7428 Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 

Dated: February 12, 2010. 

Alexander Cristofaro, 

Director, Office of Regulatory Policy and 

Management. 

[FR Doc. 2010–3249 Filed 2–18–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 790 

[EPA–HQ–OPPT–2009–0894; FRL–8802–6] 

RIN 2070–AJ59 

Amendments to Enforceable Consent 

Agreement Procedural Rules 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to revise the 

procedures for developing Enforceable 

Consent Agreements (ECAs) to generate 

test data under the Toxic Substances 

Control Act (TSCA). The main features 

of the ECA process that EPA is 

proposing to change include when and 

how to initiate negotiations and 

inserting a firm deadline at which 

negotiations will terminate. EPA is also 

proposing to amend several sections in 

40 CFR part 790 to place the ECA 

provisions in one section and the 

Interagency Testing Committee (ITC) 

provisions in a separate section, to make 

it clearer that there is one ECA 

negotiation procedure applicable to all 

circumstances when an ECA would be 

appropriate and to make conforming 

changes in other sections that reference 

the ECA procedures. 

DATES: Comments must be received on 

or before March 22, 2010. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2009–0894, 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–2009–0894. 

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– 

2009–0894. 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. 

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, 

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 

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 

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: 

Jessica Barkas, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (202) 250– 

8880; e-mail address: 

barkas.jessica@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does This Action Apply to Me? 

You may be potentially affected by 

this action if you manufacture (defined 

by statute to include import) or process 

chemical substances. Potentially 

affected entities may include, but are 

not limited to: 

• Manufacturers (defined by statute to 

include importers) of chemical 

substances (NAICS codes 325 and 

324110), e.g., chemical manufacturing 

and petroleum refineries. 

• Processors of chemical substances 

(NAICS codes 325 and 324110), e.g., 

chemical manufacturing and petroleum 

refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. 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 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 


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Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 7429 

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. Background 

A. What Action is the Agency Taking? 

EPA promulgated the ECA rules at 40 

CFR part 790 in 1986. The procedures 

were developed in consultation with the 

Natural Resources Defense Council and 

the Chemical Manufacturers 

Association; several public meetings to 

discuss the procedures were held before 

the procedural rule was promulgated as 

an interim final rule. 

ECAs are enforceable agreements 

between EPA and one or more chemical 

manufacturers or processors to conduct 

specific testing on a particular chemical 

substance. These agreements are 

designed to provide EPA with data 

identified as necessary to evaluate a 

particular chemical substance without 

the need for EPA to first make the riskor exposure-based findings for, or 

promulgate, a TSCA section 4 test rule, 

and without introducing delays inherent 

in the rulemaking process. ECAs were 

intended to permit EPA to obtain test 

data more quickly than test rules, while 

preserving opportunity for input from 

the public and the affected 

manufacturer(s). 

When EPA promulgated the original 

ECA rules, it anticipated that the 

timeline for completing an ECA, from 

ITC recommendation to agreement 

finalization, would be 50 weeks. EPA 

indicated uncertainty about the 

feasibility of the schedule from the 

outset, noting in Appendix A to subpart 

E of part 790 that the schedule was 

subject to amendment, by rule, should 

it prove unrealistic in practice. Since 

the publication of the ECA rule, the 

average time to complete an ECA has 

been approximately two years and 

negotiations have taken well over two 

years for several chemicals. Negotiations 

for ECAs on many chemicals have been 

started but never formally concluded, or 

have been terminated. EPA now 

proposes to revise the ECA procedural 

rule to increase the efficiency and 

flexibility of the ECA process. 

EPA recognizes the value of an open 

and transparent process for developing 

these agreements, and proposes to retain 

the opportunities for public 

involvement in negotiations, to review 

draft agreements, and to object to 

agreements. Key features that EPA is 

proposing to change involve 

determining when and how to initiate 

negotiations and inserting a firm 

deadline at which negotiations will 

terminate, and no ECA will be agreed to 

absent an affirmative decision by EPA to 

extend negotiations. EPA is also 

proposing to amend several sections in 

40 CFR part 790 to place the ECA 

procedure in one section, to make it 

clearer that there is one ECA negotiation 

procedure applicable to all 

circumstances when an ECA would be 

appropriate, and to make conforming 

changes in other sections that reference 

the ECA procedures. 

B. What is the Agency’s Authority for 

Taking This Action? 

Section 4 of TSCA authorizes EPA to 

require manufacturers and processors of 

chemical substances and mixtures to 

test these chemicals to generate data 

that is relevant to determining whether 

the chemicals present an unreasonable 

risk. Section 4(a) of TSCA empowers the 

Agency to promulgate rules which 

require such testing. Section 4 of TSCA 

provides implied authority to enter into 

enforceable consent agreements 

requiring testing where such agreements 

provide procedural safeguards 

equivalent to those that apply where 

testing is conducted by rule. 

