[Federal Register Volume 76, Number 204 (Friday, October 21, 2011)]
[Proposed Rules]
[Pages 65580-65608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26894]
[[Page 65579]]
Vol. 76
Friday,
No. 204
October 21, 2011
Part III
Environmental Protection Agency
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40 CFR Parts 721 and 799
Certain High Production Volume Chemicals; Test Rule and Significant New
Use Rule; Fourth Group of Chemicals; Proposed Rule
Federal Register / Vol. 76 , No. 204 / Friday, October 21, 2011 /
Proposed Rules
[[Page 65580]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 721 and 799
[EPA-HQ-OPPT-2010-0520; FRL-8876-6]
RIN 2070-AJ66
Certain High Production Volume Chemicals; Test Rule and
Significant New Use Rule; Fourth Group of Chemicals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to issue a test rule under Toxic Substances
Control Act (TSCA) section 4(a)(1)(B) to require manufacturers and
processors of 23 high production volume (HPV) chemical substances to
develop screening-level health, environmental, and fate data based on
the potential for substantial exposures of workers and consumers to
these chemicals. EPA is also proposing to issue simultaneously a
significant new use rule (SNUR) for another 22 HPV chemical substances
under TSCA section 5(a)(2). The SNUR would require persons to file a
significant new use notice (SNUN) with EPA prior to manufacturing,
importing, or processing any of these chemical substances for use in a
consumer product or for any use, or combination of uses, that is
reasonably likely to expose 1,000 or more workers at a single corporate
entity. The required notification would provide EPA with the
opportunity to evaluate the intended use and, if necessary, to prohibit
or limit that activity before it occurs. EPA is also soliciting comment
on a number of issues with regard to both the test rule and the SNUR.
DATES: Comments must be received on or before January 19, 2012.
You may submit a request for an opportunity to present oral
comments. This request must be made in writing. If such a request is
received on or before January 19, 2012, EPA will hold a public meeting
on this proposed rule in Washington, DC.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2010-0520, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2010-0520. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2010-0520. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
Submission of requests: You may submit a request for an opportunity
to present oral comments. This request must be made in writing and
submitted to the mailing or hand delivery addresses provided in this
unit. If such a request is received, EPA will announce the scheduling
of the public meeting in a subsequent document in the Federal Register.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Robert Jones (test rule) or Amy Breedlove (SNUR), Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8161 or (202)
564-9823; e-mail address: [email protected] or
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by these actions if you manufacture
(defined by statute to include import) or process any of the chemical
substances that are listed in Tables A. or B. in Unit III. Potentially
affected entities may include, but are not limited to:
Manufacturers (defined by statute to include importers) of
one or more of the subject chemical substances (NAICS codes 325 and
324110), e.g., chemical manufacturing and petroleum refineries.
Processors of one or more of the subject chemical
substances (NAICS codes 325 and 324110), e.g., chemical manufacturing
and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of
[[Page 65581]]
entities not listed in this unit could also be affected. The North
American Industrial Classification System (NAICS) codes have been
provided to assist you and others in determining whether this action
might apply to certain entities. If you have any questions regarding
the applicability of this action to a particular entity, consult either
technical person listed under FOR FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. See Unit
VI. for export notification requirements.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
C. Can I request an opportunity to present oral comments to the agency?
You may submit a request for an opportunity to present oral
comments. This request must be made in writing. If such a request is
received on or before January 19, 2012, EPA will hold a public meeting
on this proposed rule in Washington, DC. This written request must be
submitted to the mailing or hand delivery addresses provided under
ADDRESSES. If such a request is received, EPA will announce the
scheduling of the public meeting in a subsequent document in the
Federal Register. If a public meeting is announced, and if you are
interested in attending or presenting oral and/or written comments at
the public meeting, you should follow the instructions provided in the
subsequent Federal Register document announcing the public meeting.
II. Background
A. What action is the agency taking and why?
Congress gave EPA (also referred to as ``Agency'') broad authority
to require testing of chemical substances when EPA can establish a
minimum level of risk concern for a chemical substance (hazard and
exposure are considered), and/or when EPA can establish that there is
or may be substantial production and release or exposure of a chemical
substance (production volume and exposure are considered). HPV chemical
substances often have either significant release or human exposure
scenarios that would stimulate EPA interest and support an EPA decision
to require testing or to require notification before additional
exposures occur. EPA is proposing to regulate 45 HPV chemical
substances with either a test rule or a SNUR. EPA is proposing a test
rule under TSCA section 4(a)(1)(B) for 23 of these 45 HPV chemical
substances and a SNUR under TSCA section 5(a)(2) for the other 22 HPV
chemical substances (see Tables A. and B. in Unit III.).
These 45 HPV chemical substances are among the chemical substances
that were included in EPA's HPV Challenge Program (hereafter HPV
Challenge) initiated in 1998. Of the 2,782 chemical substances
originally included in the HPV Challenge, 1,858 were officially
sponsored either directly in the HPV Challenge or indirectly through
international efforts, although 5 were later withdrawn. Another 416 of
the 2,782 chemical substances were removed from the scope of the HPV
Challenge for a variety of reasons (e.g., polymers, inorganics, etc.).
The remaining 508 of the 2,782 chemical substances were termed
``orphans'' because they were not sponsored and there were no other
factors that removed the chemical substances from the scope of the HPV
Challenge. Of the 508 orphans, 405 are no longer produced at HPV
levels. Of the remaining 103 chemical substances, 63 have been included
in one of three test rules, or EPA has otherwise received data adequate
to meet its needs. The remaining 40, plus the 5 chemical substances
whose HPV Challenge sponsorships were withdrawn, are the subject of
this proposed test rule and SNUR. For more information on the HPV
Challenge go to http://www.epa.gov/hpv/ or see the Federal Register of
March 16, 2008 (71 FR 13708) (FRL-7335-2). This action contains the
fourth and final test rule in the series and includes the last
unsponsored/orphan chemical substances in the HPV Challenge.
The data that EPA seeks through the HPV Challenge is the Screening
Information Data Set (SIDS) developed by the Organisation for Economic
Co-operation and Development (OECD), of which the United States is a
member. SIDS consists of tests for six endpoints (Ref. 1), including
acute toxicity, repeated dose toxicity, developmental and reproductive
toxicity, genetic toxicity, ecotoxicity, and environmental fate. The
six SIDS endpoints provide a minimum, internationally-agreed-upon set
of test data for screening HPV chemical substances for human and
environmental hazards, and assist EPA and others in making an informed,
preliminary judgment about the hazards of HPV chemical substances.
B. What is the agency's authority for taking these actions?
1. Test rule. EPA is proposing this test rule under TSCA section
4(a)(1)(B) which directs EPA to require by rule that manufacturers and/
or processors of chemical substances and mixtures conduct testing, if
the EPA Administrator finds that:
i. A chemical substance or mixture is or will be produced in
substantial quantities, and (1) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or (2)
there is or may be significant or substantial human exposure to such
substance or mixture.
ii. There are insufficient data and experience upon which the
effects of the manufacture, distribution in commerce, processing, use,
or disposal of such
[[Page 65582]]
substance or mixture or of any combination of such activities on health
or the environment can reasonably be determined or predicted.
iii. Testing of such substance or mixture with respect to such
effects is necessary to develop such data.
2. SNUR. Section 5(a)(2) of TSCA authorizes EPA to determine that a
use of a chemical substance is a ``significant new use.'' EPA must make
this determination by rule after considering all relevant factors,
including those listed in TSCA section 5(a)(2). Once EPA determines
that a use of a chemical substance is a significant new use, TSCA
section 5(a)(1)(B) requires persons to submit a SNUN to EPA at least 90
days before they manufacture, import, or process the chemical substance
for that use.
C. Applicability of General Provisions
1. Test rule. General provisions for test rules appear under 40 CFR
part 790 (subparts A, B, C, and E), 40 CFR part 791, 40 CFR part 792,
and 40 CFR part 799 (subpart A). 40 CFR part 790, subpart A, describes
the scope, purpose, and authority for test rules and consent
agreements, provisions for submitting information to the Agency, and
the treatment of confidential business information. 40 CFR part 790,
subpart B covers the procedures for developing consent agreements and
test rules. 40 CFR part 790, subpart C covers the implementation,
enforcement, and modification of test rules. This subpart includes
information about persons subject to testing and required to submit
letters-of-intent to conduct testing and persons who must submit
testing exemption applications, and includes information about the
submission of study plans and how to modify test standards and
schedules if necessary. Subpart E of 40 CFR part 790 provides detailed
information about exemptions from test rules. 40 CFR parts 791 and 792
respectively cover provisions for data reimbursement and required good
laboratory practice standards. 40 CFR part 799, subpart A, provides
additional information on the scope and purpose of the rule, the
applicability of the rule, submitting information, test standards, the
availability of test guidelines, distinguishing positive and negative
results, the effects of non-compliance, chemicals for which the testing
reimbursement period has passed, and imports and exports.
Persons who export or intend to export a chemical substance
identified in a final test rule are subject to the export notification
provisions of TSCA section 12(b). Regulations that interpret TSCA
section 12(b) appear at 40 CFR part 707, subpart D, notices of export
under section 12(b).
2. SNUR. General provisions for SNURs appear under 40 CFR part 721,
subpart A. These provisions describe persons subject to the rule,
recordkeeping requirements, exemptions to reporting requirements, and
applicability of the rule to uses occurring before the effective date
of the final rule. Provisions relating to user fees appear at 40 CFR
part 700. According to 40 CFR 721.1(c), persons subject to SNURs must
comply with the same notice requirements and EPA regulatory procedures
as submitters of Premanufacture Notices (PMNs) under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submission requirements of TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6
or 7 to control the activities on which it has received the SNUN. If
EPA does not take action, EPA is required under TSCA section 5(g) to
explain in the Federal Register its reasons for not taking action.
D. What is the agency's ``B Policy''?
TSCA section 2(b) states that it is the policy of the United States
that: (1) Adequate data should be developed with respect to the effect
of chemical substances and mixtures on health and the environment and
that the development of such data should be the responsibility of those
who manufacture and those who process such chemical substances and
mixtures; (2) adequate authority should exist to regulate chemical
substances and mixtures which present an unreasonable risk of injury to
health or the environment and to take action with respect to chemical
substances and mixtures which are imminent hazards; and (3) authority
over chemical substances and mixtures should be exercised in such a
manner as not to impede unduly or create unnecessary economic barriers
to technological innovation while fulfilling the primary purpose of
this Act to assure that such innovation and commerce in such chemical
substances and mixtures do not present an unreasonable risk of injury
to health or the environment (15 U.S.C. 2601(b)(1)).
TSCA section 4(a)(1)(B) authorizes and requires EPA to issue a test
rule for a chemical substance if EPA finds, among other things, that
the chemical substance ``is or will be produced in substantial
quantities'' and either ``enters or may reasonably be anticipated to
enter the environment in substantial quantities'' or ``there is or may
be significant or substantial human exposure.''
TSCA, however, does not say what is ``significant'' or
``substantial'' under TSCA section (4)(a)(1)(B). EPA, therefore,
published a policy, known as the ``B Policy,'' in 1993 (Ref. 2) for
aiding in the determination of when production or environmental release
is substantial or when human exposure is either significant or
substantial for the purpose of issuing a test rule under TSCA section
(4)(a)(1)(B). Under the ``B Policy,'' ``produced in substantial
quantities'' generally means manufactured or imported in one million
pounds or more per year; a ``substantial environmental release'' is
generally either one million pounds per year or ten percent of total
manufactured and imported volume, whichever is less; and ``substantial
human exposure'' is generally 100,000 or more people in the general
population, or 10,000 or more consumers, or 1,000 or more workers.
