[Federal Register Volume 75, Number 33 (Friday, February 19, 2010)]
[Proposed Rules]
[Pages 7428-7434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3242]
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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: [email protected].
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: [email protected].
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