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.

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 Peñalva-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 Peñalva-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 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.