Biotechnology Regulatory Services; Changes Regarding the Solicitation of Public Comment for Petitions for Determinations of Nonregulated Status for Genetically Engineered Organisms, 13258-13260 [2012-5364]
Download as PDF
<![CDATA[
13258
Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices
pmangrum on DSK3VPTVN1PROD with NOTICES
techniques or other forms of information
technology should be addressed to: Desk
Officer for Agriculture, Office of
Information and Regulatory Affairs,
Office of Management and Budget
(OMB),
OIRA_Submission@OMB.EOP.GOV or
fax (202) 395–5806 and to Departmental
Clearance Office, USDA, OCIO, Mail
Stop 7602, Washington, DC 20250–
7602. Comments regarding these
information collections are best assured
of having their full effect if received
within 30 days of this notification.
Copies of the submission(s) may be
obtained by calling (202) 720–8958.
An agency may not conduct or
sponsor a collection of information
unless the collection of information
displays a currently valid OMB control
number and the agency informs
potential persons who are to respond to
the collection of information that such
persons are not required to respond to
the collection of information unless it
displays a currently valid OMB control
number.
Animal Plant and Health Inspection
Service
Title: Emergency Management
Response System (EMRS).
OMB Control Number: 0579–0071.
Summary of Collection: The Animal
Health Protection Act (AHPA) of 2002 is
the primary Federal law governing the
protection of animal health. The law
gives the Secretary of Agriculture broad
authority to detect, control, or eradicate
pests or diseases of livestock or poultry.
The Secretary may also prohibit or
restrict import or export of any animal
or related material if necessary to
prevent the spread of any livestock or
poultry pest or disease. Through the
Foreign Animal Disease Surveillance
Program, the Animal and Plant Health
Inspection Service (APHIS) compiles
essential epidemiological and diagnostic
data that are used to define foreign
animal diseases (FAD) and their risk
factors. The data is compiled through
the Veterinary Services Emergency
Management Response System, a webbased database for reporting
investigations of suspected FAD
occurrences.
Need and Use of the Information:
APHIS collects information such as the
purpose of the diagnostician’s visit to
the site, the name and address of the
owner/manager, the type of operation
being investigated, the number of and
type of animals on the premises,
whether any animals have been moved
to or from the premises and when this
movement occurred, number of sick or
dead animals, the results of physical
examinations of the affected animals,
VerDate Mar<15>2010
14:56 Mar 05, 2012
Jkt 226001
the results of postmortem examinations,
and the number and kinds of samples
taken, and the name of the suspected
disease. APHIS uses the collected
information to effectively prevent FAD
occurrences and protect the health of
the United States.
Without the information, APHIS has
no way to detect and monitor foreign
animal disease outbreaks in the United
States.
Description of Respondents: Business
or other for-profit State, Local or Tribal
Government.
Number of Respondents: 471.
Frequency of Responses: Reporting:
On occasion.
Total Burden Hours: 1,884.
Animal and Plant Health Inspection
Service
Title: Importation of Fruits and
Vegetables.
OMB Control Number: 0579–0264.
Summary of Collection: Under the
Plant Protection Act (7 U.S.C. 7701–
7772), the Secretary of Agriculture is
authorized to regulate the importation of
plants, plant products, and other articles
to prevent the introduction of injurious
plant pests. Regulations contained in
Title 7 of the Code of Federal
Regulations, Part 319 (Subpart-Fruit and
Vegetables), Sections 319.56 et seq.
implement the intent of this Act by
prohibiting or restricting the
importation of certain fruits and
vegetables into the United States from
certain parts of the world to prevent the
introduction and dissemination of fruit
flies and other injurious plant pests that
are new to the United States or not
widely distributed within the United
States. These regulations are enforced
by the Plant Protection and Quarantine,
a program with USDA’s Animal and
Plant Health Inspection Service
(APHIS).
Need and Use of the Information: The
use of certain information collection
activities including phytosanitary
certificates, fruit fly monitoring records,
and cooperative agreements will be used
to allow the entry of certain fruits and
vegetables into the United States.
Without the information all shipment
would need to be inspected very
thoroughly, thereby requiring
considerably more time and would slow
the clearance of international
shipments.
Description of Respondents: Business
or other for-profit; Federal Government.
Number of Respondents: 15.
