[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Notices]
[Page 13657]
[FR Doc No: 2013-04662]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-75-000]

Southwest Gas Storage Company; Prior Notice of Activity Under
Blanket Certificate

    On February 8, 2013, Southwest Gas Storage Company (Southwest)
filed a prior notice request pursuant to sections 157.205, 157.208(b),
157.213(b) and 157.216(b)(2) of the Commission's regulations under the
Natural Gas Act and Southwest's blanket certificate issued in Docket
No. CP99-230-000. Southwest seeks authorization to construct, modify
and abandon certain natural gas storage facilities at the Howell
Storage Field, located in Livingston County, Michigan, to improve the
storage field's operation.
    Questions regarding this application may be directed to Stephen
Veatch, Senior Director of Certificates & Tariffs, Southwest Gas
Storage Company, 5051 Westheimer Road, Houston, Texas 77056, or by
calling<PHONE_NUMBER>, by faxing<PHONE_NUMBER>, or by emailing
<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to Section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to Section 7 of the NGA.
    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 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 Applicant. On or before the comment date, it is
not necessary to serve motions to intervene or protests on persons
other than the Applicant.
    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 should submit an
original and seven copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 22, 2013.

    Dated: February 21, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-04662 Filed 2-27-13; 8:45 am]
BILLING CODE 6717-01-P


Under a least cost scenario, 16 out of the 19 chemical substances
(84%) would have a price impact at less than the 1% level. Similarly,
15 out of the 19 chemical substances (79%) would be impacted at less
than the 1% level under an average cost scenario. Thus, the potential
for adverse economic impact due to the proposed test rule is low for at
least 79% of the chemical substances in this proposed rule.
Approximately 4 chemicals (21%) of the 19 chemical substances for which
price data are available would have a price impact at a level greater
than or equal to 1% under the least (average) cost scenario.
    EPA believes, on the basis of these calculations, that the proposed
testing of the chemical substances presents a low potential for adverse
economic impact for the majority of the chemical substances. 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 of the chemicals. There are,
however, some chemical substances 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 chemical
substances. In these cases, companies may choose to use revenue sources
other than the profits from the individual chemicals to pay for
testing. Smaller businesses are less likely to have additional revenue
sources to cover the compliance costs in this situation. Therefore, the
Agency also compared the costs of compliance to company sales for small
businesses.

    EPA does not provide quantitative estimates of the benefits from
these tests. Ideally, a discussion of benefits would focus on the
additional benefits to be gained from new information relative to
information that already exists. Such an approach could examine the
value of new information provided as a result of the test rule where
such information has not been publicly available. Because of
constraints on information on the value of information, our evaluation
of benefits is qualitative and does not address incremental benefits.
We believe, however, that the net benefits of the new information are
positive.

VII. Public Comment

    As discussed in Units III.D. and III.E., the Agency solicits
comment regarding additional information pertaining to potential
exposure of workers and consumers, respectively, to the chemical
substances identified in this proposed rule. Also, as discussed in
Units III.F., the Agency solicits comment regarding additional
information pertaining to environmental releases of the chemical
substances identified in this proposed rule.
    As discussed in Unit III.F., EPA is soliciting comments which
identify existing data that may meet the requirements of studies under
this proposed rule. To the extent that data relevant to the testing
specified in this proposed rule are known to exist, EPA strongly
encourages the submission of this information as comments to the
proposed rule. Data submitted to EPA to meet the requirements of
testing under this proposed rule must be in the form of full copies of
unpublished studies or full citations of published studies, and may be
accompanied by a robust summary (Ref. 15). To the extent that studies
required under this proposed rule are currently available, and the data
are judged sufficient by EPA, testing for the endpoint/chemical
combination will not be required in the final rule based on this
proposed rule.
    EPA also solicits public comment on the test methods proposed and
the analysis detailing the burdens and costs for the regulatory impacts
resulting from this rule.
    In addition, EPA solicits comment on the proposed and alternative
approaches to the testing of Class 2 substances, whether the proposed
approach for testing Class 1 substances (i.e., that each Class 1
substance be tested at a purity of 99% or more) should be applied to
any Class 2 substances, and whether the proposed or alternative
approaches for the testing of Class 2 substances (i.e., that a
representative sample of each Class 2 substance be tested) should be
applied to any Class 1 substances.

