[Federal Register Volume 71, Number 203 (Friday, October 20, 2006)]
[Proposed Rules]
[Pages 61926-61944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17569]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[EPA-HQ-OPPT-2002-0073; FRL-8081-3]
RIN 2070-AB79
Proposed Test Rule for Certain Chemicals on the ATSDR/EPA CERCLA
Priority List of Hazardous Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: In this action, EPA is proposing to require testing for
certain chemicals on the Agency for Toxic Substances and Disease
Registry (ATSDR)/EPA Priority List of Hazardous Substances which is
compiled under the Comprehensive Environmental Response Compensation
and Liability Act (CERCLA), and is soliciting proposals for enforceable
consent agreements (ECAs). EPA is proposing a test rule under section
4(a) of the Toxic Substances Control Act (TSCA) that would require
manufacturers (including importers) and processors of four chemical
substances (chloroethane, hydrogen cyanide, methylene chloride, and
sodium cyanide) to conduct testing for certain health effects relating
to the manufacture, distribution in commerce, processing, use, or
disposal of these substances. The data that would be obtained under the
testing program will be used to address health effects data needs
identified by ATSDR and EPA for these substances, which are among the
hazardous substances most commonly found at sites listed on the CERCLA
National Priorities List (NPL) and which are also hazardous air
pollutants (HAPs) under section 112 of the Clean Air Act (CAA). EPA is
soliciting proposals for ECAs involving the conduct of physiologically
based pharmacokinetics (PBPK) studies as an alternative to the testing
proposed in this rule, as appropriate. Alternatively, if ECA proposals
involving the conduct of PBPK studies are not received, or if received,
are not considered by the Agency to be adequate, EPA may consider ECA
proposals which cover some or all of the testing identified for a given
chemical in this proposed rule.
DATES: Comments must be received on or before December 19, 2006. Your
request to present oral comments must be in writing and must be
received by EPA on or before December 19, 2006.
ADDRESSES: Submit your comments, identified by docket (ID) number EPA-
HQ-OPPT-2002-0073, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention:
Docket ID Number EPA-HQ-OPPT-2002-0073. 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, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2002-0073. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access''system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD ROM you submit. If EPA cannot read your
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comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the
regulations.gov index. Although listed in the index, some information
is not publicly available, e.g., CBI or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available electronically at
http://www.regulations.gov, or, if only available in hard copy, at the
OPPT Docket, EPA Docket Center (EPA/DC). The EPA/DC suffered structural
damage due to flooding in June 2006. Although the EPA/DC is continuing
operations, there will be temporary changes to the EPA/DC during the
clean-up. The EPA/DC Public Reading Room, which was temporarily closed
due to flooding, has been relocated in the EPA Headquarters Library,
Infoterra Room (Room Number 3334) in EPA West, located at 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. EPA visitors are required to show photographic
identification and sign the EPA visitor log. Visitors to the EPA/DC
Public Reading Room will be provided with an EPA/DC badge that must be
visible at all times while in the EPA Building and returned to the
guard upon departure. In addition, security personnel will escort
visitors to and from the new EPA/DC Public Reading Room location. Up-
to-date information about the EPA/DC is on the EPA website at http://www.epa.gov/epahome/dockets.htm.
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., N.W.,
Washington, DC 20460-0001; telephone number: (202) 554-1404; e-mail
address: [email protected].
For technical information contact: Robert Jones, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8161; e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may potentially be affected by this action if you manufacture
(defined by the statute to include import) or process, or intend to
manufacture or process, any of the chemical substances that are listed
in Sec. 799.5100(j) of the regulatory text. Any use of the term
``manufacture'' in this document will encompass ``import,'' unless
otherwise stated. In addition, as described in Unit V., any person who
exports or intends to export, any of the chemical substances in the
final rule is subject to the export notification requirements in 40 CFR
part 707, subpart D. Persons that could be subject to the requirements
in this proposed rule may include, but are not limited to:
Manufacturers (defined by statute to include importers) of
one or more of the four subject chemical sustances (NAICS code 325 and
324110), e.g., chemical manufacturing and petroleum refineries.
Processors of one or more of the four subject chemical
substances (NAICS code 325, 32411), e.g., chemical manufacturing and
petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding persons likely to be affected by this
action. Other types of persons 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 types of businesses. To
determine whether you or your business may be affected by this action,
you should carefully examine the applicability provisions in Unit IV.F.
entitled Would I Be Required to Test Under This Rule? and consult the
regulatory text at 40 CFR 799.5100(b). If you have any questions
regarding the applicability of this action to a particular person,
consult the technical person listed under FOR FURTHER INFORMATION
CONTACT.
If you are a person identified in this unit, you would be subject
to the requirements contained in the final rule only if you manufacture
(including import) or process, or intend to manufacture or process, any
of the four chemical substances that are listed in Sec. 799.5100(b) of
the regulatory text.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI that you mail to EPA as CBI and then identify electronically within
the disk or CD ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket ID number and other
identifying information (subject heading, Federal Register date and
page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
C. Can I Request an Opportunity to Present Oral Comments to the Agency?
You may submit a request for an opportunity to present oral
comments. This request must be in writing. If such a request is
received on or before December 19, 2006, EPA will hold a public meeting
on this proposed rule in Washington, DC. This written request must be
submitted to the mailing or hand delivery addresses provided under
ADDRESSES. If such a request is received, EPA will announce the
scheduling of
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the public meeting in a subsequent Federal Register document. If a
public meeting is announced, and if you are interested in attending or
presenting oral and/or written comments at the public meeting, you
should follow the instructions provided in the subsequent Federal
Register document announcing the public meeting.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to issue a rule that would require manufacturers
and processors to test certain chemical substances on the ATSDR/EPA
CERCLA Priority List of Hazardous Substances. EPA is proposing this
test rule to address data needs identified by ATSDR to enable ATSDR to
conduct comprehensive health assessments for populations living near
sites identified on the CERCLA NPL that may be exposed to any of the
four chemical substances. The four chemicals included in this proposed
rule were selected and the respective data needs were identified after
a lengthy review process. As detailed in this unit, the process began
with the listing of contaminated sites on the NPL, and the
identification of hazardous substances most commonly found at sites on
the NPL. Toxicological profiles and priority data needs were developed
for a number of these chemicals according to the ATSDR ``Decision Guide
for Identifying Substance-Specific Data Needs Related to Toxicological
Profiles'' (54 FR 37618, September 11, 1989) (Decision Guide), and the
priority data needs were reviewed by a number of Federal agencies
(e.g., ATSDR, EPA (Office of Air and Radiation (OAR), OPPT, Office of
Solid Waste and Emergency Response (OSWER), Office of Water (OW), and
Office of Research and Development (ORD)), Occupational Safety and
Health Administration (OSHA), National Institute for Occupational
Safety and Health (NIOSH), and the National Toxicology Program (NTP) at
the National Institute for Environmental Health and Science (NIEHS)),
as well as the public.
ATSDR is required under CERCLA section 104(i)(3) to perform
extensive reviews of the scientific literature in order to develop and
update toxicological profiles for the hazardous substances which are
most commonly found at sites on the NPL. The toxicological profiles are
developed by ATSDR in collaboration with EPA and NTP, independent peer
reviewers, and the public. When developing the toxicological profiles,
ATSDR identifies any available data that would be necessary for a
complete understanding of the chemicals. See CERCLA section 104(i)(3).
ATSDR then determines, by applying certain criteria, whether an
existing ``data gap'' constitutes a ``data need'' that is critical to
its ability to meet its statutory mandates under CERCLA section 104(i),
such as the performance of health assessments for NPL and certain other
facilities, or whether the missing data would only be useful to ATSDR
in conducting a thorough review of a chemical. The criteria used in
making this distinction are described in ATSDR's Decision Guide.
Chemical-specific Priority Data Needs (PDN) documents are then
compiled by ATSDR to describe the data needs identified for each
hazardous substance commonly found at sites on the NPL. PDN documents
undergo several reviews, including public review, peer review by an
external peer review panel, and review by scientists at the NTP and the
Centers for Disease Control (CDC). ATSDR also coordinates its
identification of PDNs with EPA and NIEHS through the Tri-Agency
Superfund Applied Research Committee (TASARC). On October 17, 1991,
ATSDR announced PDNs for 38 chemical substances commonly found at NPL
sites, and allowed the public to comment on the needs identified (56 FR
52178, October 17, 1991). ATSDR received comments from academic
institutions, industry groups, law firms, health groups, environmental
groups, and government agencies. Manufacturers and processors were
encouraged to volunteer to conduct research to fill specific priority
data needs. ATSDR proposed procedures for conducting the needed
research voluntarily as part of the ATSDR Substance-Specific Applied
Research Program (SSARP) (57 FR 4758, February 7, 1992). A public
meeting was held on April 29, 1992, to discuss voluntary testing
agreements associated with any of the chemical substances. ATSDR
announced final priority data needs for the 38 chemical substances and
offered the public an opportunity to participate in a voluntary testing
program to fill these data needs (57 FR 54160, November 16, 1992).
On October 27, 1992, ATSDR referred 60 data needs for the 38
chemical substances to EPA, and requested that EPA use its authority
under TSCA and the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA), 7 U.S.C. 136 to 136y, to obtain the needed data (Ref. 3).
ATSDR's request was evaluated within EPA by OPPT, OAR, OW, OSWER, and
ORD. Other Federal agencies, including OSHA, NIOSH, CPSC, and the Mine
Safety and Health Administration (MSHA) also reviewed the referral. In
addition, ATSDR's request was discussed at a TASARC meeting held in
1993.
EPA responded in part in December, 1992 (Ref. 4) and in April, 1993
(Ref. 5). These responses noted that, for a variety of reasons, 18 of
the 38 chemical substances were more suitable for consideration by EPA
for inclusion in potential future testing actions under TSCA and/or
FIFRA, and that these substances and information needs would be
prioritized based on various factors including, but not limited to, the
appropriateness of using TSCA authority to require testing and the
needs of other EPA offices and agencies for the test data.
On November 9, 1993, EPA agreed to consider the development of
testing actions for most of the PDNs for 12 of the chemical substances
referred by ATSDR (Ref. 6). The 12 chemicals included mercury, vinyl
chloride, benzene, trichloroethylene, chromium, tetrachloroethylene,
cyanide, beryllium, toluene, methylene chloride, di(2-ethylhexyl)
phthalate (DEHP), and chloroethane. Arsenic, chloroform, carbon
tetrachloride, nickel, zinc, and selenium were determined to be lower
priority candidates for testing under TSCA section 4 authority at that
time.