C. What is An ECA? 

An ECA is an enforceable legal 

agreement between EPA and one or 

more private parties, such as a group of 

chemical manufacturers, specifying that 

those private parties will conduct 

testing on a given chemical substance to 

fill an EPA-identified need. The 

violation of the terms of an ECA is a 

prohibited act under TSCA and is 

enforceable under sections 16 and 17 of 

TSCA. In addition, chemicals subject to 

ECAs, similar to chemicals subject to 

test rules, are subject to certain 

additional provisions of TSCA (e.g., 

export notification under section 12 of 

TSCA). Because private parties enter 

ECAs voluntarily, EPA need not make 

findings as to unreasonable risk of 

injury to health or the environment, 

significant or substantial human 

exposure, or other findings that would 

be required to issue a final test rule. 

ECAs were conceived as a tool for EPA 

to acquire test data more expeditiously 

than could be achieved through the 

typical rulemaking process. 

D. When Has EPA Used ECAs and Why 

is EPA Proposing to Modify the ECA 

Procedures? 

Since 1986, EPA has published a 

number of Federal Register documents 

announcing its interest in using ECAs to 

obtain various test data. In some 

instances, EPA selected one or more 

chemical substances for testing 

consideration based on an ITC 

recommendation or designation (see, 

e.g., ECA for cyclohexane, 59 FR 59660 

(November 18, 1994) (FRL–4909–5)). In 

other instances, EPA selected the 

substance or substances based on its 

own initiative (see, e.g., ECA for 1,2- 

ethylene dichloride, 68 FR 33125 (June 

3, 2003) (FRL–7300–6)). ECAs have been 

used for testing single chemical 

substances and for testing multiple 

chemical substances, usually chemical 

substances related to one another. For 

the reasons summarized in Unit II.A. 

and further explained Unit II.D., E., and 

F., EPA has been using ECAs with 

declining frequency over the last several 

years. EPA’s data needs have not 

diminished, however, and the reduced 

number of ECAs has not been offset by 

an increase in the issuance of test rules. 

Because EPA would like to continue to 

use ECAs, where appropriate, it is 

proposing to amend the rules to make 

them quicker and easier to implement, 

to preserve existing provisions for 

transparency and adequate 

opportunities for public participation, 

and to make them easier for the public 


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to understand. EPA believes that these 

changes will increase Agency efficiency 

by enhancing EPA’s ability to use ECAs 

where appropriate, thereby permitting 

EPA to focus regulatory activity (and 

resources) on those chemicals for which 

ECAs are inappropriate or for which 

agreement cannot be reached 

significantly faster than a rule can be 

promulgated. 

E. When Does EPA Use Test Rules? 

EPA typically uses test rules when it 

makes certain findings specified under 

section 4(a) of TSCA. They include the 

finding that either the manufacture, 

distribution in commerce, processing, 

use, or disposal of a chemical substance 

or mixture, or that any combination of 

such activities, may present an 

unreasonable risk of injury to health or 

the environment; or that a chemical 

substance is or will be produced in 

substantial quantities and it either 

enters or may reasonably be anticipated 

to enter the environment in substantial 

quantities, or there is or may be 

significant or substantial human 

exposure to that chemical substance or 

mixture. In addition, they include the 

findings that ‘‘there are insufficient data 

or experience upon which the effects of 

the manufacture, distribution in 

commerce, processing, use, or disposal 

of such substance or mixture or any 

combination of such activities on health 

or the environment can reasonably be 

determined or predicted,’’ and that 

‘‘testing of such substance or mixture 

with respect to such effects is necessary 

to develop such data’’ (15 U.S.C. 2603). 

EPA has typically used test rules in 

circumstances where the ITC has 

designated a chemical for testing. In 

such circumstances, EPA has a statutory 

duty to either initiate a proceeding for 

a test rule within 12 months of the 

designation, or publish reasons why a 

test rule is not necessary. EPA has also 

recently used test rules to require testing 

of several high production volume 

(HPV) chemicals. 

More generally, EPA may pursue a 

test rule whenever EPA believes it can 

make the necessary findings. This 

includes situations where no party has 

volunteered to participate in ECA 

negotiations, where ECA negotiations 

are tried and fail, where the testing 

protocols or other considerations are too 

complex or new to make negotiations an 

efficient means of requiring testing, or 

in other circumstances that lead EPA to 

believe that negotiations would be 

unlikely to produce an ECA. 

F. What are the Specific Proposed 

Changes to the ECA Rule? 

1. Proposed reorganization of 40 CFR 

part 790, subpart B and removal of 

Appendix A to subpart E of part 790. 

EPA is proposing to amend 40 CFR 

790.20 and 40 CFR 790.22 by combining 

§ 790.22 with portions of § 790.24, by 

consolidating § 790.20 with portions of 

§ 790.26 and § 790.28, and by 

consolidating § 790.22 with § 790.28 to 

improve the organization of the rules, 

and to make it more clear that there is 

one ECA negotiation procedure for all 

situations in which ECAs are 

appropriate (generally, based on EPA’s 

own initiative or an ITC 

recommendation). 