Frequency of Responses:
Recordkeeping; Reporting: On occasion.
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
Total Burden Hours: 123.
Ruth Brown,
Departmental Information Collection
Clearance Officer.
[FR Doc. 2012–5326 Filed 3–5–12; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2011–0129]
Biotechnology Regulatory Services;
Changes Regarding the Solicitation of
Public Comment for Petitions for
Determinations of Nonregulated Status
for Genetically Engineered Organisms
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service (APHIS) is
implementing changes to the way it
solicits public comment when
considering petitions for determinations
of nonregulated status for genetically
engineered organisms to allow for early
public involvement in the process.
Under the updated process, APHIS will
publish two separate notices in the
Federal Register for petitions for which
APHIS prepares an environmental
assessment. The first notice will
announce the availability of the
petition, and the second notice will
announce the availability of APHIS’
decisionmaking documents. This
change will provide two opportunities
for public involvement in the
decisionmaking process.
FOR FURTHER INFORMATION CONTACT: Dr.
T. Clint Nesbitt, Chief of Staff,
Biotechnology Regulatory Services,
APHIS, 4700 River Road Unit 147,
Riverdale, MD 20737–1236; (301) 851–
3917, email:
Thomas.C.Nesbitt@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
Under the authority of the plant pest
provisions of the Plant Protection Act (7
U.S.C. 7701 et seq.), the regulations in
7 CFR part 340, ‘‘Introduction of
Organisms and Products Altered or
Produced Through Genetic Engineering
Which Are Plant Pests or Which There
Is Reason to Believe Are Plant Pests,’’
regulate, among other things, the
introduction (importation, interstate
movement, or release into the
environment) of organisms and products
altered or produced through genetic
E:\FR\FM\06MRN1.SGM
06MRN1
Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices
engineering that are plant pests or that
there is reason to believe are plant pests.
Such genetically engineered (GE)
organisms and products are considered
‘‘regulated articles.’’
The regulations in § 340.6(a) provide
that any person may submit a petition
to the Animal and Plant Health
Inspection Service (APHIS) seeking a
determination that an article should not
be regulated under 7 CFR part 340.
Paragraph (d) provides that, for petitions
that meet the submission procedures,
format, required data, and information
requirements in paragraphs (b) and (c),
APHIS will publish a notice in the
Federal Register to inform the public
that APHIS will accept written
comments regarding the petition for a
period of 60 days from the date of the
notice.
As part of the USDA Customer
Service Plan,1 which seeks to improve
the Agency’s customer service
processes, APHIS analyzed the current
petition process using Lean Six Sigma
business process techniques. Based on
this analysis, APHIS is implementing
changes to improve our process for
evaluating and responding to petitions
for determinations of nonregulated
status. Changes include earlier
publication of the notice announcing
the petition’s availability in the Federal
Register, which will allow early public
involvement in the process, and changes
to the way we currently solicit and use
public comment.2
pmangrum on DSK3VPTVN1PROD with NOTICES
Current Comment Process for Petitions
for Determinations of Nonregulated
Status
Once APHIS deems a petition to be
complete (i.e., the petition meets all the
submission procedures, format, required
data, and information requirements in
§ 340.6(b) and (c)), APHIS, in most
instances, prepares a plant pest risk
assessment (PPRA) and a draft
environmental assessment (EA). APHIS
prepares a PPRA to assess the plant pest
risk of the article and an EA, in
accordance with the National
Environmental Policy Act (NEPA), to
provide the Agency with a review and
analysis of any potential environmental
impacts associated with the petition
request. After the completion of these
documents, APHIS typically publishes a
notice in the Federal Register
1 For more information on the USDA Customer
Service Plan, go to https://www.usda.gov/open/
Blog.nsf/dx/USDA-CSPlan.pdf/$file/USDACSPlan.pdf.
2 For information regarding APHIS’ analysis and
other internal process changes APHIS is making to
our petition process, go to https://
www.aphis.usda.gov/biotechnology/
pet_proc_imp.shtml.
VerDate Mar<15>2010
14:56 Mar 05, 2012
Jkt 226001
announcing the availability of the
petition, PPRA, and draft EA for public
comment.
After the comment period closes,
APHIS reviews all written comments
received during the comment period
and any other relevant information.