E. Why is the agency proposing both a test rule and a SNUR?
EPA is proposing these two actions together because the Agency
believes the actions are complementary and will best ensure these HPV
chemicals are adequately evaluated by the Agency. For example, if EPA
receives comments on this proposal sufficient to establish that one of
the 23 chemical substances proposed to be regulated under the test rule
is not used in a way that meets the substantial exposure criteria, but
information received indicates that the chemical substance meets the
criteria for the SNUR, EPA intends to include the chemical substance in
the final SNUR rather than the test rule, without further public notice
and comment. Simply removing such a chemical substance from the test
rule in such circumstances, without including it in the SNUR, would not
provide a regulatory mechanism for timely notification to EPA in the
event of changed circumstances that would likely justify the issuance
of a test rule for the chemical substance. Further, if public comment
on these proposed actions is sufficient to establish that any of the
uses to be covered for the 22 chemical substances proposed in the SNUR
are, in fact, on-going, yet such comments also establish that there is
already substantial exposure to the chemical substance, EPA intends to
review the status of the chemical substance and, as warranted, take
appropriate steps to promulgate a test rule rather than a SNUR for the
[[Page 65583]]
chemical substance. Unit IV. of this document details the proposed
findings to issue a test rule for the 23 chemical substances listed in
Table A. and provides additional discussion pertaining to whether the
promulgation of a test rule for 22 chemical substances listed in Table
B. may be warranted. Unit V. of this document details the proposed
findings to issue a SNUR for the 22 chemical substances listed in Table
B. and the basis to issue a SNUR for the 23 chemical substances listed
in Table A. in the event that public comments provide additional data
establishing that, for one or more of such chemical substances, there
is no ongoing use in a consumer product and no ongoing use reasonably
likely to expose 1,000 or more workers.
F. What are some future considerations?
One of EPA's top priorities is to assure the safety of chemical
substances in commerce. Under TSCA, EPA has a primary mission to
identify and, where appropriate, control unreasonable risks of
manufacturing, processing, distribution in commerce, use, and disposal
of chemical substances. It is essential that chemical substance review
be supported by information sufficient to allow informed decision
making and that information and decisions are of high quality and are
widely understandable. As such, EPA continues to collect information
from existing sources, to request new and better information where it
is determined to be needed, and to make all supporting information
publicly available, to the extent permitted under TSCA section 14 and
40 CFR part 2. Open access to information allows individuals,
communities, businesses, and governments to make informed decisions and
policies that incorporate environmental and health considerations and
minimize external and/or unintended harmful impacts. Therefore, EPA
intends to continue to focus on filling data needs on priority chemical
substances, including high production volume chemical substances. EPA
is interested in stakeholder input on a number of issues described in
this section. Some specific issues EPA has identified to date follow.
1. Coordination of simultaneous test rule and SNUR proposals. In
this action, EPA is simultaneously proposing a test rule and SNUR to
regulate two sets 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 test rule criteria and (for the latter
group of chemical substances) to require submission of advance
notification to EPA of use in a consumer product or of any use, or
combination of uses, that is reasonably likely to expose 1,000 or more
workers. With respect to chemical substances that meet some, but
potentially not all test rule criteria, the SNUR also facilitates
efficiency by mitigating the need for EPA to continually reevaluate
each HPV chemical substance to determine whether exposure potential has
changed. EPA is considering issuing further coordinated proposals of
test rules and SNURs. This would occur in conjunction with future
Inventory Update Reporting (IUR) rule data releases, covering all
newly-HPV chemical substances. EPA requests comment on this approach.
In September 2011, the IUR was renamed Chemical Data Reporting (CDR)
and moved from 40 CFR part 710 subpart C to 40 CFR part 711 (76 FR
50816, August 16, 2011) (FRL-8872-9). For more information on this
change go to http://www.epa.gov/cdr.
2. Minimum data set. For more than 15 years, EPA has used OECD's
SIDS to facilitate and standardize the screening of the relatively
large number of HPV 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. 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)?
3. Computational toxicology. The U.S. National Academy of Sciences
National Research Council in their 2007 report ``Toxicity Testing in
the 21st Century: A Vision and a Strategy'' (Ref. 3) 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 (at http://www.epa.gov/comptox/toxcast) (Ref. 4) be used to prioritize chemical
substances and support hazard findings for testing?
III. Chemical Substances Subject to This Action
The 45 chemical substances included in this action are the
remaining unsponsored/orphan chemical substances, which have not
previously been subject to test rules or other HPV Challenge-related
follow-up actions. EPA is proposing to issue a test rule under TSCA
section 4(a)(1)(B) for the 23 chemical substances listed in Table A. in
this unit and proposing to establish a SNUR under TSCA section 5(a)(2)
for the other 22 chemical substances (see Table B. in this unit).
Respecting the 23 chemical substances proposed for a section 4(a)(1)(B)
test rule (i.e., those in Table A.), in the event that public comments
provide additional data respecting any of these chemical substances,
establishing that there is no ongoing use in a consumer product and no
ongoing use reasonably likely to expose 1,000 or more workers for any
such substance, EPA intends to finalize a SNUR for each such chemical
substance. Finally, with respect to the 22 chemical substances proposed
for a SNUR (i.e., those in Table B.), in the event that public comments
provide additional data establishing that there is already substantial
exposure to the chemical substance, EPA intends to review the status of
the chemical substance and, as warranted, take appropriate steps to
promulgate a section 4(a)(1)(B) test rule for the chemical substance.
For each of these chemical substances, Tables A. and B. provide the
Chemical Abstract (CA) Index Name, Chemical Abstract Service (CAS)
Registry Number (CASRN), and 2006 IUR information on production volume,
number of workers exposed, and commercial/consumer uses. Substantial
worker exposure is deduced from the number of workers reported.
Substantial consumer exposure is deduced from production volume and
consumer uses if production volume exceeds one million pounds per year
and consumer uses are indicated, it is likely that consumer exposure
exceeds ten thousand people.
For each of the test rule candidate chemical substances, EPA has
used the 2006 IUR information to preliminarily determine that the
chemical substance is produced in substantial quantities and that there
is substantial human exposure. For each of the significant new use
(SNU) candidates, EPA has considered the 2006 IUR information in
determining the proposed SNU designations. These findings are discussed
further in Unit IV.A.1., Unit V.A., and Ref. 5.
[[Page 65584]]
Table A--Chemical Substances for Which a Test Rule Is Proposed and for Which a SNUR Is Being Considered as an Alternative Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical substance Chemical substance
2006 IUR production meets the ``B Commercial/Consumer meets the ``B
CASRN CA Index name volume (million 2006 IUR number of finding'' criteria uses indicated in finding'' criteria
lbs.) workers exposed of >=1,000 workers 2006 IUR of >=10,000
exposed consumers exposed
--------------------------------------------------------------------------------------------------------------------------------------------------------
56-40-6.............. Glycine............. 1 <= 10............. 1,000+.............. Yes................. Other; CBI......... Yes.
67-72-1.............. Ethane, 1,1,1,2,2,2- 1 <= 10............. 1,000+.............. Yes................. None............... No.
hexachloro-.
78-00-2.............. Plumbane, tetraethyl- 1 <= 10............. 100-999............. No.................. Lubricants, greases Yes.
. and fuel additives.
95-14-7.............. 1H-Benzotriazole.... 1 <= 10............. 100-999............. No.................. Lubricants, greases Yes.
and fuel
additives; metal
products; other.
118-48-9............. 2H-3,1-Benzoxazine- 10 <= 50............ 100-999............. No.................. Agricultural Yes.
2,4(1H)-dione. products (non-
pesticidal); other.
128-44-9............. 1,2-Benzisothiazol- 1 <= 10............. 100-999............. No.................. Other.............. Yes.
3(2H)-one, 1,1-
dioxide, sodium
salt (1:1).
928-72-3............. Glycine, N- 500 <= 1,000........ 1,000+.............. Yes................. None............... No.
(carboxymethyl)-,
sodium salt (1:2).
1809-19-4............ Phosphonic acid, 1 <= 10............. 1,000+.............. Yes................. CBI................ Yes.
dibutyl ester.
25377-73-5........... 2,5-Furandione, 3- 1 <= 10............. 1-99................ No.................. Other.............. Yes.
(dodecen-1-
yl)dihydro-.
26544-38-7........... 2,5-Furandione, 1 <= 10............. 100-999............. No.................. Lubricants, greases Yes.
dihydro-3- and fuel
(tetrapropenyl)-. additives; paints
and coatings; not
readily obtainable
(NRO).
27859-58-1........... Butanedioic acid,2- 1 <= 10............. 1,000+.............. Yes................. Lubricants, greases Yes.
(tetrapropenyl)-. and fuel
additives; CBI.
28777-98-2........... 2,5-Furandione, 10 <= 50............ 100-999............. No.................. Paper products..... Yes.
dihydro-3-
(octadecen-1-yl)-.
29385-43-1........... 1H-Benzotriazole, 1 <= 10............. 100-999............. No.................. Lubricants, greases Yes.
6(or75)-methyl-. and fuel additives.
32072-96-1........... 2,5-Furandione, 3- 50 <= 100........... 1,000+.............. Yes................. Paper products..... Yes.
(hexadecen-1-
yl)dihydro-.
61789-73-9........... Quaternary ammonium 1 <= 10............. 100-999............. No.................. CBI................ Yes.
compounds,
benzylbis(hydrogena
ted tallow
alkyl)methyl,
chlorides.
64665-57-2........... 1H-Benzotriazole, 1 <= 10............. 100-999............. No.................. Other.............. Yes.
6(or7)-methyl-,
sodium salt.
68131-13-5........... Naphthenic acids, 1 <= 10............. 1,000+.............. Yes................. None............... No.
reaction products
with
diethylenetriamine.
68153-60-6........... Fatty acids, tall- 1 <= 10............. 1,000+.............. Yes................. None............... No.
oil, reaction
products with
diethylenetriamine,
acetates.
68424-85-1........... Quaternary ammonium 1 <= 10............. 1,000+.............. Yes................. Other; CBI......... Yes.
compounds, benzyl-
C12-16-
alkyldimethyl,
chlorides.
68442-77-3........... 2-Butenediamide, 1 <= 10............. 1,000+.............. Yes................. None............... No.
(2E)-, N1,N4-bis[2-
(4,5-dihydro-2-
nortall-oil alkyl-
1H-imidazol-1-
yl)ethyl] derivs.
68607-28-3........... Quaternary ammonium 1 <= 10............. 1,000+.............. Yes................. Other.............. Yes.
compounds, (oxydi-
2,1-
ethanediyl)bis[coco
alkyldimethyl,
dichlorides.
68909-18-2........... Pyridinium, 1- 1 <= 10............. 1,000+.............. Yes................. Other.............. Yes.
(phenylmethyl)-, Et
Me derivs.,
chlorides.
69834-17-9........... Benzene, 1 <= 10............. 100-999............. No.................. Soaps and Yes.
decylphenoxy-. detergents.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 65585]]
Table B--List of Chemical Substances for Which a SNUR Is Proposed and for Which a Test Rule Is Being Considered as an Alternative Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical substance Chemical substance
2006 IUR meets the ``B Commercial/consumer meets the ``B
CASRN CA Index name production volume 2006 IUR number of finding'' criteria uses indicated in finding'' criteria
(million lbs.) workers exposed of >= 1,000 2006 IUR of >= 10,000
workers exposed consumers exposed
--------------------------------------------------------------------------------------------------------------------------------------------------------
98-16-8.............. Benzenamine, 3- 1 <= 10........... 1-99.............. No................ None................ No.
