[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Rules and Regulations]
[Pages 15609-15617]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6430]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[EPA-HQ-OPPT-2005-0033; FRL-9335-6]
RIN 2070-AD16
Revocation of TSCA Section 4 Testing Requirements for Certain
High Production Volume Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: EPA is revoking certain testing requirements for six chemical
substances and all the testing requirements for four chemical
substances. EPA is basing its decision to take this action on
information received since publication of the first test rule for
certain high production volume chemical substances (HPV1). HPV1
established testing requirements for those 10 chemical substances. On
the effective date of this direct final rule, persons who export or
intend to export the four chemical substances for which all the testing
requirements are revoked are no longer subject to section 12(b) of the
Toxic Substance Control Act (TSCA) export notification requirements
triggered by HPV1.
DATES: This direct final rule is effective May 15, 2012 without further
notice, unless EPA receives adverse comment in writing, or a request to
present comment orally, on or before April 16, 2012. If EPA receives
adverse comment, or a written request for an opportunity to present
oral comments, EPA will publish a timely withdrawal in the Federal
Register informing the public that this direct final rule, or relevant
portions of this direct final rule, will not take effect. If you write
EPA to request an opportunity to present oral comments on or before
April 16, 2012, EPA will hold a public meeting on this direct final
rule in Washington, DC. The announcement of the meeting will be
published in the Federal Register.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2005-0033, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online 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.,
[[Page 15610]]
Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention: Docket
ID Number EPA-HQ-OPPT-2005-0033. 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-
2005-0033. EPA's policy is that all comments received will be included
in the docket without change and may be made available online 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 email. 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 email comment
directly to EPA without going through regulations.gov, your email
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, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available in the electronic docket 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.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Catherine Roman, Chemical Control Division, Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8157; email address: roman.catherine@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general and may be of
particular interest to those persons who manufacture (defined by
statute to include import), process, or export the chemical substances
identified in this direct final rule. Because other persons may also be
interested, the Agency has not attempted to describe all the specific
persons that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the technical person listed under FOR FURTHER INFORMATION
CONTACT.
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 email. 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
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.
II. Statutory Authority
Section 4(a) of TSCA authorizes EPA to require testing if certain
findings are made. EPA is amending the chemical testing requirements
for certain HPV chemical substances in 40 CFR 799.5085 because some of
the findings that EPA made for 10 chemical substances are no longer
supported. These findings were that:
1. The chemical substances were produced in substantial quantities.
2. There are insufficient data upon which the effects of
manufacture, distribution, processing, use, or disposal of those
chemical substances on health or the environment can reasonably be
determined or predicted.
3. Testing of the chemical substance with respect to such effects
is necessary to develop such data. (See TSCA section 4(a)(1)(B)(i),
(ii), and (iii); also, see Ref. 1).
Unit III. discusses which findings are not supported for each
specific chemical substance subject to this direct final rule.
III. Amendment to Chemical Testing Requirements
EPA is amending the chemical testing requirements for certain HPV
chemical
[[Page 15611]]
substances in 40 CFR 799.5085 by direct final rule. Specifically, this
direct final rule revokes the testing requirements for the following
four chemical substances: Acetyl chloride (CAS No. 75-36-5);
imidodicarbonic diamide (CAS No. 108-19-0); methane, isocyanato- (CAS
No. 624-83-9); and urea, reaction products with formaldehyde (CAS No.
68611-64-3). This direct final rule also revokes some of the testing
requirements for the following six chemical substances: 9,10-
Anthracenedione (CAS No. 84-65-1); 1-chlorododecane (CAS No. 112-52-7);
phenol, 4,4'-methylenebis [2,6-bis(1,1-dimethylethyl)]- (CAS No. 118-
82-1); methanesulfinic acid, hydroxyl-, monosodium salt (CAS No. 149-
44-0); benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-
(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]- (CAS
No. 1324-76-1); and C.I. Solvent Black 7 (CAS No. 8005-02-5). EPA is
basing its decision to revoke all testing requirements for four
chemical substances and some of the testing requirements for six other
chemical substances on information received since publication of HPV1
(40 CFR 799.5085), as described in this unit.
A. Revocation of All Testing Requirements for Four Chemical Substances
1. Acetyl chloride. EPA is revoking all testing requirements for
acetyl chloride (CAS No. 75-36-5) because there is no longer support
for the TSCA section 4(a)(1)(B)(i) ``substantial production'' finding
for this chemical substance. ``Substantial production'' of a chemical
substance under TSCA section 4(a)(1)(B)(i) is generally interpreted by
EPA to be an aggregate production (including import) volume equaling or
exceeding 1 million pounds per year. See EPA's TSCA section 4(a)(1)(B)
Final Statement of Policy (``B'' policy) (Ref. 2). The ``substantial
production'' finding for this chemical substance was based on reports
from several companies to the 2002 TSCA Inventory Update Reporting
(IUR) rule. The Albemarle Corporation which manufactured and imported
the largest volume of acetyl chloride, without which a finding of
substantial production could not have been made, informed EPA in 2007
that its manufacture and importation of acetyl chloride at the time the
test rule was promulgated were only for non-TSCA purposes (i.e., for
use in pharmaceuticals) (Ref. 3), and was, therefore, not subject to
HPV1.
Three other companies had reported importing smaller volumes of
acetyl chloride in the 2002 IUR, the sum of which would not have
provided support for a finding of substantial production. Two of these
companies, Tessenderlo Kerley, Inc., and a company, which claimed its
name as CBI, have since ceased importation of acetyl chloride.
Tessenderlo Kerley ceased importation several years ago, and the other
company ceased importation over a year prior to the effective date of
HPV1, April 17, 2006 (Ref. 4). Neither of these companies is,
therefore, subject to HPV1. The third small importer, Chartkit Chemical
Corporation, reported that it imported only a small amount of acetyl
chloride after the effective date of HPV1 in 2006, but none since (Ref.
5). EPA's review of data in the 2006 IUR (which required reporting on
chemical substances manufactured or imported during calendar year 2005)
did not identify any companies manufacturing or importing acetyl
chloride. (Chartkit Chemical Corporation did not import acetyl chloride
in 2005, making a report to the 2006 IUR unnecessary.) Because the
finding for substantial production for acetyl chloride was not
supported when HPV1 was promulgated, the Agency is revoking all the
testing requirements for acetyl chloride (CAS No. 75-36-5) by removing
it from Table 2 in 40 CFR 799.5085(j).
