58. Bintein, S., DeVillers, J., and Karcher, W. Nonlinear
dependence of fish bioconcentration on n-octanol/water partition
coefficient. SAR and QSAR in Environmental Research. 1:29-39. 1993.
    59. Meylan, W.M., Howard, P.H., Boethling, R.S., Aronson, D.,
Printup, H., and Gouchie, S. Improved method of estimating
bioconcentration/bioaccumulation factor from octanol/water partition
coefficient. Environmental Toxicology and Chemistry. 18(4): 664-672.
1999.
    60. Smrchek, J.C. and Zeeman, M.G. Assessing Risks to Ecological
Systems from Chemicals, pp. 24-90. In. P. Callow (ed.), Handbook of
Environmental Risk Assessment and Management. Blackwell Science Ltd.
Oxford, UK. 1998.
    61. EPA. Proposed Category for Persistent, Bioaccumulative and
Toxic Chemical Substances. Federal Register (63 FR 53417, October 5,
1998) (FRL-5771-6).
    62. EPA. Policy Statement--Category for Persistent,
Bioaccumulative, and Toxic New Chemical Substances. Federal Register
(64 FR 60194, November 4, 1999) (FRL-6097-7).
    63. EPA. Significant New Use Rules; General Provisions For New
Chemical Follow-Up under sections 5 and 26(c) of TSCA. Federal Register
(54 FR 31307, July 27, 1989).
    64. ASTM International. Standard Test Method for Estimating Acute
Oral Toxicity in Rats. ASTM. E 1163. 2002.
    65. U.S. Department of Health and Human Services. National
Institutes of Health. NTP. Toxicology and carcinogenesis studies of
pentaerythritol tetranitrate (CAS No. 78-11-5) with 80% D-lactose
monohydrate (PETN, NF) in F344/N rats and B6C3F1 mice (feed studies),
Technical Report Series No. 365. August 1989.
    66. EPA. In Vitro Dermal Absorption Rate Testing of Certain
Chemicals of Interest to Occupational Safety and Health Administration;
Proposed Rule. Federal Register (64 FR 31074, June 9, 1999) (FRL-5760-
3).
    67. EPA. In Vitro Dermal Absorption Rate Testing of Certain
Chemicals of Interest to the Occupational Safety and Health
Administration; Final Rule. Federal Register (69 FR 22402, April 26,
2004) (FRL-7312-2).
    68. EPA. Toxic Substances Control Act; Data Reimbursement. Federal
Register (48 FR 31785, July 11, 1983).
    69. EPA. Toxic Substances; Test Rule Development and Exemption
Procedures. Federal Register (50 FR 20652, May 17, 1985).
    70. EPA. Laboratory Capacity and the HPV Challenge Program.
Prepared by EPAB, EETD, OPPT. Washington, DC. October 14, 1999.
    71. EPA. EPA Census of TSCA Testing Laboratories. Prepared by EPAB,
EETD, OPPT. Washington, DC. October 10, 1996.
    72. EPA. Notices of export under section 12(b). Federal Register
(45 FR 82850, December 16, 1980).
    73. EPA. Review of comments on proposed determination of physical/
chemical properties for PETN. Memorandum from Dr. Robert Boethling,
EAB, EETD, OPPT, to Greg Schweer, CITB. August 20, 2004.
    74. EPA. Request for assistance in reviewing four studies for TSCA
section 4 test rule. Memorandum from Maria Szilagyi, RAD, OPPT to
Donald Rodier, High Production Volume Chemical Branch (HPVCB), RAD.
October 5, 2004.
    75. EPA. Economic Analysis for the Final Section 4 Test Rule for
High Production Volume Chemicals. Prepared by EPAB, EETD, OPPT.
February 18, 2005.
    76. Small Business Administration, Office of Size Standards. Small
Business Size Standards matched to North American Industry
Classification System (NAICS). Available online at: http://www.sba.gov/size/sizetable2002.htm
.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), it has been determined that this
rule is a ``significant regulatory action'' because this action may
raise novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in section 3(f)(4)
of the Executive Order. Accordingly, this final rule was submitted to
the Office of Management and Budget (OMB) for review under Executive
Order 12866 and any changes made based on OMB recommendations have been
documented in the public docket for this rulemaking as required by
section 6(a)(3)(E) of the Executive Order.
    In addition, EPA has prepared an economic assessment entitled
Economic Analysis for the Final Section 4 Test Rule for High Production
Volume Chemicals (Ref. 75), a copy of which has been placed in the
public docket for this rulemaking. This economic assessment evaluates
the economic impacts of the testing that would be required by this
final rule. The total social cost of providing the test data on the 17
chemicals that were evaluated in this economic analysis is estimated to
be $4.08 million (Ref. 75). The annualized social costs of the final
rule are

estimated to be $1.44 million, using a social discount rate of 3% over
a 3-year period (Ref. 75).
    While legally subject to this final rule, Tier 2 manufacturers and
processors of a subject chemical would be required to comply with the
requirements of the rule only if they are directed to do so by EPA as
described in Sec.  799.5085(c)(5) and (c)(6) of the regulatory text.
EPA would only require such entities to test if no person in Tier 1 has
submitted a letter of intent to test, or if under 40 CFR 790.93, a
problem occurs with the initiation, conduct, or completion of the
required testing, or the submission of the required data to EPA.
Because EPA has identified at least one manufacturer in Tier 1 for each
subject chemical, the Agency assumes that, for each chemical in this
final rule, at least one such person will submit a letter of intent to
test and that person will conduct such testing and will submit the test
data to EPA. Because Tier 2 manufacturers and processors do not need to
comply with the rule initially, the economic assessment does not
address these entities.
    To evaluate the potential for an adverse economic impact of testing
on manufacturers of the chemical substances in this final rule, EPA
employed a screening approach that estimated the impact of testing
requirements as a percentage of each chemical's sale price. This
measure compares annual revenues from the sale of a chemical to the
annualized testing costs for that chemical to assess the percentage of
testing costs that can be accommodated by the revenue generated by that
chemical. Annualized testing costs divide testing expenditures into an
equivalent, constant yearly expenditure over a longer period of time.
To calculate the percent price impact, testing costs (including
laboratory and administrative expenditures) are annualized over 15
years using a 7% discount rate. Annualized testing costs are then
divided by the estimated annual revenue of the chemical to derive the
cost-to-sales ratio. EPA estimates the total annualized compliance cost
of testing for the 17 chemicals evaluated in the economic analysis to
be $0.44 million under the average cost scenario. In addition, the TSCA
section 12(b) export notification requirements (included in the total
and annualized cost estimates) that would be triggered by the rule are
expected to have a negligible impact on exporters. The TSCA section
12(b) export notification requirements under the final rule would be
required for the first export to a particular country of a chemical
subject to the rule. The Agency's estimated total costs of testing
(including both laboratory and administrative costs), annualized
testing cost, price impacts, and public reporting burden hours for this
final rule are presented in the economic assessment.
    Under a least cost scenario, 12 out of the 16 chemicals for which
price data were available (75%) would have a price impact at less than
the 1% level. Similarly, 12 out of the 16 chemicals (75%) would be
impacted at less than the 1% level under an average cost scenario.
Thus, the potential for adverse economic impact due to the rule is low
for at least 75% of the chemicals in the rule. Approximately 4
chemicals (25%) of the 16 chemicals for which price data are available
would have a price impact at a level greater than or equal to 1% under
the least and average cost scenario.
    The Agency computed a ``critical price'' for the chemical without
price data. This price is the maximum price per pound, at which the
ratio of testing costs to annual revenue would be 1%. The critical
price is informative because it represents the minimum price that is
required to support testing at the one percent level. The production
volume for isocyanatomethane (CAS No. 624-83-9) ranges from 10 million
to 50 million pounds. With an annualized testing cost estimated at
$33,585, the critical price is $0.11 per pound. Below that price, the
testing costs would represent more than 1.0% of the revenues from the
chemical. The average price for the 16 chemicals with actual price data
available is $2.67 per pound. Thus, the critical price is substantially
below this average. Only 2 of the 16 chemicals with price data were
estimated to have prices below $.11 per pound. While it cannot be shown
conclusively that the price impacts will be less than or greater than
1.0% of the sales for this chemical, the Agency believes that adverse
impacts are unlikely.
    EPA believes, on the basis of these calculations, that the testing
of the chemicals presents a low potential for adverse economic impact
for the majority of chemicals. Because the subject chemical substances
have relatively large production volumes, the annualized costs of
testing, expressed as a percentage of annual revenue, are very small
for most chemicals. There are, however, some chemicals for which the
price impact is expected to exceed 1% of the revenue from that
chemical. The potential for adverse economic impact is expected to be
higher for these chemicals. In these cases, companies may choose to use
revenue sources other than the profits from the individual chemicals to
pay for testing.