EPA is proposing to move part of 

§ 790.22 to § 790.20 so that all 

provisions pertaining to how ITC 

intends to carry out making 

recommendations or designations, and 

how EPA intends to respond to those 

ITC actions, are in one section, and so 

that all provisions pertaining to ECA 

development procedures (which can 

apply whether or not the ITC has made 

a recommendation or designation) are in 

another section. EPA proposes to 

expand the section currently numbered 

§ 790.20(b)(2), which presently only 

covers recommendation without intent 

to designate, to include the same list of 

possible actions when ITC makes a 

recommendation, whether with or 

without intent to designate, and to move 

the procedures described in § 790.22(a) 

to § 790.20. The text presently at 

§ 790.22(a) will replace § 790.20(b), and 

the current § 790.20(b) will be 

redesignated § 790.20(c). This will help 

centralize all of the ITC-related 

procedures and remove the potentially 

confusing ITC discussion from the ECA 

procedural rules. To further centralize 

and consolidate the ECA procedures, 

EPA proposes to move the criteria for 

determining when consensus is reached, 

currently in § 790.24 to § 790.22. 

EPA proposes to remove § 790.26 

(initiation and completion of 

rulemaking proceedings on ITCdesignated chemicals) and § 790.28 

(procedures for developing consent 

agreements and/or test rules for 

chemicals that have not been designated 

or recommended with intent to 

designate by the ITC). The procedures 

and explanations in these sections are 

either needlessly duplicative or would 

be superseded by or incorporated into 

the proposed changes to § 790.20 

(procedures that follow ITC 

recommendation and designation) and 

§ 790.22 (ECA procedures). First, the 

proposed amended ECA procedures 

already articulate the principle (in 

proposed § 790.22(b)(4)) that EPA may 

proceed to rulemaking under TSCA 

section 4 if ECA negotiations are not 

successful. Second, for the reasons 

described in Unit II.F.1., EPA is 

proposing to remove the Appendix A 

and schedule table referred to in 

§ 790.26(b), and the remainder of 

§ 790.26(b) as duplicative of EPA’s 

existing rulemaking obligations under 

the Administrative Procedures Act. 

Third, EPA is proposing to incorporate 

§ 790.26(c) into the text of 

§ 790.20(c)(1)(i) (§ 790.20(b)(1)(i) in the 

existing rules). Fourth, § 790.28, which 

describes the procedures for developing 

ECAs for chemicals that have not been 

designated or recommended with intent 

to designate by the ITC, is unnecessary 

in light of the proposed expansion of the 

scope of § 790.22. The procedures that 

EPA is proposing in § 790.22 will apply 

to all circumstances in which ECAs are 

appropriate, including chemicals that 

have not been designated or 

recommended with intent to designate 

by the ITC. 

EPA proposes to remove Appendix A 

to subpart E of part 790, including the 

schedule table, because the Agency 

believes that the proposed revised 

procedures in § 790.20 and § 790.22 

adequately explain timelines for 

meetings and notices and because EPA 

is proposing to limit the required 

number of meetings and notices 

associated with ECA negotiations. The 

table is merely illustrative and provides 

little additional explanatory utility. 

Furthermore, the schedule table 

commingles events relating to ITC 

recommendations-with-intent-todesignate and more generic events 

relating to all ECA negotiations in a 

manner that could generate confusion 

over what procedures apply when EPA 

wishes to acquire testing information on 

a chemical for which the ITC has not 

made a recommendation with intent to 

designate. 

In addition to the changes discussed 

in Unit II.F.1., EPA proposes to make 

additional conforming and clarifying 

changes to § 790.20. The title of the 

section will be amended to include 

‘‘recommendation with intent to 

designate,’’ and the title of § 790.20(c) 

(currently § 790.20(b)) will be amended 

to include ITC ‘‘designations.’’ Finally, 

EPA proposes to make a few conforming 

changes to § 790.1, including removing 

the reference to the Appendix A 

schedule table in § 790.1(d) and 

removing the statement in § 790.1(c), 

regarding EPA’s intent to proceed with 

rulemaking if ECA negotiations are 

unsuccessful, because the proposed 

amended § 790.22(b)(4) includes a 

similar statement of intent. 


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2. Proposed changes to the ECA 

procedures. EPA is proposing to revise 

the ECA procedures to reflect that 

negotiation of an ECA for a chemical 

will not commence until EPA has 

received and evaluated a testing 

agreement proposal, and until EPA 

believes it is likely that proceeding with 

negotiation of a consent agreement, 

based on the proposal, would be an 

efficient and successful means of 

developing the test data. When 

evaluating testing proposals, EPA would 

generally consider factors such as 

whether it appears to address EPA’s 

testing interests and whether it appears 

to be a good faith attempt to present an 

agreement acceptable to EPA. 