2. Imidodicarbonic diamide. EPA is revoking all the testing
requirements for imidodicarbonic diamide (CAS No. 108-19-0), also known
as biuret, by removing imidodicarbonic diamide from Table 2 in 40 CFR
799.5085(j). EPA considers the test requirements for this chemical
substance unnecessary at this time because sufficient data have been
provided to allow the Agency to reverse its finding under TSCA section
4(a)(1)(B)(ii) for ``insufficient data.'' Information that satisfied
HPV1's requirements was voluntarily submitted by The Fertilizer
Institute (TFI) on behalf of a member company that manufactures the
chemical substance as an impurity in its products. EPA considers a
company that manufactures a chemical substance only as an impurity to
be a Tier 2 manufacturer with regard to its obligations under HPV1.
Although subject to HPV1 and responsible for providing reimbursement to
persons in Tier 1, Tier 2 manufacturers do not have to respond to HPV1
with a letter of intent to test or a request for exemption, unless
directed to do so by EPA through a document published in the Federal
Register. Although EPA did not publish such a document, TFI, acting on
behalf of its member company, volunteered to provide information to EPA
on the endpoints specified by HPV1 for that chemical substance. This
information (Refs. 6-8) was provided to the Agency and found to meet
the standards prescribed by EPA (Refs. 9-11) and is being made
available in the docket for this direct final rule and will be added to
the High Production Volume Information System (HPVIS).
3. Methane, isocyanato. EPA is revoking all the testing
requirements for methane, isocyanato- (CAS No. 624-83-9) by removing it
from Table 2 in 40 CFR 799.5085(j). On May 11, 2007, Bayer CropScience
submitted a test plan and robust summaries of existing data for
methane, isocyanato- along with a request that EPA determine if the
robust summaries satisfied the Agency's need for data on physical/
chemical properties (Ref. 12). In the same letter, Bayer CropScience
requested a waiver for the requirement to determine an octanol-water
partition coefficient and the requirement to conduct aquatic toxicity
tests because of the extreme reactivity in water of methane,
isocyanato-. Bayer CropScience also asked EPA to consider, as a
substitute for aquatic toxicity studies of methane, isocyanato-, robust
summaries of aquatic toxicity studies of dimethyl urea (CAS No. 96-31-
1) (DMU), one of the two degradation products of methane, isocyanato-
in water, the other being carbon dioxide. EPA concluded that the
submitted data satisfied the Agency's need for data on the physical/
chemical properties of boiling point, melting point, vapor pressure,
and water solubility (Ref. 13). EPA also agreed that methane,
isocyanato- hydrolyzes very rapidly and, as a result, an octanol-water
partition coefficient is not relevant (Ref. 13). Because of the rapid
hydrolysis of methane, isocyanato- to carbon dioxide and DMU, EPA is
revoking the requirement to test for aquatic toxicity (fish acute
toxicity, Daphnia acute toxicity, and toxicity to algae). EPA believes
that the aquatic toxicity studies of DMU, provided by Bayer
CropScience, which the Agency reviewed and found adequate, provide
information on the aquatic effects of methane, isocyanato- (Ref. 14).
Therefore, EPA, in this direct final rule, is revoking the testing
requirements for boiling point, melting point, vapor pressure, octanol-
water partition coefficient, water solubility, fish acute toxicity,
Daphnia acute toxicity, and toxicity to algae for methane, isocyanato-
by removing it from Table 2 in 40 CFR 799.5085(j).
4. Urea, reaction products with formaldehyde. EPA is revoking all
the testing requirements for urea, reaction products with formaldehyde
(CAS No. 68611-64-3) by removing it from Table
[[Page 15612]]
2 in 40 CFR 799.5085(j). EPA considers the test requirements for this
chemical substance unnecessary at this time because sufficient data
have been provided to allow the Agency to reverse its finding under
TSCA section 4(a)(1)(B)(ii) for ``insufficient data.'' Information
which satisfied HPV1's requirements was voluntarily submitted by TFI on
behalf of its member companies that manufacture this chemical substance
as an impurity in their products. EPA considers companies that
manufacture a chemical substance only as an impurity to be Tier 2
manufacturers with regard to their obligations under HPV1. Although
subject to HPV1 and responsible for providing reimbursement to persons
in Tier 1, Tier 2 manufacturers did not have to respond to HPV1 with a
letter of intent to test or a request for exemption, unless directed to
do so by EPA through a document published in the Federal Register.
Despite the lack of an EPA published Federal Register document, TFI,
acting on behalf of its member companies, volunteered to provide
information to EPA on the endpoints specified by HPV1 for this chemical
substance. This information (Refs. 7 and 16) has been provided to the
Agency and found to meet the standards for testing prescribed by EPA
(Refs. 17-19) and is being made available in the docket for this direct
final rule and will be added to HPVIS.
B. Revocation of Some Test Requirements for Six Chemical Substances
1. 9,10-Anthracenedione. In a letter dated July 10, 2006, the
Chemical Products Corporation (CPC) requested EPA's permission to
submit the values for boiling point and vapor pressure of 9,10-
anthracenedione (CAS No. 84-65-1) contained in the International
Uniform Chemical Information Database (IUCLID) instead of conducting
the tests required by HPV1 (Ref. 20). CPC stated that the ASTM methods
specified by HPV1 would not work for 9,10-anthracenedione because the
boiling point and vapor pressure listed for that chemical substance in
IUCLID and the boiling point listed for that chemical substance in the
``Handbook of Chemistry and Physics'' (Ref. 21) fell outside the
determination ranges of the ASTM methods. EPA agreed and approved CPC's
request to submit IUCLID and other existing values because those values
matched or were in close agreement with measured values in various
literature sources (Ref. 22). CPC also requested a modification of the
ASTM method E 324 to determine the melting point for 9,10-
anthracenedione (Ref. 23). While evaluating this request, EPA reviewed
available data on measured melting points of 9,10-anthracenedione and
found the existing data to be in sufficiently close agreement that they
could be used to satisfy the Agency's data need for that endpoint (Ref.