For testing purposes, sodium cyanide was deemed most relevant for
testing by ATSDR. Sodium cyanide is prevalent at hazardous waste sites
and is suitable for testing by the oral route, the major route of
concern identified by ATSDR. Hydrogen cyanide is the most prevalent
form of cyanide found in air, and is suitable for testing by
inhalation, the major route of concern identified by EPA's OAR (Ref.
12). Simple cyanides, such as sodium cyanide and hydrogen cyanide
dissociate completely yielding the cyanide ion that is the object of
concern. Complex cyanides are less bioavailable and therefore less
toxic. Complex cyanides are not good cyanide species for testing free
cyanide toxicity (Ref. 13).
On September 30, 1994 (59 FR 49934) (FRL-4756-5), EPA invited
manufacturers and processors to voluntarily develop and submit testing
program proposals to EPA for consideration in the development of ECAs.
The notice described testing needs for vinyl chloride, benzene,
trichloroethylene, tetrachloroethylene, hydrogen cyanide, sodium
cyanide, toluene, methylene chloride, chloroethane, mercury, chromium,
and beryllium. The metals (mercury, chromium, and beryllium) were
included, but the specific tests for these
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substances were not described in the solicitation.
EPA received no proposals for testing through the solicitation, but
the American Chemistry Council, rather than entering into an ECA with
EPA, agreed to test vinyl chloride under a voluntary agreement with
ATSDR (Ref. 11). That testing has been completed and accepted by ATSDR.
EPA, at this point, has determined that it would propose testing
for the following substances under a TSCA section 4 test rule:
Chloroethane (Chemical Abstract Service Registry Number (CAS No.) 75-
00-3), hydrogen and sodium cyanide (CAS Nos. 74-90-8 and 143-33-9,
respectively), and methylene chloride (CAS No. 75-09-2). Testing on
DEHP is being deferred until EPA further defines its testing objectives
and approach. At ATSDR's recommendation, and with TASARC's concurrence,
testing for the metals will be considered for inclusion under separate
TSCA section 4 testing actions, to the extent that the TSCA section 4
findings can be made, because these metals present unique issues
related to fate, transport, speciation, bioavailability, and metabolism
under different environmental conditions, and other issues specific to
metals (Ref. 8).
Benzene, tetrachloroethylene, toluene, and trichloroethylene are
among the 20 chemicals sponsored under Tier 1 of the pilot phase of
EPA's Voluntary Children's Chemical Evaluation Program (VCCEP). The
VCCEP is intended to provide data to help the public understand the
potential health risks to children associated with certain chemicals.
As explained in the December 26, 2000 Federal Register notice that
announced the VCCEP (65 FR 81699) (FRL-6758-5), companies that
manufacture or import certain chemicals may volunteer to sponsor an
evaluation of these chemical substances in Tier 1 of the VCCEP pilot.
As part of their sponsorship, companies collect and/or develop health
effects and exposure information on their chemical(s). The VCCEP
consists of three tiers to which a sponsor can commit to separately.
Tier 1 includes an assessment of acute toxicity, repeated dose toxicity
with reproductive and developmental toxicity screens, and genotoxicity,
as well as an assessment of readily available exposure information. As
part of the VCCEP Tier 1 sponsorship commitment, sponsors also assess
the need for additional toxicity and exposure data, which could be
provided by the next tier, to more fully characterize the risks the
chemical may pose to children. After the submission of Tier 1
information and its evaluation by a Peer Consultation Group, EPA will
review the sponsor's submission and the Peer Consultation report and
then announce the Agency's decision as to whether additional
information (i.e., toxicity testing and/or exposure information) is
needed to adequately characterize the chemical's risk to children. If
additional information is needed, companies may sponsor chemicals at a
higher Tier under VCCEP. Additional information about the VCCEP,
including the framework document and archives of public meetings, is
available at the website http://www.epa.gov/chemrtk/vccep/childhlt.htm.
EPA has decided not to include benzene, tetrachloroethylene,
toluene, and trichloroethylene in this proposed TSCA section 4 test
rule. Instead, EPA has decided to continue evaluation and review of the
data needs for these four substances within the context of previous
commitments made by the sponsors of these substances under VCCEP. EPA
expects that one of the outcomes of this evaluation will be an Agency
decision on whether to pursue one or more TSCA section 4 testing
action(s) for these chemicals.
ATSDR has developed criteria for evaluating the status of the PDNs
as new information becomes available (67 FR 4836, January 31, 2002) and
ATSDR provides updates on the status of the PDNs in the SSARP
approximately every 3 years. Based on these criteria and the review of
the current literature, ATSDR determines whether a PDN has been filled
or is unchanged. A PDN is considered by ATSDR to be filled if
information (i.e., new peer-reviewed and publicly available studies) to
address the PDN has been identified and accepted by ATSDR. In addition,
ATSDR considers a PDN to be filled if a study to generate the needed
information has been initiated. In this latter case, even though the
study has not yet been completed, ATSDR no longer considers it a
priority to initiate additional studies at this time. During the
literature review by ATSDR, new studies may be identified suggesting
other effects of concern which were not included in the original list
of PDNs. In such cases, additional PDNs may be added to the SSARP. This
proposed TSCA section 4 test rule incorporates the PDNs listed in the
latest update of the SSARP (70 FR 73749, December 13, 2005).
In addition to its proposal to require the testing of four chemical
substances, EPA is soliciting proposals for ECAs as an alternative to
the testing proposed in this document, as appropriate (see Unit IV.E.).
B. How Would the Data Developed Under this Test Rule Be Used?
ATSDR and EPA's OAR have asked that OPPT obtain specific data for
these chemicals through its authority under TSCA to assist ATSDR and
EPA in fulfilling their responsibilities under various statutes. For
example, EPA is proposing to use its TSCA section 4 authority to obtain
data supporting ATSDR's Substance-Specific Applied Research Program, a
program for collecting the data and other information needed for
developing health assessments for populations located near ``Superfund
sites,'' i.e., sites that are included on the NPL under CERCLA, 42
U.S.C. 9601 et seq. ATSDR referred the chemicals subject to this action
to EPA under the authority of section 104(i) of CERCLA, 42 U.S.C.
9604(i).
Section 104(i)(2) of CERCLA requires ATSDR and EPA to prepare and
revise a list of hazardous substances which are most commonly found at
sites listed on the CERCLA NPL and which ATSDR and EPA, in their sole
discretion, determine are posing the most significant potential threat
to human health.
Section 104(i)(3) of CERCLA directs ATSDR to prepare toxicological
profiles for each substance included on the ATSDR/EPA list of chemicals
most commonly found at NPL sites and it prescribes the profiles'
contents. Each profile includes an examination, summary, and
interpretation of available toxicological information and
epidemiological evaluations on a hazardous substance to ascertain
levels of human exposure and the associated human health effects. The
adequacy of data currently available and under development are also
evaluated in the toxicological profiles. ATSDR will update the
toxicological profiles with the data obtained under the testing program
proposed in this rule. If ATSDR determines that adequate information on
a chemical substance is not available or is under development, ATSDR is
required to assure the initiation of a program of research on the
substance to determine its health effects including using toxicological
testing. See CERCLA section 104(i)(5)(A) and (C).
Section 104(i)(5)(C) of CERCLA requires ATSDR to coordinate with
EPA and NTP to avoid duplicative research being conducted in other
programs and under other authorities. Section 104(i)(5)(D) of CERCLA
states ``it is the sense of Congress that the costs of research
programs'' initiated by ATSDR ``be borne by the manufacturers and
processors of the hazardous substance
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in question as required in programs of toxicological testing under the
Toxic Substances Control Act.''
For purposes of the chemicals included in this proposed rule, ATSDR
has determined that adequate information on the health effects of these
chemical substances for certain endpoints is not available (70 FR
73749, December 13, 2005) (Ref. 3). Testing under TSCA would ensure
that these substances are tested at the earliest practicable date.
EPA is often in a position of making decisions in the face of
uncertainty. Requiring these additional data will allow EPA to refine
risk assessments and reduce uncertainty. Nevertheless, EPA will
continue to make decisions as the state-of-the-science evolves and data
are being generated. The data that would be developed under the rule,
as proposed, would provide a stronger scientific basis for risk
assessments developed by EPA, other Federal agencies, State, and local
governments, and the general public. Assessments affect decisions for
listing/delisting the chemicals from regulatory lists of chemicals
including, for example, the CERCLA section 104(i)(2)(A) list of
hazardous substances most commonly found at sites on the NPL, and the
list of HAPs under section 112 of CAA. The data would also be expected
to influence other regulatory decisions such as how much of the
chemical should be removed from Superfund sites, and what
concentrations can safely be allowed in the air and water. The data
would improve decisions setting protective standards and guidelines,
and they could affect decisions for regulating the manufacturing,
processing, distribution in commerce, use, and disposal of these
chemical substances.
EPA would also use the data provided by this proposed TSCA test
rule in various chemical evaluations EPA performs to meet the
requirements under CAA, 42 U.S.C. 7401 et seq. For example, section
112(f) of CAA, 42 U.S.C. 7412(f), requires EPA to assess risks of HAPs
remaining (i.e., residual risks) after maximum achievable control
technology (MACT) standards have been imposed. MACT standards are
technology-based air emission standards required under section 112(d)
of CAA, 42 U.S.C. 7412(d). Studies included in this proposed rule would
generate data useful for determining the nature and magnitude of
residual risks. Based on these and other available data, EPA must
decide whether additional standards (post-MACT standards) will be
necessary for protecting the public health with an ample margin of
safety.
In addition, the chemical substances identified in this proposed
test rule are all included on the list of HAPs in section 112(b)(1) of
CAA, 42 U.S.C. 7412(b)(1). Pursuant to section 112(b)(4) of CAA, 42
U.S.C. 7412(b)(4), ``if the Administrator determines that information
on health or environmental effects of a substance is not sufficient to
make a determination [that the list of HAPs should be modified], the
[Agency] may use any authority available to the Administrator to
acquire such information.'' If the data collected under the final TSCA
test rule show that a chemical substance is not a concern to human
health, this information may be helpful in making decisions concerning
the potential delisting of any substance from the CAA HAPs list.
