be incurred by any company unless a company decides to pursue a SNU as
defined in this proposed SNUR. However there are limited costs
associated with the recordkeeping requirements required by this SNUR,
whether or not a SNUN is submitted. Furthermore, while the expense of a
notice and the uncertainties of possible EPA regulation may discourage
certain innovations, that impact would be limited because such factors
are unlikely to discourage an innovation that has high potential value.
EPA's complete economic analysis is available in the public docket for
this proposed rule (Ref. 46).
    2. Export notification. Under section 12(b) of TSCA and the
implementing regulations at 40 CFR part 707, subpart D, exporters must
notify EPA if they export or intend to export a chemical substance or
mixture for which, among other things, a rule has been proposed or
promulgated under TSCA section 5. For persons exporting a chemical
substance the subject of a proposed or final SNUR, a one-time notice
must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical substance, depending on the number of required notifications
(i.e., the number of countries to which the chemical substance is
exported). Although EPA estimates that an exporting company making
notifications may need to prepare 12 notifications per year at a cost
of $78.56 each, EPA is unable to make any estimate of the likely number
of export notifications for the chemical substances covered in this
proposed SNUR (Ref. 46).

VIII. Request for Public Comment

    EPA is interested in stakeholder input on a number of issues in
this action as well as future actions on high production volume
chemical substances.
    1. In this document, EPA is proposing either a test rule or SNUR to
regulate a given set of chemical substances. EPA believes that this is
an efficient way to require submission of test data on chemical
substances that meet all of the necessary exposure criteria and require
submission of a notification to EPA if

and when additional exposure criteria are met. The SNUR also
facilitates efficiency by mitigating the need for EPA to continually
reevaluate each HPV chemical substance to determine whether conditions
have changed so as to increase potential exposure. EPA is considering
proposing further combined test rules/SNURs in conjunction with future
CDR data releases, covering all newly-HPV chemical substances. EPA
requests comment on this approach.
    2. EPA is proposing to incorporate the ``B Policy'' worker exposure
threshold into the proposed SNU designations because it is a clear,
numeric criterion that has been used to determine substantial human
exposure since 1993. EPA is interested in receiving comment concerning
use of the ``B Policy'' in this context.
    3. EPA solicits comment on whether any of the chemical substances
proposed for the SNUR are already being manufactured or processed for
one of the significant new uses listed in Unit V., and should
consequently be included in the test rule. Analogously, EPA solicits
comment on whether any of the chemical substances proposed for the test
rule are no longer used in applications that meet the substantial human
exposure finding described in the ``B Policy'' and should consequently
be included in the SNUR.
    4. EPA solicits comment on whether any of the chemical substances
proposed for the test rule or the SNUR should be subject to neither a
test rule nor a SNUR. EPA requests comment on this topic so as to
confirm or refute the Agency's general expectation that either a SNUR
or a test rule is warranted for each chemical substance listed in
Tables A. and B. of Unit III. EPA's general expectation is as follows:
If additional information indicates that a test rule is not warranted
for a particular chemical substance listed in Table A. because
particular uses are not ongoing, EPA generally anticipates that such
information would indicate that a SNUR is warranted instead.
Conversely, if additional information indicates that a SNUR is not
warranted for a particular chemical substance listed in Table B.
because particular uses are already ongoing, EPA generally anticipates
that such information would indicate that a test rule is warranted
instead.
    5. EPA solicits comment on whether there is a better alternative to
proposing the SNUR trigger of >=1000 workers exposed at a single
corporate entity. The test rule findings are based on >=1000 workers
exposed at the national level. EPA asks for comment on whether there is
an approach that would reduce the discrepancy between the corporate
level for the SNUR and national level for the test rule.
    6. EPA solicits comment respecting relevant trends in production
volume for the chemical substances proposed to be subject to either a
test rule or a SNUR. EPA is especially interested in such trend
information in the case that a commenter believes that neither a test
rule nor a SNUR is warranted for a chemical substance because the
chemical substance currently has an overall production volume of less
than 1 million lbs. per year. Because production volume may vary from
year to year, EPA does not believe that the mere fact that the most
recent annual production volume is less than 1 million pounds would
necessarily establish that a test rule is not warranted (and such
information would not by itself suggest that a SNUR is unwarranted,
since substantial production is not a required finding for SNURs). More
detailed comments, distinguishing a long-term decline in production
volume from a short-term dip, would be especially helpful to the Agency
in evaluating any comments that current production volumes are too low
to warrant the regulatory action proposed.
    7. As described in Unit IV.B., to the extent that EPA learns that
consumer uses, or uses that could affect 1,000 workers or more, are
already ongoing for a chemical substance listed in Table B., it intends
to evaluate whether taking steps to promulgate a test rule for the
chemical substance is warranted. To assist the Agency in such
circumstances, EPA solicits comment respecting the sufficiency of the
available data and the need for additional testing on the chemical
substances in Table B., consistent with the standards set forth in TSCA
sections 4 (a)(1)(B)(ii) and (a)(1)(B)(iii).
    8. The U.S. National Academy of Sciences National Research Council
in their 2007 report ``Toxicity Testing in 21st Century: A Vision and a
Strategy'' encouraged ``work[ing] towards a transition to new
integrative and predictive molecular and computational techniques to
enhance efficiency and accuracy and to reduce reliance on animal
testing.'' EPA requests suggestions on practical, implementable ways to
work toward this goal in its actions under TSCA. Should tools such as
ToxCast (http://www.epa.gov/ncct/toxcast/) be used to prioritize
chemical substances and support hazard findings for testing in the
future?
    9. EPA solicits comments which identify existing data that may meet
the requirements of studies under the proposed test rule. To the extent
that data relevant to the testing specified in the 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 the 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. 8).
To the extent that studies required under the proposed rule are
currently available, and the data are judged sufficient by EPA, testing
for the endpoint/chemical substance combination will not be required in
the final test rule based on this proposed rule.
    10. Persons who believe that adequate information regarding a
chemical substance subject to the proposed test rule can be developed
using a category or the SAR approach are encouraged to submit
appropriate information, along with their rationale substantiating this
belief, during the comment period on the proposed rule.
    11. EPA solicits comment on the proposed test rule approaches for
Class 1 and Class 2 chemical substances. Should each Class 1 chemical
substance be tested at a purity of 99% or more? Should the proposed
test substance purity for Class 1 chemical substances be applied to any
Class 2 chemical substances? Should the proposed approach for testing
Class 2 chemical substances (i.e., that a representative sample of each
Class 2 chemical substance be tested) be applied to any Class 1
chemical substances?
    12. For more than 15 years, EPA has used OECD's SIDS to facilitate
and standardize the screening of the relatively large number of
chemical substances on the TSCA Inventory. EPA requests comment on
whether SIDS continues to be the most appropriate data set to screen
chemical substances for potential environmental and health hazards and
whether EPA should consider other data sets in the event of any future
test rule on new HPV chemical substances. Are additional or different
tests also appropriate? Should EPA consider having more than one
screening data set depending on the nature of exposures, e.g., a
different set of tests for children's exposures or environmental
releases?
    13. At the present time, EPA does not have sufficient information
to know with any degree of certainty which if any of the chemical
substances that are listed in the proposed regulatory text are solely
closed system intermediates as defined in the voluntary HPV Challenge
guidance document (Ref. 38). Persons who believe that a chemical
substance