22). EPA is, therefore, revoking the requirement that the boiling
point, vapor pressure, and melting point of 9,10-anthracenedione be
determined by the ASTM methods specified in HPV1 and accepts the
submitted existing data as sufficient to satisfy those data needs,
making the testing requirements unnecessary. Therefore, EPA is revoking
the testing requirements for boiling point, vapor pressure, and melting
point for 9,10-anthracenedione by removing those requirements from
those listed for 9,10-anthracenedione in Table 2 in 40 CFR 799.5085(j).
The test requirements for 9,10-anthracenedione that are not revoked by
this direct final rule include tests to determine octanol/water
partition coefficient and water solubility, and to screen for
reproduction/developmental toxicity. Studies responding to those test
requirements have been submitted to the Agency (Ref. 24).
2. 1-Chlorododecane. In a letter dated February 21, 2008, EPA
informed Lonza, Inc., that the testing of 1-chlorododecane (CAS No.
112-52-7), which Lonza had committed to sponsor, did not have to
include a test for melting point because, in publicly available
documents, 1-chlorododecane is reported to be a liquid (Ref. 25).
Therefore, EPA is revoking the testing requirement for melting point
for 1-chlorododecane by removing that requirement from those listed for
1-chlorododecane in Table 2 in 40 CFR 799.5085(j). The test
requirements for 1-chlorododecane that are not revoked by this direct
final rule include tests for boiling point, vapor pressure, octanol/
water partition coefficient, water solubility, biodegradation, Daphnia
chronic toxicity, toxicity to algae, acute mammalian toxicity,
mutagenicity, chromosomal damage, and 28-day repeated-dose toxicity
with a reproduction/developmental toxicity screen. Studies responding
to those test requirements have been submitted to the Agency (Ref. 26).
3. Phenol, 4,4'-methylenebis[2,6-bis(1,1-dimethylethyl)]-. In
letters dated May 12, 2006, July 14, 2006, May 1, 2007, and May 16,
2007 (Refs. 27-30), the Albemarle Corporation requested EPA to review
existing data that it was submitting for phenol, 4,4'-methylenebis[2,6-
bis(1,1-dimethylethyl)]- (CAS No. 118-82-1) to determine if they
satisfied the Agency's need for data on water solubility, octanol/water
partition coefficient, acute mammalian toxicity, bacterial reverse
mutation, and screening level reproduction/developmental toxicity. EPA
found that the data satisfied the Agency's data needs for those testing
endpoints in HPV1, making the testing requirements unnecessary (Refs.
31-33). Therefore, EPA is revoking the testing requirements for water
solubility, octanol/water partition coefficient, acute mammalian
toxicity, bacterial reverse mutation assay, and a reproduction/
developmental toxicity screen for phenol, 4,4'-methylenebis[2,6-
bis(1,1-dimethylethyl)]- by removing those requirements from Table 2 in
40 CFR 799.5085(j). The test requirements for phenol, 4,4'-
methylenebis[2,6-bis(1,1-dimethylethyl)]- that are not revoked by this
direct final rule include tests for melting point, boiling point, vapor
pressure, inherent biodegradation, and chromosomal damage. Studies
responding to those test requirements have been submitted to the Agency
(Ref. 34).
4. Methanesulfinic acid, hydroxyl-, monosodium salt. On May 14,
2007, the Sodium Formaldehyde Sulfoxylate Consortium (SFS Consortium)
formed under the auspices of the Synthetic Organic Chemical
Manufacturers Association (SOCMA) submitted existing data to satisfy
some of the testing requirements for methanesulfinic acid, hydroxyl-,
monosodium salt (CAS No. 149-44-0) (Ref. 35). The submitted studies
used the dihydrate form of methanesulfinic acid, hydroxyl-, monosodium
salt (CAS No. 6035-47-8) as the test substance to address the endpoints
of inherent biodegradation, fish acute toxicity, Daphnia acute
toxicity, and toxicity to algae (Ref. 35). Although the hydrated form
is identified by a different CAS number, in general, EPA does not
recognize a hydrate as a separate entity from the corresponding
anhydrous material for TSCA purposes, and accepts studies of the
hydrated form of a chemical substance as predictive of the effects of
the anhydrous chemical (Ref. 15). EPA found that the submitted study on
ready biodegradation satisfied the need for information on
biodegradability, making the test requirement for inherent
biodegradation unnecessary (Refs. 36 and 37). The existing studies on
fish acute toxicity, Daphnia acute toxicity, and toxicity to algae were
reviewed by the Agency and found to satisfy EPA's data needs for those
endpoints (Ref. 38).
In the test plan submitted with the May 14, 2007 letter, the SFS
Consortium
[[Page 15613]]
requested that EPA revoke the requirement to determine vapor pressure
because the chemical substance is an organo-metallic salt that does not
volatilize (Ref. 35). The SFS Consortium also requested that EPA revoke
the requirement to determine the octanol/water partition coefficient
(log Kow) because its estimated value was -6.17 and HPV1 did
not require a determination of octanol/water partition coefficient if
its estimated value is less than zero (Ref. 35). EPA agreed with the
SFS Consortium's position that testing was not needed to determine
vapor pressure (Ref. 39) and octanol/water partition coefficient (Ref.
40). Also, in the test plan submitted on May 14, 2007, (Ref. 35), the
SFS Consortium reported that in a test to determine boiling point, the
test substance decomposed. EPA, therefore, is waiving the test for
boiling point (Ref. 41).
EPA is revoking the testing requirements for boiling point, vapor
pressure, octanol/water partition coefficient, biodegradation, fish
acute toxicity, Daphnia acute toxicity, and toxicity to algae for
methanesulfinic acid, hydroxyl-, monosodium salt by removing those
requirements from those listed for that chemical substance in Table 2
in 40 CFR 799.5085(j). The testing requirements for methanesulfinic
acid, hydroxyl-, monosodium salt that are not revoked by this direct
final rule include tests for melting point, water solubility,
chromosomal damage, and 28-day repeated-dose toxicity with a
reproduction/developmental toxicity screen. Studies responding to those
test requirements, also using the dihydrate form of methanesulfinic
acid, hydroxyl-, monosodium salt, were submitted to the Agency (Ref.
