[Federal Register Volume 73, Number 226 (Friday, November 21, 2008)]
[Notices]
[Pages 70640-70643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27765]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-8392-2]
TSCA Inventory Reset and Inorganic High Production Volume
Challenge Programs; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is convening a public meeting to engage interested
stakeholders in a public dialogue about the development of two
enhancements to the Agency's Chemical Assessment and Management Program
(ChAMP): The Toxic Substances Control Act (TSCA) Chemical Substance
Inventory Reset (Inventory Reset) and the Inorganic High Production
Volume (IHPV) Challenge programs.
DATES: The meeting will be held on December 8, 2008, from 1 p.m. to 4
p.m.
You may register for the meeting on or before December 3, 2008. See
Unit III. for additional registration information.
To request accommodation of a disability, please contact any of the
persons listed under FOR FURTHER INFORMATON CONTACT, preferably at
least 10 days prior to the meeting, to give EPA as much time as
possible to process your request.
Comments may be submitted at the public meeting or directly to
regulations.gov identified by docket ID number EPA-HQ-OPPT-2008-0785
for the Inventory Reset Program and EPA-HQ-OPPT-2008-0807 for the IHPV
Challenge Program until January 23, 2008.
ADDRESSES: The meeting will be held at the Environmental Protection
Agency, 2777 Crystal Dr. (One Potomac Yard), Rm. S1204, Arlington, VA
22202.
Requests to make oral comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2008-0785 for the Inventory Reset Program and
EPA-HQ-OPPT-2008-0807 for the IHPV Challenge Program, may be submitted
to the technical person listed under FOR FURTHER INFORMATION CONTACT.
Submit your written comments, identified by docket ID number EPA-
HQ-OPPT-2008-0785 for the Inventory Reset Program and EPA-HQ-OPPT-2008-
0807 for the IHPV Challenge Program, 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-2008-0785 for the Inventory
Reset Program and EPA-HQ-OPPT-2008-0807 for the IHPV Challenge Program.
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-
2008-0785 for the Inventory Reset Program and EPA-HQ-OPPT-2008-0807 for
the IHPV Challenge Program. 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
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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. For
additional information about EPA's public docket, visit the EPA Docket
Center homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: EPA has established two dockets for this action under
docket ID numbers EPA-HQ-OPPT-2008-0785 for the Inventory Reset Program
and EPA-HQ-OPPT-2008-0807 for the IHPV Challenge Program. All documents
in these two dockets 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 Federal holidays. The telephone
number of the EPA/DC Public Reading Room is (202) 566-1744, and the
telephone number for the OPPT Docket is (202) 566-0280. Docket visitors
are required to show photographic identification, pass through a metal
detector, and sign the EPA visitor log. All visitor bags are processed
through an X-ray machine and subject to search. Visitors will be
provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, 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 on the Inventory Reset Program contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; e-mail address: [email protected].
For technical information on the IHPV Challenge Program contact:
Louis Scarano, Risk Assessment Division (7403M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(617) 918-8318; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. This action may,
however, be of particular interest to those persons who manufacture
(including import) or process chemical substances that are subject to
TSCA. Potentially affected entities may include, but are not limited
to:
Manufacturers, importers, and processors of chemical substances or
mixtures (NAICS codes 325 and 324110; e.g., chemical manufacturing and
processing 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 you mail to EPA, mark the outside of the disk or CD-ROM
that 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 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 is ChAMP?
ChAMP (see http://www.epa.gov/champ) is EPA's new Chemical
Assessment and Management Program. Under ChAMP, EPA is fulfilling U.S.
commitments made under the Security and Prosperity Partnership of North
America (SPP; see http://www.spp.gov). The August 2007 SPP Leaders'
Summit, held in Montebello, Canada, called for cooperation in the areas
of chemicals regulation and information, and outlined commitments made
on behalf of the United States, Canada, and Mexico to work together to
ensure the safe manufacture and use of industrial chemicals. Among
other things, each country is sharing scientific information and
approaches to chemical testing and risk management.
Under the SPP commitment relating to chemicals, the United States
committed to complete screening-level hazard and risk characterizations
and initiate action, as appropriate, on more than 6,750 chemicals
produced above 25,000 pounds per year by 2012. The U.S. commitment to
complete assessments and initiate needed action
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on these chemicals will apply the results of EPA's work on high
production volume (HPV) chemicals (see http://www.epa.gov/chemrtk/index.htm) and extend similar efforts to moderate production volume
(MPV) chemicals. HPV chemicals are produced in or imported into the
United States in quantities of 1 million pounds or more per year and
MPV chemicals are those produced in or imported into the United States
in quantities between 25,000 and 1 million pounds per year.
B. ChAMP Enhancements Planned by EPA
On September 24, 2008, EPA outlined progress to date on ChAMP
commitments, as well as the Administrator's decisions on proposed
program enhancements to reset the TSCA Inventory to better reflect the
chemical substances currently being manufactured or processed in the
United States, and to collect health and safety information on IHPV
chemicals (see http://www.epa.gov/champ/pubs/JG.SDA.Speech.pdf). These
decisions were made following stakeholder discussions on these
proposals that were held earlier in 2008 and reflect the comments and
input received from a wide range of stakeholders during those
discussions. See http://www.epa.gov/champ/pubs/programs.htm#enhancements for more information on these discussions and
the related presentations given by EPA on these topics.
