at pH 7 to ensure
environmental relevance. The required test methods and estimated log
Kow ranges that determine which test method must be used for
this endpoint for a given chemical are shown in Table 1 of this unit.
The ranges of the estimated log Kows have been modified
slightly since the proposal to eliminate the overlap of ranges stated
in the proposal.
[[Page 13715]]
Table 1.--Test Requirements for the n-Octanol/water Partition
Coefficient Endpoint
------------------------------------------------------------------------
Test requirements
Testing category and references Special conditions
------------------------------------------------------------------------
Physical/chemical properties n-Octanol/water n-Octanol/water
partition partition
coefficient (log coefficient or
10 basis) or log log Kow:
Kow: Which method is
The appropriate required, if any,
log Kow test, if is determined by
any, must be the test
selected from substance's
those listed in estimated log Kow
this column--see as follows:
special log Kow <0: no
conditions in the testing required.
adjacent column.. log Kow range 0-1:
Method A: 40 CFR Method A or B.
799.6755 (shake log Kow range >1-
flask). 4: Method A or B
Method B: ASTM E or C.
1147 (liquid log Kow range >4-
chromatography). 6: Method B or C.
Method C: 40 CFR log Kow >6: Method
799.6756 C.
(generator Test sponsors are
column). required to
provide in the
final study
report the
underlying
rationale for the
method selected.
In order to
ensure
environmental
relevance, EPA
highly recommends
that the selected
study be
conducted at pH
7.
------------------------------------------------------------------------
For the ``water solubility'' endpoint, the test method, if any,
will be determined by the test substance's estimated water solubility.
EPA recommends that water solubility be quantitatively estimated prior
to initiating this study. One recommended method for estimating water
solubility is described in the article entitled Improved Method for
Estimating Water Solubility From Octanol/Water Partition Coefficient
(Ref. 51). EPA requires that test sponsors provide in the final study
report the underlying rationale for the test standard selected for this
endpoint. The required test methods have been developed to meet a wide
variety of needs and, as such, are silent on experimental conditions
related to pH. Therefore, EPA highly recommends that all required water
solubility tests be conducted at pH 7 to ensure environmental
relevance. The estimated water solubility ranges that EPA proposed for
use in selecting an appropriate test standard have been modified
slightly since the proposal to eliminate overlaps. The estimated water
solubility ranges that EPA is requiring in this final rule to select an
appropriate test standard are shown in Table 2 of this unit.
Table 2.--Test Requirements for the Water Solubility Endpoint
------------------------------------------------------------------------
Test requirements
Testing category and references Special conditions
------------------------------------------------------------------------
Physical/chemical properties Water solubility: Water solubility:
The appropriate Which method is
method to use, if required, if any,
any, to test for is determined by
water solubility the test
must be selected substance's
from those listed estimated water
in this column-- solubility. Test
see special sponsors are
conditions in the required to
adjacent column.. provide in the
Method A: ASTM E final study
1148 (shake report the
flask). underlying
Method B: 40 CFR rationale for the
799.6784 (shake method selected.
flask). In order to
Method C: 40 CFR ensure
799.6784 (column environmental
elution). relevance, EPA
Method D: 40 CFR highly recommends
799.6786 that the selected
(generator study be
column). conducted at pH
7.
>5,000 milligrams/
liters (mg/L) :
Method A or B.
>10 mg/L--5,000 mg/
L: Method A, B,
C, or D.
>0.001 mg/L--10 mg/
L: Method C or D.
<=0.001 mg/L: No
testing required.
------------------------------------------------------------------------
2. Environmental fate and pathways.
Inherent Biodegradation: ASTM 1625 (semicontinuous activated sludge
test) (Ref. 52) or
ISO 9888 (Zahn-Wellens Method) (Ref. 53).
Either method may be used, and no special conditions apply.
3. Aquatic toxicity.
Test Group 1: Acute toxicity to fish (ASTM E 729) (Ref. 54).
Acute toxicity to Daphnia (ASTM E 729) (Ref. 54).
Toxicity to plants (algae) (ASTM E 1218) (Ref. 55).
Test Group 2: Chronic toxicity to Daphnia (ASTM E 1193) (Ref. 56).
Toxicity to plants (algae) (ASTM E 1218) (Ref. 55).
For the ``aquatic toxicity'' endpoint, the OECD HPV SIDS Program
recognizes that, for certain chemicals, acute toxicity studies are of
limited value in assessing the substances' aquatic toxicity. This issue
arises with respect to chemicals with high log Kow values.
In such cases, toxicity is unlikely to be observed over the duration of
acute toxicity studies because of reduced uptake and the extended
amount of time required for such substances to reach toxic
concentrations in the test organism. For such situations, the OECD HPV
SIDS Program recommends use of chronic toxicity testing in Daphnia in
place of acute toxicity testing in fish and Daphnia. EPA is requiring
that the aquatic toxicity testing requirement be determined based on
the test substance's measured log Kow as determined by using
the approach outlined in Unit V.A.1., in the discussion of ``n-octanol/
water partition coefficient,'' and in Table 3 in Sec. 799.5085(j) of
the regulatory text. For test substances determined to have a log
Kow of less than 4.2, one or more of the following tests
(described as ``Test Group 1'' in Table 3 in Sec. 799.5085(j) of the
regulatory text) are required: Acute toxicity to fish (ASTM E 729),
Acute toxicity to Daphnia (ASTM E 729), and Toxicity to plants (algae)
(ASTM E 1218). For test substances determined to have a log
Kow that is greater than or equal to 4.2, one or both of the
following tests (described as ``Test Group 2'' in Table 3 in Sec.
799.5085(j) of the regulatory text) are required: Chronic toxicity to
Daphnia (ASTM E 1193) and Toxicity to plants (algae) (ASTM E 1218). As
outlined in Table 3 in Sec. 799.5085(j) of the regulatory text,
depending on the testing required in Test Group 1, the Test Group 2
chronic Daphnia test may substitute for either or both the acute
[[Page 13716]]
fish toxicity test and the acute Daphnia test.
EPA recognizes that in some circumstances, acute aquatic toxicity
testing (Test Group 1) may be relevant for certain chemical substances
having a log Kow equal to or greater than 4.2. Using SAR, a
log Kow of 4.2 corresponds with a fish bioconcentration
factor (BCF) of about 1,000 (Refs. 57-59). A chemical with a fish BCF
value of 1,000 or more is characterized as having a tendency to
accumulate in living organisms relative to the concentration of the
chemical in the surrounding environment (Ref. 60). For the purposes of
this final rule, EPA's use of a log Kow equal to or greater
than 4.2 (which corresponds with a fish BCF value of 1,000) is
consistent with the approach taken in the Agency's proposed (Ref. 61)
and final (Ref. 62) Policy Statement under TSCA section 5 entitled
Category for Persistent, Bioaccumulative, and Toxic New Chemical
Substances. EPA has also used a measured BCF that is equal to or
greater than 1,000 or, in the absence of a BCF, a log Kow
value equal to or greater than 4.3 to help define the potential of a
new chemical substance to cause significant adverse environmental
effects (Ref. 63). EPA considers the difference between the log
Kow of 4.3 used with new chemical substances (Ref. 63) and
the log Kow value of 4.2 cited in this final TSCA section 4
test rule to be negligible.
Chemical substances that are dispersible in water (e.g.,
surfactants, detergents, aliphatic amines, and cationic dyes) may have
log Kow values greater than 4.2 and may still be acutely
toxic to aquatic organisms. To deal with such chemicals, EPA is
recommending that test sponsors who wish to conduct Test Group 1
studies on chemicals with a log Kow greater than or equal to
4.2 submit to EPA for approval a written request to conduct Test Group
1 studies 90 days prior to conducting such studies. EPA solicited
public comment on this approach as well as other alternative approaches
in this area but did not receive comments on this matter.
4. Mammalian toxicity--acute.
Acute Inhalation Toxicity (rat): Method A (40 CFR 799.9130)
Acute Oral Toxicity (rat): Method B (ASTM E 1163 or 40 CFR
799.9110(d)(1)(i)(A)) (Ref. 64).
For the ``mammalian toxicity--acute'' endpoint, EPA is requiring
that certain ``special conditions'' be considered in determining the
appropriate test method that would be used from among those included
for this endpoint in Table 3 in Sec. 799.5085(j) of the regulatory
text. The OECD HPV SIDS Program recognizes that for most chemical
substances, the oral route of administration will suffice for this
endpoint. However, consistent with the approach taken under the
voluntary HPV Challenge Program, EPA is requiring that for test
substances that are gases at room temperature (25[deg]C), the acute
mammalian toxicity study be conducted using inhalation as the exposure
route (described as Method A (40 CFR 799.9130) in Table 3 in Sec.
799.5085(j) of the regulatory text). For all other chemicals (i.e.,
those that are either liquids or solids at room temperature), EPA is
requiring that the mammalian acute toxicity testing be conducted via
oral administration using an ``Up/Down'' test method (described as
Method B (ASTM E 1163 or 40 CFR 799.9110(d)(1)(i)(A)) in Table 3 in
Sec. 799.5085(j) of the regulatory text). Consistent with the
voluntary HPV Challenge Program, EPA is allowing the use of the neutral
red uptake basal cytotoxicity assay to select the starting dose for the
acute oral toxicity test as noted in Unit III. and discussed in the
document Response to Public Comments (Ref. 40). This test is included
as a special condition in Table 3 in Sec. 799.5085(j) of the
regulatory text.
5. Mammalian toxicity--genotoxicity.
Gene Mutations:
Bacterial Reverse Mutation Test (in vitro): 40 CFR 799.9510
Chromosomal Damage:
In Vitro Mammalian Chromosome Aberration Test (40 CFR 799.9537), or
Mammalian Bone Marrow Chromosomal Aberration Test (in vivo in
rodents: Mouse (preferred species), rat, or Chinese hamster) (40 CFR
799.9538), or
Mammalian Erythrocyte Micronucleus Test (sampled in bone marrow) (in
vivo in rodents: Mouse (preferred species), rat, or Chinese hamster)
(40 CFR 799.9539).
Persons required to conduct testing for chromosomal damage are
encouraged to use in vitro genetic toxicity testing (i.e., the
Mammalian Chromosome Aberration Test) to generate the needed genetic
toxicity screening data, unless known chemical properties preclude its
use. These could include, for example, physical chemical properties or
chemical class characteristics. A primary focus of both the voluntary
HPV Challenge Program and this final rule is to implement this program
in a manner consistent with the OECD HPV SIDS Program and as part of a
larger international activity with global involvement. This approach
provides the same degree of flexibility as that which currently exists
under the OECD HPV SIDS testing program (Ref. 5). A subject person who
uses one of the in vivo methods instead of the in vitro method to
address a chromosomal damage test requirement must submit to EPA a
rationale for conducting that alternate test in the final study report.
EPA solicited comment on whether the Agency should instead require that
a subject person wishing to use an alternate testing scheme submit to
EPA a notice that includes the rationale for conducting the alternative
tests prior to initiation of those studies. The comments received on
this issue are addressed in Unit M.4. of the Response to Public
Comments document (Ref. 40).
6. Mammalian toxicity--repeated dose/reproduction/developmental.
Combined Repeated Dose Toxicity Study with the Reproduction/
Developmental Toxicity Screening Test: 40 CFR 799.9365, or
Reproduction/Developmental Toxicity Screening Test: 40 CFR 799.9355
and
Repeated Dose 28-Day Oral Toxicity Study in Rodents: 40 CFR
799.9305.
For the ``mammalian toxicity--repeated dose/reproduction/
developmental'' endpoint, EPA recommends the use of the combined
repeated dose toxicity study with the reproduction/developmental
toxicity screening test (40 CFR 799.9365). EPA recognizes, however,
that there may be reasons to test a particular chemical using both the
reproduction/developmental toxicity screening test (40 CFR 799.9355)
and the repeated dose 28-day oral toxicity study in rodents (40 CFR
799.9305) instead of the combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test (40 CFR 799.9365).
With regard to such cases, a subject person who uses the combination of
the reproduction/developmental toxicity screening test and the repeated
dose 28-day oral toxicity study in rodents in place of the combined
repeated dose toxicity study with reproduction/developmental toxicity
screening test must submit to EPA a rationale for conducting these
alternate tests in the final study reports. EPA solicited comment on
whether the Agency should instead require that a subject person wishing
to use an alternate testing scheme submit to EPA a notice that includes
the rationale for conducting the alternative tests prior to initiation
of those studies. The comments received on this issue are addressed in
Unit M.4. of the Response to Public Comments document (Ref. 40).
In the proposal (Ref. 2) to this final rule, EPA stated that
certain of the chemicals for which mammalian toxicity--repeated dose/
reproduction/developmental toxicity testing is required may be used
solely as ``closed system intermediates,`` and if that were the case,
such chemicals may be eligible
[[Page 13717]]
for a reduced testing battery which substitutes a developmental
toxicity study for the SIDS requirement to address repeated dose,
reproduction, and developmental toxicity. EPA requested persons who
believe their chemical is used solely as a closed system intermediate
to submit appropriate information along with their comments which
substantiate this belief. If EPA agreed that the chemical is used
solely as a closed system intermediate it would address any
developmental toxicity testing need in a subsequent rulemaking (Ref. 2,
p. 81671). In its comments on the proposal to this final rule,
ExxonMobil (Ref. 26) claimed that methyl heptenone is a closed system
intermediate. EPA's response to ExxonMobil's claim is discussed in Unit
K.5. of the Response to Public Comments document (Ref. 40).
B. When Will the Testing Imposed by this Final Rule Begin?
Once this final rule is effective, which will be 30 days after its
publication in the Federal Register, the required testing must be
initiated at a time sufficient to allow the final report to be
submitted by the deadline indicated in Sec. 799.5085(i) of the
regulatory text, i.e., 13 months after the effective date of the rule.
C. How Must the Studies Required Under this Final Rule be Conducted?
Persons required to comply with this final rule must conduct the
necessary testing in accordance with the testing requirements listed in
Tables 2 and 3 in Sec. 799.5085(j) of the regulatory text, the
reporting requirements described in Sec. 799.5085(i) of the regulatory
text, and with 40 CFR Part 792--TSCA Good Laboratory Practice Standards
(GLPS).