(trifluoromethyl)-.
100-53-8............. Benzenemethanethiol...... 1 <= 10........... 1-99.............. No................ None................ No.
104-91-6............. Phenol, 4-nitroso-....... 1 <= 10........... 1-99.............. No................ None................ No.
110-03-2............. 2,5-Hexanediol, 2,5- 1 <= 10........... 100-999........... No................ None................ No.
dimethyl-.
124-63-0............. Methanesulfonyl chloride. 1 <= 10........... 100-999........... No................ None................ No.
142-30-3............. 3-Hexyne-2,5-diol, 2,5- 1 <= 10........... 100-999........... No................ None................ No.
dimethyl-.
460-00-4............. Benzene, 1-bromo-4-fluoro- 1 <= 10........... 100-999........... No................ Not readily No.
. obtainable (NRO).
542-92-7............. 1,3-Cyclopentadiene...... 1 <= 10........... 1-99.............. No................ None................ No.
553-26-4............. 4,4'-Bipyridine.......... 10 <= 50.......... 100-999........... No................ None................ No
8007-45-2............ Tar, coal................ 1 <= 10........... 1-99.............. No................ None................ No.
28106-30-1........... Benzene, ethenylethyl-... 1 <= 10........... 100-999........... No................ None................ No.
35203-06-6........... Benzenamine, 2-ethyl-6- 10 <= 50.......... 1-99.............. No................ None................ No.
methyl-N-methylene-.
35203-08-8........... Benzenamine, 2,6-diethyl- 10 <= 50.......... 1-99.............. No................ None................ No.
N-methylene-.
37734-45-5........... Carbonochloridothioic 1 <= 10........... 100-999........... No................ None................ No.
acid, S-(phenylmethyl)
ester.
37764-25-3........... Acetamide, 2,2-dichloro- 1 <= 10........... 1-99.............. No................ None................ No.
N,N-di-2-propen-1-yl-.
61789-72-8........... Quaternary ammonium 1 <= 10........... 100-999........... No................ None................ No.
compounds,
benzyl(hydrogenated
tallow alkyl)dimethyl,
chlorides.
61790-13-4........... Naphthenic acids, sodium 1 <= 10........... 100-999........... No................ None................ No.
salts.
65996-91-0........... Distillates (coal tar), 1 <= 10........... 100-999........... No................ None................ No.
upper.
68308-01-0........... Tail gas (petroleum), 10 <= 50.......... 100-999........... No................ None................ No.
cracked distillate
hydrotreater stripper.
68478-20-6........... Residues (petroleum), 10 <= 50.......... 1-99.............. No................ None................ No.
steam-cracked petroleum
distillates
cyclopentadiene conc.,
C4-cyclopentadiene-free.
68526-82-9........... Alkenes, C6-10, 1 <= 10........... 100-999........... No................ NRO................. No.
hydroformylation
products, high-boiling.
68909-77-3........... Ethanol, 2,2'-oxybis-, 1 <= 10........... 100-999........... No................ None................ No.
reaction products with
ammonia, morpholine
derivs. residues.
--------------------------------------------------------------------------------------------------------------------------------------------------------
IV. Proposed Section 4(a)(1)(B) Test Rule and Basis to Also Consider
Table B. Chemical Substances for a Section 4(a)(1)(B) Test Rule
A. What are the proposed findings?
1. Exposure findings. EPA is proposing to require testing of the
chemical substances listed in Table A. based on its preliminary
findings under TSCA section 4(a)(1)(B)(i) relating to ``substantial''
production and ``substantial human exposure,'' as well as findings
under TSCA sections 4(a)(1)(B)(ii) and (a)(1)(B)(iii) relating to
insufficient data and the need for testing. The chemical substances in
Table A. are also listed in Table 2. of Sec. 799.5090(j) of the
proposed regulatory text along with their CASRNs.
i. Are these chemical substances produced in substantial
quantities? EPA has made preliminary findings that each of the chemical
substances included in this proposed test rule are produced in
substantial quantities. In accordance with the ``B policy'' (discussed
in Unit II.D.), each of these substances is manufactured (which, as
noted in Unit I.A., includes imported) in an amount equal to or greater
than 1 million lbs. per year (Ref. 5). These findings are based on
information gathered in the 2006 IUR the most recently available
compilation of IUR (now CDR) data.
ii. Are a substantial number of workers exposed to these chemical
substances? EPA has made preliminary findings that the manufacture,
processing, and use of 12 of the 23 chemical substances listed in Table
A. result or may result in exposure of a substantial number of workers
to the chemical substances (Ref. 5).
For chemical substances whose total production volume (manufactured
and imported) exceeded 300,000 lbs. at a site during calendar year
2005, manufacturers (which as noted in Unit I.A., includes importers)
were required through the 2006 IUR to report the number of potentially
exposed workers during industrial processing and use to the extent the
information was readily obtainable. Manufacturers of 12 of the 23
chemical substances listed in Table A. reported that more than 1,000
workers or more were potentially exposed to these chemical substances.
Based on the threshold values stated in EPA's ``B Policy,'' EPA
believes that an exposure of 1,000 workers or more on a routine or
episodic basis to a chemical substance or mixture is ``substantial'' as
that term is used with reference to ``human exposure'' in TSCA section
4(a)(1)(B)(i). Therefore, EPA's preliminary finding is that there is or
may be substantial human exposure (workers) to 12 of these 23 chemical
substances.
iii. Are a substantial number of consumers exposed to these
chemical substances? EPA has made preliminary findings that the
manufacture, processing, and use of 18 of the 23 chemical substances
listed in Table A. result or may result in exposure of a substantial
number of consumers to the chemical substances (Ref. 5).
[[Page 65586]]
In addition to worker exposure information, manufacturers of more
than 300,000 lbs. of a given chemical substance at a site during
calendar year 2005 were required to provide information regarding the
commercial and consumer uses of the chemical substance. EPA reviewed
the consumer use information reported for the 2006 IUR and carefully
considered the nature of those uses. These 18 chemical substances were
found to be used in such products as tires, footwear, flooring,
bottles, sporting equipment, games, soaps and detergents, and paper
products. Based on this review, EPA has preliminarily concluded that
the reported consumer uses may result in exposures to at least 10,000
consumers. Based on the threshold values stated in EPA's ``B Policy,''
EPA believes that an exposure of 10,000 consumers or more to a chemical
substance is ``substantial'' as that term is used with reference to
``human exposure'' in TSCA section 4(a)(1)(B)(i). Therefore, EPA's
preliminary finding is that there is or may be substantial human
exposure (consumers) to 18 of these 23 chemical substances.
2. Are sufficient data available to evaluate these chemical
substances? Under TSCA section 4(a)(1)(B)(ii), EPA has preliminarily
determined for the chemical substances in Table A. that there are
insufficient data and experience to reasonably determine or predict the
effects of the manufacture, distribution in commerce, processing, use,
or disposal of these chemical substances, or of any combination of such
activities, on human health or the environment.
In developing the testing requirements for chemical substances
contained in Table A., EPA searched for available information on
chemical/physical properties, environmental fate, ecotoxicity and human
health effects, using the data sources outlined in the OECD guidelines
found in section 3.1 (Reliability, Relevance and Adequacy) of the
``Manual for the Investigation of HPV Chemicals'' (Ref. 1) such as: The
Beilstein Database, Chemical Rubber Company's Handbook of Chemistry and
Physics, Hawley's Condensed Chemical Dictionary, Illustrated Handbooks
of Physical-Chemical Properties and Environmental Fate for Organic
Chemicals, Merck Index, Hazardous Substances Data Bank (HSDB),
Toxicology Literature Online (TOXLINE), and the National Technical
Information Service (NTIS). EPA also searched for available data as
summarized in its HPV Information System (HPVIS) (Ref. 6). When
appropriate, the Federal Research In Progress (FEDRIP) database was
also searched. Any information that was obtained from these searches
was evaluated for data acceptability using the guidelines described on
EPA's HPV Challenge Web site (http://www.epa.gov/hpv): ``Guidance for
Meeting the SIDS Requirements (the SIDS Guide)'' and ``Guidance for
Assessing the Adequacy of Existing Data.'' Furthermore, data adequacy
and reliability were evaluated using the OECD guidelines which can be
found in section 3.1 of the OECD ``Manual for the Investigation of HPV
Chemicals'' (Ref. 1). The results of EPA's data adequacy analysis can
be found in the HPV4 Data Adequacy Evaluations document (Ref. 7).
Section 799.5090(j) of the proposed regulatory text lists each
chemical substance and the SIDS tests for which adequate data are not
currently available to the Agency. The Agency preliminarily finds that
the existing data for one or more of the SIDS testing endpoints for
each of the chemical substances listed in Table 2. in Sec. 799.5090(j)
of the proposed regulatory text (i.e., chemical substances in Table A.)
are insufficient to enable EPA to reasonably determine or predict the
human health and environmental effects resulting from manufacture,
distribution in commerce, processing, use, and disposal of these
chemical substances.
To the extent that additional studies relevant to the testing
proposed in this rulemaking are known to exist, EPA strongly encourages
the submission of this information as comments to the proposed rule,
including full citations for publications and full copies of
unpublished studies. If EPA judges such data to be sufficient,
corresponding testing will not be included in the final rule.
Commenters may prepare a robust summary (Ref. 8) for each such study to
facilitate EPA's review of the full study report or publication.
Persons who believe that adequate information regarding a chemical
substance subject to this proposed rule can be developed using a
category or the Structure-Activity Relationships (SAR) approach are
encouraged to submit appropriate information, along with their
rationale substantiating this belief, during the comment period on this
proposed rule. If, based on submitted information and other information
available to EPA, the Agency agrees, EPA will take such measures as are
needed to avoid unnecessary testing in the final rule.
3. Is testing necessary for these chemical substances? EPA has also
found preliminarily that testing the 23 chemical substances identified
in Table A. is necessary to develop the needed data (TSCA section
4(a)(1)(B)(iii)). EPA has not identified any ``additional factors'' as
discussed in the ``B Policy'' (Ref. 2, p. 28743) to cause the Agency to
use decision making criteria other than those described in the ``B
Policy.'' EPA knows of no other means to generate the SIDS data other
than the testing proposed in this document, and therefore has
preliminarily found that conducting the needed SIDS testing identified
for the 23 chemical substances in Table A. is necessary to provide data
relevant to a determination of whether the manufacture, processing, and
use of the chemical substances does or does not present an unreasonable
risk of injury to human health and the environment.
B. What is the basis to also consider chemical substances from Table B.
for testing under section 4(a)(1)(B)?
As an alternative to issuing a SNUR, EPA is considering requiring
testing of one or more of the chemical substances listed in Table B.