B. Paperwork Reduction Act

    The information collection requirements contained in TSCA section 4
test rules have already been approved by OMB under the provisions of
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., and have
been assigned OMB control number 2070-0033 (EPA ICR No. 1139). The
information collection activities related to export notification under
TSCA section 12(b)(1) are already approved under OMB control number
2070-0030 (EPA ICR No. 0795). This final rule does not contain any new
or amended requirements that would require additional review and/or
approval by OMB.
    The standard chemical testing program involves the submission of
letters of intent to test (or exemption applications), study plans,
progress reports, and test results. EPA estimates that the information
collection activities related to chemical testing for all chemicals in
this final rule (representing the submission of letters of intent or
exemption applications, study plans, and the final reports; progress
reports are not required by this final rule because testing will be
completed within about 1 year) would result in an annual public
reporting burden of 1,179 hours per chemical or a total of 20,039 hours
for the17 chemicals (Ref. 75).
    The annual public reporting burden related to export notification
is estimated to be 0.5 to 1.5 burden hours for each chemical/country
combination (Ref. 75). In estimating the total burden hours approved
for the information collection activities related to export
notification, the Agency has included sufficient burden hours to
accommodate any export notifications that may be required by the
Agency's issuance of final chemical test rules (Ref. 75).
    For each manufacturer of the 17 chemicals identified in the
economic analysis, the parent company (ultimate corporate entity, or
UCE) was also identified. The economic analysis identified a total of
52 UCEs that EPA believes would be the likely respondents to the final
rule. The public reporting burden for this collection of information is
estimated to be 20,039 hours total. Dividing 20,039 hours by 52 UCEs,
results in a per respondent estimated burden of 304 hours. This burden
estimate includes time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information.

    As defined by the PRA and 5 CFR 1320.3(b), ``burden`` means the
total time, effort, or financial resources expended by persons to
generate, maintain, retain, or disclose or provide information to or
for a Federal agency. This includes the time needed to: review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements which have
subsequently changed; train personnel to be able to respond to a
collection of information; search data sources; complete and review the
collection of information; and transmit or otherwise disclose the
information.
    Under the PRA, an agency may not conduct or sponsor, and a person
is not required to respond to, an information collection request unless
it displays a currently valid OMB control number. The OMB control
numbers for EPA's regulations are listed in 40 CFR part 9 and included
on the related collection instrument. EPA is amending the table in 40
CFR part 9 to list the OMB approval number for the information
collection requirements contained in this final rule. This listing of
the OMB control numbers and their subsequent codification in the CFR
satisfies the display requirements of the PRA and OMB's implementing
regulations at 5 CFR part 1320. This ICR was previously subject to
public notice and comment prior to OMB approval, and given the
technical nature of the table, EPA finds that further notice and
comment to amend it is unnecessary. As a result, EPA finds that there
is ``good cause'' under section 553(b)(1)(B) of the Administrative
Procedure Act, 5 U.S.C. 553(b)(1)(B), to amend this table without
further notice and comment.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., after considering the potential economic impacts
of this final rule on small entities, the Agency hereby certifies that
this final rule will not have a significant adverse economic impact on
a substantial number of small entities. The Agency's determination is
based on the small entity impact analysis prepared as part of the
economic analysis for this final rule (Ref. 75), which is summarized in
Unit XI.A., and a copy of which is available in the docket for this
final rule. The following is a brief summary of the factual basis for
this certification.
    Under the RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of this final rule on small entities, small
entity is defined in accordance with the RFA as:
    1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201.
    2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000.
    3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
    Based on the industry profile for this rule that EPA prepared as
part of the Economic Analysis prepared for this final rule, EPA has
determined that this rule is not expected to impact any small not-for-
profit organizations or small governmental jurisdictions. As such, the
Agency evaluated small businesses as the small entities potentially
impacted by this final rule.
    Three factors are examined in EPA's small entity assessment (Ref.
75) in order to characterize the potential small entity impacts of this
final rule:
     The size of the adverse impact (measured as the ratio of
the cost to sales or revenue).
     The total number of small entities that experience the
adverse impact.
     The percentage of the total number of small entities that
experience the adverse impact.
    Section 601(3) of RFA establishes as the default definition of
``small business'' the definition used in section 3 of the Small
Business Act, 15 U.S.C. 632, under which the SBA establishes small
business size standards for each industry sector. (13 CFR 121.201). For
this final rule, EPA has analyzed the potential small business impacts
using the size standards established under this default definition. The
SBA size standards, which are primarily intended to determine whether a
business entity is eligible for government programs and preferences
reserved for small businesses (13 CFR 121.101), ``seek to ensure that a
concern that meets a specific size standard is not dominant in its
field of operation.'' (13 CFR 121.102(b)). See section 632(a)(1) of the
Small Business Act. Industrial sectors are identified by a NAICS code.
In most cases, SBA has specified an employee size standard (100; 500;
750; 1,000; or 1,500 employees) or, in some cases, a sales-based, or
other industry-specific indicator below which an entity in that
particular NAICS code would be considered small (Ref. 76). The SBA
employee size standards that apply to the companies that are
potentially impacted (Ref. 75) by this final rule range from 500 to
1,500 employees.
    Sales and employment data were obtained for the 52 UCEs that
manufacture the 17 chemicals subject to this final rule to identify
those UCEs that qualify for ``small business'' status, where data were
available. Based on the SBA size standards for the NAICS codes that
applied to those UCEs, 23 of the 52 UCEs (44%) were identified as
small. The significance of this final rule's impact on these small
businesses was analyzed by examining the number of small entities that
experienced different levels of costs as a percentage of their sales.
In such an analysis, small businesses are placed in the following
categories on the basis of cost-to-sales ratios: less than 1.0%, 1.0%
but less than 3.0%, and 3.0% or greater. Of the 23 companies that
qualified for small business status according to the SBA size
standards, none had a cost-to-sales ratio that exceeded 1.0%. Given
these results, EPA concludes that there is not a significant economic
impact on these small entities as a result of this final rule.
    There were an additional two UCEs for which the NAICS code, sales,
and employment data were not available. Because of this, EPA could not
determine whether they are small businesses or assess the potential
impacts of the test rule on them. However, it is very unlikely that
both of these UCEs are small entities. Moreover, given the Agency's
analysis for the identified small businesses, which concluded that
there is not a significant economic impact on any of them, EPA believes
it is reasonable to conclude that even if these two UCEs are small
entities, they will not experience a significant economic impact.
Consequently, EPA concludes that there will not be a significant
economic impact on a substantial number of small entities as a result
of the testing imposed in this final rule.
    The estimated costs of the TSCA section 12(b) export notification,
which, as a result of this final rule, would be required for the first
export to a particular country of a chemical subject to the rule, is
estimated to be $67.35 for the first time that an exporter must comply
with TSCA section 12(b) export notification requirements, and $21.81
for each subsequent export notification submitted by that exporter to
an additional country (Ref. 75). EPA has concluded that the costs of
TSCA section 12(b) export notification would