fully satisfies the terms outlined in the guidance document are
encouraged to submit appropriate information along with their comments
on this proposed rule which substantiate this belief.

IX. Materials in the Docket

    As indicated under ADDRESSES, a docket has been established for
this proposed rule under docket ID number EPA-HQ-OPPT-2010-0520. The
following is a listing of the documents that have been placed in the
docket for this proposed rule. The docket includes information
considered by EPA in developing this proposed rule, including the
documents listed in this unit, which are physically located in the
docket. In addition, interested parties should consult documents that
are referenced in the documents that EPA has placed in the docket,
regardless of whether these referenced documents are physically located
in the docket. For assistance in locating documents that are referenced
in documents that EPA has placed in the docket, but that are not
physically located in the docket, please consult either technical
person listed under FOR FURTHER INFORMATION CONTACT. The docket is
available for review as specified under ADDRESSES.

1. OECD Secretariat. Manual for the Investigation of HPV Chemicals.
OECD Programme on the Co-Operative Investigation of High Production
Volume Chemicals. Paris, France. December, 2009. Available on-line
at: http://www.oecd.org/document/7/0,3746,en_2649_34379_1947463_1_1_1_1,00.html.
2. EPA. TSCA section 4(a)(1)(B) Final Statement of Policy; Criteria
for Evaluating Substantial Production, Substantial Release, and
Substantial or Significant Human Exposure; Notice. Federal Register
(58 FR 28736, May 14, 1993).
3. U.S. National Academy of Sciences, National Research Council.
``Toxicity Testing in the 21st Century: A Vision and a Strategy.''
2007. Available on-line at: http://dels.nas.edu/resources/static-assets/materials-based-on-reports/reports-in-brief/Toxicity_Testing_final.pdf.
4. EPA. National Center for Computational Toxicology.
ToxCastTM. 2007. http://www.epa.gov/ncct/toxcast/.
5. EPA. OPPT. Testing of Certain High Production Volume Chemicals-4
(Exposure Findings Supporting Information). Prepared by OPPT,
Economics, Exposure and Technology Division. March, 2011.
6. EPA. OPPT. High Production Volume Chemical Data Information
System (HPVIS). Data from HPVIS on 23 HPV chemicals. June 2011.
7. EPA. OPPT. Risk Assessment Division. HPV4 Data Adequacy
Evaluations. 2010.
8. EPA. OPPT. Draft Guidance on Developing Robust Summaries. October
22, 1999. Available on-line at: http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
9. ASTM International. Standard Test Method for Relative Initial and
Final Melting Points and the Melting Range of Organic Chemicals.
ASTM E 324-99. 1999.
10. OECD. Guideline for the Testing of Chemicals: Melting Point/
Melting Range. OECD 102. July 27, 1995.
11. ASTM International. Standard Test Method for Vapor Pressure of
Liquids by Ebulliometry. ASTM E 1719-05. 2005.
12. ASTM International. Standard Test Method for Determining Vapor
Pressure by Thermal Analysis. ASTM E 1782-03 (2008).
13. ASTM International. Standard Test Method for Partition
Coefficient (n-Octanol/Water) Estimation by Liquid Chromatography.
ASTM E 1147-92 (2005).
14. ASTM International. Standard Test Method for Measurements of
Aqueous Solubility. ASTM E 1148-02 (2008).
15. ASTM International. Question about ASTM E 324. E-mail from Diane
Rehiel, ASTM, to Greg Schweer, CITB, CCD, OPPT, EPA. September 15,
2004.
16. Meylan, W.M. and Howard, P.H. Atom/Fragment Contribution Method
for Estimating Octanol-Water Partition Coefficients. Journal of
Pharmaceutical Sciences. Vol. 84(1):83-92. 1995.
17. 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. Vol. 15(2):100-
106. 1996.
18. ASTM International. Standard Test Method for Determining Ready,
Ultimate, Biodegradability of Organic Chemicals in a Sealed Vessel
CO2 Production Test. ASTM E 1720-01. (Reapproved 2008).
19. 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.
20. 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.
21. 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.
22. ISO. Water quality--Evaluation of ultimate aerobic
biodegradability of organic compounds in aqueous medium--Carbon
dioxide evolution test. ISO 9439. 1999.
23. 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.
24. 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.
25. 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
10631. 1995.
26. ASTM International. Standard Guide for Conducting Acute Toxicity
Tests on Test Materials with Fishes, Macroinvertebrates, and
Amphibians. ASTM E 729-96 (2007).
27. ASTM International. Standard Guide for Conducting Static
Toxicity Tests with Microalgae. ASTM E 1218-04e1. 2004.
28. ASTM International. Standard Guide for Conducting Daphnia magna
Life-Cycle Toxicity Tests. ASTM E 1193-97 (2004).
29. Veith, G.D. and Kosian, P. Estimating bioconcentration potential
from Octanol/Water Partition Coefficients, in Physical Behavior of
PCBs in the Great Lakes (MacKay, Paterson, Eisenreich, and Simmons,
eds.), Ann Arbor Science, Ann Arbor, MI. 1982.
30. Bintein, S.; DeVillers, J.; and Karcher, W. Nonlinear dependence
of fish bioconcentration on n-Octanol/Water Partition Coefficient.
SAR and QSAR in Environmental Research. Vol. 1, pp. 29-39. 1993.
31. EPA. Category for Persistent, Bioaccumulative, and Toxic New
Chemical Substances; Notice. Federal Register (64 FR 60194, November
4, 1999) (FRL-6097-7). Available online at: http://www.epa.gov/oppt/newchems/pubs/pbtpolcy.htm.
32. EPA. Significant New Use Rules; General Provisions for New
