36196 Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices 

(Amendment) (Final Rule); in 40 CFR 

part 1042, subparts C, D, G and H; was 

approved 07/08/2009; OMB Number 

2060–0287; expires 07/31/2012. 

EPA ICR Number 1745.06; Criteria for 

Classification of Solid Waste Disposal 

Facilities and Practices (Renewal); in 40 

CFR part 257, subpart B; was approved 

07/10/2009; OMB Number 2050–0154; 

expires 07/31/2012. 

EPA ICR Number 2027.04; NESHAP 

for Flexible Polyurethane Foam 

Fabrication (Renewal); in 40 CFR part 

63, subpart MMMMM; was approved 

07/10/2009; OMB Number 2060–0516; 

expires 07/31/2012. 

EPA ICR Number 2056.03; NESHAP 

for Miscellaneous Metal Parts and 

Products (Renewal); in 40 CFR part 63, 

subpart MMMM; was approved 07/10/ 

2009; OMB Number 2060–0486; expires 

07/31/2012. 

EPA ICR Number 1656.13; Risk 

Management Program Requirements and 

Petitions to Modify the List of Regulated 

Substances under Section 112(r) of the 

Clean Air Act (Renewal); in 40 CFR part 

68; was approved 07/10/2009; OMB 

Number 2050–0144; expires 07/31/2012. 

EPA ICR Number 2317.01; Generator 

Standards Applicable to Laboratories 

Owned by Eligible Academic Entities 

(Final Rule); in 40 CFR part 262, subpart 

K; was approved 07/10/2009; OMB 

Number 2050–0204; expires 07/31/2012. 

OMB Comments Filed 

EPA ICR Number 2355.01; 

Restructuring of Stationary Source 

Audit Program (Proposed Rule); OMB 

filed comment on 06/30/2009. 

EPA ICR Number 1975.06; NESHAP 

for Stationary Reciprocating Internal 

Combustion Engines (40 CFR part 63, 

subpart ZZZZ) (Proposed Rule); OMB 

filed comment on 07/04/2009. 

EPA ICR Number 2348.01; NESHAP 

for Paints and Allied Products 

Manufacturing (40 CFR part 63, subpart 

CCCCCCC) (Proposed Rule); OMB filed 

comment on 07/07/2009. 

EPA ICR Number 2332.01; NESHAP 

for Aluminum, Copper, and Other 

Nonferrous Foundries (Proposed Rule); 

OMB filed comment on 07/10/2009. 

Dated: July 16, 2009. 

John Moses, 

Director, Collection Strategies Division. 

[FR Doc. E9–17397 Filed 7–21–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2003–0010; FRL–8426–6] 

1,2-Ethylene Dichloride; Completion of 

EPA Program Review 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: EPA issued a testing consent 

order that incorporated an enforceable 

consent agreement (ECA) for 1,2- 

Ethylene Dichloride (EDC) in June 2003, 

using authorities under section 4 of the 

Toxic Substances Control Act (TSCA). 

The companies subject to the ECA 

agreed to conduct toxicity testing in a 

tiered testing program that included 

development of pharmacokinetics and 

mechanistic data and a computational 

dosimetry model for route-to-route 

extrapolations. The testing program was 

designed to satisfy the toxicological data 

needs for EDC identified in a TSCA 

section 4 proposed test rule for a 

number of hazardous air pollutant 

chemicals. The modeling is intended to 

allow toxicological studies conducted 

using oral exposures to be interpreted so 

that they could also be used to predict 

the effects of inhalation exposures. This 

notice announces the completion of the 

program review component of the ECA 

for EDC. This notice also states EPA’s 

findings and conclusion regarding the 

adequacy of the derived models to 

perform satisfactory route-to-route 

extrapolations, responds to comments 

on the Tier I Program Review Testing, 

and establishes revised deadlines for 

completion of Tier II testing and 

computational route-to-route dosimetry 

modeling for extrapolations listed under 

Tier II of the ECA for EDC. 

FOR FURTHER INFORMATION CONTACT: For 

general 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. 

For technical information contact: 

John Schaeffer, Chemical Control 

Division (7405M), Office Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (202) 564– 

8173; e-mail address: 

schaeffer.john@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 are or may 

be required to conduct testing of 

chemical substances under TSCA. Since 

other entities may also be interested, the 

Agency has not attempted to describe all 

the specific entities 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. How Can I Get Copies of this 

Document and Other Related 

Information? 

