2013-26848. HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta[γ]-2-benzopyran) TSCA Risk Assessment; Notice of Public Meetings and Opportunity To Comment

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA's contractor, The Scientific Consulting Group (SCG), Inc., has identified a panel of scientific experts to conduct a peer review of EPA's draft Toxic Substances Control Act (TSCA) chemical risk assessment, “TSCA Workplan Chemical Risk Assessment for HHCB.” EPA will hold three peer review meetings by web connect and teleconference. EPA invites the public to register to attend the meetings as observers and/or speakers providing oral comments during any or all of the peer review meetings as discussed in this document. The public may also provide comment on whether they believe the appearance of conflict of interest exists for any proposed peer review panel expert.

DATES:

Meetings. The peer review meetings will be held on Wednesday, December 4, 2013, from 12:00-2:00 p.m. EST; Thursday, January 9, 2014, from 10:30 a.m.-3:30 p.m. EST; and Thursday, February 6, 2014, from 10:30 a.m.-12:30 p.m. EST.

Conflict of interest comments. Comments on the appearance of a conflict of interest for any proposed peer review panel expert must be submitted on or before November 29, 2013.

Comments. Written comments by the public must be submitted on or before January 16, 2014, to be sure they are contained in the peer review record and are available to the peer reviewers.

Registration for meetings. To participate in any of the public peer review meetings, you must register no later than 11:59 p.m., EST, on November 29, 2013.

ADDRESSES:

Meetings. Meetings will be held via web connect and teleconferencing. See Unit III.C. in SUPPLEMENTARY INFORMATION. Registration. See Unit III. in SUPPLEMENTARY INFORMATION.

Comments. Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2012-0722, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online 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 William Jefferson Clinton Complex East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attn: Docket ID Number EPA-HQ-OPPT-2012-0722. 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-2012-0722. EPA's policy is that all comments received will be included in the 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 email. The regulations.gov Web site 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 email comment directly to EPA without going through regulations.gov, your email 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, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket 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 William Jefferson Clinton Complex West, 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 [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 technical information contact: Stan Barone, Jr., Risk Assessment Division (7403M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number [phone]; email address: [e-mail].

For peer review meeting logistics or registration contact: Susie Warner, The Scientific Consulting Group (SCG), Inc., 656 Quince Orchard Rd., Suite 210, Gaithersburg, MD 20878-1409; telephone number: [phone], ext. 227; fax number: [phone]; email 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 interest to a wide range of stakeholders including those interested in environmental and human health assessment, the chemical industry, chemical users, consumer product companies, and members of the public interested in the assessment of chemical risks. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

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 email. 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 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

On January 9, 2013, EPA published a document in the Federal Register (78 FR 1856) (FRL-9375-1) on the availability of five draft TSCA risk assessments for public comment. The Agency also asked for nominations for external experts to conduct peer reviews of the draft TSCA risk assessments, including one entitled, “TSCA Workplan Chemical Risk Assessment for HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta[γ]-2-benzopyran).” HHCB (CASRN 1222-05-5) is one of 83 chemicals identified for review and assessment in EPA's TSCA Work Plan, which were released on March 1, 2012, at http://www.epa.gov/​oppt/​existingchemicals/​pubs/​workplans.html.

This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This is an external peer review draft assessment and has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy.

The draft HHCB TSCA risk assessment is being peer reviewed consistent with guidelines for the peer review of influential scientific information for scientific assessments. EPA asked a contractor, SCG, to assemble a panel of experts to evaluate the draft HHCB TSCA risk assessment report for specific uses of HHCB. SCG evaluated 4 candidates that were nominated as peer reviewers by the February 8, 2013 deadline established in the January 9, 2013 Federal Register document and evaluated over 70 additional experts before submitting the proposed peer review panel members. The proposed peer review panel was vetted by the contractor for conflict of interest and the appearance of bias according to Agency peer review guidance as detailed in the contract. This proposed peer review panel includes: Daniel Schlenk (chair), Tom Armstrong, Peter Chapman, William Doucette, Valerie Forbes, Robert W. Gensmer, Patrick Guiney, Duane Huggett, Shane Snyder, and Lawrence Whitehead.

The biographies for the proposed panel members are available in the docket (docket ID number EPA-HQ-OPPT-2012-0722). The public may provide comments to this docket on the appearance of a conflict of interest for any proposed peer review panel member. This comment period on the peer review panel membership closes on November 29, 2013. The final list of peer review panel members will be available on the SCG's Web site at http://www.scgcorp.com prior to the first meeting.

The peer review panel is responsible for the review of the scientific and technical merit of the draft HHCB TSCA risk assessment, which is available through http://www.regulations.gov and at http://www.epa.gov/​oppt/​existingchemicals/​pubs/​workplans.html. The peer review panel will not address potential policy implications or risk management options that may result from the draft HHCB TSCA risk assessment. Members of the public may register to attend any or all three meetings as observers and may also register to offer oral comments on each day of the meetings. A registered speaker is encouraged to focus on issues directly relevant to science-based aspects of the draft HHCB TSCA risk assessment.