The data that would be developed under the final TSCA test rule may
also be used to support assessments and other Agency actions, such as
those related to the accidental release prevention program under
section 112(r) of CAA, 42 U.S.C. 7412(r). The development of data under
the final rule may also be used in conjunction with EPA's efforts to
fulfill the Agency's statutory obligation under section 103(d) of CAA,
42 U.S.C. 7403(d), to conduct a research program on the health effects
of air pollutants. For a more detailed discussion about how testing
generally relates to requirements under the CAA, refer to the proposed
TSCA section 4 test rule for HAPs at 61 FR 33178, June 26, 1996 (FRL-
4869-1) and amended at 62 FR 67466, December 24, 1997 (FRL-5742-2) and
at 63 FR 19694, April 21, 1998 (FRL-5780-6).
In developing this proposed rule, EPA and ATSDR have made maximum
use of scientifically adequate existing test data to avoid unnecessary,
duplicative testing, thereby avoiding the excessive use of animal
testing. If at any time, including after this rule is finalized, the
Agency receives adequate existing data that fulfill a specific data
need for one of these chemicals, EPA will ensure that unnecessary
testing is not required. In addition, EPA is particularly interested in
receiving ECA proposals for PBPK studies as an alternative to the
testing specified in this proposed rule, as appropriate (see Unit
IV.E.).
All of the chemicals included in this proposed rule are of broad
programmatic interest, and are included in the Agency's Integrated Risk
Information System (IRIS). The health effects data that would be
generated by the final rule may result in improvement of the health
effects database and increased confidence in the reference doses (RfDs)
and reference concentrations (RfCs) developed by EPA that are contained
in IRIS. Improvements to the quality of IRIS data can result in
considerable benefits to the public, because IRIS is publicly available
and is used by a wide variety of governmental and non-governmental
entities for assessing the safety of chemicals.
C. What is the Agency's Authority for Taking this Action?
EPA is proposing a test rule under TSCA section 4(a), 15 U.S.C.
2603(a), that would require certain health effects testing for four
chemical substances for which the ATSDR has PDNs. In addition, EPA's
OAR may use the submitted data to implement section 112 of CAA. With
this data, OAR will be able to characterize risks associated with both
acute and longer term exposures.
Section 2(b)(1) of TSCA, 15 U.S.C. 2601(b)(1), states that it is
the policy of the United States that ``adequate data should be
developed with respect to the effect of chemical substances and
mixtures on health and the environment and that the development of such
data should be the responsibility of those who manufacture [which is
defined by statute to include import] and those who process such
chemical substances and mixtures[.]'' To implement this policy, TSCA
section 4(a) mandates that EPA require by rule that manufacturers and
processors of chemical substances and mixtures conduct testing if the
Administrator finds that:
(1)(A)(i) the manufacture, distribution in commerce, processing,
use, or disposal of a chemical substance or mixture, or that any
combination of such activities, may present an unreasonable risk of
injury to health or the environment,
(ii) there are insufficient data and experience upon which the
effects of such manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combination
of such activities on health or the environment can reasonably be
determined or predicted, and
(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data; or
(B)(i) a chemical substance or mixture is or will be produced in
substantial quantities, and (I) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or
(II) there is or may be significant or substantial human exposure to
such substance or mixture,
(ii) there are insufficient data and experience upon which the
effects of the manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combination
of such activities on health or the environment can reasonably be
determined or predicted, and
(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data[.]
[[Page 61931]]
If EPA makes these findings for a chemical substance or mixture,
the Administrator must require that testing be conducted on that
chemical substance or mixture. The purpose of the testing would be to
develop data about the substance's or mixture's health and
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 substance or mixture, or any combination of such activities, does
or does not present an unreasonable risk of injury to health or the
environment.
Once the Administrator has made a finding under TSCA section
4(a)(1)(A)(i) (i.e., a finding that a chemical substance may present an
unreasonable risk of injury to health or the environment) or a finding
under TSCA section 4(a)(1)(B)(i) (i.e., a finding that a chemical
substance is or will be produced in substantial quantities and it may
either enter the environment in substantial quantities or there may be
significant or substantial human exposure to the chemical substance),
EPA may require any type of health or environmental effects testing
necessary to address unanswered questions about the effects of the
chemical substance. EPA need not limit the scope of testing required to
the factual basis for TSCA section 4(a)(1)(A)(i) or (B)(i) findings as
long as EPA also finds that there are insufficient data and experience
upon which the effects of the manufacture, distribution in commerce,
processing, use, or disposal of such substance or mixture or of any
combination of such activities on health or the environment can
reasonably be determined or predicted, and that testing is necessary to
develop such data. This approach is explained in more detail in EPA's
TSCA section 4(a)(1)(B) Final Statement of Policy published in the
Federal Register issue of May 14, 1993 (58 FR 28736, 28738-28739)
(``B'' Policy).
III. Findings
A. What is the Basis for EPA's Proposal to Test These Chemical
Substances?
As indicated in Unit II.C., in order to issue a rule under TSCA
section 4(a) requiring the testing of chemical substances or mixtures,
EPA must make certain findings for those chemicals regarding:
1. Risk (TSCA section 4(a)(1)(A)(i)); or
2. Production and either substantial release or significant or
substantial human exposure (TSCA section 4(a)(1)(B)(i)); and
3. That the available data and experience are insufficient for EPA
to determine or predict the health or environmental effects of the
manufacture, distribution in commerce, processing, use, or disposal of
the chemicals or mixtures subject to the rule or of any combination of
such activities; and
4. That testing is necessary to develop the data.
B. What are EPA's Preliminary Findings Regarding the Chemical
Substances in This Proposed Rule?
EPA is proposing to require the testing of the chemical substances
included in this test rule based on its preliminary findings under both
TSCA section 4(a)(1)(A)(i) relating to risk to health or the
environment and TSCA section 4(a)(1)(B)(i) relating to ``substantial''
production, and ``substantial'' release into the environment, and/or
``significant'' and/or ``substantial'' human exposure, as well as
findings under TSCA sections 4(a)(1)(A)(ii) and (iii) and TSCA sections
4(a)(1)(B)(ii) and (iii), regarding the insufficiency of the available
data and experience and whether testing is necessary to develop the
data.
EPA has made preliminary findings under TSCA section 4(a)(1)(A)(i)
that the chemical substances identified in this proposal may present an
unreasonable risk of injury to health or the environment. Consistent
with criteria discussed in its ``B'' Policy, EPA has also made
preliminary findings under TSCA section 4(a)(1)(B)(i) that the chemical
substances are produced in substantial quantities, and that they enter
or may reasonably be anticipated to enter the environment in
substantial quantities, and/or that there is or may be significant and/
or substantial human exposure to these chemicals. EPA is making
preliminary findings that the available data and experience are
inadequate for determining or predicting the effects of manufacture,
distribution in commerce, processing, use, or disposal of each of these
substances on health or the environment or of any combination of such
activities, (TSCA sections 4(a)(1)(A)(ii) and 4(a)(1)(B)(ii)), and EPA
is making preliminary findings that testing is necessary to develop the
needed data (TSCA sections 4(a)(1)(A)(iii) and 4(a)(1)(B)(iii)).
In EPA's ``B'' Policy, discussed in Unit II.C., EPA explained that
it generally considers ``substantial'' production of a chemical
substance or mixture to be aggregate production (including import)
volume equaling or exceeding one million pounds (lbs) per year (58 FR
28736, 28746, May 14, 1993). The ``B'' Policy also provides guidelines
that are generally considered in evaluating whether there is
``substantial release,'' and/or ``substantial human exposure'' of
workers, consumers, and the general population to a chemical substance
or mixture. Refer to EPA's ``B'' Policy for further discussion on how
EPA generally evaluates chemicals or mixtures under TSCA section
4(a)(1)(B)(i). For the reasons set out in the ``B'' Policy, EPA
believes that the guidance included in the ``B'' Policy is appropriate
for consideration in this proposed rule and EPA sees no reason not to
act consistently with the guidelines with respect to the chemicals
included in this proposed rule.
A detailed discussion of EPA's preliminary findings for each
chemical substance included in this proposed rule is contained in a
separate document entitled TSCA Section 4(a) Preliminary Findings:
Supporting Document for the Proposed Test Rule for Certain Chemical
Substances on the ATSDR/EPA CERCLA Priority List of Hazardous
Substances that is available in the docket (Ref. 1). Table 1 of this
unit (Summary, TSCA Section 4(a) Preliminary Statutory Findings)
provides a summary of the preliminary findings EPA has made for the
four chemicals that are the subject of this proposed rule.
[[Page 61932]]
Table 1.-- Summary, TSCA Section 4(a) Preliminary Statutory Findings
----------------------------------------------------------------------------------------------------------------
Health effects used in Basis for the TSCA Testing endpoints \1\
Chemical substance CAS No. making the TSCA section section 4(a)(1)(B)(i) (reference to TSCA test
4(a)(1)(A)(i) findings findings guidelines)
----------------------------------------------------------------------------------------------------------------
Chloroethane Lung, liver, and heart Substantial production: Sec. 799.9110 acute
CAS No. 75-00-3...................... toxicity >=1,000,000 lbs/year oral toxicity
Neurological effects... Substantial human Sec. 799.9310 90-day
Gastrointestinal exposure: >=1,000 oral toxicity in
effects. workers. rodents
Sec. 799.9370
prenatal developmental
Toxicity--inhalation
Sec. 799.9380
reproduction and
fertility effects--
oral and inhalation
Sec. 799.9430
combined chronic
toxicity/
carcinogenicity--inhal
ation
Sec. 799.9620
neurotoxicity
screening battery--
oral and inhalation
Sec. 799.9630
developmental
neurotoxicity--inhalat
ion
Sec. 799.9780
immunotoxicity--oral
and inhalation
----------------------------------------------------------------------------------------------------------------
Hydrogen cyanide Acute toxicity Substantial production: Sec. 799.9135 acute
CAS No. 74-90-8...................... Neurotoxicity.......... >=1,000,000 lbs/year inhalation toxicity
Thyroid toxicity....... Substantial with histopathology
environmental release: Sec. 799.9346 90-day
>=1,000,000 lbs/year. inhalation toxicity
Substantial human Sec. 799.9370
exposure: >=1,000 prenatal developmental
workers. Toxicity--inhalation
Sec. 799.9380
reproduction and
fertility effects--
inhalation
Sec. 799.9620
neurotoxicity
screening battery--
inhalation
Sec. 798.6500
schedule-controlled
operant behavior--
inhalation
----------------------------------------------------------------------------------------------------------------
Sodium cyanide Acute toxicity Substantial production: Sec. 799.9370
CAS No. 143-33-9..................... Neurotoxicity.......... >=1,000,000 lbs/year Prenatal Developmental
Thyroid toxicity....... Substantial human Toxicity--oral
exposure: >=1,000
workers.