EPA will consider this approach based on its preliminary findings under
TSCA section 4(a)(1)(B)(i) relating to ``substantial'' production, its
further analysis of the factors listed under TSCA sections 4
(a)(1)(B)(ii) and (a)(1)(B)(iii) relating to insufficient data and the
need for testing and additional data received in public comments. If
information received in public comments establishes that consumer uses,
or uses that could affect 1,000 workers or more, are already ongoing,
then that information may indicate that a SNUR is inappropriate for the
particular chemical substance listed in Table B. The same information,
however, may prompt EPA to conclude that a test rule is appropriate for
such a substance, since evidence of ongoing use may also be evidence of
substantial human exposure. If public comments provide the basis to
conclude that there is already or may be substantial human exposure to
one of the chemical substances in Table B., and there is a basis to
make the other findings required under TSCA sections 4 (a)(1)(B)(ii)
and (a)(1)(B)(iii), then EPA intends to review the status of the
chemical substance and, as warranted, take appropriate steps to
promulgate a test rule rather than a SNUR for the chemical substance.
EPA has made preliminary findings that each of the chemical
substances listed in Table B. are produced in substantial quantities
(manufactured, including imported, in an amount equal to or greater
than 1 million lbs. per year (Ref. 5)). These findings are based on
information gathered in the 2006 IUR
[[Page 65587]]
rule. The 2006 data are the most recently available compilation of IUR
(now CDR) data.
C. What testing is being proposed in this action and is also being
considered for chemical substances in Table B.?
EPA is proposing specific testing and reporting requirements for
the chemical substances from Table A. (specified in Sec.
[emsp14]799.5090(j) of the proposed regulatory text) and is also
considering the same requirements with respect to the chemical
substances listed in Table B. All of the proposed testing requirements
are listed in Table 2. in Sec. 799.5090(j) of the proposed regulatory
text and consist of a series of test methods covering many of the
endpoints in the OECD HPV SIDS testing battery.
EPA's TSCA 799 test guidelines (40 CFR part 799, subparts E and H)
have been harmonized with the OECD test guidelines. However, EPA is
specifying that the American Society for Testing and Materials
International (ASTM International) or the TSCA 799 test guidelines be
used rather than OECD test guidelines because the language in the ASTM
International standards and the TSCA 799 test guidelines makes clear
which steps are mandatory and which steps are only recommended.
Accordingly, to comply with the testing being proposed, EPA is
proposing that testing must be conducted in accordance with ASTM
International or TSCA 799 test guidelines. Note: ASTM issues its test
methods under a fixed designation (e.g., E1719); the number immediately
following the designation indicates the year of original adoption or,
in the case of revision, the year of last revision. A number in
parentheses indicates the year of last re-approval. A superscript
epsilon (e) indicates an editorial change since the last revision or
re-approval. Most of the proposed testing requirements for a particular
endpoint are specified in one test standard. In the case of certain
endpoints, however, any of multiple listed methods could be used. For
several of the proposed test standards, EPA has identified and is
proposing certain ``special conditions'' as discussed in this unit. The
following endpoints and test standards are included in this proposed
test rule.
1. Physical/chemical properties. Melting Point: ASTM E 324-99
(capillary tube) (Refs. 9 and 10).
Boiling Point: ASTM E 1719-05 (ebulliometry) (Ref. 11). Vapor
Pressure: ASTM E 1782-08 (thermal analysis) (Ref. 12). n-Octanol/Water
Partition Coefficient: Method A (40 CFR 799.6755--shake flask); Method
B (ASTM E 1147-92(2005)--liquid chromatography) (Ref. 13); Method C (40
CFR 799.6756--generator column).
Water Solubility: Method A (ASTM E 1148-02--shake flask) (Ref. 14);
Method B (40 CFR 799.6784--shake flask); Method C (40 CFR 799.6784--
column elution); Method D (40 CFR 799.6786--generator column).
For those chemical substances needing melting points
determinations, EPA is proposing that melting points be determined
according to ASTM method E 324-99. Although ASTM International
indicates on its Web site, http://www.astm.org/DATABASE.CART/WITHDRAWN/E324.htm, that ASTM E 324-99 has been withdrawn, ASTM International's
withdrawal of the method means only that ASTM International no longer
continues to develop and improve the method. It does not mean that ASTM
International no longer considers the method to be valid. ASTM
International has explained that ASTM E 324-99 was withdrawn because:
The standard utilizes old, well-developed technology; it is
highly unlikely that any additional [changes] and/or modifications
will ever be pursued by the E15 [committee]. The time and effort
needed to maintain these documents detract from the time available
to develop new standards which use modern technology (Ref. 15).
ASTM International still makes the method available for
informational purposes and it can still be purchased from ASTM
International at the address listed in Sec. 799.5090(h) of the
proposed regulatory text.
EPA concludes that ASTM International's withdrawal of ASTM E 324-99
does not have negative implications on the validity of the method, and
EPA is proposing that melting points be determined according to ASTM E
324-99.
For those chemical substances that are liquid at room temperature,
EPA is proposing a measured freezing point to meet the obligation to
report the melting point. Since ASTM E 324-99 (capillary tube) does not
specifically include instructions for determining freezing point, EPA
is instead proposing to require, for substances which are liquid at
room temperature, OECD 102 (melting point/melting range), which
includes guidance for determining freezing point (Ref. 10).
For the ``n-Octanol/Water Partition Coefficient (log 10 basis)''
and water solubility endpoints, EPA is proposing that certain ``special
conditions'' be considered by test sponsors in determining the
appropriate test method that would be used from among those included
for these endpoints in Table C. of this unit and in Table 3. in Sec.
799.5090(j) of the proposed regulatory text.
For the ``n-Octanol/Water Partition Coefficient (log 10 basis)''
endpoint, also known as log Kow, EPA proposes that an
appropriate selection be made from among three alternative methods for
measuring the chemical substance's n-Octanol/Water Partition
Coefficient (log 10 basis; ``log Kow''). Prior to
determining the appropriate standard to use, if any, to measure the n-
Octanol/Water Partition Coefficient, EPA is recommending that the log
Kow be quantitatively estimated. EPA recommends that the
method described in ``Atom/Fragment Contribution Method for Estimating
Octanol-Water Partition Coefficients'' (Ref. 16) be used in making such
estimation. EPA is proposing that test sponsors must submit with the
final study report the underlying rationale for the test standard
selected for this endpoint. EPA is proposing this approach recognizing
that, depending on the chemical substance's log Kow, one or
more test methods may provide adequate information for determining the
log Kow, but that in some instances one particular test
method may be more appropriate. In general, EPA believes that the more
hydrophobic a subject chemical substance is, the less well Method A (40
CFR 799.6755--shake flask) will work and Method B (ASTM E 1147-
92(2005)) and Method C (40 CFR 799.6756--generator column) become more
suitable, especially Method C. The proposed test methodologies have
been developed to meet a wide variety of needs and, as such, are silent
on experimental conditions related to pH. Therefore, EPA highly
recommends that all required n-Octanol/Water Partition Coefficient
tests be conducted at pH 7 to ensure environmental relevance.'' Table
C. of this unit shows the proposed test standards and log
Kow ranges that would determine which tests must be
conducted for this endpoint.
[[Page 65588]]
Table C--Test Requirements for the n-Octanol/Water Partition Coefficient
Endpoint
------------------------------------------------------------------------
Test requirements
Testing category and references Special conditions
------------------------------------------------------------------------
Physical/chemical properties n-Octanol/water n-Octanol/water
partition partition
coefficient (log 10 coefficient or log
basis) or log Kow: Kow:
The appropriate log Which method is
Kow test, if any, required, if
would be selected any, is
from those listed determined by
in this column--see the test
special conditions substance's
in the adjacent estimated log
column. Kow as follows:
Method A: 40 CFR log Kow < 0: no
799.6755 (shake testing required.
flask). log Kow range 0-1:
Method B: ASTM E Method A or B.
1147-92 (2005) log Kow range > 1-4:
(liquid Method A or B or C.
chromatography). log Kow range > 4-6:
Method C: 40 CFR Method B or C.
799.6756 (generator log Kow > 6: Method
column). 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.
------------------------------------------------------------------------
For the ``Water Solubility'' endpoint, EPA proposes an appropriate
selection be made from among four alternative methods for measuring
that endpoint. The test method used, if any, would be determined by
first quantitatively estimating the test substance's water solubility.
One recommended method for estimating water solubility is described in
``Improved Method for Estimating Water Solubility from Octanol/Water
Partition Coefficient'' (Ref. 17). EPA is also proposing that test
sponsors be required to submit in the final study report the underlying
rationale for the test standard selected for this endpoint. The
proposed test methodologies have been developed to meet a wide variety
of needs and, as such, are silent on experimental conditions related to
pH. Therefore, EPA proposes that all required water solubility tests be
conducted starting at pH 7 to ensure environmental relevance. The
estimated water solubility ranges that EPA is proposing for use in
selecting an appropriate proposed test standard are shown in Table D.
of this unit.
Table D--Test Requirements for the Water Solubility Endpoint
------------------------------------------------------------------------
Test requirements
Testing category and references Special conditions
------------------------------------------------------------------------
Physical/chemical properties Water solubility: Water solubility:
The appropriate Which method is
method to use, if required, if any,
any, to test for would be determined
water solubility by the test
would be selected substance's
from those listed estimated water
in this column--see solubility. Test
special conditions sponsors must
in the adjacent provide in the
column final study report
Method A: ASTM E the underlying
1148-02 (Re- rationale for the
approved 2008) method and pH
(shake flask). selected. In order
Method B: 40 CFR to ensure
799.6784 (shake environmental
flask). relevance, EPA
Method C: 40 CFR highly recommends
799.6784 (column that the selected
elution). study be conducted
Method D: 40 CFR starting at pH 7.
799.6786 (generator > 5,000 milligrams/
column). liters (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.
------------------------------------------------------------------------
2. Environmental fate and pathways. Ready Biodegradation: Method
A--ASTM E 1720-01(Reapproved 2008) (Sealed vessel CO2
production test) (Ref. 18); Method B--International Organization for
Standardization (ISO) 14593 (CO2 headspace test) (Ref. 19);
Method C-- ISO 7827 (Method by analysis of dissolved organic carbon
(DOC)) (Ref. 20); Method D--ISO 9408 (Determination of oxygen demand in
a closed respirometer) (Ref. 21); Method E--ISO 9439 (Carbon dioxide
evolution test) (Ref. 22); Method F--ISO 10707 (Closed bottle test)
(Ref. 23); Method G--ISO 10708 (Two-phase closed bottle test) (Ref.
24).
For the ``Ready Biodegradation'' endpoint, EPA proposes an
appropriate selection be made from among seven alternative methods for
measuring the chemical substance's ready biodegradability. For most
test substances, EPA considers Method A (ASTM E 1720-01) and Method B
(ISO 14593) to be generally applicable, cost effective, and widely
accepted internationally. However, any test method used will depend on
the physical and chemical properties of the test substance, including
its water solubility. An additional document, ISO 10631 (Ref. 25),
provides guidance for selection of an appropriate test method for a
given test substance considering the substance's physical and chemical
properties. EPA is also proposing that test sponsors be required to
submit in the final study report the underlying rationale for the test
standard selected for this endpoint.
3. Aquatic toxicity. Test Group 1: Acute toxicity to fish (ASTM E
729-96 (2007)) (Ref. 26); Acute toxicity to Daphnia (ASTM E 729-
96(2007)) (Ref. 26); and Toxicity to plants (algae) (ASTM E 1218-04e1)
(Ref. 27). Test
[[Page 65589]]
Group 2: Chronic toxicity to Daphnia (ASTM E 1193-97 (2004)) (Ref. 28);
and Toxicity to plants (algae) (ASTM E 1218-04e1) (Ref. 27).