D. What Substances Will be Tested Under this Final Rule?
With one exception, the ``Class 1'' chemical substances listed in
Table 2 in Sec. 799.5085(j) of the regulatory text (i.e., 12 of the 17
chemical substances included in this final rule) must be tested at a
purity of at least 99%. The exception is 1,3- propanediol, 2,2-
bis[(nitrooxy)methyl]-, dinitrate (ester) (CAS No. 78-11-5), also known
as pentaerythritol tetranitrate (PETN), which cannot be tested at 99%
purity because of its explosive properties and must either be diluted
in water or tested in a mixture with an appropriate stabilizing
compound (e.g., D-lactose monohydrate is the stabilizer in PETN, NF
which is a mixture that is 20% by weight PETN and 80% by weight D-
lactose monohydrate. PETN, NF is the form of PETN which was tested by
NTP in several toxicity studies (Ref. 65)). EPA has specified in Sec.
799.5085 (a) of the regulatory text that, if the test sponsor elects to
test this chemical in a mixture with a stabilizing compound (as opposed
to dilution of the chemical in water), then the stabilizer used must be
tested as a control.
The term Class 1 chemical substance refers to a chemical substance
having a chemical composition that consists of a single-chemical
species (not including impurities) that can be represented by a
specific, complete structure diagram. In those instances in which the
test sponsor(s) believes that a 99% level of purity is unattainable for
a given chemical, the sponsor may request a modification under the
procedures described in 40 CFR 790.55.
For the ``Class 2'' chemical substances listed in Table 2 in Sec.
799.5085(j) of the regulatory text (i.e., 5 of the 17 chemical
substances included in this final rule), EPA is requiring that the
substance to be tested be any representative form of the chemical
substance. The term Class 2 chemical substance refers to a chemical
substance having a composition that cannot be represented by a specific
complete chemical diagram, because such a substance generally contains
two or more different chemical species (not including impurities).
In providing a different approach for identifying the substance to
be tested with regard to Class 2 substances, EPA recognizes two
characteristics which further distinguish Class 2 from Class 1 chemical
substances. First, unlike for Class 1 substances, knowledge of the
composition of commercial Class 2 substances can vary in quality and
specificity from substance to substance.
The composition of the chemical species which comprise a Class 2
substance may be:
Well characterized in terms of molecular formula,
structural diagrams, and compositional percentages of all species
present (for example, methyl phenol);
Less well-characterized, for example, characterized only
by molecular formula, non-specific structural diagrams, and/or by
incomplete or unknown compositional percentages of the species present
(for example C12-C14 tert-alkyl amines); or
Poorly characterized because all that is known is the
identity of only some of the chemical species present and their
percentages of composition, or of only the feedstocks and method used
to manufacture the substance (for example, nut shell liquor of cashew).
Second, the composition of some Class 2 substances may vary from
one manufacturer to another, or, for a single manufacturer, from
production run to production run, because of small variations in
feedstocks, manufacturing methods, or other production variables. Small
variations in the feedstock or in chemical production methods or
conditions can account for the types of small variations in composition
typically allowable within a given Class 2 listing on the TSCA
Inventory. By contrast, a ``Class 1'' designation generally applies to
a substance which is an individual chemical whose only variables are
its impurities.
EPA believes that, for purposes of this final rule, the testing of
any representative form of a subject Class 2 substance would provide
data necessary to support the development of preliminary or screening
level hazard and risk characterizations for the subject Class 2
substance. However, EPA encourages the selection of representative
forms of the test substances that meet industry or consensus standards,
where they exist. In accordance with TSCA GLPS at 40 CFR part 792, the
final study report must include test substance identification
information, including name, CAS number, strength, purity, and
composition, or other appropriate characteristics. (See 40 CFR
792.185). In future TSCA section 4 test rules involving Class 2
substances, testing requirements relative to the number and specificity
of the representative form of the substance may differ from the testing
requirement in this final rule (i.e., testing of any representative
form of the subject Class 2 substances). For example, EPA may require
testing of more than one representative form of a Class 2 substance or
may specify the representative form to be tested and/or may specify
equivalence data that must be submitted by exemption applicants. (See
40 CFR 790.82).
E. Am I Required to Test Under this Final Rule?
1. Am I subject to this final rule? You are subject to this final
rule and may be required to test if you manufacture (which is defined
by statute to include import) or process, or intend to manufacture or
process, one or more chemical substances listed in Table 2 in Sec.
799.5085(j) of the regulatory text during the time period discussed in
Unit V.E.2. However, if you do not know or cannot reasonably ascertain
that you manufacture or process a listed test rule substance (based on
all information in your possession or control, as well as all
information that a reasonable person similarly situated might be
expected to possess, control, or know, or could obtain without an
unreasonable burden), you are not
[[Page 13718]]
subject to the rule for that listed substance.
2. When will my manufacture or processing (or my intent to do so)
cause me to be subject to this final rule? You are subject to this
final rule if you manufacture or process, or intend to manufacture or
process, a substance listed in Table 2 in Sec. 799.5085(j) of the
regulatory text at any time from the effective date of the final test
rule to the end of the test cost reimbursement period.
The term reimbursement period is defined at 40 CFR 791.3(h) and may
vary in length for each substance to be tested under a final TSCA
section 4(a) test rule, depending on what testing is required and when
testing is completed. (See Unit V.E.4.).
3. Will I be required to test if I am subject to the rule? It
depends on the nature of your activities. All persons who are subject
to this TSCA section 4(a) test rule, which, unless otherwise noted in
the regulatory text, incorporates EPA's generic procedures applicable
to TSCA section 4(a) test rules (contained within 40 CFR part 790),
fall into one of two groups, designated here as Tier 1 and Tier 2.
Persons in Tier 1 (those who must initially comply with the rule) must
either:
Submit to EPA letters of intent to conduct testing,
conduct this testing, and submit the test data to EPA or
Apply to and obtain from EPA exemptions from testing.
Persons in Tier 2 (those who do not have to initially comply with the
rule) need not take any action unless they are notified by EPA that
they are required to do so, as described in Unit V.E.3.d. Note that
persons in Tier 1 who obtain exemptions and persons in Tier 2 are
nonetheless subject to providing reimbursement to persons who actually
conduct the testing, as described in Unit V.E.4.
a. Who is in Tier 1 and Tier 2? All persons subject to this final
rule are considered to be in Tier 1 unless they fall within Tier 2.
Table 3 of this unit describes who is in Tier 1 and Tier 2.
Table 3.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
Tier 1 (Persons initially required to Tier 2 (Persons not initially
comply) required to comply)
------------------------------------------------------------------------
Persons who manufacture (as defined at A. Persons who manufacture (as
TSCA section 3(7)), or intend to defined at TSCA section 3(7))
manufacture, a test rule substance, or intend to manufacture a
and who are not listed under Tier 2 test rule substance solely as
one or more of the following:
--As a byproduct (as defined at
40 CFR 791.3(c));
--As an impurity (as defined at
40 CFR 790.3);
--As a naturally occurring
chemical substance (as defined
at 40 CFR 710.4(b));
--As a non-isolated
intermediate (as defined at 40
CFR 704.3);
--As a component of a Class 2
substance (as described at 40
CFR 720.45(a)(1)(i));
--In amounts of less than 500
kg (1,100 lbs.) annually (as
described at 40 CFR
790.42(a)(4)); or
--In small quantities solely
for research and development
(R & D) (as described at 40
CFR 790.42(a)(5)).
B. Persons who process (as
defined at TSCA section 3(10))
or intend to process a test
rule substance (see 40 CFR
790.42(a)(2)).
------------------------------------------------------------------------
b. When is it appropriate for a person required to comply with the
rule to apply for an exemption rather than to submit a letter of intent
to conduct testing? You may apply for an exemption if you believe that
the required testing will be performed by another person (or a
consortium of persons formed under TSCA section 4(b)(3)(A)). You can
find procedures relating to exemptions in 40 CFR 790.80 through 790.99,
and Sec. 799.5085(c)(2), (c)(5), and (c)(9) of the regulatory text. In
this final rule, EPA will not require the submission of equivalence
data (i.e., data demonstrating that your substance is equivalent to the
substance actually being tested) as a condition for approval of your
exemption. Therefore, 40 CFR 790.82(e)(1) and 40 CFR 790.85 do not
apply to this final rule.
c. What will happen if I submit an exemption application? EPA
believes that requiring the collection of duplicative data is
unnecessarily burdensome. As a result, if EPA receives a letter of
intent to test from another source or has received (or expects to
receive) the test data that are required under this final rule, the
Agency would conditionally approve your exemption application under 40
CFR 790.87.
The Agency would terminate a conditional exemption if a problem
occurs with the initiation, conduct, or completion of the required
testing, or with the submission of the required data to EPA. EPA may
then require you to submit a letter of intent to test or an exemption
application. See 40 CFR 790.93 and Sec. 799.5085(c)(8) of the
regulatory text. In addition, the Agency would terminate a conditional
exemption if no letter of intent to test has been received by persons
required to comply with the rule. See, e.g., Sec. 799.5085(c)(6) of
the regulatory text. (Note that the provisions at 40 CFR 790.48(b) have
been incorporated into the regulatory text of this rule, thus persons
subject to this rule are not required to comply with 40 CFR 790.48
itself (see Sec. 799.5085(c)(4), (c)(5), (c)(6), (c)(7), and (d)(3))
Persons who obtain exemptions or receive them automatically will
nonetheless be subject to providing reimbursement to persons who
actually conduct the testing, as described in Unit V.E.4.
d. What are my obligations if I am in Tier 2? If you are in Tier 2,
you are subject to the rule and you are responsible for providing
reimbursement to persons in Tier 1, as described in Unit V.E.4. You are
considered to have an automatic conditional exemption. You do not need
to submit a letter of intent to test or an exemption application unless
you are notified by EPA that you are required to do so.
If a problem occurs with the initiation, conduct, or completion of
the required testing, or the submission of the required data to EPA,
the Agency may require you to submit a letter of intent to test or an
exemption application. See 40 CFR 790.93 and Sec. 799.5085(c)(8) of
the regulatory text.
[[Page 13719]]
In addition, you will need to submit a letter of intent to test or
an exemption application if:
No manufacturer in Tier 1 has notified EPA of its intent
to conduct testing.
EPA has published a Federal Register document directing
persons in Tier 2 to submit to EPA letters of intent to conduct testing
or exemption applications. (See Sec. 799.5085(c)(4) and (c)(5) of the
regulatory text.)
The Agency would conditionally approve an exemption application under
40 CFR 790.87, if EPA has received a letter of intent to test or has
received (or expects to receive) the test data required under this
final rule.
e. Subdivision of Tier 2 entities. If the Agency needs testing from
persons in Tier 2, EPA may propose to subdivide the group of subject
persons in Tier 2 into Tier 2A (Tier 2 manufacturers, i.e., those who
manufacture, or intend to manufacture a test rule substance solely as
one or more of the following: A byproduct; an impurity; a naturally
occurring substance; a non-isolated intermediate; a component of a
Class 2 substance; in amounts less than 1,100 lbs. annually; or in
small quantities solely for R & D) and Tier 2B (all processors, i.e.,
those who process, or intend to process, a test rule substance (in any
form). The terms ``process'' and ``processor'' are defined by TSCA
section 3(10) and 3(11) respectively). The Agency may propose to seek
testing from Tier 2A manufacturers before proceeding to Tier 2B
processors.
EPA solicited comment on the subdivision of Tier 2 entities in
another recent proposed TSCA section 4 test rule pertaining to dermal
absorption rate testing (Ref. 55, pp. 31081-31082). Although commenters
did not favor the subdivision of Tier 2 entities as a general matter,
EPA decided to implement the approach in the final rule (Ref. 67, pp.
22417, 22426, and 22437-22438). The Agency indicated that subdividing
Tier 2 up front in test rules may facilitate compliance by requiring
Tier 2 manufacturers, when required to comply, to submit letters of
intent to test or exemption applications before processors are called
upon to do so. The Agency's expectation was that it may generally be
less administratively complex for manufacturers to conduct the testing
(including coordinating efforts to determine who will actually conduct
testing) than for processors to do so. This is because there may
generally be fewer manufacturers (even as byproducts, impurities, etc.)
than processors (Ref. 68, p. 31789). EPA also believes that testing
costs have traditionally been passed by manufacturers along to
processors, enabling them to share in the costs of testing (Ref. 69, p.
20654), and has not received evidence to the contrary.
Although the subdivision of Tier 2 entities was not included in the
proposal to this final rule, and is thus not being implemented in this
final rule, such an approach could be proposed, if needed, to
facilitate compliance with the rule.
f. How did EPA decide who would be in Tier 1 and Tier 2 and who
would be excluded from the rule? Under 40 CFR 790.2, EPA may establish
procedures applying to specific test rules that differ from the generic
procedures governing TSCA section 4 test rules in 40 CFR part 790. For
the purposes of this final rule, EPA is setting forth certain
requirements that differ from those under 40 CFR part 790.
In this final rule, EPA has reconfigured the tiers in 40 CFR
790.42. In addition to processors, manufacturers of less than 500 kg
(1,100 lbs.) per year (``small-volume manufacturers''), and
manufacturers of small quantities for research and development (``R & D
manufacturers''), EPA has added the following persons to Tier 2:
Byproduct manufacturers; impurity manufacturers; manufacturers of
naturally occurring substances; manufacturers of non-isolated
intermediates; and manufacturers of components of Class 2 substances.
For further discussion on this point, see Unit F. of the Response to
Public Comments document (Ref. 40).
TSCA section 4(b)(3)(B) requires all manufacturers and processors
of a chemical substance to test that chemical substance if EPA has made
findings for that chemical substance, and therefore issued a TSCA
section 4(a) test rule requiring testing. However, practicality must be
a factor in determining who is subject to a particular test rule. Thus,
persons who do not know or cannot reasonably ascertain that they are
manufacturing or processing any of the substances subject to this final
rule, e.g., manufacturers or processors of a substance as a trace
contaminant who are not aware of these activities, are not subject to
the rule. (See Unit V.E.1. and Sec. 799.5085(b)(2) of the regulatory
text.)
4. How do the reimbursement procedures work? In the past, persons
subject to test rules have independently worked out among themselves
their respective financial contributions to those persons who have
actually conducted the testing. However, if persons are unable to agree
privately on reimbursement, they may take advantage of EPA's
reimbursement procedures at 40 CFR part 791, promulgated under the
authority of TSCA section 4(c). These procedures include:
The opportunity for a hearing with the American
Arbitration Association.
Publication by EPA of a Federal Register document
concerning the request for a hearing.
The appointment of a hearing officer to propose an order
for fair and equitable reimbursement.
The hearing officer may base his or her proposed order on the
production volume formula set out at 40 CFR 791.48, but is not
obligated to do so. Under this final rule, amounts manufactured as
impurities will be included in production volume (40 CFR 791.48(b)),
subject to the discretion of the hearing officer (40 CFR 791.40(a)).