----------------------------------------------------------------------------------------------------------------
Methylene chloride Neurotoxicity Substantial production: Sec. 799.9370
CAS No. 75-09-2...................... Liver toxicity......... >=1,000,000 lbs/year prenatal developmental
Developmental toxicity. Substantial toxicity--inhalation
Oncogenicity........... environmental release: Sec. 798.6500
Teratogenicity......... >=1,000,000 lbs/year. schedule-controlled
Substantial human operant behavior--oral
exposure: >=1,000 Sec. 799.9630
workers, >=10,000 developmental
consumers, >=100,000 neurotoxicity--inhalat
general population. ion
----------------------------------------------------------------------------------------------------------------
\1\ Support for the preliminary finding that the available data are insufficient to determine or predict the
human health effects of a chemical substance for these particular endpoints and for the finding that testing
is necessary to develop the necessary data can be found in ``TSCA Section 4(a) Preliminary Findings:
Supporting Document for the Proposed Test Rule for Certain Chemical Substances on the ATSDR/EPA CERCLA
Priority List of Hazardous Substances'' (Ref. 1).
IV. Proposed Testing
A. How Would the Studies Proposed Under This Test Rule Be Conducted?
EPA is proposing specific testing and reporting requirements for
each of the chemical substances specified in Table 2 of Sec.
799.5100(j) of the proposed regulatory text, according to the test
standards set forth at Sec. 799.5100(j) of the proposed regulatory
text. Testing under this proposed rule would be conducted in accordance
with TSCA Good Laboratory Practice Standards (GLPS) (40 CFR part 792).
B. What Substances Would Be Tested Under This Rule?
EPA is proposing that, with the exception of hydrogen cyanide and
sodium cyanide, the chemical substances listed in Table 2 of Sec.
799.5100(j) of the proposed regulatory text be tested at a purity of at
least 99%. EPA is proposing that hydrogen cyanide and sodium cyanide be
tested at a purity of at least 95%. Using data on relatively pure
chemicals, EPA avoids the possible confounding effects of impurities
that might be found in technical grade substances. EPA believes that
the specified purities of 95% and 99% are available or readily
achievable for all substances covered by this rule based on a search of
on-line information from catalogs of chemical suppliers (http://chemacx.cambridgesoft.com/chemacx/index.asp) and chemical safety
information provided on-line by the International Programme on Chemical
Safety (IPCS) (http://www.inchem.org).
C. When Would Any Testing Imposed by This Rule Begin?
The proposed testing requirements contained in this proposed rule
are not effective until and unless the Agency issues a subsequent final
rule. Based on the effective date of the final rule, which is typically
30 days after the publication of a final rule in the Federal Register,
the test sponsor would need to plan the initiation of the required
testing at a time sufficient to allow the final report to be submitted
by the deadline indicated in Sec. 799.5100(j) of the proposed
regulatory text.
D . May I Submit Data From Studies in Which the Test Substance was
Administered by a Route of Administration Other Than the Route
Specified for Testing Under This Proposed Rule?
EPA may accept data from studies in which the test substance was
administered by a route of administration other than the route
specified in the test under this proposed rule. Such data could result
in a decision by EPA not to include the related testing under the
proposed rule
[[Page 61933]]
in the final rule or in EPA's withdrawal of the related testing
following promulgation of the final rule. These data, however, must be
accompanied by an appropriate analysis that includes a scientifically
sound route-to-route extrapolation of the quantitative dose-response
relationship to meet the testing requirements from this rulemaking.
Route-to-route extrapolations are generally conducted with the use of a
PBPK model. A PBPK model simulates the kinetics (i.e., absorption,
distribution, metabolism, and elimination) of a chemical substance, and
can be used to derive an internal dose at a target site (or an internal
dose that can be used as a surrogate for the dose at a target site)
that would result from a given exposure scenario. The internal dose can
then be related to the response to develop a more robust and
biologically relevant characterization of the dose-response
relationship. For example, a PBPK model would first be used to estimate
an internal dose (e.g., average blood level) that would occur in a test
species from an exposure at a given level to the chemical in drinking
water. The model can then be used to estimate what the level of
chemical in air would need to be to yield a comparable average blood
level for the test species assuming a continuous inhalation exposure.
This prediction then forms the basis for the route-to-route
extrapolation.
There is no prescriptive formula or generic PBPK model that can be
used to conduct a route-to-route extrapolation. EPA realizes that PBPK
modeling expertise is often required, and that the approach and
supporting arguments must be developed and evaluated on a case-by-case
basis. Increasingly, however, route-to-route extrapolation using a PBPK
model has been shown to be a useful and less expensive alternative to
conducting studies via different routes of exposure. By potentially
reducing the number of toxicity tests that are performed to fill the
data needs, use of PBPK approaches can also reduce the number of test
animals that otherwise would have been required.
Some of the main factors to consider in presenting a scientifically
supportable route-to-route extrapolation include:
1. The nature of the adverse effect,
2. The adequacy of the kinetic and physiology data used to develop
the PBPK model for the test species of interest, and
3. Sufficient understanding of the chemical-specific toxicokinetic
processes that might result in a difference in the internal dose
depending upon the route of exposure.
The nature of the adverse effect is a key determinant of whether a
route-to-route extrapolation is feasible. If an adverse effect is
observed at a target site following delivery of the chemical or a
metabolite via the systemic circulation, then, regardless of the route
of exposure, a given internal concentration in the blood should
reproducibly yield a comparable response. If, however, the adverse
effect of interest occurs from direct action with barrier tissues at
the portal-of-entry (e.g., epithelial damage in the nasal region or the
gastrointestinal (GI) tract), then one would not expect similar
toxicity to occur from a different route of exposure. Secondly, the
PBPK model must be calibrated and tested with sufficient data in the
test species of interest to support a credible estimate of the internal
dose. Third, the kinetics of the chemical must be sufficiently
understood with respect to differences in internal disposition that may
occur following different routes of exposure. For example, if the
chemical is extensively metabolized in the liver, then the initial
level of parent compound in the systemic circulation will depend upon
whether the chemical is orally absorbed, and immediately enters the
liver from the portal circulation where some portion will be
metabolized before being systemically distributed, or is absorbed
through the lungs and is immediately available for systemic
distribution.
E. May I Submit Proposals for Enforceable Consent Agreements (ECAs)?
Yes. EPA encourages the submission of such proposals, which could
lead to the development of ECAs. EPA is particularly interested in
receiving proposals for ECAs involving the conduct of PBPK studies as
an alternative to the testing specified in this proposed rule, as
appropriate. Route-to-route extrapolation using a PBPK model is a
potentially useful and less expensive alternative to conducting studies
via different routes of exposure. PBPK approaches can additionally
reduce the number of test animals that would otherwise have been needed
in order to conduct the toxicity tests specified in the rule.
Alternatively, if ECA proposals involving the conduct of PBPK studies
are not received, or if received, are not considered by the Agency to
be adequate, EPA may consider ECA proposals received which cover some
or all of the testing identified for a given chemical in this proposed
rule.
Each ECA proposal submitted to EPA in response to this proposed
rule should include the name of the chemical(s), a detailed description
of the proposed study(ies), and, in the case of ECAs involving the
conduct of PBPK studies, a discussion of how the proposed studies would
support the application of the pharmacokinetics data in performing
route-to-route extrapolations. Such discussions should reflect an
understanding of the factors involved in developing a scientifically
supportable route-to-route extrapolation (see Unit IV.D.), the existing
database on the chemical, and the testing specified in this proposed
test rule.
Each study proposal should be labeled: ``Proposal for Study of
(name of chemical),'' identified by docket ID number EPA-HQ-OPPT-2002-
0073, and sent according to the instructions under ADDRESSES.
EPA would review the proposals and decide whether to proceed with
the ECA process under the procedures in 40 CFR 790.22. To initiate the
ECA procedures, EPA would publish a notice in the Federal Register
soliciting persons interested in participating in or monitoring
negotiations for the development of an ECA to send EPA a written notice
of their interest.
F. Would I Be Required to Test Under This Rule?
Under TSCA sections 4(a)(1)(A)(ii) and 4(a)(1)(B)(ii), EPA has made
preliminary findings that there are insufficient data and experience to
reasonably determine or predict health effects resulting from the
manufacturing, processing, distribution in commerce, use, or disposal
of the chemical substances listed in this proposed rule or of any
combination of such activities. As a result, under TSCA section
4(b)(3)(B), manufacturers and processors of these substances, and those
who intend to manufacture or process them, would be subject to the rule
with regard to those listed chemicals which they manufacture or
process.
1. Would I be subject to this rule? You would be subject to the
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 of the chemical substances listed
in Table 2 of Sec. 799.5100(j) in the proposed regulatory text during
the time period discussed in Unit IV.F.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
[[Page 61934]]
information that a reasonable person similarly situated might be
expected to possess, control, or know, or could obtain without
unreasonable burden), you would not be subject to the final rule for
that listed substance.
2. When would my manufacture or processing (or my intent to do so)
cause me to be subject to this rule? You would be subject to the final
rule if you manufacture or process, or intend to manufacture or
process, a substance listed in Table 2 of Sec. 799.5100(j) of the
proposed 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 when testing is completed. See
Unit IV.F.4.
3. Would I be required to test if I were subject to the rule? It
depends on the nature of your activities. All persons who would be
subject to the final TSCA section 4(a) test rule, which unless
otherwise noted in the regulatory text would incorporate EPA's generic
procedures applicable to TSCA section 4(a) test rules (contained within
40 CFR part 790), would fall into one of two groups, designated here as
Tier 1 and Tier 2. Persons in Tier 1 (those who would have to initially
comply with the final rule) would either: Submit to EPA letters of
intent to conduct testing, conduct this testing, and submit the test
data to EPA; or apply to and obtain from EPA exemptions from testing.