For the ``Aquatic Toxicity'' endpoint, the OECD HPV SIDS Program
recognizes that, for certain chemical substances, acute toxicity
studies are of limited value in assessing the chemical substance's
aquatic toxicity. This issue arises when considering chemical
substances with high log Kow values. In such cases, toxicity
is unlikely to be observed over the duration of acute toxicity studies
because of reduced uptake and the extended amount of time required for
such chemical substances to reach steady state or toxic concentrations
in the test organism. For such situations, the OECD HPV SIDS Program
recommends use of chronic toxicity testing in Daphnia in place of acute
toxicity testing in fish and Daphnia. EPA is proposing that the aquatic
toxicity testing requirement be determined based on the test chemical
substance's measured log Kow as determined by using the
approach outlined in this unit in the discussion of ``n-Octanol/Water
Coefficient,'' and in Table 3. in Sec. 799.5090(j) of the proposed
regulatory text. For test chemical substances determined to have a log
Kow of less than 4.2, one or more of the following tests
(described as ``Test Group 1'' in Table 3. in Sec. [emsp14]799.5090(j)
of the proposed regulatory text) are proposed: Acute toxicity to fish
(ASTM E 729-96 (2007)); Acute toxicity to Daphnia (ASTM E 729-96
(2007)); and Toxicity to plants (algae) (ASTM E 1218-04e1). For test
chemical substances determined to have a log Kow that is
greater than or equal to 4.2, one or both of the following tests
(described as ``Test Group 2'' in Table 3. in Sec. [emsp14]799.5090(j)
of the proposed regulatory text) are proposed: Chronic toxicity to
Daphnia (ASTM E 1193-97 (2004)) and Toxicity to plants (algae) (ASTM E
1218-04e1). As outlined in Unit IV.C.3. and in Sec.
[emsp14]799.5090(j) of the proposed regulatory text, depending on the
testing proposed in Test Group 1, the Test Group 2 chronic Daphnia test
may substitute for either or both the acute fish toxicity test and the
acute Daphnia test.
Using SAR, a log Kow of 4.2 corresponds with a fish
bioconcentration factor (BCF) of about 1,000 (Refs. 17, 29, and 30). A
chemical substance with a fish BCF value of 1,000 or more is
characterized as having a tendency to accumulate in living organisms
relative to the concentration of the chemical substance in the
surrounding environment (Ref. 30). For the purposes of this proposed
rule, EPA's use of a log Kow equal to or greater than 4.2
(which corresponds with a fish BCF value of 1,000) is consistent with
the approach taken in the Agency's Final Policy Statement under TSCA
section 5 entitled ``Category for Persistent, Bioaccumulative, and
Toxic New Chemical Substances'' (Ref. 31). EPA has also used a measured
BCF that is equal to or greater than 1,000 or, in the absence of
bioconcentration data, a log P [same as log Kow] value equal
to or greater than 4.3 to help define the potential of a new chemical
substance to cause significant adverse environmental effects
(``Significant New Use Rules; General Provisions For New Chemical
Follow-Up'' under TSCA sections 5 and 26(c) (Ref. 32; see also 40 CFR
721.3)). EPA considers the difference between the log Kow of
4.3 cited in the 1989 Federal Register document (Ref. 32) and the log
Kow value of 4.2 cited in this proposed TSCA section 4 test
rule to be negligible.
EPA recognizes that in some circumstances, acute aquatic toxicity
testing (Test Group 1) may be relevant for certain chemical substances
having a log Kow equal to or greater than 4.2. Chemical
substances that are dispersible in water (e.g., surfactants,
detergents, aliphatic amines, and cationic dyes) may have log
Kow values greater than 4.2 and may still be acutely toxic
to aquatic organisms. For any chemical substance listed in Table 3. in
Sec. 799.5090(j) of the proposed regulatory text for which a test
sponsor believes that an alternative to the log Kow
threshold of 4.2 is appropriate, the test sponsor may request a
modification of the test standard in the final rule 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 to be used
for determining whether acute or chronic aquatic toxicity testing must
be performed for a specific test substance. EPA is soliciting public
comment on this approach as well as other alternative approaches in
this area.
4. Mammalian toxicity--acute. Acute Inhalation Toxicity (rat):
Method A (40 CFR 799.9130). Acute Oral Toxicity (rat): Method B (ASTM E
1163-98(2002) (Ref. 33) or 40 CFR 799.9110(d)(1)(i)(A)).
For the ``Mammalian Toxicity--Acute'' endpoint, EPA is proposing
that certain special conditions such as the chemical substance's
physical/chemical properties or physical state be considered in
determining the appropriate test method from among those included for
this endpoint in Table 3. in Sec. [emsp14]799.5090(j) of the proposed
regulatory text. The OECD HPV SIDS Program recognizes that, for most
chemical substances, the oral route of administration will suffice for
this endpoint. However, consistent with the approach taken under the
voluntary HPV Challenge, EPA is proposing that, for test chemical
substances that are gases at room temperature (25 [deg]C), the acute
mammalian toxicity study be conducted using inhalation as the exposure
route (described as Method A (40 CFR 799.9130) in Table 3. in Sec.
799.5090(j) of the proposed regulatory text). In the case of a
potentially explosive test chemical substance, care must be taken to
avoid the generation of explosive concentrations. For all other
chemical substances (i.e., those that are either liquids or solids at
room temperature), EPA is proposing that acute toxicity testing be
conducted via oral administration using an ``Up/Down'' test method
(described as Method B (ASTM E 1163-98 (2002) or 40 CFR
799.9110(d)(1)(i)(A)) in Table 3. in Sec. 799.5090(j) of the proposed
regulatory text). Consistent with the voluntary HPV Challenge, EPA is
proposing to allow the use of the Neutral Red Uptake (NRU) basal
cytotoxicity assay to select the starting dose for the acute oral
toxicity test (Refs. 34 and 35). This test is included as a Special
Condition in Table 3. in Sec. [emsp14]799.5090(j) of the proposed
regulatory text. A document developed by National Institutes of Health/
National Institute of Environmental Health Sciences (NIH/NIEHS)
provides guidance on how to use the NRU assay to estimate a starting
dose for an acute oral toxicity test (Ref. 36). Recent versions of the
standardized protocols for the NRU assay are available at the NIEHS/
Interagency Coordinating Committee on the Validation of Alternative
Methods (ICCVAM) Web site, http://iccvam.niehs.nih.gov/methods/acutetox/invitrocyto/invcyt_proto.htm (Refs. 34, 35, and 37).
Dermal toxicity testing is not proposed in this rulemaking, and the
Agency does not intend to include any dermal toxicity testing in any
TSCA section 4 HPV SIDS rulemakings.
5. Mammalian toxicity--genotoxicity. Gene Mutations. Bacterial
Reverse Mutation Test (in vitro): 40 CFR 799.9510 Chromosomal Damage.
In Vitro Mammalian Chromosome Aberration Test (40 CFR 799.9537), or
the In Vivo Mammalian Bone Marrow Chromosomal Aberration Test (rodents:
Mouse (preferred species), rat, or Chinese hamster) (40 CFR 799.9538),
or the In Vivo Mammalian Erythrocyte Micronucleus Test (sampled in bone
marrow) (rodents: Mouse (preferred species), rat, or Chinese hamster)
(40 CFR 799.9539).
[[Page 65590]]
Persons who would be required to conduct testing for chromosomal
damage are encouraged to use in vitro genetic toxicity testing (i.e.,
the Mammalian Chromosome Aberration Test) to generate the needed
genetic toxicity screening data, unless known chemical properties
preclude its use. These could include, for example, physical chemical
properties or chemical class characteristics. A primary focus of both
the voluntary HPV Challenge and this proposed rule is to implement this
program in a manner consistent with the OECD HPV SIDS Program and as
part of a larger international activity with global involvement. This
proposed approach provides the same degree of flexibility as that which
currently exists under the OECD HPV SIDS testing program (Ref. 1). A
person subject to this rule who uses one of the in vivo methods instead
of the in vitro method to address this end-point would be required to
submit to EPA in the final report a rationale for conducting that
alternate test.
6. Mammalian toxicity--repeated dose/reproduction/developmental.
Combined Repeated Dose Toxicity Study with the Reproduction/
Developmental Toxicity Screening Test: 40 CFR 799.9365. Reproduction/
Developmental Toxicity Screening Test: 40 CFR 799.9355. Repeated Dose
28-Day Oral Toxicity Study: 40 CFR 799.9305.
For the ``Mammalian Toxicity--Repeated Dose/Reproduction/
Developmental'' endpoint, EPA recommends the use of the Combined
Repeated Dose Toxicity Study with the Reproduction/Developmental
Toxicity Screening Test (40 CFR 799.9365) as the test of choice. EPA
recognizes, however, that there may be reasons to test a particular
chemical substance using both the Reproduction/Developmental Toxicity
Screening Test (40 CFR 799.9355) and the Repeated Dose 28-Day Oral
Toxicity Study (40 CFR 799.9305) instead of the Combined Repeated Dose
Toxicity Study with the Reproduction/Developmental Toxicity Screening
Test (40 CFR 799.9365). With regard to such cases, EPA is proposing
that a person subject to this rule, who uses the combination of the
Reproduction/Developmental Toxicity Screening Test and the Repeated
Dose 28-Day Oral Toxicity Study in place of the Combined Repeated Dose
Toxicity Study with Reproduction/Developmental Toxicity Screen would be
required to submit to EPA in the final study reports a rationale for
conducting these alternate tests.
Certain of the chemical substances for which Mammalian Toxicity--
Repeated Dose/Reproduction/Developmental testing is proposed may be
used solely as ``closed system intermediates,'' as described in the EPA
guidance document developed for the voluntary HPV Challenge (Ref. 38).
As described in that guidance, such chemical substances may be eligible
for a reduced testing battery which substitutes a developmental
toxicity study for the SIDS requirement to address repeated dose (e.g.,
subchronic), reproductive, and developmental toxicity. In other words,
since only the developmental toxicity study would be conducted for
those chemical substances that qualify for a reduced testing battery,
repeated dose (e.g., subchronic) and reproductive studies would not be
conducted. 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.
If, based on submitted information and other information available to
EPA, the Agency believes that a chemical substance is considered likely
to meet the requirements for use solely as a closed system
intermediate, EPA would not address any developmental toxicity testing
needs in this proposed rule.
D. When would any testing imposed by this proposed rule begin?
The testing requirements contained in this proposed rule are not
effective until and unless the Agency issues a final test rule. Based
on the effective date of the final test rule, which is typically 30
days after the publication of a final rule in the Federal Register, the
test sponsor may plan the initiation of any required testing as
appropriate to submit the required final report by the deadline
indicated in Sec. 799.5090(i) of the proposed regulatory text.
E. How would the studies proposed under this test rule be conducted?
Persons required to comply with the final rule would have to
conduct the necessary testing in accordance with the testing and
reporting requirements established in the regulatory text of the final
rule, with 40 CFR part 790--Procedures Governing Testing Consent
Agreements and Test Rules (except for paragraphs (a), (d), (e), and (f)
of Sec. [emsp14]790.45; Sec. 790.48; paragraph (a)(2) and paragraph
(b) of Sec. [emsp14]790.80; paragraph (e)(1) of Sec. 790.82; and
Sec. 790.85), and with 40 CFR part 792--Good Laboratory Practice
Standards.
