27450 Federal Register / Vol. 73, No. 92 / Monday, May 12, 2008 / Notices 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2008–0309; FRL–8363–2] 

Sixty-Second Report of the TSCA 

Interagency Testing Committee to the 

Administrator of the Environmental 

Protection Agency; Receipt of Report 

and Request for Comments 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: The Toxic Substances Control 

Act (TSCA) Interagency Testing 

Committee (ITC) transmitted its sixtysecond report to the Administrator of 

EPA on April 17, 2008. In the 62nd ITC 

Report, which is included with this 

notice, the ITC is revising the TSCA 

section 4(e) Priority Testing List by 

removing four tungsten compounds and 

four cresols. 

DATES: Comments must be received on 

or before June 11, 2008. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2008–0309, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East Bldg., 

Rm. 6428, 1201 Constitution Ave., NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2008–0309. 

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– 

2008–0309. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The regulations.gov website is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD-ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. For additional information 

about EPA’s public docket, visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the docket 

are listed in the docket index available 

in regulations.gov. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

Federal 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: 

Colby Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 554–1404; e-mail address: 

TSCA-Hotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

This notice is directed to the public 

in general. It may, however, be of 

particular interest to you if you 

manufacture (defined by statute to 

include import) and/or process TSCAcovered chemicals and you may be 

identified by the North American 

Industrial Classification System 

(NAICS) codes 325 and 32411. Because 

this notice is directed to the general 

public and other entities may also be 

interested, the Agency has not 

attempted to describe all the specific 

entities that may be interested in this 

action. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 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 e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD-ROM that 

you mail to EPA, mark the outside of the 

disk or CD-ROM that you mail to EPA, 

mark the outside of the disk or CD-DOM 

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. 


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Federal Register / Vol. 73, No. 92 / Monday, May 12, 2008 / Notices 27451 

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. Background 

The Toxic Substances Control Act 

(TSCA) (15 U.S.C. 260l et seq.) 

authorizes the Administrator of EPA to 

promulgate regulations under TSCA 

section 4(a) requiring testing of 

chemicals and chemical groups in order 

to develop data relevant to determining 

the risks that such chemicals and 

chemical groups may present to health 

or the environment. Section 4(e) of 

TSCA established the ITC to 

recommend chemicals and chemical 

groups to the Administrator of EPA for 

priority testing consideration. Section 

4(e) of TSCA directs the ITC to revise 

the TSCA section 4(e) Priority Testing 

List at least every 6 months. 

You may access additional 

information about the ITC at http:// 

www.epa.gov/opptintr/itc. 

A. The 62nd ITC Report 

The ITC is revising the TSCA section 

4(e) Priority Testing List by removing 

four tungsten compounds and four 

cresols. 

B. Status of the Priority Testing List 

The Priority Testing List includes 2 

alkylphenols, 1 tungsten compound, 12 

lead compounds, 16 chemicals with 

insufficient dermal absorption rate data, 

and 208 High Production Volume (HPV) 

Challenge Program orphan chemicals. 

List of Subjects 

Environmental protection, Chemicals, 

Hazardous substances. 

Dated: May 5, 2008. 

Charles M. Auer, 

Director, Office of Pollution Prevention and 

Toxics. 

Sixty-Second Report of the TSCA 

Interagency Testing Committee to the 

Administrator of the Environmental 

Protection Agency 

Table of Contents 

Summary 

I. Background 

II. TSCA Section 8 Reporting 

A. TSCA Section 8 Reporting Rules 

B. ITC’s Use of TSCA Section 8 and 

Other Information 

III. ITC’s Activities During this 

Reporting Period (December 2007 to 

May 2008) 

IV. Revisions to the TSCA Section 4(e) 

Priority Testing List: Chemicals 

Removed from the Priority Testing 

List 

A. Tungsten Compounds 

B. Cresols 

V. References 

VI. The TSCA Interagency Testing 

Committee 

Summary 

The ITC is revising the Toxic 

Substances Control Act (TSCA) section 

4(e) Priority Testing List by removing 

four tungsten compounds and four 

cresols. The TSCA section 4(e) Priority 

Testing List is Table 1 of this unit. 