42).
5. Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-
(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]-. On
July 17, 2006, the Color Pigments Manufacturers Association (CPMA)
submitted a test plan for benzenesulfonic acid, [[4-[[4-
(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-
ylidene]methyl]phenyl]amino]- (CAS No. 1324-76-1), also known as C.I.
Pigment Blue 61. CPMA also submitted robust summaries of existing data
which CPMA asked EPA to accept as satisfying some of the Agency's data
needs for C.I. Pigment Blue 61. Some of the existing data described in
the summaries addressed C.I. Pigment Blue 56, a close analog of C.I.
Pigment Blue 61, which CPMA requested EPA to accept as satisfying the
Agency's data needs for C.I. Pigment Blue 61, providing a structure-
activity relationship (SAR) argument in the test plan to justify that
request (Refs. 43 and 44). CPMA also asked EPA to accept results for
water solubility and octanol/water partition coefficient which were
obtained by using an alternative method, due to the extremely low
predicted solubility of C.I. Pigment Blue 61, instead of the methods
specified by the test rule (Ref. 43). Finally, CPMA asked EPA to accept
that determining a melting point for C.I. Pigment Blue 61 was not
relevant because the pigment thermally decomposes before it melts (Ref.
43).
EPA reviewed the submitted information on physical/chemical
properties and decided that melting point, boiling point, and vapor
pressure determinations were not relevant because C.I. Pigment Blue 61
decomposes before it melts and the decomposition temperature had been
reported (Ref. 45). EPA accepted the submitted data on water solubility
as satisfying the Agency's data needs for that endpoint, but did not
accept the calculated value submitted to satisfy the testing
requirement for octanol/water partition coefficient (Ref. 45). EPA
believes the calculated value would, most likely, underestimate the
measured value (Ref. 45) required to be determined by HPV1.
EPA reviewed CPMA's SAR argument concerning C.I. Pigment Blue 61
and C.I. Pigment Blue 56 and agreed that C.I. Pigment Blue 56 is an
acceptable surrogate for C.I. Pigment Blue 61, thereby allowing
adequate data on C.I. Pigment Blue 56 to satisfy data needs for C.I.
Pigment Blue 61 (Ref. 46). As a result, a biodegradation study of C.I.
Pigment Blue 56, found adequate by an EPA review, satisfies the need
for biodegradation data on C.I. Pigment Blue 61 (Ref. 46). Likewise, a
chromosomal damage test of C.I. Pigment Blue 56, which EPA reviewed and
found adequate, will satisfy the data need for that endpoint (Ref. 47)
for C.I. Pigment Blue 61. EPA's review of the existing data on C.I.
Pigment Blue 61 found the studies on fish acute toxicity, mammalian
acute toxicity, and bacterial mutation assay to be adequate to satisfy
the data needs for those endpoints (Ref. 47). The existing study on
repeated-dose toxicity, however, did not satisfy the test requirement
for that endpoint (Ref. 47).
Therefore, EPA is revoking the testing requirements for melting
point, boiling point, vapor pressure, water solubility, biodegradation,
fish acute toxicity, mammalian acute toxicity, bacterial reverse
mutation, and chromosomal damage for C.I. Pigment Blue 61 by removing
those requirements from those listed for that chemical substance in
Table 2 in 40 CFR 799.5085(j). In order to clarify that test
requirements for acute toxicity to Daphnia and toxicity to algae had
not been satisfied by existing studies, and that the fish acute
toxicity test requirement had been satisfied, the test symbol C2
replaces C1 for C.I. Pigment Blue 61 in Table 2 in 40 CFR 799.5085(j).
The testing requirements for C.I. Pigment Blue 61 that are not revoked
by this direct final rule include tests for octanol/water partition
coefficient, acute toxicity to Daphnia, toxicity to algae, and combined
28-day repeated-dose toxicity with a reproduction/developmental
toxicity screen. Studies responding to those test requirements were
submitted to the Agency. The full studies were claimed to be CBI and
are not available to the public, but robust summaries of those studies
(Ref. 48) are in the docket.
6. C.I. Solvent Black 7. On July 29, 2006 and August 4, 2006, the
Solvent Black 7 Consortium formed under the auspices of SOCMA submitted
eight existing studies on C.I. Solvent Black 7 (CAS No. 8005-02-5) and
requested EPA to determine if they satisfied some of the Agency's data
needs specified in HPV1 (Ref. 49). EPA found that the studies satisfied
the need for data on inherent biodegradation, fish acute toxicity,
Daphnia acute toxicity, toxicity to algae, acute mammalian toxicity,
chromosomal damage, and repeated-dose 28-day oral toxicity in rodents,
making those test requirements for C.I. Solvent Black 7 unnecessary
(Ref. 50). Although the 28-day oral toxicity study in rodents was
accepted, it lacked a required screening test for reproduction/
developmental toxicity. Although a test for chronic toxicity to Daphnia
was not required for this chemical substance, SOCMA submitted a Daphnia
magna reproduction test because the log Kow of C.I. solvent
Black 7 is close to 4.2 and a log Kow greater than 4.2 would
have made a Daphnia chronic toxicity test a requirement (Refs. 1 and
51). The submitted study was evaluated and was not found adequate to
satisfy the objectives of a Daphnia chronic toxicity study because the
study was only 10 days long instead of 21 days, and only one
concentration was tested and it was lethal, preventing observation of
sub-lethal endpoints (Ref. 52).
Therefore, EPA is revoking the testing requirements for inherent
biodegradation, fish acute toxicity, Daphnia acute toxicity, toxicity
to algae, acute mammalian toxicity, chromosomal damage, and repeated-
dose 28-day oral toxicity in rodents for C.I. Solvent Black 7 (CAS No.
8005-02-5) by removing those requirements from those listed for that
chemical substance
[[Page 15614]]
in Table 2 in 40 CFR 799.5085(j). In order to clarify that the
requirement for a reproduction/developmental toxicity screening test
had not been satisfied, but that the requirement for a repeated-dose
28-day oral toxicity test had been satisfied, the test symbol F2
replaces F1 for C.I. Solvent Black 7 in Table 2 in 40 CFR 799.5085(j).