F. What forms of chemical substances would be tested under this rule?
EPA is proposing two distinct approaches for identifying the
specific chemical substances that would be tested under a final rule
originating from this proposed rule, the application of which would
depend on whether the chemical substance is considered to be a ``Class
1'' or a ``Class 2'' chemical substance. First introduced when EPA
compiled the TSCA Chemical Substance Inventory, the term Class 1
chemical substance refers to a chemical substance having a chemical
composition that consists of a single chemical species (not including
impurities) that can be represented by a specific, complete structure
diagram. By contrast, a Class 2 chemical substance has a composition
that cannot be represented by a specific, complete chemical structure
diagram, because such a substance generally contains two or more
different chemical species (not including impurities). Table 2. in
Sec. [emsp14]799.5090(j) of the proposed regulatory text identifies
the listed chemical substances as either Class 1 or Class 2 chemical
substances.
EPA is proposing that, for the Class 1 chemical substances that are
listed in this proposed rule, the test chemical substance have a purity
of 99% or greater. EPA has generally applied this standard of purity to
the testing of Class 1 chemical substances in the past under TSCA
section 4(a) testing actions, except for chemical substances where it
has been shown that such purity is unattainable. EPA is soliciting
comment on whether a purity level of 99% or greater cannot be attained
for any of the Class 1 chemical substances listed in this proposed
rule. For the Class 2 chemical substances that are listed in this
proposed rule, EPA is proposing that the test chemical substance be any
representative form of the chemical substance, to be defined by the
test sponsor(s).
EPA solicits comment on the proposed alternative approach to the
testing of Class 2 chemical substances included in this proposed rule.
G. Who would be required to test under this rule?
1. Would I be subject to this rule? If this proposed rule becomes
final, you would be subject to the final rule and may be required to
test if you manufacture (which is defined by statute to include import)
or process, or intend to manufacture or process, one or more chemical
substances listed in this
[[Page 65591]]
proposed rule during the time period described in this unit. However,
if you do not know or cannot reasonably ascertain that you manufacture
or process a listed test rule chemical substance (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 would not be subject to the rule for that listed chemical
substance.
2. When would my manufacture or processing (or my intent to do so)
cause me to be subject to this rule? You would be subject to this rule
if you manufacture or process, or intend to manufacture or process, a
chemical substance listed in the rule at any time from the effective
date of the final test rule to the end of the test data reimbursement
period. The term ``reimbursement period'' is defined at 40 CFR 791.3(h)
and may vary in length for each substance to be tested under a final
TSCA section 4(a) test rule, depending on what testing is required and
when testing is completed.
3. Would I be required to test if I were subject to the rule? It
depends on the nature of your activities. All persons who would be
subject to this TSCA section 4(a) test rule, which, unless otherwise
noted in the regulatory text, incorporates EPA's generic procedures
applicable to TSCA section 4(a) test rules (contained within 40 CFR
part 790), would fall into one of two groups, designated here as Tier 1
and Tier 2. Persons in Tier 1 (those who would have to initially comply
with the final rule) would either submit to EPA letters of intent to
conduct testing, conduct this testing, and submit the test data to EPA,
or apply to and obtain from EPA exemptions from testing. Addresses of
the EPA Document Control Office where this information should be sent
are found in this document under ADDRESSES.
Persons in Tier 2 (those who would not have to initially comply
with the final rule) would not need to take any action unless they are
notified by EPA that they are required to do so (because, for example,
no person in Tier 1 had submitted a letter of intent to conduct
testing). Note that both persons in Tier 1 who obtain exemptions and
persons in Tier 2 would nonetheless be subject to providing
reimbursement to persons who actually conduct the testing.
4. Who would be in Tier 1 and Tier 2? All persons who would be
subject to the final rule are considered to be in Tier 1 unless they
fall within Tier 2. Table E. of this unit describes who is in Tier 1
and Tier 2.
Table E--Persons Subject to the Rule: Tier 1 and Tier 2
------------------------------------------------------------------------
Tier 1 (persons initially required to Tier 2 (persons not initially
comply) required to comply)
------------------------------------------------------------------------
Persons who manufacture (as defined at A. Persons who manufacture (as
TSCA section 3(7)) or intend to defined at TSCA section 3(7))
manufacture, a test rule chemical or intend to manufacture a
substance, and who are not listed test rule chemical substance
under Tier 2. 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
chemical substance (as
defined at 40 CFR
710.4(b));
--As a non-isolated
intermediate (as defined at
40 CFR 704.3);
--As a component of a Class
2 substance (as described
at 40 CFR 720.45(a)(1)(i));
--In amounts of less than
500 kilograms (kg) (1,100
lbs.) annually (as
described at 40 CFR
790.42(a)(4)); or
--In small quantities solely
for research and
development (R & D) (as
described at 40 CFR
790.42(a)(5)).
B. Persons who process (as
defined at TSCA section 3(10))
or intend to process a test
rule substance (see 40 CFR
790.42(a)(2)).
------------------------------------------------------------------------
Under 40 CFR 790.2, EPA may establish procedures for specific test
rules that differ from the generic procedures governing TSCA section
4(a) test rules in 40 CFR part 790. For purposes of this proposed rule,
EPA is proposing to establish certain requirements that differ from
those under 40 CFR part 790.
In this proposed test rule, EPA has configured the tiers in 40 CFR
790.42 as in previous HPV test rules (Refs. 39, 40, and 41). In
addition to processors, manufacturers of less than 500 kg (1,100 lbs.)
per year (``small-volume manufacturers''), and manufacturers of small
quantities for research and development (``R&D manufacturers''), EPA
has added the following persons to Tier 2: Byproduct manufacturers,
impurity manufacturers, manufacturers of naturally occurring chemical
substances, manufacturers of non-isolated intermediates, and
manufacturers of components of Class 2 chemical substances. The Agency
took administrative burden and complexity into account in determining
who was to be in Tier 1 in this proposed rule. EPA believes that those
persons in Tier 1 who would conduct testing under this proposed rule,
when finalized, would generally be large manufacturers of chemical
substances who, in the experience of the Agency, have traditionally
conducted testing or participated in testing consortia under previous
TSCA section 4(a) test rules.
The Agency also believes that byproduct manufacturers, impurity
manufacturers, manufacturers of naturally occurring chemical
substances, manufacturers of non-isolated intermediates, and
manufacturers of components of Class 2 chemical substances historically
have not themselves participated in testing or contributed to
reimbursement of those persons who have conducted testing. EPA
understands that these manufacturers may include persons for whom the
marginal transaction costs involved in negotiating and administering
testing arrangements are deemed likely to raise the expense and burden
of testing to a level that is disproportional to the additional
benefits of including these persons in Tier 1. Therefore, EPA does not
believe that the likelihood of the persons proposed to be added to Tier
2 actually conducting the testing is sufficiently high to justify
burdening these persons with Tier 1 requirements (e.g., submitting
requests for exemptions). Nevertheless, these persons, along with all
other persons in Tier 2, would be subject to reimbursement obligations
to persons who actually conduct the testing.
TSCA section 4(b)(3)(B) requires all manufacturers and/or
processors of a
[[Page 65592]]
chemical substance to test that chemical substance if EPA has made
findings under TSCA sections 4(a)(1)(A)(ii) or (a)(1)(B)(ii) for that
chemical substance, and issued a TSCA section 4(a) test rule requiring
testing. However, practicality must be a factor in determining who is
subject to a particular test rule. Thus, persons who do not know or
cannot reasonably ascertain that they are manufacturing or processing a
chemical substance subject to this proposed rule, e.g., manufacturers
or processors of a chemical substance as a trace contaminant who are
not aware of and cannot reasonably ascertain these activities, would
not be subject to the rule. See Sec. [emsp14]799.5090(b)(2) of the
proposed regulatory text.
5. Who is in the Tier 2 subdivisions? The Agency is proposing to
prioritize which persons in Tier 2 would be required to perform
testing, if needed. Specifically, the Agency is proposing that Tier 2
entities be subdivided into:
i. Tier 2A--manufacturers, i.e., those who manufacture, or intend
to manufacture, a test rule chemical substance solely as one or more of
the following: A byproduct, an impurity, a naturally occurring chemical
substance, a non-isolated intermediate, a component of a Class 2
chemical substance, in amounts less than 1,100 lbs. annually, or in
small quantities solely for research and development.
ii. Tier 2B--processors, i.e., those who process, or intend to
process, a test rule chemical substance (in any form). The terms
``process'' and ``processor'' are defined by TSCA sections 3(10) and
3(11), respectively.
If the Agency needs testing from persons in Tier 2, EPA would seek
testing from persons in Tier 2A before proceeding to Tier 2B. It is
appropriate to require manufacturers in Tier 2A to submit letters of
intent to test or exemption applications before processors are called
upon because the Agency believes that testing costs are traditionally
passed by manufacturers along to processors, enabling them to share in
the costs of testing (Ref. 42). In addition, as stated by EPA in the
Data Reimbursement rule, ``[t]here are [typically] so many processors
[of a given test rule chemical substance] that it would be difficult to
include them all in the technical decisions about the tests and in the
financial decisions about how to allocate the costs'' (Ref. 43).
6. When would it be appropriate for a person who would be required
to comply with the rule to apply for an exemption rather than to submit
a letter of intent to conduct testing? You may apply for an exemption
if you believe that the required testing will be performed by another
person (or a consortium of persons formed under TSCA section
4(b)(3)(A)). Procedures relating to exemptions are in 40 CFR 790.80
through 790.99, and Sec. [emsp14]799.5090(c)(2), (c)(5), (c)(7), and
(c)(11) of the proposed regulatory text. In this proposed rule, EPA
would not require the submission of equivalence data (i.e., data
demonstrating that your chemical substance is equivalent to the
chemical substance actually being tested) as a condition for approval
of your exemption. Therefore, 40 CFR 790.82(e)(1) and 40 CFR 790.85
would not apply to this proposed rule.
7. What would happen if I submitted an exemption application? If
EPA has received a letter of intent to test from another source or has
received (or expects to receive) the test data that would be required
under this rule, the Agency may conditionally approve your exemption
application under 40 CFR 790.87.
The Agency would terminate conditional exemptions if a problem
occurs with the initiation, conduct, or completion of the required
testing, or with the submission of the required data to EPA. EPA may
then require you to submit a notice of intent to test or an exemption
application. See 40 CFR 790.93 and Sec. 799.5090(c)(8) of the proposed
regulatory text for details on submitting this notice. In addition, the
Agency would terminate a conditional exemption if no letter of intent
to test has been received from persons required to comply with the
rule. See, e.g., Sec. 799.5090(c)(6) of the proposed regulatory text.
Note that the provisions at 40 CFR 790.48(b) have been incorporated
into the regulatory text of this proposed rule; thus, persons subject
to the final rule are not required to comply with 40 CFR 790.48 itself
(see Sec. 799.5090(c)(4)-(c)(7) and Sec. 799.5090(d)(3) of the
proposed regulatory text). Persons who obtain exemptions or receive
them automatically would nonetheless be subject to providing
reimbursement to persons who do actually conduct the testing, as
described in Unit IV.G.4.
8. What would my obligations be if I were in Tier 2? If you are in
Tier 2, you would be subject to the rule and you would be responsible
for providing reimbursement to persons in Tier 1. The obligation to
provide reimbursement is not affected by placement in Tier 2A or Tier
2B. Concerning testing, if you are in Tier 2, you are considered to
have an automatic conditional exemption. You would not need to submit a
letter of intent to test or an exemption application unless you are
notified by EPA that you are required to do so. As previously noted,
Tier 2A manufacturers would be notified to test before Tier 2B
processors.
If a problem occurs with the initiation, conduct, or completion of
the required testing, or with the submission of the required data to
EPA, the Agency may require you to submit a notice of intent to test or
an exemption application. See 40 CFR 790.93 and Sec. 799.5090(c)(10)
of the proposed regulatory text.