have a negligible impact on exporters of the chemicals in this final
rule, regardless of the size of the exporter.
    Therefore, the Agency certifies that this final rule will not have
a significant adverse economic impact on a substantial number of small
entities.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4), EPA has determined that this regulatory
action does not contain a Federal mandate that may result in
expenditures of $100 million or more for State, local, and tribal
governments, in the aggregate, or for the private sector in any 1 year.
The analysis of the costs associated with this action are described in
Unit VIII. In addition, since EPA does not have any information to
indicate that any State, local, or tribal government manufactures or
processes the chemicals covered by this action such that this final
rule would apply directly to State, local, or tribal governments, EPA
has determined that this final rule does not significantly or uniquely
affect small governments. Accordingly, this final rule is not subject
to the requirements of sections 202, 203, 204, and 205 of UMRA.

E. Executive Order 13132

    Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This final rule establishes
testing and recordkeeping requirements that apply to manufacturers
(including importers) and processors of certain chemicals. Because EPA
has no information to indicate that any State or local government
manufactures or processes the chemical substances covered by this
action, this rule does not apply directly to States and localities and
will not affect State and local governments. Thus, Executive Order
13132 does not apply to this final rule.

F. Executive Order 13175

    Under Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 6, 2000), this
final rule does not have tribal implications because it will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and the Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in the Executive order. As
indicated in this unit, EPA has no information to indicate that any
tribal government manufactures or processes the chemical substances
covered by this action. Thus, Executive Order 13175 does not apply to
this final rule. Although Executive Order 13175 was not yet in effect
when EPA developed the proposed rule, its predecessor, Executive Order
13084, was and EPA's conclusions under Executive Order 13175 are
consistent with EPA's considerations under Executive Order 13084.

G. Executive Order 13045

    This final rule does not require special consideration pursuant to
the terms of Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997), because it is not likely to have an annual effect on the
economy of $100 million or more and it does not have a potential effect
or impact on children. This final rule establishes testing and
recordkeeping requirements that apply to manufacturers (including
importers) and processors of certain chemicals, and will result in the
production of information that will assist the Agency and others in
determining whether the chemical substances in this final rule present
potential risks, allowing the Agency and others to take appropriate
action to investigate and mitigate those risks.

H. Executive Order 13211

    This final rule is not a ``significant energy action'' as defined
in Executive Order 13211, entitled Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) because it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. As such, the
Agency has concluded that this final rule is not likely to have adverse
energy effects.

I. National Technology Transfer and Advancement Act

    As noted in the proposed rule, section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C 272 note) directs EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by voluntary consensus
standards bodies. The NTTAA directs EPA to provide Congress, through
OMB, explanations when the Agency decides not to use available and
applicable voluntary consensus standards.
    Because this final rule involves technical standards, the Agency
conducted a search to identify potentially applicable voluntary
consensus standards. EPA identified 11 applicable voluntary consensus
standards (Refs. 44-48, 52-56, and 64), listed in Table 4 of this unit,
and is allowing their use in this final rule. Of the 11 voluntary
consensus standards, 3 of those issued by ASTM evaluate the same type
of toxicity as TSCA and OECD test guidelines, as shown in Table 4 of
this unit.

                               Table 4.--Applicable Voluntary Consensus Standards
----------------------------------------------------------------------------------------------------------------
                                          Title of Voluntary       TSCA Guideline/CFR
Voluntary Consensus Standard No./Year     Consensus Standard            Citation           OECD Test Method No.
----------------------------------------------------------------------------------------------------------------
ASTM E 324 (1999)                      Standard Test Method                              .......................
                                        for Relative Initial
                                        and Final Melting
                                        Points and the Melting
                                        Range of Organic
                                        Chemicals
----------------------------------------------------------------------------------------------------------------

ASTM E 729 (2002)                      Standard Guide for                                .......................
                                        Conducting Acute
                                        Toxicity Tests on Test
                                        Materials with Fishes,
                                        Macroinvertebrates,
                                        and Amphibians
----------------------------------------------------------------------------------------------------------------
ASTM E 1147 (1997)                     Standard Test Method     799.6755, 799.6756       .......................
                                        for Partition
                                        Coefficient (N-Octanol/
                                        Water) Estimation by
                                        Liquid Chromatography
----------------------------------------------------------------------------------------------------------------
ASTM. E1148 (2002)                      Standard Test Method    799.6784, 799.6786       .......................
                                        for Measurements of
                                        Aqueous Solubility
----------------------------------------------------------------------------------------------------------------
ASTM E 1163 (2002)                     Standard Test Method     799.9130 (if gas at      425
                                        for Estimating Acute     room temp.).
                                        Oral Toxicity in Rats
----------------------------------------------------------------------------------------------------------------
ASTM E 1193 (2004)                     Standard Guide for                                .......................
                                        Conducting Daphnia
                                        Magna Life-Cycle
                                        Toxicity Tests
----------------------------------------------------------------------------------------------------------------
ASTM E 1218 (2004)                     Standard Guide for                                .......................
                                        Conducting Static
                                        Toxicity Tests with
                                        Microalgae
----------------------------------------------------------------------------------------------------------------
ASTM E 1625 (2001)                     Standard Test Method                              .......................
                                        for Determining
                                        Biodegradability of
                                        Organic Chemicals in
                                        Semi-Continuous
                                        Activated Sludge
                                        (SCAS)
----------------------------------------------------------------------------------------------------------------
ASTM E 1719 (1997)                     Standard Test Method                              .......................
                                        for Vapor Pressure of
                                        Liquids by
                                        Ebulliometry
----------------------------------------------------------------------------------------------------------------
ASTM E 1782 (2003)                     Standard Test Method                              .......................
                                        for Determining Vapor
                                        Pressure by Thermal
                                        Analysis
----------------------------------------------------------------------------------------------------------------
ISO 9888 (1999)                        Water Quality--                                   .......................
                                        Evaluation of Ultimate
                                        Aerobic
                                        Biodegradability of
                                        Organic Compounds in
                                        Aqueous Medium--Static
                                        Test (Zahn-Wellens
                                        Method), Second
                                        Edition
----------------------------------------------------------------------------------------------------------------

    Copies of the ASTM and ISO standards referenced in this final rule
have been placed in the public version of the official record for this
final rule and are available to read, but not to copy, at the EPA
Docket location described in ADDRESSES. You may obtain copies of the
ASTM standards from the American Society for Testing and Materials, 100
Bar Harbor Dr., West Conshohocken, PA 19428-2959, and a copy of the ISO
standard from the International Organization for Standardization, Case
Postale, 56 CH-1211 Geneve 20 Switzerland. EPA received the required
approval from the Director of the Federal Register for the
incorporation by reference of the ASTM and ISO standards used in this
final rule in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
    EPA is not aware of any potentially applicable n-octanol/water
partition coefficient (generator column), water solubility (column
elution and generator column), acute inhalation toxicity, bacterial
reverse mutations, in vivo mammalian bone marrow chromosomal
aberrations, combined repeated dose with reproductive/developmental
toxicity screen, repeated dose 28-day oral toxicity screen, or the
reproductive developmental toxicity screen which could be considered in
lieu of the TSCA guidelines published in 40 CFR 799.6756, 799.6784,
799.6786, 799.9130, 799.9510, 799.9538, 799.9365, 799.9305, and
799.9355, respectively, upon which the test standards in this final
rule are based.