After reviewing and evaluating the
comments on the petition, draft EA,
PPRA, and other data, APHIS prepares
a final EA, PPRA, and NEPA decision
document, which can be either a
Finding of No Significant Impact
(FONSI) or notice of intent (NOI) to
prepare an environmental impact
statement (EIS).3
If APHIS determines, based on the
PPRA, that the regulated article is
unlikely to pose a plant pest risk and a
FONSI is reached, APHIS subsequently
furnishes a response to the petitioner
approving the petition. APHIS also
publishes a notice in the Federal
Register announcing the regulatory
status of the GE organism and the
availability of APHIS’ final EA, PPRA,
FONSI, and regulatory determination.
Copies of these documents are made
available as indicated in the Federal
Register notice.
Changes to the Comment Process for
Petitions for Determinations of
Nonregulated Status
Under our updated process, APHIS
intends to decide whether a petition is
complete within 3 months of its receipt.
If APHIS deems that a petition is not
complete, APHIS will so inform the
petitioner. For petitions APHIS deems
complete, APHIS will follow the process
for public involvement described below.
EA Comment Process for Petitions for
Determinations of Nonregulated Status
For complete petitions, APHIS will
make the petition available for public
comment before preparing our EA and
PPRA.4 APHIS will, therefore, publish
two separate notices in the Federal
Register—a notice announcing the
availability of the petition, with an
opportunity for public comment,
followed by a notice announcing the
availability of APHIS’ EA and PPRA and
3 If an EIS is determined to be necessary, APHIS
completes the NEPA EIS process in accordance
with Council on Environmental Quality regulations
(40 CFR part 1500–1508) and APHIS’ NEPA
implementing regulations (7 CFR part 372) and
prepares a record of decision prior to either
approving or denying the petition.
4 This notice describes our process for handling
most petitions for determinations of nonregulated
status. APHIS may decide that an EIS is necessary,
either when we deem the petition to be complete
or at any time during the EA process, in which case
APHIS would complete the NEPA EIS process in
accordance with Council on Environmental Quality
regulations and APHIS’ NEPA implementing
regulations.
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
13259
an opportunity for public involvement
on those documents. This will provide
two separate and specific opportunities
for public involvement in the
decisionmaking process.
First Opportunity for Public
Involvement
The first opportunity for public
involvement will be a public comment
period on the petition itself, once it is
deemed complete by APHIS. APHIS will
publish a notice in the Federal Register
to inform the public that APHIS will
accept written comments regarding a
petition for a determination of
nonregulated status for a period of 60
days from the date of the notice. The
comment period will provide the public
with an opportunity to raise any issues
regarding the petition and will be used
by APHIS as a scoping opportunity to
identify potential issues and impacts
that APHIS would then determine
should be considered in our evaluation
of the petition.
Second Opportunity for Public
Involvement
The second opportunity for public
involvement will come with the
publication of a notice of availability for
APHIS’ EA and PPRA in the Federal
Register. This second notice will follow
one of two approaches for public
participation based on whether or not
APHIS decides the petition for a
determination of nonregulated status is
for a GE organism that raises substantive
new issues.
Approach 1
This approach for public participation
will be used when APHIS decides,
based on our review of the petition and
our evaluation and analysis of
comments received from the public
during the 60-day comment period on
the petition, that the petition involves a
GE organism that raises no substantive
new issues. This would include
instances, for example, where APHIS
decides that the petition involves gene
modifications that do not raise
substantive new biological, cultural, or
ecological issues due to the nature of the
modification or APHIS’ familiarity with
the recipient organism.
Under this approach, APHIS will
publish a notice in the Federal Register
announcing APHIS’ preliminary
regulatory determination and the
availability of APHIS’ EA, FONSI, and
PPRA for a 30-day public review. Upon
completion of the 30-day review period,
APHIS will review and evaluate any
information received. If APHIS
determines that no substantive
information has been received that
E:\FR\FM\06MRN1.SGM
06MRN1
13260
Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices
pmangrum on DSK3VPTVN1PROD with NOTICES
would warrant APHIS altering its
preliminary regulatory determination or
FONSI, substantially changing the
proposed action identified in the EA, or
substantially changing the analysis of
impacts in the EA, our preliminary
regulatory determination will become
final and effective upon notification of
the public through an announcement on
our Web site. APHIS will also furnish a
response to the petitioner regarding our
final regulatory determination. No
further Federal Register notice will be
published announcing the final
regulatory determination.