VIII. Materials in the Docket

    As indicated under ADDRESSES, a docket has been established for
this proposed rulemaking under docket ID number EPA-HQ-OPPT-2007-0531.
The following is a listing of the documents that have been placed in
the public docket for this proposed rule. The docket includes
information considered by EPA in developing this proposed rule,
including the documents listed in this unit, which are physically
located in the docket. In addition, interested parties should consult
documents that are referenced in the documents that EPA has placed in
the public docket, regardless of whether these referenced documents are
physically located in the public docket. For assistance in locating
documents that are referenced in documents that EPA has placed in the
public docket, but that are not physically located in the docket,
please consult the technical contact listed under FOR FURTHER
INFORMATION CONTACT. The public docket is available for review as
specified under ADDRESSES.
    1. EPA. Data Collection and Development on High Production Volume
(HPV) Chemicals. Notice. Federal Register (65 FR 81686, December 26,
2000) (FRL-6754-6).
    2. EPA. Proposed Test Rule for the Testing of Certain High
Production Volume Chemicals. Proposed Rule. Federal Register (65 FR
81658, December 26, 2000) (FRL-6758-4).
    3. EPA. Final Test Rule for the Testing of Certain High Production
Volume Chemicals. Final Rule. 40 CFR part 799. Federal Register (71 FR
13708, March 16, 2006) (FRL-7335-2).
    4. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy. Notice.
Federal Register (58 FR 28736, May 14, 1993).
    5. EPA, OPPT. HPV Challenge Program Chemical List. This list is
updated periodically, and is available on-line at: http://www.epa.gov/
oppt/chemrtk/pubs/update/hpvchmlt.htm.
    6. OECD Secretariat. Manual for the Investigation of HPV Chemicals.
OECD Programme on the Co-Operative Investigation of High Production
Volume Chemicals. Paris, France. September 2004. Available on-line at:
http://www.oecd.org/document/7/0,2340,en_2649_34379_1947463_1_1_
1_1,00.htm.
    7. International Council of Chemical Associations (ICCA). ICCA HPV
Working List of Chemicals. October 2005. This list is updated
periodically, and is available on-line at: http://www.cefic.org/
activities/hse/mgt/hpv/hpvinit.htm.
    8. EPA. TSCA section 4(a)(1)(B) Proposed Statement of Policy.
Notice. Federal Register (56 FR 32294, July 15, 1991).
    9. OECD Secretariat. Summary Record of the 13th Joint Meeting of
the OECD Chemicals Group and Management Committee of the Special
Programme on the Control of Chemicals, November 8-10, 1989. ENV/CHEM/
CM/89.2. February 1990.
    10. OECD Secretariat. Proposal for Further Work on the
Investigation of High Production Volume Chemicals. OECD Chemicals Group
and Management Committee of the Special Programme on the Control of
Chemicals. ENV/CHEM/CM/89.14. October 1989.
    11. OECD. Decision-Recommendation on the Co-Operative Investigation
and Risk Reduction of Existing Chemicals-C(90)163/FINAL. January 31,
1991.
    12. CMA (ACC). Comments on EPA's TSCA section 4(a)(1)(B) Proposed
Statement of Policy submitted to the TSCA Public Docket Office, EPA.
September 13, 1991.
    13. Epoxy Resin Systems Task Group of the Society of the Plastics
Industry, Inc. Comments on EPA's TSCA section 4(a)(1)(B) Proposed
Statement of Policy submitted to the TSCA Public Docket Office, EPA.
September 13, 1991.
    14. EPA, Office of Pollution Prevention and Toxics (OPPT). Chemical
Hazard Data Availability Study: What Do We Really Know About the Safety
of High Production Volume Chemicals? April 1998. Available on-line at:
http://www.epa.gov/chemrtk/pubs/general/hazchem.htm.
    15. EPA, OPPT. Draft Guidance on Developing Robust Summaries.
October, 22, 1999. Available on-line at: http://www.epa.gov/HPV/pubs/
general/robsumgd.htm.
    16. EPA, Office of Prevention, Pesticides and Toxic Substances
(OPPTS). Letter from Susan H. Wayland, Deputy Assistant Administrator,
to participants in the voluntary HPV Challenge Program. October 14,
1999. Available on-line at http://www.epa.gov/chemrtk/pubs/general/
ceoltr2.htm.
    17. EPA, OPPT, Economics, Exposure and Technology Division (EETD),
Economic and Policy Analysis Branch (EPAB). Economic Analysis for the
Proposed Section 4 Test Rule for High Production Volume Chemicals;
Final Report. February 2008.
    18. EPA, OPPT, EETD. Testing of Certain High Production Volume
Chemicals; Second Group of Chemicals (Exposure Findings Supporting
Information). July 2008.

    19. EPA. OPPT. Chemical Information and Testing Branch (CITB).
Response to public comments regarding testing of certain high
production volume chemicals. May 31, 2005.
    20. NIOSH. National occupational exposure survey field guidelines.
Vol. I. Seta JA, Sundin DS, Pedersen DH, eds. Cincinnati, OH: U.S.
Department of Health and Human Services, Centers for Disease Control,
National Institute for Occupational Safety and Health, DHHS (NIOSH)
Publication No. 88-106. 1988. Available on-line at: http://www.cdc.gov/
niosh/88-106.html.
    21. EPA. Inert Reassessment--Oxalic Acid (CAS Reg. No. 144-62-7).
Action Memorandum. From: Pauline Wagner, Chief, Inert Ingredient
Assessment Branch, To: Lois A. Rossi, Director, Registration Division.
September 6, 2005.
    22. American Society for Testing and Materials International (ASTM
International). Standard Test Method for Relative Initial and Final
Melting Points and the Melting Range of Organic Chemicals. ASTM. E 324-
99. 1999.
    23. ASTM International. Standard Test Method for Vapor Pressure of
Liquids by Ebulliometry. ASTM. E 1719-05. 2005.
    24. ASTM International. Standard Test Method for Determining Vapor
Pressure by Thermal Analysis. ASTM. E 1782-03. 2003.
    25. ASTM International. Standard Test Method for Partition
Coefficient (n-Octanol/Water) Estimation by Liquid Chromatography.
ASTM. E 1147-92(2005). 2005.
    26. ASTM International. Standard Test Method for Measurements of
Aqueous Solubility. ASTM. E 1148-02. 2002.
    27. 49. ASTM International. Question about ASTM E 324. E-mail from
Diane Rehiel, ASTM, to Greg Schweer, CITB, CCD, OPPT, EPA. September
15, 2004.
    28. Meylan, W.M. and Howard, P.H. Atom/Fragment Contribution Method
for Estimating Octanol-Water Partition Coefficients. Journal of
Pharmaceutical Sciences. 84(1):83-92. 1995.
    29. Meylan, W.M., Howard, P.H., and Boethling, R.S. Improved Method
for Estimating Water Solubility From Octanol/Water Partition
Coefficient. Environmental Toxicology and Chemistry. 15(2):100-106.
1996.
    30. ASTM International. Standard Test Method for Determining Ready,
Ultimate, Biodegradability of Organic Chemicals in a Sealed Vessel
CO2 Production Test, ASTM E 1720-01. 2001.
    31. International Organization for Standardization (ISO). Water
quality--Evaluation of ultimate aerobic biodegradability of organic
compounds in aqueous medium--Method by analysis of inorganic carbon in
sealed vessels (CO2 headspace test). ISO 14593. 1999.
    32. ISO. Water quality--Evaluation in an aqueous medium of the
``ultimate'' aerobic biodegradability of organic compounds--Method by
analysis of dissolved organic carbon (DOC). ISO 7827. 1994.
    33. ISO. Water quality--Evaluation of ultimate aerobic
biodegradability of organic compounds in aqueous medium by
determination of oxygen demand in a closed respirometer. ISO 9408.
1999.
    34. ISO. Water quality--Evaluation of ultimate aerobic
biodegradability of organic compounds in aqueous medium--Carbon dioxide
evolution test. ISO 9439. 1999.
    35. ISO. Water quality--Evaluation in an aqueous medium of the
``ultimate'' aerobic biodegradability of organic compounds--Method by
analysis of biochemical oxygen demand (closed bottle test). ISO 10707.
1994.
    36. ISO. Water quality--Evaluation in an aqueous medium of the
ultimate aerobic biodegradability of organic compounds--Determination
of biochemical oxygen demand in a two-phase closed bottle test
(available in English only). ISO 10708. 1997.
    37. ISO. Water quality--Guidance for the preparation and treatment
of poorly water-soluble organic compounds for the subsequent evaluation
of their biodegradability in an aqueous medium. ISO 10634. 1995.
    38. ASTM International. Standard Guide for Conducting Acute
Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and
Amphibians. ASTM. E 729-96(2002). 2002.
    39. ASTM International. Standard Guide for Conducting Static
Toxicity Tests with Microalgae. ASTM. E 1218-04e1. 2004.
    40. ASTM International. Standard Guide for Conducting Daphnia magna
Life-Cycle Toxicity Tests. ASTM. E 1193-97(2004). 2004.
    41. Veith, G.D. and Kosian, P. Estimating bioconcentration
potential from octanol/water partition coefficients, in Physical
Behavior of PCB's in the Great Lakes (MacKay, Paterson, Eisenreich, and
Simmons, eds.), Ann Arbor Science, Ann Arbor, MI. 1982.
    42. 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.
    43. EPA. Document containing EPA's Policy Statement under TSCA
section 5 entitled Category for Persistent, Bioaccumulative, and Toxic
New Chemical Substances. Notice. Federal Register (64 FR 60194,
November 4, 1999) (FRL-6097-7). Available on-line at: http://
www.epa.gov/oppt/newchems/pubs/pbtpolcy.htm.
    44. EPA. Significant New Use Rules; General Provisions for New
Chemical Follow-Up. Final Rule. Federal Register (54 FR 31307, July 27,
1989).
    45. EPA, OPPT. Development of Chemical Categories in the HPV
Challenge Program (Draft). August 25, 1999. Available on-line at:
http://www.epa.gov/chemrtk/pubs/general/categuid.htm.
    46. EPA, OPPT. Guidance for Testing Closed System Intermediates for
the HPV Challenge Program (Draft). March 17, 1999. Available on-line
at: http://www.epa.gov/oppt/chemrtk/pubs/general/closed9.htm.
    47. EPA, OPPT, EETD, EPAB. Analysis of Laboratory Capacity to
Support U.S. EPA Chemical Testing Program Initiatives. August 2004.
    48. EPA, OPPT. The Use of Structure-Activity Relationships (SAR) in
the High Production Volume Chemicals Challenge Program. August 26,
1999. Available on-line at: http://www.epa.gov/chemrtk/pubs/general/
sarfinl1.htm.
    49. EPA, OPPT, EETD, EPAB. Economic Analysis in Support of the TSCA
12(b) Information Collection Request. October 30, 1998.
    50. NIEHS 2001b. Guidance Document on Using In Vitro Data to
Estimate In Vivo Starting Doses for Acute Toxicity. NIH Publication No.
01-4500. August 2001. Available on-line at: http://
iccvam.niehs.nih.gov/methods/acutetox/inv_cyto_guide.htm.
    51. NIEHS 2003a. Test Method Protocol for Solubility Determination,
in vitro Cytotoxicity Validation Study--Phase III. National Toxicology
Program (NTP) Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM). September 24, 2003. Available on-line
at: http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_
proto.htm.
    52. NIEHS 2003b. Test Method Protocol for the BALB/c 3T3 Neutral
Red Uptake Cytotoxicity Test, a Test for Basal Cytotoxicity for an in
vitro Validation Study--Phase III. National Toxicology Program (NTP)
Interagency Center for the Evaluation of Alternative Toxicological
Methods (NICEATM). November 4, 2003. Available on-line at: http://
iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm.
    53. NIEHS 2003c. Test Method Protocol for the NHK Neutral Red
Uptake Cytotoxicity Test, a Test for