Chemical Follow-Up; Final Rule. Federal Register (54 FR 31298, July
27, 1989).
33. ASTM International. Standard Test Method for Estimating Acute
Oral Toxicity in Rats. ASTM E 1163-98 (2002).
34. 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. NTP/NICEATM. November 4, 2003.
Available online at: http://iccvam.niehs.nih.gov/methods/acutetox/invidocs/phIIIprot/3t3phIII.pdf.
35. 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. NTP/NICEATM. November 4, 2003.
Available online at: http://iccvam.niehs.nih.gov/methods/acutetox/invidocs/phIIIprot/nhkphIII.pdf.
36. 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 online at: http://iccvam.niehs.nih.gov/methods/acutetox/inv_cyto_guide.htm.
37. 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
online at: http://iccvam.niehs.nih.gov/methods/acutetox/invidocs/phIIIprot/solphIII.pdf.
38. EPA. OPPT. Guidance for Testing Closed System Intermediates for
the HPV Challenge Program (Draft) (March 17, 1999). Available online
at: http://www.epa.gov/oppt/chemrtk/pubs/general/closed9.htm.
39. EPA. Testing of Certain High Production Volume Chemicals; Final
Rule. Federal Register (71 FR 13708, March 16, 2006) (FRL-7335-2).
40. EPA. Testing of Certain High Production Volume Chemicals; Second
Group of Chemicals; Proposed Rule. Federal Register (73 FR 43314,
July 24, 2008) (FRL-8373-9).
41. EPA. Proposed Test Rule for the Testing of Certain High
Production Volume Chemicals; Third Group of Chemicals. Federal
Register (75 FR, February 25, 2010) (FRL-9116-2).
42. EPA. Toxic Substances; Test Rule Development and Exemption
Procedures; Interim Final Rule. Federal Register (50 FR 20652, May
17, 1985).
43. EPA. Toxic Substances Control Act; Data Reimbursement; Final
Rule. Federal Register (48 FR 31786, July 11, 1983).
44. EPA. Analysis of Laboratory Capacity to Support U.S. EPA
Chemical Testing Program Initiatives. Economic and Policy Analysis
Branch. Washington, DC. October 28, 2010.
45. EPA. OPPT. Economic Analysis for the Proposed High Production
Volume Challenge Chemicals Test Rule--Fourth Group of Chemicals.
Prepared by the Economic and Policy Analysis Branch, Economics,
Exposure and Technology Division. August 15, 2011.
46. EPA. OPPT. Economic Analysis of the Significant New Use Rule for
High Production Volume Chemical Substances. Prepared by the Economic
and Policy Analysis Branch, Economics, Exposure and Technology
Division. May 26, 2011.

X. Statutory and Executive Order Reviews

A. Regulatory Planning and Review

    This proposed rule is not a ``significant regulatory action'' under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993) and 13563, entitled (76 FR 3821, January 21,
2011).

B. Paperwork Activities

    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires
approval by the Office of Management and Budget (OMB) under the PRA,
unless it has been approved by OMB and displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations in title
40 of the CFR, after appearing in the Federal Register, are listed in
40 CFR part 9, and included on the related collection instrument, or
form, if applicable.
    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.
    For this rulemaking, the paperwork activities are addressed in 3
parts, based on the separate activities.
    1. Paperwork activities related to testing. The proposed testing in
this rulemaking does not impose any new or amended paperwork collection
requirements that would require additional review and/or approval by
OMB under the PRA. 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
proposed test rule is provided in the economic analysis (Ref. 45).
    The standard chemical substance 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 23 chemical substances is 38,000 hours
(average cost scenario). EPA assumes that industry will form a ``task
force'' or panel to coordinate testing where appropriate. A consortium
represents all the manufacturers of a chemical substance. EPA estimates
23 consortia for the proposed rule; with an estimated burden per
consortium of 2,000 hours (rounded) (Ref. 45).
    2. Paperwork activities related to SNUNs. The information
collection requirements related to the proposed SNUR have already been
approved by OMB pursuant to the PRA under OMB control number 2070-0038
(EPA ICR No. 1188). This action does not impose any burden requiring
additional OMB approval.
    If an entity were to submit a SNUN to the Agency, the annual burden
is estimated to average 91.68 hours per response. This burden estimate
includes the time needed to review instructions, search existing data
sources, gather and maintain the data needed, and complete, review, and
submit the required SNUN. In addition, depending on whether or not an
entity submits a SNUN, EPA has estimated the burden of the associated
recordkeeping requirements (Ref. 46).
    3. Paperwork activities related to export notifications. The
information collection activities related to export notification under
TSCA section 12(b)(1) are already approved under OMB control number
2070-0030 (EPA ICR No. 0795). This proposed rule 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.
    The estimated burden of the information collection activities
related to export notification is estimated to average 1 burden hour
for each chemical substance/country combination for an initial
notification and 0.5 hours for each subsequent notification (Ref. 46).
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 substance 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.
    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 rule 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 proposed rule.

