E6-1107. Review of Chemical Proposals for Addition under the Stockholm Convention on Persistent Organic Pollutants; Solicitation of Information for the Development of Risk Profiles

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice solicits information relevant to the development of risk profiles pursuant to the Stockholm Convention on Persistent Organic Pollutants (POPs Convention) for the following chemicals which are being reviewed for possible addition to the POPs Convention's Annexes A, B, and/or C as POPs: Hexabromobiphenyl (HBB) (CAS No. 36355-01-8); pentabromodiphenyl ether (PBDE) (CAS No. 32534-81-9); chlordecone (CAS No. 143-50-0); lindane (CAS No. 58-89-9); and perfluorooctane sulfonate (PFOS). EPA is issuing this notice to alert interested and potentially affected persons of these proposals and the status of their review under the POPs Convention, and to encourage such persons to provide information relevant to the development of risk profiles under Article 8 and Annex E of the POPs Convention.

DATES:

Comments must be received on or before February 14, 2006.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2005-0555, by one of the following methods.

• http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• E-mail: [e-mail].
• 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-2005-0555. 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 [phone]. Such deliveries are only accepted during the Docket'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-2005-0555. EPA's policy is that all comments received will be included in the public docket without change and may be made available online 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” systems, 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 public 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 regulations.gov index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through regulations.gov or in hard copy at the OPPT Docket, EPA Docket Center (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone].

FOR FURTHER INFORMATION CONTACT:

For general information contact: Colby Linter, 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: [phone]; e-mail address: [e-mail].

For technical information contact: Amy Breedlove, Chemical Control Division, (7405M), Office Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

-This action is directed to the public in general, and may be of particular interest to chemical substance and pesticide manufacturers, importers, and processors. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. 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 as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed 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. Procedures for preparing confidential information related to pesticides and industrial chemicals are in Unit I.B.1. Send confidential information about industrial chemicals using the submission procedures under ADDRESSES. Send confidential information about pesticides to: Cathleen McInerney Barnes, International Programs Manager, Office of Pesticide Programs (7506C), Environmental Protection Agency, Washington, DC 20460-0001 or hand delivered to: Cathleen Barnes, Government and International Services Branch, Office of Pesticide Programs, Rm. 1104G, Crystal Mall #2, 1801 Bell St., Arlington, VA.

3. Commenters should note that none of the CBI information received by EPA will be forwarded to the POPs Secretariat. Information from submissions containing CBI may be incorporated into larger products by EPA but CBI will be masked in any such products.

4. 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.

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v. If you estimate potential costs or burdens, explain how you arrived at the estimate.

vi. Provide specific examples to illustrate your concerns, and suggested alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

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viii. Make sure to submit your comments by the comment period deadline identified.

II. Background

The POPs Convention is a multilateral environmental agreement designed to protect human health and the environment from POPs. The United States signed the POPs Convention in May of 2001 but has not yet ratified it (and thus is not a Party to the POPs Convention). The POPs Convention, which went into force in May of 2004, requires the Parties to reduce or eliminate the production and use of a number of intentionally produced POPs used as pesticides or industrial chemicals. The POPs Convention also calls upon Parties to take certain specified measures to reduce releases of certain unintentionally produced POPs with the goal of their continuing minimization and, where feasible, ultimate elimination. It also imposes controls on the handling of POPs wastes and on trade in POPs chemicals. In addition, there are specific science-based procedures that Parties to the POPs Convention must use when adding new chemicals to the POPs Convention's Annexes.

-The first meeting of the committee that reviews proposals for listing of new chemicals, called the POPs Review Committee (POPRC), took place November 7-11, 2005, in Geneva, Switzerland. Information about the POPs Convention and the November POPRC meeting is available at the POPs Convention website at http://www.pops.int and http://www.pops.int/​documents/​meetings/​poprc, respectively. The POPRC had before it five proposals which were submitted for its consideration by Parties to the POPs Convention, for addition to Annexes A, B, and/or C of the POPs Convention. Three of the five proposals were for industrial chemicals:

• PBDE.
• HBB.
• PFOS.

Two of the five proposals were for pesticides:

• Lindane.
• Chlordecone.

-In accordance with the procedure laid down in Article 8 of the POPs Convention, during the November meeting POPRC examined the proposals and applied the screening criteria in Annex D of the POPs Convention (“Information Requirements and Screening Criteria”). With regard to all five chemicals, POPRC decided that it was satisfied that the screening criteria had been fulfilled and that further work should therefore be undertaken in accordance with the provisions of the POPs Convention.

-The next step in the process is for POPRC to prepare a risk profile for each of the chemicals to, as noted in Annex E of the POPs Convention, “evaluate whether the chemical is likely, as a result of its long-range environmental transport, to lead to significant adverse human health and/or environmental effects, such that global action is warranted.” The risk profile must further evaluate and elaborate on the information referred to in Annex D of the POPs Convention and include, as far as possible, the information listed in Annex E of the POPs Convention (“Information Requirements for the Risk Profile”). A draft outline of the risk profile has been developed by POPRC, available at http://www.pops.int/​documents/​meetings/​poprc. As requested by POPRC through the POPs Convention Secretariat, the risk profile will take into account information to be submitted by Parties and Observers (the current step). If, on the basis of the risk profile, POPRC decides that the chemical is likely, as a result of its long-range environmental transport, to lead to significant adverse human health and/or environmental effects, such that global action is warranted, it will proceed to develop a risk management evaluation. This will include an analysis of the possible control measures as well as the socio-economic considerations, and at that stage information relating to socio-economic considerations will be requested from Parties and Observers. See Annex F of the POPs Convention (“Information on Socio-economic Considerations”).