Should APHIS determine that we
have received substantive new
information within 30 days of
publication of the Federal Register
notice that would warrant APHIS
altering our preliminary regulatory
determination or FONSI, substantially
changing the proposed action identified
in the EA, or substantially changing the
analysis of impacts in the EA, our
preliminary determination will not
become effective. In this case, APHIS
intends to notify the public through an
announcement on our Web site of our
intent to conduct additional analysis.
APHIS will also inform the petitioner of
our intent.
Based on the information APHIS
received and our further analysis, the
Agency will prepare an amended EA, a
new FONSI, and/or a revised PPRA, as
necessary. APHIS will then publish a
notice in the Federal Register
announcing the availability of these
documents for public review and
APHIS’ preliminary regulatory
determination. After reviewing and
evaluating any additional information
received within 30 days of publication
of this Federal Register notice, our
preliminary regulatory determination
will become final and effective upon
notification of the public through an
announcement on our Web site. APHIS
will also furnish a response to the
petitioner regarding our final regulatory
determination. No further Federal
Register notice will be published
announcing the final regulatory
determination.
Approach 2
A second approach for public
participation will be used when APHIS
determines that the petition for a
determination of nonregulated status is
for a GE organism that raises substantive
new issues. This could include petitions
involving a recipient organism that has
not previously been determined by
APHIS to have nonregulated status or
when APHIS determines that gene
modifications raise substantive
biological, cultural, or ecological issues
VerDate Mar<15>2010
14:56 Mar 05, 2012
Jkt 226001
not previously analyzed by APHIS.
Substantive issues would be identified
by APHIS based on our review of the
petition and our evaluation and analysis
of comments received from the public
during the 60-day comment period on
the petition.
Under this approach, APHIS will
solicit written comments on a draft EA
and PPRA for 30 days through the
publication of a Federal Register notice.
The draft EA and PPRA will be made
available as indicated in the Federal
Register notice. Upon completion of the
30-day comment period, APHIS will
review and evaluate all written
comments received during the comment
period and any other relevant
information. After reviewing and
evaluating the comments on the draft
EA and PPRA and other information,
APHIS will revise the PPRA as
necessary and prepare a final EA. Based
on the final EA, APHIS will prepare a
NEPA decision document—either a
FONSI or NOI to prepare an EIS. If a
FONSI is reached, APHIS will furnish a
response to the petitioner, either
approving or denying the petition.
APHIS will publish a notice in the
Federal Register announcing the
regulatory status of the GE organism and
the availability of APHIS’ final EA,
PPRA, FONSI, and our regulatory
determination.
These changes to the public
participation process are effective
March 6, 2012. All petitions for
determinations of nonregulated status
for GE organisms received by APHIS on
or after this date will be handled using
the new process for handling petitions
described in this notice. For petitions
received before this date and currently
under consideration by APHIS, our
ability to transition to the new process
will depend upon the current status of
the petition. For those petitions where
APHIS has not completed a draft EA
and PPRA, APHIS will follow the new
process, i.e., the complete petition will
be published for a 60-day comment
period followed by later public
involvement regarding the EA and
PPRA. For those petitions where APHIS
has completed or is nearing completion
of a draft EA and PPRA, APHIS will
follow our previous process, i.e., the
petition, draft EA, and PPRA will be
made available in a single Federal
Register notice for a 60-day comment
period. APHIS will notify petitioners
which process their petition will follow
and will make this information available
at https://www.aphis.usda.gov/
biotechnology/pet_proc_imp.shtml.
These public participation process
changes are consistent with (1) 7 CFR
part 340, (2) the National Environmental
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
Policy Act (NEPA) of 1969, as amended
(42 U.S.C. 4321 et seq.), (3) regulations
of the Council on Environmental
Quality for implementing the
procedural provisions of NEPA (40 CFR
parts 1500–1508), (4) USDA regulations
implementing NEPA (7 CFR part 1b),
and (5) APHIS’ NEPA Implementing
Procedures (7 CFR part 372).
Authority: 7 U.S.C. 7701–7772 and 7781–
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
371.3.