Basal Cytotoxicity for an in vitro Validation Study--Phase III.
National Toxicology Program (NTP) Interagency Center for the Evaluation
of Alternative Toxicological Methods (NICEATM). November 4, 2003.
Available on-line at: http://iccvam.niehs.nih.gov/methods/acutetox/
invitrocyto/invcyt_proto.htm.
    54. EPA. Toxic Substances; Test Rule Development and Exemption
Procedures. Interim Final Rule. 40 CFR part 790. Federal Register (50
FR 20652, May 17, 1985).
    55. EPA. Toxic Substances Control Act; Data Reimbursement. Final
Rule. 40 CFR part 791. Federal Register (48 FR 31786, July 11, 1983).
    56. EPA. OPPT. High Production Volume Chemical Data Information
System (HPVIS). Data from HVPIS on 18 HPV chemicals. May 2008.
    57. NIOSH. National occupational exposure survey analysis of
management interview responses. Vol. III. Pedersen DH, Sieber WK, eds.
Cincinnati, OH: U.S. Department of Health and Human Services, Centers
for Disease Control, National Institute for Occupational Safety and
Health, DHHS (NIOSH) Publication No. 89-103. 1989. Available on-line
at: http://www.cdc.gov/niosh/89-103.html.
    58. NIOSH. National occupational exposure survey sampling
methodology. Vol. II. Sieber WK, ed. Cincinnati, OH: U.S. Department of
Health and Human Services, Centers for Disease Control, National
Institute for Occupational Safety and Health, DHHS (NIOSH) Publication
No. 89-102. 1989. Available on-line at: http://www.cdc.gov/niosh/89-
102.html.
    59. ASTM International. Standard Test Method for estimating Acute
Oral Toxicity in Rats. ASTM E 1163-98(2002). 2002.

IX. Statutory and Executive Order Reviews

A. Executive Order 12866

    Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), this proposed rule is not a
``significant regulatory action'' subject to review by the Office of
Management and Budget (OMB) under Executive Order 12866, because it
does not 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, EPA did not submit
this proposed rulemaking to OMB for review under Executive Order 12866.
    EPA has prepared an economic analysis of this proposed action,
which is contained in a document entitled Economic Analysis for the
Proposed Section 4 Test Rule for High Production Volume Chemicals;
Final Report (Ref. 17). A copy of the economic analysis is available in
the docket for this proposed rule and is summarized in Unit VI.

