E7-10699. Review of Draft Risk Management Evaluations and Risk Profiles for Chemicals Proposed for Addition under the Stockholm Convention on Persistent Organic Pollutants

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice requests comment on draft risk management evaluations being developed pursuant to the Stockholm Convention on Persistent Organic Pollutants (POPs) for the following chemicals which are being reviewed for possible addition to the Stockholm Convention’s Annexes A, B, and/or C: Chlordecone (CAS No. 143-50-0), hexabromobiphenyl (HBB) (CAS No. 36355-01-8), lindane (CAS No. 58-89-9), pentabromodiphenyl ether (PeBDE) (CAS No. 32534-81-9), and perfluorooctane sulfonate (PFOS). Additionally, this notice requests comment on draft risk profiles being developed pursuant to the Stockholm Convention for the following chemicals which are also being reviewed for possible addition to the Stockholm Convention’s Annexes A, B, and/or C: Alpha-hexachlorocyclohexane (alpha-HCH) (CAS No. 319-84-6), beta-hexachlorocyclohexane (beta-HCH) (CAS No. 319-85-7), commercial octabromodiphenyl ether (octaBDE) (CAS No. 32536-52-0 ), pentachlorobenzene (PeCB) (CAS No. 608-93-5), and short-chained chlorinated paraffins (SCCP) (CAS No. 85535-84-8). EPA is issuing this notice in advance of the aforementioned documents’ release to increase awareness of the status of the reviews of certain proposals under the Stockholm Convention, to alert interested and potentially affected persons of the documents’ pending release, and to request comments on them when they are available for EPA’s consideration in its development of comments of the documents and its submission to the Stockholm Convention Secretariat (hereafter Secretariat).

DATES:

The Secretariat is expected to post these draft risk management evaluations and draft risk profiles on or about May 29, 2007, on its website http://www.pops.int. Comments on these draft documents must be received by EPA no later than 15 days after the Secretariat makes the draft documents available.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2006-0794, 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-2006-0794. 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 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-2006-0794. 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. For additional information about EPA’s public docket, visit the EPA Docket Center homepage at http://www.epa.gov/​epahome/​dockets.htm.

Docket: All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. 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 [phone], and the telephone number for the OPPT Docket is [phone]. 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: [phone]; e-mail address: [e-mail].

For technical information contact: Ellie Clark, Chemical Control Division (7405M), 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].

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—i. 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.

ii. 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: Janice K. Jensen, Office of Pesticide Programs (7506P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or hand delivered to: Janice K. Jensen, Government and International Services Branch, Office of Pesticide Programs, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Rm. S-11315, Arlington, VA 22202.

iii. Commenters should note that none of the CBI information received by EPA will be forwarded to the Secretariat. Information from submissions containing CBI may be considered by EPA in the development of the U.S. response. If commenters wish EPA to consider incorporating information in documents with CBI as part of the U.S. response, commenters should provide a sanitized copy of the documents. Sanitized copies must be complete, except that all information claimed as CBI must be deleted. EPA will place sanitized copies in the public docket.

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?

The Agency is issuing this notice to increase awareness of the proposals to list certain chemicals under Annexes A, B, or C of the Stockholm Convention, and to provide interested persons with an opportunity to provide comments to EPA for its consideration in the development of the U. S.’ comments on the draft risk profiles and risk management evaluations. By May 29, 2007, the Secretariat is expected to have invited Parties and observers to submit to the POPs Review Committee (POPRC) (via the Secretariat) comments on the draft risk profiles and draft risk management evaluations (http://www.pops.int) and requested that comments be submitted by July 1, 2007. The United States is an observer. The United States intends to submit its comments on the drafts by July 1, 2007, to meet the Secretariat’s deadline. Because of the short-time period for review, EPA is issuing this notice in advance of the documents being posted by the Secretariat to alert interested parties to the upcoming opportunity to participate in the review and comment process. In light of the POPRC deadlines for the receipt of comments, the Agency’s public comment period for this action will close 15 days after the Secretariat posts the draft risk profiles and risk management evaluations on its website. The chemical listing process is discussed in more detail in Unit II.B. Individuals or organizations that wish to submit information directly to POPRC via the Secretariat should work through their respective observer organizations, if any.