Persons in Tier 2 (those who would not have to initially comply
with the final rule) would not need to take any action unless they are
notified by EPA that they are required to do so, as described in Unit
IV.F.3.b. Note that persons in Tier 1 who obtain exemptions and persons
in Tier 2 would nonetheless be subject to providing reimbursement to
persons who do actually conduct the testing, as described in Unit
IV.F.4.
a. Who would be in Tier 1 and Tier 2? All persons subject to the
final rule would be considered to be in Tier 1 unless they fall within
Tier 2. The table in this unit describes who is in Tier 1 and Tier 2.
Table 2.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
Tier 1 (Persons initially required to Tier 2 (Persons not initially
comply) required to comply)
------------------------------------------------------------------------
Persons who manufacture (as defined at A. Persons who manufacture
TSCA section 3(7)), or intend to (as defined at TSCA section
manufacture, a test rule subtance, and 3(7)) or intend to
who are not listed under Tier 2 manufacture a test rule
substance solely as one or
more of the following:
-As a byproduct (as defined
at 40 CFR 791.3(c));
-As an impurity (as defined
at 40 CFR 790.3);
-As a naturally occurring
substance (as defined at 40
CFR 710.4(b));
-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
kilogram (kg) (1,100 lbs)
annually (as described at 40
CFR 790.42(a)(4)); or
-In small quantities solely
for research and development
(as described at 40 CFR
790.42(a)(5)).
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)).
------------------------------------------------------------------------
Under 40 CFR 790.2, EPA may establish procedures applying to
specific test rules that differ from the generic procedures governing
TSCA section 4(a) test rules in 40 CFR part 790. For purposes of this
proposed rule, EPA is proposing to establish certain requirements that
differ from those under 40 CFR part 790.
In this proposed test 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.
The Agency took administrative burden and complexity into account in
determining who was to be in Tier 1 in this proposed rule. EPA believes
that those persons in Tier 1 who would conduct testing under this rule,
when finalized, would generally be large chemical manufacturers who, in
the experience of the Agency, have traditionally conducted testing or
participated in testing consortia under previous TSCA section 4(a) test
rules.
The Agency also believes that byproduct manufacturers, impurity
manufacturers, manufacturers of naturally occurring substances,
manufacturers of non-isolated intermediates, and manufacturers of
components of Class 2 substances historically have not themselves
participated in testing or contributed to reimbursement of those
persons who have conducted testing. EPA understands that these
manufacturers may include persons for whom the marginal transaction
costs involved in negotiating and administering testing arrangements
are deemed likely to raise the expense and burden of testing to a level
that is disproportional to the additional benefits of including these
persons in Tier 1. Therefore, EPA does not believe that the likelihood
of the persons proposed to be added to Tier 2 actually conducting the
testing is sufficiently high to justify burdening these persons with
Tier 1 requirements (e.g., submitting requests for exemptions).
Nevertheless, these persons, along with all other persons in Tier 2,
would be subject to reimbursement obligations to persons who actually
conduct the testing, as described in Unit IV.F.4.
TSCA section 4(b)(3)(B) requires all manufacturers and/or
processors of a chemical substance to test that chemical substance if
EPA has made findings under TSCA sections 4(a)(1)(A)(ii) or
4(a)(1)(B)(ii) for that chemical substance, and therefore issued a TSCA
section 4(a) test rule requiring testing. However, practicality must be
a factor in determining who is subject to a particular test rule. Thus,
persons who do not know or cannot reasonably ascertain that they are
manufacturing or processing a substance subject to this proposed rule,
e.g., manufacturers or processors of a substance as a trace contaminant
who are not aware of and cannot reasonably ascertain these activities,
would not be subject to the rule. See Unit IV.F.1. and Sec.
799.5100(b)(2) of the proposed regulatory text.
[[Page 61935]]
b. Subdivision of Tier 2 entities. The Agency is proposing to
prioritize which persons in Tier 2 would be required to perform
testing, if needed. Specifically, the Agency is proposing that Tier 2
entities be subdivided into:
i. 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 research and development.
ii. Tier 2B. Tier 2 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 sections 3(10) and 3(11),
respectively.
If the Agency needs testing from persons in Tier 2, EPA would seek
testing from persons in Tier 2A before proceeding to Tier 2B. It is
appropriate to require manufacturers in Tier 2A to submit letters of
intent to test or exemption applications before processors are called
upon because the Agency believes that testing costs are traditionally
passed by manufacturers along to processors, enabling them to share in
the costs of testing (Ref. 9). In addition, ``[t]here are [typically]
so many processors [of a given test rule chemical] that it would be
difficult to include them all in the technical decisions about the
tests and in the financial decisions about how to allocate the costs''
(Ref. 10).
c. When would it be 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 in the proposed regulatory text at Sec. 799.5100(c)(2),
(c)(5), (c)(7), and (c)(11). In this proposed rule, EPA would 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 would not apply to this test rule.
d. What would happen if I submitted an exemption application? EPA
believes that requiring the collection of duplicative data is
unnecessarily burdensome. As a result, if EPA has received a letter of
intent to test from another source or has received (or expects to
receive) the test data that would be required under the 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 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. 799.5100(c)(10) of the
proposed 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.
799.5100(c)(8) of the proposed 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. Sec.
799.5100(c)(4)-(c)(9) and 799.5100(d)(3) of the proposed regulatory
text)).
Persons who obtain exemptions or who receive them automatically
would nonetheless be subject to providing reimbursement to persons who
do actually conduct the testing, as described in Unit IV.F.4.
e. What would my obligations be if I were in Tier 2? If you are in
Tier 2, you would be subject to the rule and you would be responsible
for providing reimbursement to persons in Tier 1, as described in Unit
IV.F.4. You are considered to have an automatic conditional exemption.
You would 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 the proposed regulatory
text at Sec. 799.5100(c)(10).
In addition, you would need to submit a letter of intent to test or
an exemption application if:
i. No manufacturer in Tier 1 has notified EPA of its intent to
conduct testing; and
ii. 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 the proposed regulatory text at Sec.
799.5100(c)(4), (c)(5), (c)(6), and (c)(7).
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 that would be required
under the final rule. EPA is not aware of any circumstances in which
test rule 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.
f. What would happen if no one submitted a letter of intent to
conduct testing? EPA anticipates that it will receive letters of intent
to conduct testing for all of the tests specified and chemical
substances included in the rule. However, in the event it does not
receive a letter of intent for one or more of the tests required by the
rule for any of the chemical substances in the rule within 30 days
after the publication of a Federal Register document notifying Tier 2
processors of the obligation to submit a letter of intent to conduct
testing or to apply for an exemption from testing, EPA would notify all
manufacturers and processors of the chemical substance 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 would additionally
notify all manufacturers and processors that all exemption applications
concerning the test(s) have been denied, and would give them an
opportunity to take corrective action. If no one has notified EPA of
its intent to conduct the required testing of the chemical substance
within 30 days after receipt of the certified letter or publication of
the Federal Register document, all manufacturers and processors subject
to the rule with respect to that chemical substance who are not already
in violation of the rule would be in violation of the rule.
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
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Association; publication by EPA of a Federal Register document
concerning the request for a hearing; and the appointment of a hearing
officer to propose an order for fair and equitable reimbursement. The
hearing officer may base his or her proposed order on the production
volume formula set out at 40 CFR 791.48, but is not obligated to do so.
Under this proposed rule, amounts manufactured as impurities would be
included in production volume (40 CFR 791.48(b)), subject to the
discretion of the hearing officer (40 CFR 791.40(a)). The hearing
officer's proposed order may become the Agency's final order, which is
reviewable in Federal court (40 CFR 791.60).
G. What Would I Need To Do If I Cannot Complete the Testing Required by
the Rule?
A company who submits a letter of intent to test under the final
rule and that subsequently anticipates difficulties in completing the
testing by the deadline set forth in the final rule may submit a
modification request to the Agency, pursuant to 40 CFR 790.55. EPA will
determine whether modification of the test schedule is appropriate, and
may first seek public comment on the modification.
H. What Reporting Requirements are Proposed Under This Test Rule?
You would be required to submit interim progress reports for a
specific test every 6 months, beginning 6 months after the effective
date of the final rule. You would be required to submit a final report
for a specific test by the deadline indicated as the number of months
after the effective date which would be shown in Table 2 of Sec.
799.5100(j) of the proposed regulatory text.
I. Would There Be Sufficient Test Facilities and Personnel To Undertake
the Testing in This Proposed Test Rule?
EPA's most recent analysis of laboratory capacity (Ref. 7)
indicates that available test facilities and personnel would adequately
accommodate the majority of the testing proposed in this rule. However,
the laboratory capacity for conducting certain tests appears to be
constrained because there is a limited number of testing laboratories
with the facilities to perform these tests. For example, the current
demand for inhalation testing appears to be high. EPA is proposing a
relatively small number of inhalation tests (14). Although EPA realizes
that in some cases these tests may take longer than anticipated to
complete, the Agency believes it will be possible to complete the
testing proposed within the time frame specified in this proposed rule.
As explained in Unit IV.D., EPA is encouraging the submission of
existing data from studies conducted via a route of administration
other than the route specified in this proposed rule along with PBPK
information which, together, could result in a decision by EPA not to
include the related proposed testing in the final rule. Submission of
such existing data after promulgation of the final rule could result in
a decision by EPA to withdraw the related testing requirements from the
final rule. In addition, in Unit IV.E., EPA is encouraging test
sponsors to submit ECA proposals for PBPK studies that could further
reduce the number of studies, particularly inhalation studies,
specified in the rule. See Unit IV.G. for information regarding
obtaining a modification of the test schedule.
J. Might EPA Seek Further Testing of the Chemicals in This Proposed
Test Rule?
If EPA determines that it needs additional data regarding any of
the chemical substances included in this proposed rule, the Agency
might seek further health and/or environmental effects testing for
these chemical substances. Should the Agency decide to seek such
additional testing, EPA would initiate a separate action for that
purpose.
V. Export Notification
Any person who exports, or intends to export, one of the chemical
substances contained in a final TSCA section 4 action in any form
(e.g., as byproducts, impurities, components of Class 2 substances,
etc.) is subject to the export notification requirements in TSCA
section 12(b)(1) and 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 (45 FR 82844, December
16, 1980). 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.
VI. Economic Impacts
EPA has prepared an economic assessment entitled Economic
Assessment for the Proposed ATSDR Test Rule for Four Chemicals (Ref.