The hearing officer's proposed order may become the Agency's final
order, which is reviewable in Federal court (40 CFR 791.60).
F. What are the Reporting Requirements Under this Final Rule?
A final report must be submitted for each test for each chemical 13
months after the effective date of the final rule, i.e., by the
deadline indicated in Sec. 799.5085(i) of the regulatory text. EPA
requests that a robust summary of each final test report be prepared
and submitted with each final report. The term ``robust summary'' is
used to describe the technical information necessary to adequately
describe an experiment or study and includes the objectives, methods,
results, and conclusions of the full study report, which can either be
an experiment or in some cases an estimation or prediction method.
``Draft Guidance on Developing Robust Summaries'' (Ref. 14) is
available on the website of the voluntary HPV Challenge Program, http://www.epa.gov/chemrtk/robsumgd.htm, and in the public docket for this
final rule. EPA is not requiring the submission of interim progress
reports for the testing required in this final rule. For the short-term
studies required by this final rule, interim progress reports would
likely yield little useful information. Furthermore, by not requiring
interim progress reports for these short-term studies, the overall
burden of the rule will be somewhat reduced.
G. What Would I Need to Do If I Cannot Complete the Testing?
A company that submits a letter of intent to test under this final
rule and that subsequently anticipates difficulties in completing the
testing by the deadline may submit a request to the Agency to modify
the test schedule, pursuant to 40 CFR 790.55. EPA will
[[Page 13720]]
determine whether modification of the test schedule is appropriate, and
may first seek public comment on the modification.
H. Will There Be Sufficient Test Facilities and Personnel to Undertake
the Testing in this Final Rule?
Various surveys of the availability of test facilities and
personnel to handle the additional demand for testing services created
by TSCA section 4(a) test rules indicate that available test facilities
and personnel will adequately accommodate the testing specified in this
final rule (Refs. 70 and 71). For further discussion on this point, see
Unit J. of the Response to Public Comments document (Ref. 40).
I. Might EPA Seek Further Testing of the Chemicals in this Final Rule?
If EPA determines that it needs additional data regarding any of
the chemical substances included in this final rule, the Agency might
seek further health and/or environmental effects testing for those
chemical substances. Should the Agency decide to seek such additional
testing, EPA would initiate a separate action under TSCA section 4 for
that purpose.
VI. Export Notification
Any person who exports, or who intends to export, one of the
chemical substances contained in this final rule in any form (e.g., as
components of Class 2 substances, byproducts, impurities, etc.) is
subject to the export notification requirements in TSCA section
12(b)(1) and at 40 CFR part 707, subpart D. This approach is consistent
with the Agency's approach when the export notification regulations
were originally promulgated in 1980 (Ref. 72). Export notification is
generally not required for articles, as provided by 40 CFR 707.60(b).
Section 12(b) of TSCA states, in part, that any person who exports or
intends to export to a foreign country a chemical substance or mixture
for which the submission of data is required under section 4 must
notify the EPA Administrator of such export or intent to export. The
Administrator in turn will notify the government of the importing
country of EPA's regulatory action with respect to the substance.
VII. Decision Not to Pursue Rulemaking
EPA has decided to withdraw 20 chemicals included in the proposal
for this final rule for the reasons presented in Unit VII.A. and B.
A. Voluntary Commitments to the HPV Challenge Program
Since the publication of the proposed rule (Ref. 2), commitments
have been made to sponsor 13 of the 37 chemicals originally proposed
for testing. ``Viable'' commitments have been made for 11 chemicals
through the voluntary HPV Challenge Program and 2 chemicals are now
sponsored through the ICCA HPV Initiative (Ref. 6). Any U.S. HPV
chemicals that are handled under the ICCA HPV Initiative are considered
by EPA to be ``sponsored'' and are not anticipated to be addressed in
either the voluntary HPV Challenge Program or in any TSCA section 4 HPV
SIDS rulemaking unless the international commitments are not met. These
13 chemicals are:
1,2,3-Propanetriol, trinitrate (CAS No. 55-63-0).
Methanesulfonic acid (CAS No. 75-75-2).
Phenol, 2-(1,1-dimethylethyl)- (CAS No. 88-18-6).
Phenol, 2-ethyl- (CAS No. 90-00-6).
1-Naphthalenol (CAS No. 90-15-3).
Benzenesulfonic acid (CAS No. 98-11-3).
Phenol, 2,4-dimethyl- (CAS No. 105-67-9).
2-Propen-1-ol (CAS No. 107-18-6).
Phenol, 2,4,6-tris(1,1-dimethylethyl)- (CAS No. 732-26-3).
Benzensulfonic acid, hydroxy- (CAS No. 1333-39-7).
Benzenesulfonamide, N-butyl- (CAS No. 3622-84-2).
Quaternary ammonium compounds, benzylbis(hydrogenated
tallow alkyl)methyl, salts with bentonite (CAS No. 68153-30-0).
Quaternary ammonium compounds, bis(hydrogenated tallow
alkyl)dimethyl, salts with bentonite (CAS No. 68953-58-2).
EPA believes that these voluntary commitments will result in the
generation of data necessary to support development of preliminary or
screening level hazard and risk determinations for these chemicals.
Therefore, testing of these chemicals under TSCA section 4 is not
necessary at the present time. EPA is not including these chemicals in
the final rule, and testing of these chemicals under this final rule is
not required. Specific information on sponsorship, test plans, and
other pertinent information may be obtained by visiting EPA's voluntary
HPV Challenge Program website at http://www.epa.gov/chemrtk/viewsrch.htm. This approach is not intended to set a precedent for how
EPA will address this issue in future HPV SIDS test rules.
B. TSCA Section 4(a)(1)(B)(i) Finding Not Made
In developing the finding of substantial production for this final
rule, EPA determined that, based on 2002 IUR data, seven chemicals that
had been included in the proposed rule are no longer produced or
imported in amounts equal to or greater than 1 million pounds per year.
Because the 2002 IUR data show manufacture (including import) below the
1 million pounds per year threshold which EPA generally relies upon as
``substantial production'' under TSCA section 4(a)(1)(B)(i), the
following seven chemicals are not included in the final rule:
Thiourea (CAS No. 62-56-6).
1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester
(CAS. No. 84-69-5).
Acetonitrile, hydroxy- (CAS No. 107-16-4).
Methanone, (2-hydroxy-4-methoxyphenyl)phenyl- (CAS No.
131-57-7).
2-Naphthalenesulfonic acid, 6-[(2,4-diaminophenyl)azo]-3-
[[4-[[4-[[7-[(2,4-diaminophenyl)azo]-1-hydroxy-3-sulfo-2-
naphthalenyl]azo]phenyl]amino]-3-sulfophenyl]azo]-4-hydroxy-, trisodium
salt (CAS No. 6473-13-8).
Methanesulfonic acid, hydroxy-, monosodium salt (CAS No.
870-72-4).
Octadecanoic acid, 2-(hydroxymethyl)-2-[[(1-
oxooctadecyl)oxy]methyl]-1,3-propanediyl ester (CAS No. 28188-24-1).
C. TSCA Section 4(a)(1)(B)(ii) Finding Not Made
1. Melting point, boiling point and vapor pressure of PETN. As
discussed in Unit K.2. of the Response to Public Comments document
(Ref. 40), EPA reviewed data submitted by SII (Ref. 28) on the
physical/chemical properties of PETN (CAS No. 78-11-5). EPA believes
those data are sufficient for melting point, boiling point and vapor
pressure, but that data are still needed on the n-octanol/water
partition coefficient and water solubility (Ref. 73). Therefore, EPA is
not finalizing the proposed testing to determine the melting point,
boiling point and vapor pressure of PETN in this final rule, but EPA is
still requiring the testing of PETN for n-octanol/water partition
coefficient and water solubility, as well as environmental fate,
toxicity to algae, and screening level reproduction/developmental
toxicity.
2. Reproduction/developmental toxicity screening test of sorbic
acid. As discussed in Unit K.3. of the Response
[[Page 13721]]
to Public Comments document (Ref. 40), EPA reviewed four studies on
sorbic acid (2,4-hexadienoic acid, (2E,4E)-) (CAS No. 110-44-1) which
ADC (Ref. 24) thought might satisfy the testing proposed to be
conducted according to 40 CFR 799.9355 to obtain screening level data
on the reproductive and developmental toxicity of sorbic acid. EPA
determined that the studies provided sufficient information on this
endpoint(s) at this time for sorbic acid (Ref. 74). Therefore, EPA is
not requiring the reproduction/developmental toxicity screening test of
sorbic acid in this final rule. EPA is still requiring the testing of
sorbic acid for aquatic toxicity and the determination of melting
point, boiling point, vapor pressure, n-octanol/water partition
coefficient, and water solubility.
VIII. Economic Impacts
EPA has prepared an economic assessment entitled Economic Analysis
for the Final Section 4 Test Rule for High Production Volume Chemicals
(Ref. 75), a copy of which has been placed in the public docket. This
economic assessment evaluates the potential for significant economic
impacts as a result of the testing that would be required by this final
rule. The total social cost of this final rule is estimated to be $4.08
million, using a social discount rate of 3% over a 3-year period (Ref.
75).
While legally subject to this final rule, Tier 2 manufacturers and
all processors of a subject chemical would only be required to comply
with the requirements of the rule if they are directed to do so by EPA
as described in Sec. 799.5085(c)(5) and (c)(8) of the regulatory text.
EPA would require Tier 2 manufacturers or processors to test only if no
Tier 1 manufacturer has submitted a letter of its intent to conduct
testing, or if, under 40 CFR 790.93, a problem occurs with the
initiation, conduct, or completion of the required testing, or the
submission of the required data to EPA. Because EPA has identified at
least one manufacturer in Tier 1 for each subject chemical, the Agency
expects that, for each chemical in this final rule, at least one such
person will submit a letter of intent to conduct the required testing
and that person will conduct such testing and will submit the test data
to EPA. EPA believes that there will not be any costs to Tier 2
manufacturers or processors for conducting the testing required by the
final rule because EPA is not aware of any circumstances in which Tier
1 entities have sought reimbursement from Tier 2 entities either
through private agreements or by soliciting the involvement of the
Agency under the reimbursement regulations at 40 CFR part 791. Given
this consistent experience with previous test rules, EPA does not
believe that there will be any administrative, negotiation, or any
other costs associated with seeking reimbursement from Tier 2
companies.
To evaluate the potential for an adverse economic impact of testing
on manufacturers of the chemical substances in this final rule, EPA
employed a screening approach that compares the annual revenues from
the sale of a chemical to the annualized testing costs for that
chemical and expresses the testing costs as a percent of revenues
generated from each chemical. Annualized testing costs divide testing
expenditures into an equivalent, constant yearly expenditure over a
longer period of time. To calculate the percent price impact, testing
costs (including laboratory and administrative expenditures) are
annualized over 15 years (the expected life of a chemical) using a 7%
discount rate. Annualized testing costs are then divided by the
estimated annual revenue of the chemical to derive the cost-to-sales
ratio.
EPA estimates the cost to industry of testing the 17 chemicals
evaluated in the economic analysis to be $4.03 million with an average
cost of $237,000 per chemical (Ref. 75). In addition, the TSCA section
12(b) export notification, that is required only for the first export
by a particular exporter to a particular country of each chemical
subject to the rule, is estimated to average $67.35 (Ref. 75). The
Agency's estimated total costs of testing (including both laboratory
and administrative costs), annualized testing costs, price impacts, and
public reporting burden hours for this final rule are presented in the
economic impact analysis (Ref. 75).
Price data were available for 16 of the 17 chemicals, with an
average price of $2.62 per pound for those 16 chemicals. The price
impact of the test costs is a function of the chemical's price per
pound and the production volume. For 12 of the chemicals (75%) for
which price data were available, the price impact is less than 1.0%.
With a price impact of less than 1.0%, EPA concludes that for these
chemicals the potential for adverse economic impacts is low.
For 4 of the 16 chemicals (25%) with price data, the price impact
is in excess of 1.0%. For chemicals where the profit margins are low,
the costs of testing may use a significant part of the profits
generated by the chemical.
The Agency computed ``critical prices`` for the remaining chemical
for which price data were not available. The ``critical price'' is the
price per pound below which there would be an impact of 1.0% or
greater. The production volume for this chemical falls between 10
million to 50 million pounds. Assuming a production volume at the
midpoint of that range equal to 30 million pounds per year and
annualized testing costs of $33,585, the critical price is $0.11 per
pound. Below that price, the testing costs would represent more than
1.0% of the revenues from the chemical. The average price for the 16
chemicals with actual price data available is $2.62 per pound. Thus,
the critical price is substantially below this average. Only 2 of the
16 chemicals with price data were estimated to have prices below $0.11
per pound. While it cannot be shown conclusively that the price impacts
will be less than or greater than 1.0% of the sales for this chemical,
the Agency believes that adverse impacts are unlikely.
On the basis of these calculations, EPA believes that the required
chemical testing presents a low potential for adverse economic impact
for the majority of the chemicals subject to the rule. Because the
subject chemical substances have relatively large production volumes,
the annualized costs of testing, expressed as a percentage of annual
revenues, are very small for most chemicals. There are, however, four
chemicals for which it cannot be shown that the price impact will be
below 1.0% of the revenue for these chemicals. For these chemicals,
companies may choose to use revenue sources other than profits from the
individual chemicals to pay for testing. To account for this, the
Agency also compared the costs of compliance to company sales data.
These calculations were made as part of the Agency's small entity
impact analysis (Ref. 75), conducted in accordance with the
requirements of the RFA, as amended by the Small Business Regulatory
Enforcement Fairness Act. These results are presented in Unit XI.C.
IX. Submissions to EPA
You may make submissions such as letters of intent to test,
applications for exemption from testing, study plans, applications for
modification, and final study reports through the mail or in person. To
ensure proper receipt by EPA, it is imperative that you direct such
submissions to the attention of ``TSCA Section 4.''
1. By mail. Mail your submission to: Document Control Office
(7407M), Office of Pollution Prevention and Toxics (OPPT),
Environmental Protection Agency, 1200 Pennsylvania
[[Page 13722]]
Ave., NW., Washington, DC 20460-0001 (Attention: TSCA Section 4).
2. In person or by courier. Deliver your submission to: OPPT
Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. (Attention: TSCA Section 4).
The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the DCO is (202) 564-8930.
Such deliveries are only accepted during the DCO's normal hours of
operation.