B. What is the Stockholm Convention Chemical Listing Process?

The Stockholm Convention is a multilateral environmental agreement designed to protect human health and the environment from persistent organic pollutants. The United States signed the Stockholm Convention in May of 2001 but has not yet ratified it (and thus is not a Party to the Stockholm Convention). The United States currently participates as an observer in Stockholm Convention activities. The Stockholm 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 Stockholm 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. The Stockholm Convention 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 Stockholm Convention must use when considering the addition of new chemicals to the Stockholm Convention’s Annexes. Article 8 of the Stockholm Convention provides the process that must be followed for listing new chemicals in Annexes A, B, and/or C, and is described in summary in this unit.

1. A Party to the Stockholm Convention may submit a proposal to the Secretariat for listing a chemical in Annexes A, B, and/or C. The proposal shall contain the information specified in Annex D of the Stockholm Convention (“Information Requirements and Screening Criteria”).

2. The Secretariat verifies that the proposal contains the information specified in Annex D, and if the Secretariat is satisfied, the proposal is forwarded to POPRC.

3. POPRC examines the proposal, applies the Annex D screening criteria, and determines whether the screening criteria have been fulfilled.

4. If POPRC is satisfied that the criteria have been fulfilled, POPRC, through the Secretariat, will make the proposal and POPRC’s evaluation available to all Parties and observers and invite them to submit the information specified in Annex E (“Information Requirements for the Risk Profiles”).

5. Draft risk profiles are prepared by ad hoc working groups under POPRC in accordance with Annex E for consideration by POPRC and made available to all Parties and observers to collect technical comments.

6. POPRC reviews the draft risk profile and technical comments, completes the risk profile, and determines 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.

7. If POPRC determines that action is warranted, then POPRC, through the Secretariat, will ask Parties and observers to provide information specified in Annex F (“Information on Socio-Economic Considerations”) to aid in the development of risk management evaluations (that include an analysis of possible control measures).

8. Draft risk management evaluations are prepared by ad hoc working groups under POPRC in accordance with Annex F for consideration by POPRC and made available to Parties and observers to collect technical comments.

9. POPRC reviews the draft risk management evaluation prepared by the ad hoc working group and completes it.

10. On the basis of the risk profile and the risk management evaluation for each chemical, POPRC recommends whether the chemical should be considered by the Conference of the Parties (COP) for listing in Annexes A, B, and/or C. (The type(s) of control measure(s) that might be introduced for a specific chemical would dictate whether the chemical would be listed in Annex A (elimination), Annex B (restriction), and/or Annex C (unintentional production) of the Stockholm Convention.).

11. COP makes the final decision on listing the chemical in Annexes A, B, and/or C.

EPA anticipates issuing Federal Register notices soliciting information, when appropriate.

C. What Comments Are Being Requested for the Draft Risk Management Evaluations?

For the chemicals currently at the risk management stage (see Unit II.G.), EPA is seeking comments on whether the draft risk management evaluations adequately reflect the socio-economic considerations specified in Annex F to the Stockholm Convention, and on whether the risk management measures recommended in the documents are reasonably supported in the draft documents. The types of information that the Stockholm Convention directs should be considered at this stage is discussed in Unit II.G.

In particular, because the possible control measures under the Stockholm Convention include, among others, the prohibition or restriction of production and use, commenters should consider whether accurate, high-quality information is available to support the draft recommendations.

D. What Information is Being Requested for the Draft Risk Profiles?

For chemicals at the risk profile stage (see Unit II.H.), EPA is seeking comments on whether the draft risk profiles adequately cover the information types specified in Annex E to the Stockholm Convention, and whether the information in the document adequately supports the determination of whether or not 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, as required under Article 8, paragraph 7(a) of the Stockholm Convention.

E. How Should the Information be Provided?

1. EPA requests that commenters include clear and precise references for any sources that they might refer to. 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 their comments which chemical the information concerns.

2. Although POPRC has developed provisional arrangements for the treatment of CBI, as mentioned in Unit I.B.1.iii., no CBI will be forwarded to the Secretariat. EPA will, however, consider such information in development of the U.S. response to the Secretariat. Instructions on where and how to submit comments and confidential information can be found in Unit I.B.1. 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.

F. 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. 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 the 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.”

G. What is the Status of Chemicals at the Risk Management Stage?

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

• Pentabromodiphenyl ether.
• Hexabromobiphenyl.
• Perfluorooctane sulfonate.

Two of the five proposals were for pesticides:

• Lindane.
• Chlordecone.

In accordance with the procedure laid down in Article 8 of the Stockholm Convention and discussed in Unit II.B., during the November meeting POPRC examined the proposals and applied the screening criteria in Annex D of the Stockholm Convention. 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 to develop risk profiles. Therefore, POPRC, through the Secretariat, requested that Parties and observers provide information relevant to POPRC’s development of risk profiles for the five chemicals listed in this unit. In the Federal Register of January 30, 2006 (71 FR 4913) (FRL-7758-9), EPA invited commenters to provide EPA with information for the risk profiles.