J. Executive Order 12898

    Pursuant to Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), the Agency has considered
environmental justice-related issues with regard to the potential
impacts of this action on the environmental and health conditions in
minority and low-income populations. The Agency believes that the
information collected under this final rule will assist EPA and others
in determining the hazards and risks associated with the chemicals
covered by the rule. Although not directly impacting environmental
justice-related concerns, this information will better enable the
Agency to protect human health and the environment.

XII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9
    Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 799
    Environmental protection, Chemicals, Hazardous substances,
Incorporation by reference, Laboratories, Reporting and recordkeeping
requirements.

    Dated: March 1, 2006.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241,

242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5,
300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-
6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

0
2. In Sec.  9.1, the table is amended by adding an entry for Sec.
799.5085 in numerical order under the indicated heading to read as
follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                   40 CFR citation                      OMB control No.
------------------------------------------------------------------------
                                * * * * *

------------------------------------------------------------------------
    Identification of Specific Chemical Substance and Mixture Testing
                              Requirements
------------------------------------------------------------------------
                                * * * * *
799.5085.............................................          2070-0033
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 799--[AMENDED]

0
3. The authority citation for part 799 continues to read as follows:

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

0
4. By adding Sec.  799.5085 to subpart D to read as follows:

Sec.  799.5085  Chemical testing requirements for certain high
production volume chemicals.

    (a) What substances will be tested under this section? Table 2 in
paragraph (j) of this section identifies the chemical substances that
must be tested under this section. For the chemical substances
identified as ``Class 1'' substances in Table 2 in paragraph (j) of
this section, the purity of each chemical substance must be 99% or
greater, except for 1,3-propanediol, 2,2-bis[(nitrooxy)methyl]-,
dinitrate (ester) (CAS No. 78-11-5), also known as pentaerythritol
tetranitrate (PETN). PETN cannot be tested at 99% purity because of its
explosive properties. It must be diluted in water or tested as a
stabilized mixture with an appropriate stabilizer (e.g., D-lactose
monohydrate is the stabilizer in PETN, NF which is a mixture of 20% by
weight PETN and 80% by weight D-lactose monohydrate). The stabilizer
used must be tested as a control. For the chemical substances
identified as ``Class 2'' substances in Table 2 in paragraph (j), a
representative form of each chemical substance must be tested. The
representative form selected for a given Class 2 chemical substance
should meet industry or consensus standards where they exist.
    (b) Am I subject to this section? (1) If you manufacture (including
import) or intend to manufacture, or process or intend to process, any
chemical substance listed in Table 2 in paragraph (j) of this section
at any time from April 17, 2006 to the end of the test data
reimbursement period as defined in 40 CFR 791.3(h), you are subject to
this section with respect to that chemical substance.
    (2) If you do not know or cannot reasonably ascertain that you
manufacture or process a chemical substance listed in Table 2 in
paragraph (j) of this section during the time period described in
paragraph (b)(1) of this section (based on all information in your
possession or control, as well as all information that a reasonable
person similarly situated might be expected to possess, control, or
know, or could obtain without an unreasonable burden), you are not
subject to this section with respect to that chemical substance.
    (c) If I am subject to this section, when must I comply with it?
(1)(i) Persons subject to this section are divided into two groups, as
set forth in Table 1 of this paragraph: Tier 1 (persons initially
required to comply) and Tier 2 (persons not initially required to
comply). If you are subject to this section, you must determine if you
fall within Tier 1 or Tier 2, based on Table 1 of this paragraph.

   Table 1.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
                                          Persons not initially required
  Persons initially required to comply     to comply with this section
       with this section (Tier 1)                    (Tier 2)
------------------------------------------------------------------------
Persons not otherwise specified in       A. Persons who manufacture (as
 column 2 of this table that              defined at TSCA section 3(7))
 manufacture (as defined at TSCA          or intend to manufacture a
 section 3(7)) or intend to manufacture   chemical substance included in
 a chemical substance included in this    this section solely as one or
 section.                                 more of the following:
                                         --As a byproduct (as defined at
                                          40 CFR 791.3(c));
                                         --As an impurity (as defined at
                                          40 CFR 790.3);
                                         --As a naturally occurring
                                          substance (as defined at 40
                                          CFR 710.4(b));
                                         --As a non-isolated
                                          intermediate (as defined at 40
                                          CFR 704.3);
                                         --As a component of a Class 2
                                          substance (as described at 40
                                          CFR 720.45(a)(1)(i));
                                         --In amounts of less than 500
                                          kg (1,100 lbs.) annually (as
                                          described at 40 CFR
                                          790.42(a)(4)); or
                                         --For R & D (as described at 40
                                          CFR 790.42(a)(5)).
                                         B. Persons who process (as
                                          defined at TSCA section 3(10))
                                          or intend to process a
                                          chemical substance included in
                                          this section (see 40 CFR
                                          790.42(a)(2)).
------------------------------------------------------------------------

    (ii) Table 1 of paragraph (c)(1)(i) of this section expands the
list of persons specified in Sec.  790.42(a)(2), (a)(4), and (a)(5) of
this chapter, who, while legally subject to this section, must comply
with the requirements of this section only if directed to do so by EPA
under the circumstances set forth in paragraphs (c)(5) and (c)(8) of
this section.
    (2) If you are in Tier 1 with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, you must, for each
test required under this section for that chemical substance, either
submit to EPA a letter of intent to test or apply to EPA for an
exemption from testing. The letter of intent to test or the exemption
application must be received by EPA no later than May 15, 2006.
    (3) If you are in Tier 2 with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, you are considered
to have an automatic conditional exemption and you will be required to
comply with this section with regard to that chemical substance only if
directed to do so by EPA under paragraphs (c)(5) or (c)(8) of this
section.
    (4) If no person in Tier 1 has notified EPA of its intent to
conduct one or more of the tests required by this section on any
chemical substance listed in Table 2 in paragraph (j) of this section
by May 15, 2006, EPA will publish a Federal Register document that will
specify the test(s) and the chemical substance(s) for which no letter
of intent has been