X. Materials in the Docket
As indicated under ADDRESSES at the beginning of this document, an
official docket was established for this final rule under docket ID
number EPA-HQ-OPPT-2005-0033. The docket includes information
considered by EPA in developing this final rule, such as the documents
specifically referenced in this action, any public comments received,
and other information related to this action. In addition, interested
parties should consult documents that are referenced in the documents
that EPA has placed in the public docket, regardless of whether these
referenced documents are physically located in the public docket. For
assistance in locating documents that are referenced in documents that
EPA has placed in the public docket, but that are not physically
located in the docket, please consult the technical contact listed
under FOR FURTHER INFORMATION CONTACT. The public docket is available
for review as specified under ADDRESSES.
A. Supporting Documentation
The items listed in this Unit X.A., although supporting
documentation for this final rule, are not referenced in this preamble,
but they are available in the public docket for this final rule:
Anon. Final report on the safety assessment of sorbic acid and
potassium sorbate. Journal of the American College of Toxicology. 7(6):
837-880. 1988.
Buell, D.A., Blaustein, M.B., and Lynch, J.R. An Assessment of the
National Occupational Exposure Survey. Prepared by Temple, Barker &
Sloane, Inc. and Exxon Corp. Undated.
Demaree, G.E., et al. Preliminary studies on the effect of feeding
sorbic acid upon growth, reproduction and cellular metabolism of albino
rats. Journal of the American Pharmaceutical Association. 44:619-621.
1955.
Environmental Defense (ED) (formerly Environmental Defense Fund,
Inc.) Toxic Ignorance. 1997.
EPA 1983. Ethyltoluenes, Trimethylbenzenes, and the C9
Aromatic Hydrocarbon Fraction; Proposed Test Rule. Federal Register (48
FR 23088, May 23, 1983).
EPA 1985a. Identification of Specific Chemical Substance and
Mixture Testing Requirements; Ethyltoluenes, Trimethylbenzenes, and the
C9 Aromatic Hydrocarbon Fraction. Federal Register (50 FR
20662, May 17, 1985).
EPA 1985b. Toxic Substances; Biphenyl; Final Test Rule. Federal
Register (50 FR 37182, September 12, 1985).
EPA 1986. Methylcyclopentane and Commercial Hexane; Proposed Test
Rule. Federal Register (51 FR 17854, May 15, 1986).
EPA 1988. Commercial Hexane and Methylcyclopentane; Final Test
Rule. Federal Register (53 FR 3382, February 5, 1988).
EPA 1990. Testing Consent Agreements and Test Rules; Final Rule.
Federal Register (55 FR 18881, May 7, 1990).
EPA 1994. Office of Water Chemicals, Final Test Rule;
Clarification. Federal Register (59 FR 45629, September 2, 1994).
EPA 1996. Announcement of the availability of draft test guidelines
and solicitation of public comment. Federal Register (61 FR 31522, June
20, 1996) (FRL-5367-7).
EPA 1998. Announcement of the availability of the final harmonized
test guidelines. Federal Register (63 FR 41845, August 5, 1998) (FRL-
5740-1).
EPA 1999a. OPPT. Determining the Adequacy of Existing Data.
February 10, 1999. Available online at: http://www.epa.gov/chemrtk/datadfin.htm.
EPA 1999b. OPPT. Development of Chemical Categories in the HPV
Challenge Program (Draft). August 25, 1999. Available online at: http://www.epa.gov/chemrtk/categuid.htm.
EPA 1999c. OPPT. The Use of Structure-Activity Relationships (SAR)
in the High Production Volume Chemicals Challenge Program. August 26,
1999. Available online at: http://www.epa.gov/chemrtk/sarfinl1.htm.
EPA 1999d. Office of Prevention, Pesticides, and Toxic Substances
(OPPTS). Letter from Susan H. Wayland, Deputy Assistant Administrator,
to participants in the voluntary HPV Challenge Program. October 14,
1999. Available online at: http://www.epa.gov/chemrtk/ceoltr2.htm.
EPA 2000a. OPPT. Economic Impact of a Section 4 Test Rule for High
Production Volume Chemicals. Prepared by the Economic Policy and
Analysis Branch (EPAB), Economics, Exposure, and Technology Division
(EETD), OPPT. December 2000.
EPA 2000b. Toxic Substance Control Act Test Guidelines; Final Rule.
Federal Register (65 FR 78746, December 15, 2000) (FRL-6551-2).
EPA 2002a. Agency Information Collection Activities; OMB Responses.
Federal Register (67 FR 39712, June 10, 2002) (FRL-7225-8).
EPA 2002b. Notification of Chemical Exports--TSCA Section 12(b):
Request for Comment on Renewal of Information Collection Activities.
Federal Register (67 FR 53792, August 19, 2002) (FRL-7192-7).
EPA 2002c. Revised final health effects test guidelines; acute
toxicity testing--Background and acute oral toxicity; Notice of
availability. Federal Register (67 FR 77064, December 16, 2002) (FRL-
7282-3).
EPA 2003. Review of comments on biodegradation testing of a
proposed test rule chemical (PETN). Memorandum from Dr. Robert
Boethling, Exposure Assessment Branch (EAB), EETD to Paul Campanella,
Chemical Information and Testing Branch (CITB), Chemical Control
Division (CCD). February 26, 2003.
EPA 2004a. HPV Challenge Program Disclaimer on posted robust
summaries and test plans. May 13, 2004. (For example, see http://www.epa.gov/chemrtk/quatcatg/c15210tc.htm).
EPA 2004b. IUR Data on methyl heptenone. E-mail message from Lynne
Blake-Hedges, EPAB, EETD to Catherine Roman, EPA. July 8, 2004.
EPA 2004c. IUR Data on PETN. E-mail message from Lynne Blake-
Hedges, EPAB, EETD to Catherine Roman, EPA. July 22, 2004.
EPA 2004d. Memorandum from Larry Newsome, High Production Volume
Chemicals Branch (HPVCB), Risk Assessment Division (RAD) to Greg
Schweer, CITB, CCD. August 5, 2004.
EPA 2004e. Memorandum from Katherine Anitole, Existing Chemicals
Assessment Branch (ECAB), RAD to Greg Schweer, CITB, CCD. August 13,
2004.
EPA 2004f. 1-Chlorododecane. E-mail from Lynne Blake-Hedges, EPAB,
EETD to Catherine Roman, EPA. August 25, 2004.
EPA 2004g. TETRATOX test. Memorandum from Donald Rodier, RAD, to
Greg Schweer, CITB, CCD. November 1, 2004.
EPA 2004h. OPPT. Status and Future Directions of the High
Production Volume Challenge Program. December 1, 2004. Available online
at: http://www.epa.gov/chemrtk/hpvstatr.htm.
FDRL 1975. Food and Drug Research Labs. Teratologic evaluation of
FDA 73-4 (potassium sorbate: Sorbistat) in mice and rats. Prepared
under DHEW
[[Page 13723]]
Contract No: FDA 223-74-2176. NTIS No. PB-245520. Waverly, NY. 1975.
Hawley's Condensed Chemical Dictionary. 14\th\ Edition. Revised by
Richard J. Lewis, Sr. Publisher: John Wiley & Sons, Inc. 2002.
Larsen, J., Schultz, T.W., Rasmussen, L., Hooftman, R., and Pauli,
W. Progress in an ecotoxicological standard protocol with protozoa:
Results from a pilot ring test with Tetrahymena pyriformis.
Chemosphere. 35(5): 1023-1041. 1997.
LeBlanc, G.A. Interspecies relationships in acute toxicity of
chemicals to aquatic organisms. Environmental Toxicology and Chemistry.
3: 47-60. 1984.
National Institute of Environmental Health Sciences (NIEHS) 1997.
Validation and Regulatory Acceptance of Toxicological Test Methods: A
Report of the ad hoc Interagency Coordinating Committee on the
Validation of Alternative Methods. NIH Publication No: 97-3981. 1997.
Available online at: http://iccvam.niehs.nih.gov/docs/guidelines/validate.pdf.
NIEHS 2001a. Report of the International Workshop on In Vitro
Methods for Assessing Acute Systemic Toxicity. NIH Publication No. 01-
4499. August 2001. Available online at: http://www.epa.gov/chemrtk/nih/2001a.pdf.
NIEHS 2001b. Guidance Document on Using In Vitro Data to Estimate
In Vivo Starting Doses for Acute Toxicity. NIH Publication No. 01-4500.
August 2001.
NIEHS 2003a. Test Method Protocol for Solubility Determination, in
vitro Cytotoxicity Validation Study--Phase III. National Toxicology
Program (NTP) Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM). September 24, 2003.
NIEHS 2003b. Test Method Protocol for the BALB/c 3T3 Neutral Red
Uptake Cytotoxicity Test, a Test for Basal Cytotoxicity for an in vitro
Validation Study--Phase III. National Toxicology Program (NTP)
Interagency Center for the Evaluation of Alternative Toxicological
Methods (NICEATM). November 4, 2003. Available online at: http://iccvam.niehs.nih.gov/methods/invidocs/phIIIprot/3t3phIII.pdf.
NIEHS 2003c. Test Method Protocol for the NHK Neutral Red Uptake
Cytotoxicity Test, a Test for Basal Cytotoxicity for an in vitro
Validation Study--Phase III. National Toxicology Program (NTP)
Interagency Center for the Evaluation of Alternative Toxicological
Methods (NICEATM). November 4, 2003. Available online at: http://iccvam.niehs.nih.gov/methods/invidocs/phIIIprot/nhkphIII.pdf.
National Institute for Occupational Safety and Health (NIOSH)
1983a. NOES. Estimated numbers of employees potentially exposed to
pentaerythritol tetranitrate by occupation within 2-digit Standard
Industrial Classification (SIC). 1981-1983. Available online at: http://www.cdc.gov/noes/noes4/83538sco.html.
NIOSH 1983b. NOES. Estimated number of employees potentially
exposed to light oil by occupation within 2-digit Standard Industrial
Classification (SIC). 1981-1983. Available online at: http://www.cdc.gov/noes/noes4/x2973sco.html.
NIOSH 1983c. NOES. Estimated number of employees potentially
exposed to 1-chlorododecane by occupation within 2-digit Standard
Industrial Classification (SIC). 1981-1983. Available online at: http://www.cdc.gov/noes/noes4/x2609sco.html.
NIOSH 1988. National occupational exposure survey analysis of
management interview responses. Vol. III. Pedersen DH, Sieber WK, eds.
Cincinnati, OH: U.S. Department of Health and Human Services, Centers
for Disease Control, National Institute for Occupational Safety and
Health, DHHS (NIOSH) Publication No. 89-103. March 1988. Available
online at: http://www.cdc.gov/niosh/89-103.html.
OECD 2001a. Guidance Document on Acute Oral Toxicity Testing. OECD
Series on Testing and Assessment No. 24. June, 2001.
OECD 2001b. Acute Oral Toxicity--Fixed Dose Procedure. OECD Test
Guideline 420. Adopted December 17, 2001.
OECD 2001c. Acute Oral Toxicity--Acute Toxic Class Method. OECD
Test Guideline 423. Adopted December 17, 2001.
OECD 2001d. Acute Oral Toxicity-Up-and-Down Procedure. OECD Test
Guideline 425. Adopted December 17, 2001. Available online at: http://www.oecd.org/document/23/0,2340,en_2649_34379_1948503_1_1_1_1,00.html.
Schultz, T.W. TETRATOX: Tetrahymena pyriformis population growth
impairment endpoint--a surrogate for fish lethality. Toxicology
Methods. 7: 289-309. 1997.
Scientific Committee on Cosmetic Products and Non-Food Products
(SCCNFP). Opinion concerning The 1\st\ Update of the Inventory of
Ingredients Employed in Cosmetic Products. Section II. Perfume and
Aromatic Raw Materials. October 24, 2000.
Sodium Formaldehyde Bisulfite Manufacturers Association (SFBMA).
Comments on Hydroxymethanesulfonic acid, monosodium salt submitted to
the EPA. July 17, 2003.
United Nations. Report of the United Nations Conference on
Environment and Development (UNCED), Agenda 21, Chapter 19, Programme
Area C--Information Exchange on Toxic Chemicals and Chemical Risks.
1992.
Walker, R., Toxicology of sorbic acid and sorbates. Food Additives
and Contaminants. 7(5): 671-676. 1990.
B. References
The items listed in Unit X.B. are referenced in this preamble and
are available in the public docket for this final rule:
1. EPA. Data Collection and Development on High Production Volume
(HPV) Chemicals. Federal Register (65 FR 81686, December 26, 2000)
(FRL-6754-6).
2. EPA. Proposed test rule for the Testing of Certain High
Production Volume Chemicals. Federal Register (65 FR 81658, December
26, 2000) (FRL-6758-4).
3. EPA. TSCA section 4(a)(1)(B) Final Statement of Policy. Federal
Register (58 FR 28736, May 14, 1993).
4. EPA, OPPT. HPV Challenge Program Chemical List. This list is
updated periodically, and is available online at: http://www.epa.gov/oppt/chemrtk/hpvchmlt.htm.
5. OECD Secretariat. Manual for the Investigation of HPV Chemicals.
OECD Programme on the Co-Operative Investigation of High Production
Volume Chemicals. Paris, France. December 2003. Available online at:
http://www.oecd.org/document/7/0,2340,en_2649_34379_1947463_1_1_1_1,00.html.
6. International Council of Chemical Associations (ICCA). ICCA HPV
Working List. Chemicals. August 2003.
7. OECD Secretariat. Summary Record of the 13\th\ Joint Meeting of
the OECD Chemicals Group and Management Committee of the Special
Programme on the Control of Chemicals, November 8-10, 1989. ENV/CHEM/
CM/89.2. February 1990.
8. OECD Secretariat. Proposal for Further Work on the Investigation
of High Production Volume Chemicals. OECD Chemicals Group and
Management Committee of the Special Programme on the Control of
Chemicals. ENV/CHEM/CM/89.14. October 1989.
9. OECD. Decision-Recommendation on the Co-Operative Investigation
and Risk Reduction of Existing Chemicals--C(90)163/FINAL. January 31,
1991.
10. EPA. TSCA section 4(a)(1)(B) Proposed Statement of Policy.
Federal Register (56 FR 32294, June 15, 1991).
11. ACC. Comments on EPA's TSCA section 4(a)(1)(B) Proposed
Statement of Policy submitted to the TSCA Public
[[Page 13724]]
Docket Office, EPA . September 17, 1991.