Under the current regulations, at 

§ 790.22 (b)(1), where there is an ITC 

recommendation with intent to 

designate, solicitation for negotiation 

participants occurs at the same time the 

ITC report is published, rather than after 

EPA has had a chance to determine 

whether an ECA would even be an 

appropriate means for obtaining the test 

data in a given instance. In such 

circumstances, negotiation would begin 

before EPA is able to determine whether 

any party would be interested in 

submitting a testing proposal that might 

form an adequate basis to begin 

negotiations and before EPA has 

concluded that negotiating an ECA 

would likely be successful and more 

efficient than promulgating a test rule. 

EPA believes these circumstances create 

the unwarranted potential for wasting 

time and resources on negotiations over 

a clearly inadequate proposal. In EPA’s 

judgment, not requiring that a 

minimally acceptable proposed testing 

agreement be submitted to, and 

evaluated by, EPA before commencing 

negotiations has contributed to 

substantial delay in ECA completion, 

which would be remedied by the 

proposed change. 

Additional aspects of the current ECA 

regulations have also been found to 

contribute to delay. At present, the only 

time limits or deadlines in the ECA 

procedures are in the presumptive 

schedule in Appendix A to subpart E of 

part 790, and the provision in 

§ 790.22(b)(6) that, in certain 

circumstances, EPA will terminate 

negotiations 10 weeks after the deadline 

for requests to participate in 

negotiations. EPA has found the 

schedule to be unrealistic in most 

circumstances in light of the number of 

steps it suggests, and notes that the 

schedule explicitly notes only one point 

when EPA could terminate negotiations, 

rather than whenever such negotiations 

become unproductive or unduly 

prolonged. Section 790.22(b)(6) 

currently permits EPA to terminate 

negotiations over chemicals that the ITC 

has recommended for testing with an 

intent to designate if the Agency 

concludes early in the process that 

negotiations will be fruitless (‘‘EPA will 

terminate negotiations after 10 weeks 

and proceed with rulemaking unless 

negotiations are likely to result in a draft 

consent agreement within 4 additional 

weeks’’). This opportunity occurs only 

ten weeks after the earliest time 

negotiations begin, before the comment 

period for the interested parties, and 

before the ‘‘comment resolution 

meeting.’’ Further, there is no express 

provision at all for terminating 

unsuccessful ECA negotiations on 

chemical substances or mixtures that 

have not been recommended with intent 

to designate by the ITC (i.e., those 

substances that the ITC has simply 

recommended and those substances that 

EPA has selected on its own initiative). 

EPA proposes to amend § 790.22 to 

expressly allow EPA to affirmatively 

terminate negotiations at any time it 

believes negotiations are unlikely to 

produce a final agreement, regardless of 

whether the chemical substance or 

mixture subject to the negotiation was 

selected for testing consideration based 

on an ITC recommendation-with-intentto-designate, an ITC recommendation, 

or EPA’s own initiative. Furthermore, 

the proposed amendments would 

provide that if negotiations have not 

concluded within six months (again, 

regardless of the circumstances by 

which the chemical substance or 

mixture was selected for testing 

consideration), ECA negotiations 

automatically terminate and EPA may 

pursue a test rule instead. For the cases 

in which the parties are very near 

agreement at the end of six months, EPA 

proposes that the rules be amended to 

permit EPA to provide one or more 

extensions of up to 60 days each where 

it seems likely to EPA that agreement 

will be reached in that additional time. 

EPA would notify all interested parties 

of any extension(s). 

The current ECA regulations discuss a 

number of public meetings that do not 

seem to be necessary or helpful in many 

instances. Current § 790.22(a) and the 

schedule in Appendix A to subpart E of 

part 790 discuss a focus meeting that is 

to be held to discuss ITC 

recommendations-with-intent-todesignate. Current § 790.28 directs that 

the same schedule is to be followed for 

chemicals for which there has been no 

ITC designation or recommendationwith-intent-to-designate, making it 

unclear whether a public focus meeting 

must be used in situations other than 

when the ITC has made a 

recommendation-with-intent-todesignate. While such a meeting may be 

helpful as an initial public comment 

gathering tool when the ITC has made 

a recommendation-with-intent-todesignate, it is confusing to include this 

meeting in the procedures for 

negotiating an ECA because not all 

chemicals that the ITC recommendswith-intent-to-designate will ultimately 

be the subject of an ECA. Additionally, 

it would not be necessary to hold the 

focus meeting in other situations in 

which a chemical substance or mixture 

might be selected for testing 

consideration because there would not 

be an ITC recommendation-with-intentto-designate to discuss (such as when 

EPA seeks testing data on its own 

initiative or based on an ITC 

recommendation without intent to 

designate). 