In addition, you would need to submit a notice of intent to test or
an exemption application if: i. no manufacturer in Tier 1 has notified
EPA of its intent to conduct testing; and ii. EPA has published a
Federal Register document directing persons in Tier 2 to submit to EPA
letters of intent to conduct testing or exemption applications. See
Sec. 799.5090(c)(4), (c)(5), (c)(6), and (c)(7) of the proposed
regulatory text. EPA is not aware of any circumstances in which test
rule Tier 1 entities have sought reimbursement from Tier 2 entities
either through private agreements or by soliciting the involvement of
the Agency under the reimbursement regulations at 40 CFR part 791.
9. What would happen if no one submitted a letter of intent to
conduct testing? EPA anticipates that it will receive letters of intent
to conduct testing for all of the tests specified and chemical
substances included in the final rule. However, in the event it does
not receive a letter of intent for one or more of the tests required by
the final rule for any of the chemical substances in the final rule
within 30 days after the publication of a Federal Register document
notifying Tier 2 processors of the obligation to submit a letter of
intent to conduct testing or to apply for an exemption from testing,
EPA would notify all manufacturers and processors of the chemical
substance of this fact by certified letter or by publishing a Federal
Register document specifying the test(s) for which no letter of intent
has been submitted. This letter or Federal Register document would
additionally notify all manufacturers and processors that all exemption
applications concerning the test(s) have been denied, and would give
them an opportunity to take corrective action. If no one has notified
EPA of its intent to conduct the required testing of the chemical
substance within 30 days after receipt of the certified letter or
publication of the Federal Register document, all manufacturers and
processors subject to the final rule with respect to that chemical
substance who are not already in violation of the final
[[Page 65593]]
rule would be in violation of the final rule.
10. What are the reimbursement procedures? In the past, persons
subject to test rules have independently worked out among themselves
their respective financial contributions to those persons who have
actually conducted the testing. However, if persons are unable to agree
privately on reimbursement, they may take advantage of EPA's
reimbursement procedures at 40 CFR part 791, promulgated under the
authority of TSCA section 4(a). These procedures include: The
opportunity for a hearing with the American Arbitration Association;
publication by EPA of a document in the Federal Register concerning the
request for a hearing; and the appointment of a hearing officer to
propose an order for fair and equitable reimbursement. The hearing
officer may base his or her proposed order on the production volume
formula set out at 40 CFR 791.48, but is not obligated to do so. Under
this proposed rule, amounts manufactured as impurities would be
included in production volume (40 CFR 791.48(b)), subject to the
discretion of the hearing officer (40 CFR 791.40(a)). The hearing
officer's proposed order may become the Agency's final order, which is
reviewable in Federal court (40 CFR 791.60).
H. What reporting requirements would be required under this test rule?
For each test for each chemical substance, you would be required to
submit a study plan 90 days after the effective date of the final rule
and a final report for a specific test by the deadline indicated as the
number of months after the effective date of the final rule, which
would be shown in Sec. 799.5090(i) of the regulatory text. Addresses
of the EPA Document Control Office where this information should be
sent are found in this document under ADDRESSES.
I. What would I need to do if I cannot complete the testing required by
the final rule?
A company who submits a letter of intent to test under the final
rule and who subsequently anticipates difficulties in completing the
testing by the deadline set forth in the final rule may submit a
modification request to the Agency, pursuant to 40 CFR 790.55. EPA will
determine whether modification of the test schedule is appropriate, and
may first seek public comment on the modification.
J. Would there be sufficient test facilities and personnel to undertake
the testing proposed under this test rule?
EPA's most recent analysis of laboratory capacity (Ref. 44)
indicates that available test facilities and personnel would adequately
accommodate the testing proposed in this rule.
K. Might EPA seek further testing of the chemical substances in this
proposed test rule?
If EPA determines that it needs additional data regarding any of
the chemical substances included in this proposed rule, the Agency
would seek further health and/or environmental effects testing for
these chemical substances. Should the Agency decide to seek such
additional testing via a test rule, EPA would initiate a separate
action for this purpose.
V. Proposed TSCA Section 5(a)(2) SNUR and Basis To Potentially Add One
or More Chemical Substances From Table A. to the SNUR
EPA has preliminarily determined that each of the 45 substances
listed in Tables A. and B. in Unit III. is produced in substantial
quantities (>=1 million lbs./yr) and made preliminary findings that
there may be substantial human exposure to 23 of these substances.
However, for 22 of the 45 chemical substances, the Agency does not
currently have exposure information that would adequately support such
findings under TSCA section 4(a)(1)(B). For those remaining 22 chemical
substances (i.e., Table B.), EPA is proposing to establish significant
new use reporting and recordkeeping requirements under TSCA section
5(a)(2) that would require EPA notification prior to worker or consumer
exposures rising to substantial levels.
A. What are the rationale and objectives for taking this action?
1. Rationale. Each of the chemical substances included in Table B.
is produced in substantial quantities. EPA considered the factors set
out in TSCA section 5(a)(2) and the longstanding use of the exposure
thresholds in the ``B Policy'' (see Unit V.B.) to determine that
manufacturers and processors of any of these chemical substances should
be required to notify EPA if exposure to any of these chemical
substances is expected to increase significantly. Accordingly, the
significant new uses are: Any use in a consumer product, and 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). The SNUR facilitates efficiency by mitigating the need
for EPA to continually reevaluate each HPV chemical substance to
determine whether exposure potential has increased so that there is or
may be substantial human exposure. EPA recognizes, however, that the
proposed SNU designation would not encompass every new use that could
potentially give rise to significant or substantial human exposure.
Consistent with EPA's past practice for issuing SNURs under TSCA
Section 5(a)(2), EPA's decision to propose a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. Rather,
the Agency's action is based on EPA's determination that if the use
begins or resumes, it may present a risk that EPA should evaluate
before the manufacturing or processing for that use begins. Since the
new use does not currently exist, deferring a detailed consideration of
potential risks or hazards related to that use is an effective use of
resources. If a person decides to begin manufacturing or processing the
chemical for the use, the notice to EPA allows EPA to evaluate the use
according to the specific parameters and circumstances surrounding that
intended use.
2. Objectives. Under TSCA section 5(a)(1)(B), any person intending
to manufacture, import, or process any of these chemical substances for
one or more of the designated SNUs would be required to notify EPA with
a SNUN before that activity begins. EPA would then have an opportunity
to review and evaluate data submitted in a SNUN and, if warranted
pursuant to TSCA sections 5(e), 5(f), 6 or 7, EPA would be able to
regulate prospective manufacturers (which, as noted in Unit I.A.,
includes importers) or processors of the chemical substances before the
designated SNUs of the chemical substance occurs.
B. How were the significant new uses determined?
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a SNU must be made after consideration of
all relevant factors including:
1. The projected volume of manufacturing and processing of a
chemical substance.
2. The extent to which a use changes the type or form of exposure
of human beings or the environment to a chemical substance.
[[Page 65594]]
3. The extent to which a use increases the magnitude and duration
of exposure of human beings or the environment to a chemical substance.
4. The reasonably anticipated manner and methods of manufacturing,
processing, distribution in commerce, and disposal of a chemical
substance.
In addition to these factors, the statute authorizes EPA to
consider any other relevant factors. To determine what would constitute
a SNU of the chemical substances listed in Table B. and of the chemical
substances listed in Table A., EPA considered the section 5(a)(2)
factors, as well as EPA's 1993 ``B Policy'' (Ref. 2), discussed in Unit
II.D.
For the first section 5(a)(2) factor, production volume, EPA
considered the fact that all 22 of the chemical substances in Table B.,
and all 23 of the chemical substances in Table A., have been produced
in substantial amounts, i.e., volumes above one million lbs./year. EPA
would expect that increased or expanded use of these chemical
substances could correspond to a further increase in annual production
volume and thereby increase exposures.
Next, EPA considered the extent to which a use changes the type or
form of exposure of human beings or the environment to a chemical
substance. Current IUR information available to EPA indicates that all
but 2 of the 22 chemical substances in Table B. are used solely for
industrial purposes. For the remaining two chemical substances in Table
B., EPA could find no evidence of any ongoing consumer uses. With
respect to these 22 chemical substances (i.e., Table B.), any use in
consumer products would likely result in new consumer exposures to
these chemical substances. These potential new users could be exposed
via pathways different from industrial users, and consumers may be less
likely to use, or have access to, appropriate protective equipment
(e.g. gloves or respirators) than industrial users. An expansion into
use in consumer products may also include new environmental releases,
deliberate or accidental (e.g., consumers may dispose of a chemical
substance by pouring it down a storm drain or household sink).
With respect to the chemical substances listed in Table A., EPA has
information indicating that ongoing use of certain of these chemical
substances already involves the exposure of 10,000 or more consumers.
If public comment on this proposal is accompanied by additional
information that contradicts the information upon which EPA has based
its preliminary conclusions (i.e., less than 10,000 consumers are
exposed), that information could potentially also establish that there
are no ongoing uses of the chemical substance in consumer products. If
EPA concludes, on the basis of public comments, that there is an
inadequate basis to issue a test rule for the chemical substance, it
would also conclude, as a general matter, that there is an adequate
basis to issue a SNUR for the chemical substance. In such a case, EPA
intends to incorporate the chemical substance into the final SNUR
without further opportunity for public notice and comment. EPA believes
that the commencement of consumer uses of the chemical substances in
Table A. (if such uses are not currently ongoing) would be a SNU of the
chemical substances. This is because potential new users could be
exposed via pathways different from industrial users, and may be less
likely to use appropriate protective equipment (e.g. gloves or
respirators) than industrial users. An expansion into use in consumer
products may also include new environmental releases (e.g., consumers
may dispose of a chemical substance by pouring it down a storm drain or
household sink).
EPA also considered the extent to which a use increases the
magnitude and duration of human or environmental exposure to a chemical
substance. Commencement of a chemical substance's use in a consumer
product would increase the amount and time that consumers were exposed
to the chemical substance. In determining substantial consumer
exposure, EPA considered the production volume and consumer uses. If
production volume exceeds one million pounds per year and consumer uses
are indicated, it is likely that consumer exposure exceeds the
substantial threshold of ten thousand people as defined by the ``B
Policy.'' EPA has reached this conclusion with respect to the chemical
substances in Table B. and the chemical substances in Table A. (to the
extent that use of the chemical substances in Table A. in consumer
products is not already ongoing).
EPA also considered how the number of workers exposed (as reported
under the IUR rule) might change if use of a chemical substance changed
or expanded. For example, the commencement of additional new uses may
increase the total production volume of a chemical substance, thereby
increasing the magnitude and duration of exposure for industrial
workers. None of the 22 chemical substances listed in Table B. are
known to meet the ``B Policy'' threshold for substantial worker
exposure (>= 1,000 workers) at this time. However, if exposure were to
increase such that 1,000 or more workers at a single corporate entity
were reasonably likely to be exposed, EPA believes that the increased
exposure would be a significant change. In this context, ``single
corporate entity'' refers to the aggregate of all of the domestic
facilities owned or operated by an individual corporation. Therefore,
the SNUR notification requirements would be triggered 90 days before
the sum of all potentially exposed workers at domestic facilities
comprising the single corporate entity was expected to reach 1,000
workers or more.
