
[Federal Register: February 19, 2010 (Volume 75, Number 33)]
[Proposed Rules]               
[Page 7428-7434]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe10-23]                         

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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.

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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 e-
mail. 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

[[Page 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 risk- or 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

[[Page 7430]]

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 Sec.  790.22 with 
portions of Sec.  790.24, by consolidating Sec.  790.20 with portions 
of Sec.  790.26 and Sec.  790.28, and by consolidating Sec.  790.22 
with Sec.  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 Sec.  790.22 to Sec.  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 Sec.  
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 Sec.  790.22(a) to Sec.  
790.20. The text presently at Sec.  790.22(a) will replace Sec.  
790.20(b), and the current Sec.  790.20(b) will be redesignated Sec.  
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 Sec.  790.24 to Sec.  790.22.
    EPA proposes to remove Sec.  790.26 (initiation and completion of 
rulemaking proceedings on ITC-designated chemicals) and Sec.  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 Sec.  790.20 (procedures that 
follow ITC recommendation and designation) and Sec.  790.22 (ECA 
procedures). First, the proposed amended ECA procedures already 
articulate the principle (in proposed Sec.  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 
Sec.  790.26(b), and the remainder of Sec.  790.26(b) as duplicative of 
EPA's existing rulemaking obligations under the Administrative 
Procedures Act. Third, EPA is proposing to incorporate Sec.  790.26(c) 
into the text of Sec.  790.20(c)(1)(i) (Sec.  790.20(b)(1)(i) in the 
existing rules). Fourth, Sec.  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 Sec.  790.22. The 
procedures that EPA is proposing in Sec.  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 Sec.  790.20 and Sec.  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-to-
designate 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 Sec.  790.20. 
The title of the section will be amended to include ``recommendation 
with intent to designate,'' and the title of Sec.  790.20(c) (currently 
Sec.  790.20(b)) will be amended to include ITC ``designations.'' 
Finally, EPA proposes to make a few conforming changes to Sec.  790.1, 
including removing the reference to the Appendix A schedule table in 
Sec.  790.1(d) and removing the statement in Sec.  790.1(c), regarding 
EPA's intent to proceed with rulemaking if ECA negotiations are 
unsuccessful, because the proposed amended Sec.  790.22(b)(4) includes 
a similar statement of intent.

[[Page 7431]]

    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 Sec.  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 Sec.  
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 Sec.  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-intent-to-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 
Sec.  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-to-designate. Current Sec.  790.28 directs 
that the same schedule is to be followed for chemicals for which there 
has been no ITC designation or recommendation-with-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-to-designate. While such a meeting may be helpful as an initial 
public comment gathering tool when the ITC has made a recommendation-
with-intent-to-designate, it is confusing to include this meeting in 
the procedures for negotiating an ECA because not all chemicals that 
the ITC recommends-with-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-intent-to-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 Sec.  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-to-designate, and to move it from 
the ECA procedures (at Sec.  790.22(a)(6) in the existing rule) to the 
ITC response procedures at Sec.  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 Sec.  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 Sec.  790.22(b)(8), so EPA believes it 
is unnecessary to include regulatory language in proposed Sec.  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

[[Page 7432]]

Federal Register documents will be maintained.
    The proposed amendments to Sec.  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-for-profit 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

[[Page 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).


Sec.  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:


Sec.  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 ITC-
recommended 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:


Sec.  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

[[Page 7434]]

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.


Sec. Sec.  790.24, 790.26, and 790.28  [Removed]

    5. Remove Sec. Sec.  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