The regulations at current § 790.22 

call for a public meeting to discuss 

EPA’s preliminary testing 

determinations—this is referred to in 

the regulations and in the schedule in 

Appendix A to subpart E of part 790 as 

the ‘‘course setting’’ meeting. These 

meetings are in addition to the ECA 

negotiation meeting or meetings (which 

are also public). EPA believes that it is 

unnecessary and unduly rigid to require 

a course setting meeting in all 

circumstances in which EPA intends to 

attempt to negotiate an ECA, regardless 

of need or public interest. Therefore, 

EPA proposes to retain this as a 

requirement only for ITC 

recommendations-with-intent-todesignate, and to move it from the ECA 

procedures (at § 790.22(a)(6) in the 

existing rule) to the ITC response 

procedures at § 790.20(b)(6) in this 

proposed rule. 

EPA proposes to amend the rules so 

that the only meetings required by the 

ECA procedures, consolidated in 

proposed § 790.22, would be the 

negotiation meeting or meetings. 

Negotiation meetings under the 

proposed ECA procedures could include 

the draft ECA comment resolution 

meeting described in the current 

§ 790.22(b)(8), so EPA believes it is 

unnecessary to include regulatory 

language in proposed § 790.22 expressly 

allowing for such a meeting. Other 

notices regarding EPA’s views on testing 

needs, solicitation of interested parties 

to participate in negotiations, and 

invitations to submit draft testing 

agreement proposals can be efficiently 

accomplished through Federal Register 

documents, through the EPA website, 

and through other forms of public 

communication. In particular, the 

solicitation of interested parties to 

participate in negotiations through 


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Federal Register documents will be 

maintained. 

The proposed amendments to 

§ 790.22 reflect this streamlined, flexible 

approach to public meetings, and make 

several other minor changes to 

modernize and streamline the ECA 

negotiation and public communication 

process (e.g., rather than placing 

meeting minutes, other background 

documents, etc. into a ‘‘public file’’ in 

the OPPTS Reading Room, EPA is 

proposing to place these documents in 

an Internet-accessible public docket 

established by EPA at http:// 

www.regulations.gov). 

III. Statutory and Executive Order 

Reviews 

A. Regulatory Review 

Under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993), 

this proposed rule is not a ‘‘significant 

regulatory action’’ subject to review by 

the Office of Management and Budget 

(OMB) under Executive Order 12866, 

because it does not meet the criteria in 

section 3(f)(4) of the Executive Order. 

Accordingly, EPA did not submit this 

proposed rulemaking to OMB for review 

under Executive Order 12866. 

B. Paperwork Reduction Act 

This action does not impose any new 

information collection burden, because 

the development of an ECA does not 

involve information collection activities 

as defined by the Paperwork Reduction 

Act (PRA), 44 U.S.C. 3501 et seq. 

However, the information collection 

requirements contained in an ECA are 

already approved by OMB pursuant to 

the PRA under OMB control number 

2070–0033 (EPA ICR No. 1139). Under 

the PRA, an agency may not conduct or 

sponsor, and a person is not required to 

respond to, an information collection 

request unless it displays a currently 

valid control number assigned by OMB. 

The OMB control numbers for EPA’s 

regulations in title 40 of the CFR are 

listed in 40 CFR part 9, and will be 

included in the individual ECAs. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA), 5 

U.S.C. 601 et seq., after considering the 

potential economic impacts of this 

proposed rule on small entities, the 

Agency hereby certifies that this 

proposed rule would not have a 

significant adverse economic impact on 

a substantial number of small entities. 

Small entities include small 

businesses, small organizations, and 

small governmental jurisdictions. For 

purposes of assessing the impacts of 

today’s proposed rule on small entities, 

small entity is defined as: (1) A small 

business as defined by the Small 

Business Administration’s (SBA) 

regulations at 13 CFR 121.201; (2) a 

small governmental jurisdiction that is a 

government of a city, county, town, 

school district or special district with a 

population of less than 50,000; and (3) 

a small organization that is any not-forprofit enterprise which is independently 

owned and operated and is not 

dominant in its field. 

This action will not have a significant 

economic impact on a substantial 

number of small entities. In determining 

whether a rule has a significant 

economic impact on a substantial 

number of small entities, the impact of 

concern is any significant adverse 

economic impact on small entities, 

since the primary purpose of regulatory 

flexibility analysis is to identify and 

address regulatory alternatives ‘‘which 

minimize any significant economic 

impact of the rule on small entities’’ (5 

U.S.C. 603 and 604). Thus, an agency 

may certify that a rule will not have a 

significant economic impact on a 

substantial number of small entities if 

the rule relieves regulatory burden, or 

otherwise has a positive economic effect 

on all of the small entities subject to the 

rule. 