2), 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 is being proposed. The total cost of
providing test information specified in this proposed rule is estimated
to be $8.6 million for all four chemicals subject to the rule (Ref. 2).
While they would be legally subject to this test 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)(4) through
(c)(10) of the proposed regulatory text. EPA would require Tier 2
manufacturers and/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 proposed rule, at least one such person would submit a
letter of intent to conduct the required testing and that person would
conduct such testing and would submit the test data to EPA. EPA
believes that there would 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
would be any administrative, negotiation, or any other costs associated
with seeking reimbursement from Tier 2 entities.
To evaluate the potential for an adverse economic impact of testing
on manufacturers of the chemical substances in this proposed rule, EPA
employed a screening approach that 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
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annualized over 15 years (the expected life of a chemical) using a 7%
discount rate. Annualized testing costs are then divided by the
estimated total supply of the chemical to derive a unit test cost. The
unit test costs are then divided by the chemical's sales price to
determine the impact of testing requirements.
EPA estimates the annualized cost to industry of testing the 4
chemicals evaluated in the economic analysis to be $0.9 million with an
average annualized cost of testing of approximately $237,000 per
chemical (Ref. 2). In addition, the TSCA section 12(b) export
notification that would be required only for the first export by a
particular exporter to a particular country of each chemical subject to
a final TSCA section 4 action, is estimated to average $67.33 for the
first time that an exporter must comply with TSCA 12(b) export
notification requirements, and $21.81 for each subsequent export
notification submitted by an exporter (Ref. 2). 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 proposed rule are presented in the economic
assessment (Ref. 2).
Prices were estimated for each of the four chemicals. The price
impact of the test costs is a function of the chemical's price and the
production volume. For three of the four chemicals included in the
proposed rule the price impact of the proposed requirements is
estimated to be less than 1.0%. EPA concludes that for these chemicals
the potential for adverse economic impacts is low.
For one of the four chemicals, chloroethane, the estimated price
impact is in excess of 1.0%. EPA concludes that there is a potential
for adverse economic impacts as a result of the test requirements for
this chemical. For chemicals where the profit margins are low, the
costs of testing may use a significant part of the profits generated by
the chemical.
On the basis of these calculations, EPA believes that the proposed
test rule presents a low potential for adverse economic impact for the
majority of the chemicals subject to the proposed rule. Because the
subject chemical substances have relatively large production volumes,
the annualized unit costs of testing, relative to the price of the
chemicals, would be very small for most chemicals. However, it cannot
be shown that the price impact for chloroethane would be below 1.0%.
For this chemical, companies may choose to use revenue sources other
than profits from the individual chemicals to pay for testing.
EPA does not provide quantitative estimates of the benefits from
these tests. Ideally, a discussion of benefits would focus on the
additional benefits to be gained from new information relative to
information that already exists. Such an approach could examine the
value of new information over and above the value of the information
described in the ATSDR toxicological profiles. Because of information
constraints on the value of the new information, our evaluation of
benefits is qualitative and does not address incremental benefits. We
believe, however, that the net benefits of the new information are
positive.
VII. Materials in the Docket
As indicated under ADDRESSES, a docket was established for this
rulemaking under docket ID number EPA-HQ-OPPT-2002-0073. The following
is a listing of the documents that have been placed in the docket for
this proposed rule. The docket includes information considered by EPA
in developing this proposed rule, including the documents listed in
this unit, which are physically located in the docket. In addition,
interested parties should consult documents that are referenced in the
documents that EPA has placed in the docket, regardless of whether
these other documents are physically located in the docket. For
assistance in locating documents that are referenced in documents that
EPA has placed in the docket, but that are not physically located in
the docket, please consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
1. EPA. TSCA Section 4(a) Preliminary Findings: Supporting Document
for the Proposed Test Rule for Certain Chemical Substances on the
ATSDR/EPA CERCLA Priority List of Hazardous Substances. Washington, DC.
(October, 2005)
2. EPA. Economic Assessment for the Proposed ATSDR Test Rule for
Four Chemicals. (July 12, 2006)
3. ATSDR. Letter from Barry Johnson, Assistant Surgeon General,
ATSDR, Atlanta GA, to Linda Fisher, Assistant Administrator, Office of
Prevention, Pesticides and Toxic Substances, EPA. Washington, DC.
(October 27, 1992)
4. EPA. Letter to Barry Johnson, Assistant Surgeon-General, ATSDR,
from Mark Greenwood, Director, Office of Pollution Prevention and
Toxics. (December 30, 1992)
5. EPA. Letter to Barry Johnson, Assistant Surgeon-General, ATSDR,
from Joseph Carra, Deputy Director, Office of Pollution Prevention and
Toxics. (April 22, 1993)
6. EPA. Letter to Barry Johnson, Assistant Surgeon-General, ATSDR,
from Lynn Goldman, Assistant Administrator, Office of Prevention,
Pesticides and Toxic Substances. (November 9, 1993)
7. EPA. Analysis of Laboratory Capacity to Support U.S. EPA
Chemical Testing Program Initiatives. Economic and Policy Analysis
Branch. Washington, DC. (August, 2004)
8. ATSDR. Letter from Christopher De Rosa, P.h. D., Director,
Division of Toxicology, Agency for Toxic Substances and Disease
Registry to Charles Auer, Director, Chemical Control Division, Office
of Pollution Prevention and Toxic Substances. (July 3, 1996)
9. EPA. Toxic Substances; Test Rule Development and Exemption
Procedures. Interim Final Rule. 40 CFR part 790. Federal Register (50
FR 20652, 20654, May 17, 1985).
10. EPA. Toxic Substances Control Act; Data Reimbursement. Final
Rule. 40 CFR part 791. Federal Register (48 FR 31786, 31789, July 11,
1983).
11. Huntington Life Sciences. Vinyl Chloride Combined Inhalation
Two-Generation Reproduction and Developmental Toxicity Study in CD
Rats. Submitted to Chemical Manufacturers Association, Chemstar
Department. 1300 Wilson Blvd., Arlington, VA 22209. (January 30, 1998)
12. ATSDR. Toxicological Profile for Cyanide, Draft for Public
Comment. U.S. Department of Health and Human Services. Public Health
Service. Agency for Toxic Substances and Disease Registry. Division of
Toxicology/Toxicology Information Branch. 1600 Clifton Rd., NE., MS F-
32, Atlanta GA 30333. (September 2004)
13. EPA. National Primary Drinking Water Regulations; Synthetic
Organic Chemicals and Inorganic Chemicals. Final Rule. 40 CFR parts 141
and 142. Federal Register (57 FR 138, July 17, 1992)
VIII. Statutory and Executive Order Reviews
A. Executive Order 12866
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has designated this proposed rule as a ``significant
regulatory action'' under section 3(f) of the Executive Order.
Accordingly, EPA submitted this proposed rulemaking to OMB for review
under Executive Order 12866 and any changes made in response to OMB
comments have been documented in the public docket for this rulemaking
as
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required by section 6(a)(3)(E) of the Executive Order.
In addition, EPA has prepared an economic analysis of this proposed
action, which is contained in a document entitled Economic Assessment
for the Proposed ATSDR Test Rule for Four Chemicals (Ref. 2). A copy of
the economic analysis is available in the docket for this proposed rule
and is summarized in Unit VI.
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 proposed rule would not impose any
new or amended requirements that would require additional review and/or
approval by OMB.
Under the PRA, an agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information that is
subject to approval under the PRA, unless it displays a currently valid
OMB control number. The OMB control numbers for the EPA regulations
codified in chapter 40 of the CFR, after appearing in the preamble of
the final rule, are listed in 40 CFR part 9, displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers incertain EPA regulations is
consolidated in 40 CFR part 9.
The estimated paperwork burden and costs for this proposed TSCA
section 4 rule are provided for public comment in this proposal. The
final rule would present estimates which have been adjusted to reflect
any changes made since the proposed rule to reflect public comment
received and the content of the final rule.
The standard chemical testing program involves the submission of
letters of intent to test (or exemption applications), study plans,
semi-annual progress reports, test results, and some administrative
costs. For this proposed rule, EPA estimates the public reporting
burden for all four chemicals is 10,782 hours. The estimated burden
increase for each chemical would on average be 2,695 hours, and the
reporting burden per respondent would be 449 hours on average (Ref. 2).
The estimated burden of the information collection activities related
to export notification is estimated to average 1 burden hour for each
chemical/country combination for an initial notification and .5 hours
for each subsequent notification (Ref. 2). In estimating the total
burden hours approved for the information collection activities related
to export notification, the Agency has included sufficient burden hours
to accommodate any export notifications that may be required by the
Agency's issuance of final chemical test rules. As such, EPA does not
expect to need to request an increase in the total burden hours
approved by OMB for export notifications.
As defined by PRA and 5 CFR 1320.3(b), ``burden'' means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to: Review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information.
Comments are requested on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested
methods for minimizing respondent burden, including through the use of
automated collection techniques. Send comments to EPA as part of your
overall comments on this proposed action in the manner specified under
ADDRESSES. In developing the final rule, the Agency will address any
comments received regarding the information collection requirements
contained in this proposal.
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 proposed rule on small entities, the Agency hereby certifies
that this proposed rule would not have a significant adverse economic
impact on a substantial number of small entities. The factual basis for
the Agency's determination is presented in the small entity impact
analysis prepared as part of the economic analysis for this proposed
rule (Ref. 2), which is summarized in Unit VI., and a copy of which is
available in the docket for this rulemaking. 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 proposed 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; and
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 that EPA prepared as part of the
economic analysis for this rulemaking (Ref. 2), EPA has determined that
this proposed rule is not expected to impact any small not-for-profit
organizations or small governmental jurisdictions. As such, the
Agency's analysis presents only the estimated potential impacts on
small businesses. Using the size standards established under the SBA
regulations at 13 CFR 121.201 for firms in the NAICS codes that would
likely be subject to this proposed rule, EPA identified two small
businesses that would be potentially impacted by the proposed test
rule.
As summarized in Unit VI., EPA estimates that the annualized cost
for testing in this proposed rule would be $0.9 million (Ref. 2). The
impact on these two small companies is expected to be less than 1% of
company sales, which is not expected to be a significant adverse
impact. The estimated cost of a TSCA section 12(b)(1) export
notification, which, as a result of the final rule, would be required
for the first export to a particular country of a chemical subject to
the rule, is estimated to be $67.33 and $21.81 for each subsequent
export notification submitted by an exporter (Ref. 2). EPA has
concluded that the costs of TSCA section 12(b)(1) export notification
would have a negligible impact on exporters of the chemicals in the
final rule, regardless of the size of the exporter.