12. Epoxy Resin Systems Task Group of the Society of the Plastics
Industry, Inc. Comments on EPA's TSCA section 4(a)(1)(B) Proposed
Statement of Policy submitted to the TSCA Public Docket Office, EPA.
September 17, 1991.
13. EPA, Office of Pollution Prevention and Toxics (OPPT). Chemical
Hazard Data Availability Study: What Do We Really Know About the Safety
of High Production Volume Chemicals? April 1998. Available online at:
http://www.epa.gov/chemrtk/hazchem.htm.
14. EPA, OPPT. Draft Guidance on Developing Robust Summaries.
October, 22, 1999. Available online at: http://www.epa.gov/chemrtk/robsumgd.htm.
15. ACC. Comments on EPA's Proposed Test Rule for Testing of
Certain High Production Volume Chemicals submitted to the TSCA Public
Docket Office, EPA. April 25, 2001.
16. American Petroleum Institute (API). Comments on EPA's Proposed
Test Rule for Testing of Certain High Production Volume Chemicals
submitted to the TSCA Public Docket Office, EPA. April 20, 2001.
17. Synthetic Organic Chemical Manufacturers Association (SOCMA).
Comments on EPA's Proposed Test Rule for Testing of Certain High
Production Volume Chemicals submitted to the TSCA Public Docket Office,
EPA. April 25, 2001.
18. Center for Regulatory Effectiveness (CRE). Comments on EPA's
Proposed Test Rule for Testing of Certain High Production Volume
Chemicals submitted to the TSCA Public Docket Office, EPA. April 25,
2001.
19. Environmental Defense (ED). Comments on EPA's Proposed Test
Rule for Testing of Certain High Production Volume Chemicals submitted
to the TSCA Public Docket Office, EPA. April 25, 2001.
20. American Coke and Coal Chemicals Institute (ACCCI). Comments on
EPA's Proposed Test Rule for Testing of Certain High Production Volume
Chemicals submitted to the TSCA Public Docket Office, EPA. April 25,
2001.
21. Color Pigments Manufacturers Association, Inc. (CPMA). Comments
on EPA's Proposed Test Rule for Testing of Certain High Production
Volume Chemicals submitted to the TSCA Public Docket Office, EPA. April
23, 2001.
22. Ecological and Toxicological Association of Dyes and Organic
Pigments Manufacturers (ETAD). Comments on EPA's Proposed Test Rule for
Testing of Certain High Production Volume Chemicals submitted to the
TSCA Public Docket Office, EPA. April 25, 2001.
23. Merisol USA LLC (Merisol). Comments on EPA's Proposed Test Rule
for Testing of Certain High Production Volume Chemicals submitted to
the TSCA Public Docket Office, EPA. April 25, 2001.
24. Ashland Distribution Company (Ashland). Comments on EPA's
Proposed Test Rule for Testing of Certain High Production Volume
Chemicals submitted to the TSCA Public Docket Office, EPA. April 25,
2001.
25. Dow Chemical Company (Dow). Comments on EPA's Proposed Test
Rule for Testing of Certain High Production Volume Chemicals submitted
to the TSCA Public Docket Office, EPA. April 24, 2001.
26. ExxonMobil Chemical Company (EMCC). Comments on EPA's Proposed
Test Rule for Testing of Certain High Production Volume Chemicals
submitted to the TSCA Public Docket Office, EPA. April 23, 2001.
27. Lonza Group. Comments on EPA's Proposed Test Rule for Testing
of Certain High Production Volume Chemicals submitted to the TSCA
Public Docket Office, EPA. April 25, 2001.
28. Sciences International Inc. (SII). Comments on EPA's Proposed
Test Rule for Testing of Certain High Production Volume Chemicals
submitted to the TSCA Public Docket Office, EPA. April 24, 2001.
29. Dyno Nobel, Inc., (Dyno Nobel). Comments on EPA's Proposed Test
Rule for Testing of Certain High Production Volume Chemicals submitted
to the TSCA Public Docket Office, EPA. April 25, 2001.
30. Institute of Makers of Explosives (IME). Comments on EPA's
Proposed Test Rule for Testing of Certain High Production Volume
Chemicals submitted to the TSCA Public Docket Office, EPA. April 25,
2001.
31. People for the Ethical Treatment of Animals (PETA). Comments on
EPA's Proposed Test Rule for Testing of Certain High Production Volume
Chemicals submitted to the TSCA Public Docket Office, EPA. April 25,
2001.
32. Physicians Committee for Responsible Medicine (PCRM). Comments
on EPA's Proposed Test Rule for Testing of Certain High Production
Volume Chemicals submitted to the TSCA Public Docket Office, EPA. April
25, 2001.
33. Doris Day Animal League (DDAL). Comments on EPA's Proposed Test
Rule for Testing of Certain High Production Volume Chemicals submitted
to the TSCA Public Docket Office, EPA. April 25, 2001.
34. The Humane Society of the United States (HSUS). Comments on
EPA's Proposed Test Rule for Testing of Certain High Production Volume
Chemicals submitted to the TSCA Public Docket Office, EPA. April 25,
2001.
35. Alternative Research & Development Foundation (ARDF). Comments
on EPA's Proposed Test Rule for Testing of Certain High Production
Volume Chemicals submitted to the TSCA Public Docket Office, EPA. April
24, 2001.
36. American Anti-Vivisection Society (AAVS). Comments on EPA's
Proposed Test Rule for Testing of Certain High Production Volume
Chemicals submitted to the TSCA Public Docket Office, EPA. April 24,
2001.
37. New England Anti-Vivisection Society (NEAVS). Comments on EPA's
Proposed Test Rule for Testing of Certain High Production Volume
Chemicals submitted to the TSCA Public Docket Office, EPA. April 19,
2001.
38. Silicones Environmental, Health and Safety Council (SEHSC).
Comments on EPA's Proposed Test Rule for Testing of Certain High
Production Volume Chemicals submitted to the TSCA Public Docket Office,
EPA. April 25, 2001.
39. EPA, OPPT. Compilation of Non-Substantive Comments Submitted by
Private Citizens in Response to EPA's Proposed Test Rule for Testing of
Certain High Production Volume Chemicals submitted to the TSCA Public
Docket Office, EPA. April 25, 2001.
40. EPA. Response to Public Comments. Prepared by CITB, OPPT. May
31, 2005.
41. EPA. Comparison of 1990 High Production Volume (HPV) Chemicals
with National Occupational Exposure Survey (NOES) Database. November
13, 1998.
42. EPA. Guidelines for Exposure Assessment. Federal Register (57
FR 28888, May 29, 1992).
43. American Chemistry Council (ACC) (formerly Chemical
Manufacturers Association). Public Availability of SIDS-Related Testing
Data for U.S. High Production Volume Chemicals. June 12, 1998.
44. American Society for Testing and Materials International (ASTM
International). Standard Test Method for
[[Page 13725]]
Relative Initial and Final Melting Points and the Melting Range of
Organic Chemicals. ASTM. E 324. 1999.
45. ASTM International. Standard Test Method for Vapor Pressure of
Liquids by Ebulliometry. ASTM. E 1719. 1997.
46. ASTM International. Standard Test Method for Determining Vapor
Pressure by Thermal Analysis. ASTM. E 1782. 2003.
47. ASTM International. Standard Test Method for Partition
Coefficient (N-Octanol/Water) Estimation by Liquid Chromatography.
ASTM. E 1147. 1997.
48. ASTM International. Standard Test Method for Measurements of
Aqueous Solubility. ASTM. E 1148. 2002.
49. ASTM International. Question about ASTM E 324. E-mail from
Diane Rehiel, ASTM, to Greg Schweer, CITB, CCD, OPPT, EPA. September
15, 2004.
50. Meylan, W.M. and Howard, P.H. Atom/Fragment Contribution Method
for Estimating Octanol-Water Partition Coefficients. Journal of
Pharmaceutical Sciences. 84(1):83-92. 1995.
51. Meylan, W.M., Howard, P.H., and Boethling, R.S. Improved Method
for Estimating Water Solubility From Octanol/Water Partition
Coefficient. Environmental Toxicology and Chemistry. 15(2):100-106.
1996.
52. ASTM International. Standard Test Method for Determining
Biodegradability of Organic Chemicals in Semi-Continuous Activated
Sludge (SCAS). ASTM. E 1625. 2001.
53. International Organization for Standardization (ISO). Water
Quality--Evaluation of Ultimate Aerobic Biodegradability of Organic
Compounds in Aqueous Medium--Static Test (Zahn-Wellens Method). Second
Edition. ISO 9888. 1999.
54. ASTM International. Standard Guide for Conducting Acute
Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and
Amphibians. ASTM. E 729. 2002.
55. ASTM International. Standard Guide for Conducting Static
Toxicity Tests with Microalgae. ASTM. E 1218. 2004.
56. ASTM International. Standard Guide for Conducting Daphnia Magna
Life-Cycle Toxicity Tests. ASTM. E 1193. 2004.
57. Veith, G.D. and Kosian, P. Estimating bioconcentration
potential from octanol/water partition coefficients, in Physical
Behavior of PCB's in the Great Lakes (MacKay, Paterson, Eisenreich, and
Simmons, eds.), Ann Arbor Science, Ann Arbor, MI. 1982.
58. Bintein, S., DeVillers, J., and Karcher, W. Nonlinear
dependence of fish bioconcentration on n-octanol/water partition
coefficient. SAR and QSAR in Environmental Research. 1:29-39. 1993.
59. Meylan, W.M., Howard, P.H., Boethling, R.S., Aronson, D.,
Printup, H., and Gouchie, S. Improved method of estimating
bioconcentration/bioaccumulation factor from octanol/water partition
coefficient. Environmental Toxicology and Chemistry. 18(4): 664-672.
1999.
60. Smrchek, J.C. and Zeeman, M.G. Assessing Risks to Ecological
Systems from Chemicals, pp. 24-90. In. P. Callow (ed.), Handbook of
Environmental Risk Assessment and Management. Blackwell Science Ltd.
Oxford, UK. 1998.
61. EPA. Proposed Category for Persistent, Bioaccumulative and
Toxic Chemical Substances. Federal Register (63 FR 53417, October 5,
1998) (FRL-5771-6).
62. EPA. Policy Statement--Category for Persistent,
Bioaccumulative, and Toxic New Chemical Substances. Federal Register
(64 FR 60194, November 4, 1999) (FRL-6097-7).
63. EPA. Significant New Use Rules; General Provisions For New
Chemical Follow-Up under sections 5 and 26(c) of TSCA. Federal Register
(54 FR 31307, July 27, 1989).
64. ASTM International. Standard Test Method for Estimating Acute
Oral Toxicity in Rats. ASTM. E 1163. 2002.
65. U.S. Department of Health and Human Services. National
Institutes of Health. NTP. Toxicology and carcinogenesis studies of
pentaerythritol tetranitrate (CAS No. 78-11-5) with 80% D-lactose
monohydrate (PETN, NF) in F344/N rats and B6C3F1 mice (feed studies),
Technical Report Series No. 365. August 1989.
66. EPA. In Vitro Dermal Absorption Rate Testing of Certain
Chemicals of Interest to Occupational Safety and Health Administration;
Proposed Rule. Federal Register (64 FR 31074, June 9, 1999) (FRL-5760-
3).
67. EPA. In Vitro Dermal Absorption Rate Testing of Certain
Chemicals of Interest to the Occupational Safety and Health
Administration; Final Rule. Federal Register (69 FR 22402, April 26,
2004) (FRL-7312-2).
68. EPA. Toxic Substances Control Act; Data Reimbursement. Federal
Register (48 FR 31785, July 11, 1983).
69. EPA. Toxic Substances; Test Rule Development and Exemption
Procedures. Federal Register (50 FR 20652, May 17, 1985).
70. EPA. Laboratory Capacity and the HPV Challenge Program.
Prepared by EPAB, EETD, OPPT. Washington, DC. October 14, 1999.
71. EPA. EPA Census of TSCA Testing Laboratories. Prepared by EPAB,
EETD, OPPT. Washington, DC. October 10, 1996.
72. EPA. Notices of export under section 12(b). Federal Register
(45 FR 82850, December 16, 1980).
73. EPA. Review of comments on proposed determination of physical/
chemical properties for PETN. Memorandum from Dr. Robert Boethling,
EAB, EETD, OPPT, to Greg Schweer, CITB. August 20, 2004.
74. EPA. Request for assistance in reviewing four studies for TSCA
section 4 test rule. Memorandum from Maria Szilagyi, RAD, OPPT to
Donald Rodier, High Production Volume Chemical Branch (HPVCB), RAD.
October 5, 2004.
75. EPA. Economic Analysis for the Final Section 4 Test Rule for
High Production Volume Chemicals. Prepared by EPAB, EETD, OPPT.
February 18, 2005.
76. Small Business Administration, Office of Size Standards. Small
Business Size Standards matched to North American Industry
Classification System (NAICS). Available online at: http://www.sba.gov/size/sizetable2002.htm.
XI. Statutory and Executive Order Reviews
A. Executive Order 12866
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), it has been determined that this
rule is a ``significant regulatory action'' because this action may
raise novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in section 3(f)(4)
of the Executive Order. Accordingly, this final rule was submitted to
the Office of Management and Budget (OMB) for review under Executive
Order 12866 and any changes made based on OMB recommendations have been
documented in the public docket for this rulemaking as required by
section 6(a)(3)(E) of the Executive Order.
In addition, EPA has prepared an economic assessment entitled
Economic Analysis for the Final Section 4 Test Rule for High Production
Volume Chemicals (Ref. 75), a copy of which has been placed in the
public docket for this rulemaking. This economic assessment evaluates
the economic impacts of the testing that would be required by this
final rule. The total social cost of providing the test data on the 17
chemicals that were evaluated in this economic analysis is estimated to
be $4.08 million (Ref. 75). The annualized social costs of the final
rule are
[[Page 13726]]
estimated to be $1.44 million, using a social discount rate of 3% over
a 3-year period (Ref. 75).
While legally subject to this final rule, Tier 2 manufacturers and
processors of a subject chemical would be required to comply with the
requirements of the rule only if they are directed to do so by EPA as
described in Sec. 799.5085(c)(5) and (c)(6) of the regulatory text.
EPA would only require such entities to test if no person in Tier 1 has
submitted a letter of intent to test, or if under 40 CFR 790.93, a
problem occurs with the initiation, conduct, or completion of the
required testing, or the submission of the required data to EPA.