C. Small Entity Impacts

    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 each of the economic analyses for this
proposed rule (Refs. 45 and 46), which are summarized in Unit VII., and
copies of which are available in the docket for this proposed rule. 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 RFA as:
     A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201.
     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.
     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 rule (Ref. 45), 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.
    For this rulemaking, EPA considered the potential impact on small
entities associated with the proposed testing, SNU notifications, and
export notifications.
    1. Potential small entity impacts related to the proposed testing.
Two factors are examined in EPA's small entity impact analysis (Ref.
45) in order to characterize the potential small entity impacts of the
proposed testing on small business:
     The size of the adverse economic impact (measured as the
ratio of the cost to sales or revenue).
     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 rule, EPA has
analyzed the potential small business impacts using the size standards
established under this default definition. The SBA size standards,
which are primarily intended to determine whether a business entity is
eligible for government programs and preferences reserved for small
businesses (13 CFR 121.101), ``seek to ensure that a concern that meets
a specific size standard is not dominant in its field of operation.''
(13 CFR 121.102(b)). See section 632(a)(1) of the Small Business Act.
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 substance manufacturing industrial sector (i.e., NAICS
code 325 and NAICS code 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 substance manufacturers, EPA believes that a standard based
on total annual sales may provide a more appropriate means to judge the
ability of a chemical substance manufacturing firm to support chemical
substance 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 substance industry usually impacted by TSCA
section 4(a) test rules, but has not yet reached a determination. As
stated in this unit, therefore, the factual basis for the RFA
determination for this proposed rule is based on an analysis using the
default SBA size standards. Although EPA is not 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.
    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
affected (Ref. 45). For a conservative estimate of the number of small
businesses affected by the HPV rules, the Agency uses an employment
threshold of less than 1,500 employees for all businesses regardless of
the NAIC-specific threshold to determine small business status (Ref.
45).
    For each manufacturer of the 23 chemical substances covered by the
proposed testing, 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 59 affected UCEs. Sales data could be found for 52 of these
UCE's and employment data could be found for 57 of these UCEs. Two
companies could not be classified as small or large because there were
no employment data available (Ref. 45).
    Parent company sales data were collected to identify companies that
qualified as a ``small business'' for purposes of RFA analysis. Based
on the SBA size standard applied (1,500 employees or less), 25
companies (42.4%) were identified as small (Ref. 45).
    The potential significance of the proposed testing'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 (Ref. 45).
    Of the 25 businesses designated as small business, none had cost-
to-sales ratios of greater than 1% and 3% under both the least and
average cost scenarios. For the chemical substances where sales data
were unavailable, EPA used the median revenue of all other small
businesses equal to $2.56 million. The costs for these companies were
estimated to be well below 1% 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 the
proposed testing, if finalized (Ref. 45).
    2. Potential small entity impacts related to the SNUR. A SNUR
applies to any person (including small or large entities) who intends
to engage in any activity described in the rule as a ``significant new
use.'' By definition of the word ``new'' and based on all information
currently available to EPA, it appears that no small or large entities
presently engage in such activity. Since a SNUR only requires that any
person who intends to engage in such activity in the future must first
notify EPA by submitting a SNUN, there are no costs associated with the
SNUN until it is submitted. However there are limited costs associated
with the recordkeeping requirements required by this SNUR, whether or
not a SNUN is submitted. Although some small entities may decide to
conduct such activities in the future, EPA cannot presently determine
how many, if any, there may be.
    EPA's experience to date is that, in response to the promulgation
of over 1,000 SNURs, the Agency receives on average less than 10
notices per year. Of those SNUNs submitted, none appear to be from
small entities in response to any SNUR. In addition, the estimated
reporting cost for submission of a SNUN (see Unit VII.), are minimal
regardless of the size of the firm. Therefore, EPA believes that the
potential economic impact of complying with this SNUR is not expected
to be significant or adversely impact a substantial number of small
entities. In a SNUR that published on June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented its general determination that proposed
and final SNURs are not expected to have a significant economic impact
on a substantial number of small entities, which was also provided to
the Chief Counsel for Advocacy of the Small Business Administration
(Ref. 46).
    3. Potential small entity impacts related to export notifications.
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 substance subject to the
final rule, is estimated to be $85.70 for the first time that an
exporter must comply with TSCA section 12(b)(1) export notification
requirements, and $26.86 for each subsequent export notification
submitted by that exporter (Refs. 45 and 46). EPA has concluded that
the costs of TSCA section 12(b)(1) export notification would have a
negligible impact on exporters of the chemical substances in the final
rule, regardless of the size of the exporter.
    Any comments regarding the potential adverse economic 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

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA), 2 U.S.C. 1531-1538, EPA has determined that this proposed rule
does not contain a Federal mandate that may result in expenditures of
$100 million or more for State, local, and Tribal governments, in the
aggregate, or the private sector in any one year. It is estimated that
the total aggregate costs of this proposed rule to the private sector,
which are summarized in Unit VII., would be $7.65 million. The total
annualized costs of this proposed rule to the private sector are
estimated to be $2.71 and $2.92 million using a 3% and 7% discount rate
over 3 years (average cost scenario).
    In addition, since EPA does not have any information to indicate
that any State, local, or Tribal government manufactures or processes
the chemical substances covered by this action such that the final rule
would apply directly to State, local, or Tribal governments, EPA has
determined that this proposed test rule and SNUR 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. Federalism

    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 they 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 chemical substances. Because EPA
has no information to indicate that any State or local government
manufactures or processes the chemical substances covered by these
actions, this proposed test rule and SNUR is not expected to affect any
State or local governments. Thus, Executive Order 13132 does not apply
to this proposed rule.