1. Docket. EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2003–0010. 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., Confidential Business Information 

(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. 

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices 36197 

II. Background 

A. What is the EPA Program Review for 

EDC? 

In the Federal Register of September 

5, 2006 (71 FR 52329) (FRL–8088–3), 

EPA announced that it was conducting 

the program review component of the 

ECA for the EDC alternative testing 

program, and solicited public comment 

on data received under the Tier I 

Program Review testing segment of the 

ECA for EDC (CAS No. 107–06–2). 

Comments were to inform EPA’s 

decision on whether or not additional 

data and/or model development are 

needed before Tier II testing and 

computational route-to-route dosimetry 

modeling extrapolations could proceed 

for the Tier II endpoints listed in the 

ECA for EDC. Details of the testing 

program for EDC are available in the 

ECA and in the Federal Register of June 

3, 2003 (68 FR 33125) (FRL–7300–6), in 

which EPA announced it had entered 

into an ECA and issued a testing 

consent order for EDC. The ECA for EDC 

was developed in response to EPA’s 

request for ECA proposal for health 

effects testing of a number of hazardous 

air pollutants (HAPs or HAP chemicals), 

including EDC (see the proposed test 

rule in the Federal Register of June 26, 

1996 (61 FR 33177) (FRL–4869–1), and 

the proposed test rule, as amended, in 

the Federal Register of December 24, 

1997 (62 FR 67466) (FRL–5742–2); 

February 5, 1998 (63 FR 5915) (FRL– 

5769–3); and April 21, 1998 (63 FR 

19694) (FRL–5780–6)). The HAPs 

rulemaking proposed testing for health 

effects by the inhalation route of 

exposure. In the proposed rule, EPA 

also invited the submission of proposals 

that included pharmacokinetics studies 

and model development that would 

permit the extrapolation of testing 

administered by other exposure routes, 

such as the oral route, to predict for 

inhalation exposures. On November 22, 

1996, Dow Chemical Company, Vulcan 

Materials Company (no longer in 

existence), Occidental Chemical 

Corporation, Oxy Vinyls, LP, Georgia 

Gulf Corporation, Westlake Chemical 

Corporation, PPG Industries, Inc., and 

Formosa Plastics Corporation, U.S.A. 

(the ‘‘Companies’’), under the auspices 

of the HAP Task Force, submitted a 

proposal for alternative testing of EDC 

that included physiologically based 

pharmacokinetics (PBPK) and model 

development to support route-to-route 

extrapolation of testing to be conducted 

under the ECA by the oral route. EPA 

considered this proposal sufficient to 

enter into ECA negotiations with the 

Companies and other interested parties 

(62 FR 66626; December 19, 1997) 

(FRL–5763–1). The ECA for EDC that 

resulted was announced in the Federal 

Register of June 3, 2003 (68 FR 33125). 

Since the route-to-route extrapolation of 

test results was a new approach, EPA 

and the Companies included a program 

review step within the testing program. 

The testing program consists of Tier I 

HAPs Testing; Tier I Program Review 

Testing; EPA Program Review; and Tier 

II Testing. 

Tier I HAPs Testing consisted of 

endpoint testing conducted by 

inhalation exposure for acute toxicity, 

with bronchoalveolar lavage (BAL) and 

histopathology, and acute neurotoxicity. 

The Tier I Program Review Testing 

consisted of studies to develop PK/ 

MECH data, analyze glutathione 

metabolism, and perform model 

simulation. These studies were 

conducted to extend the computational 

dosimetry model of D’Souza et al. (1987, 

1988; Refs. 1 and 2) to improve the 

model’s application to the specific 

health effects endpoints for EDC listed 

in the ECA. The studies also enabled 

EPA to validate the model and verify the 

model’s ability to adequately perform 

quantitative route-to-route 

extrapolations of dose response. Further 

description of the Tier I HAPs Testing 

and the Tier I Program Review Testing 

is provided in the Federal Register of 

September 5, 2006 (71 FR 52329). That 

notice, as well as the final study reports, 

can be accessed in the docket (EPA– 

HQ–OPPT–2003–0010) as explained in 

Unit I.B. 

