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
Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices 36199 

1 ISO/IEC 17025 General requirements for the 

competence of testing and calibration laboratories. 

which was expected to ‘‘* * * have the 

overall effect of improving data quality 

and encouraging advancement of 

analytical technologies.’’ EPA has 

recently revisited the 1997 concept, 

gauged the Agency’s progress towards 

achieving its goals, and redefined steps 

needed to ensure continued progress. 

The Agency has determined that 

while specifying performance criteria in 

a manner that is independent of 

methods, techniques, or instruments 

may be possible, developing a single 

protocol for the validation of these 

measurements that could be applied to 

all measurements, including 

measurements made with techniques 

yet to be invented, may not be possible. 

Accordingly, EPA is introducing 

principles that reflect flexible 

approaches to environmental 

measurement. These principles capture 

the Agency’s experience of the past ten 

years, set the stage for future progress in 

improving data quality, and encourage 

the advancement of environmental 

measurement technologies. 

Key goals for this flexible approach 

are as follows: Increased emphasis on 

flexibility when choosing sampling and 

analytical approaches to meet regulatory 

requirements for measurements; 

development of processes for validation 

to confirm measurements meet quality 

requirements; increased collaboration 

with stakeholders to develop validation 

processes for new measurement 

technology; and timely assessment of 

new or modified technologies, methods, 

and procedures. 

The purpose of this notice is to 

provide the public with an up-to-date 

communication on the Agency’s 

progress to Flexible Measurement—The 

Evolution of the Performance Approach. 

FOR FURTHER INFORMATION CONTACT: For 

specific information regarding this 

notice, contact Lara Autry, 

Environmental Protection Agency, 

Office of the Science Advisor, E243–05, 

109 TW Alexander Drive, Research 

Triangle Park, NC 27709; telephone 

number: 919–541–5544; fax number: 

919–541–4261; e-mail address: 

autry.lara@epa.gov. 

SUPPLEMENTARY INFORMATION: The 

Forum on Environmental Measurements 

(FEM) is a standing committee of senior 

EPA mangers established to develop 

policies to guide the EPA measurement 

community in validating and 

disseminating methods for 

environmental monitoring; for ensuring 

that monitoring studies are scientifically 

rigorous, statistically sound, and yield 

representative data; and for employing a 

quality systems approach that ensures 

that the data gathered and used by the 

Agency is of known and documented 

quality. The Forum was established to 

promote consistency and consensus 

within the EPA on measurement issues. 

Historically, most EPA programs have 

specified required analytical methods to 

be used by the regulated community in 

the analysis of environmental samples 

for regulatory compliance purposes. 

EPA has published its methods in 

regulations and a number of compendia, 

such as ‘‘Manual of Methods for 

Chemical Analysis of Water and 

Wastes’’ and ‘‘Methods for the 

Determination of Organic Compounds 

in Drinking Water.’’ The requirement to 

use specific analytical methods for 

compliance purposes is one of several 

means for assuring appropriate 

consistency and reliability in 

environmental monitoring. 

In certain instances, in order to 

provide regulated parties with the 

flexibility to use alternative methods, 

EPA programs have established 

administrative processes by which the 

public could submit a proposed method 

for Agency review and approval. Before 

alternative methods are used in 

regulatory compliance applications, 

EPA’s regulations require that such 

methods be approved by the Agency 

through formal rulemaking. 

In past instances, the approval 

processes have been lengthy. For 

example, in some cases, the approval 

process took several years to receive 

consent for a proposed method or 

method modification after the Agency 

completed its evaluation. The approach 

of specifying required methods and 

approving new methods was identified 

as a major barrier to using innovative 

monitoring technology. In order to 

address these concerns, EPA’s former 

Environmental Monitoring Management 

Council (EMMC) established a work 

group of scientists representing EPA’s 

Headquarters and Regional offices to 

consider the advisability for establishing 

a performance-based approach to 

specifying analytical testing 

requirements. Based on the work 

group’s recommendations in 1997, the 

Agency announced its intent to 

incorporate the PBMS approach, to the 

extent feasible, into its programs. 