F. Indian Tribal Government Implications

    Under Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (59 FR 22951, November 9, 2000), EPA has
determined that this proposed rule does not have Tribal implications
because it will not have substantial direct effects on Tribal
governments, on the relationship between the Federal Government and the
Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes, as specified in the
Executive Order. Thus, Executive Order 13175 does not apply to this
proposed rule.

G. Protection of Children

    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 the rulemaking 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, notification
and recordkeeping requirements that apply to manufacturers (including
importers) and processors of certain chemical substances. The
development of data about those chemical substances can subsequently be
used to assist the Agency and others in determining

whether the chemical substances in this proposed rule present potential
risks, allowing the Agency and others to take appropriate action to
investigate and mitigate those risks.

H. Effect on Energy Supply, Distribution, or Use

    This proposed rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations that Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because it is not a significant regulatory action under Executive Order
12866.

I. Technical Standards

    Section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA), 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.
    The proposed test 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 the
final rule, EPA is proposing the use of voluntary consensus standards
issued by ASTM International and ISO which evaluate the same type of
toxicity as the TSCA 799 test guidelines and OECD test guidelines,
where applicable. Copies of the 17 ASTM International and ISO standards
referenced in the proposed regulatory text at Sec.  799.5090(h) have
been placed in the docket for this proposed rule. You may obtain copies
of the ASTM International standards from the American Society for
Testing and Materials International, 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 Geneve 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 International 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 799 test
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 rule, and, specifically, invites
the public to identify potentially applicable consensus standard(s) and
to explain why such standard(s) should be used here.

J. Environmental Justice

    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 test rule, if finalized,
will assist EPA and others in determining the potential hazards and
risks associated with the chemical substances covered by this proposed
test rule. Although not directly impacting environmental justice-
related concerns, this information will enable the Agency to better
protect human health and the environment, including in low-income and
minority communities.

List of Subjects

40 CFR Part 721

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

40 CFR Part 799

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

    Dated: September 28, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 continues to read as
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

    2. Add Sec.  721.10228 to subpart E to read as follows:

Sec.  721.10228  High production volume challenge program chemical
substances.

    (a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified in Table 1. are
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.

        Table 1--List of Chemical Substances Included in the SNUR
------------------------------------------------------------------------
 Chemical abstract service registry number  Chemical abstract (CA) index
                  (CASRN)                               name
------------------------------------------------------------------------
98-16-8...................................  Benzenamine, 3-
                                             (trifluoromethyl)-.
100-53-8..................................  Benzenemethanethiol.
104-91-6..................................  Phenol, 4-nitroso-.
110-03-2..................................  2,5-Hexanediol, 2,5-dimethyl-
                                             .
124-63-0..................................  Methanesulfonyl chloride.
142-30-3..................................  3-Hexyne-2,5-diol, 2,5-
                                             dimethyl-.
460-00-4..................................  Benzene, 1-bromo-4-fluoro-.
542-92-7..................................  1,3-Cyclopentadiene.

553-26-4..................................  4,4'-Bipyridine.
8007-45-2.................................  Tar, coal.
28106-30-1................................  Benzene, ethenylethyl-.
35203-06-6................................  Benzenamine, 2-ethyl-6-
                                             methyl-N-methylene-.
35203-08-8................................  Benzenamine, 2,6-diethyl-N-
                                             methylene-.
37734-45-5................................  Carbonochloridothioic acid,
                                             S-(phenylmethyl) ester.
37764-25-3................................  Acetamide, 2,2-dichloro-N,N-
                                             di-2-propen-1-yl-.
61789-72-8................................  Quaternary ammonium
                                             compounds,
                                             benzyl(hydrogenated tallow
                                             alkyl)dimethyl, chlorides.
61790-13-4................................  Naphthenic acids, sodium
                                             salts.
65996-91-0................................  Distillates (coal tar),
                                             upper.
68308-01-0................................  Tail gas (petroleum),
                                             cracked distillate
                                             hydrotreater stripper.
68478-20-6................................  Residues (petroleum), steam-
                                             cracked petroleum
                                             distillates cyclopentadiene
                                             conc., C4-cyclopentadiene-
                                             free.
68526-82-9................................  Alkenes, C6-10,
                                             hydroformylation products,
                                             high-boiling.
68909-77-3................................  Ethanol, 2,2'-oxybis-,
                                             reaction products with
                                             ammonia, morpholine derivs.
                                             residues.
------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Use in a consumer product.
    (ii) Any use, or combination of uses, that is reasonably likely to
expose 1,000 or more workers at a single corporate entity (defined as
the aggregate of all of the domestic facilities owned or operated by an
individual corporation).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), and (c) are applicable to manufacturers, importers,
and processors of these substances.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

PART 799--[AMENDED]

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

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

    4. Add Sec.  799.5090 to subpart D to read as follows:

Sec.  [emsp14]799.5090  Chemical testing requirements for certain high
production volume chemicals; fourth 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'' chemical substances in Table 2. in paragraph
(j) of this section, the purity of each chemical substance must be 99%
or greater, unless otherwise specified in this section. For the
chemical substances identified as ``Class 2'' chemical substances in
Table 2. in paragraph (j), a representative form of each chemical
substance must be tested. The representative form selected for a given
Class 2 chemical substance should meet industry or consensus standards
where they exist.
    (b) Am I subject to this section? (1) If you manufacture (including
import) or intend to manufacture, or process or intend to process, any
chemical substance listed in Table 2. in paragraph (j) of this section
at any time from 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
------------------------------------------------------------------------
                                          Persons not initially required
  Persons initially required to comply     to comply with this section
       with this section (Tier 1)                    (Tier 2)
------------------------------------------------------------------------
Persons not otherwise specified in       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 chemical substance (as
                                             described at 40 CFR
                                             720.45(a)(1)(i));
                                            --In amounts of less than
                                             500 kg (1,100 lbs.)
                                             annually (as described at
                                             40 CFR 790.42(a)(4)); or
                                            --For research and
                                             development (as described
                                             at 40 CFR 790.42(a)(5)).