The first peer review meeting on December 4, 2013, will be dedicated to hearing registered speakers' oral comments on the draft HHCB TSCA risk assessment and reviewing the charge to the peer reviewers. Each speaker is allowed between 3-5 minutes, depending on the number of registered speakers. Given time constraints, a maximum of 30 speakers will be allowed to offer comments. If more than 30 speakers register to provide oral comments, speakers will be selected by SCG in a manner designed to optimize representation from all organizations, affiliations, and present a balance of science issues relevant to the Agency's TSCA risk assessment. Peer review panel members will have access to written comments and materials and electronic materials submitted to the docket by January 16, 2014. Registered observers and speakers will not be allowed to distribute any written comments or materials or electronic materials directly to the peer review panel members. To submit written comments, please follow one of the methods outlined in ADDRESSES. The public comment period closes on January 16, 2014.

The second peer review panel meeting on January 9, 2014, will be devoted to deliberations of the draft HHCB TSCA risk assessment by the peer review panel, guided by the charge questions to the peer review panel.

The third and final peer review panel meeting on February 6, 2014, will focus on the peer review panel's discussion of its draft HHCB TSCA risk assessment recommendations to EPA, which will be posted on the contractor Web site prior to the final peer review meeting. The final peer review panel report will be prepared by SCG and made available to the public according to the Agency peer review guidance at http://www.epa.gov/​peerreview. EPA will consider SCG's peer review panel report of the comments and recommendations from the three peer review meetings, as well as written comments and materials and electronic materials in the docket at http://www.regulations.gov,, as it proceeds to finalize the HHCB TSCA risk assessment.

If potential risks are indicated in the revised TSCA risk assessment following peer review and public comment, the Agency will take the necessary risk reduction efforts as warranted. If no risks are identified in the revised TSCA risk assessment following revision in response to peer review, the Agency may conclude its work on the chemical being assessed.

III. How can I request to participate in these meetings?

A. Registration

To attend the peer review meetings, you must register for the meeting no later than 11:59 p.m., EST, on November 29, 2013. To register for the meeting, go to http://www.scgcorp.com/​dcm-nmp2013/​,, complete the online registration form, and submit the required information. You may also register through the U.S. Postal Service or by overnight/priority mail by sending the necessary registration information (see Unit III.B.) to the SCG Meeting Coordinator, Ms. Susie Warner. The U.S. Postal Service or overnight/priority mail address is: The Scientific Consulting Group, Inc., 656 Quince Orchard Rd., Suite 210, Gaithersburg, MD 20878-1409. For questions or additional information, contact Ms. Warner by: Telephone: [phone], ext. 227; fax: [phone]; or email: [e-mail]. Registrations sent via U.S. Postal Service or overnight/priority mail must be received no later than 11:59 p.m., EST, on November 29, 2013. There will be no on-site registration, so members of the public who do not register by 11:59 p.m., EST, on November 29, 2013, using one of the methods described in this unit, may not receive web access information in time to attend the first peer review meeting.

B. Required Registration Information

Members of the public may register to attend any or all three meetings as observers, or register to speak if planning to offer oral comments during the scheduled public comment session of a meeting. To register for the meetings online or by mail, you must provide your full name, organization or affiliation, and contact information. You must also indicate which meetings you plan to attend and if you would like to speak during the scheduled public comment session of a meeting. If you register to speak, you must also indicate if you have any special requirements related to your oral comments (e.g., translation).

If you indicate that you wish to speak, you will be asked to select one category most closely reflecting the content of your oral comments. The comment categories related to the charge questions are:

1. General comments on the risk assessment document;

2. Comments on the exposure assessment;

3. Comments on the hazard assessment;

4. Comments on the risk characterization; or

5. Other issues.

Should more than 30 speakers register for a single meeting, these categories will be used to ensure that a balance of substantive science issues relevant to the assessment is heard. Additional information on the selection of speakers and speaking times will be sent out by SCG 3 days prior to each peer review meeting to all individuals registered to speak.

To accommodate as many registered speakers as possible, registered speakers may present oral comments only, without visual aids or written material. Peer review panel members will have access to any written comments and materials and electronic materials previously submitted to the docket. Registered observers and speakers will not be allowed to distribute any written comments and materials or electronic materials directly to the peer review panel members.

C. Web Meeting Access

Each peer review meeting will be held via web connect and teleconferencing. SCG will provide all registered participants with information on how to participate in advance of the first peer review meeting.

List of Subjects

Environmental protection, Chemicals, Peer review, Risk assessments, HHCB, Fragrances.

Dated: October 31, 2013.

Jeff Morris,

Acting Director, Office of Pollution Prevention and Toxics.