[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Notices]
[Pages 67142-67144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26848]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2012-0722; FRL-9902-43]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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 (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-
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 (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 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 (202) 564-1169; email 
address: [email protected].
    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: (301) 
670-4990, ext. 227; fax number: (301) 670-3815; email address: 
[email protected].

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.

[[Page 67143]]

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[[gamma]]-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

[[Page 67144]]

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: (301) 670-4990, ext. 
227; fax: (301) 670-3815; or email: [email protected]. 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.
[FR Doc. 2013-26848 Filed 11-7-13; 8:45 am]
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