Because EPA has identified at least one manufacturer in Tier 1 for each
subject chemical, the Agency assumes that, for each chemical in this
final rule, at least one such person will submit a letter of intent to
test and that person will conduct such testing and will submit the test
data to EPA. Because Tier 2 manufacturers and processors do not need to
comply with the rule initially, the economic assessment does not
address these entities.
To evaluate the potential for an adverse economic impact of testing
on manufacturers of the chemical substances in this final rule, EPA
employed a screening approach that estimated the impact of testing
requirements as a percentage of each chemical's sale price. This
measure compares annual revenues from the sale of a chemical to the
annualized testing costs for that chemical to assess the percentage of
testing costs that can be accommodated by the revenue generated by that
chemical. Annualized testing costs divide testing expenditures into an
equivalent, constant yearly expenditure over a longer period of time.
To calculate the percent price impact, testing costs (including
laboratory and administrative expenditures) are annualized over 15
years using a 7% discount rate. Annualized testing costs are then
divided by the estimated annual revenue of the chemical to derive the
cost-to-sales ratio. EPA estimates the total annualized compliance cost
of testing for the 17 chemicals evaluated in the economic analysis to
be $0.44 million under the average cost scenario. In addition, the TSCA
section 12(b) export notification requirements (included in the total
and annualized cost estimates) that would be triggered by the rule are
expected to have a negligible impact on exporters. The TSCA section
12(b) export notification requirements under the final rule would be
required for the first export to a particular country of a chemical
subject to the rule. The Agency's estimated total costs of testing
(including both laboratory and administrative costs), annualized
testing cost, price impacts, and public reporting burden hours for this
final rule are presented in the economic assessment.
Under a least cost scenario, 12 out of the 16 chemicals for which
price data were available (75%) would have a price impact at less than
the 1% level. Similarly, 12 out of the 16 chemicals (75%) would be
impacted at less than the 1% level under an average cost scenario.
Thus, the potential for adverse economic impact due to the rule is low
for at least 75% of the chemicals in the rule. Approximately 4
chemicals (25%) of the 16 chemicals for which price data are available
would have a price impact at a level greater than or equal to 1% under
the least and average cost scenario.
The Agency computed a ``critical price'' for the chemical without
price data. This price is the maximum price per pound, at which the
ratio of testing costs to annual revenue would be 1%. The critical
price is informative because it represents the minimum price that is
required to support testing at the one percent level. The production
volume for isocyanatomethane (CAS No. 624-83-9) ranges from 10 million
to 50 million pounds. With an annualized testing cost estimated at
$33,585, the critical price is $0.11 per pound. Below that price, the
testing costs would represent more than 1.0% of the revenues from the
chemical. The average price for the 16 chemicals with actual price data
available is $2.67 per pound. Thus, the critical price is substantially
below this average. Only 2 of the 16 chemicals with price data were
estimated to have prices below $.11 per pound. While it cannot be shown
conclusively that the price impacts will be less than or greater than
1.0% of the sales for this chemical, the Agency believes that adverse
impacts are unlikely.
EPA believes, on the basis of these calculations, that the testing
of the chemicals presents a low potential for adverse economic impact
for the majority of chemicals. Because the subject chemical substances
have relatively large production volumes, the annualized costs of
testing, expressed as a percentage of annual revenue, are very small
for most chemicals. There are, however, some chemicals for which the
price impact is expected to exceed 1% of the revenue from that
chemical. The potential for adverse economic impact is expected to be
higher for these chemicals. In these cases, companies may choose to use
revenue sources other than the profits from the individual chemicals to
pay for testing.
B. Paperwork Reduction Act
The information collection requirements contained in TSCA section 4
test rules have already been approved by OMB under the provisions of
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., and have
been assigned OMB control number 2070-0033 (EPA ICR No. 1139). The
information collection activities related to export notification under
TSCA section 12(b)(1) are already approved under OMB control number
2070-0030 (EPA ICR No. 0795). This final rule does not contain any new
or amended requirements that would require additional review and/or
approval by OMB.
The standard chemical testing program involves the submission of
letters of intent to test (or exemption applications), study plans,
progress reports, and test results. EPA estimates that the information
collection activities related to chemical testing for all chemicals in
this final rule (representing the submission of letters of intent or
exemption applications, study plans, and the final reports; progress
reports are not required by this final rule because testing will be
completed within about 1 year) would result in an annual public
reporting burden of 1,179 hours per chemical or a total of 20,039 hours
for the17 chemicals (Ref. 75).
The annual public reporting burden related to export notification
is estimated to be 0.5 to 1.5 burden hours for each chemical/country
combination (Ref. 75). In estimating the total burden hours approved
for the information collection activities related to export
notification, the Agency has included sufficient burden hours to
accommodate any export notifications that may be required by the
Agency's issuance of final chemical test rules (Ref. 75).
For each manufacturer of the 17 chemicals identified in the
economic analysis, the parent company (ultimate corporate entity, or
UCE) was also identified. The economic analysis identified a total of
52 UCEs that EPA believes would be the likely respondents to the final
rule. The public reporting burden for this collection of information is
estimated to be 20,039 hours total. Dividing 20,039 hours by 52 UCEs,
results in a per respondent estimated burden of 304 hours. This burden
estimate includes time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information.
[[Page 13727]]
As defined by the PRA and 5 CFR 1320.3(b), ``burden`` means the
total time, effort, or financial resources expended by persons to
generate, maintain, retain, or disclose or provide information to or
for a Federal agency. This includes the time needed to: review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements which have
subsequently changed; train personnel to be able to respond to a
collection of information; search data sources; complete and review the
collection of information; and transmit or otherwise disclose the
information.
Under the PRA, an agency may not conduct or sponsor, and a person
is not required to respond to, an information collection request unless
it displays a currently valid OMB control number. The OMB control
numbers for EPA's regulations are listed in 40 CFR part 9 and included
on the related collection instrument. EPA is amending the table in 40
CFR part 9 to list the OMB approval number for the information
collection requirements contained in this final rule. This listing of
the OMB control numbers and their subsequent codification in the CFR
satisfies the display requirements of the PRA and OMB's implementing
regulations at 5 CFR part 1320. This ICR was previously subject to
public notice and comment prior to OMB approval, and given the
technical nature of the table, EPA finds that further notice and
comment to amend it is unnecessary. As a result, EPA finds that there
is ``good cause'' under section 553(b)(1)(B) of the Administrative
Procedure Act, 5 U.S.C. 553(b)(1)(B), to amend this table without
further notice and comment.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., after considering the potential economic impacts
of this final rule on small entities, the Agency hereby certifies that
this final rule will not have a significant adverse economic impact on
a substantial number of small entities. The Agency's determination is
based on the small entity impact analysis prepared as part of the
economic analysis for this final rule (Ref. 75), which is summarized in
Unit XI.A., and a copy of which is available in the docket for this
final rule. The following is a brief summary of the factual basis for
this certification.
Under the RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of this final rule on small entities, small
entity is defined in accordance with the RFA as:
1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201.
2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000.
3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
Based on the industry profile for this rule that EPA prepared as
part of the Economic Analysis prepared for this final rule, EPA has
determined that this rule is not expected to impact any small not-for-
profit organizations or small governmental jurisdictions. As such, the
Agency evaluated small businesses as the small entities potentially
impacted by this final rule.
Three factors are examined in EPA's small entity assessment (Ref.
75) in order to characterize the potential small entity impacts of this
final rule:
The size of the adverse impact (measured as the ratio of
the cost to sales or revenue).
The total number of small entities that experience the
adverse impact.
The percentage of the total number of small entities that
experience the adverse impact.
Section 601(3) of RFA establishes as the default definition of
``small business'' the definition used in section 3 of the Small
Business Act, 15 U.S.C. 632, under which the SBA establishes small
business size standards for each industry sector. (13 CFR 121.201). For
this final rule, EPA has analyzed the potential small business impacts
using the size standards established under this default definition. The
SBA size standards, which are primarily intended to determine whether a
business entity is eligible for government programs and preferences
reserved for small businesses (13 CFR 121.101), ``seek to ensure that a
concern that meets a specific size standard is not dominant in its
field of operation.'' (13 CFR 121.102(b)). See section 632(a)(1) of the
Small Business Act. Industrial sectors are identified by a NAICS code.
In most cases, SBA has specified an employee size standard (100; 500;
750; 1,000; or 1,500 employees) or, in some cases, a sales-based, or
other industry-specific indicator below which an entity in that
particular NAICS code would be considered small (Ref. 76). The SBA
employee size standards that apply to the companies that are
potentially impacted (Ref. 75) by this final rule range from 500 to
1,500 employees.
Sales and employment data were obtained for the 52 UCEs that
manufacture the 17 chemicals subject to this final rule to identify
those UCEs that qualify for ``small business'' status, where data were
available. Based on the SBA size standards for the NAICS codes that
applied to those UCEs, 23 of the 52 UCEs (44%) were identified as
small. The significance of this final rule's impact on these small
businesses was analyzed by examining the number of small entities that
experienced different levels of costs as a percentage of their sales.
In such an analysis, small businesses are placed in the following
categories on the basis of cost-to-sales ratios: less than 1.0%, 1.0%
but less than 3.0%, and 3.0% or greater. Of the 23 companies that
qualified for small business status according to the SBA size
standards, none had a cost-to-sales ratio that exceeded 1.0%. Given
these results, EPA concludes that there is not a significant economic
impact on these small entities as a result of this final rule.
There were an additional two UCEs for which the NAICS code, sales,
and employment data were not available. Because of this, EPA could not
determine whether they are small businesses or assess the potential
impacts of the test rule on them. However, it is very unlikely that
both of these UCEs are small entities. Moreover, given the Agency's
analysis for the identified small businesses, which concluded that
there is not a significant economic impact on any of them, EPA believes
it is reasonable to conclude that even if these two UCEs are small
entities, they will not experience a significant economic impact.
Consequently, EPA concludes that there will not be a significant
economic impact on a substantial number of small entities as a result
of the testing imposed in this final rule.
The estimated costs of the TSCA section 12(b) export notification,
which, as a result of this final rule, would be required for the first
export to a particular country of a chemical subject to the rule, is
estimated to be $67.35 for the first time that an exporter must comply
with TSCA section 12(b) export notification requirements, and $21.81
for each subsequent export notification submitted by that exporter to
an additional country (Ref. 75). EPA has concluded that the costs of
TSCA section 12(b) export notification would
[[Page 13728]]
have a negligible impact on exporters of the chemicals in this final
rule, regardless of the size of the exporter.
Therefore, the Agency certifies that this final rule will not have
a significant adverse economic impact on a substantial number of small
entities.
D. Unfunded Mandates Reform Act
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4), EPA has determined that this regulatory
action does not contain a Federal mandate that may result in
expenditures of $100 million or more for State, local, and tribal
governments, in the aggregate, or for the private sector in any 1 year.
The analysis of the costs associated with this action are described in
Unit VIII. In addition, since EPA does not have any information to
indicate that any State, local, or tribal government manufactures or
processes the chemicals covered by this action such that this final
rule would apply directly to State, local, or tribal governments, EPA
has determined that this final rule does not significantly or uniquely
affect small governments. Accordingly, this final rule is not subject
to the requirements of sections 202, 203, 204, and 205 of UMRA.
E. Executive Order 13132
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
This final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This final rule establishes
testing and recordkeeping requirements that apply to manufacturers
(including importers) and processors of certain chemicals. Because EPA
has no information to indicate that any State or local government
manufactures or processes the chemical substances covered by this
action, this rule does not apply directly to States and localities and
will not affect State and local governments. Thus, Executive Order
13132 does not apply to this final rule.
F. Executive Order 13175
Under Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 6, 2000), this
final rule does not have tribal implications because it will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and the Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in the Executive order. As
indicated in this unit, EPA has no information to indicate that any
tribal government manufactures or processes the chemical substances
covered by this action. Thus, Executive Order 13175 does not apply to
this final rule. Although Executive Order 13175 was not yet in effect
when EPA developed the proposed rule, its predecessor, Executive Order
13084, was and EPA's conclusions under Executive Order 13175 are
consistent with EPA's considerations under Executive Order 13084.
G. Executive Order 13045
This final rule does not require special consideration pursuant to
the terms of Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997), because it is not likely to have an annual effect on the
economy of $100 million or more and it does not have a potential effect
or impact on children. This final rule establishes testing and
recordkeeping requirements that apply to manufacturers (including
importers) and processors of certain chemicals, and will result in the
production of information that will assist the Agency and others in
determining whether the chemical substances in this final rule present
potential risks, allowing the Agency and others to take appropriate
action to investigate and mitigate those risks.
H. Executive Order 13211
This final rule is not a ``significant energy action'' as defined
in Executive Order 13211, entitled Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) because it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. As such, the
Agency has concluded that this final rule is not likely to have adverse
energy effects.
I. National Technology Transfer and Advancement Act
As noted in the proposed rule, section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C 272 note) directs EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by voluntary consensus
standards bodies. The NTTAA directs EPA to provide Congress, through
OMB, explanations when the Agency decides not to use available and
applicable voluntary consensus standards.
Because this final rule involves technical standards, the Agency
conducted a search to identify potentially applicable voluntary
consensus standards. EPA identified 11 applicable voluntary consensus
standards (Refs. 44-48, 52-56, and 64), listed in Table 4 of this unit,
and is allowing their use in this final rule. Of the 11 voluntary
consensus standards, 3 of those issued by ASTM evaluate the same type
of toxicity as TSCA and OECD test guidelines, as shown in Table 4 of
this unit.
Table 4.--Applicable Voluntary Consensus Standards
----------------------------------------------------------------------------------------------------------------
Title of Voluntary TSCA Guideline/CFR
Voluntary Consensus Standard No./Year Consensus Standard Citation OECD Test Method No.
----------------------------------------------------------------------------------------------------------------
ASTM E 324 (1999) Standard Test Method .......................
for Relative Initial
and Final Melting
Points and the Melting
Range of Organic
Chemicals
----------------------------------------------------------------------------------------------------------------
[[Page 13729]]
ASTM E 729 (2002) Standard Guide for .......................
Conducting Acute
Toxicity Tests on Test
Materials with Fishes,
Macroinvertebrates,
and Amphibians
----------------------------------------------------------------------------------------------------------------
ASTM E 1147 (1997) Standard Test Method 799.6755, 799.6756 .......................
for Partition
Coefficient (N-Octanol/
Water) Estimation by
Liquid Chromatography
----------------------------------------------------------------------------------------------------------------
ASTM. E1148 (2002) Standard Test Method 799.6784, 799.6786 .......................
for Measurements of
Aqueous Solubility
----------------------------------------------------------------------------------------------------------------
ASTM E 1163 (2002) Standard Test Method 799.9130 (if gas at 425
for Estimating Acute room temp.).