TABLE 1.—TSCA SECTION 4(E) PRIORITY TESTING LIST (MAY 2008) 

ITC Report Date Chemical Name/Group Action 

31 January 1993 2 Chemicals with insufficient dermal absorption rate data Designated 

32 May 1993 10 Chemicals with insufficient dermal absorption rate data Designated 

35 November 1994 4 Chemicals with insufficient dermal absorption rate data Designated 

37 November 1995 Branched 4-nonylphenol (mixed isomers) Recommended 

41 November 1997 Phenol, 4-(1,1,3,3-tetramethylbutyl)- Recommended 

53 November 2003 Sodium tungstate (Na2 (WO4)), dihydrate Recommended 

55 December 2004 204 High Production Volume (HPV) Challenge Program orphan chemicals Recommended 

56 August 2005 4 HPV Challenge Program orphan chemicals Recommended 

60 May 2007 12 Lead and lead compounds Recommended 

I. Background 

The ITC was established by section 

4(e) of TSCA ‘‘to make 

recommendations to the Administrator 

respecting the chemical substances and 

mixtures to which the Administrator 

should give priority consideration for 

the promulgation of rules for testing 

under section 4(a).... At least every six 

months ..., the Committee shall make 

such revisions to the Priority Testing 

List as it determines to be necessary and 

transmit them to the Administrator 

together with the Committee’s reasons 

for the revisions’’ (Public Law 94–469, 

90 Stat. 2003 et seq., 15 U.S.C. 2601 et 

seq.). ITC reports are available from the 

ITC’s website (http://www.epa.gov/ 

opptintr/itc) within a few days of 

submission to the EPA Administrator 

and from the EPA’s website (http:// 

www.epa.gov/fedrgstr) after publication 

in the Federal Register. The ITC 

produces its revisions to the Priority 

Testing List with administrative and 

technical support from the ITC staff, ITC 

members, and their U.S. Government 


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27452 Federal Register / Vol. 73, No. 92 / Monday, May 12, 2008 / Notices 

organizations, and contract support 

provided by EPA. ITC members and 

staff are listed at the end of this report. 

II. TSCA Section 8 Reporting 

A. TSCA Section 8 Reporting Rules 

Following receipt of the ITC’s report 

(and the revised Priority Testing List) by 

the EPA Administrator, EPA’s Office of 

Pollution Prevention and Toxics (OPPT) 

may add the chemicals from the revised 

Priority Testing List to the TSCA section 

8(a) Preliminary Assessment 

Information Reporting (PAIR) or TSCA 

section 8(d) Health and Safety Data 

Reporting (HaSDR) rules. The PAIR rule 

requires manufacturers (including 

importers) of chemicals added to the 

Priority Testing List to submit to EPA 

certain production and exposure 

information (http://www.epa.gov/oppt/ 

chemtest/pubs/pairform.pdf). As 

provided for in the PAIR rule, whenever 

EPA announces the receipt of an ITC 

report, EPA amends, unless otherwise 

instructed by the ITC, the PAIR rule by 

adding the recommended (or 

designated) chemicals that have been 

added to the Priority Testing List by the 

ITC. 

The HaSDR rule requires certain past, 

current, and proposed manufacturers, 

importers, and (if specified by EPA) 

processors of listed chemicals to submit 

to EPA copies and lists of unpublished 

health and safety studies on the listed 

chemicals that they manufacture, 

import, or (if specified by EPA) process. 

As provided for in the HaSDR rule, 

whenever EPA announces the receipt of 

an ITC report, EPA amends, unless 

otherwise instructed by the ITC, the 

HaSDR rule by adding the 

recommended (or designated) chemicals 

that have been added to the Priority 

Testing List by the ITC. 

