Environmental Protection Agency (EPA).
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.
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.
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 Start Printed Page 70641regulations.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.Start Further Info
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: TSCA-Hotline@epa.gov.
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: firstname.lastname@example.org.
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@example.com.End Further Info End Preamble Start Supplemental 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.
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 Start Printed Page 70642on 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 Start Printed Page 70643agenda 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.Start List of Subjects
List of Subjects
- Environmental protection
- 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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