Oral Toxicity in Rats
----------------------------------------------------------------------------------------------------------------
ASTM E 1193 (2004) Standard Guide for .......................
Conducting Daphnia
Magna Life-Cycle
Toxicity Tests
----------------------------------------------------------------------------------------------------------------
ASTM E 1218 (2004) Standard Guide for .......................
Conducting Static
Toxicity Tests with
Microalgae
----------------------------------------------------------------------------------------------------------------
ASTM E 1625 (2001) Standard Test Method .......................
for Determining
Biodegradability of
Organic Chemicals in
Semi-Continuous
Activated Sludge
(SCAS)
----------------------------------------------------------------------------------------------------------------
ASTM E 1719 (1997) Standard Test Method .......................
for Vapor Pressure of
Liquids by
Ebulliometry
----------------------------------------------------------------------------------------------------------------
ASTM E 1782 (2003) Standard Test Method .......................
for Determining Vapor
Pressure by Thermal
Analysis
----------------------------------------------------------------------------------------------------------------
ISO 9888 (1999) Water Quality-- .......................
Evaluation of Ultimate
Aerobic
Biodegradability of
Organic Compounds in
Aqueous Medium--Static
Test (Zahn-Wellens
Method), Second
Edition
----------------------------------------------------------------------------------------------------------------
Copies of the ASTM and ISO standards referenced in this final rule
have been placed in the public version of the official record for this
final rule and are available to read, but not to copy, at the EPA
Docket location described in ADDRESSES. You may obtain copies of the
ASTM standards from the American Society for Testing and Materials, 100
Bar Harbor Dr., West Conshohocken, PA 19428-2959, and a copy of the ISO
standard from the International Organization for Standardization, Case
Postale, 56 CH-1211 Geneve 20 Switzerland. EPA received the required
approval from the Director of the Federal Register for the
incorporation by reference of the ASTM and ISO standards used in this
final rule in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
EPA is not aware of any potentially applicable n-octanol/water
partition coefficient (generator column), water solubility (column
elution and generator column), acute inhalation toxicity, bacterial
reverse mutations, in vivo mammalian bone marrow chromosomal
aberrations, combined repeated dose with reproductive/developmental
toxicity screen, repeated dose 28-day oral toxicity screen, or the
reproductive developmental toxicity screen which could be considered in
lieu of the TSCA guidelines published in 40 CFR 799.6756, 799.6784,
799.6786, 799.9130, 799.9510, 799.9538, 799.9365, 799.9305, and
799.9355, respectively, upon which the test standards in this final
rule are based.
J. Executive Order 12898
Pursuant to Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), the Agency has considered
environmental justice-related issues with regard to the potential
impacts of this action on the environmental and health conditions in
minority and low-income populations. The Agency believes that the
information collected under this final rule will assist EPA and others
in determining the hazards and risks associated with the chemicals
covered by the rule. Although not directly impacting environmental
justice-related concerns, this information will better enable the
Agency to protect human health and the environment.
XII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Incorporation by reference, Laboratories, Reporting and recordkeeping
requirements.
Dated: March 1, 2006.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241,
[[Page 13730]]
242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5,
300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-
6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.
0
2. In Sec. 9.1, the table is amended by adding an entry for Sec.
799.5085 in numerical order under the indicated heading to read as
follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Identification of Specific Chemical Substance and Mixture Testing
Requirements
------------------------------------------------------------------------
* * * * *
799.5085............................................. 2070-0033
* * * * *
------------------------------------------------------------------------
* * * * *
PART 799--[AMENDED]
0
3. The authority citation for part 799 continues to read as follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
0
4. By adding Sec. 799.5085 to subpart D to read as follows:
Sec. 799.5085 Chemical testing requirements for certain high
production volume chemicals.
(a) What substances will be tested under this section? Table 2 in
paragraph (j) of this section identifies the chemical substances that
must be tested under this section. For the chemical substances
identified as ``Class 1'' substances in Table 2 in paragraph (j) of
this section, the purity of each chemical substance must be 99% or
greater, except for 1,3-propanediol, 2,2-bis[(nitrooxy)methyl]-,
dinitrate (ester) (CAS No. 78-11-5), also known as pentaerythritol
tetranitrate (PETN). PETN cannot be tested at 99% purity because of its
explosive properties. It must be diluted in water or tested as a
stabilized mixture with an appropriate stabilizer (e.g., D-lactose
monohydrate is the stabilizer in PETN, NF which is a mixture of 20% by
weight PETN and 80% by weight D-lactose monohydrate). The stabilizer
used must be tested as a control. For the chemical substances
identified as ``Class 2'' substances in Table 2 in paragraph (j), a
representative form of each chemical substance must be tested. The
representative form selected for a given Class 2 chemical substance
should meet industry or consensus standards where they exist.
(b) Am I subject to this section? (1) If you manufacture (including
import) or intend to manufacture, or process or intend to process, any
chemical substance listed in Table 2 in paragraph (j) of this section
at any time from April 17, 2006 to the end of the test data
reimbursement period as defined in 40 CFR 791.3(h), you are subject to
this section with respect to that chemical substance.
(2) If you do not know or cannot reasonably ascertain that you
manufacture or process a chemical substance listed in Table 2 in
paragraph (j) of this section during the time period described in
paragraph (b)(1) of this section (based on all information in your
possession or control, as well as all information that a reasonable
person similarly situated might be expected to possess, control, or
know, or could obtain without an unreasonable burden), you are not
subject to this section with respect to that chemical substance.
(c) If I am subject to this section, when must I comply with it?
(1)(i) Persons subject to this section are divided into two groups, as
set forth in Table 1 of this paragraph: Tier 1 (persons initially
required to comply) and Tier 2 (persons not initially required to
comply). If you are subject to this section, you must determine if you
fall within Tier 1 or Tier 2, based on Table 1 of this paragraph.
Table 1.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
Persons not initially required
Persons initially required to comply to comply with this section
with this section (Tier 1) (Tier 2)
------------------------------------------------------------------------
Persons not otherwise specified in A. Persons who manufacture (as
column 2 of this table that defined at TSCA section 3(7))
manufacture (as defined at TSCA or intend to manufacture a
section 3(7)) or intend to manufacture chemical substance included in
a chemical substance included in this this section solely as one or
section. more of the following:
--As a byproduct (as defined at
40 CFR 791.3(c));
--As an impurity (as defined at
40 CFR 790.3);
--As a naturally occurring
substance (as defined at 40
CFR 710.4(b));
--As a non-isolated
intermediate (as defined at 40
CFR 704.3);
--As a component of a Class 2
substance (as described at 40
CFR 720.45(a)(1)(i));
--In amounts of less than 500
kg (1,100 lbs.) annually (as
described at 40 CFR
790.42(a)(4)); or
--For R & D (as described at 40
CFR 790.42(a)(5)).
B. Persons who process (as
defined at TSCA section 3(10))
or intend to process a
chemical substance included in
this section (see 40 CFR
790.42(a)(2)).
------------------------------------------------------------------------
(ii) Table 1 of paragraph (c)(1)(i) of this section expands the
list of persons specified in Sec. 790.42(a)(2), (a)(4), and (a)(5) of
this chapter, who, while legally subject to this section, must comply
with the requirements of this section only if directed to do so by EPA
under the circumstances set forth in paragraphs (c)(5) and (c)(8) of
this section.
(2) If you are in Tier 1 with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, you must, for each
test required under this section for that chemical substance, either
submit to EPA a letter of intent to test or apply to EPA for an
exemption from testing. The letter of intent to test or the exemption
application must be received by EPA no later than May 15, 2006.
(3) If you are in Tier 2 with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, you are considered
to have an automatic conditional exemption and you will be required to
comply with this section with regard to that chemical substance only if
directed to do so by EPA under paragraphs (c)(5) or (c)(8) of this
section.
(4) If no person in Tier 1 has notified EPA of its intent to
conduct one or more of the tests required by this section on any
chemical substance listed in Table 2 in paragraph (j) of this section
by May 15, 2006, EPA will publish a Federal Register document that will
specify the test(s) and the chemical substance(s) for which no letter
of intent has been
[[Page 13731]]
submitted, and notify manufacturers and processors in Tier 2 of their
obligation to submit a letter of intent to test or to apply for an
exemption from testing.
(5) If you are in Tier 2 with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, and if you
manufacture or process this chemical substance as of April 17, 2006, or
within 30 days after publication of the Federal Register document
described in paragraph (c)(4) of this section, you must, for each test
specified for that chemical substance in the document described in
paragraph (c)(4) of this section, either submit to EPA a letter of
intent to test or apply to EPA for an exemption from testing. The
letter of intent to test or the exemption application must be received
by EPA no later than 30 days after publication of the document
described in paragraph (c)(4) of this section.
(6) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after the publication of the Federal Register
document described in paragraph (c)(4) of this section, EPA will notify
all manufacturers and processors of those chemical substances of this
fact by certified letter or by publishing a Federal Register document
specifying the test(s) for which no letter of intent has been
submitted. This letter or Federal Register document will additionally
notify all manufacturers and processors that all exemption applications
concerning the test(s) have been denied, and will give the
manufacturers and processors of the chemical substance(s) an
opportunity to take corrective action.
(7) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after receipt of the certified letter or
publication of the Federal Register document described in paragraph
(c)(6) of this section, all manufacturers and processors subject to
this section with respect to that chemical substance who are not
already in violation of this section will be in violation of this
section.
(8) If a problem occurs with the initiation, conduct, or completion
of the required testing or the submission of the required data with
respect to a chemical substance listed in Table 2 in paragraph (j) of
this section, under the procedures in Sec. Sec. 790.93 and 790.97 of
this chapter, EPA may initiate termination proceedings for all testing
exemptions with respect to that chemical substance and may notify
persons in Tier 1 and Tier 2 that they are required to submit letters
of intent to test or exemption applications within a specified period
of time.
(9) If you are required to comply with this section, but your
manufacturing or processing of a chemical substance listed in Table 2
in paragraph (j) of this section begins after the applicable compliance
date referred to in paragraphs (c)(2), (c)(5), or (c)(8) of this
section, you must either submit a letter of intent to test or apply to
EPA for an exemption. The letter of intent to test or the exemption
application must be received by EPA no later than the day you begin
manufacturing or processing.
(d) What must I do to comply with this section? (1) To comply with
this section you must either submit to EPA a letter of intent to test,
or apply to and obtain from EPA an exemption from testing.
(2) For each test with respect to which you submit to EPA a letter
of intent to test, you must conduct the testing specified in paragraph
(h) of this section and submit the test data to EPA.
(3) You must also comply with the procedures governing test rule
requirements in part 790 of this chapter, as modified by this section,
including the submission of letters of intent to test or exemption
applications, the conduct of testing, and the submission of data; Part
792--Good Laboratory Practice Standards of this chapter; and this
section. The following provisions of 40 CFR part 790 do not apply to
this section: Paragraphs (a), (d), (e), and (f) of Sec. 790.45;
paragraph (a)(2) and paragraph (b) of Sec. Sec. 790.80; 790.82(e)(1);
790.85; and 790.48.
(e) If I do not comply with this section, when will I be considered
in violation of it? You will be considered in violation of this section
as of 1 day after the date by which you are required to comply with
this section.
(f) How are EPA's data reimbursement procedures affected for
purposes of this section? If persons subject to this section are unable
to agree on the amount or method of reimbursement for test data
development for one or more chemical substances included in this
section, any person may request a hearing as described in 40 CFR part
791. In the determination of fair reimbursement shares under this
section, if the hearing officer chooses to use a formula based on
production volume, the total production volume amount will include
amounts of a chemical substance produced as an impurity.
(g) Who must comply with the export notification requirements? Any
person who exports, or intends to export, a chemical substance listed
in Table 2 in paragraph (j) of this section is subject to part 707,
subpart D, of this chapter.
(h) How must I conduct my testing? (1) The tests that are required
for each chemical substance are indicated in Table 2 in paragraph (j)
of this section. The test methods that must be followed are provided in
Table 3 in paragraph (j) of this section. You must proceed in
accordance with these test methods as required according to Table 3 in
paragraph (j) of this section, or as appropriate if more than one
alternative is allowed according to Table 3 in paragraph (j) of this
section. Included in Table 3 in paragraph (j) of this section are the
following 11 methods which are incorporated by reference:
(i) Standard Test Method for Relative Initial and Final Melting
Points and the Melting Range of Organic Chemicals, ASTM E 324-99.
(ii) Standard Test Method for Partition Coefficient (N-Octanol/
Water) Estimation by Liquid Chromatography, ASTM E 1147-92. (Reapproved
1997)
(iii) Standard Guide for Conducting Acute Toxicity Tests on Test
Materials with Fishes, Macroinvertebrates, and Amphibians, ASTM E 729-
96. (Reapproved 2002)
(iv) Standard Test Method for Measurements of Aqueous Solubility,
ASTM E 1148-02.
(v) Standard Test Method for Estimating Acute Oral Toxicity in
Rats, ASTM E 1163-98. (Reapproved 2002)
(vi) Standard Guide for Conducting Daphnia Magna Life-Cycle
Toxicity Tests, ASTM E 1193-97. (Reapproved 2004)
(vii) Standard Guide for Conducting Static Toxicity Tests with
Microalgae, ASTM E 1218-04.
(viii) Standard Test Method for Determining Biodegradability of
Organic Chemicals in Semi-Continuous Activated Sludge (SCAS), ASTM E
1625-94. (Reapproved 2001)
(ix) Standard Test Method for Vapor Pressure of Liquids by
Ebulliometry, ASTM E 1719-97.
(x) Standard Test Method for Determining Vapor Pressure by Thermal
Analysis, ASTM E 1782-03.
(xi) Water Quality--Evaluation of Ultimate Aerobic Biodegradability
of Organic Compounds in Aqueous Medium--Static Test (Zahn-Wellens
Method), Second Edition, June 1, 1999, ISO 9888-99.
