80 FR 51561 - Notice of a Public Meeting and Opportunity for Public Comment on Considerations for Risk Assessment of Genetically Engineered Algae

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 164 (August 25, 2015)

Page Range		51561-51562
FR Document		2015-21039

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.

Federal Register, Volume 80 Issue 164 (Tuesday, August 25, 2015)

[Federal Register Volume 80, Number 164 (Tuesday, August 25, 2015)]
[Notices]
[Pages 51561-51562]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices 51561

Nucleopolyhedrovirus—3AP2. Active DATES: Meeting. The workshop will be FOR FURTHER INFORMATION CONTACT: For
ingredient: Insecticide—Polyhedral held on Wednesday, September 30, technical information contact: Carolina
occlusion bodies of Spodoptera 2015, from 8 a.m. to noon, EDT. Peñalva-Arana, Risk Assessment
frugiperda Multiple Meeting registration. Advance Division, Office of Pollution Prevention
Nucleopolyhedrovirus (MNPV)—3AP2 registration must be completed no later and Toxics, Environmental Protection
at 74.5%. Proposed use: Manufacturing/ than 11:59 p.m., EDT, on Friday, Agency, 1200 Pennsylvania Ave. NW.,
formulating use. Contact: BPPD. September 25, 2015. On-site registration Washington, DC 20460–0001; telephone
3. File Symbol: 87978–U. Docket ID will be permitted, but seating and number: (202) 564–4816; email address:
number: EPA–HQ–OPP–2015–0494. speaking priority will be given to those penalva-arana.carolina@epa.gov.
Applicant: MacIntosh and Associates, who register by this deadline. For workshop logistics or registration
Inc., 1203 Hartford Ave., St. Paul, MN To request accommodation of a contact: Erin Pittorino, ERG, 110
55116–1622 (on behalf of AgBiTech Pty disability, please contact the workshop Hartwell Ave., Lexington, MA 02421;
Ltd, 8 Rocla Ct., Glenvale, Queensland logistics person listed under FOR telephone number: (781) 674–7260;
4350, Australia). Product name: FURTHER INFORMATION CONTACT, email address: erin.pittorino@erg.com.
Fawligen. Active ingredient: preferably at least 10 days prior to the For general information contact: The
Insecticide—Polyhedral occlusion meeting, to give EPA as much time as TSCA-Hotline, ABVI-Goodwill, 422
bodies of Spodoptera frugiperda possible to process your request. South Clinton Ave., Rochester, NY
Multiple Nucleopolyhedrovirus Comments. EPA will hear oral 14620; telephone number: (202) 554–
(MNPV)—3AP2 at 32%. Proposed use: comments on Wednesday, September 1404; email address: TSCA-Hotline@
Control of listed moth larvae on food 30, 2015, and accept comments and epa.gov.
and nonfood crops. Contact: BPPD. materials submitted in the docket by
SUPPLEMENTARY INFORMATION:
October 31, 2015.
Authority: 7 U.S.C. 136 et seq. I. General Information
ADDRESSES: Meeting. The workshop will
Dated: August 18, 2015. be held at the Omni Shoreham Hotel, A. Does this action apply to me?
John E. Leahy, Jr., 2500 Calvert St. NW., Washington, DC
Acting Director, Biopesticides and Pollution 20008. The workshop will also be This action is directed to the public
Prevention Division, Office of Pesticide available via Web connect and in general, and may be of interest to a
Programs. teleconferencing for all registered wide range of stakeholders including