                                         Tier 2B. 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 40 CFR
790.42(a)(2), (a)(4) and (a)(5), 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 Federal Register
document described in paragraph (c)(4) of this section.
    (6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its
intent to conduct one or more of the tests required by this section on
any chemical substance listed in Table 2. in paragraph (j) of this
section within 30 days after the publication of the Federal Register
document described in paragraph (c)(4) of this section, EPA will
publish another Federal Register document that would specify the
test(s) and the chemical substance(s) for which no letter of intent has
been submitted, and notify processors in Tier 2B of their obligation to
submit a letter of intent to test or to apply for an exemption from
testing.
    (7) If you are in Tier 2B (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 Federal Register 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 Federal
Register 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 40 CFR 790.93
and 790.97, 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 submission of study plans prior to testing, the
conduct of testing, and the submission of data; 40 CFR part 792--Good
Laboratory Practice Standards; 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; Sec.  790.48; paragraph (a)(2)
and paragraph (b) of Sec.  790.80; paragraph (e)(1) of Sec.  790.82;
and Sec.  790.85.
    (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 40 CFR part
707, subpart D.
    (h) How must I conduct my testing? 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 publication of the final rule in the
Federal Register] unless an extension is granted in writing pursuant to
40 CFR 790.55. A robust summary of the final report for each specific
test may be submitted electronically 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
on-line at: http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
    (j) Designation of specific chemical substances and testing
requirements. The chemical substances identified by chemical substance
name, Chemical Abstract Service Registry Number (CASRN), 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
----------------------------------------------------------------------------------------------------------------
  Chemical abstract service registry      Chemical abstract (CA) index                Required tests (see Table
            number (CASRN)                            name                  Class        3. of this section)
----------------------------------------------------------------------------------------------------------------
56-40-6...............................  Glycine.........................          1  A3
67-72-1...............................  Ethane, 1,1,1,2,2,2-hexachloro-.          1  C6
78-00-2...............................  Plumbane, tetraethyl-...........          1  A4, A5, C6, E2
95-14-7...............................  1H-Benzotriazole................          1  A3, C6, F1
118-48-9..............................  2H-3,1-Benzoxazine-2,4(1H)-dione          1  A3, A4, A5, C3, E1, E2, F1
128-44-9..............................  1,2-Benzisothiazol-3(2H)-one,             1  A2, A3, A4, A5, C1, F1
                                         1,1-dioxide, sodium salt (1:1).
928-72-3..............................  Glycine, N-(carboxymethyl)-,              1  A1, A3, A4, A5, B
                                         sodium salt (1:2).
1809-19-4.............................  Phosphonic acid, dibutyl ester..          1  A1, A4, C1, E1, E2, F1
25377-73-5............................  2,5-Furandione, 3-(dodecen-1-             1  A1, A2, A3, A4, A5, B, C1,
                                         yl)dihydro-.                                 D, E2, F1
26544-38-7............................  2,5-Furandione, dihydro-3-                1  A1, A2, A3, A4, A5, B, C1,
                                         (tetrapropenyl)-.                            D, E1, E2, F1
27859-58-1............................  Butanedioic acid, 2-                      1  A1, A2, A3, A4, A5, C1, D,
                                         (tetrapropenyl)-.                            E1, E2, F1
28777-98-2............................  2,5-Furandione, dihydro-3-                1  A2, A3, A4, A5, C1, D, E1,
                                         (octadecen-1-yl)-.                           E2, F1
29385-43-1............................  1H-Benzotriazole, 6(or 7)-methyl-         1  A3, A4, A5, E2, F1
                                         .
32072-96-1............................  2,5-Furandione, 3-(hexadecen-1-           1  A1, A2, A3, A4, A5, B, C1,
                                         yl)dihydro-.                                 D, E1, E2, F1
61789-73-9............................  Quaternary ammonium compounds,            2  A3
                                         benzylbis(hydrogenated tallow
                                         alkyl)methyl, chlorides.
64665-57-2............................  1H-Benzotriazole, 6(or 7)-methyl-         1  A1, A3, A4, A5, E1, E2, F1,
                                         , sodium salt.
68131-13-5............................  Naphthenic acids, reaction                2  C1, D, E1, E2, F1
                                         products with
                                         diethylenetriamine.
68153-60-6............................  Fatty acids, tall-oil, reaction           2  A1, A2, A3, A4, A5, B, C1,
                                         products with                                D, E1, E2, F1
                                         diethylenetriamine, acetates.
68424-85-1............................  Quaternary ammonium compounds,            1  A1, A2, A3
                                         benzyl-C12-16-
                                         alkyldimethyl,chlorides.
68442-77-3............................  2-Butenediamide, (2E)-, N1,N4-            2  A1, A2, A3, A4, A5, B,
                                         bis[2-(4,5-dihydro-2-nortall-               C1, D, E1, E2, F1
                                         oil alkyl-1H-imidazol-1-
                                         yl)ethyl] derivs.
68607-28-3............................  Quaternary ammonium compounds,            2  A1, A2, A3, A4, A5,
                                         (oxydi-2,1-ethanediyl)bis[coco
                                         alkyldimethyl, dichlorides.