[[Page 13732]]
(2) The Director of the Federal Register approved this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies of the ASTM guidelines from the American
Society for Testing and Materials, 100 Bar Harbor Dr., West
Conshohocken, PA 19428-2959, and a copy of the ISO guideline from the
International Organization for Standardization, Case Postale, 56 CH-
1211 Geneve 20 Switzerland. You may inspect each test method at the EPA
Docket Center, EPA West, Rm. B102, 1301 Constitution Ave., NW.,
Washington, DC or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call (202) 741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(i) Reporting requirements. A final report for each specific test
for each subject chemical substance must be received by EPA by May 17,
2007, unless an extension is granted in writing pursuant to 40 CFR
790.55. A robust summary of the final report for each specific test
should be submitted in addition to and at the same time as the final
report. The term ``robust summary'' is used to describe the technical
information necessary to adequately describe an experiment or study and
includes the objectives, methods, results, and conclusions of the full
study report which can be either an experiment or in some cases an
estimation or prediction method. Guidance for the compilation of robust
summaries is described in a document entitled Draft Guidance on
Developing Robust Summaries which is available at: http://www.epa.gov/chemrtk/robsumgd.htm.
(j) Designation of specific chemical substances and testing
requirements. The chemical substances identified by chemical name,
Chemical Abstract Service Number (CAS No.), and class in Table 2 of
this paragraph must be tested in accordance with the requirements
designated in Tables 2 and 3 of this paragraph, and the requirements
described in 40 CFR Part 792--Good Laboratory Practice Standards:
Table 2.--Chemical Substances And Testing Requirements
----------------------------------------------------------------------------------------------------------------
Required tests/(See Table 3
CAS No. Chemical name Class of this section)
----------------------------------------------------------------------------------------------------------------
74-95-3 Methane, dibromo- 1 A, C1, E2, F2
----------------------------------------------------------------------------------------------------------------
75-36-5 Acetyl chloride 1 A, B, C2, E2, F1
----------------------------------------------------------------------------------------------------------------
78-11-5 1,3-Propanediol, 2,2- 1 A4, A5, B, C6, F2
bis[(nitrooxy)methyl]-,
dinitrate (ester)
----------------------------------------------------------------------------------------------------------------
84-65-1 9,10-Anthracenedione 1 A, F2
----------------------------------------------------------------------------------------------------------------
108-19-0 Imidodicarbonic diamide 1 A, B, C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
110-44-1 2,4-Hexadienoic acid, 1 A, C4
(2E,4E)-
----------------------------------------------------------------------------------------------------------------
112-52-7 Dodecane, 1-chloro 1 A, B, C3, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
118-82-1 Phenol, 4,4'- 1 A, B, D, E1, E2, F2
methylenebis[2,6-bis(1,1-
dimethylethyl)]-
----------------------------------------------------------------------------------------------------------------
149-44-0 Methanesulfinic acid, 1 A, B, C1, E2, F1
hydroxy-, monosodium salt
----------------------------------------------------------------------------------------------------------------
409-02-9 Heptenone, methyl- 2 A, B, C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
594-42-3 Methanesulfenyl chloride, 1 A, B, C1, E1, E2, F2
trichloro-
----------------------------------------------------------------------------------------------------------------
624-83-9 Methane, isocyanato- 1 A, C1
----------------------------------------------------------------------------------------------------------------
1324-76-1 Benzenesulfonic acid, [[4- 2 A, B, C1, D, E1, E2, F1
[[4-(phenylamino)phenyl][4-
(phenylimino)-2,5-
cyclohexadien-1-
ylidene]methyl]phenyl]amino
]-
----------------------------------------------------------------------------------------------------------------
2941-64-2 Carbonochloridothioic acid, 1 A, B, C1, E2, F1
S-ethyl ester
----------------------------------------------------------------------------------------------------------------
8005-02-5 C.I. Solvent Black 7 2 A, B, C1, D, E2, F1
----------------------------------------------------------------------------------------------------------------
65996-78-3 Light oil (coal), coke-oven 2 A, B, C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68611-64-3 Urea, reaction products with 2 A, B, C1, D, E1, E2, F1
formaldehyde
----------------------------------------------------------------------------------------------------------------
[[Page 13733]]
Table 3--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2 of This Paragraph
----------------------------------------------------------------------------------------------------------------
Test requirements and
Testing category Test symbol references Special conditions
----------------------------------------------------------------------------------------------------------------
Physical/chemical properties A 1. Melting Point: ASTM n-Octanol/water
E 324 (capillary tube) Partition Coefficient
2. Boiling Point: ASTM or log Kow:
E 1719 (ebulliometry). Which method is
3. Vapor Pressure: ASTM required, if any, is
E 1782 (thermal determined by the test
analysis). substance's
4. n-Octanol/Water estimated\1\ log Kow
Partition Coefficient as follows:
(log 10 basis) or log log Kow <0: no testing
Kow: (See special required.
conditions for the log log Kow range 0-1:
Kow test requirement Method A or B.
and select the log Kow range >1-4:
appropriate method to Method A or B or C.
use, if any, from log Kow range >4-6:
those listed in this Method B or C.
column.). log Kow >6: Method C.
Method A: 40 CFR Test sponsors are
799.6755 (shake flask). required to provide in
Method B: ASTM E 1147 the final study report
(liquid the underlying
chromatography). rationale for the
Method C: 40 CFR method selected. In
799.6756 (generator order to ensure
column). environmental
5. Water Solubility: relevance, EPA highly
(See special recommends that the
conditions for the selected study be
water solubility test conducted at pH 7.
requirement and select Water Solubility:
the appropriate method Which method is
to use, if any, from required, if any, is
those listed in this determined by the test
column.). substance's
Method A: ASTM E 1148 estimated\2\ water
(shake flask). solubility. Test
Method B: 40 CFR sponsors are required
799.6784 (shake flask). to provide in the
Method C: 40 CFR final study report the
799.6784 (column underlying rationale
elution). for the method
Method D: 40 CFR selected. In order to
799.6786 (generator ensure environmental
column). relevance, EPA highly
recommends that the
selected study be
conducted at pH 7.
>5,000 mg/L: Method A
or B.
>10 mg/L --5,000 mg/L:
Method A, B, C, or D.
> 0.001 mg/L--10 mg/L:
Method C or D.
<=0.001 mg/L: No
testing required.
----------------------------------------------------------------------------------------------------------------
Environmental fate and pathways-- B For B, choose either of None
Inherent biodegradation the methods listed in
this column:
1. ASTM 1625
(semicontinuous
activated sludge test)
OR.
2. ISO 9888 (Zahn-
Wellens method).
----------------------------------------------------------------------------------------------------------------
Aquatic toxicity C1 For C1, Test Group 1 or The following are the
Test Group 2 listed in special conditions for
this column must be C1, C2, C3, C4, C5,
used to fulfill the and C7 testing; there
testing requirements-- are no special
See special conditions for C6.
conditions. If log Kow <4.2: Test
Test Group 1 for C1:... Group 1 is required
1. Acute Toxicity to If log Kow >= 4.2: Test
Fish: ASTM E 729. Group 2 is required
2. Acute Toxicity to Which test group is
Daphnia: ASTM E 729. required is determined
3. Toxicity to Plants by the test
(Algae): ASTM E 1218. substance's measured
Test Group 2 for C1:... log Kow as obtained
1. Chronic Toxicity to under A\3\.
Daphnia: ASTM E 1193.
2. Toxicity to Plants
(Algae): ASTM E 1218.
--------------------------------------------------
C2 For C2, Test Group 1 or
Test Group 2 listed in
this column must be
used to fulfill the
testing requirements--
See special
conditions.
Test Group 1 for C2:...
1. Acute Toxicity to
Daphnia: ASTM E 729.
2. Toxicity to Plants
(Algae): ASTM E 1218.
Test Group 2 for C2:...
1. Chronic Toxicity to
Daphnia: ASTM E 1193.
2. Toxicity to Plants
(Algae): ASTM E 1218.
--------------------------------------------------
[[Page 13734]]
C3 For C3, Test Group 1 or
Test Group 2 listed in
this column must be
used to fulfill the
testing requirements--
See special
conditions.
Test Group 1 for C3:...
1. Acute Toxicity to
Fish: ASTM E 729.
2. Toxicity to Plants
(Algae): ASTM E 1218.
Test Group 2 for C3:...
1. Chronic Toxicity to
Daphnia: ASTM E 1193.
2. Toxicity to Plants
(Algae): ASTM E 1218.
--------------------------------------------------
C4 For C4, Test Group 1 or
Test Group 2 listed in
this column must be
used to fulfill the
testing requirements--
See special
conditions.
Test Group 1 for C4:...
1. Acute Toxicity to
Fish: ASTM E 729.
2. Acute Toxicity to
Daphnia: ASTM E 729.
Test Group 2 for C4:...
1. Chronic Toxicity to
Daphnia: ASTM E 1193.
--------------------------------------------------
C5 For C5, Test Group 1 or
Test Group 2 below
must be used to
fulfill the testing
requirements--See
special conditions.
Test Group 1 for C5:...
1. Acute Toxicity to
Daphnia: ASTM E 729.
Test Group 2 for C5:...
1. Chronic Toxicity to
Daphnia: ASTM E 1193.
--------------------------------------------------
C6 Toxicity to Plants
(Algae): ASTM E 1218
--------------------------------------------------
C7 For C7, Test Group 1 or .......................
Test Group 2 of this
column must be used to
fulfill the testing
requirements--See
special conditions.
Test Group 1 for C7:...
1. Acute Toxicity to
Fish: ASTM E 729.
Test Group 2 for C7:...
1. Chronic Toxicity to
Daphnia: ASTM E 1193.
----------------------------------------------------------------------------------------------------------------
Mammalian toxicity--Acute D See special conditions Which testing method is
for this test required is determined
requirement and select by the test
the method that must substance's physical
be used from those state at room
listed in this column. temperature
Method A: Acute (25[deg]C). For those
Inhalation Toxicity test substances that
(rat): 40 CFR 799.9130. are gases at room
Method B: EITHER:...... temperature, Method A
1. Acute (Up/Down) Oral is required;
Toxicity (rat): ASTM E otherwise, use either
1163 OR. of the two methods
2. Acute (Up/Down) listed under Method B.
Oral Toxicity (rat): In Method B, 40 CFR
40 CFR 799.9110(d)(1)(i)(A)
799.9110(d)(1)(i)(A). refers to the OECD 425
Up/Down Procedure\4\.
Estimating starting
dose for Method B:
Data from the neutral
red uptake basal
cytotoxicity assay\5\
using normal human
keratinocytes or mouse
BALB/c 3T3 cells may
be used to estimate
the starting dose.
----------------------------------------------------------------------------------------------------------------
Mammalian toxicity--Genotoxicity E1 Bacterial Reverse None
Mutation Test (in
vitro): 40 CFR
799.9510
--------------------------------------------------------------------------
[[Page 13735]]
E2 Conduct any one of the Persons required to
following three tests conduct testing for
for chromosomal chromosomal damage are
damage: encouraged to use the
In vitro Mammalian in vitro Mammalian
Chromosome Aberration Chromosome Aberration
Test: 40 CFR 799.9537 Test (40 CFR 799.9537)
OR. to generate the needed
Mammalian Bone Marrow data unless known
Chromosomal Aberration chemical properties
Test (in vivo in (e.g., physical/
rodents: mouse chemical properties,
(preferred species), chemical class
rat, or Chinese characteristics)
hamster): 40 CFR preclude its use. A
799.9538 OR. subject person who
Mammalian Erythrocyte uses one of the in
Micronucleus Test vivo methods instead
[sampled in bone of the in vitro method
marrow] (in vivo in to address a
rodents: Mouse chromosomal damage
(preferred species), test requirement must
rat, or Chinese submit to EPA a
hamster): 40 CFR rationale for
799.9539. conducting that
alternate test in the
final study report.
--------------------------------------------------------------------------
Mammalian toxicity--Repeated dose/ F1 Combined Repeated Dose Where F1 is required,
reproduction/ developmental Toxicity Study with EPA recommends use of
the Reproduction/ the Combined Repeated
Developmental Toxicity Dose Toxicity Study
Screening Test: 40 CFR with the Reproduction/
799.9365 OR Developmental Toxicity
Reproduction/ Screening Test (40 CFR
Developmental Toxicity 799.9365). However,
Screening Test: 40 CFR there may be valid
799.9355 AND. reasons to test a
Repeated Dose 28-Day particular chemical
Oral Toxicity Study in using both 40 CFR
rodents: 40 CFR 799.9355 and 40 CFR
799.9305. 799.9305 to fill
Mammalian Toxicity--
Repeated Dose/
Reproduction/
Developmental data
needs. A subject
person who uses the
combination of 40 CFR
799.9355 and 40 CFR
799.9305 in place of
40 CFR 799.9365 must
submit to EPA a
rationale for
conducting these
alternate tests in the
final study reports.
Where F2 or F3 is
required, no rationale
for conducting the
required test need be
provided in the final
study report.
--------------------------------------------------
F2 Reproduction/
Developmental Toxicity
Screening Test: 40 CFR
799.9355
--------------------------------------------------
F3 Repeated Dose 28-Day
Oral Toxicity Study in
rodents: 40 CFR
799.9305
----------------------------------------------------------------------------------------------------------------
\1\ EPA recommends, but does not require, that log Kow be quantitatively estimated prior to initiating this
study. One method, among many similar methods, for estimating log Kow is described in the article entitled
Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients) by W.M. Meylan and P.H.
Howard in the Journal of Pharmaceutical Sciences. 84(1):83-92. January 1992. This reference is available under
docket ID number EPA-HQ-OPPT-2005-0033 at the EPA Docket Center, Rm. B102, 1301 Constitution Ave., NW.,
Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
\2\ EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating
this study. One method, among many similar methods, for estimating water solubility is described in the
article entitled Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient by
W.M. Meylan, P.H. Howard, and R.S. Boethling in Environmental Toxicology and Chemistry. 15(2):100-106. 1996.
This reference is available under docket ID number EPA-HQ-OPPT-2005-0033 at the EPA Docket Center, Rm. B102,
1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays.
\3\ Chemical substances that are dispersible in water may have log Kow values greater than 4.2 and may still be
acutely toxic to aquatic organisms. EPA recommends, but does not require, that test sponsors who wish to
conduct Test Group 1 studies on such chemicals to submit to EPA for approval a written request to conduct Test
Group 1 studies 90 days prior to conducting such studies. The written request should include the rationale for
conducting Test Group 1 studies.
\4\ The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available under docket ID number EPA-HQ-
OPPT-2005-0033 at the EPA Docket Center, Rm. B102, 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m.
to 4:30 p.m., Monday through Friday, excluding legal holidays.
\5\ The neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the
mammalian toxicity-acute endpoint, is available under docket ID number EPA-HQ-OPPT-2005-0033 at the EPA Docket
Center, Rm. B102, 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
(k) Effective date. This section is effective on April 17, 2006.
[FR Doc. 06-2483 Filed 3-15-06; 8:45 am]
BILLING CODE 6560-50-S