At the same time, the Agency 

intended that PBMS would provide the 

regulated community with flexibility in 

conducting required environmental 

monitoring, expedite the use of new and 

innovative techniques, and result in less 

costly approaches to conducting 

required monitoring and measurements. 

Under PBMS, the Agency envisioned 

that this approach would continue to 

allow use of its current required 

methods as well. 

EPA has revisited the 1997 concept, 

gauged the Agency’s progress towards 

achieving its goals, and redefined steps 

needed to ensure continued progress. 

EPA has determined that while it may 

sometimes be possible to specify 

performance criteria in a manner that is 

independent of methods, techniques, or 

instruments, the development of a 

single protocol for validating these 

measurements that could be applied to 

all measurements, including 

measurement made with techniques yet 

to be invented, is simply not possible. 

Accordingly, EPA is introducing flexible 

approaches in environmental 

measurement. These flexible approaches 

capture the Agency’s experience of the 

past ten years, set the stage for future 

progress in improving data quality, and 

encourage the advancement of 

environmental measurement 

technologies. 

The key goals for the flexible 

approaches are as follows. 

(1) Increase Emphasis on the Flexibility 

of Choosing Sampling and Analytical 

Approaches To Meet Regulatory 

Requirements for Measurements 

Setting measurement requirements 

begins with indentifying goals and 

considering such factors as action 

levels, technology performance, 

mandates, and/or limitations of the 

program or project. These goals may be 

applied broadly across a program and 

established by a program office, or may 

be specific to a project or permit. Goals 

are translated into measurement 

requirements, which may take a variety 

of forms. In some applications, a general 

requirement on accuracy may be 

present; while in others, measurement 

requirements may be coupled to a 

technology, method, or procedure (e.g., 

criteria for evaluating modifications to 

published reference methods). 

The Agency recognizes that some of 

its measurement quality requirements 

that appear throughout its regulations 

may be more specific than necessary, 

and it will strive to make these 

requirements more flexible as time and 

resources permit. 

(2) Develop Processes for Validations 

That Confirm That Measurements Meet 

Quality Requirements 

A validation process should provide 

evidence that measurement quality 

requirements are achieved. According to 

ISO 17025,1 ‘‘validation is the 

confirmation by examination and the 

provision of objective evidence that the 

particular requirements for specific 


jlentini on DSKJ8SOYB1PROD with NOTICES
36200 Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices 

intended use are fulfilled.’’ Validation is 

typically performed in two phases. The 

first phase provides evidence on general 

performance of a measurement system 

for a range of materials that define a 

matrix class; the second phase (often 

called ‘‘verification’’), demonstrates that 

the requirements for a specific use are 

met. Both phases are important for 

scientific and legal defensibility. 

More general measurement 

requirements call for more specific 

validation processes. A general 

requirement on accuracy that is 

specified in a manner independent of 

technique, method, or instrument 

should be accompanied by detailed 

validation for each method of 

measurement. Conversely, a 

measurement quality requirement to use 

a particular procedure can require 

essentially no validation, as a detailed 

procedure often includes a complete 

specification of required quality control 

activities. 

EPA intends to develop processes for 

validation that allow for an appropriate 

choice of specificity. For some 

applications, validation processes may 

continue to use defined procedures with 

ongoing quality control. For other 

applications, validation processes may 

place emphasis on greater flexibility and 

include verification that the 

requirements for a specific use are 

achieved. 

(3) Increase Collaboration With 

Stakeholders To Develop Validation 

Processes for New Measurement 

Technology 

Validation required for new 

technology may be difficult to specify in 

advance due to the wide variety of 

performance issues which may be 

encountered. The Agency anticipates 

that developing validation processes for 

applications of new technology will 

require collaborating with stakeholders 

to ensure timely development of these 

processes. During this process, the 

Agency expects to continue to play a 

key role in the validation development. 

(4) Timely Assessment of New or 

Modified Technologies, Methods, and 

Procedures 

In the event that the measurement 

requirements in a program are specific 

to a technology, method, or procedure, 

the Agency is committed to the 

assessment of proposed alternatives to 

these requirements and to rendering 

timely decisions of these alternatives 

when approval is sought. 