As specified in the ECA, the EPA 

program review is required before the 

Tier II Testing segment is undertaken. In 

the Federal Register of September 5, 

2006 (71 FR 52329), EPA announced 

that it was conducting the program 

review component of the ECA for EDC, 

and solicited public comment on data 

received under the Tier I Program 

Review Testing segment of the ECA. 

Comments were to inform EPA’s 

decision on whether or not additional 

data and/or model development were 

needed before Tier II Testing and 

computational route-to-route dosimetry 

modeling extrapolations can proceed for 

the Tier II endpoints listed in the ECA 

for EDC. 

B. What were the Public Comments on 

the Tier I Program Review Testing for 

EDC? 

EPA received two public comments in 

response to its solicitation for comments 

on the Tier I Program Review Testing. 

Comments from People for the Ethical 

Treatment of Animals (PETA) were on 

behalf of themselves and the following 

organizations: The Physicians’ 

Committee for Responsible Medicine, 

the Humane Society of the United 

States, the Doris Day Animal League, 

and Earth Island Institute. PETA 

expressed support for the use of PBPK 

modeling to limit additional animal 

testing through the use of route-to-route 

extrapolation to existing studies. 

However, PETA also stated that they 

disagreed that additional Tier II tests 

(i.e., for reproductive effect or 

subchronic neurotoxicity) are needed; 

contending that existing studies for 

these effects are adequate. EPA 

disagrees, and its basis for requiring this 

additional testing is discussed in 

previous Federal Register documents, 

cited in Unit II.A. A second comment, 

from a private citizen, was focused on 

opposition to the manufacture of 

chlorine compounds in general, 

including EDC, and not the testing 

program. 

C. What are the Conclusions of the EPA 

Tier I Program Review Testing for EDC? 

The companies have completed the 

Tier I and Tier I Program Review testing 

segments of the ECA for EDC. The 

companies have also examined 

additional PBPK models and other 

available information in order to more 

fully update the model developed by 

D’Souza et al., 1987, 1988; as specified 

in the ECA agreement. The results of 

this work, the updated model, and 

model simulations have been discussed 

with EPA (Refs. 3 through 6) and have 

also been recently published as a peerreviewed article in the scientific 

literature (Ref. 7). It is EPA’s conclusion 

that the PBPK model developed by the 

test sponsors under the EDC ECA is 

acceptable for route-to-route 

extrapolations and that Tier II testing 

and extrapolation reporting can proceed 

as per the schedule set forth below (Ref. 

8). Specifically, EPA concludes that: 

1. The PK/MECH data report and Tier 

I toxicity studies have been conducted 

in accordance with the protocols and 

specifications as described in Appendix 

C of the ECA. 

2. The available study records are 

sufficient to allow an evaluation of the 

quality of the studies performed. 

3. The EDC PBPK model is 

appropriately chemical-specific, and 

suitably based on the current 

understanding of the kinetics of EDC. 

4. The species, dose level, exposure 

regimens, and vehicles used are relevant 

for the toxicity data that are the object 

of the Tier II extrapolations. 

5. The Tier I Program Review PK/ 

MECH data, along with additional data, 

show that periodicity was demonstrated 

and that the various data sets bearing on 

the issue of periodicity can be properly 


jlentini on DSKJ8SOYB1PROD with NOTICES
36198 Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices 

interpreted and managed in the studies 

that support the model. 

6. Refinements of the model related to 

absorption, tissue distribution, and 

metabolism were accomplished, or 

suitably explained, including the role of 

extrahepatic metabolism as it impacts 

the model dose metrics and route-toroute extrapolation; appreciably 

improving prior PBPK models of EDC. 

It is EPA’s decision that the HAP Task 

Force can proceed with the Tier II 

Testing under the schedule set forth in 

Table 1. of this Federal Register 

document. 

TABLE 1.—REQUIRED TESTING, TEST STANDARDS, AND REPORTING REQUIREMENTS FOR EDC 

Testing segment Required testing Test standard Deadline for final report1 (months) 

.

Tier II testing and/or extrapolation reporting Subchronic toxicity route-to-route 

extrapolation of dose-response 

(oral Tier II testing to inhalation) 

of a study reported by Daniel, et 

al., (1994) 

ECA appendix C.2 and C.6 12 

.

