81 FR 70419 - Notice of a Public Meeting and Opportunity for Public Comment on EPA's Draft Algae Guidance for the Preparation of TSCA Biotechnology Submissions

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 197 (October 12, 2016)

Page Range		70419-70420
FR Document		2016-24653

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.

Federal Register, Volume 81 Issue 197 (Wednesday, October 12, 2016)

[Federal Register Volume 81, Number 197 (Wednesday, October 12, 2016)]
[Notices]
[Pages 70419-70420]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].
    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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; 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 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]
BILLING CODE 6560-50-P

Federal Register / Vol. 81, No. 197 / Wednesday, October 12, 2016 / Notices 70419

become a party must file a notice of Control Act (TSCA). EPA encourages all instructions for submitting comments.
intervention or motion to intervene, as members of the public interested in Do not submit electronically any
appropriate. Such notices, motions, or participating in this meeting to register information you consider to be
protests must be filed on or before the to attend. Due to space limitations, the Confidential Business Information (CBI)
comment date. On or before the Agency anticipates that approximately or other information whose disclosure is
comment date, it is not necessary to 120 people will be able to attend the restricted by statute.
serve motions to intervene or protests meeting in person, with seating • Mail: Document Control Office
on persons other than the Applicant. available on a first-come, first-serve (7407M), Office of Pollution Prevention
The Commission encourages basis. For registrants not able to attend and Toxics (OPPT), Environmental
electronic submission of protests and in person, Web connect and Protection Agency, 1200 Pennsylvania
interventions in lieu of paper using the teleconference capabilities will also be Ave. NW., Washington, DC 20460–0001.
‘‘eFiling’’ link at http://www.ferc.gov. provided. • Hand Delivery: To make special
Persons unable to file electronically arrangements for hand delivery or
DATES: Meeting. The meeting will be
should submit an original and 5 copies delivery of boxed information, please
held on Thursday, October 27, 2016,
of the protest or intervention to the follow the instructions at http://
from 8:00 a.m. to 12:00 p.m., MST.
Federal Energy Regulatory Commission, www.epa.gov/dockets/contacts.html.
Meeting registration. Registration
888 First Street NE., Washington, DC Additional instructions on
online, by U.S. Postal Service, or by
20426. commenting or visiting the docket,
overnight/priority mail is available for
This filing is accessible on-line at along with more information about
this meeting, and must be received no
http://www.ferc.gov, using the dockets in general is available at http://
later than 11:59 p.m., MST, on Tuesday,
‘‘eLibrary’’ link and is available for www.epa.gov/dockets.
October 25, 2016. On-site registration
review in the Commission’s Public will be permitted, but seating and FOR FURTHER INFORMATION CONTACT:
Reference Room in Washington, DC. speaking priority will be given to those Carolina Peñalva-Arana, Risk
There is an ‘‘eSubscription’’ link on the who register by the above listed Assessment Division, Office of Pollution
Web site that enables subscribers to deadline. Prevention and Toxics, Environmental
receive email notification when a To request accommodation of a Protection Agency, 1200 Pennsylvania
document is added to a subscribed disability, please contact the meeting Ave. NW., (MC 7403M) Washington, DC
docket(s). For assistance with any FERC logistics person listed under FOR 20460–0001; telephone number: (202)
Online service, please email FURTHER INFORMATION CONTACT, 564–4816; email address: penalva-
FERCOnlineSupport@ferc.gov, or call preferably at least 10 days prior to the arana.carolina@epa.gov.
(866) 208–3676 (toll free). For TTY, call For general information contact: The
meeting, to give EPA as much time as
(202) 502–8659. TSCA-Hotline, ABVI-Goodwill, 422
possible to process your request.
Comment Date: 5:00 p.m. Eastern Comments. EPA will hear oral South Clinton Ave., Rochester, NY
Time on October 18, 2016. comments on Thursday, October 27, 14620; telephone number: (202) 554–
DATED: September 28, 2016. 2016 and accept written comments and 1404; email address: TSCA-Hotline@
Kimberly D. Bose, electronic materials submitted on or epa.gov.
Secretary. before November 30, 2016. SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–24613 Filed 10–11–16; 8:45 am] ADDRESSES: Meeting. The meeting will I. General Information
BILLING CODE 6717–01–P be held at Arizona State University, Old
Main Building, 400 E Tyler Mall, A. Does this action apply to me?
Tempe, AZ 85281. The meeting will This action is directed to the public
ENVIRONMENTAL PROTECTION also be available via web connect and in general, and may be of interest to a
AGENCY teleconferencing for all registered wide range of stakeholders including
participants, for further information see those interested in environmental and
[EPA–HQ–OPPT–2015–0508; FRL–9952–63] Unit III.A. in the SUPPLEMENTARY human health assessment, the industrial
INFORMATION. and commercial biotechnology
Notice of a Public Meeting and
Meeting registration. To register go to industry—including those employing
Opportunity for Public Comment on
https://www.epa.gov/reviewing-new- modern versions sometimes referred to
EPA’s Draft Algae Guidance for the
chemicals-under-toxic-substances- as synthetic biology, the algae
Preparation of TSCA Biotechnology
control-act-tsca/announcing-second- production industry, chemical
Submissions
public-meeting-and and follow the link producers and users, consumer product
AGENCY: Environmental Protection to complete the online registration form. companies, and members of the public
Agency (EPA). To register by U.S. Postal Service or interested in the risk assessment of
ACTION: Notice. overnight/priority mail, mail your genetically engineered algae and
registration to: Carolina Peñalva-Arana, cyanobacteria subject to TSCA
SUMMARY: EPA will be hosting a public Risk Assessment Division, Office of oversight. Since others also may be
meeting to receive public input and Pollution Prevention and Toxics, interested, the Agency has not
comments on EPA’s draft Algae Environmental Protection Agency, 1200 attempted to describe all the specific
Guidance for the Preparation of TSCA Pennsylvania Ave. NW., (MC 7403M) entities that may be affected by this
Biotechnology Submissions (Algae Washington, DC 20460–0001; telephone action.
Guidance) in Tempe, AZ on October 27,
mstockstill on DSK3G9T082PROD with NOTICES