Today’s notice is not a formal agency 

action, but a statement of the Agency’s 

approach to environmental 

measurement flexibility. It creates no 

rights enforceable by any party in 

litigation with the United States. 

Dated: June 30, 2009. 

Kevin Teichman, 

Acting EPA Science Advisor. 

[FR Doc. E9–17402 Filed 7–21–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2009–0481; FRL–8429–8] 

Proposed Stipulated Injunction 

Involving Pesticides and Eleven 

Species Listed as Threatened or 

Endangered Under the Endangered 

Species Act; Notice of Availability; 

Reopening of Comment Period 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice; reopening of comment 

period. 

SUMMARY: EPA issued a notice in the 

Federal Register of July 1, 2009, 

announcing the availability of a 

proposed Stipulated Injunction that 

would establish a series of deadlines for 

the Agency to make ‘‘effects 

determinations’’ and initiate 

consultation, as appropriate, with the 

U.S. Fish and Wildlife Service for 

certain pesticides in regard to one or 

more of 11 species found in the greater 

San Francisco Bay area that are listed as 

endangered or threatened under the 

Endangered Species Act. The proposed 

Stipulated Injunction, if entered by the 

Court, would resolve a lawsuit brought 

against EPA by the Center for Biological 

Diversity in the United States District 

Court for the Northern District of 

California. The July 1, 2009 notice 

provided a 15–day comment period 

which closed on July 16, 2009. This 

document reopens the comment period 

for 30 days. 

DATES: Comments, identified by docket 

identification (ID) number EPA–HQ– 

OPP–2009–0481, must be received on or 

before August 17, 2009. 

ADDRESSES: Follow the detailed 

instructions as provided under 

ADDRESSES in the Federal Register 

document of July 1, 2009. 

FOR FURTHER INFORMATION CONTACT: Arty 

Williams, Environmental Fate and 

Effects Division (7507P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (703) 305– 

7695; e-mail address: 

williams.arty@epa.gov. 

SUPPLEMENTARY INFORMATION: On July 1, 

2009 (74 FR 31427) (FRL–8425–1), EPA 

issued a notice in the Federal Register 

opening a 15–day comment period on a 

proposed Stipulated Injunction. The 

proposed Stipulated Injunction if 

entered by the United States District 

Court for the Northern District of 

California, would resolve a lawsuit 

brought against EPA by the Center for 

Biological Diversity (Center for 

Biological Diversity v. EPA, No. C 07– 

02794 JCS (N.D.Cal.)). 

The original comment period closed 

on July 16, 2009. However, based on 

comments received, EPA is reopening 

the comment period for 30 days to allow 

the public additional time to develop 

meaningful comments on the proposed 

Stipulated Injunction. Comments must 

be received on or before August 17, 

2009. 

To submit comments, or access the 

docket, please follow the detailed 

instructions as provided under 

ADDRESSES in the July 1, 2009 Federal 

Register document. If you have 

questions, consult the person listed 

under FOR FURTHER INFORMATION

CONTACT. 

List of Subjects 

Environmental protection, 

Endangered species. 

Dated: July 15, 2009. 

Debra Edwards, 

Director, Office of Pesticide Programs. 

[FR Doc. E9–17396 Filed 7–17–09; 4:15 pm] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

EPA–HQ–OPP–2009–0484; FRL–8425–8] 

Notice of Receipt of Several Pesticide 

Petitions Filed for Residues of 

Pesticide Chemicals in or on Various 

Commodities 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces the 

Agency’s receipt of several initial filings 

of pesticide petitions proposing the 

establishment or modification of 

regulations for residues of pesticide 

chemicals in or on various commodities. 

DATES: Comments must be received on 

or before August 21, 2009. 

ADDRESSES: Submit your comments, 

identified by the docket identification 

(ID) number and the pesticide petition 

number (PP) for the petition of interest 

as shown in the body of this document, 

by one of the following methods: 


jlentini on DSKJ8SOYB1PROD with NOTICES