B. ITC’s Use of TSCA Section 8 and 

Other Information 

The ITC’s use of TSCA section 8 and 

other information is described in the 

52nd ITC Report (http://www.epa.gov/ 

opptintr/itc). 

III. ITC’s Activities During this 

Reporting Period (December 2007 to 

May 2008) 

During this reporting period, the ITC 

discussed tungsten compounds and 

cresols. 

IV. Revisions to the TSCA Section 4(e) 

Priority Testing List: Chemicals 

Removed from the Priority Testing List 

A. Tungsten Compounds 

Of the 22 tungsten compounds added 

to the Priority Testing List in the 53rd

ITC Report (Ref. 1) and the 56th ITC 

Report (Ref. 2), 12 were removed in the 

58th ITC Report (Ref. 3), and 5 were 

removed in the 59th ITC Report (Ref. 4). 

At this time the ITC is removing 4 

tungsten compounds from the Priority 

Testing List (see Table 2 of this unit). 

TABLE 2.—TUNGSTEN COMPOUNDS

BEING REMOVED FROM THE PRIORITY TESTING LIST

CAS No. Chemical Name 

1314–35–8 Tungsten oxide (WO3) 

7440–33–7 Tungsten 

11120–25–5 Tungstate 

(W12(OH)2O4010-), ammonium (1:10) 

13472–45–2 Tungstate (WO4

2-), sodium 

(1:2), (T-4)- 

Prior to removing these 4 tungsten 

compounds, the PAIR reports submitted 

in response to the December 7, 2004, 

PAIR rule (Ref. 5) were reviewed. The 

ITC is removing tungstate 

(W12(OH)2O4010-), ammonium (1:10) and 

tungstate (WO4

2-), sodium (1:2), (T-4)- 

because the data submitted in response 

to the December 7, 2004 PAIR rule 

suggested low potential for occupational 

exposure. The ITC is removing tungsten 

from the Priority Testing List because 

the toxicological profile for tungsten 

(http://www.atsdr.cdc.gov/toxprofiles/ 

tp186.html) summarizes the health 

effects information. The ITC is removing 

tungsten oxide (WO3), a.k.a. tungsten 

trioxide because of the voluntary 

information provided by the 

International Tungsten Industry 

Association and their cooperation in a 

National Toxicology Program/National 

Institute for Occupational Safety and 

Health research program to address 

exposure and toxicity data needs. The 

ITC is retaining tungstate (WO4

2-), 

disodium, dihydrate, (T-4)-, a.k.a. 

sodium tungstate (Na2 (WO4)), dihydrate 

(CAS No. 10213–10–2), on the Priority 

Testing List because of ongoing 

discussions with the International 

Tungsten Industry Association to 

obtain: 

1. Recent non–Confidential Business 

Information estimates of annual 

production or importation volume data 

and trends, and chemical–specific use 

information, including percentages of 

production or importation that are 

associated with different uses. 

2. Estimates of the number of exposed 

humans and concentrations of sodium 

tungstate, dihydrate to which humans 

may be exposed in each relevant 

manufacturing, processing, or other 

occupational scenario. 

3. Case studies from occupationally 

exposed workers and pharmacokinetics, 

dermal, inhalation, as well as any oral 

acute toxicity, subchronic toxicity, 

chronic toxicity, genotoxicity, 

carcinogenicity, neurotoxicity, 

reproductive and developmental 

toxicity, and epidemiology studies. 

B. Cresols 

Cresols were added to the Priority 

Testing List in the 61st ITC Report to 

obtain unpublished data on dermal 

sensitization (Ref. 6). The four cresols 

are listed in Table 3 of this unit. 