1. Inventory Reset Program. TSCA section 8(b) requires EPA to
``compile, keep current, and publish a list of each chemical substance
which is manufactured or processed in the United States.'' The basic
purpose of this list, called the TSCA Chemical Substance Inventory (or
TSCA Inventory) is to define, for the purpose of TSCA, what chemical
substances presently exist in U.S. commerce. Substances on the TSCA
Inventory are considered to be existing chemical substances. Substances
not included on the TSCA Inventory are considered to be new chemical
substances and are subject to the Premanufacture Notification (PMN)
requirements set forth in TSCA section 5(a)(1).
The TSCA Inventory supports EPA's TSCA regulatory functions, and as
such, it must accurately identify those chemical substances that exist
in commerce in the United States. Companies also must be certain that
the chemical substances they manufacture or import are on the TSCA
Inventory so that they are in full compliance with TSCA reporting and
inventory listing requirements. There are currently more than 83,000
chemical substances on the TSCA Inventory. EPA is developing an
Inventory Reset Program as a vehicle to keep the TSCA Inventory current
as instructed under TSCA section 8(b) by removing chemical substances
no longer being manufactured or imported. EPA anticipates a program
that would invite companies to certify that they have manufactured or
imported specific chemical substances within an appropriate timeframe
followed by an opportunity for public comment on an updated TSCA
Inventory before completing the reset.
2. IHPV Challenge Program. EPA is committed to developing a program
to characterize the toxicity, environmental fate, and physicochemical
properties of IHPV chemicals. Inorganic chemical substances are defined
according to the TSCA Inventory Update Rule (IUR) as chemical
substances that do not contain carbon or contain carbon only in the
form of carbonato [=CO3], cyano [-CN], cyanato [-OCN], isocyano [-NC],
or isocyanato [-NCO] groups, or the chalcogen analogues of such groups.
See 40 CFR 710.46(b)(3). Such chemicals substances include metals,
ammonia, minerals, and inorganic acids.
The Agency intends to begin a phased, multi-year approach to
develop and implement a program for IHPV chemicals similar to that of
the Agency's HPV Challenge Program (see http://www.epa.gov/chemrtk/index.htm). This would allow for additional stakeholder engagement on
approaches, as well as an opportunity to fully utilize the work
currently underway in the European Union and Canada. The IHPV Challenge
Program would entail industry ``sponsorship'' and commitment to gather
and evaluate available data and to develop an HPV dossier that
describes data gaps and proposes a test plan to fill those gaps.
Currently, EPA anticipates combining the sponsorship approach with a
vigorous use, as needed, of test rules under TSCA section 4 for
unsponsored chemicals or where timely and complete action by the
sponsors does not occur. After collection of the information, EPA would
apply a ChAMP assessment approach (i.e., screening-level hazard and
risk characterizations) to these chemicals which would be followed by
an assessment process for MPV inorganic chemicals.
C. Why is EPA Convening a Public Meeting?
The Agency will describe its proposed approach to both the
Inventory Reset Program and the IHPV Challenge Program at the December
8, 2008, public meeting and encourages constructive feedback during
that meeting to ensure the program's success. The December 8, 2008,
public meeting is an important part of what is envisioned as a
collaborative development process for the IHPV Challenge and Inventory
Reset programs. As such, the public meeting is intended to further
discussion on these programs and identify additional details and/or
issues for further consideration. At the public meeting, the Agency
will describe its proposed approach to the IHPV Challenge Program and
the options and alternatives EPA is considering for ``resetting'' the
TSCA Inventory. To inform the discussions at the meeting, EPA is
developing a background document on the IHPV Challenge Program,
including websites and descriptions of related international efforts,
and a background document on the Inventory Reset Program. The Agency
intends to post these documents on the ChAMP website (http://www.epa.gov/champ) the week of November 24, 2008. In addition, the IHPV
document will be available in the Docket at EPA-HQ-OPPT-2008-0807 and
the Inventory Reset Document at EPA-HQ-OPPT-2008-0785. EPA encourages
the public to review these background documents before the meeting and
to participate in the discussion and provide feedback at the meeting.
EPA is soliciting public comment on all aspects of both programs.
In addition to participating in the discussion at the public
meeting, you may submit additional comments at the public meeting or
directly to the docket until January 23, 2008. EPA will consider the
discussion at the public meeting and all comments received, along with
other relevant information, to further inform the Agency's development
and implementation of these programs.
III. How Can I Request to Participate in this Meeting?
You may submit a request to participate in this meeting, for both
or one of the two programs described in this notice, to the respective
technical persons listed under FOR FURTHER INFORMATION CONTACT. Do not
submit any information in your request that is considered CBI. Requests
to participate in the meeting, should be identified by docket ID
numbers EPA-HQ-OPPT-2008-0785 for the Inventory Reset Program and EPA-
HQ-OPPT-2008-0807 for the IHPV Challenge Program, must be received on
or before December 3, 2008. Such requests will assist in planning the
agenda for the meeting to ensure that there is adequate time on the
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agenda for those wishing to speak at the meeting, as well as to ensure
that there is adequate seating for everyone. Please note, however, that
members of the public may attend without prior registration.
List of Subjects
Environmental protection, Chemicals, High production volume
chemicals, Inorganic chemicals, Reporting and recordkeeping
requirements, TSCA Inventory, TSCA Inventory Reset.
Dated: November 17, 2008.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. E8-27765 Filed 11-20-08; 8:45 am]
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