number: (202) 564–4816; email address:
2016. The draft Algae Guidance penalva-arana.carolina@epa.gov. B. How can I get copies of this document
describes EPA’s data needs to support Comments. Submit your written and other related information?
risk assessments of genetically comments, identified by docket ID The docket for this action, identified
engineered algae and cyanobacteria that number EPA–HQ–OPPT–2015–0508 by by docket identification (ID) number
are manufactured, imported, or one of the following methods: EPA–HQ–OPPT–2015–0508, is available
processed, and are subject to regulations • Federal eRulemaking Portal: http:// at http://www.regulations.gov or at the
under section 5 of The Toxic Substances www.regulations.gov. Follow the online Office of Pollution Prevention and

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70420 Federal Register / Vol. 81, No. 197 / Wednesday, October 12, 2016 / Notices

Toxics Docket (OPPT Docket), more than 3 minutes. To accommodate ENVIRONMENTAL PROTECTION
Environmental Protection Agency as many registered speakers as possible, AGENCY
Docket Center (EPA/DC), West William speakers may present oral comments
[EPA–R07–OW–2016–0586; FRL–9954–03–
Jefferson Clinton Bldg., Rm. 3334, 1301 only, without visual aids or written Region 7]
Constitution Ave. NW., Washington, material. However, additional
DC. The Public Reading Room is open supporting materials may be submitted Notice of Approval of the Primacy
from 8:30 a.m. to 4:30 p.m., Monday electronically to the docket at any time. Application for National Primary
through Friday, excluding legal Given time constraints, the number of Drinking Water Regulations for the
holidays. The telephone number for the speakers allowed during the comment State of Nebraska
Public Reading Room is (202) 566–1744, periods will be decided upon by the
and the telephone number for the OPPT meeting chair. Speakers will be selected AGENCY: Environmental Protection
Docket is (202) 566–0280. Please review in a manner designed to optimize Agency (EPA).
the visitor instructions and additional representation from all organizations, ACTION: Notice of approval and
information about the docket available affiliations, and present a balance of solicitation of requests for a public
at http://www.epa.gov/dockets. science issues relevant to the meeting’s hearing.
Documents and meeting information objective.
will also be available at the registration Written comments and electronic SUMMARY: The Environmental Protection
Web site. materials may be submitted on or before Agency (EPA) is hereby giving notice
November 30, 2016 to the docket ID that the State of Nebraska is revising its
C. What should I consider as I prepare approved Public Water Supply
my comments for EPA? number EPA–HQ–OPPT–2015–0508, for
further information see ADDRESSES Supervision Program under the
When preparing oral comments see section above. Nebraska Department of Health and
tips at https://projects.erg.com/ Human Services. The EPA has
conferences/oppt/workshophome.htm IV. How can I request to participate in determined that these revisions are no
and for submitting written comments this meeting? less stringent than the corresponding
see the commenting tips at http:// A. Registration Federal regulations. Therefore, the EPA
www.epa.gov/dockets/comments.html. intends to approve these program
To attend the meeting and receive revisions.
II. Background remote access, your registration must be
The objective of this meeting is to received no later than 11:59 p.m. MST DATES: This determination to approve
inform and discuss EPA’s draft Algae on Tuesday, October 25, 2016 using one the Nebraska program revision is made
Guidance document that describes data of the methods described under pursuant to 40 CFR 142.12(d) (3). This
needs to support risk assessments of ADDRESSES. While on-site registration determination shall become final and