TABLE 3.—CRESOLS BEING REMOVED

FROM THE PRIORITY TESTING LIST

CAS No. TSCA Inventory Name 

Common 

Name 

95–48–7 Phenol, 2- 

methylo-Cresol 

106–44–5 Phenol, 4- 

methylp-Cresol 

108–39–4 Phenol, 3- 

methylm -Cresol 

1319–77–3 Phenol, methyl- Mixed 

Cresols 

In response to the 61st ITC Report, the 

Cresols Panel of the American 

Chemistry Council (ACC) submitted a 

February 27, 2008 letter to EPA’s Office 

of Pollution Prevention and Toxics 

Document Control Office (Ref. 7). The 

Cresols Panel also submitted several 

references which are summarized in this 

unit. In a 1972 report to the Research 

Institute for Fragrance Materials, 

Kligman performed a maximization test 

on 25 volunteers and determined that pcresol at 4% concentration in 

petrolatum produced no sensitization 

reactions (Ref. 8). In a 1980 report to the 

Research Institute for Fragrance 

Materials, Kligman performed a 

maximization test on 25 volunteers and 

determined that o-cresol at 4% 

concentration in petrolatum produced 

no sensitization reactions (Ref. 9). 

In later reports, Bruze (1986) showed 

that guinea pigs sensitized with 2- 

methylolphenol (CAS No. 623–05–2) or 

4-methylolphenol (CAS No. 90–01–7) 

and challenged with o-cresol or p-cresol 

following a guinea pig maximization 

test protocol react positively at rechallenge with both o- and p-cresol (Ref. 

10). Bruze and Zimerson (1997) 

challenged patients with known contact 

allergy to phenol-formaldehyde resin 

and methylol phenol to o-cresol and pcresol and found that 4 of 10 patients 

were sensitive to o-cresol, and 1 of 2 

patients were sensitive to p-cresol (Ref. 


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11). Bruze and Zimerson (2002) 

established a dose-response relationship 

to cresol sensitization (Ref. 12). 

Seidenari et al. (1991) patch-tested adult 

patients that were sensitized to textile 

dyes for reaction to m-cresol and found 

that there were positive effects in 2 of 

81 patients tested with 2% m-cresol 

(Ref. 13). These findings were 

summarized in the 2006 Cosmetic 

Ingredient Review (Ref. 14). At this time 

there do not appear to be any dermal 

sensitization studies with mixed cresols. 

After reviewing the studies submitted 

by the Cresols Panel, it was determined 

that the information contained in this 

voluntary submission met the data 

needs. As a result, the ITC is removing 

o-cresol, p-cresol, m-cresol and mixed 

cresols from the Priority Testing List. 

V. References 

1. ITC. Fifty-Third Report of the ITC. 

Federal Register (69 FR 2468, January 

15, 2004) (FRL–7335–2). Available online at: http://www.epa.gov/fedrgstr. 

2. ITC. Fifty-Sixth Report of the ITC. 

Federal Register (70 FR 61520, October 

24, 2005) (FRL–7739–9). Available online at: http://www.epa.gov/fedrgstr. 

3. ITC. Fifty-Eighth Report of the ITC. 

Federal Register (71 FR 39188, July 11, 

2006) (FRL–8073–7). Available on-line 

at: http://www.epa.gov/fedrgstr. 

4. ITC. Fifty-Ninth Report of the ITC. 

Federal Register (72 FR 2756, January 

22, 2007) (FRL–8110–2). Available online at: http://www.epa.gov/fedrgstr. 

5. EPA. Preliminary Assessment 

Information Reporting; Addition of 

Certain Chemicals. Federal Register (69 

FR 70552, December 7, 2004) (FRL–

7366–8). Available on-line at: http:// 

www.epa.gov/fedrgstr. 

6. ITC. Sixty-First Report of the ITC. 

Federal Register (73 FR 5080, January 

28, 2008) (FRL–8347–1). Available online at: http://www.epa.gov/fedrgstr. 