submitted, and notify manufacturers and processors in Tier 2 of their
obligation to submit a letter of intent to test or to apply for an
exemption from testing.
    (5) If you are in Tier 2 with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, and if you
manufacture or process this chemical substance as of April 17, 2006, or
within 30 days after publication of the Federal Register document
described in paragraph (c)(4) of this section, you must, for each test
specified for that chemical substance in the document described in
paragraph (c)(4) of this section, either submit to EPA a letter of
intent to test or apply to EPA for an exemption from testing. The
letter of intent to test or the exemption application must be received
by EPA no later than 30 days after publication of the document
described in paragraph (c)(4) of this section.
    (6) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after the publication of the Federal Register
document described in paragraph (c)(4) of this section, EPA will notify
all manufacturers and processors of those chemical substances of this
fact by certified letter or by publishing a Federal Register document
specifying the test(s) for which no letter of intent has been
submitted. This letter or Federal Register document will additionally
notify all manufacturers and processors that all exemption applications
concerning the test(s) have been denied, and will give the
manufacturers and processors of the chemical substance(s) an
opportunity to take corrective action.
    (7) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after receipt of the certified letter or
publication of the Federal Register document described in paragraph
(c)(6) of this section, all manufacturers and processors subject to
this section with respect to that chemical substance who are not
already in violation of this section will be in violation of this
section.
    (8) If a problem occurs with the initiation, conduct, or completion
of the required testing or the submission of the required data with
respect to a chemical substance listed in Table 2 in paragraph (j) of
this section, under the procedures in Sec.  Sec.  790.93 and 790.97 of
this chapter, EPA may initiate termination proceedings for all testing
exemptions with respect to that chemical substance and may notify
persons in Tier 1 and Tier 2 that they are required to submit letters
of intent to test or exemption applications within a specified period
of time.
    (9) If you are required to comply with this section, but your
manufacturing or processing of a chemical substance listed in Table 2
in paragraph (j) of this section begins after the applicable compliance
date referred to in paragraphs (c)(2), (c)(5), or (c)(8) of this
section, you must either submit a letter of intent to test or apply to
EPA for an exemption. The letter of intent to test or the exemption
application must be received by EPA no later than the day you begin
manufacturing or processing.
    (d) What must I do to comply with this section? (1) To comply with
this section you must either submit to EPA a letter of intent to test,
or apply to and obtain from EPA an exemption from testing.
    (2) For each test with respect to which you submit to EPA a letter
of intent to test, you must conduct the testing specified in paragraph
(h) of this section and submit the test data to EPA.
    (3) You must also comply with the procedures governing test rule
requirements in part 790 of this chapter, as modified by this section,
including the submission of letters of intent to test or exemption
applications, the conduct of testing, and the submission of data; Part
792--Good Laboratory Practice Standards of this chapter; and this
section. The following provisions of 40 CFR part 790 do not apply to
this section: Paragraphs (a), (d), (e), and (f) of Sec.  790.45;
paragraph (a)(2) and paragraph (b) of Sec.  Sec.  790.80; 790.82(e)(1);
790.85; and 790.48.
    (e) If I do not comply with this section, when will I be considered
in violation of it? You will be considered in violation of this section
as of 1 day after the date by which you are required to comply with
this section.
    (f) How are EPA's data reimbursement procedures affected for
purposes of this section? If persons subject to this section are unable
to agree on the amount or method of reimbursement for test data
development for one or more chemical substances included in this
section, any person may request a hearing as described in 40 CFR part
791. In the determination of fair reimbursement shares under this
section, if the hearing officer chooses to use a formula based on
production volume, the total production volume amount will include
amounts of a chemical substance produced as an impurity.
    (g) Who must comply with the export notification requirements? Any
person who exports, or intends to export, a chemical substance listed
in Table 2 in paragraph (j) of this section is subject to part 707,
subpart D, of this chapter.
    (h) How must I conduct my testing? (1) The tests that are required
for each chemical substance are indicated in Table 2 in paragraph (j)
of this section. The test methods that must be followed are provided in
Table 3 in paragraph (j) of this section. You must proceed in
accordance with these test methods as required according to Table 3 in
paragraph (j) of this section, or as appropriate if more than one
alternative is allowed according to Table 3 in paragraph (j) of this
section. Included in Table 3 in paragraph (j) of this section are the
following 11 methods which are incorporated by reference:
    (i) Standard Test Method for Relative Initial and Final Melting
Points and the Melting Range of Organic Chemicals, ASTM E 324-99.
    (ii) Standard Test Method for Partition Coefficient (N-Octanol/
Water) Estimation by Liquid Chromatography, ASTM E 1147-92. (Reapproved
1997)
    (iii) Standard Guide for Conducting Acute Toxicity Tests on Test
Materials with Fishes, Macroinvertebrates, and Amphibians, ASTM E 729-
96. (Reapproved 2002)
    (iv) Standard Test Method for Measurements of Aqueous Solubility,
ASTM E 1148-02.
    (v) Standard Test Method for Estimating Acute Oral Toxicity in
Rats, ASTM E 1163-98. (Reapproved 2002)
    (vi) Standard Guide for Conducting Daphnia Magna Life-Cycle
Toxicity Tests, ASTM E 1193-97. (Reapproved 2004)
    (vii) Standard Guide for Conducting Static Toxicity Tests with
Microalgae, ASTM E 1218-04.
    (viii) Standard Test Method for Determining Biodegradability of
Organic Chemicals in Semi-Continuous Activated Sludge (SCAS), ASTM E
1625-94. (Reapproved 2001)
    (ix) Standard Test Method for Vapor Pressure of Liquids by
Ebulliometry, ASTM E 1719-97.
    (x) Standard Test Method for Determining Vapor Pressure by Thermal
Analysis, ASTM E 1782-03.
    (xi) Water Quality--Evaluation of Ultimate Aerobic Biodegradability
of Organic Compounds in Aqueous Medium--Static Test (Zahn-Wellens
Method), Second Edition, June 1, 1999, ISO 9888-99.

    (2) The Director of the Federal Register approved this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies of the ASTM guidelines from the American
Society for Testing and Materials, 100 Bar Harbor Dr., West
Conshohocken, PA 19428-2959, and a copy of the ISO guideline from the
International Organization for Standardization, Case Postale, 56 CH-
1211 Geneve 20 Switzerland. You may inspect each test method at the EPA
Docket Center, EPA West, Rm. B102, 1301 Constitution Ave., NW.,
Washington, DC or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
.

    (i) Reporting requirements. A final report for each specific test
for each subject chemical substance must be received by EPA by May 17,
2007, unless an extension is granted in writing pursuant to 40 CFR
790.55. A robust summary of the final report for each specific test
should be submitted in addition to and at the same time as the final
report. The term ``robust summary'' is used to describe the technical
information necessary to adequately describe an experiment or study and
includes the objectives, methods, results, and conclusions of the full
study report which can be either an experiment or in some cases an
estimation or prediction method. Guidance for the compilation of robust
summaries is described in a document entitled Draft Guidance on
Developing Robust Summaries which is available at: http://www.epa.gov/chemrtk/robsumgd.htm
.

    (j) Designation of specific chemical substances and testing
requirements. The chemical substances identified by chemical name,
Chemical Abstract Service Number (CAS No.), and class in Table 2 of
this paragraph must be tested in accordance with the requirements
designated in Tables 2 and 3 of this paragraph, and the requirements
described in 40 CFR Part 792--Good Laboratory Practice Standards:

                             Table 2.--Chemical Substances And Testing Requirements
----------------------------------------------------------------------------------------------------------------
                                                                                Required tests/(See Table 3
                 CAS No.                          Chemical name            Class           of this section)
----------------------------------------------------------------------------------------------------------------
74-95-3                                   Methane, dibromo-                       1  A, C1, E2, F2
----------------------------------------------------------------------------------------------------------------
75-36-5                                   Acetyl chloride                         1  A, B, C2, E2, F1
----------------------------------------------------------------------------------------------------------------
78-11-5                                   1,3-Propanediol, 2,2-                   1  A4, A5, B, C6, F2
                                           bis[(nitrooxy)methyl]-,
                                           dinitrate (ester)
----------------------------------------------------------------------------------------------------------------
84-65-1                                   9,10-Anthracenedione                    1  A, F2
----------------------------------------------------------------------------------------------------------------
108-19-0                                  Imidodicarbonic diamide                 1  A, B, C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
110-44-1                                  2,4-Hexadienoic acid,                   1  A, C4
                                           (2E,4E)-
----------------------------------------------------------------------------------------------------------------
112-52-7                                  Dodecane, 1-chloro                      1  A, B, C3, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
118-82-1                                  Phenol, 4,4'-                           1  A, B, D, E1, E2, F2
                                           methylenebis[2,6-bis(1,1-
                                           dimethylethyl)]-
----------------------------------------------------------------------------------------------------------------
149-44-0                                  Methanesulfinic acid,                   1  A, B, C1, E2, F1
                                           hydroxy-, monosodium salt
----------------------------------------------------------------------------------------------------------------
409-02-9                                  Heptenone, methyl-                      2  A, B, C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
594-42-3                                  Methanesulfenyl chloride,               1  A, B, C1, E1, E2, F2
                                           trichloro-
----------------------------------------------------------------------------------------------------------------
624-83-9                                  Methane, isocyanato-                    1  A, C1
----------------------------------------------------------------------------------------------------------------
1324-76-1                                 Benzenesulfonic acid, [[4-              2  A, B, C1, D, E1, E2, F1
                                           [[4-(phenylamino)phenyl][4-
                                           (phenylimino)-2,5-
                                           cyclohexadien-1-
                                           ylidene]methyl]phenyl]amino
                                           ]-
----------------------------------------------------------------------------------------------------------------
2941-64-2                                 Carbonochloridothioic acid,             1  A, B, C1, E2, F1
                                           S-ethyl ester
----------------------------------------------------------------------------------------------------------------
8005-02-5                                 C.I. Solvent Black 7                    2  A, B, C1, D, E2, F1
----------------------------------------------------------------------------------------------------------------
65996-78-3                                Light oil (coal), coke-oven             2  A, B, C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68611-64-3                                Urea, reaction products with            2  A, B, C1, D, E1, E2, F1
                                           formaldehyde
----------------------------------------------------------------------------------------------------------------