Done in Washington, DC, this 29th day of
February 2012.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2012–5364 Filed 3–5–12; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2012–0005]
Notice of Availability of a Pest Risk
Analysis for the Importation of Litchi,
Longan, and Rambutan From the
Philippines Into the Continental United
States
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice of availability and
request for comments.
AGENCY:
We are advising the public
that we have prepared a pest risk
analysis that evaluates the risks
associated with the importation into the
continental United States of fresh litchi,
longan, and rambutan fruit from the
Philippines. Based on that analysis, we
believe that the application of one or
more designated phytosanitary
measures will be sufficient to mitigate
the risks of introducing or disseminating
plant pests or noxious weeds via the
importation of fresh fruit of litchi,
longan, and rambutan from the
Philippines. We are making the pest risk
analysis available to the public for
review and comment.
DATES: We will consider all comments
that we receive on or before May 7,
2012.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2012-00050001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2012–0005, Regulatory Analysis
and Development, PPD, APHIS, Station
SUMMARY:
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Notices]
[Pages 13258-13260]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5364]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2011-0129]
Biotechnology Regulatory Services; Changes Regarding the
Solicitation of Public Comment for Petitions for Determinations of
Nonregulated Status for Genetically Engineered Organisms
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service (APHIS) is implementing changes to the way it
solicits public comment when considering petitions for determinations
of nonregulated status for genetically engineered organisms to allow
for early public involvement in the process. Under the updated process,
APHIS will publish two separate notices in the Federal Register for
petitions for which APHIS prepares an environmental assessment. The
first notice will announce the availability of the petition, and the
second notice will announce the availability of APHIS' decisionmaking
documents. This change will provide two opportunities for public
involvement in the decisionmaking process.
FOR FURTHER INFORMATION CONTACT: Dr. T. Clint Nesbitt, Chief of Staff,
Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 851-3917, email:
Thomas.C.Nesbitt@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
Under the authority of the plant pest provisions of the Plant
Protection Act (7 U.S.C. 7701 et seq.), the regulations in 7 CFR part
340, ``Introduction of Organisms and Products Altered or Produced
Through Genetic Engineering Which Are Plant Pests or Which There Is
Reason to Believe Are Plant Pests,'' regulate, among other things, the
introduction (importation, interstate movement, or release into the
environment) of organisms and products altered or produced through
genetic
[[Page 13259]]
engineering that are plant pests or that there is reason to believe are
plant pests. Such genetically engineered (GE) organisms and products
are considered ``regulated articles.''
The regulations in Sec. 340.6(a) provide that any person may
submit a petition to the Animal and Plant Health Inspection Service
(APHIS) seeking a determination that an article should not be regulated
under 7 CFR part 340. Paragraph (d) provides that, for petitions that
meet the submission procedures, format, required data, and information
requirements in paragraphs (b) and (c), APHIS will publish a notice in
the Federal Register to inform the public that APHIS will accept
written comments regarding the petition for a period of 60 days from
the date of the notice.
As part of the USDA Customer Service Plan,\1\ which seeks to
improve the Agency's customer service processes, APHIS analyzed the
current petition process using Lean Six Sigma business process
techniques. Based on this analysis, APHIS is implementing changes to
improve our process for evaluating and responding to petitions for
determinations of nonregulated status. Changes include earlier
publication of the notice announcing the petition's availability in the
Federal Register, which will allow early public involvement in the
process, and changes to the way we currently solicit and use public
comment.\2\
---------------------------------------------------------------------------
\1\ For more information on the USDA Customer Service Plan, go
to https://www.usda.gov/open/Blog.nsf/dx/USDA-CSPlan.pdf/$file/USDA-
CSPlan.pdf.
\2\ For information regarding APHIS' analysis and other internal
process changes APHIS is making to our petition process, go to
https://www.aphis.usda.gov/biotechnology/pet_proc_imp.shtml.
---------------------------------------------------------------------------
Current Comment Process for Petitions for Determinations of
Nonregulated Status
Once APHIS deems a petition to be complete (i.e., the petition
meets all the submission procedures, format, required data, and
information requirements in Sec. 340.6(b) and (c)), APHIS, in most
instances, prepares a plant pest risk assessment (PPRA) and a draft
environmental assessment (EA). APHIS prepares a PPRA to assess the
plant pest risk of the article and an EA, in accordance with the
National Environmental Policy Act (NEPA), to provide the Agency with a
review and analysis of any potential environmental impacts associated
with the petition request. After the completion of these documents,
APHIS typically publishes a notice in the Federal Register announcing
the availability of the petition, PPRA, and draft EA for public
comment.