The proposed changes discussed in 

this document are expected to 

streamline and improve the ECA 

procedures in a way that will benefit all 

participants. EPA has therefore 

concluded that this proposed rule will 

not have any adverse impacts on 

affected small entities. However, EPA 

continues to be interested in the 

potential impacts of the ECA procedures 

on small entities and welcomes 

comments on issues related to such 

impacts. 

D. Unfunded Mandates Reform Act 

This action does not impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA), Public 

Law 104–4. Therefore, this action is not 

subject to the requirements of UMRA. 

E. Federalism 

Pursuant to Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), EPA has determined 

that this proposed rule does not have 

‘‘federalism implications,’’ because it 

will not have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government, as 

specified in Executive Order 13132. 

Thus, Executive Order 13132 does not 

apply to this proposed rule. 

F. Tribal Implications 

Under Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000), EPA has 

determined that this proposed rule does 

not have tribal implications because it 

will not have any effect on tribal 

governments, on the relationship 

between the Federal Government and 

the Indian tribes, or on the distribution 

of power and responsibilities between 

the Federal Government and Indian 

tribes, as specified in the executive 

order. Thus, Executive Order 13175 

does not apply to this proposed rule. 

G. Children’s Health Protection 

Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 1985, April 23, 1997), does 

not apply to this action because this is 

not designated as an ‘‘economically 

significant’’ regulatory action as defined 

by Executive Order 12866 (see Unit 

III.A.), nor does this action establish an 

environmental standard that is intended 

to have a disproportionate effect on 

children. To the contrary, this action 

will revise procedures which will 

facilitate the development of data and 

information that EPA and others can use 

to assess the risks of chemicals, 

including potential risks to children. 

H. Energy Effects 

This action is not subject to Executive 

Order 13211, entitled Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) because this action is not 

expected to affect energy supply, 

distribution, or use. 

I. Technology Standards 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), Public Law No. 

104–113, 12(d) (15 U.S.C. 272 note), 

directs EPA to use voluntary consensus 

standards in its regulatory activities 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, and business 

practices) that are developed or adopted 

by voluntary consensus standards 

bodies. The NTTAA directs EPA to 

provide Congress, through OMB, 

explanations when the Agency decides 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 7433 

not to use available and applicable 

voluntary consensus standards. 

This proposed rulemaking does not 

involve technical standards. Therefore, 

EPA is not considering the use of any 

voluntary consensus standards. 

J. Environmental Justice 

This action does not involve special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994). 

List of Subjects in 40 CFR Part 790 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: February 2, 2010. 

Stephen A. Owens, 

Assistant Administrator, Office of Prevention, 

Pesticides and Toxic Substances. 

Therefore, it is proposed that 40 CFR 

part 790 be amended as follows: 

PART 790—[AMENDED] 

1. The authority citation for part 790 

continues to read as follows: 

Authority: 15 U.S.C. 2603. 

2. Section 790.1 is amended as 

follows: 

a. By revising paragraph (c). 

b. By removing paragraph (d). 

§ 790.1 Scope, purpose, and authority. 

* * * * * 

(c) EPA intends to use enforceable 

consent agreements to accomplish 

testing where a consensus exists among 

EPA, affected manufacturers and/or 

processors, and interested members of 

the public concerning the need for and 

scope of testing. 

3. Section 790.20 is revised to read as 

follows: 

§ 790.20 Recommendation, 

recommendation with an intent to 

designate, and designation of testing 

candidates by the ITC. 

(a) Interagency Testing Committee 

(ITC) recommendations and 

recommendations with intent to 

designate. The ITC has advised EPA that 

it will discharge its responsibilities 

under section 4(e) of the Toxic 

Substances Control Act (TSCA) in the 

following manner: 

(1) When the ITC identifies a 

chemical substance or mixture that it 

believes should receive expedited 

consideration by EPA for testing, the 

ITC may add the substance or mixture 

to its list of chemicals recommended for 

testing and include a statement that the 

ITC intends to designate the substance 

or mixture for action by EPA in 

accordance with section 4(e)(1)(B) of 

TSCA. 

(2) Chemical substances or mixtures 

selected for expedited review under 

paragraph (a)(1) of this section may, at 

a later time, be designated for EPA 

action within 12 months of such 

designation. The ITC’s subsequent 

decision would be based on the ITC’s 

review of TSCA sections 8(a) and 8(d) 

data and other relevant information. 

(3) Where the ITC concludes that a 

substance or mixture warrants testing 

consideration but that expedited EPA 

review of testing needs is not justified, 

the ITC will add the substance or 

mixture to its list of testing 

recommendations without expressing an 

intent to designate the substance or 

mixture for EPA action in accordance 

with section 4(e)(1)(B) of TSCA. 

(4) The ITC reserves its right to 

designate any chemical that it 

determines the Agency should, within 

12 months of the date first designated, 

initiate a proceeding under section 4(a) 

of TSCA. 