Subchronic neurotoxicity (oral) 40 CFR 799.9620 (as annotated in 

ECA appendix D.2) 

18 

.

Subchronic neurotoxicity route-toroute extrapolation of dose-response (oral Tier II testing to inhalation) ECA appendix C.3 and C.6 21 

.

Reproductive toxicity (oral) 40 CFR 799.9380 (as annotated in 

ECA appendix D.3) 

25 

.

Reproductive toxicity route-to-route 

extrapolation of dose-response 

(oral data to inhalation, including 

Tier II testing and extant studies 

reported by Alumot, et al., 

(1976), Rao, et al., (1980), and 

Lane, et al., (1982)) 

ECA appendix C.4 and C.6 28 

1Number of months after the date of publication of this Federal Register document, which announces that EPA has concluded the EPA Program Review, when the final report is due. In addition, every 6 months from the effective date of the Order until the end of the ECA testing program, interim reports describing the status of all testing to be performed under this ECA must be submitted by the Companies to EPA. 

III. References 

1. D’Souza, R.W., Francis, W.R., Bruce 

R.D., and Andersen, M.E. 

Physiologically based pharmacokinetic 

model for ethylene dichloride and its 

application in risk assessment. P. 286– 

301, In: Pharmacokinetics in Risk 

Assessment. National Academy Press. 

Washington, D.C. (1987). 

2. D’Souza, R.W., Francis, W.R., and 

Andersen, M.E. Physiological model for 

tissue glutathione depletion and 

increased resynthesis after ethylene 

dichloride exposure. Journal of 

Pharmacology and Experimental 

Therapeutics. 245(2):563–568. (1988). 

3. EPA, Office of Prevention, 

Pesticides and Toxic Substances, 

Chemical Control Division. Letter from 

Jim Willis, Director, CCD to Dr. Peter 

Voytek, HAP Task Force. RE: EPA Tier 

I Program Review for EDC. January 10, 

2007. 

4. EPA and HAP Task Force. 

Technical Consultation Meeting on 1, 2- 

Ethylene Dichloride Program Review. 

February 12, 2007. 

5. HAP Task Force. Letter from Peter 

E. Voytek, Manager, HAP Task Force to 

Jim Willis, Director, Chemical Control 

Division, Office of Pollution Prevention 

and Toxics, with Enclosure: Response to 

Issues Raised in EPA’s Tier 1 Data 

Evaluation Meeting. May 23, 2007. 

6. Sweeny, L. M. and Gargas, M.I. 

Physiologically based pharmacokinetic 

model development and simulations for 

ethylene dichloride (1,2-dichlorethane) 

in rats. Prepared by the Sapphire Group, 

Dayton Ohio for the HAP Task Force, 

Millwood, Virginia. Revised Draft 

Report. March 11, 2009. 

7. Sweeny, L. M., Saghir, S. A., and 

Gargas, M.I. Physiologically based 

pharmacokinetic model development 

and simulations for ethylene dichloride 

(1,2-dichlorethane) in rats. Regulatory 

Toxicology and Pharmacology. 51:311– 

323. (2008). 

8. EPA. Email from Rob Dewoskin, 

PhD, DABT, US EPA/NCEA (National 

Center for Environmental Assessment) 

to John Schaeffer. Review of Final report 

- EDC ECA Program Review Completion. 

April 22, 2009. 

List of Subjects 

Environmental protection, 1,2- 

Ethylene Dichloride, EDC, Hazardous 

chemicals. 

Dated: July 10, 2009. 

Jim Willis, 

Director, Chemical Control Division, Office 

of Pollution Prevention and Toxics. 

[FR Doc. E9–17170 Filed 7–21–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–ORD; FRL–8930–3] 

Flexible Approaches to Environmental 

Measurement—The Evolution of the 

Performance Approach 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: Assuring the quality of 

environmental measurements is 

essential to the implementation of the 

Environmental Protection Agency’s 

(EPA’s or the Agency’s) environmental 

programs, both regulatory and 

voluntary. In an October 6, 1997, Notice 

of Intent (FRL–5903–2), the Agency 

outlined a ‘‘Performance Based 

Measurement System (PBMS)’’ concept 


jlentini on DSKJ8SOYB1PROD with NOTICES