The testing requirements not revoked by this direct final rule include
the tests to determine five physical/chemical properties and to screen
for reproduction/developmental toxicity. Studies responding to those
test requirements have been submitted to the Agency (Refs. 51 and 53).
IV. Economic Analysis
In the economic impact analysis of this direct final rule, the
Agency estimated the total testing cost to industry to be $4.03 million
for all 17 chemical substances, with an average of approximately
$237,000 per chemical substance (Ref. 54). This total included an
additional 25% in administrative costs. An amendment to HPV1 revoking
testing requirements for Coke-Oven Light Oil (Coal) reduced the total
cost to industry to an estimated $3.7 million for the remaining 16
chemical substances, with an average compliance cost of approximately
$232,000 per chemical substance. This direct final rule would have the
effect of further reducing the total testing cost by an estimated $1.5
million (approximately 41%), by eliminating all the testing
requirements for acetyl chloride; imidodicarbonic diamide; methane,
isocyanato-; and urea, reaction products with formaldehyde; as well as
some of the testing requirements for 9,10-anthracenedione; 1-
chlorododecane; phenol, 4,4'-methylenebis [2,6-bis (1,1-
dimethylethyl)]-; methanesulfinic acid, hydroxy-, monosodium salt;
benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylmino)-2,5-
cyclohexadien-1-ylidene]methyl]phenyl]amino]-; and C.I. Solvent Black 7
(Ref. 55). In addition, the 25% administrative costs would be
eliminated for these tests. The reduced total cost for the remaining 12
chemical substances with testing requirements is estimated to be $2.2
million (i.e., $3.7 million minus $1.5 million), with an average
compliance cost per chemical substance of approximately $184,000 (Ref.
55).
V. Export Notification
On the effective date of the revocations in this direct final rule
of the TSCA section 4 testing requirements for acetyl chloride (CAS No.
75-36-5); imidodicarbonic diamide (CAS No. 108-19-0), methane,
isocyanato- (CAS No. 624-83-9); and urea, reaction products with
formaldehyde (CAS No. 68611-64-3), persons who export or intend to
export those chemical substances will no longer be subject to any TSCA
section 12(b) export notification requirements triggered by HPV1 (See
40 CFR part 707, subpart D). The export notification requirements
remain the same for the other six chemical substances discussed in the
preamble of this direct final rule that are listed as subject to the
requirements of HPV1 (Ref. 1); these chemical substances are 9,10-
anthracenedione (CAS No. 84-65-1); 1-chlorododecane (CAS No. 112-52-7);
phenol, 4,4'-methylenebis[2,6-bis(1,1-dimethylethyl)]- (CAS No. 118-82-
1); methanesulfinic acid, hydroxy-, monosodium salt (CAS No. 149-44-0);
benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-
cyclohexadien-1-ylidene]methyl]phenyl]amino]- (CAS No. 1324-76-1); and
C.I. Solvent Black 7 (CAS No. 8005-02-5).
VI. Direct Final Rule Procedures
EPA is publishing this direct final rule without prior proposal
because the Agency views this as a non-controversial amendment and
anticipates no adverse comment as this action simply revokes testing
which is not feasible, or testing for which the substantial production
finding was not supported, or testing for which EPA has adequate data
at this time. This direct final rule is effective May 15, 2012 without
further notice, unless EPA receives adverse comment or a written
request for an opportunity to present oral comments on or before April
16, 2012. If EPA receives adverse comment or a written request for an
opportunity to present oral comments on one or more distinct
amendments, paragraphs, or sections of this direct final rule, the
Agency will publish a timely withdrawal in the Federal Register
indicating which provisions will become effective and which provisions
are being withdrawn due to adverse comment or a written request for an
opportunity to present oral comments. Any distinct amendment,
paragraph, or section of this direct final rule for which the Agency
does not receive adverse comment or a request for an opportunity to
present oral comments is effective May 15, 2012, notwithstanding any
adverse comment or request on any other distinct amendment, paragraph,
or section of this direct final rule. For any distinct amendment,
paragraph, or section of this direct final rule that is withdrawn due
to adverse comment or a request for an opportunity to present oral
comments, EPA will publish a notice of proposed rulemaking in a future
issue of the Federal Register. The Agency will address the comment or
request for an opportunity to present oral comments on any such
distinct amendment, paragraph, or section as part of that notice of
proposed rulemaking.
VII. References
Each reference listed in this unit has a docket ID number (EPA-HQ-
OPPT-2005-0033) followed by a four-digit document ID number. All
document ID numbers are listed in numerical order in the docket. To
access a particular document in the docket, go to http://www.regulations.gov and follow the online instructions.
1. EPA. Testing of Certain High Production Volume Chemicals; Final
Rule. Federal Register (71 FR 13708, March 16, 2006) (FRL-7335-2).
(Document ID number EPA-HQ-OPPT-2005-0033-0001).
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) (FRL-4059-9). (Document ID number EPA-
HQ-OPPT-2005-0033-0060).
3. Albemarle Corporation. Letter from M.G. Clisby to Catherine
Roman, Chemical Information and Testing Branch (CITB), Chemical
Control Division (CCD), Office of Pollution Prevention and Toxics
(OPPT), EPA. April 16, 2007. (Document ID number EPA-HQ-OPPT-2005-
0033-0344).
4. Tessenderlo Kerley, Inc. Email from Dawn Kominski to Catherine
Roman, CITB, CCD, OPPT, EPA. March 23, 2007. (Document ID number
EPA-HQ-OPPT-2005-0033-0342).
5. Charkit Chemical Corporation. Letter from Bryant Hinnant to
Document Control Office, OPPT, EPA. December 7, 2006. (Document ID
number EPA-HQ-OPPT-2005-0033-0220).
6. TFI. Submission for fulfillment of data requirements for biuret
under TSCA section 4. July 2007. (Document ID number EPA-HQ-OPPT-
2005-0033-0343).
7. Organisation for Economic Co-operation and Development (OECD).
Screening Information Data Set (SIDS), Urea, CAS No.: 57-13-6. Also,
a supporting document for biuret. 1994. (Document ID number EPA-HQ-
OPPT-2005-0033-0360).