(b) Preliminary EPA evaluation of ITC 

recommendations with intent to 

designate. Following receipt of an ITC 

report containing a recommendation 

with an intent to designate, EPA will 

use the following procedure for 

completing a preliminary evaluation of 

testing needs on those chemical 

substances that the ITC has 

recommended with intent to designate. 

(1) EPA will publish the ITC report in 

the Federal Register and announce that 

interested persons have 30 days to 

submit comments on the ITC’s testing 

recommendations. 

(2) EPA will publish a Federal 

Register document adding all ITCrecommended chemicals to the 

automatic reporting provisions of its 

rules under sections 8(a) and 8(d) of 

TSCA (40 CFR parts 712 and 716). 

(3) EPA will hold a public ‘‘focus 

meeting’’ to discuss the ITC’s testing 

recommendations and obtain comments 

and information from interested parties. 

(4) EPA will evaluate submissions 

received under TSCA sections 8(a) and 

8(d) reporting requirements, comments 

filed on the ITC’s recommendations, 

and other information and data 

compiled by the Agency. 

(5) EPA will make a preliminary staff 

determination of the need for testing 

and, where testing appears warranted, 

will tentatively select the studies to be 

performed. 

(6) EPA will hold a public meeting to 

announce its preliminary testing 

determinations. 

(c) EPA response to ITC designations 

and recommendations. (1) Where a 

substance or mixture is designated for 

EPA action under section 4(e)(1)(B) of 

TSCA, the Agency will take either one 

of the following actions within 12 

months after receiving the ITC 

designation: 

(i) Initiate rulemaking proceedings 

under section 4(a) of TSCA. Where the 

testing recommendations of the ITC 

raise unusually complex and novel 

issues that require additional Agency 

review and opportunity for public 

comment, the Agency may initiate 

rulemaking by publishing an Advance 

Notice of Proposed Rulemaking 

(ANPRM). 

(ii) Publish a Federal Register 

document explaining the Agency’s 

reasons for not initiating such 

rulemaking proceedings. EPA may 

conclude that rulemaking proceedings 

under section 4(a) of TSCA are 

unnecessary if it determines that the 

findings specified in section 4(a) of 

TSCA cannot be made or if the Agency 

entered into a consent agreement 

requiring the testing identified by the 

ITC. 

(2) Where a substance or mixture has 

been recommended for testing by the 

ITC, whether with or without an intent 

to designate, EPA will use its best efforts 

to act on the ITC’s recommendations as 

rapidly as possible consistent with its 

other priorities and responsibilities. 

EPA may respond to the ITC’s 

recommendations with action such as: 

(i) Initiating rulemaking proceedings 

under section 4(a) of TSCA, 

(ii) Publishing a Federal Register 

document explaining the Agency’s 

reasons for concluding that testing is 

unnecessary, or 

(iii) Entering into a consent agreement 

in accordance with this subpart. 

4. Section 790.22 is revised to read as 

follows: 

§ 790.22 Procedures for developing 

consent agreements. 

(a) Preliminary EPA evaluation of 

proposed consent agreement. Where 

EPA believes that testing of a chemical 

substance or mixture may be needed, 

and wishes to explore whether a 

consent agreement may satisfy the 

identified testing needs, EPA will invite 

manufacturers and/or processors of the 

affected chemical substance or mixture 

to submit a proposed consent agreement 

to EPA. EPA will evaluate the 

proposal(s) and may request additional 

clarifications of or revisions to the 

proposal(s). 

(b) Negotiation procedures for consent 

agreements. If, after evaluating the 

proposed consent agreement(s), EPA 


srobinson on DSKHWCL6B1PROD with PROPOSALS
7434 Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 

believes it is likely that proceeding with 

negotiation of a consent agreement 

would be an efficient means of 

developing the data, EPA will use the 

following procedures to conduct such 

negotiations: 

(1) In the Federal Register, EPA will 

give notice of the availability of the 

proposal(s) that is the basis for 

negotiation, invite persons interested in 

participating in or monitoring 

negotiations to contact the Agency in 

writing, set a deadline for interested 

parties to contact the Agency in writing, 

and set a date for the negotiation 

meeting(s). 

(2) The Agency will meet with 

interested parties at the negotiation 

meeting(s) for the purpose of attempting 

to negotiate a consent agreement. Only 

the submitter(s) of the proposal(s) that is 

the basis for negotiation and those 

persons who submit written requests to 

participate in or monitor negotiations by 

the deadline established under 

paragraph (b)(1) of this section will be 

deemed ‘‘interested parties’’ for purposes 

of this section. 

(3) All negotiation meetings will be 

open to members of the public, but only 

interested parties will be permitted to 

participate in negotiations. The minutes 

of each meeting will be prepared by 

EPA. Meeting minutes, the proposed 

consent agreement(s), background 

documents and other materials 

distributed at negotiation meetings will 

be placed in an Internet-accessible 

public docket established by EPA. 