The Agency has also examined the standard practices that the
industry uses in carrying out chemical testing in response to test
rules, such as this one.
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Based on that examination, EPA believes that:
Small businesses do not perform the testing themselves,
nor do they participate in the organization of the testing effort,
because health effects testing of chemical substances is generally
carried out by consortia of the large manufacturers or importers of the
chemical substances;
A small business would experience only very minor costs,
if any, in securing an exemption from testing requirements, because
exemption request requirements, described generally at 40 CFR 790.80
through 790.99 and the proposed regulatory text at Sec.
799.5100(c)(2), (c)(5), and (c)(7), are minimal and EPA does not charge
a fee for filing such a request; and
Small businesses are unlikely to be affected by the
reimbursement requirements because manufacturers (including importers)
with a significant share of production or importation are the entities
that will likely pay the highest share of testing costs, and the
marginal benefit of securing reimbursement from small contributors may
not be worth the cost.
In addition, in analyzing potential impacts, the RFA recognizes
that it may be appropriate at times for Federal agencies to use an
alternate definition of small business. As such, RFA section 601(3)
also provides that an agency may establish a different definition of
small business after consultation with the SBA Office of Advocacy and
after notice and an opportunity for public comment. Even though the
Agency has used the default SBA definition of small business to conduct
its analysis of potential small entity impacts for this proposed rule,
EPA does not believe that the SBA size standards are generally the best
size standards to use in assessing potential small entity impacts with
regard to TSCA section 4(a) test rules.
The SBA size standards, which are primarily intended to define
whether a business entity is eligible for Federal 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. The SBA size standard is generally
based on the number of employees an entity in a particular industrial
sector may have. For example, in the chemical manufacturing industrial
sector (i.e., NAICS code 325), approximately 98% of the industries
would be classified as small businesses under the default SBA
definition. The SBA size standard for 47% of this industry sector is
500 employees, and the size standard for 21% of this industry sector is
750 employees and for 32% is 1,000 employees. As a result, when
assessing the potential impacts of test rules on chemical
manufacturers, EPA believes that a standard based on total annual sales
may provide a more appropriate means to judge the ability of a chemical
manufacturing firm to support chemical testing without significant
costs or burdens.
EPA is currently determining what level of annual sales would
provide the most appropriate size cutoff with regard to various
segments of the chemical industry usually impacted by TSCA section 4(a)
test rules, but has not yet reached a determination. As stated in this
unit, therefore, the factual basis for the RFA determination for this
proposed rule is based on an analysis using the default SBA size
standards. Although EPA is not proposing to establish an alternate
small business definition in the small entity impact analysis conducted
for this proposed rule, EPA is interested in receiving comments on
whether the Agency should consider establishing an alternate small
business definition to use in the small entity impact analyses for
future TSCA section 4(a) test rules, and what size cutoff may be
appropriate.
Any comments regarding the impacts that this action may impose on
small entities, or regarding whether the Agency should consider
establishing an alternate definition of small business to be used for
analytical purposes for future test rules and what size cutoff may be
appropriate, should be submitted to the Agency in the manner specified
under ADDRESSES.
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 proposed rule
does not contain a Federal mandate that may result in expenditures of
$100 million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any 1 year. It is estimated that
the total one-time total cost of the rule, which is summarized in Unit
VI., is $8.6 million, with an annualized cost estimated to be $0.9
million, and the estimated annual cost per chemical to be approximately
$237,000. 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 rule
would apply directly to State, local, or tribal governments, EPA has
determined that this proposed rule would not significantly or uniquely
affect small governments. Accordingly, this proposed rule is not
subject to the requirements of sections 202, 203, 204, or 205 of UMRA
E. Executive Order 13132
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999), EPA has determined that this proposed rule does not have
``federalism implications,'' because 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 the Executive Order. This proposed rule would establish 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 proposed rule.
F. Executive Order 13175
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 6, 2000), EPA has
determined that this proposed rule does not have tribal implications
because it will not have any affect 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 Order. As indicated
previously, 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 rule.
G. Executive Order 13045
This proposed 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 will not have an annual effect on the economy of
$100 million or more, nor does it establish an environmental standard,
or otherwise have a disproportionate effect on children. This proposed
rule would establish testing and record keeping requirements that apply
to manufacturers (including importers)
[[Page 61940]]
and processors of certain chemicals, and would result in the production
of information that will assist the Agency and others in determining
whether the chemical substances in this proposed rule present potential
risks, allowing the Agency and others to take appropriate action to
investigate and mitigate those risks.
H. Executive Order 13211
This proposed rule is not subject to 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 designated as an ``economically significant'' regulatory
action as defined by Executive Order 12866, nor is it likely to have
any significant adverse effect on the supply, distribution, or use of
energy.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note), directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures and business practices) that are developed or
adopted by voluntary consensus standard bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
This proposed rule involves technical standards because it proposes
to require the use of particular test methods. If the Agency makes
findings under TSCA section 4, EPA is required by TSCA section 4(b) to
identify the specific standards or test methods that are to be used for
the development of the data required in the test rules issued under
TSCA section 4. If finalized as proposed, the testing that would be
required under this action would be conducted according to the test
standards proposed for use in this action, i.e., 40 CFR 799.9110 (acute
oral toxicity), 40 CFR 799.9135 (acute inhalation toxicity with
histopathology), 40 CFR 799.9310 (90-day oral toxicity in rodents), 40
CFR 799.9346 (90-day inhalation toxicity), 40 CFR 799.9430 (combined
chronic toxicity/carcinogenicity), 40 CFR 799.9370 (prenatal
developmental toxicity), 40 CFR 799.9630 (developmental neurotoxicity),
40 CFR 799.9380 (reproduction and fertility effects), 40 CFR 799.9620
(neurotoxicity screening battery), 40 CFR 798.6500 (schedule-controlled
operant behavior), and 40 CFR 799.9780 (immunotoxicity).
The test standards identified in this proposed rule are based on
the harmonized guidelines that are available at http://www.epa.gov/opptsfrs/home/guidelin.htm. EPA established a unified library for test
guidelines that have been issued by OPPTS for use in testing chemical
substances to develop data for submission to EPA under TSCA, the
Federal Food, Drug and Cosmetic Act (FFDCA), or FIFRA. This unified
library of test guidelines represents an Agency effort that began in
1991 to harmonize the test guidelines within OPPTS, as well as to
harmonize the OPPTS test guidelines with those used internationally,
such as those of the Organization for Economic Cooperation and
Development (OECD) of the European Community. The purpose for
harmonizing these guidelines into a single set of OPPTS guidelines is
to minimize variations among the testing procedures that must be
performed to meet the Agency's identified data needs under FIFRA,
FFDCA, and TSCA. The process for developing and amending the OPPTS
harmonized test guidelines includes several opportunities for public
participation and the extensive involvement of the scientific
community, including external peer review by the FIFRA Scientific
Advisory Panel (SAP), EPA's Science Advisory Board (SAB), and other
expert scientific organizations, as appropriate. By identifying the
test guidelines in its proposed TSCA test rules, EPA is providing the
public another opportunity to review and comment on a particular test
guideline before it is promulgated for use in a TSCA test rule.
In developing this proposed rule, EPA conducted a search to
identify potentially applicable voluntary consensus standards. No such
standards were identified for certain of the endpoints that the Agency
is proposing to test based on the preliminary findings under TSCA
section 4 that are discussed in Unit III. Specifically, EPA could not
identify any applicable voluntary consensus standards involving test
methods for acute inhalation toxicity with histopathology,
developmental neurotoxicity, neurotoxicity screening battery,
immunotoxicity, and combined chronic toxicity/carcinogenicity.
The Agency did, however, identify potentially applicable voluntary
consensus standards involving test methods for acute oral toxicity, 90-
day oral toxicity in rodents, 90-day inhalation toxicity, and prenatal
developmental toxicity. After careful consideration, the Agency has
determined that the potentially applicable voluntary consensus
standards that were identified are generally impractical for this
rulemaking because they are not designed to provide the specific data
that is proposed to be required in this test rule. As discussed in Unit
II., the Agency is proposing to require the development of specific
data in order to satisfy the identified data needs for each chemical in
this proposed rule. The following paragraphs explain why each
potentially applicable voluntary consensus standard is impractical and
fails to satisfy the identified priority data need discussed in Unit
II.
1. Acute oral toxicity. The standard proposed for use in this
rulemaking (40 CFR 799.9110) requires evaluation of both sexes and has
an observation period twice as long as the similar standard test for
acute oral toxicity, ASTM E 1163. Evaluating both sexes allows for
evaluation of possible differences in sensitivity to substances based
on gender. The longer observation period provides time for an adverse
response to develop and to be observed. These differences make the use
of ASTM E 1163 impractical for this rulemaking because the proposed
standard is more useful and more effectual in providing the data that
addresses the identified Agency need.
2. 90-day oral toxicity in rodents. The standard proposed for use
in this rulemaking (40 CFR 799.9310) requires more frequent evaluation
of animals for clinical signs, clinical pathology of all animals, and
evaluation of more organs and tissues than the similar standard test
for 90-day oral toxicity in rodents, ASTM E 1372-95. The additional
procedures found in the TSCA guideline provide closer monitoring of the
animals for adverse effects, a thorough examination of all animals that
may discover effects overlooked by examining only a few selected
animals, and may find effects in organs and tissues that would not be
examined under ASTM E 1372-95. These differences make the use of ASTM E
1372-95 impractical for this rulemaking because the proposed standard
is more useful and more effectual in providing the data that addresses
the identified Agency need.
3. 90-day inhalation toxicity. The standard proposed for use in
this rulemaking (40 CFR 799.9346) requires more frequent evaluation of
animals for clinical signs and clinical pathology of more (all) animals
than the similar standard test for 90-day inhalation
[[Page 61941]]
toxicity in rodents, ASTM E 1373-01. The additional procedures found in
the TSCA guideline provide closer monitoring of the animals for adverse
effects. Performing histopathology on all animals under the TSCA
guideline is more likely to observe effects that could be overlooked
after examining only a sample of animals under ASTM E 1373-01. These
differences make the use of ASTM E 1373-01 impractical for this
rulemaking because the proposed standard is more useful and effectual
in providing the data that addresses the identified Agency need.