B. Paperwork Reduction Act

    This proposed rule does not impose any new or amended paperwork
collection requirements that would require additional review and/or
approval by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
et seq. Although the activities are approved, OMB has specified that
the additional burden associated with a new test rule is not covered by
the ICR until the final rule is effective. The information collection
requirements contained in TSCA section 4 test rules have already been
approved by OMB under PRA, and have been assigned OMB control number
2070-0033 (EPA ICR No. 1139). In the context of developing a new test
rule, the Agency must determine whether the total annual burden covered
by the approved ICR needs to be amended to accommodate the burden
associated with the new test rule. If so the Agency must submit an
Information Correction Worksheet (ICW) to OMB and obtain OMB approval
of an increase in the total approved annual burden in the OMB
inventory. The Agency's estimated burden for this test rule is provided
in the economic analysis (Ref. 17).
    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 rulemaking does not
propose any new or changes to the export notification requirements, and
is not expected to result in any substantive changes in the burden
estimates for EPA ICR No. 0795 that would require additional review
and/or approval by OMB.
    Under PRA, an agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information that is subject
to approval under PRA, unless it displays a currently valid OMB control
number. The OMB control numbers for the EPA regulations codified in
title 40 of the CFR, after appearing in the preamble of the final rule,
are listed in 40 CFR part 9, displayed either by publication in the
Federal Register or by other appropriate means, such as on the related
collection instrument or form, if applicable. The display of OMB
control numbers in certain EPA regulations is consolidated in 40 CFR
part 9.
    The standard chemical testing program involves the submission of
letters of intent to test (or exemption applications), study plans,
semi-annual progress reports, test results, and some administrative
costs. For this proposed rule, EPA estimates the public reporting
burden for all 19 chemicals is 9,008 hours, with an estimated burden
per chemical of 474 hours (Ref. 17). The estimated burden of the
information collection activities related to export notification is
estimated to average 1 burden hour for each chemical/country
combination for an initial notification and 0.5 hours for each
subsequent notification (Ref. 17). In estimating the total burden hours
approved for the information collection activities related to export
notification, the Agency has included sufficient burden hours to
accommodate any export notifications that may be required by the
Agency's issuance of final chemical test rules. As such, EPA does not
expect to need to request an increase in the total burden hours
approved by OMB for export notifications.
    As defined by PRA and 5 CFR 1320.3(b), ``burden'' means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to: Review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information.
    Comments are requested on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested
methods for minimizing respondent burden, including through the use of
automated collection techniques. Send comments to EPA as part of your
overall comments on this proposed action in the manner specified under
ADDRESSES. In developing the final rule, the Agency will address any
comments received regarding the information collection requirements
contained in this proposal.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., after considering the potential economic impacts
of this proposed rule on small entities, the

Agency hereby certifies that this proposed rule would not have a
significant adverse economic impact on a substantial number of small
entities. The factual basis for the Agency's determination is presented
in the small entity impact analysis prepared as part of the economic
analysis for this proposed rule (Ref. 17), which is summarized in Unit
VI., and a copy of which is available in the docket for this proposed
rulemaking. The following is a brief summary of the factual basis for
this certification.
    Under RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of this proposed rule on small entities, small
entity is defined in accordance with the RFA as:
    1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201.
    2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000.
    3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
Based on the industry profile that EPA prepared as part of the economic
analysis for this proposed rulemaking (Ref. 17), EPA has determined
that this proposed rule is not expected to impact any small not-for-
profit organizations or small governmental jurisdictions. As such, the
Agency's analysis presents only the estimated potential impacts on
small business.
    Two factors are examined in EPA's small entity impact analysis
(Ref. 17) in order to characterize the potential small entity impacts
of this proposed rule on small business:
    1. The size of the adverse economic impact (measured as the ratio
of the cost to sales or revenue).
    2. The total number of small entities that experience the adverse
economic 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 SBA establishes small business
size standards (13 CFR 121.201). For this proposed rulemaking, EPA has
analyzed the potential small business impacts using the size standards
established under this default definition. The SBA size standards,
which are primarily intended to determine whether a business entity is
eligible for government programs and preferences reserved for small
businesses (13 CFR 121.101), ``seek to ensure that a concern that meets
a specific size standard is not dominant in its field of operation.''
(13 CFR 121.102(b)). See section 632(a)(1) of the Small Business Act.
In analyzing potential impacts, RFA recognizes that it may be
appropriate at times to use an alternate definition of small business.
As such, section 601(3) of RFA provides that an agency may establish a
different definition of small business after consultation with the SBA
Office of Advocacy and after notice and an opportunity for public
comment. Even though the Agency has used the default SBA definition of
small business to conduct its analysis of potential small business
impacts for this proposed rule, EPA does not believe that the SBA size
standards are generally the best size standards to use in assessing
potential small entity impacts with regard to TSCA section 4(a) test
rules.
    The SBA size standard is generally based on the number of employees
an entity in a particular industrial sector may have. For example, in
the chemical manufacturing industrial sector (i.e., NAICS codes 325 and
324110), approximately 98% of the firms would be classified as small
businesses under the default SBA definition. The SBA size standard for
75% of this industry sector is 500 employees, and the size standard for
23% of this industry sector is either 750; 1,000; or 1,500 employees.
When assessing the potential impacts of test rules on chemical
manufacturers, EPA believes that a standard based on total annual sales
may provide a more appropriate means to judge the ability of a chemical
manufacturing firm to support chemical testing without significant
costs or burdens.
    EPA is currently determining what level of annual sales would
provide the most appropriate size cutoff with regard to various
segments of the chemical industry usually impacted by TSCA section 4(a)
test rules, but has not yet reached a determination. As stated in this
unit, therefore, the factual basis for RFA determination for this
proposed rule is based on an analysis using the default SBA size
standards. Although EPA is not currently proposing to establish an
alternate definition for use in the analysis conducted for this
proposed rule, the analysis for this proposed rule also presents the
results of calculations using a standard based on total annual sales
(40 CFR 704.3). EPA is interested in receiving comments on whether the
Agency should consider establishing an alternate definition for small
business to use in the small entity impact analyses for future TSCA
section 4(a) test rules, and what size cutoff may be appropriate.
    The SBA has developed 6 digit NAICS code-specific size standards
based on employment thresholds. These size standards range from 500 to
1,500 employees for the various 6 digit NAICS codes that are
potentially impacted (Ref. 17). For a conservative estimate of the
number of small businesses affected by this proposed rule, the Agency
chose an employment threshold of less than 1,500 employees for all
businesses regardless of the NAICS-specific threshold to determine
small business status.
    For each manufacturer of the 19 chemicals covered by this proposed
rule, the parent company (ultimate corporate entity, or UCE) was
identified and sales and employment data were obtained for companies
where data was publicly available. The search determined that there
were 48 affected UCEs. Sales and employment data could be found for 45
and 46 of these UCEs (88%), respectively.
    Parent company sales data were collected to identify companies that
qualified as a ``small business'' for purposes of the RFA analysis.
Based on the SBA size standard applied (1,500 employees or less), 20
companies were identified as small.
    The potential significance of this proposed rule's impact on small
businesses was analyzed by examining the number of small entities that
experienced different levels of costs as a percentage of their sales.
Small businesses were placed in the following categories on the basis
of cost-to sales ratios: less than 1%, greater than 1%, and greater
than 3%. This analysis was conducted under both a least and average
cost scenario.
    Of the 20 small businesses analyzed for small business impacts, one
company had no sales data available. Another two companies could not be
classified as small or large because there were no employment data
available, but were still included in the small business impact
analysis. Of the 19 designated as small businesses, none had cost-to-
sales ratios of greater than 1% under both the least and average cost
scenarios. For the chemicals where sales data were unavailable, EPA
used the median sales value sales of all other small businesses equal
to $15.4 million. The costs for the three companies were estimated to
be well below 0.01% of this sales level. Given these results, the
Agency has determined that there is not a significant economic impact
on a substantial number of small entities as a result of this proposed
rule, if finalized.
    The estimated cost of the TSCA section 12(b)(1) export
notification, which, as a result of the final rule,