       Table 3--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2 of This Paragraph
----------------------------------------------------------------------------------------------------------------
                                                                 Test requirements and
           Testing category                  Test symbol               references           Special conditions
----------------------------------------------------------------------------------------------------------------
Physical/chemical properties           A                        1. Melting Point: ASTM   n-Octanol/water
                                                                 E 324 (capillary tube)   Partition Coefficient
                                                                2. Boiling Point: ASTM    or log Kow:
                                                                 E 1719 (ebulliometry).  Which method is
                                                                3. Vapor Pressure: ASTM   required, if any, is
                                                                 E 1782 (thermal          determined by the test
                                                                 analysis).               substance's
                                                                4. n-Octanol/Water        estimated\1\ log Kow
                                                                 Partition Coefficient    as follows:
                                                                 (log 10 basis) or log   log Kow < 0: no testing
                                                                 Kow: (See special        required.
                                                                 conditions for the log  log Kow range 0-1:
                                                                 Kow test requirement     Method A or B.
                                                                 and select the          log Kow range >1-4:
                                                                 appropriate method to    Method A or B or C.
                                                                 use, if any, from       log Kow range >4-6:
                                                                 those listed in this     Method B or C.
                                                                 column.).               log Kow >6: Method C.
                                                                 Method A: 40 CFR        Test sponsors are
                                                                 799.6755 (shake flask).  required to provide in
                                                                 Method B: ASTM E 1147    the final study report
                                                                 (liquid                  the underlying
                                                                 chromatography).         rationale for the
                                                                 Method C: 40 CFR         method selected. In
                                                                 799.6756 (generator      order to ensure
                                                                 column).                 environmental
                                                                5. Water Solubility:      relevance, EPA highly
                                                                 (See special             recommends that the
                                                                 conditions for the       selected study be
                                                                 water solubility test    conducted at pH 7.
                                                                 requirement and select  Water Solubility:
                                                                 the appropriate method  Which method is
                                                                 to use, if any, from     required, if any, is
                                                                 those listed in this     determined by the test
                                                                 column.).                substance's
                                                                 Method A: ASTM E 1148    estimated\2\ water
                                                                 (shake flask).           solubility. Test
                                                                 Method B: 40 CFR         sponsors are required
                                                                 799.6784 (shake flask).  to provide in the
                                                                 Method C: 40 CFR         final study report the
                                                                 799.6784 (column         underlying rationale
                                                                 elution).                for the method
                                                                 Method D: 40 CFR         selected. In order to
                                                                 799.6786 (generator      ensure environmental
                                                                 column).                 relevance, EPA highly
                                                                                recommends that the
                                                                                selected study be
                                                                                conducted at pH 7.
                                                                                >5,000 mg/L: Method A
                                                                                or B.
                                                                                >10 mg/L --5,000 mg/L:
                                                                                Method A, B, C, or D.
                                                                                > 0.001 mg/L--10 mg/L:
                                                                                Method C or D.
                                                                                < =0.001 mg/L: No
                                                                                testing required.
----------------------------------------------------------------------------------------------------------------
Environmental fate and pathways--      B                        For B, choose either of  None
 Inherent biodegradation                                         the methods listed in
                                                                 this column:
                                                                1. ASTM 1625
                                                                 (semicontinuous
                                                                 activated sludge test)
                                                                 OR.
                                                                2. ISO 9888 (Zahn-
                                                                 Wellens method).
----------------------------------------------------------------------------------------------------------------
Aquatic toxicity                       C1                       For C1, Test Group 1 or  The following are the
                                                                 Test Group 2 listed in   special conditions for
                                                                 this column must be      C1, C2, C3, C4, C5,
                                                                 used to fulfill the      and C7 testing; there
                                                                 testing requirements--   are no special
                                                                 See special              conditions for C6.
                                                                 conditions.              If log Kow < 4.2: Test
                                                                Test Group 1 for C1:...   Group 1 is required
                                                                1. Acute Toxicity to     If log Kow >= 4.2: Test
                                                                 Fish: ASTM E 729.        Group 2 is required
                                                                2. Acute Toxicity to     Which test group is
                                                                 Daphnia: ASTM E 729.     required is determined
                                                                3. Toxicity to Plants     by the test
                                                                 (Algae): ASTM E 1218.    substance's measured
                                                                Test Group 2 for C1:...   log Kow as obtained
                                                                1. Chronic Toxicity to    under A\3\.
                                                                 Daphnia: ASTM E 1193.
                                                                2. Toxicity to Plants
                                                                 (Algae): ASTM E 1218.
                                      --------------------------------------------------
                                       C2                       For C2, Test Group 1 or
                                                                 Test Group 2 listed in
                                                                 this column must be
                                                                 used to fulfill the
                                                                 testing requirements--
                                                                 See special
                                                                 conditions.
                                                                Test Group 1 for C2:...
                                                                1. Acute Toxicity to
                                                                 Daphnia: ASTM E 729.
                                                                2. Toxicity to Plants
                                                                 (Algae): ASTM E 1218.
                                                                Test Group 2 for C2:...
                                                                1. Chronic Toxicity to
                                                                 Daphnia: ASTM E 1193.
                                                                2. Toxicity to Plants
                                                                 (Algae): ASTM E 1218.
                                      --------------------------------------------------