[FR Doc. 2015–21037 Filed 8–24–15; 8:45 am] participants, for further information see those interested in environmental and
BILLING CODE 6560–50–P Unit III.A. under SUPPLEMENTARY human health assessment, the industrial
INFORMATION. and commercial biotechnology
Meeting registration. You may register industry—including those employing
ENVIRONMENTAL PROTECTION online, by U.S. Postal Service, by modern versions sometimes referred to
AGENCY overnight/priority mail, or in person at as synthetic biology, the algae
the meeting. To register online go to production industry, chemical
https://projects.erg.com/conferences/ producers and users, consumer product
[EPA–HQ–OPPT–2015–0508; FRL–9932–32]
oppt/workshophome.htm and complete companies, and members of the public
Notice of a Public Meeting and the online registration form. To register interested in the assessment of
Opportunity for Public Comment on by U.S. Postal Service or overnight/ biotechnology risks. Since others also
Considerations for Risk Assessment of priority mail, mail your registration to: may be interested, the Agency has not
Genetically Engineered Algae Erin Pittorino, ERG, 110 Hartwell Ave., attempted to describe all the specific
Lexington, MA 02421. entities that may be affected by this
AGENCY: Environmental Protection Comments. Submit comments and action.
Agency (EPA). materials, identified by docket ID B. How can I get copies of this document
ACTION: Notice. number EPA–HQ–OPPT–2015–0508, by and other related information?
one of the following methods:
SUMMARY: EPA will be hosting a public • Federal eRulemaking Portal: http:// The docket for this action, identified
meeting entitled, ‘‘Workshop for Public www.regulations.gov. Follow the online by docket ID number EPA–HQ–OPPT–
Input on Considerations for Risk instructions for submitting comments. 2015–0508, is available at http://
Assessment of Genetically Engineered Do not submit electronically any www.regulations.gov or in person at the
Algae’’ on September 30, 2015. The information you consider to be Office of Pollution Prevention and
objective of this workshop is to receive Confidential Business Information (CBI) Toxics Docket (OPPT Docket),
public input and comments on EPA’s or other information whose disclosure is Environmental Protection Agency
data needs to support risk assessments restricted by statute. Docket Center (EPA/DC), West William
of biotechnology products subject to • Mail: Document Control Office Jefferson Clinton Bldg., Rm. 3334, 1301
oversight under the Toxic Substances (7407M), Office of Pollution Prevention Constitution Ave. NW., Washington,
Control Act that make use of genetically and Toxics (OPPT), Environmental DC. The Public Reading Room is open
engineered algae and cyanobacteria. The Protection Agency, 1200 Pennsylvania from 8:30 a.m. to 4:30 p.m., Monday
workshop will inform an update to an Ave. NW., Washington, DC 20460–0001. through Friday, excluding legal
EPA guidance document entitled • Hand Delivery: To make special holidays. The telephone number for the
‘‘Points to Consider in The Preparation arrangements for hand delivery or Public Reading Room is (202) 566–1744,
asabaliauskas on DSK5VPTVN1PROD with NOTICES