genetically engineered algae and will be available, seating will be on a effective on November 14, 2016, unless
cyanobacteria, which are subject to first-come, first-serve basis, with (1) a timely and appropriate request for
TSCA oversight. Members of the public priority given to early registrants, until a public hearing is received or (2) the
are invited to review the draft Algae room capacity is reached. Time Regional Administrator elects to hold a
Guidance document and supporting permitting, on-site registrants may offer public hearing on his own motion. Any
documentation, and provide comments oral comments following those of early interested person, other than Federal
on the draft Algae Guidance document. registrants. For meeting logistics or Agencies, may request a public hearing.
This information is distributed solely registration questions contact the person A request for a public hearing must be
for informational purposes and should listed under FOR FURTHER INFORMATION submitted to the Regional Administrator
not be construed to represent any CONTACT. at the address shown below by
Agency determination or policy. The November 14, 2016. If a substantial
meeting will be open to the public and B. Required Registration Information request for a public hearing is made
experts in biotechnology, algae Members of the public may register to within the requested thirty-day time
production, and risk assessment, and all attend or offer oral comments during the frame, a public hearing will be held and
are encouraged to attend and present scheduled public comment periods of a notice will be given in the Federal
their views. the meeting. To register for the meeting Register and a newspaper of general
online or by mail, you must provide circulation. Frivolous or insubstantial
III. Meeting requests for a hearing may be denied by
your full name, organization or
A. Web Meeting Access affiliation, and contact information. If the Regional Administrator. If no timely
The meeting will be available via Web you indicate that you wish to speak, you and appropriate request for a hearing is
connect and teleconferencing for will be asked to select a session to give received, and the Regional
registered participants. All registered your oral comments in during the Administrator does not elect to hold a
participants will receive information on meeting. hearing on his own motion, this
how to connect to the meeting prior to determination will become effective on
List of Subjects November 14, 2016. All interested
its start.
Environmental Protection, Business parties may request a public hearing on
B. Public Participation and Industry, Chemicals, Ecology, the approval to the Regional
Members of the public may register to Health and Safety, Industrial Safety. Administrator at the EPA Region 7
attend the meeting as observers and may address shown below.
mstockstill on DSK3G9T082PROD with NOTICES

Authority: 15 U.S.C. 2601 et seq.
also register to offer oral comments on ADDRESSES: Any request for a public
the day of the meeting. Registered Dated: October 4, 2016. hearing shall include the following
speakers are encouraged to focus on Jeffrey T. Morris, information: (1) Name, address and
science-based aspects directly relevant Acting Director, Office of Pollution Prevention telephone number of the individual,
to the meeting’s objective and to address and Toxics. organization or other entity requesting a
specific scientific points in their oral [FR Doc. 2016–24653 Filed 10–11–16; 8:45 am] hearing; (2) a brief statement of the
comments. Each speaker is allowed no BILLING CODE 6560–50–P requesting person’s interest in the

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Document Created: 2016-10-12 00:56:10
Document Modified: 2016-10-12 00:56:10

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Meeting. The meeting will be held on Thursday, October 27, 2016, from 8:00 a.m. to 12:00 p.m., MST.
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
FR Citation		81 FR 70419