would be required for the first export to a particular country of a
chemical subject to the rule, is estimated to be $80.22 for the first
time that an exporter must comply with TSCA section 12(b)(1) export
notification requirements, and $25.56 for each subsequent export
notification submitted by that exporter (Refs. 17, 48, and 49). EPA has
concluded that the costs of TSCA section 12(b)(1) export notification
would have a negligible impact on exporters of the chemicals in the
final rule, regardless of the size of the exporter.
    Any comments regarding the impacts that this action may impose on
small entities, or regarding whether the Agency should consider
establishing an alternate definition of small business to be used for
analytical purposes for future test rules and what size cutoff may be
appropriate, should be submitted to the Agency in the manner specified
under ADDRESSES.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA), Public Law 104-4, EPA has determined that this proposed
rulemaking does not contain a Federal mandate that may result in
expenditures of $100 million or more for State, local, and tribal
governments, in the aggregate, or the private sector in any 1 year. It
is estimated that the total aggregate costs of this proposed rule,
which are summarized in Unit VI., would be $4.4 million. The total
annualized costs of this proposed rule are estimated to be $1.68
million. In addition, since EPA does not have any information to
indicate that any State, local, or tribal government manufactures or
processes the chemicals covered by this action such that this rule
would apply directly to State, local, or tribal governments, EPA has
determined that this proposed rule would not significantly or uniquely
affect small governments. Accordingly, this proposed rule is not
subject to the requirements of sections 202, 203, 204, and 205 of UMRA.

E. Executive Order 13132

    Under Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999), EPA has determined that this proposed rule does not
have ``federalism implications'' because it will not have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in the Executive Order. This proposed rule would establish testing and
recordkeeping requirements that apply to manufacturers (including
importers) and processors of certain chemicals. Because EPA has no
information to indicate that any State or local government manufactures
or processes the chemical substances covered by this action, this
proposed rule does not apply directly to States and localities and will
not affect State and local governments. Thus, Executive Order 13132
does not apply to this proposed rule.

F. Executive Order 13175

    Under Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has
determined that this proposed rule does not have tribal implications
because it will not have any affect on tribal governments, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in the Executive Order. As
indicated previously, EPA has no information to indicate that any
tribal government manufactures or processes the chemical substances
covered by this action. Thus, Executive Order 13175 does not apply to
this proposed rule.

G. Executive Order 13045

    This proposed rule is not subject to Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997), because it does not
establish an environmental standard intended to mitigate health or
safety risks, will not have an annual effect on the economy of $100
million or more, nor does it otherwise have a disproportionate effect
on children. This proposed rule would establish testing and
recordkeeping requirements that apply to manufacturers (including
importers) and processors of certain chemicals, and would result in the
development of data about those chemicals that can subsequently be used
to assist the Agency and others in determining whether the chemicals in
this proposed rule present potential risks, allowing the Agency and
others to take appropriate action to investigate and mitigate those
risks.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because it is unlikely to have any significant adverse effect on the
supply, distribution, or use of energy.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note), directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus 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.
    This proposed rule involves technical standards because it proposes
to require the use of particular test methods. If the Agency makes
findings under TSCA section 4(a), EPA is required by TSCA section 4(b)
to include specific standards or test methods that are to be used for
the development of the data required in the test rules issued under
TSCA section 4. For some of the testing that would be required by this
rule, EPA is proposing the use of voluntary consensus standards issued
by ASTM and ISO which evaluate the same type of toxicity as the TSCA
and OECD test guidelines, where applicable. Copies of the 17 ASTM and
ISO standards referenced in the proposed regulatory text at Sec.
799.5087(h) have been placed in the docket for this proposed
rulemaking. 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 copies of the ISO standards from the
International Organization for Standardization, Case Postale, 56 CH-
1211 Gen[egrave]ve 20 Switzerland. In the final rule, EPA intends to
seek approval from the Director of the Federal Register for the
incorporation by reference of the ASTM and ISO standards used in the
final rule in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
    EPA is not aware of any potentially applicable voluntary consensus
standards which evaluate partition coefficient (n-octanol/water)
generator column, water solubility (column elution and generator
column), acute inhalation toxicity, bacterial reverse mutations, in
vivo mammalian bone marrow chromosomal aberrations,

combined repeated dose with reproductive/developmental toxicity screen,
repeated dose 28-day oral toxicity screen, or the reproductive
developmental toxicity screen which could be considered in lieu of the
TSCA guidelines, 40 CFR 799.6756, 799.6784, 799.6786, 799.9130,
799.9510, 799.9538, 799.9365, 799.9305, and 799.9355, respectively,
upon which the test standards in this proposed rule are based. The
Agency invites comment on the potential use of voluntary consensus
standards in this proposed rulemaking, and, specifically, invites the
public to identify potentially applicable consensus standard(s) and to
explain why such standard(s) should be used here.

J. Executive Order 12898

    This proposed rule does not have an adverse impact on the
environmental and health conditions in low-income and minority
communities that require special consideration by the Agency under
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994). The Agency believes that
the information collected under this proposed rule, if finalized, will
assist EPA and others in determining the potential 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 better protect human
health and the environment, including in low-income and minority
communities.

List of Subjects in 40 CFR Part 799

    Environmental protection, Chemicals, Hazardous substances,
Laboratories, Reporting and recordkeeping requirements.