                                       C3                       For C3, Test Group 1 or
                                                                 Test Group 2 listed in
                                                                 this column must be
                                                                 used to fulfill the
                                                                 testing requirements--
                                                                 See special
                                                                 conditions.
                                                                Test Group 1 for C3:...
                                                                1. Acute Toxicity to
                                                                 Fish: ASTM E 729.
                                                                2. Toxicity to Plants
                                                                 (Algae): ASTM E 1218.
                                                                Test Group 2 for C3:...
                                                                1. Chronic Toxicity to
                                                                 Daphnia: ASTM E 1193.
                                                                2. Toxicity to Plants
                                                                 (Algae): ASTM E 1218.
                                      --------------------------------------------------
                                       C4                       For C4, Test Group 1 or
                                                                 Test Group 2 listed in
                                                                 this column must be
                                                                 used to fulfill the
                                                                 testing requirements--
                                                                 See special
                                                                 conditions.
                                                                Test Group 1 for C4:...
                                                                1. Acute Toxicity to
                                                                 Fish: ASTM E 729.
                                                                2. Acute Toxicity to
                                                                 Daphnia: ASTM E 729.
                                                                Test Group 2 for C4:...
                                                                1. Chronic Toxicity to
                                                                 Daphnia: ASTM E 1193.
                                      --------------------------------------------------
                                       C5                       For C5, Test Group 1 or
                                                                 Test Group 2 below
                                                                 must be used to
                                                                 fulfill the testing
                                                                 requirements--See
                                                                 special conditions.
                                                                Test Group 1 for C5:...
                                                                1. Acute Toxicity to
                                                                 Daphnia: ASTM E 729.
                                                                Test Group 2 for C5:...
                                                                1. Chronic Toxicity to
                                                                 Daphnia: ASTM E 1193.
                                      --------------------------------------------------
                                       C6                       Toxicity to Plants
                                                                 (Algae): ASTM E 1218
                                      --------------------------------------------------
                                       C7                       For C7, Test Group 1 or  .......................
                                                                 Test Group 2 of this
                                                                 column must be used to
                                                                 fulfill the testing
                                                                 requirements--See
                                                                 special conditions.
                                                                Test Group 1 for C7:...
                                                                1. Acute Toxicity to
                                                                 Fish: ASTM E 729.
                                                                Test Group 2 for C7:...
                                                                1. Chronic Toxicity to
                                                                 Daphnia: ASTM E 1193.
----------------------------------------------------------------------------------------------------------------
Mammalian toxicity--Acute              D                        See special conditions   Which testing method is
                                                                 for this test            required is determined
                                                                 requirement and select   by the test
                                                                 the method that must     substance's physical
                                                                 be used from those       state at room
                                                                 listed in this column.   temperature
                                                                Method A: Acute           (25[deg]C). For those
                                                                 Inhalation Toxicity      test substances that
                                                                 (rat): 40 CFR 799.9130.  are gases at room
                                                                Method B: EITHER:......   temperature, Method A
                                                                1. Acute (Up/Down) Oral   is required;
                                                                 Toxicity (rat): ASTM E   otherwise, use either
                                                                 1163 OR.                 of the two methods
                                                                 2. Acute (Up/Down)       listed under Method B.
                                                                 Oral Toxicity (rat):    In Method B, 40 CFR
                                                                 40 CFR                   799.9110(d)(1)(i)(A)
                                                                 799.9110(d)(1)(i)(A).    refers to the OECD 425
                                                                                Up/Down Procedure\4\.
                                                                                Estimating starting
                                                                                dose for Method B:
                                                                                Data from the neutral
                                                                                red uptake basal
                                                                                cytotoxicity assay\5\
                                                                                using normal human
                                                                                keratinocytes or mouse
                                                                                BALB/c 3T3 cells may
                                                                                be used to estimate
                                                                                the starting dose.
----------------------------------------------------------------------------------------------------------------
Mammalian toxicity--Genotoxicity       E1                       Bacterial Reverse        None
                                                                 Mutation Test (in
                                                                 vitro): 40 CFR
                                                                 799.9510
                                      --------------------------------------------------------------------------

                                       E2                       Conduct any one of the   Persons required to
                                                                 following three tests    conduct testing for
                                                                 for chromosomal          chromosomal damage are
                                                                 damage:                  encouraged to use the
                                                                In vitro Mammalian        in vitro Mammalian
                                                                 Chromosome Aberration    Chromosome Aberration
                                                                 Test: 40 CFR 799.9537    Test (40 CFR 799.9537)
                                                                 OR.                      to generate the needed
                                                                Mammalian Bone Marrow     data unless known
                                                                 Chromosomal Aberration   chemical properties
                                                                 Test (in vivo in         (e.g., physical/
                                                                 rodents: mouse           chemical properties,
                                                                 (preferred species),     chemical class
                                                                 rat, or Chinese          characteristics)
                                                                 hamster): 40 CFR         preclude its use. A
                                                                 799.9538 OR.             subject person who
                                                                Mammalian Erythrocyte     uses one of the in
                                                                 Micronucleus Test        vivo methods instead
                                                                 [sampled in bone         of the in vitro method
                                                                 marrow] (in vivo in      to address a
                                                                 rodents: Mouse           chromosomal damage
                                                                 (preferred species),     test requirement must
                                                                 rat, or Chinese          submit to EPA a
                                                                 hamster): 40 CFR         rationale for
                                                                 799.9539.                conducting that
                                                                                alternate test in the
                                                                                final study report.
                                      --------------------------------------------------------------------------
 Mammalian toxicity--Repeated dose/    F1                       Combined Repeated Dose   Where F1 is required,
 reproduction/ developmental                                     Toxicity Study with      EPA recommends use of
                                                                 the Reproduction/        the Combined Repeated
                                                                 Developmental Toxicity   Dose Toxicity Study
                                                                 Screening Test: 40 CFR   with the Reproduction/
                                                                 799.9365 OR              Developmental Toxicity
                                                                Reproduction/             Screening Test (40 CFR
                                                                 Developmental Toxicity   799.9365). However,
                                                                 Screening Test: 40 CFR   there may be valid
                                                                 799.9355 AND.            reasons to test a
                                                                Repeated Dose 28-Day      particular chemical
                                                                 Oral Toxicity Study in   using both 40 CFR
                                                                 rodents: 40 CFR          799.9355 and 40 CFR
                                                                 799.9305.                799.9305 to fill
                                                                                Mammalian Toxicity--
                                                                                Repeated Dose/
                                                                                Reproduction/
                                                                                Developmental data
                                                                                needs. A subject
                                                                                person who uses the
                                                                                combination of 40 CFR
                                                                                799.9355 and 40 CFR
                                                                                799.9305 in place of
                                                                                40 CFR 799.9365 must
                                                                                submit to EPA a
                                                                                rationale for
                                                                                conducting these
                                                                                alternate tests in the
                                                                                final study reports.
                                                                                Where F2 or F3 is
                                                                                required, no rationale
                                                                                for conducting the
                                                                                required test need be
                                                                                provided in the final
                                                                                study report.
                                      --------------------------------------------------
                                       F2                       Reproduction/
                                                                 Developmental Toxicity
                                                                 Screening Test: 40 CFR
                                                                 799.9355
                                      --------------------------------------------------
                                       F3                       Repeated Dose 28-Day
                                                                 Oral Toxicity Study in
                                                                 rodents: 40 CFR
                                                                 799.9305
----------------------------------------------------------------------------------------------------------------
\1\ EPA recommends, but does not require, that log Kow be quantitatively estimated prior to initiating this
  study. One method, among many similar methods, for estimating log Kow is described in the article entitled
  Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients) by W.M. Meylan and P.H.
  Howard in the Journal of Pharmaceutical Sciences. 84(1):83-92. January 1992. This reference is available under
  docket ID number EPA-HQ-OPPT-2005-0033 at the EPA Docket Center, Rm. B102, 1301 Constitution Ave., NW.,
  Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
\2\ EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating
  this study. One method, among many similar methods, for estimating water solubility is described in the
  article entitled Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient by
  W.M. Meylan, P.H. Howard, and R.S. Boethling in Environmental Toxicology and Chemistry. 15(2):100-106. 1996.
  This reference is available under docket ID number EPA-HQ-OPPT-2005-0033 at the EPA Docket Center, Rm. B102,
  1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
  legal holidays.
\3\ Chemical substances that are dispersible in water may have log Kow values greater than 4.2 and may still be
  acutely toxic to aquatic organisms. EPA recommends, but does not require, that test sponsors who wish to
  conduct Test Group 1 studies on such chemicals to submit to EPA for approval a written request to conduct Test
  Group 1 studies 90 days prior to conducting such studies. The written request should include the rationale for
  conducting Test Group 1 studies.
\4\ The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available under docket ID number EPA-HQ-
  OPPT-2005-0033 at the EPA Docket Center, Rm. B102, 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m.
  to 4:30 p.m., Monday through Friday, excluding legal holidays.
\5\ The neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the
  mammalian toxicity-acute endpoint, is available under docket ID number EPA-HQ-OPPT-2005-0033 at the EPA Docket
  Center, Rm. B102, 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through
  Friday, excluding legal holidays.