With respect to the chemical substances listed in Table A., EPA has
information that ongoing use of certain of these chemical substances
already involves the exposure of 1,000 or more workers. If EPA
concludes, on the basis of public comments, that there is no basis to
issue a test rule for such chemical substance then it would also
conclude, as a general matter, that there is an adequate basis to issue
a SNUR for the chemical substance. In such a case, EPA intends to
incorporate the chemical substance into the final SNUR without further
opportunity for public notice and comment. Chemical substances from
Table A., like the chemical substances from Table B., are high
production volume chemical substances. If exposure to a Table A.
chemical substance were to increase such that 1,000 or more workers at
a single corporate entity were to become reasonably likely to be
exposed, EPA believes that the increased exposure would be a
significant change.
With respect to the chemical substances in Tables A. and B., EPA
also considered the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of
these chemical substances in determining what would be a SNU. Given the
production volume of these chemical substances, any change in these
methods or practices could affect human or environmental exposures, but
the lack of available toxicity data, and of more detailed information
about existing methods and practices, hampers EPA's ability to more
fully consider this fourth factor.
Finally, EPA considered the ``B Policy.'' Since 1993, EPA has used
the production, exposure, and release benchmarks in the ``B Policy''
for making TSCA section 4 test rule findings. EPA has also considered
and incorporated the production, worker, and consumer exposure
benchmarks in the selection of chemical substances to be included and
development of the SNUs included in today's proposed action. These
chemical substances have already been in production at high
[[Page 65595]]
volumes, and at least some workers are exposed. EPA is proposing to
incorporate certain ``B Policy'' exposure thresholds into its rationale
for the proposed SNUs because they are clear numeric criteria that have
been used to determine substantial human exposure since 1993. They have
provided a clear threshold--well understood by EPA, industry, and other
stakeholders--of levels of worker or consumer exposure that are
important under TSCA. EPA is interested in receiving comment concerning
use of the ``B Policy'' in this context.
C. What were the alternatives to proposing this SNUR?
Before proposing this SNUR, EPA considered promulgating a TSCA
section 8(a) reporting rule. Under a TSCA section 8(a) rule, EPA could,
among other things, generally require persons to report information to
the Agency when they intend to manufacture, import, or process a listed
chemical substance for a specific use or any use. However, if EPA were
to require reporting under TSCA section 8(a) instead of TSCA section
5(a), EPA would not have the opportunity to assess the risk of the new
use prior to commencement of that activity, or, if warranted, to take
immediate follow-up regulatory action under TSCA sections 5(e) or 5(f)
to prohibit or limit the activity before it begins.
D. What would be the applicability of the final rule to uses occurring
before the effective date of the final rule?
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA
is best served by designating a use as a SNU as of the date of
publication of the proposed rule rather than as of the effective date
of the final rule. If uses begun after publication of the proposed rule
were considered ongoing rather than new, it would be difficult for EPA
to establish SNUR notice requirements, because a person could defeat
the SNUR by initiating the proposed SNU before the rule became final,
and then argue that the use was ongoing as of the effective date of the
final rule. Thus, persons who, after publication of the proposed SNUR,
begin commercial manufacture, import, or processing of the chemical
substance(s) listed in Table B. for a use proposed in this action for a
SNU would have to cease any such activity before the effective date of
the rule if and when finalized. To resume their activities, these
persons would have to comply with all applicable SNUR notice
requirements and wait until the notice review period, including all
extensions, expires. EPA has promulgated provisions to allow persons to
comply with SNURs before the effective date. If a person were to meet
the conditions of advance compliance under Sec. 721.45(h), that person
would be considered to have met the requirements of the final SNUR for
those activities.
E. Do test data and other information have to be submitted?
TSCA section 5 does not require developing any particular test data
before submission of a SNUN, except where the chemical substance is
also subject to a test rule under TSCA section 4 (see TSCA section
5(b)), or when a chemical substance is included on the list described
under section 5(b)(4). Unless submission of data is required under
section 4 or 5(b)(4), persons are required only to submit test data in
their possession or control and to describe any other data known to or
reasonably ascertainable by them (40 CFR 721.25). However, as a general
matter, EPA recommends that SNUN submitters include data that would
permit a reasoned evaluation of risks posed by the chemical substance
during its manufacture, import, processing, use, distribution in
commerce, or disposal. EPA encourages persons to consult with the
Agency before submitting a SNUN. As part of this optional pre-notice
consultation, EPA would discuss specific data it believes may be useful
in evaluating a significant new use. SNUNs submitted for significant
new uses without any test data may increase the likelihood that EPA
will take action under TSCA section 5(e) to prohibit or limit
activities associated with this chemical substance.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
1. Human exposure and environmental releases that may result from
the significant new uses of the chemical substances.
2. Potential benefits of the chemical substances.
3. Information on risks posed by the chemical substances compared
to risks posed by potential substitutes.
F. How do I submit a SNUN?
EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what data may be useful in evaluating a
SNU. Discussions with the Agency prior to submission can afford ample
time to conduct any tests that might be helpful in evaluating risks
posed by the substance. According to 40 CFR 721.1(c), persons
submitting a SNUN must comply with the same notice requirements and EPA
regulatory procedures as persons submitting a PMN, including submission
of test data on health and environmental effects as described in 40 CFR
720.50. SNUNs must be submitted to EPA, on EPA Form No. 7710-25 in
accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR
720.40.
EPA published a final rule on January 6, 2010 (75 FR 773) (FRL-
8794-5), that established standards and requirements for the use of the
electronic-PMN (e-PMN) software and EPA's Central Data Exchange (CDX)
to electronically submit these notices. The Agency is introducing
electronic reporting via CDX using the e-PMN in three phases over a
two-year period. The effective date of the rule was April 6, 2010.
Until April 6, 2011, submissions were permitted via CDX, optical disc,
or paper. After April 6, 2011, paper submissions are no longer being
accepted. After April 6, 2012, all submissions will be required to be
submitted electronically via CDX. Regardless of the delivery method,
EPA requires that all submissions be generated using the new e-PMN
software. For additional information and instructions go to: http://www.epa.gov/opptintr/newchems/epmn/epmn-index.htm. Until April 6, 2012,
SNUNs may still be mailed to the Environmental Protection Agency, OPPT
Document Control Office (7407M), 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460-0001.
G. What are the recordkeeping requirements?
EPA is proposing that persons subject to this proposed SNUR be
required to maintain several records in addition to those required by
40 CFR 721.40 (persons required to submit a SNUN must retain
documentation of information contained in that SNUN). EPA is proposing
to require manufacturers and processors to maintain the records
described in 40 CFR 721.125 (a), (b), and (c) in this SNUR. Section
721.125(a) requires records documenting manufacture and importation
volume and dates; Sec. 721.125(b) documents volumes purchased in the
U.S. by processors, the names and addresses of suppliers, and the dates
of purchase; and Sec. 721.125(c) requires records documenting the
names and addresses (including shipment destination address, if
different) of all persons outside the site of manufacture, importation,
or processing to whom the manufacturer, importer, or processor directly
sells or transfers the chemical
[[Page 65596]]
substance, the date, and the quantity of each sale or transfer. These
records would help EPA to determine compliance with the SNUR.
VI. Export Notification Requirements
Test rule: Any person who exports, or intends to export, one of the
chemical substances contained in this proposed test rule in any form
(e.g., as byproducts, impurities, components of Class 2 chemical
substances, etc.) will be subject to the export notification
requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart
D, but only after the final rule is issued and only if the chemical
substance is contained in the final rule. Export notification is
generally not required for articles, as provided by 40 CFR 707.60(b).
Section 12(b) of TSCA states, in part, that any person who exports or
intends to export to a foreign country a chemical substance or mixture
for which the submission of data is required under TSCA section 4 must
notify the EPA Administrator of such export or intent to export. The
EPA Administrator in turn will notify the government of the importing
country of the availability of data.
VII. Economic Impacts
A. What would be the economic impacts of the proposed test rule?
EPA has prepared an economic assessment entitled ``Economic
Analysis for the Proposed High Production Volume Challenge Chemicals
Test Rule--Fourth Group of Chemicals'' (Ref. 45), a copy of which has
been placed in the docket for this proposed rule. This economic
assessment evaluates the potential for significant economic impacts as
a result of the testing that would be required by this proposed rule.
The analysis covers 23 chemical substances. The total social cost of
providing test data on the 23 chemical substances that were evaluated
in this economic analysis is estimated to be $7.72 million assuming an
average cost scenario. Total costs of compliance to industry are
estimated at $7.65 million (Ref. 45).
While legally subject to this test rule, processors of a subject
chemical substance would be required to comply with the requirements of
the final rule only if they are directed to do so by EPA as described
in Sec. 799.5090(c)(5) and (c)(6) of the proposed regulatory text. EPA
would only require processors to test if no person in Tier 1 has
submitted a notice of its intent to conduct testing, or if under 40 CFR
790.93, a problem occurs with the initiation, conduct, or completion of
the required testing or the submission of the required data to EPA.
Because EPA has identified at least one manufacturer in Tier 1 for each
subject chemical substance, the Agency assumes that, for each chemical
substance in this proposed rule, at least one such person will submit a
letter of intent to conduct the required testing and that person will
conduct such testing and will submit the test data to EPA. Because
processors would not need to comply with the proposed rule initially,
the economic assessment does not address processors.
Compliance costs include costs of testing and administering the
testing, as well as reporting costs. In addition, they include the
estimated cost of the TSCA section 12(b) export notification
requirements, which, under the final rule, would be required for the
first export to a particular country of a chemical substance subject to
the final rule, estimated to range from $27.50 per notice to $86.99 per
notice (Ref. 45). These export notification requirements (included in
the total and annualized cost estimates) that would be triggered by the
final rule are expected to have a negligible impact on exporters.
The potential for adverse economic impact as a result of the rule
is expected to be higher for smaller businesses. Smaller businesses are
less likely to have additional revenue sources to cover the compliance
costs. Therefore, the Agency compared the costs of compliance to
company sales for small businesses. EPA estimates that there are 25
small entities that would be affected by this proposed rule. Of these,
EPA estimates that there is no small business for which the cost impact
of the testing exceeds 1 percent of the company's revenue. EPA
believes, on the basis of these calculations, that the proposed testing
of the chemical substances presents a low potential for adverse
economic impact for the majority of chemical substances.
The benefits resulting from this proposed test rule are discussed
qualitatively in the ``Economic Analysis for the Proposed High
Production Volume Challenge Chemicals Test Rule-Fourth Group of
Chemicals'' (Ref. 45). EPA believes that the net benefits of this
proposed rule are positive, but quantification of the benefits of the
proposed rule would require more specific information about use
patterns and preferences than is available.
B. What would be the economic impacts of the proposed SNUR?
1. SNUNs. EPA has evaluated the potential costs of establishing
SNUR reporting and recordkeeping requirements for potential
manufacturers, importers, and processors of the chemical substance
included in this proposed rule. While most businesses are subject to a
$2,500 user fee required by 40 CFR 700.45(b)(2)(iii), small businesses
with an annual sales of less than $40 million when combined with those
of the parent company (if any) are subject to a reduced user fee of
$100 (40 CFR 700.45(b)(1)). The costs of submission of SNUNs will not
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
[[Page 65597]]
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
[[Page 65598]]
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
[[Page 65599]]
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
[[Page 65600]]
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
[[Page 65601]]
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
[[Page 65602]]
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.
[[Page 65603]]
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)).
[[Page 65604]]
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
[[Page 65605]]
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.
[[Page 65606]]
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\..
[[Page 65607]]
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.
[[Page 65608]]
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