    Dated: July 17, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
    1. The authority citation for part 799 would continue to read as
follows:

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

    2. By adding Sec.  799.5087 to subpart D of part 799 that would
read as follows:

Sec.  799.5087  Chemical testing requirements for certain high
production volume chemicals; second group of 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 substance must be 99% or greater,
unless otherwise specified in this section. For the chemical substances
identified as ``Class 2'' substances in Table 2 in paragraph (j), a
representative form of each substance must be tested. The
representative form selected for a given Class 2 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 the effective date of the final rule to the end of the
test data reimbursement period as defined in 40 CFR 791.3(h), you are
subject to this section with respect to that chemical substance.
    (2) If you do not know or cannot reasonably ascertain that you
manufacture or process a chemical substance listed in Table 2 in
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 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
------------------------------------------------------------------------
                                          Tier 2 (Persons not initially
 Tier 1 (Persons initially required to     required to comply with this
       comply with this section)                     section)
------------------------------------------------------------------------
Persons not otherwise specified in       Tier 2A. Persons who
 column 2 of this table that              manufacture (as defined at
 manufacture (as defined at TSCA          TSCA section 3(7)) or intend
 section 3(7)) or intend to manufacture   to manufacture a chemical
 a chemical substance included in this    substance included in this
 section.                                 section solely as one or more
                                          of the following:
                                         --As a byproduct (as defined at
                                          40 CFR 791.3(c));
                                         --As an impurity (as defined at
                                          40 CFR 790.3);
                                         --As a naturally occurring
                                          substance (as defined at 40
                                          CFR 710.4(b));
                                         --As a non-isolated
                                          intermediate (as defined at 40
                                          CFR 704.3);
                                         --As a component of a Class 2
                                          substance (as described at 40
                                          CFR 720.45(a)(1)(i));
                                         --In amounts of less than 500
                                          kilogram (kg) (1,100 lbs.)
                                          annually (as described at 40
                                          CFR 790.42(a)(4)); or
                                         --For research and development
                                          (as described at 40 CFR
                                          790.42(a)(5)).
                                         B. Persons who process (as
                                          defined at TSCA section 3(10))
                                          or intend to process a
                                          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 in Tier 2, that is those persons specified in Sec.
790.42(a)(2), (a)(4) and (a)(5) of this chapter, who, while legally
subject to this section, must comply with the requirements of this
section only if directed to do so by EPA under the circumstances set
forth in paragraphs (c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) of this
section.
    (2) If you are in Tier 1 with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, you must, for each
test required under this section for that chemical substance, either
submit to EPA a letter of intent to test or apply to EPA for an
exemption from testing. The letter of intent to test or the exemption
application must be received by EPA no later than 30 days after the
effective date of the final rule.
    (3) If you are in Tier 2 with respect to a chemical substance
listed in Table

2 in paragraph (j) of this section, you are considered to have an
automatic conditional exemption and you will be required to comply with
this section with regard to that chemical substance only if directed to
do so by EPA under paragraphs (c)(5), (c)(7) or (c)(10) of this
section.
    (4) If no person in Tier 1 has notified EPA of its intent to
conduct one or more of the tests required by this section on any
chemical substance listed in Table 2 in paragraph (j) of this section
within 30 days after the effective date of the final rule, EPA will
publish a Federal Register document that would specify the test(s) and
the chemical substance(s) for which no letter of intent has been
submitted and notify manufacturers in Tier 2A of their obligation to
submit a letter of intent to test or to apply for an exemption from
testing.
    (5) If you are in Tier 2A (as specified in Table 1 in paragraph (c)
of this section) with respect to a chemical substance listed in Table 2
in paragraph (j) of this section, and if you manufacture, or intend to
manufacture, this chemical substance as of [date 30 days after date of
publication of the final rule in the Federal Register], or within 30
days after publication of the Federal Register document described in
paragraph (c)(4) of this section, you must, for each test specified for
that chemical substance in the document described in paragraph (c)(4)
of this section, either submit to EPA a letter of intent to test or
apply to EPA for an exemption from testing. The letter of intent to
test or the exemption application must be received by EPA no later than
30 days after publication of the document described in paragraph (c)(4)
of this section.
    (6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its
intentto conduct one or more of the tests required by this section on
any chemical substance listed in Table 2 in paragraph (j) of this
section within 30 days after the publication of the Federal Register
document described in paragraph (c)(4) of this section, EPA will
publish another Federal Register document that would specify the
test(s) and the chemical substance(s) for which no letter of intent has
been submitted, and notify processors in Tier 2B of their obligation to
submit a letter of intent to test or to apply for an exemption from
testing.
    (7) If you are in Tier 2B (as specified in Table 1 in paragraph (c)
of this section) with respect to a chemical substance listed in Table 2
in paragraph (j) of this section, and if you process, or intend to
process, this chemical substance as of [date 30 days after date of
publication of the final rule in the Federal Register], or within 30
days after publication of the Federal Register document described in
paragraph (c)(6) of this section, you must, for each test specified for
that chemical substance in the document described in paragraph (c)(6)
of this section, either submit to EPA a letter of intent to test or
apply to EPA for an exemption from testing. The letter of intent to
test or the exemption application must be received by EPA no later than
30 days after publication of the document described in paragraph (c)(6)
of this section.
    (8) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after the publication of the Federal Register
document described in paragraph (c)(6) of this section, EPA will notify
all manufacturers and processors of those chemical substances of this
fact by certified letter or by publishing a Federal Register document
specifying the test(s) for which no letter of intent has been
submitted. This letter or Federal Register document will additionally
notify all manufacturers and processors that all exemption applications
concerning the test(s) have been denied, and will give the
manufacturers and processors of the chemical substance(s) an
opportunity to take corrective action.
    (9) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after receipt of the certified letter or
publication of the Federal Register document described in paragraph
(c)(8) of this section, all manufacturers and processors subject to
this section with respect to that chemical substance who are not
already in violation of this section will be in violation of this
section.
    (10) If a problem occurs with the initiation, conduct, or
completion of the required testing or the submission of the required
data with respect to a chemical substance listed in Table 2 in
paragraph (j) of this section, under the procedures in Sec. Sec.
790.93 and 790.97 of this chapter, EPA may initiate termination
proceedings for all testing exemptions with respect to that chemical
substance and may notify persons in Tier 1 and Tier 2 that they are
required to submit letters of intent to test or exemption applications
within a specified period of time.
    (11) If you are required to comply with this section, but your
manufacture or processing of, or intent to manufacture or process, a
chemical substance listed in Table 2 in paragraph (j) of this section
begins after the applicable compliance date referred to in paragraphs
(c)(2), (c)(5) or (c)(6) 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 manufacture 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 one day after the date by which you are required to comply with
this section.
    (f) How are EPA's data reimbursement procedures affected for
purposes of this section? If persons subject to this section are unable
to agree on the amount or method of reimbursement for test data
development for one or more chemical substances included in this
section, any person may request a hearing as described in 40 CFR part
791. In the determination of fair reimbursement shares under this
section, if the hearing officer chooses to use a formula based on
production volume, the total production volume amount will include
amounts of a chemical substance produced as an impurity.
    (g) Who must comply with the export notification requirements? Any
person who exports, or intends to export, a chemical substance listed
in Table 2 in paragraph (j) of this section is subject to part 707,
subpart D, of this chapter.
    (h) How must I conduct my testing? (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.
    (i) Reporting requirements. A final report for each specific test
for each subject chemical substance must be received by EPA by [date 13
months after the effective date of the final rule] 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/HPV/pubs/general/
robsumgd.htm.
    (j) Designation of specific chemical substances and testing
requirements. The chemical substances identified by chemical name,
Chemical Abstract Service registry 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
               CAS No.                      Chemical Name                Class               Table 3 of this
                                                                                paragraph)
----------------------------------------------------------------------------------------------------------------
75-07-0                                Acetaldehyde              1                       C2, F2
----------------------------------------------------------------------------------------------------------------
78-11-5                                1,3-Propanediol, 2,2-     1                       C4
                                        bis[(nitrooxy)methyl]-
                                        , dinitrate (ester)
----------------------------------------------------------------------------------------------------------------
84-65-1                                9,10-Anthracenedione      1                       C6
----------------------------------------------------------------------------------------------------------------
89-32-7                                1H,3H-Benzo[1,2-c:4,5-    1                       A3, A4, A5, B, C1, D,
                                        c']difuran-1,3,5,7-                               E1, F1
                                        tetrone
----------------------------------------------------------------------------------------------------------------
110-44-1                               2,4-Hexadienoic acid,     1                       C6, F2
                                        (E,E)-
----------------------------------------------------------------------------------------------------------------
118-82-1                               Phenol, 4,4'-             1                       C1
                                        methylenebis[2,6-
                                        bis(1,1-dimethylethyl)-

