Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Rules and Regulations 15609 

ACTION: Withdrawal of direct final rule. 

SUMMARY: The EPA issued ‘‘Revisions to 

Final Response to Petition From New 

Jersey Regarding SO2 Emissions From 

the Portland Generating Station’’ as a 

direct final rule on December 22, 2011. 

Because the EPA received an adverse 

comment to the parallel proposal issued 

under the same name on December 22, 

2011, we are withdrawing the direct 

final rule amendments to ‘‘Revisions to 

Final Response to Petition From New 

Jersey Regarding SO2 Emissions From 

the Portland Generating Station’’ 

published in the Federal Register on 

December 22, 2011. 

DATES: As of March 16, 2012, the EPA 

withdraws the direct final rule 

amendments published on December 

22, 2011. See 76 FR 79541. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OAR–2011–0081. All 

documents in the docket are listed on 

the http://www.regulations.gov Web 

site. Although listed in the index, some 

information is not publicly available, 

e.g., confidential business information 

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 either 

electronically through http:// 

www.regulations.gov or in hard copy at 

Air Docket, EPA/DC, EPA West, Room 

3334, 1301 Constitution Ave., NW., 

Washington, DC. The Public Reading 

Room is open from 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number 

for the Public Reading Room is (202) 

566–1744. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Todd Hawes (919) 541–5591, 

hawes.todd@epa.gov, or Ms. Gobeail 

McKinley (919) 541–5246, 

mckinley.gobeail@epa.gov, Office of Air 

Quality Planning and Standards, Air 

Quality Policy Division, Mail Code 

C539–04, Research Triangle Park, NC 

27711. 

SUPPLEMENTARY INFORMATION: 

I. Background Information 

The EPA issued ‘‘Revisions to Final 

Response to Petition From New Jersey 

Regarding SO2 Emissions From the 

Portland Generating Station’’ as a direct 

final rule on December 22, 2011. See 76 

FR 79541. The direct final rule revised 

the preamble and rule text to the ‘‘Final 

Response to Petition From New Jersey 

Regarding SO2 Emissions From the 

Portland Generating Station’’ (Portland) 

published November 7, 2011, to clarify 

that Portland significantly contributes to 

nonattainment or interferes with 

maintenance of the 1-hour sulfur 

dioxide national ambient air quality 

standard in the State of New Jersey, and 

not in specific counties within the state. 

See 76 FR 69052. The revisions did not 

change the conclusions that the EPA 

made in the final rule and did not affect 

the emission limits, increments of 

progress, compliance schedules, or 

reporting provisions. 

The EPA issued a parallel proposal 

under the same name on December 22, 

2011, that proposed to make the same 

revisions outlined in the direct final and 

solicited comment on those revisions. 

See 76 FR 79574. We stated in the direct 

final rule amendments that if we 

received adverse comment to the 

parallel proposal by February 21, 2012, 

we would publish a timely notice of 

withdrawal of the direct final rule in the 

Federal Register. We received one 

adverse comment on the proposed 

amendments on February 21, 2012. We 

are consequently withdrawing the 

‘‘Revisions to Final Response to Petition 

From New Jersey Regarding SO2

Emissions From the Portland Generating 

Station’’ published as a direct final rule 

in the Federal Register on December 22, 

2012 as of March 16, 2012. See 76 FR 

79541. The EPA will address the 

adverse comment in a subsequent final 

action based on the parallel proposal 

also published on December 22, 2011. 

See 76 FR 79574. As stated in the 

parallel proposal, we will not institute 

a second comment period on this action. 

List of Subjects in 40 CFR Part 52 

Approval and promulgation of 

implementation plans, Environmental 

protection, Administrative practice and 

procedures, Air pollution control, 

Incorporation by reference, 

Intergovernmental relations, and 

Reporting and recordkeeping 

requirements, Sulfur dioxide. 

Dated: March 12, 2012. 

Lisa P. Jackson, 

Administrator. 

PART 52—[AMENDED] 

Accordingly, the amendments to the 

rule published in the Federal Register 

on December 22, 2011 (76 FR 79541) on 

pages 79541–79544 are withdrawn as of 

March 16, 2012. 

[FR Doc. 2012–6427 Filed 3–15–12; 8:45 am] 

BILLING CODE 6560–50–P 

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., 


srobinson on DSK4SPTVN1PROD with RULES
15610 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Rules and Regulations 

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: TSCAHotline@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 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Rules and Regulations 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 nonTSCA 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 octanolwater 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 octanolwater 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 


srobinson on DSK4SPTVN1PROD with RULES
15612 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Rules and Regulations 

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 


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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 repeateddose 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 sublethal 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 repeateddose 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 


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15614 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Rules and Regulations 

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 noncontroversial 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. 


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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 octanolwater 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 octanolwater 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). 


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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: 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Rules and Regulations 15617 

PART 799—[AMENDED] 

■ 1. The authority citation for part 799 

continues to read as follows: 

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

■ 2. In § 799.5085, revise the section 

heading and Table 2 of paragraph (j) to 

read as follows: 

§ 799.5085 Chemical testing requirements 

for first group of high production volume 

chemicals (HPV1). 

* * * * * 

(j) * * * 

TABLE 2—CHEMICAL SUBSTANCES AND TESTING REQUIREMENTS

CAS No. Chemical name Class Required tests 

(see table 3 of this section) 

74–95–3 ............ Methane, dibromo- .............................................................................................. 1 A, C1, E2, F2. 