4. Prenatal developmental toxicity. The standard proposed for use
in this rulemaking (40 CFR 799.9370) would require the use of a greater
number of test subjects, which increases the power of the test to
detect adverse effects, as compared to the similar standard test method
for assessing developmental toxicity in rats and rabbits, ASTM E 1483-
92. The standard proposed for use in this rulemaking would also require
a longer dosing period (beyond organogenesis through late gestational
development) which reduces the possibility of maternal and/or fetal
recovery from treatment related effects that may otherwise not be
observed from shorter dosing periods. Extending the dosing period also
increases the sensitivity of the test to detect developmental effects
of chemicals which exert their effect during late gestation. Finally,
the proposed test guideline periodically adjusts dose based on the
increasing body weight of the pregnant animal so that the dose in
milligram (mg)/kg is constant rather than declining. These differences
make the use of ASTM E 1483-92 impractical for this rulemaking because
the proposed standard is more useful and effectual in providing the
data that addresses the identified Agency need.
EPA found no other potentially applicable voluntary consensus
standards that it believes could provide a possible substitute for the
TSCA test guidelines being proposed. The Agency invites comment on its
determination regarding the potentially applicable voluntary consensus
standards considered for this proposed rule, and specifically invites
the public to identify potentially applicable voluntary consensus
standard(s) and to explain why such standard(s) should be used in the
final rule.
J. Executive Order 12898
This proposed rule does not have an adverse impact on the
environmental and health conditions in low-income and minority
communities. Therefore, under 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 does
not need to consider environmental justice-related issues.
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Laboratories, Reporting and recordkeeping requirements.
Dated: October 6, 2006.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxics
Substances.
Therefore, it is proposed that 40 CFR chapter I, subchapter R be
amended as follows:
PART 799--[AMENDED]
1. The authority citation for part 799 would continue to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
2. By adding Sec. 799.5100 to subpart D to read as follows:
Sec. 799.5100 Chemical testing requirements for certain chemicals on
the ATSDR/EPA CERCLA Priority List of Hazardous Substances.
(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. The purity of each chemical
substance to be tested except sodium cyanide and hydrogen cyanide must
be 99% or greater. The purity of sodium cyanide and hydrogen cyanide
must be 95% or greater.
(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 [insert date 30 days after date of publication of the
final rule in the Federal Register] 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 chemical substance included in
manufacture, a chemical substance this section solely as one or
included in this 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
kilogram (kg) (1,100 lbs)
annually (as described at 40
CFR 790.42(a)(4)); or
-For research and development
(as described at 40 CFR
790.42(a)(5)).
[[Page 61942]]
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)(4) through (c)(7)
and (c)(10) 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 [insert date 60 days
after date of publication of the final rule in the Federal Register].
(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), (c)(7), or (c)(10) 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 [insert date 60 days after date of publication of the final rule in
the Federal Register], EPA will publish a Federal Register document
that would specify the test(s) and the chemical substance(s) for which
no letter of intent has been submitted, and notify manufacturers in
Tier 2A 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 2A with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, and if you
manufacture, or intend to manufacture, this chemical substance as of
[insert date 30 days after date of publication of the final rule in the
Federal Register], 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 in Tier 1 or Tier 2A 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 within 30 days after the publication of the Federal Register
document described in paragraph (c)(4) of this section, EPA will
publish another Federal Register document that would specify the
test(s) and the chemical substance(s) for which no letter of intent has
been submitted, and notify processors in Tier 2B of their obligation to
submit a letter of intent to test or to apply for an exemption from
testing.
(7) If you are in Tier 2B with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, and if you process,
or intend to process, this chemical substance as of [insert date 30
days after date of publication of the final rule in the Federal
Register], or within 30 days after publication of the Federal Register
document described in paragraph (c)(6) of this section, you must, for
each test specified for that chemical substance in the document
described in paragraph (c)(6) 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)(6) of this section.
(8) 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)(6) 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.
(9) 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)(8) 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.
(10) 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.
(11) If you are required to comply with this section, but your
manufacturing or processing of, or intent to manufacture or process, 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)(7) 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.
[[Page 61943]]
(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 (b) of Sec. 790.80; and paragraph (e)(1) of Sec.
Sec. 790.82, 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 one 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? The chemical substances
identified by Chemical Abstract Service Registry Number (CAS No.) and
chemical name in Table 2 in paragraph (j) of this section must be
tested as follows:
(1) Testing standards. Testing must be conducted in accordance with
test standards specified in Table 2 in paragraph (j) of this section.
The test standards cited in Table 2 in paragraph (j) of this section
apply as they exist on the effective date indicated in paragraph (k) of
this section.
(2) Required tests. In Table 2 in paragraph (j) of this section,
the column ``Required Tests'' references the applicable test guideline
on which the test standard is based.
(3) Testing specifications. The following limitations apply when
specified for a particular chemical substance in Table 2 in paragraph
(j) of this section under ``Testing specifications.''
(i) Test species. The test animal must be:
(A) The rat or the mouse.
(B) The mouse.
(C) The rat.
(D) The rabbit.
(ii) Route of exposure. Animals must be exposed via:
(A) Oral.
(B) Inhalation.
(C) Gavage.
(iii) Duration and frequency of exposure. (A) The substance must be
administered by both acute and subchronic exposures.
(B) Animals must be exposed for a 4-hour period in an acute study.
(C) Animals must be exposed for 6 hours per day, 5 days per week
for a 90-day period in a 90-day study.
(D) A multiple fixed-interval fixed-ratio schedule shall be used.
Fixed-ratio and fixed-interval contingencies shall alternate throughout
daily test sessions of at least 60 minutes duration.
(iv) Specific organ gross pathology and histopathology. (A) The
thyroid glands shall be subjected to gross pathologic examination and
shall be trimmed and weighed wet as soon as possible after dissection
to avoid drying.
(B) The thyroid glands from all animals in the control and high
dose groups shall undergo full histopathological examination; in the
event that there are excessive early deaths or other problems that
occur within the high dose group that could compromise the significance
of the data, full histopathology shall be performed on the thyroid
glands from all animals from the next highest exposure group.
(v) Specific hormone level determinations. T3 and T4 hormone levels
shall be measured at terminal sacrifice.
(i) Reporting requirements. Interim progress reports for each test
must be submitted every 6 months, beginning 6 months after the
effective date of this rule as specified in paragraph (k) of this
section. The number of interim progress reports that must be submitted
for each test is listed in Table 2 in paragraph (j) of this section. A
final report for each test for each subject chemical substance must be
received by EPA by the deadline indicated in that table as the number
of months after the effective date of this rule as specified in
paragraph (k) of this section.
(j) Designation of specific chemical substances and testing
requirements. The chemical substances identified by name and CAS No. in
Table 2 of this paragraph must be tested in accordance with the testing
requirements and limitations designated in this section, and the
requirements described in Part 792--Good Laboratory Practice Standards
of this chapter.
Table 2.--Test Requirements and Reporting Dates
--------------------------------------------------------------------------------------------------------------------------------------------------------
Testing
Chemical name and type specifications (all Number of interim 6- Final report per test
CAS No. of testing Required tests references are to month reports (months after
Sec. 799.5100(h)(3) required per test effective date)
--------------------------------------------------------------------------------------------------------------------------------------------------------
75-00-3............................ Chloroethane: .....................
Acute oral toxicity... Sec. 799.9110....... (i)(C)............... 0.................... 6
90-day oral toxicity Sec. 799.9310....... (i)(A)............... 2.................... 18
in rodents.
Prenatal developmental Sec. 799.9370....... (i)(B), (i)(D), 2.................... 15
toxicity. (ii)(B).
Reproduction and Sec. 799.9380....... (i)(C), (ii)(A), 4.................... 29
fertility effects. (ii)(B).
Combined chronic Sec. 799.9430....... (i)(B), (ii)(B)...... 9.................... 60
toxicity/
carcinogenicity.
Neurotoxicity Sec. 799.9620....... (i)(C), (ii)(A), 3.................... 21
screening battery. (ii)(B), (iii)(A),
(iii)(B), (iii)(C).
Developmental Sec. 799.9630....... (i)(C), (ii)(B)...... 3.................... 21
neurotoxicity
Immunotoxicity........ Sec. 799.9780....... (i)(A), (ii)(A), 2.................... 18
(ii)(B).
--------------------------------------------------------------------------------------------------------------------------------------------------------
74-90-8............................ Hydrogen cyanide: .....................
Acute inhalation Sec. 799.9135....... (i)(C), (iv)(A), 1.................... 9
toxicity with (iv)(B).
histopathology.
90-day inhalation Sec. 799.9346....... (i)(A), (iv)(A), 2.................... 18
toxicity. (iv)(B), (v).
Prenatal developmental Sec. 799.9370....... (i)(C), (i)(D), 2.................... 15
toxicity. (ii)(B).
[[Page 61944]]
Reproduction and Sec. 799.9380....... (i)(C), (ii)(B)...... 4.................... 29
fertility effects.
Neurotoxicity Sec. 799.9620....... (i)(C), (ii)(B), 3.................... 21
screening battery. (iii)(A), (iii)(B),
(iii)(C).
Schedule-controlled Sec. 798.6500....... (i)(C), (ii)(B), 6.................... 36
operant behavior. (iii)(C), (iii)(D).
--------------------------------------------------------------------------------------------------------------------------------------------------------
143-33-9........................... Cyanide: Sodium .....................
cyanide.
Prenatal developmental Sec. 799.9370....... (i)(C), (i)(D), 1.................... 12
toxicity. (ii)(A).
--------------------------------------------------------------------------------------------------------------------------------------------------------
75-09-2............................ Methylene chloride: .....................
Prenatal developmental Sec. 799.9370....... (i)(C), (i)(D), 2.................... 15
toxicity. (ii)(B).
Schedule-controlled Sec. 798.6500....... (i)(C), (ii)(A), 6.................... 36
operant behavior. (iii)(C), (iii)(D).
Developmental Sec. 799.9630....... (i)(C), (ii)(B)...... 3.................... 21
neurotoxicity.
--------------------------------------------------------------------------------------------------------------------------------------------------------
(k) Effective date. This section is effective on [insert date 30
days after date of publication of the final rule in the Federal
Register].
[FR Doc. E6-17569 Filed 10-19-06; 8:45 am]
BILLING CODE 6560-50-S