----------------------------------------------------------------------------------------------------------------
119-61-9                               Methanone, diphenyl-      1                       B, C2
----------------------------------------------------------------------------------------------------------------
144-62-7                               Ethanedioic acid          1                       A1, A2, A3, A5, B, C1,
                                                                                E2, F2
----------------------------------------------------------------------------------------------------------------
149-44-0                               Methanesulfinic acid,     1                       E1
                                        hydroxy-, monosodium
                                        salt
----------------------------------------------------------------------------------------------------------------
2524-04-1                              Phosphorochloridothioic   1                       A1, A2, A3, A4, A5, B,
                                        acid, O,O-diethyl                                 C1, E1, E2, F2
                                        ester
----------------------------------------------------------------------------------------------------------------
4719-04-4                              1,3,5-Triazine-           1                       C6
                                        1,3,5(2H,4H,6H)-
                                        triethanol
----------------------------------------------------------------------------------------------------------------
6381-77-7                              D-erythro-Hex-2-enonic    1                       A4, B, C1
                                        acid, [gamma]-lactone,
                                        monosodium salt
----------------------------------------------------------------------------------------------------------------
31138-65-5                             D-gluco-Heptonic acid,    1                       A1, A2, A4, A5, B, C1,
                                        monosodium salt,                                  D, E1, E2, F1
                                        (2.xi.)-
----------------------------------------------------------------------------------------------------------------
66241-11-0                             C.I. Leuco Sulphur        2                       A1, A2, A3, A4, A5, B,
                                        Black 1                                           C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68187-76-8                             Castor oil, sulfated,     2                       A1, A2, A4, A5, C1, D,
                                        sodium salt                                       E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68187-84-8                             Castor oil, oxidized      2                       A1, A2, A3, A4, A5, B,
                                                                                C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68479-98-1                             Benzenediamine, ar,ar-    1                       A1, A2, A3, A4, A5, C1,
                                        diethyl-ar-methyl-                                E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68527-02-6                             Alkenes, C12-24, chloro   2                       A1, A2, A3, A4, A5, B,
                                                                                C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68647-60-9                             Hydrocarbons, C > 4       2                       A2, A3, A5, B, C1, D,
                                                                                E1, E2, F1
----------------------------------------------------------------------------------------------------------------

       Table 3.--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2 of This Paragraph
----------------------------------------------------------------------------------------------------------------
                                                                Test Requirements and
          Testing Category                      Test                  References           Special Conditions
----------------------------------------------------------------------------------------------------------------
Physical/Chemical Properties          A                        1. Melting Point: ASTM   n-Octanol/water
                                                                E 324-99 (capillary      Partition Coefficient
                                                                tube)                    or log Kow:
                                                               2. Boiling Point: ASTM   Which method is
                                                                E 1719-05                required, if any, is
                                                                (ebulliometry).          determined by the test
                                                               3. Vapor Pressure: ASTM   substance's estimated
                                                                E 1782-03 (thermal       \i\ log Kow as follows:
                                                                analysis).              log Kow < 0: no testing
                                                               4. n-Octanol/Water        required.
                                                                Partition Coefficient   log Kow range 0-1:
                                                                (log 10 basis) or log    Method A or B.
                                                                Kow: (See Special       log Kow range > 1-4:
                                                                Conditions for the log   Method A or B or C.
                                                                Kow test requirement    log Kow range > 4-6:
                                                                and select the           Method B or C.
                                                                appropriate method to   log Kow > 6: Method C.
                                                                use, if any, from       Test sponsors must
                                                                those listed in this     provide in the final
                                                                column.).                study report the
                                                                Method A: 40 CFR         underlying rationale
                                                                799.6755 (shake flask).  for the method and pH
                                                                Method B: ASTM E 1147-   selected. In order to
                                                                92(2005) (liquid         ensure environmental
                                                                chromatography).         relevance, EPA highly
                                                                Method C: 40 CFR         recommends that the
                                                                799.6756 (generator      selected study be
                                                                column).                 conducted at pH 7.
                                                               5. Water Solubility:     Water Solubility:
                                                                (See special            Which method is
                                                                conditions for the       required, if any, is
                                                                water solubility test    determined by the test
                                                                requirement and select   substance's estimated
                                                                the appropriate method   \ii\ water solubility.
                                                                to use, if any, from     Test sponsors must
                                                                those listed in this     provide in the final
                                                                column.).                study report the
                                                                Method A: ASTM E 1148-   underlying rationale
                                                                02 (shake flask).        for the method and pH
                                                                Method B: 40 CFR         selected. In order to
                                                                799.6784 (shake flask).  ensure environmental
                                                                Method C: 40 CFR         relevance, EPA highly
                                                                799.6784 (column         recommends that the
                                                                elution).                selected study be
                                                                Method D: 40 CFR         conducted starting at
                                                                799.6786 (generator      pH 7.
                                                                column).                > 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, consult ISO       Which method is
 Ready Biodegradation                                           10634 for guidance,      required, if any, is
                                                                and choose one of the    determined by the test
                                                                methods listed in this   substance's physical
                                                                column:                  and chemical
                                                               1. ASTM 1720-01 (sealed   properties, including
                                                                vessel CO2 production    its water solubility.
                                                                test).                   ISO 10634 provides
                                                                OR....................   guidance for selection
                                                               2. ISO 14593 (CO2         of an appropriate test
                                                                headspace test).         method for a given test
                                                                OR....................   substance. Test
                                                               3. ISO 7827 (analysis     sponsors must provide
                                                                of DOC).                 in the final study
                                                                OR....................   report the underlying
                                                               4. ISO 9408               rationale for the
                                                                (determination of        method selected.
                                                                oxygen demand in a
                                                                closed respirometer).
                                                                OR....................
                                                               5. ISO 9439 (CO2
                                                                evolution test).
                                                                OR....................
                                                               6. ISO 10707 (closed
                                                                bottle test).
                                                                OR....................
                                                               7. ISO 10708 (two-phase
                                                                closed bottle test).
----------------------------------------------------------------------------------------------------------------
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, and
                                                                used to fulfill the      C7 testing; there are
                                                                testing requirements--   no special conditions
                                                                See Special              for C6. Which test
                                                                Conditions.              group is required is
                                                               Test Group 1 for C1:...   determined by the test
                                                               1. Acute Toxicity To      substance's measured
                                                                Fish: ASTM E 729-        log KOW as obtained
                                                                96(2002).                under Test Category A,
                                                               2. Acute Toxicity To      or using an existing
                                                                Daphnia: ASTM E 729-     measured log KOW. \iii\
                                                                96(2002).               If log Kow < 4.2: Test
                                                               3. Toxicity To Plants     Group 1 is required.
                                                                (Algae): ASTM E 1218-   If log Kow <= 4.2: Test
                                                                04e1.                    Group 2 is required,
                                                               Test Group 2 for C1:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                     --------------------------------------------------

