Document ID: EPA-HQ-OPPT-2015-0508-0001
Agency: epa
Document Type: Notice
Title: Meetings: Considerations for Risk Assessment of Genetically Engineered Algae
Posted Date: 2015-08-25T04:00Z

[Federal Register Volume 80, Number 164 (Tuesday, August 25, 2015)]
[Notices]
[Pages 51561-51562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21039]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0508; FRL-9932-32]

Notice of a Public Meeting and Opportunity for Public Comment on 
Considerations for Risk Assessment of Genetically Engineered Algae

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA will be hosting a public meeting entitled, ``Workshop for 
Public Input on Considerations for Risk Assessment of Genetically 
Engineered Algae'' on September 30, 2015. The objective of this 
workshop is to receive public input and comments on EPA's data needs to 
support risk assessments of biotechnology products subject to oversight 
under the Toxic Substances Control Act that make use of genetically 
engineered algae and cyanobacteria. The workshop will inform an update 
to an EPA guidance document entitled ``Points to Consider in The 
Preparation of TSCA Biotechnology Submissions for Microorganisms''. EPA 
encourages all members of the public interested in participating in 
this workshop to register to attend, whether in-person or through the 
Web-connect and teleconference that will also be available.

DATES: Meeting. The workshop will be held on Wednesday, September 30, 
2015, from 8 a.m. to noon, EDT.
    Meeting registration. Advance registration must be completed no 
later than 11:59 p.m., EDT, on Friday, September 25, 2015. On-site 
registration will be permitted, but seating and speaking priority will 
be given to those who register by this deadline.
    To request accommodation of a disability, please contact the 
workshop 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 Wednesday, September 30, 
2015, and accept comments and materials submitted in the docket by 
October 31, 2015.

ADDRESSES: Meeting. The workshop will be held at the Omni Shoreham 
Hotel, 2500 Calvert St. NW., Washington, DC 20008. The workshop will 
also be available via Web connect and teleconferencing for all 
registered participants, for further information see Unit III.A. under 
SUPPLEMENTARY INFORMATION.
    Meeting registration. You may register online, by U.S. Postal 
Service, by overnight/priority mail, or in person at the meeting. To 
register online go to https://projects.erg.com/conferences/oppt/workshophome.htm and complete the online registration form. To register 
by U.S. Postal Service or overnight/priority mail, mail your 
registration to: Erin Pittorino, ERG, 110 Hartwell Ave., Lexington, MA 
02421.
    Comments. Submit comments and materials, 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: For technical information contact: 
Carolina Pe[ntilde]alva-Arana, Risk Assessment Division, Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-4816; email address: penalva-arana.carolina@epa.gov.
    For workshop logistics or registration contact: Erin Pittorino, 
ERG, 110 Hartwell Ave., Lexington, MA 02421; telephone number: (781) 
674-7260; email address: erin.pittorino@erg.com.
    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 assessment of 
biotechnology 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. How can I get copies of this document and other related information?

    The docket for this action, identified by docket ID number EPA-HQ-
OPPT-2015-0508, is available at http://www.regulations.gov or in person 
at the Office of Pollution Prevention and 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 workshop information will 
also be available at the registration Web site.

[[Page 51562]]

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

    When preparing comments for EPA, whether oral or in writing, see 
the tips at https://projects.erg.com/conferences/oppt/workshophome.htm 
and at http://www.epa.gov/dockets/comments.html.

II. Background

    The objective of this workshop is to discuss EPA's data needs to 
support risk assessments of biotechnology products subject to oversight 
under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., 
that make use of genetically engineered algae and cyanobacteria. The 
workshop will inform an update to the EPA guidance document entitled 
``Points to Consider in The Preparation of TSCA Biotechnology 
Submissions for Microorganisms''.
    Members of the public are invited to review the presentations and 
supporting documentation, including the EPA guidance document, and to 
provide comments on the workshop subject matter by the end of the 
comment period specified. 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 are 
encouraged to attend and present their views.

III. Meeting

A. Web Connect and Teleconferencing Access

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

B. Public Participation at the Meeting

    Members of the public may register to attend the workshop as 
observers and may also register to speak offering oral comments on the 
day of the workshop. A registered speaker is encouraged to focus on 
issues directly relevant to science-based aspects of the workshop and 
to address specific scientific points in the speaker's oral comments. 
Each speaker is allowed between 2-3 minutes. To accommodate as many 
registered speakers as possible, speakers may present oral comments 
only, without visual aids or written material. Given time constraints, 
the number of speakers allowed during the comment periods will be 
decided upon by the workshop 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 
workshop.

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

A. Registration

    To attend the workshop in person or to receive access through Web 
connect and teleconference, you must register no later than 11:59 p.m., 
on Friday, September 25, 2015, 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 and until room capacity is reached. The Agency anticipates 
that approximately 150 people will be able to attend the workshop in 
person, with seating available on a first-come, first-serve basis. For 
registrants not able to attend in person, the workshop will also 
provide Web connect and teleconference capabilities.
    Time permitting, on-site registrants may offer comments following 
those who registered earlier. For workshop 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 speak if planning 
to offer oral comments during the scheduled public comment periods. 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 one of 
these categories that most closely reflect the content of your oral 
comments: Environmental Protection, Algae/Cyanobacteria Production, 
Biotechnology, Biological/Genetic Engineering, Risk Assessment, 
Microorganisms, Ecotoxicity, Industrial Chemicals, Guidance or Other.

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

    Date: August 18, 2015.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2015-21039 Filed 8-24-15; 8:45 am]
 BILLING CODE 6560-50-P