68909-18-2............................  Pyridinium, 1-(phenylmethyl)-,            2  A1, A2, A3, A4, A5, C1, D,
                                         Et Me derivs., chlorides.                    E1, E2, F1
69834-17-9............................  Benzene, decylphenoxy-..........          1  A1, A2, A3, A4, A5, B, C1,
                                                                                D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------

                Table 3--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2
----------------------------------------------------------------------------------------------------------------
                                          Test         Test requirements and
           Testing category              symbol             references                  Special conditions
----------------------------------------------------------------------------------------------------------------
Physical/chemical properties..........        A   1. Melting Point: ASTM E 324-
                                                   99 (capillary tube), if a
                                                   Freezing Point: Organisation
                                                   for Economic Co-operation and
                                                   Development (OECD) 102
                                                   (melting point/melting
                                                   range).
                                        ........  2. Boiling Point: ASTM E 1719-
                                                   05 (ebulliometry).
                                        ........  3. Vapor Pressure: ASTM E 1782- ..............................
                                                   03 (thermal analysis).
Physical/chemical properties                  A   4. n-Octanol/Water Partition    n-Octanol/Water Partition
 (continued).                                      Coefficient (log 10 basis) or   Coefficient or log Kow: Which
                                                   log Kow: (see special           method is required, if any,
                                                   conditions for the log Kow      is determined by the test
                                                   test requirement and select     substance's estimated \1\ log
                                                   the appropriate method to       Kow as follows:
                                                   use, if any, from those        log Kow <0: no testing
                                                   listed in this column).         required.
                                                  Method A: 40 CFR 799.6755       log Kow range 0-1: Method A or
                                                   (shake flask)..                 B.
                                                  Method B: ASTM E 1147-92(2005)  log Kow range > 1-4: Method A
                                                   (liquid chromatography)..       or B or C.
                                                  Method C: 40 CFR 799.6756       log Kow range > 4-6: Method B
                                                   (generator column).             or C.
                                                                                log Kow > 6: Method C.
                                                                                Test sponsors must provide in
                                                                                the final study report the
                                                                                underlying rationale for the
                                                                                method and pH selected. In
                                                                                order to ensure environmental
                                                                                relevance, EPA highly
                                                                                recommends that the selected
                                                                                study be conducted at pH 7.
                                                  5. Water Solubility: (See       Water Solubility:
                                                   special conditions for the     Which method is required, if
                                                   water solubility test           any, is determined by the
                                                   requirement and select the      test substance's estimated
                                                   appropriate method to use, if   \2\ water solubility. Test
                                                   any, from those listed in       sponsors must provide in the
                                                   this column).                   final study report the
                                                  Method A: ASTM E 1148-02         underlying rationale for the
                                                   (shake flask).                  method and pH selected. In
                                                  Method B: 40 CFR 799.6784        order to ensure environmental
                                                   (shake flask).                  relevance, EPA highly
                                                  Method C: 40 CFR 799.6784        recommends that the selected
                                                   (column elution).               study be conducted starting
                                                  Method D: 40 CFR 799.6786        at pH 7.
                                                   (generator 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--ready        B   For B, consult ISO 10631 for    Which method is required, if
 biodegradation.                                   guidance, and choose one of     any, is determined by the
                                                   the methods listed in this      test substance's physical and
                                                   column:                         chemical properties,
                                                  1. ASTM 1720-01 (sealed vessel   including its water
                                                   CO2 production test) or.        solubility. ISO 10631
                                                  2. ISO 14593 (CO2 headspace      provides guidance for
                                                   test) or.                       selection of an appropriate
                                                  3. ISO 7827 (analysis of DOC)    test method for a given test
                                                   or.                             substance. Test sponsors must
                                                  4. ISO 9408 (determination of    provide in the final study
                                                   oxygen demand in a closed       report the underlying
                                                   respirometer) or.               rationale for the method
                                                                                selected.
                                        ........  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 Test    The following are the special
                                                   Group 2 listed in this column   conditions for C1, C2, C3,
                                                   must be used to fulfill the     C4, C5, and C7 testing; there
                                                   testing requirements--see       are no special conditions for
                                                   special conditions.             C6.
                                                  Test Group 1 for C1:..........  Which test group is required
                                                  1. Acute Toxicity To Fish:       is determined by the test
                                                   ASTM E 729-96 (2007)..          substance's measured log Kow
                                                  2. Acute Toxicity To Daphnia:    as obtained under Test
                                                   ASTM E 729-96 (2007)..          Category A, or using an
                                                  3. Toxicity To Plants (Algae):   existing measured log Kow.\3\
                                                   ASTM E 1218-04\e1\..           If log Kow <4.2: Test Group 1
                                                  Test Group 2 for C1:..........   is required.
                                                  1. Chronic Toxicity To          If log Kow = 4.2:
                                                   Daphnia: ASTM E 1193-97         Test Group 2 is required.
                                                   (2004).
                                                  2. Toxicity To Plants (Algae):
                                                   ASTM E 1218-04\e1\..