(4) If EPA concludes at any time that 

negotiations are unlikely to produce a 

final agreement, EPA will terminate 

negotiations and may proceed with 

rulemaking. If EPA terminates 

negotiations, no further opportunity for 

negotiations will be provided. EPA will 

notify all interested parties of the 

termination. 

(5) The period between the first 

negotiation meeting and final 

agreement, if any (‘‘the negotiation 

period’’), will be no longer than six 

months, unless extended prior to its 

expiration in accordance with paragraph 

(b)(7) of this section. This period will 

include all negotiation meetings, and 

the processes discussed in paragraphs 

(b)(6) and (b)(9) of this section. If the 

negotiation period passes without the 

production of a final agreement, 

negotiations and development of the 

subject ECA will terminate 

automatically. 

(6) EPA will circulate a draft of the 

consent agreement to all interested 

parties if EPA concludes that such draft 

is likely to achieve final agreement. A 

period of 30 days will be provided for 

submitting comments or written 

objections under paragraph (b)(8)(i)(B) 

of this section. 

(7) If, prior to the expiration of the 

negotiation period, final agreement has 

not been reached, EPA may at its 

discretion provide one or more 

extensions, each of which may be up to 

60 days, if it seems likely to EPA that 

a final agreement will be reached during 

that time. EPA will notify all interested 

parties of any extension(s). 

(8)(i) EPA will enter into consent 

agreements only where there is a 

consensus among the Agency, one or 

more manufacturers and/or processors 

who agree to conduct or sponsor the 

testing, and all other interested parties 

who identify themselves in accordance 

with paragraph (b)(2) of this section. 

EPA will not enter into a consent 

agreement in either of the following 

circumstances: 

(A) EPA and affected manufacturers 

and/or processors cannot reach a 

consensus in the timeframe described in 

paragraph (b)(5) of this section. 

(B) A draft consent agreement is 

considered inadequate by other 

interested parties who have submitted 

timely written objections to the draft 

consent agreement, which provide a 

specific explanation of the grounds on 

which the draft agreement is 

objectionable. 

(ii) EPA may reject objections 

described in paragraph (b)(8)(i)(B) of 

this section only where the Agency 

concludes the objections: 

(A) Are not made in good faith; 

(B) Are untimely; 

(C) Do not involve the adequacy of the 

proposed testing program or other 

features of the agreement that may affect 

EPA’s ability to fulfill the goals and 

purposes of the Toxic Substances 

Control Act (TSCA); or 

(D) Are not accompanied by a specific 

explanation of the grounds on which the 

draft agreement is considered 

objectionable. 

(iii) The unwillingness of some 

manufacturers and/or processors to sign 

the draft consent agreement does not, in 

itself, establish a lack of consensus if 

EPA concludes that those manufacturers 

and/or processors who are prepared to 

sign the agreement are capable of 

accomplishing the testing to be required 

and that the draft agreement will 

achieve the purposes of TSCA in all 

other respects. 

(9) Where a consensus exists, as 

described in paragraph (b)(8)(i) of this 

section, concerning the contents of a 

draft consent agreement, the draft 

consent agreement will be circulated to 

EPA management and the parties that 

are to conduct or sponsor testing under 

the agreement, for final approval and 

signature. 

(10) Upon final approval and 

signature of a consent agreement, EPA 

will publish a Federal Register 

document announcing the availability of 

the consent agreement and codifying (in 

subpart C of part 799) the name of the 

substance(s) to be tested and the citation 

to the Federal Register document. 

§§ 790.24, 790.26, and 790.28 [Removed] 

5. Remove §§ 790.24, 790.26, and 

790.28. 

Appendix A to Subpart E of Part 790 

[Removed] 

6. Remove Appendix A to subpart E 

of part 790. 

[FR Doc. 2010–3242 Filed 2–18–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 226 

RIN 0648–AX06 

Endangered and Threatened Species; 

Proposed Rule to Revise the Critical 

Habitat Designation for the 

Endangered Leatherback Sea Turtle; 

Extension of Public Comment Period 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Proposed rule; extension of 

public comment period. 

SUMMARY: On January 5, 2010, NMFS 

proposed regulations to revise the 

critical habitat designation for the 

endangered leatherback sea turtle 

(Dermochelys coriacea) by designating 

additional areas within the Pacific 

Ocean. Specific areas proposed for 

designation include two adjacent 

marine areas totaling approximately 

46,100 square miles (119,400 square km) 

stretching along the California coast 

from Point Arena to Point Vincente; and 

one 24,500 square mile (63,455 square 

km) marine area stretching from Cape 

Flattery, WA, to the Umpqua River 

(Winchester Bay), OR, east of a line 

approximating the 2,000 meter depth 

contour. The areas proposed for 

designation comprise approximately 

70,600 square miles (182,854 square km) 

of marine habitat. NMFS is extending 

the comment period on the proposed 

regulations until April 23, 2010. 


srobinson on DSKHWCL6B1PROD with PROPOSALS