After the comment period closes, APHIS reviews all written comments
received during the comment period and any other relevant information.
After reviewing and evaluating the comments on the petition, draft EA,
PPRA, and other data, APHIS prepares a final EA, PPRA, and NEPA
decision document, which can be either a Finding of No Significant
Impact (FONSI) or notice of intent (NOI) to prepare an environmental
impact statement (EIS).\3\
---------------------------------------------------------------------------
\3\ If an EIS is determined to be necessary, APHIS completes the
NEPA EIS process in accordance with Council on Environmental Quality
regulations (40 CFR part 1500-1508) and APHIS' NEPA implementing
regulations (7 CFR part 372) and prepares a record of decision prior
to either approving or denying the petition.
---------------------------------------------------------------------------
If APHIS determines, based on the PPRA, that the regulated article
is unlikely to pose a plant pest risk and a FONSI is reached, APHIS
subsequently furnishes a response to the petitioner approving the
petition. APHIS also publishes a notice in the Federal Register
announcing the regulatory status of the GE organism and the
availability of APHIS' final EA, PPRA, FONSI, and regulatory
determination. Copies of these documents are made available as
indicated in the Federal Register notice.
Changes to the Comment Process for Petitions for Determinations of
Nonregulated Status
Under our updated process, APHIS intends to decide whether a
petition is complete within 3 months of its receipt. If APHIS deems
that a petition is not complete, APHIS will so inform the petitioner.
For petitions APHIS deems complete, APHIS will follow the process for
public involvement described below.
EA Comment Process for Petitions for Determinations of Nonregulated
Status
For complete petitions, APHIS will make the petition available for
public comment before preparing our EA and PPRA.\4\ APHIS will,
therefore, publish two separate notices in the Federal Register--a
notice announcing the availability of the petition, with an opportunity
for public comment, followed by a notice announcing the availability of
APHIS' EA and PPRA and an opportunity for public involvement on those
documents. This will provide two separate and specific opportunities
for public involvement in the decisionmaking process.
---------------------------------------------------------------------------
\4\ This notice describes our process for handling most
petitions for determinations of nonregulated status. APHIS may
decide that an EIS is necessary, either when we deem the petition to
be complete or at any time during the EA process, in which case
APHIS would complete the NEPA EIS process in accordance with Council
on Environmental Quality regulations and APHIS' NEPA implementing
regulations.
---------------------------------------------------------------------------
First Opportunity for Public Involvement
The first opportunity for public involvement will be a public
comment period on the petition itself, once it is deemed complete by
APHIS. APHIS will publish a notice in the Federal Register to inform
the public that APHIS will accept written comments regarding a petition
for a determination of nonregulated status for a period of 60 days from
the date of the notice. The comment period will provide the public with
an opportunity to raise any issues regarding the petition and will be
used by APHIS as a scoping opportunity to identify potential issues and
impacts that APHIS would then determine should be considered in our
evaluation of the petition.
Second Opportunity for Public Involvement
The second opportunity for public involvement will come with the
publication of a notice of availability for APHIS' EA and PPRA in the
Federal Register. This second notice will follow one of two approaches
for public participation based on whether or not APHIS decides the
petition for a determination of nonregulated status is for a GE
organism that raises substantive new issues.
Approach 1
This approach for public participation will be used when APHIS
decides, based on our review of the petition and our evaluation and
analysis of comments received from the public during the 60-day comment
period on the petition, that the petition involves a GE organism that
raises no substantive new issues. This would include instances, for
example, where APHIS decides that the petition involves gene
modifications that do not raise substantive new biological, cultural,
or ecological issues due to the nature of the modification or APHIS'
familiarity with the recipient organism.
Under this approach, APHIS will publish a notice in the Federal
Register announcing APHIS' preliminary regulatory determination and the
availability of APHIS' EA, FONSI, and PPRA for a 30-day public review.
