[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 61927]]

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

[[Page 61928]]

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

[[Page 61929]]

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

[[Page 61930]]

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

[[Page 61936]]

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

[[Page 61937]]

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

[[Page 61938]]

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.

[[Page 61939]]

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