of TSCA Biotechnology Submissions for delivery of boxed information, please and the telephone number for the OPPT
Microorganisms’’. EPA encourages all follow the instructions at http:// Docket is (202) 566–0280. Please review
members of the public interested in www.epa.gov/dockets/contacts.html. the visitor instructions and additional
participating in this workshop to Additional instructions on information about the docket available
register to attend, whether in-person or commenting or visiting the docket, at http://www.epa.gov/dockets.
through the Web-connect and along with more information about Documents and workshop information
teleconference that will also be dockets in general is available at will also be available at the registration
available. http://www.epa.gov/dockets. Web site.

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51562 Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices

C. What should I consider as I prepare optimize representation from all ENVIRONMENTAL PROTECTION
my comments for EPA? organizations, affiliations, and present a AGENCY
When preparing comments for EPA, balance of science issues relevant to the
whether oral or in writing, see the tips workshop. [EPA–HQ–OAR–2012–0103; FRL–9933–05–
at https://projects.erg.com/conferences/ IV. How can I request to participate in
OAR]
oppt/workshophome.htm and at http:// this meeting?
www.epa.gov/dockets/comments.html. Agency Information Collection
A. Registration Activities; Submission to OMB for
II. Background Review and Approval; Comment
The objective of this workshop is to To attend the workshop in person or Request; Diesel Emissions Reduction
discuss EPA’s data needs to support risk to receive access through Web connect Act (DERA) Rebate Program; EPA ICR
assessments of biotechnology products and teleconference, you must register no No. 2461.02, OMB Control No. 2060–
subject to oversight under the Toxic later than 11:59 p.m., on Friday, 0686 RENEWAL
Substances Control Act (TSCA), 15 September 25, 2015, using one of the
AGENCY: Environmental Protection
U.S.C. 2601 et seq., that make use of methods described under ADDRESSES. Agency (EPA).
genetically engineered algae and While on-site registration will be
cyanobacteria. The workshop will ACTION: Notice.
available, seating will be on a first-
inform an update to the EPA guidance come, first-serve basis, with priority SUMMARY: The Environmental Protection
document entitled ‘‘Points to Consider given to early registrants and until room Agency (EPA) is planning to submit an
in The Preparation of TSCA capacity is reached. The Agency information collection request (ICR),
Biotechnology Submissions for anticipates that approximately 150 ‘‘Diesel Emissions Reduction Act
Microorganisms’’. people will be able to attend the (DERA) Rebate Program’’ (EPA ICR No.
Members of the public are invited to
workshop in person, with seating 2461.02, OMB Control No. 2060–0686
review the presentations and supporting
available on a first-come, first-serve RENEWAL) to the Office of Management
documentation, including the EPA
basis. For registrants not able to attend and Budget (OMB) for review and
guidance document, and to provide
in person, the workshop will also approval in accordance with the
comments on the workshop subject
provide Web connect and Paperwork Reduction Act (44 U.S.C.
matter by the end of the comment
teleconference capabilities. 3501 et seq.). Before doing so, EPA is
period specified. This information is
soliciting public comments on specific
distributed solely for informational Time permitting, on-site registrants
aspects of the proposed information
purposes and should not be construed may offer comments following those
collection as described below. This is a
to represent any Agency determination who registered earlier. For workshop proposed extension of the ICR, which is
or policy. The meeting will be open to logistics or registration questions currently approved through October 31,
the public and experts in biotechnology, contact the person listed under FOR 2015. An Agency may not conduct or
algae production, and risk assessment FURTHER INFORMATION CONTACT. sponsor and a person is not required to
are encouraged to attend and present
B. Required Registration Information respond to a collection of information
their views.
unless it displays a currently valid OMB
III. Meeting Members of the public may register to control number.
A. Web Connect and Teleconferencing attend or speak if planning to offer oral DATES: Comments must be submitted on
Access comments during the scheduled public or before October 26, 2015.
comment periods. To register for the ADDRESSES: Submit your comments,
The workshop will be available via meeting online or by mail, you must
Web connect and teleconferencing for referencing Docket ID No. EPA–HQ–
provide your full name, organization or OAR–2012–0103, online using
registered participants. All registered affiliation, and contact information. If
participants will receive information on www.regulations.gov (our preferred
you indicate that you wish to speak, you method), by email to a-and-r-docket@
how to connect to the workshop prior to
will be asked to select one of these epa.gov, or by mail to: EPA Docket
its start.
categories that most closely reflect the Center, Environmental Protection
B. Public Participation at the Meeting content of your oral comments: Agency, Mail Code 28221T, 1200
Members of the public may register to Environmental Protection, Algae/ Pennsylvania Ave. NW., Washington,
attend the workshop as observers and Cyanobacteria Production, DC 20460.
may also register to speak offering oral Biotechnology, Biological/Genetic EPA’s policy is that all comments
comments on the day of the workshop. Engineering, Risk Assessment, received will be included in the public
A registered speaker is encouraged to Microorganisms, Ecotoxicity, Industrial docket without change including any
focus on issues directly relevant to Chemicals, Guidance or Other. personal information provided, unless
science-based aspects of the workshop the comment includes profanity, threats,
Authority: 15 U.S.C. 2601 et seq. information claimed to be Confidential
and to address specific scientific points
in the speaker’s oral comments. Each Date: August 18, 2015. Business Information (CBI) or other
speaker is allowed between 2–3 Wendy C. Hamnett, information whose disclosure is
minutes. To accommodate as many restricted by statute.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Director, Office of Pollution Prevention and
registered speakers as possible, speakers Toxics. FOR FURTHER INFORMATION CONTACT:
may present oral comments only, [FR Doc. 2015–21039 Filed 8–24–15; 8:45 am] Tyler Cooley, Office of Transportation
without visual aids or written material. BILLING CODE 6560–50–P
and Air Quality, (Mail Code: 6406A),
Given time constraints, the number of Environmental Protection Agency, 1200
speakers allowed during the comment Pennsylvania Ave. NW., Washington,
periods will be decided upon by the DC 20460; telephone number: 415–972–
workshop chair. Speakers will be 3937; fax number: 202–343–2803; email
selected in a manner designed to address: cooley.tyler@epa.gov.

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Document Created: 2018-02-23 11:03:11
Document Modified: 2018-02-23 11:03:11

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 workshop will be held on Wednesday, September 30, 2015, from 8 a.m. to noon, EDT.
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:
FR Citation		80 FR 51561