    (k) Effective date. This section is effective on April 17, 2006.
[FR Doc. 06-2483 Filed 3-15-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Page 41702]
[FR Doc No: 2022-14926]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10615-059]

Tower Kleber Limited Partnership; Notice of Petition for
Declaratory Order

    Take notice that on April 28, 2022, pursuant to Rule 207(a)(2) of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, Tower Kleber Limited Partnership (Tower Kleber)
filed a petition for declaratory order requesting the Commission
declare that the Michigan Department of Environment, Great Lakes, and
Energy has waived its authority to issue a certification for the Tower
Kleber Project No. 10615 under Section 401 of the Clean Water Act, 33
U.S.C. 1341(a)(1), as more fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    Any person wishing to comment on Tower Kleber's Petition may do
so.\1\ The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically may mail similar
pleadings to the Federal Energy Regulatory Commission, 888 First Street
NE, Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
---------------------------------------------------------------------------

    \1\ Tower Kleber's request is part of its relicensing proceeding
in Project No. 10615-058.
---------------------------------------------------------------------------

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on August 8, 2022.

    Dated: July 7, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-14926 Filed 7-12-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43182-43183]
[FR Doc No: 2019-17825]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2018-0012]

Advisory Committee on Construction Safety and Health (ACCSH):
Notice of Meeting

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Announcement of a teleconference/WebEx meeting of ACCSH.

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

SUMMARY: ACCSH will hold a teleconference/WebEx meeting September 9,
2019, to consider a proposed rule on occupational exposure to beryllium
and beryllium compounds in the construction industry.

DATES: ACCSH will meet from 10:00 a.m. to 12:00 p.m., ET, Monday,
September 9, 2019, by teleconference/WebEx.

ADDRESSES:
    Submission of comments and requests to speak: Submit comments and
requests to speak at the ACCSH meeting by September 4, 2019, identified
by the docket number for this Federal Register notice (Docket No. OSHA-
2018-0012), using one of the following methods:
    Electronically: You may submit comments, including attachments,
electronically at: http://www.regulations.gov, the Federal eRulemaking
Portal. Follow the online instructions for submitting comments.
    Facsimile: If your comments, including attachments, do not exceed
10 pages, you may fax them to the OSHA Docket Office at<PHONE_NUMBER>.
    Regular mail, express mail, hand delivery, and messenger or courier
service: You may submit comments and attachments to the OSHA Docket
Office, Docket No. OSHA-2018-0012, Occupational Safety and Health
Administration, U.S. Department of Labor, Room N-3653, 200 Constitution
Avenue NW, Washington, DC 20210. Deliveries (express mail, hand
(courier) delivery, and messenger service) are accepted during the OSHA
Docket Office's normal business hours, 10:00 a.m. to 3:00 p.m., ET.
    Instructions: All submissions must include the agency name and the
OSHA docket number for this Federal Register notice (Docket No. OSHA-
2018-0012). Because of security-related procedures, submissions by
regular mail may result in a significant delay in receipt. Please
contact the OSHA Docket Office for information about security
procedures for making submissions by express mail, hand (courier)
delivery, and messenger service.
    Requests for special accommodations: Please submit requests for
special accommodations for this ACCSH meeting by September 4, 2019, to
Ms. Gretta Jameson, OSHA, Office of Communications, Room N-3647, U.S.
Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210;
telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, U.S. Department of Labor; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    For general information about ACCSH: Mr. Damon Bonneau, OSHA,
Directorate of Construction, U.S. Department of Labor; telephone (202)
693-2183; email<EMAIL_ADDRESS>    For copies of this Federal Register Notice: Electronic copies of
this Federal Register Notice are available at: http://www.regulations.gov. This notice, as well as news releases and other
relevant information, are also available at OSHA's web page at
www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    ACCSH advises the Secretary of Labor and the Assistant Secretary of
Labor for Occupational Safety and Health (Assistant Secretary) in the
formulation of standards affecting the construction industry, and on
policy matters arising in the administration of the safety and health
provisions under the Contract Work Hours and Safety Standards Act
(Construction Safety Act (CSA)) (40 U.S.C. 3701 et seq.) and the
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et
seq.) (see also 29 CFR 1911.10 and 1912.3). In addition, the OSH Act
and CSA require the Assistant Secretary to consult with ACCSH before
the agency proposes any occupational safety and health standard
affecting construction activities (29 CFR 1911.10; 40 U.S.C. 3704).
    ACCSH operates in accordance with the CSA, the OSH Act, the Federal
Advisory Committee Act (FACA) (5 U.S.C. App. 2), and regulations issued
pursuant to those statutes (29 CFR part 1912, 41 CFR part 102-3). ACCSH
generally meets two times a year.

II. Meeting Information

    Attending the meeting: Attendance at this ACCSH meeting will be by
teleconference/WebEx only. The dial-in number and passcode for the
meeting are as follows: Dial-in number: 1-888-

658-5408; Passcode: 2389167. Directions for signing into the WebEx
portion of the meeting will be posted in the Docket and on the ACCSH
web page, https://www.osha.gov/doc/accsh/index.html, prior to the
meeting. For additional information about the telecommunication
requirements for the meeting, please contact Ms. Veneta Chatmon, OSHA,
Directorate of Construction, Room N-3468, U.S. Department of Labor, 200
Constitution Avenue NW, Washington, DC 20210; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    Meeting agenda: The tentative agenda for this meeting includes:
     ACCSH's consideration of, and recommendation on, the
following proposal:
    1. Occupational exposure to beryllium and beryllium compounds in
the construction industry.
    Requests to speak at ACCSH meeting: Attendees who want to address
ACCSH at the meeting must submit a request to speak, as well as any
written or electronic presentation, by September 4, 2019, using one of
the methods listed in the ADDRESSES section. The request must state:
     The amount of time requested to speak;
     The interest you represent (e.g., business, organization,
affiliation), if any; and
     A brief outline of your presentation.
    PowerPoint presentations and other electronic materials must be
compatible with PowerPoint 2010 and other Microsoft Office 2010
formats.
    OSHA will place comments and requests to speak, including personal
information, in the public docket, which may be available online.
Therefore, OSHA cautions interested parties about submitting personal
information such as Social Security Numbers and birthdates.
    Docket: To read or download documents in the public docket for this
ACCSH meeting, go to http://www.regulations.gov. All documents in the
public docket are listed in the index; however, some documents (e.g.,
copyrighted material) are not publicly available to read or download
through http://www.regulations.gov. All submissions are available for
inspection and, when permitted, copying at the OSHA Docket Office at
the above address. For information on using http://www.regulations.gov
to make submissions or to access the docket, click on the ``Help'' tab
at the top of the homepage. Contact the OSHA Docket Office for
information about materials not available through that website and for
assistance in using the internet to locate submissions and other
documents in the docket.

Authority and Signature

    Loren Sweatt, Principal Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice under the authority granted by 29 U.S.C. 655(b)(1) and 656(b), 5
U.S.C. App. 2, Secretary of Labor's Order No. 1-2012 (77 FR 3912), and
29 CFR part 1912.

    Signed at Washington, DC, on August 14, 2019.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2019-17825 Filed 8-19-19; 8:45 am]
BILLING CODE 4510-26-P