7. ACC. 2008. February 27, 2008 letter 

from the Cresols Panel of the American 

Chemistry Council (ACC) to EPA’s 

Office of Pollution Prevention and 

Toxics Document Control Office. Docket 

ID Number: EPA–HQ–OPPT–2007–

1124. 

8. Kligman, A.M. Report to Research 

Institute for Fragrance Materials (RIFM). 

November 22, 1972. As cited in: Opdyke 

D.L. J. (1974). Food Cosmetology 

Toxicology. 12: 389 and 390. Fragrance 

raw materials monographs. p-Cresol. 

9. Kligman, A.M. Report to Research 

Institute for Fragrance Materials (RIFM). 

March 26, 1980. 

10. Bruze, M. 1986. Sensitizing 

capacity of 2-methylol phenol, 4- 

methylol phenol, and 2,4,6-trimethylol 

phenol in the guinea pig. American 

Journal of Contact Dermatitis. 14: 32–

38. 

11. Bruze, M. and Zimerson, E. 1997. 

Cross-reaction patterns in patients with 

contact allergy to simple phenols. 

American Journal of Contact Dermatitis. 

37: 82–86. 

12. Bruze, M. and Zimerson, E. 2002. 

Contact allergy to o-cresol – A sensitizer 

in phenol-formaldehyde resin. 

American Journal of Contact Dermatitis. 

13: 198–200. 

13. Seidenari, S. Manzini, B.M., and 

Danese, P. 1991. Contact sensitization to 

textile dyes: description of 100 subjects. 

American Journal of Contact Dermatitis. 

24: 253–258. 

14. Cosmetic Ingredient Review (CIR). 

2006. Final report on the safety 

assessment of sodium p-chloro-mcresol, p-chloro-m-cresol, chlorothymol, 

mixed cresols, m-cresol, o-cresol, pcresol, isopropylcresols, thymol, ocymen-5-ol, and carvacrol. International 

Journal of Toxicology. 25 (Supplement 

l): 29–127. 

VI. The TSCA Interagency Testing 

Committee 

Statutory Organizations and Their 

Representatives 

Council on Environmental Quality 

Vacant 

Department of Commerce 

National Institute of Standards and 

Technology 

Dianne Poster, Chair 

National Oceanographic and 

Atmospheric Administration 

Tony Pait, Member 

Environmental Protection Agency 

John Schaeffer, Member 

Gerry Brown, Alternate 

National Cancer Institute 

Vacant 

National Institute of Environmental 

Health Sciences 

Scott Masten, Alternate 

National Institute for Occupational 

Safety and Health 

Dennis W. Lynch, Vice Chair 

Mark Toraason, Alternate 

National Science Foundation 

Judy Raper, Member 

Margaret Cavanaugh, Alternate 

Occupational Safety and Health 

Administration 

Thomas Nerad, Member 

Maureen Ruskin, Alternate 

Liaison Organizations and Their 

Representatives 

Agency for Toxic Substances and 

Disease Registry 

Daphne Moffett, Member 

Glenn D. Todd, Alternate 

Consumer Product Safety Commission 

Jacqueline Ferrante, Member 

Department of Agriculture 

Clifford P. Rice, Member 

Laura L. McConnell, Alternate 

Department of Defense 

Laurie Roszell, Member 

Department of the Interior 

Barnett A. Rattner, Member 

Food and Drug Administration 

Kirk Arvidson, Alternate 

Ronald F. Chanderbhan, Alternate 

Technical Support Contractor 

Syracuse Research Corporation 

ITC Staff 

John D. Walker, Director 

Carol Savage, Administrative 

Assistant 

TSCA Interagency Testing Committee 

(7401M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; e-mail 

address: savage.carol@epa.gov; url: 

http://www.epa.gov/opptintr/itc. 

[FR Doc. E8–10511 Filed 5–9–08; 8:45 am] 

BILLING CODE 6560–50–S 


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