8. IUCLID Data Set, Biuret, CAS No. 108-19-0. March 7, 2007.
(Document ID number EPA-HQ-OPPT-2005-0033-0359).
9. EPA. Memorandum from Tracy Williamson, Industrial Chemistry
Branch (ICB), Economics, Exposure, and Technology Division (EETD),
OPPT, to Greg Schweer, CITB, CCD, OPPT. Review of the physical-
chemical endpoints for HPV orphan chemical biuret (CAS No.
[[Page 15615]]
108-19-0). Sept 17, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-
0356).
10. EPA. Email from Robert Boethling, Exposure Assessment Branch
(EAB), EETD, OPPT, to Greg Schweer, CITB, CCD, OPPT. Review of TFI
submission on biuret. August 20, 2007. (Document ID number EPA-HQ-
OPPT-2005-0033-0347).
11. EPA. Email from David Brooks, High Production Volume Chemical
Branch (HPVCB), Risk Assessment Division (RAD), OPPT, to Greg
Schweer, CITB, CCD, OPPT. Review of biuret (CAS No. 108-19-0).
October 2, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0358).
12. Bayer CropScience. Letter to Document Control Office, OPPT, EPA,
submitting a test plan and request for review of existing data on
physical chemical properties and aquatic toxicity. May 11, 2007.
(Document ID number EPA-HQ-OPPT-2005-0033-0249).
13. EPA. Email from Tracy Williamson, ICB, EETD, OPPT, to Catherine
Roman, CITB, CCD, OPPT. June 18, 2007. (Document ID number EPA-HQ-
OPPT-2005-0033-0281).
14. EPA. Email and attached review of aquatic studies of methane,
isocyanato from David Brooks, HPVCB, RAD, OPPT, to Greg Schweer,
CITB, CCD, OPPT. August 29, 2007. (Document ID number EPA-HQ-OPPT-
2005-0033-0284).
15. EPA. Emails on acceptability of studies on dihydrate form of CAS
No. 149-44-0. August 18, 2009. (Document ID number EPA-HQ-OPPT-2005-
0033-0357).
16. TFI. Submission for Fulfillment of Data Requirements for Urea,
Reaction Products with Formaldehyde under TSCA Section 4. Revised
March 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0361).
17. EPA. Memorandum from Kathryn Schechter, ICB, EETD, OPPT, to Greg
Schweer, CITB, CCD, OPPT. September 13, 2007. (Document ID number
EPA-HQ-OPPT-2005-0033-0345).
18. EPA. Email from David Brooks, HPVCB, RAD, OPPT, to Mike
Mattheisen and Catherine Roman, CITB, CCD, OPPT. April 23, 2008.
(Document ID number EPA-HQ-OPPT-2005-0033-0346).
19. EPA. Email from Robert Boethling, EAB, EETD, OPPT, to Greg
Schweer, CITB, CCD, OPPT. August 14, 2007. Includes copyrighted
attachment: Ahapir, Nir, et al. Purification and Characterization of
TrzF: Biuret Hydrolysis by Allophanate Hydrolase Supports Growth.
Applied and Environmental Microbiology. 72(4):2941-2495 (2006).
(Document ID number EPA-HQ-OPPT-2005-0033-0363).
20. CPC. Letter from Jerry A. Cook to Document Control Office, OPPT,
EPA, concerning existing data on boiling point and vapor pressure.
July 10, 2006. (Document ID number EPA-HQ-OPPT-2005-0033-0182).
21. CRC Handbook of Chemistry and Physics. 85th Edition. David R.
Lide, ed., CRC Press. Boca Raton, FL. 2004.
22. EPA. Letter from Greg Schweer, CITB, CCD, OPPT, to Jerry A.
Cook, CPC, concerning acceptance of existing data on boiling point,
vapor pressure, and melting point. August 30, 2006. (Document ID
number EPA-HQ-OPPT-2005-0033-0211).
23. CPC. Email from Jerry Cook to Catherine Roman, CITB, CCD, OPPT,
EPA, concerning determination of melting point. July 24, 2006.
(Document ID number EPA-HQ-OPPT-2005-0033-0348).
24. CPC. Studies submitted for 9,10-anthracenedione on octanol/water
partition coefficient, water solubility, and a screen for
reproduction/developmental toxicity. Submitted on February 15, 2007.
(Document ID numbers EPA-HQ-OPPT-2005-0033-0222.1, EPA-HQ-OPPT-2005-
0033-0222.1, and EPA-HQ-OPPT-2005-0033-0222.2, respectively).
25. EPA. Letter from Mike Mattheisen, CITB, CCD, OPPT, to John Van
Miller, Toxicology/Regulatory Services, Charlottesville, VA.
February 21, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0291).
26. Lonza, Inc. Studies submitted for 1-chlorododecane on boiling
point, vapor pressure, octanol/water partition coefficient, water
solubility, biodegradation, Daphnia chronic toxicity, toxicity to
algae, acute mammalian toxicity, mutagenicity, chromosomal damage,
and 28-day repeated-dose toxicity with a reproduction/developmental
toxicity screen. Submitted on September 17, 2008. (Document ID
numbers EPA-HQ-OPPT-2005-0033-0314.6, EPA-HQ-OPPT-2005-0033-314.10,
EPA-HQ-OPPT-2005-0033-0314.8, EPA-HQ-OPPT-2005-0033-0314.11, EPA-HQ-
OPPT-2005-0033-0314.9, EPA-HQ-OPPT-2005-0033-0314.7, EPA-HQ-OPPT-
2005-0033-0314.5, EPA-HQ-OPPT-2005-0033-0314.1, EPA-HQ-OPPT-2005-
0033-0314.2, EPA-HQ-OPPT-2005-0033-0314.3, and EPA-HQ-OPPT-2005-
0033-0314.4, respectively).
27. Albemarle Corporation. Letter from Ronald Zumstein to Document
Control Office, OPPT, EPA, concerning existing data on water
solubility and octanol-water partition coefficient. May 12, 2006.
(Document ID number EPA-HQ-OPPT-2005-0033-0163).
