Document ID: EPA-HQ-OPPT-2015-0508-0021
Agency: epa
Document Type: Notice
Title: Meetings: Draft Algae Guidance for Preparation of Toxic Substances Control Act Biotechnology Submissions
Posted Date: 2016-10-12T04:00Z

[Federal Register Volume 81, Number 197 (Wednesday, October 12, 2016)]
[Notices]
[Pages 70419-70420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24653]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0508; FRL-9952-63]

Notice of a Public Meeting and Opportunity for Public Comment on 
EPA's Draft Algae Guidance for the Preparation of TSCA Biotechnology 
Submissions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA will be hosting a public meeting to receive public input 
and comments on EPA's draft Algae Guidance for the Preparation of TSCA 
Biotechnology Submissions (Algae Guidance) in Tempe, AZ on October 27, 
2016. The draft Algae Guidance describes EPA's data needs to support 
risk assessments of genetically engineered algae and cyanobacteria that 
are manufactured, imported, or processed, and are subject to 
regulations under section 5 of The Toxic Substances Control Act (TSCA). 
EPA encourages all members of the public interested in participating in 
this meeting to register to attend. Due to space limitations, the 
Agency anticipates that approximately 120 people will be able to attend 
the meeting in person, with seating available on a first-come, first-
serve basis. For registrants not able to attend in person, Web connect 
and teleconference capabilities will also be provided.

DATES: Meeting. The meeting will be held on Thursday, October 27, 2016, 
from 8:00 a.m. to 12:00 p.m., MST.
    Meeting registration. Registration online, by U.S. Postal Service, 
or by overnight/priority mail is available for this meeting, and must 
be received no later than 11:59 p.m., MST, on Tuesday, October 25, 
2016. On-site registration will be permitted, but seating and speaking 
priority will be given to those who register by the above listed 
deadline.
    To request accommodation of a disability, please contact the 
meeting logistics person listed under FOR FURTHER INFORMATION CONTACT, 
preferably at least 10 days prior to the meeting, to give EPA as much 
time as possible to process your request.
    Comments. EPA will hear oral comments on Thursday, October 27, 2016 
and accept written comments and electronic materials submitted on or 
before November 30, 2016.

ADDRESSES: Meeting. The meeting will be held at Arizona State 
University, Old Main Building, 400 E Tyler Mall, Tempe, AZ 85281. The 
meeting will also be available via web connect and teleconferencing for 
all registered participants, for further information see Unit III.A. in 
the SUPPLEMENTARY INFORMATION.
    Meeting registration. To register go to https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/announcing-second-public-meeting-and and follow the link to complete 
the online registration form. To register by U.S. Postal Service or 
overnight/priority mail, mail your registration to: Carolina 
Pe[ntilde]alva-Arana, Risk Assessment Division, Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., (MC 7403M) Washington, DC 20460-0001; telephone 
number: (202) 564-4816; email address: penalva-arana.carolina@epa.gov.
    Comments. Submit your written comments, identified by docket ID 
number EPA-HQ-OPPT-2015-0508 by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     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: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets in general is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Carolina Pe[ntilde]alva-Arana, Risk 
Assessment Division, Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., (MC 7403M) 
Washington, DC 20460-0001; telephone number: (202) 564-4816; email 
address: penalva-arana.carolina@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

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 industrial and 
commercial biotechnology industry--including those employing modern 
versions sometimes referred to as synthetic biology, the algae 
production industry, chemical producers and users, consumer product 
companies, and members of the public interested in the risk assessment 
of genetically engineered algae and cyanobacteria subject to TSCA 
oversight. 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. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPPT-2015-0508, is available at http://www.regulations.gov or at the Office of Pollution Prevention and

[[Page 70420]]

Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW., Washington, DC. The 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 (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets. Documents and 
meeting information will also be available at the registration Web 
site.

C. What should I consider as I prepare my comments for EPA?

    When preparing oral comments see tips at https://projects.erg.com/conferences/oppt/workshophome.htm and for submitting written comments 
see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

    The objective of this meeting is to inform and discuss EPA's draft 
Algae Guidance document that describes data needs to support risk 
assessments of genetically engineered algae and cyanobacteria, which 
are subject to TSCA oversight. Members of the public are invited to 
review the draft Algae Guidance document and supporting documentation, 
and provide comments on the draft Algae Guidance document. This 
information is distributed solely for informational purposes and should 
not be construed to represent any Agency determination or policy. The 
meeting will be open to the public and experts in biotechnology, algae 
production, and risk assessment, and all are encouraged to attend and 
present their views.

III. Meeting

A. Web Meeting Access

    The meeting will be available via Web connect and teleconferencing 
for registered participants. All registered participants will receive 
information on how to connect to the meeting prior to its start.

B. Public Participation

    Members of the public may register to attend the meeting as 
observers and may also register to offer oral comments on the day of 
the meeting. Registered speakers are encouraged to focus on science-
based aspects directly relevant to the meeting's objective and to 
address specific scientific points in their oral comments. Each speaker 
is allowed no more than 3 minutes. To accommodate as many registered 
speakers as possible, speakers may present oral comments only, without 
visual aids or written material. However, additional supporting 
materials may be submitted electronically to the docket at any time. 
Given time constraints, the number of speakers allowed during the 
comment periods will be decided upon by the meeting chair. Speakers 
will be selected in a manner designed to optimize representation from 
all organizations, affiliations, and present a balance of science 
issues relevant to the meeting's objective.
    Written comments and electronic materials may be submitted on or 
before November 30, 2016 to the docket ID number EPA-HQ-OPPT-2015-0508, 
for further information see ADDRESSES section above.

IV. How can I request to participate in this meeting?

A. Registration

    To attend the meeting and receive remote access, your registration 
must be received no later than 11:59 p.m. MST on Tuesday, October 25, 
2016 using one of the methods described under ADDRESSES. While on-site 
registration will be available, seating will be on a first-come, first-
serve basis, with priority given to early registrants, until room 
capacity is reached. Time permitting, on-site registrants may offer 
oral comments following those of early registrants. For meeting 
logistics or registration questions contact the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. Required Registration Information

    Members of the public may register to attend or offer oral comments 
during the scheduled public comment periods of the meeting. To register 
for the meeting online or by mail, you must provide your full name, 
organization or affiliation, and contact information. If you indicate 
that you wish to speak, you will be asked to select a session to give 
your oral comments in during the meeting.

List of Subjects

    Environmental Protection, Business and Industry, Chemicals, 
Ecology, Health and Safety, Industrial Safety.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: October 4, 2016.
Jeffrey T. Morris,
Acting Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2016-24653 Filed 10-11-16; 8:45 am]
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