78–11–5 ............ 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester) ............................... 1 A4, A5, B, C6, F2. 

84–65–1 ............ 9,10-Anthracenedione ......................................................................................... 1 A4, A5, F2. 

110–44–1 .......... 2,4-Hexadienoic acid, (E,E)- ............................................................................... 1 A, C4. 

112–52–7 .......... 1-Chlorododecane ............................................................................................... 1 A2, A3, A4, A5, B, C3, D, 

E1, E2, F1. 

118–82–1 .......... Phenol, 4,4’-methylenebis[2,6bis(1,1-dimethylethyl)]- ......................................... 1 A1, A2, A3, B, E2. 

149–44–0 .......... Methanesulfinic acid, hydroxy-, monosodium salt ............................................... 1 A1, A5, E2, F1. 

409–02–9 .......... Heptenone, methyl- ............................................................................................. 2 A, B, C1, D, E1, E2, F1. 

594–42–3 .......... Methanesulfenyl chloride, trichloro- ..................................................................... 1 A, B, C1, E1, E2, F2. 

1324–76–1 ........ Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5- 

cyclohexadien-1-ylidene]methyl]phenyl]amino]-.

2 A4, C2, F1. 

2941–64–2 ........ Carbonochloridothioic acid, S-ethyl ester ............................................................ 1 A, B, C1, E2, F1. 

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 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R4–ES–2010–0079; 

FXES11130900000C3–123–FF09E30000] 

RIN 1018–AX27 

Endangered and Threatened Wildlife 

and Plants; Establishing a Manatee 

Refuge in Kings Bay, Citrus County, FL 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Final rule. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service, establish a manatee 

refuge in Citrus County, Florida, in the 

waters of Kings Bay, including its 

tributaries and connected waters. This 

action is based on our determination 

that there is substantial evidence 

showing that certain waterborne 

activities would result in the taking of 

one or more manatees and that certain 

waterborne activities must be restricted 

to prevent the taking of one or more 

manatees in Kings Bay. In making this 

rule final, we considered the biological 

needs of the manatee, the level of take 

at these sites, and the likelihood of 

additional take of manatees due to 

human activity at these sites. 

This final rule is modified from the 

proposed rule to ensure that the 

provisions do not compromise human 

safety and to clarify certain aspects. The 

modifications are not considered 

significant as they are within the scope 

of the proposed rule. To avoid creation 

of a hazard to human safety, watercraft 

may be operated at 25 miles per hour 

during daylight hours in a portion of the 

manatee refuge from June 1 through 

August 15. The portion of the rule 

prohibiting use of mooring and 

floatlines that can entangle manatees 

has been removed. Language regarding 

prohibitions on waterborne activities in 

Three Sisters Spring has been revised to 

improve clarity. We also announce the 

availability of a final environmental 

assessment and Finding of No 

Significant Impact for this action. 

DATES: This rule is effective March 16, 

2012. 

ADDRESSES: This final rule, and 

supporting documentation, including 

public comments, are available on the 

Internet at http://www.regulations.gov at 

Docket No. FWS–R4–ES–2010–0079. 

Comments and materials received, as 

well as supporting documentation used 

in preparing this final rule, are also 

available for public inspection, by 

appointment, during normal business 

hours at the U.S. Fish and Wildlife 

Service, North Florida Ecological 

Services Office, 7915 Baymeadows Way, 

Suite 200, Jacksonville, Florida, 32256. 

FOR FURTHER INFORMATION CONTACT: 

Field Supervisor, U.S. Fish and Wildlife 

Service, North Florida Ecological 

Services Office, 7915 Baymeadows Way, 

Suite 200, Jacksonville, Florida, 32256; 

by telephone (904/731–3336); by 

facsimile (904/731–3045); by email: 

manatee@fws.gov; or on-line at http://

www.fws.gov/northflorida. Persons who 

use a telecommunications device for the 

deaf (TDD) may call the Federal 

Information Relay Service (FIRS) at 

800–877–8339. 

SUPPLEMENTARY INFORMATION: 

Background 

Previous Federal Actions 

The West Indian manatee (Trichechus 

manatus) was listed as an endangered 

species on June 2, 1970 (35 FR 8491), 

under the Endangered Species 

Conservation Act of 1969 and this status 

was retained under the Endangered 

Species Act of 1973, as amended (ESA) 

(16 U.S.C. 1531 et seq.), and the 

population is further protected as a 

depleted stock under the Marine 

Mammal Protection Act of 1972, as 

amended (MMPA) (16 U.S.C. 1361 et 

seq.). On October 22, 1979, the U.S. Fish 

and Wildlife Service (Service) adopted a 

regulatory process to provide a means 

for establishing manatee protection 

areas in waters under the jurisdiction of 

the United States where manatees were 

taken by waterborne activities (44 FR 

60964). The first manatee protection 

areas were designated in Kings Bay on 

November 12, 1980, for the purpose of 

preventing the take of manatees by 

harassment from waterborne activities 

and included the Banana Island 

Sanctuary (including King Spring), the 

Sunset Shores Sanctuary, and the 

Magnolia Springs Sanctuary (45 FR 

74880). The Service subsequently 

designated four additional manatee 

protection areas in Kings Bay on May 

12, 1994, and on October 16, 1998, 

(including the Buzzard Island 

Sanctuary, Tarpon Springs Sanctuary, 

Warden Key Sanctuary, and Three 


srobinson on DSK4SPTVN1PROD with RULES