Upon completion of the 30-day review period, APHIS will review and
evaluate any information received. If APHIS determines that no
substantive information has been received that
[[Page 13260]]
would warrant APHIS altering its preliminary regulatory determination
or FONSI, substantially changing the proposed action identified in the
EA, or substantially changing the analysis of impacts in the EA, our
preliminary regulatory determination will become final and effective
upon notification of the public through an announcement on our Web
site. APHIS will also furnish a response to the petitioner regarding
our final regulatory determination. No further Federal Register notice
will be published announcing the final regulatory determination.
Should APHIS determine that we have received substantive new
information within 30 days of publication of the Federal Register
notice that would warrant APHIS altering our preliminary regulatory
determination or FONSI, substantially changing the proposed action
identified in the EA, or substantially changing the analysis of impacts
in the EA, our preliminary determination will not become effective. In
this case, APHIS intends to notify the public through an announcement
on our Web site of our intent to conduct additional analysis. APHIS
will also inform the petitioner of our intent.
Based on the information APHIS received and our further analysis,
the Agency will prepare an amended EA, a new FONSI, and/or a revised
PPRA, as necessary. APHIS will then publish a notice in the Federal
Register announcing the availability of these documents for public
review and APHIS' preliminary regulatory determination. After reviewing
and evaluating any additional information received within 30 days of
publication of this Federal Register notice, our preliminary regulatory
determination will become final and effective upon notification of the
public through an announcement on our Web site. APHIS will also furnish
a response to the petitioner regarding our final regulatory
determination. No further Federal Register notice will be published
announcing the final regulatory determination.
Approach 2
A second approach for public participation will be used when APHIS
determines that the petition for a determination of nonregulated status
is for a GE organism that raises substantive new issues. This could
include petitions involving a recipient organism that has not
previously been determined by APHIS to have nonregulated status or when
APHIS determines that gene modifications raise substantive biological,
cultural, or ecological issues not previously analyzed by APHIS.
Substantive issues would be identified by APHIS based on our review of
the petition and our evaluation and analysis of comments received from
the public during the 60-day comment period on the petition.
Under this approach, APHIS will solicit written comments on a draft
EA and PPRA for 30 days through the publication of a Federal Register
notice. The draft EA and PPRA will be made available as indicated in
the Federal Register notice. Upon completion of the 30-day comment
period, APHIS will review and evaluate all written comments received
during the comment period and any other relevant information. After
reviewing and evaluating the comments on the draft EA and PPRA and
other information, APHIS will revise the PPRA as necessary and prepare
a final EA. Based on the final EA, APHIS will prepare a NEPA decision
document--either a FONSI or NOI to prepare an EIS. If a FONSI is
reached, APHIS will furnish a response to the petitioner, either
approving or denying the petition. APHIS will publish a notice in the
Federal Register announcing the regulatory status of the GE organism
and the availability of APHIS' final EA, PPRA, FONSI, and our
regulatory determination.
These changes to the public participation process are effective
March 6, 2012. All petitions for determinations of nonregulated status
for GE organisms received by APHIS on or after this date will be
handled using the new process for handling petitions described in this
notice. For petitions received before this date and currently under
consideration by APHIS, our ability to transition to the new process
will depend upon the current status of the petition. For those
petitions where APHIS has not completed a draft EA and PPRA, APHIS will
follow the new process, i.e., the complete petition will be published
for a 60-day comment period followed by later public involvement
regarding the EA and PPRA. For those petitions where APHIS has
completed or is nearing completion of a draft EA and PPRA, APHIS will
follow our previous process, i.e., the petition, draft EA, and PPRA
will be made available in a single Federal Register notice for a 60-day
comment period. APHIS will notify petitioners which process their
petition will follow and will make this information available at https://www.aphis.usda.gov/biotechnology/pet_proc_imp.shtml.
These public participation process changes are consistent with (1)
7 CFR part 340, (2) the National Environmental Policy Act (NEPA) of
1969, as amended (42 U.S.C. 4321 et seq.), (3) regulations of the
Council on Environmental Quality for implementing the procedural
provisions of NEPA (40 CFR parts 1500-1508), (4) USDA regulations
implementing NEPA (7 CFR part 1b), and (5) APHIS' NEPA Implementing
Procedures (7 CFR part 372).
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 29th day of February 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-5364 Filed 3-5-12; 8:45 am]
BILLING CODE 3410-34-P