                                               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 (2007)..
                                                  2. Toxicity To Plants (Algae):
                                                   ASTM E 1218-04\e1\.
                                        ........  Test Group 2 for C2:            ..............................
                                                  1. Chronic Toxicity To
                                                   Daphnia: ASTM E 1193-97
                                                   (2004)..
                                                  2. Toxicity To Plants (Algae):
                                                   ASTM E 1218-04\e1\..
                                               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 (2007).
                                        ........     2. Toxicity To Plants
                                                      (Algae): ASTM E 1218-
                                                      04\e1\.
                                        ........  Test Group 2 for C3:
                                        ........     1. Chronic Toxicity To
                                                      Daphnia: ASTM E 1193-97
                                                      (2004).
                                        ........     2. Toxicity To Plants
                                                      (Algae): ASTM E 1218-
                                                      04\e1\.
                                               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 (2007).
                                        ........     2. Acute Toxicity To
                                                      Daphnia: ASTM E 729-96
                                                      (2007).
                                        ........  Test Group 2 for C4:
                                        ........     1. Chronic Toxicity To
                                                      Daphnia: ASTM E 1193-97
                                                      (2004).
                                               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
                                                      (2007).
                                        ........  Test Group 2 for C5:
                                        ........     1. Chronic Toxicity To       ..............................
                                                      Daphnia: ASTM E 1193-97
                                                      (2004).
                                               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 (2007).
                                        ........  Test Group 2 for C7:
                                           .....  1. Chronic Toxicity To
                                                   Daphnia: ASTM E 1193-97
                                                   (2004).
Mammalian toxicity--acute.............        D   See special conditions for      Which testing method is
                                                   this test requirement and       required is determined by the
                                                   select the method that must     test substance's physical
                                                   be used from those listed in    state at room temperature (25
                                                   this column.                    [deg]C). For those test
                                                  Method A: Acute Inhalation       substances that are gases at
                                                   Toxicity (rat): 40 CFR          room temperature, Method A is
                                                   799.9130..                      required; otherwise, use
                                                  Method B: either:.............   either of the two methods
                                                  1. Acute (Up/Down) Oral          listed under Method B.
                                                   Toxicity (rat): ASTM E 1163-   In Method B, 40 CFR
                                                   98 (2002).                      799.9110(d)(1)(i)(A) refers
                                                  or............................   to the OECD 425 Up/Down
                                                  2. Acute (Up/Down) Oral          Procedure.\4\
                                                   Toxicity (rat): 40 CFR         Estimating starting dose for
                                                   799.9110(d)(1)(i)(A).           Method B: Data from the
                                                                                neutral red uptake basal
                                                                                cytotoxicity assay \5\ using
                                                                                normal human keratinocytes or
                                                                                mouse BALB/c 3T3 cells may be
                                                                                used to estimate the starting
                                                                                dose.
Mammalian toxicity--genotox-icity.....       E1   Bacterial Reverse Mutation      None.
                                                   Test (in vitro): 40 CFR
                                                   799.9510.

                                             E2   Conduct any one of the          Persons required to conduct
                                                   following three tests for       testing for chromosomal
                                                   chromosomal damage:             damage are encouraged to use
                                                  In vitro Mammalian Chromosome    the in vitro Mammalian
                                                   Aberration Test: 40 CFR         Chromosome Aberration Test
                                                   799.9537.                       (40 CFR 799.9537) to generate
                                                  or............................   the needed data unless known
                                                  Mammalian Bone Marrow            chemical properties (e.g.,
                                                   Chromosomal Aberration Test     physical/chemical properties,
                                                   (in vivo in rodents: Mouse      chemical class
                                                   (preferred species), rat, or    characteristics) preclude its
                                                   Chinese hamster): 40 CFR        use. A subject person who
                                                   799.9538.                       uses one of the in vivo
                                                  or............................   methods instead of the in
                                                  Mammalian Erythrocyte            vitro method to address a
                                                   Micronucleus Test [sampled in   chromosomal damage test
                                                   bone marrow] (in vivo in        requirement must submit to
                                                   rodents: mouse (preferred       EPA a rationale for
                                                   species), rat, or Chinese       conducting that alternate
                                                   hamster): 40 CFR 799.9539..     test in the final study
                                                                                report.
Mammalian toxicity--repeated dose/           F1   Combined Repeated Dose          Where F1 is required, EPA
 repro-duction/developmental.                      Toxicity Study with the         recommends use of the
                                                   Reproduction/Developmental      Combined Repeated Dose
                                                   Toxicity Screening Test: 40     Toxicity Study with the
                                                   CFR 799.9365.                   Reproduction/Developmental
                                                  or............................   Toxicity Screening Test (40
                                                  Reproduction/Developmental       CFR 799.9365). However, there
                                                   Toxicity Screening Test: 40     may be valid reasons to test
                                                   CFR 799.9355.                   a particular chemical
                                                  and...........................   substance using both 40 CFR
                                                  Repeated Dose 28-Day Oral        799.9355 and 40 CFR 799.9305
                                                   Toxicity Study in rodents: 40   to fill Mammalian Toxicity--
                                                   CFR 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.
----------------------------------------------------------------------------------------------------------------
\1\ EPA recommends, but does not require, that log Kow be quantitatively estimated prior to initiating this
  study. One method, among many similar methods, for estimating log Kow is described in the article entitled
  Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients) by W.M. Meylan and P.H.
  Howard in the Journal of Pharmaceutical Sciences. 84(1):83-92. January 1992. This reference is available under
  docket ID number EPA-HQ-OPPT-2010-0520 at the EPA Docket Center, Rm. 3331 in the EPA West Building located at
  1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
  legal holidays.
\2\ EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating
  this study. One method, among many similar methods, for estimating water solubility is described in the
  article entitled Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient by
  W.M. Meylan, P.H. Howard, and R.S. Boethling in Environmental Toxicology and Chemistry. 15(2):100-106. 1996.
  This reference is available under docket ID number EPA-HQ-OPPT-2010-0520 at the EPA Docket Center, Rm. 3331 in
  the EPA West Building located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m.,
  Monday through Friday, excluding legal holidays.
\3\ Chemical substances that are dispersible in water may have log Kow values greater than 4.2 and may still be
  acutely toxic to aquatic organisms. Test sponsors who wish to conduct Test Group 1 studies on such chemical
  substances 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.
\4\ The OECD 425 Up/Down Procedure, revised by OECD in December 2001, is available under docket ID number EPA-HQ-
  OPPT-2010-0520 at the EPA Docket Center, Rm. 3331 in the EPA West Building located at 1301 Constitution Ave.,
  NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
\5\ The neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the
  mammalian toxicity-acute endpoint, is available under docket ID number EPA-HQ-OPPT-2010-0520 at the EPA Docket
  Center, Rm. 3331 in the EPA West Building 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. 2011-26894 Filed 10-20-11; 8:45 am]
BILLING CODE 6560-50-P