[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Rules and Regulations]
[Pages 15609-15617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6430]


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

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.

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

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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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