A. What Action is the Agency Taking?

-The Agency is issuing this notice to increase awareness of the proposals concerning the chemicals, and to provide interested persons with an opportunity to provide relevant information. The POPs Convention Secretariat's invitation to submit information states that the POPs Convention Secretariat is only accepting responses from Parties and Observers. The United States is an Observer. EPA is requesting that any information be submitted to EPA no later than February 14, 2006. The United States intends to make an initial submission by January 27, 2006, to meet the POPs Secretariat's deadline. However, EPA also plans to make a second submission, as appropriate, based on information resulting from this notice on or about mid-to-late February 2006. In addition, EPA will consider the information during its review of the risk profiles developed by the POPRC in the coming months. Individuals or organizations that wish to submit information directly to the POPs Convention Secretariat should work through their respective observer organizations, if any.

B. What Information is Being Requested?

-The EPA is seeking information that is supplementary to the information in the proposals on the chemicals and POPRC's evaluation of the proposals against Annex D of the POPs Convention's screening criteria. The proposals and the evaluations are available at the POPs Convention website at http://www.pops.int/​documents/​meetings/​poprc/​default.htm.

EPA has previously solicited information through the Lindane Reregistration Eligibility Document (RED) and through its participation in the draft North American Regional Action Plan (NARAP) on Lindane and other Hexachlorocyclohexane Isomers. Consequently, EPA is only interested in any new information on lindane that may have been developed since those activities.

Commenters are invited to provide information they deem relevant to POPRC's development of risk profiles, such as that specified in Annex E of the POPs Convention and other related information, as described below:

1. Sources, including as appropriate:

i. Production data, including quantity and location.

ii. Uses.

iii. Releases, such as discharges, losses, and emissions.

2. Hazard assessment for the endpoint or endpoints of concern (as identified in the proposals and/or POPRC's evaluation of the proposals against the screening criteria of Annex D of the POPs Convention), including a consideration of toxicological interactions involving multiple chemicals.

3. Environmental fate, including data and information on the chemical and physical properties of a chemical as well as its persistence and how they are linked to its environmental transport, transfer within and between environmental compartments, degradation, and transformation to other chemicals. (POPRC is to make a determination of the bioconcentration factor or bio-accumulation factor, based on measured values, available, except when monitoring data are judged to meet this need.)

4. Monitoring data.

5. Exposure in local areas and, in particular, as a result of long-range environmental transport, and including information regarding bio-availability.

In addition, POPRC has identified some additional types of information on several of the chemicals that would be useful in the development of the risk profiles. That information can be found in the Letter of Invitation on the POPs Convention website at http://www.pops.int/​documents/​meetings/​poprc/​default.htm.

C. How Should the Information be Provided?

-1. EPA requests that commenters, where possible, use the form developed by POPRC to provide their information. The form can be found on the POPs Convention website at http://www.pops.int/​documents/​meetings/​poprc. Commenters are requested to include clear and precise references for all sources. Without the exact source of the information, POPRC will not be able to use the information. If the information is not readily available in the public literature, commenters may consider attaching the original source of the information to their submission. Commenters should indicate clearly on the form which chemical the information concerns and use one form per chemical. If for some reason the form does not provide an adequate mechanism for a type of comment or information, EPA requests that such comment or information be submitted using a similar format; this will increase the likelihood of the relevant information being considered.

-2. Although POPRC has developed provisional arrangements for the treatment of confidential information, as mentioned in Unit I.B.3. no CBI will be forwarded to the POPs Convention Secretariat. EPA will, however, consider such information in development of the U.S. response to the POPs Convention Secretariat. Instructions on where and how to submit comments and confidential information can be found in Unit I.B.2. and ADDRESSES.

-3. Anyone wishing to have an opportunity to communicate with EPA orally on this issue should consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

D. What is the Agency's Authority for Taking this Action?

-EPA is requesting comment and information under the authority of section 102(2)(F) of the National Environmental Policy Act, 42 U.S.C. section 4321 et seq., which directs all agencies of the Federal Government to “[r]ecognize the worldwide and long-range character of environmental problems and, where consistent with the foreign policy of the United States, lend appropriate support to initiatives, resolutions and programs designed to maximize cooperation in anticipating and preventing a decline in the quality of mankind's world environment.” Section 17(d) of Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) also provides additional support in that it directs the Administrator of EPA “in cooperation with the Department of State and any other appropriate Federal agency, [to] participate and cooperate in any international efforts to develop improved pesticide research and regulations.”

List of Subjects

• Environmental protection
• Chemicals
• Hazardous substances

Dated: January 23, 2006.

Charles M. Auer,

Director, Office of Pollution Prevention and Toxics.