The second meeting of POPRC took place November 6-10, 2006, in Geneva, Switzerland. EPA provided notice of this meeting and POPRC’s intention to consider risk profiles for the five chemicals in the Federal Register of October 6, 2006 (71 FR 59108) (FRL-8099-2). Information about the November POPRC meeting is available at the Stockholm Convention website http://www.pops.int.documents/​meetings/​poprc_​2/​meeting_​docs.htm.

In accordance with the procedure laid down in Article 8 of the Stockholm Convention and discussed in Unit II.B., during the November 2006 meeting POPRC examined the draft risk profiles with respect to the requirements in Annex E of the Stockholm Convention. With regard to all five chemicals, POPRC decided that, based on finalized risk profiles, these chemicals were likely, as a result of their long-range environmental transport, to lead to significant adverse-human health and environmental effects such that global action is warranted. Additionally, in accordance with paragraph 7(a) of Article 8 of the Stockholm Convention, POPRC invited Parties and observers to submit to the Secretariat the information specified in Annex F to the Stockholm Convention by February 9, 2007. In the Federal Register of December 20, 2006 (71 FR 76325) (FRL-8109-1), EPA invited commenters to provide EPA with risk management information to support the development of its submission to the Secretariat. On February 9, 2007, EPA provided comments to the Secretariat.

POPRC, through ad hoc working groups, is preparing draft risk management evaluations that are to include an analysis of possible control measures, which in accordance with Annex F of the Stockholm Convention (“Information on Socio-Economic Considerations”) should encompass “the full range of options, including management and elimination.” The risk management evaluations include socio-economic considerations associated with possible control measures (see Unit II.C.) and reflect due regard for the differing capabilities and conditions among the Parties. Additionally, these documents should discuss any specific exemptions or acceptable purposes being considered. Following the receipt of comments, the ad hoc working groups will further refine the draft risk management evaluations, which will then be considered by the full POPRC in November 2007 and proceed as discussed in Unit II.B.

H. What is the Status of Chemicals at the Risk Profile Stage?

As stated in Unit II.G., the second meeting of POPRC took place on November 6-10, 2006, in Geneva, Switzerland. EPA provided notice of this meeting and POPRC’s intention to consider proposals for the five chemicals listed in this unit in the Federal Register of October 6, 2006. Information about the November POPRC meeting is available at the Stockholm Convention website (http://www.pops.int and http://www.pops.int/​documents/​meeting/​poprc_​2/​meeting_​docs.htm), respectively. POPRC had before it five proposals which were submitted for its consideration by Parties to the Stockholm Convention, for addition to Annexes A, B, and/or C of the Stockholm Convention.

Two of the five proposals were for industrial chemicals:

• Octabromodiphenyl ether.
• Short-chained chlorinated paraffins.

One of the five proposals was for a chemical with both industrial and pesticidal uses:

• Pentachlorobenzene.

Two of the five proposals were for pesticides:

• Alpha-hexachlorocyclohexane.
• Beta-hexachlorocyclohexane.

In accordance with the procedure laid down in Article 8 of the Stockholm Convention and discussed in Unit II.B., during the November meeting POPRC examined the proposals and applied the screening criteria in Annex D of the Stockholm Convention. With regard to all five chemicals, POPRC decided that it was satisfied that the screening criteria had been fulfilled and, in accordance with paragraph 4(a) of Article 8 of the Stockholm Convention, POPRC invited Parties and observers to submit to the Secretariat the information specified in Annex E to the Stockholm Convention by February 9, 2007. In the Federal Register of December 20, 2006, EPA invited commenters to provide EPA with risk profile information to support the development of its submission to the Secretariat. EPA provided comments to the Secretariat on February 9, 2007.

POPRC, through ad hoc working groups, has prepared draft risk profiles for each of the chemicals to, as noted in Annex E of the Stockholm 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 draft risk profiles also further evaluate and elaborate on the information referred to in Annex D of the Stockholm Convention and include, as far as possible, the information listed in Annex E of the Stockholm Convention. Following the receipt of comments, the ad hoc working groups will further refine the draft risk profiles, which will then be considered by the full POPRC in November 2007, and proceed as discussed in Unit II.B.

List of Subjects

• Environmental protection
• Chemicals
• Hazardous substances

Dated: May 23, 2007.

Charles M. Auer,

Director, Office of Pollution Prevention and Toxics.