                                      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 729-96
                                                                (2002).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                                               Test Group 2 for C2:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                     --------------------------------------------------
                                      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 729-96
                                                                (2002).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                                               Test Group 2 for C3:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                     --------------------------------------------------
                                      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 729-96
                                                                (2002).
                                                               2. Acute Toxicity To
                                                                Daphnia: ASTM E 729-96
                                                                (2002).
                                                               Test Group 2 for C4:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97 (2004).
                                                               2. [Reserved]..........
                                     --------------------------------------------------
                                      C5                       For C5, 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 C5:...
                                                               1. Acute Toxicity To
                                                                Daphnia: ASTM E 729-96
                                                                (2002).
                                                               2. [Reserved]..........
                                                               Test Group 2 for C5:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97 (2004).
                                                               2. [Reserved]..........
                                     --------------------------------------------------
                                      C6                       Toxicity To Plants       ........................
                                                                (Algae): ASTM E 1218-
                                                                04e1
                                     --------------------------------------------------

                                      C7                       For C7, 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 C7:...
                                                               1. Acute Toxicity To
                                                                Fish: ASTM E 729-96
                                                                (2002).
                                                               2. [Reserved]..........
                                                               Test Group 2 for C7:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97 (2004).
                                                               2. [Reserved]..........
----------------------------------------------------------------------------------------------------------------
Mammalian Toxicity--Acute             D                        See special conditions   Which testing method is
                                                                for this test            required is determined
                                                                requirement and select   by the test substance's
                                                                the method that must     physical state at room
                                                                be used from those       temperature (25[deg]C).
                                                                listed in this column.   For those test
                                                               Method A: Acute           substances that are
                                                                Inhalation Toxicity      gases at room
                                                                (rat): 40 CFR 799.9130.  temperature, Method A
                                                               Method B: EITHER:......   is required; otherwise,
                                                               1. Acute (Up/Down) Oral   use either of the two
                                                                Toxicity (rat): ASTM E   methods listed under
                                                                1163-98 (2002).          Method B.
                                                                OR....................  In Method B, 40 CFR
                                                               2. Acute (Up/Down) Oral   799.9110(d)(1)(i)(A)
                                                                Toxicity (rat): 40 CFR   refers to the OECD 425
                                                                799.9110(d)(1)(i)(A).    Up/Down Procedure. \iv\
                                                                                Estimating starting dose
                                                                                for Method B: Data from
                                                                                the neutral red uptake
                                                                                basal cytotoxicity
                                                                                assay \v\ 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.                subject person who uses
                                                                OR....................   one of the in vivo
                                                               Mammalian Erythrocyte     methods instead of the
                                                                Micronucleus Test        in vitro method to
                                                                [sampled in bone         address a chromosomal
                                                                marrow] (in vivo in      damage test requirement
                                                                rodents: mouse           must submit to EPA a
                                                                (preferred species),     rationale for
                                                                rat, or Chinese          conducting that
                                                                hamster): 40 CFR         alternate test in the
                                                                799.9539.                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                 Developmental Toxicity
                                                                OR....................   Screening Test (40 CFR
                                                               Reproduction/             799.9365). However,
                                                                Developmental Toxicity   there may be valid
                                                                Screening Test: 40 CFR   reasons to test a
                                                                799.9355.                particular chemical
                                                                AND...................   using both 40 CFR
                                                               Repeated Dose 28-Day      799.9355 and 40 CFR
                                                                Oral Toxicity Study in   799.9305 to fill
                                                                rodents: 40 CFR          Mammalian Toxicity--
                                                                799.9305.                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
----------------------------------------------------------------------------------------------------------------
i. 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-2007-0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located at
  1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
  legal holidays.

ii. 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-2007-0531 at the EPA Docket Center, Rm. 3334 in
  the EPA West Bldg. located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday
  through Friday, excluding legal holidays.
iii. 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. Test sponsors who wish to conduct Test Group 1 studies on such chemicals
  may request a modification to the test standard as described in 40 CFR 790.55. Based upon the supporting
  rationale provided by the test sponsor, EPA may allow an alternative threshold or method be used for
  determining whether acute or chronic aquatic toxicity testing be performed for a specific substance.
iv. The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available under docket ID number EPA-HQ-
  OPPT-2007-0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located at 1301 Constitution Ave.,
  NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
v. 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-2007-0531 at the EPA Docket
  Center, Rm. 3334 in the EPA West Bldg. located at 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 [date 30 days
after date of publication of the final rule in the Federal Register].
[FR Doc. E8-16992 Filed 7-23-08; 8:45am]

BILLING CODE 6560-50-S