28. Albemarle Corporation. Letter from Kim Boudreaux to Document
Control Office, OPPT, EPA, concerning existing data on acute
toxicity, gene mutation, and reproductive/developmental toxicity.
July 14, 2006. (Document ID numbers EPA-HQ-OPPT-2005-0033-0181, EPA-
HQ-OPPT-2005-0033-0181.1, EPA-HQ-OPPT-2005-0033-0181.2, and EPA-HQ-
OPPT-2005-0033-0181.3).
29. Albemarle Corporation. Letter from Kim Boudreaux to Document
Control Office, OPPT, EPA, concerning an existing Ames study. May 1,
2007. (Document ID numbers EPA-HQ-OPPT-2005-0033-0250, EPA-HQ-OPPT-
2005-0033-0250.1, and EPA-HQ-OPPT-2005-0033-0250.2).
30. Albemarle Corporation. Letter from Kim Boudreaux to Document
Control Office, OPPT, EPA, concerning existing data on repeated-dose
toxicity and reproduction/developmental toxicity screening. May 16,
2007. (Document ID number EPA-HQ-OPPT-2005-0033-0247).
31. EPA. Letter from Greg Schweer, CITB, CCD, OPPT, to Ronald
Zumstein and Kim Boudreaux, Albemarle Corporation, concerning EPA's
acceptance of existing data on water solubility and octanol-water
partition coefficient. August 9, 2006. (Document ID number EPA-HQ-
OPPT-2005-0033-0210).
32. EPA. Letter from Greg Schweer, CITB, CCD, OPPT, to Kim
Boudreaux, Albemarle Corporation, concerning EPA's acceptance of
existing data on mammalian acute toxicity. April 5, 2007. (Document
ID number EPA-HQ-OPPT-2005-0033-0237).
33. EPA. Letter from Greg Schweer, CITB, CCD, OPPT, to Kim
Boudreaux, Albemarle Corporation, concerning EPA's acceptance of
existing data on bacterial reverse mutation and reproductive/
developmental toxicity. October 23, 2007. (Document ID number EPA-
HQ-OPPT-2005-0033-0285).
34. Albemarle Corporation. Studies submitted for phenol, 4,4'-
methylenebis[2,6-bis(1,1-dimethylethyl)]- on melting point, boiling
point, vapor pressure, inherent biodegradation, and chromosomal
aberration. Submitted on October 31, 2007 and November 1, 2007.
(Document ID numbers EPA-HQ-OPPT-2005-0033-0274, EPA-HQ-OPPT-2005-
0033-0274, EPA-HQ-OPPT-2005-0033-0274, EPA-HQ-OPPT-2005-0033-0275.1,
and EPA-HQ-OPPT-2005-0033-0257, respectively).
35. SFS Consortium, SOCMA. Letter to Document Control Office, OPPT,
EPA, submitting a test plan and request for review of existing data
on biodegradation and aquatic toxicity. May 14, 2007. (Document ID
number EPA-HQ-OPPT-2005-0033-0238).
36. EPA. Memorandum from Robert Boethling, EAB, EETD, OPPT, to Greg
Schweer, CITB, CCD, OPPT, concerning biodegradation test
requirement. July 6, 2007. (Document ID number EPA-HQ-OPPT-2005-
0033-0277).
37. EPA. Memorandum from Jed Costanza, EAB, EETD, OPPT, to Mike
Mattheisen,CITB, CCD, OPPT. October 9, 2008. (Document ID number
EPA-HQ-OPPT-2005-0033-0352).
38. EPA. Email from David Brooks, HPVCB, RAD, OPPT, to Catherine
Roman, CITB, CCD, OPPT. Review of CAS No. 149-44-0. August 13, 2009.
(Document ID number EPA-HQ-OPPT-2005-0033-0349).
39. EPA. Memorandum from Daniel Lin, ICB, EETD, OPPT, to Greg
Schweer, CITB, CCD, OPPT, concerning vapor pressure requirement.
June 19, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0278).
[[Page 15616]]
40. EPA. Letter from Charles Auer, OPPT, to Tucker Helmes, SOCMA.
May 28, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0307).
41. EPA. Memorandum from Greg Fritz, ICB, EETD, OPPT, to Mike
Mattheisen, CITB, CCD, OPPT. August 25, 2008. (Document ID number
EPA-HQ-OPPT-2005-0033-0351).
42. SOCMA. Studies submitted for methanesulfinic acid, hydroxyl-,
monosodium salt on melting point, water solubility, chromosomal
damage, and 28-day repeated-dose toxicity with a reproduction/
developmental toxicity screen. Submitted on June 16, 2008. (Document
ID number EPA-HQ-OPPT-2005-0033-0309).
43. CPMA. Letter to Document Control Office, OPPT, EPA, from J.
Lawrence Robinson concerning existing data and test plan. July 17,
2006. (Document ID number EPA-HQ-OPPT-2005-0033-0185).
44. CPMA. Letter to Document Control Office, OPPT, EPA, from J.
Lawrence Robinson concerning existing data and test plan. May 9,
2007. (Document ID EPA-HQ-OPPT-2005-0033-0246).
45. EPA. Memorandum from Diana Darling, ICB, EETD, OPPT, to Greg
Schweer, CITB, CCD, OPPT. Testing requirements and existing data for
physical/chemical properties of the HPV test rule chemical, C.I.
Pigment Blue 61 (CAS No. 1324-76-1). May 17, 2007. (Document ID
number EPA-HQ-OPPT-2005-0033-0280).
46. EPA. Memorandum from Robert Boethling, EAB, EETD, OPPT, to Greg
Schweer, CITB, CCD, OPPT. Review of SAR argument and a
biodegradation test concerning an HPV test rule chemical, C.I.
Pigment Blue 61 (CAS No. 1324-76-1). May 15, 2007. (Document ID
number EPA-HQ-OPPT-2005-0033-0279).
47. EPA. Email and attached review from David Brooks, HPVCB, RAD,
OPPT, to Greg Schweer and Catherine Roman, CITB, CCD, OPPT. Review
of C.I. Pigment Blue (CAS No. 1324-76-1). August 22, 2007. (Document
ID number EPA-HQ-OPPT-2005-0033-0286).
