[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]
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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.
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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
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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\
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\1\ For more information on the USDA Customer Service Plan, go
to http://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
http://www.aphis.usda.gov/biotechnology/pet_proc_imp.shtml.
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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\
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\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.
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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.
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\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.
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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 http://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]
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