48. SOCMA. Robust summaries submitted for C.I. Pigment Blue 61 on
octanol/water partition coefficient, acute toxicity to Daphnia,
toxicity to algae, and combined 28-day repeated-dose toxicity with a
reproduction/developmental toxicity screen. Submitted on November
14, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0318).
49. SOCMA. Letters from C. Tucker Helmes to Document Control Office,
OPPT, EPA. Submission of existing data on C.I. Solvent Black 7. June
29, 2006 and August 4, 2006. (Document ID numbers EPA-HQ-OPPT-2005-
0033-0168, EPA-HQ-OPPT-2005-0033-0169, EPA-HQ-OPPT-2005-0033-0170,
EPA-HQ-OPPT-2005-0033-0171, EPA-HQ-OPPT-2005-0033-0172, EPA-HQ-OPPT-
2005-0033-0173, EPA-HQ-OPPT-2005-0033-0174, EPA-HQ-OPPT-2005-0033-
0175, EPA-HQ-OPPT-2005-0033-0176, and EPA-HQ-OPPT-2005-0033-0184).
50. EPA. Memorandum from Mark Townsend, HPVCB, RAD, OPPT, to Greg
Schweer, CITB, CCD, OPPT. November 27, 2006. (Document ID number
EPA-HQ-OPPT-2005-0033-0283).
51. SOCMA. Letter from C. Tucker Helmes to Document Control Office,
OPPT, EPA. Justification for providing Daphnia reproduction study
for C.I. Solvent Black 7. February 28, 2008. (Document ID number
EPA-HQ-OPPT-2005-0033-0290).
52. EPA. Email from David Brooks, HPVCB, RAD, OPPT, to Mike
Mattheisen, CITB, CCD, OPPT. July 15, 2008. (Document ID number EPA-
HQ-OPPT-2005-0033-0353).
53. SOCMA. Studies submitted for C.I. Solvent Black 7 on physical/
chemical properties and prenatal developmental toxicity. Submitted
on February 28, 2008. (Document ID numbers EPA-HQ-OPPT-2005-0290.2
and EPA-HQ-OPPT-2005-0033-0290.4).
54. EPA, EPAB, EETD, OPPT. Economic Analysis for the Final Section 4
Test Rule for High Production Volume Chemicals. October 28, 2005.
(Document ID number EPA-HQ-OPPT-2005-0033-0131).
55. EPA. Email from Stephanie Suazo, EPAB, EETD, OPPT, to Catherine
Roman, CITB, CCD, OPPT. RE: ``Revised Economic Analysis for
Revocation of Testing Requirements'' with attached economic
analysis. December 14, 2009. (Document ID number EPA-HQ-OPPT-2005-
0033-0350).
VIII. Statutory and Executive Order Reviews
This direct final rule only eliminates existing requirements; it
does not otherwise impose any new or revised requirements. As such,
this action is not subject to review by the Office of Management and
Budget (OMB) as a ``significant regulatory action'' under Executive
Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Nor does it impose or change any information
collection burden that requires additional review by OMB under the
provisions of the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501
et seq.).
Because this direct final rule eliminates existing requirements
without imposing any new or revised requirements, the Agency certifies
pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), that this action will not have a significant
economic impact on a substantial number of small entities.
For the same reasons, it is not subject to the requirements of
sections 202 and 205 of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1531-1538), and does not significantly or uniquely affect small
governments or impose a significant intergovernmental mandate, as
described in sections 203 and 204 of UMRA. This direct final rule does
not have tribal implications, as specified in Executive Order 13175,
entitled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000), or federalism
implications as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
Since this action is not economically significant under Executive
Order 12866, it is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), and 13211, ``Actions concerning
Regulations that Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001).
This action does not involve technical standards; thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.
This direct final rule does not involve special consideration of
environmental justice related issues as specified in Executive Order
12898, entitled ``Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations'' (59 FR 7629, February
16, 1994).
IX. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: March 9, 2012.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, 40 CFR chapter I is amended as follows:
[[Page 15617]]
PART 799--[AMENDED]
0
1. The authority citation for part 799 continues to read as follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
0
2. In Sec. 799.5085, revise the section heading and Table 2 of
paragraph (j) to read as follows:
Sec. 799.5085 Chemical testing requirements for first group of high
production volume chemicals (HPV1).
* * * * *
(j) * * *
Table 2--Chemical Substances and Testing Requirements
----------------------------------------------------------------------------------------------------------------
Required tests (see table 3 of this
CAS No. Chemical name Class section)
----------------------------------------------------------------------------------------------------------------
74-95-3..................... Methane, dibromo-...... 1 A, C1, E2, F2.
78-11-5..................... 1,3-Propanediol, 2,2- 1 A4, A5, B, C6, F2.
bis[(nitrooxy)methyl]-
, dinitrate (ester).
84-65-1..................... 9,10-Anthracenedione... 1 A4, A5, F2.
110-44-1.................... 2,4-Hexadienoic acid, 1 A, C4.
(E,E)-.
112-52-7.................... 1-Chlorododecane....... 1 A2, A3, A4, A5, B, C3, D, E1, E2, F1.
118-82-1.................... Phenol, 4,4'- 1 A1, A2, A3, B, E2.
methylenebis[2,6bis(1,
1-dimethylethyl)]-.
149-44-0.................... Methanesulfinic acid, 1 A1, A5, E2, F1.
hydroxy-, monosodium
salt.
409-02-9.................... Heptenone, methyl-..... 2 A, B, C1, D, E1, E2, F1.
594-42-3.................... Methanesulfenyl 1 A, B, C1, E1, E2, F2.
chloride, trichloro-.
1324-76-1................... Benzenesulfonic acid, 2 A4, C2, F1.
[[4-[[4-
(phenylamino)phenyl][4-
(phenylimino)-2,5-
cyclohexadien-1-
ylidene]methyl]phenyl]
amino]-.
2941-64-2................... Carbonochloridothioic 1 A, B, C1, E2, F1.
acid, S-ethyl ester.
8005-02-5................... C.I. Solvent Black 7... 2 A, F2.
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-6430 Filed 3-15-12; 8:45 am]
BILLING CODE 6560-50-P